Tobacco Vol12 PDF

IARC HANDBOOKS OF CANCER PREVENTION
Vol 12: Methods for Evaluating Tobacco Control Policies

International Agency for Research on Cancer
World Health Organization
Volume 12
Methods for Evaluating

Tobacco Control Policies
IARC
ISBN 978 92 832 3012 0
2008
9 789283 230120
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IARC HANDBOOKS OF CANCER PREVENTION
Tobacco Control
IARC

World Health Organization
Volume 12
Methods for Evaluating

Tobacco Control Policies
IARC
2008
This Handbook was made

possible thanks to the
generous funding by the
Ministre de la Sant,
de la Jeunesse et des
Sports
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The International Agency for Research on Cancer (IARC) was established in 1965 by the World Health Assembly, as an
indepently financed organization within the framework of the World Health Organization. The headquarters of the Agency
are in Lyon, France.
The Agency conducts a programme of research concentrating particularly on the epidemiology of cancer and the
study of potential carcinogens in the human environment. Its field studies are supplemented by biological and chemical
research carried out in the Agencys laboratories in Lyon and, through collaborative research agreements, in national
research institutions in many countries. The Agency also conducts a programme for the education and training of
personnel for cancer research.
The publications of the Agency contribute to the dissemination of authoratative information on different aspects of
cancer research. Information about IARC publications, and how to order them, is available via the Internet at:
http://www.iarc.fr/.
This publication represents the views and opinions of an IARC Working Group on Methods for Evaluating Tobacco
Control Policies which met in Lyon, France, 12 - 19 March 2007.
Funding
The IARC Tobacco Control Handbook Volume 12 was funded by the Ministre de la Sant, de la Jeunesse
et des Sports, France.
iii
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IARC Handbooks of Cancer Prevention
Published by the International Agency for Research on Cancer,

150 cours Albert Thomas, 69372 Lyon Cedex 08, France
International Agency for Research on Cancer, 2008
Distributed by
WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 3264;
fax: +41 22 791 4857; email: bookorders@who.int).
Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol
2 of the Universal Copyright Convention. All rights reserved.
The designations employed and the presentation of the material in this publication do not imply the expression of any
opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any
country, territory, city, or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or
recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
The authors alone are responsible for the views expressed in this publication.
The International Agency for Research on Cancer welcomes requests for permission to reproduce or translate its
publications, in part or in full. Requests for permission to reproduce or translate IARC publications whether for sale
or for noncommercial distribution should be addressed to WHO Press, at the above address
(fax: +41 22 791 4806; email: permissions@who.int).
Format for bibliographic citation:
IARC Handbooks of Cancer Prevention, Tobacco Control, Vol. 12: Methods for Evaluating Tobacco Control Policies
(2008: Lyon, France).
IARC Library Cataloguing in Publication Data
Methods for evaluating tobacco control policies / IARC Working Group on Methods
for Evaluating Tobacco Control Policies, Lyon, France, International Agency for Research on Cancer, 2008
(IARC Handbooks of Cancer Prevention ; 12)
1. Health Policy 2. Neoplasms - prevention & control 3. Program Evluation

4. Smoking - prevention & control 5. Tobacco Industry - legislation and jurisprudence.
I. IARC Working Group on Methods for Evaluating Tobacco Control Policies II. Series
ISBN 978-92-832-3012-0 (NLM Classification QZ 39)

ISSN 1027-5622
iv
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Table of Contents
List of participants ....................................................vi

Chapter 5
Acknowledgements ..................................................viii Strategies for evaluating specific policy domains ....189
Section 5.1
Preface .....................................................................ix
Measures to assess the effectiveness of tobacco
taxation.....................................................................189
Chapter 1
Ensuring effective evaluation of tobacco control
Section 5.2
interventions ............................................................1
Measures to assess the effectiveness of
smoke-free policies ..................................................215
Chapter 2
General methods and common measures ...............33
Section 5.3
Section 2.1
product regulation ....................................................231
The importance of design in the evaluation of
tobacco control policies ...........................................33
Section 5.4
Measures to assess the effectiveness of
Section 2.2
restrictions on tobacco marketing communications ...259
Developing and assessing comparable questions in
cross-cultural survey research on tobacco...............59
Section 5.5
Chapter 3
product labelling policies ..........................................287
Outcomes and major determinants ..........................75
Section 5.6
Section 3.1
Measures to assess the impact of anti-tobacco
Measuring tobacco use behaviours .........................75
public communication campaigns ............................319
Section 3.2
Section 5.7
General mediators and moderators of tobacco
use behaviours.........................................................107
cessation interventions.............................................351
Section 3.3
Chapter 6
Measurement of nicotine dependence .....................123
Summary .................................................................367
Chapter 4
Chapter 7
Existing data sources ...............................................137
Recommendations ...................................................381
Section 4.1
References ...............................................................383
Data sources for monitoring tobacco control
policies .....................................................................137
Appendices ..............................................................413
Section 4.2
Working Procedures for the IARC Handbooks of
Using production, trade and sales data in tobacco
Tobacco Control .......................................................453
control ......................................................................153
Section 4.3
Data sources for monitoring global trends in
tobacco use behaviours ...........................................161
v
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LIST OF PARTICIPANTS
Ron Borland (Co-Chair) Carolyn Dresler (not attending) Prakash C. Gupta

Cancer Control Research Institute Tobacco Prevention and Cessation Healis-Sekhsaria Inst. for Public Health
The Cancer Council Victoria Program Plot No. 28, Sector 11
1 Rathdowne Street Arkansas Department of Health CBD Belalpur
Carlton, Victoria 3053 4815 W Markham St. 601/B Great Eastern Chambers
Australia PO Box 1437, Slot H-3 Navi Mumbai
Little Rock, AR 72203-1437 India
K. Michael Cummings (Co-Chair) USA
Department of Health Behaviour David Hammond
Roswell Park Cancer Institute Jean-Francois Etter Department of Health Studies and
Elm and Carlton Streets Faculte de Medecine Gerontology
Buffalo, NY 14263 Universite de Geneve University of Waterloo
USA 1 rue Michel-Servet 200 University Avenue West
CH-1211 Geneve 4 Waterloo, Ontario N2L 3G1
Timothy Baker (not attending) Switzerland Canada
Center for Tobacco Research and
Intervention Geoffrey T. Fong Gerard Hastings (not attending)
Univeristy of Wisconsin Medical School Ontario Institute for Cancer Research Centre for Tobacco Control Research
1930 Monroe Street, Suite 200 and Department of Psychology University of Stirling and the
Madison, WI 53711-2027 University of Waterloo Open University
USA 200 University Avenue West Stirling FK9 4LA
Waterloo, Ontario N2L 3G1 Scotland
Ursula Bauer Canada
Tobacco Control Program Andrew Hyland
New York State Department of Health Gary A. Giovino Department of Health Behaviour
ESP Corning Tower, Room 710 Department of Health Behavior Roswell Park Cancer Institute
Albany, NY 12237-0676 School of Public Health and Health Elm and Carlton Streets
USA Professions Buffalo, NY 14263
SUNY at Buffalo USA
Frank J. Chaloupka 622 kimball Tower
Economics, College of Business Buffalo, NY 14214-3079 Luk Joossens, (not attending)
Administration USA Belgian Foundation Against Cancer
Health Policy and Administration 479 Chausse de Louvain
University of Illinois at Chicago G. Emmanuel Guindon B-1030 Brussels
601 S. Morgan St, Room 2103 Centre for Health Economics Belgium
Chicago, IL 60607-7121 and Policy Analysis
USA Health Sciences Centre 3H1 area
McMaster University
1200 Main Street West
Hamilton, Ontario L8N 3Z5
Canada
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List of Participants
Alan Lopez, (not attending) Megan E. Piper Martina Potschke-Langer

The University of Queensland Center for Tobacco Research & Cancer Prevention and WHO
Herston Road Intervention Collaborating Center for Tobacco
Herston Qld 4006 University of Wisconsin Control
Australia Medical School Deutsches Krebsforschungszentrum
1930 Monroe St., Suite 200 Im Neuenheimer Feld 280 D-69120
Anne Marie MacKintosh (not Madison, WI 53711-2027 Heidelberg
attending) USA Germany
Institute for Social Marketing
University of Stirling and the Open James F. Thrasher IARC Secretariat
University Health Promotion, Education and Andrea Altieri
Stirling FK9 4LA Behavior Robert Baan
Scotland School of Public Health Julien Berthiller
University of South Carolina Paolo Boffetta (Group Head)
Ann McNeill 800 Sumter Street, Room # 215 Lars Egevad
Division of Epidemiology & Public Columbia, SC 29208 Fabrizio Giannandrea (Post-Meeting)
Health USA; and Julia Heck
University of Nottingham Instituto Nacional de Salud Pblica, Mara E. Len (Responsible Officer)
Clinical Sciences Building Cuernavaca, Beatrice Secretan
Notthingham NG5 1BP Mexico Kurt Straif
UK
Charles (Wick) Warren Administrative assistance
Mark Parascandola Office on Smoking and Health Catherine Benard (Secretarial)
Tobacco Control Research Branch Centers for Disease Control and Latifa Bouanzi (Library)
National Cancer Institute Prevention John Daniel (Editor)
6130 Executive Blvd. MSC 7337 4770 Buford Highway, NE Jennifer Donaldson (Editor)
Bethesda, MD 20892 Atlanta, GA 30341-3717 Roland Dray (Graphics)
USA USA Sharon Grant (Library)
Georges Mollon (Photography)
Armando Peruga Representatives Sylvia Moutinho (Secretarial)
Tobacco Free Initiative Nathan Jones Annick Rivoire (Secretarial)
World Health Organization Office on Smoking and Health Josephine Thevenoux (Layout)
Geneva Global Tobacco Control Program
Switzerland Centers for Disease Control and
Prevention
Patrick Petit 4770 Buford Highway, NE
Tobacco Free Initiative Atlanta, GA 30341-3717
World Health Organization USA
Geneva
Switzerland
vii
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Acknowledgements
The Working Group acknowledges the major contribution to the work presented in this Handbook by
Mary E. Thompson (University of Waterloo, Waterloo, Ontario, Canada), Daniel M. Bolt (University of
Wisconsin, Madison, Wisconsin, USA), Matthew C. Farrelly (RTI International, Research Triangle Park,
North Carolina, USA), Timothy P. Johnson (University of Illinois, Chicago, Illinois, USA) and Karl E.
Wende and Jennifer L. Graf (University of Buffalo, Buffalo, New York, USA).
The IARC secretariat is grateful to the staff of the Libraries at the International Agency for Research on
Cancer, Lyon, France and the World Health Organization, Geneva, Switzerland.
viii
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Preface
The IARC Handbooks on Cancer been covered in the Handbooks. through the Framework Conven-
Prevention have traditionally However, we know from tion on Tobacco Control (WHO
presented the scientific evidence numerous publications that one FCTC). The WHO FCTC
on the effects of interventions, way of inducing quitting in a encompasses a range of
such as sun protection or dietary proportion of the population of measures, in their totality
chemoprevention, on preventing smokers is through policy representing a comprehensive
cancer, as well as the evaluation measures, implemented by local, approach designed to control
of the strength of the evidence in regional, and/or national govern- tobacco use and supply. The body
addressing the alleged protective ments, intended to reduce both of policies stipulated in the WHO
effect. the number of smokers and the FCTC treaty became binding
In Volume 11, the first amount smoked in persistent international law on February 27,
dedicated to tobacco control, the users (e.g. by increasing the cost 2005. Of the 38 articles, articles 6
effects of smoking cessation on of tobacco products through the to 14 cover policy interventions
the risk of developing or dying of use of pricing and taxation directed at preventing tobacco
cancer, cardiovascular diseases, policies). Interventions, which use, decreasing consumption,
or chronic obstructive pulmonary have been implemented at the reducing toxicity, protecting non-
disease were examined. In that individual and societal level to smokers, and diminishing tobacco
volume, the health benefits of control the use of tobacco and use initiation. Articles 15 to 17
quitting smoking were investigated concomitant health effects, have relate to measures controlling the
by comparing epidemiological been adopted at different paces availability of tobacco (WHO,
studies reporting the risk of and with varying degrees of 2003). In other words, the policies
disease in never, former, and comprehensiveness in countries are a series of measures
current smokers, as well as around the world, generating an conceived to counteract multiple
differences in risk with length of irregular response to the tobacco domains of tobacco availability
smoking abstinence, when epidemic. These interventions and use. The joint observance of
available. An evaluation of the have included, to list a few, total or the treaty by countries around the
weight of the evidence was given partial bans on smoking in work world will make it a global
for each disease contemplated. and public places; suppression of response to the tobacco epidemic.
For IARC, Volume 11 was tobacco advertising, promotion, However, the reach of the policy
exceptional in including disease and sponsorship; anti-tobacco interventions included in the WHO
outcomes other than cancer. education and communication FCTC will depend on how
Given the prominent etiologic campaigns to raise awareness; effectively countries formulate and
position of smoking in other changes to tobacco product implement these policies. As of
disease outcomes, limiting the labeling; and smoking cessation November 7, 2008, 161 countries
review to cancer would have given services. have become parties to the treaty
a partial picture of the benefits A global, coordinated effort to (http://www.who.int/tobacco/frame
derived from quitting smoking. use legislation and associated work/en/index.html; accessed
How individuals overcome the programmes to arrest the tobacco November 10, 2008).
smoking habit to achieve use epidemic is now led by the The FCTC has propelled
sustained abstinence has not World Health Organization tobacco control into a new era, as
ix
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countries all over the world policy works, the potential effectiveness of policies on
incorporate its policies and moderator variables to consider tobacco taxation, smoke-free
recommendations into their own when evaluating a given policy, environments, tobacco product
laws. As tobacco control policies and the data sources that might be regulations, limits on tobacco
are formulated and implemented, useful for evaluation. marketing communications, pro-
it is important that they undergo The working group proposed a duct labeling, anti-tobacco public
rigorous evaluation. In the same common conceptual framework to communication campaigns, and
way that evidence-based guide future FCTC policy tobacco use cessation inter-
medicine has been built from evaluation, specifying two levels of ventions. Additionally, it provides
thorough evaluation of treatment mediating variables: those specific examples of measures used to
options, evidence-based public to the policy, and those that are assess key constructs, with
health must build on a database of part of more general pathways to special attention to measurement
rigorous evaluations of public the outcomes of interest. It also issues with survey methods. Also
health policies. Such knowledge accepted that various other factors provided are descriptions of
will allow implementation of the (moderators) might affect the size sources of data on tobacco control
most powerful policy interventions, of the effect, and recognized the policies, tobacco production and
and will do so in ways that will possibility of effects incidental to trade, and repositories of youth
maximize their effectiveness. those an intervention is designed and adult surveillance surveys.
Towards this goal, IARC to produce. Given the already These sources of information are
convened a working group of well-established relationship particularly important for making
international tobacco control between tobacco use and comparisons between countries,
experts from March 12-19, 2007 to disease, and the lag time between and in some cases can be used to
propose a framework for guiding reductions in tobacco use demonstrate the impact of
the evaluation of tobacco control prevalence and observed reduc- policies, although not the
policies expected to be formulated tions in disease outcomes, this mechanisms by which they occur.
worldwide in response to WHO Handbook (V Volume 12) recom- Thus, Volume 12 is offered as a
FCTC. Four broad questions were mends that tobacco use be guide to evaluators in the field,
considered by the working group, utilized as the appropriate and consequently a frame for
each with several more specific endpoint for most policy future IARC Handbooks that focus
related sub-questions, to guide the evaluations. The group elaborated on evaluating the impacts of
review of the scientific literature on on the model most completely for societal level interventions to
the methods and measures of tobacco use outcomes, but it was control cancer, and other
tobacco policy evaluation. The also applied to policies affecting preventable diseases, caused by
broad questions cover how the product harmfulness. tobacco use.
effects of a policy are determined, Included in this Handbook are
the core constructs for under- logic models outlining relevant
standing how and why a given constructs for evaluating the
x
CHAPITRE1.janvier12:Layout 1 12/01/2009 13:29 Page 1
Chapter 1
Ensuring effective evaluation of tobacco control
interventions
Introduction to the disseminated programmes of Lopez, 2003). If current trends

non-governmental agencies. continue, it will cause some 10
This volume is concerned with This chapter provides an million deaths each year by 2030,
methods for evaluating the evidence introduction to the importance of with around 70% in low-resource
for the effects of policy initiatives. By having well-evaluated, population- countries (Peto & Lopez, 2001;
policies we mean the enacted level tobacco control interventions Ezzati & Lopez, 2004). This
decisions of governments and their and of having a framework for projected shift is due, in part, to
consequences on the environment achieving them. It outlines criteria increasing population size and
(legal, social and physical) in which used to evaluate constructs and increased smoking in low-resource
tobacco use takes place or on measures, and how these relate to countries, but it is also partly due to
tobacco use directly; that is, specific strategies for most effectively greater success in controlling
instances of the policys mani- gathering information to evaluate smoking in many higher-resource
festations (interventions). This the effectiveness of interventions, countries. In the 21st century, if
means evaluating the effects of the mechanisms by which they current usage patterns persist,
laws, regulations, taxes, admin- work, and the conditions that smoking will cause approximately
istrative decisions, programmes and moderate their effects. 1000 million deaths, a tenfold
efforts to publicise or disseminate Cigarette smoking is not only the increase over the previous century
discrete interventions such as most prevalent form of tobacco use, (Gajalakshmi et al., 2000). A
smoking cessation aids. It includes it is also among the most harmful, substantial fraction of these
evaluation of policies that have the as it kills one in two long term users expected deaths could be averted
explicit goal of tobacco control, as prematurely. In the 20th century, by efforts to discourage tobacco use
well as policies that affect tobacco cigarette smoking caused an and to assist those addicted to
use incidentally, although our focus estimated 100 million deaths tobacco to quit (IARC, 2007a).
is primarily on the former. The worldwide. Most of these deaths Most countries have ratified the
Working Group (WG) is primarily were in developed countries of the World Health Organizations (WHO)
interested in evaluating inter- world where cigarette smoking first Framework Convention for Tobacco
ventions that are designed to have became popular in the 1920s to Control (FCTC). It is the first piece
effects at a population level, 1940s. This resulted in an epidemic of international law emanating from
especially those enacted at a of smoking-induced cancer, heart the WHO. Its objective is:
national level, but the principles disease, and chronic obstructive
apply to many subnational- and pulmonary disease (COPD) deaths. to protect present and future
even local-level policies. While the In 2000, tobacco use was generations from the devastating
focus of the WG is on how to assess responsible for approximately 4.83 health, social, environmental and
policy consequences of govern- million deaths, evenly divided economic consequences of tobacco
ments, the evaluation framework we between the industrialised and non- consumption and exposure to
have developed could equally apply industrialised worlds (Ezzati & tobacco smoke by providing a
1
framework for tobacco control Technical Cooperation and Com- designed to reduce tobacco use.
measures to be implemented by munication of Information spells These will include but not be
the Parties at the national, regional out a framework for research, restricted to those mandated or
and international levels in order to surveillance and technical coop- recommended by the Convention.
reduce continually and substantially eration to facilitate the achieve- Ensuring the right mix of policies
the prevalence of tobacco use and ment of the policy goals. requires an understanding of the
exposure to tobacco smoke. Article 20, Research, surveil- determinants of tobacco use and
(Article 3) (WHO, 2003). lance and exchange of informa- of how tobacco harms health.
tion, calls for The parties [to] Tobacco use is determined by
To achieve this objective, the undertake to develop and promote multiple factors, and attempts to
WHO FCTC calls for a national research and to coordi- control the epidemic require
comprehensive range of nate research programmes at the changes in societies as well as
measures, specifically: regional and international levels in individuals (see Figure 1.1).
Price and tax measures to the field of tobacco control. The Analysis of the factors that
reduce demand (Article 6) article, among other things, calls influence tobacco use should
Protection from exposure to for the development and promo- encompass smokers, those
tobacco smoke (Article 8) tion of national research efforts, vulnerable to uptake, tobacco
Regulation of the contents of national systems of surveillance of products, those who produce and
tobacco products (Article 9) tobacco consumption and related sell tobacco products, and
Regulation of tobacco product social, economic and health indi- governments who determine the
disclosures (Article 10) cators; coordination of activities so parameters of use. The role of
Controls on packaging and that data can be compared across cultural and economic diversity
labelling of tobacco products countries; exchange of publicly should also be considered.
(Article 11) available scientific, technical, Further, we need to understand
Programmes of education, socio-economic, commercial and how both the determinants of use
communication, training and legal information, as well as infor- and actual use and/or exposures
public awareness (Article 12) mation regarding practices of the are affected by interventions.
Bans on tobacco advertising, tobacco industry; and that the fi- Policies and the disseminated
promotion and sponsorship nancial and institutional resources programmes that result from pol-
(Article 13) be put in place to allow this to hap- icy decisions are of particular in-
Programmes to promote and pen. terest because of their potential to
assist tobacco cessation and Article 22, Cooperation in the affect large numbers of people, in
prevent and treat tobacco scientific, technical, and legal some cases entire populations. As
dependence (Article 14) fields and provision of related a result, it is important to be able
Elimination of illicit trade in expertise, expands on Article 20 to show that they achieve their ob-
tobacco products (Article 15) with regard to such things as jectives and do so in a cost-effec-
Measures to prevent sale of providing developing countries tive way, with any incidental
and promotion of tobacco to with technical and material effects ideally having net benefits.
young people (Article 16) support and training, and Evaluation allows the most effec-
Provision of support for identifying methods for tobacco tive interventions to be maintained
alternative crops to tobacco control, including comprehensive (and perhaps improved further)
(Article 17) treatment for nicotine addiction. while less effective interventions
The WHO FCTC will likely are either improved or aban-
In addition, Part VII of the result in the proliferation of policies doned.
WHO FCTC, on Scientific and and associated programmes
2
Ensuring effective evaluation of tobacco control interventions
Environment: Physical, institutional, communication, policy, legal, scientific,

cultural, social & inter-personal
Tobacco Cues Tobacco

marketing Use Control
Tobacco People: Awareness, appraisals, Host

industry experiences, habits, values, Biology
control expectancies, choices,etc
Tobacco
products Tobacco use
Active and passive exposures Socio-economic effects
Health outcomes
Figure 1.1 Major influences on tobacco use and its consequences

Used with permission of Ron Borland
Tobacco and health products cause should consider mouth lining or stomach because
the composition of what is the lungs are more sensitive. The
The amount of harm created by ingested and how the products are evidence that exclusive cigar or
tobacco use in a given population designed to be used. Thus for pipe smokers have notably less
is a function of the toxicity of the combusted tobacco products, the health risk than cigarette smokers
products, the site(s) of exposure, focus needs to be on the smoke, (Doll, 2004) is probably because
the toxins taken in, the period over rather than on the unburned these smokers tend to only take
which exposures occur, and the product, although the composition the smoke into their mouths.
distribution of those exposures in of the unburned product is Decades of research on the
the population (IARC, 2004, relevant to the extent that it health effects of tobacco have
2007b). The harms from tobacco influences the composition and/or identified numerous diseases
use are mainly from long-term density of the smoke. Mode of causally related to tobacco use,
use, which is made more likely by ingestion is often ignored; including several sites of cancer
the addictive nature of the however, some chemicals are (including lung, oral cavity, esoph-
product. Calculation of the more toxic when absorbed agus, larynx, stomach and pan-
potential harms that tobacco through the lungs than through the creas), major vascular diseases
3
(including ischemic heart disease, witz, 1999). Most of the harm is due the toxin-reduced forms) can
peripheral vascular disease and to other constituents in tobacco and reduce harm, but does not
cerebrovascular disease), major tobacco smoke (IARC, 2004). Thus eliminate it (Critchley & Unal,
respiratory diseases (including nicotine only indirectly contributes to 2003; Foulds et al., 2003; Roth et
chronic obstructive pulmonary dis- most of the harms, by leading to al., 2005; Henley et al., 2007).
ease, tuberculosis, and pneumo- prolonged use of dirty delivery Reducing or eliminating smoked
nia), reproductive effects and systems, especially cigarettes. tobacco use is a higher priority for
reduced bone health. Epidemio- The epidemiology is clear. The health than reducing smokeless
logical methods have been ap- health risks of smoking are far tobacco use. Research is needed
plied to estimate how much of greater than those associated with to determine whether smokeless
these diseases in different popu- smokeless tobacco use. The tobacco might play a role in this or
lations with different tobacco use health risk of each kind of whether nicotine replacement
histories is due to tobacco (Peto et smokeless tobacco varies signi- products and other cessation aids
al., 1992). ficantly as a function of their are all that is needed.
While prolonged exposures are toxicity. For smoked products, the
responsible for most fatal likely variability in toxicity does not Patterns of tobacco use
consequences of tobacco use, seem to translate into clear
there is increasing evidence of differences in health risks. To date, Tobacco is a plant containing the
adverse short-term effects, seen cigarettes with levels of toxins psychoactive and addictive drug
most clearly in the rapidly reduced by enough to be plausibly nicotine. It has a long history of
reversible impacts of passive less harmful are not used by use and has been used in a wide
smoke exposures on nonsmokers, so are irrelevant to variety of forms. The two main
smokers (Raitakari et al., 1999; tobacco control efforts. forms of tobacco use are by smok-
Wong et al., 1999; Wakefield et Some harms, particularly minor ing and by chewing or parking
al., 2003a). There is no safe level harms and those related to wads of tobacco in the mouth and
of exposure to tobacco smoke. cardiovascular disease, are allowing the active ingredients to
Risks of cardiovascular problems reversible on quitting smoking. be absorbed (smokeless use). In
are largely reversible, and effects While quitting can improve health, the 20th century, the use of ciga-
seem to asymptote at lower doses cutting down on consumption does rettes came to dominate both the
than those related to cancers and not seem to (Hecht et al., 2004; smoked and overall markets in
chronic lung conditions (e.g. Tverdal & Bjartveit, 2006). This nearly all countries. It is also the
emphysema), where the dose- may be in part because, for some product that has been the focus of
response curve is more linear illnesses much of the harm occurs most of the research. In most
across typical exposure patterns at relatively small doses, and partly countries factory-made cigarettes
(Law & Wald, 2003; Pechacek & because smokers who reduce the dominate the market; however
Babb, 2004). The addictive nature number of cigarettes they smoke, roll your own cigarettes have en-
of tobacco makes it likely that often smoke the remaining joyed a resurgence in some coun-
people who begin to use it will not cigarettes harder, ingesting more tries. In other countries, most
be able to stop before the negative toxins per cigarette, thus reducing notably India, people consume a
effects associated with long-term or eliminating the potential benefits diverse range of tobacco prod-
harm start to occur. of smoking less (National Cancer ucts, both smoked and smoke-
Nicotine is the main psycho- Institute, 2001). There has been less. Among smoked products,
active ingredient of tobacco and the some success in reducing the the bidi (tobacco hand-rolled in a
source of its addictiveness, but is toxicity of smokeless tobacco leaf) is the predominant form used
otherwise a minor contributor to the products. Changing from smoked in the Indian sub-continent. Use of
harm (Murray et al., 1996; Beno- to smokeless products (particularly water pipes is common, particu-
4
larly in the Middle East. Cigars oc- The experience of countries like The most comprehensive
cupy a position as a luxury to- Singapore and Thailand, which change in tobacco control has
bacco product, but use is have so far successfully prevented been in attitudes and rules about
generally low. All forms of female uptake, suggest that the smoking in enclosed public places
smoked tobacco are extremely Lopez et al. model does not de- and workplaces. As late as 20
dangerous to health, and there scribe a necessary progression, but years ago, smoking was
has been no major progress to- that the epidemic may be able to be effectively ubiquitous in most
wards creating less toxic versions largely averted in some sub-popu- countries, with smoking allowed
of these products that are suffi- lations, most notably women, when virtually everywhere (except
ciently acceptable to consumers to effective tobacco control policies where there was a danger of fires
be successfully marketed. are implemented. or damage to equipment). In some
Smokeless tobacco is not used in Over the last 2030 years, countries, this environment has
many parts of the world, but use is smoking prevalence has fallen transformed; several countries
significant in other parts, with the markedly in some countries. This (starting with Ireland and Norway)
products used ranging widely in is well documented for some in- now prohibit smoking in all public
places like India (e.g. gutka, use dustrialised countries (Gilmore, places and workplaces, and other
with betel quid, nicotine tooth- 2000; Giovino, 2002; White et al., countries are following rapidly.
paste), but is limited to one main 2003). One country, Bhutan, has The social acceptance of
form in others (e.g. snuff (pow- banned the sale of tobacco prod- smoking is declining in most places
dered tobacco) either in loose or ucts to its citizens. However, in where it has been studied. This
prepackaged, small tea-bag-like some other countries, rates of to- decline seems to be related to the
portions). Use of smokeless tobacco use may have increased. length of time the society has taken
bacco is increasing in some places The great diversity both between to regard the problem as serious,
(e.g. Sweden) (Foulds et al., 2003). countries and within countries and to progress in the imple-
Non-cigarette tobacco use is over time creates huge challenges mentation of smoke-free places. In
under-researched in comparison to and opportunities for scientific un- Thailand, for example, equivalent
cigarette use. derstanding. One challenge, for levels of smokers see their habit as
The proportion of the population example, concerns preventing non-normative (i.e., that society
who use tobacco varies greatly women from smoking in societies disapproves) as in Western
from around 20% to around 60% where few currently smoke. This countries such as Australia,
(Shafey et al., 2003). In many coun- challenge needs to be taken up in Canada, the UK and the USA, all
tries, few women smoke, often ac- ways that are not contrary to the of which have decades of strong
companied by high smoking rates greater emancipation of women in action. By contrast, even though
in males (e.g. in Asia). By contrast, those societies. In developed personal disapproval of smoking is
in most developed countries female countries, e.g. in North America high in neighbouring Malaysia,
smoking rates are typically only a and Western Europe, the tobacco which has only recently taken up the
few percentage points below that of industry skilfully used female issue systematically, smokers are
males. There has been some pre- emancipation as a strategy for far less likely to perceive societal
dictability in these patterns of use, linking smoking to images of the disapproval (ITC South East Asia
leading to Lopez, Collishaw & modern woman. The slogan project, unpublished data).
Pihas (1994) four-stage model of Youve come a long way baby However, it is not just trends in
the tobacco epidemic, with devel- from the notoriously successful tobacco use and tobacco-related
oped countries first to experience it. Virginia Slims advertising cam- knowledge that are likely to affect
In this model, female smoking ini- paign typifies this strategy (US efforts to control tobacco use.
tially lags behind male smoking, Department of Health and Human Broader societal issues may also
with female rates eventually rising. Services, 2001). play a key role. The rapid
5
emergence of China and other beyond the scope of this volume to potency and their timing (see
countries as economic power- speculate as to what these effects Figure 1.2). While the under-
houses is likely to affect tobacco might be. However, unless efforts standing of their potency is focal to
use, at least in those countries, as are made to understand how this volume, it needs to be
more and more people have tobacco control fits into broader remembered that the sooner
money to spend on consumer social changes that are sweeping action is taken, the more lives will
products like tobacco that are the world, important determinants be saved. Every year of delay
marketed to appeal to modern of use may be missed, with the adds millions to the eventual
sensibilities. Worldwide concerns resultant reduction in the capacity burden of lives lost. Enough is
about the environment, including to identify and implement policies known to act in a comprehensive
the issue of global warming, and and programmes that work. manner now. The evaluation effort
the rise of religious funda- In thinking about the potential is primarily about helping us refine
mentalism in some countries are health benefits of interventions, it those interventions, to ensure they
also likely to have effects, but it is is important to consider both their are delivered in ways that
maximise their effects, and only
secondarily, to the development of
new more effective interventions.
Where does th is volume f it

within Tobacco Control?
This Handbook is not intended to

be a one-stop resource for all
tobacco control evaluation needs.
It is designed to present a
framework for evaluation directed
at policy effects and to provide
strategies and measures that are
specific to tobacco control, rather
than try to replicate material that is
general to all forms of evaluation.
In analysing the potential
contribution of research to policy
evaluation, it is useful to outline
the various roles it can play.
Impact of policies depends on factors including: Applied science proceeds through
- Intervention date a series of iterative stages once a
- Effect size problem has been identified (in
this case tobacco as a cause of
Figure 1.2 Projected impact of population-level tobacco control health harm): elaboration of a
interventions on estimated cumulative tobacco deaths theory or theories as to the cause
Estimated cumulative tobacco deaths 1950-2050 showing the effects of of the problem and of possible
different intervention strategies. In red baseline, in blue if proportion of young solutions, observation and des-
adults taking up smoking halves by 2020 and in green, if adult consumption cription of the problem informed
halves by 2020 by the theory, understanding
Adapted from Jha & Chaloupka (1999), The World Bank
causal mechanisms, intervention
6
development, intervention deploy- cochrane.org, for reviews) pro- 1. A research design

ment and evaluation, and vides regularly updated reviews of 2. The choice of constructs and
re-evaluation of the problem. From evidence in these areas. How- measures to assess them
this, there might be the need for ever, we are concerned with the (predictors and outcomes)
new or revised solutions, which evaluation of effects of these in- 3. A sampling strategy
may require refinement of the terventions when applied to popu- 4. Study implementation
theory or development of a new lations. 5. Data analysis
one. Research can play a number The focus of this volume is the Of these, we only focus on the
of important roles in the process of evaluation of tobacco control poli- first two, although some attention
developing and disseminating the cies in the short to medium term. is given to issues of sampling,
most effective policy interventions. We concluded that for policies di- particularly of the value of having
It can be used to: rected at tobacco use, tobacco representative samples as a core
use was the outcome of interest, part of the research design. We do
1. help in the development of new rather than on the subsequent not consider data analysis as the
interventions; health effects. Clearly, as we tools here are largely generic and
2. help make the case for an move forward, we will want to are covered in the main computer
intervention being adopted; evaluate the summative effects of analysis packages, including the
3. fine-tune an intervention before all the efforts to reduce tobacco emerging techniques of GEE
implementation to meet local use, and the consequential health models (Generalized Estimating
needs (formative evaluation); outcomes. For a few jurisdictions Equations) (Hanley et al., 2003).
4. document the quality of that have had active tobacco con- This Handbook was not written
implementation (process evalu- trol programmes for decades, this with the needs of those conducting
ation); process is already underway evaluations at a community level in
5. assess the effectiveness of (Thun & Jemal, 2006). However, mind. However, much within it is
component parts, or of the the reality is that for most coun- likely to be relevant, at least at a
intervention under ideal cir- tries, we will never know exactly conceptual level. The cumulative
cumstances; how many tobacco-caused deaths approach adopted means that for
6. evaluate the effects of the are being averted, because there evaluations of interventions that
intervention as implemented, is insufficient data on how many have been shown to be effective in
both intended and incidental; such deaths are currently occur- comparable situations, the need
7. determine the cost-effective- ring. The global estimates referred for intense evaluation will be less,
ness of the intervention; and to earlier are a result of careful ex- as the evaluation can rely on
8. assess the cumulative effects trapolation from those countries indicators validated in previous
of changes in outcomes on where good data is available and work. However, for novel inter-
health. from studies that have been able ventions, the more powerful
Of these, only number 6 is of to estimate the fraction of deaths methods outlined here should still
focal interest here. All of the oth- from various causes that are due be used wherever the resources
ers are important, but to have cov- to tobacco. The methods for doing allow. The US Centers for Disease
ered them all would have made this are beyond our remit, as are Control (CDC) has published a
the volume too broad and too ways to model the potential im- useful guide to the evaluation of
long. We also do not consider pacts of interventions on smoking more local programmes (Mac-
evaluation of the efficacy of dis- prevalence or on the burden of Donald et al., 2001). A major
crete interventions that can readily disease (e.g. Levy et al., 2006). difference between that guide and
be tested in randomised trials; e.g. The typical evaluation research the present volume is the capacity
smoking cessation aids. The study can be thought of as having to use national surveys and data
Cochrane Collaboration (www. five components: collections in ways that are not
7
usually possible for local initiatives. weak, and there exists the poten- In the broad area of tobacco
That said, to evaluate local tial for poorly thought-through pro- industry control, there is some
initiatives country-level data can grammes to actually be consideration of illicit trade in the
be used as a control, with counterproductive. Most of the re- section on sources of production
complementary data collected search on the effects of prevention and trade (Section 4.2) and in the
from the community to assess the programmes in schools is from in- section on tax policies (Section
intervention effects. dustrialised countries. School pro- 5.1). Neglected areas include
grammes are plausibly of more restrictions on the number or type
Policy areas not importance in non-industrialised of outlets in which products are
emphasised in this volume countries, where school is a con- sold. There are few examples of
duit for new knowledge into the attempts to restrict the number or
There are a number of tobacco community in a way it no longer is type of outlet selling tobacco.
control policy domains that are in industrialised countries. The dif- However, it seems inevitable that
either not included, or not ficulty of developing successful in the future some jurisdictions will
emphasised. This is not because prevention education comes at try to restrict access to all
the WG believes that they are not least in part from the problem that smokers, not just youth.
important, but because it sought to raising the issue engenders inter- We also do not address the
keep the size of the volume est and thus curiosity about the evaluation of policies that restrict
manageable. Policy domains not products. Doing this in a way that for-profit companies from opera-
focussed on include some that are overcomes the potential threat of ting in the market. Some countries
designed to affect tobacco use curiosity leading to increased ex- have actual or virtual state
directly, such as sales to minors, perimentation, and that has a net monopolies on the sale or
restrictions on sales outlets, and negative effect on use, has proven production of tobacco products.
school-based prevention. Others difficult. This may explain the in- Several countries have been
are directed more at the tobacco terest of some tobacco companies forced to abandon these mono-
industry, or parts of it, and include in promoting such strategies. To polies by the World Trade
prevention of illicit trade, industry the extent that educational pro- Organisation. It has been argued
subsidisation, controls on access grammes are translated into the that non-profit control of the
of for-profit companies into the mass media, strategies for evalu- industry should make tobacco
market (and the role of ating them are covered in Section control efforts easier (Borland,
government monopolies), and 5.6 on Measuring the Impact of 2003), but there is little work
agricultural policies that affect leaf Anti-Tobacco Public Communica- evaluating either the move to free
production. tion Campaigns. markets or the potential of
The most significant area we Another prevention strategy we restricting the markets. In both
have not focussed attention on in do not address the evaluation of is these areas, research is needed
the volume is the lack of detailed policies to prohibit sales of tobacco to evaluate possible options and
attention to population-level pre- products to minors, and to enforce to estimate likely effects.
vention policies. There is a large these laws by using young people
body of evidence on the effective- attempting purchases. Such A critique of current
ness of school-based education programmes can result in a approaches to evaluation
programmes (Thomas & Perera, decline in the proportion of such
2006). The current evidence shows attempts that result in sales, but To achieve maximally effective
that, taken in isolation of other soci- the evidence that this actually tobacco control requires the
etal efforts, the impact of school- reduces youth smoking is not development and ongoing
based programmes is generally strong (Stead & Lancaster, 2000). refinement of a viable set of
8
methods for integrating research the population for a number of separately: the questions of effi-
and evaluation in the imple- related reasons. First, imple- cacy, effectiveness, and dissemi-
mentation of tobacco control mented policies cannot be nation (Flay et al., 2005). First is
interventions. The population randomised and analogue the efficacy question: Can this
health challenge is to use scientific studies, where randomisation can intervention work? That is, when
methods to ensure that systems occur, may lack critical elements implemented in a controlled and
are set up to understand the of policy interventions (e.g. optimal way, does it work? Here
effects of the policy initiatives in authority of law, or it being applied the double-blinded randomised
such a way as to allow their to all in the community). Second, controlled trial (RCT) is the gold
evolution into the most effective over-reliance on RCTs, which standard, where possible. Second
ways of controlling the epidemic of focus on the detection of is the question of effectiveness:
tobacco use and related harms. intervention effects, can lead to a does it actually work when
Evaluation researchers in tobacco neglect of theory, which is critical implemented under real-world
control, like professionals in other for generalising from results to conditions, and with what degree
areas of population health, have related areas, and for of variation? Third is the question
been concerned for some time understanding the mechanisms of dissemination: Is the inter-
about limitations in the evaluation by which interventions work. vention used by enough of the
framework used. Third, RCTs are not able to population who would benefit from
The current dominant model of answer questions about the it to have an impact? An effective
intervention evaluation for im- relative effectiveness of inter- intervention that few are prepared
proving population health involves ventions across different to offer or few are prepared to use
extrapolation from the use of populations. Fourthly, when RCTs is of little benefit. One must also
randomised controlled trials are compromised, in terms of consider the extent to which the
(RCTs) of clinical (most typically, deviation from the double-blinded intervention is similarly attractive
pharmaceutical) therapies. It is ideal, they are less powerful, and for all with the problem. When only
based on the desire to identify the may be less strong than a subset of the population
active therapeutic agent or agents alternative methods with different benefits, any barriers to selective
within any intervention. This validity limitations. Finally, focus- adoption or influence should be
model is important and extremely sing on RCTs to provide answers examined. As we move from
successful for testing the efficacy to questions can result in a addressing questions of efficacy,
and often effectiveness of discrete neglect of other evaluation through effectiveness, to dissemi-
interventions offered at the techniques, which although not as nation issues, it becomes
individual (and even small group) inferentially strong as RCTs, may increasingly difficult to fit the
levels, particularly where double have complementary strengths. It conditions for RCTs, even for
blinding is possible. This is where is important to understand the clinical interventions.
neither researcher nor participant conditions under which RCTs are RCTs involve a number of
know who is getting the thera- limited and what the implications (usually implicit) assumptions.
peutic agent under evaluation and are for inference. First, RCTs assume that the
who is getting either a placebo or measurement required for the
the existing best-practice inter- Limitations of RCTs evaluation does not affect the
vention. RCTs produce consi- integrity of the intervention.
derable certainty about causes. Determining whether a discrete Second, it is presumed that the
However, reliance on RCTs is not intervention works involves interventions can be evaluated in
always possible or appropriate for answering three questions, which isolation of environmental factors,
the evaluation of policy impact in sometimes can only be answered including the societys response to
9
the intervention and to other Finally, there is no capacity to dent on how the individual
cultural trends; i.e., that the consider closely related indeed, responds to them. For clinical
effectiveness of the intervention functionally equivalent inter- interventions, the frame is quite
can be determined prior to its ventions as a class, and develop different. Their questions are
widespread implementation. Third, different criteria for evaluating new framed: If the appropriate system
it is assumed that any impact of versions of essentially the same is put in place to ensure the
personal choice over whether to intervention. For example, different person with the illness uses the
have the intervention can be executions of a cognitive-beha- intervention properly (or is given it
separated from the core thera- vioural cessation treatment or even properly), then can we
peutic effect. Fourth, it is assumed the various forms of Nicotine demonstrate a benefit? The
that the intervention is uniformly Replacement Therapy (NRT) get question the WG ask is quite
effective for all who are eligible to treated as independent interven- different and much broader: Can
be given it. None of these tions. In the case of NRT, all a system be put in place that will
assumptions are tenable for policy variants have had to go through the make the intervention work, and
interventions and disseminated same process of testing through how can that system be optimised
programmes. independent randomised trials under different conditions?
The assumption that a given before they were able to be Where limitations exist on the
dose of an intervention is marketed. internal validity of RCTs for
assumed to have an equivalent Population interventions tend making the inferences of interest,
effect on all who have the to be different in observable ways the strategy of using meta-
condition it is intended to treat is wherever they are implemented. analyses of similar studies to draw
problematic even with many Information-based interventions inferences is similarly problematic.
pharmaceuticals. The solution to are dependent on language, and Alternative means are required to
this problem has been to treat the language used must vary by control for these threats to
each identified population as novel culture, not just linguistic group. inference. It is only in the context
and to require separate RCTs. Language must be kept up-to- of being able to assume
This might work for major distinct date to make it contemporary, and generality, having few enough
differences, but when there are thus attract interest (and some- interventions to assume each is
many possible populations to times increase) comprehension. an independent case, and having
consider, the strategy becomes People-based interventions in- the capacity to test interventions in
cumbersome and costly. More variably differ. Policy-related isolation of their context, that the
efficient strategies are required. interventions encompass those model of RCTs as the keystone of
RCTs are similarly a cum- major aspects of the system that evaluation is possible.
bersome method for evaluating allow them to operate, not just the The allure of having a simple
interventions that vary continu- core requirements. It is not model based on RCTs to allow
ously, as they involve creating reasonable to assume that definitive inferences about the
discrete categories for randomi- population-based interventions effects of interventions treated in
sation. This means there is, for have their effects independent of isolation seems to have distracted
example, poor quality information anything the person does or us from considering the potential
on optimal dosage, both amount thinks, unlike most pharma- utility of other approaches. In
per dose and duration of use. This ceutical interventions. Like particular, the RCT-focussed
makes RCTs a particularly virtually all psychological and framework tends to neglect the
cumbersome method for evalu- social interventions, as well as role of theory and of the potential
ating interventions where the dose some pharmaceutical and other contribution of combined studies
of an intervention can vary ones, the effectiveness of policy with different kinds of limitations.
considerably. interventions is critically depen-
10
The contribution of theory is provide maximal help to all, or to This knowledge is part of a
undervalued in tobacco control produce the desired structural or foundation that is sometimes
and in public health more cultural changes. No single theory forgotten. The question we are
generally. We agree with the can encompass the complexity of really asking is: Under what
noted psychologist Kurt Lewin: controlling tobacco use; however, conditions can the desired effects
There is nothing so practical as a more can be done to consider how be optimised? This includes
good theory. Some in the social theories that deal with different as- concern about the form of the
sciences take theory to refer to the pects of the problem interrelate, in- intervention, the ways it is
existing, sometimes demonstrably cluding different timescales for delivered, and various charac-
limited social science models, and change (e.g. behaviour change teristics of the populations to
take the theories from other areas versus change in cultural norms whom it is provided.
(typically from the biological and practices). The set of theories A new evaluation framework,
sciences) to be accepted fact, used should be compatible with one that is less reliant on the RCT,
rather than theoretical models; e.g. each other, even if the nature of is required. It should have a
of how a chemical will affect the interrelationships is not fully ar- systems perspective; use the best
behaviour. Theory is thought of in ticulated. possible methods, including RCTs
an encompassing sense of the The most important implication where appropriate; allow a more
accumulation of our under- of considering theory is that it central role for theory, to allow
standing of how things work, not allows explicit linkage of tobacco more efficient consideration of
merely the original ideas. Theory control to relevant existing know- possible variation in effects across
provides the mechanism to ledge. A focus on evaluating populations; and provide a more
systematically use existing know- interventions in isolation tends to efficient means of understanding
ledge to understand likely future distract from what is known, effects of dosing and other
effects. The aim should be to specifically: aspects of implementation.
develop consistent sets of ideas One approach to evaluation
(theories) that describe and predict Information campaigns can that is popular among public
actual outcomes. A hunch or a increase knowledge about health practitioners, but that has
past empirical finding is an tobacco. less credibility with researchers, is
unarticulated theory of what will Knowledge can change beliefs that of programme evaluation (e.g.
happen in the future. Unless and attitudes. Patton, 1997). These models have
articulated, these implicit theories Beliefs and attitudes can affect grown in areas where there are no
cannot be subject to proper tobacco use. simple relationships between
scrutiny. If they turn out to predict Advertising can change beha- programmes and sought policy
outcomes, there is no capacity to viour independent of conscious outcomes, yet there is a need to
work out why without first awareness of the influence. demonstrate progress. Thus the
articulating them. There are programmes and focus of these models of program
Theories specify mechanisms aids that can help people quit evaluation is often on determining
or mediating pathways of effects, using tobacco. intermediate effects when it is
allowing these pathways to be There are ways that the toxicity difficult to demonstrate effects on
tested. They also can specify con- of products can be reduced. the main outcome goals. We
ditions under which interventions Price rises affect levels of believe that there is value in
will work (i.e. moderate interven- consumption of tobacco pro- extending these models to
tion impact). One can test whether ducts. consideration of outcomes as well.
these factors affect outcomes, and Poorly designed and/or exe- The essence of these approaches
thus be better placed to develop cuted communications can is to test the theory behind the
the suite of interventions needed to have boomerang effects. programme, sometimes also
11

called the programme logic, to effective evaluation we need to Evaluation is enhanced by
assess whether the various consider what effects might occur showing the mechanisms of the
aspects of a programme can be (theory), and design studies that effects, not just restricting itself to
shown to contribute to the allow detection of effects in the determination of effect size. This
achievement of its goals (Mac- variables of interest (description) is critical in population research
Donald et al., 2001). The WG has and making of valid causal because most of the outcomes we
adopted the idea of using logic inferences about the contribution are interested in are potentially
models as a core element of the of the intervention to the observed determined by multiple factors;
framework we have developed. changes in outcomes. thus it helps demonstrate a
We found that doing so increased contribution from the focal
conceptual clarity and provided a Theory interventions as distinct from other
useful organising frame for interventions happening at the
thinking about the policies and a Evaluation must begin with a same time. Thus, the theory
more coherent way to organise the theoretical evaluation of how an needs to spell out the mediational
chapters and sections. intervention might work. Often model of how an intervention
there will be one clear theoretical might work. Mediational models
Framework for tobacco mechanism, generally provided as allow us to test each step along a
control evaluation part of the justification of having proposed causal chain from
the policy, but sometimes intervention exposure to beha-
The role of evaluation is to alternative modes of effect might viour (see Figure 1.3). If some
determine the effects of inter- be postulated. This is particularly relationships are not as predicted,
ventions, determine under what the case when the head of power the intervention may not be
circumstances these effects (constitutional source of capacity working, at least in the way it was
occur, and help identify ways to to legislate/regulate) under which intended to work. In cases where
make the interventions more policies are enacted is limited. the intervention is known to be
effective. To do this involves Thus policies to protect workers potent, evaluation of mediators
determining how the interventions from exposure to passive smoking may only need to proceed as far
work, and diagnosing any prob- cannot explicitly consider the as assessing uptake/exposure.
lems that either prevent them from possible benefits of smoke-free However, where the potency is
working as desired or diminish places for reducing cigarette unproven, testing the inter-
their impact, in particular any consumption or for enhancing ventions impact through to the
differences of effects within the quitting. Good evaluation requires desired outcomes (e.g. smoking
target population (equity issues). consideration of all potentially cessation) becomes necessary. In
In doing this one should consider important outcomes, not just those an area like tobacco control where
the totality of effects, both used to justify or provide a legal the main outcomes of interest
intended and incidental. To do basis for the policy. (e.g. smoking cessation, pre-
Policy Policy- specific General Policy

as implemented mediators mediators outcomes
Figure 1.3 A generalised model of mediation
12
vention of uptake) are determined whose spokespeople are old, requires a good description of the
by multiple factors, mediational which are typically not seen as problem and its context, and of
models can also help establish the relevant to young people (the how these are changing. This
relative contribution of specific converse is less likely to be true). involves finding appropriate
interventions. Testing mediational Something as simple as choice of measures of the constructs of
models can also enhance under- actor can create moderator interest and of collecting data
standing of basic mechanisms effects, which under other using the appropriate measures.
and facilitate the development of conditions would not be present The goal here is to provide
new and improved interventions. (or be so small as to be ignored). population estimates of what
Other theoretically important Incidental effects must also be people do and think, focusing on
factors are those that may considered. Sometimes it can be key outcomes. It involves
moderate the relationship useful to separate these out from collecting data in four principal
between the intervention and the intended effects (see Figure domains: 1) who uses tobacco,
outcomes. That is, what conditions 1.5). Incidental effects can occur what they use, how much, and
affect the efficacy of the for a range of reasons; some may where and when they use it, as
intervention, or how does its be theoretically expected, while well as any relevant knowledge,
effectiveness vary by identifiable others may not. Some can occur beliefs and attitudes (including
sub-groups. Where one finds or as a result of counter-actions of those of ex-smokers and non-
theorizes moderator effects, it is sections of the tobacco industry to smokers); 2) tobacco industry
important to understand where reduce the threats of policies to behaviour, including charac-
they occur along the proposed their profitability. These effects teristics of their products; 3)
mediational pathways, or indeed can be incorporated within the tobacco control activities to which
whether different mediational more general model (Figure 1.4) people are exposed; and 4)
pathways exist for different groups as all such effects can be either aspects of the broader environ-
or situations (see Figure 1.4). For due to reactions to the policy, or to ment that might affect tobacco use
example, if an intervention is not independent other factors (and or tobacco harm outcomes
seen to be relevant to or targeted thus should be treated as (cultural norms, controls on
at a group, this group may not moderators). activities like alcohol consumption
respond to it. Here, making the that are linked to tobacco use).
intervention relevant might be all Description High-quality data collections, such
that is needed to remove the as regular cross-sectional sur-
moderating effect. A good The relevant theory tells us which veys, are essential to describing
example of this is advertisements constructs to measure. Evaluation the nature of the problem and the
Policy as Policy- specific General Policy

implemented mediators mediators outcomes
Moderators
Figure 1.4 A generalised model of mediation, making allowance for moderator effects
13
Incidental effects
Policy as Policy- specific General Targeted policy

Moderators
Figure 1.5 A generalised model of mediation, making allowance for both moderator and unintended or
incidental effects
quantification of trends in tobacco be through rules and restrictions, constructs of interest actually
use and in key determinants of making available alternatives or measure something different
use. In tobacco control, because substitutes, and/or providing rele- (usually a closely related con-
the tobacco industry or sections of vant resources and/or skills. The struct) or are contaminated by
it might be motivated to moderate mediational pathways vary both some systematic error (e.g. social
the effects of policies, it is for outcomes and policies. For ex- desirability can affect responses
important to conduct surveillance ample, mediational pathways to about beliefs and intentions).
of possible counteractions to knowledge acquisition are shorter Confounding occurs when the
policies. More generally, possible than ones to smoking cessation. association with the outcome of
incidental effects of policies interest appears stronger or
should always be considered and Inference weaker than it truly is as a result
measured where appropriate. of an uncontrolled association
There are five broad types of The core of good evaluation is between the intervention and
outcomes that relate to indivi- designing studies to detect other mechanisms of effect (e.g. a
duals: improvements in knowl- changes in outcomes that might different policy intervention). The
edge, changes to attitudes and be attributable to a specific contribution of chance is a
related normative beliefs, changes intervention, and putting in place function of naturally occurring
to behaviour patterns, changes in measures to rule out alternative variability in outcomes of interest,
exposures, and health outcomes explanations. These alternative and its impact is controlled for by
(particularly acute ones that can explanations are of three types: ensuring adequate sample sizes.
be detected soon after a policy is those related to systematic errors The quality of evidence from
implemented). Interventions typi- of measurement (bias), those any single study is a joint function
cally change the environmental related to alternative mechanisms of the study design and of the
conditions that affect and thus of effect (confounding), and quality of the measures used: that
sustain these outcomes. Mecha- chance effects. Bias occurs where is, their reliability and validity.
nisms for behaviour change can the measures used to assess the Where optimal research designs
14
are not available, one must focus the risks of wasting resources. case in ways that enhance
on the relative strengths of This involves a model in which shareholder value, which is why
different designs. It is not enough science plays a role of evaluating they are almost invariably directed
to conduct meta-analyses of the interventions once they are at increasing or at least main-
individually strongest studies. A disseminated, not just restricting taining use. Even the best
diversity of research designs (and its activity to evaluating inter- thought-through interventions
associated measures) with ventions before they are sometimes fail to work as
complementary strengths, should disseminated. It is a science of expected, and policies that work in
be combined, and that information evidence in action, not just of one context sometimes stop
combined in ways that increase evidence preceding action. One working when the context
the validity of inferences. Demon- aim of this volume is to provide the changes. Because neither past
stration of similar effects with conceptual framework and some of experience nor theory can be
different methods and/or mea- the tools to allow more effective relied upon to always deliver the
sures increases confidence in the evaluation of implemented policies best solution to our problems,
reality of effects and of the and programmes. It is designed to methods must be established to
plausible causal mechanisms. complement the often (necessarily) check when and how things are
limited evaluation of interventions working. This is what modern
Evaluation as a dynamic that occurs before they are evaluation is about. A framework
process implemented. for effectively evaluating policy
There is the possibility that interventions is essential.
The evaluation of policy inter- empirical work will show the Such a model places less
ventions occurs after they are theoretical model used to develop stringent tests on demonstrating
instituted, as they first must be and or evaluate the intervention to that something has equivalent
implemented somewhere before it be flawed: either incorrect in some effects in a new context or when
is known how they actually work. of its assertions (including delivered in a new form (where
Because the authority of inclusion of factors that have little there is no reason to expect
government policy or law may or no influence), or incomplete by changes in efficacy) than it does
affect compliance, it is not ignoring important factors. It is for evaluation of truly novel
possible to confidently generalise only by specifying models that one interventions or their implemen-
from the results of analogue can systematically work to make tation under conditions where
studies conducted prior to imple- them better. differences in effects is plausible.
mentation. This means one A model of evaluation is However, it still calls for stronger
cannot in principle be certain of required that is designed for the evaluation methods when evi-
the effectiveness of interventions dynamic, ever-changing world in dence accumulated to question an
before they are implemented; which we live. The potential of the assumption of equivalence. Thus
hence, lack of evidence needs to worlds diversity must be viewed it provides an explicit link between
be used with caution as a reason as a tool to aid in understanding, the roles of ongoing auditing of
for delaying needed policy not an obstacle to be overcome. programmes to ensure continued
change. Scientific methods can Each action of government is an effectiveness and more intensive
be used to help us minimise our attempt to influence outcomes in evaluation activity when there are
risk of error, but they can never ways consistent with policy goals, concerns. As these decisions are
eliminate it completely. Science which, hopefully, aim to improve based around clearly articulated
should not inhibit action when the health and well-being of the theories, the framework is open to
there is a need for action, but community. Similarly, the actions scrutiny and should allow the most
rather act to maximise the of tobacco companies are also cost-effective possible evaluation
chances of success and minimise designed to affect smoking, in this by demanding plausible reasons
15
before testing for differences in relevance for communication, without such bans feel a need to
effects. changes quite rapidly in some justify their positions. Before the
communities. Similarly, across tipping point, even quite intense
Characteristics of interven- cultures, intervention may need to interventions may have limited
tions be framed differently to ensure impact (as has been the case for
cultural relevance. Under some implementing smoke-free homes
Typically, policy interventions are circumstances it can be useful to (Hovell et al., 2000)), while after it
designed to have sustained conceptually separate the core people may be readily able to
effects, but in some cases this concepts in an intervention from change without help (as evi-
may require designing ongoing the mode of communication used denced by rapid adoption of the
programmes to ensure that this to convey them. Thus evaluation practice in some countries (e.g.
happens. Further, there may be might focus on the cultural Borland et al., 1999)). Where
short-term onset effects. For relevance of the intervention or on things change, the rate of change
example, there is evidence that its underlying potency, or both. must be considered as well. When
warning labels on cigarette packs Analogous to the way societies it is more rapid than the time for
have an onset effect as well as a and/or people change, inter- the institutionalisation of inter-
sustained effect (Hammond et al., ventions need to change to ventions through traditional testing
2007a). We need evaluation maintain their relevance. This calls of efficacy and so on, then new
methods that can differentiate for an equivalent model to that of methods must be adopted to allow
onset effects from sustained how to create new immunizations interventions to be changed in
effects, and which also can help for emerging strains of influenza. train with the changing context.
us understand the conditions Here, the rate of change in the This is one of the reasons why it is
under which both kinds of effects problem is too rapid for RCTs to important to pre-test the mes-
are maximised. be practical, and quite different sages used for cultural relevance,
It is necessary to understand methods are used. even for proven interventions
what, if anything, is required to Changes to interventions may when applied in new contexts.
sustain potential enduring effects: also be required as a society This is also why it is important to
that is, what endures without progresses through the adoption conduct ongoing evaluation of
further intervention and what of an innovation cycle for adopting disseminated interventions.
requires regular updating, or a new sets of values and beha-
sustained presence. For example, vioural options for tobacco use. How policy interventions
anti-smoking mass media cam- Take, for example, encouraging that target behaviour work
paigns have a short-term impact the adoption of smoke-free
on quitting (Snyder, 2001). It homes. This happens first in the Evaluations of population-level in-
seems important to maintain cues face of social disapproval, or at terventions are typically interested
in the environment to remind least lack of understanding. An in determining the overall effect of
people of information for that entity instituting a ban will often be the intervention. As a conse-
information to have a maximal asked to justify it, and some might quence, it is not so much about
impact. The form of some kinds of see it as unreasonable. However, asking whether an intervention of
interventions may also need to as such bans become more this kind can work, but of asking
change over time if the effects of common, there comes a tipping under what circumstances does it
the intervention are to be point where smoke-free environ- work and how to optimise those
sustained. This applies particularly ments become the norm. Since conditions to get maximal impact.
to communication-based inter- justification is no longer neces- This involves consideration of the
ventions. What is seen as sary, smokers often just do not reach of the intervention (some-
up-to-date, and thus of most smoke when indoors, and those times no more than awareness),
16
the ways people respond to it and cheaper brand, or seek out coherent theory or set of theories
its underlying potency or efficacy. sources of cheaper cigarettes, or as to what tobacco control is
There are three key aspects of even re-interpret smoking as about. This should extend beyond
interventions from the perspective something more exclusive and the list of tasks identified in the
of the individual: awareness of, ac- thus desirable. Like awareness, WHO FCTC to an analysis of how
ceptance of, and actions taken in re- acceptance can only really be the various domains of inter-
sponse to policies. Evaluation must evaluated at a population level, vention are theorised to contribute
deal with all three. The first aspect although it is typically the to the overall goal. The nature of
is determining the extent to which acceptance of each individual that the relationship between tobacco
the target population is aware of the is critical. In some collectivist use and harm must be sufficiently
intervention, which is a function of cultures, the views of community understood to know what
its implementation, dissemination, leaders are also critical, as they behavioural aims are appropriate.
and surrounding publicity about it. determine what it is acceptable to Such an analysis should consider
Awareness is generally a prerequi- think and do. These roles are in the broad scope of potential
site of policy effects, except in those addition to the roles of leaders in impacts, not just those that are
rare cases where the policy creates all cultures as policy makers. part of the rationale for
environmental conditions that can The third aspect is the implementing any particular policy
have direct conditioned effects; i.e. evaluation of the actions that initiative. For example, the impact
independent of conscious aware- result: that is, the consequences of smoke-free places, introduced
ness. or outcomes of the intervention in to protect non-smokers, also have
The second aspect is terms of both intended and beneficial effects on smokers and
documenting attitudes towards the unintended incidental effects. This do not appear to have some of the
intervention by the target is a function of both the actions adverse effects on economic
population, as this can affect their taken by the individual and the activity that some had feared
responses to it. Policies that are potency of the intervention. While (Scollo et al., 2003). Detailed
unpopular are more likely to be traditional intervention evaluation analysis of the conceptual foun-
resisted, and forms of assistance restricts its focus on outcomes dations of specific interventions is
that seen as inappropriate to the among those who are encouraged provided in the relevant sections
persons needs are unlikely to be to use the interventions, for policy later in this volume. Here the WG
adopted. Thus, a smoker who interventions this is not a useful addresses a few broader issues.
objects to smoke-free rules is restriction; one must consider the A broad schematic overview of
more likely to ignore the rules or to total impact on the population, key influences on tobacco use and
seek convenient alternatives, including those who are tobacco-related harm is provided
while a smoker who approves and unaffected. Outcomes should be in Figure 1.1. This figure makes it
sees this as an opportunity to gain considered as a joint function of clear that policy and socio-cultural
greater control over their smoking, the potency of the interventions, influences have indirect effects on
may not only comply, but use the the ways they are used or use and that the most proximal de-
opportunity to either quit alto- responded to (a function of terminants of use are the product;
gether or reduce their attitudes to them), and the degree cues in the environment; charac-
consumption. A price increase will of exposure to them. teristics of people, including cog-
only cause smokers to try to quit if nitions about the products; and the
they see the increased price as The theories behind persons biology (both conditioned
making smoking no longer worth tobacco control and innate). Further, the behav-
the cost. Alternatively they could iour and the product jointly deter-
smoke more of each cigarette to A critical step in developing an mine exposures, which, in
maintain the value, or shift to a evaluation framework is having a interaction with existing biology,
17
determine harm (see Figure 1.6). model for this. It is possible to elab- Tobacco control efforts can be
The role of a systematic science of orate this figure to include other im- focussed on users and potential
tobacco control is to analyse and pacts of policies (see Figure 1.7). users of tobacco products (e.g.
clarify the components of this sys- With generic models of this kind, changing knowledge and beliefs),
tem and their interrelationships areas that require greater attention or they can be designed to directly
over time, with the aim of introduc- can be expanded upon and boxes reduce use (e.g. price and
ing interventions that will minimise where things are more straightfor- availability controls), or to reduce
the harms. Figure 1.6 is a generic ward can be combined. use indirectly by changing the
environment to increase cues to
inhibit use (e.g. warning labels on
Policy-related Other Tobacco packs), or reduce cues to use (e.g.
interventions influences industry by constraining tobacco com-
panies marketing practices), or by
changing the nature of the
tobacco products on the market
(see Figure 1.8). Efforts can also
Propositions Sensory Tobacco be directed at reducing the toxicity
about tobacco stimuli products of tobacco products (targeting the
industry), and at reducing the
exposures of non-smokers (tar-
geting tobacco users). To
Tobacco product intervene in any of these ways
Conscious processing contents with either people or companies
requires a good understanding
(theory) of how the factors
producing unwanted effects
Tobacco use operate and how the intervention
Tobacco product will affect those operations. It is
yields beyond the scope of this volume
to spell out such a complex theory,
Patterns of Toxin exposure although in each section, relevant
use per use elements are canvassed.
Tobacco in dustry controls
Tobacco industry controls are

Cumulative exposure about targeting the 4 Ps of mar-
keting: Product, Price, Place (or
availability) and Promotion; to
which a fifth P can be added,
Tobacco harms Packaging; and, unrelated to mar-
keting, the imposition of specific
obligations to provide information
(for example, warning material) re-
Figure 1.6 Schematic diagram of main pathways by which policies gardless of its impact on the mar-
affect tobacco use, tobacco exposures and tobacco harms ketability of the products. This is
18
Policy-related Other Tobacco

interventions influences industry
Propositions about Sensory stimuli Tobacco

tobacco products
Tobacco
Conscious processing product
contents
Tobacco use Tobacco

product yields
Passive Patterns of Toxin exposure

exposures use per use
Cumulative exposure
Tobacco harms
Figure 1.7 Model from Figure 1.6 expanded to illustrate where effects other than on tobacco use fit in
achieved through a mix of laws tions to counter the intended ef- constituents or emissions (e.g.
and agreements, generally tar- fects, or to otherwise minimise ad- upper limits on tar, nicotine and
geted at manufacturers or distrib- verse effects on their business. carbon monoxide as measured by
utors, but in other cases, at other Product controls (see Section ISO standard testing; restrictions
points in the supply chain (e.g. re- 5.3) include rules about what types on additives/ ingredients), or on
tailers). Evaluation of tobacco in- of products can be sold (e.g. engineering features (e.g. man-
dustry controls also requires an smokeless tobacco is banned from dating reduced ignition propensity
analysis of possible industry ac- sale in some jurisdiction), levels of cigarettes, filters). The aims of
19
Tobacco Industry Control
Production regulations
- types
Tobacco
- constituents
products
- engineering
Tobacco Price controls and taxes

harms
Constraints on
availability
Controls on promotion
Cues to use
Tobacco Controls on packaging
use
Information
requirements;
warning labels
Cues to
inhibit use Tobacco Use Control
Passive Rules on use, e.g.

exposures smoke-free policies
Education campaigns
Tobacco users and

potential users
Cessation aids
Figure 1.8 Schematic overview of tobacco control interventions and how they relate to tobacco products,
users and potential users
20
product rules vary from preventing young people (Wilson et al., 1987; it provides cues to inhibit use.
new forms of tobacco (to a Assunta & Chapman, 2004a; Warning and other risk-related in-
market) becoming established Prokhorov et al., 2006). The formation can be required on pack-
(e.g. bans on smokeless), to effects of such policies may ets, at the point of sale, on any
reducing their appeal (e.g. bans operate through reducing cues to permitted advertisements, or in
on flavourings), both of which are use, or by making the product less conjunction with any depiction of
designed to reduce use, and rules attractive, reduce the value of trademarks or commercial mention
to reduce the harmfulness of the using such products. of products.
products (e.g. constituent limits), Controls on promotion (see Tobacco industry controls are
which can also have direct effects Section 5.4) are the most promi- often about reducing cues to use
on the harm caused. nent form of control on the indus- tobacco, while tobacco use control
Price controls (see Section 5.1) try. They are essentially about efforts and information provision
includes efforts to damper reducing cues to use, but in doing requirements directed at industry
demand through increasing prices so, might also reduce the appeal are about increasing cues to
(e.g. taxation of various forms), of the products. Controls include discourage use. For cues to use,
which can have direct effects on bans on paid advertising, spon- the effect on behaviour is often
use, as well as strategies to sorships, and product placement, conditioned such that they will
prevent price-related marketing and encompass restrictions on stimulate tobacco use unless
(e.g. setting minimum and/or packaging (including controls on actively resisted. By contrast, cues
maximum prices to prevent dis- the use of trademarks, e.g. to inhibit use are more likely to
counting and other forms of generic packaging). Because to- operate via conscious processing.
price-related marketing). bacco is sold in a competitive mar- Evaluation of tobacco industry
Place or availability controls ket, some signs differentiating control is first about assessing
refer to efforts to reduce the products as belonging to a manu- compliance with the rules. This is
availability of the products and facturer/marketer are necessary. unlikely to be an issue where the
include restrictions on the number Even in places when brand dis- rules are to control obvious
or types of outlets, and to whom plays and advertising is banned at activities of small numbers of
they can be sold (e.g. age limits point of sale, a generic sign say- companies (e.g. compliance with
and bans on vending machines). ing that tobacco is sold is allowed. labelling requirements), but can be
Many of the existing rules have This promotes availability. To- an issue where there is more
been put in place to discourage bacco retailers can also promote potential for avoidance (e.g. many
use by young people, but res- products to customers by word of potential actors or where the
trictions could also be used to mouth. action is not so obvious; e.g.
reduce impulsive purchases and/or The final type of rules is inde- payment/avoidance of taxes).
to discourage use in certain venues pendent of attempts to control Evaluation is next about deter-
(e.g. bans on sales in bars). marketing, and is about what form mining the effects of the rules.
Packaging controls include and content are required for warn- What is involved here varies as a
rules about what can be on the ings. The content may include function of whether the rules
pack (e.g. use of terms like Light facts about the adverse effects of mandate some actions (e.g.
and Mild; see Section 5.5). It tobacco use, benefits of quitting, warning labels, higher prices) or
also includes rules that prohibit and information about toxin levels whether they mandate removing
sale of single cigarettes and (see Section 5.5). Here the aim is something (e.g. promotional cues
establish a minimum pack size to to discourage use or at least en- to smoke) that would otherwise be
stop use of packs with small sure that any continuing or new there. In the former case, issues of
numbers of cigarettes, which are use occurs in the context of some reactions to the change need to be
known to appeal primarily to information about the risks; that is, evaluated. In the latter, the extent
21
of previous response to the cues Provision of messages essen- pharmaceuticals and coaching or
(or other things) removed must be tially relates to mass media advice programmes of various
known before the impact of their campaigns, where the intent is to types. As noted earlier, this
removal can be effectively evalu- expose as many people as volume is not concerned with
ated. As noted above, it is possible to the campaign (see evaluating the efficacy of these
necessary to monitor and evaluate Section 5.6). This may include products or services themselves,
any industry actions that might campaigns to promote pro- but on evaluation of their com-
occur to reduce the impact of the grammes. Campaigns are munity-wide dissemination and
rules on their businesses. designed to inform people and to use. Beyond this, there is interest
make the issue emotionally salient in considering the effects of the
Tobacco use control enough to stimulate appropriate existence of cessation services on
action. One of the enduring the broader community. There is
Tobacco use interventions are challenges of tobacco control is some evidence that awareness of
those targeted at tobacco users or that because the main adverse the availability of quit-smoking
potential users directly. They in- effects of smoking are not evident programmes can stimulate quitting
clude rules about use, attempts to until after a long lag time, smokers activity even among those who do
provide messages aimed at pro- do not experience any significant not use the services (Ossip-Klein
viding information and changing sense of the harm they are doing, et al., 1991).
attitudes and beliefs, and pro- and thus tend to underestimate its Evaluation of tobacco use
grammes to deliver interventions harmfulness (Slovic, 1998). There interventions should consider both
that can facilitate appropriate be- are extra issues to consider in the their intended effects and
haviour change, or in the case of evaluation of prevention cam- incidental effects. They need to be
prevention interventions, effec- paigns. Focussing on an issue informed by a sophisticated
tively inoculate against uptake of increases awareness of it and may understanding of psychological
any of addiction-level use. increase interest, which if principles, and where there are
Rules about use include unchecked could lead to increased competing psychological pro-
policies to make various places experimental use. Designing pre- cesses involved, it is important to
smoke-free (see Section 5.2). vention campaigns or programmes put in place measures of all
Smoke-free rules are generally in ways that overcome this relevant processes. Where addi-
designed to protect non-smokers, increased interest requires tional effects to those sought are
although in doing so they have thought. There is evidence that known (or hypothesised) they can
effects on smokers that need to be some prevention campaigns, become further justifications for
understood. Rules could also be especially those emanating from action (or inaction, if they are or
about which products could be tobacco companies, can have might be undesirable).
used, and by whom. However, adverse effects (Wakefield et al.,
where there are restrictions on 2006), presumably through the Use of logic models
use of products or who can use increased interest in the issue they
them, they are usually also engender. Achieving a comprehensive
codified as rules against selling Programmes to disseminate approach to tobacco control
such products (e.g. smokeless interventions include rules regu- requires adoption of a range of
tobacco) or selling to particular lating cessation medications, different strategies, underpinned
individuals (e.g. minors), so these provision of services, and sub- by differing constructs and
are best considered under sidies to products or services (see theories. It is important to spell
industry control even when the Section 5.7). The kinds of out the relevant concepts to
parallel restrictions are imposed products/services vary, including consider in each area in which a
on individuals as well. self-help resources, stop-smoking policy intervention might be
22
planned. The WG has adopted the theory and not directly in The problem of the measure that is
strategy of encouraging the use of relationship to what measures available not being a direct
logic models or flow charts to spell them, error is localised in the measure of the construct of interest
out the main constructs that need imperfect relationship between the may be greater when existing data
to be measured for each type of underlying construct and the are used, as compromises are
policy. The criterion we adopted measures used to assess it. commonly made in the interests of
was to divide an area to the point Many of the concepts that need to being able to use what is at hand.
where the causal pathways were be measured are not directly These data were often collected for
sufficiently different to make observable, or, where they are, quite different purposes to those of
dealing with the various possi- they sometimes stretch the focal interest, and thus the
bilities difficult within the one capacity of the respondent to measures used are often of related
frame. The WG used Figures 1.4 recall or otherwise come up with a constructs, not the exact ones
and 1.5 as generic models, but as valid answer (e.g. remembering being studied. Dependent on the
will be seen, found the need to quit attempts months or years study, evaluators may be forced to
modify them considerably for some ago). As a result, most measures use measures of constructs with
policy areas. We accept that as are subject to a range of possible different limitations. They need a
knowledge about how some of biases as indicators of their target language to help them talk about
these interventions work accu- constructs. Exceptions are the quality of measures in
mulates, new distinctions may characteristics such as sex and relationship to the constructs they
become necessary, which could date of birth, which in most are using the measures to assess.
lead to further subdivisions of cultures at least can be reported Unfortunately there is no con-
intervention type. Further, in some very reliably (although not in all). sistent language for talking about
cases, distinctions may be shown One of the great challenges of these distinctions, and the WG
to be of lesser importance, allowing measurement is that the mea- were unable to develop one for this
some of the existing boxes to be sures that are most easily volume. The WG views the
combined. It is only once a obtained are often not ideal development of such a language
coherent theoretical model of the operationalisations of the con- as critical to reducing the potential
domain has been established that structs of interest. For self- for conceptual confusion that can
determining the constructs to reported data, most things people occur from failing to consider the
measure becomes possible. report are used as indicators of limits of specific measures to
behaviour patterns or of under- actually measure the constructs
Measurement issues lying beliefs, behaviour patterns evaluators are interested in
and/or understanding, not as measuring.
Measurement is critical to simple answers to the question.
evaluation. To measure the con- The lack of direct measures also Determining what to
cepts of interest, these concepts occurs for many physical mea- measure
must first be defined in ways that sures. For example, cotinine
make them amenable to measure- levels are sometimes used to Choice of potential measures
ment. These definitions constitute assess intake of nicotine or extent begins with an elaboration of the
the constructs. Constructs can be of smoking. However, because theory or theories as to how the
operationalised in many ways. people differ both in size and in intervention might work, including
This operationalisation must come rate of nicotine metabolism, the range of expected outcomes
from a clear consideration of the cotinine is a biased measure of and potentially mediating (or
concepts and thus of the intake or exposure at an individual intermediate) and moderating
underlying theory. Because con- level, although it can be a good variables (effect modifiers), as well
structs are defined in terms of the estimator at a population level. as incidental effects. It might also
23
consider questions like: What they must assess how well the This can be assessed through the
outcomes will lead to health constructs of interest can be meas- relationship between the measure
gains? and What might influence ured. Where adequate measures and a gold-standard measure (cri-
policy adoption and/or continu- do not exist, there will unavoidably terion validity), or by showing that
ation? Evaluators should also be gaps in the modelling. Some- the measure related to other theo-
consider whether the same times these gaps can be covered, retically related constructs as hy-
outcomes are relevant to all at least in part, by using sets of pothesized (convergent validity).
cultures. For example, in Islamic measures of related constructs. One form of convergent validity is
countries and others where In Chapters 4 and 5 of this predictive validity, where the
alcohol use is prohibited or not Handbook the WG provides measure is shown to predict out-
socially significant, consideration guidance on measures that might comes as theorised. A valid meas-
of smoking policies in bars is of be used in various evaluation ure of one construct is unlikely to
little interest. Also the relevance of contexts. For any domain of be an equally valid measure of
some issues can change as a interest we attempt to characterise even a closely related construct.
function of a societys status in constructs that might be Also, the validity of a measure
regards to tobacco control efforts. measured as one of: may vary as a function of how it is
For example, support for and 1. Core constructs: those that being used. Thus reports of
reports of smoke-free hospitals should be included whenever awareness of environmental cues
are now so high in many this domain is being studied. are not a valid measure of the ex-
countries, it is no longer These will include key out- tent to which any single individual
necessary to ask. However, in comes along with major is exposed (because of differ-
countries where passive smoking theorized mediators and ences in sensitivity), but may be a
has not become an issue, asking moderators. Not having mea- valid measure of overall commu-
about smoke-free hospitals may sures of any of these is likely to nity exposure (as the individual er-
be critical to assessing emerging compromise the study, or at rors are assumed to cancel out
community concern. This analysis least limit the range of across the population). Validity
identifies the concepts that it inferences that can be drawn. also only relates to the contexts in
would be desirable to measure. 2. Important complementary con- which it is established. As the
Next, evaluators need to constructs, to use for detailed context changes the validity of a
sider how they want to operational- investigation of a domain. measure may vary. For example,
ize the concepts as constructs. 3. Other measures or indicators self-reported age is generally a
This needs to be done in a way that that may add some limited or valid measure of how old some-
ensures that the constructs are uncertain value, but which we body is. This is so in cultures
structurally independent of related cannot recommend (for or where birthdays (anniversaries)
constructs they might want to relate against), or only recommend in are important occasions, but may
them to in causal pathways. Fur- limited circumstances. be less so in cultures where peo-
ther, they need to consider whether 4. Not recommended: these only ple take no notice of birthdays.
the construct can always be meas- need to be specified for com- Also the validity of measures
ured in the same way. Physical monly used measures that have varies directly with the precision
measures typically measure the been shown to have no utility. required of the measures: meas-
same thing regardless of context, The quality or validity of the ures that may be valid for detect-
but answers to questions may not. measures used for each construct ing large-scale effects might not
For example, the direction of social also must be considered. Validity be adequate for detecting small
desirability biases might switch as of measures refers to the extent to effects.
smoking becomes less socially which they actually assess the The WG uses the following
normative. For any given study, construct they are designed to. broad categories to provide an
24
indication of the quality of in mind that the quality of a program of activity that is put in
measures: measure may be dependent on place to implement it (which is
the type of study in which it is usually more difficult to
Gold standard measure. Estab- collected and the use to be made document). Policy documents
lished valid measure of a of it. The assessments made here should be collated and coded in
construct of interest that is assume the measures are made ways that allow appropriate
better than alternatives in all in appropriate circumstances. comparisons to be made. There is
ways. now an international repository of
Clearly validated outcome or Types of data u se d in information about the content of
predictor. There is evidence that evaluation national tobacco control policies
this is a good way of measuring (See Section 4.1), making this
the construct, in at least some The type of data needed for task easier, at least for national-
specifiable contexts. Limits to evaluation varies, and in some level policies. Some countries
validity should be noted. cases it can be found in existing collect this information for sub-
Evidence of utility. There exists data collections, although some- national policies, but in most
some validity data, but it is not times measured in ways that are cases, the information will need to
strong. It might be one of a less than ideal for the new be collected from each jurisdiction.
range of alternatives with no purposes to which it is going to be Where there are many such sets
clear way of differentiating put. In some cases, measures of of rules (e.g. of workplaces, local
between them. These should the variables of interest are governments), it is usually more
only be chosen when no better available from more than one convenient to either obtain
measure is available. source. In these cases, decisions samples of policies, or to use
Face validity. This involves an need to be made as to which respondents in population studies
analysis of the extent to which sources of information are most to report on the rules that apply to
the question taps the construct, useful. Issues to consider here them. Clearly, this latter form is
and may be all that is available are validity, practicality of subject to the problem that
for single item self-report collection, and the extent to which ordinary people often do not know
measures. the data can be related to specific about rules, and where they do
Where possible, we also individuals. However, in most not, may respond in terms of what
provide an indication of the cases, the necessary information they remember. For example,
sensitivity of the construct to will need to be collected, giving when asked if there are bans on
measurement error. For example, the researcher greater control smoking in their workplace, some
how robust is a question to over the ways in which the will know the formal rules and
differences in wording? Or indeed, relevant constructs are measured. respond appropriately, whereas
might wording or contextualizing Some of the main types of data others may know the rules but
statements need to differ by and major ways of collecting it are respond in terms of what actually
context and/or by characteristics outlined below. happens (e.g. if there is a rule, but
of the respondent? For example, it is ignored, they will report that
some questions need to change 1. Documentation of policies. there is no rule, interpreting the
for use with current smokers as Critical to any form of evaluation is question to mean, Can people
compared to ex-smokers; e.g. documenting the nature of the smoke?). Others will only be able
How confident are you that you intervention. Documentation of to answer in terms of what they
will be able to stay quit, if/when policy can occur at two levels: the infer from their recalled obser-
you try (The last qualifying phase espoused intent or formal policy vations, e.g. Nobody smokes
is not needed for ex-smokers)? (something that is typically there, so it must be banned. This
Users of this manual should keep documented), and the actual means that such reports may not
25
be able to help differentiate point-of-sale displays, bill- 3. Effects on and characteristics

between policy existence and boards, and posters. They can of individuals
policy implementation. Indeed, be collected through obser- a) Self-report data. Characteris-
generally there are difficulties in vation in sampled settings. tics of individuals (knowledge,
directly determining implemen- They may also be estimated attitudes and behaviour) are
tation, especially for complex from reports from relevant generally only available from
policies independent of their organisations (e.g. of work- self-reports (some scope for
effects. This is only a problem places as to the restrictions on proxy reports, but limited be-
when the research questions smoking), but are assessed yond smoking status). Self-re-
include asking whether problems more often by reports from port data can be of internal
with a policy occur at the level of ordinary citizens as to what they cognitive states that are not in-
policy content, or are a problem of experience, or for smokers, dependently verifiable (e.g. of
implementation. what they actually did (e.g. attitudes, knowledge or experi-
when last at a restaurant, did ences), as well as of things that
2. Identifying changes in the you smoke?). These reports can, at least in theory, be vali-
environment or factors that can be averaged across dated, such as behaviours.
might moderate policy effects. communities to estimate overall Sometimes answers to ques-
The challenges of doing this levels of these features. Like tions can also be used to infer
differ by the environment under other respondent reports, these internal states of which the re-
consideration. are subject to sensitivity bias, spondent is either not aware or
a) Mass media. Monitoring of limiting their use for individual- not thought able to report accu-
national and regional media, level analyses. rately (e.g. personality traits).
with sampling of communities c) Production and sales data. Many countries have routine
for audit of local media, is the Various forms of sales data, or behavioural risk factor surveil-
most objective source of what proxies for sales data, may be lance studies and/or tobacco
is potentially available. This available, usually related to specific surveillance studies,
does not cover some important reporting on taxes and excises. and these can be useful in a
sources like the Internet. An These may be national-level, range of contexts. Many coun-
aggregated respondent report but in some cases can be tries use standardised methods
is useful where there are separated by type of outlet or and questions, and are working
sufficient observations per locality. At a national level, towards common repositories
community unit. Individual there are some international of data (see Section 4.3). Self-
reports are subject to sen- repositories of this information reports are affected by ques-
sitivity bias, such that when (see Section 4.2). Self-report of tion wording and by other
thinking about quitting, or trying price paid is a fairly accurate aspects of the ways in which
to quit, the person is likely to be indicator of prices, but little is the information is collected (see
sensitized to mentions or known of possible systematic Section 2.2 for some exam-
images of tobacco or smoking. biases. ples).
This means that respondent d) Characteristics of tobacco b) Physical measures. This in-
reports should not be used as products on the market. These cludes biological and chemical
indicators of exposure in most include composition and engi- measures (e.g. of cotinine lev-
individual-level analyses. neering features of products els). These are often used to
b) Physical environment. These and performance characteris- measure behaviour indirectly,
consist of rules about public tics. These can either be gath- but this should be done with
tobacco use and cues to ered from the manufacturers or caution. Limitations of these
tobacco use from things like through independent testing. measures as well as their
26
strengths are well documented (or the required power to detect) The time interval over which
(Benowitz, 1996a; Matt et al., and the desire to explore potential the response is deemed to be
1999; Al Delaimy, 2002 ). moderator effects. In principle, valid is a crucial issue in testing
c) Proxy reports. For observable making a study larger does not causal models. Causes precede
aspects of behaviour, reports improve its representativeness. effects, so one must assume that
of others who know the target However, because size does in- predictor variables when mea-
individual may be useful. crease power to detect moderator sured at the same time as out-
effects, larger samples can be comes, predated the occurrence
Survey methods for evalua- used to increase confidence in the of the outcomes. Sometimes ques-
t io n generalisability of the findings to all tions are given a time frame or tim-
groups who have a sufficient ing of events is asked for to assist
Survey methods are crucial to sample size for such possible in determining sequences. Self-re-
many forms of policy evaluation. interactions to be tested. ports of periods or of dates are
These can range from surveys of Question asking: The main subject to biases in reporting with
individuals to surveys of informants issue with surveys is inconsistency events sometimes displaced in
about the activities of organisations and bias in the ways in which peo- time. Self-reports are typically bet-
(e.g. of governments or work- ple respond to questions. This is ter for recent events (due to mem-
places). Two key issues are part of a general phenomenon of ory effects). Salient events may be
addressed here: the sampling the frame of reference or context reported as experienced more re-
frame and the way the questions for the question affecting how it is cently than in reality, and less
are asked and answered. understood, and thus how it is re- salient events are prone to be for-
Sampling: To be able to gener- sponded to. Variation in frame of gotten.
alise to a population, the sample reference includes mode of sur- Aside from issues concerning
needs to be representative of the veying (e.g. face to face vs. phone the context of survey delivery, the
population. This is a function of interview vs. self-completion). way in which respondents
both the sampling frame and par- There is emerging evidence that interpret questions and response
ticipation. It is thus desirable to some modes of surveying result in formats affects their answers. One
have broadly representative sam- better response rates for sub-sec- key aspect is the extent to which
ples, recognizing that true repre- tions of the population. There is an the conceptual framework under-
sentativeness is unattainable. urgent need for research to de- pinning the questions reasonably
Participation is also crucial. Any bi- velop optimal methods for calibrat- applies across the cultural con-
ases in participation threaten rep- ing both questions and sample texts under consideration. As
resentativeness. Because often characteristics across modes (see research moves from studying
nothing is known about all or some Dillman & Christian, 2005, for a dis- issues like tobacco within Western
of those who do not participate, cussion of general issues concern- European and North American
quantitative estimation of biases is ing mixed-mode surveying). As it is cultures, to studying tobacco use
either impossible, or partial at best, beyond the scope of this volume to across cultural settings where
meaning their likely effects need to document the entire range of is- there may be different values and
be inferred. The higher the re- sues corresponding to questions assumptions, there is a need to
sponse rate, the less likely major (there are several excellent texts question the underlying assum-
biases are, but unless the rates are on this topic; e.g. Foddy, 1993; ptions that frame the research.
close to 100%, biases can occur. Fowler, 2001), we deal only with Within all cultures, there will be
Sample size is another two issues in this chapter. These variation that researchers should
important consideration. The two are the time frame over which an- try to characterise and under-
main factors to consider here are swers apply, and cultural factors in stand. The possibility that cultural
the size of effects that are expected interpreting question meaning. differences may compromise the
27
utility of some questions needs to in different ways. Where the place measures of key outcomes
be reviewed on a case-by-case answers are relatively invariant to (at least) as long as possible
basis. Some of these issues and the form of wording, one can have before the policies are imple-
methods for overcoming them are considerable confidence in gene- mented. Obviously the best way to
covered in Section 2.2. ralisability across the inevitable do this is if the measures can be
In principle, the response to a wording differences between part of the countrys ongoing
question can be directly compared languages. However, where res- surveillance system. Where this is
when the respondents are an- ponses are sensitive to wording, it not possible, the studies should be
swering the same question. Peo- is less likely that different forms implemented as early in the
ple generally assume this means are actually measuring the same process of discussing policy
the same wording. However, construct, and extra care will be change as possible.
under some conditions, the same required in translation. For detection of trends, it is
wording can result in quite differ- important that both sampling
ent questions being answered, Study designs for evaluating frame and participation rates
and different wording may be re- population interventions remain constant. This is to
quired to achieve equivalence. maximise the likelihood that
The most obvious example is ask- To best understand the impli- biases are likely to remain
ing questions in different lan- cations of policy change (including constant so that any changes are
guages, but it can occur for the community-wide dissemination of unlikely to be due to a sampling
same language where respon- interventions), research designs effects. Repeatability is more
dents assumptions about what is should be as strong as possible. In important than representativeness
being asked can vary systemati- Section 2.1 the relative strengths for determination of trends
cally, and achieving equivalence of various evaluation designs are because it requires comparability
requires different contextualising can-vassed. In short, evaluation is between estimates over time.
words for different individuals. strengthened with more obser- Such a research agenda re-
This can be caused by words hav- vations (both before and after the quires monitoring of all relevant
ing different nuances in different intervention) within the population variables in a diverse range of
cultures, or effects due to the fa- an intervention occurs in, the more communities or jurisdictions over
miliarity and or normativeness of populations that are studied in a period of time in which there are
the issues being asked about. parallel, and the more alternative differences in policy implementa-
As surveys become stan- explanations for outcomes that tion between those communities.
dardised, there is a tendency for are assessed within each study. In This will include use of repeated
surveys to converge on common addition, the use of cohorts adds cross-sectional surveying, and
ways of asking questions, thus considerable power by allowing where possible, more in-depth lon-
implicitly operationalising the mediation and moderation effects gitudinal cohort studies of samples
constructs they are interested in. to be tested more precisely. of relevant individuals (e.g. smok-
To the extent that either the Finally, representativeness of the ers, and young people at risk of
operationalisation has an arbitrary sample to the study population uptake), to begin to explore how
element or the measure is flawed, can increase the generalisability of the changes come about and
there is a risk of institutionalizing findings. The ITC study (Fong et whether some groups are affected
error. To avoid this, it may be al., 2006a) is a good example of differently to others. This survey-
important to analyze whether what can be achieved by ing will need to be complemented
different ways of asking questions attempting to implement as many by longitudinal monitoring of eco-
may improve the ability to of these attributes as possible. logical variables. The level (nation,
measure a construct. There is Achieving the strongest pos- state, local area) of the variable
always a role for asking questions sible evaluation involves putting in measurement will determine the
28
practicality of maintaining ongoing Temporal relationship between outcomes of interest. Smoking

monitoring of all activity or whether intervention and change in prevalence or rates of quitting are
some sampling is necessary. target outcome; determined by multiple factors,
Such a program of data collec- Exposure-response gradient; and establishing the contribution
tion is needed to provide the infra- Biopsychosocial plausibility; of each individual intervention is
structure necessary for under- that is, the effects can be ex- difficult. The task of differentiating
standing the mechanisms of pop- plained as occurring through a the contribution of all possible
ulation level change. Among other plausible mix of biological, psy- contributors to the observed
things, it would increase under- chological and/or social pro- effects is difficult.
standing of which factors are cul- cess; In providing a summative
ture-sensitive, and which are not, Coherence across lines of evi- evaluation of the effects of an
and how the roles of various fac- dence with different threats to intervention, we need to not only
tors change as a persons position validity, e.g. similar results consider the size and nature of
towards changing and adopting tar- using aggregate data and self- effects, we also need to consider
get behaviour changes. Similarly, it reported consumption could the possibility that there is no
would allow for an understanding rule out response biases; meaningful effect. In particular, it
of how community readiness to Coherence of results from is important to make a clear
change affects realized change demonstrations of effects on distinction between evidence of
and how readiness can be modified, different parts of the theorised the absence of effects, and the
as well as the conditions that facili- causal pathway, or by demon- situation where there is a lack of
tate the institutionalization of strating efficacy of components evidence; that we really do not
change. For policy makers, it can (e.g. the evidence of efficacy of know whether an intervention
provide information on need for fur- many cessation aids makes it works or not. We recognize that
ther action. more likely that they have ef- science cannot prove the null
fects when delivered as part of hypothesis, but it can and should
Drawing conclusions about programmes of help); make statements about inter-
causes Evidence that this type of interventions where there is a
vention can have effects on consistent failure to find evidence
The approach the WG has taken to other comparable outcomes of any meaningful effect.
evaluation shares more with the (e.g. on other behaviour pat- We need to qualify effects with
methods used in epidemiology to terns); a statement about generalisability.
determine causes of illness, than Consistency of observed ef- Some interventions have similar
the reliance on RCTs to assess fects across studies and popu- effects in most contexts, others
clinical interventions. As a result, lations, or clear patterns in the can be quite context-specific. This
when considering criteria to use in variability to demonstrate limits consideration needs to cover cul-
drawing conclusions about the to generalisability; tural adjustments to the interven-
effectiveness of policy inter- To which we would add: Elimi- tion itself, as well as factors in the
ventions, we have adapted the nation of theoretically possible environment that might affect its
criteria used in the epidemiology of alternative mechanisms for ex- potency (effect moderators). It is
disease (Hill, 1965). The adapted plaining the observed effects. also important to consider the di-
criteria are: Policy evaluation has added rection of effects. Some interven-
challenges to other forms of tions might prove counter-
Magnitude of the observed outcome evaluation, because productive. Clearly less evidence
effect, particularly in rela- policies usually occur in a mix and should be required to stop an in-
tionship to known naturally policies are only one set of factors tervention where the evidence
occurring variations; that are responsible for the suggests that it is counter-produc-
29
tive, than if it suggested no effect quitting. However, nobody has helping to show that policy
or only a small positive effect. shown that there is more quitting evaluation has rigorous methods
The levels of evidence in the context of stronger health and can make important
framework used to evaluate warnings being introduced. How contributions to knowledge.
discrete interventions is not reliably can one conclude that We also hope it will act as a
appropriate for use in evaluating stronger health warnings stimulate stimulus for further action to
policy interventions. We see more quitting? improve evaluation methods and
promise in adapting the criteria Finally, once the effectiveness measures. As such, this Hand-
used by the International Agency of an intervention is established, book will need to be kept as up-to-
for Research on Cancer (IARC) less powerful research designs date as possible. This might
for its Cancer Prevention will be needed to monitor involve periodic revisions once the
Handbooks. This is essentially a continuation of effects and/or to principles have been tested, or
four-level system: Sufficient evi- assess whether similar magni- some other mechanism for
dence of an effect, Limited tudes of effect are attained with moving our expected standards
evidence, Insufficient evidence, new populations. It is only when forward. There is a particular need
and Evidence suggesting lack of there is reason to believe that to update the material on specific
effect. The WGs concerns with there are real differences that measures and on the status of
adapting this framework to our stronger research methods might data repositories, as these are in
purposes, is that it does not allow need to be reapplied. a constant state of change.
for gradations in confidence of We hope this Handbook will
concluding no effects, it does not How to use this Handbook provide a stimulus to work towards
clearly differentiate adverse greater coordination of the ways in
effects, and it does not consider This Handbook is designed as a which policy evaluation operates
issues of generalisability, all of guide for program and policy and the development and/or
which are desirable qualifiers in evaluators. The WG hopes it will expansion of international reposi-
the policy context. One possibility be used as a tool for training new tories to collect the relevant data
would be to adopt a matrix as evaluators and those who need to and reports, and user-friendly
shown on this page, with understand evaluation principles. ways to extract this information
additional statements on effect It can act as a reference source for and synthesise it.
size (for established effects) and arguments about the role of Some future actions the WG
on generalisability. evaluation and the way to think would like to see:
The effect size could be rated about evaluation, and by
as: Small, Medium, or Large (or extension the development of Work to coordinate and arrive
undetermined). Consideration effective interventions. In doing at a set of core terms that are
needs to be given to whether the so, we hope it provides a most useful for our field.
highest level of certainly could be framework for increasing the Work on what the criteria for
applied to interventions where scientific credibility of the field, by validation should be for the
there had not been a direct
demonstration of effects on the The evidence matrix
target outcome, or whether
inferred effects could ever be No evidence is available
rated as better than Probable. For Possible effect: Negative Not meaningful Positive
example, it has been shown that
Probable effect: Negative Not meaningful Positive
larger health warnings lead to
more thought about quitting, and Established effect: Negative Not meaningful Positive
that more thoughts predict future
30
various kinds of measures In conclusion, this volume out the latest methods and some
used, and how that relates to should be thought of as an impor- guidance in assessing the need to
the different types of mea- tant step in a process, rather than move beyond the measures and
sures. as a static recipe book for evalu- methods described here. We be-
Development and agreement ating tobacco control interven- lieve that this dynamic but sys-
on use of prototype formats for tions. The methods described and tematic approach is the best way
reporting on frequently re- the measures provided are the to approach the future because it
peated interventions, such as best available today. The princi- provides a framework that allows
mass media campaigns. This ples outlined in this volume will evidence to guide action both be-
will facilitate their combination persist, but those principles re- fore and after programmes or poli-
into meta-analytic studies, es- quire that methods and measures cies are implemented.
pecially important for under- be adapted to the changing world.
standing where and when The WG has built into this Hand-
things work. book some guidelines for seeking
31
section2.1plus2.2janvier12:Layout 1 12/01/2009 13:34 Page 33
2.1 The importance of design in the evaluation of

tobacco control policies
Introduction and Rootman et al., 2001 for the design, not in the statistics. No
evaluation of health interventions). statistical method, not even those
The goal of this section is to We focus on impact evaluation, that whose name may imply some
describe elements of research is, whether the implemented policy special status in this regard (e.g.
design for evaluation studies and led to desired outcome(s), rather causal models) can confirm causal
how they can form the basis for than other forms of evaluation, such direction. A structural equation
stronger conclusions about the as process evaluation (e.g. model (with or without latent
impact of policies. The groundwork identifying and evaluating the variables) that yields a significant
for evidence-based medicine has processes that led to the creation coefficient for AB cannot be used
come from painstaking evaluation and/or the implementation of a by itself to conclude that A causes
studies of treatment options. It policy). B rather than B causes A. To do so
follows then that the foundation of More specifically, our aim is to would be to fall prey to the logical
an emerging evidence-based public highlight how the inclusion of error of affirming the consequent:
health policy must begin with specific features in the design of a
building a database from rigorous policy evaluation study can lead to Statement: If A causes B, then the
evaluation of public health policies. more concrete conclusions about AB path will be statistically
It should be noted that the elements the possible causal impact of that significant
of research design that we offer in policy. This section focuses mostly Observation: The AB path is
the domain of population-level on the structural aspects of statistically significant
tobacco control can easily be research design. Good evaluation False Conclusion: Then A causes B
applied in efforts to evaluate any design involves the selection of
population-level policy or inter- appropriate measures of high The advantage of more
vention in public health. Just as validity and reliability. Guidelines advanced statistical techniques is
surely as the laws of gravity operate and recommendations for such that they can take into account
in Mumbai as they do in Lyon, the measures, across tobacco policy characteristics of the data to yield a
principles of causality, and the domains, are provided in other better estimate of the AB path
methods employed to make more sections of this Handbook. coefficient. For example, structural
confident judgments about causal This section does not provide a equation modeling with latent
relations, are not constrained by review of the statistical analyses variables (Bollen, 1989; Hoyle,
location nor area of research. that are employed in evaluation 1995; Kline, 2005) explicitly models
This section does not offer a studies. However, we do wish to the measurement error from
comprehensive review of evaluation point out one common mis- multiple measures of a construct
research design. (see Cook & conception about the role of (latent variable), so that the resulting
Campbell, 1979; Shadish et al., statistical methods in attempts to estimate of the relation between that
2002; Rossi et al., 2003 for ascertain causality from data: latent variable and another variable
discussions of evaluation research, causality is to be found in the is free of the measurement error
33
that would otherwise have biased This suggestion is part of the sured or design features to be
the estimate1. However, this recommendations for best incorporated, so that the evaluation
statistical method does not practices that the US Centers for of the policy can explicitly take
advance in any way the argument Disease Control and Prevention them into account.
that A causes B rather than B created for tobacco control
causes A. In fact, a system of programmes in 1999. They Causality
variables with paths going in one strongly recommended that 10%
direction will yield exactly the of the total budget for a Ultimately, the goal of scientific
same model fit as if that same comprehensive tobacco control inquiry is to attempt to identify
system of variables had all the programme be allocated for causal relationships. The concept
paths going in the opposite evaluation and surveillance efforts of cause has challenged and
direction. associated with the programme vexed philosophers and scientists
The key to advancing the quest (1999a).The WHO EURO Working alike through the centuries. The
for causality is to be found instead Group on Health Promotion seminal work of epidemiologists,
in the design of a study. Here we Evaluation made a similar call for such as Doll and Hill (1950,1954),
offer a review of the elements of resources for proper evaluation Wynder and Graham (1950), and
the design of evaluation studies (Rootman et al., 2001). Levin et al. (1950), on the
that will increase the confidence Planning should first identify the association between smoking and
with which causal statements can constructs that are theorized to be lung cancer, stimulated the
be made between and among affected by the policy being thinking about identifying criteria
variables (e.g. whether a tobacco evaluated (i.e. outcome variables that would be used in the
control policy had a desirable and mediators), as well as those determination of causality in
causal impact on behaviour). that could influence the strength of epidemiology. This influential work
In our review of research the impact of policies on those was the basis of the US Surgeon
design features for the evaluation outcome variables and mediators Generals Report of 1964, and
of tobacco control policies, we (i.e. moderators). The choices of was summarized in several
describe the framework of the which constructs to include in an articles including one by A.
International Tobacco Control evaluation study come from this Bradford Hill (1965). We have
Policy Evaluation Project (ITC process. This Handbook provides adapted the original nine
Project), which incorporates a descriptions of the constructs, and considerations of Hill, in assessing
number of the design features that their measures, for many of the the strength of evidence, into
are discussed here (Fong et al., Framework Convention on seven criteria concerning the
2006a; Thompson et al., 2006). Tobacco Control (FCTC) policy possible causal impact of a
domains. tobacco control policy:
The importance of pre-eval- Identification of other possible Consistency of observed
uation knowledge in the events that might act as associations across studies
design of evaluation of confounding factors (e.g. other and populations
policies tobacco control policies being Magnitude of the reported
implemented and programmes in association
The planning and design of operation, tobacco industry ini- Temporal relationship between
evaluation efforts should be the tiatives) should also be addressed intervention and change in
first step in the process of in the planning stage. Knowledge target outcome
formulating and implementing a of possible confounders may allow Exposure-response gradient
policy (or any kind of intervention). additional variables to be mea- Biopsychosocial plausibility
1
This assumes that the common variance of the multiple measures of the construct perfectly capture the latent variable that the measures
are intended to capture.
34
The importance of design in the evaluation of tobacco control policies
Coherence of results across dependence? What are the most reduced; however, it should be
other lines of evidence valid measures of perceived risk noted that this conclusion is not
Evidence that this type of among smokers? These basic automatic. It may be that the way
intervention can have effects measurement issues must be in which a sample deviates from
on other comparable outcomes dealt with in order for the validity the population is not (strongly)
(e.g. other behaviour patterns). of a causal inference to be associated with the variables
addressed with any substance or being analyzed; thus, the net
From criteria for causality to meaning. Sections 3.1 to 3.3 of impact may not be as great as
research design: the frame- this Handbook review the might have been expected.
work of Cook and Campbell construct validity of measures to Another way in which external
assess the effectiveness of validity applies to the evaluation of
Cook and Campbells (1979) tobacco control policies. policies and interventions is in the
seminal treatise on the relationship External validity, also known as distinction between efficacy and
between research design of a ecological validity, refers to the effectiveness (the former referring
study and the strength with which extent in which the conclusions of to a treatment effect in a controlled
a causal relationship might be a given study are maintained context, and the latter referring to
ascertained, is our starting point for across different persons, settings, the effect of that same treatment
a discussion of how design treatments, and outcomes in a more real world setting). In
features can be employed to (Shadish et al., 2002). External general, effectiveness is lower
evaluate the impact of population- validity considers issues such as than efficacy. Interventions
level tobacco control policies. whether a phenomenon studied in originally developed and tested in
Central to the Cook and a laboratory setting, often highly controlled experimental
Campbell framework is the concept involving university undergra- settings are often not as effective
of validity. Cook and Campbell duates, will be obtained in a when implemented in the real
defined four kinds of validity that are real-world environment, which world. This necessitates changes
critical in assessing the validity of a includes individuals from the in an intervention when brought
causal statement: construct validity, general population. However, in into real world settings in order to
external validity, statistical conclu- the public health realm, two issues maintain its effectiveness, as in
sion validity, and internal validity. of external validity (whether or not the more controlled settings.
Construct validity refers to the the issue is expressed in these The two types of validity
extent in which a measure terms) arise. First, there is the described above set the stage for
captures the construct that it is importance of sampling. In the next two forms, which deal
intended to assess. An issue that evaluating a tobacco control policy with the relationship between two
arises in considering construct being implemented in a large and variables and whether the
validity is the method of diverse population (e.g. in an measured association is indicative
measurement and whether there entire country), probability of a causal relationship. For
exists a close or distant sampling methods will provide the simplicity, our discussion revolves
relationship between those best assurance that the study around whether there is a causal
measurements and the construct. sample will be representative of relationship between two vari-
In the area of tobacco control, the population from which the ables, although the logic applies to
examples include: Is cotinine a sample has been drawn and to relationships among more com-
valid measure of exposure to which the intended intervention is plex sets of variables.
tobacco smoke? Is the Fager- directed. To the extent that a Statistical conclusion validity
strom Test for Nicotine sample deviates from a repre- refers to whether there exists a
Dependence (Heatherton et al., sentative sample, the external statistical association between the
1991) a valid measure of nicotine validity may be correspondingly two variables. Issues surrounding
35
the consideration of statistical 1. Who the study is collecting internal validity. One such feature
conclusion validity include: statis- measurements from relative to is the inclusion of multiple
tical power, assumptions of the the policy that is being measures within the domain of the
statistical tests being employed, evaluated. Some evaluation policy that is being evaluated,
the inflation of Type I error rates studies only measure the toward the goal of achieving
due to the conduct of multiple impact of the policy by col- convergent validity (multiple
statistical tests, unreliability of lecting measurements from measures of the same construct
measures, as well as the selection those who were exposed to the should be related to each other).
of appropriate covariates/control policy; other evaluation stu- For example, in a study of the
variables in estimating the dies, however, measure the impact of graphic warning labels,
relationship between the two impact by also collecting we would have greater confidence
variables. Though correlation is parallel measurements from that there was a causal impact of
important and necessary, it is not those who were NOT exposed the labels if, after being exposed
sufficient to imply a relationship for to the policy. to them, smokers were signi-
causation, as captured in the 2. When the measurements were ficantly more likely to: (1)
dictum correlation does not suffice collected relative to the policys self-report that the warnings made
to establish causation. implementation. Some evalua- them think about the health risks
Internal validity refers to the tion studies only collect of smoking, (2) more likely to call a
extent to which the studys design measurements after the policy quit line, and (3) more likely to cite
is rigorous enough to support the was implemented; others the warnings as a reason for
conclusion that the statistical collect measurements both seeking assistance for quitting,
relationship between two variables before and after the policy was than if only one of these measures
is due, at least in part, to a causal implemented. was included in the study.
relationship. Here we focus on 3. How many measurements are Another study feature is the
issues of internal validity, as adding collected. Evaluation studies inclusion of measures that are
design features to a study (e.g. a vary in the number of relevant to some other policy that
control group) is largely prompted measurement time points, is NOT being evaluated, as it is
by the objective of increasing the ranging from a pre-post design not changing in the study
internal validity of the study. The involving one pre-policy and population toward the goal of
most relevant threats to internal one post-policy time point, to a establishing discriminant validity
validity in the evaluation of tobacco time series design involving (i.e. measures of different con-
control policies are presented in many measurements over time. structs should NOT be so related
Table 2.1. A further design parameter to each other). In the policy
arises in evaluation studies evaluation context, measures of
Basic study designs and fea- involving more than one mea- the non-changing policy should
tures surement over time; that is, NOT show change that is
whether those multiple measure- comparable to that in measures of
We now proceed to a description ments are obtained on the same the policy under evaluation. In
of aspects of an evaluation study, individuals (the longitudinal or addition, inclusion of measures
and make a distinction between cohort design) or on different that will allow the testing of
study design and a study feature. individuals (the repeat cross- mediational models are designed
The study design is the sectional design). to elucidate the causal pathways
structural aspect of an evaluation In contrast, a study feature is a between the policy and an
study, defined by three dimen- non-structural aspect of a study important outcome variable, such
sions: whose inclusion will enhance the as a quit attempt. For example, in
ability to address threats to an evaluation study of graphic
36
AMBIGUOUS TEMPORAL PRECEDENCE: Lack of clarity about which variable occurred first may yield confusion
about which variable is the cause and which is the effect.
Cross-sectional survey data are particularly vulnerable to this threat.
SELECTION: Differences in respondent characteristics between groups that could also cause the observed effect.
For example, observed differences between countries could be due to characteristics of the inhabitants rather
than to differences in policies. Cross-sectional studies are particularly vulnerable to this threat.
CONCURRENT EVENT CONFOUNDING (HISTORY): Events occurring concurrently with treatment could cause the
observed effect.
For example, observed differences between countries could be due to other events or some other intervention (e.g.
mass media campaign) rather than to differences in policies. This kind of confounding also includes activities of
tobacco companies, which may be covert. These other events can cause the observed effect to seem stronger or
weaker, positive or negative, compared to the policy/interventions true effect. Concurrent event confounding could
occur in longitudinal (cohort) studies, as well as in cross-sectional studies.
TEMPORAL TREND CONFOUNDING (MATURATION): Naturally occurring changes over time could be confused
with a treatment effect.
For example, trends over time occurring prior to the policy being evaluated, that are unrelated to the policy, could
mimic the expected impact of policy or an adverse impact of policy (e.g. bar revenues dropping prior to the
implementation of the policy could be the cause of a decrease in bar revenues observed after a smoke-free law
compared to before the law).
ATTRITION: Loss of respondents to treatment or to measurement can produce artefactual effects if that loss is
systematically correlated with conditions.
Artefactual effects due to attrition can occur in cohort surveys of different groups (e.g. countries) where the attrition
rate varies across the groups, and that attrition is linked to the outcome variable either directly or indirectly, via its
linkage with an important predictor of that outcome variable. Related to attrition is non-respondent bias, in which non-
respondents in an evaluation study could be differentially affected by the intervention (e.g. the very disadvantaged,
who may be missed by both the intervention and its evaluation). Note that attrition effects in cohort surveys and
selection effects in cross-sectional studies both involve biases in the sample that could lead to artefactual effects.
CONDITIONING (TESTING): Exposure to a test can affect scores on subsequent exposures to that test, an
occurrence that can be confused with a treatment effect.
An example of this threat is the presence of time-in-sample effects in cohort studies: participation in prior waves of
a survey change the responses at the current wave (e.g. knowledge items, if repeated, can lead to observed higher
levels of knowledge because of taking part in prior surveys).
Table 2.1 Selected Threats to Internal Validity and Examples
37
warnings, confidence that the analysis. For instance, the unit has affected them since. One
introduction of graphic warning could be human respondents to a should be cautious about the
labels was responsible for an survey, consumption figures from findings of studies relying solely
increase in quit line calls, rather an economic database, or a venue on such strategies, as con-
than a mass media campaign, at which the levels of respirable siderable experimental and survey
would be greater if there were suspended particulates are being evidence has demonstrated that
measures included of the mass measured. The diagram of this such recall is subject to strong
media campaign (e.g. recall design is as follows: retrospective biases related to the
measures of the campaign), and respondents theories on how the
that these measures were not X O1 intervention might have affected
correlated with the likelihood of them. These recall biases can
quit line calls. O1 occurs after the policy X occur when the respondent
In short, the internal validity of has been implemented. remembers the past as being
an evaluation study can be In this post-only design, there more similar to the present than it
increased by including multiple is no sense of what the actually was (consistency bias).
measures of the policy, or other observations would have been in When asked to estimate whether
intervention, that is hypothesized the absence of X ; therefore, this an intervention affected them, the
to be responsible for the policys design alone is very poor. It does recall bias could be in the direction
impact, as well as measure(s) of not defend against any of the of greater contrast (i.e.
other possible causes. threats to internal validity except remembering the past as being
ambiguity about temporal more discrepant from the present
Designs for evaluation precedence. The history effects, than it actually was, with the
studies and all threats associated with magnitude of this contrast bias
changes over time, are un- being correlated with the res-
In considering designs, we use the controlled. pondents belief about the strength
terminology of Cook and Campbell Given that none of the threats of the intervention (Conway &
(Cook & Campbell,1979; Shadish to internal validity are dealt with in Ross, 1984; Ross, 1989; Pearson
et al., 2002) in which X stands for this design, its value for evaluating et al., 1992)).
the treatment/policy that is being policies, or interventions of any Another more promising
evaluated (e.g. introduction of kind, is low. And yet it should be method of amplifying the value of
graphic warning labels, increase in noted that the absence of a pre- the one-group posttest-only
taxation, smoke-free legislation), test in this design often arises design is to incorporate data about
and O stands for an observation when the need for evaluation is pre-policy observations that are
(e.g. a survey data wave, quarterly recognized too late for a proper available from other sources. For
report of cigarette consumption, or pre-test to be planned and example, if a new tobacco sur-
a set of data gathered by an air implemented. This highlights the veillance survey were created
quality monitoring device). need for evaluation strategies to after a tobacco policy had been
be established well before the implemented, incorporating pre-
Designs without control groups intervention is applied, as valence data from other
discussed earlier. surveillance surveys conducted
The one-group posttest-only In an effort to estimate the prior to the policy would offer
design: impact of X, researchers some comparison with a pre-
sometimes ask post-only res- policy measurement. The
In this design, the researcher has pondents to recall their behaviour, adequacy of this strategy would
conducted one post-policy obser- opinions, or attitudes prior to X, or depend on the similarity between
vation on some relevant unit of to make a judgment as to how X the two surveys (e.g. sampling,
38
method of measuring the outcome acquiescence bias)) are controlled example of the importance of
variable(s)). for at the individual level. This taking into account these time
leads to greater statistical power, related trends is presented later in
The one-group pretest-posttest and the magnitude of this this section.
design: increased statistical power is a In addition, designs with
function of the extent to which multiple measurements over time
This design adds a pre-policy individuals responses at O1 and allow the evaluation of poli-
observation to the previous O2 are correlated. ces/interventions whose intensity
design, and is denoted as follows: varies over time, permitting the
Multiple pretest-multiple possibility of correlating intensity of
O1 X O2 posttest design: intervention (e.g. measured by
programme expenditures) with its
Here the addition of the pre- This design extends the single- corresponding impact. An example
policy observation allows the group pretest-posttest design by of this approach was used in
computation of the difference the inclusion of additional pretest studies evaluating the California
score, O2 O1, some portion of measurements and multiple Tobacco Control Programme,
which might be causally posttest measurements within the which distinguished between three
attributable to the intervention X. group that received the time periods characterized by
The presence of an explicit policy/interventions, as in this different levels of program
measurement of the pre-post example with 3 pretest and 3 intensity: pre-programme, early
difference makes this far superior posttest measurements: programme, and late program
to the post-only design. (Pierce et al., 1998a).
This design is considerably O1 O2 O3 X O4 O5 O6
better than the one-group posttest
only design. There is an explicit With many time point Designs with a separate con-
measurement prior to the policy measurements, this design trol group but with no pretest
that is not inferred or reliant on the becomes a time series design.
validity of a respondents memory Variations within this multiple time Posttest-only design with non-
or estimate of effect. The O1 acts point model include multiple equivalent groups:
as a control against which the pretest-single posttest and the
post-policy measurement O2 can single pretest-multiple posttest In this design, a control group is
be assessed. In a repeat cross- designs. These designs provide added to the one-group posttest-
sectional design, when O1 and O2 opportunities for assessing the only design. This design can be
are taken from different samples impact of policies/interventions on utilized if the evaluation process
in the same population, the control the time related trends in the started too late to conduct a
exists at the level of the group. In outcome variable that are proper pretest measurement. If
a cohort design, when O1 and O2 unrelated to the policy, but which individuals were randomised to
are measured from the same without knowledge or mea- conditions, the groups would be
individuals, there is an additional surement of those trends, would equivalent on average, as
level of power: each individual bias the measurement of the randomisation equates groups
acts as their own control. Thus, policys impact. When present, with respect to all features of the
response tendencies (e.g. the time related trends constitute an individuals being measured.
tendency to use the high end of a important confounding factor However, in the evaluation of
response scale, or to agree with against which the effect of the national-level tobacco control
survey questions (also known as policy must be evaluated. An policies, or in other cases where
39
the unit of intervention is a O1 X O2 groups depends on the selection

jurisdiction or organization, there O3 O4 of those control groups and their
is no possibility of randomisation, similarity. Various strategies can
and hence, no possibility of The quasi-experimental design be used to enhance the selection
equating groups2. The resulting combines both elements that were of control groups that are
design is the posttest-only design used to enhance the internal objectively similar to the poli-
with nonequivalent groups: validity of the one-group posttest cy/intervention group on dimen-
design; added is a longitudinal sions that matter (e.g. smoking
X O1 component and a between-groups prevalence, socio-economic sta-
O2 component. In this design, the tus, similar levels of tobacco
critical starting point for an control intensity prior to the
Case-control studies fall into assessment of the causal impact policy/intervention that is being
this category, and often include of X is the construction of a evaluated in the study).
various procedures to enhance multiple difference score; the It would be more reasonable,
the possibility of causal infer- change over time of the for instance, to compare the
ences, such as methods for intervention group is compared to impact of graphic warnings in
matching the two nonequivalent the change over time of the group Canada to a control group in the
groups. Issues surrounding these that was not exposed to the USA than to a control group in
methods are well-identified in the intervention. The expectation, if Bangladesh. It should be noted
epidemiological literature (Roth- the policy was effective, is that the also that the similarity is not
man & Greenland, 1998), but it pre-post difference in the policy limited to the characteristics of the
should be noted that some of group will be greater than the pre- group. Relevant concurrent events
them, although possible with post difference in the non-policy should also be similar in the two
medical records among patient group. countries. If, for example, the
populations, may not be possible The internal validity of the impact of graphic warnings in
for implementation in evaluation quasi-experimental design, al- Canada were compared over time
studies of national-level policies. though generally greater than the with a control group in the USA,
single group pre-post design, is but during that time between the
Pretest-posttest designs with a dependent on the extent to which pre- and post-policy measure-
control group: the non-policy group is similar to ments there was a large decrease
the policy group (e.g. similar levels in taxes in the USA, but not in
This design is the basic quasi- of economic development, tobacco Canada, the test of the graphic
experiment in which the pre-post use prevalence). The greater the warnings would be confounded by
measurement of the group that similarity, the more reasonable the the fact that the control group had
received the policy is compared to comparison will be. changed in ways that would mimic
another group that did not receive Randomisation to conditions is the hypothesized impact of the
the policy: impossible in studies of policies. warnings. Although the dis-
The strategy of strengthening an crepancy of the difference scores
evaluation study via control would be consistent with the
2
It should be noted that even in a fantasy world where people are actually randomly assigned to live in two different countries, one of which
implemented a policy that the other did not, the randomisation would simply equate the personal characteristics of the respondents across
the two groups. On average, the two countries would be populated by people who were equal on age, gender, age of initiation, number of
past quit attempts, attitudes about the tobacco industry, etc. But left uncontrolled, would be the concurrent events that might occur along
with the intervention that was being evaluated. The randomisation of people would offer no assistance for eliminating the possibility that
observed differences between the two countries was due to differences in concurrent events. This demonstrates the limitations of
randomised trials in the real world, even if such were possible.
40
conclusion that the graphic cause must precede the effect. countries) are non-equivalent; that
warnings had a desirable impact, The temporal priority condition is, they could differ on dimensions
the pattern of the data could also provides challenges to cross- that are correlated with the
be explained by a significant sectional studies by measuring outcome measures used for the
unfavorable change in the dif- possible causes and effects at the evaluation of the policies. Selec-
ference score in the US control same point in time. It should be tion biases are difficult to identify
group due to the decrease in noted, however, that the temporal and eliminate. Randomisation to
taxes. priority condition refers to the conditions of an experiment is a
This example points out that temporal ordering of the under- powerful method for equalizing
the structural features of the lying constructs that are being potential biases due to the non-
design endow an evaluation study measured, rather than the equivalence of characteristics of
with the potential for teasing apart temporality of the data collection individuals. However, randomi-
possible alternative explanations, or observances per se. sation is not possible in studies
but that full realization of this In most cases, it is relatively evaluating national-level tobacco
potential is found in the selection simple to establish that the policy control policies; therefore,
of measures and analytic stra- precedes a measurement. Even in selection bias in some form
tegies that are designed to test for a posttest-only design, temporal remains in all evaluation studies.
the causal mechanisms that precedence is established: the One approach to dealing with
underlie an observed difference measurement followed the imple- selection bias within a given
between a policy group and a non- mentation of the policy. However, evaluation study is to select
policy group. These strategies are because the key question is control groups that are as similar
described below in the section on whether the evaluation measure as possible to the policy group.
mediation. changed as a result of the policy Thus, in evaluating the impact of
(i.e. whether the policy caused a policies in Canada, using the USA
Threats to internal validity change in the evaluation as a non-policy control group
and methods for reduction measure), the single mea- would be advantageous, as they
surement made in the posttest- are quite similar on many cultural
Having described some of the only design is insufficient even as and societal dimensions. If a
basic designs and strategies used the temporal precedence con- policy in Canada were evaluated
in evaluation studies, we now dition is satisfied. using, say, Kenya, as a control
proceed to a discussion of the This discussion highlights the group, the inherent differences in
threats to internal validity and importance of multiple time point the two countries would be much
methods for reducing them. As studies in assessing the causal greater, leaving room for many
mentioned earlier, the rigor of an impact of a policy/intervention, more confounding factors.
evaluation study is not only found and is illustrated in greater detail A second approach is to
in its design, but also in the below. measure differences between
features added to a study to countries on constructs that might
enhance its power and internal Selection: systematic differ- vary and act as possible
validity. Examples are provided ences over conditions in confounding factors in the
below. respondent characteristics that evaluation of policies. For
could also cause the observed example, in evaluating a policy in
Ambiguous temporal prece- effect: China compared to the USA, a
dence: possible confounder might be the
Selection bias refers to the fact fact that China is known to be a
A necessary, but not sufficient that individuals in different groups more collectivistic society, while
condition for causality is that a (e.g. different states, provinces, the USA is a more individualistic
41
society. Knowing this difference, tobacco research, it has been increased resources for cessation
the evaluation study could add a shown that tobacco industry- programmes, and/or campaigns to
measure of individualism-collec- funded studies of secondhand raise awareness of existing
tivism (Triandis & Gelfand, 1998), smoke are much more likely to cessation programmes.
and correlate this variable with the conclude that it is not harmful, For example, in 2003,
policy-relevant variables in each which is at odds with the very countries of the European Union
country. If individualism-collec- large number of non industry- implemented new tobacco-use
tivism was uncorrelated with the funded studies concluding that warnings, which were prominently
policy-relevant variables, then this secondhand smoke is harmful displayed covering 30% of the
would suggest that, even though (Barnes & Bero, 1997,1998; for package area. This corresponded
the two countries differed on this, review, see Bero, 2005) with the minimal standard of
it was not correlated with the warning labels under the
policy and thus could not be a History: events occurring con- Framework Convention on
viable alternative explanation for currently with treatment could Tobacco Control (FCTC). The ITC
observed policy impact. cause the observed effect: Four Country Survey was
The third approach considers launched in October 2002, in
multiple evaluation studies of the The internal validy of studies that order to collect the pre-policy data
same policy in different settings evaluate the impact of policies for evaluating the impact of this
and different times (i.e. of the over time, is threatened by events enhancement of the warning
overall consistency of the effects). occurring concurrently with treat- labels. In May 2003, the second
This is adopted from one of Hills ment/target policy which could wave was conducted in the same
criteria. If graphic warning labels cause the observed event. It is manner as the first post-policy
are found to be effective in often the case that one treat- data collection.
motivating individuals to quit ment/policy intervention is By the time of the second
smoking in Canada, Thailand, implemented in conjunction with survey, another important tobacco
Venezuela, Brazil, and Belgium, other policies/initiatives relevant to control policy had been put into
then our confidence increases in tobacco control. There are often action. In February 2003, the
making a general conclusion other events, programmes, and United Kingdom implemented a
about the causal impact of graphic interventions that are ongoing at comprehensive ban on advertising
warning labels. Making general the time of the policy that is being and promotion of tobacco-related
conclusions about policy impact evaluated. Therefore, a major products, via billboards, maga-
will not and cannot occur on the challenge is to estimate the impact zines and newspapers, direct mail,
basis of a single study, but rather of a specific policy in the field of domestic sponsorship (May 2003),
after the consideration of multiple other interventions that are website advertising and promo-
studies across multiple countries ongoing simultaneously. tions, and exterior signs in store
and time points. This principle is This is likely a common windows. This second policy
not limited to the evaluation of occurrence. If a government complicated the quest for
tobacco control policies. launches a comprehensive toba- measuring the impact of the
It is worth noting that lack of cco control programme, a frequent enhancement of the European
consistency across studies and recommended strategy would Unions warning labels. Below, we
provides an opportunity to be to implement multiple policies outline an empirical strategy for
examine what factors might be and interventions. This compre- distinguishing the effects of
responsible for that variance. It hensive approach might include different interventions.
may be that studies with weak mass media campaigns, higher Factors that also influence the
designs yield different conclusions taxation, advertising/ promotion/- outcome measures of an
than those with stronger ones. In marketing restrictions, bans, evaluation study of a specific
42
tobacco control policy include activities. In contrast, more policy- Maturation: naturally occurring
activities of the tobacco industry, specific outcome measures, such changes over time could be
which are designed to reduce or as label salience or the self- confused with a treatment
neutralize the effect of tobacco reported extent to which a smoker effect:
control policies and programmes. states that the warnings have
Without consideration of these made them think about the health Typically, the term maturation
countermeasures (which could risks of smoking, would be less refers to natural changes in
include explicit inclusion of likely to be influenced by industry individuals over time, such as
industry activity variables), a activities. And here there is a changes that children undergo as
policy evaluation study could lead trade-off: the measures of policy they grow older. However, the
to incorrect conclusions. impact that are specific to that concept might instead be called
Although the importance of policy are less vulnerable to time-dependent changes that are
identifying and measuring the influence by tobacco industry unrelated to the treatment. An
impact of tobacco industry counter-activity; as the measures example of how this concept must
activities cannot be over-empha- become broader (e.g. going from be identified and controlled for,
sized, the impact of such activities label salience to perceptions of comes from the claim made by
will vary depending on the out- risk to intentions to quit to quit opponents to the comprehensive
come measure. Broad, down- attempts), they are more smoke-free legislation in Ireland
stream outcome measures, such vulnerable to impact from tobacco that sales volume in pubs had
as prevalence rates, quit attempts, industry influences. declined as measured before and
etc., are likely to be most strongly after the March 29, 2004 ban
affected by tobacco industry (Figure 2.1).
Irish Ban
March 2004
Year
<HDU
Figure 2.1 Pub sales volumes immediately before and after implementation of the Irish smoking ban in
&HQWUDO6WDWLVWLFV2IILFHRI,UHODQG
2004
Source: Central Statistics Office of Ireland
Sales volumes are indexed so that sales volume in 1995 = 100
43
The data on the volume of pub in 2001, and then began to fall Time trends can also work in
sales before 2003 and after the fairly steeply. When the full nine the opposite direction. Suppose
2004 ban, as shown in Figure 2.1, year profile is considered, the that the ban in Ireland was
reveals that the volume of pub decrease between 2003 and 2004 implemented between 1997 and
sales (indexed at 100 for volume does not appear to be any 1998. If the evaluation study had
of pub sales in 1995) in 2004 was different than what would be been conducted with data from
lower (103.9) than it was for 2003 expected by the secular trends. only those years, it would have
(109.6). With just those two data The decline between 2003 and shown an increase in sales, which
points, it might be concluded that 2004 was not significantly more might lead to the false conclusion
the Irish ban caused a decline in dramatic than the declines that the ban was the cause of this
sales in pubs. experienced between 2001 and increase. Again, consideration of
However, Figure 2.2 presents 2002, and between 2002 and the pre-policy time trends would
the volume of pub sales for nine 2003. When the more long-term reveal that the secular trend was
years (19952003) prior to the maturation trends are con- indicative of increasing sales, and
Irish ban. Taking into consi- sidered, there was no greater taking that trend into account
deration the data from years prior decline after the smoke-free law would likely lead to a more proper
to 2003 leads to a very different had been implemented. Thus, the conclusion that the ban had no
conclusion. hypothesis that the Irish ban had a impact on sales.
Sales volumes had been rising detrimental impact on the volume The implications for research
steadily since 1995, hit their peak of pub sales is not supported. design are clear: evaluating the
Irish Ban
March 2004
Year
<HDU
Figure 2.2 Pub sales in volumes in Ireland for the period 1995-2004
&HQWUDO6WDWLVWLFV2IILFHRI,UHODQG
Source: Central Statistics Office of Ireland
Sales volumes are indexed so that sales volume in 1995 = 100
44
impact of policies is best impact of an intervention over time for the subsequent three. Biener
conducted with the inclusion of is the interrupted time series et al. (2000) used similar methods
data that allow the evaluation to design (a specific version of this to analyze prevalence data in
take place within the context of general design is the regression Massachusetts versus the
time trends. This example discontinuity design). In these remaining US states (except
highlights the value of having a designs, which require a fairly California because of their similar
surveillance system in place for lengthy series of observations over comprehensive programme), and
collecting data over time on time, the impact of an intervention concluded that the Massachusetts
outcome variables of interest. can be measured by its impact on programme led to a continued
Although the Irish pub data the mean function of the time downward trend in prevalence,
illuminate the importance of time series. In the regression dis- compared to the flattening of the
trend data, it also provides an continuity analytic framework, a downward trend in the other US
example of how even good time distinction is made between the states during that same time
trend data alone can sometimes be regression line that fits the data period.
incapable of yielding a clear points (capturing the relation Keeler and colleagues (1993)
estimate of policy impact. To between the outcome variable and examined monthly time series data
illustrate this, suppose the ban time) before the intervention, and from 1980 to 1990 in California in
occurred in 2001 instead of 2003, the regression line that fits the data their analysis of the association of
and the evaluation was conducted points after the intervention. The cigarette prices, taxes, income, and
with pub volume data from just 2001 analysis compares the two lines; anti-smoking regulations with
and 2002. Here, consideration of the effect of the intervention is cigarette consumption. Reduced
the time trend might be taken to measured as the difference in the consumption was found to be
mean that the ban definitely slope, the intercept, or both associated with tobacco control
reduced sales; however, it was still parameters of the line. This kind of policies. They highlighted the
positive up to that point. design can provide powerful impact of the tax increase in 1989,
If only the time trend were evidence for the impact of a policy which led to a greater decline in
taken into account, one might be in its temporal context. There are consumption, followed by additional
even more confident of the a number of sources that describe tax increases at other points along
conclusion that the ban decreased these models (Trochim, 1984; the time series.
sales. However, in 2001, Ireland Trochim et al., 1991; Box et al., In general, multiple time point
passed a law that limited the use 1994). data, particularly if such data are
of alcohol, which had an adverse Time series approaches have also available with control groups,
impact on sales volume. Because been used in evaluating the provide strong potential for teasing
of the presence of this known impact of tobacco control out possible confounding due to
negative causal factor, the impact programmes. For example, Pierce time related alternative factors,
of the Irish smoking ban would et al. (1998a) used piecewise and for providing confirmatory
remain ambiguous. Although time regression analysis on time series evidence for the impact of policies
trend data are important in data on cigarette consumption and programes. The strength of
resolving some threats to internal from 1983-1997 in California, this potential (and therefore
validity, they fail to eliminate the versus the rest of the USA, to confidence in attributing changes
threat to validity represented by demonstrate that the California in behaviour or some other
concurrent events in the absence Tobacco Control Programme, important outcome measure)
of information on the impact of initiated in 1989, led to declines in grows with the number of post-
such events. consumption. They also found that intervention data points, which
A research design that is also the impact of the programme was means that more definitive
concerned with understanding the greater for the first five years than conclusions might be reached
45
only after a greater delay than will lead to an artificial Time-in-sample: exposure to a
would be desired. The ability to enhancement of the treatment test can affect scores on sub-
come to more definitive con- effect. The cumulative result of sequent exposures to that test,
clusions increases with the attrition will be the net effect of an occurrence that can be con-
number of other evaluation conservative and liberal biases, fused with a treatment effect:
studies of a particular policy, or which will lead to uncertainty
type of policy; within a specific regarding the overall impact of A time-in-sample effect (also
(well-designed) study, the ability differential attrition in any given known as rotation group bias) is a
grows with the passage of time. survey situation. phenomenon whereby an indivi-
Both require greater effort/time Although attrition is unique to duals responses to the same
than is possible within a single cohort surveys, non-response bias question over time varies as a
pre-post evaluation study. is a problem in cross-sectional function of how many times the
studies, as well as cohort surveys. individual has responded to the
Attrition: loss of respondents to Non-response bias occurs when same question in the past (i.e. the
treatment or to measurement the surveyed sample differs from number of prior survey waves the
can produce artefactual effects the population, because some individual has participated in
if that loss is systematically types of respondents are less (Duncan & Kalton, 1987)). In a
correlated with conditions: likely to agree to participate in the cohort survey of nutrition, res-
survey, or are less apt to be pondents were systematically
Attrition is a major concern in contacted in the first place. This rotated out of the survey, so that
cohort surveys. In surveys about poses the same problems as at each survey wave there were
smoking, for example, those who attrition; many factors contributing respondents who had participated
quit are less likely to stay in the to non-response bias are present 1, 2, 3, and up to 9 times before. It
survey, even when specific in biases from attrition. was found that respondents
provisions have been made for As with all threats to validity, an reported eating smaller quantities
those who quit to move to a non- approach to dealing with attrition of food purely as a function of the
smoker/quitter survey, as in the is to measure its impact. The goal number of prior survey waves they
ITC Surveys (Thompson et al., is to develop a model of the had been administered (Nusser et
2006). Thus, it may be that if a correlates of attrition that identifies al., 1996). It is valuable to take into
policy or intervention is successful variables that are associated with account the time-in-sample effect
in increasing the proportion of the likelihood of attrition and the in the analysis of cohort data.
individuals who quit, the greater strength of the relationship.
attrition rate in the policy group, Toward this end, it is valuable in Additive and interactive effects
skewed as it is for those that quit, cohort designs to replenish cohort of threats to internal validity:
will attenuate the observed members lost to attrition at each the impact of a threat can be
treatment effect (i.e. it will make the stage with newly recruited added to that of another threat
statistical test of group differences respondents from the same or may depend on the level of
more conservative). Another sampling frame. Differences another threat:
potential bias due to attrition is between the responses of the
seen in respondents with low cohort and the newly recruited This statement reminds us that, as
socioeconomic status (SES), who replenishment sample can then be with any study, there exists more
are more likely to drop out. If the attributed to biases in attrition, and than one threat to internal validity
policy/intervention is more likely to to time-in-sample effects, to which and more than one source of bias
have an impact on high SES we turn next. in the estimate of an intervention
individuals, the differential drop out effect. Some of these biases may
46
be in the direction of over- post-policy time point, for example, ation of the graphic warning labels
estimating the effect; others may cannot be measured quantitatively. introduced in Thailand in 2005
be in the direction of under- The reason is that the actual value knowing that a post-policy
estimating the effect. The impact is dependent on knowledge of the measurement is required. But
of one source of bias can depend impact of spurious causal factors. when adding another group to the
on the level of a second source of The value of the second or third design, should this second group
bias. For example, the overall time point depends on whether the be a pre-policy measurement in
impact of participation bias over other causal factors would have Thailand, or a post-policy mea-
time will depend on the level of exerted a policy-consistent or surement in another country, such
attrition. policy-inconsistent impact, which is as the neighboring country of
unknown. In fact, if we actually felt Malaysia? It is strongly recom-
Cost ef fectiveness in the confident enough about the impact mended that a pre-intervention
design of evaluation studies of the other causal factors to put measurement be added. This is
them in such a formula, there because the starting point for all
On some dimensions, study would be little need to actually considerations of measuring the
design can be guided by a conduct the evaluation study in the causal impact of an intervention is
calculation of costs in relation to its first place! Even though we cannot in the difference between pre- and
benefits. The allocation of total be specific about the value of a post-policy (i.e. how respondents
sample size to number of clusters, certain design feature in an changed from pre- to post-policy
and number of individuals within evaluation study, we can make on a label-relevant variable).
clusters, is one example where some general statements about Having an explicit measurement of
prior information (e.g. the the likely relative value of one this pre-post difference is much
incremental cost of conducting the feature or design element over preferred to adding a control group
study in an additional cluster; the another. (Malaysia), as the researcher
intraclass correlation, a measure of As described earlier, the single- would still have to infer what the
the correlation of individuals within group post-only design is not outcome variable would look like in
a cluster compared to the sufficient for evaluation of a policy the absence of the policy at a time
correlation of individuals belonging (or any other intervention). So what prior to the policys implementation.
to different clusters) can be entered could be added to this single As long as there is sufficient time to
into formulas to create the optimal measurement? There are two collect pre-policy data, this recom-
sampling design given specific basic possibilities: (1) create a one- mendation is also the easiest to
resources available for the study. group pretest-posttest design by implement. In the evaluation of
In principle, the same is true for adding a pre-policy measurement national-level policies, it is simpler
designing an evaluation study to from the same sampling frame as to obtain multiple measurements
reduce threats to internal validity, the post-policy measurement: within ones own country than it is
that is, a study that stands to yield either the same individuals who will to obtain the same measurements
a more confident judgment about be measured at post-policy (cohort in a different country.
the causal impact of the design) or other individuals (repeat Thus, the single expansion
policy/intervention. But here, cross-sectional design); and (2) would favor the addition of pre-
however, the process cannot be create a posttest-only design with policy measures. In addition, the
guided by formula or algorithm in nonequivalent groups by adding a logistics of setting up the parallel
the same way as can be post-policy measurement from study (e.g. a survey) in another
accomplished in creating an another group who is not receiving country, with the establishment of
optimal sampling plan. The the policy/intervention. a second research team, and the
increment in internal validity due to For example, suppose a challenges of making the two
the addition of a second or third researcher is planning an evalu- parallel research efforts com-
47
parable in method and measures, Considerations of study fea- a powerful research design
would be great. tures in the evaluation of allowing more confident infer-
policies ences to be made about the
Summary of study design causal effects of policies and/or
considerations We have made a distinction combinations of policies. We now
between study designs and study turn to an illustration of the use of
To summarize, in the absence of features. In addition to the two these strategies in the Inter-
a randomised trial, there are two design considerations, there are national Tobacco Control Policy
study design strategies that can two study feature strategies that Evaluation Project.
be employed for the rigorous contribute to increasing an
evaluation of the effects of evaluation studys internal validity. The International Tobacco
policies. First is the use of The first is the measurement of Control Policy Evaluation
measurements both before and policy-specific variables that are Project (ITC Project)
after the policys implementation. theorised to be affected initially
These measurements can be after the policy is implemented. The ITC Project was established
taken from either units (usually, For example, in evaluating the with the goal of measuring the
but not limited to, individuals; the impact of a new warning label psychosocial and behavioural
same logic would apply if the policy on behaviour, one might impact of key policies of the FCTC
measures were of households, reasonably predict that for the on tobacco use among adult
schools, or other venues) that are policy to exert its effect on smokers (Fong et al., 2006a;
either the same (as in a cohort behaviour, the target population Thompson et al., 2006). As
design) or different, but drawn must first report noticing the new smokers are directly affected by
from the same sampling process warning labels (Hammond et al., tobacco control policies, this
(as in a repeat cross-sectional 2006). A second strategy is the understanding is crucial to
design). The second design measurement of policy-specific assessing the extent to which the
strategy is the use of a quasi- variables for policies that have not FCTC objectives are met, and of
experimental design, in which one changed; such variables act as desirable and undesirable col-
group that is exposed to a policy another form of control. In a lateral effects. The ITC Surveys
is compared to a similar country where labels have been were explicitly shaped by the four
unexposed group, as discussed enhanced and where taxation has strategies described above. To
above. Combining these two not, for example, we would expect date (as of December 2007), the
strategies in a single study yields that label salience would be ITC Surveys are a set of parallel
a two-group, pre-post design, improved over time, but taxation- prospective cohort surveys of
which offers a higher degree of relevant variables (e.g. perceived representative samples of adult
internal validity than either feature cost of cigarettes) would not. smokers in 15 countries
alone. The utility of longitudinal Recommendations for measures Canada, USA, UK, Australia,
designs is strengthened if there in each FCTC policy domain are Ireland, Thailand, Malaysia, South
are multiple data collections provided in other sections of this Korea, Mexico, Uruguay, France,
before and/or after policy Handbook. Germany, The Netherlands, New
implementation, allowing more Combining the two design and Zealand, and China, with
precise specification of effects two study feature strategies, along additional ITC Surveys under
(e.g. taking into account temporal with the inclusion of other development in other countries
trends that were occurring before explanatory variables (covariates) (Bangladesh, India and Bhutan).
the implementation of the policy). that might help explain differences With these additions, the ITC
between two jurisdictions, creates project will be conducting
48
evaluation of FCT policies in levels of analysis (e.g. social relate to their effectiveness.
countries inhabitated by over 50% structure and organization), and Several key characteristics of this
of the world populations, 60% of by factors at even finer levels of conceptual model require further
the world smokers, and 70% of analysis (e.g. individual differ- explanation. First, the model
the worlds tobacco users. ences of genetic susceptibility, focuses on how policies affect the
The ITC evaluation framework such as high versus low behaviour of individual smokers,
utilises multiple country controls, a metabolism for nicotine). Ulti- and thus circumvents the potential
longitudinal design, and a pre- mately, however, it is individuals hazards of making inferences
specified, theory-driven conceptual whose behaviour will or will not be about individuals from aggregates
model to test hypotheses about influenced by policies, and in (i.e. policy studies in which
the anticipated effects of specific order for us to understand these countries are the unit of analysis,
policies. behaviours, we must focus on the or individual-level studies that are
individual. repeat cross-sectional analyses
Conceptual model of the ITC The second assumption is that conducted over time).The pre-
Project: there exists a causal chain of sence of macro-level causal
changes within the individual forces that exert pressure on an
The first step in creating the ITC through which the impact of policy individual, are acknowledged in
Surveys was to determine how flows. This assumption directly the ITC conceptual model. For
policies may achieve their relates to the idea of mediation: example, societal norms toward
desirable effects. How do policies that policy causes changes in one smoking, economic conditions,
work? or more constructs, and/or a chain messages from the media that are
In order to address this of constructs within the individual, either pro- or anti-tobacco use,
important issue, a couple of which then eventuates in and the influence of family and
assumptions need to be des- behavioural change. The ITC friends are taken into con-
cribed. The first is that the most Project team created a conceptual sideration. The model specifies,
appropriate level of analysis, to model of how tobacco control however, that the impact of those
understand the mechanisms by policies might work based on a macro-level causes must be
which policies may ultimately combination of existing models measured at the level of the
change public health outcomes, is from the psychosocial literature individual through their percep-
that of the individual person. It is and from health communication tions of the presence of such
the individual who smokes or does theories. The resulting conceptual factors (e.g. beliefs about the
not smoke, the individual who is model, which is presented in norms and expectations of
influenced by anti-smoking media Figure 2.3, guided the selection of society, close friends, and family
campaigns or by marketing questions included in all ITC on smoking). In the end, it is the
campaigns of the tobacco indus- Surveys. individual who takes up smoking,
try, the individual who is or is not The ITC conceptual model who increases or decreases
influenced by societal norms or by assumes that each policy tobacco consumption, who does
influences from close friends and ultimately has an influence on or does not attempt to quit, who is
family, and the individual who behaviour through a specific successful or unsuccessful at
does or does not form intentions to causal chain of psychological attempting to quit, and who may
quit and then either does or does events. It is a general framework contract a smoking-related
not engage in an attempt to quit. for thinking about policies and disease and die. Of critical impor-
Having said this does not their effects on a broad array of tance, and a focus in the ITC
preclude the possibility, indeed the important psychosocial and conceptual model, is to capture
reality, that the individual can be behavioural variables, and for and measure the influences of the
influenced by forces at broader testing how policy distinctions many macro-level causes as
49
Policy
Policy-specific variables
Label salience Moderators

Perceived cost
Ad/promo awareness Country
Awareness of Sociodemographics
alternative products (e.g. age, sex, SES, ethnic background)
Proximal behaviours
(e.g. forgoing a cigarette Past behaviour
because of labels) (e.g. smoking history, CPD,
quit attempts)
Personality
Psychosocial mediators (e.g. time perspective)
Outcome expectancies Psychological state

Beliefs and attitudes (e.g. stress)
Perceived risk
Perceived severity Potential exposure to policy
Self-efficacy/perceived (e.g. employment status)
behavioural control
Normalisation beliefs
Quit intentions
Policy-relevant outcomes
Quit attempts
Successful quitting
Consumption changes
Brand switching
Tax/price avoidance
Attitude/belief changes
(e.g. justification)
Economic Public health

impact impact
Figure 2.3 Conceptual model guiding the formulation of questions in the ITC Surveys
Adapted from Fong et al., (2006a)
50
experienced by the individual. The more downstream effects The policy-relevant outcomes
Ultimately, in order for us to are on the non-specific psycho- that are measured in the ITC
understand the impact of policies social mediators, which are surveys include those that confer
and other macro-level influences conceptually distant from the policy public health benefits (for
on populations, it is essential to and theorised to be affected by example, quitting), but also
measure them at the individual multiple influences, not just include important compensatory
level. It is a fallacy that the policies. Among these are behaviours that the smoker may
presence of macro-level causal variables such as self-efficacy and engage in that, although
forces requires that macro-level intentions, which come from well- responsive to the policy, may not
modelling be conducted. known psychosocial models of lead to the economic and public
Second, policies are seen as health behaviour, including the health benefits that are ultimately
potentially affecting individuals theory of planned behaviour the goal of such policies. For
along a variety of psychosocial (Ajzen, 1991), social cognitive example, smokers may switch to
and behavioural variables, of theory (Bandura, 1986), the Health discount brands in response to
which there are two classes. The Belief Model (Becker, 1974), and price increases, which would
most immediate effects are those Protection Motivation Theory confer no public health benefit.
on the policy-specific variables (Rogers & Prentice-Dunn, 1997). The ITC Project thus attempts to
(those variables that are proximal The ITC conceptual model holds provide a more complete account
(conceptually closest), or most that policies will affect these of the effects that may result from
specifically related to the policy general mediating variables the implementation of a tobacco
itself). Thus, new graphic warning indirectly, through their prior effects control policy, and includes both
labels should increase salience on the policy-specific variables. As the detection of desirable effects
and the ability to notice warnings; each policy has its own policy- and of unintended, undesirable
price should affect perceived costs specific variables, there exists side effects.
of cigarettes (for example, belief potential to estimate the relative In summary, the ITC con-
that cigarettes have become too contributions of various policies to ceptual model is a causal chain
expensive); and lifting of res- the outcomes of interest. model, and, as such, suggests
trictions on alternative nicotine Third, the ITC conceptual that the policy-specific variables
products should lead to increased model explicitly identifies the play a critical mediating role
awareness of the availability of mediators of policy and articulates because they reside between the
those products. These effects may the goal of understanding the policy and the outcome variables
also increase the likelihood of psychosocial processes that that are important in public health
discrete behaviours specifically explain how and why a given (e.g. quitting behaviour). These
linked to the manifestations of the policy may lead to changes in causal paths, from policy-specific
policy such as smokers hesitating, smoking behaviour. The longi- variables to behaviour, could be
or even forgoing or stubbing out tudinal design allows the explicit direct, but more typically will be
cigarettes because of the warning testing of the causal chain of through the more general
labels. Examples of survey effects that is depicted in the mediators. In some cases, there
questions designed to measure model. With a repeat cross- may be pathways through several
policy-specific variables are pre- sectional design, the capabilities kinds of mediators, both the
sented in Table 2.2. Other of modeling the dependence of policy-specific, proximal variables,
sections of this Handbook change in an outcome on the and the more general, distal
describe these and other mea- changes in an explanatory variables. Policies are theorized to
sures of policy-specific variables variable are diminished as data on vary in the psychosocial routes
in each of the FCTC policy the same individuals are not that they take to affect behaviour,
domains. collected prospectively. that is, each policy has a different
51
Policy Domain Examples of Questions Measuring Policy-Specific Variables
Warning Labels In the last month, how often, if at all, have you noticed warning labels on cigarette packages?
Warning labels make me think about the health risks of smoking (level of agreement or
disagreement with this statement)
Smoke-Free Legislation Which of the following best describes the rules about smoking in drinking establishments, bars,
and pubs where you live?
Smoking is not allowed in any indoor area
Smoking is allowed only in some indoor areas
There are no rules or restrictions
For each of the following public places, please tell me if you think smoking should be allowed in
all indoor areas, in some indoor areas, or not allowed indoors at all?
Hospitals
Workplaces
Drinking establishments (e.g. pubs/bars)
Restaurants and cafs
Price/Taxation Where did you last buy cigarettes for yourself?
How much did you pay for your cigarettes?
The last time you bought cigarettes for yourself, did you buy them by the carton, the pack, or as
single cigarettes?
The last time you bought cigarettes or tobacco for yourself, did you use any coupons or discounts
to get a special price?
Pro-Tobacco Advertising In the last 6 months...how often have you noticed things that promote smoking?
In the last 6 months, have you noticed cigarettes or other tobacco products being advertised in any
of the following places: television, radio, at the cinema/movie theatre before or after the film/movie,
on posters or billboards, in newspapers or magazines, on shop/store windows or inside shops/stores
where you buy tobacco?
Now I would like you to think about advertising or information that talks about the dangers of
smoking, or encourages quitting. In the last 6 months, how often, if at all, have you noticed such
advertising or information?
Product Regulation Do you agree or disagree with this statement about light cigarettes: Light cigarettes are less
harmful than regular cigarettes?
Table 2.2 Examples of Questions Designed to Measure Policy-Specific Variables in the ITC Surveys
Adapted from Fong et al. (2006a)
52
Policy Proximal variables Distal variables Behaviour

(Policy-Specific) (Psychosocial Mediators)
Figure 2.4 Schematic model of how a policy intervention might work (general pathway)
Label Salience Perceived risk Intentions to

Labels Quit attempt
Perc Effectiveness Perceived severity quit
Depth of Processing
Figure 2.5 Schematic model of how an intervention such as warning labels on cigarettes might work
Denorm beliefs
Ad Ban Advertising salience Social accept Intentions to Quit attempt
Positive association Subjective norms quit
Figure 2.6 Schematic model of how an invervention such as banning of pro-tobacco advertissement
might work
mediational model for how it is which in turn affect behaviour The specific articulation of
theorized to operate (Figure 2.4). (Figure 2.5). these mediational models leads to
For example, an enhancement In contrast, advertising bans specific, theory-driven empirical
in warnings may first increase may first decrease awareness of tests. The strategy of testing the
salience/noticing, depth of pro- tobacco-favorable messages, impact of policies through media-
cessing, and other constructs that which may lead to reductions in tional models of this kind differs
have been identified by com- the perceptions that smoking is a from the approach taken in
munication theory as being an socially acceptable behaviour, dealing with threats to internal
important initial step for a then to the idea that subjective validity. That approach, which is
communication attempt to be and societal norms are more a process of falsification, uses
effective. The resulting heightened negative toward smoking, which is research design and analytic tools
perception of the risk or hazards of theorized to lead to quit attentions to determine that a possible
smoking should affect overall and quitting behaviour (Figure confounding factor was NOT
attitudes and outcome expec- 2.6). responsible for the observed
tancies, which affect intentions, pattern of data, whereas explicit
53
tests of mediational models level. And what role do microbe- validity is the concurrent events
provide the possibility for con- havioural reactions, such as forego- threat (also known as a history
firmatory analyses, which test ing a cigarette as a result of threat): the presence of events
whether a policy had its impact on noticing/reading warning labels, that occurred concurrently, such
an important outcome variable play in determining longer-term out- as multiple policies, or a mass
because it first caused changes in comes, such as quitting? media campaign that was imple-
a policy-relevant mediator. In order to address these and mented at the same time as the
In general, the design of the other conceptual questions about policy that is being evaluated.
ITC Surveys is guided by the the impact of warning labels, the How can these threats be
possibility of disentangling the ITC Surveys include multiple meas- measured and dealt with?
web of alternative explanations ures to empirically identify from the The only method of keeping
and competing forces through the service results which measures possible alternative causes from
careful selection of specific, may be important in understanding becoming confounders is to
theory-driven mediators. the impact of warning labels. In this measure their potential impact,
The ITC conceptual model of- regard, it should be noted that the and explicitly including them in a
fers an opportunity to test how best measure for understanding model that competitively tests their
policies impact or fail to impact an- the impact of warnings may depend impact. For example, if a mass
ticipated behaviour. For example, on whether the warning is text- media campaign is being imple-
the mere existence of a policy, based or whether it includes mented at the same time as a
even if implemented properly, graphic images. policy to be evaluated, measures
does not guarantee that smokers Mediational models have the of noticing, and the impact of, that
will be exposed to its conse- potential to identify causal mec- mass media campaign (see
quences in the ways anticipated. hanisms, and the importance of Section 5.6) could be included in
Using the example of warning la- this is that knowledge of the causal a post-policy survey, and those
bels, some smokers barely look at mechanisms can inform the measures used as covariates in
a pack when they are smoking and creation of interventions of an analysis of the impact of the
may rarely or never notice the potentially greater power. Thus, the policy. Although the study might
warnings. This, however, could be general mediation model is originally have been concep-
due to motivated avoidance, and it realized differently in diverse policy tualized as evaluating the policy,
is important to measure whether domains; different policies are including measures of the mass
this has an impact on behaviour. In mediated by different constructs. media campaign would augment
a cohort survey of Ontario smok- Because the ITC Surveys measure the study as a simultaneous
ers, Hammond and collaborators all of these constructs, it is possible evaluation of the impact of both
(2003) found that avoidance of the to begin to distinguish whether a policy and the campaign. The
graphic Canadian warning labels, change of behaviour (e.g. quit general point here is that
by means such as covering them attempt) was due to a given policy, unconfounding of alternative
up or by putting them in a cigarette in the context of other policies, or events in the evaluation of a policy
case, was not associated at follow- to other alternative events that can only be attempted through the
up with a decreased likelihood of a occurred at the same time. measurement of the possible
quit attempt. impact of those alternative events.
Additional research questions The use of mediational models It should also be noted that
can be addressed, such as whether as a mechanism for establish- even randomisation to conditions
is it sufficient for someone merely to ing the effect of policies: does not eliminate the threat to
notice warnings or whether it is nec- internal validity posed by con-
essary to read them closely, or As described earlier, an important current events. If randomisation
process them at a deeper cognitive and vexing hazard to internal were possible in policy evaluation
54
Taxation Taxation
Labels Rate of quit Labels Rate of quit

Countries attempts Countries attempts
Ad/Promo Ad/Promo
Smoke-free Smoke-free
(a) Basic layout of mediational model designed to test whether (b) Between the two ITC survey waves, for each of the four policy
any of the policies might have been causally responsible for the domains, did any of the countries make a change?
difference between countries in the rate of quit attempts.
Taxation
0
Labels Labels
* Rate of quit * Rate of quit
Countries Ad/Promo attempts Countries attempts
*
* Ad/Promo
0 Smoke-free
(c) Between the two ITC survey waves, suppose there were two (d) The reduced mediational model, having eliminated
policy domains in which one country changed: Labels and Taxation and Smoke-free policies as possible mediators
Ad/Promo (starred paths from countries to those two policy
domains). There were no changes over time in the other two
domains. Thus, those paths are equal to zero, indicating that
differences across countries in the rate of quit attemps could not
have been mediated by changes in Taxation and Smoke-free
policies.
Labels
* Rate of quit Labels Rate of quit
* *
Countries attempts Countries attempts
*
*
Ad/Promo 0
(e) We then examine the paths from each of the two policy (f) Thus, Ad/Promo was not supported as a mediator between
domains (that is, the policy-specific measures for each of the countries and rate of quit attempts. That is, changes in Ad/Promo do
domains) to rate quit attempts to test whether the change in not help explain why countries varied in quit attempts. In contrast, the
those policy-specific measures is associated with differences significant paths from Countries to Labels and from Labels to Rate of
in the Rate of quit attempts. We find that the Label measures quit attempts supports the contentions that the change in warning
are associated with the Rate of quit attemps (indicated by a labels mediated the pathway from Countries to Rate of quit attemps
star), but the Ad/Promo measures are not (indicated by a 0). and that the change in warning labels was responsible for the increase
in the rate of quit attemps.
Figure 2.7 The use of mediational models for isolating the effects of specific policies
55
studies, there would still be the the ITC surveys, and several other quit attempts); personality charac-
need to measure the impact of countries are anticipated to do so teristics (time perspective, de-
other possible influences on in the future. pression, sensation seeking);
behaviour that had occurred The ITC Project is also other environmental effects (stress
between the policy intervention examining the impact of smoke- levels); and potential exposure to
and the post-policy assessment free laws in several ITC countries. policy (unemployed people should
point. To date, the impact has been be less affected by workplace
A more complete articulation of remarkably similar in Ireland smoking policies).
the strategy of teasing apart the (Fong et al., 2006b) and Scotland Dealing with hypothesised
impact of multiple policies, and/or (Hyland et al., 2007). Ongoing ITC moderators is relatively straight-
the presence of other possible surveys will allow a rigorous forward when they are postulated
influences/confounding factors comparative evaluation of the merely to add predictive power to
can be found in the approach to impact of smoke-free laws in other linear models. The issues become
mediational analyses (e.g. Baron ITC countries including France, more complex when different
& Kenny 1986; MacKinnon et al., Germany, The Netherlands and mediational pathways are postu-
2002; Mathieu & Taylor, 2006; and China. Given that the ITC Surveys lated for subpopulations. For
Spencer et al., 2005). An are using identical or very similar example, individuals who avoid
extended example of the logic of measures and parallel data warnings might change behaviour
the approach is provided in collection methods across the set through more emotion-related
Figures 2.7 a-f. The scenario is of ITC countries, the potential for pathways, while those who take in
that ITC countries varied in the making conclusions about the the information on warning labels
rate of quit attempts. For commonality or differences of the might be influenced through more
simpliciity, four policies are listed: impact of smoke-free laws, gra- cognitive pathways. The ITC
taxation, labels, ad/promo, and phic warnings, and the other Surveys have the design and the
smoke free, and the analysis FCTC policy domains will be measures that will allow the
involved the policy-specific varia- strong. creation of separate models for
bles associated with each of the Thus country and the these different subpopulations,
four policies. environmental and cultural factors which will make it possible to test
that country embodies, consti- whether different subpopulations
Moderator variables in the ITC tutes an important moderator within a country, as well as
Project: variable in the ITC conceptual between different country popu-
model. lations, respond in the same way
One of the most intriguing lines of Further, within a country, it is or differently to tobacco control
inquiry in the ITC Project is to possible to test for differential policies.
determine whether the impact of policy impact on subgroups of a
the same or similar FCTC policy population, by including variables Conclusions
differs across different countries. to determine which subgroups are
In the domain of health warnings more favourably (and less This section has provided some
(Article 11), the ITC Project is favourably) influenced by FCTC basic principles of how evaluation
addressing whether the impact of policies. These moderators fall studies can be designed to offer
graphic warnings differs across into five broad classes: socio- more confident judgments about
different countries. Among the ITC demographics (age, sex, SES, the causal impact of tobacco
countries to date, Thailand and ethnic background); past beha- control policies. It has also
Australia have introduced graphic viour (smoking history, current illustrated the use of study designs
warnings since the beginning of consumption (cigarettes per day), (the structural aspects of an
56
evaluation study) and study putative mediator but not another, of these policies on tobacco use,
features (the selection of measures non-policy interventions (e.g. but also to provide valuable
to be used in an evaluation study, mass media campaigns) can be insights into the development of
including theoretically guided tailored to influence those more effective non-policy efforts to
mediators and moderators). mediators that had been identified reduce the burden of tobacco use
The eventual outcome of in the evaluation study to be the throughout the world.
rigorous evaluation studies does operating causal forces leading to
not end with a causal statement, favorable changes in behaviour.
however. If mediational analyses Thus, rigorous evaluation of
demonstrate that a given policy FCTC policies has the potential
works through changes in one not only to demonstrate the impact
57
2.2 Developing and assessing comparable

questions in cross-cultural survey research on
tobacco
Introduction linguistic groups. In most cases, meanings ascribed to the same

however, the implications and question, whether phrased in the
The WHO FCTC aims to address methods we describe extend to same or different languages.
the global tobacco epidemic by intranational studies involving Conversely, true differences may be
coordinating national policies to different ethnic groups or even obscured by such factors as the
combat tobacco use. This volume single ethnic groups that speak the differential influence of social
illustrates possible conceptual same language (e.g. Spanish- desirability or the exclusion of items
frameworks, methods, and data speaking Latinos in the USA; people that are important indicators of
sets that will be useful for from different socioeconomic study constructs in one cultural
conducting comparative, interna- groups). In this regard, our general context but not in another. Whereas
tional research to better understand approach may be useful to the implications of these issues
which policies work and why. This researchers interested in ensuring appear most obvious for inter-
section aims to provide researchers the validity of comparative analyses national comparative research, if left
with a basic overview of mea- across cultural subgroups within unaddressed, they may also impede
surement issues involved in the increasingly multi-cultural, intra- our understanding of why certain
design and analysis of cross-cultural national settings. tobacco policies work better among
comparative research, as well as Cross-cultural and cross- some socio-cultural groups than
some of the methods currently national research is often done among others. In the end, valid
recommended for attempting to under the unexamined assumption cross-cultural comparison demands
resolve these issues. When that question meaning, compre- that measurement error be
possible, we illustrate our points hension and measurement pro- minimised across the settings and
with examples from cross-cultural perties are equivalent across groups of interest (Bollen et al.,
tobacco research. The organisation cultural groups (Bollen et al., 1993; 1993; Smith, 2004a).
of the section follows the general Smith, 2004a). However, cross-
stages of research design, illus- cultural differences in language,
trating the corresponding methods social conventions, cognitive Equivalence of conceptual
used to assess and to avoid abilities and response styles may frameworks
introducing systematic measure- cause systematic measurement
ment error due to cultural error that biases results in un- Cross-cultural survey research
differences across the populations predictable ways (Fiske et al., 1998; should begin by assessing whether
in which the research is carried out. Harkness et al., 2003a). Apparent the conceptual definitions and
The growing literature that we differences found across socio- theoretical frameworks that orient
discuss generally reflects concerns cultural groups may be merely due the study reasonably apply across
related to conducting comparative to measurement artefacts, such as the contexts in which the survey
research across nations and systematic group differences in the data will be collected. Consideration
59
of the universal applicability or this literature may simply not exist. however. As the number of
culturally-specific nature of study This problem may be addressed nations or cultural groups involved
concepts is important because by establishing collaborative in the study increases, so do the
their definitions should inform research groups that involve at amount of difficulty and time spent
subsequent stages of question least one representative from each to coordinate efforts and reach
selection, development, adapta- country or cultural group in which consensus (Kuechler, 1987).
tion and assessment. For surveys will be conducted Granting agencies often demand
example, some concepts may (Kuechler, 1987). Ideally, each clearly defined conceptual frame-
have single or multiple dimen- representative should have native works before they will fund a
sions, each of which should be language proficiency and be project, and without funding to
reflected in its conceptual knowledgeable of both the study develop this framework, it may be
definition. In some populations the topic and the particular contexts in difficult to engage collaborators.
social acceptability of smoking can which data collection will take The local representatives with
be characterised by at least two place. Formulating the studys whom collaboration occurs may
dimensions, one that references conceptual framework in dialogue actually be quite cosmopolitan,
close social network members among a team of such researchers perhaps directly or indirectly
and another that concerns per- can help anticipate incongruities in socialised into the Western
ceptions of a more distal, abstract the conceptual framework across scientific enterprise. Hence, the
socio-cultural milieu (Thrasher et survey contexts, and thereby avoid cultural perspective any parti-
al., 2006a). These referents may any ethnocentric or universalist cular representative provides may
be further subdivided by tendencies in measurement that be a hybrid form that is at once
perceptions of the actual beha- might result (Van de Vijver & transnational yet circumscribed by
viour (i.e. descriptive norms) and Hambleton, 1996). Furthermore, particular social class, gender,
desired behaviour (i.e. injunctive this dialogue may help identify and cultural divisions within the
or prescriptive norms) (Cialdini, cultural or contextual factors that country of interest. In this regard,
2003). Hence, at least four may be important modifiers of people who have direct know-
dimensions could be delineated tobacco policy effects. Such ledge of the local realities of target
within a conceptual definition of potential modifiers may otherwise populations in which survey
the social acceptability of escape consideration because research will take place may make
smoking. Nevertheless, the researchers in one context either more substantial contributions
number of dimensions may vary take them for granted because of toward the development of
between or within any particular their ubiquity or have never culturally applicable concepts.
population. Cross-cultural studies considered them because of their Even so, status asymmetries
should consider construct absence. For example, strong among group members may
dimensionality and whether it religious beliefs in some countries ultimately overwhelm more local
might differ across cultural groups. may play such a role. (and perhaps more locally
Ensuring the equivalence of The collaborative process of relevant), epistemologies, theories
concepts across cultural contexts defining the concepts and and concepts, particularly if they
or groups should begin with framework that orient ques- are incongruent with Western
literature reviews on the topic and tionnaire design goes some way scientific principles (Johnson,
concepts of interest. Pertinent toward ensuring that the survey 1998). These challenges should
literature may nevertheless es- instrument will be meaningful for be recognised and, to the extent
cape the reach of search engines study participants. There are a possible, overcome. Collaboration
or the linguistic capabilities of number of tensions and difficulties with representatives from each
those conducting the reviews, or with the collaborative approach, cultural setting nevertheless
60
Developing and assessing comparable questions in cross-cultural survey research on tobacco
forces at least some consideration prehension and meaning, pre- Hambleton et al., 2005). When
of cultural particularities and testing is needed in each major cultural anchoring is discovered,
concerns. The resulting concep- cultural context or major socio- unambiguous phrasing in the
tual framework should be more cultural group under consideration translated version of the question
likely to fit the contexts studied (see page 68). may necessitate changing the
than a framework constructed in One reason why item selection wording of the original language
the absence of input and matters is that wording that item in order to maintain
involvement of representatives appears neutral may actually equivalence (see page 68). Literal
from these different settings. contain phrases or terms with question translation may never-
culturally idiosyncratic conno- theless result in equivalent
tations, making translation difficult meanings across languages.
Question selection and (Harkness, 2003). Attempts to However, it is crucial to consider
development: equivalence capture the meaning of culturally whether the resulting question
of indicators anchored wordingno matter adequately captures the concept
how unambiguous in the original of interest and whether a non-
The practice of selecting or languagemay produce awkward literal adaptation of the question is
developing questionnaire items in translations that violate question necessary to do so (Van de Vijver
one language and translating design principles and thereby & Leung, 1997; Van de Vijver,
them into other languages is introduce systematic error. One 2004).
common in cross-cultural survey clear example comes from the Cross-cultural survey research
research. The use of established German General Social Survey generally involves translating
items saves time, is inexpensive, item Das leben en vollen zgen items that are established mea-
and allows for ready comparison genieen, which literally trans- sures for particular constructs in
with other studies that have used lates to English as the nonsensical one language group. For this
the same measures. Ideally, these Enjoy life in full trains. For reason, our next sub-section
items will have been pre-tested American English, a more focuses more intensively on
and found to have suitable appropriate translation is the translation approaches. However,
measurement properties across adapted, non-literal phrase Live researchers may nevertheless
subgroups who speak the source life to the fullest (Harkness, consider developing a core set of
language, as well as among those 2003). The often unconscious indicators for use across all sites,
from the linguistic and cultural embedding of cultural anchors in supplemented by culture-specific
groups in which the research will questions may lead to their dis- indicators of the same constructs.
be conducted. Such analyses covery only through the translation The selection of culturally-specific
have been done only for a few process itself. Similarly, question indicators should consider
tobacco survey questions, inclu- meanings may not be shared measurement research on the
ding those related to dependence across contexts, and different same or related concepts
(see Section 3.3). If sound items will need to be developed in conducted within the culture.
measurement properties have order to adequately reflect study However, such research may not
been found for the item in one concepts. For these reasons, exist or may involve items that
linguistic or cultural context, these cross-cultural survey methodo- researchers believe are inade-
properties do not necessarily carry logists increasingly argue for quate to capture the meaning of
over to the translated version of methods that open up the the concept of interest. Item
the item, no matter how good the translation process to greater development can follow any of a
translation (Harkness et al., scrutiny and more conscious variety of methods that are
2003b). To help ensure equi- group decision-making (Harkness standard practice in measurement
valence of question com- & Schoua-Glusberg, 1998; development, including expert-
61
driven techniques (DeVellis, parison of dissimilar stimuli. was through the term vicio or
1991) or those that involve Furthermore, cross-cultural com- vice, which connotes a guilty
eliciting meanings from the target parison of only those items with pleasure that is difficult to control,
group of interest, as with focus similar content may exclude potentially dangerous, and often
groups (Stewart & Shamdasani, culturally specific items that are looked down upon socially.
1998), structured interviews the best and most meaningful Participants generally agreed that
(Spradley, 1979), free-listing, pile indicators of the concept of the term addiction, as well as the
sorts and other qualitative tech- interest. Overall, this approach term droga or drug also had
niques (Bernard, 1994; Berkowitz, involves relatively high develop- these connotations. Analyses of
2001). Rapid anthropological ment costs, openness to making data from a subsequent pilot
assessment techniques have also changes to the source instrument, survey of items developed to
been developed to reduce the time and complex organisational struc- capture these additional meanings
and effort required for more ture to adequately coordinate (fumar es un vicio [smoking is a
traditional ethnographic methods, teams (Harkness et al., 2003b). vice]; el cigarro es una droga [a
with one such effort having already cigarette is a drug]) found that
developed a framework for Example of focus groups for these items loaded onto the same
tobacco-related research among item development: dimension as the primary indicator
youth (Mehl et al., 2002). These of perceived behavioural control
and other methods could also be Before fielding an international (tabaco es adictivo [tobacco is
used for developing equivalent survey of adult smokers in Mexico, addictive]), improving the mea-
concept definitions across con- in-depth interviews and focus surement properties of the
texts. groups were conducted with adult construct ( Thrasher et al., 2006a).
One rarely used approach to smokers, with discussions orien- While the meaning of a cigarette
item selection and development ted by the conceptual domains is a drug would likely translate
involves simultaneous, yet included in the survey (Thrasher & back to English, the use of an
independent work by each group Bentley, 2006; Thrasher et al., equivalent English language item
responsible for a particular 2006a). One concept of interest that included the term vice may
linguistic or cultural subgroup involved perceived voluntary be meaningful only within certain
involved in the study (Harkness et control over smoking behaviour. subcultural religious groups. As
al., 2003b). This strategy is likely This attribution to tobacco con- such, this example helps illustrate
to work best when teams use sumption behaviour may not only the development of a culturally-
conceptual definitions that ade- be relevant to self-efficacy specific item that complements a
quately apply across contexts, regarding quit attempts, but also core item shared across surveys.
thereby removing the likelihood to perceptions of tobacco products Cognitive testing of the original
that the concepts under con- as deviant when compared to item in English and Spanish
sideration are too culturally- other products that people freely (see sub-section on Questionnaire
specific and, hence, idiosyncratic. decide to consume. When Pre-Testing) could complement
Each team would assemble prompted, most all Mexican further statistical analyses (see
and/or develop items that they smokers agreed that tobacco was sub-section on Quantitative
believe best reflect the study addictive; however, they found it assessment) in order to determine
concepts. In the end, however, difficult to explain what addiction whether the single item on vice in
incommensurability of items meant. It became clear that the the Mexico sample might be used
across contexts presents analytic more common manner of talking as equivalent to the single item on
difficulties, as few statistical about and understanding toba- addiction in samples from other
techniques allow direct com- ccos hold over their behaviour countries.
62
Developing and assessing comparable questions in cross-cultural survey research in tobacco
Approaches to survey trans- recommendations regarding in- that two additional roles be filled in
lation strument design, see: Dillman the team approach. Reviewers
(2007), Bradburn and coworkers should have language abilities that
Translation of surveys in cross- (2004) and/or Willis ( 2005)). If this are as strong as the translators,
cultural research is often an is not possible, then translation supplemented with knowledge of
afterthought, with little attention should be conducted by people questionnaire design principles,
paid to the design issues involved who are fluent in both languages study design and the topic of
in the complex task of producing and practiced in the translation interest. Adjudicators should at
instruments with comparable between them. At first glance, a least share this methodological
measurement properties across single-person translation appears and topical knowledge, as they will
languages and contexts (Hark- time- and cost-effective. However, make the final decisions about
ness & Schoua-Glusberg, 1998; relying on a single person to make which translation to adopt,
Harkness, 2003). Steps described all translation decisions may preferably in cooperation with the
above to ensure the applicability introduce comprehension prob- reviewers and translators who
and relevance of construct defini- lems due to regional variance in have been more intimately
tions across diverse contexts linguistic expression and meaning, involved in the details of
provide a foundation for sound as well as the translators own translation and evaluation. When
translation practices (Harkness et idiosyncratic interpretations and an adjudicator does not under-
al., 2003b). Yet, even with such a inevitable oversights (Harkness et stand the source or target
framework in place, any of a al., 2004). Since these issues may language well, Harkness suggests
variety of translation methods result in non-equivalent stimuli that consultants should be hired to
could be followed, each with its and, hence, invalid comparison, provide this skill. Team ap-
own advantages and dis- the efficacy of single-translator proaches involve greater expense,
advantages. Generally, survey methods increasingly has been time and coordination than single-
research follows the Ask-the- called into question (Harkness & person translations; however, this
Same-Question model, in which a Schoua-Glusberg, 1998; Hamble- approach is recommended and
questionnaire is developed in the ton et al., 2005). used by numerous ongoing survey
source language and translated A team approach to trans- operations, including the Survey of
to other target languages. lation, which involves more than Health Ageing and Retirement in
Because of its widespread use, one person who is fluent in the Europe (Brsch-Supan et al.,
we describe methods based on source and target languages, 2005), the US Consumer
this model, including the de- appears to help overcome some Assessment of Health Care
centering approach, whose biases that result from single- Providers and Systems (Weidmer
iterative process of translation person translations. Team et al., 2006), the US Census
demands at least some flexibility approaches open up to exami- Bureau (Pan & de la Puente,
in the wording of the source nation and discussion the complex 2005) and the European Social
language questionnaire. decision-making that occurs in Survey (Harkness & Blom, 2006).
Ideally, people who translate a translation, providing a greater The committee approach to
questionnaire should be skilled, range and more balanced translation is increasingly viewed
professional translators who are critiques of translation options as the gold standard in cross-
bilingual in the source and target (Guillemin et al., 1993; McKay et cultural survey research (Hark-
languages, while having at least al., 1996; Harkness & Schoua- ness & Schoua-Glusberg, 1998;
some basic training in general Glusberg, 1998). Aside from Harkness et al., 2004). Generally
principles for developing ques- skilled, professional translators (of two to four translators are used,
tions with good measurement which there may be more than with each additional translator
properties (for some basic one), Harkness (2003) suggests providing more material for critical
63
discussion of translation possi- may anticipate and address appear harmonised. For exam-
bilities. The parallel translation questionnaire problems that other- ple, one project using this method
method involves each translator wise only come to light in translated an English language
independently translating the pre-testing or data analysis. This item that included the term
same source questionnaire in its is not to suggest, however, that embarrassed, which existed in
entirety. Some of the costs this strategy should replace the target languages but had
associated with parallel trans- questionnaire pre-testing. Both stronger connotations than in
lations can be cut by employing researchers and translators are English. Researchers decided to
split translations, in which each likely to come from social strata substitute another term, unhappy
translator is assigned different that differ from the majority of about, which was easier to
parts of the source questionnaire. research participants. Hence, harmonise across the target
In either case, translators bring translation assessment proce- languages and did not com-
their independent translations to a dures described below are critical promise the measurement pro-
reconciliation meeting where at to ensuring sound comprehension perties of the original language
least one reviewer and perhaps and equality of measurement. item (Eremenco et al., 2005).
the adjudicator work with the Researchers may want to The iterative approach to
translators to reach agreement on consider allowing for minor translation is difficult, time-
the best translation. The chosen changes to the source language consuming and expensive, and
wording could be taken directly questionnaire due to issues that each additional language included
from one translation, a mixture of emerge through translation. As in the process will multiply these
the different phrasings offered, or described earlier, cultural an- disadvantages (Harkness et al.,
a previously unconsidered word- choring of words and phrases may 2003b). Unlinking questions from
ing that emerges from discussion result in translated items that shift their cultural connotations may
of the independent translations. original meaning or that violate result in unwanted ambiguity due
Because each question is good question design principles. to vague, unidiomatic phrasing.
translated independently by at Either way, systematic mea- Furthermore, changes in source
least two people, parallel surement error may result. One item wording may necessitate pre-
translations are likely to offer a possible approach to equalising testing in order to ensure that
greater range of translation question meaning involves an measurement properties have not
possibilities than either split iterative translation process called suffered.
translations or a single translator decentering (Werner & Camp- Whichever translation approach
would produce. The final versions bell, 1970). In this method, a is taken, we strongly recommend
can be adjudicated at the source questionnaire provides the that those involved in cross-
reconciliation meeting or, perhaps starting point for translation to cultural tobacco research docu-
provided to the adjudicator for target languages, which could be ment their decisions regarding
later consideration. done using any of the afore- item selection, development and
The team approaches to mentioned methods. However, translation. Study concepts should
translation may seem extravagant translators and reviewers signal be clearly specified and linked to
in the context of many low- which items appear to introduce original, source language items.
resource environments. However, non-equivalence of meaning. Translators should be encour-
the relatively low additional cost of Those in charge of each lan- aged to keep notes regarding their
hiring a second translator is likely guage version of the ques- decision-making processes when
to offset subsequent costs and tionnaire then work in iterative translating the item to another
data quality issues that might fashion, changing items by language. Similarly, team ap-
result from an unscrutinised tacking back and forth across the proaches to translation review
translation. Indeed, this process translations until all versions should involve further docu-
64
mentation about how final would be administered, these three and roll-your-own cigarettes? This
decisions were made. If the entire people helped ensure the use of clarification to this standard
questionnaire is not subject to natural terminology and compre- question had been included in the
later pre-testing, these notes will hensibility among smokers. source language questionnaire in
help determine which subset of Because of logistical and cost order to ensure that respondents
items should be scrutinised more constraints, representatives were considered roll-your-own ciga-
closely. This documentation will not included from each of the rettes, particularly as switching to
also enable future researchers to different regions of Mexico where lower-cost tobacco is a common
adequately interpret the data the survey would be administered. response to raising the price of
associated with these questions, This was a potential limitation. cigarettes (Young et al., 2006).
while providing critical information The reconciliation meeting One non-smoking translator
for further improvement of the involved a full day of work with deleted the last clause of the
measures in later studies. three translators (one was unable English version because she had
to make the meeting but provided never heard of people using such
Example of the committee her independent translation), cigarettes in Mexico. However, we
approach: two bilingual reviewers, and a did not want to exclude mention of
bilingual reviewer/adjudicator. After this practice since it occurs in
One example of the committee beginning the session with a Mexico, although at a low pre-
approach using parallel translation further discussion of question valence. Indeed, one aim of the
involves translating an American design principles, we examined survey was to estimate this
English-language source survey of the original English version and all prevalence, although it would be
adult smokers to the Mexican four translations, addressing one measured with more precision in a
variety of Spanish. Independent question at a time. As emphasised question that appeared later in the
translations of the survey were in the description of the survey instrument. Two general
provided by four bilingual pro- methodology, this process pro- options for describing factory-
fessional translators, three of duced a range of possible made cigarettes emerged: one
whom were Mexican nationals and translations, even for questions was a more literal translation
the fourth an American who had that, on the surface, appeared (cigarros hechos en fbricas,
been living in Mexico for 19 years straightforward. The beginning of literally cigarettes made in fac-
and working as a professional the process was time-consuming tories) and the other turned the
translator for 24 years. Although all and challenging. However, de- focus toward branded and mar-
of them had at least some cision-making became easier as keted cigarettes (cigarros de
experience with survey translation, participants became comfortable marcas comerciales, literally,
each was provided with summary with the process and as we commercial cigarette brands).
materials on question design reached agreement on terms, This second focus was discarded
principles and asked to follow grammatical structure, and res- since rolling tobacco is also
them. Two of the Mexican ponse options that were repeated branded and marketed, even
translators were recruited because throughout the questionnaire. though unbranded, loose tobacco
they were regular smokers, as was As an illustration of the can be bought in some regions of
a young adult, bilingual Mexican decision-making processes in- Mexico. The more literal trans-
research assistant who had been volved in this method, the lation sounded awkward and
involved in earlier stages of the following describes how we seemed to divert attention from
project and who served as a translated the last phrase of the the main question content. In the
reviewer at the reconciliation question On average, how many end, we decided on a phrase that
meeting. As members of the target cigarettes do you smoke each could be roughly translated as
population in which the survey day, including both factory-made cigarettes from the pack
65
(cigarros de cajetilla), since the and tobacco cigarettes that you in order to project an image of
word for pack (cajetilla) connoted make by hand?). Finally, inter- themselves that accords with their
factory-made without sounding viewer training included a focus on perceptions of social norms and
awkward, while setting up the the meaning of the question, so expectations (Marlow & Crowne,
contrast with the roll-your-own that interviewers could anticipate 1960). The phenomenon appears
type cigarettes that would be and respond to any com- to be universal across societies,
mentioned thereafter. prehension difficulties that they with stronger effects found when
For the final clause in the sensed among participants. considering self-report of beha-
question, two options emerged This example illustrates a viours or beliefs that are socially
from the three independent number of the advantages that sanctioned within a given cultural
translations. One used a term for accompany the committee ap- context (Johnson & Van de Vijver,
rolling that is also common for proach to translation. Importantly, 2004). Hence, the differential
rolling marijuana cigarettes (cigar- there were a variety of options to effects of social desirability on
ros forjados a mano) while the choose from. Consistency of self-reported tobacco attitudes,
other introduced the participant as terminology and phrasing across beliefs, and behaviours should be
the one who made (hacer) the translation options would have proportional to the level of
cigarettes (cigarros hechos por provided support for selecting a tobaccos social unacceptability
usted, literally cigarettes made by particular translation. The exam- across the socio-cultural groups
you). There was agreement that ple above indicated incon- under consideration. Because
either option could confuse people sistencies in the terms and social desirability effects also
who did not engage in rolling wording, which led to group appear stronger among minority
cigarettes this would be the vast decision-making about the best or disenfranchised groups within a
majority of study participants. way to resolve discrepancies. society (Ross & Mirowsky, 1984;
However, reference to the par- Moreover, resolutions to dis- Edwards & Riordan, 1994;
ticipant making the cigarettes crepancies did not appear in the Warnecke et al., 1997), it may
seemed on track, since not originally translated versions. disproportionately influence na-
including the participant as agent Finally, the version agreed upon in tional samples that contain more
could cause people to think of the reconciliation meeting still minority group participants.
cigars, which are also hand rolled, needed to be altered a little after Social desirability appears
but by someone else. We agreed cognitive testing indicated undesi- positively correlated with a num-
on a longer version cigarettes that rable connotations for one part of ber of macro-level societal
you make by hand (cigarros que the question. characteristics, such as higher
usted hace a mano). Later levels of collectivism and lower
cognitive interviews indicated that Culturally moderated levels of individualism. Higher
this phrase nevertheless connoted response styles levels of social desirability appear
marijuana cigarettes for some congruent with, and may stem
participants, and so the final, pre- Comparisons across cultural from, collectivist codes of social
tested version clarified that these groups may be biased by interaction that emphasise cour-
were cigarettes made with to- systematic differences in res- tesy, maintaining harmonious
bacco: En general, cuntos ponse styles, such as social relations and saving face (Marn &
cigarros al da fuma, incluyendo los desirability, extreme responding, VanOss Marn, 1991; Johnson &
cigarros de cajetilla y los cigarros and acquiescence. Of particular Van de Vijver, 2004). Smokers
de tabaco que usted hace a mano? concern are social desirability from collectivist societies that
(Literally, In general, how many effects, which manifest when stigmatise tobacco use may view
cigarettes do you smoke each day, respondents misrepresent or edit true representation of their
including cigarettes from the pack their true responses to a question thoughts and behaviours in an
66
interview context as threatening with questions read by inter- minimise the social distance
these more important elements of viewers, even when the questions between respondents and inter-
social interaction. On the other are contradictory, a process viewers by attempting to match
hand, people from individualist referred to as acquiescent them on ethnic background or
societies appear to have stronger responding. demographic characteristics in
prohibitions against providing Although there is general hopes of minimising the social
misleading information (Triandis, agreement that social desirability, desirability pressures placed on
1995). Hence, smokers in these extreme responding and acquie- respondents. For example, in
societies may be less likely to scence are each moderated by contexts where deference to
provide socially desirable res- culture, there is less consensus or authority is a key cultural value,
ponses independent of the extent available evidence regarding how interviews conducted by older
of social sanctions against to best account for these potential people of higher social status may
smoking. This suggests that sources of measurement error induce strong social desirability
individualism/collectivism and when conducting cross-cultural effects. Numerous studies are
social sanctions against tobacco research. Several researchers available that demonstrate res-
are likely to interact, producing have attempted to neutralise pondent deference to interviewers
differential social desirability social desirability effects by who represent differing cultural
effects on tobacco survey ques- explicitly measuring these pro- backgrounds (Cotter et al., 1982;
tions. The strongest effects of pensities and then statistically Anderson et al., 1988; Finkel et
social desirability should occur adjusting for them (Nederhof, al., 1991; Davis, 1997; Johnson et
under conditions of strong 1985). Most reported attempts to al., 2000), although it should be
stigmatization of smoking beha- introduce social desirability cor- noted that none of these studies
viour in a collectivist society, rections, however, have been are based on experimental evi-
whereas the weakest effects unsuccessful ( Ones et al.,1996; dence. Under some circum-
would occur in individualist Ellingson et al., 1999; Fisher & stances, too little social distance
societies with weak stigmatisation. Katz, 2000), suggesting that other between respondents and the
Future research should empirically approaches should be explored person interviewing them may
test this proposition. (for reviews of other methods of encourage socially desirable
Several other response styles addressing social desirability in responding (Dohrenwend et al.,
have also been found to vary survey research, see Nederhof 1968). Concern with the effects of
across cultures (Baumgartner & (1985) and Paulhus (1990)). social distance can also be
Steenkamp, 2001). Two that have Some researchers have also extended to interview mode, as
perhaps received the most reported studies in which they the degree of privacy afforded by
attention are extreme response assessed extreme responding each mode of data collection may
styles (Smith, 2004b) and acquie- and/or acquiescence via structural exert differential pressures on
scence (Knowles & Condon, equation modelling ( Mirowsky & respondents to provide socially
1999). Extreme response styles Ross, 1991; Greenleaf, 1992; desirable information. Although
refer to the greater preference of Watson, 1992; Billiet & McClen- little information is available with
respondents from some cultures to don, 2000; Cheung & Rensvold, which to examine cultural varia-
select the most extreme endpoints 2000). In general, however, there bility in mode of interview effects
of response scales, whereas is no consensus on how to best (Marn & Marn, 1989), it would
respondents from other cultures confront problems of systematic seem likely that the social
are more likely to make less cross-cultural variability in survey sensitivity of the answers being
extreme choices when answering. response styles. requested and respondent culture
Moreover, some respondents During data collection, efforts might interact with survey mode in
exhibit a greater tendency to agree are also commonly made to ways that either magnify or
67
minimise substantive differences views may be of higher quality translation. Although backtrans-
across groups. These effects may because it better approximates lation may reveal some problems
be difficult to predict, particularly the dyadic interplay of survey with target translations, it does not
given the near absence of administration than do focus adequately assess the translated
research on this topic. Re- group dynamics. Finally, another questions comprehensibility with-
searchers should thus carefully promising tool for assessing in the target population (Harkness
consider how the social sensitivity respondent cognitions related to & Schoua-Glusberg, 1998;
of the topics examined might vary translated questions is beha- Harkness, 2003). Furthermore,
across the groups studied, the vioural coding, a technique which the methodology provides no
types of questions asked, and how codes respondent and/or inter- guidance about what qualifies as
the mode of data collection might viewer reactions to questions in an acceptable level of similarity
influence participants responses. recorded interviews to identify across the source and back-
problematic survey questions translated versions. Finally, when a
Questionnaire pre-testing (Fowler, 1995; Van der Zouwen & back-translated questionnaire
and translation assessment Smit, 2004; Johnson et al., 2006). depends on a single translator for
Overall, we emphasise the impor- the forward translation into the
We focus on two approaches to tance of translation assessment target languageas it often
questionnaire pre-testing and and pre-testing as a means of doesit neither opens up the
translation assessment. First, we ensuring sound measurement translation process to critical
discuss back-translation, which properties of the target language scrutiny nor does it produce the
has been used frequently and survey instruments. range of translation options that are
even viewed as a gold standard found in team approaches. These
for translation assessment; how- Back-translation: factors recommend against the use
ever, we describe a number of of back-translation as the only
pitfalls that recommend against its Back-translation is often mistaken method of translation assessment.
use as a sole assessment as a method of translation, but it is Translation quality also needs to be
method. Second, cognitive inter- actually a method for assessing evaluated in a more direct fashion.
viewing is described, since it is the quality of a translation that has An example provided earlier
increasingly recognized as a already been made into a target helps illustrate these concerns.
crucial pre-testing stage before language (Harkness, 2003). It The German General Social
surveys go into the field within involves independent translation Survey item Das leben en vollen
particular socio-cultural settings. of the target language ques- zgen genieen literally trans-
We suggest that the rationale in tionnaire back into the source lates to English as Enjoy life in full
favour of this approach be language and comparing the trains. This translation is readily
extended to support the use of result with the original source back-translated to and reproduces
cognitive interviewing to assess language questionnaire. Back- with fidelity the original German
translated questionnaires. Another translation presumes that the source language phrase. How-
method for determining compre- greater the similarity between the ever, the nonsensical nature of the
hension and meaning attributed to results, the more acceptable the English translation could go
items involves focus group translation (Brislin, 1970). How- undetected without further review.
evaluation with members of the ever, languages are not iso- Moreover, an appropriate British
target population. This assess- morphic, and an unnatural adaptation of this phrase (Live life
ment approach is likely to be sounding or even incompre- to the full) would sound awkward
better than no pre-testing of the hensible target language trans- in American English, for which
survey instrument; however, the lation may produce, or even be different wording would be
information from cognitive inter- necessary for, a good back- necessary (i.e. Live life to the
68
fullest.). Such nuances would be categories provided. As each step Table 2.3). An interview protocol is
missed, and in fact be dis- along this pathway may introduce generally developed to anticipate
couraged, with back-translation measurement error, cognitive inter- which kinds of probes, if any, will
that did not entail further review by view techniques focus on these be necessary for each question.
bilinguals (Harkness, 2003). aspects of the recall process. However, the interviewer may also
The think aloud and verbal freely employ probes to address
Cognitive interviewing: report protocols generally involve issues that unexpectedly emerge
asking participants to openly during the course of an interview.
Cognitive interviewing is in- describe the stream of thought in As such, the use of verbal probes
creasingly used to pre-test and which they engage as they answer demands the active involvement
thereby improve comprehension a survey question (Ericsson & and training of the interviewer.
and related measurement pro- Simon, 1984; Conrad & Blair, However, training is less of an
perties of questionnaires within 2004). Responses are usually issue for the survey respondent
particular societies (Willis, 2005). audio-recorded and transcribed for than in the think-aloud. Probes
The rationale for and principles analysis. Advantages of the may nevertheless influence res-
that orient this practice should method include the minimal pondents in ways that do not
extend to assessment of trans- training requirements for the adequately reflect cognitive
lated questionnaires. In the interviewer, whose main task is processes under real survey
absence of such pre-testing, there simply to read the question and conditions. In particular, care must
is no guarantee that the target listen. This generally passive be taken to develop unbiased,
language instrument will have interviewer stance may result in neutral probes that do not lead
sound measurement properties, lesser bias than more pro-active participants to respond in par-
even when the instrument has methods. However, although the ticular ways.
been pre-tested in the source open-ended format of this ap- When addressing survey
language and best practices have proach may allow unanticipated instruments within particular socio-
been followed when translating it response issues to emerge, cultural settings, Willis (2005)
(Harkness et al., 2003b). We subjects may need to be trained to recommends that each round of
describe a few basic principles of think aloud, with some people cognitive interviews involve survey
cognitive interviewing, while unable to develop the skills administration among 8 to 12
referencing key works for readers necessary to provide useful feed- people from the target population.
who are interested in more detail. back. Even good participants At least two testing rounds are
Cognitive interviewing follows wander off track, thinking in ways necessary to assess the adequacy
from research on the cognitive that may only vaguely correspond of the original questionnaire as
processes involved in responding with the mental processes required well as changes that result from
to survey questions (Willis, 2005). to respond to the question under the first round. Although the
The response process generally normal circumstances (Willis, number of testing rounds will
involves question comprehension 2005). depend on the quality of the
(i.e. meaning of terms and per- Verbal probing techniques are original instrument and the
ceived intent of question), retrieval increasingly favoured over think- proposed revisions, Willis sug-
from memory (i.e. availability of aloud strategies in cognitive gests that there are likely to be
and strategies to access relevant interviews (Willis, 2004, 2005). diminishing returns after three
information), judgment processes Probes have been developed in rounds of testing. This may or may
(i.e. motivation to respond and to accordance with principles of not be the case in dealing with
respond truthfully) and mapping sound question design, with more complicated cross-cultural
the internally generated response specific probes used to uncover issues that involve translated
to the question onto the response specific processing issues (see questionnaires, where each round
69
READING: Is it difficult for interviewers to read the question in the same way to all respondents?
What to read: interviewer may have difficulty determining what parts of the question to read
Missing information: information that the interviewer needs to administer the question is not provided
How to read: question is not fully scripted and therefore difficult to understand
INSTRUCTIONS: Look for problems with any introductions, instructions or explanations from the respondents point
of view
Conflicting or inaccurate instructions, introductions or explanations
Complicated instructions, introductions or explanations
CLARITY: Identify problems with communicating question intent or meaning to the respondent
Wording: question is lengthy, awkward, ungrammatical or contains complicated syntax
Technical terms: terms undefined, unclear or complex
Vague: multiple ways to interpret the question or to decide what is to be included or excluded
Reference periods: missing, not well specified, or in conflict
ASSUMPTIONS: Determine problems with the assumptions made or underlying logic

Inappropriate assumptions are made about the respondent or about his/her living situation
Assumes constant behaviour or experience for situations that vary
Double-barrelled: contains more than one implicit question
KNOWLEDGE/MEMORY: Check whether respondents are likely to or not know or have trouble remembering infor-
mation
Knowledge may not exist: respondent is unlikely to know the answer to a factual question
Attitude may not exist: respondent is unlikely to have formed an attitude about the argument being asked about
Recall failure: respondent may not remember the information asked for
Computation problem: the question requires a difficult mental calculation
SENSITIVITY/BIAS: Assess questions for sensitive nature or wording and for bias
Sensitive content (general): the question asks about a topic that is embarrassing, very private, or that involves illegal
behaviour
Sensitive wording (specific): given that the general topic is sensitive, the wording should be improved to minimize
sensitivity
Socially acceptable: a socially desirable response is implied by the question
RESPONSE CATEGORIES: Assess the adequacy of the range of options

Open-ended question: is inappropriate or difficult to answer without categories to guide
Mismatch: question does not match response categories
Technical terms: are undefined, unclear or complex
Vague: responses categories are subject to multiple interpretations
Overlapping: categories are not mutually exclusive
Missing: some eligible responses are not included
Illogical order: order not intuitive
ORDERING OR CONTEXT problems across questions
Table 2.3 Questionnaire Design Issues, from Willis (2005)
Adapted from Willis & Lessler (1999) and Willis (2005)
70
would be followed by efforts to Prevention. The goal was to to both the English and Spanish
coordinate and translate ques- produce a Spanish-language language questions: For this
tionnaire changes until any version of the ATS questionnaire question, we want you to think of
cross-group discrepancies in that was equally comprehensible all the cigarettes you ever smoked
question interpretation and com- and that shared the same in your whole life, not on a single
prehension appear to be resolved. meaning among Latinos in the US day. In this case, changes made
Where equivalence of meaning who speak different national to the Spanish-language items
cannot be achieved, researchers varieties or dialects of Spanish. In meant re-evaluating and changing
should document why, and make the first step, a committee the wording of the original,
sure this documentation is approach was used involving English-language version in order
accessible to those who will independent, parallel translations to reinforce equivalence. Ane-
ultimately analyse the data. by bilingual translators of Mexican, cdotal evidence suggests that
Researchers who use the data at Puerto Rican and South American similar comprehension problems
a later date may otherwise believe heritage. This was followed by two characterised the original English-
that the questions are equivalent rounds of cognitive interviews with language version, so the addition
and make invalid comparisons Latinos from nine countries and of this introductory phrase may
across cultural groups. Drawing Puerto Rico. The first round have improved comprehension
from the previous example involved 40 participants using across languages.
regarding the vice connotation of think-alouds after every ques-
addiction in Mexico (see page tion. In the second round, the Quantitative assessment of
62), it may be inappropriate to resulting survey was administered measurement properties
compare Mexican smokers and in normal fashion to 28 par- and systematic
smokers from other countries on ticipants, followed by a debriefing measurement error
the item tobacco is addictive if that targeted particular com-
the dominant meaning of addiction prehension issues. Despite all precautions to ensure
is compulsive behaviour in other One of the many issues that item equivalence across social-
countries. This situation could be came up concerned the trans- cultural groups and linguistic
documented by describing how lation of the often-asked variants of a questionnaire, some
addiction in Mexico appears to English-language question, Have unaccounted-for factor may none-
more strongly connote vice and you smoked 100 or more theless systematically and
less strongly denote compulsion cigarettes in your life. Participants differentially influence responses
than in other countries. repeatedly thought that this provided by the groups under
question referred to daily smoking, consideration. The strategies des-
Cognitive interviewing even after the word entire was cribed here are best employed
example: inserted to read in your entire life after collecting pilot data, but
(en toda su vida) and the phrase before implementing the full
One recent example of cognitive was printed in boldface type to survey. Results can be used to
interviewing to pre-test translated ensure its emphasis by survey eliminate, change or replace items
items involved the Spanish administrators. This underscores that appear to be biased. However,
version of the Adult Tobacco the point that modification of a these methods can also be used to
Survey (ATS) for the United question may not resolve the assess measurement equivalence
States National Center for Health problem, hence modified versions after survey data are collected, with
Statistics and the Office on should also be pre-tested (Forsyth the drawback that it is too late to
Smoking and Health at the et al., 2004). To resolve the issue, change items with poor mea-
Centers for Disease Control and an introductory phrase was added surement qualities. As has been
71
emphasised when addressing other techniques (Groves, 2001). Never- the two indicators show inconsis-
measurement equivalence issues theless, theory and previous em- tent results, then strong claims
described in this section, it is pirical findings can be drawn upon about either result will depend on
recommended that such issues be in order to predict how the indica- ones ability to convincingly argue
documented so that others who tor should correlate with other vari- for the use of one indicator over
use the data at a later date will be ables. In other words, expected another. Although such post-hoc
aware of these issues. correlations with other particular argumentation may be suspect, it
Three approaches are briefly variables provide evidence of con- can also establish the focus for
described here: single indicators, vergent validity. The absence of subsequent research to clarify
alternative indicators and latent such correlations does not neces- measurement and the interpreta-
variable Structural Equation Model- sarily disprove the validity of the tions that result. With three alterna-
ing (SEM). When multiple indicators measure, however. Rather than tive indicators of the same
of a construct are used, more sta- disconfirming the validity of the construct, results from the third in-
tistical means are available to try to measure, this lack of correlation dicator can tip the balance in favour
rule out systematic measurement may instead merely indicate the in- of the preponderance of evi-
error across groups. However, adequacy or general inapplicability dence. Consistency across all
some approaches demand that sin- of the theory. Indeed, even when three indicators provides relatively
gle constructs be measured with a the measure under consideration is strong confirmation of the validity of
large number of items, which makes correlated with a set of theoretically the results. Smith suggests that the
them less applicable to survey re- related variables, this merely pro- most robust evidence will come
search. These methods, such as vides evidence not confirma- from consistent results across al-
multi-trait multi-method (Saris, tionof the measures convergent ternative indicators that not only
2003a), multi-dimensional scaling validity; systematic measurement contain linguistically different stim-
(Fonatine, 2003), and item re- error across the theoretical set of uli, but that also have different re-
sponse theory approaches (Saris, variables may still bias group com- sponse formats (Smith, 2004a).
2003b) are detailed elsewhere. parisons.
Simultaneous assessment of
Single-item measures of Alternative measures of the multiple indicators:
constructs: same construct:
Data collection on multiple indi-
When a single item is used to When there are multiple indicators cators of the same construct also
measure a construct, it may be dif- of a particular construct, differen- allows for statistical assessment of
ficult to assess whether observed tial item functioning across cultural all indicators simultaneously,
similarities or differences in the groups can be assessed by alter- instead of the sequential format
measure are valid or whether these natively considering each indica- outlined above. Simultaneous
observations result from some tor (Bollen et al., 1993; Smith, consideration of multiple indica-
other nuisance factor. Differential 2004a). With two items, a rela- tors lessens the impact of idio-
patterns of item non-response or tively clear indication involves con- syncratic, and therefore prob-
do not know may indicate non- sistent results for group lematic, indicators (Bollen, 1989;
equivalence. Indeed, these non- differences in means (e.g. both Bollen et al., 1993). It also allows
random patterns violate assum- higher in one group versus an- for the application of more formal
ptions that are necessary when other) and in correlations with statistical procedures to test,
dealing with this issue through pair- other constructs (e.g. number of improve and attempt to equalise
wise or listwise deletion, as well as days and number of cigarettes per construct measurement properties
when using multiple imputation day correlated with addiction). If across groups.
72
Exploratory factor analysis mates assume continuous, section suggests that these
(EFA) techniques can provide normally distributed indicators, comparative studies should
evidence for the equivalence of SEM allows estimation using non- consider measurement equiva-
construct dimensionality and dis- normally distributed categorical lence issues in the following ways:
crimination across groups, and ordinal indicators (Joreskog &
although special techniques are Sorbom, 1996; Muthen & Muthen, Research teams should
often necessary to ensure ade- 2004). SEM techniques estimate include collaborators from the
quate comparison (Van de Vijver items unique weighted contri- socio-cultural groups in which
& Leung, 1997). Items may be butions toward the measurement the study is being conducted in
considered for elimination if of latent variables. EFA, on the order to help anticipate issues
substantial group differences are other hand, involves summing or regarding the comparability of
found for factor loading values on averaging variables that comprise the theoretical framework,
the same dimension or for the a particular dimension, treating constructs and the mea-
extent of cross-loading across each indicator as equally weighted. surement of these constructs
dimensions. Cronbachs alpha Finally, several SEM packages across groups. When research
may also be used to determine now adjust for study design effects involves participants from
group differences in inter-item and sampling weightsadjust- distinct language groups, at
reliability. Although some statistics ments that are often important in least one, and preferably more,
are available for evaluating generating reliable, unbiased team members should be
factorial agreement across estimates in cross-cultural survey fluent in the source language
groups, the sampling distributions research. Taken as a whole, these and the target language in
for these statistics are unknown, key advantages recommend SEM which the survey will be
hence there are no statistical methods over standard EFA administered.
means of testing for what counts techniques. Cepeda-Benito and Whenever possible, it is
as an unacceptable difference colleagues (Cepeda-Benito et al., recommended to use mea-
(Van de Vijver, 2003). Moreover, 2004) provide a recent example of sures that have been
these techniques generally as- the use of these models to appropriately validated for the
sume normally distributed, compare the structure of the populations in which the
continuous variables, and survey Questionnaire of Smoking Urges questionnaire will be adminis-
indicators often violate these survey instrument across samples tered. Even when a measure
assumptions. of American and Spanish smokers. has been validated within one
Latent variable structural population group, its validity
equation modelling (SEM) offers a Summary and Recommen- may not extend to other
more direct means of testing dations groups, and additional steps
invariance of construct para- may be necessary to increase
meters and measurement pro- Evaluation of tobacco control validity and improve the value
perties across groups (Bollen, policies and other population-level of comparisons across groups.
1989, 2002; Joreskog & Sorbom, interventions often involves data Translation of questionnaire
1996). As with EFA, the dimen- collection efforts across diverse items from one language to
sionality of different concepts can national, cultural, linguistic and another should involve ex-
be examined. However, a key social groups. Comparison across perienced translators. Review
advantage of SEM concerns the such groups is often necessary to and adjudication of multiple,
ability to use statistical tests of clarify policy effects, how these independent translations of the
construct parameter equivalence effects happen, and how effects same items is currently
across groups. Moreover, whereas might differ across populations. considered the gold standard.
factor analysis parameter esti- The literature discussed in this If only one person translates
73
the questionnaire, then trans- All surveys, not just those that acquiescence, extreme res-
lation review should involve a are translated, should be pre- ponding) may influence res-
group of bilingual people who tested to assess compre- ponses.
are knowledgeable of ques- hension issues among the Researchers should docu-
tionnaire design principles and populations in which the sur- ment decisions related to
of key study concepts. Trans- vey will be administered. measurement development
lation assessment should not Ideally, pre-testing would in- and item wording, especially
merely consist of backtrans- volve cognitive interviewing where conceptual equivalence
lation. before a survey is fielded. is suspect, translation is dif-
Researchers should carefully Cognitive interviewing or other ficult, or where cognitive
select and translate items with pre-testing methods may also interviewing or other pre-
the goal of achieving equi- be used post-hoc to increase testing methods reveal sys-
valence of construct meaning the validity of comparisons or tematic differences in meaning.
across study populations. In to determine whether incon- Researchers should also
some cases, literal translation sistent results may be due to document issues around
of a questionnaire item across differential question com- survey administration.
linguistic variants of the survey prehension.
will not adequately capture the Researchers should consi-
construct of interest, and more der and seek solutions to
flexible translation and adap- minimise the ways in which
tation of the question will be culturally moderated response
necessary. factors (e.g. social desirability,
74
chap3.1janvier13:Layout 1 13/01/2009 09:55 Page 75
3.1 Measuring tobacco use behaviours
Introduction semination of tobacco-related Natura l history of toba cco use

surveillance data.
The majority of tobacco control In addition, Section 1-d of Article The natural history of tobacco use is
policies are designed to reduce 21 requires each ratifying nation to often conceptualized as a series of
tobacco use or exposure to tobacco provide periodic updates on sur- steps that can progress from never
smoke in the environment; stra- veillance and research as specified use, to trial, experimentation, estab-
tegies that are clearly supported by in Article 20. Article 22 calls for lished use, attempting to quit,
the scientific literature (US cooperation among the Parties to relapse, and/or maintenance of
Department of Health and Human promote the transfer of technical cessation (Figure 3.1 and Table 3.1)
Services, 2004, 2006; IARC, 2004, and scientific expertise on sur- (US Department of Health and
2007a). Preventing initiation and veillance and evaluation, among Human Services, 1990, 1994;
promoting quitting are the two major other topics (WHO, 2003). Marcus et al., 1993; Pierce et al.,
tobacco control strategies designed This section will first review the 1998b; Mayhew et al., 2000; Choi et
to reduce use. To facilitate pro- natural history of tobacco use (e.g. al., 2001; Hughes et al., 2003). Prior
gress, article 20 of the WHO initiation, current use, cessation). In to actual initiation of use, never
Framework Convention on Tobacco epidemiologic studies of disease users often think about use, a step
Control (FCTC) calls for Parties to: etiology, such as those discussed in in the process that is described in
IARC Monographs (e.g. IARC 2004) Section 3.2. After initial trial, users
(a) establish progressively a national and reports of the Surgeon General can either continue to experiment or
system for the epidemiological (US Department of Health and discontinue and become former
surveillance of tobacco con- Human Services, 2004), tobacco use triers. Experimenters can either
sumption and related social, behaviours (e.g. number of years progress to established user or
economic and health indicators smoked, number of cigarettes con- discontinue use and become former
(b) cooperate with competent inter- sumed each day) serve as inde- experimenters. Recent research
national and regional inter- pendent variables. In the evaluation suggests that nicotine dependence
governmental organizations and of the tobacco policies discussed in may appear during the experi-
other bodies, including govern- this Handbook, tobacco use mentation phase, before use
mental and nongovernmental behaviours serve as dependent becomes established (DiFranza et
agencies, in regional and global variables. The section will then al., 2002a; OLoughlin et al., 2003;
tobacco surveillance and ex- discuss factors that can influence the Fidler et al., 2006). Use becomes
change of information on the validity of self-report and factors that established when a threshold of
indicators specified in para- can influence comparability across cumulative lifetime exposure is
graph 3(a) of this Article surveys. The section will end by surpassed. The exact threshold of
(c) cooperate with the World Health describing several measures to established use is unknown and
Organization in the develop- assess use, providing examples likely varies considerably, but is
ment of general guidelines or from cross-national surveillance and often considered as having smoked
procedures for defining the evaluation systems (Section 4.3), as at least 100 lifetime cigarettes, or
collection, analysis and dis- well as national sources. being exposed to a similar amount
75
Never user
Trier Former trier
Experimenter Former
experimenter
Transition to established
use (100 cigarettes)
Non daily user

Daily user
Quit attempt
Former user
Note: Use involves consumption of cigarettes, other forms of smoked tobacco products, and/or various
smokeless tobacco products.
Figure 3.1 The natural history of tobacco use
76
Measuring tobacco use behaviours
I. Initiation
a. Intention to try (Section 3.2)
b. Initial trial
i. Discontinuation after initial trial
c. Experimentation
i. Discontinuation of experimentation
II. Transition to established use

a. Ever daily versus never-daily
III. Current use

a. Frequency of use (daily versus non-daily)
b. Type of product used
c. Brand used
d. Intensity of use (units/day)
e. Topography (for smoked products)
f. Purchase patterns (partly covered in Section 5.1)
IV . Cessation
a. Intention to quit (Section 3.2)
b. Quit attempt
i. Intentionality
1. Planned
2. Spontaneous
ii. Dose management
1. Abrupt discontinuance
2. Gradual reduction
iii. Methods (Section 5.7)
1. Assisted
2. Unassisted
c. Maintenance of abstinence versus return to use
Here the term use means consumption of cigarettes, other forms of smoked tobacco products, and/or various forms of smokeless
tobacco
Table 3.1 The Natural History of Tobacco Use: Key Constructs
of other tobacco products. Estab- Services, 1990; Gilpin & Pierce, Validity of self-repor t of cur-
lished use is generally manifested 1994; Hughes et al., 2003; West, rent toba cco use behaviours
as daily use. However, persistent, 2006). Quit attempts can be
regular non-daily use can also planned or spontaneous, involve Survey-based measures of cur-
take place (Evans et al.,1992; abrupt discontinuance or gradual rent tobacco use behaviours,
Husten et al., 1998; Trosclair et reduction in use before quitting, assessed in samples that are
al., 2005). Once past the threshold and may or may not be assisted representative of a given popu-
of established use, discontinuance by one or more of several lation, allow researchers and
involves an attempt to quit, with available treatment strategies policy-makers to estimate patterns
the outcome of each quit attempt (Fiore et al., 1990; Giovino et al., of and trends in use overall and for
being either relapse or main- 1993; West, et al., 2001). subgroups in the population.
tenance of cessation (US Depart- National prevalence estimates
ment of Health and Human have, in the vast majority of cases,
77
been based on self-reports of Saliva is the biological fluid of natively, some actual non-users of
personal behaviours. Self-report, choice in population-based sur- a product (e.g. cigarettes) may be
however, may be subject to veys, because it is the easiest to exposed to extremely high doses
misclassification bias. Survey res- obtain. Hair nicotine levels reflect of secondhand smoke, or they
pondents can either state that they exposure over a longer period of may use other tobacco products
do not currently use tobacco, time (Al-Delaimy, 2002). Hair or nicotine replacement therapy,
when in fact they do (mis- samples are even easier to obtain and thus may test positive for
classification of use as non-use), than saliva. However, measure- cotinine. Exposure to secondhand
or that they do currently use ment of nicotine in hair can be smoke, and use of other tobacco
tobacco when, in fact they do not influenced by hair color, treatment, products that are available in a
(misclassification of non-use as and growth rate and identifying given nation, should be deter-
use). Each of these misclassi- nicotine from actual tobacco use mined by questionnaire assess-
fication biases can compromise versus exposure to environmental ment and accounted for in validity
the validity of a survey estimate. sources can be problematic (Al- assessments. In addition, cotinine
Delaimy, 2002). levels may be influenced by
Determining validity: Unfortunately, the use of racial/ethnic differences in the rate
biomarkers as indicators of actual of nicotine metabolism and intake
Validation of self-report is generally use is also subject to error. of nicotine per cigarette smoked
conducted using biomarkers of Studies using cotinine to validate (Caraballo et al., 1998; Perez-
exposure to tobacco or tobacco self-report must determine a cut- Stable et al., 1998; Benowitz et al.,
smoke as criteria. Biomarkers of off for discriminating users from 2002), suggesting that different
exposure that have been used in non-users. Cut-offs generally cut-offs may be needed for
studies include nicotine; cotinine, a range from 10.0-20.0 ng/ml for different racial/ethnic groups.
major metabolite of nicotine; car- serum or saliva cotinine among Furthermore, the cut-off for
bon monoxide; and thiocyanate adults (Pirkle et al., 1996; Cara- pregnant women is lower (e.g. 10
(Society for Research on Nicotine ballo et al., 2001, 2004; Society for ng/ml) than for the general adult
and Tobacco, 2002; Al-Delaimy, Research on Nicotine and Tobac- population (Rebagliato et al.,
2002). Nicotine and cotinine are co, 2002) and 5.0-11.4 ng/ml 1998; Owen & McNeil, 2001;
almost exclusively specific to saliva or serum for adolescents Society for Research on Nicotine
tobacco products. Very low levels (McNeill et al., 1987; Caraballo et and Tobacco, 2002).
of nicotine can be found in some al., 2004; Post et al., 2005). Self-reports from studies with a
vegetables, but their impact on Optimally, a cut-off is selected in a high demand for abstinence can
cotinine levels is insignificant manner that results in the highest be biased (Velicer et al., 1992;
(Pirkle et al., 1996; Society for accuracy, defined as the best Patrick et al., 1994; Benowitz et
Research on Nicotine and Tobac- combination of sensitivity and al., 2002). Misclassification of use
co, 2002). Cotinine is preferred specificity (Caraballo et al., 2001, and non-use has been observed
over nicotine as a biomarker, 2004). However, actual users may in clinical studies of adult smokers
because it has a longer half-life in have cotinine levels below the cut- who have been advised to quit
biological fluids than nicotine (~16 off if their most recent use was not and subsequently interviewed
hours versus ~2 hours), thus recent enough or of sufficient about their smoking, often times
reflecting use over the previous intensity (in terms of units/day) to by persons associated with the
three days for the general generate adequate levels of intervention. This is particularly
population (Society for Research cotinine to exceed the cut-off, and true among subjects who have
on Nicotine and Tobacco, 2002). thus be incorrectly classified as diseases or conditions that would
Cotinine can be obtained from deceivers (Dolcini et al., 1996; benefit from quitting. For example,
saliva, urine, and blood (serum). Caraballo et al., 2004). Alter- it was reported that 15 (65%) of 23
78
self-reported quitters in a vention took place, compared to report (27.5% versus 24.7%); for
cessation trial of chronic ob- three other Finnish communities Poland, the difference was 4.2
structive pulmonary disease (Vartiainen et al., 2002). percentage points (41.8% versus
patients in the Netherlands mis- However, in cultures in which 37.6%).
reported use as non-use smoking among women is socially Misclassification of use as non-
(Monninkhof et al., 2004). In a US unacceptable, misclassification use is also more likely in
study to increase smoking ces- appears to be more common. household interviews with ado-
sation among pregnant women, Household interviews were con- lescents, where privacy may be
49% of self-reported quitters ducted on 1403 Southeast Asian compromised and disclosure is
receiving the intervention mis- adult immigrants who resided in lessened among those who do not
classified use as non-use the USA (Wewers et al., 1995). want their parents to learn about
(Kendrick et al., 1995). In the UK, The cotinine-adjusted estimates of their behaviour (Turner et al.,
11 (22%) of 51 myocardial current smoking prevalence were 1992; US Department of Health
infarction survivors who had been substantially higher than those and Human Services, 1994;
advised to quit smoking mis- based on self-report for Cam- Brittingham et al., 1998; Fowler &
classified use as non-use when bodian females (21.5% versus Stringfellow, 2001; Kann et al.,
followed-up during the year after 6.6%) and Laotian females 2002). The prevalence of seven
infarction (Sillet et al., 1978). In the (10.8% versus 4.2%). In 1992, tobacco use behaviours was
same report, 40% of subjects in a health surveys were conducted studied (e.g. lifetime cigarette use,
trial of nicotine gum misclassified among 1000 adults residing in current cigarette use, current
their use as non-use. Pitkranta in the District of Karelia, smokeless tobacco use, current
Population-based surveys, how- Russia and among 2000 adults cigar use) in an experiment that
ever, are, in general, comprised of residing in North Karelia, Finland varied mode of administration (pa-
people who experience smoking- (Laatikainen et al., 1999). The per-and-pencil instrument (PAPI)
attributable morbidity at approxi- cotinine-adjusted estimates of with computer-assisted self-
mately the rate of the general current smoking prevalence were interview (CASI) and survey
population, are not linked to substantially higher than esti- setting (school versus home))
advice to quit, and administered mates based only on self-report (Brener et al., 2006). Prevalence
by interviewers or data collectors among women from Pitkranta differed only for smoking a whole
who are not known to the res- (21% versus 10%) than among cigarette before age 13 (lower in
pondent. In general, self-reports of women from North Karelia (16% the PAPI condition) and current
current use from surveys are versus 13%). The researchers smokeless tobacco use (higher in
reasonably accurate, providing attributed the difference to mis- the school setting). Thus, for most
estimates of prevalence that are classification of actual use as of the tobacco-use behaviours
comparable to those obtained non-use, most likely because of measured, home settings can
from use of a biomarker (Pierce et the social unacceptability of provide prevalence estimates as
al., 1987; Velicer et al., 1992; smoking among women in that high as school settings if privacy is
Patrick et al., 1994; Caraballo et region of Russia. More recently, increased (both PAPI and CASI
al., 2001, 2004; Vartiainen et al., concerns were raised about mis- afford more privacy than either
2002). Data from the surveys used classification of use as non-use in face-to-face or telephone inter-
to evaluate the North Karelia population-based surveys conduc- views). It was also demonstrated
project indicate very little mis- ted in the UK and Poland (West et that when adequate privacy is
classification of use as non-use, al., 2007). For the UK, cotinine- provided, estimates of cigarette
with no difference in mis- adjusted prevalence estimates smoking from adolescent surveys
classification in North Karelia, were 2.8 percentage points higher conducted in households are
where the community-based inter- than estimates based on self- similar to those obtained from
79
surveys conducted in school they have smoked during a recent if estimates of adolescent drug
settings (Gfroerer et al., 1997). period of time, even when cotinine use obtained from data collected
Privacy in these studies is afforded levels are below threshold values, confidentially would differ from
by computer-assisted technology, may still be accurate, because those based on data that were
which may not be available in all nicotine dosing from infrequent collected anonymously (OMalley
countries. The four major surveys smoking may not result in levels of et al., 2000). They observed no
of adolescents discussed in this cotinine that are high enough to differences in prevalence esti-
Handbook (see Section 4.3) are exceed the cut-off value (Cara- mates, but cautioned that any
conducted in schools, which afford ballo et al., 2004, Dolcini et al., work conducted without anonymity
even more privacy than homes and 1996). The Centers for Disease must convince respondents that
provide more efficient venues for Control and Prevention conducted all their answers will be kept
data collection. a test-retest study of reporting and completely confidential. If a survey
Self-reports of the number of found that answers were reaso- respondent believes that the
cigarettes smoked each day nably stable over a two-week veracity of their self-report will be
appear to be underreported in period, with estimates of pre- checked biochemically, then they
surveys (Hatziandreu et al., 1989; valence being virtually identical may be more likely to disclose use
Section 4.2). Even though cotinine (Fowler & Stringfellow, 2001; (Murray & Perry, 1987; Cohen et
levels increase with increasing Brener et al., 1995). The reliability al., 1988; Aguinis et al., 1993).
number of cigarettes smoked each of answers does not prove that Question wording can also
day (Caraballo et al., 2001; they were not distorted on both influence the validity of self-report
Blackford et al., 2006), survey occasions, but remembering an (Babor et al., 1990; Brener et al.,
respondents demonstrate evi- exaggerated answer is likely more 2003; Section 2.2). Survey res-
dence of digit bias towards round difficult than remembering a true pondents must first understand a
numbers (e.g. 10, 15, 20, 30 one (Fowler & Stringfellow, 2001). question, interpret it properly, and
cigarettes per day) (Klesges et al., then encode it into memory. The
1995), and appear to round down Methods to enhance validity: outputs from this process are then
more often than they round up. used to search memory and
Comparisons between consump- Methodological techniques have retrieve relevant information,
tion data and survey-based esti- been developed to enhance pri- which is evaluated in the decision-
mates of consumption should be vacy in survey settings, such as making stage of the process. If the
conducted routinely in countries to having the respondent complete a information retrieved is considered
provide a crude indicator of the paper-and-pencil survey form in- to be an adequate response, then
discrepancies between the two stead of answering a face-to-face a response will be generated. If
sources of information. interview, which can be overheard not, then additional retrieval
Some adolescent survey res- (Brittingham et al., 1998); listen to attempts will be made, sometimes
pondents may indicate they survey questions using head- involving estimation strategies or
smoke or use smokeless tobacco phones connected to a laptop adoption of simple rules of thumb
when they actually do not, per- computer, providing answers via that people use to make judge-
haps to impress their friends the keyboard (Horm et al., 1996; ments quickly and efficiently.
(Cohen et al., 1988; Fowler & Brener et al., 2006); and respond If questions are difficult to
Stringfellow, 2001; Stein et al., to questions posed in a telephone understand, for example by asking
2002). However, misclassifying interview by pressing the appro- about more than one concept,
non-use as use appears to be far priate number button on the key then the accuracy of response will
less common than misclassifying pad instead of replying verbally be compromised. If questions are
use as non-use (Stein et al., (Biener et al., 2004). An experi- biased, for example by presenting
2002). Adolescent reports that ment was conducted to determine tobacco use in a negative context,
80
then answers will also likely be being measured. Adult respon- The prevalence of smoking was
biased. Survey questions must be dents to the 1992 National Health higher in the group given multiple
clear and objective, and con- Interview Survey (NHIS) who had response options (14.0%), com-
structed in a manner that involves ever smoked 100 lifetime ciga- pared to the group given the usual
the use of cognitive interviewing rettes were randomly assigned to question with the dichotomous re-
techniques, such as those des- be asked, Do you smoke now? sponse categories (9.2%). Most of
cribed in Section 2.2. (the question used prior to 1992) the women given the multiple
In an experiment involving the or Do you now smoke cigarettes choice question reported that they
use of three different sets of every day, some days, or not at had cut down since learning that
questions assessing smoking all? (the question used since they were pregnant, a response
behaviours that held all other 1992). Prevalence was 25.6% for option that allows them to disclose
conditions constant, researchers those who were asked the first their smoking and still display a
obtained similar estimates of question and 26.5% for those partially positive image. The re-
adolescent smoking prevalence asked the second (Centers for searchers estimated that this in-
from the three conditions (Brener et Disease Control and Prevention, crease in disclosure would identify
al., 2004). Using a convenience 1994a). Including an option on an additional 55000 pregnant
sample of 4140 high school non-daily smoking expanded the smokers in the USA each year. In
students (most were 14-18 years range of possible affirmative op- a survey conducted among preg-
old), approximately equal numbers tions, and by doing so provided nant women in the UK, cigarette
were randomly assigned to receive data on an important behaviour, smokers were identified as those
questions assessing 14 tobacco that of occasional smoking. who answered yes to the ques-
use behaviours, based on the The effect of question wording tion, Do you smoke at all nowa-
actual questions or adapting the on self-disclosure of smoking in a days? Approximately 4% of
question styles of one of these multiethnic prenatal population in pregnant women misclassified use
three US surveys: Monitoring the the USA was studied (Mullen et as non-use (Owen & McNeill,
Future Survey, Youth Risk Be- al., 1991). Questions about smo- 2001). Widespread adoption of
haviour Survey, or National king were embedded in a survey the question used by Mullen and
Household Survey on Drug Abuse. instrument assessing multiple risk col-leagues might reduce such
Questionnaire type was signifi- behaviours. In one condition, sub- misclassification.
cantly associated with three jects were asked Do you smoke? The overall content of a ques-
tobacco-use behaviours: lifetime and were forced to answer either tionnaire may also influence
cigarette use, smoking a whole yes or no. All other subjects disclosure. Respondents ans-
cigarette before age 13, and were asked, Which of the follow- wering a questionnaire that allows
purchasing cigarettes at a store or ing statements best describes them to portray some positive
gas station. Nine other measures, your cigarette smoking. Would attributes may be more likely to
including those assessing pre- you say: 1) I smoke regularly now, disclose negative attributes, than
valence of cigarette smoking and at about the same amount as be- if they were answering a ques-
smokeless tobacco use, did not fore finding out I was pregnant; 2) tionnaire that only assessed
vary by questionnaire type. No one I smoke regularly now, but Ive cut negative attributes (Fowler &
questionnaire type proved superior down since I found out I was preg- Stringfellow, 2001).
in this experiment. Each set of nant; 3) I smoke every once in a In 2002, the Society for Re-
questions was written in a clear while; 4) I have quit smoking since search on Nicotine and Tobacco
and objective manner. finding out I was pregnant; or 5) I Subcommittee on Biochemical
Question wording can also wasnt smoking around the time I Verification concluded that the
influence the prevalence estimate found out I was pregnant, and I added precision gained by
obtained depending on what is dont currently smoke cigarettes. biochemical verification is not
81
required and may not be feasible prevalence of use. For example, in veys is that they are less expen-
in large-scale population-based a country where multiple forms of sive to conduct than household in-
studies with limited face-to-face tobacco are available, as in India terviews. Telephone surveys are
contact (Society for Research on and the USA, a survey providing an generally not conducted in devel-
Nicotine and Tobacco, 2002). estimate of a tobacco use would oping countries, where coverage
Nevertheless, strategic assess- result in a higher estimate of does not permit the drawing of a
ment of validity in situations in prevalence than one that only representative sample. In de-
which social desirability may lead reports on the prevalence of veloped countries, however, the
to substantial underreporting, tobacco smoking. Similarly, an increasing prevalence of adults
could be beneficial (Wewers et al., estimate of cigarette smoking who own a wireless telephone, but
1995; Laatikainen et al., 1999). In prevalence would be lower than live in a household with no land-
addition, data collected in coun- estimates of tobacco use and of line telephone, presents a poten-
tries that routinely gather bio- tobacco smoking. In the same way, tial for bias, because sample
specimens for cotinine validation estimates of current daily smoking frames for telephone surveys are
and assessment of exposure to would be lower than estimates of drawn from numbers for landline
secondhand smoke, could provide current smoking, which include telephones. According to data
a sense of the scope and nature both daily and non-daily smoking. from the 2004 and 2005 US Na-
of underreporting, especially as tional Health Interview Survey
tobacco control progresses and Sample frame: (NHIS), approximately 1.7% of
tobacco use becomes increasingly adults lived in households that did
undesirable in a given society. The sample frame of a survey can not have any telephone service,
influence the prevalence esti- 5.6% of adults lived in households
Iss ues to consider when com- mates generated. For example, with only wireless telephones, and
paring dif ferent survey e sti- prevalence could differ sub- 92.8% of adults lived in house-
mates stantially for surveys of persons holds with landline telephones
aged 15 years and older, aged 25 (Blumberg et al., 2006). The pre-
Surveillance and evaluation years and older, and 25 to 64 valence of cigarette smoking was
systems will provide comparable years old. Likewise, a frame 19.7% (95% CI: 19.2-20.2) among
estimates of tobacco use be- drawn only from major metro- adults living in households with
haviours to the extent that they use politan areas in a given country landline telephones, 32.9% (95%
similar methods. The factors that would likely produce substantially CI: 30.9-35.0) among adults in
influence validity (e.g. assurance of different prevalence estimates households with only wireless
privacy and that answers will than if the entire population were telephones, and 36.9% (95% CI:
remain completely confidential, sampled. Each of the estimates 33.4-40.3) among adults in house-
question wording, social desira- from the sample frames discussed holds with no telephone service.
bility) will influence estimates of here could be valid for the popu- Thus, all other things being equal,
prevalence and thus comparisons lation covered by the respective the prevalence of cigarette smok-
between surveys. Factors that can sample frame. Thus, knowledge of ing that would have been esti-
influence prevalence estimates in each surveys sample frame is mated from a telephone survey,
ways that do not influence validity important when making com- that only reached households with
are described below. parisons across surveys. landline telephones, would have
Another sample frame issue been 19.7%, whereas the preva-
Definition of a user: deals with telephone coverage. lence in all households in the
Telephone surveys are frequently NHIS was 20.9%, a difference of
Differing definitions of a user will conducted in developed countries. 1.2 percentage points (P < 0.05).
often yield differing estimates of The major advantage of such sur- Telephone surveys provide valu-
82
able information. Rates of cover- Editing procedures: are lower in surveys with a tobacco
age will likely vary across nations. focus than in general health
The small difference in cigarette Surveys that are administered via surveys. The phenomenon was
smoking prevalence estimates self-administered questionnaires, studied using a factorial design and
seen in the USA suggest that com- such as the youth surveys des- concluded, after a series of multi-
parisons of prevalence estimates cribed in Section 4.3, require variate analyses, that the intro-
from telephone and household sur- decision rules for dealing with duction to the tobacco survey cued
veys should consider the possible inconsistent answers. The effects some people, mainly women, who
influence of coverage bias. of five approaches for handling didnt want to spend the time on the
Samples for surveys of ado- such inconsistencies in the 1998 survey, to misclassify themselves
lescents are drawn either from Florida Youth Tobacco Survey as non-users (Cowling et al.,
school-based frames, providing were described (Bauer & John- 2003). The researchers argued
access to enrolled students, or son, 2000). The approaches that the social stigmatization of
from household lists and subse- ranged from doing nothing, which tobacco use in California may have
quent enumerations of house- ignored inconsistencies and contributed to the misclassification
hold members. Only household analyzed each item as a separate bias they observed.
frames provide access to school entity, to a preponderance ap-
dropouts, who are more likely to proach, which evaluated each Type of parental consent in
smoke cigarettes than students of record and assigned values based school-based surveys of adoles-
the same age (Gfroerer et al., on the weight of the evidence for cents:
1997). This issue poses greater each respondent. The cigarette
concern for older (i.e. ages 16-17 smoking prevalence estimates In most countries, letters are sent
years) adolescents than for their generated from these approaches home notifying parents that their
younger counterparts, who are ranged from 25.6% (95% CI: 24.1- children will participate in a survey
less likely to have dropped out of 27.1) to 29.7% (95% CI: (parental notification). In some
school. Another comparability is- 28.2-31.2). Boys exhibited more countries, such as the USA and
sue is that household surveys may inconsistencies and therefore more Australia, two types of parental
not report data for an age group variability across approaches. permission are required for
that is comparable to one found in While recognizing the impossibility school-based survey research. In
a school survey. For example, if a of discerning which approach is the both systems, a letter is sent to
household survey reports esti- most valid, the authors suggested parents describing the upcoming
mates for young people who are that editing procedures be survey research project and
12-17 years old, and a school sur- described when findings are requesting their childs parti-
vey reports estimates for students reported. Approaches for handling cipation. In active parental per-
enrolled in grades 9-12 (most of inconsistencies can influence pre- mission, a form must be returned,
whom are 14-18 years old), then valence estimates and survey signed by a parent, granting the
the school survey will likely have comparability (Brittingham et al., child permission to participate. If
higher prevalence estimates sim- 1998; Bauer & Johnson, 2000). no signed form is returned,
ply because there are no 12-13 disapproval is assumed. In pas-
year olds enrolled in schools in Type of survey: sive permission, parents send
this frame, and the household age back a signed form only if they do
group does not include 18 year Recent reports indicate that pre- not want their child to participate. If
olds. Consumers of survey data valence estimates obtained from no form is returned, parental
should consider these and other surveys in California (Cowling et approval is assumed. In the USA,
factors when comparing data from al., 2003) and New Hampshire selected state and municipal
school and household surveys. (Ramsey et al., 2004) in the USA governments require active
83
permission. Three US reports lessened any concerns students diligently to maximize response
have noted that estimates of had about their parents negative rates, and continue to monitor res-
tobacco use are lower when active attitudes about certain risk be- ponse rates, sample characteristics,
parental permission is required haviours and facilitated disclosure. and prevalence estimates across
(Severson & Ary, 1983; Dent et Thus, comparisons of estimates surveys with differing response
al., 1993; Anderman et al., 1995). from school surveys in various rates to identify variables that might
It is suggested that active countries should assess the compromise comparisons.
permission laws exclude high risk degree to which active consent is
students because they are less required and the participation rate Survey-base d measures of
likely to return signed permission in each condition. tobacco use behaviours
forms. Differences were not ob-
served in ever smoking or Response rates: A general outline of the variables
smoking during the previous week used to monitor the natural history
in a study of active versus passive Concern has been raised about of tobacco use is presented in
consent conditions in Australia the effects of declining response Table 3.1. A description of de-
(White et al., 2004). rates in telephone surveys, tailed question items for almost
An analysis of the 2001 Youth especially in the USA. As the US every component of the process,
Risk Behaviour Survey (YRBS) rates declined in the 1990s, no dif- and some commentary on each,
data was undertaken to determine ferences in the degree of are provided in Tables 3.2 through
if type of parental consent was representation in samples of 3.18. Intention to try (I.a. in Table
related to the magnitude of esti- population subgroups were ob- 3.1) and intention to quit (IV.a. in
mates for 26 behaviours, including served (Biener et al., 2004). The Table 3.1) are discussed in
lifetime cigarette smoking, current researchers also compared ciga- Section 3.2. The methods used in
cigarette smoking, and current rette smoking prevalence esti- cessation attempts (IV.b.iii. in
smokeless tobacco use (Eaton et mates from telephone surveys Table 3.1) are discussed in
al., 2004). Of 13195 eligible conducted in Massachusetts and Section 5.7. Topography (as an
students, 65% lived in passive California, where response rates indicator of smoke intake) (III.e. in
conditions. In passive condition dropped substantially, with those Table 3.1) is discussed in the text
schools, 86.7% of sampled stu- from the Tobacco Use Supplement below; however, no survey items
dents participated; 77.3% of stu- to the Current Population Survey are recommended for this topic,
dents in active condition schools (TUS-CPS), in which response as questionnaire assessments of
did so. The difference was due to rates dropped only very slightly and smoking topography have not
the 9.5% of students in the active were substantially higher in 1998- been shown to be valid.
condition who did not return a 1999 (76%-81% in the TUS-CPS Tables 3.2 through 3.18 list
permission form. Type of consent versus 69% in Massachusetts and questions relevant for each topic
did not influence any of the 51% in California). The smoking that is either used in the cross-
tobacco measures; in fact, it was prevalence estimates obtained national surveys described in
related to only two of the 26 from the Massachusetts and Section 4.3, or in country-specific
behaviours measured. The con- California surveys remained rea- surveys. The latter are added in
clusion was that the requirement sonably close (as judged by over- instances where they supplement
for active consent will not lapping confidence intervals) to the items used in the cross-
influence prevalence estimates if those from the TUS-CPS, with no national surveys. In reliability
participation rates are sufficiently evidence of an increasing disparity assessments shown in the tables,
high (Eaton et al., 2004). It was over time. kappa statistics of 61-80% were
also argued that the anonymity Despite the findings from this considered substantial and 81-
offered by the YRBS might have study, researchers should work 100% were almost perfect (Brener
84
Construct Construct I.b. on Table 3.1 (Initial Trial)
Measure On how many occasions (if any) during your lifetime have you smoked cigarettes? Number of
occasions: 0, 1-2, 3-5, 6-9, 10-19, 20-39, 40 or more (ESPAD)
How old were you when you first tried a cigarette? I have never smoked cigarettes; 7 years old or
younger; 8 or 9 years old; 10 or 11 years old; 12 or 13 years old; 14 or 15 years old; 16 years old or
older (GSHS)
Have you ever tried or experimented with cigarette smoking, even one or two puffs? (GYTS)
Have you ever smoked tobacco? (at least one cigarette, cigar or pipe) (HBSC)
Sources ESPAD, GSHS, GYTS, HBSC
Validity Face validity. Kappa for ever use of cigarettes was 83.8% in CDC 14-day reliability study among high
school students (Brener et al., 1995). 81.5% agreement in a two year study (Shillington & Clapp, 2000).
92.3% of baseline ever users reported consistently at follow-up survey, with consistency decreasing with
increasing time between assessments (Huerta et al., 2005).
Variation Items are adaptable for assessments of other tobacco products. For example, a survey could ask, On
how many occasions (if any) during your lifetime have you used smokeless tobacco? Number of
occasions: 0, 1, 2-3, 4-9, 10-19, 20-39, 40 or more
Comments This variable is assessed mostly in youth surveys. The only cross-national adult survey which
conceptually can indicate ever use is the GATS, which asks non-current users: In the past, have you
smoked tobacco (cigarettes, cigars or pipes) on a daily basis, less than daily, or not at all?
Definitions Ever users have tried one or more smoke or smokeless tobacco products. Never users have not tried
tobacco, even the least amount asked about. Definitions more specific to product type(s) can be
employed (e.g. ever smoker, ever cigarette smoker, ever user of smokeless tobacco, ever user of betel
quid).
GYTS: Global Youth Tobacco Survey

HBSC: Health Behaviour of School-aged Children
ESPAD: European School Survey Project on Alcohol and Other Drugs
GSHS: Global School Health Survey
GATS: Global Adult Tobacco Survey
CDC: Centers for Disease Control and Prevention
Table 3.2 Initial Trial - Ever Use of Cigarettes or Smoked Tobacco
et al., 1995). Also, intraclass Initial trial: indicators (Starr et al., 2005).
correlation coefficients (ICC) of Reducing the number of people
0.75 and higher were considered This construct distinguishes who ever try tobacco will reduce
excellent, and 0.60 to 0.74 were persons who have never used the number who become estab-
considered good (Johnson & Mott, from those who have ever used lished users (US Department of
2001). Most of the measures are tobacco (Table 3.2). The propor- Health and Human Services,
listed in terms of smoking tion of young people who have 1994; Starr et al., 2005). Best
behaviour. Modifications of each never tried a cigarette is one of the measured in school surveys of
item can be made for smokeless Center for Disease Control and adolescents, initial trial can be
tobacco use. Preventions (CDC) key outcome assessed for whichever tobacco
85
products are of most relevance in Tobacco Surveillance System and Human Services, 1994).
a particular country. Trends in this Collaborating Group, 2005; White Trends over time in average age or
measure have been studied for & Hayman, 2006). Here we define grade of first use have been
more than 30 years in the USA, a trier as someone who has tried reported (Kopstein, 2001; John-
where lifetime use of cigarettes smoking, but has only taken one or ston et al., 2006). Measures of
among high school seniors (i.e. more puffs, but never a whole actual age of first use have been
12th grade students, the vast cigarette/cigar/pipe, or as some- used to calculate the incidence of
majority being 17-18 years old) one who has tried smokeless initiation of first use (Centers for
was 73.6% in 1975 and 50% in tobacco, but only on one occasion Disease Control and Prevention,
2005 (Johnston et al., 2006). (Table 3.3). 1998; Kopstein, 2001). The ave-
Cross-national findings on initial The age of first use is another rage age of first use varies across
use have been reported in several CDC key outcome indicator (Starr countries, likely reflecting the
reports (Warren et al., 2000; Global et al., 2005). The younger people influence of media and of cultural
Youth Tobacco Survey Colla- are when they start using tobacco, values (Warren et al., 2000; Global
borative Group, 2002; Godeau et the more likely they are to use it as Youth Tobacco Survey Colla-
al., 2004; Hibell et al., 2004; Global adults (US Department of Health borative Group, 2002; Global
Construct Construct I.b. and I.c. on Table 3.1 (Initial Trial and Experimentation)
Measure How many cigarettes have you smoked in your entire life? None; 1 or more puffs, but never a whole
cigarette; 1 cigarette; 2 to 5 cigarettes; 6 to 15 cigarettes (about pack total); 16 to 25 cigarettes (about
1 pack total); 26 to 99 cigarettes (more than 1 pack but less than 5 packs); 100 or more cigarettes (5
or more packs) (GYTS OPTIONAL)
Source GYTS
Validity Face validity. 10-18 year old US smokers who had smoked 20-98 lifetime cigarettes were more likely
to report that they smoked because it relaxes or calms them and because its really hard to quit than
were smokers who had smoked fewer than 20 lifetime cigarettes (Centers for Disease Control and
Prevention, 1994a).
Variation Items are adaptable for assessments of other tobacco products. For example, a survey could ask, On
how many occasions (if any) during your lifetime have you used smokeless tobacco? Number of
occasions: 0, 1, 2-3, 4-9, 10-19, 20-39, 40 or more
The parenthetical examples of the number of packs listed in the item above for cigarettes apply only in
countries in which there are 20 cigarettes in each package.
Comments Definitions for cigarette smoking are based on Choi et al., 2001.
Definitions A trier is someone who has tried smoking, but has only taken a few puffs or someone who has tried
smokeless tobacco, but only once. An experimenter is someone who has smoked more than a few
puffs, but fewer than 100 cigarettes. For other tobacco products, the US National Center for Health
Statistics uses cut-offs of from 1-49 cigars or pipes full of tobacco or having used smokeless tobacco
on from 1-19 occasions.
Table 3.3 Trial versus Experimentation
86
Tobacco Surveillance System policies aim first to prevent initial lished use. The question
Collaborating Group, 2005). Table trial and, if initial use has occurred, recommended in Table 3.5 per-
3.4 describes the construct Age of to prevent progression beyond mits use of other time periods after
First Use. such use. Researchers used one initial trial. Three months since
month with or without use to initial use can be used to define
Discontinuation after initial trial: distinguish recent from non- former triers. This strategy, while
recent experimenters (Choi et al., somewhat arbitrary, is based on
Some young people will try 2001). However, approximately the assumption that triers who
tobacco, for example, by taking a three in 10 non-recent experi- have not used for at least three
few puffs on a cigarette, and then menters, according to their months, would be less likely to
never use again. Tobacco control definition, progressed to estab- progress to established user than
Construct Construct I.b. on Table 3.1 (Inital Trial)
Measure When (if ever) did you first do each of the following things? A) Smoke your first cigarette? Never; 9
years old or less; 10 years old; 11 years old; 12 years old; 13 years old; 14 years old; 15 years old; 16
years or older (ESPAD)
older (GSHS)
older (GYTS)
At what age did you first do the following things? Smoke a cigarette: Never, ___ (write in age). (HBSC)
Sources ESPAD, GYTS, GSHS, HBSC
Validity Face validity. Kappa for smoking first whole cigarette before age 13 years was 68.1% in CDC 14-day
reliability study among high school students (Brener et al., 1995). Intraclass correlation coefficient (ICC)
was good (range = .637 - .666) in three tests of children and moderate (0.517) in a fourth in a two year
reliability study (Johnson & Mott, 2001). The ICC was 0.73 for males and 0.76 for females in an Israeli
study (Huerta et al., 2005). Forward telescoping (producing older estimates of age of first use upon
re-interview) has been observed (Shillington & Clapp, 2000; Johnson & Mott, 2001).
Variation Items are adaptable for assessments of other tobacco products.
Comments The NSDUH asks adolescents and adults, How old were you the first time you smoked part or all of a
cigarette? (http://oas.samhsa.gov/nsduh.htm). This measure has been used to assess incidence of
initiation (Centers for Disease Control and Prevention, 1998); NSDUH even assesses month of first
use in recent initiators (http://www.oas.samhsa.gov/2k4/season/season.htm).

NSDUH: US National Survey on Drug Use and Health
Table 3.4 Age of First Use
87
would those abstinent for less and use of smokeless tobacco on Transition to established use:
than three months. at least 20 occasions to measure
established use in a manner Young people who have become
Experimentation: similar to the 100 cigarette ques- established users are, compared to
tion. Indicators of nicotine depen- those who have not, at far greater
Experimentation occurs when dence have been observed during risk of continuing to smoke as
someone progresses beyond the experimentation process adults (US Department of Health
initial trial. Experimentation with (Centers for Disease Control and and Human Services, 1994; Choi
cigarettes can be distinguished Prevention, 1994b; DiFranza et et al., 2001). Preventing pro-
from initial trial and from estab- al., 2002b; OLoughlin et al., gression to established use is a
lished use with the question 2003). goal of tobacco control. CDC has
recommended in Tables 3.3 and identified the proportion of young
3.6. Experimenters are those who Discontinuation of experimenta- people who have smoked 100
have consumed from 1-99 ciga- tion: cigarettes or more during their
rettes. Regarding the use of other lifetimes as a key outcome indi-
tobacco products, experimen- Another goal of tobacco control is cator for evaluating comprehensive
tation can be operationalised as to prevent the progression from tobacco control programmes (Starr
smoking from 1-49 cigars or pipes experimentation to established et al., 2005). Similar indicators for
full of tobacco, or having used use. As discussed above, a cut-off other tobacco products are recom-
smokeless tobacco on from 2-19 of three months of abstinence mended in Table 3.6. Several other
occasions. These are somewhat since experimenting can be used measures of transition have been
arbitrary cut-offs; the US National to define former experimenters described as well (Johnston,
Center for Health Statistics uses (see Table 3.5). 2001).
50 cigars, 50 pipes full of tobacco,
Construct Construct I.b.i and I.c.i. on Table 3.1 (Discontinuation)
Measure When was the last time you smoked a cigarette, even one or two puffs? I have never smoked a
cigarette; today; not today, but some time during the past week; not in the past week, but some time in
the past month; 2-3 months ago; 4-6 months ago; 7-12 months ago; 1 or more years ago (GYTS
OPTIONAL)
Source GYTS
Validity Face validity. In one study, non-recent experimenters (those experimenters who had not smoked within
the previous 30 days) were less likely to progress to established smoking than were current
experimenters (Choi et al., 2001).
Definitions A former trier is someone who has smoked only a few puffs or who has tried smokeless tobacco only
once who has not used it for > 3 months. A former experimenter is someone who has experimented
(defined in Table 3.3) and has not smoked/used tobacco for > 3 months.
Table 3.5 Time Since Last Use Among Triers or Experimenters
88
Construct Construct II. on Table 3.1(Transition to established use)
Measure How many cigarettes have you smoked in your entire life? None; 1 or more puffs, but never a whole
cigarette; 1 cigarette; 2 to 5 cigarettes; 6 to 15 cigarettes (about pack total); 16 to 25 cigarettes (about
1 pack total); 26 to 99 cigarettes (more than 1 pack but less than 5 packs); 100 or more cigarettes (5
or more packs) (GYTS OPTIONAL)
Have you smoked 100 cigarettes or more in your lifetime? (ITC)
Have you smoked at least 100 cigarettes in your entire life? (NHIS, BRFSS, NSDUH, ATS, TUS-CPS)
Sources GYTS, ITC, NHIS, BRFSS, NSDUH, ATS, TUS-CPS
Validity Evidence of utility predictive validity. Adolescents who have smoked at least 100 lifetime cigarettes
are more likely to be established smokers in the future than those who have not (Choi et al., 2001).
Variation Items are adaptable for assessments of other tobacco products. On how many occasions (if any) during
your lifetime have you used smokeless tobacco? Number of occasions: 0, 1, 2-3, 4-9, 10-19, 20-39,
40 or more
Comments Having ever smoked 100 cigarettes is considered established use (Choi et al., 2001; Starr et al., 2005).
It is a useful measure because it can be used as a marker for a threshold even for never daily users.
However, some people have difficulty understanding the concept of having ever smoked a total of 100
lifetime cigarettes. For other tobacco products, the use of > 50 cigars or pipes full of tobacco or having
used smokeless tobacco on > 20 or more occasions can be used as cut-offs to define established use.

ITC: International Tobacco Control Policy Evaluation Survey
NHIS: US National Health Interview Survey
BRFSS: US Behavioural Risk Factor Surveillance System
ATS: US Adult Tobacco Survey
TUS-CPS: US Tobacco Use Supplement to the Current Population Survey
Table 3.6 Threshold for Transition to Regular Use
Ever daily versus never-daily: The average age of first daily Current use:
use can vary among ethnic groups
In the USA in 1991, approximately within a country and over time Current use is influenced primarily
7.5% of established smokers had (Centers for Disease Control and by rates of initiation and quitting, as
never smoked on a daily basis Prevention, 1991). Compared with well as by mortality, and to a far
(Husten et al., 1998). Among all younger age of first daily use, lesser extent, immigration into and
established smokers, never daily starting at an older age has been emigration out of a given popu-
smoking was more common associated with slightly lower rates lation. Current use is the most
among non-Whites (range = 12- of subsequently developing tob- important construct because of its
17%) than among Whites (6%); acco-attributable disease (US importance as an outcome variable
among current smokers, never Department of Health and Human in policy evaluation studies. CDC
daily smoking was also more Services, 2004). Description of rates it a key outcome indicator
common among non-Whites ever daily use constructs and age (Starr et al., 2005).
(range = 11-17%) than among of first daily use are found in Each of the seven surveys
Whites (4%). Tables 3.7 and 3.8. described in Section 4.3 mea-
sures current use (Table 3.9). In
89
three (European School Survey the adult surveys. In the Global who had ever smoked > 100
Project on Alcohol and Other Adult Tobacco Survey (GATS) lifetime cigarettes who currently
Drugs (ESPAD), Global School and the STEPwise Approach to smoke daily, weekly, or monthly.
Health Survey (GSHS), Global Chronic Disease Factor Sur- Trends in and patterns of
Youth Tobacco Survey (GYTS)) of veillance (STEPS) survey, a current use have been reported in
the four surveys of young people, current smoker is someone who numerous reports and publi-
a current user is someone who currently smokes tobacco pro- cations (US Department of Health
used tobacco at least once during ducts daily or less than daily. and Human Services, 1994,1998,
the previous 30 days (month) GATS and STEPS can distinguish 2001; Warren et al., 2000;
(Warren et al., 2000, 2006; Hibell between current daily and current Kopstein, 2001; Giovino, 2002;
et al., 2004; WHO, 2007a). In the non-daily smoking (Table 3.9). White & Hayman, 2006). The
Health Behaviour of School-aged GATS can also classify current WHO Global InfoBase documents
Children (HBSC) survey, a current non-daily smokers as ever daily or prevalence of current use of
user is someone who uses either never daily smokers. The Inter- various indicators, including cur-
daily or weekly (Godeau et al., national Tobacco Control Policy rent smoking, current daily
2004; Hublet et al., 2006). Current Evaluation Survey (ITC) classifies smoking, and current tobacco use
use is defined slightly differently in current cigarette smokers as those for countries throughout the world
Construct Construct II.a. on Table 3.1 (Ever daily and never daily)
Measure When (if ever) did you first do each of the following things? B) Smoke cigarettes on a daily basis:
Never; 9 years old or less; 10 years old; 11 years old; 12 years old; 13 years old; 14 years old; 15 years
old; 16 years or older (ESPAD)
Have you ever smoked cigarettes daily, that is, at least one cigarette every day for 30 days? (NYTS)
In the past, have you smoked tobacco (cigarettes, cigars or pipes) on a daily basis, less than daily, or
not at all? (GATS)
In the past, did you ever smoke daily? (STEPS)
Sources ESPAD, NYTS, GATS, STEPS
Validity Face validity. Kappa for ever daily use was 86.6% in CDC 14-day reliability study among high school
students (Brener et al., 1995).
Variation In GATS, current non-daily smokers are asked, Have you smoked tobacco daily in the past? Items are
adaptable for assessments of other tobacco products.
Comments The prevalence of never daily smoking among adult smokers in the USA was documented (Husten et
al., 1998).
Definitions An ever daily user is someone who has ever smoked tobacco or used smokeless tobacco on a daily
basis. A never daily user has never smoked tobacco or used smokeless tobacco on a daily basis.

NYTS: National Youth Tobacco Survey
STEPS: STEPwise Approach to Chronic Disease Factor Surveillance
Table 3.7 Ever daily versus Never Daily Use
90
Construct Construct II.a. on Table 3.1 (Ever daily and Never Daily)
Measure When (if ever) did you first do each of the following things? Smoke cigarettes on a daily basis: Never;
9 years old or less; 10 years old; 11 years old; 12 years old; 13 years old; 14 years old; 15 years old;
16 years or older (ESPAD)
How old were you when you first started smoking daily? (GATS, STEPS)
Sources ESPAD, GATS, STEPS
Validity Face validity. Kappa for first smoking daily before age 13 years was 71.8% in CDC 14-day reliability
study among high school students (Brener et al., 1995). ICC was excellent for adults assessments of
age of first daily use (.815) in a two year reliability study (Johnson & Mott., 2001). Forward telescoping
(producing older estimates of age of first daily use upon re-interview) has been observed (Johnson &
Mott., 2001).
Comments The NSDUH asks adolescents and adults, How old were you when you first started smoking every
day? (http://oas.samhsa.gov/nsduh.htm). This measure has been used to assess incidence of initiation
of daily use (Centers for Disease Control and Prevention, 1998). Measures like this have been used to
calculate incidence of initiation of cigarette smoking (Pierce et al., 1994; Pierce & Gilpin, 1995; Centers
for Disease Control and Prevention, 1998).

Table 3.8 Age at first daily use
(http://www.who.int/ncd_surveillanc non-daily smoking remained sta- in countries, such as India, where

e/infobase/web/InfoBaseCommon). ble at about 18-19% of all current there exists a variety of commonly
smokers from 1993 to 2004 used forms of tobacco products.
Frequency of use: (Trosclair et al., 2005). The variety of forms available, and
In surveys of young people, the possibility of switching or
Frequency of use refers to the current frequent users are those multiple concurrent uses may
number of days when tobacco is who smoked on > 20 or more of the influence the probabilities of
used during a given time period previous 30 days. Frequency of quitting and of disease risk.
(e.g. the previous seven days or use is a predictor of quitting (with Country-specific lists of products
the previous 30 days). Frequency more frequent use associated with to be monitored should be in-
of use is often dichotomized as a lower probability of subsequent corporated into each countrys
either current daily or current non- quitting than less frequent use) survey. Examples of items used in
daily use (Table 3.9). In the USA, (Hyland et al., 2004). the various cross-national surveys
current non-daily smoking is more are provided in Table 3.10.
common among African Ameri- Per capita consumption (by
cans and Hispanics than it is Type of product used: weight) of various tobacco
among non-Hispanic Whites (US products is often documented by
Department of Health and Human It is important to measure the type government agricultural agencies
Services, 1998). Overall, current of product consumed, particularly (Capehart, 2007). A useful rule of
91
Construct Constructs III. and III.a. on Table 3.1 (Current use)
Measure Surveys of Youth
How frequently have you smoked cigarettes during the LAST 30 DAYS? Not at all; less than 1 cigarette
per week; less than 1 cigarette per day; 1-5 cigarettes per day; 6-10 cigarettes per day; 11-20 cigarettes
per day; more than 20 cigarettes per day (ESPAD)
During the past 30 days, on how many days did you smoke cigarettes? 0 days; 1 or 2 days; 3 to 5 days;
6 to 9 days; 10 to 19 days; 20 to 29 days; all 30 days (GSHS)
During the past 30 days (one month), on how many days did you smoke cigarettes? 0 days; 1 or 2
days; 3 to 5 days; 6 to 9 days; 10 to 19 days; 20 to 29 days; all 30 days (GYTS)
Do you smoke now? Not at all; occasionally, but less than once a month; some time each month, but
less than one cigarette per week; sometime per week, but less than one cigarette per day; every day
at least one cigarette? (GYTS OPTIONAL)
How often do you smoke at present? Every day; at least once a week, but not every day; less than
once a week; I do not smoke (HBSC)
Surveys of Adults
Do you currently smoke tobacco (cigarettes, cigars or pipes) on a daily basis, less than daily, or not at
all? (GATS)
Do you smoke every day, less than every day, or not at all? (including factory-made cigarettes or
hand-rolled cigarettes). NON-DAILY SMOKERS ARE ASKED: Do you smoke at least once a week?
THOSE WHO ANSWER NO ARE ASKED: Do you smoke at least once a month? (ITC)
Do you currently smoke any tobacco products, such as cigarettes, cigars, or pipes? IF YES: Do you
currently smoke tobacco products daily? (STEPS)
Sources ESPAD, GSHS, GYTS, HBSC, GATS, ITC, STEPS
Validity Evidence of utility. Self-reports of current use have been shown to be reasonably valid for adults and
youths, when adequate privacy is afforded (Turner et al., 1992; Velicer et al., 1992; Patrick et al., 1994;
US Department of Health and Human Services, 1994; Gfroerer et al., 1997; Brittingham et al., 1998;
Caraballo et al., 2001; Fowler & Stringfellow, 2001; Kann et al., 2002; Caraballo et al., 2004; Brener et
al., 2006). Kappa for smoking on > 14 days during the previous 30 days was 80.1% in CDC 14-day
reliability study among high school students (Brener et al., 1995). Evidence indicated that for persons
aged > 18 years, current smoking prevalence estimates based on proxy reports are virtually identical
to those based on self-report (Gilpin et al., 1994).
Definitions Among Youth: A current user is someone who used tobacco at least once during the previous 30 days
(month). A current frequent user is someone who used tobacco on > 20 of the previous 30 days. Among
Adults: A current user is someone who consumes tobacco daily or less than daily (GATS, STEPS) or
someone who consumes tobacco daily or less than daily during the previous month (ITC). A current daily
user is someone who reports using on a daily basis.
Among both Youth and Adults: Frequency refers to the number of days smoked each month.
Table 3.9 Current Use (Daily versus Non-Daily)
92
Comments Comparisons of adolescent prevalence estimates with those of adults can be problematic. For example,
estimates of current use among adolescents are often considerably higher than those among adults.
However, adolescents who smoke generally do so on fewer days each month than do adult smokers.
Ideally, comparisons of use among youth and adults would be made with a measure of the number of
days smoked during the previous 30 days (e.g. > 20 of 30 days). In countries where adult surveys do
not measure the number of days smoked out of the previous 30 days, then comparing adult prevalence
of current use with the prevalence of current frequent use among adolescents would be preferred to
comparisons of past month use, because the vast majority of adult users consume tobacco on > 20 of
the previous 30 days. Some countries measure use during the previous week. Comparisons of weekly
use among adolescents and adults would provide more comparable estimates than past month use.

Table 3.9 Current Use (Daily versus Non-Daily)
thumb is that when the amount of (Centers for Disease Control and 2001), they have been banned in a
tobacco consumed in a particular Prevention, 1994c; Tomar et al., number of countries (e.g. Euro-
product (e.g. snuff) comprises less 1995; Slade, 2001; Cummings et pean Union countries, Australia)
than 1% of total tobacco con- al., 2002a; Wayne & Connolly and replaced either by other terms
sumed, then use of that product 2002; Carpenter et al., 2005; or specific color schemes that
need not be assessed in surveys. Lewis & Wackowski, 2006). indicate strength based on
Exceptions to that rule may occur Tobacco control practitioners can machine-measured yields. All of
when use of a product that is rarely use this information to implement these indicators are still mis-
consumed in the overall population policies (e.g. counter-marketing leading, since the tests used to
is more common among a sub- campaigns, tobacco product regu- determine strength do not reflect
group of the population. In the lation) designed to reduce overall actual human exposure (National
USA, for example, the use of bidis use. Survey-based measures of Cancer Institute, 2001; Hammond
is rare in the adult population, but brand used are presented in Table et al., 2006b). Thus, it is important
of concern among young people 3.11; measures of brand switching to capture the extent of use of
(National Youth Tobacco Survey are described in Table 3.12. these terms, either via survey-
(NYTS) data, US National Survey Sub-brand characteristics (e.g. based questions (Table 3.11), or
on Drug Use and Health (NSDUH) strength, flavoring, length) are via documentation of what is on the
data). often determined by either asking actual package.
for the name of the specific brand Detailed measurement of infor-
Brand used: purchased or asking the name of a mation about tobacco product
brand family, followed by each of packaging is important in order to
The prevalence of use of specific several possible sub-brand charac- determine the variant of product
brands among users of a par- teristics (Table 3.11). Strength has type used, movement between
ticular product type (e.g. often been described by industry price sectors, and, potentially, to
manufactured cigarettes) reflects terms such as light and mild. assess the use of tobacco from
the influence of both marketing Because these terms are mis- illicit sources. Interviewers can
campaigns and product design leading (National Cancer Institute, either collect empty packages or
93
take digital photographs of a given probability of developing a to- chase patterns after price in-
respondents current pack. Pac- bacco-attributable disease (US creases, may influence the
kage characteristics to document Department of Health and Human probability of subsequent quitting,
include: brand name, strength, Services, 2004; IARC, 2004). with those switching to less expen-
flavoring, length, pack type (hard sive cigarettes appearing to be
pack versus soft pack), package Smoke intake: less likely to quit than those who
color, color in words (e.g. Silk Cut do not (Hyland et al., 2005; see
Silver, Silk Cut Purple), filter (e.g. The intake of smoke from a Section 5.1 for items assessing
non-filter, charcoal [if designated]), cigarette is generally determined adult purchase patterns). Among
UPC code, number of cigarettes in laboratory studies of smoking young people, policies are often
per pack, constituents measured topography, which assess how enacted to reduce sales to minors
and levels, text, warning label(s) cigarettes are smoked. Variables (underage persons) (Lantz et al.,
(words, picture [if applicable], and measured include the number of 2000). These policies are not con-
location[s]), and the presence or puffs taken per cigarette, the sidered effective on their own
absence of a tax stamp. duration of each puff, inter-puff (Fichtenberg & Glantz, 2002b;
In addition to survey based interval, puff volume, the draw Fielding et al., 2005), in part
measures, governments should rate of each puff, the unsmoked because young people are more
make available to researchers and butt length, and the amount of likely to give other people money to
policy makers sub-brand-specific obstruction of filter ventilation purchase cigarettes for them when
sales data on a region-specific holes (Pechacek et al., 1984). restrictions on sales to minors are
basis. This will allow researchers Unfortunately, questionnaire as- implemented (Everett Jones et al.,
to better document the influence sessments of this construct have 2002; White & Hayman, 2006).
of tobacco product marketing not proven to be valid. Two See Table 3.14 for questionnaire
practices. alternative techniques have been items on adolescent purchase pat-
developed that estimate smoke terns.
Intensity of use: intake from the study of cigarette
filter butts: one measures the Quit attempts
Intensity of use reflects the amount of solanesol, a naturally
average number of cigarettes, occurring component of tobacco A key outcome indicator of a
cigars, or pipes full of tobacco that is deposited during smoking policy is whether it leads to an
smoked each day for daily in the cigarette filter butt (Watson attempt to discontinue use (Starr
smokers, or on the days during et al., 2004a); and the other et al., 2005; Fong et al., 2006a).
which the respondent smoked for studies the staining pattern on As shown in Table 3.15, ques-
non-daily smokers. Selected filter butts as a proxy measure for tionnaire items that assess
questionnaire items used to total smoke volume (OConnor et whether a respondent has ever
assess intensity are listed in Table al., 2005; Strasser et al., 2006; tried to quit, the number of lifetime
3.13. Intensity decreases following OConnor et al., 2007). Either of quit attempts, and the duration
the implementation of smoke-free these techniques would require and recency of the last quit
policies (Fichtenberg & Glantz, the collection of filter butts from attempt are drawn from the ITC
2002a; Section 5.2) and price survey respondents. baseline survey. ITC follow-up
increases (Chaloupka et al., 2001; assessments determine whether a
Warner, 2006; Section 5.1). Purchase patterns: respondent has tried to quit since
Intensity is inversely associated the prior assessment and the
with the probability that a Some policies influence how peo- longest period of abstinence
respondent will quit (Hyland et al., ple obtain cigarettes. The ways in during that time period. The GATS
2004), and is directly related to the which adults change their pur- question assesses whether a quit
94
Construct Construct III.b. on Table 3.1(Type of product use)
Measure During the past 30 days, on how many days did you use any other form of tobacco, such as [COUNTRY
SPECIFIC EXAMPLES]? 0 days; 1 or 2 days; 3 to 5 days; 6 to 9 days; 10 to 19 days; 20 to 29 days;
all 30 days (GSHS)
During the past 30 days (one month), did you use any form of smoked tobacco products other than
cigarettes (e.g. cigars, water pipe, cigarillos, little cigars, pipe)? (GYTS)
During the past 30 days (one month), did you use any form of smokeless tobacco products (e.g.
chewing tobacco, snuff, dip)? (GYTS)
Do you currently use smokeless tobacco on a daily basis, less than daily, or not at all? (GATS)
On average, how many times a day do you use the following: [snuff by mouth, snuff by nose, chewing
tobacco, betel quid, any others]? (GATS)
In the past month, have you used any other tobacco product besides cigarettes? IF YES: What did
you use? FOR EACH PRODUCT USED, How often do you currently smoke/use [PRODUCT]? Would
that be daily, less than daily but at least once a week, less than weekly but at least once a month, less
than monthly, or have you stopped altogether? (ITC)
Do you currently use any smokeless tobacco such as [snuff, chewing tobacco, betel quid]? IF YES:
Do you currently use smokeless tobacco products daily? (STEPS EXPANDED)
On average, how many times a day do you use [snuff by mouth, snuff by nose, chewing tobacco, betel
quid, other]? (STEPS EXPANDED)
Source GSHS, GYTS, GATS, ITC, STEPS
Validity Evidence of utility. Only 2% of adolescents in Sweden who reported that they did not use cigarettes or
snus during the previous month had cotinine levels > 5 ng/ml (Post, 2005). It was shown that the use
of cotinine and thiocyanate could distinguish smokers from smokeless tobacco users (Noland et al.,
1988). Kappa for use of chewing tobacco during the previous 30 days was 72.3% in CDC 14-day
reliability study among high school students (Brener et al., 1995).
Variation Country-specific lists are used. In general, use of a product need not be measured in surveys if
consumption of tobacco in that product is by weight < 1% of the total tobacco consumed in the country,
as reported by government agricultural statistics. Exceptions to this rule can occur as, for example,
when use of a particular product among youth is of concern.

Table 3.10 Type of Tobacco Product Used
95
Construct Construct III.c. on Table 3.1(Brand use)
Measure During the past 30 days (one month), what brand of cigarettes did you usually smoke? (SELECT
ONLY ONE RESPONSE) Did not smoke cigarettes during the past 30 days; no usual brand; Add 5
most common brands; other (GYTS)
What brand did you buy when you last purchased cigarettes? Were these cigarettes filtered or non-
filtered? Were these cigarettes light, mild, or low-tar? (GATS)
Do you smoke factory-made cigarettes, roll-your-own cigarettes, or both? IF BOTH: For every 10
(ten) cigarettes you smoke, how many are roll-your-own? In the last month, what brand of [cigarettes/roll-
your-own cigarettes] did you smoke more than any other? [SUB-BRAND CHARACTERISTICS ARE
IDENTIFIED AS NECESSARY FOR EACH NATION] (ITC)
Sources GYTS, GATS, ITC
Validity Face validity.
Variation In ITC, sub-brand characteristics (e.g. length, filter versus non-filter) are identified in one of two possible
ways. In many countries, such as Canada, Australia, and the United Kingdom, lists of every possible
brand are developed and a code is given to each brand. The interviewer needs to determine the
complete name of the brand the respondent is using. Often, the prompt, How do you ask for your
specific brand in the store? is used to try to elicit the full name. In other countries (e.g. USA, China),
where the variety of sub-brands is too great, brand names are given specific codes and interviewers
determine specific sub-brand characteristics (e.g. menthol versus non-menthol, King Size, 100s, or
some other length).
Country-specific terms that communicate concepts similar to light, mild, or low-tar should be
substituted as appropriate. These can include colour, as well as terms such as Fine or Smooth.
Items are adaptable for assessments of other tobacco products and for non-cigarette potential reduced
exposure products (PREPs).
Comments If necessary, country representatives should generate a list of all the brands on the market and have it
available for interviewers to use to code answers. Observation of packaging to assess colour(s),
presence of a legal tax stamp, and/or counterfeit brands would complement self-report.

Table 3.11 Brand Characteristics
attempt of at least 24 hours was tionnaires assess whether a than those that were planned
made during the previous 12 serious attempt was made during (Larabie, 2005; West & Sohal,
months. A baseline question from the previous 12 months, the 2006). Items assessing this
the Smoking Toolkit Study (West, number of attempts, and, for up to construct from ITC and from the
2006) assesses whether a serious three attempts, the recency and Smoking Toolkit Study (West,
quit attempt (i.e. whether the duration of each. 2006) are presented in Table 3.16.
person decided to make sure they
never smoked another cigarette) Intentionality: Dose management:
was ever made and, if so, the
duration and recency of the last Spontaneous quit attempts People who quit abruptly (some-
quit attempt. The follow-up ques- appeared to be more successful times referred to as cold turkey)
96
Construct Construct III.c. on Table 3.1(Brand Use)
Measure About how long have you been smoking [current brand]? IF UNKNOWN: Would that be less than one
year, or at least one year? (ITC)
Approximately how long have you been smoking [NAME OF CURRENT BRAND]? Before the [NAME
OF CURRENT BRAND] that you smoke now, what brand did you smoke? (AUTS)
Sources ITC, AUTS
Comments Using data from the USA, it was demonstrated that 9.2% of smokers switched cigarette brands and
6.7% switched companies during the previous year (Siegel et al., 1996). Rates of switching may be
higher in locations where high prices lead to smokers searching out less expensive brands. During a
three year cohort study, it was observed that US adolescents who used snuff were more likely to switch
from a brand with low nicotine dosage to a brand with high, than to switch from a high dosage brand to
a low dosage brand (Tomar et al., 1995).
AUTS: Adult Use Tobacco Survey

Table 3.12 Brand Switching
appear more likely to succeed Key constructs to measure prevalence surveys. The key
than those who gradually reduce constructs involve current use.
the number of cigarettes they Several reports describe important Since current use is influenced
smoke each day (Fiore et al., constructs for tracking progress in primarily by initiation and ces-
1990; Gritz et al., 1999). Items reducing smoking prevalence (US sation, these constructs are
assessing this construct from the Department of Health and Human included as well.
ITC and the Smoking Toolkit Services, 1989, 1990, 1994, 1998, Two constructs, both used in
Study (West, 2006) are presented 2001; WHO, 1998a; Husten et al., adult surveys, that are too
in Table 3.17. 1998; Pierce et al., 1998b; complex to include in Table 3.19
Warren et al., 2000; Burns et al., will be presented here. GATS
Maintenance of abstinence versus 2000; Johnston, 2001; Kopstein, questions permit a six category
return to use: 2001;Giovino, 2002; Global Youth classification of use status: 1)
Tobacco Survey Collaborating current daily use; 2) current non
Discontinuing use of tobacco and Group, 2002; Godeau et al., 2004; daily use formerly daily; 3) cur-
maintaining abstinence are the Hibell et al., 2004; Global Tobacco rent use - never daily; 4) former
most important disease preventing Surveillance System Collaborating daily use; 5) former use - never
actions a user can take (US Group, 2005; Starr et al., 2005; daily; and 6) never used. These
Department of Health and Human Trosclair et al., 2005; Hublet et al., categories can be defined based
Services, 2004; Dresler et al., 2006; Johnston et al., 2006; on answers to three questions: 1)
2006). Items assessing duration of Mochizuki-Kobayashi et al., 2006; Do you currently smoke [use
abstinence are presented in Table Warren et al., 2006; White & smokeless] tobacco on a daily
3.18. Hayman, 2006; WHO, 2007a). basis, less than daily, or not at
Table 3.19 contains a list of key all?; 2) Have you smoked [used
constructs to measure in smokeless] tobacco daily in the
97
Construct Construct III.D. on Table 3.1(Intensity of use)
Measure Youth Surveys
How frequently have you smoked cigarettes during the LAST 30 DAYS? Not at all; less than 1 cigarette
per week; less than 1 cigarette per day; 1-5 cigarettes per day; 6-10 cigarettes per day; 11-20 cigarettes
per day; more than 20 cigarettes per day (ESPAD)
During the past 30 days (one month), on the days you smoked, how many cigarettes did you usually
smoke? I did not smoke cigarettes during the past 30 days (one month); less than 1 cigarette per day;
1 cigarette per day; 2 to 5 cigarettes per day; 6 to 10 cigarettes per day; 11 to 20 cigarettes per day;
more than 20 cigarettes per day (GYTS)
Adult Surveys
On average, how many of the following do you smoke each <day/week>? Manufactured cigarettes;
hand-rolled cigarettes; pipes full of tobacco; cigars, cheroots, cigarillos; water pipe rocks (GATS)
On average, how many cigarettes do you smoke each <day/week/month>, including factory-made
cigarettes and roll-your-own cigarettes? (ITC)
On average, how many of the following do you smoke each day? Manufactured cigarettes; hand-
rolled cigarettes; pipes full of tobacco; cigars, cheroots, cigarillos; other (STEPS)
Sources ESPAD, GYTS, GATS, ITC, STEPS
Validity Evidence of utility. In several countries, cotinine levels increased with increasing cigarettes per day
(CPD) and levelled off between 10-20 CPD (Caraballo et al., 1998; Blackford et al., 2006). Indicators
of nicotine dependence are associated with smoking intensity in adolescents (OLoughlin et al., 2003)
and adults (Shiffman et al., 2004). Kappa for smoking > 1 cigarette/day during the previous 30 days was
76.2% in CDC 14-day reliability study among high school students (Brener et al., 1995).
Variation Items are adaptable for assessments of other tobacco products. Smokeless tobacco is measured in
GATS in terms of the number of times the respondent uses a given product each day.
Comments Intensity is the number of cigarettes/cigars/pipes full of tobacco smoked each day for daily smokers
and on the days smoked for less than daily smokers (Marcus et al., 1993; Centers for Disease Control
and Prevention, 1994a).

Table 3.13 Intensity of Use (Number of Cigarettes or Other Tobacco Products Smoked
During a Selected Time Period)
98
Construct Construct III.f. on Table 3.1(Purchase patterns)
Measure During the past 30 days (one month), how did you usually get your own cigarettes? (SELECT ONLY
ONE RESPONSE) I did not smoke cigarettes during the past 30 days (one month); I bought them in a
store, shop or from a street vendor; I bought them from a vending machine; I gave someone else money
to buy them for me; I borrowed them from someone else; I stole them; an older person gave them to
me; I got them some other way (GYTS)
During the past 30 days (one month), did anyone ever refuse to sell you cigarettes because of your
age? I did not try to buy cigarettes during the past 30 days (one month); yes, someone refused to sell
me cigarettes because of my age; no, my age did not keep me from buying cigarettes (GYTS)
In the area where you live, do you know of any places that sell single or loose cigarettes? Yes; No
(GYTS OPTIONAL)
Where, or from whom, did you get the last cigarette you smoked? Tick only one box: I didnt buy it
My parents gave it to me; my brother or sister gave it to me; I took it from home without my parent(s)
permission; friends gave it to me; I got someone to buy it for me; other (specify) OR I bought itat a
hotel, pub, bar, tavern, RSL club; at a supermarket; at a news agency; at a milk bar or delicatessen; at
a convenience store (e.g. Food Plus); at a tobacconist/tobacco shop; at a take-away food shop; at a
petrol station; through the internet; other (specify) (ASSAD)
If you bought your last cigarette, was it from a coin-operated (vending) machine? (ASSAD)
Sometimes people break open a packet of cigarettes and sell single cigarettes. In the last four weeks,
have you bought cigarettes that were not in a full packet (for example, buying one or more cigarette(s)
at a time)? IF YES: Thinking of the last time you bought cigarettes that were not in a full packet, where
did you buy the cigarette(s) from? I bought the cigarette(s) at a shop; I bought the cigarette(s) from a
friend or relative; I bought the cigarette(s) from someone else (ASSAD)
Sources GYTS, ASSAD (White & Hayman, 2006)
Comments Those who purchase in locations that provide less expensive cigarettes are less likely to quit (Hyland
et al., 2005). Young people are more likely to have other people purchase cigarettes for them in regions
where sales to minors are restricted (Everett Jones et al., 2002; White & Hayman, 2006).

ASSAD: Australian Secondary Students Alcohol and Drug Survey
Table 3.14 Purchase Patterns
99
Construct Construct IV.b. on Table 3.1 (Quit attempts)
Measure Ever:
ITC BASELINE: Have you ever tried to quit smoking? IF YES: How many times have you ever tried
to quit smoking? How long ago did your most recent serious quit attempt end? Thinking about your last
serious quit attempt, how long did you stay smoke free? (ITC)
Have you ever made a serious attempt to stop smoking? By serious attempt I mean you decided that
you would try to make sure that you never smoked another cigarette. Yes; No; Dont know
IF YES: Thinking back to your most recent attempt to quit smoking, how long ago was it? SHOW
SCREEN: Within the last week; within the last 2-3 weeks; a month ago; more than 1 month and up
to 2 months; more than 2 months and up to 3 months; more than 3 months and up to 6 months; more
than 6 months and up to a year; more than one year and up to 5 years; longer than 5 years; dont
know.
AND: How long ago did your most recent quit attempt last? Less than a day; more than a day but
less than 3 days; more than 3 days up to a week; more than a week up to a month; more than 1
month and up to 2 months; more than 2 months and up to 3 months; more than 3 months and up to
6 months; more than 6 months and up to a year; more than one year and up to 5 years; more than
5 years; dont know; I am still not smoking (STS Baseline Questionnaire)
Past 12 months:
During the past year, have you ever tried to stop smoking cigarettes? I have never smoked cigarettes;
I did not smoke during the past year; yes; no (GYTS)
During the past 12 months, have you tried to stop smoking? IF YES: Thinking about the last time you
tried to quit, how long did you stop smoking? (GATS)
Follow-up assessments in a cohort study:

ITC FOLLOW-UP WAVES:
FOR RESPONDENTS WHO WERE CURRENTLY SMOKING AT THE PREVIOUS WAVE: Have you
made any attempts to stop smoking since we last spoke with you in [month of last interview]? IF YES:
Are you back smoking or are you still stopped? IF BACK SMOKING: What is the longest time that you
stayed smoke free since [month of last interview]? IF STILL STOPPED: When did you quit? (ITC)
FOR RESPONDENTS WHO WERE ABSTINENT AT THE PREVIOUS WAVE: The last time we spoke
with you in [month of last interview] you had quit smoking. Are you back smoking or are you still
stopped? IF BACK SMOKING: What is the longest time that you stayed smoke free since [month of
last interview]? IF STILL STOPPED: So you have quit smoking since [quit date reported previously]
is that correct? IF NO: When did you quit? (ITC)
Have you made a serious attempt to stop smoking in the past 12 months? By serious attempt I mean
you decided that you would try to make sure that you never smoked another cigarette. Please include
any attempt that you are currently making. Yes; no; dont know.
IF YES: How many serious attempts to stop smoking have you made in the last 12 months?
(Choose one option only) 1 attempt; 2 attempts; 3 attempts; more than 3 attempts; dont know. How
long ago did your quit attempt start? (assessments are made for up to 3 attempts). How long ago
did your quit attempt last before you went back to smoking? (assessments are made for up to 3
attempts; still not smoking is an option) (STS Wave 1 and 2 postal questionnaires)
Sources ITC; STS (West, 2006); GATS
Table 3.15 Quit Attempts
100
Validity Face validity. However, respondents appear to forget many short quit attempts, especially those that
took place more than three months before the interview (Gilpin & Pierce, 1994; West et al, 2007). Having
ever quit for > 12 months or having quit for > 7 days during the previous 12 months has been classified
as a strong quitting history and is predictive of subsequent cessation (Pierce et al., 1998b).
Comments ITC items are specifically crafted to assess change in a cohort study.
Definitions A quit attempt is an activity by a user in which the person tries to stop using with the intention of never
using again. Some surveys only classify periods of abstinence as quit attempts that last for > 24 hours.

STS Smoking Toolkit Study
Table 3.15 Quit Attempts
past?; and 3) In the past, have Services, 1998; Burns et al., Detailed measurement of infor-
you smoked [used smokeless] 2000). mation about tobacco product
tobacco on a daily basis, less than packaging is important in order to
daily, or not at all? (Note that Summary determine the variant of product
respondents are skipped past type used, movement between
questions that do not apply to This section describes the key price sectors, and, potentially, to
them, as indicated by their an- concepts within the natural history assess the use of tobacco from
swer(s) to initial item(s).) of tobacco use, providing a illicit sources.
The second construct involves conceptual model to guide mea- Other important constructs in
a technique that assesses tobacco surement of key constructs. the measurement of tobacco use
use activity during the 12 months Current tobacco use is the most behaviour include early use, fre-
prior to being interviewed. The US important construct because of its quency and intensity of current
Tobacco-Use Supplement to the importance as an outcome in use, quit attempts, and duration of
Current Population Survey asks policy evaluation studies. Studies abstinence among former smo-
current daily smokers, current non- that have examined the validity of kers.
daily smokers, and former smokers self-reported measures of current Consumers of survey data, in
abstinent < 12 months, Around use generally find these measures which tobacco use measures are
this time 12 months ago were you to be valid, although there are included, should be aware of
smoking cigarettes every day, conditions where the validity may factors that can influence popu-
some days, or not at all? This be reduced. lation estimates of tobacco use
question, which can be adapted to It is important to measure the and take those into consideration
smokeless tobacco use, enables a type of tobacco used, particularly when comparing estimates from
retrospective cohort assessment of in those countries in which there surveys conducted within and
cessation activity, transitioning exists a variety of forms. The across countries.
from daily to non-daily use, transi- variety of forms available, and the
tioning from non-daily to daily use, possibility of switching, or multiple
and relapse to daily or non-daily concurrent use may influence the
use (Gilpin & Pierce, 1994; US probability of quitting and disease
Department of Health and Human risk.
101
Construct Construct IV.b.i on Table 3.1 (Intentionality)
Measure When you made your last quit attempt, when did you choose your quit day? Chose it on the actual
day when you stopped; chose it on the day before you stopped; chose it more than one day before; or
actually decided to quit after having not smoked for some other reason (ITC)
Had you been seriously thinking about quitting in the days before you finally decided to stop, or was it
a spur-of-the-moment decision? I had already been seriously thinking about quitting; it was a spur-of-
the-moment decision (ITC)
Which of the following statements best describes how your most recent quit attempt started? SHOW
SCREEN: I did not plan the quit attempt in advance; I just did it; I planned the quit attempt for later the
same day; I planned the quit attempt the day beforehand; I planned the quit attempt a few days
beforehand; I planned the quit attempt a few weeks beforehand; I planned the quit attempt a few months
beforehand; none of these (other specify) (STS Baseline Questionnaire)
Please circle which applies to each quit attempt. (Choose one response for each quit attempt) I planned
the quit for later the same day or for a date in the future; I planned to quit as soon as I made the decision
(STS Wave 1 & 2 postal questionnaires)
Sources ITC; STS

Validity Face validity. Unplanned quit attempts were more likely to succeed than planned attempts (Larabie,
2005; West & Sohal, 2006)

STS: Smoking Toolkit Study
Table 3.16 Quit Attempts Intentionality
Construct Construct IV.b.ii on Table 3.1 (Dose management)
Measure On your most recent quit attempt, did you stop smoking suddenly or did you gradually cut down on the
number of cigarettes you smoked? Stopped suddenly; cut down gradually (ITC)
Did you cut down gradually by delaying the first cigarette you had each day for longer and longer, or
just by trying to smoke less and less? By delaying the first cigarette of the day; by trying to smoke less
and less; both (ITC)
Did you cut down the amount you smoked before trying to stop completely? (Choose one response
for each quit atempt) Cut down first; stopped without cutting down; cannot remember (STS)
Sources ITC; STS
Validity Face validity. Abstainers were more likely to stop without cutting down than were relapsers, who were
more likely to quit using gradual reduction (Fiore et al., 1990; Gritz et al., 1999).

STS: Smoking Toolkit Study
Table 3.17 Quit Attempts Dose Management
102
Construct Construct IV.c. on Table 3.1 (Maintenance of abstinence)
Measure How long ago did you stop smoking? I have never smoked cigarettes; I have not stopped smoking;1-
3 months; 4-11 months; 1 year; 2 years; 3 years or longer (GYTS)
When was the last time you smoked a cigarette, even one or two puffs? I have never smoked a
cigarette; today; not today, but some time during the past week; not in the past week, but some time in
the past month; 2-3 months ago; 4-6 months ago; 7-12 months ago; 1 to 4 years ago; 5 or more years
ago (GYTS OPTIONAL)
How long has it been since you last smoked regularly? (GATS)
ITC FOLLOW-UP WAVES:

FOR RESPONDENTS WHO WERE CURRENTLY SMOKING AT THE PREVIOUS WAVE: Have you
made any attempts to stop smoking since we last spoke with you in [month of last interview]? IF YES:
Are you back smoking or are you still stopped? IF BACK SMOKING: What is the longest time that you
stayed smoke free since [month of last interview]? IF STILL STOPPED: When did you quit? (ITC)
ALTERNATIVE METHOD: Have you made any attempts to stop smoking since we last spoke with you
in [month of last interview]? IF YES: The last time we spoke with you in [month of last interview] you
said that you smoked [daily/less than daily but at least once a week/less than once a week but at least
once a month]. Do you still smoke [daily/less than daily but at least once a week/less than once a week
but at least once a month]?
IF NO AND RESPONDENT SMOKED DAILY AT LAST INTERVIEW: Are you now smoking at least
once a week, or less than once a week, but at least once a month?
IF NO AND RESPONDENT SMOKED WEEKLY AT LAST INTERVIEW: Are you now smoking
daily or are you smoking less than once a week, but at least once a month?
IF NO AND RESPONDENT SMOKED MONTHLY AT LAST INTERVIEW: Are you now smoking
daily or less than daily, but at least once a week?
FOR RESPONDENTS WHO WERE ABSTINENT AT THE PREVIOUS WAVE: The last time we spoke
with you in [month of last interview] you had quit smoking. Are you back smoking or are you still
stopped? IF BACK SMOKING: What is the longest time that you stayed smoke free since [month of
last interview]? IF STILL STOPPED: So you have quit smoking since [quit date reported previously]
is that correct? IF NO: When did you quit? (ITC)
How long ago did you stop smoking daily? (STEPS)
Sources GYTS, GATS, ITC, STEPS
Validity Evidence of utility. Self-reports of having quit are reasonably valid when adequate privacy is afforded
and demand for abstinence is not high (Velicer et al., 1992).
Comments ITC items are specifically crafted to assess change in a cohort study.
Definitions A former user is someone who has used more than the threshold level of established use and who no
longer uses. Sustained former use occurs when a former user has been abstinent for at least 12 months
(6 to 12 months, Starr et al., 2005; 12 months, Giovino & Borland, personal communication).

Table 3.18 Duration of Abstinence in Former Smokers
103
Construct Numerator Denominator Comments
Initiation of Use
Ever use Number of ever users Total number of A similar construct could be assessed for
respondents ever daily use.
Early initiation Number of ever users who Number of ever users GYTS uses 10 years old as cut-off.
tried using before a given A similar constuct could be measured
age for initiation of daily use before a given
age.
Transition to established Number of current daily Number of ever users Indicates probability of transition to and
use users maintenance of more established use.
(See Johnston, 2002 for other indicators
of transition)
Discontinuance Number of former triers Number of ever users A similar construct could be assessed for
former experimenters.
Maintenance of Use
Current use Number of current users Total number of Various measures include current
respondents smoking, current smokeless tobacco
use, current tobacco use, and current
use of individual products. Similar
constructs could be assessed for current
daily use.
Frequency of use Number of daily users Number of current users An inverse construct would define the
percentage of current users who do not
use on a daily basis. Some surveys
describe frequent use as use on > 20 of
the previous 30 days.
Intensity of use Number of current users Number of current users Cut-offs should be standardised to permit
who use more than a given comparisons. For example, for adult
amount cigarette smokers, use of > 15
cigarettes/day could serve as a measure
of heavy smoking. Mean numbers can
also be presented.
Brand use Number of current users Number of current users Variants could involve descriptors of roll-
who use a given brand your-own cigarettes, Western versus
domestic brands, and sub-brand
characteristics as appropriate to a given
nation (e.g. light/mild, menthol)
Purchase location Number of current users Number of current users For adults, type of venue could indicate
who purchase in a given tax avoidance strategies. For youth,
location source of tobacco could indicate efforts
Table 3.19 Suggested Prevalence Indicators of Tobacco Use Behaviours
104
Cessation of Use
Former use among ever Number of former uses Number of ever users Often called the quit ratio or
users prevalence of cessation this is a crude
measure of quitting (Pierce et al., 1989;
US Department of Health and Human
Services, 1989, 1990).
Sustained abstinence Number of former Number of ever users Relapse is less likely after being
users abstinent for > 6 abstinent for > 12 months.
months
Making a quit attempt Number of current users Number of current users Making a quit attempt is a dependent
who tried to quit during the plus the number of former variable in many policy analyses
previous 12 months plus users abstinent for <12
the number of former users months
abstinent for <12 months
Former use for > 1 months Number of former users Number of current users Indicates > 1 month of abstinence
among anyone who used abstinent for 1-12 months who tried to quit during the among those who tried to quit during
during the previous 12 previous 12 months plus the previous 12 months. People
months and made a quit the number of former users abstinent for < 1 month would be not
abstinent for 1-12 months included in this anlysis (Centers for
Disease Control and Prevention, 1993)
Notes: The numbers in the numerator and denominator could be either the actual number of respondents in the survey or the weighted population
estimate. Also, fractions would be multiplied by 100 to obtain percentages.
Table 3.19 Suggested Prevalence Indicators of Tobacco Use Behaviours
105
3.2 General mediators and moderators of

tobacco use behaviours
Introduction practical as a good theory that WG established a short list of the

explains what to measure, how to variables considered to be the most
Presented in this section are a core interpret the results, what course of relevant and useful for the
set of general mediator and action to take based on these evaluation of tobacco control poli-
moderator variables that should be results, and what consequences cies and interventions in general.
considered when evaluating tobac- can be expected from these actions. Researchers can complement this
co control programmes and policies. To establish a list of these me- list by adding other relevant
A brief description and assessment diators and moderators, the measures, depending on the aim
of several standard measures for Working Group (WG) drew on and cultural context of each study,
assessing these constructs are relevant behaviour theories (Conner and the specific interventions under
provided as well. Mediators are & Norman, 1996) including the evaluation.
variables situated on the causal Social Cognitive Theory (Bandura, Guiding principles in the
pathway between a policy and its 1986), the Health Belief Model establishment of this list were the
public health impact (i.e. variables (Janz & Becker, 1984), the Trans- usefulness of each measure, its
that are affected by policies and that theoretical Model of Change influence in the published literature,
in turn, influence health or (Prochaska et al., 1992), the Pro- and the availability of associated
behavioural outcomes). For in- tection Motivation Theory (Rogers, validation studies (which were not
stance, motivation to quit may 1975), the Theory of Planned always available). Some measures
increase after an anti-tobacco infor- Behavior (Ajzen, 1991), and the for which no psychometric tests of
mation campaign, and motivation in Prime Theory (West & Hardy, validity were available were never-
turn predicts whether smokers will 2006). In particular, readers are theless included because of their
quit. Moderators are factors not referred to the theoretical framework face validity and lack of alternative
directly affected by the specific of the International Tobacco Control validated measures. Efficiency was
policy under scrutiny, but that Policy Evaluation Survey (ITC), also an important criterion of
moderate the effect of that policy. which was developed specifically for selection: the WG chose instru-
For example, an information cam- the evaluation of the WHO ments that were both brief and
paign may be effective among one Framework Convention on Tobacco informative, excluding long instru-
age group while being ineffective in Control (FCTC), and within which ments, even if they were widely
another (Figure 3.2). Analyzing surveys can be developed and used. When several comparable
mediators sheds light on how poli- interpreted (Fong et al., 2006a; scales were available, the most
cies and interventions have an Thompson et al., 2006). A com- influential one was chosen, based
impact; analyzing moderators aids prehensive list of all the psycho- on the number of citations to the
in understanding under what con- social determinants of smoking original articles describing these
ditions and in which groups they behaviour would result in a long scales (Bakkalbasi et al., 2006).
work, or do not work. In the context questionnaire in the context of The psychological determinants
of policy evaluation, nothing is as policy evaluation. Therefore, the of tobacco use and cessation range
107
Moderators
Sociodemographic characteristics
Personality
Mental health
Alcohol and substance use
Policy Policy Psychosocial mediators Policy relevant Public

specific outcomes health and
Knowledge economic
variables
In particular, impact
Beliefs about risks, costs and
tobacco use
benefits
behavior
Self-exempting beliefs,
justifications, regret
Attitudes towards smoking
Functional utility of smoking
Anti tobacco industry attitudes
Concerns about SHS
Smoking susceptibility
Intention to quit, quit date
Recent quit attempts and duration
Self-efficacy
Social influences, perceived

social norms
Figure 3.2 The role of psychosocial variables in the causal chain between policy and public health impact
108
General mediators and moderators of tobacco use behaviours

from cognitive, motivational, and Depending on the context, eva- predictors of behaviour. Three
emotional variables to personality luators can also assess illicit drug questions are proposed to assess
traits, personal life events, and use, for instance by using the a respondents perceived risk of
psychopathology variables. It is WHO ASSIST questionnaire disease: How would you compare
important to note that many quit (WHO ASSIST Working Group, your chance of getting lung cancer
attempts are not planned (Larabie, 2002; Newcombe et al., 2005). compared to the chance of a
2005), that the triggers of relapse The set of general mediators nonsmoker? Do you worry that
are often quite contextual, and and moderators considered in this smoking will damage your
that the timely response of the section was derived from theory, health? How much do you think
subject in each specific situation is published research, and the WGs you would benefit from quitting
determinant (West & Hardy, subjective assessment of what is smoking? (Table 3.21). Additional
2006). Thus, ideally, measure- relevant for policy evaluation. This specific beliefs are covered in
ments should be both timely and list (Table 3.20), though not other sections of this Handbook.
contextual, which is not always comprehensive, is believed to
feasible. Therefore, the WG represent a core set of measures Validity: For the question on
excluded the assessment of tem- useful in explaining how policies worrying that smoking will
porary states of mind (e.g. the and interventions work, in which damage the smokers health, the
euphoria caused by an alcoholic population subgroups they work, test-retest intraclass correlation,
drink) that are good proximal and how to improve them. assessed eight months apart in
predictors of relapse, because daily smokers with no quit
their assessment requires specific Items and scales used to attempts, was r=0.59 (Yan, 2007).
techniques (ecological momentary assess the psychological In an analysis of daily smokers in
assessments) that are not easily determinants of smoking the ITC surveys, this question
implemented in the context of predicted whether participants
policy evaluation (Shiffman et al., Mediators made a quit attempt (very worried
2002). versus not at all worried, odds
Smoking prevalence is much Cognitive variables ratio (OR) = 3.24 for quit attempts,
higher in psychiatric patients than 95% confidence interval (CI):
in the general population, and on Perceived risk and outcome 2.67-3.94) (Thompson et al.,
average, smokers with psychiatric expectancies 2006; Yan, 2007). For the ques-
disorders are more dependent on tion on the benefits of quitting
tobacco than other smokers For many quitters, smoking ces- smoking, the test-retest intraclass
(Breslau, 1995). There is also a sation is preceded by a change in correlation was r=0.54, for
concern that, in countries where beliefs about the costs and assessments made eight months
smoking prevalence declines, an benefits of smoking and of quitting apart in daily smokers with no quit
increasing proportion of the (Etter et al., 2000a). These beliefs attempts (Yan, 2007). In an
remaining smokers have psy- are often the target of prevention analysis of daily smokers in the
chiatric disorders (Lasser et al., interventions, and it is therefore ITC surveys, the question on the
2000). Thus, an assessment of important to include them in benefits of quitting predicted
mental health is relevant to the programme evaluations. Asses- smoking cessation after eight
study of smoking behaviour. In sing personalized beliefs that the months (extremely versus not at
addition, it is suggested that respondent has about himself or all, OR = 2.11, 95% CI: 1.23-3.60)
alcohol use and abuse be as- herself is suggested, rather than (Yan, 2007). These questions
sessed, as both are strongly general awareness, since per- therefore have some evidence of
associated with tobacco use. sonalized beliefs are stronger validity.
109
I. Mediators
a. Cognitive variables:
Knowledge
Beliefs about the risks, costs, and benefits of smoking and of quitting
Self-exempting beliefs, justifications, regret
Attitudes towards smoking, functional utility of smoking
Anti-tobacco industry attitudes
Concerns about exposing others to secondhand smoke
b. Motivational variables:
Smoking susceptibility (adolescents)
Intention to quit and quit date
Recent quit attempts and duration of the last quit attempt
c. Self-efficacy
d. Social influences, perceived social norms
II. Moderators
a. Sociodemographic characteristics:
Age
Sex
Socioeconomic status (education, income, occupation)
Ethnicity, primary language, minority group status
Religion
Family structure, peer and family smoking
Country of residence and language of the interview (recorded by the interviewer)
b. Personality
c. Mental health:
WHO-5 Well-Being Index
2-item screening for current symptoms of depression
d. Alcohol use and abuse:

Alcohol Use Disorders Identification Test (AUDIT-C)
Table 3.20 List of Some Relevant Psychosocial Determinants of Smoking
110
Construct Question and Link Responses, Scoring Adult / Recommended / Validity Level References
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Table 3.21 Measures of the Psychosocial Determinants of Smoking

111
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115
Self-exempting beliefs, justifica- less likely to make a quit attempt in and a differential score (advan-
tions, and regret the next eight months than those tages minus drawbacks) pros-
who strongly agreed (OR = 0.42, pectively predicted both smoking
Smokers continue to smoke, and 95% CI: 0.24-0.75), but they were cessation in current smokers and
nonsmokers start to smoke even as likely to quit smoking (Yan, relapse in former smokers, with
though they are aware of the risks 2007). This question may never- differences between smokers and
of smoking, in part because of self- theless be retained because of its quitters ranging from 0.5 to 1.4
exempting beliefs and other face validity. standard deviation units of this
justifications (Chapman et al., 1993; scale (Etter et al., 2000a). This
Weinstein, 1999). Quitting smoking Attitudes towards smoking scale can therefore be considered
may require shedding such beliefs to have adequate validity (Table
and accepting information about Attitudes are defined as the 3.21).
the risks of smoking. The WG degree to which people have a
suggests including one question favorable or unfavorable evalu- Functional utility of smoking
derived from the ITC survey, on ation of smoking (Ajzen, 1991).
whether people think that the Among the main drawbacks of Many smokers use cigarettes to
medical evidence that smoking is smoking, as reported by smokers control their weight or as response
harmful is exaggerated (Table themselves, are the health risks, to stress, even though tobacco
3.21). the financial costs, the bad smell, withdrawal itself is a strong
and the fact that secondhand stressor. Two questions from the
Validity: In daily smokers in the ITC smoke (SHS) bothers other ITC survey, whether smoking
survey, the test-retest reliability on people (Etter et al., 2000a). helps smokers control their weight,
the question "the medical evi- Among the most frequently cited and whether smoking calms them
dence... is exaggerated" was 0.64 advantages of smoking are the down when they are stressed or
(Yan, 2007). This question pre- pleasure to smoke, its relaxing upset, should be included.
dicted smoking cessation after effects, and the relief of withdrawal
eight months (strongly disagree symptoms (Etter et al., 2000a). Validity: In a prospective sample
versus strongly agree, OR = 2.23, These elements are captured by of 272 current and former
95% CI: 1.17-4.23) (Yan, 2007). several scales, for instance the smokers, the item "smoking calms
This question has some evidence Attitudes Towards Smoking Scale me down when I am stressed or
of validity. (ATS-18) (Etter et al., 2000a); upset" had a test-retest correlation
using a few items from this scale of 0.8, and the item predicted
Regret is recommended. relapse in ex-smokers (difference
between abstainers and relapsers,
Many smokers express regret that Validity: The ATS-18 has a robust 2.3 standard deviation units,
they ever started to smoke. The factor structure across various p<0.001) (Etter et al., 2000a). This
WG suggests including one ques- samples, and test-retest correla- item can therefore be considered
tion on whether the respondent tions were high (in the range of 0.8 to have adequate validity.
would start smoking, if they had to to 0.9) (Etter & Perneger, 1999; For the question on whether
do it over again. Etter et al., 2000a; Christie & smoking helps smokers control
Etter, 2005). The hypothesized their weight, the test-retest relia-
Validity: In daily smokers in the association between attitudes and bility (eight months apart) in
ITC survey, the test-retest cor- intention to quit has been re- smokers in the ITC survey was
relation for this question was 0.62 produced in several studies (Etter r=0.74 (Yan, 2007). In the same
(Yan, 2007). Smokers who strongly & Perneger, 1999; Etter et al., sample, this question predicted
disagreed with this statement were 2000a; Christie & Etter, 2005), smoking cessation after eight
116
months (strongly disagree versus tell the truth predicted smoking smokers with no quit attempts,
strongly agree, OR = 1.39, 95% CI: cessation after eight months (nei- was also moderate (r=0.50).
1.06-1.82) (Yan, 2007). Therefore, ther agree nor disagree versus However, in an analysis of daily
this question has some evidence of strongly agree, OR = 0.65, 95% CI: smokers, this question predicted
validity. 0.43-0.97). The question on whe- smoking cessation after eight
ther the industry tried to convince months (often or very often versus
Anti-tobacco industry attitudes the public that SHS carries no risk never, OR = 1.37, 95% CI: 1.16-
also predicted smoking cessation 1.62) (Yan, 2007). Therefore,
Criticism of tobacco companies is (disagree versus strongly agree, these questions have some
a strategy sometimes used in OR = 0.76, 95% CI: 0.61-0.93) evidence of validity.
prevention campaigns. Good cam- (Yan, 2007). These questions have
paigns can modify attitudes adequate evidence of validity. Motivational variables
towards these companies, which in
turn may lower the risk of youth Concerns about exposing others to Smoking susceptibility (adoles-
smoking initiation (Sly et al., secondhand smoke (SHS) cents)
2001a). Assessing anti-industry
attitudes is therefore relevant in the Decreasing exposure to second- To assess the susceptibility of
context of programme evaluation. hand smoke (SHS) is a priority of taking up smoking, Pierce's Smo-
Two suggested items derived from the FCTC. Policies targeting SHS king Susceptibility Scale, a brief,
the ITC surveys, whether tobacco may affect smokers' concerns three item, and widely cited mea-
companies can be trusted to tell about exposing others to it, which sure intended for adolescents, is
the truth about the dangers of their justifies including this topic. Two suggested (Pierce et al., 1996).
products, and whether they have suggested questions are whether
tried to convince the public that smokers think that their smoke is Validity: Pierce's Smoking Sus-
there is no health risk from SHS, dangerous to those around them, ceptibility Scale has good
should be included. and do smokers think about the predictive validity: in young never
harm their smoking might be doing smokers, 6.5% of those with
Validity: For the question on to other people. susceptibility ratings=0 had taken
whether the industry tells the up smoking four years later,
truth, the test-retest reliability in Validity: In the ITC surveys, the compared with 20.6% of those
smokers in the ITC survey was test-retest correlation for the item with ratings=3 (Pierce et al.,
r=0.59 (eight months apart) (Yan, your cigarette smoke is dan- 1996). This scale can therefore be
2007). For the question on gerous to those around you considered to have adequate
whether the industry tried to assessed eight months apart in validity, and the research papers
convince the public that SHS daily smokers with no quit describing it are widely cited
carries no risk, the test-retest attempts, was moderate (r=0.47) (Pierce et al., 1996; Choi et al.,
reliability was 0.45 (Yan, 2007). (Yan, 2007). However, in an 2001; Pierce et al., 2005).
The figures are lower than usually analysis of daily smokers, this
recommended (Nunnally & question predicted smoking ces- Intention to quit smoking
Bernstein, 1994), but eight months sation after eight months (strongly
may have been too long of an agree versus strongly disagree, Intention to quit is a key predictor
interval to assess test-retest for OR = 2.59, 95% CI: 1.03-6.46) of smoking abstinence, as well as a
opinion items. In an analysis of (Yan, 2007). The test-retest cor- key variable that policies and
daily smokers in the ITC surveys, relation for the item on the harm interventions intend to modify.
the question on whether the done to other people assessed Several approaches have been
tobacco industry can be trusted to eight months apart in daily used to assess intention or
117
motivation to quit (Prochaska et al., stages separately. Smoking status tion can nevertheless be retained
1992; Sciamanna et al., 2000). In and quit attempts are discussed in because of its face validity and
particular, the concept of stages of Section 3.1. Intentions may fluc- usefulness, and because eight
change has been widely used. It tuate even in short intervals of time months may have been too long of
proposes that people gradually (Hughes et al., 2005). Therefore, it an interval for analyses exploring
progress towards smoking ces- may be preferable to ask about this construct.
sation through a series of stages, immediate plans to stop, since
defined in particular by the level of reports of plans beyond the short- Previous quit attempts: Quit
motivation to quit (Prochaska et al., term may lack validity. A single attempts may be affected by
1992). Indeed, the two most widely question can be used on whether policy interventions, and are there-
cited papers in the smoking and smokers are seriously thinking of fore a relevant measure for policy
tobacco literature, as ranked in the quitting (No; Yes, but I have not evaluation. Having recently made
report by Byrne and Chapman decided when; Yes, I plan to quit a quit attempt predicts future
(2005), describe the stages of within the next 30 days) (Table cessation, and the duration of the
change theory (Prochaska et al., 3.21). longest time off smoking is a
1992, 1994). However, this theory particularly good predictor of
has been criticized on the grounds Validity: In daily smokers in the future cessation (Ferguson et al.,
that it does not accurately reflect ITC survey, those who were not 2003; Hyland et al., 2006). It is
reality, and that interventions planning to quit were much less worthwhile to ask smokers about
based on it are no more effective likely to have quit eight months the occurrence and duration of
than other interventions (West, later than those who planned to recent quit attempts.
2005a). Furthermore, in the case of quit in the next month (OR = 0.16,
smokers unmotivated to quit (pre- 95% CI: 0.11-0.23) (Yan, 2007). Self-efficacy
contemplators), the stage of
change theory recommends to Quit date Self-efficacy is the confidence in
prescribe interventions of doubtful one's ability to stop smoking or to
efficacy (e.g. information on health Setting a quit date and sticking to abstain from smoking in relapse
risks) instead of effective treat- it is a strategy recommended to situations (e.g. when having a
ments of dependence. This may be smokers in major guidelines (Fiore drink with smokers) (Bandura,
counterproductive if, for instance, et al., 2000). A question on the 1986). Self-efficacy predicts ces-
the lack of motivation is due to the planned quit date could be asked sation in current smokers (Etter et
severity of dependence and to the of those who plan to quit in the al., 2000b) and relapse to smoking
intensity of withdrawal symptoms next 30 days (Table 3.21). in former smokers (Gulliver et al.,
(West, 2005a). In addition, the 1995). There are several multi-
stage of change is presented as a Validity: In daily smokers in the ITC item scales measuring self-
single variable describing beha- survey with no quit attempts efficacy across various relapse
viour change, when in fact it is a between the two assessments situations that have satisfactory
haphazard mix of four different eight months apart, the test-retest validation data, in particular,
elements (smoking status, inten- reliability of the question on whe- predictive validity (De Vries et al.,
tion to quit, past quit attempts, and ther smokers willing to quit had set 1988; Velicer et al., 1990; Etter et
duration of abstinence). Because a quit date was low (r=0.43) (Yan, al., 2000b). However, these scales
this theory is so controversial, it 2007). In addition, having set a quit are too long for the purpose of
should be used with caution, and date was not a significant predictor policy evaluation, and single item
reliance should instead be placed of cessation after eight months (no measures may be preferable. A
on more face valid measures of versus yes, OR = 0.75, 95% CI: single item measure of self-
each of the four components of 0.47-1.17) (Yan, 2007). This ques- efficacy derived from the ITC
118
survey that asks whether res- daily smokers, was moderate tions in each country or standard
pondents are sure that they would (r=0.42, r=0.40, and r=0.33, res- questions from the World Bank
succeed if they tried to quit, is pectively), but eight months may be surveys would be recommended
suggested (Table 3.21). too long of an interval to assess (Grosh & Glewwe, 1998).
test-retest reliability of opinion
Validity: The test-retest intraclass questions. In an analysis of daily Other smokers in the household,
correlation for this self-efficacy smokers in the ITC surveys, an- friends who smoke
item, assessed eight months apart swers to the first two questions
in daily smokers with no quit ("people believe..." and "fewer pla- Workplace and home smoking
attempts, was moderate (r=0.51) ces...") were not predictive of restrictions are important policy
(Yan, 2007). However, in an smoking cessation after eight outcomes, and in turn, they are
analysis of daily smokers in the months (Yan, 2007). However relevant determinants of smoking
ITC surveys, this question pre- people who agreed with "society behaviour. The presence of other
dicted smoking cessation after disapproves of smoking" were smokers in the household de-
eight months (extremely sure more likely to have quit eight creases the chances of quitting
versus not at all sure, OR = 2.46, months later than people who smoking (Hymowitz et al., 1997),
95% CI: 1.68-3.59) (Yan, 2007). disagreed with this affirmation (OR and increases the risk of smoking
Therefore, this question has = 1.34, 95% CI: 1.01-1.78) (Yan, initiation in nonsmokers (Conrad
adequate evidence of validity. 2007). In spite of their mixed per- et al., 1992; OLoughlin et al.,
formance on validation tests, these 1998; Tyas & Pederson, 1998). To
Social influences, perceived social questions can be included because assess this, it is recommended
norms of their face validity and utility. that questions about how many
people in the household are
Social influences are crucial in an Moderators smokers, and how many of the
adolescents decision to take up respondents five best friends are
smoking (De Vries et al., 1995). In Socio-demographic characteristics smokers, be used (Table 3.21).
many countries, social pressures
also make it less acceptable for Sociodemographic characteristics Validity: In the ITC survey, the
adults to smoke (Albers et al., are strong determinants of smo- test-retest intraclass correlation for
2004). Including three questions king behaviour (Townsend et al., the item on how many of their five
derived from the ITC survey to 1994). Relevant variables include: best friends smoke, assessed
assess social influences is age, sex, marital status and social eight months apart in daily
recommended. These questions support, socioeconomic status smokers, was r=0.64 (Yan, 2007).
cover whether others who are (education, income, occupation), In an analysis of daily smokers,
important to the respondent be- ethnicity, primary language, mino- this question predicted smoking
lieve that they should not smoke, rity group status, religion, family cessation after eight months
whether the respondent feels that structure, peer and family smoking, (four friends versus 0 friends OR
there are fewer places where they country of residence and language = 0.63, 95% CI: 0.43-0.92) (Yan,
feel comfortable smoking, and of the interview (recorded by 2007). Therefore, this question
the respondents perception of interviewer). has adequate evidence of validity.
the opinion that society disa- The most appropriate ques-
pproves of smoking. tions to assess sociodemo- Peer and family smoking (5-items),
graphic characteristics vary be- adolescents only
Validity: The test-retest intraclass tween countries (e.g. for ethnicity,
correlation for these three items, minority group status, education, Peer and family smoking predicts
assessed eight months apart in etc.). Using either census ques- smoking initiation in adolescents
119
(Conrad et al., 1992; OLoughlin et Mental health and can therefore be considered
al., 1998; Tyas & Pederson, 1998). to have adequate validity.
A useful 5-item scale developed to Smoking behaviour is strongly
assess the smoking status of associated with mental health, A 2-item screening test for depres-
family members and best friends including depression (Glassman et sion
has been developed (Pierce et al., al., 1990), which justifies the
1998c). This widely cited scale is inclusion of a brief assessment of A second way to assess de-
intended for adolescents ages 12- mental health in surveys of the pression in population surveys is to
17, and can be administered over general population. Among brief use a brief screening test, for
the phone (Table 3.21). assessments suitable for general instance, a widely cited 2-item test
population surveys, evaluators can (Whooley et al., 1997). This test
Validity: Peer and family smoking choose, according to their specific screens specifically for depres-
were not strong predictors of needs, between the WHO-5 Well- sion, whereas WHO-5 monitors a
susceptibility to smoke (Pierce et Being Index, which is a measure of broader index of mental health.
al., 1998c) (OR = 1.19, non signi- mental well-being (Bonsignore et Another possibility is to use
ficant). Nevertheless, this scale al., 2001), and a 2-item screening Kessler's K-6 scale (a 6-item
can be used, as several other test for depression (Whooley et al., measure of psychological distress)
studies have shown the impor- 1997). Mental health patients are (Kessler et al., 2002). Finally, a
tance of peer and family smoking often hard to reach and may not question on whether the res-
(Conrad et al., 1992; OLoughlin et take part in population surveys. pondent has ever been diagnosed
al., 1998; Tyas & Pederson, Because particular attention should or treated for depression could also
1998). Also because this scale is be paid to this group, population be included.
widely used (cited by at least 227 surveys should be supplemented
articles), it enables comparison with specific surveys of mental Validity: In patients without sub-
between samples. health patients. stance abuse, Whooleys 2-item
test had a sensitivity of 96%, a
Personality WHO-5 Well-Being Index (WHO-5) specificity of 66%, and an area
under the Receiver Operating
Personality traits affect smoking Being a WHO product, the 5-item Characteristic (ROC) curve of 0.84,
behaviour. For instance, a heri- WHO-5 Well-Being Index (WHO- using the Diagnostic Interview
table tendency for sensation 5) enables its users to compare Schedule (DIS-II-R) as the criterion
seeking or for novelty seeking pre- their results with other WHO (Whooley et al., 1997). The sensi-
dicts smoking behaviour (Zuc- surveys (Table 3.21) (Bonsignore tivity of this 2-item scale was better
kerman et al., 1990; Pomerleau et et al., 2001). than for the Center for Epidemio-
al., 1992; Etter et al., 2003a). Most logic Studies-Depression scale
personality questionnaires are too Validity: Using the Composite (CES-D short) (84%) and for the
long to be used in policy evaluation International Diagnostic Interview Beck Depression Inventory (BDI
surveys (Cloninger et al., 1993; (CIDI) as the measure, WHO-5 short) (87%), and its specificity was
Barrett et al., 1998); however, had a sensitivity of 93% and a similar or somewhat lower (CES-D
depending on the research goals, specificity of 64% to detect short=75%, BDI short=67%)
short versions of some personality depression in primary care pa- (Whooley et al., 1997). In another
questionnaires, such as for tients (Henkel et al., 2003). study conducted in primary care
sensation seeking, have been WHO-5 performed better than a patients, this 2 item test had a sim-
validated and could be considered clinical diagnosis to detect de- ilar area under the ROC curve
for inclusion (Hoyle et al., 2002; pression, using CIDI as the (0.859) compared with WHO-5
Stephenson et al., 2003). criterion (Henkel et al., 2004a), (0.862), and a comparable sensi-
120
tivity (92% versus 93% for WHO-5) progress towards more effective project (Fong et al., 2006a;
and specificity (59% versus 64% and acceptable interventions. Thompson et al., 2006). This
for WHO-5), using CIDI as the cri- Importantly, analyzing psycho- model was developed specifically
terion (Henkel et al., 2004b). social factors is also an issue of for the evaluation of the FCTC,
Whooleys 2-item screening test social inequalities. Some inter- and it is therefore relevant for the
can therefore be considered to ventions may have adverse purpose of this Handbook. The
have adequate validity. effects in a number of subgroups, WG also included some elements
and interventions targeted at the believed to be important, such as
Alcohol use and abuse: Alcohol Use general population may not reach mental health and substance use.
Disorders Identification Test several subgroups in which Whenever possible, validated
(AUDIT-C) smoking prevalence is particularly measures were included (psycho-
high (e.g. mental health patients, metric validation studies were not
Alcohol use and abuse is strongly some minorities). always available). Some mea-
associated with tobacco use, and, The issue of translation and sures that were not well validated
in former smokers, with relapse cultural adaptation of the measures were nevertheless included be-
(Hymowitz et al., 1991). This described in this section are cause of their usefulness and face
justifies the inclusion of a well- addressed elsewhere in this validity. The WGs selection was
validated and widely cited test of Handbook (Section 2.2). Depen- also based on a subjective
alcohol use and abuse: the 3-item ding on the construct under assessment of what is useful and
Alcohol Use Disorders Identifi- scrutiny, even well-translated ques- important. Thus, this list should be
cation Test (AUDIT C) (Table tions may not be relevant, or may supplemented by other elements
3.21) (Bush et al., 1998; Reinert & not be understood in a culture according to the specific needs of
Allen, 2002; Rumpf et al., 2002). distant from where the instrument each study and country, and take
was initially developed (Beaton et into account new contributions to
Validity: The brief, 3-item version al., 2000). Many of the measures theory (West & Hardy, 2006).
(AUDIT-C) performs as well as the discussed here were developed in Even though this list is not
full version of AUDIT to detect at- high-income, English-speaking comprehensive, the WG believes
risk drinkers (Bush et al., 1998; countries, and there are very few that it represents a core set of
Reinert & Allen, 2002; Rumpf et data on their relevance or psycho- measures that are useful in
al., 2002). AUDIT-C has good metric properties in other cultures. analyzing how policies and
sensitivity (54% to 98%) and Establishing a list of the interventions work, in which
specificity (57% to 93%) for va- psychosocial determinants of population groups they work, and
rious definitions of heavy drinking. smoking is an impractical task that why some interventions do not
AUDIT-C can therefore be con- inevitably results in a list that is too work. Progress in this field is
sidered to have adequate validity. long for some purposes, and too possible only if thorough evalu-
short for others. Such a list is ations enlighten the path.
Discussion potentially endless. The WG
selected a core set of measures Summa ry and recommenda-
An assessment of the psycho- with general relevance for the tions
social determinants of smoking is evaluation of tobacco control
essential to understand how programmes and policies. Their This section describes mediators
policies and interventions produce choice was based on influential and moderators theorized to be
their effects, and how to improve theories of behaviour change, and important in understanding how
them. Evaluation studies that in particular on a model derived policies and interventions affect
neglect these elements loose an from these theories: the con- tobacco use behaviours, and
opportunity to help the field ceptual framework of the ITC under what circumstances they
121
have an impact. A core set of researchers should, whenever sensitive to wording and to cultural
measures likely to be important possible, use them rather than context; therefore, the methods for
has been identified. Researchers develop their own ad hoc mea- translations and cultural adap-
should select from this list and, sures. Investigators should report tations described in Section 2.2
when appropriate, supplement it the psychometric properties of should be utilised in populations
with other relevant measures, their measurement instruments, where these measures have not
depending on the specific context and at least the test-retest been previously validated.
and goals of each study. There reliability, convergent validity,
are validated measures of many of and/or predictive validity. Psycho-
the reviewed constructs, and logical measures are particularly
122
3.3 Measurement of nicotine dependence
Introduction (Shiffman et al., 2003). Also, long- Meas ures of cigarette-induced

term use of nicotine medications nicotine dependence
In this section, evidence of the has no documented untoward
validity of self-report measures of health effects, so therefore mea- The following section provides a
nicotine/tobacco dependence in surement of dependence to nicotine brief review of data on the
adults is examined. Measures are medications will not be included in measurement properties of seven
concentrated on that are potentially this review. Finally, while depen- self-report measures developed to
appropriate for population-based/ dence on tobacco products is assess the construct of cigarette-
epidemiologic research, as nicotine clearly evident among some youth, induced nicotine dependence: 1)
dependence is often assessed as a research on measures of nicotine Fagerstrm Test for Nicotine
potential moderator of programme dependence in adolescents is Dependence (FTND); 2) Heaviness
and policy effects. The Working limited, and will not be considered in of Smoking Index (HSI); 3) Diag-
Group (WG) has focused mainly on this section. For those interested in nostic and Statistical Manual-IV
scales measuring cigarette depen- a measure of nicotine dependence (DSM-IV) criterion of dependence;
dence, as cigarette smoking among youth, please refer to the 4) International Statistical Classi-
accounts for most of the health paper which describes the mea- fication and Related Health Prob-
damage caused by tobacco, and surement properties of the Hooked lems-10 (ICD-10) criteria; 5) Ci-
because the most widely used and on Nicotine Checklist (DiFranza et garette Dependence Scale (CDS);
best studied scales measure al., 2002b). 6) Nicotine Dependence Syndrome
cigarette dependence. This section Nicotine dependence is a hypo- Scale (NDSS); and 7) Wisconsin
has not attempted to review evi- thetical construct that is designed to Inventory of Smoking Dependence
dence evaluating measures to explain and predict societally- Motives (WISDM).
assess nicotine dependence of important outcomes, such as an Each measure will be evaluated
other types of smoked tobacco inability to quit smoking, heavy use, based on a review of the items that
products (e.g. cigars, pipe tobacco, and other problems occasioned by constitute the scales in terms of
bidis, hookah), although adaptations smoking or tobacco use (Piper et al., their reading level, face validity,
of measures used to assess 2006). Assessing tobacco depen- coverage of the dependence do-
cigarette smoking dependence dence is difficult and is made even main, and cross-cultural applica-
would be reasonable to consider. more so in population-based epi- bility. The WG will review the
The WG did include a review of demiologic research by the need for psychometrics of each scale,
measures of dependence on efficient assessment (valid and brief). including its reliability (e.g. internal
smokeless tobacco products, since Ideally, a measure should reflect the consistency) and factor structure,
the pattern of compulsive use of nature or domain of the construct of and will examine the predictive
these products is similar to that interest (i.e. tobacco dependence), validity of each measure, focusing
observed for cigarette smoking predict important outcomes (e.g. on two specific tobacco depen-
(IARC, 2007b). Persistent use of likelihood of quitting, problems en- dence criteria: a pattern of
nicotine medications has been countered through use), and be pervasive and heavy smoking and
described, but it is very rare relatively brief to assess. the ability to quit smoking.
123
Pervasive and heavy smoking use. Obviously, a pattern of of cigarettes smoked per day) can
could be assessed using self- heavy, pervasive smoking will predict outcomes, such as re-
report measures (e.g. cigarettes capture the degree of exposure to lapse, as well as longer measures
smoked per day or lifetime nicotine and the harmful (e.g. DSM-III-R, FTQ, and FTND)
cigarettes smoked), or using bio- constituents of tobacco/ciga- (Razavi et al., 1999; Breslau &
markers of exposure (e.g. carbon rettes. Moreover, a relative Johnson, 2000; Dale, et al., 2001).
monoxide (CO), cotinine, puff inability to quit smoking will When considering the infor-
topography) (see Section 3.1), and forecast the likely continued mation comprised here, it is
the ability to quit smoking could be exposure to such elements. important to remember that
assessed using a number of Evidence shows that past, current, reliability and validity are not
strategies as well (see Section and future use of tobacco directly inherent in measures. It can not be
3.1). These criteria reflect the predict outcomes of societal assumed that one can generalize
sheer volume of tobacco products import, such as money expended psychometric properties across
consumed and the intransigence of in buying tobacco products and different use contexts, or that
drug use, both of which have disease outcomes (and asso- validity for one use of a measure
significant effects on the health and ciated costs) caused by tobacco is generalizeable for a different
economics of both the individual use (US Department of Health and use (e.g. predicting relapse
and society. Although it is not a Human Services, 2004; Centers likelihood versus withdrawal
validation criterion, the evidence of for Disease Control and Pre- severity). Rather, these features
genetic linkages to the various vention, 2005). are estimated based on patterns
measures of tobacco dependence of statistical covariation and are
will be examined. This information Overarching issues: influenced by the nature of the
may be helpful for researchers who population being assessed
are interested in using epide- It is important to note that de- (Nunnally & Bernstein, 1994;
miological measures to make pendence is a construct (i.e. a McDonald, 1999). For instance,
inferences regarding etiology. hypothetical entity). It is not, in there may be less variance in item
It is important to note that other theory, equivalent to any single scores, or item scores might have
criteria could be used to evaluate measure or criterion (Piper et al., a less skewed distribution, when a
the performance of dependence 2006); although single items can dependence measure is used in a
measures. For instance, such be used to estimate a persons clinical population rather than a
measures could be evaluated with standing on the construct. Thus, nationally representative popu-
respect to prediction of withdrawal dependence is an inferred in- lation. This could easily affect both
severity or other outcomes fluence or force that produces the reliability and validity estimates.
theoretically linked to dependence outcomes associated with it (e.g. Different populations might yield
(Piper et al., 2006). However, high rates of smoking, relapse), different psychometric data be-
such outcomes seem less although it is not the only predictor cause of true differences in the
relevant than the ones selected for of such outcomes. Generally it severity or range of dependence.
measures to be used in epi- takes multiple variables or items to However, differences might also
demiologic research. For the adequately assess a complex, arise because of other factors,
purposes of epidemiologic re- hypothetical entity such as such as secular or environmental
search, a measure should reflect nicotine dependence (Clark & events that might affect scores on
or predict outcomes of societal Watson, 1995). In this section, dependence measures, while not
import, such as degree of tobacco however, considerable attention is actually changing the dependence
exposure and use, the intran- devoted to very brief measures of per se. One study showed that US
sigence of use, and the likelihood dependence, as evidence shows smokers had higher frequencies
of important negative outcomes of that such measures (i.e. number of severe nicotine dependence
124
Measurement of nicotine dependence
(FTND 6) than did Spanish response burden. In fact, as multidimensional measures tend
smokers (de Leon et al., 2002). It efficient as some of the uni- to ask about relatively discrete
is possible that such population dimensional measures are, some processes (e.g. a taste motive for
differences reflect different de- data suggest that particular items smoking) rather than global
grees or sources of error across from these measures possess consequences of smoking (e.g.
the two populations (restrictions in predictive validities that meet or smoking causing problems in life),
smoking in the home, the amount exceed those of the whole these multidimensional measures
of discretionary income, gender measure (Storr et al., 2005). Such may be more suitable for genetics
differences in smoking across the items might be especially valuable research, as they may tap pro-
populations, the ways the smo- for epidemiologic research. cesses that reflect a stronger
kers answer the questions and, A review of multidimensional genetic signal (Baker et al., in
indeed, understand them and so measures of nicotine dependence press). Finally, because multi-
on) rather than differences in the are included despite their length dimensional measures tend to ask
biological/psychological internal and reduced efficiency, because about internal and subjective
processes that make up depen- they have the potential to provide phenomena (e.g. role of affect
dence. There are numerous information about the mechanism regulation) rather than externally
environmental or social sources of underlying nicotine dependence referenced events (e.g. latency to
error variance that could dif- not supplied by unidimensional smoke in the morning, number of
ferentially affect the validity of a measures. For instance, multi- cigarettes consumed each day),
measure across populations: smo- dimensional measures are in- these measures may be less
king policies in the workplace, tended to assess particular facets susceptible to biasing by error due
taxes, religious or social norms, to of dependence or dependence to regional secular or policy
list few. processes (e.g. particular motives influences. Workplace smoking
In recognition of the depen- for drug use). Thus, these restrictions, for example, might
dence of psychometric properties measures may provide greater exert a more direct and larger
on the population being assessed, insights into the nature of tobacco effect on number of cigarettes
reliability and validity data from dependence than do unidimen- smoked per day than on the
both clinical trials and epi- sional measures. They also may smokers liking of the taste of
demiologic studies conducted provide greater discrimination cigarettes. On the other hand,
around the world, and present amongst smokers/tobacco users multidimensional scales tend to
data relating to the heritability of to the extent that smokers may be ask about relatively subtle, psy-
dependence as it is assessed distinguished on the basis of chological variables (e.g. asking
using the different measures, will something other than a single individuals to attribute smoking
be presented. The tobacco intensity dimension (which might urges or affect), and it is possible,
dependence measures will be be well captured by a single indeed probable, that cultures
divided into two groups: uni- severity dimension). For instance, may differ in how they make
dimensional and multidimen- some scales appear to reflect attributions or label internal phe-
sional. Unidimensional measures motives associated with initial nomena. Of course, while entire
are intended to assess depen- versus extensive use of tobacco multidimensional scales can be
dence as a single dimension (Piper et al., 2004), and other quite lengthy, individual items or
(although some, it turns out, may scales differ in sensitivity to use subscales can be selected for use
actually be multifactorial). Such patterns of highly dependent (Lerman et al., 2006); thus, this
measures are useful, because the users versus chippers (those section will review relevant
best of them are fairly efficient in who engage in periodic or light subscale data.
that they possess significant tobacco use) (Shiffman & Sayette, The foregoing discussion
validity given their length/ 2005). Since the subscales of should make clear that blanket
125
recommendations cannot be John et al., 2004a), Switzerland 0.70 (Etter et al, 1999), while a
given regarding dependence. Ra- (Etter et al., 1999), Australia study with a German population
ther, the investigator must both (Pergadia et al., 2006a), Canada found low internal consistency for
weigh practical issues (e.g. (Howard et al., 2003), Austria the FTND ( =.57) in two separate
response burden) and clearly (Lesch et al., 2004), and Brazil, samples (John et al., 2004b), and
identify the goals of assessment Mexico, Poland, and China a study in China found that FTQ
(e.g. predict probability of relapse) (Blackford et al., 2006; Huang et had low internal consistency as
in order to select an appropriate al., 2006). The HSI has also been well ( =.58) (Huang et al., 2006).
dependence instrument or as- used in research in Spain (Diaz et Some studies have shown that
sessment strategy. al., 2005), Australia, Canada, UK, the FTND has a two-factor
and the USA (Heatherton et al., structure, suggesting that it does
Unidimensional measures of 1991; Hymowitz et al., 1997; not measure a unitary construct of
tobacco dependence Hyland et al., 2006). One of the physical dependence (Payne et
questions on the FTND concerns al., 1994; Etter et al., 1999;
Fagerstrm Test for Nicotine smoking in forbidden places. The Haddock et al., 1999; Radzius et
Dependence and the Heaviness of validity of this question may be al., 2003; Breteler et al., 2004;
Smoking Index affected by regional differences in John et al., 2004b). A population-
environmental restrictions in based study in France found that
The first unidimensional measure of smoking (Huang et al., 2006). In while a two-factor model fit the
tobacco dependence is actually a addition, two questions in this data well, the two factors were
group of measures arising from the scale assume a pattern of daily highly correlated (Chabrol et al.,
Fagerstrm Tolerance Question- smoking (e.g. questions 1 & 4, the 2003). Inter-item correlations also
naire (FTQ) (Fagerstrm, 1978): two questions in the HSI). It is very reveal that not all items are highly
these comprise the FTQ itself, as likely that scores on these items related (r = 0.06-0.39) (Trans-
well as the 6-item Fagerstrm Test will have reduced validity if used disciplinary Tobacco Use Re-
for Nicotine Dependence (FTND) with non-daily smokers. An search Center (TTURC) Tobacco
(Heatherton et al., 1991) and the 2- important goal of future research Dependence Phenotype Work-
item Heaviness of Smoking Index is to identify dependence mea- group, 2007). These studies
(HSI) (Kozlowski et al., 1994). See sures that are appropriate for suggest that the two factors reflect
Appendix 1 for the items and non-daily smokers. morning smoking (i.e. whether
scoring. These measures are one smokes more in the morning
based on the construct of physical Reliability and structure: Com- and whether one would rather give
dependence, which includes facets pared with the FTQ, the FTND has up the first cigarette of the day or
such as the need to smoke early in demonstrated better psychometric all others), and smoking pattern
the morning to alleviate overnight properties, such as internal con- (i.e. the number of cigarettes
withdrawal, the need to smoke sistency (Payne et al., 1994; smoked per day, time to first
numerous cigarettes per day, and Pomerleau et al., 1994; Haddock cigarette, difficulty refraining from
the invariance of smoking beha- et al., 1999); however, these smoking, and smoking when ill),
viour (i.e. smoking even when you improved reliability coefficients are although some data indicate that
are ill) (Fagerstrm, 1978). The still low (Etter, 2005) and below time to first cigarette loaded on
Flesch-Kincaid Reading Grade traditionally accepted standards both factors (Radzius et al., 2003).
Level is 4.4 for the FTND and 4.2 for clinical use ( =0.80) (Nunnally Latent class analyses suggest that
for the HSI. & Bernstein, 1994). Using a the FTND divides smokers into
The FTND has been translated French translation of the FTND groups based on severity of
and used with population samples with light smokers found internal dependence (Storr et al., 2005);
in Germany (John et al., 2003a; consistencies of approximately that is the two factors do not
126
appear to pick-out smokers who heightened risk for psychiatric morning) predicts relapse vul-
differ in terms of types of de- comorbidities in a large population nerability, as well as, or better
pendence. sample in Germany (John et al., than, much longer multidimen-
The HSI is comprised of only 2005). sional instruments (TTURC
two items, which limits the Some data indicate that the Tobacco Dependence Phenotype
relevance of internal consistency standard scoring method used Workgroup, 2007). Recent popu-
estimates. However, zero-order with the FTND (adding up item lation-based research shows that
correlations between the two responses) may not produce an a single item on the HSI (item #1)
items in the measure indicate optimal scaling of dependence is highly effective in predicting the
moderate levels of association level. Latent class analysis likelihood of future cessation
(e.g. rs 0.30) (TTURC Tobacco suggested that some items are (TTURC Tobacco Dependence
Dependence Phenotype Work- particularly important to the Phenotype Workgroup, 2007).
group, 2007). assessment of dependence level
(those that capture variance due Heritability: In a study of young
Validation: The FTND and HSI to morning smoking) and that they adult Australian Twins, HSI-
predict both behavioural and are relatively underweighted in the assessed dependence was found
biochemical indices of smoking in typical scoring method (Storr et to be highly heritable (71%)
Chinese-, English-, French-, and al., 2005). Therefore, investigators (Lessov et al., 2004). In addition,
German-speaking populations using the FTND may wish to the FTND and HSI were both
(e.g. CO, cotinine, lifetime amount explore alternative, empirically- related to the dopa decarboxylase
smoked) (Heatherton et al., 1989, based scoring or cut-score gene, which is involved in the
1991; Kozlowski et al., 1994; Etter determination methods (e.g. la- synthesis of dopamine, nore-
et al., 1999; John et al., 2003a; tent class analysis, Receiver pinephrine, and serotonin (Ma et
Huang et al., 2006). This should Operating Characteristic curves al., 2005). One haplotype was
not be surprising, given that the (Swets et al., 2000)). significantly related to depen-
FTND and HSI directly assess While the FTND certainly can dence in both African-American
smoking heaviness. However, it is predict future smoking or likeli- and Euro-American smokers,
encouraging to note that smokers hood of cessation, the HSI while another was related to
are indeed able to estimate their appears to account for much of dependence only in Euro-Ameri-
amount of smoking as indexed by the predictive validity of that can smokers (Ma et al., 2005).
biochemical tests in response to measure (Breslau & Johnson, Additional studies link FTND-
single items (e.g. Question #4 on 2000; Heatherton et al., 1989; defined dependence to particular
the FTND, How many ciga- TTURC Tobacco Dependence genetic variants (Bierut et al.,
rettes/day do you smoke?). The Phenotype Workgroup, 2007). 2007; Gelernter et al., 2007;
FTND has demonstrated an ability Population-based studies con- Saccone et al., 2007).
to predict cessation outcomes in ducted in Australia, Canada, the
smoking cessation studies (Camp- UK, and the USA found that the Summary: The FTND has been
bell et al., 1996; Westman et al., two HSI items (number of widely used in a number of
1997; Alterman et al., 1999; cigarettes smoked and time to first different countries and a number
Patten et al., 2001; TTURC cigarette in the morning) were the of different languages. It is short
Tobacco Dependence Phenotype strongest predictors of quitting and has an accessible reading
Workgroup, 2007), and with col- (Hymowitz et al., 1997; Hyland et level. In addition, while there are
lege students in a popu- al., 2006). Furthermore, recent concerns regarding its structure
lation-based study (Sledjeski et research has shown that a single and reliability, it has been found to
al., 2007). In addition, the FTND item on the FTND and HSI (Item predict smoking heaviness and
has been shown to index a #1 latency to first cigarette in the cessation outcome. However, it
127
appears that the HSI is a more ICD-10, DSM-III-R (the 1987 cluding Arabic, Chinese, English,
efficient predictor of outcome than revision of DSM-II), and DSM-IV French, Russian, and Spanish.
is the FTND (using only two items). symptoms of dependence with a The DIS, CIDI, and other diag-
FTND and HSI scores have also Flesch-Kincaid Reading Grade nostic interviews comprise a
been found to be heritable and Level of 8.1 (see Appendix 4 for series of branching questions that
related to specific dependence- items and scoring). To the best of are aimed at eliciting information
linked genetic variants. our knowledge, this is the only about features relevant to nicotine
published, self-report DSM/ICD dependence.
The Diagnostic and Statistical Man- questionnaire of tobacco/nicotine Some aspects of the DSM-
ual, International Statistical Classi- dependence. Most of the existing derived interviews and similar
fication of Diseases and Related research has utilised the DSM instruments may cause problems
Health Problems, 10th Revision and criteria, and that will be the focus in any sample, or when using the
the Tobacco Dependence Screener of this Handbooks review of instrument with culturally diverse
diagnostic classifications of tobac- populations. Another important
Two different diagnostic systems co dependence. caveat to observe, in regards to
are commonly used to diagnose DSM and ICD structured the DSM measure of dependence,
tobacco dependence: both are clinical interviews, such as the is that the scoring algorithm used
typically considered to be uni- World Mental Health Survey in establishing formal DSM
dimensional measures of tobacco Initiative version of the Composite diagnoses does not appear to
dependence. One is the Diag- International Diagnostic Interview yield decision rules that agree with
nostic and Statistical Manual of (CIDI), or the National Institute of empirical methods, such as latent
Mental Disorders, 4th Edition Mental Health Diagnostic Inter- class analysis (Muthen &
(DSM-IV) (American Psychiatric view Schedule (DIS), have been Asparouhov, 2006). Thus, the
Association, 1995)1 which is translated into various languages investigator may wish to explore
based on an empirically driven, and used in at least 11 population- different methods for item-
syndromal medical model, rather based studies (Hughes et al., weighting and cut-score estimation
than on a theoretical model of 2006) in countries including: if a categorical outcome is
dependence (see Appendix 2 for Germany (John et al., 2003b desired. In addition, it should be
the criteria). The second is the (DSM); John et al., 2004a (DSM); noted that the tobacco sections of
International Statistical Classi- Hoch et al., 2004 (DSM)), DIS and CIDI are quite long (over
fication of Diseases and Related Australia (Pergadia et al., 2006b 30 items), and were designed to
Health Problems, 10th Revision (DSM)), Canada and Taipei be administered either in a face-
(ICD-10), an international diag- (Howard et al., 2003 (DSM)), to-face interview or by a trained
nostic classification system that Spain (de Leon et al., 2002 professional. New technology has
was endorsed by the 43rd World (DSM)), Austria (Lesch et al., made it possible to have indivi-
Health Assembly in May 1990 and 2004 (DSM & ICD)), Switzerland duals respond to text-based
came into use by WHO Member (Angst et al., 2005 (DSM)), Japan presentations of the questions, but
States as of 1994 (see Appendix (Yoshimura, 2000 (ICD)), Korea it is unknown how valid this
3 for the criteria (WHO, 1993)). (Lee et al., 1990 (DSM)), and the presentation method would be
The Tobacco Dependence USA (Breslau et al., 2004 (DSM); and it would remain quite time
Screener (TDS) (Kawakami et al., Hughes et al., 2004a (DSM & consuming.
1999) is a 10-item, self-report ICD)). The ICD-10 criteria are
questionnaire designed to assess available in 42 languages, in-
1
There has been a text revision of the DSM-IV (American Psychiatric Association, 2000), however this revision did not alter any
diagnostic criteria for any diagnostic categories, including the substance dependence diagnosis
128
Reliability and structure: Data on 2004). Investigators might wish to DSM-IV nicotine dependence
the reliability and structure of analyze these item parcels diagnosis is associated with
diagnostic interview measures of separately since they may be greater risk of psychiatric comor-
nicotine dependence arise from addressing somewhat distinct bidities in adults and youth (Grant
studies using face-to-face admi- constructs. et al., 2004; John et al., 2004a;
nistration strategies. Therefore, The TDS, a written ques- Dierker et al., 2006). In addition,
the following conclusions cannot tionnaire assessing the presence DSM diagnoses of nicotine
be generalized to a different of diagnostic criteria, has demon- dependence were significantly
administration format. There is strated acceptable internal associated with self-rated general
evidence that the various consistency in Japanese smokers health in a population sample in
structured diagnostic measures ( = 0.74-0.81) (Kawakami et al., Germany (John et al., 2005). In
yield reliable diagnoses as 1999), but was less internally sum, there is substantial evidence
assessed by test-retest reliability consistent among smokers in the that DSM/ICD diagnoses are
( = 0.63, Grant et al., 2004; = USA ( = 0.64) (Piper et al., 2008). meaningfully related to smoking
0.88, Hughes et al., 2004a; = To date, there have been no heaviness and a variety of health
0.73, Koenen et al., 2005). One- studies comparing the reliability of outcomes.
factor analysis indicated that the interview measures with the Studies have shown that the
responses to the CIDI had a paper-pencil measure. Therefore, TDS is associated with the
strong single factor structure one cannot assume that the smoking heaviness measures
(Strong et al., 2003); although psychometric data generated by (e.g. number of cigarettes smoked
other factor analyses of the the interview-format delivery of per day, CO levels) and years of
structured diagnostic items found DSM or ICD items would smoking (Kawakami et al., 1999;
that a two-factor structure was a generalize to a self-administered Piper et al., 2004). With respect to
better fit (Johnson et al., 1996; format. relapse, one study found that
Radzius et al., 2004; Muthen & Japanese smokers with lower
Asparouhov, 2006). Patterns of Validation: Evidence suggests that TDS scores were more likely to
covariation that were found the small set of dichotomous DSM quit smoking after a health risk
amongst the symptoms could be items can distinguish between appraisal (Kawakami et al., 1999).
best accounted for by two factors light versus heavy smoking However, data from smokers who
(Muthen et al., 2006). The first (Strong et al., 2003). An epi- participated in smoking cessation
accounted for covariance in the demiological study found that the studies in the USA, revealed that
tolerance, larger amounts, and DSM-III-R (as assessed by the the TDS did not predict abstinence
time spent using items (see DIS), was a significant, though at 1-week or 6-months post-quit
Appendix 2). Thus, this factor weak, predictor of cigarette (TTURC Tobacco Dependence
seems to be highly related to abstinence over one year, but that Phenotype Workgroup, 2007).
sheer amount smoked. The se- the FTND was a better predictor
cond factor was related to and that number of cigarettes Heritability: There has been
persistent desired/unsuccessful smoked per day was the best considerable research supporting
efforts to cut down or quit, and predictor (Breslau & Johnson, the heritability of DSM/ICD-
continued use despite emotional/- 2000). Another study showed that diagnosed nicotine dependence.
physical problems. Confidence in DSM-IV diagnoses of nicotine In the Australian Twin sample
this solution is bolstered by the dependence predicted heaviness study, analyses revealed that all of
fact that it was obtained in three of use and cessation outcome in a the DSM-IV symptoms and diag-
separate groups of individuals. It population-based study of college nosed DSM-IV dependence were
is also consistent with other recent students (Sledjeski et al., 2007). meaningfully heritable (45-73%),
factor analyses (Lessov et al., Several studies have shown that and that the DSM-IV criteria of
129
tolerance, withdrawal, and dif- outcomes as well as the and 0.83 for the full scales.
ficulty quitting were the most diagnostic measures (e.g. John et Factor analysis suggested a
highly heritable symptoms of al., 2004a). In terms of the unidimensional structure for the
nicotine dependence for both men prediction of likelihood of future CDS-12.
and women (Lessov et al., 2004). cessation, it is unclear that diag-
A study of twin fathers, using the nostic measures possess any Validation: The CDS scales were
Vietnam Era Twin Registry, found incremental validity relative to significantly correlated with
that paternal DSM diagnosis of briefer measures, such as the number of cigarettes smoked per
nicotine dependence was sig- HSI. The diagnostic scales have day (whether a smoker was a
nificantly associated with offspring relatively high reading levels, daily or occasional smoker),
DSM diagnosis of nicotine which may hinder their use with strength of urges during the last
dependence (Volk et al., 2007). certain populations (even if quit attempt, and cotinine level
However, one study found that administered orally). (Etter et al., 2003b). Curiously, the
DSM nicotine dependence was CDS-5 was more strongly
not related to familial liability to Cigarette Dependence Scale correlated with cotinine levels than
smoking persistence, because was the CDS-12. This was
familial density of persistence was The Cigarette Dependence Scale probably due to the fact that the
not associated with smoking (CDS) is another unidimensional question about smoking heavi-
persistence among nicotine- tobacco dependence measure ness (Question #2) determined a
dependent daily smokers (John- (Etter et al., 2003b). This assay greater portion of total scale
son et al., 2002). Other genetics was developed using smokers variance in the 5-item version. In
research has linked DSM- reports of signs that they believed one study, none of the three
diagnosed nicotine dependence indicated addiction to cigarettes. dependence measures (i.e. the
with the CYP2E1 genotype, which Both a 5- and 12-item version of FTND, CDS-5, or CDS-12) was a
codes for a protein that meta- the CDS were developed (see significant predictor of relapse
bolizes alcohol and tobacco Appendix 5). The items overlap likelihood (Etter et al., 2003b);
smoke nitrosamines, and is somewhat with the Fagerstrm however, only a third of potential
implicated in creating metabolic tests (e.g. they both assess respondents participated in the
cross-tolerance between alcohol number of cigarettes smoked per follow-up study, which might have
and tobacco (Howard et al., 2003). day and time to first cigarette in the produced considerable response
morning). The Flesch-Kincaid bias. In a second study, the CDS-
Summary: There is evidence that Reading Grade Levels were 4.9 for 12 weakly predicted smoking
diagnostic measures effectively the CDS-12 and 6.8 for the CDS-5. abstinence at 1-month post-quit,
index smoking heaviness, smo- but in a counterintuitive direction
king-related health and mental Reliability and structure: To date, (e.g. higher CDS-12 scores
health risks, and likelihood of only two published studies have predicted abstinence) (Etter,
future cessation. There is also reported data on the two versions 2005).
strong evidence of heritability of of the CDS, using data collected
DSM-diagnosed nicotine depen- via the mail or Internet (Etter et al., Heritability: To date, no data
dence. It is unclear whether 2003b; Etter, 2005). The CDS-12 regarding heritability or genetics
paper-pencil versions of such had strong internal consistency, have been published using the
measures (the TDS) are com- the CDS-5 was within the CDS.
parable to the interview versions acceptable range, and both scales
of such measures. Moreover, were slightly skewed toward Summary: While the CDS scales
there is evidence that the FTND higher values. Test-retest cor- do index smoking heaviness well,
may predict cessation and health relations were 0.60 for all items there is little evidence that they
130
predict likelihood of cessation 6). The Flesch-Kincaid Reading item scale. The internal con-
effectively, or that they index other Grade Level is 7.7. This reading sistency for the NDSS total scale,
health outcomes of public health level is somewhat elevated relative the NDSS-T, is good (Shiffman et
importance. Further, there is little to other self-administered scales, al., 2004); however, data show
evidence that they possess which may reflect the fact that that the internal consistencies of
incremental validity relative to some items contain unusual words individual subscales are prob-
other measures, such as the and require integration of more lematic (Piper et al., 2006). Prin-
diagnostic measures or the FTND. than one sentence or statement. cipal components analysis re-
Overall, this measure is promising For instance, the item, My vealed a 5-factor structure for the
in that it can be used with paper- smoking pattern is very irregular NDSS (Shiffman et al., 2004) as
pencil administration and it has throughout the day. It is not predicted by the underlying theory.
good reliability, but a meaningful unusual for me to smoke many Significant differences in the
evaluation must await additional cigarettes in an hour, then not have scores on the subscales between
validity research. another one until hours later, White and African-American
involves three negatives over its smokers suggest the scale may
Multidimensional Measures of two sentences. In addition, some operate differently in subpopu-
Tobacco Dependence questions are double-barrelled, lations, although there were no
such as Its hard to estimate how ethnic differences in the total
Nicotine Dependence Syndrome many cigarettes I smoke per day NDSS score (Shiffman et al.,
Scale because the number often 2004). A more recent study, using
changes. If a person answers no, the 19-item questionnaire with the
The Nicotine Dependence Syn- it is unclear whether the answer Finnish Twin Cohort Study
drome Scale (NDSS) (Shiffman et refers to difficulty of estimation per population, found that a 3-factor
al., 2004) is a 19-item multi- se, or because the number of structure (priority/drive, continuity/
dimensional scale based on cigarettes smoked per day does stereotypy, and tolerance) best fit
Edwards and Gross 1976 theory not change. Some items may be the data, with the internal
of the alcohol dependence significantly influenced by cultural consistencies of the three factors
syndrome. The NDSS was factors, such as eating in ranging from 0.83 to 0.92 (Broms
intended to complement, not re- restaurants that are smoke-free or et al., 2007).
place, traditional dependence experiences during air travel.
measures, such as the DSM- These features may make the Validation: Much of the initial
based assessments, and there- NDSS somewhat less appropriate validation work was done with the
fore there is little content overlap than some other measures for 30- and 23-item NDSS, prior to its
between the NDSS and the uni- individuals of modest reading being refined to the 19-item
dimensional measures. The abilities or educational status. The version. These results indicated
NDSS assesses five dimensions NDSS has been translated into that the NDSS-T predicted time to
of nicotine dependence: Drive Finnish (Broms et al., 2007). lapse and time to relapse, but no
reflects craving, withdrawal, and individual subscale predicted
smoking compulsions; Priority Reliability and structure: To date, lapse or relapse (Shiffman et al.,
reflects preference for smoking four studies of adult smokers have 2004). However, new data
over other reinforcers; Tolerance generated data on the NDSS; one suggest that the NDSS subscales
reflects reduced sensitivity to the study has reported on the NDSS are significantly, though modestly,
effects of smoking; Continuity in adolescents aged 12-18 (Clark related to cigarettes smoked per
reflects the regularity of smoking et al., 2005). day (r = 0.12-0.26) and that the
rate; and Stereotypy reflects the Psychometric data discussed Tolerance and Continuity sub-
invariance of smoking (Appendix here are based on the revised 30- scales are modestly related to CO
131
level (r = 0.12 and 0.13, smoking heaviness measures, different smoking dependence
respectively) (Piper, et al., 2008). other dependence measures, and motives: Affiliative Attachment,
In samples of treatment-seeking smoking cessation likelihood Automaticity, Behavioral Choice/
smokers, the NDSS Priority and (Broms et al., 2007; Piper et al., Melioration, Cognitive Enhance-
the Stereotypy subscales were 2008). The majority of this re- ment, Craving, Cue Expo-
found to predict cessation out- search has been done on clinical sure/Associative Processes, Loss
comes for up to 6-months populations and it is not known of Control, Negative Rein-
post-quit (TTURC Tobacco how well these results would forcement, Positive Reinforce-
Dependence Phenotype Work- generalize to population-based ment, Social and Environmental
group, 2007; Piper, et al., 2008). samples. There is evidence that Goads, Taste and Sensory
The NDSS Drive, Tolerance, and the various subscales of the Properties, Tolerance, and Weight
the total score were found to measure are differentially related Control (see Appendix 7 for the
predict heaviness of smoking and to various dependence criteria items and scoring). The Flesch-
cessation outcome in a popu- (Shiffman & Sayette, 2005; Broms Kincaid Reading Grade Level is
lation-based sample of college et al., 2007; TTURC Tobacco 4.6; however, balanced against
students (Sledjeski et al., 2007). In Dependence Phenotype Work- this easy reading level is the fact
Finnish smokers, the NDSS was group, 2007). This suggests that that the total scale is quite long.
significantly correlated with both some of the subscales possess Therefore, investigators might
FTND and DSM-IV, as assessed discriminative validity with respect wish to use individual, theoretically
by the CIDI measures of de- to different dimensions or aspects targeted subscales in epide-
pendence (Broms et al., 2007). of dependence. However, there is miologic research (subscales
The NDSS subscales accounted evidence that the NDSS is not range from 4-7 items) (Lerman et
for 51% of the variance in self- able to predict the major deal., 2006). Finally, relatively subtle
reported difficulty abstaining pendence criteria of smoking psychological concepts are ad-
among chippers (light/non-daily heaviness or cessation likelihood dressed in this measure, such as
smokers) (Shiffman & Sayette, better than shorter measures thinking of cigarettes as a friend or
2005), with the Drive subscale (TTURC Tobacco Dependence experiencing a loss of control, and
having the strongest relation ( = Phenotype Workgroup, 2007). In this may affect the validity of such
0.61), relative to the other scales addition, the marginal reliabilities items in some cultures. There are
( = 0.13-0.28). of some of the subscales, and the English and Spanish versions of
reading level and complexity of the WISDM (D.W. Wetter,
Heritability: In the Finnish cohort, some of the items, may dis- personal communication, Decem-
NDSS was found to have a courage use in large popu- ber 12, 2006).
significant heritability estimate of lation-based samples. While all subscales assess
0.30, relative to a heritability dependence, it should be noted
estimate of 0.40 for the FTND Wisconsin Inventory of Smoking that some of the subscales (i.e.
(Broms et al., 2007). Dependence Motives Cue Exposure/Associative Proce-
sses, Social/Environmental Goads,
Summary: Like the CDS, the The Wisconsin Inventory of and Taste/Sensory Properties)
NDSS is a relatively new scale Smoking Dependence Motives represent early-onset motives,
and it is not yet possible to draw (WISDM) (Piper et al., 2004) is a which are present for all smokers
firm conclusions about its validity 68-item measure developed to even at modest levels of smoking
relative to other dependence assess the discrete motivational experience, while other subscales
instruments. In its favour is the basis of dependence. This mea- represent late-onset motives (i.e.
fact that some of its subscales sure has 13 theoretically-based Affiliative Attachment, Automa-
have been shown to predict subscales designed to tap ticity, Behavioral Choice/ Melio-
132
ration, Cognitive Enhancement, WISDM (TTURC Tobacco Depen- subscales may code for biological
Craving, and Tolerance), which dence Phenotype Work-group, diversity so as to permit genetic
are present only in individuals who 2007). mapping.
smoke at a moderate daily rate or The various WISDM subscales
have at least moderate smoking show different patterns of relations Summary: Like the CDS and the
experience (Piper et al., 2004). with the dependence criteria. For NDSS, the WISDM is a relatively
instance, the Tolerance subscale new scale and it is too soon to
Reliability and structure: To date, was the best predictor of CO level, draw firm conclusions about its
only one study has published data but the Craving, Cue Exposure/ validity relative to other depen-
on the WISDM (Piper et al., 2004). Associative Processes, and dence instruments. However, data
Across two different samples all Tolerance subscales were the reveal that some of its subscales
13 subscales had strong internal best predictors of DSM-IV depen- predict smoking heaviness
consistencies that were evident dence when entered together into measures and smoking cessation
across gender and across Whites a multiple regression equation likelihood (Piper et al., 2008).
and African-Americans. A new (Piper et al., 2004). One study There is also evidence that the
study found that the internal found that although the total score various subscales of the measure
consistency of the subscales was not a significant predictor of are differentially related to various
ranged from 0.74-0.94 with the relapse after controlling for dependence criteria (TTURC
total scale having a Chronbachs treatment, the combination of Tobacco Dependence Phenotype
alpha of 0.96 (Piper et al., 2008). Automaticity, Behavioral Choice/- Workgroup, 2007; Piper et al.,
Factor analytic strategies indi- Melioration, Cognitive Enhance- 2008), suggesting that this mea-
cated that the WISDM-68 is ment, and Negative Reinforce- sure is able to capture different
multidimensional, although some ment subscales all predicted dimensions or aspects of depen-
scales hit on related or over- relapse by the end of treatment in dence. However, there is evi-
lapping dimensions of depen- a multivariate model (Piper et al., dence that the WISDM is not able
dence. Thus, it is safe to say that 2004). Data from two different to predict the major dependence
some of the subscales are tapping smoking cessation trials found that criteria of smoking heaviness or
the same underlying dimensions. WISDM Automaticity and Tole- cessation likelihood better than
rance were predictive of outcome shorter measures (TTURC
Validation: The total WISDM was at 6-months post-quit (TTURC Tobacco Dependence Phenotype
correlated with smoking heaviness Tobacco Dependence Phenotype Workgroup, 2007). Some WISDM
(cigarettes per day r = 0.63; CO r Workgroup, 2007). subscales have been related to
= 0.55) (Piper et al., 2004). Data various dependence-linked gene-
also indicated that WISDM Total Heritability: There is evidence that tic components. It is important to
predicted outcome at both 1-week the Taste/Sensory Properties note that the WISDM research has
and 6-months post-quit (TTURC subscale was significantly related been done on clinical populations
Tobacco Dependence Phenotype to a genetic variant that deter- and it is not known how well these
Workgroup, 2007). Thus, there is mines sensitivity to bitter tastes results would generalize to
evidence that the whole scale is (the phenylthiocarbamide (PTC) population-based samples.
meaningfully related to the major haplotype) (Cannon et al., 2005).
dependence criteria. However, as Data have also revealed a Summary:
with the NDSS, it appears that significant relation between the
some shorter measures, such as WISDM Tolerance subscale with Assessment of cigarette-induced
the HSI, predict smoking heavi- the ratio of 3-hydroxycotinine to nicotine dependence is an
ness and cessation likelihood as cotinine (Piper et al., 2008). These important goal for three reasons.
well or better than the longer data suggest that some WISDM First, the human and economic
133
costs of cigarette-induced, nico- dependence measures accounts public health outcomes. However,
tine dependence is significant. for a large proportion of variance the relative lack of validity
Second, only a portion of cigarette in outcomes in cessation information on these scales may
smokers are dependent (as likelihood. This is no doubt due to mean that researchers should use
defined by traditional instruments), the fact that cessation likelihood is these instruments only in the
and those who are dependent are affected by countless situa- context of exploratory research.
indeed distinguishable from other tional/environmental factors, and They might be most appropriate
smokers on the basis of factors, other person factors. In addition, if for research addressing etiology
such as likelihood of future one uses a brief measure, such as and cultural or population-based
cessation and amount smoked the HSI, it is important to differences in smoking deter-
daily. Finally, cigarette-induced recognize that it does not tap all minants.
nicotine dependence may serve to dependence factors. It also does
moderate individuals responses not appear to predict certain core Measures of smokeless
to different tobacco control pro- features of dependence well, such tobacco-induced nicotine
grammes and policies, as well as as withdrawal, and it may be dependence
the proximal and distal effects of inappropriate in populations that
these interventions. do not smoke daily or have Like cigarettes, smokeless tobac-
It is important to note that there significant restrictions on smoking co (ST) products contain nicotine,
is considerable evidence that the (e.g. restrictions that constrain although the levels vary con-
various measures of nicotine smoking in certain contexts or siderably across products (Hatsu-
dependence are not highly related times of day). kami et al., 1992; IARC, 2007b).
to one another, and can have very There may be situations when Data on patterns of use of ST
different relations with validity there is a need to assess support the conclusion that many
measures (Hughes et al., 2004a; particular, relatively discrete, users are nicotine dependent
Piper et al., 2006). Thus it is facets of nicotine dependence. (Henningfield et al. 1997; IARC,
critical that investigators select For example, identifying specific 2007b). Many ST users experi-
measure(s) that are psycho- tobacco dependence mechanisms ence withdrawal symptoms upon
metrically sound, appropriate for may facilitate: identification of a abstinence (Hatsukami et al.,
the intended population, and more proximal phenotype (Can- 1992; 1999). Studies have used a
target the constructs in which the non et al., 2005), identification of biomarker of nicotine uptake,
researchers are interested. If the specific dependence dimensions cotinine, to show that daily users
goal is to assess a central core of with which one could create of ST exhibit levels of nicotine
nicotine dependence as a pre- treatment algorithms, monitoring absorption that are equivalent to
dictor of cigarette use cessation of the development of tobacco daily cigarette smokers (Gritz et
likelihood, or as an index of dependence, or identification of a al., 1981).
associated health risks, then the specific group of dependent Dependence on smokeless
FTND or HSI appear best suited tobacco users for whom a policy is tobacco has often been assessed
for this purpose (Tables 3.22 and particularly effective or ineffective. with questionnaires derived from
3.23). These instruments are brief If this is the goal of the research, FTND, with the addition of specific
and have relatively impressive then a multifactorial measure (i.e. items, in particular, swallowing the
predictive validities, and their the NDSS and the WISDM-68, tobacco juice (Boyle et al., 1995;
reading level should make them and their subscales) would be Ebbert et al., 2006). In three
appropriate for a broad range of optimal, despite the fact that there different samples, use of ST within
populations. However, it is is little evidence for incremental 30 minutes of waking and
important to note that none of the validity in predicting important swallowing the tobacco juice were
134
Construct Tobacco Dependence
Measure 1 Fagerstrm Test of Nicotine Dependence (FTND) 6 items
Source Heatherton et al., 1991
Variation It is possible to change the wording of the items to be culturally appropriate or to reflect non-cigarette
tobacco use. However, these changes may affect the reliability and validity of the data obtained.
Validity Predicts both behavioural (e.g. lifetime amount smoked) and biochemical (e.g. CO, cotinine) indices
of smoking in multiple countries
Predicts cessation
Evidence of linkage to specific dependence-linked genetic variants
Comments This measure is recommended as an assessment of dependences ability to predict cessation

and heavy use
Brief and well-known
Strong predictive validity of heavy use and cessation
Internal consistency is modest, which may reflect a 2-factor structure
Some items may be influenced by smoking restrictions in the environment
Has been translated into a number of different languages
Measure 2 Heaviness of Smoking Index (HSI) 2 items from the FTND: number of cigarettes smoked per day and
time to first cigarette in the morning
Source Kozlowski et al., 1994
Validity Predicts both behavioural (e.g. lifetime amount smoked) and biochemical (e.g. CO, cotinine)
indices of smoking in multiple countries
Predicts cessation the HSI appears to be the strongest predictor of cessation, accounts for
much of the predictive validity of the FNTD
Highly heritable (71%) and linked to specific dependence-linked genetic variants
Comments This measure is recommended as the most efficient measure to assess dependences ability to predict
cessation.
Brief
Using this measure may only involve the addition of item (time to first cigarette) if number of
cigarettes per day is already being collected
Items may be influenced by smoking restrictions in the environment
Table 3.22 Measures of Cigarette-Induced Nicotine Dependence
135
Construct Tobacco Dependence
Measure Fagerstrm Test of Nicotine Dependence (FTND) 6 items
Sources Boyle et al., 1995; Ebbert et al., 2006
Validity Predicts both behavioural (e.g. lifetime amount smoked) and biochemical (e.g. CO, cotinine)
indices of smoking in multiple countries
Predicts cessation
Evidence of linkage to specific dependence-linked genetic variants
Comments This measure is recommended as an assessment of dependences ability to predict cessation and
heavy use
Brief and well-known
Internal consistency is modest, which may reflect a 2-factor structure
Some items may be influenced by smoking restrictions in the environment
Table 3.23 A Measure of Smokeless Tobacco-Induced Nicotine Dependence
the variables most consistently to provide a means for identifying measures of cigarette and smoke-
associated with cotinine level ST users who are nicotine depen- less tobacco nicotine depen-
(Boyle et al., 1995) (see Appendix dent. dence. For cigarette smoking, the
8 for the items and scoring). 2-item Heaviness of Smoking
Summary and recommenda- Index is recommended for use in
Summary: tions population level studies. If only a
single item measure is possible,
Like cigarettes, smokeless to- Nicotine dependence is an the use of time to first cigarette in
bacco can result in nicotine important construct to assess as a the morning is recommended.
dependence. While less research moderator for the effects of For smokeless tobacco, the
has been done to validate self- tobacco control programmes and FTND-ST appears to be a useful
report measures of ST-induced policies. In this section the measure of nicotine dependence.
nicotine dependence, question- evidence was reviewed on the
naires derived from FTND appear validity of various proposed
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section4.1janvier12:Layout 1 12/01/2009 13:49 Page 137
4.1 Data sources for monitoring tobacco control

policies
Introduction this section is concerned with core teristics: (1) include all relevant
governmental policy interventions, tobacco control policies and
since in most countries, only govern- regularly be updated to include new
Do we know why the prevalence of ments have a population-wide reach innovative policies; (2) characterise
smoking in Sri Lanka decreased and the capacity and authority to the interventions against current
from 54% in 1988 to less than 40% consistently enforce stringent mea- best practice standards; (3) include
in 2003? What is this decrease sures. Such interventions typically the degree of enforcement of policy
related to? Does tobacco control include any governmental form of interventions; (4) rely on credible
have a part in this? If so, what regulation, funding decision, insti- sources; (5) cover all countries, as
specific policy interventions were tutional statement, organisational well as all relevant sub-national
most useful in decreasing the development, or administrative ac- jurisdictions; (6) be updated as
prevalence in Sri Lanka? How does tion to apply (or not apply) tobacco changes occur, or at least at regular
that compare to other countries? To control policies. Further down, this and short intervals, while keeping
respond to these and similar ques- section discusses evaluation criteria historical information; and (7) span
tions on the relationship between for tobacco control policy inter- a long enough period to link
the implementation of specific ventions monitoring systems, and changes in tobacco control policies
tobacco control policies and toba- reviews currently available data to changes in the prevalence of
cco use prevalence in any country, sources based on these criteria. The tobacco use and other impact indi-
researchers and policy-makers last part of the section builds on the cators. Therefore, tobacco control
need a solid understanding of the first two and discusses renewed monitoring systems are assessed in
current state of policies and their efforts to build comprehensive this paper in relation to the following
specific impact at the country level tobacco control monitoring systems variables:
(http://www.who.int/ncd_ surveillance/ in the new international tobacco
infobase/web/InfoBaseCommon/). control context. Policy scope
This section describes the cur- Characterization of interventions
rently available sources of Criteria for assessing against best practice standard
information on tobacco control poli- tobacco control policy inter- Characterization of degree of
cy interventions, with special vention monitoring systems enforcement
attention to the new WHO Global Source of the primary data
Tobacco Control Report system, An ideal global tobacco control Geographical/jurisdictional
and assesses their credibility, monitoring system would track coverage and comparability of
completeness, and usefulness. It interventions to decrease tobacco data across jurisdictions
also discusses important metho- use in all relevant policy domains, Timeliness and frequency of
dological issues and gauges future and would make the data com- data collection
prospects for such systems. Alt- parable across all jurisdictions, Characterization of evolution of
hough tobacco control policy based on an explicit and transparent policies over time.
interventions can be initiated by protocol. Such a monitoring system
private sectors of the civil society, would have the following charac-
137
Scope of policies covered: differences in effectiveness. In- Cummings et al., 2003; Glantz et
creasing prices through high al., 2005; Wiehe et al., 2005).
Tobacco control interventions are taxes, as well as smoke-free Tobacco control monitoring sys-
wide in scope and vary in time and environments, are generally seen tems should be assessed on the
space. However, despite the as the most effective tobacco strategic choice of the policy
sheer diversity of possible policy control policies (Ranson et al., domains and interventions they
interventions, they can be re- 2000), and therefore are con- cover. Although this choice is
grouped in a few convenient sidered essential in any in- generally implicit in all datasets,
categories that generally fall under formation system. the data collector should clearly
demand reduction measures If resources allow, clearly describe the basis for that choice,
and supply reduction measures ineffective policies could be whether in terms of efficacy, or
(although some policies do not monitored. This could provide a any other criteria.
easily yield to this rather strict scan of the policy environment
dichotomy) (Table 4.1). In asses- and assess the imbalances Characterization of tobacco
sing the scope of tobacco control produced by focusing on ineffec- control policies based on best
data systems, one must bear in tive measures. For example, in the practice standards:
mind that not all tobacco control context of constant aggressions
policies are equal. Supply reduc- from the tobacco industry to avoid Once the scope is established, the
tion policies are generally effective tobacco control, moni- data system must be assessed in
considered not to be very effective toring measures that are in- relation to its capacity to
at reducing tobacco use, except efficient, but at the same time (and characterise each policy accor-
perhaps for anti-smuggling mea- for the same reason?) the darling ding to an explicit standard or
sures under certain conditions of the industry, might indicate how recognised best practices. For
(Rowena et al., 2000). Given the misguided the policy priorities of a example, it is generally acknow-
limited resources devoted to data given jurisdiction are. Examples ledged that bans on advertising,
gathering, efforts should first be are the effectiveness of school- promotion, and sponsorship
dedicated to demand reducing based education programmes and should be comprehensive. There-
policies. Even among such poli- prohibition sales of tobacco pro- fore, systems monitoring mar-
cies, however, there are wide ducts to minors (Ling et al., 2002; keting restrictions should be
Demand Reduction Policy Domains Supply Reduction Policy Domains
Price and tax of tobacco products Liability and litigation
Protection from exposure to secondhand tobacco smoke Access to tobacco by youth
Tobacco advertising, promotion and sponsorship Banning sales of tobacco products
Packaging and labelling of tobacco products Crop substitution
Treatment of tobacco dependence Contents of tobacco products
Education, communication and public Awareness Illicit trade in tobacco products
Table 4.1 Tobacco Control Interventions
138
Data sources for monitoring tobacco control policies
assessed on their ability to provide and/or films, and sponsored standard considers that bans with
information that would allow events. In addition, the existence smoking rooms are not complete,
gauging the policies of any given of each element of the policy the Italian ban would not
jurisdiction against this standard. should be assessed with a Yes/No complete. However, the require-
According to this standard, the question that leaves little room for ments for smoking rooms are so
monitoring system must then interpretation and explicitly meets stringent, that Italian law de facto
select all relevant variables the best practice standards. The can be considered providing for a
describing the components of this monitoring system should clearly complete smoking ban, as
policy and collect the data accor- describe the criteria used in smoking rooms are rarely
dingly (Joossens et al., 2006). answering Yes/No questions, and available.
Following with the previous these criteria should be termed in Characterizing of any given
example, to ascertain the existence the same language as the laws. policy intervention becomes even
of a comprehensive ban on For instance, these apply notably more difficult in the absence of
advertising, promotion, and spon- in deciding whether a smoking clear information on regulations.
sorship, the monitoring system ban is complete, whether health Some countries have legal
should provide information warnings are effective, whether systems where regulation is very
separately on each form of com- advertisements are banned from general, leaving it to admini-
mercial communication, recom- the media, etc. strative actions to determine how
mendation or action, and any form To have a clear charac- regulations are to be applied.
of contribution to any event, terization of any given policy Some regulations have loopholes;
activity, or individual with the aim, intervention is not always easy. some countries have contradictory
effect, or likely effect of promoting a Even with all necessary legal decrees issued by many types of
tobacco product or tobacco use information, the data collector is authorities, with uncertain rules
either directly or indirectly. Such a left to match their own definition of determining which decree has
policy would include data on the the desired policy with the jargon precedence. In other countries,
existence of direct advertising bans of the law. One desired policy one must consider jurisprudence
of tobacco products or brands in might be a complete smoking ban. and court orders suspending or
every existing media, including However, even good laws typically modifying regulations.
national and international TV from do not provide for complete bans In summary, any tobacco
any source (cable, satellite, and could include some exemp- control monitoring system, be-
internet, etc.), national and inter- tions. The Irish law is a case in cause it attempts to verify the
national radio, local and inter- point; it does not provide for a existence of an implicitly defined
national magazines and news- complete ban strictly speaking. good" policy intervention, must
papers, billboards, points-of-sale, However, judging when exemp- synthesize complex information to
the internet, and cinemas. More- tions are minor or not might be a answer simple questions. At one
over, the monitoring system should challenge, and setting a clear and time or another, collecting the
collect data on the ban of each detailed standard of excellence is information may call for some
specific form of promotion of important in assessing and judgment by the data collector. A
tobacco products, brand names, or collecting data for monitoring good tobacco control monitoring
company names, including direct tobacco control policies. More system should minimize the
mail giveaways, promotional dis- complicated is the assessment of impact of these judgment calls
counts, non-tobacco products the Italian law. It does contain a and make them as explicit as
identified with cigarette brand smoking ban, but exceptions are possible.
names, brand name of non- allowed in the form of smoking
tobacco products used for tobacco rooms, usually not considered a
product, product placement in TV best practice. If the applied
139
Enforcement survey reported that they had two obvious problems with such
seen billboards with tobacco measures: first is that the
Any characterization of a policy advertisement in the month before existence of enforcement efforts
intervention is not complete the survey, despite a successful does not indicate enforcement of
without assessing the actual complete ban enforced 5 years the law necessarily; and second,
enforcement of the measure. It is earlier. It is thus possible that the absence of enforcement
not enough to know that a policy survey respondents did not efforts is not an indication of lack
intervention legally exists without understand the question or that of enforcement in countries where
knowing if it is applied. The they might actually be reporting tobacco control measures are
system monitoring tobacco control types of advertisement that are widely respected without severe
policies can use two types of not covered by the law (Global enforcement. Countries where
measures to assess the en- Youth Tobacco Survey fact interventions are self-enforcing
forcement of a policy intervention: sheets; http://www.cdc.gov/toba- from the beginning, or where
de facto implementation of the cco/global/GYTS/factsheets/paho/ significant efforts might not be
intervention in conformity with the factsheets.htm). needed after many years of
policy, and enforcement efforts by A more feasible alternative is successful enforcement, will fare
the government. The first type of to rely on the opinion of key quite badly next to a country with a
measure is best since it addresses informants or experts, providing severe enforcement problem
exactly what needs to be gauged, some sort of qualitative direct despite significant government
while the second method is an observation. The panel of key efforts. In addition, such statistics
indirect indicator that looks at the informants or experts is especially are not always available. In fact, in
process leading to enforcement. sensitive to judgment calls and some countries, it is not clear who
De facto implementation must be assessed very carefully. should enforce the law, and
requires specific quantitative me- In this respect, developing a gathering statistics then becomes
trics based on direct observation stringent, multi-layered protocol is difficult. In the case of smoke-free
of people or events, outside the probably a sound base, but there environments, for example, some-
purview of a monitoring system. is not yet a consensus on what times police are in charge of
Such measures are often would be a method that is enforcement and often do not use
unrealistic for many countries with inclusive enough at the national fines to enforce the law, given the
low resources; measuring level, yet comparable enough at low social acceptability of a fine for
enforcement of smoking bans, the international level. Indeed, smoking in a restaurant; casual
for example, may require popu- qualitative assessment of enforce- reprimand is used instead and no
lation surveys, sometimes inclu- ment is not easy, especially at the trace is left in any official record.
ding biological measures of international level, where national Given these difficulties and
exposure to secondhand smoke. experts might have a widely inherent limitations of the second
Other metrics might include data different appreciation of enforce- approach of measuring enforce-
provided by the industry, because ment. ment efforts, it is probably better to
of clear legal obligations (e.g. Methods based on quantitative mainly rely on the first approach,
detailed sales or advertising data), measures can be used to gauge but to also use some basic
that can help understand the efforts (usually by the govern- measures of government efforts
impact of policy. Although pre- ment) leading to enforcement. that are in line with recom-
ferable to other approaches, direct These can be measured by mendations on enforcement.
observation is not exempt from enforcement budget, number of Monitoring systems could, in this
problems. Even surveys are full-time equivalent inspectors, case, gather data on the existence
difficult to interpret. In Brazil, for number of inspections, number of of a clearly identified body in
example, 70% of respondents to a fines distributed, etc. There are charge of enforcing the law, and if
140
possible, the budget or staff of that on surveys, ad hoc metrics, order to increase flexibility of the
specific agency or unit, if it exists. qualitative measures, and expert exercise and country level
Whichever approach is used, a judgment. Moreover, it is very dif- relevance and buy-in.
monitoring system should be ficult to use a method that is The coverage of specific sub-
assessed on its explanation of the suitable for all national contexts; national jurisdictions follows the
measure of enforcement used. hence, the importance of descri- same principle. In the countries
The choice of approach and bing and justifying methods used. where this is relevant, inclusion is
method must thus be explicit. If it an absolute priority. In Canada, for
uses a survey, a panel of experts, Geographical/jurisdictional example, very stringent smoke-
or any other investigation method coverage free laws are enforced at the
to determine the actual impact of provincial level, and excluding
a policy, this method must be An ideal monitoring system should provinces would result in faulty
described in detail so that the provide data on policy inter- answers. Yet, there are only a few
reader can clearly understand it ventions in all countries of the cases where inclusion of sub-
strengths and limitations. world, and in all relevant sub- national jurisdictions is essential,
national jurisdictions within each and once more, local knowledge
Source of the primary data country. Worldwide geographical on the existence and relevance of
coverage comes at a cost; a these policies is critical. Should
The scope and characterization of balance must be struck between municipal by-laws be included for
policy interventions described coverage and thoroughness. Not example? What if a city comprises
above are key to assess the only can resources prove to be a a significant minority or even a
relevance of the contents of an constraint, but the wider the majority of the population and has
information system. However, the geographical coverage, the more such by-laws? Given the com-
crucial element to evaluate the difficult it becomes to make the plexity of some political systems
quality of the information it provides data comparable, and the less and jurisdictions, this will typically
is the assessment of the primary uniform relevant policy scope require local consultation. These
source of data. Written laws and tends to be. The goal of the questions can only be resolved on
regulations are the usual source of monitoring system must thus be a case-by-case basis, hence the
primary data for policy inter- carefully considered before necessity of the monitoring system
ventions. Monitoring systems deciding what the best geo- to outline clear guidelines for
should make all legal documents graphical coverage is. inclusion/exclusion. Among the
available for users to consult when In general, global coverage guidelines is the stability of these
in doubt (online if possible), so that should be the main goal, with very institutions and laws, number of
the reader can see what relevant clear questions and definitions people affected by the laws, their
information was collected. and thought to specific regional share in the national population,
However, assessing the exis- issues. Given the broad diversity strong within-country variations,
tence of some policy interventions in national contexts, this type of etc.
cannot be done by looking at the exercise should also be
written regulations. This is decentralized; hence, the neces- Timeliness and frequency of
typically the case of treatment and sity for a wide, yet highly data collection
education efforts. The presence of coordinated, network in order to
an easily reachable quitline, for make the data comparable. Such Given the pace of change in the
example, requires a measure of focus, however, should not field of tobacco control, an ideal
actual existence and use. Ob- preclude the existence of regional monitoring system should be live,
serving and characterizing these variations over and above a that is, updated as changes occur.
policy interventions must often rely common core set of questions, in Live systems demand the
141
existence of a stable tobacco databases. Described below are tained in the WHO FCTC, the policy
control country level network and the reporting instruments of the scope of the COP reporting
a central coordination mechanism. WHO FCTC, the precursors of the instrument is very large, but does
Short of that standard, and in the GTCR, and the GTCR itself. not directly prioritize policies in
absence of a stable network, the terms of effectiveness. This
frequency of updates should The reporting instrument of instrument contains "Group 1"
mainly depend on budgetary the Conference of Parties to questions, which are wide in scope
issues, with a careful balance to the WHO FCTC: and range from tobacco use
be struck between the frequency prevalence to measures taken to
of updates and budgetary The WHO Framework Convention curb illicit trade, as well as
sustainability. In all cases, the on Tobacco Control (WHO FCTC) education, and public awareness
data should not be more than one is the first treaty negotiated under programmes. Core Group 1 ques-
or two years old, or the time it the auspices of the WHO. It was tions require information about
takes for these policies to sig- adopted unanimously at the 56th tobacco use, licit supply of tobacco,
nificantly affect prevalence. World Health Assembly, in May duty-free sales volume, price and
2003. Its provisions obligate only tax measures to reduce demand for
Change of policies over time parties that have ratified the treaty, tobacco, regulation of tobacco
which as of September 2008 were product disclosures, illicit trade in
Old data should also be kept and 160 WHO member states. An tobacco products measures,
made available, so that re- important provision of the WHO seizures of illicit tobacco, edu-
searchers can track the evolution FCTC is that each Party is cation, communication, training and
of policy in an attempt to link it to obligated to submit periodic reports public awareness activities,
prevalence. Old laws, date of on its implementation of the measures on sales to and by
changes in the law, date of Convention, in accordance with minors, liability measures,
changes in the implementation of Article 21. To this end, the first management of tobacco depen-
the law, etc., are all very important meeting of the COP in 2006 dence and cessation services,
for monitoring systems whose aim provisionally adopted a reporting measures to support alternatives to
is to track the evolution of policy, system whose objective is to tobacco growing, research, sur-
and not just current policy, if we understand and learn from the veillance and exchange of in-
are to assess these measures. various experiences of parties in formation, programmes and plans,
implementing the WHO FCTC. national coordinating mechanisms,
Description and assessment Questions in the reporting and technical and financial
of current data collection instrument are clustered into three assistance provided and received.
systems groups. Only Group 1 questions The data is collected at the
have been designed and applied country level, and its purpose is
Only two global tobacco control by countries reporting to the not to provide a uniform
monitoring systems are presently second meeting of the COP in framework for comparison, but
operational: the WHO Global 2007 [the third meeting of the COP rather a way of observing the
Tobacco Control Report (GTCR) on November 2008 approved progress of the implementation of
and the reporting instrument of the changes to Group1 questions]. the treaty obligations within each
Conference of the Parties (COP) country. Therefore the possibility
to the WHO FCTC. The GTCR is Scope and characterization of of comparing answers across
based on the previous work of the interventions: countries is extremely limited,
National Tobacco Information although the questions on
Online System (NATIONS) and on Given the need to report on the legislative measures are in
still existing WHO regional wide range of obligations con- general quite detailed.
142
Enforcement: Timeliness, frequency of data mation, since there is no a

collection, and trend: detailed protocol to make the data
There are no enforcement comparable.
measures considered in the COP Group 1 questions must be ans- The reporting instrument,
reporting instrument. wered within two years of entry into however, might evolve towards a
force of the Convention for that monitoring system. An indepen-
Data sources: Party, and then every three years dent assessment of the current
after that. Group 2 and 3 questions system is scheduled for 2009; the
The information is self-reported by must be reported within five and COP will further consider the
governments, which are required eight years of entry into force of the matter of reporting in 2010. Al-
to provide the supporting Convention for that country, res- ready decisions of the second
legislative documents. However, pectively. [Group 2 questions were COP, that gathered in Bangkok in
there is no external validation approved in November 2008. the summer of 2007, point to the
planned. The absence of any However, Group 3 questions have need for increased standardi-
formal standardization process, not been designed yet]. By the end sation through an improved
beyond the instructions of the of 2008, 140 parties will all have questionnaire, as well as through
reporting instrument, might mean completed the Group 1 questions the long-term evolution of the
that the user should go back to for the first time. questionnaire with Group 2 and
supporting documents in a The main goal of the reporting Group 3 questions.
systematic fashion. This is espe- instrument is to report on treaty
cially the case for the questions implementation and not on The Global Tobacco Control
regarding legislation, where tracking the evolution of tobacco Report (GTCR) precursors:
countries are asked if they have control. In this respect, following NATIONS and the WHO
"adopted and implemented legis- the trend of legislative measures regional databases
lative, executive, administrative, or is not an objective of the COP
other measures" on specific reporting instrument. The periodic Although NATIONS (http://apps.
policies whose level of imple- reports submitted by parties, nccd.cdc.gov/nations/) is not
mentation is sometimes quite however, may allow some trend updated anymore, it was the first
vague (e.g. smoke-free environ- analysis within each country. global monitoring system for
ments are defined as "full," In summary, the WHO FCTC tobacco control and played a
"partial," or "none", without any reporting system in its current historical role for later efforts.
specific definitions of these terms). form is not designed to be a NATIONS was a collaborative
thorough, scientifically-oriented, effort by the United States Centers
Geographical coverage: annual monitoring programme. It for Disease Control and Pre-
has serious limitations on the vention (CDC) and the WHO, and
The geographical coverage of the immediate use of its data for also involved the American
reporting instrument is limited to monitoring policy interventions Cancer Society (ACS), and the
the signatory parties, although the and comparing legislative mea- World Bank (WB). Its aim was to
number of parties increases sures across countries. Once the monitor tobacco use and control,
regularly and might finally include data are available publicly, based on data gathered from
all WHO member states. The however, independent researchers several sources that stretched
issue of subnational legislation is can undertake the type of work from governmental and inter-
also absent from the ques- they choose to, but it will be based national agencies to commercial
tionnaire. on their own interpretation of the entities, scientific literature, etc. A
data and their own assumption on lot of the data was originally
the comparability of the infor- collected by the ACS and the
143
WHO to prepare the monograph tionSources/Publications/Catalogu agreement, they prescribe a 100%

Tobacco Control Country Profiles, e/20070226_1). What follows is a to smoke-free environments or not.
which was first published in 2000, description of the EURO database. The same issue applies to all
followed by a second edition in other tobacco control measures,
2003 (Shafey et al., editors). After Scope and characterization of where a clearer and more explicit
the adoption of the WHO FCTC by interventions: protocol would be needed. The
WHO Member States in May description of each tobacco control
2003, the data and further The scope of policies covered in measure, and their charac-
responsibility for collection efforts the EURO database is ample terization in terms of Yes and
was transferred to the WHO, and (Table 4.2). As for NATIONS, the No, are much more detailed than
they undertook the creation of data covers more than tobacco in NATIONS, thus leaving less
regional databases through their control (e.g. prevalence, mortality, room for interpretation by the data
regional offices. economics of tobacco); it ad- collector. The format of some of the
The data gathering process ditionally covers policies, such as data could also be improved, such
also underwent important changes. taxation and cessation. as the tax data that provides not
Data collection was decentralized The criteria for guiding the the rates, but the share of the price
to the regional level in order to choice of policies are not explicitly of a pack that goes into different
increase proximity to the countries provided, and the dataset includes types of taxes; the underlying tax
and obtain more accurate infor- tobacco control measures of very rates and the methodology to
mation on tobacco control diverse cost-efficiency without convert them in share of the prices
measures and their implemen- characterizing them. The protocol would be useful. However, most
tation. The data being collected and definitions to make the data legal documents that were relied
through the WHO regional offices comparable is also absent from the on are available on the website
became official, and had to be publicly available information on (except for taxes), thus mitigating
validated by national authorities the website. This might lead to that problem.
before it could be published. The some comparability issues. In the
WHO Regional Office for Europe case of smoke-free environments, Enforcement:
(EURO)(http://data.euro.who.int/to for example, the situation of a
bacco/) has so far provided the country is classified into one of The enforcement is assessed by
most comprehensive data col- three categories: smoking bans, the opinion of the focal point1
lection effort and has the most restrictions, and voluntary agree- collected by completion of a
complete regional dataset of all ments. The first problem is that questionnaire. A score of 1 to 5 is
regional offices. This database is smoking bans in the EURO provided for the enforcement of
used in turn to support the database are not really complete smoke-free legislation, bans on
European Tobacco Control Report, and might allow for some excep- direct and indirect advertising,
a publication with detailed infor- tions. The second problem is that product regulation, and sales to
mation on the state of tobacco voluntary agreements are not minors. However, the assessment
control in the 52 countries of EURO described to ascertain if, indepen- is not published on the website.
(http://www.euro.who. int/Informa- dently regulated by law of the
1
A National Focal point (NFP) is a national centre, designated by each State Party, which is accessible at all times for communications
with WHO International Health Regulation Contact Points. While the exact structure and organisation of the NFP are left to the State,
IHR (2005) define the role, functions and operational requirements for real time management of information and for efficient
communications. It is foreseen that NFPs will be offices rather than individuals.
144
Tobacco Use Smoking prevalence in adults

Smoking prevalence in young people
Economics Cigarette consumption

Cost (in money and labour) of tobacco products
Tobacco tax revenues from excise duties
Duty stamps, earmarking of tobacco taxes
Licensing
Government ownership and financial incentives
Studies of smuggling, economic and social costs, and litigation
Annual price variations of tobacco products in real terms (%)
Structure of taxation of tobacco products
Laws and Regulations Direct advertising of tobacco products

Indirect advertising of tobacco products
Distribution of tobacco products through various outlets
Regulations for sale of tobacco products
Smoke-free areas
Smoke-free public transport
Health warnings
Measurement, regulation and disclosure of tobacco product ingredients
and smoke constituents
Treatment of dependence:
- Interventions to support smoking cessation
- Quitlines
- Availability of smoking cessation treatment
- Training for health professionals
General policy: different sub-national laws or regulations
Public information and advocacy
Participation in WHO networks
Health Consequences and Costs Average number of years lost per death from smoking (years)
Deaths attributed to smoking in all ages
Deaths attributed to smoking in middle age (35-69 years)
Proportion of deaths attributed to smoking in all ages (%)
Proportion of deaths attributed to smoking in middle age (35-69 years) (%)
Standardised death rate from trachea, bronchus, or lung cancer
(per 100 000)
EURO: WHO Regional Office for Europe
Table 4.2 Scope of Policies Covered by the EURO Tobacco Control Regional Database
145
Data sources: potential inaccuracies for coun- that of EURO and the regions with
tries that legislated during this least policy database docu-
This database relies on a ques- period. The process of updating mentation, and the datasets cover
tionnaire that was distributed to the data is not specified and there mainly the information available in
national level tobacco control focal is no built-in regular update legal texts for a subset of countries.
points, who often work from within mechanism. Criteria for assessing this infor-
their national Ministry of Health, mation are much more detailed,
thus ensuring accuracy and Situations in other regions: with very specific questions leaving
country endorsement. The data little room for interpretation.
source is thus highly credible, but Not all regional offices had the Overall, the WHO regional
this process is not described on means to set up systems as databases represented until now
the website, so the reader cannot complete as that of EURO the best existing global data source
assess the validity of the infor- (http://www.who.int/tobacco/global on tobacco control policies.
mation. Main sources are _data/regional_databases/en/inde However, they suffer from many
legislative measures to control x.html). In the Africa Regional issues, of which timeliness and
tobacco, although other policies Office (AFRO), the system does lack of enforcement data are the
are also monitored, such as not exist and the outdated most immediately obvious ones.
prevalence and epidemiological NATIONS represents the main Most important is that the tobacco
impact of tobacco consumption, source of data. In the Eastern control indicators are not the same
as well as tobacco economics. Mediterranean Region (EMRO; between regions, and are not
http://www.emro.who.int/TFI/Coun defined with the same criteria
Geographical coverage: tryProfile-Part6.htm) and the (besides the fact that these criteria
South East Asia Region (SEARO; are never fully described). This
The EURO database covers all http://www.searo.who.int/), the raises serious issues of overall
European countries. Although data was compiled in 2000-2002 comparability.
data from subnational jurisdictions and has been updated in 2008.
is not available, its existence is The policy scope is much The Global Tobacco Control
assessed for eight categories of narrower than in EURO, reasons Report (GTCR) system
legislative measures. for selecting the indicators are not
specified beyond being relevant The Global Tobacco Control
Timeliness, frequency of data and readily available, and geo- Report (GTCR), released in early
collection, and trend: graphical coverage could be 2008, is the central instrument of
improved. As for other regions, the a worldwide tobacco control
The data collection involves a lot protocol or criteria for interpreting monitoring effort by WHO
of back and forth between the laws is not explicitly described, (http://www.who.int/tobacco/mpow
countries and the regional office, thus raising issues of com- er/en/). The objective of the report
in order to clarify and standardize parability between countries, but is to monitor a core of essential
answers, as well as ensure mostly between regions (some tobacco control policy initiatives,
country buy-in. This, however, EMRO legal texts are available and to report on their imple-
creates long delays between online). In the Pan American mentation on an annual basis. The
initiation and conclusion of the Health Organization (PAHO; GTCR aims to provide a highly
data collection effort. The last (http://www.paho.org/tobacco/Pati structured and focused framework
round of data collection, for osHome.asp) and the WHO through which progress towards
example, was initiated in June Western Pacific Region (WPRO; the implementation of defined,
2005, but was not completed until (http://www.wpro.who.int/), the concrete tobacco control mea-
the fall of 2006, which allowed for situation is somewhat in between sures at the country level will be
146
compared in a standardised by type of media; complete well as direct and indirect

manner across countries. Essen- smoking bans by sector; the advertising bans for each country
tial indicators are measured availability of tobacco dependence (Table 4.4). The assessment of
through a short questionnaire that treatment; and existence of na- enforcement is integrated globally
is completed by country level focal tional tobacco control policy through an enforcement score,
points. objectives. Policies such as where a highly enforced policy is
awareness campaigns or anti- worth two points, a moderately
Scope and characterisation of smuggling initiatives are not enforced policy one point, and a
interventions: considered. Answers to this an- minimally enforced policy no
nual questionnaire will be points, hence a maximum score of
The GTCR focuses on a few analysed in the GTCR, which will 10 points given the five experts.
policies that were selected based use gaps between optimal and This system, although very simple,
on their efficiency and cost- existing policies revealed in these works quite well with the majority of
efficiency. The questionnaire data and analyses to develop a countries with legislation providing
requires information on national strong advocacy message. Table the assessment and enforcement
prevalence of daily tobacco use; 4.3 provides the scope of policies scores conforming to expec-
the share of tobacco taxes in the covered by the GTCR. tations. Moreover, the scores are
price of a pack; the existence of credible at the global level, with a
visible health warnings occupying Enforcement: wide dispersion of values, as well
at least 30% of the package of as within countries, with very few
tobacco products; complete The GTCR uses the following polarized expert assessments and
advertising, marketing, and pro- protocol to assess the enforcement yet very few consensual situations.
motion bans of tobacco products of smoke-free environments, as The score, however, suffers from
Tobacco use Internationally comparable smoking prevalence in adults
Economics Structure of taxation of tobacco products

Earmarking of tobacco taxes
Tobacco tax revenues from excise duties
Price of main cigarette brands
Laws and Regulations

Direct advertising of tobacco products
Indirect advertising of tobacco products
Smoke-free areas
Health warnings
Treatment of dependence:
- Interventions to support smoking cessation
- Quitlines
- Availability of smoking cessation treatment
General policy: different sub-national laws or regulations
GTCR: Global Tobacco Control Report
Table 4.3 Scope of Policies Covered by the GTCR
147
1 Choose five key (non-paid) experts of different institutions and professions. Preferably select individuals with the
following background: (1) one health professional with a strong background in tobacco control, (2) one academic
who specializes in tobacco control, (3) the head of a prominent non-governmental organisation in tobacco control,
(4) the government official responsible for tobacco control activities, (5) the WHO focal point for tobacco control (who
usually is also filling out the questionnaire).
2 Consult the experts separately. In many countries, tobacco control networks are very small and the same individuals
might wear many hats. For example, the chief tobacco control officers in the government are often dedicated to the
point of also being the head of leading tobacco control non-governmental organisations. All such experts are likely
to know each other and might not want to openly disagree or share the same limited experience, especially if this
disagreement might have some impact on issues not related to monitoring.
3 Ask each expert to score, in writing, enforcement for three broad categories of tobacco control measures on a scale
of 1 to 3 (minimally, moderately or highly enforced: (1) smoke-free environments, (2) direct advertising, (3) indirect
advertising (promotion and sponsorship).
4 Review the expert's opinion at the national level. The GTCR national focal point: review these answers and clarify
any pending issue or obtain more information regarding widely different answers.
5 Review national findings at the regional level. Consistency and comparability of the national answers could then be
compared at the regional level and scores revised if needed.
6 Integrate results globally.
GTCR: Global Tobacco Control Report
Table 4.4 GTCR Protocol to Assess in Country Enforcement of Smoke-Free Environments, and Direct
and Indirect Advertising Bans
the pitfalls of such measures provide supporting information for spreads throughout data collection
described earlier, and the data these answers in the form of legal and is completed by a final country
collectors are aware of some coun- texts and official policy guidelines, validation of the data. This
tries where there are very close although supporting documents validation includes official signing
links between the experts. The are generally incomplete. This off on the questionnaire answers
system, however, is successful information is then assessed at by an authorized civil servant2.
enough to serve as a basis for the the regional level by a regional Additional primary data sources
next round of data collection. data collector and then again at are the actual knowledge of the
the worldwide level. For most country informant on local policies
Data sources: countries, this process results in a regarding the treatment of tobacco
large flow of communications cessation. For example, the
In most cases, the source of where questionnaire answers are informant has to collect infor-
primary data is legislation as questioned, answered again, mation on the national availability
assessed by country level infor- documented, and finally validated of quitlines, as well as counselling
mants. Informants also have to by all. The validation process thus services for cessation. This
2
This validation process was not followed for the European region in the first release, since the source of the data was the already
validated data used for the European Tobacco Control Report, in addition to minor updates.
148
information is not backed by Timeliness, frequency of data A new context

supporting documents unless collection, and trend:
policy papers, or even leaflet The environment of tobacco
advertisements for these services, The GTCR will be released control has evolved very rapidly
are available. annually, even if annual dif- over the past few years and many
Some questionnaire items ferences are minimal. Some initiatives either directly promote
proved difficult to respond to. The changes in the data might occur policy monitoring systems or
simplicity of the questionnaire despite the absence of any new create a strong demand for them.
could not capture well the com- measures, since a much larger A major change has been the
plexity of national tax data. team will be in charge of reversal of the tide in most high-
Government spending on tobacco assessing questionnaire answers income countries, with decreasing
control also proved an elusive and comparing it to legislation; prevalence and number of smo-
piece of information, because hence, possible revisions and kers. However, despite pre-
such expenditures are not clearly refinements. The GTCR will keep valence rates that are also often
labelled and are often scattered an annual record of the situation in decreasing in low- and middle-
across many budget items. It is each country, which will permit income countries, higher demo-
therefore likely that future editions trends analysis. graphic growth will inevitably lead
of the GTCR will need to modify to deaths on a massive scale.
the questionnaire to better capture Ref lections on the future of Tobacco companies are also
very complex information. Finally, tobacco control monitoring instituting shifts in their operations
it proved easier to handle systems that are geared to these new
prevalence data through WHOs markets. For this reason, tobacco
Global InfoBase than through None of the existing monitoring control needs to quickly implement
prevalence-related questions on systems fully meets all the criteria the same shift and undertake
the questionnaire, given the clear developed in the second part of massive efforts in low- and
advantage and networks InfoBase this section, and thus it remains middle-income countries.
developed over the years. difficult to answer the questions Many factors could help this
outlined in the introduction without shift. The most important factor,
Geographical coverage: undertaking a detailed country and one that is often forgotten, is
analysis and relying on experts that tobacco control is now a tried
The geographical coverage is very opinion (Joossens & Raw, 2006). and tested policy, with a tried and
wide, including all 193 WHO In other words, reliable, com- tested network of dedicated
member states; although 21 parable, comprehensive, and individuals and institutions.
countries, mostly from the Wes- ready-to-use time series on the Tobacco control advocates can
tern Pacific and Americas regions, prevalence of tobacco use and build on a lot of existing know-
did not participate in the first tobacco control measures do not ledge, experience, and suc-
release. At this stage, the GTCR exist and cannot be related to cesses, as well as failures.
questionnaire does not collect each other. This means that given Awareness is also much higher,
information on subnational juris- the current stage of existing data, as not even the tobacco industry
dictions, but does ask questions to it remains challenging to properly can argue anymore that tobacco is
certify the existence of such and systematically assess all not bad for health.
measures, in order to consider the aspects of tobacco control as a The WHO FCTC is also a major
feasibility of collecting these public policy intervention at the structuring element for tobacco
measures in the next release. international level, although the control. By signing it, a country de
GTCR offers a good basis to do so facto accepts its premises and
if developed properly. commits itself in front of the world
149
community to enact very specific social determinants and impact. process with clear objectives and
tobacco control measures, and Secondhand smoke, for example, constant reassessment of policy
report on the implementation of was not a major concern for public means. The most striking
their international treaty obliga- policy before research clearly implication of this policy process is
tions. By virtue of being a treaty, linked it to specific health the ensuing need for a dedicated
the WHO FCTC makes tobacco conditions (US Department of network of individuals, institutions,
control a concern that is much Health and Human Services, and ongoing discussions regar-
broader than health, but an 1986). Realizing that youth ding both the evolution and
altogether international affairs prevalence is a major explanatory continuity of the system, as well as
issue; hence, additional pressure factor for future adult prevalence, the nature and usefulness of the
through linkage with other "high has meant that tobacco control collected data. Health practitioners,
politics" issues. could adopt much more aggres- economists, epidemiologists, data
Finally, new private and sive policies towards this specific managers and collectors, govern-
highly significant initiatives, such market. Knowledge that some of ment officials, and many others
as the large donation by New the harm caused by tobacco to the need a very high level of
York City Mayor Michael Bloom- cardiovascular system can be collaboration in order to set up and
berg add fuel and momentum to reversed within a few years of maintain a good tobacco control
tobacco control. These initiatives cessation, has given a tre- monitoring system. A prerequisite
not only help strengthen existing mendous boost to cessation to any good monitoring system is,
efforts, such as the WHO FCTC, policies. The tobacco industrys therefore, a good organisation,
but also help empower tobacco reaction to original advertising which points directly to the most
control advocates who can then bans has prompted a policy important ingredients: dedicated
set the standards at a higher reaction that now stretches to work with regular, predictable, and
level and convince governments promotion and sponsorship, etc. stable funding.
to follow suit. This new focus on Linking smoking further to a Referring back to the questions
tobacco control is thus a general discomfort and economic outlined in the first paragraph of
fantastic opportunity to start costs for nonsmokers, and the introduction: why cant we
working on monitoring systems, realizing that smoking bans were better assess the impact of
as it creates a new demand for also a very efficient way to help specific tobacco control policy
such information. It is time to addicted smokers quit, helped interventions in terms of efficiency
rethink tobacco control based on justify further tobacco control in and efficacy? One important factor
past experience and highlight the field of secondhand smoke. is the capacity to build and sustain
some of the improvements that The health impact on non- policy monitoring systems. In fact,
should be implemented. These smokers, however, remains a many initiatives were started and
obviously have to do with the crucial underpinning for public left incomplete, mainly because of
nature and analysis of the data, intervention in this field. irregular or insufficient funding
but mostly with the capacity to Monitoring systems for tobacco (perhaps as a reflection of lack of
gather them. control must thus be flexible political will). As this section made
enough to evolve and keep up clear, a high-quality international
with the changes in overall policy monitoring system is first and
Capacity for relevant data objectives, tobacco control en- foremost a good and stable
collection vironment, and consumption network of competent and highly
patterns. Monitoring systems for coordinated individuals and
Tobacco control is also a field that tobacco control are consequently institutions. Such networks are
has greatly evolved with our much more than just gathering difficult to build and maintain. In
knowledge of tobacco and of its data. They involve a complex addition, close supervision of
150
country level activities is impossible system. It follows that in this new relationship between this data
to perform from the outside, and international context, capacity collection system and the WHO
this necessitates close involvement building should come first with FCTC should be carefully as-
of local authorities and staff, hence data collection undertaken as an sessed. Although the WHO FCTC
the absolute necessity of country integral part of it. This would does not yet cover all countries and
buy-in. ensure country buy-in, help keep does not gather data with the aim
This means that the most competent data collectors in the of comparing them (at least for
pressing demand from countries is network, and answer the needs of now), there is nevertheless a
in capacity building to gather and countries regarding the WHO significant overlap between the
analyse data. Indeed, based on FCTC. Most importantly, this COP reporting instrument and
past experiences, building a would ensure that the data GTCR. The closer these processes
sustainable tobacco control collection system does not vanish are, the easier data collection
monitoring system is impossible after a round of data collection, as becomes, and the more efficient
without a prior effort to build a it will be linked to the overall policy the entire system will be.
solid network of competent indi- needs of the countries making
viduals and institutions, and a these efforts relevant not only for
national level capacity that can international users, but also for Conclusions
sustain this system. Previous data local users. This network also
collection efforts were mainly needs to be expanded outside of This section describes the few
donor-driven. A network of infor- the traditional country level existing data collection initiatives
mants was set up from various individuals from ministries of on policy interventions in the field
sources (ministries of health, non- health, and include officials from of tobacco control. Only the WHO
governmental organisations, etc.), external affairs and economic GTCR system is, at this moment,
questionnaires were answered, ministries, as made possible, if not a repository of good quality
stipends paid, and when funds necessary, by the WHO FCTC. information on a wide range of
dried up, this embryo of a network tobacco control policy inter-
was unfortunately left to dis- ventions for the large majority of
integrate. These data collection Towards one ef fective policy countries. It is also the only one
efforts provided highly valuable data collection system with sustainable funding, and
information, and individuals who therefore the most promising
worked on them were pioneers in A monitoring system that is solidly initiative to support prospective
tobacco control, but unfortunately anchored in a network to be national policy changes over time.
a lot of the data cannot be used assembled by a significant Nevertheless, the GTCR only
now. capacity building effort is a focuses on policy domains that
The incredible opportunity that necessary condition for success, have been proven to be effective
now exists, thanks to the WHO but surely not a sufficient con- in reducing tobacco use. Its main
FCTC, is a global demand for dition; dispersing efforts among limitation is that it does not yet
capacity building, as countries will several systems should be contain information about sub-
start to struggle to meet inter- avoided. Countries should not be national policies. All policy
national obligations. Answering this burdened by excessive data researchers studying policy dif-
demand quickly is crucial to build collection, at least with regards to ferences between countries are
a comprehensive international tobacco control. This means, for encouraged to use the WHO
network for tobacco control. This example, completing the integra- GTCR system in their investi-
network is in turn a necessary tion of the WHO regional data- gations.
condition to the emergence of a bases and GTCR. It also means
global tobacco control monitoring that over the next few years, the
151
4.2 Using production, trade, and sales data in

tobacco control
Introduction nately, such a system is not yet the import and export of
available. Tobacco control resear- manufactured tobacco products can
Article 20 of the Framework chers and advocates must find provide valuable information on
Convention on Tobacco Control important data, such as cross- important, key players in the na-
(FCTC) calls for parties to: country estimates of production, tional tobacco control debate. For
trade, and tobacco consumption example, a close examination of
(a) establish progressively a na- from a variety of sources. trade patterns in tobacco products
tional system for the epide- The objectives of this section are can reveal the precise origin of
miological surveillance of to- 3-fold: to discuss the potential cigarette imports; similarly, it can
bacco consumption and rela- usefulness of production and trade identify key export markets. Such
ted social, economic and data in tobacco control, with par- information can be invaluable in
health indicators; ticular attention to the advantages identifying important players in the
(b) cooperate with competent and disadvantages of using these national tobacco control arena.
international and regional inter- data to measure tobacco con- Finally, production figures can be
governmental organizations sumption; to examine the use of combined with import and export
and other bodies, including export and import statistics for figures, to provide a measure of
governmental and nongovern- measuring the illegal cigarette trade; national consumption of manu-
mental agencies, in regional and to review the availability and factured tobacco products that may
and global tobacco surveil- quality of existing data. be useful in attempting to quantify
lance and exchange of the magnitude of the smuggling
information on the indicators Trade and production data in market. Sales data, based on tax
specified in paragraph 3(a) of tobacco control records, can also be used as an
this Article (WHO, 2003). estimate of the consumption of
Data on trade and production of various tobacco products.
One can envisage that as the FCTC manufactured tobacco products can
is progressively implemented in a be obtained from national statistical Using aggregate data to
substantial number of countries, a agencies and international data- measure cigarette consump-
comprehensive and sustainable bases with relative ease and tion: advantages and dis-
surveillance system will emerge. provide valuable information to advantages
Such a system would allow advo- tobacco control advocates. First,
cates and researchers a one stop production data can provide a good Estimates of consumption and
source of information where com- indicator of the importance of the prevalence of use of tobacco
parable key tobacco control sta- national tobacco industry at both the products can originate from various
tistics, such as mortality attributable national and international levels types of data. They can be based on
to tobacco use, prevalence of and, in the absence of trade, (self-reported) tobacco use preva-
tobacco use, and consumption of production data can provide an lence surveys, which provide
and trade in manufactured tobacco accurate measure of the national information on the proportion of
products are accessible. Unfortu- tobacco market. Secondly, data on tobacco users in a given population.
153
Prevalence data combined with cigarettes smoked each day is tobacco consumption (Rijo,
tobacco use intensity data (e.g. underreported. In addition, many 2005); and Thailand where high
number of cigarette smoked per population-based surveys do not levels of use of hand-rolled
day) can also yield total con- interview people in the military, tobacco have been reported
sumption estimates. Consump-tion prison, and psychiatric institutions (Sarntisart, 2003)
can also be derived from aggre- and thus will not assess use in The major problem with
gate production and trade populations with fairly substantial aggregate data is perhaps that,
statistics. Production plus imports smoking prevalence. Another unlike prevalence survey-based
minus exports will yield apparent potential limitation is the infre- data, they cannot be used for
consumption estimates. For quent availability of trend data. analyzing changes in sex, age,
example: Finally, the subjective nature of income, and education distri-
cigarette consumption = ciga- surveys and differences in survey bution, and they do not permit a
rette production + cigarette methodology (questions, defini- distinction between a change in
imports cigarette exports tions, languages, etc.) also make the number of smokers and
per capita cigarette con- comparison of estimates across changes in consumption per
sumption = cigarette con- countries difficult. smoker (Warner, 1977). Other
sumption / (pop. 15+) Aggregate production and important problems include illicit
trade statistics are objective data trade in cigarettes and illegal
National cigarette sales data, that eliminate the underreporting manufacturing and counterfeit
based on sales or tax records, can problem inherent in data based on trade, resulting in export and
also be an estimator of con- subjective survey responses import data not being registered in
sumption (Guindon & Boisclair, (Warner, 1977). These data are official figures, which may lead to
2003). also readily available across time under or overestimating con-
Prevalence surveys can and countries. This feature, as sumption of tobacco products
provide important insights into well as the availability of cen- (WHO, 1998a). The problem of
patterns of and changes in tralized data sources using stockpiling may also emerge, as
consumption according to sex, common methodologies, allows not all cigarettes will be consumed
age, income, and education for good comparability. However, in the year they are produced or
(Warner, 1977). They also allow most of these large-scale tobacco imported. If this stockpiling is
distinguishing between a change statistics are only available for significant it may bias con-
in the number of smokers and manufactured cigarettes. Data sumption estimates. However, it is
changes in consumption per from the Global Youth Tobacco doubtful that stockpiling will affect
smoker. On the other hand, Survey (GYTS) indicate that more trends since it is not likely to vary
consumption data (the number of than 10% of students used tobac- from year-toyear, although tobac-
cigarettes consumed) based on co products other than cigarettes, co companies have been known
surveys can suffer from significant with the rate being highest in the to time cigarette stockpiling
underreporting (Warner, 1978; southeast Asia region and the against health measures so that
Jackson & Beaglehole, 1985; eastern Mediterranean region they appear less effective (WHO,
Hatziandreu et al., 1989; Foss et (Warren et al., 2006). Specific 1998a). Transient populations will
al., 1998). Surveys generally examples include: India where affect aggregate trade and
provide valid estimates of pre- tobacco consumption is domina- production statistics to a varying
valence (Velicer et al., 1992; ted by use of non-cigarette degree. Finally, the question of
Patrick et al., 1994; Caraballo et tobacco (bidis, leaf tobacco etc.), measurement units can yield
al., 2001; Caraballo et al., 2004), resulting in cigarette consumption diverging trends and biased point
suggesting that the number of repre-senting only 15% of total estimates. More specifically:
154
Using production, trade and sales data in tobacco control

Apparent consumption will units, trade statistics in metric bility through time, adding all
underestimate true consump- tons, and one gram of cigarette production data points in a
tion in countries where tobacco equals one cigarette, true particular year can lead to under-
products are illegally imported consumption will be over-esti- estimation.
and consumed, while it will mated if the country is a net Sales data based on tax
overestimate true consumption importer of cigarettes, and records are also aggregate data,
where tobacco products are underestimated it if the country and similarly present the same
illegally exported to another is a net exporter. general advantages and dis-
country. Apparent consumption will advantages as those described
Trade and production data can overestimate true consumption above for production and trade
be reported in weight or in in countries with large transient statistics. It should be noted,
physical units. In countries populations (for example however, that sales data are not
where cigarette weights have tourists or military), and small as readily available across
not remained constant over indigenous populations, such countries and are not available in
time, cigarette consumption as Malta and the Maldives. centralised databases. On the
expressed in units and in weight In addition to the measurement other hand, they do not suffer from
can show diverging trends. For issues described above, pro- the limitations associated with
example, Australian cigarettes duction and trade figures reported measuring and reporting units or
became progressively lighter in by national statistical agencies stockpiling. They also present the
the late 1980s. When ex- may not accurately reflect true advantage (unlike estimates
pressed in grams per capita, figures. There may be a time lag obtained from trade and pro-
cigarette consumption in of three to six months between duction statistics) of yielding
Australia fell by 4.9% between recording export and import consumption estimates that ex-
1986 and 1990, while it in- statistics. It may also be the case clude duty-free sales, most of
creased by 5% when expressed that import statistics are recorded which are to non-residents and
in units (Chapman, 1992). more rapidly and accurately are not consumed in the country.
Trade and production statistics because of more prevalent import Finally, sales data may be
for an individual country can duties (as compared to export segmented by tobacco products
also be reported in different duties). Finally, there may be (e.g. cigarettes, cigars, etc.),
units. For example, manu- reporting errors at the national brands and brand variant (e.g.
factured cigarette imports and level, and between the national length-type, and descriptor-type,
exports are often reported in statistical agencies, international such as light or mild), and thus
metric tons, while production is agencies, and organisations that yield information on market shares
expressed in units. When this report cross-country statistics. by individual brands, brand family,
is the case, it is usually Production data can be used and brand variant.
assumed in the calculations at the global level as a proxy for
that one cigarette weighs one world consumption. It will be a Population adjustments:
gram. But this assumption may poor proxy for consumption in
not hold and thus bias most countries, but as world Total cigarette consumption can
consumption estimates. The exports must equal world imports, be useful to gauge the size of a
direction of the bias will aggregating cigarette production tobacco market, but it does not
depend on two factors: the true for all countries would do away allow for comparison across time
conversion factor, and the with the problems associated with and across countries. To achieve
respective size of imports and smuggling and attenuate the the latter, total cigarette con-
exports. For example, in a problems associated with mea- sumption or sales can be
country where production surement units. Unfortunately, weighted by population in order to
statistics are expressed in because of unequal data availa- provide an indicator of individual
155
consumption, usually by dividing Agriculture (USDA) data showed released figures which showed
total cigarette consumption by the that recorded cigarette exports that the gap had been reduced to
population aged 15 years and exceeded recorded imports by 126 billion cigarettes in 2001.
above. The age group 0-14 is more than 300 billion each year in Caution with the analysis of USDA
normally omitted because of its the period 1995-2000. The only data is necessary.
limited contribution to tobacco use plausible explanation for these Another explanation might be
(Chapman, 1992). However, dif- missing cigarettes is smuggling that the reduction of smuggling
ferences between countries in (Joossens & Raw, 1995; Joossens occurred as some major inter-
demographic distribution and & Raw, 1998). national tobacco companies have
tobacco use prevalence in the 10- Some cautious interpretation reviewed their export practices
20 age group can be important of these results is advisable due to lawsuits. The reduction of
and diminish comparability. (Merriman et al., 2000). Many the gap may finally be explained
factors may explain a discrepancy through the increase of illegal
The use of export and between recorded exports and manufacturing and counterfeit
import statistics for imports. An analysis of data from cigarette trade, which is a growing
measuring the illegal the United Nations Commodity concern in many countries. The
cigarette trade Trade Statistics Database (UN illegal nature of their production
Comtrade) shows large dis- means that they are not registered
The gap between global exports crepancies between total reported in the official export and import
and global imports is often used to imports and exports of many data.
make estimates of the overall size goods. However, researchers Finally, the analysis of export
of cigarette smuggling. World admit that cigarettes are different and import practices can also be
cigarette production is known from other commodities, as used to study the smuggling
fairly accurately, and, since there cigarette exports consistently problem at the national level. For
are not large numbers of greatly exceed imports. It is con- instance, exports from the British
cigarettes in storage because cluded that the most reasonable tobacco companies to Andorra
they do not keep for long, world explanation for the observed data increased from 13 million ciga-
production is very close to world is that a large and growing rettes in 1993 to 1,520 million in
consumption. Global imports fraction of international trade is 1997. Taking into account that
should thus be close to exports, smuggled (Merriman et al., 2000). almost none of these cigarettes
after allowing for legitimate trade USDA statistics for the period were legally re-exported, that
usually excluded from national 2001-2004 showed that the gap Andorra only has a population of
statistics. (These are principally between recorded cigarette im- 63000, and that smokers in
imports for duty-free sales to tra- ports and exports had been Andorra on the whole do not
vellers, diplomatic staff, and reduced to around 150 billion smoke British brands, it was clear
military establishments.) cigarettes annually. There may be that these increased exports were
Imports, however, have long different explanations for these intended for the smuggling market
been lower than exports to an reductions. USDA data are not (Joossens & Raw, 2002). Induced
extent that cannot be explained by always reliable at the national or by high taxes in the early 1990s,
legitimate duty-free sales. Even the worldwide level. In 2002, the cigarette smuggling increased
lag time of three to six months USDA magazine Tobacco: World substantially in Canada. Virtually
between recording export and Markets and Trade published data all smuggled cigarettes had been
import statistics, cannot explain the which showed that the gap previously exported from Canada.
differences between them which between exports and imports was As Canada did not, and still does
have been high for years. World- 276 billion cigarettes in 2001. Two not, export a large amount of
wide, United States Department of years later, the same magazine cigarettes, exports proved to be
156
an accurate indicator for smug- Availability and quality of United Nations Statistical
gling (Galbraith & Kaiserman, existing data Division (UNSD) Industrial
1997). Similarly, a significant and Commodity Production Statis-
unlikely decrease in apparent This section describes various tics Dataset:
cigarette consumption per capita cross-country sources of pro-
was observed in Brazil, while duction and trade statistics that The current version of the UNSD
apparent consumption was rising provide information on manu- Industrial Commodity Production
rapidly in Paraguay in the late factured tobacco products, and Statistics Dataset contains the
1980s and early 1990s, driven by discusses their strengths and entire database of industrial
a 16-fold increase in exports to weaknesses. commodity statistics, including
Paraguay (Shafey et al., 2002). manufactured cigarettes and
The aforementioned examples United Nations Commodity cigars, cheroots, and cigarillos
indicate the usefulness of exa- Trade Statistics Database (UN covering the period 1950-2003
mining production, trade, and Comtrade): (1970-2003 for manufactured
consumption data to gain insights cigarettes). Data for the time
into the smuggling market. That The United Nations Commodity period 1994-2003 are available in
said, other methods exist and Trade Statistics Database (UN print in the 2003 Industrial
have been used to estimate the Comtrade) contains detailed im- Commodity Statistics Yearbook
size of national smuggling market. port and export statistics, including (United Nations Statistical Divi-
Tobacco consumption estimated manufactured cigarettes and sion, 2003). The data contained in
from production and trade or sales cigars, cheroots, and cigarillos this database has primarily been
data can be compared to esti- reported by statistical authorities collected from questionnaires sent
mates of consumption based on of close to 200 countries or areas yearly to national statistical
prevalence surveys while taking (http://unstats. un.org/unsd/com- authorities. However, data have
into account under-reporting. The trade/). It contains annual trade also been collected from other
United Kingdom has used this (import and export) data from governmental agencies, spe-
method extensively to estimate 1962 to the present. UN Comtrade cialised agencies, intergovern-
the size of the smuggling market is considered the most compre- mental bodies, private institutes,
(for more details, see HM hensive trade database available and associations. The UNSD
Customs & Excise, 2001). In and is continuously updated. Un- Industrial Commodity Production
Thailand, individuals who reported like other existing data sources Statistics Dataset can be con-
using tobacco products during where only total amounts are sidered the most reliable and
face-to-face interviews, were obtainable, UN Comtrade makes comprehensive production dataset
asked to present their tobacco available the complete trade available (http://unstats.un.org/
package to the interviewer. An matrix. Whenever trade data are unsd/industry/ics_ intro.asp).
examination of the health war- received from the national autho-
nings (i.e. absence of warnings or rities, they are standardised by the Food and Agriculture Organi-
a warning in a language other than United Nations Statistics Division zation of the United Nations
Thai) can reveal if the tobacco and then added to UN Comtrade. (FAO) FAOSTAT:
products are likely to have been Despite its comprehensiveness
legally purchased (Sarntisart, and its online availability, UN The Food and Agriculture Orga-
2003). Comtrade is rarely used by nization of the United Nations
tobacco control researchers and FAOSTAT provides access to
advocates. over 3 million time-series and
cross-sectional data relating to
157
food and agriculture from over 100 the data contained in these The World Cigarette Reports,
countries and areas (http://faostat. commodity and country reports published by ERC Statistics
fao.org/). are not official USDA data, but International PLC, a London-
The FAOSTAT TradeSTAT represent estimates made by FAS based market research organisa-
module contains detailed agri- Attachs. The publication Tobac- tion, provides some original
cultural trade data, including co: World Markets and Trade was statistical information, including
import and export statistics for discontinued in September 2005, up-to-date production and trade
manufactured cigarettes and while tobacco attach reports figures for a number of countries
cigars, cheroots, and cigarillos were discontinued in January covered (ERC Statistics Inter-
(i.e. as a grouping). Data are 2006. national PLC, World Cigarette Mar-
obtained from national statistical Data from the USDA are kets; http://www.erc-world. com).
and agricultural agencies and are arguably the most widely used
standardised, processed, and and cited cross-national con- United Nations Population
validated by the FAO Statistics sumption and trade statistics in Division (UNOP) World
Division, whereby the national tobacco control research and ad- population prospects:
commodity classification (usually vocacy. The WHO Global Status
the Harmonized System) is Report (WHO, 1997) relies almost This dataset provides the official
converted to the FAO commodity exclusively on data from the United Nations population esti-
classification. TradeSTAT has just USDA. The much cited analysis of mates and projections pre-pared
recently begun providing detailed the impact of USA trade policy on by the Population Division of the
trade matrices. cigarette use in Asia, utilised Department of Economic and
cigarette consumption estimates Social Affairs of the United Nations
United States Department of that were derived from USDA data Secretariat (http://www.un. org/esa/
Agriculture (USDA), Foreign (Chaloupka & Laixuthai, 1996). population/publications/WPP2004
Agricultural Service (FAS): Other more recent research /wpp2004.htm). Detailed popula-
examples include Gilmore & tion estimates stratified by sex and
- Tobacco: World Markets and McKee (2004) and Gilmore & age for close to 200 countries and
Trade McKee (2005). areas are available.
(http://www.fas.usda.gov/tobac In addition to the data sources
co_arc.asp) Market research reports: discussed above, there exists a
- Attach Reports (http://www. number of initiatives that report
fas.usda.gov/scriptsw/Attache There is a plethora of reports cross-country data for smaller
Rep/default.asp) published by market research groupings of countries often on a
firms on the manufactured tobac- regional basis. Examples include
The USDAs FAS World Market co sector. Most provide country the Organization for Economic
and Trade reports provide the snapshots using various market Cooperation and Development
latest data on a number of agri- size indicators including apparent (OECD) Health Data which re-
cultural commodities, outlining the consumption, which, as men- ports tobacco consumption
current supply, demand, and trade tioned earlier, is constructed from estimates for OECD member
estimates both for the USA and for trade and production figures. states. The latest version of the
many major countries. FAS These reports often present mar- OECD database was released in
international offices provide infor- ket share data by brands, brand June 2006, and contains a
mation on production, consump- families, and companies. Many number of comparable statistics
tion, and trade of many com- reports offer little original infor- on health and health systems
modities, including manufactured mation (e.g. some rely almost across OECD countries. The
cigarettes. It should be noted that entirely on USDA published data). database contains more than
158
1200 series covering a wide range (ADB) Key Indicators (http://www. those published by other organi-
of health topics (i.e. health status, adb.org/Documents/Books/Key_In sations, such as the United
health care resources, health care dicators/2006/default.asp), which Nations Statistical Division and the
utilisation, expenditure on health, reports up-to-date manufactured FAO, or by national statistical
health care financing, social cigarette statistics for a number of agencies. For a great number of
protection, pharmaceutical market, countries. Most data, but not all, low- and middle-income countries
and non-medical determinants of contained in the OECD, CIS, and (e.g. Albania, Algeria, Bang-
health). OECD Health Data is ADB databases are also available ladesh, Bolivia, Ecuador, Jordan,
developed jointly by the OECD in the UN databases discussed Lebanon, and Viet Nam), USDA
Secretariat and the Institut de earlier. However, these databases cigarette production and trade
Recherche et dtude en co- offer a relatively easy opportunity data appear at best to be an
nomie de la Sant (IRDES), a to compare estimates of con- extrapolation based on a gues-
French research institute spe- sumption and production from stimate. As discussed earlier, an
cialising in health economics and multiple sources. examination of what is often
health statistics. The data are referred to as the size of the
compiled from national statistical Discussion smuggling market (the difference
agencies and other relevant between total exports and total
national organisations (http://www It is important to point out that a imports) yields a very different
.oecd.org/document/30/0,2340,en large amount of the data pub- picture if looking at data from the
_2825_495642_12968734_1_1_1 lished and available from the data USDA or FAO (UN Comtrade
_1,00.html). sources described above can does not publish global figures of
A second cross-country data differ substantially. In particular, manufactured cigarettes import
source is the Interstate Statistical the trade data reported by the and export) (Guindon & Boisclair,
Committee of the Commonwealth USDA, UN Comtrade, and the 2003). For these reasons, it is
of Independent States (CIS), FAO differ widely at times. This strongly suggested to use pub-
Official Statistics of the Countries makes it important to use the best lished USDA data for low- and
of the CIS (the CIS is comprised available data by first comparing middle-income countries with
of Azerbaijan, Armenia, Belarus, data from multiple sources. great caution.
Georgia, Kazakhstan, Kyrgyzstan, It is generally the opinion that Researchers and advocates
Moldova, Russia, Tajikistan, data from UN Comtrade (export interested in production, trade,
Turkmenistan, Uzbekistan, and and import) and UNSD (pro- and consumption estimates from a
Ukraine). The CIS database duction) are the most reliable and single country are advised to
(http://www.cisstat.com/eng/cd- comprehensive available. FAOs always look first at potential local
offst.htm) is updated annually and TradeSTAT is a good source of and national primary sources of
contains annual data on more data that can be used alongside information, such as government
than 3500 socioeconomic indi- UN Comtrade. Of particular statistics agencies and ministries
cators from 1980 for all CIS concern are the country data of trade and industry.
countries. Another data source is published by the USDA. They are
the Asian Development Bank often significantly at odds from
159
4.3 Data sources for monitoring global trends in
tobacco use behaviours
Introduction vided in regards to purpose, cross-country comparisons were

methodology, survey instrument, not possible.
The purpose of this section is to survey administration procedures,
describe the data collection efforts data analyses, dissemination of To address these data gaps, the
for global surveillance on tobacco information, and utility in monitoring Pompidou Group developed a
use in youth and adults. We include and evaluating articles from the standard questionnaire for school-
only those surveillance systems that WHO FCTC (WHO, 2003). based surveys which was pilot
are cross-national and on-going. tested in eight European countries.
The youth surveys are school- Youth Further work was not done until the
based with a target survey popu- early 1990s, when the Swedish
lation of students between 11 and Purpose Government convened a meeting of
15 years of age, the primary age of 21 European countries to build on
smoking initiation in many countries. European School Survey Project the work of the Pompidou Group by
The surveillance systems described on Alcohol and Other Drugs developing a system for simul-
in this section include: The Euro- (ESPAD): taneously collecting school-based
pean School Survey Project on The Pompidou Group is a multi- data using a common methodology.
Alcohol and Other Drugs (ESPAD) disciplinary cooperation forum to This resulted in the development of
(ESPAD, 2007), the Global School- prevent drug abuse and illicit the ESPAD project which has now
Based Student Health Survey trafficking in drugs, set up in 1971 completed four cycles of data
(GSHS) (GSHS, 2007), the Global and incorporated into the Council of collection: 1995, 1999, 2003, and
Youth Tobacco Survey (GYTS) Europe in 1980. At that time, the 2007. Future expansion will occur
(GYTS, 2007), and the Health group recognized the need for on a four year cycle. The countries
Behavior in School-Aged Children countries to collect data on alcohol, that have participated in ESPAD are
Survey (HBSC) (HBSC, 2007). The tobacco, and other drug use as it shown in Table 4.5.
adult surveys have been population- relates to public health policy and The goal of ESPAD is to collect
based and target a wider age range programmes (ESPAD, 2007). Three cross-nationally comparable data on
(in most cases aged 15-64 or age points were apparent: alcohol, tobacco, and other drug
18+) than the youth surveys. The use among students in European
adult surveillance systems des- 1) Systematic information is gene- countries, and monitor the trends in
cribed include: the Global Adult rally best gathered through alcohol and drug use. This is very
Tobacco Survey (GATS) (GATS, surveys important as it relates to the
2007), the International Tobacco 2) Large-scale, on-going surveys European Union (EU) action plan on
Control Survey (ITC) (ITC, 2007), have been conducted, but only in drugs (EPHA, 2007) and the WHO
and the STEPwise Approach to a few countries and not as part of Europe declaration about young
Chronic Disease Factor Surveil- a cross-nationally coordinated people and alcohol (WHO, 2007b).
lance (STEPS) (STEPS, 2007). A system
description of these youth and adult 3) Previous surveys had different
surveillance systems will be pro- methodologies and content, so
161
1995 1999 2003 2007
Croatia Croatia Croatia Croatia

Cyprus Cyprus Cyprus Cyprus
Czech Republic Czech Republic Czech Republic Czech Republic
Denmark Denmark Denmark Denmark
Estonia Estonia Estonia Estonia
Faroe Islands Faroe Islands Faroe Islands Faroe Islands
Finland Finland Finland Finland
Hungary Hungary Hungary Hungary
Iceland Iceland Iceland Iceland
Italy Italy Italy Italy
Latvia Latvia Latvia Latvia
Lithuania Lithuania Lithuania Lithuania
Malta Malta Malta Malta
Norway Norway Norway Norway
Poland Poland Poland Poland
Portugal Portugal Portugal Portugal
Slovakia Slovakia Slovakia Slovakia
Slovenia Slovenia Slovenia Slovenia
Sweden Sweden Sweden Sweden
Turkey Ukraine Turkey Turkey
Ukraine United Kingdom Ukraine Ukraine
United Kingdom Greece United Kingdom United Kingdom
Greenland Greece Greece
Bulgaria Greenland Greenland
France Bulgaria Bulgaria
FYR Macedonia France France
Netherlands Netherlands FYR Macedonia
Romania Romania Netherlands
Russian Federation Russian Federation Romania
Austria Russian Federation
Belgium Austria
Isle of Man Belgium
Germany Isle of Man
Switzerland Germany
Switzerland
Serbia
Monaco
Armenia
Bosnia & Herzegovina
Table 4.5 Countries Participating in the European School Survey Project on Alcohol and Other Drugs
(ESPAD) by Year of Completion
162
Data sources for monitoring global trends in tobacco use behaviours
Global School-Based Student Global Youth Tobacco Survey 150 countries had conducted the
Health Survey (GSHS): (GYTS): GYTS, and over 50 countries had
The GSHS was developed by In 1998, WHO and the CDC repeated the survey at least one
WHO (Health Promotion Division) convened a meeting in Geneva to time. In 2007, 11 countries con-
in collaboration with UNAIDS, address the issue of data needs ducted GYTS for the first time, 46
UNESCO, and UNICEF, and with on tobacco use among youth completed a second round, and 8
technical assistance from the across all Member States of a third round.
United States Centers for Disease WHO. Three summary points
Control and Prevention (CDC), were made at this meeting: Health Behavior of School-aged
Division of Adolescent and School Children Survey (HBSC):
Health in 2001. A school-based 1) Research from developed In 1982, the HBSC was initiated
survey, GSHS is designed to help countries has found that the by researchers from England,
countries assess behavioural risk majority of smokers begin using France, and Norway. The purpose
and protective factors among tobacco products well before of HBSC is to collect data on
students aged 13-15 years. GSHS the age of 18 years (Perry et al., young peoples health and well-
data can be used by countries to 1994; Kessler, 1995) being, health behaviours, and the
develop priorities, establish pro- 2) Little information exists on social context in which youth live.
grammes, and advocate for tobacco use among youth in Data from HBSC have been used
resources for school and youth developing countries to influence health promotion and
health programmes and policies. It 3) To bridge this data gap and to education policy at national and
also can be used by international promote tobacco control for all international levels. In the mid-
agencies, countries, and others to WHO Member States, WHOs 1980s, HBSC was adopted by the
make comparisons across coun- Tobacco Free Initiative (TFI) WHO European Regional Office
tries regarding the prevalence of and CDCs Office on Smoking as a WHO collaborative study.
health behaviours and protective and Health (OSH) agreed to HBSC was developed by a multi-
factors and to analyze trends in support the development of the disciplinary network of researchers
the behaviours. Implementation of GYTS (GTSS Collaborating from countries in Europe and
GSHS started in 2003; by the end Group, 2005). North America. It was first
of 2006, 23 countries had Implementation of GYTS star- conducted in 1983/84 (5 countries),
completed a GSHS (Table 4.6). ted in 1999 with 12 countries then in 1985/86 (13 countries), and
(Table 4.7). By the end of 2006, then every four years: 1989/90 (16
2003 2004 2005 2006 2007
China Chile Botswana Egypt Cayman Islands

Kenya Guyana Lebanon Guatemala Djibouti
Philippines Jordan Oman Morocco Philippines
Swaziland Namibia Senegal Tanzania India
Uganda Zambia Tajikistan Uruguay Libya
Venezuela United Arab Emirates Peru
Zimbabwe St Lucia
St Vincent &
Grenadines
Table 4.6 Countries Participating in the Global School-Based Student Health Survey (GSHS) by Year of
Completion
163
164
1999 2000 2001 2002 2003 2004 2005 2006 2007
Barbados Antigua & American

Barbuda Virgin Bahrain Argentina Afghanistan American Algeria Bangladesh
Islands Samoa
China Argentina British Virgin Barbados Belize Albania Cyprus Angola Barbados
Islands
Costa Rica Bahamas Burkina Faso Botswana Benin American Virgin Egypt Burkina Faso Bosnia &
Islands Herzegovina
Fiji Bolivia Colombia Brazil Bolivia Antigua & Fiji Czech Republic Botswana
Barbuda
Jordan Chile Cuba Bulgaria Bosnia & Armenia Gaza Strip/ DRC* Brazil
Herzegovina West Bank
Poland Dominica Ecuador Costa Rica Cambodia Bahamas Ghana Eritrea Bulgaria
Russian
Federation Ghana Egypt Czech Republic Chile Bangladesh Haiti Guatemala Cambodia
South Africa Grenada Gaza Strip/ Guam Cook Islands Belarus Iraq India Colombia
West Bank
Sri Lanka Guyana Haiti Guatemala Cote dIvoire Bhutan Kuwait Indonesia Cook Islands
Ukraine India Kenya Latvia Croatia Cuba Lebanon Jamaica Costa Rica
Venezuela Indonesia Kuwait Lesotho Djibouti Dominica Lithuania Micronesia Croatia
Zimbabwe Jamaica Lebanon Mozambique El Salvador Dominican Rep Macao Morocco Djibouti
Mariana Islands Lithuania Oman Estonia Greece Malawi New Zealand Ecuador
Mexico Macao Panama Ethiopia Grenada Mauritania PNG* Estonia
Micronesia Malawi Senegal FYR Macedonia Guyana Niger Samoa FYR Macedonia
Montserrat Mali Seychelles Georgia Kazakhstan Palau Taiwan, China Georgia
Palau Mauritania South Africa Honduras Kosovo Sudan Timor-Leste Hungary
Peru Morocco St Kitts & Nevis Hungary Kyrgyzstan Swaziland Tuvalu Iran
Philippines Myanmar Syria Iran Malaysia Thailand Uruguay Jordan
Singapore Nepal Togo Jordan Moldova Ukraine USA Kenya
Suriname Niger Uganda Laos Montenegro United Arab Vanuatu Laos
Emirates
Trinidad & Nigeria United Arab Libya Namibia Latvia
Tobago Emirates
USA Saudi Arabia USA Maldives Philippines Lesotho
St Lucia Zambia Mariana Islands Puerto Rico Libya
St Vincent & Mauritius Qatar Maldives
Grenadines
Sudan Mongolia Rep of Korea Mali
Swaziland Nicaragua Romania Mexico
Tunisia Pakistan Russian Federation Mongolia
Uruguay Paraguay Somalia Mozambique
Peru Suriname Myanmar
Table 4.7 Countries Participating in the Global Youth Tobacco Survey (GYTS) by Year Survey Was Completed
1999 2000 2001 2002 2003 2004 2005 2006 2007
Poland Taiwan, China Nepal

Serbia Tajikistan Oman
Slovakia USA Panama
Slovenia Peru
Sri Lanka Philippines
Tanzania Qatar
Turkey Saudi Arabia
Venezuela Senegal
Viet Nam Serbia
Yemen Seychelles
Zimbabwe Slovakia
Slovenia
Somalia
South Africa
Sri Lanka
St Kitts & Nevis
St Lucia
St Vincent &
Grenadines
Syria
Togo
Trinidad &
Tobago
Tunisia
Turkey
Uganda
Venezuela
Viet Nam
Yemen
Zambia
Zimbabwe
Table 4.7 Countries Participating in the Global Youth Tobacco Survey (GYTS) by Year Survey Was Completed
*DRC = Democratic Republic of the Congo; PNG = Papua New Guinea
165
1983/84 1985/86 1989/90 1993/94 1997/98 2001/02 2005/06
Austria Austria Austria Austria Austria Austria Austria

Denmark* Denmark* Denmark* Denmark Denmark Denmark Denmark
England Finland Finland Finland England England England
Finland Norway Norway Norway Finland Finland Finland
Norway Belgium Belgium Belgium Norway Norway Norway
Hungary Hungary Hungary Belgium Belgium Belgium
Israel Scotland Israel Hungary Hungary Hungary
Scotland Spain Scotland Israel Israel Israel
Spain Sweden Spain Scotland Scotland Scotland
Sweden Switzerland Sweden Spain Spain Spain
Switzerland Wales Switzerland Sweden Sweden Sweden
Wales Netherlands* Wales Switzerland Switzerland Switzerland
Netherlands* Canada Netherlands Wales Wales Wales
Latvia Canada Netherlands Netherlands
N Ireland Latvia Canada Canada Canada
Poland N Ireland Latvia Latvia Latvia
Poland N Ireland N Ireland N Ireland
Czech Rep Poland Poland Poland
Estonia Czech Republic Czech Republic Czech Republic
France Estonia Estonia Estonia
Germany France France France
Greenland Germany Germany Germany
Lithuania Greenland Greenland Greenland
Russia Lithuania Lithuania Lithuania
Slovakia Russia Russia Russia
Slovakia Slovakia Slovakia
Greece Greece Greece
Portugal Portugal Portugal
Rep of Ireland Rep of Ireland Rep of Ireland
USA USA USA
FYR Macedonia FYR Macedonia
Italy Italy
Croatia Croatia
Malta Malta
Slovenia Slovenia
Ukraine Ukraine
Iceland
Luxembourg
Romania
Turkey
Table 4.8 Countries Participating in the Health Behaviour in School-Aged Survey (HBSC) by Year of
Completion
*Survey conducted after schedule
166
countries), 1993/94 (25 countries), Global Youth Tobacco Survey two-stage sample design,
1997/98 (29 countries), 2001/02 (GYTS): statistical analysis conducted
(36 countries), and 2005/06 (40 The GYTS is a school-based by the CDC (Centers for
countries) (Table 4.8; http:// www. survey of a defined geographic Disease Control and Preven-
hbsc.org/countries.html). area that can be a country, a tion, 1999b) has found that, for
province, a city, or any other geo- most sample designs, a mini-
Methodology graphic entity (Centers for Disease mum of 1500 completed
Control and Prevention, 2001). student interviews is needed to
European School Survey Project Samples are selected as follows: obtain a precision level of 5%
on Alcohol and Other Drugs The country research coordi- for a given estimate. WHO and
(ESPAD): nator identifies the grades that CDC use this information to
The ESPAD is a school-based correspond to students aged work with the countries to
survey with the target population 13-15 years in the educational determine the sample size of
being students who are, or will be, system. schools and students needed
16 years old during the year the The research coordinator pre- for each site. The desired
data are collected. ESPAD follows pares a database of schools sample size is then adjusted for
a cluster sample design to produce that include the identified anticipated non-response at the
nationally representative data; but grades. Each school is as- school, class, and student
the sampling can be either total signed a unique identifier to levels. Sample size is further
population sampling, simple cluster facilitate school selection. The increased if regional or popu-
sampling, two-stage cluster sam- number of students enrolled in lation subgroup estimates are
pling, or stratified cluster sampling. each school grade to be requested within the country.
A minimum of 2400 completed surveyed is added to the data-
interviews are recommended by base, which forms the survey Since classes are carefully
ESPAD. If students aged 15-16 are sampling frame. The amount of identified to correspond to
in two or more grades, the survey work involved in creating this students 13-15 years old, the
protocol recommends that all these database varies from country majority of selected students are
grades should be included in the to country. In some countries, in this age group. However, all
sampling frame. the creation of the sampling students in the selected classes
frame has been the most time are eligible to participate regard-
Global School-Based Student consuming part of the GYTS. less of age; therefore, some
Health Survey (GSHS): The database is sent to the students were younger than 13
A school-based survey, GSHS is CDC, where the GYTS sample years or older than 15 years.
conducted primarily among stu- is drawn using a two-stage
dents aged 13-15 years. It uses the cluster sample design. Schools Health Behavior in School-Aged
same methodology as GYTS are selected with probability Children Survey (HBSC):
(discussed below in the GYTS proportional to school enrol- The HBSC is a school-based
methodology section). In 11 coun- ment size during the first stage, survey with the target population
tries, GYTS and GSHS are and then classes within par- of students 11, 13, and 15 years
currently being conducted simul- ticipating schools are selected old. The desired mean age for the
taneously, sharing sampled as a systematic equal pro- three age groups is 11.5, 13.5,
schools, but different classes are bability sample with a random and 15.5 respectively. In some
randomly selected for each survey. start during the second stage. countries, each age group can be
All students in the selected found in the same school year,
classes are eligible to par- while in others they may be found
ticipate in the survey. For this across years with a proportion of
167
students being advanced or held Survey Instrument regular class period. The
back. Cluster sampling is used questions are translated into the
where the primary sampling unit is European School Survey Project appropriate language of instruc-
school class. The survey is carried on Alcohol and Other Drugs tion for the students and pilot
out as a nationally representative (ESPAD): tested for comprehension. All
sample in each participating coun- Questions on alcohol, tobacco, questions share common charac-
try. The recommended sample and drugs are included in the teristics to enhance the flow of the
size for each of the three age ESPAD. There are core questions survey and comprehension by the
groups is set at approximately that all countries are encouraged student.
1500 students. This target to include, as well as optional and Core GSHS questions on
population assumes a 95% confi- module questions that may be tobacco use include: age of ini-
dence interval of + 3% around a added. Countries are encouraged tiation, cigarette smoking during the
proportion of 50% and a design to field-test their questionnaire. past 30 days (i.e. current cigarette
effect of 1.2, based on analysis of The final version of the ques- smoking), use of other tobacco
existing HBSC data. tionnaire is translated into each products during the past 30 days,
Given differences in school language needed within country attempts to stop smoking during the
systems, age at admission, and the then back-translated into English past 12 months, exposure to
degree of advancement and as a quality control check. The secondhand smoke during the past
holding back among students, research protocol specifies that 7 days, and use of tobacco by
imposing a uniform approach is questionnaires should be adminis- parents or guardians.
problematic in the HBSC. To over- tered anonymously.
come this complexity, age has Tobacco-related questions in Global Youth Tobacco Survey
been a priority for sampling, with ESPAD include: lifetime cigarette (GYTS):
students of the relevant age use, use of cigarettes in the last 30 The GYTS questionnaire is a self-
selected across school years. This days (i.e. current cigarette smo- administered, school-based instru-
position can be further complicated king), age of initiation of cigarette ment consisting of a core set of
when the target population is split smoking, number of friends who questions that are used by all
across different levels of schooling, smoke cigarettes, and number of countries, unless the information
such as primary and secondary. siblings who smoke. is not relevant in that country (e.g.
Where the number of classes pro-cigarette advertising is not
eligible for sampling is unknown, Global School-Based Student permitted in Singapore, so these
probability proportionate to size Health Survey (GSHS): questions are omitted). In addition,
sampling is used, making use of The GSHS includes questions on there is an optional set of ques-
actual or estimated school size. In alcohol, and other drug use; tions from which a country can
some countries, to minimize the dietary behaviours; hygiene; men- draw depending on its needs and
number of participating schools, tal health; physical activity; priorities. Specific guidelines are
classes for one age group were protective factors; respondent followed for questionnaire trans-
randomly sampled in schools, and demographics; sexual behaviour; lation into local languages and
then classes drawn from other tobacco use; and violence and pilot testing. The final ques-
grades in the same schools. In unintentional injury. Each country tionnaire is the responsibility of
order to produce mean ages of develops their questionnaire, each participating country.
11.5, 13.5, and 15.5, the survey is which can include core modules, The 2007 core GYTS ques-
administered at appropriate times core-expanded questions, and tionnaire consists of 54 questions,
of the year. country-specific questions. The and includes items on the
final questionnaire is self-ad- following topics: prevalence of
ministered in classes during one tobacco use, age of initiation,
168
exposure to tobacco advertising, the research protocol states that management procedures across
perceptions and attitudes on the survey should be conducted the countries and within each
behavioural norms with regard to during a week that does not country across time. A GYTS
tobacco use among young people, proceed a holiday. Schools that research manual was developed,
media and advertising, school cur- cannot perform the survey during which includes detailed proce-
riculum, and secondhand smoke an assigned week are encouraged dures for administering the GYTS
exposure. The GYTS core ques- to use the following week. When in schools. The manual is modified
tionnaire includes information that possible, the survey should be for each subsequent GYTS
can be used to monitor seven conducted at the same time in all training to meet the specific needs
Articles of the WHO FCTC classes in a school; thus, avoiding of the countries in those trainings.
(Articles 8, 12, 13, 14, 16, 20, and the possibility of discussion among The manual includes information
21) (WHO, 2003). students in the school. Each on obtaining school participation,
ESPAD researcher decides who to procedures for completing all
Health Behavior in School-Aged use for survey administration (i.e. survey forms, protocol in the
Children Survey (HBSC): teachers, research assistants). classroom, and instructions for
The HBSC questionnaire consists ESPAD provides the survey admi- returning the completed forms to
of a mandatory set of items that nistrator with written instructions on CDC for data processing. The
each country is required to in- how to conduct the data collection GYTS uses a generic answer
clude: health and well-being, in a class. sheet, which allows for a maxi-
tobacco smoking, alcohol use, mum of 99 questions, with eight
cannabis use, physical activity, Global School-Based Student response categories available per
sedentary behaviour, eating ha- Health Survey (GSHS): question. There are no open
bits, body image, weight control, A survey coordinator in each ended questions, skip patterns, or
body weight, oral health, bulling, country manages the GSHS. The multiple response questions in the
physical fighting and victimization, coordinator is responsible for the GYTS. The completed answer
and injuries. Countries can also overall management of the pro- sheets are scanned through an
include items specific to their na- ject, and functions as a liaison with optical reader. Edits for con-
tional needs. The final question- other agencies and organisations sistency and out-of-range res-
naire includes items on health and in the country, as well as with ponses are performed for each
health-related behaviours and the WHO and CDC. Survey coor- question. Data quality issues of
life circumstances of young people. dinators are trained during this type have been rare;
HBSC questions on tobacco regional workshops on the specific consistency failures or out-of-
use include: lifetime tobacco use, procedures to follow for data range responses rarely exceed
current tobacco smoking, rate of collection and data management. 5% per question.
consumption of cigarettes, and The GYTS is administered
age of initiation of daily smoking Global Youth Tobacco Survey during one class period. GYTS
(GYTS): administration procedures were
Survey administration proce- As with GSHS, the GYTS is designed to protect students
dures managed by a survey coordinator privacy by assuring that student
in each country. Regional training participation was anonymous and
European School Survey Project workshops are held each year to voluntary. Before the survey is
on Alcohol and Other Drugs train the coordinators on data administered, each country fol-
(ESPAD): collection and data management lows local procedures for
The ESPAD recommends data procedures. The intent is to stan- obtaining parental permission and
collection during March/April, and dardize the data collection and institutional review.
169
Health Behavior in School-Aged Chil- culated for each school; a student smaller units (i.e. geographical
dren Survey (HBSC): level, non-response adjustment areas) to ensure coverage of all
In most cases, data collection for factor calculated by class; and a regions. This stratification is likely
HBSC is between October and post-stratification adjustment fac- to reduce standard errors and
May. Data collection consists of tor calculated by sex and grade. should be taken into account
the delivery of questionnaires to The computer program SUDAAN when they are being calculated.
selected schools for teacher admi- (http://-www.rti.org/SUDAAN/) is
nistration. In some schools, used to compute standard errors, Dissemination o f Informa-
researchers administer the sur- 95% confidence intervals, and tion
vey in the classes in an attempt to weighted prevalence estimates.
minimize teacher burden. Once Information on the ESPAD can be
collected, the data are sent to the Health Behavior in School-Aged found at http://www.espad.org. In
HBSC Internal Data Bank at the Children Survey (HBSC): addition, cross-national reports for
Norwegian Social Science Data HBSC employs a clustered study years 1995, 1999 and 2003
Services for cleaning and final sampling design, where the are available from the Swedish
country dataset preparation. primary sampling unit is the class Council for Information on Alcohol
(or school) rather than the and Other Drugs.
Data analysis individual student, as in a simple Information on the GSHS can
random sample. Given such a be found at http://www.who.int/
Global School-Based Student design, the students responses chp/gshs/en and http://www.cdc.
Health Survey (GSHS) and cannot be assumed to be in- gov/gshs. Country datasets can
Global Youth Tobacco Survey dependent, as students within the be obtained on both websites.
(GYTS): same class or school are more Information on the GYTS can
Both GSHS and GYTS data are likely to be similar to each other be found at http://www. cdc.gov/
weighted to adjust for sample than to students in general. tobacco/global. The GYTS web-
selection (school and class le- Cluster sampling, therefore, re- site includes Country Fact Sheets,
vels), non-response (school, sults in standard errors that tend Country GYTS Reports, and
class, and student levels), and to be higher than would be the access to country datasets. In
post-stratification of the sample case if the same size of sample addition, over 45 articles using
population relative to the grade were obtained using a simple GYTS data have been published
and sex distribution in the total random sample. Consequently, in peer reviewed journals, such as
population. The weighting factor standard errors must be Lancet, Tobacco Control, and
consists of the inverse of the calculated using an appropriate Morbidity and Mortality Weekly
probability of selection for each method that takes into account Reports.
school; the inverse of the pro- the correlation of young people in Information on the HBSC can
bability of selection of each schools or classes (SUDAAN, be found at http://www.hbsc.org.
classroom; within each selected STATA (http://www.stata.com/), Over 160 articles have been
school, a school level; non-res- and EPI INFO (http:// www.cdc. published featuring HBSC data,
ponse adjustment calculated by gov/epiinfo/) are statistical pac- including recent articles in the
school enrolment size category kages developed for the analysis European Journal of Public
(small, medium, large); school of complex survey data). In Health, Health Education, and the
non-response calculated within addition, a number of countries Journal of Adolescent Health.
each tertile; a class level, non- and regions stratify their samples,
response adjustment factor cal- classifying the sample frame into
170
only about cigarette smoking. survey, if they discussed reasons

2007 2008 GSHS and GYTS ask about why people their age smoke, and if
cigarette smoking, as well as use of they were taught about the specific
Bangladesh China
other tobacco products. All four health effects of smoking. The other
Brazil Indonesia
surveys ask about age of initiation three surveys do not include items
Egypt Mexico
India Pakistan of cigarette smoking, however to assess school curriculum com-
Russian Philippine ESPAD, GSHS, and GYTS ask ponents.
Federation Poland about first use, whereas HBSC asks GYTS measures exposure to
Thailand Turkey about initiation of daily smoking. pro-tobacco media messages by
Ukraine ESPAD, GSHS, and GYTS ask asking students if they have seen
Viet Nam respondents about secondhand actors smoking in movies, videos,
smoke exposure, but use different or on TV; if they saw ads on
Table 4.9 Countries Participating indicators to assess exposure. billboards or in newspapers for
in the Global Adult Tobacco Sur- ESPAD and GYTS ask about tobacco products; and if they have
veys (GATS) by Year of Survey number of friends who smoke and an object with a cigarette brand
Completion ESPAD asks about number of logo on it. GYTS also asks stu-
siblings who smoke. GSHS and dents if they have seen
GYTS ask about exposure to anti-tobacco media messages.
Summary secondhand smoke at home and in The other three surveys do not
public places during the week prior include indicators of media expo-
Comparison of youth survey to the survey, as well as smoking sure to tobacco advertising.
content behaviour of parents. GSHS and GYTS ask students
All four surveys measure tobacco GYTS assesses school curri- about cessation behaviour. Both
use prevalence (See Table 4.12 for culum by asking students if they surveys ask students if they have
a full comparison of measures by were taught about the dangers of tried to quit smoking in the year
survey). ESPAD and HBSC ask smoking in the year prior to the prior to the survey. GYTS also
2002 2003 2004 2005 2006 2007
Australia Australia Australia Australia Australia Australia

Canada Canada Canada Canada Canada Canada
United Kingdom United Kingdom Ireland Ireland China China
United States United States United Kingdom Malaysia Ireland France
United States Republic of Korea Mexico Germany
Scotland Scotland Ireland
Thailand United Kingdom Malaysia
United Kingdom United States Mexico
United States Uruguay New Zealand
Scotland
Thailand
United Kingdom
United States
Table 4.10 Countries Participating in the International Tobacco Control Survey (ITC) by Year of Survey
Completion
171
asks students if they received help dents who miss class or refuse to cco-free programming. Specifically,
to quit smoking and from whom, participate are not represented in the partner organisations will:
and measures tobacco depen- the sample. Third, extensive Refine and optimize tobacco
dency using a standard indicator reliability testing of all the instru- control programmes to help
of addiction (time to first cigarette). ments used by the different smokers stop and prevent
The other two surveys do not surveys has not been completed; children from starting
include measures of cessation. however, questions on tobacco Support public sector efforts to
GYTS assesses minors' access use in GYTS also appearing in the pass and enforce key laws and
to tobacco products by asking CDCs Youth Risk Behavioral implement effective policies, in
current smokers where they Survey (YRBS), have been shown particular, to tax cigarettes,
usually get their cigarettes, if they to have good test-retest reliability prevent smuggling, change the
have been refused purchase of in a study conducted in the USA image of tobacco, and protect
cigarettes when they tried to buy (Brener et al., 1995). workers from exposure to other
them in a store, and if they have peoples smoke
been offered free cigarettes by a Adults Support advocates efforts to
tobacco company representative. educate communities about
The other three surveys do not Purpose the harms of tobacco and to
include measures of minors' enhance tobacco control acti-
access to tobacco products. Global Adult Tobacco Survey vities so as to help make the
(GATS); world tobacco-free
In 2006, the GATS was initiated Develop a rigorous system to
Limitations of youth survey with funds from the Bloomberg monitor the status of global
content Foundation to reduce tobacco use tobacco use.
in low- and middle-income coun- The CDC Foundation worked
There are several limitations tries. The initiative places a priority with partners around the world,
inherent in each of the youth on countries with the greatest particularly with the WHO, and in
surveys. First, the target popu- number of smokers. More than high-burden countries, to develop
lations are young people in half of the world's smokers live in GATS (i.e. establish systematic,
school, and by definition, school- fifteen countries: China, India, standardised global surveillance
based surveys do not attempt to Indonesia, Russia, Bangladesh, and monitoring of the tobacco
collect information about the por- Brazil, Mexico, Turkey, Pakistan, epidemic).
tion of the youth population that is Egypt, Ukraine, Philippines, Thai-
out of school. School-based land, Viet Nam, and Poland (Table International Tobacco Control
surveys are thus not repre- 4.9). Survey (ITC):
sentative of the entire youth In addition to the CDC The ITC Project began in 2002 as
population in any country. The Foundation, other key partners in a prospective cohort study trac-
extent to which the information the Bloomberg Initiative include king and comparing the impact of
collected by a school-based the Campaign for Tobacco Free- national-level tobacco policies
survey is not representative of the Kids, the World Lung Foundation, among representative samples of
total youth population varies by the Johns Hopkins Bloomberg adult smokers in four countries:
country. Second, the school- School of Public Health, and the the USA, Canada, the United
based surveys described in this WHO. Partners are charged with Kingdom, and Australia (Table
section conduct anonymous and working collaboratively to promote 4.10). In 2004, ITC was expanded
self-administered interviews giving international support for tobacco to include smokers from Ireland
each student in a selected class control policies, increase effective and a new cohort of smokers from
one chance to participate. Stu- advocacy, and implement toba- the UK, to evaluate the 2004
172
2002 2003 2004 2005 2006 2007
Ethiopia Algeria American Samoa Burundi Aruba Angola

Fiji Bangladesh Cook Islands Cote dIvoire Iran Barbados
Oman Cameroon Jordan DRC* Kuwait Botswana
Samoa India Lebanon DPRK* Mauritania Cambodia
Indonesia Maldives Egypt Mongolia Cape Verde
Kenya Myanmar Iraq Sri Lanka China
Marshall Islands Nauru Kiribati Thailand Cuba
Micronesia Pakistan Mauritius Vanuatu Curacao
Palau Mozambique Zambia Dominica
Sri Lanka Nepal Dominican Rep
Syria Saudi Arabia Equatorial Guinea
Solomon Islands Gaza Strip
Tokelau Ghana
Tuvalu Grenada
Zimbabwe Kenya
India
Iran
Laos
Libya
Paraguay
PNG*
St Kitts & Nevis
South Africa
Tanzania
Trinidad & Tobago
Togo
Turks & Caicos
Uganda
Uruguay
Viet Nam
Zimbabwe
Table 4.11 Countries Participating in the WHO STEPwise Approach to Surveillance (STEPS) by Year of
Survey Completion
*DRC = Democratic Republic of the Congo; DPRK = Democratic Peoples Republic of Korea; PNG = Papua New
Guinea
Ireland smoke-free policy. In 2005, co, and Uruguay; in 2007 France, ITC Project uses multiple country
the collection of ITC countries was Germany and New Zealand joined controls, longitudinal designs, and
further expanded to include co- on. The objective of the ITC is to theory-driven mediational models
horts of smokers in Malaysia, apply rigorous research methods that allow tests of hypotheses
Republic of Korea, Scotland, and to evaluate the psychosocial and about the anticipated effects of
Thailand. In 2006, ITC was further behavioural effects of national given policies.
expanded to include China, Mexi- level tobacco control policies. The
173
STEPwise Approach to Chronic section). There are currently two specific probabilities) is known.
Disease Factor Surveillance primary STEPS surveillance sys- Aside from needed oversampling
(STEPS): tems: the STEPwise approach to (e.g. by urban/rural and region),
In 2000, the 53rd World Health risk factor surveillance, and the random selection was used in each
Assembly passed a resolution in STEPwise approach to stroke stage in a way that makes
support of the need to prevent and surveillance. The survey is cur- selection probabilities among
control non-communicable di- rently being implemented in over respondents as equal as possible.
seases (NCD). The goal of the 80 countries with new countries Substitution or replacement sam-
resolution was to support WHO coming on board on a regular pling was not allowed in any stage
Member States in their efforts to basis (Table 4.11). STEPS is of the sample design. Four stages
reduce morbidity, disability, and active in all WHO regions except are included in the sample design:
premature mortality related to EURO (where existing sur- primary sample units (PSU) of the
NCDs. Development of a NCD veillance systems are already in smaller, or the smallest, recog-
surveillance system was one of place for NCD risk factors). Nearly nized geopolitical area units with
the primary objectives of this all AFRO countries have done or current statistical population (i.e.
effort, and WHO STEPwise ap- plan to do STEPS surveys. individual or household); count
proach to Surveillance (STEPS) data and quality cartographic maps
was developed to meet this need. Survey methodology (e.g. county, census tract, or block
The WHO STEPS is a simple, group, rather than state in the
standardised method for collec- Global Adult Tobacco Survey USA); secondary sampling units
ting, analyzing, and disseminating (GATS): (SSU) of recognized geopolitical
data in WHO member countries. The GATS is a household survey subunits to the area units used for
By using the same stan- of adults aged 15-64 years. The PSUs; individual housing/dwelling
dardised questions and protocols, sample domains include complete units (see Census website for
all countries can use STEPS population coverage, except for definitions of these geographic
information not only for monitoring areas that have special country terms), or small groups (<10) of
within-country trends, but also for circumstances (e.g. conflict areas, neighboring housing units (HUs
making comparisons across remote areas). In addition, compact segments); and finally,
countries. The approach encou- institutional populations (e.g. pri- within-household sampling of one
rages the collection of small sons, dormitories, hospitals) are study-eligible household resident
amounts of useful information on excluded. A multi-stage sampling from a roster of residents 15-64
a regular and continuing basis. design was used to include all years of age.
As a surveillance system, household members aged 15-64 Targeted sample sizes (for both
STEPS provides information on from a sample of households, with genders combined) for urban and
NCD risk behaviours that one individual randomly selected rural respondents should be
countries can use for better public per household. Interviews were approximately 4000 each. This can
health policy decision-making. completed face-to-face. In this be accomplished by selecting the
The goal of STEPS is to build the survey, a probability sample is same number of PSUs in urban
capacity of countries to develop required; therefore, an appropriate and rural strata. These estimates
and maintain an integrated, method of random sampling is were arrived at by specifying the
systematic, data collection system used in each sampling stage so following parameters in the sample
that collects data on NCDs and that selection probabilities can be size calculation needed to detect
their risk factors, including infor- determined for all sampling units in differences in key rates (smoking
mation on tobacco use (specific each stage, and the probability of prevalence) between survey
tobacco questions included in selection for each respondent rounds: 95% confidence error
STEPS are discussed later in the (computed as the product of stage- margins of 3 percentage points
174
for tobacco use estimates of 40% respondent would be absent for The sampling scheme to be
at any given round, 80% power the entire fieldwork procedure. followed will depend on the size of
(Type I error of 0.05 and two-sided A ten minute recruitment survey the population, geographic area to
test alternatives), and a design was first conducted to screen for be sampled, and available
effect of 2.0 (arising out of the effect eligibility. A thank you letter and fi- resources. Stratification of the
of cluster sampling). Samples in nancial compensation were mailed population to be sampled is often
each round are independently immediately after the recruitment done according to physical loca-
chosen and should be propor- calls. In order to avoid call-sche- tion of the sampling units (e.g.
tionate for all demographic cate- duling bias, recruitment calls were urban versus rural). Proportional
gories except level of urbanization conducted at various times of the or disproportional allocation of
and region. day and on different days of the sampling units per strata may be
week. If a respondent agreed to enforced. Simple random sam-
International Tobacco Control participate, but did not keep a main pling or multi-stage cluster
Survey (ITC): survey appointment, up to 25 sampling are followed, and both
The ITC Project stratifies the attempts to follow-up were made at can be utilized in conjunction with
country population into several varying times of day. In addition, stratification. STEPS recommends
geographic regions. Quotas were respondents could complete the the use of multi-stage cluster
assigned for the number of main survey during two or more sampling when conducting na-
respondents (age 18 and over) in calls if requested (Thompson et al., tional surveys.
each of the strata, in order to 2006). For the actual drawing of the
ensure representation propor- sample, sampling probability
tional to a measure of regional STEPwise Approach to Chronic proportional to size is used. Once
population size. In the original four Disease Factor Surveillance the selection of the household
countries, eligible households (STEPS): and/or individuals is completed,
were then selected by random The STEPS is an adult survey con- data collection begins through
digit dialing methods until the ducted with a sample of 25-64 year interviewing. If collection of clinical
within-stratum quotas were met. olds (although many countries data is planned, participating clinics
As the survey was expanded to survey young adults age 15-18) in are identified and clinical regis-
countries that had less complete the household setting (Steps 1 and tration, blood collection, and bio-
phone coverage, the ITC em- 2) and in the clinic setting (Step 3). chemical measurement forms are
ployed multistage cluster sampling Five different sample designs are compiled along with biological
across entire countries (Thailand supported. In general, the sample samples.
and Malaysia), or within key is a multi-stage cluster sample of at
geographical areas (Mexico, least 2000 adults. Survey Instrument
Uruguay, China), which was im- Prior to survey implementation,
plemented with face-to-face inter- STEPS completes preliminary Global Adult Tobacco Survey
views. A household was deemed phases including: defining target (GATS):
eligible for inclusion in the survey if population, sample size, sampling The core GATS questionnaire was
it contained at least one eligible frame and design, selecting developed by an expert com-
smoker. In households with sample participants, and docu- mittee, including representatives
multiple eligible smokers, the Next menting sample selection. Its from WHO (regional and country
Birthday method was used to methodology emphasizes sam- offices), CDC, and international
select a single respondent. No pling a target population that at a tobacco control experts. The core
substitution within the household minimum comprises adults aged instrument was tested in cognitive
was permitted, except where it 25-64; wider age ranges are laboratory procedures in March
was known that the selected permissible, but not narrower. 2007, and was piloted tested in the
175
Philippines and India in April and sumption, type of product smoked collection of the following types of
May 2007. Results from the (hand-rolled or manufactured; data:
cognitive laboratory and pilot menthol, Virginia, or blended; Questionnaire
studies were used to finalize the pieces in pack; filtered or non- Physical measurements
core questionnaire at a meeting of filtered), cigarette brand pre- Biochemical measurements
the expert committee in June ference, duration of smoking (time Step 1 gathers information on
2007. since respondent started smoking), risk factors that can be obtained
The core GATS questionnaire dependency (time to first smoke), from the general population by
includes indicators on tobacco current use of tobacco products questionnaire. This includes infor-
prevalence (smoking and smoke- other than cigarettes (including mation on socio-demographic
less tobacco use), exposure to cigars, pipes, chewing tobacco, features, tobacco use, alcohol
secondhand smoke, cessation, snuff, and other products), consumption, physical inactivity,
risk perceptions, knowledge and number of closest friends who and fruit/vegetable intake. Step 2
attitudes, exposure to media, and smoke, smoking policy at res- includes objective data by simple
price and taxation issues. pondents place of work, support physical measurements needed to
for smoking regulations in indoor examine risk factors that are
International Tobacco Control public areas, knowledge of health physiologic attributes of the human
Survey (ITC): effects and diseases caused by body, such as height, weight, waist
The ITC questionnaire was smoking, beliefs about dangers of circumference (for obesity), and
developed by a multidisciplinary different tobacco products, per- blood pressure. Step 3 carries the
team of international tobacco conception of relative danger of objective measurements of phy-
trol experts. A pilot survey, tobacco products other than siologic attributes one step further
including the screener and main cigarettes, a module of questions with the inclusion of blood samples
survey, was conducted among 125 regarding warning labels, a for measuring lipid and glucose
respondents; the instrument was module of questions about pro- levels.
revised as a result of the pretest. tobacco advertising, a module of The STEPS tobacco questions
The questionnaire has been questions about awareness cam- were drawn from WHOs
revised at each subsequent wave, paigns that shows dangers of Guidelines for Controlling and
but the core of the instrument has smoking or encourages quitting, Monitoring the Tobacco Epidemic
remained essentially the same to desire to quit, number of quit (WHO, 1998a). Core tobacco use
facilitate comparisons and mode- attempts, duration of last smoke- questions include: current smo-
ling over time. Apart from minor free period, knowledge and use of king of any tobacco products
variations in colloquial language, cessation support products, ces- (such as cigarettes, cigars, or
the same questionnaire was used sation services available (doctor pipes); current daily smoking of
in all four English speaking coun- or health professional, telephone tobacco products; age of initiation
tries; translations are used in the quit line, clinics, participation in of daily smoking; and daily
other countries. international events such as Quit consumption of tobacco (manu-
Due to the objectives of ITC and Win Contests), and perceived factured cigarettes, hand-rolled
and the eligibility requirements of difficulty to quit smoking. cigarettes, pipes full of tobacco,
respondents, the questionnaire in- cigars/cheroots/cigaril-los, or other).
cludes questions on a wide range STEPwise Approach to Chronic Expanded tobacco use questions
of tobacco-related behaviours, Disease Factor Surveillance include: ever smoke daily; age
knowledge, and attitudes that are (STEPS): when stopped smoking daily;
targeted to current smokers. These The STEPS instrument covers current use of smokeless tobacco,
indicators include: daily cigarette three different levels of "steps" of such as snuff, chewing tobacco,
consumption, weekly cigarette con- risk factor assessment through the betel; current daily use of
176
smokeless tobacco products; with the appropriate person in the WHO STEPS Surveillance
number of times a day use each household and maintain high Manual covers details regarding
smokeless tobacco products; and quality standards. data collection, data entry and data
ever daily use of smokeless management, and data analysis.
tobacco, such as snuff, chewing International Tobacco Control
tobacco, betel. Currently no data Survey (ITC): Data analysis
are collected on cessation, Survey administration for ITC has
secondhand smoke exposure, been handled by contracting Global Adult Tobacco Survey
exposure to pro-tobacco media companies. Waves 1 and 2 of the (GATS):
and advertising, economics, survey were conducted in Canada GATS data are weighted to adjust
knowledge, and attitudes. and the USA by Environics for sample selection, non-res-
Research group. Waves 1 and 2 ponse, and post-stratification of
Survey administration proce- in Australia and the UK, and all the sample population. Since it
dure countries that participated in uses a multistage sample design,
Waves 3 and 4, were conducted estimates of standard errors must
Global Adult Tobacco Survey by Roy Morgan Research. Senior be adjusted to take into account
(GATS): representatives of the companies the design effect. Specific sta-
Survey administration of GATS participated in the protocol design, tistical analysis products are
consists of a coordinated effort in order to ensure standardization required that can accommodate
between WHO (regional and of the survey administration and the complex weighting consi-
country offices), CDC, and the calling protocol across survey derations. The computer program
country GATS coordinator working sites. All calling specifications, SUDAAN was used to compute
in the Ministry of Health. Each final questionnaires, and daily standard errors, 95% confidence
country GATS coordinator identifies reports were reviewed and intervals, and weighted estimates.
possible companies or agencies monitored by the ITC Research
that can carry out the survey. WHO Team, at the University of International Tobacco Control
and CDC meet within country with Waterloo, to maintain consistency Survey (ITC):
the GATS coordinator to make the across survey firms and countries. The ITC sampling design was
final selection, and follow-up on all chosen to provide a random,
details with the company chosen, STEPwise Approach to Chronic unbiased, representative sample
including timeline, budget, training Disease Factor Surveillance of adult smokers within each
of interviewers, and other tasks as (STEPS): geographic stratum. In order to
relevant. WHO conducts Regional STEPS adjust for disproportionate selec-
GATS interviews are con- Training Workshops for country tion and under-coverage of
ducted in households by trained STEPS research coordinators. population subgroups, weights in
interviewers. Survey teams are Part 3 in the WHO STEPS Wave 1 were calculated for each
used, which consist of a super- Surveillance Manual (available at respondent to adjust for number of
visor and interviewers. The http://www.who.int/chp/steps/man residential phone lines and adult
supervisor has the responsibility of ual/en/index.html) includes a smokers in the household. These
leading the team, identifying the Training Guide for how to plan, weights were adjusted to produce
correct geographic location for the prepare for, and deliver training to recruitment weights, so that
selection of the households, as- the data collection, data entry, and estimates of total numbers of
signing interviewers to houses, data analysis teams. STEPS has smokers in age-sex groups
and conducting quality control three separate trainings: inter- agreed with current smoking
checks on each interviewer. The viewer training, data entry training, prevalence numbers in the coun-
interviewers conduct the interview and data analysis training. Part 4 in try. The weights were also
177
adjusted for attrition between the sheets for calculating weights. 3) Assist and inform future health
recruitment and the main survey. STEPS assists the country coor- research
In subsequent waves, weights dinator in producing a Fact Sheet STEPS encourages the
were created for longitudinal or showing key findings from the coordinators to prepare Fact
cohort analyses for respondents survey, which can be used for quick Sheets and Country Reports. The
who completed two or more dissemination of the results. Fact Sheet should be a short
waves. Cross-sectional weights summary of the key results and
were calculated to incorporate used for immediate dissemination.
Dissemination of Informa-
newly recruited respondents The Country Report should be
tion
The ITC uses a complex comprehensive and include: the
survey design; therefore, standard Global Adult Tobacco Survey overall rationale, scope of the
error estimators need to be (GATS): survey, the sampling design,
adjusted to take into account the Dissemination of GATS information details of the methods for data
design effect. Specific statistical is a primary focus of WHO and collection, detailed results of the
analysis products are required that CDC. A website for easy access to survey, and implications for future
can accommodate the complex the GATS data, reports, and health and planning. It should be
weighting considerations. These country Fact Sheets is being widely distributed to relevant
packages include SUDAAN, developed by WHO (this site should government agencies and spon-
WesVar (http://www.westat.com/ be available by the end of 2008). soring organisations, non-govern-
wesvar/), STATA, and SAS mental organisations that could
(http://www.sas.com). International Tobacco Control Survey use the information, public,
(ITC): government and institutional
STEPwise Approach to Chronic Publications by ITC researchers, libraries, press and other media
Disease Factor Surveillance and other authors, featuring the outlets, and websites. Detailed
(STEPS): ITC data can be found at information about STEPS can be
Part 4, Section 3 of the WHO http://www.itcproject.org. found at http://www.who.int/chp/
STEPS Surveillance Manual in- steps/en/.
cludes discussion of the tasks that STEPwise Approach to Chronic
are needed to analyze STEPS Disease Factor Surveillance Summary
data. STEPS recommends the (STEPS):
country data analysts work with a Part 4, Section 4 of the WHO Comparison of adult survey
survey statistician for advice and STEPS Surveillance Manual in- content
support (if none is available then cludes information on reporting All three surveys measure
the country coordinator can receive and disseminating STEPS results. tobacco use prevalence and con-
assistance from the STEPS team in Countries are encouraged to sumption levels of various
Geneva). They also suggest that disseminate the results from their products (see Table 4.13 for a full
the country coordinator use EPI survey in a timely manner after comparison of measures in each
INFO (version 3.3 or higher), or survey completion. The results survey). GATS, ITC, and STEPS
other similar statistical software can help: ask about cigarette smoking and
packages, for data analysis. 1) Raise awareness about pre- use of tobacco products other
STEPS provides technical support venting chronic disease and than cigarettes. All four surveys
and training for EPI INFO, and their risk factors ask about age of initiation of daily
training for analysts for data 2) Guide public health policy and cigarette smoking; however,
cleaning, weighting, and analysis, interventions to address chro- GATS asks about first use of
upon request. The STEPS sam- nic diseases cigarettes for smokers who are not
pling workbook contains spread- daily smokers.
178
GATS and ITC query replacement therapies and anti- Further, STEPS is dependent on
respondents about secondhand depressants. A measure of countries to follow statistically valid
smoke exposure, but use different tobacco dependency, using a protocols for sample design and
indicators to assess exposure. standard indicator of addiction field procedures. It also has limited
Both ask about smoking policies in (time to first cigarette) and res- quality control measures in place to
respondents' homes and work- pondents' perceived difficulty to assure compliance with the
places. ITC asks about number of quit smoking, is applied in both protocols.
closest friends who smoke. GATS surveys.
has questions about the rules ITC includes questions that Discussion
concerning smoking in respon- assess policy-specific mediators
dents homes and if there are and psychosocial mediators of Public health surveillance involves
other members of the household policy impact. the ongoing systematic collec-
that smoke. tion, analysis, and interpretation of
GATS and ITC assess res- Limitations of adult survey outcome specific data for use in
pondents' knowledge and beliefs content planning, implementation, and
about the health effects of smoking. evaluation of public health practice
Both surveys include a battery of There are some limitations of ITC, (Taylor & Bettcher, 2000). As of
questions about the relationship GATS, and STEPS. The longi- March 14, 2007, 145 of the 192
between smoking and a variety of tudinal design of ITC is intended to WHO Member States had ratified
diseases and conditions. GATS evaluate the impact of policies on WHO FCTC. An important feature
and ITC ask respondents about smokers. The sampling metho- of the WHO FCTC is the call for
their perceptions of the relative dology screens households for countries to establish programmes
danger of tobacco products other smokers as the target population, for national, regional, and global
than cigarettes. although participating countries surveillance as stated in Article 20:
GATS and ITC include ques- have the option of including an Research, surveillance and
tions about exposure to pro- and additional sample of non-smokers. exchange of information The
antitobacco media messages. The ITC samples are designed to Parties shall establish, as appro-
Both surveys ask about res- be representative of the smoker priate, programmes for national,
pondents' exposure to pro- population of the countries or of regional, and global surveillance of
tobacco advertising in a variety of major geographic areas within the the magnitude, patterns, deter-
media, such as billboards, point of countries; they are not designed to minants and consequences of
sale, radio, television, and movies. assess national or regional levels tobacco consumption and expo-
Respondents' viewing of health of tobacco prevalence. The sure to tobacco smoke. Towards
warning labels on tobacco primary limitation facing GATS at this end, the Parties should inte-
packaging is also asked about in this time is the question of grate tobacco surveillance pro-
both surveys. GATS and ITC also coverage and sustainability. The grammes into national, regional,
include questions on price and Bloomberg Foundation intends to and global health surveillance
taxation. fund future expansion and programmes so that data are
GATS and ITC ask res- repetition of GATS, but whether comparable and can be analyzed
pondents about cessation beha- this funding can lead to expansion at the regional and international
viour. Both surveys ask of GATS to all WHO Member levels, as appropriate (WHO,
respondents about their moti- States and include provisions for 2003).
vation to quit smoking; unsuc- repeat rounds, is unknown. As a One of the primary goals of the
cessful quit attempts; and multirisk survey, STEPS has limits WHO FCTC is the development,
knowledge of cessation support on the number of tobacco-related implementation, and evaluation of
products, such as nicotine questions that can be included. effective tobacco control pro-
179
WHO FCTC Article European School Sur- Global School Health Global Youth Tobacc Health Behaviour of
vey Project on Alcohol Survey Survey School-aged Children
and Other Drugs (GSHS) (GYTS) (HBSC)
(ESPAD)
Article 20: Res earch, In the early 1990s, the GSHS data can be used Initiated in 1999, GYTS Data from HBSC has
s urveillance and ex - Swedish Government by countries to develop was developed by WHO been used to influence
change of information. convened a meeting of priorities, establish pro- Headquarters, WHO health promotion and
The Parties shall estab- 21 European countries grammes, and advo- Regional Offices, and health education policy
lish, as appropriate, pro- to build on the work of cate for resources for CDC. By the end of at national and interna-
grammes for national, the Pompidou Group by school health and youth 2006, 150 countries had tional levels. In the mid-
regional, and global sur- developing a system for health programmes and completed at least one 1980s, HBSC was
veillance of the magni- simultaneously collect- policies. GSHS also can round of GYTS; of adopted by the WHO
tude, patterns, determi- ing school-based data be used by international these, 44 countries European Regional Of-
nants, and conse- using a common agencies, countries, have completed a sec- fice as a WHO collabo-
quences of tobacco methodology. This re- and others to make ond round. In 2007, 17 rative study. HBSC was
consumption and expo- sulted in the develop- comparisons across countries conducted the developed by a multi-
sure to tobacco smoke. ment of the ESPAD countries regarding the survey for the first time, disciplinary network of
Towards this end, the project which has now prevalence of health be- 31 countries were pre- researchers from coun-
Parties should integrate completed three cycles haviours and protective pared to conduct a sec- tries in Europe and the
tobacco surveillance of data collection: 1995, factors and to analyze ond round, and 42 United States. HBSC
programmes into na- 1999, and 2003. Future trends in the behav- trained to conduct the was first conducted in
tional, regional, and expansion of ESPAD iours. Implementation of survey in the future. 1983/84 (5 countries), in
global health surveil- will occur on a four year GSHS started in 2003; 1985/86 (13 countries),
lance programmes so cycle. by the end of 2006, 24 and then every four
that data are compara- countries had com- years: 1989/90 (16
ble and can be pleted a GSHS. countries), 1993/94 (26
analysed at the regional countries), 1997/98 (29
and international levels, countries), 2001/02 (36
as appropriate. countries), and 2005/06
(41 countries).
Prevalence
Article 21: Re porting
a nd ex change of inf or- - Lifetime cigarette use - Age of initiation - Lifetime cigarette use - Lifetime tobacco
mation. - Use of cigarettes in - Cigarette smoking - Initiated smoking be- smoke
Each Party shall submit the last 30 days (i.e. during the past 30 fore age 10 - Current tobacco
to the Conference of the current cigarette days (i.e. current ciga- - Cigarette smoking smoking
Parties, through the smoking) rette smoking) during the past 30 - Consumption of
Secretariat, periodic re- - Age of initiation of cig- - Use of other tobacco days (i.e. current ciga- cigarettes
ports on its implementa- arette smoking products during the rette smoking) - Age of initiation of
tion of this Convention, past 30 days - Current use of to- daily smoking
which should include bacco other than ciga-
the following: informa- rettes
tion on surveillance and - Never smokers sus-
research as specified in ceptible to initiate
Article 20 (Research, smoking in the next
surveillance, and ex- year
change of information)
Table 4.12 European School Survey Project on Alcohol and Other Drugs (ESPAD), Global School-Based Student
Health Survey (GSHS), Global Youth Tobacco Survey (GYTS), and Health Behavior of School-Aged Children
(HBSC) Measures That Can Be Used to Monitor the WHO Framework Convention for Tobacco Control (FCTC)
180
WHO FCTC Article ESPAD GSHS GYTS HBSC
Exposure to Second- - Number of friends - Exposure to second- - Exposed to smoke

hand Smoke who smoke cigarettes hand smoke during from others in their
Article 8: Protec tion - Number of siblings the past 7 days home
f rom ex posure to t o- who smoke - Use of tobacco by par- - Exposed to smoke
bacco smoke. ents or guardians from others in public
Each Party shall adopt places
and implement in areas - Think smoking should
of existing national juris- be banned from public
diction, as determined places
by national law, and ac- - Use of tobacco by par-
tively promote at other ents
jurisdictional levels the -
adoption and implemen-
tation of effective leg-
islative, executive,
administrative, and/or
other measures, provid-
ing for protection from
exposure to tobacco
smoke in indoor work-
places, public transport,
indoor public places,
and, as appropriate,
other public places.
School
Article 12: Educa tion,
communication, training
and public awareness. - During past year in
Each Party shall pro- school, students were
mote and strengthen taught about dangers
public awareness of to- of smoking
bacco control issues, - During past year in
using all available com- school, students dis-
munication tools, as ap- cussed reasons peo-
propriate. Towards this ple their age smoke
end, each Party shall - During past year in
adopt and implement ef- school, students were
fective legislative, exec- taught about the ef-
utive, administrative, or fects of smoking
other measures, to pro-
mote public awareness
of, and access to, infor-
mation regarding the ad-
verse health,economics,
and environmental con-
sequences of tobacco
production and con-
sumption.
Table 4.12 European School Survey Project on Alcohol and Other Drugs (ESPAD), Global School-Based
Student Health Survey (GSHS), Global Youth Tobacco Survey (GYTS), and Health Behavior of School-Aged
Children (HBSC) Measures That Can Be Used to Monitor the WHO FCTC
181
Media and Advertising - During the past month,

Article 13: Tobacco ad- saw actors smoking
v ertising, promo tion, on TV, in videos, or in
and sponsorship. movies
Parties recognize that a - During the past month,
comprehensive ban on saw ads for cigarettes
advertising, promotion, on billboards
and sponsorship would - During the past month,
reduce the consumption saw ads for cigarettes
of tobacco products in newspapers or
magazines
- During the past month,
saw ads for cigarettes
at sporting events,
fairs, concerts, or
community events
- Have an object with a
cigarette brand logo
on it
Cessation
Article 14: Deman d re-
d uction me asures co n- - Attempts to stop - Current smokers who
cerning tobacco depen- smoking during the desire to stop smoking
dence and cessation. past 12 months - Current smokers who
Each Party shall de- tried to stop smoking
velop and disseminate during the past year
appropriate, compre- - Current smokers who
hensive, and integrated ever received help or
guidelines based on sci- advice from a pro-
entific evidence and gramme or profes-
best practices, taking sional to help them
into account national stop smoking
circumstances and pri- - Current smokers who
orities, and shall take ef- have or feel like hav-
fective measures to ing a cigarette first
promote cessation of to- thing in the morning
bacco use and ade-
quate treatment for
tobacco dependence
(HBSC) Measures That Can Be Used to Monitor the WHO FCTC
182
Minors Access and

Availability
Article 16: Sales to and - Current smokers who
by minors. usually get their ciga-
Each Party shall adopt rettes by buying them
and implement effective in a store, in a shop, or
legislative, executive, from a street vendor
administrative, or other - Current smokers who
measures, at the appro- were not refused pur-
priate level to prohibit chase of cigarettes
the sales of tobacco because of their age
products to persons - Students who were of-
under the age set by do- fered free cigarettes
mestic law, national law, by a cigarette com-
or age eighteen. pany representative
Each Party shall prohibit
or promote the prohibi-
tion of the distribution of
free tobacco products to
the public and espe-
cially minors.
(HBSC) Measures That Can Be Used to Monitor the WHO FCTC
grammes in all WHO Member employing research protocols with leadership capacity of the mini-
States. common sampling procedures, stries of health and other state
How do data from the core questionnaire items, field bodies responsible for tobacco
surveillance systems identified in procedures, and data manage- control, not only in terms of public
this section assist countries in ment across survey sites. health advocacy, but also in
monitoring and evaluating articles The WHO FCTC also requires negotiations with other sectors
from the WHO FCTC? As countries to monitor the treatys with respect to tobacco control.
illustrated in Tables 4.12 and 4.13, application over time. Surveillance Finally, ongoing, systematic sur-
these systems provide valuable data that encompasses a broad veillance enhances the role of the
indicators for measuring achieve- range of information about tobac- nongovernmental sector by
ment of WHO FCTC articles. The co use behaviour, and associated supporting civil society partici-
WHO FCTC calls for countries to factors, are a necessary pation in monitoring the state of
use consistent methods and component of applied research tobacco control efforts, and
procedures in their surveillance that establishes evidence-based facilitating policy and programme
efforts. The surveys described in relationships between programme development.
this section were created with the efforts and policy outcomes. In
intention of providing interna- addition, the WHO FCTC con-
tionally comparable data by tributes to strengthening the
183
WHO FCTC Article International Tobac co Cont rol STEPwise Approach to Global Adult Tobacco Survey
Policy Evaluation Survey Chronic Disease Factor Sur- (GATS)
(ITC) veillance
(STEPS)
Article 20: Rese arch, surveil- The objective of the ITC is to STEPS provides information The Bloomberg Initiative part-
lance an d ex chang e o f infor- apply rigorous research meth- on NCD risk behaviours that ners established the GATS in
mation. ods to evaluate the psychoso- countries can use for better 15 high-burden countries to
The Parties shall establish, as cial and behavioural effects of public health policy decision- collect data on tobacco use
appropriate, programmes for na- national level tobacco control making. The goal of STEPS is prevalence (cigarette smoking
tional, regional, and global sur- policies. The ITC Project uses to build the capacity of coun- and other tobacco use), expo-
veillance of the magnitude, multiple country controls, longi- tries to develop and maintain sure to secondhand smoke,
patterns, determinants, and con- tudinal designs, and theory-dri- an integrated, systematic data cessation, risk perceptions,
sequences of tobacco consump- ven mediational models that collection system that collects knowledge and attitudes, ex-
tion and exposure to tobacco allow tests of hypotheses data on NCDs, and their risk posure to media, price, and
smoke. Towards this end, the about the anticipated effects of factors. There are currently two taxation issues which are criti-
Parties should integrate tobacco given policies. primary STEPS surveillance cal measures for tobacco con-
surveillance programmes into na- systems: STEPwise approach trol programme and policy
tional, regional, and global health to risk factor surveillance and development.
surveillance programmes so that the STEPwise approach to
data are comparable and can be stroke surveillance.
anal-ysed at the regional and in-
ternational levels, as appropriate.
Prevalence
Article 21: Reporting an d ex- - Respondents are eligible to - Current smoking of any to- - Current smoking of any to-
change of information. participate if they have bacco products (such as ciga- bacco products (such as ciga-
Each Party shall submit to the smoked 100 cigarettes in their rettes, cigars, or pipes) rettes, cigars, or pipes)
Conference of the Parties, lifetime and currently smoke - Currently daily smoking of to- - Current daily smoking of to-
through the Secretariat, peri- (manufactured or hand-rolled) bacco products bacco products
odic reports on its implementa- cigarettes - Age of initiation of daily smok- - Age of initiation of daily smok-
tion of this Convention, which - Current daily smoking (manu- ing ing for daily smokers
should include the following: in- factured or hand-rolled) - Daily consumption of tobacco - Age of first cigarette smoked
formation on surveillance and - Daily cigarette consumption (manufactured cigarettes, for less than daily smokers
research as specified in Article - Weekly cigarette consumption hand-rolled cigarettes, pipes - Daily consumption of smoked
20 (research, surveillance and - Type of product smoked full of tobacco, cigars/che- and smokeless tobacco (in-
exchange of information) (hand-rolled or manufactured; roots/cigarillos, or other) cluding manufactured ciga-
menthol, Virginia, or blended; - Expanded tobacco use ques- rettes, hand-rolled cigarettes,
pieces in pack; filtered or non- tions include: ever smoke pipes full of tobacco, ci-
filtered) daily; age when stopped gars/cheroots/cigarillos, water
- Cigarette brand preference smoking daily; current use of pipe rocks, or other smoked
- Duration of smoking (time smokeless tobacco, such as products, and snuff, chewing
since respondent started snuff, chewing tobacco, betel; tobacco, betel, and other
smoking) current daily use of smokeless smokeless products)
- Dependency (time to first tobacco products; number of
smoke) times a day use smokeless to-
- Current use of tobacco prod- bacco products; and ever
ucts other than cigarettes (in- daily use of smokeless to-
cluding cigars, pipes, chewing bacco, such as snuff, chewing
tobacco, snuff, and other tobacco, betel.
products)
Table 4.13 International Tobacco Control Policy Evaluation Survey (ITC), STEPwise Approach to Chronic Disease Factor
Surveillance (STEPS), Global Adult Tobacco Survey (GATS) Measures That Can Be Used to Monitor the WHO
Framework Convention for Tobacco Control (FCTC)
184
WHO FCTC Article International Tobac co Cont rol STEPwise Approach to Global Adult Tobacco Survey
(ITC) veillance (STEPS)
Exposure to Secondhand
Smoke
Article 8: Protection from expo- - Number of closest friends - Number of family members
sure to tobacco smoke. who smoke who smoke
Each Party shall adopt and - Smoking permitted in home - Smoking permitted in home
implement in areas of existing - Smoking policies in places - Smoking policies in places re-
national jurisdiction, as deter- respondent goes often spondent goes often
mined by national law, and - Smoking policy at respon- - Smoking policy at respon-
actively promote at other juris- dents' place of work dents' place of work
dictional levels, the adoption - Support for smoking regula- - Support for smoking regula-
and implementation of effective tions in indoor public areas tions in indoor public areas
legislative, executive, adminis-
trative, and/or other measures,
providing for protection from
exposure to tobacco smoke in
indoor work and public places,
public transport, and, other
public places.
Knowledge
Article 12: Education, commu- - Knowledge of health effects - Knowledge of health effects
n icat ion, training and public and diseases caused by and diseases caused by
awareness. smoking smoking
Each Party shall promote and - Beliefs about dangers of dif- - Beliefs about dangers of dif-
strengthen public awareness ferent tobacco products ferent tobacco products
of tobacco control issues, - Perception of relative danger - Perception of relative danger
using all available communica- of tobacco products other of tobacco products other
tion tools, as appropriate. To- than cigarettes than cigarettes
wards this end, each Party
shall adopt and implement ef-
fective legislative, executive,
administrative, or other meas-
ures, to promote public aware-
ness of, and access to,
information regarding the ad-
verse health, economics, and
environmental consequences
of tobacco production and con-
sumption.
Table 4.13 International Tobacco Control Policy Evaluation Survey (ITC), STEPwise Approach to Chronic Disease
Factor Surveillance (STEPS), Global Adult Tobacco Survey (GATS) Measures That Can Be Used to Monitor the WHO
185
WHO FCTC Article I nternational Tobacco Control STEPwise Approach to Global Adult Tobacco Survey
(ITC) veillance (STEPS)
Media and Advertising - Module of questions regard- - Module of questions regard-

Article 13: To bacco adv ertis - ing warning labels ing warning labels
ing , promotion, and spons or- - Module of questions about - Module of questions about
ship. pro-tobacco advertising on pro-tobacco advertising on
Parties recognize that a com- television, radio, billboards, television, radio, billboards,
prehensive ban on advertising, internet, shop windows, in internet, shop windows, in
promotion, and sponsorship newspapers, restaurants, newspapers, restaurants,
would reduce the consumption and discos and discos
of tobacco products - Tobacco industry sponsor- - Module of questions about
ship of sporting or cultural awareness campaigns that
events shows dangers of smoking or
- Module of questions about encourages quitting in the
awareness campaigns that past 6 months
shows dangers of smoking or
encourages quitting in the
past 6 months
Cessation
Article 14: De mand redu ctio n - Desire to quit - Desire to quit
measures concerning tobacco - Quit attempts - Quit attempts
dependence and cessation. - Duration of last smoke-free - Duration of last smoke-free
Each Party shall develop and period period
disseminate appropriate, com- - Knowledge about NRT and - Knowledge about NRT and
prehensive, and integrated Zyban Zyban
guidelines based on scientific - Use of NRT or other cessa- - Use of NRT or other cessation
evidence and best practices, tion assistants assistants
taking into account national cir- - Cessation services available - Cessation services available
cumstances and priorities, and (doctor or health profes- (doctor or health professional,
shall take effective measures sional, telephone quit line, telephone quit line, clinics)
to promote cessation of to- clinics, participation in inter- - Perceived difficulty to quit
bacco use and adequate treat- national events such as Quit smoking
ment for tobacco dependence. and Win Contests)
- Perceived difficulty to quit
smoking
Table 4.13 International Tobacco Control Policy Evaluation Survey (ITC), STEPwise Approach to Chronic Disease
Factor Surveillance (STEPS), Global Adult Tobacco Survey (GATS) Measures That Can Be Used to Monitor the WHO
186
Summary and recommenda- To evaluate among youth used for evaluating policies and
tions articles of the WHO FCTC, the programmes, because of the op-
GYTS is the only source of portunity to examine and adjust for
The youth surveillance systems international data available which individual level predictors of
described in this section include: includes the following indicators: tobacco use behaviours (see
The European School Survey exposure to secondhand smoke, Section 2.1).
Project on Alcohol and Other exposure to pro- and anti-tobacco GYTS was developed, and
Drugs (ESPAD), the Global media and advertising, cessation, GATS is being developed, for
School-Based Student Health minors access to tobacco pro- countries which did not have
Survey (GSHS), the Global Youth ducts, and school curriculum. existing surveillance systems for
Tobacco Survey (GYTS), and the To evaluate among adults the collection of information on
Health Behavior in School-Aged articles of the WHO FCTC, GATS, tobacco use and its determinants.
Children Survey (HBSC). The and ITC have the most com- Countries interested in devel-
adult surveillance systems des- prehensive set of indicators, oping a tobacco control sur-
cribed include: the Global Adult including: exposure to second- veillance system are encouraged
Tobacco Survey (GATS), the hand smoke, economics (price to join one of these international
International Tobacco Control and taxation), cessation, product systems. Those countries that
Survey (ITC), and the STEPwise labeling, and exposure to pro- and have existing national surveys are
Approach to Chronic Disease anti-tobacco media and adver- encouraged to link to these inter-
Factor Surveillance (STEPS). tising. Where possible longitudinal national efforts.
studies, such as ITC, should be
187
5.1 Measures to assess the effectiveness of

tobacco taxation
Introduction enforcement of tobacco control primary purpose of tobacco taxation

policies, mass media information was the efficient generation of
Significant increases in cigarette campaigns, and increased aware- revenue for use in financing
and other tobacco product taxes are ness of and access to cessation government spending. As evidence
widely considered to be a highly services and products), the impact about the impact of higher taxes on
effective mechanism to reduce is increased. Given this evidence, tobacco use has accumulated, an
tobacco use and, as a result, the Article 6 (Figure 5.1) of the WHO increasing number of governments,
death, disease, and economic and FCTC, calls for Parties to the treaty particularly in high resource coun-
social costs caused by tobacco use to use tax and price policies to tries, have used higher tobacco
(Jha & Chaloupka, 1999; Jha et al., reduce tobacco use, while Article 15 product taxes as a tool for reducing
2006). These tax increases are (Figure 5.2) calls for the adoption tobacco use and its consequences
effective in inducing current tobacco and implementation of measures (Jha & Chaloupka, 1999). Similarly,
users to quit, preventing youth from aimed at eliminating the illicit trade these taxes can be used to correct
becoming regular users, keeping in tobacco products that can for the externalities caused by
former users from restarting, and undermine the effectiveness of in- tobacco use, such as the health
reducing the amount consumed by creased tobacco taxes. consequences of exposure to
continuing users (Chaloupka et al., This section focuses on mea- environmental tobacco smoke
2000a). When the revenues from sures to evaluate the effectiveness among non-smokers, or the finan-
these taxes are used to support of tobacco taxation. Historically (and cial costs of publicly financed
other tobacco control efforts (e.g. still the case in many countries), the healthcare services in treating
1. The Parties recognize that price and tax measures are an effective and important means of reducing tobacco consumption
by various segments of the population, in particular young persons.
2. Without prejudice to the sovereign right of the Parties to determine and establish their taxation policies, each Party should
take account of its national health objectives concerning tobacco control and adopt or maintain, as appropriate, measures
which may include:
a. Implementing tax policies and, where appropriate, price policies, on tobacco products so as to contribute to the
health objectives aimed at reducing tobacco consumption; and
b. Prohibiting or restricting, as appropriate, sales to and/or importations by international travelers of tax- and duty-free
tobacco products
3. The Parties shall provide rates of taxation for tobacco products and trends in tobacco consumption in their periodic reports
to the Conference of the Parties in accordance with Article 21.
WHO (2003)
Figure 5.1 WHO FCTC Article 6: Price and Tax Measures to Reduce the Demand for Tobacco
189
1. The Parties recognize that the elimination of all forms of illicit trade in tobacco products, including smuggling, illicit
manufacturing and counterfeiting, and the development and implementation of related national law, in addition to
subregional, regional and global agreements, are essential components of tobacco control.
2. Each Party shall adopt and implement effective legislative, executive, administrative or other measures to ensure
that all unit packets and packages of tobacco products and any outside packaging of such products are marked to
assist Parties in determining the origin of tobacco products, and in accordance with national law and relevant bilateral
or multilateral agreements, assist Parties in determining the point of diversion and monitor, document, and control
the movement of tobacco products and their legal status. In addition, each Party shall:
a. require that unit packets and packages of tobacco products for retail and wholesale use that are sold on its
domestic market carry the statement: Sales only allowed in (insert name of the country, subnational, regional,
or federal unit) or carry other effective marking indicating the final destination or which would assist authorities
in determining whether the product is legally for sale in the domestic market; and
b. consider, as appropriate, developing a practical tracking and tracing regime that would further secure the
distribution system and assist in the investigation of illicit trade.
3. Each Party shall require that the packaging information or marking specified in paragraph 2 of this Article shall be
presented in legible form and/or appear in its principal language or languages.
4. With a view to eliminating illicit trade in tobacco products, each Party shall:
a. Monitor and collect data on cross-border trade in tobacco products, including illicit trade, and exchange
information among customs, tax and other authorities, as appropriate, and in accordance with national law
and relevant applicable bilateral or multilateral agreements;
b. enact or strengthen legislation, with appropriate penalties and remedies, against illicit trade in tobacco products,
including counterfeit and contraband cigarettes;
c. take appropriate steps to ensure that all confiscated manufacturing equipment, counterfeit and contraband
cigarettes and other tobacco products are destroyed, using environmentally-friendly
methods where feasible, or disposed of in accordance with national law;
d. adopt and implement measures to monitor, document and control the storage and distribution of tobacco
products held or moving under suspension of taxes or duties within its jurisdiction; and
e. adopt measures as appropriate to enable the confiscation of proceeds derived from the illicit trade in tobacco
products.
5. Information collected pursuant to subparagraphs 4(a) and 4(d) of this Article shall, as appropriate, be provided in
aggregate form by the Parties in their periodic reports to the Conference of the Parties in accordance with Article
21.
WHO (2003)
Figure 5.2 WHO FCTC Article 15: Illicit Trade in Tobacco Products
diseases caused by tobacco. income populations, and cause contained in Figure 5.3 (the bold
However, a number of arguments significant job losses. The alter- variables are covered in the text
have been raised in opposition to native goals and potential con- here; the other measures are
increased tobacco taxes, including sequences of increased tobacco discussed elsewhere in this
that higher taxes will promote taxation suggest the need to Handbook and will not be des-
extensive tax avoidance among measure several outcomes cribed in detail in this section).
continuing users, result in resulting from a change in tobacco There are other outcomes that
increased smuggling of tobacco taxation. A simple conceptual can be affected by tobacco
products, unfairly burden low- framework for these outcomes is taxation, as well as by other
190
Measures to assess the effectiveness of tobacco taxation
Policy
Tobacco Taxes
- Products taxed
- Level of taxes
- Structure of taxes
- Use of revenues
- Tax compliance Moderators
- Tax administration
Industry structure (4.2)
Production costs
Neighbors taxes/prices
Potential for smuggling
Proximal variables
- Retail Tobacco Prices

- Industry price-related
marketing strategies (5.4)
Moderators
Income/SES
Distal Variables Age
Purchase behaviour Gender
Consumption (3.1)
- Brand switching (4.2, 5.4, 3.1) Dependence (3.3)
- Participation in promotions (5.4) Retail market structure
- Purchase quantity Location
- Purchase location Product availability
- Tax avoidance Inflation
Smuggling
Behaviour change
- Cessation (3.1)
- Initiation (3.1)
- Consumption (4.2, 3.1)
- Compensation (3.1)
- Tax incidence/equity
Figure 5.3 Conceptual framework for the evaluation of tobacco tax policies
Numbers in parentheses refer to sections in the Handbook covering those topics
In bold, variables covered in the main text
191
tobacco control policies and other motives have become more Not that long ago, the
programmes. These include the important, revenue generation conventional wisdom was that the
effects of the reductions in remains a significant factor. The addictive nature of tobacco use
tobacco use that result from tax less than proportionate response implied that increases in prices
increases, and other factors, on of tobacco product consumption to would have little or no effect on
outcomes such as overall changes in tobacco product prices use. However, considerable eco-
economic activity, as reflected by (relatively inelastic demand in nomic research over the past three
employment, national income, and the language of economists), the decades has clearly demonstrated
development. Opponents of to- small number of producers, that increases in tobacco taxes and
bacco tax increases, for example, significant consumption, and lack prices are effective in reducing
argue that higher taxes will have a of good substitutes make tobacco tobacco use. Well over one
negative impact as jobs in tobacco products particularly attractive hundred studies from high-income
growing, manufacturing, and targets for excise and other countries consistently find that a
related activities are lost when taxation. As Adam Smith des- 10% increase in cigarette prices
tobacco use declines. These cribes in The Wealth of Nations, will lead to relatively immediate
outcomes are beyond the scope of Sugar, rum, and tobacco, are reductions in overall tobacco use of
this Handbook; approaches to commodities which are no where between 2.5% and 5% (Chaloupka
assessing these are described necessaries of life, which have et al., 2000a). About half of the
elsewhere (see, for example, Tool become objects of almost uni- impact on aggregate consumption
5 of the World Banks Economics versal consumption, and which results from reductions in the
of Tobacco Toolkit (http://www. are therefore extremely proper prevalence of smoking and half
worldbank.org/tobacco) on mea- subjects of taxation. (Smith, from reductions in cigarette
suring the employment impact of 1776). With few exceptions, consumption among continuing
tobacco control policies (Zhang, tobacco product taxes have been smokers (Chaloupka et al., 2000a).
2002)). This section will focus relatively easy to administer and Growing evidence from low- and
primarily on measuring tobacco collect, have provided limited middle-income countries suggests
product taxes and prices, the opportunities for tax avoidance that the same price increase
purchase behaviour of users, the and evasion, and have generated reduces overall smoking by up to
extent of individual tax avoidance, significant revenues (Sunley et al., twice as much (Jha & Chaloupka,
larger scale tobacco product 2000; Yurekli, 2002). 1999; Ross & Chaloupka, 2006).
smuggling, and, briefly, the In recent decades, as evidence Given the addictive nature of
incidence of tobacco taxation. on the health consequences of tobacco use, the impact of a
tobacco use has accumulated, permanent price increase will take
Motives for tobacco taxation additional motives for tobacco several years to fully appear, as
taxation have emerged. Of par- addicted users respond to the
It is important to understand the ticular importance is the use of increase in price. Estimates from
underlying motivation for tobacco tobacco taxation as a tool for the USA suggest that the long-run
tax increases in order to assess improving public health. This mo- reductions in use resulting from a
their effectiveness. Historically, tive has gained prominence as permanent price increase are
the primary motivation for tobacco economic evidence emerged on about double the short-run effects
taxation was the efficient genera- the effectiveness of increased (Chaloupka et al., 2000b).
tion of government revenue, with tobacco product taxes and prices in The reductions in prevalence
nearly all countries having taxed reducing tobacco use, particularly caused by tax and price increases
tobacco products for many among children and less educated, are largely the result of increased
decades or, in some cases, lower-income populations (Chalou- cessation among current tobacco
centuries. Even in countries where pka et al., 2000a). users. Higher taxes and prices lead
192

numerous users to try to quit; while While there has been reductions in tobacco product
many eventually relapse, a extensive research on the impact consumption, compensation),
significant number are successful of tobacco taxation on tobacco but also changes in their
in the long-term (Tauras & use behaviours, country-specific purchasing behaviour (inclu-
Chalouka, 2001; Tauras, 2004). In evidence is lacking in most coun- ding, for example, switching to
addition, key populations, such as tries. In many countries where cheaper brands, using price
youth and those on low incomes, evidence is available on aggre- reducing promotions, and
are particularly sensitive to price. gate relationships, little is known engaging in efforts to avoid the
Growing evidence indicates that about the impact of taxes and tax increases);
higher taxes and prices are prices on tobacco use among key the use of the revenues
particularly effective in reducing the subpopulations (e.g. youth, low- generated from the tax in-
number of youth who initiate income persons). Even in coun- crease to support additional
regular smoking (Tauras et al., tries where substantial research tobacco control activities, such
2001; Chaloupka, in press). Simi- has been done on these issues, as support for and promotion of
larly, as implied by economic questions remain (e.g. on non- cessation interventions (see
theory, tax and price increases linearities on the impact of tax and Section 5.7), and mass media
lead to greater reductions in price on tobacco: whether large and other public education
tobacco use among low-income, tax increases have dispropor- campaigns (see Section 5.6).
less educated populations than tionately larger or smaller effects
among higher-income, more edu- than smaller tax increases). Measuring tobacco tax
cated persons (Townsend et al. As illustrated in Figure 5.3, the policy
1994; Farrelly et al., 2001). Given effectiveness of tobacco taxation
current smoking trends, tax and in reducing tobacco use behaviour The first step in assessing the
price levels, and evidence on the and concomitant harm, generating impact of tobacco taxation is
effects of price on smoking by revenues, and covering the costs developing good measures of the
different age and income groups, of tobacco use depends on: structure of tobacco taxes. There
estimates indicate that tens of are a variety of taxes that can be
millions of premature deaths, that the degree to which increased imposed on tobacco products.
would have otherwise been caused taxes raise the prices of Generally, these include the
by tobacco use over the next 50 tobacco products, including the following types (Table 5.1):
years globally, could be averted by extent to which tobacco customs (import/export) duties,
relatively modest increases in product manufacturers, distri- excise taxes, sales taxes, and
tobacco product prices (Jha et al., butors, and retailers pass value-added taxes (VAT).
2006). along the tax increase, and/or These taxes can be imposed at
A final, related motive for engage in price-related mar- different levels and the base for
tobacco taxation is that the tax can keting efforts that offset at least one tax may include the other
be used to correct for the external some of the amount of the tax taxes. In the USA, for example,
costs resulting from tobacco use. increase, as well as the extent national excise taxes are collected
These include the healthcare to which large-scale smuggling from tobacco product manu-
costs from treating diseases of tobacco products emerges/ facturers, while state and local
among nonsmokers, as well as grows in response to the tax excise taxes are collected from
their lost productivity, that are increases; distributors. Sales taxes are
caused by exposure to tobacco the behavioural response of imposed at the retail level by many
smoke, along with the publicly tobacco users to the increased states and localities, with most
financed healthcare costs to treat taxes and prices, including not including excise taxes in the base
tobacco-attributable diseases just changes in their tobacco for computing the sales tax.
among tobacco users. use (e.g. cessation attempts, Similarly, the base for the VAT
193
Types of taxes Definition
Customs duty A tax on imports and/or exports, typically applied on a wide range of products, but may
include additional levies on particular products.
Excise tax A tax on selected goods produced for sale within a country or imported and sold in that
country; can be specific (based on quantity or weight, independent of price) or ad valorem
(assessed as a percentage of price).
Sales tax A tax on a broad range of goods and services sold within a country, generally assessed at
the point of sale to consumers and as a percentage of the retail price.
Value-added tax (VAT) A general, indirect tax on consumption that is applied at each stage of production and
distribution based on the value added to the product at that stage.
Sources: Yurekli (2002); Sunley et al.(2000)
Table 5.1 Types of Taxes Applied to Tobacco Products
used in many countries includes helpful to include measures of the industry pricing strategies (e.g.
all excise taxes that have been monetary value of the tax in industry price cuts are effectively
collected, typically from tobacco addition to the percentage rate subsidized by the government
product manufacturers. that is applied. Most countries when ad valorem taxes are
Tobacco product excises are apply some mix of specific and ad applied). In the presence of high
the most important of these, given valorem taxes to tobacco pro- inflation, however, the inflation-
that the others are typically ducts. Finally, for purposes of adjusted value of the revenues
applied to a wide range of goods comparing tobacco taxes across from specific excises will fall over
and services, including tobacco countries, it is useful to express time, unless the tax is increased
products, while excises are these taxes as a percentage of regularly, in contrast to the
applied to a few specific products retail price including, when revenues from ad valorem taxes
(e.g. alcohol and gasoline). There relevant, as a percentage of price (assuming that industry prices are
are two basic types of tobacco for different categories within a keeping pace with inflation).
excise taxes: specific taxes and product type (e.g. for locally Specific excise taxes will generally
ad valorem taxes (Table 5.2). produced and international brands result in a greater variety of
Specific excise taxes are based of cigarettes). products than will ad valorem
on some measure of quantity, Each form of the excise tax has taxes, since the price difference
such as per stick taxes on advantages and disadvantages in between higher quality and lower
manufactured cigarettes or achieving the goals discussed quality products will be smaller
weight-based taxes on roll-your- above (Sunley et al., 2000; with specific taxes, creating a
own tobacco. Ad valorem taxes Yurekli, 2002). The revenues greater incentive to produce
are based on a measure of value generated from specific excise higher quality products. In general,
and are typically applied as a taxes tend to be more stable than if the primary motive for tobacco
percentage of the price (e.g. 50% those generated from ad valorem taxation is to reduce tobacco
of the manufacturers price). When excise taxes, given that revenues consumption, imposing specific
measuring ad valorem taxes, it is from the latter vary more with tobacco excise taxes would be
194
Construct Tobacco Product Taxes
Measures Specific and ad valorem excise taxes applied to tobacco products.
Sources Ministry of Finance, others (e.g. International Monetary Fund, WHO)
Validity Gold standard
Variation Different types of excise taxes and/or different tax rates are likely to be applied to different
types of tobacco products; in some countries, sub-national tobacco excises are important to
measure.
Comments Useful to obtain other measures of tobacco tax administration, such as whether or not tax
stamps are required, as well as excise taxes in other nearby jurisdictions. Also useful to
estimate tax as a percentage of retail price for comparisons across countries and for
assessing impact of tax on price in response to tax increases.
Table 5.2 Measures of Tobacco Product Taxes

preferred, particularly when infla- these taxes are applied to tobacco free purchases. Finally, some poli-
tion is relatively low (Sunley et al., products in order to assess the cies address the ultimate impact of
2000). impact of a tobacco tax increase tax increases on retail prices for
In evaluating the impact of on the prices users pay for tobacco products, such as policies
increases in tobacco product tobacco products. Similarly, other that specify minimum prices for
taxes on key outcomes, the size aspects of tax administration will these products or that ban price
and timing of the increase will be be integral to understanding the reducing promotions for them.
important. For example, large tax impact of these taxes on tax In monitoring tobacco taxes
increases can be implemented all avoidance and smuggling, inclu- and prices over time, it will be
at once or phased in through a ding: whether or not tax stamps important to account for the
series of more incremental in- are required and, if so, the design effects of increases in the prices of
creases over time. Existing of the stamp and how it is applied; other goods and services con-
estimates suggest a relatively at what stage in the manufacturing sumed (inflation). Taxes that are
linear relationship between the and distribution process the taxes infrequently increased, or that
size of a tax increase and its are collected; regulation and increase slowly relative to the
impact on tobacco use beha- licensing of those involved in the prices of other goods and
viours; more research is needed distribution of tobacco products; services, will lose their value over
to assess potential non-linearities the treatment of existing stocks of time, potentially resulting in
in this relationship, differences in tobacco products when taxes are decreases in the inflation adjusted
the effects of one-time large increased (e.g. whether or not value of tobacco product prices
increases versus a series of floor taxes are applied); and more (as, for example, occurred in the
smaller increases that add up to (Sunley et al., 2000; Yurekli, 2002). USA through much of the 1970s
an equivalent increase over time, In addition, there are other policies and early 1980s (Chaloupka, in
and related issues. that focus on improving tax com- press)). Declines in the relative
Given that excise taxes are pliance, such as policies that target (inflation adjusted) prices of
typically included in the base for direct sales of tobacco products tobacco products, all else
sales taxes and VAT, it is (e.g. Internet, mail, and phone constant, will lead to increases in
important to understand how sales), and that limit or ban duty the use of these products.
195
Proximal variables: measur- that increases in tobacco taxes survey (Table 5.3). In places
ing tobacco product prices result in increases in tobacco where multiple methods have
product prices that will match or been used to measure price, the
Understanding how tobacco tax exceed the increase in taxes measures produced are generally
increases affect the prices users (Chaloupka et al., 2000a). highly correlated with one another
pay for tobacco products is critical A variety of approaches have and follow consistent trends.
in measuring the effectiveness of been used to measure retail
tobacco taxation in both reducing cigarette and other tobacco Technology-based systems for
tobacco use and in generating product prices at different levels of measuring prices:
revenues; that is, price is the key aggregation. These approaches
mediator for tax. Increases in differ widely in their cost and Some measures of prices based
tobacco taxes are expected to coverage. Retail price data can be on technology-based data col-
result in increases in the prices of collected from individuals, lection systems take advantage of
tobacco products. The extent to households, and retail outlets, and sophisticated technologies em-
which tax increases are passed on can be aggregated to the market, ployed by a growing number of
to tobacco users will be sub-national (e.g. state or pro- tobacco product retailers in at
moderated by number of factors, vince), or national levels. Some least some countries. Most
including the structure of the price data may be available from prevalent are the scanner-based
tobacco product market, tobacco government sources, while others data collection systems that utilise
industry pricing strategies, the will be available from commercial the universal product codes
costs of producing tobacco or other private sources. Costs of (UPCs) included on most product
products, the potential for tax obtaining or developing alternative packaging. These systems are
avoidance and smuggling, and the price databases will vary con- most widely used in high-income
extent to which tobacco use siderably based on source and/or countries, but are spreading to
responds to changes in prices level of detail. Different types of many low- and middle-income
(Chaloupka et al., 2000a). In price data are needed to answer countries. Other technologies that
countries where the tobacco different questions. For example, go beyond those based on UPCs,
product markets are dominated by a composite measure of prices is such as radio frequency identi-
one firm and/or where costs of sufficient for analyses that look at fication (RFID) tags, are starting to
producing rise rapidly with output, the impact of price on aggregate emerge, but have not yet been
it is likely that an increase in consumption, while brand specific widely implemented. Companies
tobacco product taxes will result in prices will be important for analy- such as A.C. Nielsen (http://www.
less than comparable increases in zing the effect of relative prices on acnielsen.com) and Information
tobacco product prices, parti- brand choice. As noted above for Resources International (IRI)
cularly when tobacco use is tax, it is important to account for (http://www.infores. com) collect
relatively responsive to changes in the effects of inflation when and sell these data in a growing
price. In contrast, in countries evaluating the impact of tobacco number of countries.
where the tobacco product mar- taxes on tobacco product prices, These high-tech data collection
kets are highly competitive and and of taxes/prices on tobacco systems have the advantage of
where per unit production costs use and related outcomes. collecting more comprehensive
are independent of output, in- For purposes of comparison, and more detailed data than can
creases in tobacco taxes are likely alternative retail price collection be collected using other ap-
to result in comparable increases strategies will be grouped into proaches. They essentially pro-
in the prices of tobacco products. three categories, based on the vide a census of the prices paid for
Existing empirical evidence, form of data collection: tech- every sale, by UPC, in the outlets
largely from the USA, indicates nology-based, observational, and that employ the relevant
196
Method Description
Technology-Based Uses of Universal Product Code (UPC) and scanner technology (or others) to collect detailed
information on the sale of every tobacco product, including information on price, quantity, and
use of promotion at detailed product/brand-level; limited to sample of participating vendors
with relevant technology. Also used at the household level to collect detailed information on
all household purchases of tobacco products and other consumer goods.
Observation Use of trained observers to collect information (price, price promotions, packaging
information, etc.) on selected tobacco products from a sample of tobacco product vendors.
Survey Use of mail or telephone questionnaires of tobacco product vendors to collect information
on prices and price promotions for selected products, or surveys of tobacco product users
to collect information on prices and use of promotions for the products respondent
consumes.
Table 5.3 Methods for Collecting Tobacco Product Prices
technology. Brand and package- sales that reflect at least some quantities that are purchased;
specific information can be tobacco company promotional prices are input for purchases
extracted from these data, as well efforts in the sample of par- from outlets that do not participate
as information on a variety of ticipating tobacco product outlets. in the store level, scanner-based
price-related promotions at the These data were also used to database. Both companies main-
retail level. For example, prices for examine how prices of and tain similar databases in other
single pack, carton, and any multi- promotions for premium, discount, countries, as does Sofres, Taylor
pack specials will appear and deep discount cigarettes in and Nelson, Inc. (http://www.tns-
separately for every brand in the USA affected the share of the global.com).
these data; to the extent that there cigarette market accounted for by The major limitation of these
are other in-store promotions, each category (Tauras et al., systems is their coverage. Given
such as on-package coupons or 2006). the manner in which data are
other retail value added pro- Comparable systems use collected, stores that do not
motions (e.g. a free gift with UPCs and in-home scanners to employ the relevant technologies
cigarette purchase), these will be collect data on prices and will be excluded. While these
separately available as well. This purchases at the household level technologies are relatively widely
type of data was used, for from nationally representative used in high-income countries,
example, to document the asso- samples. In the USA, for example, there are many retailers that do
ciations between retail promotions A.C. Nielsen maintains its not yet employ them; most likely in
for cigarettes and the Master HomeScan sample; IRIs com- many low- and middle-income
Settlement Agreement, state parable sample is the Combined countries. In addition, at least
cigarette excise taxes, and state Outlet Consumer Panel. Both are some large retailers in some
tobacco control programmes in panels of tens of thousands of countries (e.g. Wal-Mart in the
the USA (Loomis, et al., 2006). In households that include infor- USA) do not participate in the
addition to the price data, these mation on the outlets from which systems. To the extent that prices,
systems produce good measures household members purchase promotional activities, and sales
of market share and the share of various products and the patterns differ among included
197
and excluded outlets, the data included in consumer price indices Tobacco policy researchers
produced by these systems may in many countries. Similarly, the have also employed observational
not be representative. The home- Economist Intelligence Unit (EIU; data collection methods to
based data collections partially fill http://www. eiu.com) uses this measure cigarette and other
this gap, but generally do not approach to collect tobacco product tobacco product prices and price-
include representative samples of prices (cigarettes and pipe tobacco) related promotions. For example,
households at sub-national levels. in 129 cities around the world. In the ImpacTeen project employed
In addition, these systems do not the USA, ACCRA (formerly the these methods to collect price and
provide complete geographic American Chamber of Commerce other data from almost 17,500
coverage, but instead tend to Researchers Association) used to retail outlets in nearly 1000 US
focus their data collection efforts collect cigarette prices for 250-300 communities from 1999 through
on larger metropolitan areas. metropolitan areas each quarter 2003 (http://www.impacteen.org).
Again, to the extent that there are (http://www.coli.org). In addition, These data were used, for
differences in prices, promotional some market research companies example, to examine the impact of
efforts, and sales between more (e.g. A.C. Nielsen) conduct store cigarette prices and point-of-sale
urban and more rural markets, the observations that collect detailed cigarette marketing on youth
data produced by these systems data on pricing, product place- smoking uptake (Slater et al.,
may not be representative. In ment, in-store advertising and 2007). Similarly, the Rockefeller
addition, these data are relatively promotion, and other marketing Foundations Trading Tobacco for
expensive, particularly as the activities. Health Initiative (TTHI) developed
desired information is more In these systems, cigarette and and pilot tested methods for
disaggregated. Finally, given that other tobacco product prices are collecting these data in several
these data are provided by typically one component of a Southeast Asian countries, as well
commercial vendors, there will larger price data collection effort. as in selected other countries
likely be some constraints im- The EIU, for example, collects (http://www.tobaccoevidence.net).
posed on how the data can be prices on over 160 products. There are a number of chal-
shared and/or published. These systems have usually been lenges to employing these
developed to measure changes in methods to develop good mea-
Observational approaches to the cost-of-living over time and/or sures of tobacco product prices.
measuring prices: to compare the cost-of-living Perhaps the most significant is the
across locations. The EIU data development of the appropriate
A second approach to collecting were used, for example, to com- sample frame for use in selecting
tobacco product price data is the pare the affordability of cigarettes a representative sample of
use of observational data among low-, middle-, and high- tobacco product retailers. Alter-
collection methods. This approach income countries, and to assess native approaches include using
involves trained observers visiting the impact of affordability on business list data (available at
tobacco product vendors and cigarette consumption in these some cost from commercial
collecting information on the prices countries (Blecher & van vendors) to identify potential
of various tobacco products, as Walbeek, 2004). Some of the tobacco product vendors, sam-
well as measures of promotions more proprietary databases are pling geographic areas and
that affect the price that consumers used by companies to track their thoroughly canvassing them to
pay for these products (e.g. on own pricing and marketing stra- identify these vendors, or using
pack coupons, multi-pack pro- tegies, as well as to obtain convenience samples of vendors
motions). This approach is information on the strategies that are readily identifiable and
generally employed in collecting the employed by their competitors. easily observed. ACCRA, for
tobacco product price data that are example, requires that observers
198
visit a minimum of five stores, but differences in pricing and price- methods, relates to the aggre-
recommends more (particularly related promotional efforts, these gation of the brand specific data
when there is substantial variation differences will not be reflected in from multiple outlets into a
in price), but provides limited measures based on data from a composite price measure. Ideally,
additional guidance (for details, limited number of locations. this measure would be an average
see the ACCRA manual at A third challenge is determining price measure weighted so as to
http://www.coli.org/surveyforms/c the set of tobacco products for reflect the shares of sales of the
olimanual.pdf). In contrast, the which price and other price-related different brands that it includes, as
ImpacTeen project used business data will be collected. In contrast to well as the sales in different types
list data to develop a sample of all the high-tech methods described of outlets (to the extent that there
retailers that might sell tobacco above that produce very detailed are differences in prices across
products (based on self-reported data at the UPC level, it is not outlets). Brand share data may be
Standard Industrial Classification feasible to try and collect data for available nationally, but are less
(SIC) codes), then conducted a more than a small fraction of likely to be available locally.
short telephone screening call with available products. The EIU, for Similarly, data on the share of
each to determine whether or not example, collects data on three sales accounted for by sales in
they did sell tobacco products, and products: one pack of Marlboro (or different types of outlets are
drew their sample from those that another international brand if not unlikely to be readily available in
did sell. The TTHI, in contrast, available), one pack of a popular many countries.
employed a grid search method to local brand, and 50 grams of
canvass given geographic loca- MacBaren pipe tobacco; similarly, Survey approaches for meas-
tions to identify tobacco product ACCRA used to collect prices for a uring prices:
vendors. To the extent that there single product: a carton of Winston
are a large number of more king-sized cigarettes. Research- A third approach to collecting data
informal tobacco product vendors based observational data collection on tobacco product prices and
(e.g. street vendors, kiosks, etc. efforts have typically selected a price-related promotions is the use
that might not appear in com- subset of products that includes the of survey methods. These include
mercial business lists), the latter most widely consumed products/ mail and telephone surveys of
approach seems most appropriate. brands. When there are different tobacco product vendors and
A second challenge relates to price or other categories for some population surveys (including
the geographic area to be covered products (e.g. premium and surveys of tobacco users only).
by the observational data col- discount cigarettes, or international The cigarette price data that
lection methods. Producing and domestic cigarettes), then have been most widely used in
nationally representative price popular products/brands within economic studies of the impact of
measures in large countries would each category are collected. To the cigarette taxes and prices on
require multiple teams of ob- extent that there is limited variation smoking behaviour are the price
servers throughout the country within a given product category (e.g. data reported for the USA in the
and would involve considerable premium brand cigarettes), mea- Tax Burden on Tobacco (TBOT)
expense. Alternatively, the ap- sures of price based on (Orzechowski & Walker, 2007).
proaches used by the EIU and observational data collection for a Annual, state level average
ACCRA that limit data collection to small number of products will be a cigarette prices have been
cities or metropolitan areas and good reflection of overall prices. collected and reported for over
that employ convenience sam- A fourth challenge to five decades in the TBOT, with
ples, will be significantly less developing good measures of reported prices reflecting weighted
costly. However, to the extent that tobacco product prices, based on averages of prices for single
there are significant geographic the observational data collection packs, cartons, and vending ma-
199
chine sales (where weights are the mail survey were very low collected through population
based on national shares); since (less than 10%); response rates to surveys. A number of cross-
the growth of discount brands in the telephone survey were also sectional and longitudinal surveys
the late 1980s, alternative price low, albeit higher than to the mail have collected information on
series, one including discount survey. However, despite the cigarette prices from respondents.
brands and one excluding these relatively low response rates, the These include population surveys,
brands, have been produced. measures of price produced from such as the Global Youth Tobacco
Researchers have used these the three methods were generally Survey (GYTS), which has
price data to examine the impact of consistent with one another; included questions on price in
prices on tax paid cigarette sales though there was somewhat many of the countries in which the
(Farrelly et al., 2003a), adult smo- greater variance in the measures survey has been implemented,
king prevalence (Farrelly et al., of the extent of promotional activity. and the planned Global Adult
2001), smoking cessation (Tauras Similar efforts have been Tobacco Survey (GATS) (these
& Chaloupka, 2001; Tauras, 2004), undertaken in other countries. For surveys are described in Section
and youth smoking initiation example, data were used on 4.3). Similarly, the International
(Tauras et al., 2001). Reported cigarette prices collected from a Tobacco Control Policy Evaluation
prices are supposed to reflect the commune level survey to estimate Studys (ITC) longitudinal surveys
normal retail prices, exclusive of the impact of price on the initiation of adult smokers, that are being
any price-related promotions. The and cessation of tobacco use in conducted in a growing number of
price data are collected through a Vietnam (Laxminarayan & Deolali- countries, asks smokers how
mail survey of cigarette retailers kar, 2004). Likewise, cigarette much they pay for cigarettes. Most
across the USA. Limited infor- price data were collected from surveys that inquire about price
mation about the survey itself, market level surveys in China and only ask the relevant questions of
sampling frame, response rates, and Russia to estimate the impact of current users; some, however,
underlying data is available from price on smoking in these have asked all respondents, while
internal Tobacco Institute docu- countries (Lance et al., 2004). others have asked current and
ments (Tobacco Institute, 1991). The use of telephone or mail former users.
In exploratory work on data surveys of tobacco product The price data collected from
collection methods done as part of vendors to collect data on tobacco these surveys are useful in
the ImpacTeen project, resear- product prices and price-related developing aggregate measures
chers also conducted a mail and promotions faces several of the of price (e.g. at the national and/or
telephone survey of representative same challenges as described sub-national level, depending on
samples of tobacco product above for systematic obser- the nature of the sample).
retailers in three US states, along vational data collection. Of parti- However, the use of the indivi-
with observational data collection cular note are the difficulties in duals self-reported price in
in representative subsamples in developing an adequate sampling analyses that look at the impact of
each state. Prices were collected frame (particularly in countries/- price on respondents smoking
for ten brands of cigarettes in markets where more informal behaviour is problematic given the
three price categories (premium, vendors are important), the likely reverse causality between
discount, and deep discount), as feasibility of collecting detailed smoking behaviour and price.
well as for a few other widely data for many products, and the That is, heavier smokers, all else
consumed tobacco products. In challenges in aggregating the data the same, are more likely to
addition to price data, information in order to produce representative choose less expensive brands,
on various price-related pro- price measures. purchase in greater quantities,
motions was also collected. As Alternatively, price and price- seek out less costly vendors,
was expected, response rates to related promotions data can be engage in tax avoidance, and take
200
advantage of price-reducing pro- The last time you bought bought? Please report the cost
motions. Given this, treating the cigarettes for yourself, how many after using discounts or
self-reported price as an cigarettes did you buy? coupons.
exogenous determinant of $__ __.__ __
individuals smoking behaviour will INTERVIEWER: RECORD When asking questions about
lead to an overestimate of the NUMBER AND UNIT BELOW price and purchase-related
effects of price. Appropriately information, some surveys
aggregated measures of price 1. Cigarettes focus on the most recent
based on individual level self- 2. Packs purchase (as in the examples
reported prices can be used to How many cigarettes were above), so as to minimize
overcome this problem. in each pack ? _____ recall error and get a
In addition to using the surveys 3. Cartons consistent measure of current
to collect prices, it is important to How many cigarettes were prices. Other surveys focus on
also collect information on the in each carton? _____ the usual price paid, brand
brand that the individual pur- 4. Other: Specify: ______ consumed, and other pur-
chased including information on chase-related information. An
various characteristics of the How many cigarettes were in example of this is the series of
product (e.g. for cigarettes, length, each [FILL]? ___ price questions from the US
filter or no filter, and others), and Adult Tobacco Survey:
the quantity purchased (e.g. How much money did you pay
number of cigarettes, grams of for this purchase? How much do you usually pay
smokeless tobacco, etc.); these for a pack of cigarettes?
measures are discussed in detail _______ [FILL COUNTRY $___.___ ___
in Section 3.1. Some surveys use CURRENCY]
questions that rely on Ideally, the price questions How much do you usually pay
respondents ability to perform would be asked so as to capture for a carton of cigarettes?
mathematical computations (e.g. the use of any additional price- $___ ___.___ ___
on average, how much did you reducing promotions (e.g. cou- This approach has the ad-
pay for each pack of cigarettes pons) at this purchase; the vantage of capturing con-sumers
you bought last time?). For collection of data on use of typical behaviour, but will not pick
respondents that buy by the pack, promotions is described in more up any changes in behaviour that
this is straightforward; it is detail in Section 5.4. One example may be particularly relevant for
somewhat more difficult for those of these types of price questions, measuring price (e.g. a smoker
who buy by the carton and even from the US Current Population taking advantage of a buy-one-
more difficult for those who take Surveys Tobacco Use Supple- get-one-free promotion for a brand
advantage of multi-pack specials ment (where the majority of other than the usual brand on their
(e.g. buy-three-get-two-free). purchases are by the pack or last purchase). Some ask ques-
Alternatively, one could ask how carton), is: tions on both usual and most
much the respondent paid for their What price did you pay for the recent purchase (e.g. some
purchase and what quantity was LAST pack of cigarettes you versions of the ITC surveys
purchased (e.g. for cigarettes, in bought? Please report the cost include variants of both types of
packs, cartons, single cigarettes, after using discounts or coupons. questions).
other combinations). For example, In addition to, or as a substitute
the first draft of the GATS $___.___ ___ for, asking respondents for some
questionnaire includes the What price did you pay for the of the detailed information on the
following questions: LAST carton of cigarettes you products they consume, some
201
surveys have asked respondents products). This type of derived impact on tobacco use behaviours
to report the UPC on the pack of measure of price should be used (e.g. promote efforts to quit or
cigarettes that they are currently with more caution than the more prevent youth from starting to
consuming (which can be used to direct measures described above consume regularly), the price
determine brand, filter, flavor, given the potential compounding increases need to be noticed and
length, etc.); the same could be of errors across the various of sufficient magnitude to raise
done for other manufactured questions. This is of particular concerns in the user. How large
tobacco products. Likewise, in concern in household expenditure the increase needs to be for this to
some face-to-face surveys (e.g. surveys where one family member happen, however, is moderated
the version of the ITC survey reports on overall household by the users (or potential users)
conducted recently in Poland), expenditures and consumption, characteristics, including their
respondents are asked to show and/or in surveys where broad tobacco use. For example, eco-
the interviewer the pack that they measures of tobacco expenditures nomic theory predicts that
are currently consuming; the and use are reported, rather than low-income persons will generally
trained interviewers can then measure of product-specific be more responsive to changes in
record this information, along with expenditures and consumption. prices of the goods and services
other relevant information that can Researchers have used either they consume than will high-
be helpful in assessing the extent self-reported prices or price income persons, given that
of tax avoidance and smuggling measures based on self-reported consumption of each accounts for
(as discussed below). In many expenditures in a variety of a greater share of the individuals
countries, price is recorded on the studies. For example, one analy- budget. Empirical evidence con-
pack; to the extent that this is the sis of the demand for cigarettes in firms that this is the case for
case, respondents (or the Bulgaria used self-reported tobacco products (Townsend et al.
interviewer) asked to examine the cigarette prices (Sayginsoy et al., 1994; Farrelly et al., 2001).
pack can report the listed price. 2002), while another used a Developing good measures of
Some efforts to measure measure of price derived from this awareness and concern is
tobacco product prices rely on self-reported expenditures to more challenging than measuring
consumer or household expen- estimate the demand for tobacco observable variables like tax and
diture surveys. These surveys in Myanmar (Kyaing et al., 2005). price. Nevertheless, a number of
typically collect information on As discussed above, the ability population surveys have attemp-
expenditures on a wide variety of to use these data to assess how ted to address this by collecting
goods and services, including changes in tobacco product data on the role of tax and price
tobacco products, consumed by taxation affect the price con- changes in an individuals
the individual/household over sumers pay for these products will smoking decisions, concerns
some specified period of time (e.g. depend on the collection of other about tax and price increases,
previous week, previous month). key variables. Example questions perceptions of responses to
Some of these surveys also addressing other issues relevant increases in prices, responses to
include questions on tobacco to price are contained in other specific recent tax/price changes,
product consumption and, in sections of this Handbook (e.g. perceptions about the effective-
household surveys, who in the brand choice in Section 3.1, use of ness of price increases in
household consumed these promotions in Section 5.4). reducing smoking (particularly
products. Responses to these Finally, some surveys collect a among youth), support for tobacco
questions can be used to estimate variety of other information related tax increases, and other related
price (by dividing total expen- to tobacco taxation and tobacco attitudes and beliefs. Little
ditures on tobacco products by product prices. For tobacco tax research exists on the relation-
total consumption of these increases to have a meaningful ships of tax and price increases to
202
these questions and there is little about the rising price of absence of comparable baseline
evidence on their validity. A few cigarettes? (US-FATMESS) data or when attempting to dis-
examples of these types of Do you like raising the price of entangle the effects of tax
questions include: cigarettes to keep people from changes from other policy
In the last 6 months, have you smoking? (US-FATMESS) changes around the same time.
spent money on cigarettes that How much additional tax on a
you knew would be better pack of cigarettes would you Summary:
spent on household essentials be willing to support if some or
like food? (ITC) all the money raised was used Three alternative methods can be
In the last month, how often, if to support tobacco control used to measure tobacco product
at all, did you think about the programmes? (US Adult Toba- prices for use in assessing the
cost of smoking? (ITC) cco Survey (US ATS)) impact of tobacco taxation on
If the price of cigarette rose price and, ultimately, on tobacco
today by $__.___ per pack, how These questions can provide behaviours. These methods have
many cigarettes do you think data that may be useful for other different strengths and weak-
you would smoke per week? purposes, but are not of primary nesses and the cost of
(with comparable questions importance for evaluating the implementing each can vary
about switching to a cheaper impact of tobacco taxation considerably. To the extent that a
brand, trying to quit, buying by (except, perhaps, in some limited national measure of price is of
the carton instead of the pack, circumstances). Questions about most interest and a regularly
etc.) (variations in ITC) support for tobacco tax increases repeated population survey of
Did the price of cigarettes affect can be helpful in demonstrating tobacco use is in place, including
your decision to stop smoking? public support for these increases, questions on price in such a
(with comparable questions and those that tie support to survey would be the most efficient
about starting, daily versus funding of tobacco preven- approach to collecting this mea-
occasional smoking, and tion/cessation programmes can sure. Table 5.4 briefly summarizes
quantity smoked) (Ontario similarly demonstrate support for each.
Tobacco Research Unit Cana- these programmes; there are risks
dian tobacco survey database to furthering tobacco control, Distal variables: measuring
(OTRU)) however, if responses indicate a tobacco product purchase
Now thinking about your own lack of support. Questions on behaviour
patterns of smoking, how much expected responses to tax and
effect on your smoking do you price increases can be used to To some extent, the impact of
think each of the following estimate the potential revenue tobacco taxation on tobacco use
would have in reducing your and public health impact of behaviour will depend on oppor-
smoking...(a) if the price of proposed tax increases; these tunities for tobacco users (and
cigarettes doubled, would this types of questions are common in potential users) to minimize the
have a... (OTRU) market research studies, but their effects of the tax increase on the
The price of cigarettes has a predictive validity for tobacco prices they pay for tobacco
big influence on keeping research has not been assessed. products. These opportunities will
people your age from smoking Questions about responses to vary from location to location and
(agreement/disagreement scale) recent tax increases (or will depend on factors such as:
(1999 Florida Anti-Tobacco decreases, as was the case in
Advertising/Media Evaluation - Canada in the mid-1990s) can be the variety of tobacco products
State Survey (US-FATMESS)) useful in assessing the impact of available and the relative
Have you talked with friends these changes, particularly in the prices of these products, given
203
Construct Prices of Tobacco Products
Measure 1 Technology-based systems for measuring prices, e.g. scanner-based retail sales data,
radio frequency identification tags, in-home scanners.
Sources A. C. Nielsen (http://www.acnielsen.com), Information Resources International (IRI;

http://www.infores.com), Sofres, Taylor and Nelson, Inc. (http://www.tns-global.com)
Validity Clearly validated
Variation Comprehensiveness of sample varies over time within countries, and will vary considerably
across countries as technologies diffuse. Validity will depend on the comprehensiveness of
the system.
Comments More comprehensive data than other approaches (e.g. brand and package-specific
information, census of prices paid for every sale, price-related promotion). Limitations include
incomplete participation of tobacco product vendors (particularly where there is a large
informal sector), limited use of technology in many low- and middle-income countries,
incomplete geographic coverage, and relatively high cost of the data.
Measure 2 Observational approaches, e.g. trained observers visit tobacco product vendors and collect
price information.
Sources Economist Intelligence Unit (EIU; http://www.eiu.com), ACCRA (http://www.coli.org),

research-based efforts (e.g. ImpacTeen http://www.impacteen.org), consumer price index,
tobaccoproducts component
Variation Existing international systems (EIU) provide limited product, outlet, and geographic
coverage. More comprehensive systems could be developed at the country level for
expanded set of products, more systematic sampling of vendors, and more representative
geographic coverage. Validity will depend on the extent of implementation (e.g. products
included, sample of vendors, and geographic coverage).
Comments There are challenges in getting a comprehensive sample within and among geographic
regions. It is also a challenge to determine which prices to assess and how to aggregate
across brands. Costs of implementing a comprehensive system are likely to be high in most
countries.
Table 5.4 Measure of Tobacco Product Prices
204
Measure 3 Survey approaches: mail and telephone surveys; population surveys.
Sources U.S. Tax Burden on Tobacco (TBOT), Global Youth Tobacco Survey (GYTS), Global Adult
Tobacco Survey (GATS), The ITC Project
Variation For vendor surveys: inclusion or exclusion of price-related promotions in prices; mix of
products on which price/promotion data are collected; sample of vendors included; mail
versus telephone survey. Validity will depend on comprehensiveness of survey, sample of
vendors, and response rates. For population surveys: focus on last purchase versus usual
purchase, quantity purchased, inclusion of price promotions. Validity will depend on the
quality of the price questions.
Comments For vendor surveys: response rates are low; difficult to develop an adequate sampling frame
and collect detailed data on many products. For population surveys: self-reported price at
the individual level should not be used to study the impact of price on individual level tobacco
use behaviours; subnational aggregation of price can be problematic.
ACCRA: Formerly, American Chamber of Commerce Researchers Association
Table 5.4 Measure of Tobacco Product Prices
the opportunities for sub- chased (e.g. prices for ciga- others may come through
stitution from one type of rettes that are lower per other channels (e.g. coupons
tobacco product to another in pack/per stick when purchased in print advertising and direct
response to changes in relative by the carton rather than by the mail promotions) (see Section
prices that result from changes pack) 5.4)
in taxes (e.g. switching to roll- the availability and extent of differences in prices among
your-own tobacco in response industry promotions that local tobacco vendors (e.g.
to an increase in taxes/prices reduce the price or provide differences in prices between
on manufactured cigarettes) added value for at least some convenience stores where a
the variety of brands for a purchases including: on-pack premium is paid for the con-
given type of product, par- money off coupons; multi-pack venience) and less con-
ticularly brands in different promotions (a different form of venient, bulk purchase stores
price categories, that allow for quantity discount, such as buy- where quantity discounts are
switching to less expensive one-get-one-free promotions); extensive
brands in response to in- special price reductions at the the extent of an informal
creases in taxes and prices point of sale; distribution of free market in tobacco products
(e.g. difference in prices cigarettes at sponsored and (e.g. street vendors with no
among premium, discount, and other events; and value added fixed location), particularly as it
deep discount brands; dif- promotions, such as gifts with allows for distribution of
ferences in prices between purchases (e.g. a free smuggled and/or counterfeit
international brands and locally cigarette lighter with the pur- tobacco products
produced brands) chase of a pack of cigarettes). access to lower tax/price
the availability of discounts Some of these will be available jurisdictions and/or distribution
based on the quantity pur- at the point of sale, while channels (e.g. other countries,
205
tax-exempt jurisdictions, such the types of promotions on at least The GATS questions on price
as Native American reser- a selected set of these products. above provide a more flexible way
vations in the USA, the Internet, On the other hand, they can be of obtaining quantity purchased
and other direct tobacco applied to many different types of that can be applied in a wider
product vendors), and ready tobacco product vendors (inclu- range of settings than either of
access to these jurisdic- ding direct vendors, those in the these questions. Similar questions
tions/channels that allow rela- informal sector, and others that can be developed for other
tively easy, low cost oppor- allow for tax avoidance in nearby tobacco products. As evidenced
tunities to purchase from/ jurisdictions). by these questions, timing of
through them. Similarly, information on all of purchase can vary, with questions
As described in some detail these measures can be collected focusing on most recent purchase,
above for measuring price, there through surveys of tobacco users. regular/usual purchases, any
are multiple methods for collection As discussed in Section 3.1, purchase, and purchases over
of and/or multiple sources for surveys can provide good mea- some specified period (last week,
these data. The technology-based sures of the types of tobacco last month); the same will be true
systems can provide com- products consumed, as well as on for other questions on purchase
prehensive information on the brand choice, while the aggregate behaviour (Table 5.5).
range of products and brands that data described in Section 4.2 can
are sold in different types of be used to look at the market Purchase location:
outlets and on the relative prices share for different types of
across products/brands, many of products and/or brands. Section Many recent surveys have
the types of industry promotions 5.4 describes the use of surveys included a question or series of
for them, and/or the quantity to measure awareness of and questions on purchase location,
discounts that are available on participation in a variety of tobacco including type of vendor pur-
each. However, as discussed industry promotional efforts, in- chased from and efforts to avoid
above, these databases are cluding those that impact on the taxes by purchasing from different
limited in several ways, par- price tobacco users pay for the jurisdictions (Table 5.6). Given the
ticularly in capturing the full range products they consume. extensive variation across coun-
of tobacco product vendors (most tries, the response categories for
notably those in the informal Purchase quantity: these types of questions will need
sector, the Internet, and other to be tailored to a given country so
direct vendors), and their utility for Buying in greater quantity (e.g. by as to include responses that
assessing the tax avoidance that the carton instead of the pack) can capture the full range of vendors
can emerge in response to tax reduce the per unit cost of tobacco and locations available to tobacco
and price increases. products. Many surveys have users. For example, the following
Observational methods can assessed purchase quantity; question has been asked of
produce similar information on some examples of these ques- cigarette smokers in recent waves
some of these measures. While tions include: of the ITC survey in Poland (for
not providing the extensive detail The last time you bought ciga- both last purchase and usual
on product, brand, relative prices, rettes for yourself, did you buy purchase):
promotions, and sales that is them by the carton, the pack, or Where did you buy your last
available in the technology-based as single cigarettes? (ITC) pack of (or do you usually buy)
systems, observational methods Do you usually buy cigarettes cigarettes? (Gas station, Hyper-
can provide at least some by the pack or the carton? (US market, Grocery store/deli, To-
measures of the range of tobacco ATS) bacco Shop, News stand/Kiosk,
products and brands available and Marketplace (stationary stand/
206
Construct Purchase Behaviour - Purchase Quantity
Measure The last time you bought cigarettes for yourself, how many cigarettes did you buy?
RECORD NUMBER AND UNIT BELOW
1. Cigarettes
2. Packs How many cigarettes were in each pack? _____
3. Cartons How many cigarettes were in each carton? _____
4. Other - Specify: _____________________________
How many cigarettes were in each [FILL]?
Source GATS (draft questionnaire)
Validity Evidence of utility, but with limitations.
Variation Can be developed for other tobacco products; can be simplified where product packaging
is standardised; can ask about last purchase or usual purchase quantity. Accuracy of self-
report unclear, particularly from questions that limit responses to packs and cartons.
Comments Important for assessing efforts to minimize price in response to tax increase by buying larger
quantities which often reduce the per unit price.
Table 5.5 Measures to Assess Purchase Quantity
fixed seller), Street seller (mobile types of stores. The draft GATS are also of some use in measuring
seller), Over the Internet, Whole- questionnaire includes military the extent of tobacco users tax
saler, Black Market, Other) stores (which are often tax avoidance (i.e. their efforts to
Versions of the ITC surveys in exempt) and vending machines as avoid taxes by purchasing their
other countries exclude some of options, while noting that the list tobacco products in tax exempt
these responses, but include needs to be adjusted to fit the local locations, such as Native Ameri-
others; for example, the French environment. can reservation stores or from
version asks about purchases direct sales vendors located on
outside France, but within the EU, Tax avoidance: reservations, duty free shops,
as well as purchases outside the military stores), or from vendors
EU. US and Canadian surveys Data from the questions on based in lower tax jurisdictions
ask about purchases in other purchase quantity and location, (e.g. in neighboring or nearby
states and provinces, respectively, coupled with the price, product, countries or sub-national juris-
as well as in other countries and brand, and promotion questions dictions, the Internet, and other
on Native American reservations discussed above and elsewhere in direct vendors based in low
(which are exempt from state/ this Handbook, are helpful for tax/price jurisdictions) (Table 5.7).
provincial taxes). Most versions of assessing users efforts to Finally, they have some utility in
the ITC survey include duty-free minimize prices by changing assessing the extent of more
shops as an option, and separate various aspects of their tobacco organised smuggling (the illegal
convenience stores from other product purchase behaviour. They transportation, distribution, and/or
207
Construct Purchase Behaviour - Purchase Location
Measure Where did you buy your last pack of cigarettes?
Responses tailored to local environment, can include: gas station, hypermarket,

supermarket, grocery store/deli, convenience store, large discount store, tobacco shop,
news stand/kiosk, marketplace (stationary stand/fixed seller), street seller (mobile seller),
Native American reservation, military store, over the Internet, by mail, by telephone,
wholesaler, another jurisdiction (e.g. country, state, province), black market, others
Sources The ITC Project, GATS, and other surveys
Variation Response categories need to be tailored to the specific country; can ask about last purchase
versus usual purchase. Where used, the distribution of responses and trends over time have
expected associations with other factors.
Comments Important for assessing efforts to minimize price in response to tax/price increase by
purchasing from lower price vendor.
The ITC Project: The International Tobacco Control Policy Evaluation Study
Table 5.6 Measures to Assess Purchase Location
sale or resale of tobacco products, coupled with information on which may moderate the impact of
generally in an effort to avoid all quantity purchased, can be useful tobacco tax increases on price
taxes), and/or counterfeiting (pro- in producing upper and lower and tobacco use behaviour) is
duction and sale of cigarettes bound estimates for the extent of more difficult than measuring the
using brand names and packaging these problems. They can also be constructs described above. While
of popular brands sold by leading useful in assessing the impact of tobacco tax and price levels can
tobacco companies, typically some of the policies designed to help to explain the extent of
without paying taxes), to the increase tax compliance that were smuggling, other factors can be as
extent that some of the potential mentioned above (e.g. policies or more important in doing so;
vendors will largely be selling targeting the Internet and other these include the degree of
smuggled or counterfeit cigarettes direct sales). corruption in a country and the
(e.g. mobile street vendors selling nature of tobacco product
from backpacks or those in the Measuring tobacco product distribution (Jha & Chaloupka,
black market). When assessing smuggling 1999; Merriman et al., 2000;
tax avoidance and smuggling is of Merriman, 2001). Moreover, im-
particular interest, asking these Given the illegal nature of tobacco provements in technology,
questions for last purchase, usual product smuggling, measuring its adoption of new policies, and
purchase, and any purchase over extent for use in assessing the strengthening of enforcement ef-
a specified time period (e.g. three impact of tobacco taxation (both forts and penalties appear
or six months), particularly when as an outcome and as a factor effective in reducing the amount of
208
Construct Purchase Behaviour - Tax Avoidance
Measure Questions on purchase location, quantity, and price described in previous tables
Sources The ITC Project, GATS, and other surveys
Variation Purchase locations relevant for assessing tax avoidance will vary from country to country.
Purchasing from other jurisdictions, duty free shops, street sellers, and direct vendors (e.g.
on the Internet) will typically reflect efforts to avoid local taxes; some locations will be relevant
to assessing smuggling. Where used, associations between these measures and other
factors (e.g. local taxes, proximity to lower tax or tax-exempt jurisdictions) are expected.
Comments Information on differences in prices across vendors can help identify those that may be
relevant for tax avoidance, coupled with information on quantity purchased (both last
purchase and usual purchase) can provide a range for estimates of the extent of tax
avoidance. Will be useful in addressing concerns about loss of tax revenues to tax avoidance
in response to tax increases.
The ITC Project: The International Tobacco Control Policy Evaluation Study
Table 5.7 Measures to Assess Tax Avoidance
tobacco product smuggling Understand, Measure, and market accounted for by

(Chaloupka et al., 2008). Despite Combat Tobacco Smuggling of smuggling. Market research firms
this, concerns about smuggling the World Banks Economics of have used this approach and
often emerge as significant Tobacco Toolkit (http://www. published estimates of the share
barriers to increased tobacco worldbank.org/tobacco) (Merriman, of the market accounted for by
taxation. Developing good esti- 2001). These will be briefly smuggled cigarettes (e.g. Market
mates of the extent of smuggling described here (Table 5.8); those Research International has
can be helpful in addressing these interested in applying these published these in the World
concerns. It is worth noting that approaches should refer to the Tobacco File). Researchers have
counterfeit cigarettes are emer- tool for more details. Some of linked these data to potential
ging as a significant component of these have been applied relatively determinants of smuggling (e.g.
illicit markets in tobacco products. widely, while others have yet to be tax or price levels, corruption
Some of the methods and systematically applied (or even (Merriman et al., 2000)), and the
measures described in this section pilot tested). resulting estimates suggest that
will be applicable to assessing the The first approach is to the measure produced from the
degree of counterfeit as well; for conduct key informant interviews key informant interviews are useful
ease of exposition, however, the with relevant industry repre- in comparing across countries.
discussion here will focus on sentatives, law enforcement When aggregated, estimates of
smuggling. agents, government officials, and global smuggling produced from
Five alternative approaches to researchers working on these these data are consistent with
measuring tobacco product smug- issues to get their estimates of the those produced from other
gling are described in Tool 7 extent of the tobacco product methods described below, sug-
209
Construct Tobacco Product Smuggling
Measure 1: Surveys of industry representatives, law enforcement agents, government officials, and
Key Informant Survey- researchers to obtain their estimates of the extent of tobacco product consumption
based Estimates accounted for by smuggled products.
Measure 2: Comparison of import and export statistics to determine extent to which exported products
International Trade do not appear as imports in the countries they were shipped to; utility at the country level
Data-based Estimates is unclear.
Measure 3:
Estimates Based on Difference between estimated total consumption from self-report survey data and tax paid
Comparison of Tax Paid sales data can provide estimate of combined tax avoidance and smuggling; accuracy will
Sales Data and Self- depend on biases in both and on changes in biases over time.
report Survey Data
Measure 4: Use of tax paid sales data to estimate demand for tobacco products, controlling for key
Estimates Based on Econometric Modeling of determinants (e.g. price, income, policies) and including
Econometric Modeling measures of potential for tax avoidance and smuggling. Accuracy of estimate will
of Demand for Tobacco depend on quality of data, ability to control for key determinants of demand,
products and the ability to measure potential determinants of tax avoidance and smuggling.
Measure 5: Surveys to identify users tax avoidance efforts through questions on purchase location and
Estimates from price, can also include efforts to have survey respondents and/or interviewers report on
population Surveys aspects of packaging including tax stamps, warning labels, and other labeling/markings on
pack.
Measure 6: Observation of tobacco product vendors to look for tax stamps, warning labels, and other
Estimates Based on labeling/markings on pack in effort to identify smuggled products.
Observation of Tobacco
Product Vendors
Source Most methods are described in World Banks Economics of Tobacco Toolkit: Tool 7
Understand, Measure and Combat Tobacco Smuggling (Merriman, 2001).
Variation Alternative methods likely to produce different estimates of the extent of tobacco product
consumption accounted for by smuggling. Where multiple methods have been used,
resulting measures are generally correlated with one another and have the expected
associations with other factors (e.g. corruption).
Comments Most methods have not been applied widely and more research is needed to determine the
validity of the estimates they produce. A combination of methods is likely to be needed to
obtain good estimates of the extent of consumption accounted for by smuggling. Good
estimates will be important in addressing concerns over the extent to which smuggling will
emerge/grow in response to tobacco tax increases.
Table 5.8 Measures for Assessing Tobacco Product Smuggling
210
gesting that they are valid at some may be systematic biases in both states, weighted by state popu-
level. Whether or not they provide the tax paid sales data (Section lations and distances from state
accurate country level estimates 4.2) and the survey data (Section borders (Farrelly et al., 2003a).
has yet to be fully assessed. 3.1) that can limit the utility of this Others have looked at this issue
A second approach described approach. However, as discussed across countries (Merriman et al.,
in the World Banks smuggling in the World Bank tool, to the 2000). The World Banks smug-
tool, as well as discussed in extent that these biases are gling tool provides a detailed
Section 4.2 of this Handbook, is constant over time, changes in the step-by-step explanation for using
the use of international trade data difference between the two this approach.
to track smuggling. This approach measures can be assumed to The final approach described
looks at differences between a reflect changes in tax avoidance in the World Bank smuggling tool
countrys reported tobacco ex- and smuggling. However, to the is to use population surveys to try
ports to other countries and those extent that the biases in the two and identify the extent of use of
countries reported imports. This measures change over time and smuggled tobacco products. The
approach is useful in assessing to differing degrees, this approach question(s) on location of pur-
the extent of smuggling globally, will be less useful in measuring chase described above provide
but is of limited utility for gauging trends in tax avoidance/ smug- some information that can be
the extent of tobacco product gling. useful in assessing the extent of
consumption accounted for by A fourth approach is to use the consumption accounted for by
smuggled products at the country tax paid sales data to model the smuggled products (e.g. based on
level, given that one can not demand for tobacco products, purchases in the black market or
identify where the products that controlling for key determinants of purchases from vendors more
disappear in transit end up being sales (e.g. prices, incomes, other likely to sell smuggled products,
consumed. Some have assumed tobacco control policies) and such as mobile street vendors).
that they end up in the country that including variables that measure Some surveys have gone
they were destined for based on the opportunities for tax avoidance further in trying to identify
reported exports, but this is a and smuggling. These variables consumption of smuggled pro-
tenuous assumption at best. At would reflect the extent and ease ducts. As briefly noted above, this
the global level, estimates of access to lower tax/price is done by asking survey
produced by this approach are jurisdictions (e.g. extent of Internet respondents or, in face-to-face
comparable to those produced access, price differences between surveys, interviewers to examine
from the key informant approach. neighboring countries, distribution the package from which the user
A third approach is the of population near borders, extent is currently consuming for specific
comparison of data on tax paid of travel between countries), features that can indicate whether
tobacco product sales and corruption, and other variables or not local taxes were paid on the
national estimates of tobacco associated with tax avoidance and product. Information on the
product consumption based on smuggling. Estimates from these presence or absence of a tax
self-reported survey data. To the models can be used to produce stamp, presence or absence of
extent that there are no reporting estimates of the extent of tax local warning labels, and other
biases in either, differences avoidance and smuggling by package labeling (e.g. that
between tax paid sales and predicting what tax paid sales indicates where the product was
reported consumption will reflect would be if these variables were intended for sale or that reports
the combination of organised set to zero. Several studies in the tar, nicotine, and carbon mon-
smuggling and individual tax USA, for example, include mea- oxide) can be collected. This
avoidance. As described in other sures that reflect the differences in approach, in part, depends on
sections of this Handbook, there taxes or prices between USA whether or not tax stamps,
211
warning labels, and/or other identify smuggled cigarettes in a or nearly all countries are likely to
markings are required on tobacco small convenience sample in violate the principle of vertical
product packaging and on ones Vietnam (Joossens, 2003) and in equity, implying that these taxes
ability to link these to specific a pilot study in Poland (http:// are regressive (account for a
countries; something that seems www.tobacco evidence. net/activi- higher proportion of total income
reliably done by trained inter- ties_workshop.html), but has not for low-income persons). This
viewers rather than by survey been systematically applied at the results, in part, from the greater
respondents. For example, in national level in any country. concentration of tobacco use
recent waves of the ITC Poland As the discussion illustrates, among less educated, lower-
survey, interviewers have been each of these approaches has income persons in most countries.
trained to recognize Polish tax limitations and none will provide Even in countries where tobacco
stamps, warning labels, and the definitive measure of smug- use increases with income, the
tar/nicotine/carbon monoxide con- gling. Each approach needs to be increase is unlikely to be pro-
tent labels, as well as those from validated and refined; however, portional to income, implying that
the Ukraine, Belarus, and Russia; together they are likely to produce the share of income accounted for
if observed stamps/labels are from a good measure of the extent of by tobacco taxes falls as income
another country, this is recorded tobacco product smuggling (Table rises. However, several observers
and the country identified, if 5.8). have noted that while tobacco
possible. This approach depends taxes may be regressive, tobacco
on users willingness to produce Incidental ef fects: fairness tax increases can be progressive
the package from which they are of tobacco taxes given that tobacco use among the
currently consuming and on the poor falls more sharply when
respondents or interviewers The burden of tobacco taxation on taxes and prices are increased
ability to report this information. In the poor (regressivity of the tax) is than it does among those on
the ITC Poland survey, the vast often raised as a concern in higher incomes, so that a greater
majority of smokers have pro- debates over tobacco tax share of the increase is paid by
duced the pack from which they increases. Evaluating the impact higher-income consumers (Cha-
are consuming and interviewers of tobacco taxation and increases loupka et al., 2000a). Moreover,
appear to be successfully in tobacco taxes on equity can be the equity implications of tobacco
recording relevant information. helpful in addressing this concern. taxes should not be considered in
A related approach that is not Equity (or fairness) is a key isolation, but rather as part of the
discussed in the World Banks consideration in the development overall fairness of a countrys
smuggling tool, but that has been of any tax policy, including fiscal system, which will depend
pilot tested in limited settings, tobacco tax policy. Economists on the distributional effects of
builds on the observational data generally consider both horizontal other taxes as well as of
collection methods discussed equity and vertical equity when government spending. For
above. Observers can be trained looking at tax policy. Horizontal example, to the extent that the
to recognize local and foreign tax equity implies that individuals with new revenues generated by
stamps, warning labels, and other the same income should pay the tobacco tax increases are used to
package labels/markings, and can same tax, while vertical equity fund tobacco cessation pro-
collect this information on suggests that those with the grammes targeting the poor (e.g.
packages available for sale in the greatest ability to pay (those with subsidizing treatment and coun-
outlets observed when collecting higher incomes) should pay more seling for low-income users) and
price, promotion, and other data. in taxes that those with lesser to support other progressive
This approach has been used to ability to pay. Tobacco taxes in all programmes, concerns about the
212
burden of the tax increase on the taxation, a highly effective tool for most interest and a regularly
poor are at least somewhat reducing tobacco use. The impact repeated population survey of
alleviated. This approach was of tobacco taxes on tobacco use tobacco use is in place, including
used in the USA for example, behaviours (see Sections 4.2 and questions on price in such a
where revenues generated from 3.1) is mediated by tobacco survey would be most efficient.
cigarette tax increases have been product prices, tobacco company Measuring tobacco product pur-
used to support the expansion of price-related marketing efforts chase behaviour can be easily
the state Childrens Health (see Section 5.4), tobacco users done through the addition of a
Insurance Programme, which purchase behaviour, tax avoid- limited set of questions to this
provides health insurance for low- ance, and smuggling. survey (see Tables 5.5 and 5.6 for
income children. Measuring tobacco product recommended measures). Devel-
Evaluating the equity implica- taxes is straightforward (see Table oping accurate measures of tax
tions of tobacco taxes and tax 5.2), with information on the level avoidance and tobacco product
increases is typically a com- and structure of these taxes smuggling is more challenging
plicated exercise. Those interes- readily available from the Ministry and the validity of these measures
ted in assessing the equity of Finance and other sources (e.g. is unclear and needs further
implication of tobacco taxation are the International Monetary Fund, research. Some of the questions
encouraged to see Tool 6 Equity the WHOs Global Tobacco on purchase behaviour in
Issues, Tobacco, and the Poor of Control Report). In some coun- population surveys can be used to
the World Banks Economics of tries, it will also be important to provide a range for the extent of
Tobacco Toolkit, which provides measure subnational taxes. Three tax avoidance (see Table 5.7).
detailed, step-by-step methods for methods for measuring tobacco Multiple methods, most of which
doing this (Peck, 2002). product prices were discussed in have not been widely applied and
this section: technology-based, which need further research, can
Summary and observational, and survey-based. be used to assess the extent of
recommendations These methods have differing tobacco product smuggling (see
strengths and weaknesses and Table 5.8).
This section focused on the their costs will vary considerably
measures that are needed for (see Table 5.4). To the extent that
evaluating the impact of tobacco a national measure of price is of
213

smoke-free policies
Introduction smoke exposure and thus to implementation period of smoke-

improve health outcomes. There are free policies, variables of interest
Article 8 of the FCTC, calls for several measures that should be are those associated with com-
greater protection from exposure to considered when assessing the pliance with the policy and how this
tobacco smoke (Figure 5.4). In the effectiveness of smoke-free poli- relates to secondhand smoke (SHS)
1980s, some countries began to cies, and factors that might exposure. During post-policy
implement subnational smoke-free influence how the policy may con- introduction, these variables remain
policies. By 2004, Ireland, Norway, tribute to reductions in secondhand of interest, but there are others
and New Zealand were the first smoke exposure, as well as more including how health and economic
countries to implement compre- distal outcomes related to second- indicators may have or have not
hensive smoke-free worksite poli- hand smoke beliefs, attitudes, and changed. Understanding each of
cies that also included restaurants practices. Furthermore, there are these areas is useful for evaluation
and bars. Motivated in part by the also potential incidental effects of purposes and helps to guide
FCTC mandate to expand smoke- smoke-free regulations, such as subsequent policymaking.
free policies, other countries have possible business losses/gains, and Figure 5.5 presents the logic
followed suit, but the vast majority of increased cessation activity among model guiding the constructs
nations have not made progress in smokers. discussed in detail in this section.
this area. Understanding if these There is value to assessing First we need to understand the
policies are effective in achieving constructs around smoke-free nature of the policies. What areas
their goal of reducing exposure to initiatives, both before, during, and are covered and are there
secondhand smoke and improving after their introduction as policy. exemptions or possible loopholes?
health outcomes, is important not Before they are introduced in a Within a jurisdiction, there may be
only for policymakers in places that jurisdiction, the main variables of local policies (from local govern-
pass smoke-free policies, but also interest are an inventory of the level ment), or business-specific policies
to help inform policymaking in other of existing smoke-free policies, as that need to be considered.
jurisdictions. well as the belief about the health The next step is to consider the
The main goal of smoke-free harms, and attitudes to restrictions impact of these policies on markers
policies is to reduce secondhand in various locations. During the early of exposure to SHS, which is the
Parties recognize that scientific evidence has unequivocally established that exposure to tobacco smoke causes death,
disease and disability. Each Party shall adopt and implement in areas of existing national jurisdiction as determined by
national law and actively promote at other jurisdictional levels the adoption and implementation of effective legislative,
executive, administrative and/or other measures, providing for protection from exposure to tobacco smoke in indoor
workplaces, public transport, indoor public places and, as appropriate, other public places.
WHO (2003)
Figure 5.4 WHO FCTC Article 8: Protection from exposure to tobacco smoke
215
Public
Smoke-free policies
Incidental effects
Economic impact,
home smoking bans,
cessation behavior Policy-specific mediators
(3.1)
Compliance with
smoke-free policies
Moderators
SHS awareness /attitudes,

occupation, SES, other tobacco
control policies
General mediators
SHS exposure
Outcomes
Health of nonsmokers
Figure 5.5 Conceptual framework for the evaluation of smoke-free policies

Numbers in parentheses indicate section in the volume covering the topic
SHS = secondhand smoke
SES = socio-economic status
key proximal variable of interest. More distal variables that may their own personal spaces, such
Compliance with the policy is change in response to smoke-free as their home and car. For
critical at this point in the model, policy implementation include: example, local, grass roots
as poor compliance will weaken peoples beliefs about the dangers movements in scores of com-
the public health benefit of the of SHS, their opinions about the munities in California waged a
smoke-free policy, and could even social norms of smoking in public information campaign,
result in a backlash where different places, as well as the which led to the passage of local-
policymakers overturn the policy translation of these beliefs into level clean air policies. Policies
because it is ineffectual. changes in their personal choices can change social norms and
regarding rules about smoking in beliefs and vice versa.
216
Measures to assess the effectiveness of smoke-free policies
The primary goal of smoke-free moderate the impact of a smoke- documentation is relatively simple
policies is to protect the health of free policy. The list of moderator to obtain, and their stipulations
nonsmokers. The greatest benefits variables presented is not ex- provide a standard to be validated
should be experienced by those haustive, but is meant to provide against individual exposure data.
who previously had the greatest an overview of additional variables The negative implications are that
exposure. For example, bar- an evaluator should consider. the implementation of policies
tenders and wait staff, who More details on relevant modera- does not always correlate well
previously worked in smoky en- ting variables are presented in with actual exposure, due to poor
vironments, would derive greater Section 3.2. compliance and enforcement.
health benefits that a stay-at-home These policies only cover public
mother or an employee whose Smoke-free policy measures spaces, and measuring them can
worksite had already been smoke- get complicated in countries with
free. Through the FCTC mandate, sub-national policy activity.
There may also be some countries are obligated to push for
incidental effects that need to be stronger legislation protecting Policy-specif ic mediators or
rigorously studied in order to workers and the public from SHS. proximal measures compli-
address concerns about the impact This is usually accomplished ance with smoke-free policy
of these policies. One concern that through the passage of policies
is raised in nearly every poli- restricting where smoking can Three types of smoke-free policy
cymaking debate about the merits occur in public environments. In compliance measures are sum-
of smoke-free policies, is that its some countries, this might mean marized in Table 5.10: 1)
implementation will adversely im- something as simple as requiring self-report of policy type imple-
pact the economy, as smokers will hospitals to provide a smoke-free mented; 2) direct observation of
stop dining out and going to bars. indoor environment, while others com-pliance; and 3) government
Often this is the central issue of the have adopted comprehensive enforcement and compliance
debate and credible information regulations that prohibit smoking records.
addressing this point needs to be in all indoor workplaces, including Self-reported measures of
obtained. Some potential econo- bars and restaurants. Going exposure can provide a simple
mic issues that might be worth beyond the mandate in Article 8 of measure of the impact of a
considering are the cost savings the FCTC, some jurisdictions are smoke-free policy. Following im-
due to employees decreased pushing for outdoor smoke-free plementation of a comprehensive
health care costs, increased rules that apply to beaches, smoke-free policy, the percent of
worker prouctivity, and decreased entryways to buildings, and parks, people who report that their
establishment maintenance costs. for example. In addition to these workplace is smoke-free should
The other key incidental impact is government mandated policies, go up and the percent of people
that smoke-free policies reduce individuals or businesses may who report seeing smoking the
cigarette consumption in smokers. also adopt voluntary smoke-free last time they went to a restaurant,
From the public health perspective, policies in their homes and for example, should go down.
this is a beneficial incidental workplaces, irrespective of go- These measures are a proxy for
impact, but not the reason why vernment policy, although these the actual smoking policy, as
smoke-free policies are considered. are not the focus of this section. A shown in Table 5.9, but are also a
Lastly, there is an array of summary of commonly used key indicator of compliance with
potential moderating variables to approaches to measure smoke- the policy, and are presented as
consider for a thorough evalu- free policies is given in Table 5.9. such in the model in Figure 5.5.
ation. For example, as previously The advantages of assessing These data are relatively
mentioned, ones occupation will policies directly are that their inexpensive to collect if there is an
217
existing survey in place in the provement while pointing to areas of smoking, such as ashtrays or
relevant country, state/province, or where programmatic efforts to cigarette butts, in such studies.
community, where questions can further increase compliance The key element to consider is the
be added, and the survey can should be placed. We are not design of the observational study.
provide for population-based aware of studies that have directly Results may be biased if the
measures of policy impact on validated these specific self- venue selection is not random and
compliance. While this measure reported measures with at- assessments are made at times
may lack precision in terms of the mospheric measures of SHS or that are not representative of
extent of compliance, it does biomarkers of exposure. Obser- typical activity levels. For
provide a useful barometer of the vational studies of compliance (i.e. example, doing an observational
relative compliance levels. We when an independent observer compliance study in bars by
also note that it is important to assesses if smoking is occurring in sending field staff to these
have pre-policy data, as well as a venue) have been validated (see locations during weekday after-
post-policy data, so that the subsequent sub-section), and the noons will likely overstate
change in compliance can be difference in pollution levels is compliance, while performing
assessed. For example, post- dramatic between smoke-free and these checks only during peak
policy, 20% of people might report smoking-observed venues. times in the late evening will
that they saw smoking the last time In contrast to self-reported understate compliance. These
they went to a bar. That might measures of compliance, obser- studies may also not be as
seem high, but if the pre-policy vational studies may provide a generalizeable as self-reported
data showed 100% reported more reliable measure of data unless a large, random
seeing smoking in bars, then it compliance. Field staff are able to sample of venues is observed,
demonstrates a dramatic im- observe the presence of evidence which can be resource intensive.
Measure Smoke-free air policies in key locations
Sources Government records; The Americans for Non-smokers Rights Foundation; Smoke-
free Lists, Maps, and Data (http://www.no-smoke.org/goingsmokefree.php?id=519
accessed January 25, 2007); CDC State Tobacco Activities Tracking and
Evaluation (STATE) System (http://apps.nccd.cdc.gov/statesystem/ accessed
January 25, 2007); WHO Global Tobacco Control Report (Shafey et al., 2003)
Validity Gold standard for measuring policy itself, but a strong policy may not translate to
low SHS exposure.
Variations Details of the policies, such as the locations covered, exemption, enforcement
authority, and penalties for non-compliance should be tracked unless it proves to
be too difficult. National and state/provincial policies are easier to track than local
level policies, as there may be thousands of individual sub-national policies to track.
Comments Tracking national policy will miss local level policy action, as well as voluntary
policies passed by businesses and individuals. It may be important to track
sub-national policies in some countries.
Table 5.9 Commonly Used Approaches to Measures Smoke-free Policies
218
Construct (a) Self-Reported Measures
Measure Self-reported policy in these areas. Examples of questions include:
(Source: ITC Survey) Which of the following best describes the smoking policy where you
work? (Smoking is not allowed in any indoor area, Smoking is allowed only in some indoor
areas, or Smoking is allowed in any indoor areas)
(Source: Global ATS) Which of the following best describes the indoor smoking policy where
you work? (Smoking is not allowed in any indoor areas, Smoking is allowed only in some
indoor areas, No rules or restrictions, No indoor areas)
(Source: ITC Survey) Public Places Which of the following best describes the rules about smoking
in drinking establishments, bars, and pubs where you live? (Smoking is not allowed in any indoor
area, Smoking is allowed only in some indoor areas, No rules or restrictions)
(Source: Global Adult Tobacco Survey) During the past 7 days, did anyone smoke in the following
indoor places that you visited?
YES NO DID NOT VISIT
a. Government buildings or offices? 1 2 3
b. Health care facilities? 1 2 3
c. Schools or universities? 1 2 3
d. Private workplaces? 1 2 3
e. Bars or night clubs? 1 2 3
f. Restaurants? 1 2 3
Example question asked of individuals:
(Source: ITC Survey) The last time [you visited a bar/restaurant/etc.], were people smoking inside
the pub or bar?
01 YES
02 NO
Example question asked of business owners:
(Source: New York City Restaurateur Survey) Is smoking allowed anywhere in your
[restaurant/bar/etc.]?
1 Yes
2 No
Sources Questionnaires; for example, Hyland et al., 1999a ; Bauer et al., 2005 ; Borland et al., 2006a ;
Borland et al., 2006b ; Fong et al., 2006b
Validity Evidence of utility. No direct validity study of these self-reported measures, but observational studies
assessing the same construct have been validated and show dramatic differences in pollution levels
between smoke-free and smoking-observed venues in a variety of settings (see Leaderer et al.,
1994; Repace, 2004; Travers et al., 2004).
Variations Questions can be adapted to specific places of interest. Items reporting the observance of smoking
in various places may underestimate exposure if actual smoking not observed.
Table 5.10 Measures of Compliance with Smoke-free Policies (Proximal Variables; Policy-specific
Mediators)
219
Comments This is a more direct measure of exposure than knowledge that a policy is in place (policy-only data),
relatively easy to obtain data, adaptable to address many specific locations, as relevant by each
specific policy, but still not a direct measure of actual SHS exposure.
Construct (b) Direct Observation of Compliance Measures
Measure Observer assessments/spot checks of compliance with smoke-free regulations.
Sources In person assessments; Hyland et al., 1999a ; Weber et al., 2003 ; Skeer et al., 2004; Engelen
et al., 2006
Validity Clearly valid. Studies have shown large differences in indoor air pollution by type of smoking policy
in workplaces, restaurants, bars, and homes (Leaderer et al., 1994; Repace, 2004; Travers et al.,
2004).
Variations The study can be adapted to observe compliance in specific locations as needed by the investigator.
Comments This is an excellent approach to assess compliance and, budget permitting, should be strongly
considered. To obtain a true compliance assessment, ratings need to be done at all hours and on all
days, which can increase costs and raise issues of observer safety in some instances. Field work
coordination may be more difficult, as observers are often geographically varied in location.
Construct (c) Records of Government Statistics on Violations, Enforcement, and Compliance of Smoke-free
Policies
Measure Government records on the number of complaints, number of enforcement checks, violations, and
fines collected.
Sources Government records; Hyland et al., 1999a; Engelen et al., 2006
Validity Face validity with concerns noted below.
Variations Available data may depend on the reporting systems and available data from different jurisdictions.
Comments High violation rates could be a function of strong enforcement efforts and may not indicate better true
compliance. Complaints are also an indirect measure of compliance and the type of complaint needs
to be considered (e.g. are complaints from nonsmokers upset about people smoking, or from
smokers upset about not being able to smoke inside?).
Table 5.10 Measures of compliance with smoke-free policies
Government enforcement and conjunction with other exposure collected. Caution must be
compliance records are another assessment data sources. The maintained, as high levels of
way to assess observance of advantage of these data is that complaints and violations do not
smoke-free policies. These are not they may be readily available and necessarily indicate that the policy
recommended as the sole source easy to use. Information typically is not working well, and in fact, just
for evaluating compliance, but obtained includes the number of the opposite may be true.
they can provide useful com- complaints, enforcement opera- Jurisdictions that take an active
plementary data when used in tions, and amount of fines role in dedicated enforcement of
220
smoke-free policies will find more particulate concentration data is blood, and NNAL is commonly
violations, and often the real threat that measurements can be com- measured in the urine. Levels of
of punishment if caught violating pared with well established these two biomarkers should be
the law encourages greater standards for outdoor air, which zero if unexposed to SHS, while
compliance in the future. It is also aids in communicating results to any detectable level indicates
important to consider the nature of the public. For example, the SHS exposure. One methodo-
the complaint. Complaints from average level of particulate matter logical approach to collecting this
those who are upset at smoking observed in these types of studies type of data is to couple it with a
occurring where it is forbidden by conducted in bars is well above the particulate matter monitoring
the policy are much different than peak reading experienced during study where urine samples are
complaints by those who are the largest forest fire in the USA collected from nonsmoking field
upset with the policy itself. State of Colorados history, which staff before and after spending an
was a 24-hour average PM2.5 evening taking measurements in
General mediators or inter- concentration of 200 micrograms/ smoky venues. The change in
mediate measures: cubic metre. This compelling cotinine and NNAL give a
secondhand smoke imagery is powerful when dis- measure of exposure after even a
exposure measures cussing the risks of SHS exposure short-term visit. The finding of
and the benefits of smoke-free potent tobacco smoke carcino-
Two commonly used sources of policies. Both measures (airborne gens in the urine that were absent
actual SHS exposure measures particulate and nicotine concen- prior to going into the field
have been previously reported; trations) can complement each provides a powerful communi-
atmospheric studies, including other and selection of one measure cation message. After a smoke-
airborne particulate concentration over the other depends on the free policy has been implemented,
and nicotine studies, as well as questions being asked in the the cotinine and NNAL
biomarkers studies of exposure evaluation and resources available. measurements in field staff (taken
(see Table 5.11). Studies testing Regardless of which approach is at the beginning and at the end of
for the presence of nicotine in the considered, these data are often their work shift) would be
air have the advantage of being only collected in a small number of expected to show little difference,
specific to tobacco smoke expo- locations because of resource if any. The main disadvantage of
sure, but nicotine is not assayed in issues (i.e. expense and expertise), this type of study is the high cost
real-time and estimates will only tell but such data can round out and requirements for adequate
about average exposure over time. exposure assessment data ob- facilities to handle storing sam-
Particulate matter concentration tained from other sources. ples; hence, results are not
studies are not specific to tobacco Perhaps the scientific gold broadly available precluding much
smoke, as other factors like standard for assessing changes needed comparisons. However, if
pollution and cooking fumes emit in SHS exposure is examining resources are available a bio-
particles, but the presence of changes in biomarkers of expo- marker study can provide very
tobacco smoke is the dominant sure (Hecht, 2004). Two bio- compelling evidence of the real
source of particulate matter in most markers used specific to tobacco impact the smoke-free policy has
cultures even in the presence of smoke exposure are cotinine, a on SHS exposure.
high levels of background pollution by-product of nicotine metabolism,
found in some parts of the world. In and 4-(N-nitroso-methylamino)-1- Primary outcome of interest
these studies the data collection (3-pyridyl)-1-butanol (NNAL), a health in nonsmokers
methods allow for real-time potent tobacco specific carcino-
particulate concentration data gen. Cotinine is typically mea- The primary health outcome
collection. Another advantage with sured in the urine, saliva, hair, or expected to change following the
221
Construct (a) Atmospheric Secondhand Smoke Monitoring
Measure Direct measurement of particulate concentrations and nicotine levels in ambient air.
Particle concentrations can be assessed using a light scatter device and nicotine
concentrations can be assessed using a small portable badge that is placed on site for a
period of time and sent to a laboratory for chemical analysis
Sources Roswell Park Cancer Institute Tobacco Free Air website (www.tobaccofreeair.org);
Hammond, 1999; Navas-Acien et al., 2004; Repace 2004; Travers et al., 2004; Nebot et al.,
2005
Validity Clearly valid. A Norwegian study showed a strong correlation between ambient particulate
matter and air nicotine concentrations (r=0.83) (Ellingsen et al., 2006). One study showed
cotinine levels decreased in 35 hotel workers by 69% after implementation of a smoke-free
law, while air nicotine levels decreased by 83% (Mulcahy et al., 2005).
Variations Specific venues tested can vary depending on the policy.
Comments Real-time assessment of particle concentrations is relatively inexpensive if many samples

are being examined and can be compared to benchmarks for outdoor air quality; however,
it is not specific to SHS. Nicotine monitoring is specific to SHS levels, but may be more
costly than particle monitoring if large samples are collected and does not provide real-time
data. Results are often very simple and effective in communicating with the public and
policymakers.
Construct (b) Biomarkers of Exposure
Measure Urine, saliva, or blood cotinine levels provide most direct assessment of SHS exposure.
NNAL, a tobacco specific carcinogen, can also be examined in the urine.
Sources Anderson et al., 2003; Mulcahy et al., 2005; Farrelly et al, 2005a; Engelen et al., 2006
Validity Considered the gold standard to which other assessments measure up to.
Variations Can be combined with particle or nicotine monitoring study to provide a more detailed
assessment of what is in the air as well as in the body.
Comments Most direct SHS exposure assessment. Can be difficult and expensive to obtain, does not
rule out other sources of nicotine exposure. Helps to demonstrate the need for stronger
SHS policies and to evaluate impact of a policy. Particularly effective in communicating to
policymakers.
Table 5.11 Secondhand Smoke Exposure Measures (Intermediate Measures; General Mediators)
222
implementation of smoke-free air level in places with and without Incidental outcomes of inter-
policies is improved health in smoke-free laws, although such est economic impact,
nonsmokers. A variety of ap- studies are rare and it is difficult to smoking in the home, and
proaches have been used to identify the independent effect of smoking cessation
assess this, and we focus here on SHS beyond the effects due to
items that are not previously other tobacco control initiatives. A policy can be thought of as a
presented in Section 3.1. Some The main issues with these medication that is intended to treat
studies have relied on self- studies are that the effect size some condition. If the medication
reported respiratory symptoms expected is typically small, effects has severe side effects in relation
collected from large population- on nonsmokers specific to the to the benefit it might give the
based samples (Wakefield et al., policy cannot be disaggregated patient, then its utility is
2003a; Lam et al., 2005; Ho et al., from incidental effects on diminished. On the other hand,
2007). This has the advantage of smokers, and it is sometimes medications can have beneficial
providing more representative difficult to obtain data on the target side effects making their use
data; however, self-reported data population of interest. For even more attractive. In the case
are not validated, and the health example, if a large metropolitan of a smoke-free policy, which is
significance of the report of fewer area goes smoke-free, but the medication, the key side
stuffy noses, for example, is surrounding areas do not, it will be effect, typically discussed during
questionable. Despite this, the difficult to assess changes in policy debates, is whether the
information obtained from these disease patterns, as those who policy will have an economic
types of questions provides useful live in the smoke-free metro area impact on businesses. Another
information that fills in the causal may be employed, receive health incidental effect raised in some
chain between policy and changes care, or have other business policy debates is whether smoke-
in adverse health outcomes. Other outside of the city and vice versa. free policies will encourage
studies collect more clinical data Nationwide policy adoption would smokers to smoke more
in smaller samples of workers limit this concern. cigarettes inside their home,
assessed before and after im- We do not feel that any of thereby increasing their family
plementation of a smoke-free these measures is required to be members exposure to SHS.
policy, although findings may not assessed for all smoke-free policy Other incidental considerations
relate to the general population. evaluation studies. In the are whether there are cost
For instance, conducting a presence of an existing survey savings resulting from increased
baseline clinical assessment of a already in the field, asking about worker productivity, decreased
group of nonsmoking bartenders respiratory effects and related cleaning costs, and decreased
before a smoke-free law is symptoms is encouraged. Clinical health care costs, and whether
implemented, and then 12-months or population-based studies the policy increases cessation
after the law takes effect, can examining changes in disease indicators among smokers. The
measure changes in clinical rates are technically demanding former two are not discussed in
parameters, such as lung function studies that require much more this section, and the latter is
(measured by forced expiratory planning and resources, and described in Section 3.1.
volume in 1 second and forced groups with the capacity to
vital capacity determinations). conduct these studies are Economic outcomes:
These studies are typically encouraged to do so. Table 5.12
expensive to conduct and require provides a summary of these Table 5.13 presents a summary of
clinical facilities. Other studies measures (distal variables). measures for evaluating the
focus on examining changes in economic impact of a smoke-free
disease rates at the population policy. Historically, economic
223
Construct (a) Self-Reported Changes in Symptoms and Illness
Measure (Respiratory symptoms)

During the past 4 weeks
a. have you had wheezing or whistling in your chest? (Yes or No)
b. have you felt short of breath? (Yes or No)
c. do you usually cough first thing in the morning? (Yes or No)
d. do you cough at all during the rest of the day or night? (Yes or No)
e. do you bring up any phlegm? (Yes or No)
(Sensory symptoms)
In the past 4 weeks
a. have your eyes been red or irritated? (Yes or No)
b. have you had a runny nose, sneezing, or nose irritation? (Yes or No)
c. have you had a sore or scratchy throat? (Yes or No)
Sources Questionnaires; Farrelly et al., 2005a ; Abrams et al., 2006
Variations Questions can be adapted to include different conditions.
Comments These measures do not specifically address the impact of the policy, may be confounded
by other factors, and their clinical relevance questioned; however, they do provide a simple
way to assess how/why the policy may or may not be working.
Construct (b) Clinical Studies Assessing Changes in Worker Health
Measure Clinical parameters, such as lung function.
Sources Clinical exams; Eisner et al., 1998; Allwright et al., 2005
Validity Clearly valid, but changes in health status could be due to other factors besides the change
in SHS exposure.
Variations Studies can be designed to address health effects in particular subpopulations of interest.
Comments While these studies provide useful information about the actual near-term health impacts of
smoke-free policies, they are costly to perform and require a high level of sophistication to
conduct. Implementing this type of study is only recommended for those groups with the
resources and research interests to gain a better understanding of exactly how smoke-free
policies may change health.
Table 5.12 Health Outcomes in Nonsmokers (Distal Variables or Outcome)
224
considerations have largely been variable. Some jurisdictions have assessments provide a more
raised in the restaurant and bar a specific tax on meals, which can complete picture of what, if any,
industries, and to a lesser extent, get tracked independently and is economic impact the smoke-free
in the tourism and gambling highly specific to that industry policy is having. The other
industries. Potential economic segment. Other places rely on advantage of reports from
impacts in other industries have general sales or income tax data, individuals is that data can be
generally not been studied, nor which often takes longer to obtained close to real-time after
has there been a call by acquire and makes the data less policy implementation. Employ-
policymakers for these potential specific to certain industries. ment and taxable sales data take
effects to be known. Licensure statistics can also months or years to become
An ideal economic evaluation provide some insight into the available, and then it takes longer
would rely on objective measures potential economic impact of still to acquire enough post-law
supplemented with additional smoke-free policies. These data data to establish trends.
measures, such as the self-report only track the number of Policymakers demand an answer
of the frequency of visiting bars businesses, so they are not as to the question of whether the
and restaurants. Objective mea- specific as employment or taxable policy has hurt businesses
sures include employment sales data. They can provide immediately. Survey data, such as
statistics and taxable sales additional complementary evalu- described above, can provide an
information, as well as statistics on ation information if available, but initial glimpse of the potential
the number of licensed facilities relying solely on licensure sta- impact while a case is made that
and the number of new and tistics for an economic evaluation time is needed to examine the
expired licenses. Many countries it is not recommended. Both objective data sources. Fur-
have established monitoring sys- employment and taxable sales thermore, self-reported survey
tems in place that collect these measures are excellent objective items may be the only data source
data and access to it is simple; not measures for evaluation, and if objective employment and
so for places that do not have researchers should investigate taxable sales data collection
such systems. The actual infor- what data are available in their systems are not in place.
mation that can be obtained will country and consider analysing Another self-reported measure
differ depending on available data. both sets of data. used by some investigators to
In the USA, for example, monthly A useful complement to these assess the economic impact of a
data on the number of employees objective data sources are self- smoke-free law, is the self-
working in narrow industry sub- reported measures of changes in reporting by business owners/
segments, such as restaurants, patronage patterns after a policy is managers of changes in sales.
can only be obtained from the implemented. This information can Virtually all of the economic
Bureau of Labor Statistics at the help fill in the causal pathway studies done that have found an
county level. The data are between a policy and the inci- adverse economic impact have
uniformly collected at the national dental potential economic losses utilized this approach, whereas
level, are available monthly, and or gains. In addition, survey virtually all of the studies based on
the lag time in reporting the questions can be tailored to objective data or individual reports
information is a few months, which specific types of venues or to found either no impact or a small
is relatively quick compared with assess more subtle effects. For positive impact (Scollo et al.,
some taxable sales measures. example, survey questions might 2003). Business owners lack of
Taxable sales data share many of assess if people are dining longer, support of a smoke-free law has
the same attributes as em- spending more money when going been shown to be associated with
ployment data; however, tax out, or changing the types of more negative fiscal reports,
collection systems are much more places they frequent. These which suggests these data may be
225
Construct (a) Changes in Economic Outcomes Self-reported Consumer Patronage Practices
Measure Self-report in the change in rate of going out to bars, restaurants, and other locations
covered by smoke-free rules. Example question
(Source: ITC Survey) Do you now visit [pubs/restaurants/etc] more often than [before the
law took effect], less often, or about the same amount?
01 More Often
02 Less Often
03 Same Amount
04 Dont visit pubs now and/or didnt visit pubs a year ago
Sources Questionnaires; Hyland & Cummings, 1999a ; Blecher, 2006
Validity Evidence of utility. In New York City, taxable sales and employment in the hospitality industry
increased, while a majority of NYC consumers reported they were dining out the same or
more frequently after the 1995 law was implemented (Hyland & Cummings, 1999a; Hyland
et al., 1999b).
Variations Questions can be adapted to ask about different locations. Some have obtained more detail
by querying about the frequency of going out or actual money spent out, although
investigators are cautioned that his information is difficult to recall and obtain from
respondents to a population-based survey.
Comments An economic evaluation should not solely rely on this measure if possible. Ideally, objective
measures, like employment statistics or taxable sales data, should provide the basis of an
economic evaluation, which can be supplemented with subjective data to help portray a
more complete evaluation.
Construct (b) Changes in Economic Outcomes Business Owner Self-Reported Change in Sales
Measure (Source: New York City Restaurateur Survey) Self-reported change in business after a
smoke-free regulation takes effect. Example question[Over the past two years], would
you say your business has increased, decreased, or stayed the same?
Sources Questionnaires; Hyland & Cummings, 1999b
Validity Not recommended as a stand-alone for economic evaluation. Evidence suggests self-report
on this item is associated with opinions about the law (i.e. owners who are negative toward
smoke-free policies report more negative business outcomes), which may introduce bias
into the measurement, and the question is not specific to losses attributable to smoke-free
regulations. Some studies show negative outcomes using this approach, but objective data
like taxable sales show no impact, or a positive impact, which suggests low validity. This item
alone should never be solely relied on for an economic evaluation of a policy.
Variations Some have obtained more detail, such as asking the actual revenues, but there are
considerable levels of missing data when using this approach.
Comments Many studies do rely solely on this measure; evaluators should be cautioned and aware of
the relative merits of this approach.
Table 5.13 Measures for Evaluating the Economic Impact
226
Construct (c) Changes in Economic Outcomes Hospitality Employment Levels
Measure Government employment statistics for specific industry sectors over time.
Sources Bureau of Labor Statistics, or other similar government entity; Hyland & Cummings,
1999c
Variations Can examine specific employment sectors per the policys specifics.
Comments This is an excellent measure to evaluate. Study design is enhanced by adding in control
employment sectors, as well as data from other jurisdictions not covered by the policy.
Comparability of data sources between countries is an issue to consider.
Construct (d) Changes in Economic Outcomes Hospitality Taxable Sales
Measure Government tax receipt statistics for specific industry sectors over time.
Sources Office of Tax and Finance, or other similar government entity; Glantz & Smith, 1994; Hyland
et al., 1999b; Cowling & Bond, 2005 ; Blecher, 2006
Variations Can examine specific sectors per the policys specifics.
Comments This is an excellent measure to evaluate. Study design is enhanced by adding in control
employment sectors, as well as data from other jurisdictions not covered by the policy.
Comparability of data sources between countries is an issue to consider.
Table 5.13 Measures for Evaluating the Economic Impact
biased. For example, in New York Business owner surveys are to spend more time smoking at
City a business owner who was excellent for assessing the home, which leads to greater SHS
surveyed claimed that losses were measures that they used to exposure for other family
experienced (see, for example implement and comply with the members. While this issue was
McLaughlin and Associates Inc new policy, but are not reco- not generally raised during policy
(2001) as cited in Scollo et al., mmended for economic evalu- discussions in the USA, for
2003), but a review of the ation. example, it has gained attention in
objective employment and taxable some European debates. This is a
sales data showed no economic Smoking in the home: generally understudied area, but
down turn, which means this it is fairly straightforward to
measure has low validity (see, for Another potential incidental effect evaluate the likelihood of this
example Hyland et al., 1999b and of smoke-free policies is that it potential incidental impact. The
Hyland and Cummings, 1999c, as may cause smokers, who can no simplest approach is to ask
cited in Scollo et al., 2003). longer smoke at bars for example, smokers how their home smoking
227
strategy and home smoking Glantz, 2002a; Fong et al., have tested this specific
behaviour has changed since 2006b). The theorized mechanism hypothesis. Similarly, those with
policy implementation (see Table of action is that there is a direct lower socioeconomic status are
5.14). Other approaches could impact by decreasing the number more likely to work in smoky
involve tracking how many of opportunities to smoke and environments, and should there-
cigarettes are smoked inside the reducing sensory cues for smo- fore be impacted more by
home before and after the policy king. This reduces the likelihood of smoke-free policies than white
in a cohort design. We are aware relapse during a quit attempt. One collar workers. Viewing this from a
of only two published studies on large, prospective study on this population-perspective, relatively
this topic. One study used issue found that smoke-free large policy impacts are expected
population-based survey data worksite policies were not if few workplaces were previously
from smokers in four countries, associated with a greater rate of smoke-free and compliance is
and found that those who lived in trying to stop smoking, but rather high; however, there could be little
a community that implemented a quit attempts were significantly impact if that population is already
smoke-free bar policy were more successful (Bauer et al., working in a smoke-free environ-
significantly more likely to imple- 2005), which is consistent with ment. Lastly, those who are aware
ment 100% smoke-free home what is predicted from the of smoke-free policies and believe
policies (Borland et al., 2006a). theorized mechanism. Indicators that SHS is harmful are more likely
The other study examined of smoking cessation worth to be compliant with the policy and
differences in smoke-free home considering for evaluation are have lower SHS exposure.
policy adoption in Ireland, which quitting, quit attempts, smoking Evaluators need to consider
had already implemented a reductions, desire to quit, and moderating variables to best
smoke-free law, and the UK, utilization of evidenced-based assess how policies may or may
which had not implemented treatments to quit smoking, to not work in population subgroups.
smoke-free regulations at the time name a few. These are described
of the study. It was found that the in more detail in Section 3.1 and Summary and
percent of homes that were are not discussed further here. recommendations
smoke-free was comparable
between countries, and that Irish Moderators Article 8 of the FCTC calls for
smokers consumed fewer alco- governments to increase smoke-
holic drinks in the home Many important moderating free policies at the national and
compared to UK smokers (Hyland variables are described in Section sub-national levels. Evaluating the
et al., 2007). Therefore, this 3.2. For smoke-free policies, some effects of smoke-free policies is
potential incidental effect does not specific moderating variables of critical to understanding how they
appear to be true, and if anything interest include occupation, work and can be improved. Core
the opposite, but more studies socioeconomic status, awareness, constructs to evaluate whether
may be needed. and beliefs about SHS. Hospitality smoke-free policies are working
employees are much more likely are compliance with the policy and
Smoking cessation outcomes: to work in an environment where exposure assessment. Based on
smoking is permitted (Shopland et our assessment of the validity of
Studies have shown that smoke- al., 2004); therefore, a policy that available data and ease of
free worksite policies also prohibits smoking in the workplace assessment, we recommend, that
increase quit rates and reduce would have a disproportional in most cases, population-based
consumption among those who effect on this population, although surveys be used as the primary
continue to smoke (Fichtenberg & we are not aware of studies that means for assessing compliance
228
Measure Changes in home smoking rules
(Source: ITC Survey) Has the smoking ban in public places affected the rules
about smoking in your home?
1 It has made me more strict about the amount I smoke at home when I am with
non-smokers.
2 It has made me more strict about the amount I smoke at home in general.
3 It has made me smoke more at home when I am with non-smokers.
4 It has made me smoke more at home in general.
5 It has not affected the rules about smoking in my home.
Home smoking policy

(Source: GATS) In your home, is smoking allowed in every place, in some places
or at some times, or not allowed in any place?
(Source: Global ATS) In your home, is smoking allowed in every place, in some
places or at some times, or not allowed in any place?
(Source: Adult Tobacco Survey) Car Which statement best describes the rules
about smoking in your family car or cars? Would you saySmoking is never
allowed in any car, Smoking is allowed some times or in some cars, Smoking is
allowed in all cars, or do not have a family car.
Sources Self-report; Gillespie et al., 2005 ; Borland et al., 2006a
Variations Can also assess changes in cigarettes smoked per day in the evening after work,
for example, in a cohort design.
Comments While nationwide SHS policies do not regulate smoking in individuals private
homes and property, they may change social norms and increase awareness about
SHS harms that may result in individuals implementing such policies on their own.
As more workplaces become smoke-free, SHS exposure in the home will be of
greater relative importance. This is a relatively understudied area, but has grown
to be an important issue in some policy debates.
Table 5.14 Smoking in the Home
with smoke-free policies (Table whether smoke-free policies in economic impact on businesses,
5.10). These measures have been workplaces affect smoking at and the use of employment or
validated with ambient air home, and how smoke-free sales data to assess this impact is
monitoring, as well as biomarkers policies impact tobacco use recommended.
of exposure. Incidental impacts behaviour. In some cases, there
that may need to be examined are will be a need to evaluate potential
229
section53.janvier12:Layout 1 12/01/2009 14:11 Page 231

tobacco product regulation
Introduction searchers and public health officials dardised machine smoking mea-
must employ quasi-experimental surements, the average sales-
Tobacco product regulation is a designs and utilise opportunities for weighted tar and nicotine yield for
rapidly emerging area in tobacco natural experiments through US cigarettes decreased by about
control. Scientists, policy makers, making comparative observations 70% between the 1950s and 1990s
and international public health (Fong et al., 2006a). Additionally, it (Hoffman & Hoffman, 2001). Scien-
organisations have called for is important to begin collecting tists and public health officials
comprehensive regulation of toba- baseline data and developing initially supported this trend in the
cco products with the aim of measures and protocols for 1960s and 1970s (Parascandola,
protecting public health. A handful evaluation, so that the impact of 2005), and it took decades before
of countries and jurisdictions have future regulations can be assessed. epidemiologic studies provided
already adopted legislation requiring In 1999, a WHO Conference on the definitive evidence that changes in
reporting and testing of tobacco Regulation of Tobacco Products cigarettes designed to lower smoke
product contents and emissions. concluded that The regulatory yields did not in fact lead to any
Articles 9 and 10 of the WHO process must be guided by the best significant decrease in the tobacco-
Framework Convention on Tobacco available science and the effects related disease burden (Burns et al.,
Control (FCTC) contain the require- tracked so as to maximize health 2001). We now know that much of
ments for regulation of tobacco benefits, minimize unintended con- the apparent decline was due to the
product contents and emissions, as sequences, and thereby foster use of filter ventilation, which
well as manufacturers disclosures self-correction. (WHO, 2000). produces markedly reduced ma-
about the product (Figure 5.6). The ultimate test of the impact of chine measured yields, but not
As the regulatory landscape a regulation intended to protect necessarily on the amounts smo-
evolves around the world, it is public health is to demonstrate a kers actually take in (Kozlowski et
essential to evaluate the effec- reduction in morbidity or mortality al., 1998a).
tiveness of new regulations and associated with the regulation. Laboratory-based product testing
their impact on the product itself and However, it can take decades for remains vitally important, despite its
on the population, in order to some effects, such as changes in limitations for predicting human risk.
determine whether regulations are cancer incidence, to be seen. Thus, First, it supports monitoring of
meeting public health goals. The measures to assess product adherence to laws intended to
emergence of new legislation and regulation have historically focused regulate features of product design
regulatory standards for tobacco on the product itself, although such and performance, such as emission
products provides a unique oppor- measures have significant limita- limits based on machine mea-
tunity to study changes in the tions for predicting human risk. The surements and low ignition pro-
product and in health outcomes need for in-depth product evaluation pensity laws. Second, it allows for
over time and across countries and under actual conditions of use is the measurement of differences
regions. Because product regu- supported by the history of the between products or changes in
lations cannot be assessed through development and promotion of products that may impact exposure,
randomised clinical trials, re- light cigarettes. Based on stan- such as comparing cigarettes that
231
Regulation of the contents of tobacco products. The Conference of the Parties, in consultation with competent
international bodies, shall propose guidelines for testing and measuring the contents and emissions of tobacco
products, and for the regulation of these contents and emissions. Each Party shall, where approved by competent
national authorities, adopt and implement effective legislative, executive and administrative or other measures for
such testing and measuring, and for such regulation.
Regulation of tobacco product disclosures. Each Party shall, in accordance with its national law, adopt and implement
effective legislative, executive, administrative or other measures requiring manufacturers and importers of tobacco
products to disclose to governmental authorities information about the contents and emissions of tobacco products.
Each Party shall further adopt and implement effective measures for public disclosure of information about the toxic
constituents of the tobacco products and the emissions that they may produce.
WHO (2003)
Figure 5.6 WHO FCTC Articles 9 and 10: Regulation of the contents of tobacco products and Regulation
of tobacco product disclosures, respectively
heat versus burn tobacco or are still evolving; for many itself. Measures of product
cigarettes containing tobacco with potential outcomes validated content, design and emissions will
high versus low tobacco-specific standard measures have not yet be discussed, including the
nitrosamine (TSNA) levels. Third, been identified. While the FCTC limitations of smoking machine
systematic product testing is mandates regulation and reporting protocols for assessing actual
important because it contributes to of tobacco product contents and human exposure. Third, the
the development of general ex- emissions, guidance for imple- section will address distal mea-
pertise and capacity for tobacco mentation of these articles is still sures as well, which focus on the
product regulation. Historically, under development by the Con- impact of regulations for human
most product-related expertise ference of the Parties (COP) exposure and risk, including bio-
has been limited to the tobacco (http://www.who.int/tobacco/fctc/c markers and surveillance acti-
industry, and public health scien- op/en/). Thus, it is not clear yet vities.
tists have been at a disadvantage which specific measures will be
in understanding the relevance of required in the implementation of Existing tobacco product
product characteristics for health the FCTC. regulations
and behaviour, as in the case of This section will review existing
light and low-tar cigarettes measures relevant to tobacco Tobacco product regulation re-
(Parascandola, 2005). While product regulation as well as mains in its early stages but is
doubtless new, more sophis- discuss challenges and research evolving rapidly. A number of
ticated technologies and mea- needs. First, the characteristics of countries and jurisdictions have
sures will be developed, such some existing tobacco product adopted product regulations,
progress will be limited without a regulations will be described to including ingredient disclosure
network of experienced, public illustrate the range and types of laws, limits on tar and nicotine
health oriented scientists and provisions used in current yields, low ignition propensity (fire
technicians. regulations. Second, the section safety) standards, or bans on
The task of tobacco product will cover proximal measures for additives, such as candy fla-
evaluation is complicated by the assessing tobacco product regu- vourings. However, there is little
fact that regulatory requirements lations, which focus on the product uniformity across jurisdictions in
232
Measures to assess the effectiveness of tobacco product regulation

the content of these laws. Some South Africa, and Malaysia, as than 40 toxic emissions in both
jurisdictions require constituent well as the European Union (EU). mainstream and sidestream
disclosure only, while others set There are at least five main smoke under two different
standards or limits on content or types of tobacco product regu- smoking regimens, and informa-
emissions. Moreover, while some lations that can currently be tion on more than 20 specific
product standards target toxic observed: 1) regulations that constituents of whole/unburned
properties directly (such as by require disclosure of product tobacco (http://www.hc-sc.gc.ca/hl-
establishing maximum tar or information (such as tar and vs/tobac-tabac/legislation/reg/inde
carbon monoxide limits), others nicotine content) (Figure 5.7); 2) x_e.html).
target properties that, while not regulations intended to reduce
directly harmful, affect addic- product toxicity and harm (such as Brazil:
tiveness or consumer appeal maximum emission limits for tar
(such as by controlling flavour and nicotine) (Figure 5.8); 3) The National Health Surveillance
additives that affect the appeal of regulations intended to reduce the Agency (ANVISA) is charged with
the product to children). addictiveness and/or attrac- regulating a wide variety of con-
Currently, there is no cen- tiveness of tobacco products sumer products in the interest of
tralized, systematic monitoring of (such as bans on ingredients that public health, including cigarettes
tobacco product regulations. The impact nicotine delivery or bans and other tobacco products.
data collected in Tobacco Control on flavour additives that may ANVISA resolution No. 46 (March
Country Profiles 2003 includes make a product more attractive to 21, 2001) establishes maximum
some information on regulation for children) (Figure 5.9); 4) regu- tar, nicotine, and carbon
many countries (Shafey et al., lations intended to prevent fires monoxide yields for cigarettes,
2003). However, the available caused by cigarettes (ignition and the tobacco industry is
data does not specify the details of propensity laws) (Figure 5.10); required to submit annual reports
the regulations (i.e. which con- and 5) bans (or removal of bans) that identify and list by brand all
stituents are regulated, what on product categories (Figure ingredients and additives in every
product standards or limits are 5.11). A few examples are pro- tobacco product produced in
imposed) and it is not updated vided in Table 5.15 to illustrate the Brazil (http://www. anvisa.gov.br/
regularly. As countries continue to range of different types of product eng/tobacco/index.htm).
debate and enact new tobacco regulations that are currently
product regulations, there is a being implemented or discussed. European Union:
need for comprehensive tracking A more detailed presentation
of the evolving regulatory en- of country specific regulations In effect since 2004, a directive of
vironment. follows: the European Parliament to Mem-
A few countries and juris- ber States limits the maximum
dictions have adopted tobacco Canada: yield of tar, nicotine, and carbon
product regulations and provide monoxide in cigarettes manu-
early models of the types of The Tobacco Reporting Regu- factured or marketed in the EU (10
regulatory mechanisms that may lations, developed under the mg tar, 1 mg nicotine, and 10 mg
be implemented more widely. authority of the 1997 Tobacco Act, carbon monoxide). The directive
There are also a number of require manufacturers and im- also requires the tobacco industry
countries that have adopted porters of tobacco products to to submit to Member States a list
International Organization for Canada to submit to the Minister of ingredients, and quantities
Standards (ISO) emission limits of Health information on tobacco thereof, used in the manufacture
for tar and nicotine aimed at product composition and emis- of those tobacco products by
reducing tobacco related harm, sions. This includes, for smoked brand name and type (http://ec.
including Brazil, Thailand, China, products, information on more europa.eu/health/ph_determinants
233
Policy
Product disclosure regulation
Policy-specific mediators
Compliance with regulation
Completeness of data
Accuracy of data
Moderators
Availability of data
Other information sources
Uses made of the data
Outcomes
Policy effectiveness
Public awareness
Figure 5.7 Conceptual framework for the evaluation of product disclosure requirements
/life_style/Tobacco/tobacco_en.ht turers must also report the brand, but this regulation was
m). quantity of nicotine in each barred by a federal court
product according to standard (http://www.mass.gov/dph/mtcp/le
United States: measures. (Centers for Disease gal/prodreg.htm).
Control and Prevention, 1997a;
The Comprehensive Smoking http://www.cdc.gov/tobacco/FCLA/ New York State:
Education Act of 1984 and terms.htm).
Comprehensive Smokeless Toba- In 2004, New York State became
cco Health Education Act of 1986 Massachusetts: the first jurisdiction in the world to
require cigarette and smokeless implement reduced ignition pro-
tobacco manufacturers to submit Manufacturers of cigarettes and pensity (RIP) standards for
a list of ingredients added to smokeless tobacco products sold cigarettes; Canada became the
tobacco to the Secretary of Health in Massachusetts must report the first country to do so in 2005. Both
and Human Services. However, products nicotine yield according the New York State and Canadian
the law requires that the list not to a standardised protocol. The laws stipulate that at least 75% of
identify the specific brand or State also proposed a regulation cigarettes must self-extinguish
company using the ingredients. requiring reporting of all ingre- before burning the full length of
Smokeless tobacco manufac- dients added to cigarettes by their tobacco columns using a
234
Policy
Policies to reduce toxicity Tobacco industry
Emission standards marketing
Design requirements
Incidental effects Policy-specific mediators Moderators 1

Tobacco use Compliance with regulation Product related
behaviour Product design and beliefs and
Product marketing performance attitudes
Product related Industry innovation
beliefs and attitudes
General mediators Moderators 2

Total tobacco use Short-term measures Demographics
Exposures Biological factors
Toxicity
Outcomes
Long-term measures
Disease outcomes
Figure 5.8 Conceptual framework for the evaluation of policies to reduce tobacco toxicity
235
Policy
Product regulations to reduce Tobacco industry
addictiveness/attractiveness of marketing
tobacco products
Incidental effects Policy-specific mediators Moderators 1

Product marketing Compliance with regulation Product related
Product related Product design and beliefs and
beliefs and attitudes performance attitudes
Product toxicity Industry innovation Tobacco use
Consumer awareness behaviours
General mediators
Sensory perception
Moderators 2
Consumer reaction
Demographics
Brand shifting
Biological factors
Change in consumption
Change in how smoked
Reduced attractiveness
Outcomes
Quitting
Reduced consumption
Patterns of tobacco use
behaviour
Reduced initiation
Figure 5.9 Conceptual framework for the evaluation of policies to reduce the attractiveness and/or
addictiveness of tobacco products
236
Incidental effects Policy

Industry innovation Reduced ignition propensity
Patterns of tobacco use cigarettes
behaviour
Product marketing
Policy specific-mediators
Compliance with regulation
Product design and
performance
Outcomes
Cigarette-caused fires
(expected reduction)
Figure 5.10 Conceptual framework for the evaluation of tobacco product regulation to reduce fires
standardised method for asses- database.cart/redline_pages/e218 specific constituents in tobacco

sing ignition propensity. Both laws 7.htm?E+mystore). smoke. However, evidence shows
use the American Society for So far, no jurisdiction has suc- that there is a wide variation
Testing and Materials (ASTM) cessfully enacted comprehensive globally between countries and
method, which involves posi- regulations governing the design, cigarette brands in emissions of
tioning a cigarette on one of three contents, and emissions of tar, nicotine, and carbon mon-
standard substrates to generate tobacco products. Product per- oxide, as well as major
sufficient heat to continue burning, formance standards, for example, carcinogens, suggesting that
and thus potentially cause ignition could be used to reduce known reductions are feasible and are
of bedding or upholstered furniture harmful emissions. Currently justifiable on a precautionary
(ASTM E2187-04 Standard Test available data and methods are basis. A survey of transnational
Method for Measuring the Ignition insufficient to allow for a quan- and locally-produced cigarettes in
Strength of Cigarettes; http:// titative estimate of the public 35 countries found, when mea-
www.astm.org/cgi-bin/SoftCart.exe/ health impact of reductions in sured by a standardised machine
237
Policy
Product regulation
Ban product categories
Incidental effects
Changes in beliefs
about harmfulness of Policy-specific mediators
remaining products Compliance with regulation
Changes in product Product design and
types performance
Product design and Industry innovation
performance
Product marketing Moderators
Smuggling Demographics
Biological factors
Dependence
General mediators
Choices made by user of banned
products
Attitude to remaining
products
Outcomes
Mix of products used
Tobacco use behaviour
Way products used
Quitting
Health outcomes
Figure 5.11 Conceptual framework for the evaluation of tobacco product regulation to ban specific product
categories
238
Regulation Type Requirements
Product Disclosure Reporting of 40 constituents in mainstream and sidestream smoke and 20 specific
Example: Canada constituents of whole/burned tobacco according to specified protocols.
Tobacco Reporting Regulation
Reduce Harm Maximum cigarette emission yields: 10 mg tar, 1 mg nicotine, and 10 mg

Example: European Union caron monoxide determined by specified machine testing method.
Directive 2001/37/EC
Reduce Addictiveness and/or Proposed ban on additives that increase the addictiveness of tobacco products.
Attractiveness
Reduce Cigarette-Caused Fires Mandatory performance standards require that at least 75% of cigarettes must self-
Example: New York State extinguish before burning the full length of their tobacco columns, utilizing the
Fire Safety Standard for Cigarettes American Society for Testing and Materials (ASTM) method for measuring ignition
propensity.
Product Bans Prohibits sale and marketing of all products for oral use, except those intended to
Example: European Union be smoked or chewed, make wholly or partly of tobacco.
Directives 2001/37/EC, 92/41/EEC
Table 5.15 Product Regulations
smoking protocol, wide variation in cigarettes by the establishment of product, regulators must have
emissions of tar (6.8 to 21.6 mg), upper limits based on the median valid information about product
nicotine (0.5 to 1.6 mg), and of the existing market (Gray & design, contents, and emissions.
carbon monoxide (5.9 to 17.4 mg), Boyle, 2002). There have also Standardised reporting and dis-
with cigarettes from the Eastern been proposals to reduce nicotine closure by manufacturers assists
Mediterranean, Southeast Asia, to non-addictive levels to prevent regulators in monitoring changing
and Western Pacific WHO regions the development of nicotine trends in product design across
reporting higher deliveries than addiction in young people the market that may impact public
those from other regions (Calafat (Benowitz & Henningfield, 1994). health. Additionally, such dis-
et al., 2004). Further analyses However, so far such proposals closures allow for more effective
from this survey have revealed have not been implemented in any evaluation of the impact and
that mainstream smoke levels of regulations, and currently there is potential unintended effects of
tobacco-specific nitrosamines insufficient evidence to predict new regulatory requirements on
(TSNAs) and poly-cyclic aromatic what the potential impact of such product design and emissions.
hydrocarbons (PAHs) also vary regulations would be on health In order to guide evaluation of
widely across countries, including outcomes or smoking behaviour. tobacco product regulations, it is
within the same multinational Regulations requiring tobacco important to have a conceptual
brand (Wu et al., 2005; Ding et al., product disclosure, as required in model of the proximal and distal
2006). Given the observed varia- FCTC Article 10, also have an effects of the regulation, taking into
tion, one regulatory proposal essential role. In order to effec- account other factors that mediate
involves a system for controlling tively establish product standards or moderate those effects (policy-
toxins and carcinogens in and regulate manufacture of the specific mediators, general
239
mediators, and outcomes). The manufacturers to disclose product ignition propensity cigarette laws:
model should also include other information to consumers should does the product meet the full-
incidental effects of a regulation be evaluated ultimately in terms of length burn testing requirements
that are important to evaluating the its impact on public awareness of specific in the regulation? For tar
impact of a regulation on public the information communicated and nicotine limits: does the pro-
health. As a general framework, it and the effectiveness of those duct meet the specified maximum
is likely that the impact of tobacco communications in successfully tar and nicotine threshold
product regulations on intended informing the public about product according to the standardised test
health outcomes will be moderated characteristics. Those effects may method required in the legislation?
by changes in product design and be moderated by the availability of The specific testing that is
performance, product marketing, relevant data and the presence of required will depend on the
product-related beliefs and atti- other information sources. In requirements and goals of the law.
tudes, and tobacco use behaviour, contrast, a regulation that aims to There are a wide variety of
which in turn are expected to reduce product toxicity and harm product characteristics that could
influence exposures to tobacco should be evaluated ultimately in potentially be subject to or be
constituents and emissions. terms of its impact on disease affected by regulation. In addition
However, because tobacco outcomes. Short-term measures to assessing compliance, assess-
product regulations can have a of changes in exposures or ment of tobacco product
range of different goals, multiple toxicity, such as use of bio- characteristics is important for
conceptual models are needed to markers, may substitute for actual informing the development of new
understand different types of measures of disease outcome. or modified regulations and for
regulations, just as a variety of These outcomes are likely to be identifying potential unanticipated
methods and measures are moderated by demographic and product changes.
needed for evaluating different biological factors, as well as Both tobacco and tobacco
regulations. Five generalized logic consumers product related atti- smoke are very complex matrices,
models are provided to guide the tudes and behaviours. Thus, these consisting of thousands of com-
development of evaluations of two types of regulations require pounds. Over 3044 constituents
tobacco product regulations very different logic models for their have been isolated from tobacco
(Figures 5.7 to 5.11). These five evaluation. Before developing an (Roberts, 1988); it is estimated
logic models reflect the five major evaluation plan or protocol, it is that there are over 4800 com-
types of tobacco product regu- important to have a logic model pounds in mainstream cigarette
lations identified above (dis- that maps out the goals of the smoke (Green & Rodgman, 1996).
closure, reducing product harm, regulation and relevant factors that At least 69 carcinogens have been
reducing product addictiveness/ are expected to influence its identified in cigarette smoke,
attractiveness, preventing fires, effectiveness. including 11 classified as Group 1
product bans). The logic models known human carcinogens by
all start with the introduction of a Proximal measures IARC (Hoffmann & Hoffmann,
new policy and then proceed to 1997). Moreover, the composition
show a pathway to proximal and The most proximal measures of of cigarettes and cigarette smoke
distal variables or constructs to be the effectiveness of a tobacco has changed substantially since
used in assessing the effects of product regulation include mea- the 1950s, as the product itself
the regulation. Key mediators and sures of the product itself. The first has changed, with changes in
moderators, along with incidental step in evaluating a performance tobacco blend, processing tech-
effects, are also identified for standard regulation, for example, niques, cigarette design, the
inclusion in evaluations. For is to measure compliance through introduction of filters, and use of
example, a regulation requiring product testing. For reduced additives (Hoffmann & Hoffmann,
240
1997). At the same time, it is assessment (Fowles & Dybing, Product content
essential to study the product 2003). Further research is needed
under actual conditions of use, to understand the individual and Official testing of cigarettes has
because differences in smoking combined effects of the many generally focused on measure-
behaviour can have a substantial constituents in tobacco and ments of cigarette smoke con-
influence on product emissions. tobacco smoke. stituents (i.e. tar, nicotine, and
However, because of the carbon monoxide) using standard
complexity of tobacco smoke, it is Sampling and preparation machine smoking protocols rather
extremely difficult to estimate the than of the unburned tobacco
health effects of specific To effectively monitor products as itself. However, the composition of
constituents in tobacco and used by consumers, it is essential smoke is directly dependent on
tobacco smoke. There have been to follow an effective protocol for the profile of constituents in the
efforts to quantify the relative obtaining product samples and tobacco (Fischer et al., 1990).
contribution to risk of individual storing and preparing the product While cigarette design features
tobacco smoke constituents, for analysis. Products should be and human smoking behaviour
particularly for cancer, but such purchased from a range of retail can dramatically vary the content
estimates are fraught with un- vendors to ensure that the product (both qualitatively and quan-
certainty and numerous assump- tested is representative of the titatively) of the smoke and the
tions. Possibly the most com- product available to consumers smokers exposure, the charac-
prehensive such risk assessment, and that different manufacturing teristics of the tobacco are equally
including cancer and non-cancer lot numbers are represented in the important. Moreover, there is wide
risk indices for 158 known sample. In addition, a rigorous variation in the concentration of
hazardous chemicals in cigarette protocol should be employed for nicotine and other important
smoke, found that these known storing samples. For example, constituents in the tobacco filter in
risk agents underestimated ob- cigarettes and smokeless tobacco cigarettes from different brands
served cancer rates in cigarette should be stored at 70 Celsius and countries around the world
smokers by 5-fold, suggesting that in vacuum sealed bags to prevent (IARC, 2004). Additionally, trends
actual exposures were drama- the effects of aging. Sources of in tobacco processing and
tically underestimated and/or that guidelines and protocols for blending over time may impact
other important carcinogens or sampling and preparation are public health. For example, while
mechanisms of action exist that available in Table 5.16. increasing tobacco nitrate levels
were not included in the risk was seen as a way of reducing
Sampling ISO 8243: 2006 Cigarettes: Sampling
Sample Preparation ISO 3402: 1999 Tobacco and Tobacco Products: Atmosphere for Conditioning and Testing
Health Canada: Preparation of Cigarettes from Packaged Leaf Tobacco for Testing (Health
Canada, 1999a)
US Centers for Disease Control and Prevention: Protocol to Measure the Quantity of
Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged
in the United States (Centers for Disease Control and Prevention, 1997a).
ISO: International Organization for Standardization (www.ISO.org)
Table 5.16 Sampling and Preparations Standards
241
PAHs in tobacco smoke in the they have not adopted methods levels in US cigarettes have
1960s, in the 1980s scientists for many areas of particular increased from 1998 to 2005 by
recognized that increased nitrate interest to public health (i.e. about 11%, and concluded that
levels were also increasing the emissions as driven by users this trend was due primarily to an
yield of nitrosamines in tobacco behaviour, free-base nicotine, increase in nicotine in the raw
and smoke (Brunnemann & presence of carcinogens) (Bialous tobacco used in cigarettes
Hoffmann, 1982; Fischer et al., & Yach, 2001). Additionally, (Connolly et al., 2007).
1989a). Measurement of con- Health Canada and the US The Massachusetts Depart-
stituents in tobacco can provide Centers for Disease Control and ment of Health and the CDC also
the earliest point of monitoring for Prevention (CDC) have published require reporting of the amount of
regulation and possible interven- official methods for manufacturer nicotine that is present in the
tion. reporting of tobacco constituents. unprotonated, free-base form in
There are a range of well Table 5.17 summarizes the smokeless tobacco. This form of
established methods for mea- existing methods for whole tobac- nicotine is absorbed more easily
suring the chemical charac- co analysis and their sources. through the mucosal membranes
teristics of tobacco that have long While an exhaustive discussion of in the mouth (Brunnemann &
been in use by tobacco manu- tobacco constituents and asso- Hoffmann, 1974). Measurements
facturers and agricultural scien- ciated methods is beyond the of unprotonated nicotine content in
tists. Since the 1950s, there have scope of this section, a few key tobacco provide a more accurate
been significant developments in agents are discussed here which assessment of the quantity of
analytical methods for studying have particular relevance and nicotine in the product that is
tobacco products with the importance for product regulation. delivered to the user (Hoffmann et
introduction of technologies such al., 1995). Free nicotine content in
as gas chromatography and mass Nicotine: tobacco can be calculated using
spectrometry (Green & Rodgman, the Henderson-Hasselbalch equa-
1996). There are three standard Standardised protocols for tion, which is based on measured
setting organisations that have extracting and measuring nicotine pH and nicotine content. This
developed and adopted methods in whole tobacco using gas information is important for
for analysis of tobacco and chromatographic analysis have understanding trends in product
cigarette smoke: the International been adopted and widely used by use and for providing a basis for
Organization for Standardization industrial and professional monitoring and regulating nicotine
(ISO), the Association of organisations (ISO (15152: 2003), content in the product. A CDC
Analytical Communities Inter- CORESTA (No. 62, Feb 2005), study that measured free nicotine
national (AOAC), and the Co- AOAC (920.35)), as well as public in popular brands of smokeless
operation Center for Scientific health agencies (Health Canada, tobacco, found that the brands
Research Relative to Tobacco Massachusetts Department of with the largest amount of
(CORESTA). The CORESTA Public Health, CDC). It is im- unprotonated nicotine also are the
board is made up of 14 member portant to measure nicotine levels most frequently sold (Richter &
companies from the tobacco in tobacco as nicotine is the Spierto, 2003). In smokeless
industry (http://www.coresta. primary driver of smoking be- tobacco products, manipulation of
org/Home_Page/Presentation% haviour and addiction, and the tobacco pH and free-base nicotine
20of %20CORESTA_April07.pdf). level of nicotine in tobacco is an levels has also been used by the
Additionally, the tobacco- essential predictor of nicotine tobacco industry as part of a
related efforts of ISO have levels in smoke emissions de- graduation strategy, whereby
historically been driven primarily livered to the tobacco user. A novice users are introduced to
by the needs of industry and, thus, recent report found that nicotine products with lower nicotine
242
Analyte Analysis Method Protocols
Nicotine Gas chromatographic analysis Health Canada; CORESTA No. 62, Feb 2005;
CDC; AOAC 920.35
Total Moisture Weight before and after heating in CDC; AOAC 966.02
oven at 99 C
pH pH meter Health Canada; CDC
Free Nicotine Calculated from pH and nicotine Centers for Disease Control and Prevention
using the Henderson-Hasselbalch (1997a): Massachusetts Department of Public
equation Health
Nitrosamines Gas chromatographic analysis Health Canada; CORESTA (under develop-

ment); CDC (Song & Ashley, 1999)
Nitrates Continuous Flow Analysis Health Canada; CORESTA No. 36, Nov 1994
Metals Atomic absorption spectroscopy Health Canada; IARC (1986)

(AAS) analysis
Ammonia High Performance Liquid Health Canada

Chromatography (HPLC)
Humectants Gas chromatographic analysis
Pesticide residues Gas chromatographic analysis CORESTA No. 2, May 1997; ISO 4389:2000
ISO: http://www.iso.org
CORESTA: http://www.coresta.org/
AOAC: http://eoma.aoac.org/methods
Health Canada: http://www.hc-sc.gc.ca/hl-vs/tobac-tabac/legislation/reg/index_e.html
Massachusetts: http://www.mass.gov/dph/mtcp/legal/prodreg.htm
CDC: US Centers for Disease Control and Prevention: Protocol to Measure the Quantity of Nicotine Contained in Smokeless Tobacco
Products Manufactured, Imported, or Packaged in the United States.
Federal Register. Vol. 62, No. 85, Friday, May 2, 1997. p. 24115 - 24117 (recommended method for determination of organochlorine
pesticide residues on tobacco)
Table 5.17 Whole Tobacco Analysis Methods
delivery and eventually progress mainstream and sidestream to- N-nitrosoanatabine (NAT), and N-
to higher delivery products bacco smoke). nitrosoanabasine (NAB) are pre-
(Connolly, 1995; Tomar et al., sent in both unburned tobacco
1995). Thus, continued monitoring Nitrosamines: and tobacco smoke. NNN and
of pH levels and free-base NNK play a significant role in
nicotine in tobacco is important for Tobacco-specific N-nitrosamines cancer induction by tobacco
monitoring the addiction potential (TSNAs), N-nitrosonornicotine products (Hecht, 1998). The
of products (see following sub- (NNN), 4-(methylnitrosoamino)-1- TSNAs are formed from tobacco
section on constituents in (3-pyridyl)-1-butanone (NNK), alkaloids during the curing and
243
processing of tobacco. Studies tobacco products. While in some (Stanfill & Ashley, 2000). The UK
have suggested that the tobacco countries agents may be screened Department of Health maintains a
blend may be the most important for their direct toxicity, little is list of permitted additives to
determinant of TSNAs (UK Labo- known about the fate of these tobacco products (now numbering
ratory of the Government Che- agents after the combustion pro- over 600) along with maximum
mist, 2000; Harris, 2001). Oriental cess. Additionally, additives are inclusion limits, although their
and flue-cured Virginia tobaccos used to make tobacco smoke less effects after combustion have
contain lower levels of nitrate and harsh and to increase nicotine generally not been tested (http://
TSNAs, while higher levels are delivery, thus impacting the www.advisorybodies.doh.gov.uk/s
found in air-cured burley tobaccos physiological effects of smoking coth/technicaladvisorygroup/additi
(Fischer et al., 1989a; Bush et al., and resulting behaviours. Ammo- veslist.pdf).
2001; Peele et al., 2001). nium compounds raise the alka- Evaluation of the impact of
NNN and NNK make a likely linity of smoke, which increases product regulations that control
target for surveillance and the level of free nicotine additives is limited by inadequate
regulation as they play a signi- delivered to the smoker, and have information and scientific data
ficant role in tobacco-related been employed as an additive in about the presence of additives in
cancer, are measurable even in cigarettes (Henningfield et al., products by brand, and their
trace quantities, and are specific 2004). Menthol, a chemical com- potential effects on behaviour and
to tobacco. Moreover, in recent pound which acts as a mild local health outcomes.
years it has been demonstrated anesthetic, has been added to
that use of new curing tech- cigarettes beginning in the 1920s Product design
nologies can considerably reduce and 1930s to mask the harshness
the levels of TSNA, especially of tobacco smoke (Reid, 1993). Cigarette design has evolved over
NNK, or even completely elimi- Detecting flavouring the past half century, with the
nate them (Bush et al., 2001; compounds and other additives is introduction of filters, changes in
Peele et al., 2001). A study con- complicated by the fact that they tobacco processing techniques,
ducted by the CDC comparing may be present in very small and the introduction of new ma-
TSNA levels in cigarettes quantities and, more importantly, terials and technologies. The
purchased in 13 countries and the researchers and regulators may resulting changes in product
USA, found that in 11 of the 13 lack specific information about design and characteristics can
countries locally-purchased Marl- their presence. Regulators rely on have a substantial impact on the
boro cigarettes had significantly information from annual reports of exposure a smoker receives. The
higher TSNA levels than locally additives used and their quantities types of materials used in filters
popular non-US brands pur- by cigarette brand, such as in the and filter design can alter the
chased in the same country EU, but many countries do not yet chemical composition of the
(Ashley et al., 2003). Methods for have such requirements. Because smoke that is inhaled, including
measuring NNN and NNK have of the hundreds of additives that the levels of carbon monoxide and
been adopted by Health Canada may be in use, testing for many of other harmful constituents. Addi-
for regulation. them is impractical. At least one tionally, use of expanded or
study has quantified the presence reconstituted tobacco in cigarettes
Additives/flavourings: of 12 potentially toxic flavour- can affect tar and nicotine yields
related compounds in cigarette and the profile of constituents.
Additives may include both natural tobacco, including coumarine and Cigarette length, circumference,
and synthetic agents that impart or safrole, and found that 62% of 68 and packing density can also alter
enhance flavour. There are hun- brands tested contained one or the chemical composition of the
dreds of additives that are used in more of these 12 compounds smoke (Hoffmann & Hoffmann,
244
1997). Specific design features global_interaction/tobreg/goa_200 measures for supporting the

have also been employed to 3_principles/en/index.html). development and implementation
reduce cigarette ignition pro- Table 5.18 includes the of regulations, such as by
pensity, such as reduced tobacco TobReg recommendations and revealing unexpected product
density, reduced paper porosity, additional product characteristics changes in response to regu-
decreased circumference, and the that should be measured to lations (see following section on
removal or reduction of burn assess the impact of regulation on ventilation). Because most of the
additives. product design; reference measures are routinely used by
Physical characteristics of numbers are provided for official manufacturers in product charac-
tobacco products should be laboratory protocols where they terization and quality control, such
measured in order to inform the exist. This list is not exhaustive information should be requested
development and implementation and should be revised regularly to from manufacturers by regulators
of tobacco product regulations account for new types of products where possible.
and to support evaluation of and design innovations, such as
regulations. The WHO Study new potential reduced exposure Cigarette ventilation:
Group on Tobacco Product Regu- products (PREPs) that employ
lation (TobReg) has provided a unconventional technology. These Since the 1960s, cigarette filter
recommended list for product product characteristics are not ventilation has been the dominant
characteristics to be reported by necessarily direct targets of design feature employed by
manufacturers for all brands on an regulation or indicators of effec- manufacturers to reduce machine
annual basis (WHO Study Group tiveness of regulations in all measured tar and nicotine yields
on Tobacco Product Regulation, cases. They should be con- (Kozlowski et al., 2006). Small
2004; http://www.who.int/tobacco/ sidered, however, as useful pinholes on cigarette filters allow
Product Characteristics Measurements
Raw Materials Tobacco blend, weight of tobacco, percentage of reconstituted tobacco, percentage
of expanded tobacco, moisture content, firmness, contaminants (i.e. glass,
pesticides, heavy metals).
Filter Type, length, weight, density, ventilationa, draw resistanceb, fiber residues,
charcoal content.
Cigarette Body Rod length, tipping paper length, diameterc, air permeabilityd.
Emission Aerosol particle size with and without filter.
Ignition Propensity Percent self-extinguishing.

a
ISO 9512: 2002 Cigarettes - Determination of ventilation - Definitions and measurement principles
b
ISO 6565: 2002 Tobacco and tobacco products - Draw resistance of cigarettes and pressure drop of filter rods - Standard conditions
and measurement
c
ISO 2971: 1998 Cigarettes and filter rods - Determination of nominal diameter - Method using a laser beam measuring apparatus
d
ISO 2965: 1997 Materials used as cigarette papers, filter plug wrap and filter joining paper, including materials having an oriented
permeable zone - Determination of air permeability
Table 5.18 Product Characteristics to be Measured to Assess Impact of Product Regulation
245
the smoke to be diluted by air to 10 mg, as well as nicotine from study conducted to evaluate the
drawn in by the smoker. However, a median of 1.0 mg to 0.9 mg. impact of the New York law, found
studies have shown that smokers However, the only product design that the average percentage of
tend to place their fingers over feature that showed consistent full-length burns was 10% for five
these vent holes in order to derive change was the amount of filter leading brands sold in New York
a desired level of nicotine ventilation, as the median in- after the law went into effect,
(Kozlowski et al., 1980). Addi- creased by 479% from 1999 to compared with 99.8% for cigarette
tionally, smokers puff harder to 2005. In contrast, other product brands from California and
compensate and the greater flow design characteristics that were Massachusetts (Connolly et al.,
through the cylinder also reduces measured in the study, including 2005). These findings confirm that
the proportion of air that comes in filter weight, filter length, and the law did result in changes to the
through the vent holes. Because of tobacco length, showed no product design that achieved the
this flexibility in the cigarette changes (OConnor et al., 2006a). aims of the legislation. Product
design, machine measured ISO/ This study illustrates the im- testing can be used to assess
FTC tar yields do not reflect the portance of monitoring product compliance and product per-
actual range of exposures smokers design over time against a formance following the intro-
receive. A study comparing baseline level to understand how duction of RIP laws. It is also
ventilation (measured as the products are modified in response important to evaluate smokers
percentage of air drawn through to new regulations, and whether reactions to changes in cigarette
the filter vents) across 32 brands of the public health objectives of the design to identify potential un-
US cigarettes, with FTC tar yields regulation are being met. An intended effects on smoking
ranging from 1 mg to 18 mg, found alternative proposal involves im- behaviour. A survey of adult smo-
that the degree of ventilation (from posing maximum tar, nicotine, and kers reactions to RIP cigarettes
0 to 83%) varied inversely with carbon monoxide yields along with found that while smokers in New
standard tar, nicotine, and CO a ban on filter vents (Kozlowski & York State were more likely to
yields, suggesting that ventilation is OConnor, 2002; Kozlowski et al., report that their cigarettes went
a key determinant of machine 2006). out between puffs, they were no
measured yields (Centers for Amount of ventilation should be more likely than smokers in states
Disease Control and Prevention, measured in cigarettes, particularly without RIP laws to report
1997b). Similarly, another study for evaluating the introduction of differences in cigarette taste,
accounted for 95% of the variance new regulatory limits on emissions. suggesting that RIP cigarette laws
in ISO measured levels as a Additionally, given the elasticity in do not substantially impact
function of extent of filter venting exposures from ventilated ciga- consumer acceptability (OConnor
(King & Borland, 2004). rettes, measurements of emissions et al., 2006b). Moreover, proximal
A recent study assessed how should take this variability into measures of the product itself can-
UK cigarette manufacturers modi- account, such as by measuring not assess more distal outcomes,
fied their products in order to emissions in relation to a fixed such as changes in the number of
comply with the EC 10-1-10 amount of nicotine or per milligram fires caused by cigarettes. Distal
maximum yield regulation. Com- of nicotine. measures and surveillance are
paring 10 cigarette brands before discussed in the following section.
and after the regulation was Reduced ignition propensity:
imposed, they found that machine Product Emissions
measured tar was reduced from Reduced ignition propensity (RIP)
11-13 mg to 10 mg for each brand, regulations are relatively new, so Measuring the contents and
carbon monoxide yields dropped limited data is available on their characteristics of tobacco smoke
significantly from a median of 13 impact and effectiveness. One has been the primary focus of
246

tobacco product testing and smoke from the end of the and measuring the length of the
regulation efforts since the 1960s. cigarette to travel up a glass unsmoked cigarette left in the
Measuring the contents of tobacco enclosure to a filter pad located at ashtray (Harold & Pillsbury, 1996).
smoke provides direct information the top. Filter pads are weighed When the US Federal Trade
about the agents the smoker is before and after a smoking run to Commission adopted this method
exposed to. However, these determine the Total Particulate for use in its testing laboratory, the
measures also have substantial Matter (TPM) (the amount of agency acknowledged that these
limitations; while they allow for the particulates accumulated on the parameters were not intended to
identification of important con- filter pad). A solvent is used to mimic the smoking behaviour of
stituents in tobacco smoke, they remove the chemicals from the any particular individual or even
do not necessarily reflect expo- filter pads, and once this ex- an average smoker, but the
sure under actual smoking con- traction is complete, various application of a uniform standard
ditions. Measurements of product chemical and physical separation would, they stated, allow for
emissions have typically relied on techniques are used to isolate the meaningful comparisons across
machine collection of tobacco desired component(s). Once the products (Press release, August 1,
smoke, which does not reflect desired chemical has been 1967). ISO adopted a similar set
actual human smoking behaviour. isolated, various analytical me- of parameters in their cigarette
This section will review various thods (such as gas chro- testing method (ISO Standard
machine smoking protocols, and matography with mass spec- 3308: 2000 (4th edition), Routine
their limitations, and will then trometry) are used to determine Analytical Cigarette-Smoking
discuss specific constituents in the amount of chemical collected. Machine: Definitions and Standard
tobacco smoke that have been Gas phase chemicals, such as Conditions).
proposed for surveillance and carbon monoxide, may pass However, beginning in the
regulation. through the filter pads and into 1980s, a more profound under-
collection bags for measurement. standing of smoking behaviour
Machine smoking methods: To ensure consistency across revealed that smokers who
measurements, standard para- switched to cigarettes with lower
Machine smoking methods for meters are used to control the machine measured tar and nico-
measuring tar, nicotine, carbon machines puffing activity. The tine yields modified their smoking
monoxide, and other constituents parameters most widely in use behaviour to compensate by
in cigarette smoke have been were based on a protocol outlined taking more frequent puffs, in-
widely used in many countries by the US Department of haling the smoke more deeply,
over the past 30 years. The Agriculture (Ogg, 1964); a similar covering up filter ventilation holes,
procedure involves having a ma- protocol had been proposed by and smoking more of each
chine smoke cigarettes ac- American Tobacco Company cigarette (Benowitz et al., 1983;
cording to fixed parameters that researchers in 1936 (Bradford et National Cancer Institute, 2001).
determine the frequency, duration, al., 1936). The protocol called for More accurate measures of the
and volume of puffs, as well as the 2-second, 35-mL puffs to be taken actual smoke exposure of a given
butt length. The particulate matter until a 23-mm butt length individual can be obtained through
is collected onto a Cambridge filter remained on the cigarette. These the study of smoking topography,
pad made of extremely fine parameters were somewhat where the smoker uses a
diameter glass fibers. Mainstream arbitrarily selected based on mouthpiece connected to a device
smoke particulates are collected informal observations; Ogg repor- that measures parameters of smo-
on filter pads located behind the tedly stated that he arrived at the king behaviour (such as number of
cigarette port, while sidestream parameters he chose by informally puffs, puff volume, duration,
smoke is collected with the use of observing people smoking, timing velocity, and the intervals between
BAT fishtail devices, which allow them with the aid of a stopwatch, puffs) (Djordjevic et al., 2000; Lee
247
et al., 2003). However, while the compensatory regimen nicotine uptake among human
smoking topography measure- attempts to mimic the systematic smokers against the puffing
ments are valid for assessing differences in human smoking variables and nicotine yields
individual exposure, the para- across different products, whereby generated by the four smoking
meters vary widely across the lower nicotine yield brands are regimens, as well as a Human
population and no single set of smoked more intensely. It was Mimic regimen where brands were
smoking parameters can effec- suggested that the puff volume machine smoked using puffing
tively represent this variation. and puff frequency be varied behaviour recorded from human
Because of growing concerns according to the ISO nicotine smokers in the study. Participants
about the validity of the FTC/ISO yield. For brands with <10 mg tar, in the study smoked cigarettes
parameters, alternative machine a 40 mL puff is taken every 60 through a portable smoking
smoking regimens have been seconds. With every decrease of topography device to record their
proposed. In particular, the FTC 0.1 mg nicotine, the puff volume smoking behaviour, and they also
and ISO smoking regimens do not rises by 4 mL and the puff provided saliva samples to be
account for the fact that smokers frequency falls by 4 seconds. For analyzed for cotinine. The study
may cover ventilation holes with example, a cigarette with 0.5 mg found that, using the Human
their fingers, and alternative nicotine under the ISO method Mimic condition as a benchmark,
smoking regimens have attem- would be smoked at 60 mL puffs subjects were exposed to tar,
pted to address this. The every 40 seconds, whereas a 0.1 nicotine, and carbon monoxide
Commonwealth of Massachusetts mg cigarette would be smoked at levels that were 2 to 4 times
in the USA currently tests 76 mL puffs every 24 seconds greater than the ISO yields,
cigarettes with a 45 mL puff drawn (Kozlowski & OConnor, 2000). suggesting that the ISO standard
twice per minute with 50% of the Another alternative is to tie seriously underestimates actual
filter vent holes blocked analysis of constituents to a fixed human exposure. Moreover, while
(Commonwealth of Massachu- nicotine level whereby cigarettes the Canadian intense smoking
setts, 2007). Canadian govern- are smoked to predetermined conditions are considered to
ment testing standards require a nicotine yields and the levels of represent the maximum emissions
more intensive smoking regimen, other constituents assessed from to which a smoker is likely to be
where 55 mL puffs are drawn that (Hammond et al., 2007b). exposed, the study found that total
twice per minute with 100% of the Alternatively, TobReg of WHO has smoke volume was not sig-
vent holes blocked (Health recommended use of yields per nificantly different from the actual
Canada, 1999b). While these mg of nicotine, using standard smoke volume as measured in the
regimens also cannot represent puffing regimens. (WHO Study participants when smoking their
the wide variation in human Group on Tobacco Product Regu- usual brand. Among those
smoking patterns, they may be lation, 2004). subjects who were experimentally
less likely to underestimate actual A recent study compared the switched to a lower yield brand, all
human exposure by using more performance of these four smo- four smoking regimens produced
intense puffing parameters. This king regimens against actual a lower volume of smoke than the
may be especially important for human smoking patterns and Human Mimic. Comparing these
lower yield products for which biological measures of exposure findings to the measured salivary
smokers may compensate with to assess how well they reflect cotinine levels further reveals the
more intense puffing behaviour. actual exposures smokers are limitations of machine smoking
A compensatory machine likely to receive (Table 5.19) methods. The yields from the
smoking regimen was proposed; (Hammond et al., 2006b). The aim Massachusetts, Canadian, and
rather than smoking all brands of the study was to compare Compensatory regimens were no
using the same puffing regimen, measures of smoke volume and better at predicting measures of
248
FTC ISO Massachusetts Canadian Compensatory
Puff Volume (mL) 35 35 45 55 40
Puff Duration (seconds) 2 2 2 2 2
Interpuff Interval 60 60 30 30 30
(seconds)
Ventilation Hole Blockage (%) 0 0 50 100 50
Butt Length 23 mm or Filter Filter length + 8 Filter length + 8 Filter length + 8

filter + 3 length + 8 mm or filter mm or filter mm or filter
mm mm or overwrap overwrap + 3 mm overwap + 3 mm
filter over- + 3 mm
wrap+ 3mm
Adapted from Hammond et al., (2006b)
Table 5.19 Recommended Machine-Smoking Regimes for Cigarette Testing
nicotine uptake than the ISO lations and, where relevant, for for collecting smoke emissions
yields. Even the Human Mimic measuring basic compliance with that are more representative of
condition was only moderately constituent limits based on actual human smoking exposures.
correlated with salivary cotinine standardised machine testing Additionally, some promising
levels, reflecting the wide varia- regimens. The WHO Study Group approaches to account for varia-
bility in uptake based on nicotine on Tobacco Product Regulation tions in smoking behaviour based
metabolism among smokers even (TobReg) has recommended that on nicotine titration warrant further
when smoking the same brand. A standardised machine smoking development, including measure-
subsequent study comparing tests be used by scientists and ment of constituent yields per
emissions data from 238 regulators to the extent that it milligram of nicotine and analysis
Canadian cigarette brands tested provides a basis for a comparison of cigarette filter stains (Strasser
under ISO and Canadian intense of the results with new testing et al., 2006)
machine smoking conditions, protocols until protocols that reflect
found that the more intense variations in human smoking Constituents in mainstream
protocol was not necessarily more behaviour according to different and sidestream tobacco
representative of actual human cigarette designs are developed. smoke
smoking behaviour and exposure (WHO Study Group on Tobacco
(Hammond et al., 2007b). Product Regulation, 2004). Despite Mainstream cigarette smoke is a
Standardised machine testing its limitations for predicting actual complex and dynamic mixture of
regimens lack validity as measures human exposures, machine testing thousands of constituents that are
of actual human exposure. Despite can provide important information distributed between a vapour
its limitations, however, machine on cigarette engineering and how phase and a particulate phase
testing using ISO and alternative differences in cigarette design may (Jenkins et al., 2000). Since the
parameters remains valuable for affect smoke emissions. 1950s, following the first epi-
informing the development and There remains a need for demiologic studies linking smo-
implementation of product regu- further development of methods king and lung cancer, dozens of
249
carcinogens and other harmful Nicotine: Polycyclic aromatic hydrocar-

constituents have been identified bons:
in tobacco smoke. The primary Measuring nicotine emissions is
focus has been on PAHs, such as central to evaluating the addictive Polycyclic aromatic hydrocarbons
benzo [a]pyrene and TSNAs, such potential of tobacco products. (PAHs) are a diverse group of
as NNK, which are considered to Standardised methods for mea- carcinogens formed during the
be major lung carcinogens (Hecht, suring nicotine in machine collected incomplete combustion of organic
1999). Carbon monoxide in smoke have been widely used, but material, such as tobacco. They are
cigarette smoke has also been their ability to predict actual nicotine found in tobacco smoke, broiled
extensively studied and is likely to intake is restricted by the limitations foods, and in occupational settings,
contribute to atherosclerosis, and of standardised machine smoking such as iron and steel foundries.
other cardiovascular diseases, by parameters. It is also important to Benzo[a]pyrene is the best known
reducing delivery of oxygen measure the proportion of nicotine member of this class of compounds
through the body (US Department that is available in the unpro- and has been classified by an IARC
of Health and Human Services, tonated, free-base form, which is expert panel as carcinogenic to
2004). It is not possible to discuss more easily absorbed by the body. humans (Straif et al., 2005).
the significance of each constituent Research has shown that levels of
in this section, but a thorough list of free-base nicotine vary sub- N-Nitrosamines:
major toxic and carcinogenic stantially across different types of
constituents in the vapour phase tobacco and tobacco product Tobacco smoke nitrosamines
and particulate matter of cigarette brands, and that the tobacco (TSNAs) include a large group of
smoke is provided in IARC industry has manipulated the free- carcinogens that are known to
Monograph 83 (IARC, 2004). The nicotine content of tobacco induce tumours in a variety of
WHO TobReg study group has products through additives, such as animal species. TSNAs, such as
developed a recommended list of ammonia (Ferris et al., 2006). A NNN and NNK, are chemically
constituents to be reported or laboratory smoking device and a related to nicotine and nornicotine,
measured in mainstream and gas chromatograph-mass spec- a secondary amine tobacco alk-
sidestream smoke (2004). Addi- trometer were used to measure the aloid, and are thus only found in
tionally, Health Canada requires amount of free-base nicotine in the tobacco products. An IARC
manufacturers to report more than particulate matter of mainstream working group on smokeless
40 specific constituents annually cigarette smoke, and found that tobacco and tobacco-related
for each brand in both mainstream significant amounts of nicotine in nitrosamines concluded that ex-
and sidestream smoke. Though the particulate matter can be in posure to NNN and NNK is
essentially the same list of free-base form (Pankow et al., carcinogenic to humans (Cog-
constituents is measured for both 2003). Similarly, a research group liano et al., 2004).
mainstream and sidestream from the CDC found that the
smoke, it is important to do measured ranges of free-base Aromatic amines:
measurements for both types of nicotine in smoke particulate matter
emissions because their quantities were remarkably similar over the Aromatic amines were first iden-
may differ. These constituents are different tar and nicotine delivery tified as carcinogens in workers in
listed in Table 5.20. categories of full-flavoured, light, the dye industry. Of these, 4-
A few compounds believed to and ultra-light cigarette brands, aminobiphemyl and 2-naphthy-
be particularly important are briefly sug-gesting that standard tar and lamine are well-established human
discussed here: nicotine yields do not provide a bladder carcinogens (IARC, 1987).
valid estimate of actual nicotine The 1999 Massachusetts
emissions (Watson et al., 2004b). Benchmark Study provided the
250
Health Canada TobReg Mimimum
Nitrosamines NNN, NNK, NAT, NAB

Acrylonitrile
3, 4 Aminobiphenyl
1,2 Aminonaphthalene
Ammonia
Arsenic Arsenic
Benzene
Benzo[a]pyrene
1,3-Butadiene
Cadmium Cadmium
Carbonyls
Chromium Chromium
Eugenol
Formeldahyde
Hydrogen Cyanide Hydrogen Cyanide
Isoprene
Lead Lead
Mercury Mercury
Nickel Nickel
Nitrogen Oxides Nitrogen Oxides
Phenolics
Pyridine
Quinoline
Selenium Selenium
Styrene
Toluene
Filter efficiency
pH
Tar, nicotine, carbon Tar, nicotine/free nicotine, carbon monoxide
monoxide
Ratio of nicotine-free dry particulate matter to nicotine yield
Table 5.20 Emissions Candidates for Surveillance
most comprehensive data to date and Massachusetts machine IARC, 2004). The study also
on the profile of smoke emissions smoking methods. The primary illustrated the limitations of ISO tar
of contemporary cigarettes. Eigh- constituents varied dramatically and nicotine yields for predicting
teen leading cigarette brands from across the brands, including total doses of specific toxins and
the USA delivering a range of tar tar (6.1 mg to 48.7 mg per carcinogens in tobacco smoke.
values (from 1 mg to 26 mg per cigarette), carbon monoxide (11.0 One analysis of the Benchmark
cigarette according to FTC para- mg to 40.7 mg per cigarette), and data showed that FTC tar, nico-
meters) were screened for 44 nicotine (0.50 mg to 3.32 mg per tine, and carbon monoxide yields
constituents using both the FTC cigarette) (Borgerding et al., 2000; were poor predictors of TSNA
251
yield per cigarette, suggesting that constituents varies over time and exposure and the appearance of
information about the tobacco across puffs in response to disease symptoms, which can, as
blend could be more informative changes in temperature and with cancer, take decades.
for predicting TSNA emissions dilution of smoke and other Biomarkers of exposure and
(Harris, 2001). factors. The distribution of indi- biological impact show substantial
Indeed, measured yields of vidual constituents across the promise for assessing early
constituents can vary substantially particulate and gas phases of effects of tobacco use that are
depending on the smoking smoke also changes over time; relevant for later disease out-
parameters used for machine volatile and semi-volatile com- comes. Disease risk is presumed
measurements. One analysis pounds, such as benzene and to be a function of the amount,
found that the yields of six IARC 1,3-butadiene, can be present in site, and duration of the
Group I carcinogens (benzene, significant quantities in both exposures. Thus, biomarkers of
cadmium, 2-aminonaphthalene, phases. Recently, a high through- exposure may provide more
nickel, chromium, and 4-amino- put method for analyzing volatile accurate prediction of disease
biphenyl) in mainstream smoke, organic compounds in smoke was outcomes than standard mea-
were an average of 2-4 times published (Polzin et al., 2007). sures of tobacco consumption. In
higher when measured by the However, measuring this dynamic particular, there are substantial
more intense Health Canada mix in real-time to determine how differences in how individuals use
parameters than by ISO para- exposure varies over a series of tobacco products, and how their
meters (IARC, 2004). Another puffs, for example, is extremely bodies respond to chemical
study of mainstream smoke from complex. Efforts have been made agents in tobacco smoke that are
three popular brands of US to characterize volatile com- not reflected by simply measuring
cigarettes purchased on the open pounds in smoke in real-time number of cigarettes per day or
market in 29 countries worldwide, using time-of-flight mass spec- use of standardised machine
showed little variation in tar and trometry, but this application is smoking to predict exposures.
nicotine, but substantial dif- experimental and requires state of Additionally, biomarkers may play
ferences in the yields of NNN and the art equipment (Adam et al., a particularly important role in the
NNK within each brand (Gray et al., 2006). assessment of how differences
2000). Additionally, analyses have between products or changes in
shown that blocking filter ventilation Distal measures product design or constituents
holes can alter the characteristics may impact health. For example,
of mainstream smoke, including Biological Impact: biomarkers of toxic effects or
increasing the delivered doses of biological damage can provide
specific carcinogens and hazar- The ultimate test of the success of early indications of the impact of
dous agents (Brunnemann et al., tobacco product regulations in potential reduced exposure pro-
1990). These analyses suggest protecting public health would be ducts or constituent limits on
that standard ISO machine to observe actual reductions in disease outcomes.
measured tar and nicotine ratings tobacco-related disease inci- Biomarkers can be divided into
cannot be relied upon to estimate dence. Population level trends in at least two major categories
emissions of toxic constituents. lung cancer incidence, for (Hatsukami et al., 2006):
Further research is needed to example, have reflected changes
understand how varying smoking in cigarette smoking over time. Biomarkers of internal expo-
parameters may affect the However, such long-term health sure: biomarkers that provide a
contents of cigarette smoke. outcomes do not represent an direct or indirect measure of
Cigarette smoke is also highly effective target for regulation, the quantity of a tobacco-
dynamic, and the profile of smoke because of the delay between derived constituent or
252
metabolite in the body. These predictive measure of the total quantitative relationship of the
will not always be closely carcinogenicity related to expo- biomarker to a specific exposure
related to intake because of sure to tobacco or tobacco smoke (i.e. a chemical in tobacco smoke)
differences in rates of (Hatsukami et al., 2006). The and to a selected end-point (i.e.
metabolism. Institute of Medicine report cancer) (International Programme
Biomarkers of potential harm: Clearing the Smoke: Assessing on Chemical Safety, 1993). There
biomarkers that measure a the Science Base for Tobacco are several issues to consider in
biological effect or binding of a Harm Reduction, cited the need evaluating a candidate biomarker
tobacco constituent or for biomarker development in their including: understanding of the
metabolite in a target organ or principal research recom- role of the biomarker along a
tissue. For example, carci- mendations: Although candidate disease pathway, amount of
nogen-DNA adducts can be disease-specific surrogate mar- supportive dose-response data
used to measure the presence kers are currently available, further (e.g. quantitative data correlating
and activity of a specific validation of these markers is levels of the biomarker with
carcinogen in target tissue. needed. In addition, other smoking status and with disease
Further along, this also biomarkers that accurately reflect endpoints), specificity (is it specific
includes biomarkers that mechanisms of disease must be for exposure to tobacco toxi-
measure actual damage to or- developed to serve as inter- cants?), sensitivity (are available
gans or tissues, such as mediate indicators of disease and tests sufficiently sensitive to detect
genetic mutations or chro- disease risk. (Institute of Medicine, quantities within a range
mosomal aberrations, which 2001). Another expert committee, encountered in the population and
may or may not lead to that assembled to identify key to detect meaningful changes),
disease. research needs related to tobacco and reproducibility (e.g. intra-
It is important to distinguish harm reduction, also included subject reliability) (Institute of
between biomarkers of exposure among its recommendations the Medicine, 2001). Supportive data
versus biomarkers of biologic need to identify and validate for a biomarkers association with
effects or disease; it may be biomarkers that are predictive of tobacco use should ideally include
possible to show a reduction in later disease development differences between tobacco
exposure while the impact on (Hatsukami et al., 2002). Many users and non-users, a decrease
disease outcomes remains un- biomarkers are currently used in with cessation of tobacco use, a
certain. Additionally, it is helpful to research to study biologic effects of dose-response relationship with
distinguish between biomarkers tobacco products or potential quantity or frequency of use, and a
specific to a particular chemical, reductions in exposure from decrease with reduced smoking
such as NNAL, and biomarkers modified products. Table 5.21 lists (Hatsukami et al., 2006). Addi-
that assess the impact of complex a panel of biomarkers that have tionally, identification of multiple
exposures, such as urine been recommended as the most biomarkers along a continuum
mutagenicity. promising for use in research on from exposure to early disease
With the rise of genomics and potential reduced exposure pro- effects can provide a more robust
advances in molecular biology the ducts. However, these biomarkers profile of the relationship between
field of cancer-related biomarker are not necessarily ready for use in exposure and disease risk.
research has advanced con- a regulatory setting as they require
siderably over the past 25 years better characterization of their Biomarkers of internal expo-
(Schmidt, 2006), but to date there relation to health risks and disease. sure:
is no comprehensive set of A candidate biomarker must go
biomarkers of carcinogen expo- through a process of validation Biomarkers of internal exposure
sure or biological effects as a that establishes the qualitative and can potentially provide a more
253
Cotinine is the most widely used

General Tobacco Exposure metabolite, as it has a relatively
Nicotine/Cotinine long elimination half-life of 16
Carbon Monoxide hours (compared to only two
hours for nicotine) and can be
Cancer
easily measured in urine, serum,
NNAL
or saliva. Nicotine has also been
NNAL Glucs
measured in hair and toenails as
3-Aminobiphenyl
a means of assessing exposure to
4-Aminobiphenyl
SHS in large scale epidemiologic
Sister chromatid exchange
studies, although the reliability of
Nonmalignant Lung Disease these measures may be in-
Macrophages fluenced by hair treatment, and
other factors, and requires further
Cardiovascular Disease evaluation (Al-Delaimy, 2002; Al
Flow-mediated dilation Delaimy et al., 2002). Nicotine and
Circulating endothelial precursor cells its metabolites also make effective
Fibrinogen biomarkers because they are highly
Homocysteine specific to tobacco exposure
White blood cell count (unless the subject is using nicotine
C-reactive protein replacement therapy).
slCAM1 Carbon monoxide (CO) expo-
Glucose-clamping studies sure has also been used as a
biomarker for exposure to tobacco
Adapted from Hatsukami et. al. (2006) smoke. CO can be measured in
*Held in February, 2004, and sponsored by the National Cancer Institute, the National exhaled air, as CO boost before
Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and the and after cigarette smoking, and in
Centers for Disease Control and Prevention. blood as carboxyhemoglobin
(Benowitz, 2003). While CO is not
Table 5.21 Panel of Biomarkers: Recommended by 2004 Conference* specific to tobacco, it can serve as
on Methods and Biomarkers to Assess Potential Reduced Exposure a reliable short-term measure of
Tobacco Products (PREPS) smoking. The minor tobacco
alkaloids anabasine and anata-
bine, which are specific to tobacco
accurate estimate of actual actual uptake of nicotine by the products and can be measured in
exposure received by the smoker smoker (Benowitz, 1996b). urine, have also been used in
than can be inferred from Nicotine metabolites have studies for verifying smoking
machine-based cigarette ratings been widely used as biomarkers status (Jacob et al., 2002).
or number of cigarettes smoked. of general exposure to tobacco Chemically-specific biomarkers
For example, it was found that products, including exposure to can be used to assess exposure
over an approximately 10-fold smokeless tobacco and to to particular toxins and carci-
range in FTC cigarette ratings environmental tobacco smoke nogens in tobacco and smoke,
there was little or no significant (ETS [referred to in this volume as which may be valuable for
difference in blood nicotine levels secondhand smoke (SHS)]) evaluating the impact of product
in several studies, demonstrating among nonsmokers (Benowitz et performance standards targeting
that FTC ratings do not reflect al., 1994; Benowitz, 1999). specific constituents. Among the
254
chemical biomarkers, NNAL and carcinogens in secondhand smoke context, such as in clinical studies
its glucuronides (NNAL-Glucs), (Hammond et al., 1993). Aromatic of potential reduced exposure
which are metabolites of NNK, are amines are not specific to cigarette tobacco products (Breland et al.,
particularly useful because they smoke exposure, however, and 2006). However, at this point,
are specific for exposure to can also be associated with none of these biomarkers have
tobacco products (as NNK is a occupational and other chemical been recommended for wide-
tobacco-specific carcinogen) exposures. spread use in regulation because
(Hecht, 2002). NNAL and NNAL- Among the complex bio- their relationship to risk and health
Glucs are measured in urine and markers of DNA damage and outcomes has not been
have been used to quantify levels potential harm, urine mutagenicity sufficiently characterized.
of NNK uptake in smokers and and sister chromatid exchanges
smokeless tobacco users, and to are the most promising as Surveillance
assess changes following indicators of potential cancer
cessation or product switching effects. Both of these measures Comprehensive surveillance is
(Hecht et al., 2002; Hatsukami et have been found to be higher in essential to assess the impact of
al., 2004; Joseph et al., 2005; smokers than nonsmokers regulation on tobacco product use
Lemmonds et al., 2005). and to decrease on cessation and effects across the population.
(Vijayalaxmi & Evans, 1982; De However, this remains a challenge
Biomarkers of potential harm: Marini, 2004). However, the because capacity and infra-
measured effects may be caused structure for surveillance is limited
DNA adducts potentially provide a by diet or other factors, as well as in many countries (Jha &
direct measure of tobacco-induced cigarette smoke, and these Chaloupka, 2000). Thus, the
DNA damage. Adducts are formed differences may reflect other risk extent of surveillance efforts and
when chemical carcinogens bind to behaviour patterns associated with available infrastructure is likely to
DNA, which can alter the structure smoking. Development of complex vary widely between countries. A
of the DNA and is believed to be an measures that assess the comprehensive surveillance
important step in the pathway to combined effects of tobacco toxins programme could potentially cover
cancer. Protein adducts have also and carcinogens is important an enormous range of information.
been used to determine levels of because chemically-specific bio- Broadly, surveillance efforts
carcinogen exposure and activity, markers, while they may have should address changes in the
since most carcinogen meta- greater specificity in relation to design and performance of the
bolites that react with DNA will also exposure, may be misleading as a product itself, marketing activity,
react with proteins, such as measure of disease risk. A beliefs and attitudes around
hemoglobin, and they are more reduction in uptake of a single tobacco product use, tobacco use
readily measured than DNA tobacco smoke constituent in behaviours, including initiation and
adducts (Ogawa et al., 2006). smokers, such as NNAL, may not cessation, and health outcomes.
Hemoglobin (Hb) adducts of necessarily provide any meaningful Suggested construct areas for
aromatic amines, particularly 3- reduction in risk. Consumers may post-marketing surveillance are
and 4-aminobiphenyl, have shown interpret a claim of reduction in a drawn from published recom-
promise for use in studies of single chemical exposure as mendations and are listed in Table
tobacco-related carcinogen expo- indicating a health benefit. Thus, 5.22 (Institute of Medicine, 2001;
sure. They have been shown to be such measures should be put in Hatsukami et al., 2005).
higher in smokers than non- the context of overall hazard from In addition to measuring
smokers (Bryant et al., 1987; a complex product. potential changes in specific
Phillips, 2002), and have also been Biomarkers of potential harm tobacco constituent exposures, it
used to measure exposure to have been used in the research is important to track tobacco
255
product use and risk beliefs in goals of research efforts are to which included more than 25
relation to product regulations. understand better the nature of laboratories from 20 countries.
Product modifications in response tobacco products, how they work, The primary goal of the meeting
to regulation may impact tobacco their effects, and how they might was to establish a global network
use behaviour. Additionally, be modified to alter their effects. of government, university, and
experience with light cigarettes While testing operations adhere to independent laboratories to
has provided substantial evidence standardised protocols, research strengthen national and regional
that smokers believe these endeavors aim for flexibility and capacity for the testing and
products to be less harmful development of new methods and research of the contents and
(Cohen, 1996a; Giovino et al., measures for ongoing scientific emissions of tobacco products
2000; Ashley et al., 2001; discovery and analysis. The WHO pursuant to Article 9 of the WHO
Shiffman et al., 2001). Estab- Study Group on Tobacco Product FCTC. Future activities of the
lishment of regulatory performance Regulation has highlighted how network may include training
standards or constituent upper both research and testing capacity programmes and development of
limits, for example, may be are essential and must be common measures and protocols
misinterpreted as safe levels of coordinated (WHO Study Group (http://www.who.int/tobacco/global
exposure. While laboratory on Tobacco Product Regulation, _interaction/tobreg/ laboratory/en/
evaluation of product design and 2004). For example, as tobacco index.html). More details about
emissions can provide early products change, new products recommended equipment, per-
warning of potential adverse are introduced, and new scientific sonnel, and resources for opera-
effects, comprehensive post-mar- methods become available; there- ting a tobacco product testing
keting surveillance is essential to fore, it may be necessary to laboratory are provided by
ensure that regulations are develop new performance TobReg (2004). There is a
achieving their aims. Additionally, standards. Additionally, previous substantial need for support and
independent technical and re- efforts to promote product development of laboratory capa-
search capacity and infrastructure modification to protect public city independent of the tobacco
are needed to track changes in health, through lowering mea- industry in countries around the
tobacco products and users sured tar and nicotine yields in world with the purpose of
behaviour. cigarettes, were undermined by a achieving public health goals.
Establishing laboratory research lack of expertise on tobacco
and testing capacity is a crucial products and smoking behaviour Summary
step in supporting surveillance in the public health community
activities to inform evaluation of (Parascandola, 2005). Thus far, Articles 9 and 10 of the WHO
tobacco product regulation. In tobacco testing and measurement FCTC call for ratifying nations to
addition to tobacco product standards have been primarily adopt policies for the regulation
regulations, governments may driven by the interests of the and disclosure of tobacco product
have research capacity for tobacco industry; thus it is contents and emissions. This
studying other aspects of tobacco important that the public health chapter focuses on a review of the
products. The objective of stan- community develop capacity and methods and measures for
dardised product testing is to expertise in this area to ensure evaluating policies that are
assess product performance and that product regulations serve the intended to regulate tobacco
characterize the delivery of par- aims of public health (Bialous & products. There are currently five
ticular constituents known to be Yach, 2001). main types: 1) regulations that
important for public health, such In 2005, WHO convened the require disclosure of product
as carbon monoxide, nicotine, and first meeting of the Tobacco information; 2) regulations inten-
nitrosamines. In contrast, the Laboratory Network (TobLabNet), ded to reduce product toxicity and
256
Tobacco Product Design and Performance Product contents, design features (filter, cigarette body),
emissions of constituents that modify toxicity and addiction,
additives, ignition propensity.
Marketing Activity Product packaging and labelling, advertising content,

promotional materials.
Beliefs and Attitudes Product awareness, understanding of product design and

regulation, risk perception, sensory responses.
Tobacco Use Behaviours History, current use, brand use, quit attempts/history,
addiction/dependence, readiness and intentions to quit,
demographics, smoking topography.
Health Outcomes Biomarkers of toxin exposures, biomarkers of early biological

effects, tobacco-related disease incidence.
Other Outcomes Fires caused by cigarettes.
Table 5.22 Surveillance Construct Categories
harm; 3) regulations intended to of responses, such as tobacco tobacco product market and on
reduce the addictiveness and/or industry innovation, that may the population, as well as to detect
attractiveness of tobacco pro- interfere with the impact of the industry responses and other
ducts; 4) regulations intended to regulation. unanticipated consequences of
prevent fires caused by cigarettes; There is a need for a regulation. The challenges of
and 5) bans (or removal of bans) centralized database that would, measurement associated with
on product categories. The at a minimum, characterize evaluating the effects of tobacco
selection of specific constructs different product regulations so product regulations should not be
and methods for evaluation will that the effects of different policies underestimated. For example,
vary depending on the goals of the can be compared. Additionally, as many governments have enacted
specific policy. However, as a a condition permitting tobacco maximum smoke emissions stan-
general framework, it is likely that product sales, governments dards (i.e. tar, nicotine, and
the impact of tobacco product should require (if they do not carbon monoxide) based on
regulations on intended health already) tobacco product manu- standardised machine testing
outcomes will be moderated by facturers to regularly disclose protocols for the purpose of
changes in product design, information about their products at reducing exposure to the
performance, marketing, product- the finest level of brand constituents in tobacco products
related beliefs and attitudes, and subcategory, including sales and and resultant harm. However,
tobacco use behaviour, which in marketing data, product content, based on the evidence reviewed
turn are expected to influence and design features. This is in this Handbook, it is not
exposures to tobacco constituents needed to inform the develop- recommended that yields from
and emissions. Thus, evaluations ment, implementation, and standard machine testing pro-
should not be limited to assessing evaluation of effective regulations. tocols, such as the ISO cigarette
compliance within the intended Additionally, ongoing surveillance testing method (ISO Standard
effects of a regulation, but should is required to assess the impact of 3308:2000 (4th edition)), be used
also consider unintended effects tobacco product regulation on the to assess or predict human
257
exposure. Emission yields derived tions aimed at reducing harm, assessing human exposure and
from these protocols are not valid measures of human use and harm that have practical utility for
measures of actual human exposure are essential. There is evaluating tobacco product
exposure. In order to evaluate the an urgent need to identify valid regulations.
effectiveness of product regula- methods and measures for
258

restrictions on tobacco marketing communications
Introduction of-sale promotion, merchandising shows how merchandising,
and give-aways, and public packaging, and advertising are
The WHO FCTC proposes a relations. Table 5.23 provides an pressed into joint service:
comprehensive ban on tobacco illustrative list. What I would add is that
advertising, promotion, and spon- The communication efforts, or there is a definite sub-culture
sorship, in recognition that it would more accurately marketing commu- among younger roll-your-own
reduce consumption of tobacco nications, outlined in Table 5.23, smokers, and I believe their
products (Figure 5.12). This section aim to encourage consumption of desire to display their exclusivity
will explain how to go about tobacco products by relaying a could be supported by provision
measuring the effectiveness of variety of messages to customers. of unusually designed badges
restrictions on tobacco marketing As well as communicating basic such as (transparent?) Raw
communications, such as adver- product information and reminding lighters and rolling machines.
tising bans or limitations on the use the world about its product, This will enable them to
of specific media. First, terms are marketing communications are differentiate themselves from
defined and explanations given on used to reassure current customers uncool, older GV [Golden
how promotional activity fits into the that they have made the right Virginia] smokers, who I suspect
wider marketing strategy of tobacco decision, encourage new customers would not be particularly
corporations. The importance of to try their product, and steer motivated to buy the product by
restrictions on tobacco promotion is customers away from competitors. either the advertising or the
discussed, as well as the need to In essence the goal is to tell the packaging (Collet Dickenson
measure their effectiveness. Dif- customer or potential customer how Pierce, 1999).
ferent ways of measuring the offering fulfils their needs. For many fast moving consumer
effectiveness are looked at, with an A well-established business goods (that have a quick turnover
argument that consumer surveys literature about the value of and relatively low cost), the ultimate
are one of the most useful. Finally, integrated marketing communi- aim of integrated marketing
specific measures that can be used cations (IMC) (Schultz & Kitchen, communications is to build evo-
are offered. 2000) argues for combining mass cative brands; something the
media and other marketing com- tobacco multinationals do well, and
Defining terms: tobacco pro- munications in a marketing is crucial for their financial success.
motion and marketing communications mix. IMC holds that Brands and their carefully crafted
all company communications with imagery are the principal means of
Tobacco promotion covers all the their customers, through whatever meeting the psychosocial needs of
communication efforts tobacco channels, should be coordinated one of their most important markets:
corporations use to encourage and coherent to articulate a young people. Ultimately, if a brand
consumption of their products. completely unified message. In this of cigarettes does not convey much
These include mass media adver- way, the whole can become greater in the way of image values, there
tising (e.g. television, posters, and than the sum of the parts. For may well be little reason for a young
in the press), sponsorship of example, this comment from a smoker to persist with or adopt the
sporting and cultural events, point- tobacco industry advertising agent brand (Rothmans Marketing
259
1. Parties recognize that a comprehensive ban on advertising, promotion and sponsorship would reduce the
consumption of tobacco products.
2. Each Party shall, in accordance with its constitution or constitutional principles, undertake a comprehensive ban
of all tobacco advertising, promotion and sponsorship. This shall include, subject to the legal environment and
technical means available to that Party, a comprehensive ban on cross-border advertising, promotion and
sponsorship originating from its territory. In this respect, within the period of five years after entry into force of this
Convention for that Party, each Party shall undertake appropriate legislative, executive, administrative and/or
other measures and report accordingly in conformity with Article 21.
3. A Party that is not in a position to undertake a comprehensive ban due to its constitution or constitutional principles
shall apply restrictions on all tobacco advertising, promotion and sponsorship. This shall include, subject to the
legal environment and technical means available to that Party, restrictions or a comprehensive ban on advertising,
promotion and sponsorship originating from its territory with cross-border effects. In this respect, each Party shall
undertake appropriate legislative, executive, administrative and/or other measures and report accordingly in
conformity with Article 21.
4. As a minimum, and in accordance with its constitution or constitutional principles, each Party shall:
(a) prohibit all forms of tobacco advertising, promotion and sponsorship that promote a tobacco product by any
means that are false, misleading or deceptive or likely to create an erroneous impression about its
characteristics, health effects, hazards or emissions;
(b) require that health or other appropriate warnings or messages accompany all tobacco advertising and, as
appropriate, promotion and sponsorship;
(c) restrict the use of direct or indirect incentives that encourage the purchase of tobacco products by the public;
(d) require, if it does not have a comprehensive ban, the disclosure to relevant governmental authorities of
expenditures by the tobacco industry on advertising, promotion and sponsorship not yet prohibited. Those
authorities may decide to make those figures available, subject to national law, to the public and to the
Conference of the Parties, pursuant to Article 21;
(e) undertake a comprehensive ban or, in the case of a Party that is not in a position to undertake a comprehensive
ban due to its constitution or constitutional principles, restrict tobacco advertising, promotion and sponsorship
on radio, television, print media and, as appropriate, other media, such as the internet, within a period of five
years; and
(f) prohibit, or in the case of a Party that is not in a position to prohibit due to its constitution or constitutional
principles restrict, tobacco sponsorship of international events, activities and/or participants therein.
5. Parties are encouraged to implement measures beyond the obligations set out in paragraph 4.
6. Parties shall cooperate in the development of technologies and other means necessary to facilitate the elimination
of cross-border advertising.
7. Parties which have a ban on certain forms of tobacco advertising, promotion and sponsorship have the sovereign
right to ban those forms of cross-border tobacco advertising, promotion and sponsorship entering their territory
and to impose equal penalties as those applicable to domestic advertising, promotion and sponsorship originating
from their territory in accordance with their national law. This paragraph does not endorse or approve of any
particular penalty.
8. Parties shall consider the elaboration of a protocol setting out appropriate measures that require international
collaboration for a comprehensive ban on cross-border advertising, promotion and sponsorship.
WHO (2003)
Figure 5.12 WHO FCTC Article 13: Tobacco Advertising, Promotion and Sponsorship
260
Measures to assess the effectiveness of restrictions on tobacco marketing communications
Advertising
Broadcast media (TV, radio, cinema)
Outdoor (billboards, posters outside stores)
Press
Sponsorship of Sports and the Arts
Point-of-Sale
Promotional material in shops (branded gantries, clocks, signage, staff clothing)
Coupon Schemes
Coupons included in packs of cigarettes that can be exchanged for free gifts
Merchandising
Low cost items (pens, lighters or t-shirts), competitions, free cigarettes
Special Price Offers

Short-term low price offers advertised in-store, on pack flashes, or in other media
Promotional Mail
Marketing communications sent straight to customers
Brand Stretching
Non-tobacco products with tobacco branding (Marlboro Classic clothes)
Pack designs to communicate brand image and to add value
Internet sites
Websites promoting tobacco companies, cigarette brands, or smoking
Product Placement
Paid for placement of cigarette brands in films or television
Table 5.23 Examples of Tobacco Marketing Communications
Services, 1998). The challenge lights, exploit these emotional ciations. For example, a low tar
therefore is to cement the brand needs and insecurities: the product is supported by the
into the repertoire of the success of Marlboro Lights brands imagery, which has a high
experimental smoker (Collet derives from its beingthe association with health conscious
Dickenson Pierce, 1996). aspirational lifestyle brand people (Marketing Trends, 1995).
It has been found that younger coolthe Diet Coke of ciga- Also, the tobacco industry has
smokers give more weight to the rettes (The Leading Edge used images of happiness,
imagery of cigarettes, and pay Consultancy, 1997). physical well-being, harmony with
more attention and are receptive The power of brand imagery is nature, and a self-image of
to fashionable brands and the not only used on the young. In the intelligence to appeal to the older,
latest designs (Hastings & low tar sector, branding, names, concerned smokers to dis-
MacFadyen, 2000). Well-known and liveries are used to create courage them from quitting (Pollay,
brands, most notably Marlboro reassuring images and asso- 2000; Pollay & Dewhirst, 2002).
261
Evocative branding, created imagery (e.g. a lads cigarette, For the tobacco industry, the
through research to complement complete with scantily clad women distribution system helps build the
consumers lifestyles and aspira- on the cigarette paper!), and brand personality and target the
tions, is spread by integrated mar- nationalistic (but not jingoistic) specific need of each segment.
keting communications. This com- Scottish and Welsh cigarettes to Despite bans on the sale of
munication effort dovetails with the exploit devolution (Hastings & cigarettes to minors, distribution
companys wider marketing effort, MacFadyen, 2000). These ideas tactics still play a big role in
encompassing product design, never reached the street, but they targeting them. Wide distribution
pricing, and distribution, to ensure do illustrate how the product is ensures cigarettes become omni-
optimal consumer satisfaction. manipulated to create synergy with present and a cultural norm,
The products marketing func- the overall marketing effort. encouraging adolescents to over-
tion is reinforced by its Pricing strategies are also estimate the extent, and
prominence in the smokers life: important to tobacco companies, underestimate the social disap-
Smokers buy cigarettes fre- and the relationship between proval, of smoking (Davis, 1991;
quently. They carry their brand quality, brand image, and price is Wakefield et al., 1992; Evans et
around with them and see other particularly so, as it feeds into al., 1995). More prosaically,
brands constantly. The product is fundamental decisions about marketers can place their products
a prime means of communicating segmentation and targeting. Thus, in those outlets where it is easier
a change (Collet Dickenson for the starter segment, premium for adolescents to buy cigarettes
Pierce, 1998). pricing is appropriate. While ado- and many of them do so
New product development lescents tend to be more price successfully. In the UK, outlets
ideas ensure that the needs of sensitive than adults, they attribute such as newsagents, tobac-
consumers are met and that a greater premium to the image conists, and sweetshops are the
appropriate pharmacological and attached to the more expensive most popular source for sales to
aspirational benefits are offered. product, if they are visible and young smokers (Boreham &
The new smoker is assisted on the socially important. Therefore the Shaw, 2001; Bates et al., 2005),
passage from experimenter to pricing strategy should clearly making them a good option for
regular smoker by lower pH levels demonstrate the high quality and under-age distribution.
in cigarettes, which lowers the rate style of the brand, if the product is For the established smoker,
of absorption of nicotine, thus to meet the adolescents needs for wide distribution also helps create
minimising the initial side-effects of image and social status (DiFranza an environment of normalcy and
smoking, such as dizziness and et al., 1991; DiFranza, 1995; reassurance. Furthermore, the
nausea (Claude, 1973). Tobacco Barnard & Forsyth, 1996; Pollay et distribution network is so complete
marketers have also developed al., 1996). that the smoker can rest assured
product line extensions spe- For established smokers, their that cigarettes will always be
cifically in response to increasing addiction and maturity makes the readily available.
health propaganda. For virtually price-quality relationship less of an Thus, the industrys use of
every brand there is now a light or issue, making them more willing to integrated marketing commu-
low alternative, providing the trade down. In response, the nications is nested in their wider
worried smoker with an excuse or industry runs coupon schemes marketing effort involving a
rationalisation to continue smo- and sales promotions to reduce consumer oriented strategy to get
king. Other development ideas the perceived price of smoking. the right product, at the right time,
include an Espresso cigarette to fit These types of pricing strategies in the right place, with the right
the new caf culture and to tie the established smoker to one price (Cannon, 1992).
provide quick hit (caffeine/ particular brand and reward them The issues of product design
nicotine) with young, streetwise for their loyalty. and pricing, and how these can be
262
measured, are discussed in publicity of adverse health effects groups. For example, an evalu-
Sections 5.3 and 5.1, respectively. of smoking had reduced the sales ation of a Camel cigarette
This section is concerned with effect of cigarette advertising. campaign in the early 1990s
examining marketing communi- revealed that in a short period of
cations; the evidence base that Evaluation of advertising bans: time, it had made a huge impact
shows that these strategies do upon childrens smoking beha-
influence smokers behaviour and Evidence from studies evaluating viour (DiFranza et al., 1991). The
that they need to be restricted. the effects of advertising bans campaign featured a cartoon
also show that marketing drawn Camel, known as Joe the
Why restrictions on tobacco communications have a significant Camel, which was suspected of
marketing communications effect on consumption. The Smee having particular appeal to chil-
matter Report, which analysed Norways dren. The study asked about
1975 Tobacco Act, concluded that brand preference and compared it
To help understand the potential the Act decreased smoking with data from seven surveys
effect of removing or restricting demand between 9% and 16% conducted prior to the launch of
tobacco marketing communi- (Economics and Operational the Camel campaign. In the three
cations, it is helpful to first look at a Research Division of the years following the start of the
selection of studies that have Department of Health in England, campaign there was an increase
examined the influence exerted by Smee et al., 1992 - Economics from 0.5% to 32.8% in the
tobacco marketing, and the ap- and Operational... England). proportion of young smokers
proaches and measures that have Similarly a study of the effects of (aged up to 18) who named
been used in these studies. They the 1971 Finland Tobacco Act, Camel as their preferred brand.
can be helpful, not only in guiding which analysed data from 1960 to The study measured awareness
expectations about attributes that 1987, concluded that the of the campaign and identification
will change as a result of advertising ban produced a long- of product type and brand name
restrictions, but also in identifying term reduction of 6.7% in cigarette by showing an advert masking all
which measures are important to smoking (Pekurinen, 1989). Mea- clues (except Old Joe) to the
collect. sures of per capita annual product and brand being ad-
consumption of cigarettes and vertised. The research found that
Modelling aggregate demand: tobacco were analysed by extent children were more aware of the
of advertising bans across 22 campaign and more able to
One of the first and most countries (Saffer & Chaloupka, identify the product type and
influential studies into the effects 2000). Minimal effect was found brand name from the logo than
of tobacco promotion on con- from limited bans in reducing adults. A campaign appeal score
sumption was conducted in the tobacco use, but clear effect from was compiled by asking subjects
UK (McGuinness & Cowling, comprehensive bans. (See the to rate six unmasked Old Joe
1975). It modelled the aggregate following section on Advertising adverts across four items: cool,
demand for cigarettes in terms of bans of specific media for stupid, interesting, or boring. They
price, income, and advertising. definitions of the types of bans.) were asked if they thought Old Joe
The advertising measure was an was cool and if they would like to
estimate of the number of Evaluation of individual cam- be friends with him. Positive
messages received by a con- paigns: responses to each item were
sumer rather than expenditure. scored 1 and negative responses
Their findings suggested that Evaluation of individual cam- coded 0 and the appeal score was
advertising does have a significant paigns reveals how the tobacco the arithmetic sum of these.
effect on cigarette sales, but that industry has targeted specific Children were found to be more
263
likely than adults to find the to be particularly attracted to the cause and effect; longitudinal
campaign appealing. most heavily advertised products, designs are needed to do this. A
and it is these brands that domi- longitudinal study was undertaken
Brand awareness and appreci- nate under-age sales. For to measure the predisposing
ation: example, the three most heavily effects of cigarette advertising on
promoted brands in the USA in childrens intentions to smoke
Campaigns are also linked with 1993 (Camel, Marlboro, and when they were older (Aitken et al.,
increases in brand awareness and Newport), were the three most 1991). Two interviews were
appreciation. Qualitative work was likely to be purchased by adol- conducted among children aged
conducted which found that chil- escents (Centers for Disease 11-14 years: those who expressed
dren, as young as six years old, Control and Prevention, 1994c). a stronger intention to smoke
were aware of cigarette ad- Similar patterns of preference for during the second interview rather
vertising, and that young primary heavily advertised brands have than the first, were more likely to
school children had learned the also been observed amongst UK have liked cigarette advertising at
brand imagery or personality of adolescents (Barton, 1998), and baseline. This demonstrates that
leading cigarette brands from prolonged advertising makes nonsmokers, who felt that they
advertisements (Aitken et al., brands seem popular (Sutherland may smoke when they were older,
1985). A survey in England & Galloway, 1981). were paying more attention to
showed that 17% of 9-10 year olds Although the majority of stu- cigarette advertising than other
and 23% of 12-13 year olds were dies have examined the impact of nonsmokers.
able to name a favourite cigarette mass media advertising on smo- An important meta-analysis of
advertisement (Charlton, 1986). king, many other forms of longitudinal surveys has recently
The brands named most frequently marketing communication have been published by the Cochrane
were also those most heavily also been studied (see Table Library (Lovato et al., 2003). The
advertised in the area at the time. 5.24). It is important to keep in authors asked the question: is
In addition, it was found that the mind the discussion about inte- prior exposure to tobacco industry
children who named favourite grated marketing communi- advertising and promotion asso-
advertisements were also more cations at this point, as none of ciated with future smoking among
likely to agree with some positive these communication efforts are adolescents?. They analysed the
statements about smoking and the intended to work in isolation. outcome of nine longitudinal stu-
image of smokers. It concluded Indeed the final study listed in dies, including the study mentioned
that children receive positive mes- Table 5.24 underlines this point by above. All nine studies showed a
sages about smoking behaviour demonstrating a cumulative im- positive, consistent, and specific
from advertising, which may pact: the more forms of marketing relationship between exposure to
reinforce their decision to start communications that young peo- tobacco advertising and influence
smoking during experimentation. ple are aware of, the more likely upon adolescents to smoke
Thus, if tobacco advertising is they are to smoke. cigarettes. The authors concluded:
banned, the expectation is that Longitudinal studies
these positive messages will Longitudinal designs: suggest that exposure to
lessen or be eliminated. tobacco advertising and
The research discussed thus far promotion is associated with
Brand choice: has provided convincing evidence the likelihood that adolescents
that there is a relationship between will start to smoke. Based on
Studies have also examined brand tobacco marketing communica- the strength of this association,
choice in relation to tobacco tions and smoking behaviour. the consistency of findings
advertising. Young smokers tend However, it has not established across numerous observa-
264
Sponsorship
Exposure to a cigarette sponsored sports advertisement reinforced existing smoking behaviour, and for non-
smokers created favourable attitudes towards smoking, increased awareness, and liking of brands ( Hoek et
al., 1993)
Children show a higher awareness of the sponsoring brand, and link the exposure to brand recall and
understanding of brand imagery (Ledwith, 1984; Aitken et al., 1986; Piepe et al., 1986)
Childrens preference for motor racing is a significant independent variable in move to regular smoking
(Charlton et al., 1997)
The statement smoking cant be all that dangerous, or the Government would ban sports sponsorship was
put to over 4000 11-16 yr olds; substantially more smokers than nonsmokers agreed with it (Bates, 1999)
Merchandising
Items such as branded lighters, t-shirts, baseball caps, and badges frequently reach adolescents at the point-
of-sale, special events, or through competitions (Coeytaux et al., 1995; Gilpin et al., 1997; Pierce et al., 1999)
There is a significant relationship between experience of tobacco promotions and susceptibility to tobacco
use (Altman et al., 1996; Gilpin et al., 1997; Feighery et al., 1998)
There is a relationship between the numbers of promotional items owned and a higher likelihood of smoking
(Sargent et al., 2000)
There are relationships between smoking initiation rates and levels of promotional expenditure, and
owning/using tobacco promotional items and the onset of smoking (Bauer & Johnson, 1999; Redmond, 1999)
Brand-Stretching
For example, the endorsement of holidays, cafs and music; items that are then sold rather than given away
(Centre for Tobacco Control Research, 2001)
Initial research focussed mainly on advertising for such products, and shows that this is consistently seen as
advertising for the sponsoring tobacco brand rather than the product (Aitken et al., 1985; Centre for Tobacco
Control Research, 2001)
The awareness of brand stretching by 15 year olds is independently associated with being a smoker
(MacFadyen et al., 2001)
Packaging
Tobacco packaging both reinforces brand imagery and reduces the impact of health warnings (Beede &
Lawson, 1992; Carr-Greg & Gray, 1993; Goldberg et al., 1995; Rootman & Flay, 1995)
When fewer brand image cues were on the packaging, adolescents were able to recall more accurately non-
image health information (Beede & Lawson, 1992)
Plain packaging limits the ease with which consumers associate particular images with cigarette brands and
significantly influences smoking behaviour (Goldberg et al., 1995)
Point-of-Sale (POS)
Cigarette packets were displayed in such a way at the POS as to act like advertising (DiFranza et al., 1999)
Young adolescents who reported seeing tobacco advertising in stores were 38% more likely to experiment with
smoking, and the advertising was found to enhance brand imagery (Schooler et al., 1996; Donovan et al.,
2002)
The more youth-orientated ads were displayed outside shops, the more often children tried to buy cigarettes
(Voorhees et al., 1998)
There are greater levels of POS advertising in areas where there is likely to be a high prevalence of smoking
(e.g. low-income / ethnic minority areas); young people are unduly exposed to them (Woodruff et al., 1995;
Ruel et al., 2001; Laws et al., 2002)
Table 5.24 The Influence of Marketing Communications on Smoking Behaviour
265
Product Placement
The paid for placement of cigarette products in films and on TV is a controversial, but documented, marketing
communications tactic. Strong evidence links this with adolescent smoking (Hart, 1996; Chapman & Davis 1997;
Dalton et al., 2003)
Loyalty Schemes
There is significantly greater participation in low-income areas, and coupons may offset the effect of price
increases (Centre for Social Marketing, 1995)
Loyalty schemes involvement among 15 year olds is independently associated with smoking (MacFadyen et al.,
2001)
Free Samples
A systematic search of tobacco industry documents confirms free samples as a popular strategy (Sepe et al.,
2002)
Receipt of free samples by young people independently associated with susceptibility to smoke (Altman et al.,
1996)
Internet
Tobacco manufacturers have their own websites and sponsor further sites unrelated to tobacco. Also pro-tobacco
sites (not related to industry) include chat rooms/message boards and celebrities/attractive role models smoking,
which may appeal to the young (Center for Media Education, 1997; Center for Media Education, 1998; Hong &
Cody, 2002)
Marketing Communications
Young people are aware of all forms of tobacco marketing communications; over half of all smokers had
participated in some form of promotion; and the greater the number of tobacco marketing techniques a young
person was aware of, the more likely they were to be a smoker (MacFadyen et al., 2001)
Table 5.24 The Influence of Marketing Communications on Smoking Behaviour
tional studies, temporality of robust methodologies to monitor Alternative methodologies

exposure and smoking beha- the effectiveness of any such
viours observed, as well as the prohibitions. To a large extent, the In discussing the evidence base, it
theoretical plausibility regar- studies mentioned above have is apparent that various
ding the impact of advertising, concentrated on measuring the approaches and measures have
we conclude that tobacco influence of advertising. When been used to examine the effects
advertising and promotion measuring the effects and of tobacco promotion. These
increases the likelihood that effectiveness of tobacco mar- same approaches are relevant
adolescents will start to smoke. keting restrictions/bans it is and provide guidance as studies
From a policy perspective, important to consider all potential are designed to assess the effects
attempts to eliminate tobacco forms of remaining tobacco and effectiveness of restrictions
advertising and promotion marketing, and thereby monitor on tobacco marketing commu-
should be supported. whether or not the tobacco nications. Below, the two main
industry diverts their marketing approaches (econometric studies
A useful codicil could be added activities to less restricted media. and consumer surveys) for
to the authors final sentence: that examining the effects and effec-
there is also a need to devise tiveness of tobacco marketing
266
restrictions are discussed. In ditures, for all advertisers, in all Advertising bans in specific
addition, complementary appro- media, for all geographic market media:
aches are addressed, including areas. However, the high level of
marketing surveillance and inter- aggregation of such data results in Tobacco advertisers use a
nal document analysis that can it having very little variation, which number of media, and while each
help to contextualise, interpret, leaves little to correlate with has particular advantages and
and support results that emerge consumption. It is therefore disadvantages, a partial adver-
from consumer surveys and unlikely that any effect of tising ban will likely result in
econometric analysis. advertising will be found from use tobacco advertisers substituting a
of this type of data. banned media with a form of
Econometric studies: media that is not banned. A partial
Cross-sectional data: ban, therefore, will not necessarily
One approach is to use eco- imply a reduction in total
nometric1 studies that model The types of cross-sectional data expenditure on tobacco adver-
changes in tobacco consumption can vary, but would typically be tising. For example, in the USA
with fluctuations in tobacco local level (e.g. Metropolitan advertising expenditure fell
advertising expenditures. There Statistical Area (MSA)) and for subsequent to the 1971 TV ban,
are two main types of econometric periods of less than a year. This but rose quickly thereafter. Three
studies: comparative studies of type of data can have greater studies of advertising bans that
countries with different levels of variation than national level data, used pooled international data
controls on advertising (cross- as the cost of advertising, the mix were reported (Saffer &
country studies); and studies of target markets, and relative size Chaloupka, 2000). Two of these
which model the effect of year-to- varies across local areas. Monthly studies showed no effect of a ban,
year fluctuations in advertising or quarterly local level data would while one showed that advertising
expenditure on consumption include a relatively larger variation bans had no effect on con-
within one particular country (time- in advertising levels and in sumption in the period prior to
series studies). consumption data, and be more 1973, but thereafter, cigarette
Prior econometric studies of likely to find a positive relationship advertising bans and warning
tobacco consumption have used between advertising and con- labels had a significant negative
one of three alternative empirical sumption. effect on consumption. Studies
measures of advertising: national However, cross-sectional stu- that use advertising bans as the
aggregate expenditure data, dies are rare as the data are measure of advertising must
cross-sectional measures of expensive and difficult to therefore include bans which are
advertising, and advertising bans assemble. A report on 21 prior sufficiently comprehensive to
(Saffer & Chaloupka, 2000). empirical studies, three of which ensure that the industry cannot
were cross-sectional, found that in compensate for lost media by
National aggregate expendi- each of the three cross-sectional increasing advertising or other
ture data: studies, a significant positive marketing expenditures. Changes
effect of advertising was observed in the number of countries having
Annual national advertising (Saffer & Chaloupka, 2000). enacted more comprehensive
expenditures are the yearly total of tobacco advertising bans since
all cigarette advertising expen- the late 1980s provided the
Application of mathematical and statistical techniques to economics in the study of problems, the analysis of data, and the develop-
1
ment and testing of theories and models.
267
opportunity to re-examine the for a large number of other social, Consumer surveys:
effects of advertising bans on political, and economic factors,
tobacco consumption (Saffer & which may have a confounding Another approach to examine the
Chaloupka, 2000). Comparable effect on consumption patterns. effects of tobacco promotion is
economic and social data were Availability and completeness of through consumer surveys, which
available from 1960 for the 22 data can also be problematic. can overcome many of the
Organisation for Economic Independent researchers, in the problems associated with eco-
Cooperation and Development UK for example, have had to work nometric studies. Consumer
(OECD) countries studied. Four within the limitations of incomplete surveys can be appropriately timed
dependent variables were used in advertising data released by the to collect measures prior to the
the regressions: two measures of tobacco industry. The data introduction of marketing res-
per capita annual consumption of provides coverage of broadcast trictions and at a number of
cigarettes, and two measures of media and the press, but omits subsequent time points. At least
per capita consumption of tobacco billboard advertising and one baseline measure is required
by weight. The data came from sponsorship. Studies in the USA, prior to policy introduction, against
Health New Zealand and the however, benefit from com- which future changes can be
United States Department of prehensive data on advertising gauged. The number and timing of
Agriculture. Advertising ban expenditure which is freely post measures will depend on the
variables were created from data available to independent re- timing of restrictions being posed
on television, radio, print, outdoor, searchers, albeit in aggregated and on the rate of change
point-of-purchase, and movie form. In the absence of suitable witnessed.
advertising, as well as spon- data for advertising, dummy Consumer surveys allow social
sorship bans. These were variables can be used as proxies, scientists to develop and test
converted into a set of three like the dummy variables for multiple hypotheses about tobacco
dummy variables: Weak Ban strength of ban discussed above. marketing communications, the
was set to equal one if there were The inability of econometric policies designed to restrict them,
zero, one, or two bans in effect; studies to examine all the forms of and how they may be working. In
Limited Ban was set to equal one marketing communication used by this way, specific sub-groups and a
if there were three or four media the tobacco industry, such as range of variables can be studied.
banned; and Comprehensive loyalty schemes or point-of-sale Whereas econometric studies tend
Ban was set to equal one if there displays, was examined (Chap- to rely on aggregate data,
were five, six, or seven media man, 1989). In addition, there are consumer surveys enable hypo-
banned. The analysis allowed two further drawbacks with theses about marketing commu-
assessment of the effect of limited econometric studies: they only nications to be tested at a more
and comprehensive bans, examine the effects of advertising individual/disaggregated level,
indicating minimal effect from on overall sales, ignoring other taking into account influences of
limited bans in reducing tobacco important influences on smoking- individual characteristics.
use and clear effect on con- related cognition and beliefs; and This thinking can be built into a
sumption from comprehensive they usually only provide aggre- conceptual model, as with The
bans (Saffer & Chaloupka, 2000). gated, population level data; in International Tobacco Control
Econometric studies of adver- most cases they are not able to Four Country Study (ITC) (Fong et
tising and consumption are examine effects on sub-groups al., 2006a), where policies are
complicated and have produced (e.g. young people, women, or characterised as potentially
mixed results. Part of the difficulty those on low income), some of affecting individuals along a
lies in the complexity of the whom may be particularly variety of psychosocial and
procedure; models must account vulnerable. behavioural variables, of which
268
there are two classes: policy variables indirectly, through their multinational study covering more
specific variables and psycho- prior effect on the policy-specific, than one jurisdiction, it allows for
social mediators. proximal variables (Fong et al., a quasi-experimental design:
Policy specific variables are 2006a). comparisons can be drawn
those that are proximal The ITC conceptual model between countries where specific
(conceptually closest), or most includes proximal and distal policies are being introduced and
specifically related to the policy measures so as to construct a others where they are not. It also
itself. For example, graphic causal chain model. The route is a telephone survey, which
warning labels should increase from policy specific variables to brings benefits in terms of
the prominence and noticeability behaviour can be traced through sampling and ease of respondent
of warnings, price should affect these measurements. For exam- access, but limits the complexity
the perceived costs of cigarettes, ple, withdrawal of tobacco of the questions that can be asked
and lifting of restrictions on marketing communications may because it is not possible to use
alternative nicotine products first decrease awareness of show cards or any visual images.
should lead to increased tobacco marketing activity, which The ITC project is conducted
awareness of their availability may then affect awareness and with adult smokers, and therefore
(Fong et al., 2006a). Discrete familiarity with brands, per- examines effect amongst those
behavioural changes may also ceptions of smoking norms, already involved with tobacco
occur as a result of the policy, overall attitudes, intentions about products. A sample of over 2000
such as smokers hesitating, or quitting (or intention to smoke adult smokers is sought in each
even abstaining from cigarettes among young people), and country at each wave of fieldwork
because of the warning label. ultimately effect behaviour, such (Thompson et al., 2006).
Similar examples can be as quit attempts, quit success or, As previously noted, consumer
drawn in marketing commu- among young people, uptake of surveys have the advantage of
nications. Restrictions on these smoking (Figure 5.13). This model enabling specific sub-groups to be
should lead to reductions in allows researchers to test how studied, such as young people;
awareness of the specific types of policies impact or fail to impact some of whom will already be
communication that have been anticipated behaviour. involved with tobacco products
restricted, such as billboards or Three different studies have and some of whom will not.
press ads. Given the links found been undertaken to assess Consumer surveys, unlike eco-
between tobacco advertising tobacco marketing restrictions: the nometric studies, enable the
awareness and brand awareness ITC Four Country Survey potential impact of tobacco
and appreciation (Aitken et al., (Thompson et al., 2006), the marketing restrictions to be
1985), restrictions on marketing Centre for Tobacco Control examined separately for young
may also reduce familiarity with Research (CTCR) study (http:// people. In particular, they enable
tobacco brands. www.ctcr.stir.ac.uk), and the the examination of how young
Psychosocial mediators are Global Youth Tobacco Survey people growing up in an
those variables that are distal (GYTS) (The Global Youth environment surrounded by tobac-
(conceptually distant) from the Tobacco Survey Collaborative co marketing compare with those
policy, and which are thought to Group, 2002). growing up in an environment in
be affected by multiple means, not The ITC project brings which tobacco marketing is
just policies. Self-efficacy and strengths to the consumer survey restricted.
intentions are amongst such design. It is longitudinal, which The CTCR study and the
variables. It is thought that policies enables disentangling cause and GYTS focus on youth. The CTCR
will affect these general mediating affect relationships. As a study is an ongoing, face-to-face,
269
in-home survey which, though The GYTS is a school-based concerning the impact of tobacco
logistically challenging, enables survey of 13-15 year olds which control policies. Nevertheless, it is
complex questioning procedures began in 1999 (The Global Youth a valuable study that can add to
(particularly the use of visual aids Tobacco Survey Collaborative the understanding of the likely
displaying brand colours and Group, 2002). It includes questions effect of marketing restrictions,
design features). It uses cross- on prevalence of cigarette and particularly where consistencies
sectional surveys of 11-16 year other tobacco use, attitudes toward and overlaps can be seen with the
olds across the UK. Surveys are tobacco, access to tobacco ITC Four Country study.
conducted at approximately two products, exposure to secondhand
yearly intervals to monitor smoke, school curricula on Enhancing benefits of con-
changes in key measures (such tobacco, media, advertising, and sumer surveys:
as awareness of tobacco smoking cessation. The question
marketing, engagement with focus, in relation to marketing The benefits of consumer surveys
tobacco marketing, brand aware- restrictions, is on marketing are enhanced when comple-
ness and familiarity, perceived penetration: awareness of media mentary methods are used to
smoking prevalence, intentions to messages and receipt of tobacco measure both marketing and
smoke, and smoking behaviour) at branded items/gifts. Like the ITC policy inputs; a clear notion of
different time points prior and Four Country study, the GYTS also what is happening out there will
subsequent to the implementation uses multiple countries, a common enhance the ability to measure its
of the UK ban on advertising and methodology, and a core effectiveness. The policy and
promotions (Tobacco Advertising questionnaire, which has the marketing arenas need to be
and Promotions Act, 2002; potential to allow comparison systematically monitored in order
http://www. opsi.gov.uk/acts/acts- across different levels of tobacco to gauge the effect of
2002/ukpga_20020036_en_1). control (for details see Section 4.3) developments. For example,
Approaches to measuring the Figure 5.13 demonstrates some of
marketing related measures are Limitations: the responses that the tobacco
discussed below. industry may take. First, there is
Two baseline surveys were The consumer survey approach the issue of checking compliance,
conducted: two years prior to the has its limitations. It relies on but equally, if not more important,
ban and six months prior to the gaining access to and cooperation is being aware of the innovative
ban. These surveys provide data from a representative sample of ways the industry may compensate
on young peoples response to respondents, and on self-report for newly imposed restrictions.
tobacco marketing prior to the measures which participants may Research tools, which aid work
regulations. Measures taken under- or over-report. in the fields of surveillance, industry
approximately 18 months post- The CTCR study is a national document analysis, and policy
ban gave an indication of study conducted over a number of tracking, have been developed
short-term response following the years. It monitors response to which enable the measurement of
initial phases of implementation of tobacco control policies as they inputs. Monitoring these inputs also
the tobacco marketing restrictions. change over time, providing data assists in contextualising and
Continuation at two year intervals on reactions at different time interpreting results from the
will provide insights into the points following staged imple- consumer surveys and may help to
potential longer-term impact of mentation of the tobacco clarify any unusual or unexpected
these restrictions, and give an advertising and promotions ban. survey results.
indication of the length of time The lack of a comparison country Multiple studies can also help
before impacts may become or countries means that it cannot to complement and reinforce
apparent. provide conclusive evidence results from individual surveys.
270
Policy variables
advertising bans
advertising restrictions
promotions bans
promotions restrictions
sponsorship restrictions
sponsorship bans
Tobacco industry innovation

Tobacco industry Changes in:
Product design
compliance
Product promotion
Sponsorship
Tobacco point of sale marketing
Price Strategies
Moderating variables
socio-economic
measures Proximal variables
gender tobacco company marketing expenditure
age types of marketing/compliance
income awareness of each marketing channel
education engagement in types of marketing (eg. participation in
parental smoking* promotional offers)
peer smoking*
sibling smoking*
other tobacco
control policies
Distal variables
brand awareness and familiarity
attitudes/beliefs about brands
beliefs and attitudes towards tobacco industry
beliefs and attitudes towards tobacco control
self-efficacy
intention to quit
intention to smoke*
perception of health risks
perception of prevalence of smoking/perceived smoking norms
Tobacco Use Behaviours

smoking prevalence/uptake of smoking*
quit attempts
quit success
brand choice
Figure 5.13 Conceptual framework for the evaluation of tobacco marketing restriction policies
*Appropriate measures for youth/adolescent studies
271
For example, while the CTCR check the applicable box. Table cigarette marketing. Survey parti-
study is an appropriate design for 5.25 lists the types of measures cipants were shown photographs
examining the responses of recorded within the stores. of the stores exteriors, along with
adolescents to the advertising and A small panel of 28 retailers the names and addresses of 12 of
promotions ban, the lack of a were recruited to participate in this the stores, and were asked to
comparison country limits the protocol, and a trained observer indicate the frequency of going to
conclusions which can be drawn. visited every two months. The each one. Those who reported at
The ITC Four Country survey panel consisted of a sample of least weekly visits to any of the
monitors similar issues with adult different store types, but was not specific stores in the photographs
smokers and does include com- intended to be a representative were classed as having frequent
parison countries. Therefore, sample. Rather, this study sought exposure to cigarette marketing.
where findings are consistent insight into the range of tobacco This survey data was then
between the two studies, the ITC marketing at point-of-sale and how combined with the observation to
Four Country study helps lend this might change over time and in calculate a measure of cigarette
support for any findings from the response to new restrictions. brand impressions per week. This
CTCR study that are indicative of This observational protocol was computed by multiplying the
policy effects. could be implemented with a frequency of visits to the specific
much larger and representative stores by the total number of
Marketing surveillance: sample of stores to enable marketing materials and product
comparison of data by different facings in each, and then
As part of the CTCR study, a store types, area types, religions, summing all the individual store
series of marketing surveillance and additional characteristics. scores for each student.
activities were undertaken to Such an approach would enable Additional surveillance under-
provide information about the comparison of data by different taken within the CTCR study
marketing approaches being used store types, different area types, includes regular audits of the
by the tobacco industry both regions, and so on. press to identify any marketing or
before and after the ban. This Observations were conducted editorial coverage of tobacco
exercise was designed to capture in all 53 stores that sold cigarettes products or issues. A selection of
the range and nature of activities, within the study community the most widely read newspapers
rather than quantify the amount of (Feighery et al., 2006). Two and magazines are purchased
marketing activity. An obser- surveyors used a protocol for over a one week period each six
vational protocol was developed counting and categorising ciga- months and are content analysed
to explore the tobacco industrys rette marketing materials and shelf for coverage of tobacco or
response to regulation in retail space allocated to cigarettes in smoking. A bi-monthly audit of the
outlets (Devlin et al., 2006); all stores. Counts were made of the retail press is similarly undertaken
other forms of tobacco marketing features, such as number of to provide insight into the type of
communications had been pro- branded signs, merchandising communication and messages
hibited, but point-of-sale was still fixtures, and functional items, being relayed from the tobacco
available. The protocol was along with amount of shelf space industry to the retailers. A small
designed to be generic to allow it to allocated to the three most panel of about 28 smokers also
be adapted to cross-country popular cigarette brands among complete a form each month
comparisons, and to be executed youth in the USA. These data recording any tobacco marketing
longitudinally so long-term patterns were used alongside survey that they encounter, as well as
could be uncovered. It was mainly responses to assist with develop- recording their cigarette/tobacco
comprised of closed questions ment of multiple measures of purchases over a one week
requiring the trained observer to adolescents exposure to retail period. This gives an idea of the
272
Store Information
Characteristics of surrounding area (residential or commercial)
Presence or absence of tobacco ads on exterior of store
Presence or absence of minimum age of purchase signage
Size of outlet (number of cash registers)
Whether tobacco products or counter visible on entry to store
Cigarette/Tobacco Availability
Visibility, variety of brands, variety of pack sizes, presence of any promotions
Positioning of tobacco products
Which brands are most prominent
Availability, price, and price promotion of four particular brands
Advertising and Other Tobacco Marketing Practices

Presence or absence of advertising for four particular brands
Types of promotions observed in store and associated brands
Presence or absence of tobacco branded accessories
Use of Functional Objects at Point-of-Sale

Method of displaying tobacco products
Features of the cigarette display cabinet
Any noticeable changes in the cabinet
Presence or absence of tobacco branded fixtures or fittings in the store
Presence or absence of tobacco control signage
Table 5.25 Types of Measures Recorded within Retail Outlets to Monitor the Tobacco Industrys
Response to Regulations
wide range of marketing activities, tobacco corporations (category C) which three sites were randomly
and can include, for example, (see Table 5.26). All of the terms selected for coding each week for
promotions that occur in night- in category A, and all combined reliability purposes. A coding
clubs, direct mail, free gifts, and terms from categories A and B manual and procedures were
special price offers. were searched. Terms from designed by a research team, in
categories B and C were com- collaboration with a senior
Internet: bined, and five search term research associate and a clinical
combinations from each tobacco psychologist. After training on 12
Given the increasing restrictions brand name were randomly websites and proving satisfactory
on other routes for tobacco selected using a website providing reliability, each coder was
marketing, the internet requires an algorithm for generating assigned 15 websites to code per
careful monitoring. A represen- random numbers. To account for week over the period from
tative sample of websites with a differing results from different November 1999 to May 2000. The
dominant tobacco theme were search engines, three that content analysis looked for the
researched (Hong & Cody, 2002). employed different algorithms presence or absence of five
Three lists of search terms were were used. The first 200 pro- features: site category, online
generated: general smoking terms tobacco-related websites from purchasing of tobacco products
(category A), terms commonly each search term were recorded. and consumer-awareness infor-
associated with smoking (category After removal of duplicates, there mation, portrayal of human
B), and brand names of American was a total of 716 websites from characters, lifestyle and message
273
Category A Category B Category C

General Smoking Terms Terms Commonly Associated with Tobacco Companies
Tobacco
Tobacco Sports Vacations Brown & Williamson

Cigarettes Car racing Glamour Philip Morris
Smokeless tobacco Tennis Romance Ligget
Chew tobacco Rodeo Woman RJ Reynolds
Cigars Celebrities Fetish
Pipe tobacco Movies Sex
Snuff Film Gambling
Freedom Wine
Rights Cognac
Adventure Beer
Travel Champagne
Cruises
Adapted from Hong & Cody (2002)
Table 5.26 Categories of Search Terms Used to Sample Pro-Tobacco Websites
appeals, and interactive site to search2 (http://www. tobacco- circumvented Singapores adver-
features. It is therefore recognized archives.com and http:// www. tising ban based its findings on
that this media is an unmonitored, tobaccopapers.com). The analysis internal industry documents
unregulated source of tobacco of industry documents has shown (Assunta & Chapman, 2004b). In
marketing targeting young people. that they clearly recognise the this study, document collection
power of advertising to retain and websites, primarily the Tobacco
recruit smokers, despite their Archives, were systematically
Internal tobacco industry docu- public pronouncements to the searched using geographic terms
ment analysis: contrary (Hastings & McFadyen, and the names of public and
2000; Cummings et al., 2002a). private entities relating to
Following the Master Settlement Similarly, documents detailing Singapore. The resulting docu-
Agreement in the USA and the industrys reactions to inputs, ments were then dated, evaluated
Health Select Committees and their strategies for dealing according to their degree of
investigation into tobacco com- with them, can be used to importance, and a select group
panies in the UK, online data- measure the effects of tobacco were subjected to further analysis.
bases of the tobacco industrys restrictions. For example, a study The findings allowed the re-
internal documents are available into how the tobacco industry searchers to examine how the
2
Marketing search terms for the database should include the following: above the line, advert, below the line, billboard, brand, campaign,
coupon, customer, direct mail, email, internet, marketing, mass media, packaging, point-of-purchase, point-of-sale, poster, pricing,
product placement, promotion, samples, SMS, target, text message, and website. This list is not exhaustive and care must be taken to
search for variations and plurals, possibly by truncation, of the terms above. Brand names should also be included in the strategy (see
Cummings et al., 2002a for further search strategies using online databases, and Mekemson & Glantz, 2002 for a sample strategy to
locate documents covering tobacco and smoking product placement in movies).
274
tobacco companies conducted time, and make it theoretically gives an indication of which
their business in the strict anti- possible to relate tobacco control marketing practices are going to
tobacco environment present in inputs to outputs (Wakefield & change or be eliminated, and
the country, and attempted to Chaloupka, 1998). provides a guide to which mea-
counter some of the governments sures would be expected to show
tobacco control measures. With Consumer surveys: the an impact. For example, in 2003
knowledge of this kind, it is questions to ask the UK introduced a com-
possible to both tackle the tobacco prehensive ban on most forms of
industrys creative responses to The types of questions that can be tobacco marketing commu-
restrictions and monitor the extent used in consumer surveys will be nication, which was implemented
to which they are working. examined, as well as how to in phases from February 2003 until
identify the issues that should be July 2005. It was important to
Policy tracking: addressed and developing specific check whether awareness of each
questions to measure them. prohibited medium, which during
Although there has been Previous studies on the the first phase included billboards
increased interest in the field of influence of tobacco advertising and press advertising, had
tobacco control policy research, and marketing can help form a reduced. At the same time, it was
there have been few published basis for identifying the issues that also useful to measure whether
accounts of the measurements of ought to be examined when remaining, unrestricted media,
the comprehensiveness and measuring the impact of res- which included point-of-sale dis-
strengths of policies (Wakefield & trictions on marketing. Under- plays, had increased.
Chaloupka, 1998). A ratings standing the relationships As well as specific media, it is
system was developed and between advertising/marketing, also crucial to monitor the
implemented which evaluated the and other variables, helps to cumulative effect that wide
extensiveness of state laws develop hypotheses about which ranging bans can have by dis-
restricting youth access to tobacco variables might be expected to be rupting the integrated marketing
in the USA (Alciati et al., 1998). influenced by the elimination of, or communications mix. As dis-
State laws were analysed on severe restrictions on, marketing. cussed previously, this is a vital
youth access to tobacco and The focus here will be on pillar in the industrys attempts to
assigned ratings on nine items: six marketing-related proximal and build and maintain evocative
on tobacco-control provisions, and distal variables (see Figure 5.13). brands. It therefore is logical to
three on enforcement provisions. Proximal variables are concep- develop measures of brand
For each item, a target was tually closest to the restrictions salience and image, and monitor
specified reflecting public health being imposed on marketing how these fair, following policy
objectives. Points were awarded communications. First, an changes.
for achieving the target, while assessment must be made of Sample questions are drawn
criteria for lower ratings were awareness, familiarity, and from the GYTS and the two on-
established for situations when the engagement with specific types of going longitudinal studies
target was not met. Ratings marketing communication to see discussed previously (the ITC
produced by this type of system whether, and to what extent, these Four Country study and the CTCR
can, by producing maximum lessen when marketing res- study). These studies have slightly
values, indicate that all ideal trictions are imposed. Identifying differing methodologies: the ITC
aspects of a law are in place, suitable measures requires Four Country study is a telephone
facilitate comparison among states familiarity with the content of the survey which brings benefits in
(and possibly among countries), marketing restrictions which are to terms of sampling and ease of
permit tracking of changes over be implemented. This knowledge respondent access, but limits the
275
complexity of the questions that establish how much marketing In this way the interviews
can be asked because, for communication is still getting opened their minds to the broader
example, it is not possible to use through. It is difficult to ascertain range of marketing practices and
show cards. The CTCR study is a this, however, without confusing encouraged them to describe
face-to-face, in-home survey the respondent. Terms like these in their own terminology. This
which is logistically more difficult, marketing communications, not only helped with understanding
but enables complex questioning which are technically correct and the language and concepts young
procedures; particularly the use of capture the generality of the people use to describe marketing
visual aids displaying brand concept, are less likely to be communications, but also revealed
colours and design features. The understood than more familiar the range of promotional activity to
GYTS is a school-based, self- words like advertising or pro- which they were aware of being
completion survey of 13-15 year motion, which will not capture the exposed to.
olds, which again limits the breadth of activity that may be In subsequent focus groups,
complexity of the questions that involved (see Table 5.23), and may prompt cards, with descriptions of
can be asked. not be consistently interpreted. different forms of tobacco
The studies also target different Hence, qualitative research marketing, were developed and
sub-groups: the ITC consists of a played a crucial role in the presented to respondents, to
cohort of adult smokers, the CTCR development of the questionnaire examine whether or not they could
study is conducted with a cross- for the CTCR study, ensuring relate to and understand the
section of young people aged 11 to appropriate and comprehensible descriptions. The final stage was to
16 years, and the GYTS consists of questioning about a wide range of pilot the questions using cognitive
students aged 13-15 years. tobacco marketing activities. interview techniques, whereby
Therefore, while some measures While young people could respondents were interviewed
may be common, others will be visualise and describe images of using the questionnaire and, upon
specific to the particular target conventional advertising (i.e. completion, were interviewed to
group. For example, in the ITC press, poster, and television analyse their comprehension of
study, it makes sense to look at adverts), it was much more specific questions and their ability
adult smokers cessation behaviour challenging to get them to think to answer them.
following marketing restrictions, about, and describe, other forms The result was the
whereas, with young people in the of marketing communications. development of questions that
CTCR study (the majority of whom The qualitative interviews described specific tobacco mar-
do not smoke), it is more relevant to therefore tried to focus the young keting communications in a young
look at measures of intention to respondents minds on different person friendly way (see Figure
smoke (see Figure 5.13). locations where they might be 5.14). Furthermore, because
exposed to tobacco marketing respondents might be interviewed
Specific types of marketing communications, and walk them in the presence of a family
communication through various circumstances, member, their privacy was pro-
asking them to describe any ways tected by presenting the various
Despite a ban on marketing, and that they might see or have their descriptions on prompt cards, so
thus limited exposure, there can attention drawn to products. For they could express their answers
still be significant penetration and example, they were asked to confidentially.
continuation of the relationship imagine themselves walking into a Figure 5.15 shows how the ITC
between marketing and youth shop, and to describe all the things attempted to gain an overall
smoking (Braverman & Aar, they could see when they measure of awareness of tobacco
2004). Therefore, at the most basic approached the door, entered the marketing using very general lay
level, there is a need to try and shop, approached the counter, etc. terminology. Whereas the CTCR
276
question did not impose a time advertising, there is the possibility The GYTS measures aware-
frame, the ITC study tried to limit of some ambiguity over the amount ness of cigarette brands on TV,
recall to the previous six months to recalled. Response categories of including those within coverage of
help participants focus their a lot and a few may be too sporting events (see Figure 5.21).
attention on a specific and ambiguous to appropriately dis- This is likely to provide a measure
manageable period. This is less tinguish between different amounts of overall awareness of cigarette
than ideal; it could, for instance, recalled; one respondents brands on television, but does not
pick up non-marketing influences perception of a lot may be specifically measure awareness of
such as peer smoking or be anothers perception of a few. sports sponsorship. Again, the
interpreted differently by Other forms of tobacco response categories rate fre-
respondents. Nonetheless, it does marketing communications need quency, which may give rise to
help to start putting together a to be addressed with separate ambiguity.
picture of what may be happening. questions; sports and event The remaining form of
When asked alongside other more sponsorship need careful con- marketing communication is,
specific questions, it provides a sideration. In the ITC survey it was rather confusingly, referred to as a
useful gauge for the amount of important to try and distinguish promotion. This can come in
pro-smoking messages that are between overt brand sponsorship many guises: from money-off
being perceived. Furthermore, it is (e.g. Marlboro or Formula 1) from coupons to free samples, as
likely to provide a general mea- more covert corporate social illustrated in Table 5.24. All these
sure of tobacco marketing, as it responsibility (e.g. the British variants need to be covered. An
has been argued that advertising American Tobacco Companys extra complexity is the need to
can affect behaviour even if an support for good causes, such as measure not just awareness of
advert is not actively processed farming methods in Malawi). these activities, but participation in
and respondents cannot recall Therefore, a rather complicated them (e.g. have people taken
seeing it (Shapiro et al., 1997). set of questions were asked here advantage of price promotions, as
Figure 5.16 looks at specific (Figure 5.18). well as hearing about them). The
media and measures how suc- In the ITC survey, respondents ITC study drew on knowledge
cessfully any controls are working found it difficult to answer this gained from the CTCR study and
by examining awareness of bank of questions, so it may be also subdivided promotions down
communications in each of these. preferable to use the slightly sim- into specific descriptions of
The media included in this question pler version presented in Figure marketing (Figure 5.22).
can be varied to suit the jurisdiction 5.19. This is a classic example of
(e.g. in the UK, where television the dilemma faced by ques- Measuring branding
advertising for tobacco products tionnaire designers: how to reflect
has been forbidden for nearly 20 the complexities of the real world Branding is a traditional adver-
years, this option may be omitted). by phrasing accurate questions tising method used to create a
The GYTS survey takes a that do not cause confusion (for a response from a target audience
slightly different approach. It detailed discussion about issues based on cumulative impressions
focuses on specific media and related to question wording see and positive reinforcement. At one
asks young people to rate the Oppenheim, 1992). level, measuring branding is no
amount they have seen within a The CTCR study was also more complex than measuring
short prior time period of one interested in which sports or individual marketing commu-
month (Figure 5.17). While these events young people associated nications, and simple measures
questions are likely to sufficiently with tobacco and, where possible, can be constructed to determine
discriminate between those who do the brands they connected with spontaneous and prompted
and do not recall each form of these (Figure 5.20). awareness of different brands
277
Im going to show you some cards (SHOWCARDS 10-26) with descriptions of some other ways that companies
might try to attract attention to cigarettes. For each one can you tell me if you have seen anything like this.
(Answer categories were: Yes; No; or Dont Know. For each marketing type responders were aware of, they
were asked to say which make or brand it was connected with.)
a. SHOWCARD 10 Adverts for cigarettes on large posters or billboards in the street

b. SHOWCARD 11 Adverts for cigarettes in newspapers or magazines
c. SHOWCARD 12 Signs or posters about cigarettes in shops or on shopfronts:
on shop windows
on shop doors
on cigarette display units inside shops
on clocks inside shops
on staff aprons or overalls
on signing mats inside shops
some other sign or poster about cigarettes (in shops or on shopfronts)
d. SHOWCARD 13 Free trial cigarettes being given out or offers to send away for free cigarettes
e. SHOWCARD 14 Free gifts from the shop keeper when people buy cigarettes
f. SHOWCARD 15 Free gifts when people save coupons or tokens from inside cigarette packs
g. SHOWCARD 16 Free gifts when people save parts of cigarette packs (eg. pack fronts)
h. SHOWCARD 17 Free gifts, showing cigarette brand logos, being given out at events such
as concerts, festivals or sports events
i. SHOWCARD 18 Special price offers for cigarettes
j. SHOWCARD 19 Promotional mail, from cigarette companies, being delivered to peoples homes
k. SHOWCARD 20 Clothing or other items with cigarette brand names or logos on them
l. SHOWCARD 21 Competitions or prize draws linked to cigarettes
m. SHOWCARD 22 Famous people, in films or on TV, with a particular make or brand of cigarettes
n. SHOWCARD 23 New pack design or size
o. SHOWCARD 24 Internet sites promoting cigarettes or smoking (do not include anti-smoking sites)
p. SHOWCARD 25 Email messages or mobile phone text messages promoting cigarettes or smoking
(do not include anti-smoking messages)
q. SHOWCARD 26 Leaflets, notes or information inserted in cigarette packs
r. NO SHOWCARD Have you come across any other ways that companies try to attract attention
to cigarettes?
Figure 5.14 Question assessing awareness and involvement in tobacco promotions

Centre for Tobacco Control Research (CTCR) Ad-ban study (University of Strathclyde)
278
to create evocative images for

Thinking about everything that happens around you, in the last 6 months how
often have you noticed things that promote smoking?
their brands, and arguably a key
task of tobacco control in general,
01 Never and marketing restrictions in
02 Rarely particular, is to undermine them.
03 Sometimes Measuring the results is tricky; this
04 Often type of complexity lends itself
05 Very Often more readily to qualitative
methods than quantitative ones.
Nonetheless, questionnaires can
Figure 5.15 General Measurement of Pro-Smoking Messages in the
be used successfully to tackle the
International Tobacco Control Policy Evaluation Study
problem. Figure 5.25 illustrates
how semantic scales can help
unravel dimensions like popularity,
Now I want to ask you about tobacco advertising. In the last 6 months, have
appeal to specific sub-groups, and
you noticed cigarettes or tobacco products being advertised in any of the
following places?
masculinity. Rating, ranking, and
pick-any (in which respondents
(Read out each statement) are asked which brand(s), if any,
01 Yes they associate with a series of
02 No attributes) measures of brand
image associations have been
a. On television reported to be comparable
b. On radio (Driesener & Romaniuk, 2006).
c. At the [cinema/movie theatre], before or after the [film/movie]
d. On posters or billboards Conclusions
e. In newspapers or magazines
f. On [shop store] windows or inside [shops/stores] where you buy
tobacco
This section has explained what is
g. Other meant by tobacco marketing
communications, that they do
influence tobacco consumption,
Figure 5.16 Measuring Awareness of Tobacco Ads in Specific Media especially by the young, and that it
in the International Tobacco Control Policy Evaluation Study is therefore crucial to instigate
controls and measure their
effectiveness. It has been shown
that this can best be done by
(Figure 5.23). The latter of course tially masked brand examples, as monitoring a range of distal and
requires visual prompts depicting in Figure 5.24. proximal variables using con-
a selection of brands. However, Deeper engagement ventures sumer surveys.
there is the need to delve deeper into the rather illusive area of Consumer surveys are further
and assess not just the ability to brand image: the emotional enhanced when surveillance
recall brands, with or without associations and feelings that are systems are put in place to
prompting, but familiarity and attached to marques, such as for monitor changes in tobacco
engagement with them. The Marlboro or Benson & Hedges. As marketing activity following res-
former can be done by checking if noted earlier, the tobacco industry trictions. This helps in con-
respondents can complete par- goes to great lengths and expense textualising the findings and
279
During the past 30 days (one month), how many advertisements for cigarettes have you seen on billboards?
a. A lot
b. A few
c. None
During the past 30 days (one month), how many advertisements or promotions for cigarettes have you seen in
newspapers or magazines?
a. A lot
b. A few
c. None
Figure 5.17 Measuring Awareness of Tobacco Ads in Specific Media in the Global Youth Tobacco Survey
In the last 6 months, have you seen any advertising by tobacco companies that is NOT promoting particular products
or brands, but the COMPANY itself?
01 Yes
02 No
Still thinking about the last 6 months, have you seen or heard about any sport or sporting event that is sponsored by or
connected with BRANDS of cigarettes?
01 Yes
02 No
In the last 6 months, have you seen or heard about any sport or sporting event that is sponsored by or connected with
tobacco COMPANIES?
01 Yes
02 No
In the last 6 months, have you seen or heard about any music, theatre, art, or fashion events that are sponsored by or
connected with BRANDS of cigarettes?
01 Yes
02 No
connected with tobacco COMPANIES?
01 Yes
02 No
Figure 5.18 Measuring Tobacco Sponsorship the Hard Way in the International Tobacco Control Policy
Evaluation Study
280
In the last 6 months, have you seen or heard about any sport or sporting event that is sponsored by or connected with
a tobacco company or brand?
01 Yes
02 No
connected with a tobacco company or brand?
01 Yes
02 No
Figure 5.19 A Simpler Way of Measuring Tobacco Sponsorship in the International Tobacco Control
Policy Evaluation Study
interpreting any changes or lack of in phases, making it conducive to precise wording of questions will
expected changes. conducting follow-up surveys after vary according to the sample
The consumer surveys need to each phase. being interviewed. Before going
take baseline measures prior to The final subsection examined into the field, therefore, it is crucial
any changes in marketing res- specific questions that have been to conduct a thorough pilot study.
trictions, and several follow-up successfully used to do this This should include qualitative
surveys over a period of years to monitoring and showed how work to check matters of content
monitor short-term and longer- particular questions will vary and language, and quantitative
term effects. The length of depending on the target group and research to check understanding
follow-up will partly be dictated by the administration mode. and feasibility.
the implementation time table of In applying the methodologies
the restrictions. For example, in discussed here, however, it is
the UK their ban was implemented important to recognise that the
281
Can you think of any sports or games that are sponsored by or connected with any makes or brands of cigarettes?
FOR EACH SPORT or GAME MENTIONED, ASK: What make(s) or brand(s) is it connected with?
PROBE FOR SPORT/GAME AND MAKE(S)/BRAND(S)

REPEAT FOR MAXIMUM OF 6 SPORTS/GAMES
Sport or Game Make(s) or Brand(s)
1. ............
2. ................
3. ...
4. .......... .
5. ..................
6. . ....................
Can you think of any other events or shows that are sponsored by or connected with any makes or brands of cigarettes?
FOR EACH EVENT or SHOW MENTIONED, ASK: What make(s) or brand(s) is it connected with?
PROBE FOR EVENT? SHOW AND MAKE(S)/BRAND(S)

REPEAT FOR MAXIMUM OF 6 SPORTS/GAMES
Event or Show Make(s) or Brand(s)
1. .......................
2. ... ...................
3. .... ...................
4. ... ...................
5. .. ..................
6.. ...........................
Figure 5.20 Measuring Awareness of Tobacco Sponsorship Among Young People in the Centre for
Tobacco Control Resarch (CTCR) study at the University of Strathclyde
282
During the past 30 days (one month), when you have watched sports events or other programmes on TV how often did
you see cigarette brand names?
a. I never watch TV
b. A lot
c. Sometimes
d. Never
Figure 5.21 Measuring Sponsorship in the Global Youth Tobacco Survey
In the last 6 months, have you noticed any of the following types of tobacco promotion:
READ OUT EACH STATEMENT
01 YES
02 NO
a. Free samples of cigarettes. If yes: Have you received free samples of cigarettes?
b. Special price offers for cigarettes. If yes: have you used special price offers?
c. Free gifts or special discount offers on other products when buying cigarettes?
d. (IF YES) Were these free gifts or special discounts from:
1. the shop-keeper when buying cigarettes

2. you or someone else saving coupons or tokens from inside cigarette packs
3. you or someone else saving parts of cigarette packs (e.g. pack fronts)
4. free gifts showing cigarette brand logos, given out at events such as concerts, festivals or sports
events
If yes to any of the above ask: Have you personally received such gifts?
e. Email messages promoting cigarettes or tobacco products. If yes: Have you received promotional
email messages?
f. Mobile phone text messages promoting cigarettes or tobacco products. If yes: Have you received
mobile phone text messages
g. Mail promoting cigarettes or tobacco products. If yes: Have you received..
h. Clothing or other items with a cigarette brand name or logo. If yes: have you received.
i. Competitions linked to cigarettes. If yes: have you participated in any competitions linked to
cigarettes?
j. Internet sites promoting cigarettes or tobacco products. If yes: Have you visited any internet sites..
k. Leaflets promoting cigarettes or tobacco products. If yes: Have you received any leaflets ..
l. Signs or posters or branded items in bars, pubs or clubs
Figure 5.22 Measuring Awareness and Involvement in Tobacco Promotions in the International Tobacco
Control Policy Evaluation Study
283
Can you tell me the names of as many makes or brands of cigarettes that you have either seen or heard of:
Record up to a maximum of 10 ...
Question: Now can you tell me whether you have seen any of these makes before?
VISUAL PROMPTS 6-10

POINT TO EACH PROMPT ONE AT A TIME
FOR EACH ONE ASK: Have you ever seen this one?
Visual prompt Yes No Dont Know
6. Windsor Blue
7. Berkeley
8. Benson & Hedges
9. Lambert & Butler
10. Marlboro
Figure 5.23 Measurement of Brand Awareness in the Centre for Tobacco Control Research (CTCR) study
at the Univ ersity of Strathclyde
Im going to show you some packets of cigarettes that have the name covered up on them. For each one Id like you to
tell me what make or brand you think it is. Please dont worry if you dont know the make or brand.
SHOW VISUAL PROMPTS
This brand is very popular with This brand is very unpopular with
people my age people my age
DK
Benson & Hedges 1 2 3 4 5 6
Lambert & Butler 1 2 3 4 5 6
Marlboro 1 2 3 4 5 6
You never see this brand in shops around here You always see this brand in shops around
here
DK
Figure 5.24 Measurement of Brand Familiarity in the Centre for Tobacco Control Research (CTCR) at
the University of Strathclyde
284
Most smokers smoke this brand Few smokers smoke this brand
DK
Attractive looking brand Unattractive looking brand

DK
Female brand Male brand

DK
Figure 5.24 Measurement of Brand Familiarity in the Centre for Tobacco Control Research (CTCR) at
the University of Strathclyde
285
5.5 Measures to evaluate the effectiveness of

tobacco product labelling policies
Background prohibit packaging elements that and legible (WHO, 2003). Beyond
are deemed to be misleading to these minimum requirements, Arti-
The cigarette package serves as the smokers. As a consequence, cle 11 also states that warnings
cornerstone of tobacco marketing labelling policies have begun to alter should cover 50% or more of a
and advertising campaigns (Slade, the traditional appearance of the packages principle surfaces, and
1997; Pollay, 2001). Package design cigarette package. may be in the form of pictures.
helps to reinforce brand imagery The importance of tobacco label- To date, at least eight countries
communicated through other media ling policies is highlighted in Article have implemented picture-based
and plays a central role in retail 11 of the WHO FCTC (WHO, 2003). health warnings that meet the
marketing. The importance of Article 11 sets international stan- FCTCs recommended standard
cigarette packaging only increases dards for packaging and labelling of (see Figure 5.27). A number of other
as other forms of marketing are tobacco products in three broad jurisdictions, including the European
restricted, as indicated in the fol- categories: 1) mandatory health Union, have recently implemented
lowing quote from a Philip Morris warnings; 2) restrictions on brand prominent text warnings which meet
executive: "Our final communication descriptors, such as the use of light the minimum FCTC standard. More
vehicle with our smoker is the pack and mild; and 3) information on obscure text warnings remain in
itself. In the absence of any other cigarette contents and emissions1 many other markets, including the
marketing messages, our pac- (Figure 5.26). USA, China, and Russia.
kaging...is the sole communicator of
our brand essence. Put another Health warning labelling Constituents & emissions
waywhen you dont have anything labelling
elseour packaging is our mar- Cigarette packages in the vast
keting. (Alechnowicz & Chapman, majority of countries carry a health There is general agreement that
2004). warning (Aftab et al., 1999). How- tobacco packaging should include
Governments in many juris- ever, the position, size, and general at least minimal information about
dictions have begun to apply greater strength of these warnings vary some of the hazardous and addi-
restrictions on tobacco labelling. As considerably across jurisdictions. ctive constituents in tobacco and
much as half of the package is now FCTC Article 11 requires that tobacco smoke. FCTC Article 11
used by regulators to communicate package health warnings must requires that packages contain
the health effects of smoking. cover at least 30% of the package information on relevant consti-
Governments have also begun to surface and be large, clear, visible, tuents and emissions of tobacco
1
Tobacco labelling policies apply to a broad range of tobacco products, including a range of combustible products, such as
cigars, and the packaging of loose or fine cut tobacco, as well as non-combustible tobacco products. However, much of this
section will focus on labelling policies for factory-made, pre-packaged cigarettes given that they are the primary target of
labelling policies, and the area in which most research has been conducted. Labelling policies for other types of products will
be described briefly in a separate section to follow.
287
1. Each Party shall, within a period of three years after entry into force of this Convention for that Party, adopt and
implement, in accordance with its national law, effective measures to ensure that:
(a) Tobacco product packaging and labelling do not promote a tobacco product by any means that are false, misleading,
deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions,
including any term, descriptor, trademark, figurative or any other sign that directly or indirectly creates the false
impression that a particular tobacco product is less harmful than other tobacco products. These may include terms
such as low tar, light, ultra-light, or mild; and
(b) Each unit packet and package of tobacco products and any outside packaging and labelling of such products also
carry health warnings describing the harmful effects of tobacco use, and may include other appropriate messages.
These warnings and messages:
(i) shall be approved by the competent national authority,

(ii) shall be rotating,
(iii) shall be large, clear, visible and legible,
(iv) should be 50% or more of the principal display areas but shall be no less than 30% of the principal display areas,
(v) may be in the form of or include pictures or pictograms.
2. Each unit packet and package of tobacco products and any outside packaging and labelling of such products shall,
in addition to the warnings specified in paragraph 1(b) of this Article, contain information on relevant constituents
and emissions of tobacco products as defined by national authorities.
3. Each Party shall require that the warnings and other textual information specified in paragraphs 1(b) and paragraph
2 of this Article will appear on each unit packet and package of tobacco products and any outside packaging and
labelling of such products in its principal language or languages.
4. For the purposes of this Article, the term outside packaging and labelling in relation to tobacco products applies
to any packaging and labelling used in the retail sale of the product.
WHO (2003)
Figure 5.26 WHO FCTC Article 11: Packaging and labelling of tobacco products
products as defined by national three emissions in the mainstream generated under the ISO testing
authorities. At present, however, smoke: tar, nicotine, and carbon method are unrelated to individual
national authorities have taken monoxide (CO). Emission levels levels of exposure or risk (Burns et
much different approaches to are generated by machine- al., 2001), there are growing calls
labelling constituents and emis- smoking cigarettes according to a from within the tobacco control
sions, and there remains con- standard set of puffing conditions; community for the ISO numbers to
siderable disagreement regarding typically the International Stan- be removed from packages. Some
what should be considered rele- dards Organization (ISO) method, jurisdictions have supplemented
vant information. which serves as the current the ISO numbers with additional
The current regulatory practice international standard. However, emission information. For exam-
in many jurisdictions is to require in light of research indicating that ple, Canada increased the list of
manufacturers to print levels for the tar and nicotine levels emissions that must be reported
288
Measures to evaluate the effectiveness of tobacco product labelling policies
Figure 5.27 Picture-based warnings
289
(by adding benzene, formal- false, misleading, deceptive or For example, consumers who buy
dehyde, and hydrogen cyanide to likely to create an erroneous loose or fine-cut tobacco, without
tar, nicotine, and CO), and impression about its any manufactured packaging,
requires a second set of numbers characteristics, health effects, may not be exposed to product
from a more intensive machine hazards or emissions, including health warnings. Even consumers
smoking method for each emis- any term, descriptor, trademark, who buy fine-cut tobacco, sold in
sion (Figure 5.28). Other figurative or any other sign that government-mandated packaging,
jurisdictions have replaced quan- directly or indirectly creates the will have different patterns of
titative emission values with false impression that a particular exposure than those who smoke
descriptive, non-numerical infor- tobacco product is less harmful manufactured cigarettes, and who
mation on hazardous emissions than other tobacco products. are likely to be exposed to the
and toxicants. A consensus has These may include terms such as warnings each time they reach for
yet to emerge on best practices low tar, light, ultra-light, or the package. As a result, studies
for this area of tobacco labelling mild. Although there is evidence conducted in markets with a
policy. to suggest that other packaging considerable proportion of fine-cut
elements, such as the use of tobacco sales, such as the United
Brand descriptor labelling colour, may also create mis- Kingdom, New Zealand, and
leading perceptions of risk Thailand, may need to stratify for
Tobacco manufacturers incor- (Wakefield et al., 2002), light and fine-cut versus manufactured or
porate a variety of common terms mild descriptors are the only mixed use. Smuggled or con-
into the names of their cigarette packaging elements to be traband cigarettes may also alter
brands. Words such as light and restricted to date. patterns of exposure in cases
mild are ostensibly used to when the contraband product is
denote flavour and taste; Methodological issues in evalu- not manufactured to the same
however, light and mild brands ating tobacco labelling policies labelling specifications.
are often promoted as healthier
products and are typically applied Evaluating tobacco labelling Issues in attribution: dealing with
to brands that generate lower policies presents several unique multiple sources of health infor-
machine levels of tar (Pollay, challenges; this section reviews mation:
2001; Pollay & Dewhirst, 2002). some of the principal methodo-
Not surprisingly, light and mild logical and analytical consi- Health behaviours with multiple
brands are perceived by many derations. determinants present a challenge
consumers to deliver less tar and to policy evaluation. The problem
lower risk than regular or full Alternative tobacco products: of attribution is particularly acute
flavour varieties despite evidence for health warning labels. First,
to the contrary (Ashley et al., Labelling policies have generally labelling policies are often
2001; Shiffman et al., 2001). been designed with factory-made, implemented simultaneously with
A growing number of juris- pre-packaged cigarettes in mind. other tobacco control measures,
dictions, including Brazil and the However, a substantial proportion including increases in taxation and
European Union, have prohibited of tobacco users throughout the smoke-free policies. As a result, it
the use of light and mild on world use tobacco products that is difficult to isolate the effect of an
packages. Similar prohibitions are are either packaged in a different individual policy on overall pre-
proposed in FCTC Article 11: way, or have no manufactured valence. Second, many of the
"tobacco product packaging and packaging at all. This has specific themes and messages in
labelling do not promote a tobacco important implications for patterns labelling policies are commu-
product by any means that are of exposure to health warnings. nicated through other sources.
290
European Union (United Kingdom): Three ISO emissions
Canada: Six ISO emissions and Health Candada Intense emission
Australia: Descriptive information
Figure 5.28 Constituent labelling policies in the European Union, Canada and Australia
291
Mass media campaigns and implications for regulators in terms Youth:

health professionals often target of ensuring periodic changes to the
the same health effects, warnings, as well as studies that One policy-relevant question
particularly with regards to com- compare labelling policies across concerns the impact of warning
mon diseases such as cancer and jurisdictions. For example, a recent labels in reducing youth uptake.
cardiovascular disease. The study found that new text-based Evaluating the impact of health
impact of package-based labelling warnings, introduced in the United warnings among youth during
policies may also be confounded Kingdom in 2003, were con- periods of smoking initiation
with health warnings in other siderably more likely to be noticed requires a different conceptual
settings. Various jurisdictions than Australian text-based war- approach. Given that the cigarette
require health warnings in retail nings, which were only slightly package serves as the medium for
outlets and warnings on print smaller, but had been in place for labelling policies, consumption
advertisements for tobacco pro- more than eight years at the time of levels may be positively asso-
ducts. Third, perceptions of risk the survey (Bornstein, 1989). ciated with knowledge of the
and health knowledge are Ideally, labelling policies should be warning labels. In other words,
influenced by an inter-related set evaluated at similar post-imple- individuals who smoke 20
of factors at the individual, social, mentation dates; at the least, cigarettes a day will be exposed to
and environmental level. Few differences in follow-up periods the warnings more frequently than
studies are able to measure more should be clearly noted and taken individuals who smoke less than
than a small number of these into account when interpreting daily. Furthermore, occasional
factors within a single study and findings. youth smokers are less likely to
none can fully isolate the There is preliminary evidence buy their own package, reducing
contributions of each. These reali- to suggest that not all measures of the likelihood of exposure to
ties underscore the importance of effectiveness decline at the same warning labels, compared to more
the methodological features rate over time. Proximal mea- regular smokers who are more
described in Section 2.1. In sures of salience, such as noticing likely to buy their own package
addition, environmental scans of warnings, may erode more quickly (Leatherdale, 2005). As a result,
other mass media campaigns and than distal measures, such as individuals who smoke more
policy interventions can provide reporting that health warnings frequently are more likely to recall
important context. motivate quitting and increase the content, location, and other
thoughts about the health risks of aspects of labelling policies, a
Wear-out and impact over time: smoking (Hammond et al., counter-intuitive association at first
2007a). It is even plausible that for glance (Robinson & Killen, 1997).
It is widely accepted that the some smokers the impact of A second issue concerns
salience of advertising and health health warnings could increase longitudinal studies that use
communications is typically grea- over time. For example, the measures of exposure or
test upon first exposure (Bornstein, cessation and telephone quitline knowledge as predictors of future
1989; Henderson, 2000). The initial information included in many smoking behaviour among youth.
impact of comprehensive labelling health warnings may only become During youth and young
policies, such as the introduction of relevant to smokers as they adulthood, the rate of smoking
large graphic warnings on contemplate quitting. In a popu- undergoes significant increases.
packages, is often magnified by lation-based survey, however, the As youth smoking behaviour
media coverage. As a result, ebb and flow among individuals increases, so too will their
measures of effectiveness are likely will balance out, and one would exposure to the package and their
to be strongly associated with the still anticipate decreases in mea- knowledge of the warnings. Thus,
implementation date. This has sures of effectiveness over time. whereas a negative association
292
between exposure and future scores the importance of suitable health warnings are tailored to
smoking behaviour may be research designs and appropriate particular sub-groups of smokers.
expected for anti-smoking cam- interpretations of the data when Warnings on the risks of smoking
paigns in other media, this is not evaluating warning labels among while pregnant, for example, have
the case for warning labels. youth. little relevance for older males.
Failure to account for the Thus, it is conceivable that some
somewhat counter-intuitive asso- Evaluation of individual messages warnings may perform very well
ciation between smoking and & content: among sub-groups who comprise
exposure to health warnings can the target audience, but relatively
result in misleading interpretations Beyond the question of whether poorly among the population as a
of data. For example, one study health warnings are generally whole. As a consequence, survey
characterized an association effective, there is a growing body of measures may need to be
between increased smoking and research on the individual elements adapted and the findings may
increased knowledge of health of a warning. These elements can need to be stratified among
warnings as paradoxical, and broadly be categorized in terms of relevant sub-groups. One might
also found evidence that US design and content components. expect the tailoring of warnings to
health warnings were ineffective To date, much of the research has increase, as the use of picture-
(Robinson & Killen, 1997). This focused on important design ele- based warnings increase, along
may have been the case; how- ments including the size, position, with the typical number of rotating
ever, without a comparison group, and use of pictures on the package warnings in a given jurisdiction.
the authors had no way of (Strahan et al., 2002). In contrast, In general, population-based
knowing whether the increases in relatively few studies have exa- surveys may be most appropriate
smoking behaviour were greater, mined the content of individual for identifying the overall ef-
less, or no different than they messages. fectiveness of a set of health
would have been if no warnings or Population-based surveys that warnings. However, the task of
more comprehensive warnings compare labelling policies across evaluating the content of individual
had been implemented. It may be, time or jurisdictions are somewhat warnings is best suited to
for example, that fewer youth ill-suited to the task of evaluating experimental or qualitative designs,
initiated smoking than would have individual warnings. Policies typi- in which the content and design
otherwise occurred without the cally differ on more than one di- can be systematically varied.
health warnings. In fact, this was mension, and policy changes ty-
the pattern reported in a longi- pically involve increases in the size, Geographic & cultural differences:
tudinal study comparing changes number, position, and type of in-
in youth smoking in Canada and formation presented in each Very little research has examined
the USA following the introduction warning. Evaluating individual com- potential geographic and cultural
of graphic warning labels on ponents or messages becomes differences in the effectiveness of
Canadian packages. Smoking more complicated as the number of health warnings. Although the
rates and knowledge of the warnings and complexity of in- fundamental principles underlying
warnings rose among Canadian formation increases; it is far easier the effectiveness of warnings are
youth as they aged; however, the to evaluate the effectiveness of a unlikely to vary across cultures
increase in smoking was sig- single warning through survey- and regions, the effectiveness of
nificantly less than among US based research than to evaluate the individual messages may indeed
adolescents and the increase in content of 16 individual warnings. perform differently. First, smokers
knowledge of the warnings con- When assessing the impact of in different parts of the world have
siderably greater (Fong et al., individual warnings, it is also different levels of existing health
2002). Overall, this study under- important to consider that many knowledge. This has implications
293
for the type of messages to be information being removed is used the light and mild descriptors.
included in warnings. For exam- as a brand identifier. In the case of These considerations are impor-
ple, Australian smokers may have bans on the use of light and tant in terms of how the data are
a relatively higher level of health mild, the terminology that was interpreted and how the effective-
literacy than smokers in other previously used to identify a class ness of light and mild policies is
regions, which may account for of products no longer exists. conceptualized.
the decision to include a warning Smokers may retain the same
for peripheral vascular disease misleading perceptions of these Defining misleading descriptors:
on packages. Picture-based products after the terms have
warnings may be particularly been prohibited, but survey There is widespread confusion
important in populations with lower measures can no longer refer to among both consumers and many
literacy rates (CRATEC, 2003). light or mild cigarettes in the within the tobacco control
In addition, the images used in same way as in the past. community regarding several key
one jurisdiction may not be equally Therefore, survey measures must terms relevant to labelling policy.
effective in another. For example, be designed so that the wording Many fail to make the distinction
several of the picture-based and meaning of questions remains between light and mild and low
warnings that appear on constant before and after the tar. Whereas light and mild are
Venezuelan and Uruguayan removal of these terms. This terms used in the name of a
packages, and elsewhere, use creative challenge is only now brand, strictly speaking low tar
symbols that may be culturally being confronted by researchers refers to the emission levels under
specific. Finally, similar sets of with the recent advent of light machine testing. Although there is
warnings may be more effective in and mild prohibitions. One a very strong correlation between
areas where smokers have approach, discussed later in this the two (manufactures often
relatively little access to anti- section, is to make the res- attach light and mild des-
smoking information from mass pondents own brand the criptors to brands that generate
media or health professionals. referent for questions. lower tar levels under the ISO
Few of these issues have been Another implication of the smoking machine), one can have
addressed to date; however, they removal of brand information is a light cigarette that does not
are likely to gain prominence as a that the beliefs associated with generate low tar levels and vice
growing number of jurisdictions in light and mild cigarettes are versa. Strictly speaking, in
Asia, Africa, and the Middle East likely to persist for some time after jurisdictions with bans, light and
enhance their labelling policies to the descriptors disappear from mild cigarettes do not exist,
meet Article 11, and must rely on packages. This situation is similar whereas low tar cigarettes do.
an evidence base that derives to advertising, promotion, and To complicate matters further, the
from relatively few Western and sponsorship bans; one should not terms light and mild can also be
Latin American countries. expect beliefs to change imme- used to refer to sensory properties
diately upon the implementation of of a cigarette. Thus, smokers may
Evaluating the removal of infor- the policy, but more gradually over still retain the concept of a
mation: time. Indeed, anecdotal evidence cigarette as light or mild even
suggests that many retailers and in the absence of a brand
Unlike other labelling policies, consumers continue to use the descriptor. Given the potential for
restrictions on brand descriptors terms light and mild well after confusion, survey measures
result in the removal, rather than their removal. Other packaging should be explicit about the
the provision of, information. This elements and aspect of cigarette intended meaning of these terms
presents a challenge to evalu- design may also reinforce the and should avoid using them
ation, particularly when the same beliefs and perceptions as interchangeably. This becomes
294
apparent when measuring these model, as illustrated in Figure The extent to which information is
concepts in jurisdictions where the 5.29. Other psychosocial varia- processed or elaborated upon has
light and mild brand descriptors bles, such as social norms and been shown to be the most
have been removed. beliefs about the tobacco industry, important determinant of memory
could also be added to this model, and attitude change in response to
Measures but have been excluded in the new information (Anderson,
interest of brevity. The following 1990). A number of measures
This section provides an overview sub-section begins with a review have been developed to assess
of the key constructs and of quantitative measures, followed cognitive processing of health
individual measures that have by qualitative measures, and a warnings as a general indicator of
been used to assess labelling brief discussion of the role of their salience. These measures
policies. The constructs range industry documents (Tables 5.27- range from more shallow
from the extent to which labelling 5.39; see also Appendices 9 and measures of processing, such as
policies are noticed and pro- 10). a general awareness of warnings,
cessed, the extent to which they to deeper measures of pro-
alter key beliefs (such as levels of Measures of labelling salience cessing, including reading the
health knowledge), to their impact and processing: warnings and thinking about them
upon downstream behavioural when they are not in sight
outcomes. These measures can Health warnings must be cog- (Borland & Hill, 1997a; Canadian
be organised within a conceptual nitively processed to be effective. Cancer Society, 2001; Hammond
Construct Noticing Health Warnings
Measure In the last month, how often, if at all, have you noticed the warning labels on cigarette
packs? (Never, Rarely, Sometimes, Often, Very Often)
Sources Hammond et al., 2006a; Hammond et al., 2007a
Validity The time reference varies across different versions: some questions include no time
reference (How often do you notice), whereas others refer to the last month or last
three months. The response categories also vary and are often collapsed into a smaller
number of categories in analysis. The basic question can also be asked within the context
of noticing other forms of anti-tobacco media (e.g. In the last 6 months, have you noticed
advertising or information that talks about the dangers of smoking, or encourages quitting
in any of the following places? (Yes, No to a list of 9 media channels, including on cigarette
packages)).
Comments Overall, a straightforward measure of the salience and processing of warnings that should
be considered within the core set of variables to assess health warnings. As close to a gold
standard in this domain as exists. Using the same wording to ask about salience of other
media channels provides a useful comparative index for the salience of various health
information channels. A recommended and essential measure for evaluating health
warnings.
Table 5.27 Essential Measure of Labelling Salience and Processing
295
POLICY Health Warnings
Salience & processing

POLICIY-
SPECIFIC Awareness of warnings
Knowledge of warnings
MEDIATORS
Noticing of warnings
Depth of processing
Cessation Brand appeal Affective Health knowledge

GENERAL knowledge reactions Perceived risk
Attractiveness
MEDIATORS Fear Beliefs about
Self-efficacy Disgust
Quit-line health effects
information Thinking/worry
Website about health risks
information
Avoidance
Quit
Covering warnings
intentions
Requesting packs
Smoking behaviour
Changes in consumption
Quit attempt
OUTCOMES Abstinence
Figure 5.29 Conceptual framework for the evaluation of health warning policies
296
Construct (a) General Awareness
Measure Have you seen health warnings on cigarette packages? (Yes, No)
Sources Borland & Hill, 1997a; Health Canada, 2005
Validity Good face validity; associated with policy strength.
Variations Response categories are consistent across measures. Alternative wordings include:
Are you aware of health warnings on cigarette packages? and Are there health warnings
on packages?
Some questions refer specifically to the release of new warnings. For instance,
Are you aware of any recent changes to health warnings on cigarette packs? and
Have you noticed any changes to the health warnings on cigarette packages since
[date]?
Comments Provides an overall measure of general awareness. Limited value in examining changes
and comparing across jurisdictions, given almost universal awareness among smokers.
Most useful for examining policy implementation and rollout when the question makes
reference to new warnings, or in jurisdictions with very weak health warnings and no
previous research. Overall, an informative measure, but only recommended under these
circumstances.
Construct (b) Reading/Looking Closely at Health Warnings
Measure In the last month, how often, if at all, have you read or looked closely at the warning labels
on cigarette packs? (Never, Rarely, Sometimes, Often, Very Often)
Sources Hammond et al., 2006a; Hammond et al., 2007a
Validity Face validity; good convergent validity with other measures; good predictive validity for
strength of policy and motivation to quit smoking.
Variations The time reference varies across different versions. Also, some versions refer to reading,
other versions use broader language, such as looking closely, and some versions include
both terms. Looking closely may be more appropriate for pictorial warnings.
Comments Strong correlation with noticing, but conceptualized as a deeper measure of processing.
Overall, a recommended and important, but not essential, measure of salience and
processing that may be particularly relevant for textual aspects of warnings.
Construct (c) Discussing the Health Warnings With Others
Measure In the last month, how often, if at all, have you talked about the health warning with
others? (Never, Rarely, Sometimes, Often, Very Often)
Source Hammond et al., 2003
Table 5.28 Additional Measures of Labelling Salience and Processing
297
Validity Good face validity, convergent validity, and predictive validity for motivation to quit and future
smoking behaviour when included as part of a composite measure.
Variations Variations of this measures use slightly different terms, including discussed and mentioned
rather than talked about, as well as different response options, such as Never, Rarely,
Sometimes, Frequently.
Comments These measures provide a deeper measure of processing for labels and may be useful for
comprehensive evaluations of labelling policies. Recommended, but not essential.
Construct (d) Thinking About Health Warnings
Measure In the last month, how often have you thought about what the health warnings have to say?
(Never, Rarely, Sometimes, Often, All the time)
Sources Canadian Cancer Society, 2001; Hammond et al., 2003; Christie & Etter, 2004
Validity Good face validity, convergent validity, and predictive validity for motivation to quit and future
smoking behaviour when included as part of a composite measure.
Variations In the last month, have you ever thought about the warning labels or what they had to say
when a cigarette pack wasn't in sight? This variation of the measure requires a higher
threshold of processing than the items above.
Comments These measures provide a deeper measure of processing for labels and may be useful for
comprehensive evaluations of labelling policies. Recommended, but not essential.
Table 5.28 Additional measures of labelling salience and processing
et al., 2003; Christie & Etter, 2004; the uncertainty regarding when wear-out (i.e. decrease in the
Hammond et al., 2004a; Health health warnings begin appearing salience of the warning labels) of
Canada, 2005; Koval et al., 2005; on packages. health warnings (Health Canada,
Hammond et al., 2006a; Ham- In contrast to general mea- 2005; Hammond et al., 2007a).
mond et al., 2007a). sures of awareness, the extent to Additional data of this type may
Measures of general aware- which smokers notice, read, and help to answer the question as to
ness are typically endorsed by a think about the warnings appears whether the rate of decline among
vast majority of respondents, to be highly dependent on the measures of salience is asso-
including non-smokers, regardless size, type, and location of the ciated with design features, such
of the type of warning level. These warning (Borland & Hill, 1997a; as the size of warnings and the
questions are often used to Health Canada, 2005; Hammond use of pictures. In most cases,
examine the implementation, or et al., 2007a). These measures of these measures have been
roll-out, of new package war- processing are also subject to the analyzed as individual items,
nings following a change in policy. implementation date. Several although in one case a depth of
This information is critical for any studies have used measures of processing scale was developed
population-based survey conduc- processing collected from the and tested (Hammond et al.,
ted shortly after the imple- same population over time and 2003). In that instance, nine items
mentation of a new policy, given can be used to measure the were used to create a scale to
298
Construct Health Warnings - Eye Tracking
Measure Participants wore eye-tracking equipment and viewed US cigarette advertisements with
health warnings.
Sources Fischer et al.,1989b; Krugman et al., 1994
Validity Good predictive validity for recall and recognition of health warnings
Variations Viewing time serves as another measure of attention, where warnings are flashed on a
screen and the amount of time is recorded (Peters et al., 2007).
Comments Eye tracking measures can help to identify the most salient design aspects of warning labels
and serve as an objective measure of attention; however, these measures are limited to
laboratory based research designs.
Table 5.29 Physiological Measures of Salience and Processing
measure cognitive processing wordings (Canadian Cancer include a number of rotating

labelled as depth of processing. Society, 2001; Hammond et al., health warnings, emission label-
Responses to each of the nine 2004; Health Canada, 2005; Ham- ling is consistent across packages
items were rated using a 5-point mond et al., 2007a). for a given brand. As a result,
Likert-type format going from "not there may be little reason for
at all/never" to "all the time/a lot" Contents & emissions: smokers to read or attend to this
and values added to create an information on a regular basis. As
index. Examples of items included Several studies have assessed a consequence, we have not
were How carefully have you ever the extent to which smokers recommended a specific measure
read the messages on the outside process emission information in this section.
of a cigarette package? and How printed on the side of packages.
often have you thought about what These measures mirror the pro- Physiological measures of
messages on the inside of cessing items used to gauge salience and processing:
packages have to say? health warnings, although a more
Although the wording of items limited set has been used. Both Physiological measures have
is relatively similar across surveys, studies of which we are aware, been used in conjunction with
different time periods are used in indicate that smokers are less survey measures to quantify
both the question and the likely to read or look at emission attention to and processing of
response option in many cases. information than health warnings health warnings. These mea-
For example, whereas some on the face of packages sures have an advantage in that
noticing questions refer to the (Thompson et al., 2006). More they are more objective given
past month, others refer to the generally, it is unclear whether that they do not rely on self-
past three months, or use no time salience and processing type reporting. In several cases, they
reference at all (Tables 5.27 and measures are as informative for have been used to compare the
5.28). Nevertheless, findings from emission labelling policies as for salience of warnings with pac-
the same population are relatively health warning policies. Unlike kage design or within the context
similar across different question health warnings, which typically of a tobacco advertisement. For
299
Construct (a) Health Warnings - Location
Measure Without looking at a cigarette package, where on the pack are the warnings or messages
located? (Open ended)
Validity Good face validity.
Variations The same question has been asked without the prefix (Without looking at a cigarette
package), as well as with a diagram in self-completed surveys.
Comments Useful measures for identifying basic knowledge about health warnings; however, it
becomes complicated in jurisdictions with warnings on the inside and outside of packages.
Unclear how emission and contents information should be treated, especially when provided
by industry.
Construct (b) Health Warnings Content
Measure Without looking at a cigarette package, what specific health warning messages can you
remember seeing on cigarette packages in Canada? (Open ended)
Source Health Canada, 2005
Variations The same question has been asked without the prefix, which is typically included in
telephone surveys to ensure the participant is not looking at the package during the call.
Comments Useful measures for identifying basic knowledge about health warnings and, potentially, for
identifying individual messages that are particularly salient. However, this measure will be
difficult to answer in jurisdictions with comprehensive health warnings, including multiple
warnings on different areas of the package.
Table 5.30 Measures of Knowledge of Health Warnings
example, eye movements during communication measure (Krug- have been asked using un-
exposure to an ad have been man et al., 1994) (Table 5.29). prompted recall (e.g. Where are
used as physiological indicators the warnings located?), as well as
of attention to tobacco warnings. Knowledge of health warnings using recognition tasks (e.g.
These measures that are directly Please tell me which of the
linked to cognitive processing Items assessing smokers know- following warnings appear on
have been useful to investigate ledge of health warnings are cigarette packages) (Table
the relationship between visual among commonly used survey 5.30) (Hill, 1988; Richards et al.,
attention and a more traditional measures. Knowledge questions 1989; Rootman et al., 1995;
300
Construct Emission Side Panel Content
Measure Without looking at a cigarette package, can you name any chemicals or substances that are
currently listed on cigarette packages in [country]? (Open ended)
Variations A common alternative is to ask about the quantitative level of specific emissions, such as tar
Without looking at a pack, can you tell me the tar level of your cigarettes?
Comments This measure examines basic recall of emission information printed on packages, and is
often compared against objective data collected from other sources in order to evaluate
accuracy of self-report recall. This measure should be interpreted alongside measures on
the comprehension and use of this information (described later).
Table 5.31 Measures of Knowledge of Constituents and Emissions
Construct Health Warnings Affective Reactions
Measure Have you experienced any fear as a result of the health warnings?
(Not at all / A little / A lot)
Source Hammond et al., 2004a
Validity Good face validity; good predictive validity for future smoking behaviour.
Variations Alternatives have used more comprehensive scales and asked about different affective
reactions, including disgust and anger (Peters et al., 2007).
Comments Affective reactions have been evaluated to a greater extent in qualitative evaluations of
warning labels; however, survey-based measures may be a key mediator of downstream
measures of impact.
Table 5.32 Measures of Affective Reactions to Health Warnings
Borland & Hill, 1997a; Borland & identify which individual warnings among nonsmokers. Except for
Hill, 1997b; Robinson & Killen, may be most effective. In the few questions that refer to a
1997; Hammond et al., 2003; jurisdictions with a large number respondents own cigarette pac-
Brown et al., 2005; Health Cana- of warnings, this task can be kage, most measures of
da, 2005; OHegarty et al., 2006; particularly helpful. awareness and knowledge appear
Thompson et al., 2006). Measures Many of these measures have to work equally well among
of unprompted recall for warning been assessed among the nonsmokers. Indeed, nonsmokers
label content can be used to general population, including have been found to have
301
Construct Health Warnings Avoidance
Measure In the last month, have you made any effort to avoid looking at or thinking about the warning
labels? (Yes, No)
Sources Hammond et al., 2004a; International Tobacco Control Policy Evaluation Survey (The ITC
Project)
Validity Good face validity; good predictive validity for future smoking behaviour.
Variations Several follow-up questions may be asked of those who respond yes to the initial question,
above. For example, Have you made any effort to avoid the warnings by: (1) Covering the
warnings up? (2) Keeping the pack out of sight? (3) Using a cigarette case or some other
pack? (4) By not buying packs with particular labels? (Yes, No to each question)
Comments These measures can indicate the prevalence of avoidance behaviours and whether they
reduce the effectiveness of warnings. The follow-up questions are only necessary for in-
depth exploration of avoidance.
Table 5.33 Measures of Avoidance
surprisingly high levels of aware- to be greater among heavier First, when asking about the
ness and recall for prominent smokers. This association is likely location of health warnings, one
health warnings and picture-based to be more pronounced within issue is whether respondents
warnings in particular (Health samples that include a broad consider emission information,
Canada, 2005). However, both range of smokers, and are likely to which may be printed on the sides
recall and recognition of particular be greatest in studies that of the package, as a health
messages has been shown to be compare regular smokers with warning. Canadian data suggests
highly dependent on the com- occasional or nonsmokers. The that some smokers are aware of
plexity of the health warning and its association between consumption this information, but fail to cite it as
implementation date. For example, and knowledge is also likely to be a location. Second, in telephone
virtually all Canadian smokers are stronger in jurisdictions with a or web-based surveys, some
aware of the health warnings on greater number and complexity of participants may have a pack
packages, although we are warnings. For example, packages visible as they respond to the
unaware of any research indicating in Canada carry information on the survey. As a result, some
that smokers have correctly been side panel, one of 16 health measures explicitly ask smokers
able to identify all 16 health warnings on the outside of not to look at the package to avoid
warnings that appear on packages. packages, and one of 16 this situation to the extent
Analyses must take into additional warnings on the inside possible. Third, measures of
account the consumption level of packages. In such cases, a knowledge can often be difficult to
when assessing knowledge of greater number of exposures will compare across labelling policies.
health warnings. Given the be required to recall various For example, smokers from the
inevitable link between heaviness aspects of the warnings. USA, where a total of four different
of smoking and viewing the There are several limitations text warnings appear on
warning labels, knowledge is likely with measures of knowledge. packages, have a much greater
302
Construct (a) Health Warnings Believability/Credibility
Measure Overall, do you believe the health warning message(s)? (Not at all, A little, A lot)
Source Health Canada Youth Smoking Survey

(http://www.hc-sc.gc.ca/hl-vs/pubs/tobac-tabac/yss-etj-2002/index-eng.php)
Variations Other alternatives refer to the accuracy, trustworthiness, credibility, believability and
true/false nature of the warnings or the importance of information (Cecil et al., 1996; Borland
& Hill, 1997a; Canadian Cancer Society, 2001; Hammond et al, 2004a; Brown et al., 2005;
Health Canada, 2005; OHegarty et al., 2006). Some surveys have also included more
comprehensive, but also more time consuming, scales involving numerous items.
Comments A useful, brief measure to examine credibility of message content. The measure can be
used to examine whether different design and content features change the believability of
information among smokers. This question can be asked of individual health messages,
such as in qualitative or experimental research, or to refer to a set of warnings, as is common
in population-based surveys. Note that responses to this item will also reflect denial, self-
exempting beliefs, etc.
Construct (b) Health Warnings Public Opinion/Support
Measure Do you approve of the health warnings on cigarette packages? (Yes, No)
Source Borland & Hill, 1997a
Variations Other alternatives include measures of agreement with the warnings and references to
appropriateness or desire for more information (Canadian Cancer Society, 2001; Hammond
et al., 2004a; Brown et al., 2005., Health Canada, 2005)
Comments This measure is a combination of previously administered questions and has yet to be
administered exactly as worded. Though measures of public support or approval may be
less important as a measure of effectiveness, they are a critical measure for regulators and
policy makers, and for demonstrating support for more comprehensive policies.
Table 5.34 Measures of Credibility and Public Support
likelihood of correctly identifying when Canada revised its labelling cases, neither the total number
all the messages than smokers in policy in 2000 to include pictures, nor the proportion of messages
the United Kingdom where 16 the number of individual mes- correctly identified, provide a
different text messages appear on sages doubled from eight to 16 suitable basis for comparing
packages. The same issue arises (not counting 16 additional policies given that the
in pre-post studies of a new messages that appeared on the denominator is different. More-
labelling policy. For example, inside of packages). In such over, it is both time consuming
303
Construct Health Warnings Thinking About Health Risks
Measure To what extent, if at all, do the warning labels make you think about the health risks of
smoking? (Not at all, A little, A lot)
Validity Good face validity; good convergent validity; associated with strength of policy.
Variations Similar questions ask about the extent to which warnings affect the level of concern
or worry about health risks.
Comments A key mediator of the effectiveness of health warnings. This should be considered among
the essential measures.
Table 5.35 Measures of Health Knowledge and Perceived Risk
Construct Emissions Information Comprehension
Measure If you were to look for a safer or less harmful cigarette, would you use information about the
amounts of chemicals listed on the cigarette packs to help you find a less harmful brand?
(Yes, Maybe, No)
Sources Gori, 1990; Health Canada, 2003
Variations Similar questions ask smokers to compare different tar levels of cigarettes in terms of
delivery and health risks.
Comments A critical measure to evaluate emission policies that include quantitative emission levels.
The question can also be used to refer to specific emissions, such as tar or nicotine. This
measure is essential in any survey that also asks about recall or awareness of emission
numbers on packages. The current wording can be used to refer both to descriptive (i.e.
text-based) and quantitative emission information.
Table 5.36 Measurement of Comprehension of Emissions Information
and awkward to prompt survey Krugman and Robinson presented visual information to be presented
respondents for 16 different participants with diagrams of to participants, must be ad-
warnings. various warnings in a recognition ministered either face-to-face or
Finally, some knowledge mea- task (Krugman et al., 1994; using web-based modalities.
sures may not work across all Robinson & Killen, 1997). Any
survey modalities. For example, such measures, which require
304
Construct (a) Light / Mild Descriptors Comparative Risk
Measure Light cigarettes are less harmful than regular cigarettes.

(Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly Disagree)
Source The ITC Project
Validity Good face validity; good convergent validity (Borland et al., 2004).
Variations This question can be adapted to refer to other descriptors, such as mild or smooth. In some
cases, the terms light and mild are used in the same question.
Alternatives ask smokers about differences in the tar or nicotine of light versus regular
cigarettes (Smokers of light cigarettes take in less tar than smokers of regular cigarettes).
These measures have been widely used, but require a basic familiarity with tar and nicotine,
which may not exist in all smokers in some jurisdictions (Kozlowski et al., 1998b; Shiffman
et al., 2001; Hamilton et al., 2004).
Other alternatives have asked smokers to report the number of light cigarettes that would
need to be smoked to equal the harm from 10 regular cigarettes; however, this approach
requires a level of numerical literacy beyond the capacity of smokers in many jurisdictions
(Kozlowski et al., 2000; Shiffman et al., 2001).
Comments: This is an essential construct, although there is no single gold standard question for its
measurement. The recommended measure has been selected because is it the most direct
and may be most appropriate for smokers in low- and middle-income countries.
Nevertheless, the question may need to be preceded by a general awareness questions
(e.g. Have you ever heard of light cigarettes?) in some markets or rural areas. There are
also issues with the interpretation of this measure in jurisdictions where light and mild
descriptors have been prohibited.
Construct (b) Light/Mild Descriptors Addiction
Measure Light cigarettes are less addictive than regular cigarettes.

(Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly Disagree)
Validity Good face validity; good convergent validity (Borland et al., 2004).
Variations This question can be adapted to refer to other descriptors, such as mild or smooth. In some
cases, the terms light and mild are used in the same question.
Comments A straightforward question with the same format and response options as above. A
recommended question to address perceptions of light and mild cigarettes, but not as
essential as the comparative risk question, above.
Table 5.37 Measures of Light, Mild, and Brand Descriptors
305
Construct Brand Appeal Health Warnings
Measure Do you think the new warnings make cigarettes packages look less attractive, more
attractive, or has it made no difference to their attractiveness? (Not at all, A little, A lot)
How often have you put your cigarette package away because you didnt want others to see
the warning on the package? Have you done this? (Never, Sometimes, Often)
Source Canadian Cancer Society, 2001
Variations Alternatives refer to quality of advertisements with and without warnings, whether youth
would want to use the product, intentions to purchase the product in the future, and a
measure of perceived economic values of brands (Hyland & Birrell, 1979; Brubaker & Mitby,
1990; Canadian Cancer Society, 2001; Willemsen et al., 2002; Thrasher et al., 2007).
Attractiveness scales have also been used (Loken & Howard-Pitney, 1988).
Comments These measures provide a straightforward evaluation of whether health warnings have
altered the general appeal of packaging. The second of the two measures has a higher
threshold and represents a more distal measure of appeal, which may also tap into social
norms. Both of the measures are recommended for surveys that wish to provide a
comprehensive evaluation of warnings, but are not essential.
Table 5.38 Measures of Brand Appeal
Constituents & emissions: nicotine numbers may be printed Strong emotional responses to
on the package, but few are able messages are also associated
A number of studies have to recall the tar or nicotine levels with greater behaviour change
examined whether smokers can printed on their usual brand of when supportive or efficacy
recall the emission information cigarettes. To our knowledge, no related information is also pre-
commonly printed on the side measures have been developed sented. To date, several studies
panel of cigarette packages to measure smokers knowledge have used measures of affective
(Table 5.31) (Chapman, 1986; of tobacco contents. reactions to assess the impact of
Cohen, 1996b; Health Canada, warnings labels (Environics Re-
2003; O'Connor et al., 2006c). search Group, 2000; Elliot &
These items typically ask Affective reactions to health Shanahan Research, 2002;
participants to name the emi- warnings: Environics Research Group, 2003;
ssions printed on packages using Hammond et al., 2004a; Health
unprompted recall tasks, or ask Research in the field of health Canada, 2006; Peters et al., 2007).
them to report the number communication indicates that These measures are common in
associated with a particular messages with emotionally qualitative evaluations of individual
emission (usually tar). The data arousing content are more likely to warning labels and have been
indicates that many smokers have be noticed and processed by particularly influential in develop-
a general awareness that tar and smokers (Witte & Allen, 2000). ment of picture-based warnings in
306
Construct (a) Changes in Foregoing Health Warnings
Measure In the last month, have the warning labels stopped you from having a cigarette when you
were about to smoke one? (Never, Once, A few times, Many times)
Sources Borland & Hill, 1997a; Hammond et al., 2007a
Validity Good face validity; convergent validity; associated with strength of policy.
Variations Similar measures have referred to not smoking when tempted.
Comments This question has a lower threshold than other measures that assess the behavioural
effects of health warnings.
Construct (b) Reductions in Smoking Health Warnings
Measure Are you smoking any less or more as a result of the new warnings, or are you still smoking
the same amount? (Less, Same amount, No difference)
Validity Good face validity; convergent validity; associated with strength of policy.
Variations Similar measures have referred to not smoking when tempted.
Comments The wording as a result of the warnings needs to be emphasized when asking this
question. This item is not intended to provide a precise measure of changes in consumption
as a result of the warnings; changes in consumption happen in response to a wide range of
related factors. However, this question does provide a good general measure of the extent
to which smokers have been affected by the warnings.
Construct (c) Likelihood/Motivations to Quit
Measure To what extent, if at all, do the warning labels on cigarette packs make you more likely to
quit smoking? (Not at all, A little, A lot)
Validity Good face validity; convergent validity.
Variations Alternatives refer to motivations to quit and thinking about quitting, with some differences
between response categories.
Comments The recommended wording refers directly to the likelihood of quitting smoking, which is
somewhat broader than motivation alone. In practice, however, there appears to be few
differences with regards to how these measures perform in practice given the consistency
of findings from similar samples. The question has the potential to provide a very good
summary measure of the self-reported impact of health warnings and should be considered
within the core set of items to evaluate labelling policy.
Table 5.39 Measures of Behavioural Outcomes
307
Construct (d) Quit Attempts & Abstinence
Measure To what extent, if at all, were the following reasons for your current quit attemptwarning
labels on cigarette packages? (Not at all, A little, A lot)
Validity Good face and convergent validity.
Variations Alternatives have also asked about the effect of the warnings on staying quit in the future.
This question can be asked as part of a list of reasons for quitting, which provides some
useful context on the relative influence of other potential influences on quitting.
Comments Retrospective measures, such as this, should be interpreted with caution given that they
are subject to recall biases, particularly as the time since the quit date increases. In addition,
smokers often cite a number of complementary reasons for quitting and endorsement of
this item does not mean that the quit attempt is solely attributable to health warnings.
Table 5.39 Measures of Behavioural Outcomes
several jurisdictions. Measures of manufacturers have been ac- communicating the threatening
negative emotions, including fear cused of marketing covers consequences of smoking there
and disgust, have also been used specifically intended to cover pic- would be no reason to avoid them.
in population-based surveys and ture-based warnings, prompting Furthermore, one study found that
shown to predict future cessation- calls for regulatory bans on the smokers who attempted to avoid
related behaviour (Table 5.32). sale of such covers (Table 5.33) the warnings were no less likely to
Overall, measures of emotion have (Wilson et al., 2006). see the warnings, think about
considerable promise as a proximal Although avoidance behaviours them, or engage in cessation
measure of effectiveness which may be undesirable to some behaviour at a 3-month follow-up
can be used in both qualitative and extent, these examples of fear (Hammond et al., 2004a).
quantitative research. control behaviour do not neces-
sarily reflect an adverse outcome Credibility & public support:
Avoidance: or inherent weakness of package
warnings. Research has demon- In order to be effective, the health
Warnings that result in unpleasant strated that avoidant behaviours information presented in warnings
emotions may lead some smokers and attempts at thought sup- must be credible. The credibility of
to avoid the warnings. Indeed, pression often have the opposite warnings relates not only to the
several studies indicate that a effect of increasing the presence health information contained in a
considerable portion of smokers of the unwanted thoughts warning, but also to its design and
make some attempt to avoid the (Wegner, 1994). In the context of source or attribution. Some have
warnings, including covering or the warning labels, avoidant even speculated that there may be
hiding the warnings, using another behaviour might be more rea- a trade-off between the vividness
case, or requesting different packs sonably interpreted as a measure of the information in health
to avoid particular warnings. In of effectiveness. Indeed, if the warnings and its credibility among
some jurisdictions, tobacco warnings were ineffective in smokers. In others words, if
308
pictures and text become too and Do you approve of the health lung cancer and heart disease, as
striking or graphic, smokers may warnings on cigarette packages?) well as health effects on
begin to question the accuracy of (Health Canada, 2001; Health nonsmokers, and lesser-known
the information and become more Canada, 2003). Public opinion health effects. Including lesser-
resistant to the messages. data may be particularly effective known health effects can be
Although some validated for policy makers in gauging particularly effective in attributing
scales have been used to political support for new or existing changes in knowledge to specific
evaluate the believability of health labelling polices (Table 5.34). labelling policies. Ideally, longi-
warnings (e.g. Beltramini, 1988; tudinal studies, assessing
Loken & Howard-Pitney, 1988; Health knowledge & perceived changes in health knowledge,
Cecil et al., 1996), many studies risk would also select the health
have used single questions with effects based upon the effects that
face validity (Borland & Hill, The primary objective of cigarette are targeted in the warnings. In
1997a; Canadian Cancer Society, warning labels is to communicate other words, studies should
2001; Hammond et al., 2004a; the health effects from smoking. include health effects that: a) are
Brown et al., 2005; Health Thus, measures of health know- already included on packages at
Canada, 2005; OHegarty et al., ledge and perceived risk baseline (before policy change)
2006; Peters et al., 2007). represent critical components in and will remain on packages at
Together, the findings suggest any evaluation of health warnings follow-up; b) health effects that are
that health warnings represent a (Table 5.35). To date, studies not on packages at baseline, but
credible source of information, have taken two main approaches will appear at follow-up; and c)
particularly when attributed to a to measuring the impact of health effects that are not on
well-respected department of warnings on health knowledge. packages at either baseline or
health, or a well-respected non- One approach is to ask par- follow-up. This type of design
governmental authority, such as a ticipants to self-report whether provides a measure of specificity
cancer society (Guttman & Peleg, health warnings have changed the with respect to changes in
2003; Health Canada, 2003; BRC extent or frequency with which labelling policies.
Marketing & Social Research, they think or worry about the A similar approach has been
2004). The levels of credibility do health effects of smoking. Alter- taken with respect to emission
not appear to be associated with natively, some studies have information. At least one study has
the type or design of warning assessed health knowledge examined whether knowledge of
labels; just like for text-based directly and examined changes the emissions in tobacco smoke is
warnings, smokers report high over time or across jurisdictions in higher in jurisdictions where they
levels of believability for graphic levels of knowledge. Given the are printed on the package
picture-based warnings as well. number of health effects caused (Hammond et al., 2006a). As with
Several studies have also by smoking, we are unaware of health effects, lists should include
sought to assess general mea- any study that has attempted to emissions that are, and are not,
sures of public support for health measure a complete list. How- printed on packages, in order to
warnings (Borland & Hill, 1997b; ever, studies typically measure examine the specificity of the effect.
Brown et al., 2005; Hammond et beliefs about a range of specific Overall, research conducted to
al., 2004a; OHegarty et al., 2006). health effects to determine date suggests that increases in
To our knowledge, two items have knowledge levels. Some studies the size, number, and content of
been developed to examine sup- have included bogus health warnings are associated with
port among smokers for emission effects in the list in order to identify greater thoughts about the health
labelling (Overall, do you believe response bias. Most lists include risks of smoking (Health Canada,
the health warning message(s)? major health effects, such as 2005; Hammond et al., 2007a).
309
More prominent warnings have meaning of the emission levels, ultra-light and regular brands
also been associated with although a substantial proportion using qualitative or descriptive
increased knowledge for specific associate health benefits with categories to describe exposure
health effects (Borland & lower numbers. This type of data levels and health risks. These
Hill,1997a; Hammond, 2006a). is critical to place measures of qualitative response categories
Most of these findings derive from knowledge into context; prominent have also been used to compare
population-based surveys, al- labelling that succeeds in in- perceived sensory properties and
though one study reported creasing knowledge of emission addiction levels of light/mild
significantly higher beliefs about levels is of little value if smokers cigarettes compared to regular
health effects following presen- do not understand the meaning of brands. At least one study com-
tation of graphic versus text these numbers. Indeed, the data bined items to create a sensory
warnings within an experimental appear to indicate that com- index and a health effects index
setting (OHegarty et al., 2006). municating quantitative emission (Shiffman et al., 2001). Overall,
levels promotes erroneous per- both qualitative and quantitative
Constituents & emissions: ceptions about exposure levels measures appear to yield similar
and health risks that can be findings, and indicate that a
A number of studies have sought expected from different products. substantial proportion of smokers
to examine the extent to which In general, this set of findings perceive health benefits from
smokers understand and interpret underscores the importance of cigarettes with light and mild
quantitative cigarette emission assessing more than basic recall descriptors (Table 5.37).
information (Table 5.36). These of information (Figure 5.30). At least one study, the Inter-
studies ask smokers to report national Tobacco Control Policy
either the meaning of the Light & mild descriptors: Evaluation Survey (the ITC Pro-
numbers, or the extent to which ject) (Borland et al., 2004), has
the numbers translate into dif- A variety of surveys have adopted an alternative approach
ferences in exposure from examined perceptions of light to comparative estimates. Rather
different brands (Gori, 1990; and mild brand descriptors than asking smokers to compare
Cohen, 1996a; Health Canada, (Kozlowski et al., 1998b; Kozlow- regular and light cigarettes,
2003; Thompson et al., 2006). ski et al., 2000; Ashley et al., 2001; participants were asked to
Other questions ask smokers to Shiffman et al., 2001; Etter et al., compare their usual brand with
predict the health consequences 2003c; Borland et al., 2004; regular cigarettes (e.g. Do you
of different tar levels, without Hamilton et al., 2004). Both think that the brand you usually
explicit reference to labelling poli- quantitative and descriptive mea- smoke, [current brand], might be a
cies (Gori, 1990; Cohen, 1996a). sures have been used to assess little less harmful, no different, or
Indeed, a number of studies on this the health consequences of a little more harmful, compared to
topic were conducted in the USA, smoking light/mild cigarettes. other cigarette brands?).
where there are no mandatory Several studies have asked Separate items were used to
requirements to print emission smokers how many light or ultra- collect the name, descriptors, and
levels on packages, they appear on light cigarettes would need to be relevant attributes of participants
packages less than 15% of the time, smoked to inhale the equivalent usual brand. This approach has
and are at the discretion of the level of tar as regular cigarettes. the benefit of personalizing the
manufacturer (Davis et al., 1990). Some of these measures used 10 question, and is particularly useful
Regardless of the jurisdiction cigarettes as a reference point, to implement following the
or the labelling policy, the findings whereas others were open-ended. removal of light and mild terms,
indicate that smokers have very Smokers have also been asked to at which point questions with
little or no understanding of the make comparisons between light/- direct reference to light and
310
POLICY
Emission information
Salience &
processing
Indirect effects
POLICY-SPECIFIC Industry Awareness of
MEDIATORS information
response
Knowledge of
information Moderators
Public education
about rationale and
meaning
Variant smoked
Beliefs about
GENERAL contents and
MEDIATORS emissions
General percieived risk

OUTCOMES
Perceptions of relative
risk between products
Quit intentions
Brand switching Smoking behaviour
Changes in
consumption
Quit attempt
Abstinence
Figure 5.30 Conceptual Framework for the Evaluation of Emissions and Contents Labelling Policies
311
mild cigarettes become awkward dictions that have banned light (Hyland & Birrell, 1979; Loken &
and confusing. The question also and mild, may wish to consider Howard-Pitney, 1988; Brubaker &
has a broader frame of reference. additional measures that examine Mitby, 1990; Hammond et al.,
This is an advantage in the sense the substitution of terms in their 2004b; Thrasher et al., 2007).
that it captures the effect of other place. Market-based research, Future research might also
potential misleading descriptors or such as cataloguing the infor- explore whether larger graphic
product elements. The dis- mation printed on packages, can health warnings undermine the
advantage is that information on provide objective data on the visual appeal of cigarette displays
the respondents own brand must substitution of terms which may be at retail outlets.
also be available (see Section helpful in interpreting self-reported
5.4), and there is less specificity brand data (see Section 5.4). Behavioural outcomes
with respect to the brand elements Largely, the selection of
that underlie differences in measures in this area may depend There are several approaches to
perceptions of risk. A similar upon the current state of policy predicting downstream cessa-
conceptual approach has recently more so than other areas (Figure tion-related outcomes from health
been taken with respect to 5.31). models. As with health effects,
evaluating print advertisements. some studies have used mea-
Rather than asking smokers to Brand appeal sures of processing and
compare the risks implied by the knowledge of the warnings, and
expressions light versus regu- Health warnings target psycho- modelled their effects on moti-
lar cigarettes, respondents were social variables other than vation to quit and patterns of
asked to rate the perceived risk to perceived risk and health know- smoking behaviour (see Section
their health derived from adver- ledge. More recent labelling 3.1 for measures of tobacco use
tisements for different products, policies include themes of addic- and Section 3.2 for psychosocial
and the ratings for advertisements tion, industry manipulation, outcomes). This has produced
of light versus regular ciga- aesthetic costs, financial costs, significant findings in longitudinal
rettes were compared (Hamilton and cessation beliefs, among studies to date (Hammond et al.,
et al., 2004). In most cases, others. A range of psychosocial 2003). However, this approach is
follow-up questions may be measures have been developed somewhat limited when it comes
necessary to identify which to assess each of these con- to evaluating changes in health
specific elements underlie per- structs, although these measures warnings. Unless both survey
ceptions of reduced harm. have rarely been used to evaluate waves are conducted when the
Descriptors other than light/- warning labels. same set of health warnings is on
mild are likely to receive One area that has been ex- the pack, the baseline measures
increased attention in the coming plored is the impact of health of processing or knowledge relate
years, particularly within juris- warnings on measures of brand to the old warnings, whereas any
dictions where light/mild terms appeal (Table 5.38). In theory, cessation-related activity at follow-
have already been prohibited. To replacing brand imagery with up presumably reflects the impact
our knowledge, only one study health warnings has the potential of the new warnings.
has developed measures to to change perceptions of the An alternate strategy that can
evaluate health perceptions based cigarettes and packaging. To also be used in cross-sectional
on other brand descriptors, date, the limited findings in this studies is to ask smokers to
including the words smooth and area appear to support this directly report the extent to which
ultra (Thompson et al., 2006). hypothesis, although it has yet to warnings have influenced their
Furthermore, studies with a focus be explored in much depth with motivation to quit and smoking
upon brand descriptors in juris- respect to warnings on packages behaviour (Borland & Hill, 1997a;
312
POLICY
Removal of
descriptors such as
Light and Mild
Incidental effects Salience &

POLICY-SPECIFIC processing
MEDIATORS Industry use of
alternative Awareness of
descriptors
descriptors
Moderators
Beliefs about Information provided

descriptors/brands by health groups
Addiction and government on
Health risks rationale for removal
Taste Brands smoked

Sensory properties
GENERAL
MEDIATORS
General perceived
risk
Perceptions of
relative risk between
products
Quit intentions
OUTCOMES
Smoking behaviour
Changes in consumption
Quit attempt Brand switching
Abstinence
Figure 5.31 Conceptual Framework for the Evaluation of Brand Descriptor Policies
313
Canadian Cancer Society, 2001; cluded in package health not possible with telephone based
Health Canada, 2005; Koval et al., warnings. Each of these studies surveys; and 2) focus groups are
2005; Willemsen, 2005; OHegarty reports significant increases in call well suited to open-ended ques-
et al., 2006). This approach does volumes (Willemsen et al., 2002; tions and allow for more in-depth
not have the same validity in terms Department of Health, 2006). discussion than structured sur-
of measuring actual changes in Finally, several items have veys. In many cases, focus groups
smoking behaviour, although it been created for use among are also used as a way to evaluate
can be used to examine changes former-smokers. Typically, these the effectiveness of health
across labelling policies. items ask about various reasons warnings on sub-groups, including
A third alternative is to examine for quitting, including whether the younger smokers and those from
changes in prevalence rates, or health warnings either motivated lower socio-economic groups. The
population-based cessation acti- them to quit or have helped them primary disadvantage of focus
vity, before and after the imple- to remain abstinent (Canadian groups is that the findings can be
mentation of new warnings. To our Cancer Society, 2001; Hammond hard to summarize in a systematic
knowledge, this approach has et al., 2004b; OHegarty et al., fashion, which complicates com-
been used in only one study to 2006; Thompson et al., 2006). parisons across groups and
date: Gospodinov & Irvine (2004) These measures are, however, settings. As a result, conventional
reported no discernable changes in subject to recall bias and should validity tests for quantitative data
prevalence rates, and a reduction be interpreted with particular can not be conducted with focus
of two cigarettes per week among caution (Table 5.39). group findings. Nevertheless,
smokers in the months following qualitative findings help to com-
the implementation of pictorial Formative research plement quantitative research in
health warnings in Canada. How- this area, and represent an
ever, as described earlier in this Formative research is often important step in the development
section, there are serious problems conducted to help identify the of new labelling policies.
in attributing changes in national content and design of new health Qualitative research has
level trends to changes in health warning policies. Regulators must examined many of the same
warnings, or any other individual decide what health effects to themes as population-based sur-
policy measure. Indeed, as communicate, how many, and veys, and other quantitative
Gospodinov & Irvine note, there how to present this information to methods. These include general
were significant changes in price smokers on the package. Al- knowledge of the warnings, such
over the same period of time, as though population-based surveys as the content and location, the
well as considerable sub-national may help to guide these decisions, emotional impact of warnings, as
tobacco control activity over the qualitative research is typically well as their general salience and
same time period. undertaken as part of the policy noticability (Environics Research
Yet another approach to mea- development process. Group, 2000; Elliot & Shanahan
suring the impact of warnings on The most common approach Research, 2002; CRATEC, 2003;
cessation behaviour has been to has been to conduct a series of BRC Marketing & Social Research,
look at changes in the use of focus groups (i.e. semi-structured 2004; Health Canada, 2006). In
cessation services as they relate interviews conducted within a many cases, these studies have
to information on warnings labels. group setting). Focus groups have presented different health warnings
Research conducted in the UK two important advantages over to participants in order to make
and the Netherlands has exa- population-based surveys: 1) direct comparisons between
mined changes in the usage of participants can be presented with labelling policies. These designs
national telephone helplines after visual stimuli, including examples have proven particularly effective at
the contact information was in- of health warnings in a way that is comparing the emotional reactions
314
elicited by picture versus text Alechnowicz & Chapman, 2004). Implications for study design &
warnings, for example (Environics However, to date, no com- analysis:
Research Group, 2000; Elliot & prehensive review of packaging
Shanahan Research, 2002; BRC issues related to labelling policies No single study research design is
Marketing & Social Research, has been undertaken. adequate to evaluate the impact of
2004). Focus groups have also labelling policies. Given the chal-
provided critical information Summary lenges inherent in evaluating
regarding the meaning and national level policies, individual
comprehension of the information Few of the measures used to studies are inevitably subject to a
communicated in labelling policies. evaluate warning label policies range of limitations. However,
For example, focus group have undergone formal psycho- when taken collectively, the range
measures developed, on behalf of metric analyses. Much of the of designs constitute a persuasive
Health Canada, have helped to literature in this area has been body of evidence demonstrating
demonstrate that, even though conducted on behalf of regulators, the effectiveness of compre-
most Canadian smokers are aware which may account for the lack of hensive health warnings. Quali-
of emission information on the side formal tests of validation more tative methods, including focus
of packages, very few understand common to academic research. In groups, are essential for informing
the actual meaning of the infor- addition, different studies have the early stages of design and
mation (Environics Research used different measures to assess generating new insights into
Group, 2003). Indeed, judging by the same construct. In many labelling policies. Experimental
the findings of the focus group, cases, measures differ in the research is best suited to drawing
most Canadian smokers are wording of questions and in the direct comparisons across
misusing the emission infor- time references used in mea- warnings and to isolating the
mation. Thus, carefully con- sures, such as noticing and effectiveness of individual design
structed focus group measures can awareness. This complicates and content features. For this
provide deeper, more com- comparisons across surveys and reason, experimental research
prehensive measures of meaning across labelling policies. However, provides the highest level of
that are difficult to ascertain most measures have high face internal validity. Alternatively,
through structured population- validity and several have shown population-based surveys have
based surveys. good predictive validity for down- the highest external validity and
stream outcomes, including may provide the most com-
Industry documents knowledge of health effects and prehensive measures of effec-
self-reported motivation to quit, tiveness given adequate designs.
Internal tobacco industry docu- and cessation behaviours. In External validity is particularly
ments represent a potentially rich addition, the consistency of the important in the case of warning
source of information about the findings across studies and survey labels, which operate over
effectiveness of tobacco control modalities suggests that the repeated exposures that are tied
policies. There are several infor- differences in the measures have to smoking behaviour. The pattern
mative reviews of industry only a modest effect on outcomes of exposure is the defining feature
activities and documents on proof interest. Nevertheless, virtually of product warnings and one that
duct labelling, including many all of the constructs would benefit is impossible to replicate in a
related to brand descriptors such from further developmental work, laboratory environment. As a
as light and mild (Slade, 1997; including the standardization of result, the central question of
Pollay, 2001; Pollay & Dewhirst, the wordings across surveys. whether labelling policies in-
2002; Wakefield et al., 2002; fluence beliefs, attitudes, and
Chapman & Carter, 2003; behavioural change can only be
315
assessed with population-based using descriptive, rather than and efficacy-related information.
surveys. The inferences that can quantitative means. Greater These measures may include
be made from these surveys are experimental and qualitative work survey based measures, as well
considerably enhanced within must also be undertaken to as indicators from other data
longitudinal and quasi-experi- explore how smokers interpret sources, such as usage rates from
mental designs, as discussed in and use this information, and to telephone quitlines or web-based
Section 2.1. compare different approaches services.
more systematically. These issues
Priorities for future work: are directly relevant to the ongoing Recommendations
debate regarding how to
As countries begin to implement communicate the risks of com- Comprehensive evaluations of
restrictions on misleading pac- bustible versus non-combustible health warning labels should
kaging elements, research must tobacco products. Historically, include recommended items from
begin to examine elements other emission information has been each of the key constructs (see
than light and mild brand des- used by smokers to evaluate the above). Population-based sur-
criptors. These include other relative risks of different products. veys, seeking a more limited
potentially misleading elements, As emission and content labelling evaluation of health warnings,
such as the use of colour-coding policies are developed for the full should include proximal measures
and package designs that falsely range of tobacco products, of noticing, along with inter-
convey differences in strength. To regulators will need to consider mediate measures of perceived
date, very limited work has been the delicate issue of what risk or health knowledge. Although
conducted outside the tobacco fundamental message they wish measures of general awareness
industry on these issues. There is to communicate to smokers. and knowledge of health warnings
an immediate need to develop Quantitative emission and content can be informative, these mea-
measures that can examine these information will inevitably be sures should be used with caution
issues within population-based interpreted as indicators of risks, for the purpose of comparing
samples, especially within juris- unlike descriptive information that labelling policies.
dictions where light and mild is uniform across products. Evaluations of brand des-
descriptors have already been In addition to developing new criptors, and other packaging
prohibited. survey measures, existing mea- elements, should represent a
A second priority for future sures must be administered more priority for tobacco control policy. In
research is to examine contents widely, as a greater number of addition to examining light and
and emission information more countries prepare to implement mild descriptors, research should
closely. Up to now, much of the the provisions within Article 11 of consider other potentially mis-
existing research has focussed the FCTC. In particular, few of the leading terms, as well as brand
upon awareness and under- measures reviewed in this section elements such as colour and
standing of ISO tar and nicotine have been assessed among package design. Unlike health
numbers. There is an urgent need smokers in low- and middle- warnings, these policies require the
for measures to evaluate new income countries. removal of information from the
approaches to communicating Finally, measures should be package and present challenges in
contents and emission infor- developed to examine the impact the wording of survey measures.
mation. Population-based studies of the cessation information that is There is an immediate need to
should be conducted within included in many labelling policies. develop measures that can
jurisdictions that have developed Cigarette packages are among address these issues as more
novel policies, such as com- the most prominent vehicles for countries implement recomm-
municating emission information disseminating cessation services endations under Article 11 to
316
prohibit misleading package ele- value. Rather, evaluations should Overall, the selection of mea-
ments. focus upon the meaning and use sures to evaluate tobacco labelling
Policies to communicate emis- of emission and content infor- policies will depend upon the
sions and content information via mation. Given the lack of research method and scope of the evalu-
packages, also present unique in this area, and the lack of ation, as well as the specific policy
evaluation challenges. Unlike consensus regarding the best context.
health warnings, measures of policy approach, there is a par-
salience and processing for this ticular need for formative research
type of information are of limited in this area.
317
5.6 Measures to assess the impact of

anti-tobacco public communication campaigns
Introduction what communication and evaluation guidance on measures to be used

strategies will be used. to demonstrate the effectiveness of
Public communication campaigns A comprehensive public com- the campaigns in achieving more
are used to improve awareness, munication campaign will include proximal outcomes associated with
knowledge, and understanding of multiple components and demand the WHO FCTC Article 12 directives
an issue, in an attempt to influence extensive resources, particularly for (WHO, 2003; Figure 5.32).
individual behaviour, build support media production and placement Selecting measures of effectiveness
for, and contribute to policy and (Atkin, 2001; Coffman, 2002; and demonstrating them are easiest
social change. Carefully monitoring Dorfman et al., 2002). These when a campaign is grounded in a
the implementation and outcomes components may include resources change theory that describes a
of campaigns is essential to for advertisement production and logical progression from activities to
ensuring their effectiveness and placement across a range of media; outcomes. Measures of effective-
demonstrating their contribution to a development and use of press ness then can be selected to
specific public health outcome. This materials and press events; coincide with specific expected
section summarizes the main com- advocacy activity to influence how outcomes, as described in Figures
ponents of individual behaviour messages are framed and 5.33 and 5.34. For example, a
change and public will campaigns, interpreted; and community action public communication campaign
briefly describes the theory and to make messages locally relevant, designed to increase support for
practice of public communication compelling, and supportive of and promote the enactment and
campaigns and their evaluation, and campaign goals. However, specific effective implementation of a
provides approaches for evaluating campaign components may be smoke-free air law might include:
each component to determine implemented independently and, 1. Television, radio, and print
impact, from planning and develop- depending on the desired out- advertising about the health
ment through implementation and comes, may be nearly as effective hazards associated with ex-
demonstrating results. Specific as a comprehensive campaign. posure to tobacco smoke, with
measures are identified for use as Depending on the aims of the measures of effectiveness
indicators of the achievement of campaign, and the resources and demonstrating that the target
proximal and intermediate out- opportunities of the local jurisdiction audience saw or heard and
comes of public communication (nation, province, state or com- understood the message and
campaigns. However, the key to munity), specific components or assimilated the information (i.e.,
measuring the impact of public combinations of components will be awareness, attitudes, beliefs, or
communication campaigns is arti- more relevant. This section provides knowledge increased or were
culating clearly at the outset what guidance on evaluation methods for reinforced).
the campaign is intended to use in planning and implementing a 2. Contacts with news, health,
accomplish, who the campaign is public communication campaign in community reporters, and edi-
intended to reach, what the order to increase the likelihood of torial staff to encourage news,
campaign is intended to cause, and success. It will also serve as editorial, and community interest
319
Each Party shall promote and strengthen public awareness of tobacco control issues, using all available communication
tools, as appropriate. Towards this end, each Party shall adopt and implement effective legislative, executive,
administrative or other measures to promote:
(a) broad access to effective and comprehensive educational and public awareness programmes on the health risks
including the addictive characteristics of tobacco consumption and exposure to tobacco smoke;
(b) public awareness about the health risks of tobacco consumption and exposure to tobacco smoke, and about the
benefits of the cessation of tobacco use and tobacco-free lifestyles as specified in Article 14.2;
(c) public access, in accordance with national law, to a wide range of information on the tobacco industry as relevant
to the objective of this Convention;
(d) effective and appropriate training or sensitization and awareness programmes on tobacco control addressed to
persons such as health workers, community workers, social workers, media professionals, educators, decision-
makers, administrators and other concerned persons;
(e) awareness and participation of public and private agencies and nongovernmental organizations not affiliated with
the tobacco industry in developing and implementing intersectoral programmes and strategies for tobacco control;
and
(f) public awareness of and access to information regarding the adverse health, economic, and environmental
consequences of tobacco production and consumption.
WHO (2003)
Figure 5.32 WHO FCTC Article 12: Education, communication, training and public awareness
stories about the dangers of smoke-free air policies or whether the campaign has
tobacco smoke and conveying adverse impacts of tobacco contributed to specific goals.
support for smoke-free poli- smoke exposure. Proximal out-
cies. Proximal outcomes might comes of these strategies Components of a public
be the news and special could include media coverage communicat ion campaign
interest stories and editorials of community events, opinion
that are printed or aired polling, intercept interviews, or Public communication campaigns
addressing the policy goals. other indicators of community tend to be divided into two types,
3. Media advocates might use attitudes, and meetings with or each emphasizing somewhat
similar public relations other engagement of local different strategies and outcomes:
strategies focused on media decision makers. individual behaviour change cam-
outlets in particular legislative Together, these coordinated ac- paigns, and public will or public
districts that are known to be tions, promulgating a clear and engagement campaigns (Coff-
accessed by influential lea- consistent message and demand man, 2002). Individual behaviour
ders. Outcomes might be for policy action, constitute a change campaigns seek to
documents from records of comprehensive public commu- change the types of behaviours
public comments by the nication campaign to advance the that lead to personal or social
targeted decision makers. public health as outlined in the problems or instill behaviours that
4. Community groups and mem- WHO FCTC; specifically, as will improve individual or social
bers may be organised to host directed in Article 12 (Figure 5.32). well-being (Coffman, 2002). Public
community education events, This section describes the use of will campaigns, on the other hand,
meet with political represen- public communication campaigns focus on motivating public officials
tatives, offer personal to advance these Article 12 to take policy action, which in turn
testimonials of the value of directives and measures of will motivate, support, or enhance
320
Measures to assess the impact of anti-tobacco public communication campaigns
health and healthy behaviours. below in the section). Measures of Public communication cam-
Public will campaigns are used to campaign effectiveness will center paigns include a variety of
legitimize or raise the impor- on what members of the target communication, and other stra-
tance of a social problem in the group will be aware of, know, and tegies, to educate the target
public eye as the motivation for do as a result of the com- population and disseminate infor-
policy action or change. (Coff- munication campaign that is mation in compelling and
man, 2002). Evaluation chal- different from what they were engaging ways to raise the level of
lenges, strategies, and measures aware of, knew, and did before the discomfort individuals have with a
are somewhat different for each campaign (National Cancer particular behaviour (e.g. tobacco
type of campaign. Ideally, gover- Institute, 2002), or that is different use). They also pressure decision
nmentled individual behaviour from what a comparable group is makers on specific issues for the
change campaigns will raise aware of, knows, and does related purpose of changing (or ad-
awareness, produce behavioural to topics addressed in the vancing) policies. Types of public
change, revise the social context campaign. communication include paid (or
within which behaviour occurs, Public will or engagement mass) media, public relations,
and produce new demands on the campaigns are used to build media advocacy, and community
government to further advance public demand (will) to address action implemented discreetly or
environmental shifts to reinforce a particular problem through policy in combination (Coffman, 2002;
and produce new behaviour and social action. Public will Dorfman et al., 2002). Thus, the
change. For example, a govern- campaigns focus on the publics public communication campaign
ment-sponsored campaign on the responsibility to create the components shown in Figure 5.33
health risks of tobacco use could supportive environment that will can be implemented and
lead to public demands for allow or promote a desired be- evaluated as a multi-component
government services to treat haviour change (Coffman 2002; intervention, with the interventions
tobacco dependence, and a new National Cancer Institute, 2005). and outcomes in each row
tax on tobacco products to pay for The key strategies of public will influencing outcomes in other
the services. The public will campaigns are media advocacy rows, or as discreet campaigns,
campaign for a higher tobacco tax, and public relation, with re- with outcomes following linearly
and dedicated use of the new inforcing and supporting com- from the specific intervention.
resources may be coordinated by munity action, including com-
nongovernmental organisations, munity organising and policy Paid media:
but may eventually lead to a advocacy. Public will campaigns
government-sponsored campaign seek to set the public agenda by Paid or mass media is often the
to increase access to tobacco influencing the media agenda most expensive component of a
dependence treatment. (and the way people and decision public communication campaign,
Individual behaviour change makers are exposed to and and yet may be the one that
campaigns (public education process issue information) reaches the greatest number of
campaigns) emphasize adver- through media advocacy. But the people. It can be effective in
tising and marketing as a main ultimate objective of policy or communicating a tightly controlled
strategy. Campaign planners and social change is achieved message, creating an image,
evaluators must have a clear because the public will campaign brand, theme, or call to action for
sense of what the campaign will prompts people to act, not by the overall campaign, and can
cause to happen, why it will adopting a particular health change attitudes, beliefs, and
happen, and who it will happen to, behaviour, but by supporting knowledge in the target popu-
based on some theory of (demanding) a particular policy lation. Paid media, also known as
behaviour change (described change. advertising, introduces an issue or
321
Public Proximal Outcomes Intermediate Outcomes Distal Outcomes Impacts

Communication
Campaign Awareness Attitudes and Action Behaviour Public Health
knowledge Impacts
Paid or mass Increased Changed/reinforced Calls to - Successful

media awareness among attitudes and quitline, quit quits;
target population: beliefs among attempts; - Initiation
general target population; home smoking averted;
population, increase policies; - Increased
smokers, youth, knowledge; response to compliance
decision makers: increased support call to action with policies
recall, receptivity, for policies
responsiveness
Increase Changed/reinforced Policy enactment:

Public awareness among attitudes and beliefs - increased availability of
relations target population: among target tobacco dependence Decreased
news media, population; treatment; morbidity
advocacy groups, Increased - higher prices for tobacco and
key opinion knowledge; products; mortality
leaders (business Policy discussions; - smoke-free laws; due to
Media leaders), decision increased decision - tobacco-free outdoor areas smoking and
advocacy makers maker support for - marketing restrictions tobacco use
policies and other - funding increases
actions.
Community Increase Engaged Voluntary Effective policy

Action awareness community policies adopted; implementation;
Community, among (local) members and Local policies High com-
health, social target population: leaders; enacted; pliance with
workers Community - increased Increased policies;
Media, groups, knowledge; interventions New demands
decision- community - increased provided (e.g., for policy/action
makers, opinion leaders support for smoking
administrators and decision policies cessation)
Educators, makers,
concerned community news
persons media
Figure 5.33 Flow diagram of public communication components and proximal and distal outcomes
322
Mass action
Paid media
Public relation
Media advocacy
Increase awareness among target Increase awareness among

polulation: target population:
news media, advocacy groups, key general population, smokers,
opinion leaders (business leaders), youth, decision makers:
decision makers recall receptivity,
responsiveness
Changed/reinforced attitudes and

beliefs among target population;
Changed/reinforced attitudes
increased knowledge; policy
and beliefs among target
discussions; increased decision
population; increase
Communicty action maker support for policies and other
knowledge increased support
More engaged and active actions
for policies
local communicties with an
interest in the issue
Societal policy enactment:

- increased availability of tobacco Calls to quitline, quit attempts;
dependence treatment; home smoking policies;
- higher prices for tobacco response to call to action
products;
- smoke-free laws;
- tobacco-free outdoor areas
- marketing restrictions
- funding increases Outcomes
- Successful quits;
- Initiation averted;
- Increased compliance
with policies
Figure 5.34 Conceptual framework for evaluation of anti-tobacco public communication campaigns
323
concept, delivers it to a large campaign messages through about (agenda setting), how
audience, and, if done effectively, others, specifically the news media, information is organised and
raises awareness, increases opinion leaders, and those who packaged for public consumption
knowledge, creates interest, may be perceived as having more (framing), and focuses the public on
engagement, concern, and stimu- credibility or objectivity than particular information at particular
lates conversation and action campaign sponsors or paid media times for use in decision making
(Centers for Disease Control and messages. Exposure obtained from (priming). Thus, public relations
Prevention, 2003). Paid media is public relations is earned strategies are key elements of
not a necessary part of a public coverage; earned because it is public communication campaigns
communication campaign. How- not paid for but obtained through and should be vigorously imple-
ever, if resources are available, it strategic advocacy efforts, in- mented as part of public
can dramatically expand the reach cluding working with news media engagement campaigns, in
of a campaign and reinforce and outlets, community leaders, policy particular, that seek policy or social
support the public relations and makers, and others with influence change (Wallack et al., 1993, 1999;
community action components. to disseminate key messages. Coffman, 2002). While public
Paid media also may be used as Public relations provides oppor- relations strategies are employed to
a media advocacy strategy, with tunities to reach the target audience set the public agenda and keep
key messages strategically placed through sources that appear more issues in the public eye, they are
in print, electronic, and other legitimate, and allows the provision often directed at specific policy
media, to reach influential decision of more detailed information than makers and become part of a
makers and opinion leaders, paid media, all while positioning the media advocacy strategy.
including policy makers. Mass campaign positively and potentially
media that is not paid for (e.g. influencing the policy debate Media advocacy:
media campaigns that rely on (Centers for Disease Control and
donated time and the use of public Prevention, 2003). Public relations Media advocacy is an effort to use
service announcements), can also provides the opportunity to the tools of mass media and public
serve the same function as paid localize national and international relations to reframe the public
media in an overall public news, events, and research debate, encourage a community
communication campaign, but is (Chapman & Dominello, 2001; to rethink its norms, and reach
unlikely to have the reach of paid Niederdeppe et al., 2007), and decision makers who have the
media or the target specificity; in bring to life local stories of personal power to transform the community
addition, placement most likely will tragedy (e.g. related to tobacco environment through the adoption
be outside the control of the use) that can stand on their own or of policies that enhance public
campaign. Depending on the be coordinated with and reinforce health (Wallack et al., 1993, 1999;
resources available, and the paid media messages. WHO, 2004). Media advocacy
specific targets of the campaign Public relations involves estab- differs from paid media in that its
message, paid media campaigns lishing relationships with members main target is comparatively small
can feature a variety of media of the press, and other influential (and could be only one individual),
channels including television, members of the community, and the goal is policy change that
radio, print, transit, billboards, developing supporting materials will promote, support, or reinforce
Internet, brochures, and others. including press releases and press individual behaviour change and
kits, and staging community events the public health agenda.
Public relations: and press conferences, among However, media advocacy can
other strategies. News and other use paid media as one strategy to
The goal of public relations is to media play a large role in accomplish advocacy objectives.
disseminate public communication determining what the public thinks In order to reach those individuals
324
with the power to make the policy increases the resources of, the enables campaign planners to
change, media advocacy efforts larger public communication explain why and how a campaign
can target highly organised and campaign, raising awareness, should work, thus assessing the
motivated individuals (or organi- engaging local news media, campaigns progress throughout
sations) who can pressure policy organising community events, the health communication process,
makers to make the desired disseminating information through not just at the end of the campaign
change. Media advocacy may local channels, and meeting with (Atkin, 2001; Coffman, 2002;
even target the general public in an (and advocating with) local of- National Cancer Institute, 2002;
effort to set the public agenda and ficials (Pierce et al., 1990; Bracht, Randolph & Viswanath, 2004).
reframe an issue. In this case, paid 2001). These community efforts Assessing progress enables
media is a tool of media advocacy; are often legitimized, reinforced, planners to improve the campaign
communicating a message to and supported by paid media. as it is developed and imple-
policy makers through engaged Where paid media may not be mented, before more resources
citizens as the target audience. possible, community action be- have been invested in a campaign
Mass media campaigns show- comes a crucial component of that may not succeed. Public
casing responsible tobacco public communication campaigns, communication campaigns that are
company behaviour are likely media often incorporating community grounded in theory are easier to
advocacy campaigns targeted at organising tactics to advance evaluate over the lifetime of the
politicians and voters in an effort to media and policy advocacy campaign (and easier to causally
recast the companys public image, objectives. Community action is link to outcomes), as planners are
earn the respect of the public, and both an extension of the public able to identify at the outset the
relieve public pressure on policy communication campaign to the more immediate or proximal
makers to take action that would local level, and a strategy in indicators of whether a campaign
constrain the industry. Just as paid support of key public com- is on track, as well as the longer-
media, targeted at specific groups munication campaign compo- term indicators of campaign
of individuals, may use a variety of nents. It can take the form of effectiveness. Change theories
messages that cajole, engage, community advocacy, public relevant to public communication
cause fear, or provoke anger in an relations, participation in govern- campaigns include: the theory of
effort to stimulate behaviour ment processes, decision maker reasoned action, social cognitive
change, media advocacy uses both education, leadership training, theory, the health belief model, the
positive and negative tactics to exert staged events (e.g. press events, trans-theoretical model (stages of
pressure on decision makers and media advocacy, and grassroots change), consumer information
provoke political action. mobilization), and community processing model, organisational
organisation to demand change change theory, community orga-
Community action: (Niederdeppe et al., 2007). nisation theory, and diffusion of
Community action also increases innovation theory (among others),
In the context of public com- the likelihood that the public each described briefly below. Rea-
munication campaigns, commu- communication campaign mes- ders are referred to Connell &
nity action engages the com- sages and results will endure long Kubisch (1998), Atkin (2001),
munity in defining a problem past the formal end of the Bracht (2001), Coffman (2002),
locally and taking community- campaign (Bracht, 2001). and the National Cancer Institute
specific steps to advance a (2002) for additional information,
behavioural, normative, or policy Theoretical underpinnings bibliographies, and primary
shift at the local level or in support sources.
of state or national goals. Grounding a campaign in one or The theory of reasoned action
Community action is linked to, and more theories of behaviour change postulates that attitudes and
325
norms create behavioural inten- behaviour when they feel are particularly helpful for evalu-
tions, which in turn cause susceptible or vulnerable as a ating campaign messages,
behavioural outcomes. A public result of a given behaviour, and materials, and delivery media
communication campaign may be believe that the costs of continuing during the planning phases and
designed to change or reinforce the behaviour outweigh the costs early implementation to ensure
specific attitudes and norms for of changing the behaviour. that messages are understood by
the purpose of causing behaviour The trans-theoretical model and resonate with the target
change. An evaluation of such a (Stages of Change) posits that audience.
campaign would assess rein- people proceed through (linearly The principles of community
forcement of or shifts in attitudes or cyclically) a readiness conti- organisation theory are based on
and norms, and would only expect nuum of behaviour change stages community empowerment and
behavioural change where atti- from pre-contemplation to main- capacity building. In order to be
tudes were or became consistent tenance of the behaviour change. successful and have a sustained
with the desired behaviour Public communication campaigns impact, public communication
change. If such attitudinal shifts based on this theory will identify campaigns must include partner-
failed to occur or were not the specific stages of the target ships with community members,
reinforced, the campaign would population and attempt to move organisations, and governments,
likely be revised. them to the next stage, will have and mobilize communities to
Social cognitive theory postu- different messages for audiences develop and implement strategies
lates that behaviour change in the different stages, or, in support of campaign goals.
results from motivation to change perhaps, will target people at one Evaluation of a campaign based
and the acquisition of skills and stage only. Evaluation outcome on this theory would include
abilities (self-efficacy) to change, measures will be determined by stakeholder interviews, measures
within a given environmental the purpose and target audience of community competence, moni-
context. A public communication of the campaign, and may be toring of community activities, and
campaign grounded in this theory limited to shifts along the readi- other community evaluation tech-
would try to attract the target ness to change continuum (e.g. niques.
audiences attention, convey a from happy to smoke to thinking Diffusion of innovation theory
compelling message, impart about quitting). describes how new norms, ideas,
specific skills, and provide The consumer information pro- products, and practices diffuse
motivation to undertake behaviour cessing model suggests that how through communities and become
change (preferably in conjunction much and what kind of information accepted or established in society.
with a reinforcing environmental people have and how they The theory focuses on charac-
change, such as a price increase process it, are determinants of teristics of the innovation, as well
on cigarettes, or the adoption of a whether people will use infor- as characteristics of the com-
smoke-free policy). An evaluation mation to inform and motivate munity, social networks, and
of such a campaign would assess behaviours or behaviour change. communication systems through
attitudes and knowledge (skills) in To increase the chances that which the innovation is spread.
the target population and desire to information will be used in Cigarette use is a primary
change the behaviour. In addition, decision-making, public commu- example of how a new product
a firm understanding of the nication campaigns must make catches on and diffuses through
environmental context would help information available, package it communities. Currently, smoke-
shape the development of the as innovative and useful, and free norms are being re-
campaign. ensure that it is accessible to (able established, with the diffusion
The health belief model to be processed by) the target explained by this and other
suggests that people change population. Tenets of this theory theoretical models.
326
Often, public communication models are being tested, more munication campaign component
campaigns are grounded in formal outcome studies may be at various levels of evaluation,
several theories in order to appropriate. Public communica- including establishing proximal
account for the complexities tion campaigns may be discreet outcomes.
involved in behavioural and social interventions with a beginning, an At the outset of a public
change enterprises. They may end, and a predictable sequence communication campaign, the
even adopt new theoretical of events in the middle. Often, problems and issues to be tackled
approaches as the campaign however, they are more accu- and the baseline situation will
proceeds, based on evaluation rately described as a messy have been established through
findings, which might revise their social process (Hornik, 2002), ongoing surveillance or, at the
understanding of the local (or diffused by multiple strategies, community level, a needs as-
audience-specific) change pro- through multiple channels, across sessment. The programmatic
cess, or provide new information individuals, communities, and evaluation typically is concep-
about population attitudes and institutions, with direct and indirect tualized and implemented in four
beliefs. effects and diffuse outcomes that stages (described below)
may reverberate long past the throughout the life span of the
Theory and practice of official end of the campaign intervention and beyond. For-
public communication (especially if policy change ob- mative evaluation begins as
campaign evaluation and jectives were achieved) (Freimuth campaign concepts are being
approaches to evaluating et al., 2001). As a result, developed and summative evalu-
each component evaluation resources are appro- ation focuses on the overall value
priately invested in ongoing of the campaign in terms of
In the context of the WHO FCTC, surveillance, point in time accomplishing its stated ob-
evaluation of public commu- monitoring, special studies to jectives. At the front end,
nication campaigns should assess identify opportunities for im- evaluation includes testing and
whether the campaign is meeting provement, confirm that progress verification of campaign concepts
its objectives as it is being is being made, identify mediational (formative) and careful moni-
planned, developed, and imple- and moderator effects (see toring of campaign activities and
mented in order to best ensure Section 3.2), and link interventions resources (process) to ensure
success, and demonstrate that the to specific milestones and the campaign is being developed
campaign has indeed achieved outcomes. Experimental designs and implemented appropriately,
the expected outcomes. Thus, and controlled trials often are not efficiently, and with some
evaluation resources should be possible or appropriate (Balch & likelihood of success (Atkin &
invested at the planning and Sutton, 1997; WHO, 1998b), but Freimuth, 2001). At the back end,
developmental stages to ensure instead a collection of information, outcome evaluation answers the
that specific interventions are existing data, and specific studies questions of whether the cam-
customized to the target popu- are needed to fully understand paign has achieved its short- and
lation and are culturally specific whether and how a campaign long-term objectives, and has
and appropriate. They should also worked. Tightly linking campaign value to the community in terms of
be invested over the life of the objectives to proximal outcomes advancing public health goals (a
campaign, and beyond, to assess can help demonstrate impact and, major focus of this volume). The
whether proximal and more in particular, can help rule out point is that evaluation should be
intermediate outcomes are being competing explanations for ob- well integrated into all phases of
met. Particularly where innovative served change. Table 5.40 lists the public communication cam-
or unproven strategies are being methods to assess the effec- paign, and this information should
implemented, or new theoretical tiveness of each public com- be well-utilized throughout the life
327

Communication Paid media Public relations and Media advocacy and Community action
Strategy Public service earned media government
announcements relations
Level of Evaluation
Ongoing Surveillance Structured analysis of data from existing surveillance systems
Formative
Do the messages, Focus group Key informant in- Who do you know? Community needs
materials, strategies discussions; depth interviews; inventory; key assessment;
work? Are they Internet panel document analysis informant in-depth community capacity
tailored to the studies; interviews analysis; strengths,
intended audience? Marketing surveys; weaknesses,
Document analysis opportunities, threats
(SWOT) analysis;
health risk profile
Process
Implementation Gross rating points News media News media framing Activity logs;
process: what and (GRPs)/Target rating tracking: count of analysis meeting minutes
how much was points (TRPs), which stories run; tobacco
done? Distribution, are available from control advocacy
effort expended, media buying firms groups cited; content
resources committed and media channels, analysis, slant.
provide indicators of Case study
reach, frequency,
exposure, and
impressions.
Proximal and
Intermediate
Outcomes
Knowledge, attitude, Population Special population Document analysis Community policy
policy, normative based/random digit surveys/key of legislative records. database: voluntary,
shifts dial (RDD) surveys informant interviews; Case study. statutory/regulatory;
(in-person, mail, Official records of Case study.
telephone, Internet) government policy
of knowledge, and NGO policy.
attitudes, beliefs,
behaviours; calls to
telephone help line;
web site visits,
measures of res-
ponses to specific
calls to action.
Distal Outcomes
Cigarette tax and sales records; behavioural risk factor and disease surveillance; disease
Behaviour change,
registries; vital records
disease rate change
Table 5.40 Methods to Assess the Effectiveness of Public Communication Campaigns by Campaign
Component and Level of Evaluation
328
cycle of the campaign, and baseline measures of attitudes, designed to achieve have actually
beyond, to make judgments about beliefs, and norms the public been met. As outlined in Figure
campaign progress, improve its communication campaign is 5.33, outcome evaluation
effectiveness, and inform deci- attempting to change. generally requires more resources
sions about its future (Patton, than formative or process evalu-
1997). Tables 5.41 and 5.42 list Process evaluation: ation, and, depending on the
indicators of the effectiveness of availability of financial and
each public communication com- Process evaluation is applied to scientific resources, may be
ponent and corresponding out- programme implementation and accomplished by special studies
comes by evaluation level. Each answers the question how well the or by accessing information from
level is described more fully campaign is being delivered to the routinely collected data sources.
below. intended audience. Process tools Outcomes of public commu-
measure effort and activity and nication campaigns vary from
Formative evaluation: help inform whether a campaign is cognitive shifts (proximal) through
being delivered as intended, and, social normative and behavioural
Formative research and evalu- if not, where the shortfalls are shifts (distal), including individual
ation identify the causal pathway occurring. Retrospectively, pro- knowledge, beliefs, awareness,
through which an intervention is cess evaluation can shed light on attitudes, self-efficacy, beha-
likely to work, and facilitates what went wrong, if a particular vioural intentions, behaviour
campaign improvement as it is campaign fails to meet its through environmental changes,
being developed and imple- objectives, and identify lessons on media frames, policy enactment,
mented. It does not speak to the how to make future campaigns and normative change (measured
campaigns value or impact, but more effective. Process evaluation policy enactment and compliance
identifies its strengths and involves monitoring resources, with policies).
weaknesses, and aspects of the activities, and inputs including Evaluation of more distal out-
campaign that are not working as materials produced and dis- comes assesses achievement of
planned or are not likely to tributed, news contacts made, public health goals, which almost
succeed (Mark et al., 2000). It can meetings held, and a variety of certainly do not result from public
provide information about key information related to the communication campaigns alone.
messages that are or are not placement of paid media. Process Impacts would include changes in
resonating, and the types of evaluation does not address the health behaviours (e.g. tobacco
individuals who are or are not achievement of campaign out- use), tobacco-related disease
responding to the campaign, comes or impacts, but can be rates (e.g. lung cancer incidence),
among other variables important used to link campaign activities to and, ultimately, rates of death due
to its success. Information from those outcomes by quantifying the to tobacco use. Outcome evalu-
formative evaluation is used by dose of the campaign over time ation can be the most rigorous,
campaign planners and staff to and in different communities. complex, and resource intensive
solve problems, address weak- level of evaluation, and should be
nesses, revise expectations, Outcome evaluation: considered carefully at the
revamp the campaign concepts programme (not the campaign)
and executions, or otherwise Evaluation strategies for proximal level. Public communication
improve conceptualization and outcomes are used by public campaigns, after all, constitute
implementation (Patton, 1997). communication campaign plan- only one component of the WHO
Evaluation and research, such as ners and evaluators to determine FCTC effort to transform society
marketing surveys, that inform the whether the shorter-term out- and reaffirm the right of all people
creative process, also serve as comes the campaign was to the highest standard of health.
329
Communication Paid or mass media Public relations and Media advocacy and Community action
Level of Evaluation
Formative How is the message What is the current Is the policy/ Strengths,
likely to make the information legislative environ- weaknesses,
Do the messages, audience feel? environment? ment hostile or opportunities,
materials, strategies What message is Will the message hospitable to the threats (SWOT)
change the
work? understood and will message? analysis results;
information
Are they tailored the audience take environment? What are the com- meetings with
to the intended away? What kind of news to peting priorities? community members
audience? What part of the make (how to frame Who are allies? and leaders;
message pleases, the message)? What are obstacles? formation of
annoys, angers, community advisory
scares the audience? group
Is the ad believable?
Does the message
speak to people like
me?
Is the message cul-
turally appropriate?
Is the message com-
pelling?
What is the appro-
priate channel for the
message?
What are the com-
peting messages?
Process Number of ads News media tracking: Indicators of decision Community meetings
running, placement, count of stories run; maker interest and held; coalitions
Implementation impressions, Gross tobacco control action from public formed; organi-
process: what and rating points advocacy groups hearings and official sations involved;
how much was (GRPs)/ Target cited; case study; meetings number of activities,
content analysis;
done? rating points (TRPs), trainings and events
framing analysis
Distribution, effort money spent, (point of view, planned/imple-
expended, location of out-of- accuracy, slant, mented;number of
resources committed home media, time agenda setting) people who
lines met participate;
resources invested in
outreach (money,
time, personnel);
number of materials
produced and
distributed
Table 5.41 Formative and Process Indicators of the Effectiveness of Public Communication Campaigns
by Campaign Component and Level of Evaluation
330
Communication Paid media Public relations and Media advocacy and Community action
Level of Evaluation
Short-term Confirmed aware- Did the issue get on Did the issue get on Voluntary policies
Outcomes ness (discrimination) the media agenda? the public agenda? adopted; health care
of media message; Was the issue Support for policies; policies to provide
Awareness, level of receptivity to framed according to legislative proposals tobacco dependence
knowledge, media message (e.g. the campaign submitted; legislative treatment; better
Attitude shifts talked to others objectives? bills introduced informed profes-
about it); support for Did the media sionals; improved
specific policy: coverage advance health care services;
increased availability the message? availability of cessa-
of tobacco depen- Public/decision tion support
dence treatment; maker support for
higher prices for specific policy
tobacco products;
smoke-free air laws;
marketing restric-
tions; funding
increases
Intermediate Number of respon- Policy enactment Policy enactment; Community laws and
Outcomes ses to call to action: amount of cigarette regulations enacted;
calls to quitline, or other taxes. community services
Knowledge, visits to web site, and programmes
attitude/policy shifts other); knowledge established
and attitude shifts:
reduced accep-
tability of smoking/
exposure to tobacco
smoke; increased
awareness of harm
from smoking/
tobacco smoke;
increased intentions
to quit; increased
knowledge of how to
quit
Distal Outcomes
Behaviour normative Per capital consumption of cigarettes; smoking prevalence, use of other tobacco products;
change, exposure to tobacco smoke; incidence of tobacco caused disease
disease rate change
Table 5.42 Outcome Indicators of the Effectiveness of Public Communication Campaigns by Campaign
Component and Level of Evaluation
331
If done well, they will most likely Internet surveys of the target effects occurred uniquely, tem-
contribute to population or target population, where outcome mea- porally, or to a greater extent in
group changes in, or reinfo- sures can be linked to awareness. the target population. This may be
rcement of, attitudes, knowledge, More distal outcomes, like actual achieved by identifying a
and beliefs that contribute to behaviour change, also are comparison community not re-
policy, environmental, and nor- typically measured by some kind ceiving the public communication
mative improvements that of survey of the target population. campaign. This could either be the
advance the public health. Similar survey tools and methods target population, prior to
are used to assess population implementation of the paid media
M easures to assess proxi- support for specific policy campaign (good), a similar
mal and distal outcomes initiatives. Depending on the community not receiving the
purpose of the campaign, other campaign at the same time as the
Of all the public communication measures of campaign effective- target population (better), or by
campaign components, evaluation ness may be appropriate. For varying the dose of the campaign
indicators are probably the most example, indicators of effective- across jurisdictions (Farrelly et al.,
highly developed, or as least the ness of a paid media campaign 2005b). In some cases, intercept
most familiar, for paid media. designed to promote telephone- surveys, or surveys of available
Indicators include results of focus based cessation services could members of the target population
group testing of media messages include the number of calls to a (convenience samples), will be
to ensure they speak to or helpline or number of calls among the only practical means of
resonate with the target those aware of the campaign. gleaning the potential impact of a
audience, convey the intended Paid media campaigns promoting campaign. Such surveys may be
message, and are likely to other calls to action (e.g. to visit a useful for obtaining anecdotal
provoke the desired attitude and web site, sign a petition, or send a information, identifying problems,
behaviour changes. Indicators of letter), would be similarly or fleshing out the details of
the campaigns reach into the evaluated by the number of findings from larger population
target population and the fre- individuals who respond by taking surveys, but generally are not
quency with which campaign the requested action. Systems considered to be robust indicators
messages were aired (usually would have to be established to of population level outcomes.
quantified as gross rating points compile and count these actions, Perhaps the most common
(GRP) or target rating points and may be as simple as indicators of effective public
(TRP) for television ads and monitoring hits to a web site relations result from news media
viewer impressions for print before and after a call to action, tracking. This is both a simple
media) are common process tallying the number of signatures count of news stories related to
measures. Reach also can be on a petition, or including postage the tobacco topic promoted by a
quantified by means of consumer paid (addressed) envelopes in a public relations effort (or a ratio of
surveys designed to elicit letter writing campaign, with the such stories to other health-
awareness of the campaign (i.e. postage charge providing infor- related stories), and a content
aided or unaided recall of specific mation on the number of letters analysis of those articles to
campaign ads, messages, and sent. determine characteristics such as
themes). Proximal measures of For process and outcome the message, accuracy, slant,
campaign effects, for example measures, in order to support a point of view, and prominence of
changes in awareness, attitudes, claim that changes in awareness, message, among others (Henry &
and knowledge about the issue attitudes, and behaviours result Gordon, 2001; Durrant et al.,
being promoted, can be obtained from the campaign itself, evalu- 2003; Clegg-Smith et al., 2005;
by in-person, mail, telephone, or ators need to demonstrate that the Neiderdeppe et al., 2007). It may
332
even include responses to the geographically limited topics change public policy (Wallack et
story, such as letters to the editor, might be possible, real., 1993). Indicators of media
news media-sponsored Internet searchers in the field of advocacy success include: mea-
polls, and whether the story was evaluation are still grappling sures of whether the campaign
picked up by other media with how to do so for wide- issue has become part of the
channels and outlets. Together scale public health inter- media agenda and is framed
these indicate intermediate ventions (National Cancer according to the public health
outcomes; demonstrating first that Institute, 2006). perspective (established through
the public relations efforts resulted content analysis of news media
in increased news media Process indicators become programming and print news
coverage, and second that the particularly important in making the articles), whether media support
coverage conveyed the infor- link, as well as understanding how the particular policy agenda (e.g.
mation and point of view promoted some strategies might be improved in newspaper editorials) and
by the public relations campaign. in the event that anticipated results whether their support is asso-
News media tracking efforts are not achieved. Anecdotes and ciated with policy maker support
typically are limited to print news personal statements may be (e.g. through key informant
media, which has been shown to particularly relevant to under- interviews), and whether that
be a marker of media coverage standing the influence of news particular agenda is advanced
overall (e.g. electronic media) stories on decision maker action. (e.g. in legislative debate, the
(National Cancer Institute, 2006). The longer-term goals of the introduction of legislative bills or
However, coverage of television WHO FCTC are to change the enactment of legislation).
media can be tracked as well, with individual behaviour as a result of Areas of exploration for formative
volunteers or paid viewers sys- modifications to the social, eco- and process evaluation of media
tematically viewing and cataloging nomic, and health environment, advocacy include: an assessment
television news coverage of which in turn result from of the messages connection with
specific issues for content and government intervention (WHO, people at the community level, the
characteristics. While counting 2003). These modifications medias understanding of the
news stories and describing provide the conditions within issue, how the issue can be
characteristics relevant to tobacco which people can be healthy framed to capture media and
control is straight-forward, con- (Institute of Medicine, 1988). The public attention and focus
necting them to specific implementation and success of attention on larger public health
programmatic outcomes may be these interventions are based in values (e.g. how the tobacco
more difficult, as noted by part on popular expectations and control issue can be framed to
evaluators of the American Stop demands. Media advocacy emphasize social accountability
Smoking Intervention Study: strategies put these policy change rather than personal responsibility
debates on the public and policy (Wallack & Dorfman, 2001)), how
The challenge in evaluation, maker agendas. By focusing relationships have been de-
however, is demonstrating media attention on specific public veloped with community advocacy
that news media coverage health issues (agenda setting), groups and the media, and a
does in fact influence the and focusing the debate to reflect quantification of the actions of
thinking, decisions, and the public health perspective these groups. Measures of
behaviour of the public and (framing), media advocates seek proximal outcomes associated
of policy makers. Although to influence the information the with media advocacy include:
determining such a cause- public uses to make decisions public support for specific policy
and-effect relationship for (priming), and reach opinion goals as measured by in-person,
some very focused and leaders and policy makers to mail, telephone or Internet
333
surveys, and political polling, and different time periods (near-term, longer-term outcomes are only
framing analysis to monitor and interim, long-term, or ultimate) poorly developed at this time.
assess news media reports of (Connell & Kubisch, 1998). Thus, Nonetheless, cataloging the input
specific policy initiatives and of the the measurement challenge is that supports community action
issue or problem the policy substantial. As with public (financial, in-kind, and personnel
initiative seeks to address. communication campaigns over- resources), quantifying activity
Standard methods include: key all, evaluation of community levels (number of meetings
informant and opinion leader initiatives is easier when an convened, contacts made, events
interviews, political polling, news explicit change theory is specified held), and documenting process
media tracking, and content at the outset from which to identify through case studies, can be
analysis. Since the key targets of specific indicators of the develop- helpful in discerning whether and
media advocacy are the policy ment and implementation of the how community actions contribute
makers (i.e. organisations or initiative and progress toward to public communication goals.
legislative bodies that have the anticipated short-, intermediate, Table 5.40 summarizes me-
power to make the policy change), and longer-term outcomes. Indi- thods to assess the effectiveness
indicators of success will be drawn cators should reflect the of public communication cam-
from official meeting minutes and processes through which activities paigns by campaign component
transcriptions, key opinion leader are developed and planned (com- (paid media, public relations,
interviews focusing on specific munity needs assessment, media advocacy, and linked
initiatives, and official records of meetings held, individuals pre- community action), and level of
policy enactment, as well as news sent, organisations involved), the evaluation (formative, process,
media reports. implementation of those activities outcome), as described in this
Public communication cam- (e.g. meetings with decision section. Not all jurisdictions will
paigns are most effective in makers, community forums, press have the resources to implement
changing community and social events), and proximal results of a multi-component public com-
norms, and building support for these activities (the adoption of munication campaign or field
and actually prompting the resolutions, community partici- population-based surveys to
enactment of public health policy, pation in events, news coverage, assess campaign outcomes. For
when they incorporate community improvements in awareness of such jurisdictions, the methods
action (Hopkins et al., 2001). problems and solutions, increase within each column may be used
However, what constitutes com- in community member knowledge discreetly for each level of
munity action, how community about the specific issue and evaluation within a particular
initiatives are described, quanti- support for specific action, component. It is not necessary to
fied, and measured, and what evidence of decision-maker sup- mount a population level survey in
change theories underlie their port), as well as longer-term order to demonstrate a population
development and success, have change (policy enactment or the level impact, but some population
been topics of ongoing debate achievement of a specific level data base (like emergency
(Connell & Kubisch, 1998; Bracht, objective, such as provision of room admissions for acute
2001; Connell et al., 2007). community cessation services or myocardial infarction, calls to a
Successful community action removal of pro-tobacco adver- quitline, or sales of cessation
involves change at many levels tising at a specific location) medication), with information
(individual, family, personal net- (Gambone, 1998). Methods for proximally related to the campaign
work, institutional, and com- describing, monitoring, and cap- result, is needed.
munity), including many domains turing the effects of community Tables 5.41 and 5.42 list
(economic, social, physical, and action, community interventions, formative and process indicators
community), and evolves over and measures of short- and and proximal and distal outcome
334
indicators, respectively, of the goals of the public communication questions that contribute to eff-
effectiveness of public commu- campaign. Examples of specific ective measures of intervention
nication campaigns, by campaign questions are provided below. outcomes. Also developed by the
component and level of A helpful source of indicators CDC's Office on Smoking and
evaluation. Evaluation indicators to measure outcomes associated Health, the online resource
of proximal campaign effects with public communication cam- categorizes more than 1700
should be specific to the individual paigns is the Centers for Disease tobacco-related questions from 13
campaign message and Control and Prevention (CDC) United States national and state
communication component. For manual, Key Outcome Indicators surveys that have been used
example, survey questions de- for Evaluating Comprehensive starting in 1990. The Question
signed to understand the target Tobacco Control Programmes Inventory on Tobacco resource
audiences awareness of, or (Starr et al., 2005). This user- provides easy-to-use search
reactions to, a set of commercials friendly, fairly comprehensive capabilities to locate survey
or advertisements describing the guide compiles and provides questions, including possible
health risks of exposure to information on 120 outcome answer formats, and identifies the
secondhand smoke, will be spe- indicators for use in evaluating the specific surveys in which the
cific to the content of the message short-, intermediate, and longer- questions have been used.
and the goals of the campaign term impacts of comprehensive The WHO FCTC Article 12
(e.g. to increase support for the tobacco use prevention and describes five topics about which
enactment of or compliance with a control programmes. Indicators the public should be made aware
smoke-free workplace law), and are organised according to three through public communication
will be different from survey programmatic areas (preventing tools: 1) health risks of tobacco
questions associated with a initiation, promoting cessation, consumption (including addiction),
campaign to promote cessation and eliminating exposure to 2) health risks of tobacco smoke,
among current smokers. In both tobacco smoke), and grounded in 3) benefits of quitting, 4) aspects
cases, campaign planners and evidence-based logic models. of the tobacco industry, and 5)
evaluators should test the Detailed information is provided adverse health, economic, and
messages with members of the for each indicator including indi- environmental consequences of
target audience, monitor cator definition, example data tobacco production (this topic is
implementation of the campaign, sources, specific measures (e.g. not addressed in this section). In
assess exposure to and under- question wording), and overall addition, Article 12 specifically
standing of the messages, quality of the indicator. Those addresses awareness of tobacco
determine attitudes, beliefs, and indicators useful for monitoring the issues among media pro-
knowledge related to the topic, outcomes of public commu- fessionals, decision makers,
before and after the campaign (or nication campaigns, specifically, community health and social
among those exposed and not are listed in Table 5.43. The guide workers, educators, and con-
exposed to the campaign), and is available online (in English) at cerned individuals. Various
assess changes (increases) in the http://www.cdc.gov/tobacco/Indica strategies can be used to achieve
likelihood of engaging in the tors/KeyIndicators.htm. public awareness, from traditional
particular campaign call to action The Question Inventory on paid media campaigns utilizing
(e.g. refrain from smoking in public Tobacco, formerly known as The television, radio and/or print
places, demand no smoking in Survey Questionnaire Design targeting the general population or
public places, think about quitting Resource (available online (in population subgroups (like
smoking, make a quit attempt). English) at http://apps.nccd.cdc. smokers or youth), to strategic,
The specific questions used will gov/QIT/), is another important targeted public relations and
be determined by the content and resource for identifying survey community action (or education)
335
Outcome Level Indicator Indicator description

Number
Short-term 1.6.1 Level of confirmed awareness of anti-tobacco media messages

1.6.2 Level of receptivity to anti-tobacco media messages
1.6.4 Level of support for policies
1.6.5 Level of support for increasing excise tax on tobacco products
Intermediate 1.10.1 Proportion of young people who think that smoking is cool and helps
them fit in
1.10.2 Proportion of young people who think that young people who smoke
have more friends
1.10.5 Proportion of young people who are susceptible never-smokers
1.12.1 Amount of tobacco product excise tax
3.11.1 Proportion of adult smokers who have made a quit attempt
3.11.2 Proportion of young smokers who have made a quit attempt
3.11.3 Proportion of adult and young smokers who have made a quit attempt
using proven cessation methods
Longer-term 2.7.1 Proportion of the population reporting exposure to secondhand smoke

in the workplace
2.7.2 Proportion of the population reporting exposure to secondhand smoke
in public places
2.7.3 Proportion of the population reporting exposure to secondhand smoke
at home or in vehicles
3.13.1 Proportion of smokers who have sustained abstinence from tobacco use
3.14.1 Smoking prevalence
3.14.2 Prevalence of tobacco use during pregnancy
3.14.3 Prevalence of postpartum tobacco use
3.14.4 Per capita consumption of tobacco products
From Starr et al. (2005; http://www.cdc.gov/tobacco/Indicators/KeyIndicators.htm)
Table 5.43 Example Indictors from Key Outcome Indicators for Evaluating Comprehensive Tobacco
Control Programmes Relevant to Monitoring the Effects of Public Communication Campaigns
campaigns targeting community topics included in Article 12 are lation level surveys, including
leaders, health care providers, described below. telephone surveys (care should be
business leaders, nongovern- Awareness of paid media taken with written surveys to
mental organisation directors, campaigns by the general ensure that responses are not
tribal leaders, and others. Specific population or specific targeted cued by response categories or
measures to ascertain population subgroups (e.g. smokers, youth) is other prompts). Awareness can be
level awareness and knowledge of generally ascertained by popu- ascertained by general questions
336
that require the participant to fill in developing the next campaign. In behaviours (e.g. perceptions of
details of the campaign, or of order to assess exposure to and risk, cooccurring disorders), are
specific ads, or by providing the awareness and salience of discussed in Section 3.1.
participant with some general messages to survey participants, Measures of effectiveness for
information about a campaign or measures need to be customized public relations, media advocacy,
ad in an effort to prompt or to the specific media campaign. and community action efforts are
facilitate recall (Table 5.44). Once exposure, awareness, less well developed and generally
Unaided recall is generally con- and salience are assessed and have not been collected and
sidered to be a superior method quantified, an analysis can be catalogued in the form of surveys,
for accurately estimating exposure undertaken as to whether those interviews, and question lists.
to and awareness of a campaign who were exposed to the Readers are referred to Tables
or message (Sly et al., 2001b), but campaign message were aware of 5.41 and 5.42 for listings of the
aided recall has been shown to be it or receptive to it in some way, types of information that should be
an effective measure as well are more likely to be aware of and collected in order to assess the
(Niederdeppe, 2005). Measures of understand the key messages of effectiveness of these efforts.
awareness are designed to the campaign, and whether this Additional information, resources,
determine exposure to a specific new awareness or knowledge is and how to instructions for
message or advertisement, so associated with specific proximal assessing the effects of public
that respondents can be outcomes (e.g. attitudes and relations and media advocacy
categorized according to exposure beliefs). Measures of awareness efforts, in particular, are available
level, and differences in attitudes and knowledge of specific from Radke (1998), National
and behaviours can be correlated campaign messages should be Cancer Institute (2002), Centers
to awareness. Some more general constructed to closely match for Disease Control and Pre-
measures of awareness are specific messages being delivered vention (2003) and the WHO
intended to ascertain the amount and the overall intent of the (2004), among others.
of anti-tobacco advertising to communication campaign. The
which subjects are exposed, in measures described in Table 5.45 Monitoring other communi-
order to make more general relate specifically to awareness cation campaigns
inferences about the relationship and knowledge of the topics
between anti-tobacco messaging described in Article 12. For Public communication campaigns
in general, and attitudes and campaigns that address other constitute an effort to control the
behaviours in general. Finally, topics (e.g. motivating tobacco information environment (Ran-
measures of the relevance or users to quit, issues related to dolph & Viswanath, 2004), to
salience of the media message to light and low tar cigarettes, make specific information
the individual provides key increasing support for specific available to the target population,
information on whether the policies), readers are referred to influence the public agenda, and
campaign is effectively commu- surveys and measures described frame the policy debate from a
nicating the message, the types of in this Handbook and elsewhere public health perspective, with the
individuals who are more likely to (National Cancer Institute, 2002; objective of changing behaviours,
respond to the message, and the Centers for Disease Control and norms, and policies to advance
utility of the campaign in Prevention, 2003; Starr et al., public health. However, public
contributing to programme goals. 2005). Measures of behaviours communication campaigns often
This information can be used to (e.g. quitting, uptake, abstinence) take place in a cluttered and
strengthen a poorly performing that a campaign may seek to competitive environment. They
campaign in progress or, at least, influence, as well as mediators are competing for attention with
provide useful information for and moderators of these other communication campaigns,
337
Construct (a) Awareness of Specific Anti-Tobacco Media Messages
Measure Have you recently seen an anti-smoking or anti-tobacco ad on TV that shows-- [brief
description of ad]? (Yes, Maybe, No)
What happens in this advertisement?
What do you think the main message of this ad was?
Source LMTS, 2003 (http://americanlegacy.org)
Validity Established validity (Sly et al., 2001b)
Variations Variations are possible in the amount of prompting provided to the respondent (e.g. Are
you aware of any advertising or campaign against smoking or about or against cigarette
companies that is now taking place? (Yes, No) from [source?])
What is the theme/slogan of this advertising or campaign?
Comments It may be necessary to assess overall TV viewing/radio listening patterns to understand

whether participants had the opportunity to be exposed to the media message.
Expected response categories should be pre-determined, but should not be read to the
respondent. Responses are categorized as accurately describing the ad (indicating
awareness) or not.
Construct (b) Awareness of General Anti-Tobacco Media Messages
Measure 1: Adult Now I would like you to think about advertising or information that talks about the dangers
of smoking, or encourages quitting. In the last 6 months - [since] - how often, if at all, have
you noticed such advertising or information? (Never, Rarely, Sometimes, Often, Very often)
Source The ITC Project, 2007
Variations The time period of interest, the medium specified, and the types of ads described can all vary
(e.g. During the past 7 days, how many commercials have you seen on TV about NOT
smoking cigarettes? (None, One, Two or three, Four to six, Seven or more), from Global
Adult Tobacco Survey (GATS, 2007).
In this question, one can substitute (or add) heard on the radio or seen on a billboard, as
appropriate, for seen on TV.
Comments The use of this general item is helpful to characterize level of exposure to the broad range
of state/provincial and national or other media-based anti-tobacco education campaigns.
Such questions may be particularly helpful for pre-campaign surveys to quantify the amount
of background anti-tobacco advertising to which the population is exposed.
Table 5.44 Measures to Assess Population Level Awareness and Knowledge of Public Communication
Campaign Paid or Mass Media Components
338
Measure 2: Youth During the past 30 days (one month), how many anti-smoking media messages (e.g.,
television, radio, billboards, posters, newspapers, magazines, movies) have you seen or
heard? (A lot, A few, None)
Source GYTS, 2007
Variations When you go to sports events, fairs, concerts, community events, or social gatherings, how
often do you see anti-smoking messages?
(I never go to sports events, fairs, concerts, community events, or social gatherings, A lot,
Sometimes, Never)
Comments The use of this general item is helpful to characterize level of exposure to the broad range
of state/provincial and national, or other media-based, anti-tobacco education campaigns.
Such questions may be particularly helpful for pre-campaign surveys to quantify the amount
of background anti-tobacco advertising to which the population is exposed. The variation
may be useful for assessing awareness of general anti-smoking messages in non-electronic
venues.
Measure 3: Locations In the last 6 months, have you noticed advertising or information that talks about the
dangers of smoking, or encourages quitting in any of the following places? (Yes, No)
READ OUT EACH STATEMENT
on television
on radio
at the cinema [US/Canada/AUS: at the movies]
on posters or billboards
in newspapers or magazines
on shop/store windows or inside shops/stores where you buy tobacco
on cigarette packs
leaflets
on the Internet
anywhere else? (specify)
Variations Locations listed should be relevant to the campaign and the jurisdiction and should vary, as
appropriate.
Comments Understanding where consumers are exposed to anti-tobacco media may help in planning
a public communication campaign, or may help identify specific ads or campaigns to which
consumers have been exposed.
339
Construct (c) Awareness of Smoking Related News Stories
Measure Now I want to ask you about the media more generally. First, thinking about news stories
relating to smoking or tobacco companies that might have been on TV, radio, or in the
newspapers. In the last 6 months, that is, since [6 month anchor], about how often, if at all,
have you seen or heard a news story about smoking? (Never, Rarely, Sometimes, Often,
Very often)
On balance, how did the news stories portray smoking? Were they All pro-smoking, Mostly
pro-smoking, Equally pro- and anti-smoking, Mostly anti-smoking, All anti-smoking?
Variations
Comments These questions can help assess the effects of public relations and media advocacy efforts,
when compared over time and referencing periods of campaign activity. Results should be
cross referenced with news media tracking to better understand how peoples perceptions
correspond to actual reporting.
Construct (d) Salience of the Anti-Tobacco Media Message
Measure 1: Adult This ad said something important to me. Would you say you (Strongly agree, Agree,
Disagree, Strongly disagree, Have no opinion, Dont know?
After seeing this ad, did you talk to anyone about not smoking? (Yes, Maybe, No)
Source Wakefield et al., 2003b
Validity Established validity.
Variations This question set focuses on not smoking. Depending on the content and purpose, other
topics could be inserted in place of not smoking.
Comments This type of question is used following the respondents description of a specific ad to gauge
whether the respondent found the ad to be salient to his or her situation, and whether the
ad prompted the respondent to think more about the topic.
Measure 2: Youth and On a scale from 1 to 5, where 1 means you dont like this ad at all and 5 means you like the
young adult ad very much, how much do you like this ad? (One, Two, Three, Four, Five)
Would you say the ad grabbed your attention? (Yes, No)
Did you talk to your friends about this ad? (Yes, No)
Source Legacy Media Tracking survey (LMTS; http://americanlegacy.org)
340
Validity Established validity. Thrasher et al., 2006b.
Variations Tell me how much you agree or disagree with the following statement: This ad is convincing.
Would you say you (Strongly agree, Agree, Disagree, Strongly disagree, Have no opinion,
Dont know?
Would you say the ad gave you good reasons not to smoke? (Yes, No)
Would you say the ad makes you question the motives of cigarette companies?
(Yes, No)
Did you talk to your friends about this ad? (Yes, No)
From the Legacy Media Tracking Survey
Comments The selection of appropriate questions for measuring salience depends on what the study
is most interested in understanding. Question sets, as opposed to individual questions, are
typically necessary to understand this construct. The examples provided here measure
slightly different issues: was the message noticed and did it create a buzz versus did the
message impart information that was integrated into the respondents thinking on the topic.
LMTS: Legacy Media Tracking Survey

ITC: International Tobacco Control Policy Evaluation Study
GATS: Global Adults Tobacco Survey
typically commercial advertising including paid media, public many of the same tools and
and marketing campaigns, and relations, media advocacy, and (to indicators as a public commu-
they are competing for salience, some extent) community action to nication campaign. However, key
relevance, and resonance with promote their products and steps, processes, and information
other efforts to promote beha- perspectives. Monitoring and will be unavailable to public
viours and norms and control the understanding the larger infor- communication campaign plan-
terms of the policy debate. The mation environment allows public ners and evaluators, such as the
success or failure, and the relative communication campaigns to exact target and objectives of the
impact, of a public communication adapt strategies to respond to or campaign. For example, the target
campaign will be dependent to reflect the realities of this may appear to be youth, but is
some degree on what is going on environment and better under- actually voting adults; it may
in the larger information environ- stand and document the chal- appear to be smokers, but is
ment. This is particularly important lenges and constraints that actually policy makers; it may
for public communication cam- threaten the success of a public appear to be concerned adults,
paigns focused on tobacco control communication effort. but is actually potential members
issues. Tobacco and phar- Tobacco and pharmaceutical of the jury. The objectives may
maceutical companies use the company communication cam- appear to be preventing youth
same communication strategies, paigns can be monitored with initiation or promoting adult
341
Construct: (a) Health Risks of Tobacco Consumption
Measure 1: Awareness To what extent, if at all, has smoking damaged your health? (Not at all, Just a little, A fair
Adults amount, A great deal)
How worried are you, if at all, that smoking will damage your health in the future?
To what extent, if at all, has smoking lowered your quality of life? How worried are you, if
T
at all, that smoking will lower your quality of life in the future?
Variations
Comments
Measure 2: Awareness Do you think cigarette smoking is harmful to your health? (Definitely not, Probably not,
Youth Probably yes, Definitely yes)
Source GYTS, 2007
Variations
Comments
Measure 3: Knowledge I am going to read you a list of health effects and diseases that may or may not be caused
Adults by smoking cigarettes. Based on what you know or believe, does smoking cause the
following (Yes, No to each question):
heart disease in smokers
stroke in smokers
impotence in male smokers
lung cancer in smokers
lung cancer in nonsmokers from secondhand smoke?
Variations As far as you know, are each of the following chemicals included in cigarette smoke? (Yes,
No)
cyanide
mercury
arsenic
carbon monoxide?
From the International Tobacco Control Policy Evaluation Survey
Campaign Messages
342
Comments Depending on the purpose of the campaign and the selected key messages, questions will
need to be modified to be relevant. As a baseline indicator, prior to campaign implementation
(or as general surveillance), these measures estimate population level knowledge of health
risks (but not perceptions of personal risk).
Measure 4: Knowledge It is safe to smoke for only a year or two, as long as you quit after that? Would you say you
Youth Strongly agree, Agree, Disagree, Strongly Disagree, No opinion?
Source Legacy Media Tracking Survey (LMTS, (http://americanlegacy.org)
Variations Do you think it is safe to smoke for only a year or two as long as you quit after that?
(Definitely not, Probably not, Probably yes, Definitely yes)
From the Global Youth Tobacco Survey

Comments
Measure 5: Addiction Do you consider yourself addicted to cigarettes? (Not at all, Yessomewhat addicted, Yes
Awareness Adults very addicted)
Sources The ITC Project, 2007
Variations
Comments
Measure 6: Addiction If you started smoking regularly, do you think you could stop smoking anytime you wanted?
Awareness Youth (Definitely yes, Probably yes, Probably not, Definitely not, No opinion)
Variations Once someone has started smoking, do you think it would be difficult to quit? (Definitely
not, Probably not, Probably yes, Definitely yes)
Source: Global Youth Tobacco Survey
Comments
Campaign Messages
343
Construct (b) Health Risks of Tobacco Smoke Exposure
Measure 1: Awareness Do you think that breathing smoke from other people's cigarettes is Very harmful to one's
Adults health, Somewhat harmful to one's health, Not very harmful to one's health, Not harmful at
all to one's health, Dont know/Not sure?
Source GATS, 2007
Validity
Variations
Comments The perception that environmental tobacco smoke (ETS) is harmful can be an important
factor for gauging public support for tobacco control efforts. This question also can be an
indicator of the effects of ETS education efforts.
Measure 2: Awareness Do you think the smoke from other peoples cigarettes is harmful to you? (Definitely not,
Youth Probably not, Probably yes, Definitely yes)
Source GYTS, 2007
Variations
Comments The perception that environmental tobacco smoke (ETS) is harmful can be an important
factor for gauging public support for tobacco control efforts. This question also can be an
indicator of the effects of ETS education efforts.
Measure 3: Knowledge Would you say that breathing smoke from other people's cigarettes causes (Yes, No to
Adults each question)
[RANDOMIZE ORDER]
Lung cancer in adults
Heart disease in adults
Colon cancer in adults
Respiratory problems in children
Sudden infant death syndrome?
Sources CDC Adult Tobacco Survey; 1987 National Health Interview Survey
(http://www.cdc.gov/nchs/nhis.htm)
Campaign Messages
344
Variations
Comments These items can gauge the level of public understanding of the health effects of tobacco
smoke on nonsmokers. Colon cancer is included in this series as an indicator for "over-
reporting" in order to estimate the possible magnitude of over-reporting.
Measure 4: Support for In the indoor dining area of restaurants

Policy Adults In indoor shopping malls
In public buildings
In bars and cocktail lounges
In day care centers
In indoor sporting events and concerts
do you think that smoking should be allowed in all areas, some areas, or not allowed at
all?
Source GATS, 2007
Variations
Comments Programmatic focus and activities, the goals of the communication campaign, and the local
jurisdiction will determine which environments need to be included in the survey and whether
additional environments are added. Such questions provide information on attitudes towards
restrictions on exposure to secondhand smoke; a measure of social norms.
Measure 5: Support for Are you in favour of banning smoking in public places (such as restaurants, buses,
Policy Youth streetcars, trains, in schools, on playgrounds, in gyms and sports arenas, discos)? (Yes,
No)
Source GYTS, 2007
Variations
Comments
Construct: (c) Benefits of Quitting
Measure 1: Adults How much do you think you would benefit from health and other gains if you were to quit
smoking permanently in the next 6 months? (Not at all, Slightly, Moderately, Very much,
Extremely)

Campaign Messages
345
Variations If a person has smoked a pack of cigarettes a day for more than 20 years, there is little
health benefit to quitting smoking.
(Strongly agree, Agree, Disagree, Strongly disagree, Dont know/Not sure)
Used by CDC Adult Tobacco Survey; COMMIT evaluation
Comments Recognition of the health benefits of cessation may be an important determinant of quit
attempts, and an early indicator of the effects of health education efforts.
Measure 2: What was the main reason you decided to stop smoking? (SELECT ONE RESPONSE
Youth ONLY)
a. I have never smoked cigarettes
b. I have not stopped smoking
c. To improve my health
d. To save money
e. Because my family does not like it
f. Because my friends dont like it
g. Other
Source GYTS, 2007
Variations
Comments Recognition of the health benefits of cessation may be an important determinant of quit
attempts, and an early indicator of the effects of health education efforts.
Measure 3: Are you aware of assistance that might be available to help you quit smoking, such as
Awareness of telephone quitlines, local health clinic services, and? (Yes, No)
Specific Resources
Source GATS, 2007
Variations In the last month, that is, since [date], have you noticed any advertisements for stop-
smoking medications? (Yes, No)
Used by the International Tobacco Control Policy Evaluation Survey
Comments The ? refers to (and should be replaced by) locally specific help promoted in the specific
communication campaign. Awareness of smoking cessation resources increases the
likelihood that smokers will make quit attempts. Information on the reach of interventions
enables states to assess and improve the delivery of available resources.
Campaign Messages
346
Construct (d) Tobacco Industry Awareness and Knowledge
Measure 1: Adults I am going to read you some statements about tobacco companies. Please tell me if you
strongly agree, agree, neither agree nor disagree, disagree or strongly disagree with each
of the following statements:
Tobacco companies should be allowed to advertise and promote cigarettes as they please.
Tobacco products should be more tightly regulated.
Tobacco companies can be trusted to tell the truth about the dangers of their products.
Tobacco companies should take responsibility for the harm caused by smoking.
Tobacco companies have tried to convince the public that there is little or no health risk
from secondhand smoke.
The government should do more to tackle the harm done by smoking.
The government doesnt really care about people smoking because it makes so much
money from tobacco taxes.
Variations
Comments Recommended for use as single items when space is limited:

Tobacco companies can be trusted to tell the truth about the dangers of their products.
Tobacco companies have tried to convince the public that there is little or no health risk
from secondhand smoke.
Measure 2: Youth People have different views about the issue of smoking and cigarette companies. How
much do you agree or disagree with the each of the following (strongly agree, agree,
disagree, strongly disagree):
(RANDOMIZE ORDER)
Cigarette companies should have the same right to sell cigarettes as other companies
have to sell their products. Would you say you strongly agree, agree, disagree or
strongly disagree?
Cigarette companies lie.
Cigarette companies deny that cigarettes cause cancer and other harmful diseases.
Cigarette companies deny that cigarettes are addictive.
Cigarette companies have done some really bad things.
Cigarette companies try to cover-up all the bad things they have done.
I would not work for a cigarette company
The people who run cigarette companies know what they are doing is wrong
No other companies act as badly as cigarette companies.
I would like to see cigarette companies go out of business.
Cigarette companies target teens to replace smokers who die
Cigarette companies get too much blame for young people smoking.
Anti-smoking advertisements are no more honest than cigarette ads.
Cigarette companies should have the same right to make money as any other type of
company.
The government should let companies sell whatever they want.
Cigarette companies try to get young people to start smoking
Cigarette companies target minority groups.
347
Validity Established validity. Hersey et al., 2005; Thrasher & Jackson, 2006.
Variations
Comments A five item scale measuring perceptions of the tobacco industry, based on Cigarette companies
lie, Cigarette companies try to get young people to start smoking, I would like to see cigarette
companies go out of business, I would not work for a cigarette company, and a fifth item
How much do you like cigarette companies? (5 point scale: I like them a lot [1] to I dont like
them at all [5]) showed small but significant improvement following the introduction of anti-
tobacco industry media campaigns in selected US states (Hersey et al., 2005).
LMTS: Legacy Media Tracking Survey ; ITC: International Tobacco Control Policy Evaluation Study; GATS: Global Adults Tobacco
Survey; GYTS: Global Youth Tobacco Survey; COMMIT: The Community Intervention Trial for Smoking Cessation
Campaign Messages
cessation, but the actual objec- pharmaceutical ads promoting communication campaign planners
tives are to cast the company in a proven cessation strategies. While and evaluators may include
sympathetic light, change adult tobacco and pharmaceutical com- indicators of awareness of and
opinions about the culpability of panies have vastly greater receptivity to tobacco and phar-
the company in promoting tobacco resources to invest in marketing maceutical company advertising
use, and reinforce policy maker and communication, frequently on the same population surveys
opinions about the company as public health programmes and used to monitor campaign
socially responsible. Pharma- governmental and nongovern- indicators (Farrelly et al., 2002,
ceutical company campaigns may mental organisations have access 2003b), as well as attitudes
be more transparent than tobacco to channels that are off limits to toward, salience of and per-
company campaigns; that is, tobacco companies (e.g. tele- ceptions, beliefs and behaviours
pharmaceutical campaigns that vision and radio). Public associated with exposure to the
appear to promote the use of a communication campaign plan- tobacco or pharmaceutical com-
particular cessation medication ners should avoid direct pany campaign. Reach and
may be attempting to do exactly competition with tobacco com- frequency of these campaigns
that. Public communication cam- panies, and instead utilize tools may be gleaned, imperfectly, by
paign planners may want to and strategies that give public identifying print advertising and
respond directly to tobacco campaigns the advantage (e.g. calculating impressions, and
company campaigns by coun- electronic media not available to monitoring the airwaves for the
tering or exposing the main tobacco companies and com- appearance of ads and calculating
purpose of tobacco company munity action that exposes the exposure based on observations
messaging in their own public human face of the tobacco of placement. Tobacco and
communication campaigns, and tragedy). pharmaceutical company public
may want to build on, reinforce, or To monitor the larger relations and media advocacy
avoid direct competition with information environment, public efforts may be monitored through
348
the same news media tracking evaluating public communication and tobacco-related behaviour
systems and content analysis campaigns. These multicom- change. The measures described
undertaken to monitor imple- ponent interventions seek to here, like the campaigns them-
mentation and outcomes of the improve awareness and know- selves, need to be customized to
public communication campaign ledge of tobacco-related issues the specific content, purpose, and
(National Cancer Institute, 2005, with the intention of promoting message of the communication
2006). While exact quantification individual behaviour change and effort being implemented.
of tobacco and pharmaceutical support for and progress toward Regardless of the results of the
company campaigns may be policy and social change. The public communication campaign
unnecessary (or impossible) to purpose of evaluating these (and particularly if it failed to show
obtain, a realistic understanding of campaigns is to inform the results), evaluations should be
the content and purpose of these development of effective cam- made publicly available. A system
competing messages is essential paigns, to identify and correct to collect and document campaign
to crafting a meaningful and problems while the campaign is in results would enhance our
relevant public communication process, and document the public understanding both of how public
campaign that will be effective in a health impact of the campaign. communication campaigns work
cluttered and contentious infor- Core methods include testing and how to make them better.
mation environment. campaign messages during the
design phase, monitoring the
Summary and recommenda- reach of the campaign during
tions implementation, and assessing
core constructs, including aware-
This section provides a framework ness, knowledge, attitudes,
for developing, implementing, and beliefs, and support for policies
349

tobacco cessation interventions
The importance of encouraging nicotine dependent (see Section has been recognized to be highly
smokers to quit completely is 3.3) will need support in order to be addictive (US Department of Health
reflected in the actions outlined in able to stop successfully; that and Human Services, 1988; Royal
Article 14 of the WHO FCTC (Figure support is the main subject of this College of Physicians, 2000).
5.35), and has also been section. Tobacco dependence and with-
recognized by the World Bank as In many countries, even though drawal syndrome are classified as
necessary in order to reduce the majority of smokers want to stop substance use disorders under the
tobacco related deaths in the next smoking and many try to do so, they WHO International Classification of
half-century (Jha & Chaloupka, have difficulty succeeding. For Diseases (WHO, 1992), and
1999). Tobacco control inter- example, in the UK, where there is a nicotine dependence and nicotine
ventions described here, and long established tobacco control withdrawal are classified similarly by
elsewhere in this Handbook, are movement, the natural population the American Psychiatric Asso-
expected to motivate smokers to cessation rate is only about 1-2% ciations Diagnostic and Statistical
make quit attempts. However, some per year. Smoking is a chronically Manual (American Psychiatric
smokers, especially those who are relapsing condition and tobacco use Association, 1995).
1. Each Party shall develop and disseminate appropriate, comprehensive and integrated guidelines based on scientific
evidence and best practices, taking into account national circumstances and priorities, and shall take effective measures
to promote cessation of tobacco use and adequate treatment for tobacco dependence.
2. Towards this end, each Party shall endeavour to:
(a) design and implement effective programmes aimed at promoting the cessation of tobacco use, in such locations
as educational institutions, health care facilities, workplaces and sporting environments;
(b) include diagnosis and treatment of tobacco dependence and counselling services on cessation of tobacco use in
national health and education programmes, plans and strategies, with the participation of health workers, community
workers and social workers as appropriate;
(c) establish in health care facilities and rehabilitation centres programmes for diagnosing, counselling, preventing
and treating tobacco dependence; and
(d) collaborate with other Parties to facilitate accessibility and affordability for treatment of tobacco dependence
including pharmaceutical products pursuant to Article 22. Such products and their constituents may include medicines,
products used to administer medicines and diagnostics when appropriate.
WHO (2003)
Figure 5.35 WHO FCTC Article 14: Demand reduction measures concerning tobacco dependence and cessation
351
Support for tobacco users brief advice and counseling, However, cessation interventions
trying to quit is incorporated in the intensive support, and admin- are also targeted at sub-groups of
range of tobacco control stra- istration of pharmaceuticals, that the adult population, such as
tegies, and complements the contribute to reducing or over- pregnant smokers or smokers in
other approaches described in this coming tobacco dependence in disadvantaged groups. Adole-
Handbook. Implementing some of individuals and in the population scent smokers may also be the
the interventions described in this as a whole. target of cessation interventions.
section will need significant In many countries, tobacco Target group considerations are
investments of time and money. It cessation interventions are not important and should be taken into
may be more appropriate for a widely available or integrated into account when developing proto-
country at an early stage of healthcare systems. The availa- cols and carrying out research
tackling the tobacco problem to bility and accessibility of phar- (Chesterman et al., 2005).
focus on the strategies described macological medications for smo-
in other sections (such as taxation king cessation also varies from Policy
and smoke-free policies), which country to country (Jha & Chalou-
will be less costly to implement. pka, 1999). Tobacco dependence Figure 5.37 sets out various
Strategies, such as smoke-free cessation interventions, in most cessation policies, including the
policies, also help to normalize countries, are often not as infrastructure thought necessary
non-smoking thereby providing an available as treatment for other to implement cessation policies
environment which motivates addictions, such as illicit drugs and and interventions (e.g. evidence-
tobacco users to make attempts to alcohol, suggesting that the based guidelines for tobacco
quit. Nevertheless, some of the addictive nature of tobacco use cessation policies and inter-
less intensive strategies described has not been adequately ventions). Some countries have
in this section can be promoted recognized and addressed. adopted these as a first step
and implemented with ease. For This section provides protocols towards implementing cessation
countries which have imple- for measuring the existence and policies. Guidelines have been
mented a comprehensive tobacco effectiveness of different forms of developed and implemented, inter
control strategy, the interventions tobacco cessation interventions alia, in the USA, Europe, UK,
described here become even based on measures outlined in Canada, Australia, and New
more important. Article 14 of the WHO FCTC Zealand (Fiore et al., 1996, 2000;
In this section we refer to (Figure 5.35), and following a Raw et al, 1998, 2002; West et al,
support for smokers when trying to proposed conceptual framework 2000; US Department of Health
stop as tobacco cessation for the evaluation of tobacco and Human Services, 2008). In
interventions. Tobacco cessation cessation policies and inter- addition, Figure 5.37 lists the type
interventions are sometimes ventions (Figure 5.36). Since of interventions that a country may
referred to as treatment inter- Article 14 only provides a deliver. Evidence-based cessation
ventions, and for the purpose of minimum standard, this section interventions range from less
this section, these terms will be builds on the measures advo- intensive interventions that can be
used synonymously. Our definition cated. It is the view of this working delivered on a large scale, such as
of tobacco cessation interventions group that cessation interventions brief, opportunistic advice by
originates from Raw and and policies should be evidence- healthcare professionals, to more
colleagues (2002), who defined based. intensive interventions delivered
treatment interventions as in- This section mainly focuses on to smokers either individually or in
cluding (singly or in com- interventions aimed at adult groups by a trained healthcare
bination) behavioural and pharma- smokers, as most of the research professional. Government smoke-
cological interventions such as has been carried out on them. free policies are also relevant to
352
Measures to assess the effectiveness of tobacco cessation interventions
POLICY
Availability of each tobacco

cessation policy/intervention
(Annex 1 and supplementary
measures)
Policy-specific Mediator
Awareness (see Table 5.46)
Incidental Effects Moderators

SES
Beliefs in importance Dependence
General Mediator-1
of quitting Gender
Attitude of health care Beliefs on efficacy and costs of Other tobacco control
system to tobacco treatments (see Table 5.47) policies, (e.g. taxation,
Attitudes towards cessation smoke-free, ad ban, etc)
control
policies (Table 5.47)
Self-efficacy (3.2)
Intention
Benefits of quitting
Perception of health risks
General Mediator-2
Use of cessation interventions

(Table 5.48)
Outcomes
Quit attempt (3.1)

Quit success (3.1)
Figure 5.36 Conceptual framework for the evaluation of tobacco cessation policies and interventions
Numbers in parentheses indicate sections in the volume covering the argument
353
Government policies & infrastructure on tobacco cessation
o Availability & implementation of national evidence-based cessation guidelines

o Existence of a smoking cessation coalition or partnership
o Training for smoking cessation
o Advertising/marketing of cessation interventions (e.g. helpline from government, nongovernmental or
private (pharmaceutical) sources)
o Development of a formal research programme for tobacco cessation
o National quitline number advertised on packs/adverts
o Reimbursement or level of funding or subsidy, for smoking cessation treatments including pharma-
cological interventions and mechanisms to provide this, eg through workplaces
o Availability of tobacco cessation interventions:
Brief opportunistic advice being delivered routinely by doctors
A telephone helpline (preferably freephone) for smokers & promotion of it
Smoking cessation treatment services
Stop smoking medications over the counter, prescription, give aways, approval of new medications,
marketing rules
Quit and win contests
No smoking days
Mass media quit campaigns (see Section 5.6)
New technologies such as internet smoking cessation support and automated email messaging
Intensive cessation services delivered face to face either individually or in groups, consisting
of behavioural interventions with pharmacological support
Figure 5.37 Government tobacco cessation policies and infrastructure for tobacco cessation
this section, but are covered in Efficacy of cessation interven- When evaluating population
Section 5.2. tions effectiveness and impact of
Figure 5.37 does not give an cessation interventions, the two
exhaustive list of the types of A summary of the efficacy of most key factors to be considered are
cessation policies or interventions of the interventions listed in Figure reach and efficacy (effect size).
that countries can offer, but 5.37 can be found in 11 languages Generally, interventions which are
outlines the relevant ones that a on the Treatobacco website low intensity are more likely to
country is likely to adopt to satisfy (http://www.treatobacco.net). A reach a greater number of
Article 14 of the WHO FCTC, most few of the policies and types of smokers within a population than
of which have proven effec- infrastructure have not been high intensity interventions, but
tiveness. Early studies of the evaluated, but as they are listed in will have smaller efficacy.
newer technologies, such as text Article 14 and are believed to be Conversely, more intensive inter-
messaging on on-line smoking necessary to implement smoking ventions are more effective and
cessation support, are promising. cessation interventions, they are will provide a greater degree of
retained in this section. contact between the smoker and
354
the provider than low intensity In some countries, and with Control Scale to measure country
interventions, but will not reach as some types of intervention (i.e. activity and included measures for
many people and, therefore, may high reach, low efficacy), bio- assessing treatment. In this scale,
not have a measurable population chemical validation of quit rates at treatment is given a maximum of
impact. However, these more six and twelve months post- 10 points (out of a maximum of
intensive interventions are impor- treatment may be cost-prohibitive 100 points given for all tobacco
tant, for example, to highly with low compliance. We suggest control measures), with a maxi-
dependent smokers who are likely as a minimum, data be collected mum of two points being allocated
to need more intensive support to on point prevalence at the end of for a quitline, six points maximum
stop smoking successfully. treatment and six months later, for a national network of
Though more intensive inter- with a random sample (if not all) of specialized smoking cessation
ventions are expected to incur a self-reported quitters being bio- experts or units offering individual
higher financial cost, their greater chemically validated (see Section or group support delivered by
efficacy still makes them more 3.2). properly trained professionals,
cost effective compared with other and a maximum of two points for
healthcare interventions (McNeill Assess ing the existence and reimbursement of medications.
et al., 2005). extent of implementation of The Framework Convention
When appraising evidence of tobacco cessation policies in a Alliance (2007) has documented
efficacy, it is important to know how country the availability of treatment with a
abstinence has been measured. In number of questions about gover-
2003, the Society of Research on A simple questionnaire adminis- nment policy, clinical guidelines,
Nicotine and Tobacco (SRNT) tered to policy makers, com- promotion of cessation treat-
convened a series of workgroups in missioners, or auditors will enable ments, and the availability of
order to provide guidance on assessment of the availability of individual interventions, as well as
measures used in clinical trials of cessation policies, guidelines, accessibility of medication in
treatments for smoking cessation interventions, and training within a participating countries.
(SRNT Subcommittee on Bio- country. Several tools have been There is no easy way of
chemical Verification, 2002; developed to do this. A WHO validating the responses to ques-
Hughes et al., 2003, 2004b). The Assessment Tool covers the tionnaires seeking cessation
papers emanating from these availability of cessation services services information. Ideally more
groups provide gold standards to for tobacco dependence under than one policy maker/ regu-
which those working in the smoking five domains: infrastructure, lator/programme manager should
cessation field should aspire. support for treatment, intervention be required to complete the
These include the use of bio- and treatment, healthcare questionnaire and supporting
chemical samples to validate providers, and healthcare users evidence sought via docu-
self-reports of abstinence, such as (Anderson, 2006). [In February mentation. A recent review of the
expired-air carbon monoxide (CO) 2008, WHO published the Report array of availability of cessation
or cotinine level (a metabolite of on the Global Tobacco Epidemic, interventions within England may
nicotine) at various stages of follow- available online at http://www. also be helpful in determining the
up, with the optimum being six who.int/tobacco/mpower/en/, which type of information that should be
months or longer. The rate of outlines help offered to quit collected (McNeill et al., 2005).
relapse after six months has been tobacco use by country in the Cost data will be needed to
estimated enabling some asses- world conveniently summarized in measure cost-effectiveness of
sment of quitting permanently from continent-specific spreadsheets]. cessation policies. For each
those followed-up for six months. Joossens and Raw (2006) re- cessation policy or intervention,
cently developed a new Tobacco the costs both to the provider and
355
the smoker utilizing it should be qualitative research, such as the following a television or radio
assessed. Together with an use of observational techniques to advertisement). Smokers con-
assessment of the likely benefits, an better understand the context tacting the helpline can then be
estimate of cost-efficacy can then within which brief interventions are given support either in the form of
be made (Godfrey et al., 2005). given, if they are given at all, and self-help materials, brief or
Supplementary measures will why the advice may not be having intensive counseling, or they can
be needed to assess the imple- the impact that is desired (e.g. if it be directed to other sources of
mentation of specific smoking is too brief ) (Coleman et al., information or support. The help-
cessation interventions, in order to 2004). It can also be useful to line may also be used proactively
understand data on smokers assess doctors views of referring and involve multiple call-backs
usage and perception of these smokers for further support offering further support. If the
interventions. Examples of the (McEwen et al., 2005). helpline is used in conjunction with
types of data that can be collected To be able to advise smokers media campaigns, the evaluation
for some common cessation to quit, healthcare professionals of the helpline would need to be
interventions follow. need to keep up-to-date records of assessed alongside the evaluation
the smoking status of all patients, of the media campaign. In this
Supplementary measures needed and be aware of more intensive case, the outcome measures for
to assess availability of specific support that is available to which the helpline evaluation should
cessation interventions: smokers can be referred as directly link to its intended purpose
appropriate. Auditing notes about in relation to the mass media. For
a) Brief opportunistic advice by patients can help assess whether example, if the purpose is to direct
healthcare professionals smoking status and interventions smokers where to go for further
(such as advice to quit, pre- help, assessing whether infor-
The key measure of interest is scriptions, referrals) are being mation on effective treatments
whether smokers recall receiving recorded in a systematic and was given out (and subsequently
advice to quit smoking from consistent way, and can assess used), is very different from an
healthcare professionals, and the availability of reminder assessment of effectiveness if the
whether they report acting on this systems for healthcare pro- purpose is to deliver a smoking
advice (see below). However, it fessionals to intervene on cessation intervention (Centers for
can also be useful to supplement smoking matters (Anderson & Disease Control and Prevention,
such data with an assessment of Jane-Llopis, 2004). 2004).
the proportion of healthcare Alternatively, the purpose of
professionals who report offering b) Telephone helplines the helpline may be to target
smoking cessation advice, as specific groups, such as pregnant
some smokers may not recall For countries running telephone smokers. Basic demographic and
receiving advice, or deny receiving stop smoking helplines, moni- tobacco use data (see below) are
it. Surveys of healthcare pro- toring is needed to answer useful for assessing the ability and
fessionals often demonstrate questions about their purpose, success of the helpline in reaching
higher levels of reported inter- target audiences, reach, cost, and its stated target groups. As some
vening than is suggested in effectiveness. The different pur- target groups are difficult to reach,
surveys of smokers, which may poses that telephone helplines progress can be compared be-
suggest that healthcare pro- can serve need to be identified tween a newly set-up helpline and
fessionals overestimate their (Centers for Disease Control and one that is well-established and
frequency of discussing inter- Prevention, 2004). The most strives to reach similar target
ventions. Interpretation of these common is to act as a first port-of- groups (Centers for Disease
findings can be facilitated by call for smokers seeking help (e.g. Control and Prevention, 2004).
356
Collecting data consistently panies. The limitations of using out with healthcare professionals
across different helplines will aid commercial sales databases are dedicated to giving specialist
in such comparisons. discussed in Section 3.5. Sales smoking cessation advice and
The CDC (2004) also reco- data from pharmacies might also support. Such surveys were
mmends collecting process be available. Sales data can be recently conducted as part of the
evaluation data, for example, call evaluated to assess the impact of national evaluation of smoking
volumes, how many callers get changes in policies or accessibility cessation services in England
different types of service, how (West et al., 2005). Government (Bauld et al., 2005; Coleman et al.,
many callers get through to a live data can also be sought on 2005; Pound et al., 2005). These
counselor, etc. Understanding medication subsidies or prescrip- surveys enable an assessment of
how the service is utilized and tion script receipts. the perceived barriers to giving
factors affecting the callers choice adequate advice and support to
of service will help make sense of d) No Smoking Days smokers.
effectiveness and cost data.
Knowing how callers heard about In addition to cost and target Policy specific mediators
the helpline will be important to be group, message type and media (proximal measures)
able to assess which channels of penetration can also be monitored
advertising are most cost-effec- for No Smoking Days. Smokers need to be aware of the
tive. Caller satisfaction is also availability of cessation inter-
useful to assess (e.g. are callers e) Quit and Win contests ventions before they can access
getting the service they were them. Questions can therefore be
expecting? do they receive the Similar process indicators to those asked about awareness of support
materials they were told they referred to above, for No Smoking that is available to help smokers
would? how long did they wait to Days, can also be monitored here. quit and whether they are aware
speak to a counselor?). Caller that they can get financial support
satisfaction can also be assessed f) Intensive cessation services for treatment or free cessation
by asking open ended questions treatment (see Tables 5.46a and
of a random sample of callers. It would be helpful to know how 5.46b).
many services exist in a particular Consumer surveys with smo-
c) Stop smoking medications country and any monitoring data kers and recent ex-smokers
that is routinely collected. A (usually defined as smokers who
It is worthwhile trying to obtain comprehensive evaluation of a have stopped within the last year)
sales data for stop smoking national network of smoking can assess awareness for
medications in countries. Often cessation services was recently different types of smoking ces-
these data will need to be carried out in England (Raw et al., sation policies and interventions. It
obtained from market research 2005). This study included an may also be important to ask how
companies (e.g. aggregate sales evaluation of monitoring data consumers hear about different
data on pharmaceuticals; com- collected by the services to types of interventions to help
panies which collect aggregate evaluate short- and long-term assess the most appropriate
sales data on pharmaceutical outcomes (Ferguson et al., 2005; communication routes to profile
sales, such as IMS Global Judge et al., 2005). Guidance these interventions. If appropriate,
Services, AC Nielson, and IRI). exists on the monitoring data most it might also be useful to examine
Alternatively, the pharmaceutical useful to capture on a routine basis these results by target group (e.g.
manufacturers might be able to (McNeill et al., 2005; West, 2005b). pregnant women). It is also
get permission to share sales data In addition, surveys (qualitative possible, although more resource
from the market research com- and quantitative) can be carried intensive, to carry out separate
357
Construct (a) Awareness of Tobacco Cessation Interventions
Measure 1 Are you aware of assistance that might be available to help you quit smoking, such as
telephone quitlines, local health clinic services? (Yes, No, Dont know)
Source US Adult Tobacco Use Survey from CDC (Starr et al., 2005)
Validity Unknown - face validity.
Variation Could be expanded to include a comprehensive array of culturally and country-specific

tobacco cessation interventions.
Comments Researchers might want to include a follow-up question to assess which sources of
cessation services individuals are aware of (e.g. If Yes, what is available to help you quit?).
Construct (b) Awareness of Tobacco Cessation Intervention Reimbursement
Measure 1 Does any of your health insurance cover treatment to quit smoking cigarettes or to stop
using other tobacco products? (Yes, No)
Source American Smoking and Health Survey from CDC (Starr et al.,2005)
Variation Could be expanded to assess awareness of the specific types of cessation interventions
covered (e.g. counseling, medication), rather than coverage in general.
Comments Should be adapted to other countries where treatment might be financed by sources other
than insurance. This measure isnt relevant to individuals who do not have insurance.
Construct (c) Awareness of Tobacco Cessation Intervention Medications
Measure 1 Have you heard about medications to help people stop smoking, such as nicotine
replacement therapies like nicotine gum or the patch, or pills such as Zyban? (Yes, No)
Variation Include whatever medications are relevant for the country being surveyed.
Comments Probably do not want to ask in some countries where awareness is ubiquitous.
Measure 2 In the last month have you noticed any advertisements for stop-smoking medications?
(Yes, No)
Table 5.46 Population-Level Survey Measures of Awareness of Cessation Interventions, Reimbursement,

Medications, and No Smoking Days
358
Variation This could be expanded to include advertisements for other tobacco cessation interventions.
Time reference should be specific to the policy implementation time-line.
Comments Could be adapted for different tobacco cessation interventions.
Construct (d) Awareness of No Smoking Days
Measure 1 Some months ago, there was an organized day about smoking. Do you remember what it
was called? (Yes, No)
Source Owen & Youdan, 2006
Variation Adapt or tailor according to how the day is referred to in a country.
Comments
Measure 2 No Smoking Day was held on [date]. Do you remember it? (Yes, No)
Variation Adapt or tailor according to how the day is referred to in a country.
Validity Unknown face validity.
Comments
The ITC project: The International Tobacco Control Policy Evaluation Survey
Table 5.46 Population-Level Survey Measures of Awareness of Cessation Interventions, Reimbursement,

Medications, and No Smoking Days
surveys for smokers and ex- tional No Smoking Days). which professional groups are
smokers for each individual Countries at an early stage of the being targeted to offer assistance
intervention allowing for more com- tobacco epidemic may consider within a country.
prehensive data to be assessed. asking smokers and recent ex-
Examples of questions that smokers whether they are aware General mediators (intermedi-
can be used in surveys of healthcare professionals can offer ate measures)
smokers and recent ex-smokers advice or support to stop smoking.
to assess awareness of specific It might be appropriate to separate It can be important to measure
smoking cessation interventions questions asking about advice smokers attitudes towards go-
are shown in Tables 5.46c and from doctors from questions about vernment cessation policies and
5.46d (in this case smoking advice from other healthcare interventions. Such questions can
cessation medications and na- professionals, depending on shed light on whether tobacco
359
users perceive their tobacco use might help them to stop (Siahpush which can be adapted to test use
as an addiction, in a similar way to et al., 2006). of interventions either over a time
other addictions, and whether they Specific questions can be period or during a recent quit
therefore believe it is appropriate asked about individual cessation attempt is given in Table 5.48a.
for governments to be offering interventions that smokers are As well as generic questions,
support in stopping. aware of, and for each one their smokers and recent ex-smokers
Questions assessing the pro- beliefs about usefulness and per- can also be asked further details
portion of smokers who believe ceived efficacy. Table 5.47d about specific cessation inter-
that specified cessation methods shows such a question for No ventions such as how they were
will help them to quit, can be useful Smoking Days. accessed or how they were used.
for assessing whether smokers are Some examples of these are
distinguishing between unproven General mediators (distal covered in the sections below.
and proven methods and recog- measures) Questions can also be asked
nize the importance of seeking about correct use or compliance
help with quit attempts. Beliefs A general question can be asked as well as any perceived impact.
about whether cessation support to assess which cessation
should be free to smokers also interventions, if any, smokers and a). Advice by healthcare pro-
reflects whether smokers believe ex-smokers used when trying to fessionals
that getting help can increase the stop tobacco use recently. The
likelihood of their quit attempt being time interval period over which Surveys of smokers (and recent
successful or whether really only smokers/ex-smokers should be ex-smokers) can assess whether
willpower is needed. Examples of asked to recall interventions they have visited healthcare
these types of questions are given needs consideration. Smokers professionals, whether they recall
in Table 5.47a. have been shown to forget quit being asked about their smoking
Questions can also be asked attempts, particularly shorter ones and their motivation to quit, and
about barriers to seeking help with (West, 2006), so if the period is whether they recall receiving
stopping. Table 5.47b gives an too long this is likely to result in advice to quit or support from
example of a question assessing increased forgetting. However, healthcare professionals and how
perceived barriers to using having a period which is too short they acted on the advice (see
smoking cessation medications. will increase the likelihood of Table 5.48b). They can also be
Measuring beliefs about the missing some events of interest. asked whether there were any
role of nicotine (Table 5.47c) will An alternative way of asking follow-ups offered or arranged by
also help to elucidate whether questions about intervention use their healthcare professionals.
smokers understand that they are is to link a quit attempt (e.g. the
or might be dependent on most recent quit attempt) with the b). Stop smoking helplines
nicotine. Such questions will help support used, rather than asking
to identify whether they are what methods have been used Evaluating a quitline can involve
distinguishing between habit and over a time period. This makes it taking a random sample of callers
addiction, which will also help to easier to ascertain which methods and following them up to see how
understand their responses to most likely contributed to quit many quit after a period of time,
questions on seeking help in attempts and success, but will for example six months (Centers
stopping. Questions about beliefs miss some attempts to quit. for Disease Control and
on nicotine will also help clarify Probably a combination of the Prevention, 2004). Though this
their understanding of how different types of questions is method is relatively straight-
nicotine replacement medications needed. An example of a question forward to carry out, it cannot
360
Construct (a) Beliefs About the Benefits of Tobacco Cessation Interventions
Measure 1 Which of the following cessation interventions do you think would help you to quit?:
a. Call a quitline
b. See a physician
c. Join a cessation programme
d. Use a nicotine patch, gum, nasal spray, inhaler, lozenge, or tablet
e. Use a prescription pill, such as Zyban, Bupropion or Wellbutrin
f. Use an internet smoking cessation programme
g. Quit with a friend, relative, or acquaintance
h. Other method
i. Quit on your own
Source Modified from CDC (Starr et al., 2005)
Variation Can be modified to assess any culturally relevant or country-specific cessation methods,
either evidence-based or non-evidence-based.
Comments Assesses to what extent and which individuals recognize that cessation interventions can
help them. Has not been widely used to date. There is no ranking of what would be most
helpful.
Measure 2 Im going to read a list of statements about stop-smoking medications. Please tell me if you
a. If you decided you wanted to quit, stop-smoking medications would make it easier.
b. If you decided you wanted to quit, you would be able to quit without stop-smoking
medications.
Variation This question should be asked specifically of certain medications (e.g. various Nicotine
Replacement Therapy, Bupropion).
Comments These questions could be expanded to include specific medications and other non-
medication cessation interventions.
Measure 3 Proven therapies for treatment of tobacco dependence should be covered by health
insurance plans. Do you:
a. Strongly agree
b. Agree
c. Disagree
d. Strongly disagree
Source CDC (Starr et al., 2005)
Table 5.47 Population-Level Survey Measures of Beliefs about and Barriers to Using Tobacco Cessation
Interventions, and Beliefs about Nicotine and No Smoking Days
361
Variation Adapt for country-specific funding sources.
Comments Only appropriate for countries with insurance. Could be modified to free to smokers wanting
to quit. The current item is somewhat poorly worded and may be confusing to respondents.
Construct (b) Beliefs About Barriers to Tobacco Cessation Interventions
Measure Im going to read a list of statements about stop-smoking medications. Please tell me if you
a. Stop-smoking medications are too expensive
b. You dont know enough about how to use stop-smoking medications properly
c. Stop-smoking medications are hard to get
d. Stop-smoking medications might harm your health
Variation This question should be asked specifically of certain medications (e.g. various Nicotine
Replacement Therapy, Bupropion)
Comments These questions could be expanded to include specific medications and other non-
medication cessation interventions. An item could be added to assess whether general costs
of cessation represent a barrier (e.g. Which of the following best describes your beliefs
about the costs of quitting smoking: a) Its too expensive; b) Its expensive but if I wanted to
I could afford it; and c) expense is not a problem).
Construct (c) Beliefs About Nicotine
Measure Do you believe that the nicotine in cigarettes is the chemical that causes most of the
cancers?
Variation This could be adapted to cover other diseases caused by smoking.
Comments
362
Construct (d) Beliefs About No Smoking Days
Measure Do you think No Smoking Day is a good/bad idea?
What do you think the main purpose of No Smoking Day is?
From what you remember, did you feel No Smoking Day was aimed at people like you, or
not?
Id now like to talk about No Smoking Day in general. Did it make you feel more or less
confident about stopping smoking or did it make no difference?
Variation These can be adapted to cover information on specific smoking cessation medications, if
more than one type is available in a country, distributed during No Smoking Day.
Comments
The ITC project: The International Tobacco Control Policy Evaluation Survey
determine what proportion of the success; a follow-up of a random smokers) and ascertain whether
quitting is attributable to the sample of successes to ascertain they contacted a helpline, got
helpline and what proportion long-term success, given loss to through, and the impact of that
would have quit without it; for this, follow-up; and a calculation of intervention (Table 5.48a).
a randomised controlled study success rate to assume those not
would be needed which can have followed-up relapsed to smoking. c) Stop smoking medications
significant cost implications (Cen- Appendix F of the CDC quitline
ters for Disease Control and report (Centers for Disease Surveys of smokers (and recent
Prevention, 2004). Control and Prevention, 2004) ex-smokers) can assess whether
CDC recommends that various contains a recommended mini- they have accessed, purchased,
issues be taken into account when mum data set for evaluating and/or used stop smoking
reported quit rates are being helplines, and Chapter 4 of the medications (Tables 5.48c and
assessed in the absence of a European Network of Quitlines 5.48d). It is also important to ask
control group. These include: an Best Practice Guide provides how they used the medication
exact description of how the similar information (European Net- (e.g. to cut down or to stop
callers contacting the helpline work of Quitlines, 2004). smoking altogether), for how long
were selected for inclusion in the An alternative means of they used it, and whether they are
evaluation sample; a description assessing the impact of reactive still using the medication. Res-
of baseline caller characteristics, helplines on smokers quitting ponses from population surveys to
such as dependence and intention behaviour at a national level, is to questions about accessing
to quit, as this may affect quit survey smokers (and recent ex- medications (either by purchasing
363
Construct (a) Use of Tobacco Cessation Interventions
Measure Have you used any of the following to try and stop using tobacco?
(Yes, No)
a. Counseling, including at a smoking cessation clinic?
b. Nicotine replacement therapy?
c. Other prescription medications, for example (FILL IN WHATEVER IS RELEVANT TO
THE COUNTRY)?
d. Traditional medicines, for example (FILL IN WHATEVER IS RELEVANT TO THE
COUNTRY)?
e. Acupuncture?
f. Hypnosis?
g. Quit line?
h. Anything else? (Please specify:_______________________)
Source GATS, 2007
Variation Can be modified to assess any culturally relevant or country-specific cessation methods,
either evidence-based or non-evidence-based. It can also be modified to specify which quit
attempt is of interest (e.g. most recent, any quit attempts since a policy implementation).
Comments Time scale can be varied to ask about ever used, used in last attempt, or used since policy
implementation.
Construct (b) Receipt of a Tobacco Cessation Intervention from a Healthcare Professional
Measure During any visit to a healthcare professional in the last 6 months, did you receive (Yes, No
for each):
a. Advice to stop smoking?
b. Additional help or referral to another service to help you quit?
c. Prescription for stop-smoking medication?
d. Pamphlets or brochures on how to quit?
e. Did they arrange a follow-up?
f. Did not visit a healthcare professional in the last 6 months?
During any visit to a doctor or healthcare provider in the past 12 months, did you receive
advice to quit using tobacco? (Yes, No)
Source The ITC Project, 2007 (adapted to include follow-up); GATS, 2007
Variation Can adapt for individual professionals (e.g. doctor, nurse, pharmacist).
Comments Brief advice from a physician is efficacious.
Table 5.48 Population-Level Survey Measures of the Use of Tobacco Cessation Interventions (TCI),
Receipt of TCI Information from Healthcare Professionals, Assessing the Use of Tobacco Cessation
Medications, How Medications were Obtained, and Behaviour Change on No Smoking Days
364
Construct (c) Use of Tobacco Cessation Medication

Measure Have you used any stop-smoking medication? (Yes, No, Cant remember)
In the last 6 months since [6 month anchor] have you used any stop-smoking
medication? (Yes, No, Cant remember)
In the last 6 months, which medication or medications did you use (do not prompt)? (require
type not brand name, can select more than one)
The last time you used a stop-smoking medication, did you use more than 1 product at the
same time? (Yes, No)
Which medications did you use at the same time?
For how long did you use the medication?
Variation The time scale can be adjusted to assess, all medication use, most recent use, or use since
the policy implementation.

Comments Could supplement or replace with pharmaceutical sales data.
Construct (d) Access Tobacco Cessation Medication
Measure How did you get [medication from previous answer]? (By prescription, Over the counter/off
the shelf, From a friend)
When you used [medications from previous answer], did you pay full price, get a discount,
or get it free?
Variation These may need to be changed to be country specific.
Comments Could supplement or replace with prescription or pharmacy data.
or through a healthcare e). Intensive cessation services Summa ry and recommenda-

professional) can be compared tions
with sales data and medication User satisfaction surveys can also
subsidies or pre-scription receipts. be used, if appropriate, to Article 14 of the WHO FCTC
d). No smoking days increase understanding of why obligates ratifying nations to adopt
and how cessation services have policies that promote access to
Examples of questions used in a particular impact. evidence-based tobacco cessa-
annual surveys of the UK No tion interventions. Such inter-
Smoking Day are given in Table ventions range from less intensive
5.48e. efforts, such as brief, opportunistic
365
Construct (e) Behaviour Change on No Smoking Days
Measure Did you yourself attempt to give up or cut down your smoking on No Smoking Day? (Yes,
No) (for those who answer No, ask why not)
For those who say yes:

Did you..
a. Give up for the whole day?
b. Give up smoking for part of the day?
c. Cut down your number of cigarettes on that day?
d. Or did you find you just couldnt cut your smoking?
e. Cant remember?
For those who did stop or reduce, including on the Day itself, for how long did you manage
to stop or reduce your smoking?
How long did you intend to stop or reduce smoking?
Why did you want to reduce or stop smoking on No Smoking Day?
Variation These can be adapted to similar days in other countries.

The ITC project: The International Tobacco Control Policy Evaluation Study
advice by healthcare profes- reflecting the utilisation of different sures described here are useful
sionals, to more intensive efforts cessation interventions. exemplars of how to assess
delivered to tobacco users either The effects of policies fa- utilization of cessation services.
individually or in groups by trained cilitating access to tobacco ces- Evaluations of the effects of
healthcare professionals. Core sation interventions can be policies to promote access to
constructs for evaluating access to assessed through self-report cessation interventions should
tobacco cessation interventions using standardised surveys of preferably include a longitudinal
include: proximal variables, such current and former tobacco users, design, which assesses the
as awareness of cessation inter- and by reviewing records that relationship between the utilization
ventions; intermediate variables, document trends in utilisation of of cessation treatments by current
such as specific beliefs and tobacco cessation interventions and former tobacco users and
attitudes about different cessation (e.g. calls to a helpline, sales of tobacco use behaviors.
interventions; and distal variables stop smoking medications). Mea-
366
summaryjanvier12:Layout 1 12/01/2009 14:41 Page 367
Summary
Background grammes to both discourage tobac- largely because they have been
co use and to assist those addicted unacceptable to consumers. Smoke-
In the 20th century, cigarette to tobacco to quit (IARC, 2007a). less tobacco, which is generally less
smoking caused an estimated 100 Tobacco is a plant containing the harmful than smoked tobacco
million deaths worldwide (Gajalak- psychoactive and addictive drug because it does not involve inhaling
shmi et al., 2000). Most of these nicotine. Although nicotine is the smoke, but still carcinogenic to the
deaths were in high-resource main psychoactive ingredient of oral cavity and pancreas (IARC,
countries where cigarette smoking tobacco and the source of its ad- 2007b), is not used in many parts of
first became popular in the 1920s to dictiveness, it is otherwise a minor the world, but it is common in some
1940s. This resulted in an epidemic contributor to the harm (Benowitz, areas and its use is significant and
of smoking-induced cancer, heart 1998). Most of the harm is due to increasing in some countries (e.g.
disease and chronic obstructive other constituents in tobacco, Sweden; Foulds et al., 2003). With
pulmonary disease (COPD) deaths. particularly in tobacco smoke some forms of smokeless tobacco
Cigarette smoking is not only the (IARC, 2004). The harms from there has been success in reducing
most prevalent form of tobacco use, tobacco mainly stem from long-term toxins while maintaining consumer
it is also particularly harmful, killing use, which the addictive nature of acceptability (Broadstock, 2007).
one of two long-term users, half of the product promotes. Non-cigarette tobacco use is under-
them (one in four users) in middle Across its long history, tobacco researched in comparison to ciga-
age. In 2000, smoking was res- has been processed and consumed rette use.
ponsible for approximately 4.83 in a wide variety of ways. The two In recognition of the threat that
million deaths in people 30 years of main forms of use are smoking tobacco use poses to global public
age and older, evenly divided combusted tobacco, and taking health, in May 2003, the member
between high- and low-resource unburned tobacco into the mouth or countries of the WHO adopted the
countries (Ezzati & Lopez, 2003), the nose (smokeless use). Over the Framework Convention on Tobacco
with lung cancer accounting for 0.52 20th century, the use of cigarettes, Control (WHO FCTC), the first inter-
and 0.33 million deaths, respectively primarily factory-made cigarettes, national treaty devoted to improving
(Ezzati & Lopez, 2004). If current dominated tobacco markets in public health by restraining tobacco
mortality trends continue, it will nearly all countries. Cigarettes have promotion and use (WHO, 2003).
cause some 10 million deaths each also been the focus of most tobacco Scientific evidence plays a
year by 2030, with around 70% in research. The use of other smoked central role in the WHO FCTC. Its
low-resource countries (Peto & tobacco products is now of only Foreword describes the WHO
Lopez, 2001). If present usage minor importance, except in some FCTC as "an evidence-based treaty
patterns persist, smoking will cause areas, particularly the Indian sub- that reaffirms the right of all people
approximately 1 000 000 000 deaths continent, where the use of bidis to the highest standard of health"
this century, a tenfold increase over prevails. All forms of smoked to- (WHO, 2003). The preamble to the
the previous century (Peto & Lopez, bacco are very harmful to health FCTC states that adopting nations
2001). Most of these expected (IARC, 2004), and attempts to are "determined to promote
deaths could be averted if we create less-toxic versions of these measures of tobacco control based
rapidly institute effective pro- products have generally failed, on current and relevant scientific,
367
technical, and economic consi- Article 15 dissemination of established poli-

derations" (WHO, 2003). To Illicit trade in tobacco products cy instruments as well as to aid in
achieve its objective, the WHO the subsequent evolution of new
FCTC calls for a comprehensive Article 16 policy-related interventions.
range of policies, defined for the Sales to and by minors
purposes of this Handbook as the Overview
enabling mechanisms that allow Article 17
particular rules, regulations and Provision of support for This Handbook is concerned with
programmes to operate (in other economically viable alternative the articulation of a framework and
words, frameworks that allow activities methods for conducting tobacco
instruments to be implemented). control policy evaluation, and not
The key articles of the Convention Article 20 with an evaluation of a body of
relevant to this Handbook are: Research, surveillance and research in itself. It also offers
exchange of information terminology to judge the quality of
Article 6 the evidence considered in such
Price and tax measures to Article 22 evaluations and to be applied by
reduce the demand for tobacco Cooperation in the scientific, IARC in the future evaluation of
technical, and legal fields and specific tobacco control policy
Article 8 provision of related expertise interventions. As a result, the
Protection from exposure to WGs advice to the potential
tobacco smoke The WHO FCTC is a seminal readers of the Handbook is largely
event in global health. Scientific about how to evaluate policy
Article 9 evidence has demonstrated the interventions in ways that we
Regulation of the contents of enormous health harms of tobac- believe will best advance tobacco
tobacco products co use. Scientific evidence as to control. In addition to this advice to
the effectiveness of potential researchers and evaluators, a
Article 10 interventions formed the basis for small number of recommenda-
Regulation of tobacco product the selection of the policies that tions directed at other audiences
disclosures are included in the WHO FCTC. are made.
However, whether the WHO
Article 11 FCTC is to fulfill its objective of The goals of this Handbook are to
Packaging and labelling of reducing the devastation of the move the field by:
tobacco products tobacco epidemic will depend on
how effectively countries formu- a) developing a common frame-
Article 12 late and implement these policies. work and language for tobacco
Education, communication, Moreover, history has shown us control policy evaluation;
training and public awareness that the tobacco industry will adapt b) reviewing the strengths of
and work to circumvent even the possible research designs;
Article 13 strongest policies, so govern- c) using theory to derive core
Tobacco advertising, promotion ments will also need to be ready constructs to measure when
and sponsorship to evolve and change their policies doing evaluations of key tobac-
in order to ensure they achieve co control policies;
Article 14 their goals. Good public health d) identifying measures of con-
Demand reduction measures practice demands ongoing evalu- structs, and
concerning tobacco dependence ation research as critical to e) providing an assessment of the
and cessation informing the implementation and scope and quality of existing
368
Summary
data sources. Four broad questions, explicit considerations interested in evaluating inter-
questions guided the review of must be given to equity issues ventions beyond merely auditing
the scientific literature on the both within and between coun- implementation. It should also be
methods and measures of tries. This involves always asking useful for policy and programme
tobacco policy evaluation: the question: What is needed to developers as it spells out the
1. How do we determine the optimise the intervention for theoretical frameworks upon
effects of a policy? disadvantaged groups? This may which the interventions are based,
What are the key features of range from making sure a and provides explicit models of
the policy as implemented? programme is available in dis- how they exert their effects.
Is there a common conceptual advantaged areas, to ensuring
framework that can be applied that the wording and tone of Steps towards a framework
to understand how policies communications is acceptable and for evaluation
work? comprehensible.
How might different design The Handbook outlines a The WG began by considering
features be used to reduce framework that interested organi- what outcomes to focus on. It
threats to internal validity? sations, including governments, concluded, insofar as the inter-
2. What are the core constructs can utilise to measure the ventions under consideration
for understanding how and effectiveness of interventions related to tobacco use and not to
why a given policy works? aimed at implementing tobacco the harmfulness of each unit of the
Which of these are parts of control policies that are currently product, that the focus should be
general pathways, and which being and will be adopted in the on tobacco use behaviours as the
are specific to particular poli- next several years in adherence to main outcomes of interest. This
cies? the WHO FCTC. It describes meant that, for the most part, the
What is the quality of the major steps we made to articulate WG did not consider disease or
measures used to assess core a new and coherent framework for mortality outcomes.
constructs? thinking about tobacco control The WG concluded that there
Do these measures, as well as interventions. is currently no coherent framework
the constructs they presu- The WG came from diverse for thinking about the evaluation of
mably reflect, translate into disciplines, with different theoretical tobacco control policies in the
different cultures and con- traditions and methodological ap- policy literature. The frameworks
texts? proaches. This necessitated on- borrowed from other areas such
3. What are potential moderator going work to standardise lan- as clinical medicine are not ade-
variables to consider when guage. We realised that some quate to the needs of the policy
evaluating a given policy? terminology was designed for field. Randomised clinical trials
What is the quality of the thinking about the problem from a are neither necessary nor often
measures used to assess po- different perspective to the one practical to generate evidence of
tential moderator variables? necessary for understanding the the effectiveness of tobacco con-
4. What data sources exist that complexity of population health trol policies.
might be useful for evalua- areas like tobacco control. There is The WG concluded that policy
tion? a need for ongoing work to rethink evaluation should be concep-
our terminology to better fit a tualised in a manner analogous to
How useful are these data population health framework. how epidemiologists approach the
sources for evaluation (i.e. com- The Handbook is intended to task of inferring conclusions about
pleteness and quality)? be a resource for researchers the causes of disease (US
The WG acknowledged that in interested in evaluating tobacco Department of Health, Education
attempting to answer these control policies, and others and Welfare, 1964; Hill, 1965). This
369
is a framework that encourages improves our ability to understand WG identified four aspects that
researchers to triangulate all the individual cases. Explicit com- need to be considered in evalu-
available evidence to help rule out parison with the corpus of existing ating interventions designed to
alternative explanations of ob- knowledge allows individual evalu- reduce the harms. First, one must
served effects, rather than focus on ators to say more about the consider whether the goal of the
attempting to draw conclusions programmes they evaluate than the intervention is to change tobacco
only from individual studies or from designs they have adopted would use, tobacco harmfulness, or both
meta-analyses of studies using the allow them to do if they treated their of these. Second, a theoretical
same study design. evaluations in isolation of the model or set of models describing
In the same way that evidence- accumulated knowledge. how the interventions are expected
based medicine has been built The question one usually asks to achieve their intended effects
from rigorous evaluation of treat- about policy interventions is: Under must be developed. Third, possible
ment options, evidence-based what conditions can the desired incidental effects of a policy that
public health must begin with effects be optimised?, not whether may occur must be considered.
building a database from rigorous the intervention can work. Trans- Fourth, any change in the environ-
evaluation of public health policies. lated to the individual case, the ment that could modify the impact
Evaluation of the effectiveness of question becomes: Is the inter- of the intervention (particularly
tobacco control policies at the vention working here as well as it counter-actions of the tobacco
population level has been limited should? To answer that question industry) must be monitored, and
by inadequate data sources, one must be concerned about the evaluated where necessary.
problems in measurement and form of the intervention, the ways it The first three steps in deter-
poorly conceptualised evaluation is delivered (quality of imple- mining how policies may achieve
designs. It has also been limited by mentation), and various charac- their effects require specification
a failure to look for and maximise teristics of the populations it is of a theory of how the policy is
the value of studies with indi- addressing. This is a framework that expected to work. As Kurt Lewin
vidually limited designs by sys- sees evaluation as part of a process noted years ago (1935), there is
tematically reviewing the findings of continual improvement. It is also nothing as practical as a good
from the corpus of such studies to about determining the relative theory. The WG concluded that
determine what they collectively contribution of each intervention to researchers should consider the
add to knowledge. In isolation or the overall goal, and how this might adoption of a common framework
even combined in meta-analyses be moderated by characteristics of to help identify relevant theories
of similar studies, they may have the broader environment. It involves and thus guide the selection of
little to tell us, but when they are paying more attention to the core constructs useful for
combined in ways that take articulation of theoretical mecha- evaluating how and under what
account of different threats to the nisms, and having study designs conditions tobacco control policies
validity of attributing causality by that facilitate the elaboration of work. The issues that are likely to
study type, they can sometimes be causal mechanisms. be relevant are to be considered
used to make strong inferences Good evaluation starts with an well in advance. A general frame-
about causality as well as po- analysis of the problem. Thus, the work for assessing how an
tentially increasing our under- need to build an understanding of intervention might work is illus-
standing of the conditions under the factors that are affecting or trated in Figure 6.1. At the first level
which the interventions are most can affect tobacco use and how it specifies two levels of mediating
effective. The benefits of such an use relates to the harms. Mecha- variables between a policy inter-
approach are not just with regard to nisms by which tobacco control vention and the outcomes: those
increasing our understanding of the interventions can act to reduce specific to the policy, and those
effects of the intervention, but it also harm must also be considered. The variables that are part of more
370
Summary
Policy as Policy-specific General Policy

Moderators
Figure 6.1 A generalised model of mediation making allowance for moderator effects
general pathways. It also accepts policy does not have the intended goal of information and product
that various other factors (modera- effect for some groups, but does labelling policies is improved
tors) might affect the size of the for others (i.e. clarify why modera- dissemination of knowledge to the
effect. tion occurs); and 4) in specifying potential user of the product.
There are only two main types how a policy works, it may help However, it is of interest to see
of causal chain one needs to identify alternative ways of ac- whether and how these policies
consider: the pathway from policies hieving the desired effects. These actually translate into changes in
to tobacco use, and the pathway understandings can facilitate the tobacco use behaviours. It is also
from tobacco products to levels of development of new, and hopefully important to consider effects along
exposure to toxic substances and improved, ways of targeting key different pathways to the intended
to the harms that result. Con- pathways of influence, or of tailoring means of action, as these might be
sideration of pathways may lead to interventions to better reach more important for analysis of society-
the subdivision of a policy area into resistant or needy groups. wide effects; e.g. the generally
classes of interventions that share The model outlines the primary neutral or positive effects on
common pathways. constructs involved in helping to business of smoke-free policies.
Understanding the mechanisms explain the relationship between Finally, there needs to be
by which interventions have their tobacco control policies and their consideration of unexpected ef-
effects is important because: 1) it effects on tobacco use beha- fects on other determinants of
can provide strong evidence of the viours. In a limited number of tobacco use. This consideration is
causal impact of a particular policy, cases, primarily in some aspects more important in tobacco control
especially when attempting to of product regulation, there is an than in most other areas of health
differentiate the effects of a specific alternative main path to out- because such effects may be
intervention from other possible comesthrough reduced delivery deliberately influenced by the
causes, including other tobacco of toxic chemicals. This is spelled tobacco industry (Cummings et
policies; 2) it can be used to out most clearly in the section on al., 2002b). Hence, surveillance of
diagnose the problem in cases product regulation. tobacco industry practices is
where intended effects did not It is particularly important to go required. The approach taken can
occur, by identifying where in the beyond the specific intent of some be facilitated by a theoretical
causal pathway things went wrong; policies to explore their more distal understanding of the industrys
3) it can help us understand why a ramifications. For example, the profit motive and marketing
371
practices, as this can guide the how differences in policy imple- measures of known bias are used
selection of data that are most mentation relate to effectiveness. for measuring constructs because
relevant in surveillance for coun- The model for the effects of no better measures exist, but the
ter-active effects. changes in tobacco products to differential effects of that bias in
The conceptual framework for health effects can similarly be different contexts are overlooked.
behaviour change assumes that articulated, although here the The general theoretical frame-
each policy directed at changing distinction may be more between work presented here should be
tobacco use ultimately has its constructs that are measured in applicable across socio-cultural
influence on those behaviours the environment (e.g. physical contexts. Clarification of policy
through a specific causal chain of characteristics of cigarettes) and intervention effects and the
psychological events. Policy-spe- those within the individual (e.g. moderation of these effects will
cific mediators involve such things exposures, health harms), and the often involve comparative re-
as awareness, policy-specific challenges of demonstrating links search. However, the specific
knowledge and reactions to between the twofor example, theoretical model, its associated
specific elements of the inter- the failure of current measures of constructs and the measurement
vention. For example, new graphic cigarette yield to relate to of these constructs may differ in
warning labels should increase measures of exposure to those important ways across national,
salience and visibility of warnings, chemicals in smokers. cultural, linguistic and social
and perhaps foregoing of occa- The WG set the task of using groups. Where this happens,
sional cigarettes. The second set diagrams, or logic models, to spell caution must be exercised in
of general mediators are con- out the main factors to consider for making comparisons between
structs taken from behavioural each policy area and how they such groups.
science that we know mediate interrelate when considering all
effects of behaviour; that is, they these policies simultaneously; to Section Summaries
are means by which changes in see if this approach would help
tobacco use may occur. They elucidate common constructs and General methods and common
include attitudes, normative beliefs measures that might apply across measures
and intentions. Moderators different policy domains. The logic
those things that change the models allowed the WG to readily
magnitude of the effects of an compare the similarities and The Handbook first discusses
intervention without necessarily differences in the constructs and features of research design for
being changed by the inter- measures across policy domains, evaluation studies and how those
ventioninclude socio-demogra- and of the differences of policy features can form the basis for
phic factors (e.g. age, gender, type within a broad policy domain. stronger conclusions about the
socio-economic status, cultural The models were deliberately kept impact of policies. Other aspects
background) and psychological simple in an effort to focus discussed and deliberated on
factors that are either assumed to attention on key constructs. include measurement issues in
be stable or which the intervention Finally, a major challenge is in the design and analysis of cross-
is not designed to change (e.g. the identification and validation of cultural comparative research, as
level of dependence). This frame- appropriate measures. Measure- well as some of the methods
work provides a general guide for ment validity is a particular issue, currently recommended for
thinking about policies and their with measures of constructs attempting to resolve these
effects on a broad array of varying in their validity dependent issues.
important psychosocial and be- on the purpose they are being used
havioural variables, and for testing for. This is sometimes because
372
Summary
The Importance of Design in the explain how policy affects beha- Both repeated cross-sectional
Evaluation of Tobacco Control viour and environment (or environ- and longitudinal (cohort) designs
Policies mental risk) should lead to an are useful for assessing the
appropriate study design, the impact of a given policy. The use
Evaluating the outcomes of inclusion of appropriate constructs of cohort designs provides
population-level tobacco control and measures, and the selection additional capability for tracking
policy involves three interrelated of analytic tools that are well-suited the impact of policies within
questions: to estimating the causal impact of individuals, allowing stronger tests
(1) Does the policy have an policies by providing an expla- of mediational pathways.
impact? (causality); if so, natory pathway and helping to Addition of samples from other
(2) Under what conditions? eliminate alternative explanations. populations to either or both inter-
(moderation); and Logic models describe these vention and control arms also adds
(3) How (mediation)? pathways and help identify con- strength to the evaluation design,
structs to measure. Suggestions as does having varying levels of
The choice of design elements on specific measures for many of intensity of the intervention.
will depend on which questions these constructs are provided in Similarly, parallel assessment
are considered to be a part of the other sections of this Handbook. of alternative explanations for
evaluation effort. An outcome evaluation study observed changes in outcomes
It is important to ensure that must, at a minimum, include one (e.g. possibly being due to other
the appropriate concepts are cho- post-policy measurement. In gen- policies or industry counter-ac-
sen and that for each, measures eral, the addition of one pre-policy tions) adds strength over asses-
are identified that are suitable to measurement (even cross-sec- sing these effects in separate
answer the evaluation question. tional) using the same measures studies.
This section describes key and sampling frame is a more The existence of studies with
design elements of outcome powerful evaluation strategy for complementary strengths and
evaluation studies and how each assessing change due to a policy. weaknesses is particularly useful in
contributes to reducing or elimi- The inclusion of a single, non- triangulating the results of a corpus
nating threats to the internal random control from another of evaluation studies to see if a
validity of a study. Internal validity population is considered less consistent pattern emerges.
determines the extent to which the desirable. Additional post-policy The use of probability sampling
results of the study can lead to a measurements are useful to track in an evaluation study increases
causal conclusion. the effects of a policy over time. its external validitythe extent to
Evaluation efforts should be The utility of longitudinal designs which the findings of a policy
informed by knowledge of the na- is strengthened if there are evaluation study can be gene-
ture of the policy being evaluated, multiple data collections before ralised to making conclusions
and the goals of the evaluation and/or after policy implementation, about the impact of the policy on
study should be clearly stated. as this allows more precise the larger population.
Evaluation planning should be specification of effectsfor exam- At a broader level, the design
guided by understanding what ple, taking into account temporal of an evaluation study should be
threats to internal validity may be trends that were occurring before guided by knowledge of how prior
present in the study of a given the implementation of the policy. evaluation studies in the same
policy situation, and then adding The role of time series analysis on policy domain have been con-
design elements and other mea- aggregate sales/consumption data ducted. An analysis of the
sures to reduce or eliminate those to demonstrating the effects of similarity or differences in policy
threats. price on consumption is a good impact across similar studies can
Knowledge of the mediational example of the power of multiple yield powerful conclusions about
pathways that are theorised to measurements. the overall impact of a policy.
373
Developing and assessing com- be necessary to increase validity ways in which culturally modera-
parable questions in cross- and improve the value of com- ted response factors (e.g. social
cultural survey research on parisons across groups. desirability, acquiescence, extreme
tobacco Translation of questionnaire responding) may influence res-
items from one language to another ponses.
Evaluation of tobacco control po- should involve experienced trans- Researchers should document
licies and other population-level lators. Review and adjudication of decisions related to measurement
interventions often involves data multiple, independent translations development and item wording,
collection efforts across diverse of the same items is currently especially where conceptual equi-
national, cultural, linguistic and considered the gold standard. If valence is suspect, translation is
social groups. Comparison across only one person translates the difficult, or where cognitive inter-
such groups is often necessary to questionnaire, translation review viewing or other pre-testing
clarify policy effects, how these should involve a group of bilingual methods reveals systematic dif-
effects happen and how effects people who are knowledgeable ferences in meaning. Researchers
might differ across populations. about questionnaire design prin- should also document issues
The literature discussed in this ciples and key study concepts. around survey administration.
section suggests that these Translation assessment should not
comparative studies should con- merely consist of back-translation. Outcomes and major determi-
sider measurement equivalence Researchers should carefully nants
issues in the following ways: select and translate items with the Next, the Handbook presents
Research teams should include goal of achieving equivalence of constructs that are likely to be used
collaborators from the socio- construct meaning across study across a range of policy
cultural groups in which the study populations. In some cases, literal evaluations, factors that can inf-
is being conducted in order to help translation of a questionnaire item luence the validity of self-report
anticipate issues regarding the across linguistic variants of the tobacco use behaviours, factors
comparability of the theoretical survey will not adequately capture that can influence comparability
across surveys, and measures to
framework, constructs and the the construct of interest, and more
assess use, providing examples
measurement of these constructs flexible translation and adaptation from cross-national surveillance
across groups. When research of the question will be necessary. and evaluation systems as well as
involves participants from distinct All surveys, not just those that national sources. A core set of
language groups, it is recom- are translated, should be pre- general mediator and moderator
mended that at least one, and tested to assess comprehension variables that may be relevant to
preferably more, team members issues among the populations in consider in evaluations of tobacco
are fluent in the source language which the survey will be control programmes and policies,
and the target language in which administered. Ideally, pre-testing with a brief description and
the survey will be administered. would involve cognitive inter- assessment of some standard
Whenever possible, it is viewing before a survey is fielded. measures for assessing these
constructs, are discussed. Self-
recommended to use measures Cognitive interviewing or other
report measures of nicotine/
that have been appropriately pre-testing methods may also be tobacco dependence in adults,
validated for the populations in used post-hoc to increase the concentrating on measures that
which the questionnaire will be validity of comparisons or to deter- are potentially appropriate for
administered. Even when a mine whether inconsistent results population-based/epidemiologic
measure has been validated may be due to differential question research, are reviewed as well.
within one population group, its comprehension.
validity may not extend to other Researchers should consider
groups, and additional steps may and seek solutions to minimise the
374
Summary
Measuring Tobacco Use Behav- surveys conducted within and moderator for the effects of
iours across countries. tobacco control programmes and
The Handbook describes the key Measuring the Psychosocial policies. The WG reviewed the
concepts within the natural history Determinants of Tobacco Use and evidence on the validity of various
of tobacco use, providing a Dependence proposed measures of cigarette
conceptual model to guide mea- and smokeless-tobacco-induced
surement of key constructs. Cur- The WG describes mediators and nicotine dependence. For ciga-
rent tobacco use is the most moderators theorised to be rette smoking, the 2-item Heavi-
important construct because of its important in understanding how ness of Smoking Index is reco-
importance as an outcome in policies and interventions affect mmended for use in popu-
policy evaluation studies. Studies tobacco use behaviours, and under lation-level studies. If only a single
that have examined the validity of what circumstances they have an item measure is possible we
self-report measures of current impact. A core set of measures would recommend the use of time
use generally find these measures likely to be important has been to first cigarette in the morning as
to be valid, although there exist identified. Researchers should the item. For smokeless tobacco,
some conditions under which the select from this list and, when the Fagerstrom Test for Nicotine
validity may be reduced. appropriate, supplement it with Dependence-Smokeless Tobacco
It is important to measure the other relevant measures, depen- (FTND-ST) appears to be a useful
type of tobacco used, particularly in ding on the specific context and measure of nicotine dependence.
those countries in which a variety aims of each study. There are
of types exist. The variety of forms validated measures of many of the Existing data sources
available, the possibility of swit- reviewed constructs, and re-
ching, or multiple concurrent use searchers should whenever pos- The Handbook then describes
may influence the probability of sible use these measures rather sources of details about tobacco
quitting and disease risk. than developing their own ad hoc control policies, sources of
Detailed measurement of infor- measures. Investigators should information about tobacco pro-
mation about tobacco product report the psychometric properties duction and trade and repo sitories
packaging is important in order to of their measurement instruments, of youth and adult surveillance
determine the variant of product reporting at least test-retest relia- surveys. These sources of infor-
type used, movement between bility, convergent validity and/or mation are particularly important
price sectors and, potentially, to predictive validity. Psychological for making comparisons between
assess the use of tobacco from measures are particularly sensitive countries, and in some cases can
be used to demonstrate policy
illicit sources. to wording and to cultural context,
impacts, although not the mech-
Other important constructs in so we recommend that the anisms by which they occur.
the measurement of tobacco use methods for translations and
behaviour include early use, fre- cultural adaptations described
quency and quantity of current use, elsewhere in the Handbook be
quit attempts and duration of utilised in populations where these Data sources for monitoring
abstinence among former smokers. measures have not been pre- tobacco control policies
Consumers of survey data in viously validated.
which tobacco use measures are The Handbook describes the new
included should be aware of Measurement of nicotine depend- WHO Global Tobacco Control
factors that can influence popu- ence Report (GTCR), a repository of
lation estimates of tobacco use, good-quality information on a wide
and take those into consideration Nicotine dependence is an im- range of tobacco control policies for
when comparing estimates from portant construct to assess as a the large majority of countries. The
375
GTCR contains copies of most of National data are typically prehensive set of indicators,
the legislation and regulations, available from sources such as including: exposure to second-
some measures of scope and/or government statistics agencies hand smoke, economics (price
level of policy enactment, and an and ministries of trade and and taxation), cessation, product
indicator of cases where national industry. The United Nations Sta- labelling, and exposure to pro- and
level policies may mask a diversity tistical Division (UNSD) con- anti-tobacco media and adver-
of sub-national policies. It is solidates this information based tising. Where possible, longitudinal
designed to be updated annually. on reports from countries. These studies such as ITC should be
All policy researchers studying reports are generally accurate, but used for evaluating policies and
policy differences between coun- primary sources should be used to programmes because of the oppor-
tries should use it, and indeed it confirm the data and to obtain tunity to examine and adjust for
may be the easiest way to get this other information such as data on individual level predictors of tobac-
information for some individual sales and other tobacco products. co use behaviours.
countries. GYTS was developed, and
The GTCR is limited in what it Data sources for monitoring global GATS is being developed, for
can provide on extent of imple- trends in tobacco use behaviours countries that did not have
mentation and/or enforcement. Its existing surveillance systems for
main limitation is that it does not The youth surveillance systems the collection of information on
contain information about sub- described in this section include tobacco use and its determinants.
national policies, as information of The European School Survey
this sort is only available for the Project on Alcohol and Other Strategies for evaluating
limited number of countries that Drugs (ESPAD), the Global specific policy domains
collect it. School-Based Student Health
Survey (GSHS), the Global Youth
The final section of the Handbook
Data sources on tobacco produc- Tobacco Survey (GYTS) and the
covers all major domains of
tion, trade and sales Health Behaviour in School-Aged
tobacco control policies except for
Children Survey (HBSC). The adult
prevention policies and illicit trade.
National data on the production, surveillance systems described
Here it is illustrated ways in which
trade (export and import) and sales include the Global Adult Tobacco
logic models can be used to
of tobacco products are most often Survey (GATS), the International
highlight the different foci of
available publicly at little to no cost Tobacco Control Policy Evaluation
policies. In particular, analysis of
and have been underutilised in Survey (ITC) and the STEPwise
policy areas directed at controlling
evaluations of tobacco control Approach to Chronic Disease
tobacco marketing (including some
programmes and policies. These Factor Surveillance (STEPS).
forms of product regulation) have
data 1) can provide important To evaluate articles of the
identified the importance of moni-
insights into the relevant players WHO FCTC among youth, GYTS
toring tobacco industry innovations
and sectors in the national and is the only source of international
designed to mitigate the policy
regional political economy of data available that includes the
effects, while those less targeted at
tobacco control, 2) can be used to following indicators: exposure to
the industry have not done so.
construct measures of historical secondhand smoke, exposure to
trends in tobacco consumption and pro- and anti-tobacco media and
3) provide estimates of the advertising, cessation, minors
magnitude of the smuggling mar- access and school curriculum.
ket. Thus, these data are important To evaluate articles of the
information sources for evaluation WHO FCTC among adults, GATS
of tobacco control policies. and ITC have the most com-
376
Summary
Measures to Assess the Effective- addition of a limited set of exposure to tobacco smoke. The
ness of Tobacco Taxation questions to this survey. Devel- review here also suggests that it
oping accurate measures of tax may be important for evaluators to
Article 6 of the WHO FCTC calls avoidance and tobacco product consider measuring key incidental
for ratifying nations to reduce the smuggling is more challenging, effects of public smoke-free poli-
demand for tobacco products and the validity of these measures cies such as the impact on the
through taxation policies and other is unclear and needs further behaviour of smokers, possible
product price-related policies. This research. Some of the questions changes in smoking behaviour in
section focused on the measures on purchase behaviour in popu- the home and a variety of potential
needed for evaluating the impact lation surveys can be used to economic effects.
of tobacco taxation, a highly provide a range for the extent of
effective tool for reducing tobacco tax avoidance. Multiple methods, Measures to assess the effective-
use. The impact of tobacco taxes most of which have not been ness of tobacco product regu-
on tobacco use behaviours is widely applied and which need lation
mediated by tobacco product further research, can be used to
prices, tobacco company price- assess the extent of tobacco Articles 9 and 10 of the WHO
related marketing efforts, tobacco product smuggling. FCTC call for ratifying nations to
users purchase behaviour, tax adopt policies for the regulation
avoidance and smuggling. Measures to assess the effective- and disclosure of tobacco product
Measuring tobacco product ness of smoke-free policies contents and emissions. This
taxes is straightforward, with section focuses on a review of the
information on the level and struc- Article 8 of the WHO FCTC calls methods and measures for
ture of these taxes readily for ratifying nations to adopt evaluating policies that are inten-
available from the Ministry of smoke-free policies for public ded to regulate tobacco products.
Finance and other sources (e.g. indoor locations and workplaces. There are currently five main
the International Monetary Fund, Evaluating the effects of public types:
the WHOs GTCR). In some smoke-free policies is critical to 1) regulations that require
countries, it will also be important understanding how these polices disclosure of product infor-
to measure sub-national taxes. are implemented, whether they mation;
Three methods for measuring reduce exposure to tobacco 2) regulations intended to reduce
tobacco product prices are dis- smoke, and how they can be product toxicity and harm;
cussed in this section: tech- improved. The core constructs 3) regulations intended to reduce
nology-based, observational and identified for evaluating smoke- the addictiveness and/or at-
survey-based. These methods free policies include compliance tractiveness of tobacco pro-
have differing strengths and weak- with the policy and exposure to ducts;
nesses, and their costs will vary tobacco smoke. Based on our 4) regulations intended to prevent
considerably. review of the available research cigarette-caused fires; and
To the extent that a national literature, we conclude that 5) bans (or removal of bans) on
measure of price is of the most population surveys can generally product categories.
interest and a regularly repeated be relied upon to provide valid
population survey of tobacco use measures of compliance with a The selection of specific
is in place, including questions on public smoke-free policy and constructs and methods for eva-
price in such a survey would be exposure to tobacco smoke. luation will vary depending on the
most efficient. Measuring tobacco These self-report measures have goals of the specific policy.
product purchase behaviour can been validated by ambient air However, as a general framework
be easily done through the monitoring and biomarkers of the impact of tobacco product
377
regulations on intended health effects of tobacco product the communication efforts tobacco
outcomes will likely be moderated regulations should not be under- corporations use to encourage
by changes in product design and estimated. For example, many consumption of their products,
performance, product marketing, governments have enacted maxi- including mass media advertising,
product-related beliefs and atti- mum smoke emissions standards sponsorship of sporting and
tudes, and tobacco use behaviour, (i.e. tar, nicotine and carbon cultural events, point of sale
which in turn are expected to monoxide) based on standardised promotion, merchandising and
influence exposures to tobacco machine testing protocols for the give-aways, and public relations.
constituents and emissions. Thus, purpose of reducing exposure to A core distinction to consider is
evaluations should not be limited to the constituents in tobacco between evaluation of the
assessing compliance within the products and resultant harm. pathway of intended effects, and
intended effects of a regulation, but However, based on the evidence the need to monitor, and evaluate
should also consider unintended reviewed in this Handbook, we where necessary, evidence of
effects or responses, such as recommend against using yields tobacco industry activity that might
tobacco industry innovation, that from standard machine testing reduce the impact of the policy.
may interfere with the impact of the protocols such as the ISO cigarette Various methods can be used
regulation. testing method (ISO Standard to measure the effects and
There is a need for a 3308, 2000) to assess or predict effectiveness of restrictions on
centralised database that would at human exposure. Emission yields tobacco marketing, some bor-
a minimum characterise different derived from these protocols are rowed from strategies to assess
product regulations so that the not valid measures of actual the impact of marketing. The main
effects of different policies can be human exposure. In order to approaches include using con-
compared. Additionally, as a evaluate the effectiveness of sumer surveys to examine the
condition permitting tobacco pro- product regulations aimed at target markets response to bans
duct sales, governments should reducing harm, measures of and restrictions and, if it can be
require (if they do not currently do human use and exposure are obtained, use of disaggregated
so) tobacco product manu- essential. There is an urgent need tobacco company marketing ex-
facturers to regularly disclose to identify valid methods and penditure data to model changes in
information about their products at measures for assessing human tobacco use. Given different
the finest level of brand exposure and harm that have limitations, the WG recommends a
subcategory, including sales and practical utility for evaluating mix of these approaches, along
marketing data, product content tobacco product regulations. with others where possible.
and design features. This is However, there is a critical need to
needed to inform the develop- Measures to assess the effective- develop methods and valid
ment, implementation and ness of restrictions on tobacco measures for estimating the effects
evaluation of effective regula- marketing communications of marketing bans and restrictions
tions. Additionally, ongoing at the level of the consumer.
surveillance is required to assess Article 13 of the WHO FCTC Additional key challenges in
the impact of tobacco product encourages ratifying nations to evaluating the effects of marketing
regulation on the tobacco product adopt comprehensive tobacco bans and restrictions include the
market and on the population, as marketing restrictions to the extent extended time required for past
well as to detect industry constitutionally possible. This marketing campaigns to dissipate
responses and other unantici- section identifies the key issues from peoples awareness, and the
pated consequences of regulation. and constructs for evaluating persistence of effects from recent
The challenges of measurement restrictions on tobacco marketing. campaigns. Innovative and in-
associated with evaluating the Tobacco marketing includes all creasingly subtle tobacco industry
378
Summary
marketing strategies create an should be a priority for tobacco policies and tobacco-related beha-
urgent need for ongoing control research. Unlike health viour change. The measures
monitoring of industry behaviour. warnings, these policies require described here, like the cam-
the removal of information from paigns themselves, need to be
Measures to assess effectiveness the package and present customised to the specific content,
of product labelling challenges in the wording of purpose and message of the
survey measures. Evaluation of communication effort being imple-
The WHO FCTC proposes policies intended to communicate mented.
tobacco product labelling emissions and content information Regardless of the results of the
regulations in 3 main areas: 1) via packages should focus upon public communication campaign
health warnings, 2) misleading understanding and use of this (and particularly if it failed to show
brand descriptors, such as light information rather than knowledge results), evaluations should be
and mild, and 3) information on or awareness. made publicly available. A system
the constituents and emissions of to collect and document campaign
tobacco products (Article 11). The Measuring the impact of anti- results would enhance our under-
Handbook identifies core con- tobacco public communication standing both of how public
structs for evaluating labelling campaigns communication campaigns work
policies including: proximal out- and how to make them better.
comes such as awareness, The WHO FCTC Article 12
processing and knowledge of requires ratifying countries to Measures to assess the effective-
health warnings; intermediate promote and strengthen public ness of tobacco cessation
outcomes such as health know- awareness of tobacco control interventions
ledge, perceived risk, affective issues, using all available com-
reactions, avoidance, brand munication tools, as appropriate. Article 14 of the WHO FCTC
appeal and cessation knowledge; Such campaigns seek to increase obligates ratifying nations to adopt
and distal outcomes such as awareness and knowledge of policies that promote access to
motivation to quit, changes in tobacco-related issues, with the evidence-based tobacco cessa-
consumption patterns and quitting goal of promoting individual tion interventions. Such inter-
behaviours. Few of the measures behaviour change and support for ventions range from less intensive
for each of these constructs have and progress toward policy and efforts such as brief opportunistic
undergone formal validation tes- social change. The Handbook advice by health care pro-
ting, although several of the provides a framework for fessionals to more intensive
measures described have shown evaluating multi-component public efforts delivered to tobacco users
utility for evaluating the impact of communication campaigns in either individually or in groups by
changes in product labelling. order to design effective cam- trained health professionals. Core
The selection of specific paigns, identify and correct constructs for evaluating access to
measures to evaluate tobacco problems of campaigns that are in tobacco cessation interventions
labelling policies will depend upon progress, and to document the include: proximal variables such
the policy chosen for evaluation. campaigns impact. Core methods as awareness of cessation inter-
Evaluations of health warning include testing campaign mes- ventions, intermediate variables
labels should include proximal sages during the design phase, including specific beliefs and
measures of noticing, along with monitoring the reach of the attitudes about different cessation
intermediate measures of per- campaign during implementation, interventions, and distal variables
ceived risk or health knowledge. and assessing core constructs, reflecting the utilisation of different
Evaluations of brand descriptors including awareness, knowledge, cessation interventions.
and other packaging elements attitudes and beliefs, support for
379
The effects of policies of tobacco cessation interventions sation interventions should

facilitating access to tobacco (e.g. calls to a helpline, sales of preferably employ a longitudinal
cessation interventions can be stop-smoking medications). Mea- design to assess the relationship
assessed through self-report sures described here are useful between the utilisation of ces-
using standardised surveys of exemplars of how to assess utilisation treatments by current and
current and former tobacco users sation of cessation services. former tobacco users and tobacco
and also by review of records that Evaluations of the effects of poli- use behaviours.
document trends in the utilisation cies to promote access to ces-
380
Recommendations
Evaluation requires specific, easier to collect this information, understanding where and when
committed resources. The frame- and do so in a consistent manner. things work. The continued
work the WG has developed momentum of the WHO FCTC
highlights the potential value of The WG recommends that and of the broader movement to
good evaluation for interventions, high priority be given to the fight against the global tobacco
as it allows for both ongoing development and maintenance of epidemic can be facilitated by the
improvement and the capacity to a reliable and accurate inter- existence of such a repository,
build on the accumulated know- national system for tracking with appropriate tools for easy
ledge acquired by others. tobacco control policies. access and utilisation of the
In 1999, the United States contents of the repository. Articles
Centers for Disease Control and Also critical for the field to 20 and 22 of the WHO FCTC
Prevention (CDC) recommended move forward is for sufficient effectively call for such an
that 10% of the total budget for a attention and resources to be initiative. Those conducting or
comprehensive tobacco control provided to knowledge utilisation, sponsoring evaluations should be
programme should be allocated which in this domain would include encouraged to add appropriate
for evaluation and surveillance. appropriate detailed documen- information to this repository.
The CDC recommendation was tation of the results and all the
recently endorsed by WHO and features of evaluation studies, so The W G recommends that a
represents a reasonable bench- as to allow the information to be repository be created and
mark for governments to adopt. compared and summative evalu- maintained to collect detailed
ations made. Development of a documentation of the methods
The WG strongly recommends repository to collect and organise and results of tobacco control
that countries allocate adequate this information is becoming policy surveillance and evaluation
funds for evaluation and sur- increasingly important. Comple- studies, particularly those related
veillance activities. Where a menting the repository of to WHO FCTC policies.
budget for tobacco control evaluations should be a similar
programmes exists, we recom- repository of measures, with The WG recommends that
mend that an adequate per- information as to their validity in governments work together to
centage of it be earmarked for the various contexts where they support efforts to develop com-
evaluation and surveillance. might be useful. The utility of such mon methods and measures to
a repository would be enhanced support evaluations of tobacco
Evaluation needs to begin with by the development and agree- control policies.
an understanding of the nature of ment on use of prototype
the interventions being evaluated. proformas for reporting on the Governments should be en-
Collection of this information, validity data on measures, and on couraged to collect data from the
especially for international studies, frequently repeated interventions, tobacco industry to help evaluate
is surprisingly difficult. Collective such as mass media campaigns. current and future tobacco control
effort, especially by agencies with This will facilitate their com- policies, and to assist in identifying
networks into appropriate govern- bination into meta-analytic stu- tobacco industry actions that
ment agencies, could make it dies, especially important for might counteract the effects of
381
tobacco control policies. The kind facilitate the evaluation of tobacco system be encouraged to join one
of information that should be control policies and help identify of the international systems.
readily available from the industry the potential for new policies. Those countries that have existing
and placed into the public national surveys are encouraged
repository includes disaggregated There are substantial infra- to link to these international
sub-brand specific marketing structure and information needs efforts.
activities, product sales data and that are essential to conducting
product content, design and successful policy evaluations and The information resources
performance data. It might also supporting the dissemination and called for here should make
include more general information utilisation of evaluation results. important sources of data ac-
on political contributions, funding Ongoing surveillance is required to cessible and useable for informing
of scientists, general sponsorships assess the impact of tobacco policy, development, implemen-
and other activities of the industry control policies on the tobacco tation and evaluation. Additionally,
that are designed to affect the product market and on the popu- specific dissemination strategies
environment in which they lation, as well as to detect industry should be employed to make
operate. responses to policies and other relevant information useful to
unanticipated consequences. policy-makers, public health prac-
The WG recommends that titioners and the general public.
governments mandate that The WG recommends that
tobacco companies provide them countries interested in developing
with information that might a tobacco control surveillance
382
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412
Appendix 1.
Fagerstrm Test for Nicotine Dependence (FTND) and Heaviness of
Smoking (HSI)*
Please answer the following questions:
1. How soon after you wake up do you smoke your first cigarette?
3 - Within 5 minutes
2 - 6-30 minutes
1 - 31-60 minutes
0 - After 60 minutes
2. Do you find it difficult to refrain from smoking in places where it is forbidden (e.g. in church, at the library, cinema,
etc.)?
1 - Yes
0 - No
3. Which cigarette would you hate to give up?

1 - The first one in the morning
0 - All the others
4. How many cigarettes/day do you smoke?

0 - 10 or less
1 - 11-20
2 - 21-30
3 - 31 or more
5. Do you smoke more frequently during the first hours after waking than during the rest of the day?
1 - Yes
0 - No
6. Do you smoke if you are so ill you are in bed most of the day?
1 - Yes
0 - No
* The Heaviness of Smoking Index (HSI) consists of FTND Item 1 and FTND Item 4, using the same response scales
and calculating the total score using the sum of the scores on those two items.
Total score = Sum of all questions
413
Appendix 2.
Features of Diagnostic and Statistical Manual-IV (DSM-IV)
Substance Dependence that are Targeted by Structured Diagnostic
Interviews
A maladaptive pattern of substance use, leading to clinically significant impairment or distress as manifested by three
(or more) of the following occurring at any time in the same 12-month period:
1. Tolerance, as defined by either of the following:

a. A need for markedly increased amounts of the substance to achieve intoxication or desired effect.
b. Markedly diminished effect with continued use of the same amount of substance.
2. Withdrawal, as manifested by either of the following:

a. The characteristic withdrawal syndrome for the substance
b. The same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms.
3.. The substance is often taken in larger amounts or over a longer period than was intended.
4. There is a persistent desire or unsuccessful efforts to cut down or control substance use.
5. A great deal of time is spent in activities necessary to obtain the substance (e.g. visiting multiple doctors or driving
long distances), use the substance (e.g. chain smoking), or recover from its effects.
6. Important social, occupational, or recreational activities are given up or reduced because of substance use.
7. The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological
problem that is likely to have been caused or exacerbated by the substance (e.g. current cocaine use despite
recognition of cocaine-induced depression, or continued drinking despite recognition that an ulcer was made worse
by alcohol consumption).
414
Appendix 3
Appendix 3.
Features of the International Statistical Classification and Related Health
Problems-10 (ICD-10) Substance Dependence that are Targeted by
Structured Diagnostic Interviews
Three or more of the following manifestations should have occurred together for at least one month, or if persisting for
periods of less than one month, should have occurred together repeatedly within a 12-month period:
1. A strong desire or sense of compulsion to take the substance.
2. Impaired capacity to control substance-taking behaviour in terms of onset, termination or level of use, as evidenced
by: the substance being often taken in larger amounts or over longer periods of time than intended, or any
unsuccessful effort or persistent desire to cut down or control substance use.
3. A physiological withdrawal state when substance use is reduced or ceased, as evidenced by the characteristic
withdrawal syndrome for the substance, or use of the same (or closely related) substance with the intention of relieving
or avoiding withdrawal symptoms.
4. Evidence of tolerance to the effects of the substance, such that there is a need for markedly increased amounts of
the substance to achieve intoxication or desired effect, or that there is a markedly diminished effect with continued
use of the same amount of the substance.
5. Preoccupation with substance use, as manifest by: important alternative pleasures or interests being given up or
reduced because of substance use, or a great deal of time being spent in activities necessary to obtain the substance,
take the substance, or recover from its effects.
6. Persisting with substance use despite clear evidence of harmful consequences as evidenced by continued use when
the person was actually aware of the nature and extent of harm.
415
Appendix 4.
The Tobacco Dependence Screener (TDS)*
Please answer the following questions either yes or no:
1. Have you often had periods of days when you smoked a lot more than you than you intended to?
2. Have you ever tried to quit or cut down on tobacco and found you could not?
3. Did you crave tobacco after you quit or cut down on it?
4. Did you have any of the following problems when you quit or cut down on tobacco: irritation, nervousness, restless,
trouble concentrating, headache, drowsiness, upset stomach, heart slow down, increased appetite or body weight,
hand shakes, or depression?
5. Did you ever start using tobacco again to keep from having such problems?
6. Have you ever continued to smoke when you had a serious illness that you knew made it unwise to use tobacco?
7. Have you ever continued to use tobacco after you knew that it caused you health problems?
8. Did you continue to use tobacco after you knew that it caused you mental problems?
9. Have you ever felt like you were dependent on tobacco?
10. Have you given up work or social activities so you could use tobacco?
* To get the total score for the TDS, add up all the points by giving each yes response one point, and each no response
zero points.
416
Appendix 5
Appendix 5.
The Cigarette Dependence Scale (CDS)
1. Please rate your addiction to cigarettes on a scale of 0 to 100:

a. I am NOT addicted to cigarettes at all = 0
b. I am extremely addicted to cigarettes =100
1 - 0-20
2 - 21-40
3 41-60
4 61-80
5 81-100
2. On average, how many cigarettes do you smoke per day?

1 0-5
2 6-10
3 11-20
4 21-29
5 30+
3. Usually, how soon after waking up do you smoke your first cigarette?
5 0-5 minutes
4 6-15 minutes
3 16-30 minutes
2 31-60 minutes
1 61+ minutes
4. For you, quitting smoking for good would be:

5 Impossible
4 Very difficult
3 Fairly difficult
2 Fairly easy
1 Very easy
Please indicate whether you agree with each of the following statements:
1 Totally disagree
2 Somewhat disagree
3 Neither agree nor disagree
4 Somewhat agree
5 Fully agree
5. After a few hours without smoking I feel an irresistible urge to smoke.

6. The idea of not having any cigarettes causes me stress.
7. Before going out, I always make sure that I have cigarettes with me.
8. I am a prisoner of cigarettes.
9. I smoke too much.
10. Sometimes I drop everything to go out and buy cigarettes.
11. I smoke all the time.
12. I smoke despite the risks to my health.
The CDS total scores are sums of all of the relevant 5 or 12 items.
Items included in the CDS-5.

417
Appendix 6.
The Nicotine Dependence Syndrome Scale (NDSS)
Circle the number that indicates how well each of the following statements describes you:
1 Not at all true

2 Somewhat true
3 Moderately true
4 Very true
5 Extremely true
1. After not smoking for while, I need to smoke to relieve feelings of restlessness and irritability.
2. Whenever I go without a smoke for a few hours, I experience craving.
3. After not smoking for a while, I need to smoke in order to keep myself from experiencing any discomfort.
4. When Im really craving a cigarette, it feels like Im in the grip of some unknown force that I cannot control.
5. I feel a sense of control over my smoking. I can "take it or leave it" at any time.
6. I tend to avoid restaurants that don't allow smoking, even if I would otherwise enjoy the food.
7. Sometimes I decline offers to visit with my non-smoking friends because I know that I'll feel uncomfortable if I smoke.
8. Even if traveling a long distance, I'd rather not travel by airplane because I wouldn't be allowed to smoke.
9. Since the time when I became a regular smoker, the amount I smoke has either stayed the same or has decreased
somewhat.
10. Compared to when I first started smoking, I need to smoke a lot more now in order to get what I want out of it.
11. Compared to when I first started smoking, I can smoke much, much more now before I start to feel nauseated or ill.
12. Its hard to estimate how many cigarettes I smoke per day because the number often changes.
13. My smoking pattern is very irregular throughout the day. It is not unusual for me to smoke many cigarettes in an
hour, then not have another one until hours later.
14. The number of cigarettes I smoke per day is often influenced by other factors how Im feeling, what Im doing, etc.
15. I smoke at different rates in different situations.
16. My smoking is not much affected by other things. I smoke about the same amount whether I'm relaxing or working,
happy or sad, alone or with others, etc.
17. My cigarette smoking is fairly regular throughout the day.
18. I smoke consistently and regularly throughout the day.
19. I smoke about the same amount on weekends as on weekdays.
Scoring for the NDSS involves multiplying the item score by a factor loading score and then summing the factor-corrected
scores for each subscale and for the total scale. See Shiffman et al. (2004) for the factor loadings.
418
Appendix 7
Appendix 7.
Wisconsin Inventory of Smoking Dependence Motives (WISDM)
Below are a series of statements about cigarette smoking. Please rate your level of agreement for each, using the following scale:
1 = Not true of me at all
2
3
4
5
6
7 = Extremely true of me
1. I enjoy the taste of cigarettes most of the time.

2. Smoking keeps me from gaining weight.
3. Smoking makes a good mood better.
4. If I always smoke in a certain place it is hard to be there and not smoke.
5. I often smoke without thinking about it.
6. Cigarettes control me.
7. Smoking cigarettes improves my mood.
8. Smoking makes me feel content.
9. I usually want to smoke right after I wake up.
10. Very few things give me pleasure each day like cigarettes.
11. Its hard to ignore an urge to smoke.
12. The flavor of a cigarette is pleasing.
13. I smoke when I really need to concentrate.
14. I can only go a couple hours between cigarettes.
15. I frequently smoke to keep my mind focused.
16. I rely upon smoking to control my hunger and eating.
17. My life is full of reminders to smoke.
18. Smoking helps me feel better in seconds.
19. I smoke without deciding to.
20. Cigarettes keep me company, like a close friend.
21. Few things would be able to replace smoking in my life.
22. Im around smokers much of the time.
23. There are particular sights and smells that trigger strong urges to smoke.
24. Smoking helps me stay focused.
25. Smoking helps me deal with stress.
26. I frequently light cigarettes without thinking about it.
27. Most of my daily cigarettes taste good.
28. Sometimes I feel like cigarettes rule my life.
29. I frequently crave cigarettes.
30. Most of the people I spend time with are smokers.
31. Weight control is a major reason why I smoke.
32. I usually feel much better after a cigarette.
33. Some of the cigarettes I smoke taste great.
34. Im really hooked on cigarettes.
35. Smoking is the fastest way to reward myself.
36. Sometimes I feel like cigarettes are my best friends.
37. My urges to smoke keep getting stronger if I dont smoke.
38. I would continue smoking, even if it meant I could spend less time on my hobbies and other interests.
39. My concentration is improved after smoking a cigarette.
40. Seeing someone smoke makes me really want a cigarette.
41. I find myself reaching for cigarettes without thinking about it.
42. I crave cigarettes at certain times of the day.
43. I would feel alone without my cigarettes.
419
Appendix 7.
Wisconsin Inventory of Smoking Dependence Motives (WISDM)
44. A lot of my friends or family smoke.

45. Smoking brings me a lot of pressure.
46. Cigarettes are about the only thing that can give me a lift when I need it.
47. Other smokers would consider me a heavy smoker.
48. I feel a strong bond with my cigarettes.
49. It would take a pretty serious medical problem to make me quit smoking.
50. When I havent been able to smoke for a few hours, the craving gets intolerable.
51. When I do certain things, I know Im going to smoke.
52. Most of my friends and acquaintances smoke.
53. I love the feeling of inhaling the smoke into my mouth.
54. I smoke within the first 30 minutes of awakening in the morning.
55. Sometimes Im not aware that I am smoking.
56. Im worried that if I quit smoking Ill gain weight.
57. Smoking helps me think better.
58. Smoking really helps me feel better if Ive been feeling down.
59. Some things are very hard to do without smoking.
60. Smoking makes me feel good.
61. Smoking keeps me from overeating.
62. My smoking is out of control.
63. I consider myself a heavy smoker.
64. Even when I feel good, smoking helps me feel better.
65. I reach for cigarettes when I feel irritable.
66. I enjoy the sensations of a long, slow exhalation of smoke.
67. Giving up cigarettes would be like losing a good friend.
68. Smoking is the easiest way to give myself a lift.
WISDM Subscale Scores = Mean of all subscale items
WISDM Total Score = Sum of all the subscale means
WISDM Subscale Items

Affiliative Attachment #20, 36, 43, 48, 67
Automaticity #5, 19, 26, 41, 55
Loss of Control #6, 28, 34, 62
Behavioral Choice/Melioration #10, 21, 35, 38, 46, 49, 68
Cognitive Enhancement #13, 15, 24, 39, 57
Craving #11, 29, 37, 50
Cue exposure/Associative Process #4, 17, 23, 40, 42, 51, 59
Negative Reinforcement #7, 18, 25, 32, 58, 65
Positive Reinforcement #3, 8, 45, 60, 64
Social/Environmental Goals #22, 30, 44, 52
Taste/Sensory Process #1, 12, 27, 33, 53, 66
Tolerance #9, 14, 47, 54, 63
Weight Control #2, 16, 31, 56, 61
420
Appendix 8
Appendix 8.
The Fagerstrm Test for Nicotine Dependence-Smokeless Tobacco
(FTND-ST)
1. How soon after you wake up to do you place your first dip?
Within 5 min 3
630 min 2
3160 min 1
After 60 min 0
2. How often do you intentionally swallow tobacco juice?
Always 2
Sometimes 1
Never 0
3. Which chew would you hate to give up most?
The first one in the morning 1

Any other 0
4. How many cans/pouches per week do you use?
More than 3 2
23 1
1 0
5. Do you chew more frequently during the first hours after awakening than during the rest of the day?
Yes 1
No 0
6. Do you chew if you are so ill that you are in bed most of the day?
Yes 1
No 0
421
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Appendix 9.
Quantitative Measures of Constructs to Assess Labelling Policies
I. Quantitative Measures
Health Warnings - Awareness
Measure Are you aware of any recent changes to health warnings on cigarette packs? (Yes, No)
Source Borland & Hill, 1997b
Outcome Almost universal awareness among adult smokers in Australia.
Measure Have you noticed any changes to the health warnings on cigarette packages? (Yes, No)
Outcome Almost universal awareness among general population in Canada, including non-smokers
and youth.
Measure Have you ever seen health warning messages on cigarette packages? (Yes, No)
Outcome Almost universal awareness among adult smokers in Canada.
Measure Have you noticed any changes to the warning labels on cigarette packs since [6 month
anchor]? (Yes, No)
Does the pack you are currently smoking have the new warnings? (Yes, No)
Outcome Used to evaluate the implementation of new UK warnings in 2003; high levels of awareness.
Measure Have you seen the new warning labels which include pictures? (Yes, No, Dont know)
Source Koval et al., 2005
Outcome Young adults: Current smokers and experimental/ex-smokers were more likely to have seen
new pictorial warning labels than never-smokers.
422
Appendix 9
Appendix 9.
Quantitative Measures
Health Warnings - Looking/Reading
Measure About how often do you find yourself looking at, or reading health warning messages on cigarette
packages? (Never, Less than once a week, About once a week, Once every 2 or 3 days, About once
a day, Several times per day)
Outcome Increased significantly following the implementation of new pictorial warnings.
Measure In the last month, that is, since [date], how often, if at all, have you noticed the warning labels on
cigarette packs? (Never, Rarely, Sometimes, Often, Very Often)
In the last month, how often, if at all, have you read or looked closely at the warning labels on
cigarette packs? (Never, Rarely, Sometimes, Often, Very Often)
Outcome Measures of noticing and reading strongly associated with the size and comprehensiveness of
warnings among Canadian, USA, UK, and Australian adult smokers. Changes in the warnings were
associated with increases in noticing and reading in the UK.
Depth of Processing
Measure In the past 3 months, how carefully have you ever read the inside messages in cigarette packs?
(5-point Likert scale)
In the past 3 months, how carefully have you ever read the outside messages in cigarette packs?
In the past 3 months, how often have you thought about what the inside warnings have to say?
In the past 3 months, how often have you thought about what the outside warnings have to say?
In the past 3 months, have you ever talked about the new warning labels with other smokers or non-
smokers? (Never, Rarely, Sometimes, Often, All the time)
In the past 3 months, have you ever thought about the warning labels or what they had to say when
a cigarette pack wasn't in sight? (Never, Rarely, Sometimes, Often, All the time)
In the past 3 months, have you ever saved or held on to a warning label after you had finished the
pack? (Yes, No)
Outcome Depth of Processing scale consisting of these measures was associated with intention to quit (cross-
sectional analyses), as well as future cessation-related behaviour (decreases in consumption, attempt
to quit, or abstinence) at 3-month follow-up, adjusting for demographics, intentions to quit, and
measures of consumption.
423
Appendix 9.
Health Warnings - Discussions with Others
Measure Did the box encourage you to talk about smoking with other people? (Never, Sometimes,
Often)
Over the past 4 weeks, have you discussed smoking with other people? (Never,
Sometimes, Often)
Source Christie & Etter, 2004
Outcome After four weeks using cigarette pack covers with health warnings, almost one third (32%)
said that the boxes often prompted discussions about smoking with others, 51% responded
sometimes, and 16% said never.
Measure How often have people you know mentioned or discussed the new warnings on cigarette
packs in conversations with you? (Frequently, Sometimes, Rarely, Never)
Outcome More than 80% of people had people they know discuss the new warnings.
Health Warnings - Media Sources
Measure In the last 6 months, have you noticed advertising or information that talks about the
dangers of smoking, or encourages quitting in any of the following places? (Yes, No to a
list of 9 sources, including on cigarette packages)
Outcome Between country differences observed: noticing information on cigarette packs was strongly
associated with the size and strength of the warning in Canada, USA, UK, and Australia.
Package warnings were the second most common source of health information after
television.
Emissions - Looking/Reading
Measure Overall, how often do you find yourself looking at, or reading, the information about
chemicals and substances on the side of cigarette packages? (Never, Less than once a
week, About once a week, Once every 2 or 3 days, About once a day, Several times per
day)
Outcome Descriptive: approximately 43% reported never looking at the information on the side of
packages, whereas a quarter reported looking at the side once per week or more often.
424
Appendix 9
Appendix 9.
Measure In the last month, how often have you read or looked closely at the information about the
contents on the side of the pack? (Never, Rarely, Sometimes, Often, Very often)
Outcome Descriptive: approximately 43% reported never looking at the information on the side of
packages, whereas a quarter reported looking at the side once per week or more often.
More than one half reported using the higher number in the range, mainly because it was
most harmful.
Health Warnings Eye Tracking
Measure Eye tracking: Participants wore eye-tracking equipment and viewed USA cigarette adver-
tisements with health warnings.
Source Fischer et al.,1989b
Outcome Average attention to warning was 8% of viewing time; the health warning was not viewed
at all in almost half of all cases (44%). Viewing time associated with subsequent
recall/recognition of health warnings.
Measure Eye tracking: Participants wore eye-tracking equipment and viewed cigarette ads with health
warnings, including existing mandated warnings in the USA and newly developed warnings.
Source Krugman et al., 1994
Outcome The new warnings were more likely to attract attention, attract attention in a shorter period
of time, although were less likely to hold attention over time.
Health Warnings Viewing Time
Measure Health warnings were flashed on a screen and the amount of time was recorded.
Source Peters et al., 2007
Outcome Longer viewing times were associated with picture warnings compared to text warnings.
Health Warning - Location
Measure Where on the cigarette packages have you seen warning labels? (Presented with diagram)
Circle all of the real warnings that you have actually seen on packages of cigarettes. (Four
actual and four false)
Source Robinson & Killen, 1997

Outcome Increased knowledge of pack warnings associated with higher levels of smoking.
425
Appendix 9.
Measure Without looking at a cigarette package, where on the pack are the warnings or messages
located? (Open ended)
Outcome Participants showed good recall of outside warnings; lesser recall of inside warnings.
Measure Where are the warnings on Canadian cigarette packages located? (Open ended)
Source Environics Research Group, 2003
Outcome Participants showed good recall of outside warnings; lesser, though still high, recall of inside
warnings.
Measure Knowledge of the presence and location of health warnings on packages.
Source Richards et al., 1989
Outcome 67% knew the warnings were on the side of the pack (91% of current smokers versus 60%
of non-smokers).
Health Warning Content
Measure As far as you know, what do the health warnings on cigarette packets say? (Open ended)
Source Hill, 1988
Outcome 86% knew at least one health warning. 97% of smokers could provide text of a warning;
smokers more knowledgeable about warning content. Knowledge of warnings may be
associated with intention to quit.
Measure Smokers were asked about the content of US Surgeon Generals warnings on cigarette
packages.
Source Richards et al., 1989
Outcome Very few (7%) knew there were four different warnings. Content knowledge was low: 22%
no knowledge, 48% knew general theme (health), 28% knew one specific theme, 1% knew
wording for one. Smokers and non-smokers had similar results.
Measure Circle all of the real warnings that you have actually seen on packages of cigarettes.
(Four actual and four false)
Source Robinson & Killen, 1997
Outcome Increased knowledge of pack warnings associated with higher levels of smoking.
Measure As far as you know, what do the health warnings on the front of cigarette packs say?
(Open ended)
Outcome Increase in knowledge following implementation of more comprehensive policy.
426
Appendix 9
Appendix 9.
Measure Students were asked to list everything they could remember about a cigarette package after
they had viewed an image for approximately one minute.
Source Rootman et al., 1995
Outcome Students in Canada were more likely to recall the health warning on Canadian packages
(83%) than USA students were to recall warnings on USA packages (6%).
Measure I'm now going to describe some warning labels or messages that may or may not be on
cigarette packages. I'd like you to tell whether you remember seeing each on packs, by
answering yes or no. (Recognition: four actual, four false warnings)
Which of the following types of information are provided either on the outside or the inside
of cigarette packages? (Recognition: seven actual, one false)
Can you recall any specific quit-tips that appear on cigarettes packs? (Open ended)
Outcome Respondents provided a range of responses. The mouth cancer warning was the most
common response.
Measure In your own words, write or describe the health warnings you remember. (Open ended)
Source Health Canada Youth Smoking Survey (Brown et al., 2005)
Outcome Respondents provided a range of responses. Mouth cancer and impotence most
commonly recalled warnings.
Measure Without looking at a cigarette package, what specific health warning messages can you
remember seeing on cigarette packages in Canada? (Open ended)
Outcome Respondents provided a range of responses. The mouth cancer warning was the most
common response.
Measure Participants were asked to identify current USA labels (Score out of four)
Source OHegarty et al., 2006
Outcome Descriptive only: approximately half identified at least three of the four warning messages
on USA cigarette packs.
Emission Side Panel - Content
Measure Without looking at anything, what, if any, chemicals or substances can you name that are
in cigarettes or cigarette smoke? (Open ended)
427
Appendix 9.
Without looking at a cigarette package, as far as you know, are any chemicals or
substances currently listed on cigarette packages in Canada (Yes, No)
Without looking at a cigarette package, can you name any chemicals or substances that are
currently listed on cigarette packages in Canada? (Open ended)
Outcome Higher recall for nicotine (64%) and tar (53%) than the four other emissions listed on
packages (<25%). Daily smokers more likely to recall other emissions.
Measure Without looking at a pack, can you tell me the tar level of your cigarettes? (Open ended)
Source OConnor et al., 2006c
Outcome Very few were able to correctly recall tar level. Smokers living in a country where the tar
numbers were listed on packs were more likely to report the tar level.
Measure Can you tell me, in milligrams, the tar content of your cigarettes? (Open ended)
Smokers were asked where they could obtain information on the yield of the cigarette brand
they smoked. (5 point scale: Very low (1-3mg), Low (4-6mg), Medium (7-9mg), High
(10-12mg), Very high (10-12mg))
Source Chapman et al., 1986
Outcome Only 2% of smokers correctly recalled the ISO tar level and a majority underestimated the
level of their own brand.
Measure What is the tar number of the cigarettes you smoked most recently? (Open ended) Is a
[5mg/16mg] tar cigarette lower in tar than most cigarettes on the market? (Yes, No)
Source Cohen, 1996b
Outcome Few smokers knew the tar level of cigarettes, with the exception of those who smoked
cigarettes in the 1-5mg FTC tar range.
Health Warnings Affective Reactions
Measure Some people have reported that the warning labels have made them feel different types of
emotion. On a scale from 1 to 5 where, 1 is not at all and 5 is extremely, have the warning
labels made you feel: fearful, amused, disgusted, angry?
Outcome Respondents who reported greater negative emotional responses were more likely to
engage in cessation-related behaviour (i.e. attempts to quit, reductions in consumption, or
abstinence) at 3-month follow-up.
428
Appendix 9
Appendix 9.
Measure Response to smoking-related image or word cues on four adjective pairs (e.g. good-bad,
positive-negative, favorable-unfavorable, and like-dislike)
How does this warning label make you think and feel about cigarette smoking? on a 9-point
scale (4 = extremely negative to +4 = extremely positive)
Outcome Canadian labels produced more negative affective reactions to smoking cues and to the
smoker image, among both smokers and nonsmokers, without signs of defensive reactions
from smokers. Participants in the Canadian label condition reported that their warning labels
made them feel more negative toward smoking than those in the US label condition.
Health Warnings Avoidance
Measure Since the beginning of the year, have you ever concealed the warning messages on your
cigarette package, either by placing a cardboard sleeve or other cover over your package,
OR by transferring your cigarettes to another container? (Yes, No for each option)
Do you currently do this with your cigarettes all the time, occasionally, rarely, or never?
Outcome Descriptive only.
Measure I try my best to avoid thinking about the warning labels. (Strongly disagree, Somewhat
disagree, Neutral, Somewhat agree, Strongly agree)
Have you made any efforts to avoid the labels by: (1) covering or hiding the labels? (2)
using another case? (3) any other method? (Yes, No to each question)
Have you ever bought another brand or requested a specific package to avoid a particular
warning label? (Yes, No)
Outcome Approximately 40% reported at least one avoidance behaviour. Avoidance was not asso-
ciated with future cessation related behaviour measured at 3-month follow-up.
Measure In the last month, have you made any effort to avoid looking at or thinking about the warning
labels: (1) by covering the warnings up? (2) by keeping the pack out of sight? (3) by using
a cigarette case or some other pack? (4) by not buying packs with particular labels? (Yes,
No to each question)
429
Appendix 9.
Health Warnings Accuracy
Measure How accurately do you feel the warnings depict the risks to your health? (Very inaccurately,
Somewhat inaccurately, Neutral, Somewhat accurately, Very accurately)
Outcome Fewer than 15% of smokers reported that the information in the pictorial warnings was at
all inaccurate.
Measure The messages are accurate. (Strongly Disagree, Somewhat disagree, Somewhat agree,
Strongly Agree)
The messages provide you with important information about the health effects of smoking
cigarettes. (Strongly Disagree, Somewhat disagree, Somewhat agree, Strongly Agree)
Outcome Descriptive only: Fewer than 10% of adults or youth disagreed that the warnings were
accurate, while approximately 20% or less disagreed that the messages provide important
information about health risks.
Health Warnings Believability
Measure Credibility: 7 point bi-polar scale (informative-uninformative).
Source Loken & Howard-Pitney, 1988
Outcome Specific warnings on US cigarette advertisements were rated as credible.
Measure In your opinion, are each of the following sources of information about the chemicals and
substances in cigarettes and cigarette smoke very, somewhat, not very, or not at all
trustworthy ...? (1) Canadian Cancer Society, (2) Health Canada, (3) Tobacco companies
Outcome Well respected, non-governmental organisations and Health Canada were found to be highly
credible sources of health information, whereas the tobacco companies were not.
Measure How much do you believe the information in the warning label is true or false? on a 9 point
scale (4 = completely false to +4= completely true).
US participants were asked whether Canadian labels should be used in the USA.
Outcome No differences in the believability of text or graphic warnings. A majority of both smokers and
nonsmokers endorsed the use of Canadian labels in the USA.
430
Appendix 9
Appendix 9.
Measure Do you believe the health warnings that you see on cigarette packages? (Yes, No, Not
sure, I havent see them)
Sources Health Canada Youth Smoking Survey, 2002; Brown et al., 2005 (http:// www.hcsc.gc.ca/hl-
vs/pubs/tobac-tabac/yss-etj-2002/index-eng.php)
Outcome Almost universal agreement among youth that the health warnings were believable.
Measure Perceived Believability Scale: Unbelievable/Believable, Untrustworthy/Trustworthy, Not

convincing/Convincing, Not credible/Credible, Unreasonable/Reasonable, Dishonest/Honest,
Questionable/Unquestionable, Inconclusive/Conclusive, Not authentic/Authentic, Unlikely/
Likely (Adjective pairs rated on 1-5 Likert scale)
Source Beltramini, 1988
Outcome Respondents smoking behaviour (and demographics) had no effect on perceive believability
of USA health warnings.
Measure Beltraminis 10-item Perceived Believability Scale (see above).
Source Cecil et al., 1996
Outcome Smokers score lower than non-smokers when viewing heath warnings.
Health Warnings Public Opinion/Support
Measure Respondents were asked about the adequacy of current warnings, approval for more
information if it meant that less youth would smoke, and approval of rules to make cigarette
packets less colourful and attractive. (Open ended)
Outcome Descriptive only: Half thought adequate, a third thought there should be more
- 88% approval if caused less youth to smoke
- 60% for less attractive; 87% for less attractive, if reduced uptake
Measure How much do you agree or disagree with cigarette packages having health warning
messages? (Agree a lot, agree a little, Neither agree nor disagree, Disagree a little,
Disagree a lot)
Source Health Canada Youth Smoking Survey, 2002

(http://www.hc-sc.gc.ca/hl-vs/pubs/tobac-tabac/yss-etj-2002/index-eng.php)
Outcome Descriptive only: high levels of support from youth smokers and non-smokers.
431
Appendix 9.
Measure Would you like to see more or less of the following information on cigarette packages?
(More, Less, About right)
1. health risks
2. how to quit
3. benefits of quitting
4. where to get help to quit
5. 1-800 telephone # for info and advice
6. website address
Outcome The majority of smokers reported a desire for more information for each variable. Fewer
than 30% expressed a desire for less health information on packages.
Measure Participants were asked their opinions about the size of the US labels. (Open ended)
Outcome A higher percentage of former smokers than current smokers (62.0% and 40.8%,
respectively) thought that current US labels should be larger.
Emission Labelling - Public Support
Measure Cigarette manufacturers are currently required to list three chemicals - carbon monoxide,
tar, and nicotine, and their amounts on cigarette packages. What do you think about
requiring cigarette manufacturers to add to this list three other chemicals that are found in
tobacco - formaldehyde, benzene, and hydrogen cyanide, and their amounts? (Strongly
support, Somewhat support, Somewhat oppose, Strongly oppose)
Outcome Descriptive only: approximately 90% of the general population indicated support, with
approximately 80% of youth and adult smokers indicating support.
Measure Participants were asked whether they agreed or disagreed that tar yields should be
displayed wherever cigarettes are purchased. (Agree, Disagree, Unsure)
Source Chapman et al., 1986
Outcome 72% agreement.
432
Appendix 9
Appendix 9.
Health Warnings Thinking About Health Risks
Measure In the past 3 months, how have the warning labels affected how much you think about the
health risks of smoking? Have they made you think about health risks: A lot less, A little
less, No difference, A little more, A lot more?
Outcome Associated with intentions to quit cross-sectionally, as well as cessation-related behaviour

at 3-month follow-up when combined with measures of depth of processing.
Measure To what extent, if at all, do the warning labels make you think about the health risks of
smoking? (Not at all, A little, Somewhat, A lot)
Outcome Respondents living in countries with larger, more comprehensive warnings were more likely
to report that the warnings made them think about the health risks of smoking. Changes in
the UK warnings were also associated with increases in thinking about the health risks of
smoking.
Measure Have the new health warnings made you think a lot more about the health effects of
smoking, think a little more, or have they had no impact on how much you think about the
health effects of smoking?
Outcome Descriptive only: approximately half of smokers and non-smokers reported thinking more
about health risks because of the warnings.
Measure This [Canadian] label would make me more worried about the health effects of smoking.
(5-point Likert scale where 5=strongly agree)
Outcome Graphics were rated as more likely to cause worry about the health effects of smoking than
text warnings.
Measure Do you agree or disagree that this warning is likely to prompt people to think more about
the effects of [targeted health risk] on [target group]? (1-Strongly disagree, 2-Disagree, 3-
Neither agree nor disagree, 4-Agree, 5-Strongly agree, 6-Dont know)
Source BRC Marketing & Social Research, 2004
Outcome Question was used to evaluate message targeting similar themes (e.g. the risks of smoking
while pregnant).
433
Appendix 9.
Health Warnings - Concern & Worry About Health Effects
Measure Have the new health warnings made you much more concerned about the health effects
of smoking, a little more concerned, or have they had no impact?
Outcome Descriptive only: approximately 40% of smokers and non-smokers reported thinking more
about health risks because of the warnings.
Health Warnings - Knowledge of Health Effects & Perceived Risk
Measure Thinking about the health warning messages you have seen on cigarette packages, have
these messages been very effective, somewhat effective, not very effective, or not at all
effective in each of the following ways ... Informing you about the health effects of cigarette
smoking? (Not at all effective, Not very, Somewhat, Very Effective)
Outcome A substantial proportion of smokers reported that the pictorial warnings were effective in
informing them about the health effects of smoking.
Measure I am going to read you a list of health effects and diseases that may or may not be caused
by smoking cigarettes. Based on what you know or believe, does smoking cause the
following: (1) heart disease in smokers, (2) stroke in smokers, (3) impotence in male
smokers, (4) lung cancer in smokers, (5) lung cancer in nonsmokers from secondhand
smoke, (6) blindness, (7) mouth and throat cancer, (8) peripheral vascular disease, (9)
asthma in children from secondhand smoke. (Yes, No to each question)
Note: Not all health effects included in every wave.
Outcome Specific health effects were associated with health effects listed on the label in each country.
Measure In your opinion, are there any illnesses caused by smoking? If yes, Which illnesses are
caused by smoking? (Open ended)
Smoking knowledge and attitudes (16 items)
Source Borland & Hill, 1997b
Outcome Smokers reported a greater number of smoking illnesses following implementation of new
text warnings in Australia. Acceptance of statements used in warnings became stronger at
follow-up.
434
Appendix 9
Appendix 9.
Measure Risk scores for smoking, environmental tobacco smoke, susceptibility to lung cancer,
respiratory diseases, and cardiovascular diseases, reduced life expectancy, and others.
Source Portillo & Antonanzas, 2002
Outcome Students attributed a higher health risk to smoking following the presentation of the EU
warnings packages.
Measure Cigarettes cause cancer.

Cigarettes cause strokes and heart disease.
Tobacco smoke causes fatal lung disease in nonsmokers.
(5-pint Likert scale where 5= strongly agree)
Outcome Significantly higher endorsement for two of the three statements following presentation of
graphic versus text only warnings following presentation of the warnings.
Measure I am going to read you a list of human health effects and diseases that may or may not be
caused by smoking cigarettes. Based on what you know or believe, please tell me if you
strongly agree, somewhat agree, somewhat disagree, or strongly disagree that smoking
cigarettes can cause each of the following ... lung cancer, throat cancer, mouth cancer,
emphysema, heart disease, asthma, premature death, chronic bronchitis, gum or mouth
diseases, smaller babies/reduced growth of babies during pregnancy, stroke, wrinkles and
premature ageing, premature birth or preterm birth, blood clots, miscarriages, stomach
ulcers, impotence in men, infertility, bladder cancer, gangrene, acne, multiple sclerosis,
hepatitis, arthritis, Alzheimers disease.
Note: a list of 11 health effects for secondhand smoke was also used.
Outcome Descriptive only
Emissions - Comprehension & Meaning
Measure What in your opinion is the meaning of the tar value of cigarettes? (Open ended)
Is a 10-mg tar cigarette more relevant to health than a 5-gm one, and if so, how much
more? (Yes, No; Open ended)
Source Gori, 1990
Outcome Approximately half reported that tar levels were an indicator of health risk. Overall, very low
understanding of tar levels.
435
Appendix 9.
Measure Could a pack-a-day smoker significantly lower health risks by switching from a 20-mg/16mg
tar cigarette to a 5-mg tar cigarette? (Yes, No)
Assume a person switched from a 10-mg tar cigarette to a 1-mg tar cigarette. Which of the
following is closest to your opinion? The person probably could smoke more than 1, but
these numbers cant tell you how much less tar the person would take in from the 1-mg tar
cigarette. The person could smoke more than 1 or 2, but fewer than 9 or 10, of the 1-mg tar
cigarette without taking in more tar. The person could smoke about 10 of the 1-mg tar
cigarettes without taking in more tar.
Source Cohen, 1996a,b
Outcome Substantial minority of respondents reported that lower tar cigarettes would lower health
risk or result in lower tar exposure.
Measure Tar numbers [appear/used to appear] in advertisements and sometimes on cigarette packs.
As you understand it, how closely, if at all, are the tar numbers related to the amount of tar
that smokers take into their bodies? (Closely related, Somewhat related, Not at all related)
As far as you know, are each of the following chemicals included in cigarette smoke? (1)
cyanide (2) mercury (3) arsenic (4) carbon monoxide. (Yes, No to each question)
Which of the following, if any, helps to indicate whether a cigarette brand COULD be less
harmful compared to others: . The tar or nicotine levels for a brand?
1 A little less harmful
2 No different
3 A little more harmful
Outcome Knowledge of chemicals was associated with labeling policy among smokers in Canada, the
USA, UK, and Australia: if the emission was printed on the package, participants were more
likely to report it was in smoke.
Measure Which of the following do you think is closest to the total number of chemicals or substances
that are found in cigarettes or cigarette smoke? Is the total number closest to (3, 6, 15, 500,
1000, 4000, 5000)?
Here are questions about some of the chemicals that are listed on the cigarette packs.
What specific health effects, if any, can you name that can be caused by(Each of 6
chemicals on side panel of package: tar, nicotine, CO, benzene, formaldehyde, hydrogen
cyanide)? (Open ended)
A range of numbers is reported beside each chemical on the side of the cigarette pack. For
example, a pack may say Tar 13 to 31mg. What does this range mean? (Open ended)
Do you think the range of numbers listed for a chemical on the pack means ...? (All cigarettes
in that pack will have the same amount of a chemical, but those in another pack of the same
brand may have more or less. Some cigarettes in that pack may have larger amounts of a
chemical and others in the pack may have less. Some smokers may take in larger amounts
of a chemical and other smokers may take in less. Combination of the above.)
436
Appendix 9
Appendix 9.
Now, still thinking about the numbers that go with the chemicals that are listed on the side
of a cigarette package, have you frequently, sometimes, rarely, or never done each of the
following ...?
Talked about/compared amounts with another smoker.
Used amounts to inform about health hazards of own/other brand.
Used amounts to look for brand that may be less harmful.
Used amounts to look for/try another brand close to own.
Used amounts as step to quit smoking.
If you were to look for a safer or less harmful cigarette, do you think you would or would not
use the information about the amounts of chemicals listed on the cigarette packs to help you
find a less harmful brand? (Yes or Maybe, No, None less harmful)
Outcome Generally, low knowledge of health effects and very little understanding of what the range
of numbers on Canadian cigarette packages means. Nevertheless, over half indicated they
would use the emission information to identify a less harmful cigarette brand.
Light & Mild Descriptors - Health
Measure Compared with smoking regular cigarettes, would smoking light cigarettes increase,
decrease, or have no effect on your risk of having health problems? Is that GREATLY
increase [decrease] or SOMEWHAT increase [decrease]?
If the number 100 stood for the risk to health from a regular cigarette, and 1 stood for the
risk to health for a nonsmoker, what number stands for the risk to the health of a smoker of
light cigarettes?
Source Kozlowski et al., 2000

Outcome The numerical 1-100 approach was found to be misleading relative to the ordered
categorical approach.
Measure How many light cigarettes would someone have to smoke to get the same amount of tar
as from one regular cigarette? (Open ended respondent to provide number of cigarettes,
or also could respond dont know)
Now Im going to ask you about reasons some people might give for smoking [light or ultra-
light, according to self-reported usual type] cigarettes. For each one, please tell me whether
it is one of your reasons for smoking [light or ultra-light] cigarettes.
Do you smoke [light or ultra-light] cigarettes as a step toward quitting smoking completely?
Do you smoke [light or ultra-light] cigarettes to reduce the risks of smoking without having
to give up smoking?
Do you smoke [light or ultra-light] cigarettes to reduce the tar you get from smoking?
Do you smoke [light or ultra-light] cigarettes to reduce the nicotine you get from smoking?
Do you smoke [light or ultra-light] cigarettes because you prefer the taste compared to
regular cigarettes?
If the response were yes to any of these reasons, smokers were asked: How important is
this reason to you? Is it very important or somewhat important?
437
Appendix 9.
Source Kozlowski et al., 1998b
Outcome The majority of smokers reported that lights would deliver lower amounts of tar and nicotine
than regular cigarettes - a misconception.
Measure Health knowledge summative score (from 8/10 items in 1996/2000 respectively)
Perceptions of light/mild cigarettes
Reasons for smoking light/mild
Source Ashley et al., 2001
Outcome Approximately one quarter of smokers said they smoked lights to reduce health risks, 40%
replied to smoke light/mild as a step toward quitting, and 41% said they would be more likely
to quit if they knew that light cigarettes provided the same amount of tar and nicotine as
regular cigarettes.
Measure Respondents were asked whether light/ultra-light cigarettes in comparison to regular

cigarettes were safer, healthier, and less likely to cause cancer. (5 point scale ranging from
1 = definitely not true to 5 = definitely true)
Respondents were asked to estimate the number of light and ultra-light cigarettes,
respectively, someone would have to smoke to get the same amount of tar in one regular
cigarette.
Respondents asked to estimate the risk of smoking lights and ultra-lights, respectively,
relative to the risk of not smoking (designated 0) and the risk of smoking regulars
(designated 10).
Source Shiffman et al., 2001
Outcome On average, smokers believed that lights afforded a 25% reduction in risk, and ultra-lights
a 33% reduction in risk.
Light and ultra-light cigarette smokers evaluated the risks of their own cigarette types more
favourably.
On average, half of all smokers thought that it was necessary to smoke two light cigarettes
and three ultra-light cigarettes to get as much tar as from a single regular cigarette.
Believing that lights and ultra-lights delivered less tar and nicotine independently contributed
to the belief that these cigarettes were safer.
Measure In your opinion, how many (a) light and (b) ultra-light cigarettes would someone have to
smoke to inhale the same amount of nicotine as from one regular cigarette? (Open ended)
Source Etter et al., 2003c
Outcome On average, participants reported one would have to smoke two light cigarettes or four ultra-
light cigarettes to inhale the same amount of nicotine from one regular cigarette.
438
Appendix 9
Appendix 9.
Measure Smokers were exposed to print advertisements for light and regular cigarettes and asked to
rank the products on health risk, amount of tar, and carcinogenicity, and identified the
messages they perceived the advertisements to convey. (Rating scale from 1-10)
Source Hamilton et al., 2004
Outcome Respondents perceived lights as having significantly lower health risks and carcinogen
levels than regular cigarettes.
Measure The next question is about the amount of tar smokers take into their lungs from smoking
cigarettes. Compared to smokers of regular cigarette brands, do smokers who smoke
[participants brand] take in: a lot less tar into their lungs than smokers of regular cigarettes,
a little less, about the same amount, a little more tar, a lot more tar into their lungs?
For the following questions, I will refer to all types of light, mild, and low tar cigarettes as
light cigarettes. Please tell me if you strongly agree, agree, neither agree nor disagree,
disagree, or strongly disagree with each of the following statements about light cigarettes:
Light cigarettes are less harmful than regular cigarettes.
Smokers of light cigarettes take in less tar than smokers of regular cigarettes.
How many light cigarettes would you have to smoke to harm you as much as 10 regular
cigarettes would? (Far fewer light cigarettes than 10, Somewhat fewer, Same number of
light cigarettes, Somewhat more, Far more light cigarettes than 10)
Do you think that the brand you usually smoke, [current brand], might be a little less harmful,
no different, or a little more harmful, compared to other cigarette brands?
2 No different
Which of the following, if any, helps to indicate whether a cigarette brand COULD be less
harmful compared to others: .Words in the name of the brand, such as light or mild?
2 No different
Outcome A majority of smokers surveyed in each country, except Canada, continue to believe that
light cigarettes offer some health benefit compared to regular cigarettes (Canada 43%, USA
51%, Australia 55%, UK 70%). A majority of smokers in all four countries believed that light
cigarettes are smoother on the throat and chest than regular cigarettes. Predictors of use
of light cigarettes and beliefs about possible benefits were very similar in the four countries.
439
Appendix 9.
Measure Which of the following do you think is true: a light cigarette has more tar than a regular one,
a light cigarette has less tar, or a light cigarette has the same amount of tar as a regular
Which of the following do you think is true: a light cigarette has more nicotine than a regular
one, a light cigarette has less nicotine, or a light cigarette has the same amount of nicotine
as a regular?
If you switched to [light/regular] cigarettes, how do you think this would affect your daily
intake of nicotine? (Increase, Decrease, Remain same, Depends on cigarette)
If you switched to [light/regular] cigarettes, how do you think this would affect your daily
intake of tar? (Increase, Decrease, Remain same, Depends on cigarette)
Source Castrucci & Gerlach, 2007
Outcome The majority of smokers say that lights have less tar and/or nicotine, ultra-light smokers
more likely to say these have less. In addition, 63.0% of light and 73.0% of ultra-light
smokers reported that switching would increase their intake of tar and nicotine.
Light & Mild Descriptors - Sensory Properties
Measure When you smoke a cigarette, is it easy or difficult to tell if it is a regular strength variety or
a light one, just from the experience of smoking it? (Open ended)
Light cigarettes are smoother on your throat and chest than regular cigarettes. (Strongly
agree, Agree, Neither agree nor disagree, Disagree, Strongly Disagree)
Sources The ITC Project; Borland et al., 2004
Outcome The majority of smokers contacted in Australia, Canada, UK, and USA believe light cigarettes
are smoother on their throat and chest than regular cigarettes.
Measure 3-item Sensation index:

You cough less smoking lights.
Lights feel smoother on your throat.
Lights feel easier on your chest.
Source Shiffman et al., 2001
Outcome Believing that lights and ultra-lights were less harsh independently contributed to the belief
that these cigarettes were safer.
440
Appendix 9
Appendix 9.
Light & Mild Descriptors - Addiction
Measure For the following statement/question, I will refer to all types of light, mild, and low tar
cigarettes as light cigarettes. Please tell me if you strongly agree, agree, neither agree nor
disagree, disagree or strongly disagree with each of the following statements about light
cigarettes:
Light cigarettes make it easier to quit smoking.
Do you believe that [light/ultra-light] cigarettes are more addictive, as addictive, or less
addictive than regular cigarettes?
Outcome A minority of respondents reported that light/mild cigarettes may be less addictive.
Other Brand Descriptors
Measure Which, if any, of the following terms on cigarette packs mean that the cigarettes are
supposed to be some form of light, mild, or low-tar cigarette? (Yes, No to each)
1 Smooth
2 Refined
3 Generous
4 Ultra
Do you think that the brand you usually smoke, [current brand], might be a little less harmful,
no different, or a little more harmful, compared to other cigarette brands?
2 No different
Outcome None to date.
Attractiveness
Measure How good is this advertisement? (0-very bad, to 20-very good)

How familiar is this advertisement? (0-very bad, to 20-very good)
Do you want to smoke a cigarette? (-5-would hate to, to +5-very much indeed)
Source Hyland & Birrell, 1979
Outcome Presentation of a health warning increased desire to smoke. Presence of warning decreased
perceived goodness of ad; did not affect perceived familiarity.
441
Appendix 9.
Measure Attractiveness scale: 7-point bipolar scale (attractive-unattractive).
Source Loken & Howard-Pitney, 1988
Outcome Specific warnings on cigarette advertisements can act as a counter-influence to an ads

appeal by making it appear less attractive and less persuasive than if the ad contained only
a general warning, particularly for smokers.
Measure Products shown to adolescents with/without warnings.

Would you ever use this product? (6 point scale from absolutely, definitely would not use
it to absolutely, definitely would use it)
Would most kids your age use it? (6 point scale from absolutely, definitely would not use
it to absolutely, definitely would use it)
Source Brubaker & Mitby, 1990
Outcome Less than half (43%) exposed to warnings recalled seeing them; a third of those who noticed
the warnings recalled the message content.
Measure Do you think the new warnings make cigarettes packages look less attractive, more
attractive, or has it made no difference to their attractiveness?
How often have you put your cigarette package away because you didnt want others to see
the warning on the package? Have you done this? (Often, Sometimes, Rarely, Never)
Health Warnings Consumption Patterns
Outcome Over half of smokers (63%) reported that the warnings make cigarette packages look less
attractive, and approximately one third of smokers reported that they prefer to purchase a
pack without the new warnings.
Measure Are you less inclined or more inclined to purchase cigarettes that contain the new
warnings?
If, when buying cigarettes from a shop or a vending machine, you were able to choose
between a pack with or without the new warnings, which one would you buy?
Source Willemsen, 2005
Outcome Approximately one third of smokers reported that they prefer to purchase a pack without
the new warnings; 14% became less inclined to purchase cigarettes because of the new
warnings.
Measure Auction method: smokers placed separate bids on two packs of cigarettes; one with a text-
only warning and the other with a graphic image of a smoker with cancer.
442
Appendix 9
Appendix 9.
Source Thrasher et al., 2007
Outcome The pack with a graphic image had a mean attributed value which was 17% lower ($3.21
pesos) than the normal pack with the text warning, and this difference was consistent and
statistically significant across sociodemographic groups, extent of smoking, quit attempts,
and levels of perceived smoking risks.
Measure How often, if at all, have you been tempted to have a cigarette but decide not to because
of the new warnings on the packs? (Once, A few times, Many times, Never)
What impact have the new warnings had on your smoking behaviour inside your home?
Have they motivated you to smoke much less inside your home, somewhat less, or have
they had no impact?
Outcome One fifth of smokers indicated that the warnings had stopped them from having a cigarette,
and approximately one quarter reported smoking less in the home as a result of the
warnings.
these messages been very effective, somewhat effective, not very effective, or not at all
effective in each of the following ways ...
Getting you to smoke less around others over the past year than you used to.
Getting you to smoke less this year than last year.
Outcome Descriptive only: responses to all measures increased following implementation of larger
pictorial warnings.
Measure In the past 3 months, have the warning labels made you smoke: a lot less, a little less, no
difference, a little more, a lot more?
In the past 3 months, have the warning labels ever made you delay before lighting up or
butt out a cigarette early? (5 point Likert scale)
Source Hammond et al, 2004a
Outcome Approximately one fifth of Canadian smokers reported that the pictorial warnings had made
them smoke less; less than 1% reported smoking more as a result of the warnings.
Measure In the last month, have the warning labels stopped you from having a cigarette when you
were about to smoke one? (Never, Once, A few times, Many times)
443
Appendix 9.
Outcome Larger pictorial warnings were associated with a greater likelihood of reporting forgoing a
cigarette among Canada, USA, UK, and Australian smokers.
Measure Are you smoking (somewhat) less or (somewhat) more as a result of the new warnings or
are you still smoking the same amount?
Outcome Approximately 10% of adult smokers reported they smoked less because of the warnings.
Measure Cigarettes smoked per week using data from national survey.
Source Gospodinov & Irvine, 2004 (using data from the Canadian Tobacco Use Monitoring Survey)
Outcome A reduction of 2 cigarettes per week among current smokers in the months following the
implementation of pictorial health warnings.
Health Warnings - Smoking Initiation
Measure Do you think the new warning labels might make some young people less likely to start
smoking? (Yes, No, Dont know)
Do you think the new warnings might make some young people more likely to start
smoking? (Yes, No, Dont know)
Outcome Among young adults, current smokers were less likely than experimental/ex-smokers to
believe that warning labels with stronger messages would make people their age less likely
to smoke. Experimental/ex-smokers were more likely to believe that new warning labels
would make people their age less likely to smoke than never- or current-smokers.
Although only ~8% of current smokers were more likely to believe that new warning labels
might make people their age more likely to smoke.
Health Warnings Motivation to Quit
Measure To what extent have the new warnings increased your motivation to quit smoking? Has
your motivation increased: a lot, a little, not at all?
Outcome Descriptive only: approximately 40% reported the warnings had increased their motivation
to quit.
444
Appendix 9
Appendix 9.
these messages been very effective, somewhat effective, not very effective or not at all
effective in increasing your desire to quit smoking over the past year?
Outcome None to date.
Measure How have the warnings affected the likelihood that you will quit smoking within the next
year? (A lot less likely to quit because of the labels, Somewhat less likely because of the
labels, No difference, Somewhat more likely to quit because of the labels, A lot more likely
to quit)
How have the warning labels affected your self-confidence in your ability to quit? (A lot less
confident in ability to quit, Somewhat less confident, No influence, Somewhat more
confident, A lot more confident)
Source Hammond et al, 2004b
Outcome Approximately one third of smokers reported they were at least somewhat more likely to
quit as a result of the pictorial warnings in Canada, and approximately one quarter reported
that the warnings had made them more confident in their ability to quit.
quit smoking? (Not at all, A little, Somewhat, A lot)
In the past 6 months, have each of the following things led you to think about quitting?
warning labels (Not at all, Somewhat, Very Much). Note: asked a part of a list.
Outcome Larger pictorial warnings were associated with greater proportions of smokers reporting that
the warnings increased their likelihood of quitting among Canada, USA, UK, and Australian
smokers.
Measure Did the new health warnings make you more or less motivated to quit smoking?
Outcome Approximately 18% of Dutch smokers reported that new EU text warnings motivated them
to quit.
Measure This label would motivate me to quit smoking. (5-point Likert scale, with 5=strongly agree)
445
Appendix 9.
Outcome Respondents were significantly more likely to report that graphic warnings would motivate
them to quit smoking compared to text warnings following presentation of the warnings.
Measure Do the new warnings make you think about trying to quit? (Yes, No, Dont know)
In the past month, has noticing the new warnings led you to decide not to have a cigarette?
(Yes, No, Dont know)
Outcome Young adults: ~40% of current smokers said new warnings made them think about trying to
quit; ~25% said noticing warnings led them to not have a cigarette.
Health Warnings Quit Attempts & Abstinence
these messages been very effective, somewhat effective, not very effective or not at all
effective in getting you to try to quit smoking within the past year?
Measure To what extent, if at all, were the following reasons for your current quit attempt warning
labels? (Not at all, Somewhat, Very much). Note: asked as part of a list of different reasons
for quitting.
Outcome Larger pictorial warnings were associated with greater proportions of smokers reported the
warnings as a reason for their quit attempt among Canada, USA, UK, and Australian
smokers.
Measure Prevalence estimates for weekly smokers from national survey.
Source Gospodinov & Irvine, 2004 (using data from the Canadian Tobacco Use Monitoring Survey)
Outcome No discernable change in prevalence rates in the months following the introduction of
pictorial warnings.
Health Warnings - Use of Cessation Services
Measure What was the main reason for calling the quitline? (Open ended)
Source UK Department of Health
Outcome UK pack warnings were the second largest reason cited by callers to the NHS Stop Smoking
Helpline. Between 1,500 and 4,000 callers per month have cited this reason since the written
warnings were introduced in 2003; a 12% increase.
446
Appendix 9
Appendix 9.
Measure Call volume before and after introduction of quitline number on Dutch cigarette packages.
Outcome A 3- to 4-fold increase in call volume between the months before and after the new warnings.
Health Warnings - Quitting Among Former Smokers
Measure How much did the warning labels on cigarette packages influence your decision to quit?
1. No influence on your decision to quit
2. Very little influence on your decision to quit
3. Moderate influence on your decision to quit
4. Strong influence on your decision to quit
5. Main or major influence on your decision to quit
Did the warning labels make it easier or help you to quit?
1. Not at all helpful
2. Only a little bit helpful
3. Moderately helpful
4. Very helpful
5. Extremely helpful
Outcome Asked along with price, bans/bylaws, personal health effects, health effects of others.
stay quit? (Not at all, a little, Somewhat, A lot)
Outcome More prominent warnings associated with higher responses.
Measure To what extent have the new warnings on cigarette packages made you feel better about
being a non-smoker? Have they made you feel a lot better, a little better, or have they had
no impact on you?
Outcome Approximately half of former smokers reported that the warnings had made them feel better
about being an ex-smoker.
Measure This label would motivate me not to start smoking again. (5-point Likert scale)
Outcome Respondents were significantly more likely to report that graphic warnings would motivate
them to remain abstinent compared to text warnings following presentation of the warnings.
447
Appendix 10.
Qualitative Measures from Focus Groups
Focus Groups - Health Warning Noticing & Salience
Measure Does this warning catch your attention? (Open ended)

Does it make you want to read further/know more? (Open ended)
What stands out most to you? (Open ended)
Outcome The picture was generally the first feature people looked at and related to; it determined the
strength of the warning's emotional impact and noticeability. Pictures showing children, or
clearly depicting disease (or diseased people) in some way, were the most effective.
Motivation to read further varied based on the emotional impact of the warning itself and/or
the personal relevance of the particular topic.
Measure Which graphics are most noticeable? Least noticeable? Why? (Open ended)
Which are the most memorable and least memorable graphics? Why? (Open ended)
Why are the warnings memorable? (Open ended)
Source Elliott & Shanahan Research, 2002
Outcome Examined the content of images (e.g. shocking versus non-shocking, attractive versus
unattractive). A variety of images and image styles is most likely to be effective in terms of
maintaining freshness and retaining smoker attention.
Focus Groups - Health Warning Location
Measure Can you describe what is displayed (shown) on a pack of cigarettes? (Open ended)
What would you find when you look at a pack of cigarettes (without actually looking at a
pack)?
Can you describe all that is written on a cigarette pack?
What do you recall about these warnings? What strikes you, what catches your attention?
Now, think only of the images you remember having seen. Describe all the images you can
recall.
Now, forget the images and think of only the words and what was written. Name all the
words you can recall.
For each image recalled, ask: can you recall the words associated with this image?
Source CREATEC, 2003
448
Appendix 10
Appendix 10.
Focus Groups - Health Warning Affective Reactions
Measure Did you notice who made these warnings? (Open ended)
Why do you think Health Canada made these warnings?

Who else should make these warnings?
Outcome Most thought the warnings came from the government.
Measure What do you think/how do you feel about this warning? (Open ended)
What do you think/how do you feel about the picture?
What do you think/how do you feel about the words?
What does this warning tell you about the effects of smoking?
As a smoker, does this warning affect you personally?
Outcome The emotional impact of a warning appeared to predict its ability to inform and/or motivate
thoughts of quitting. The most effective warnings generated a strong emotion supported by
factual information.
Measure Examined emotional reactions to warnings, including positive/negative message approach

(e.g. positive could relate to feeling better by not smoking).
Outcome Graphics had considerable impact on all age groups. Descriptive or emotive messages had
considerable impact for younger smokers. Too much fear is likely to lead to defensiveness
and rationalising of the messages; some warnings and explanatory messages need to
provide support and encouragement.
Focus Groups - Health Warning Believability/Credibility
Measure Are [the messages] truthful, personally relevant? (Open ended; explore more with res-
pondent)
Outcome The relevance of the warnings depended upon the demographic of the smoker.
Measure Do you agree or disagree that any or all of these messages would be more effective being
associated with or sponsored by the Ministry of Health? (Strongly disagree, Disagree,
Neither agree nor disagree, Agree, Strongly agree, Dont know)
For what particular reasons do you say that? (Open ended)
449
Appendix 10.
Outcome A large proportion of participants agreed messages would be more effective if they were
associated with the Ministry of Health, as it gave official credibility.
Measure Do you believe what this warning is saying? (Open ended)
Outcome While new information tended to interest participants, many also wanted proof or evidence
in the form of statistics or clearer pictures. Lack of supporting data was often a key argument
for rejection of disturbing new information. Most participants felt the Health Canada name
lent credibility to the claim in the warning. Some participants tended to refute the message
based on the idea that it was "not only" smoking that caused the illness or situation to occur.
Focus Groups - General Comprehension/Meaning
Measure Overall comprehension are they easy to understand, is the information reliable? Any
comprehension difficulties?
Outcome Any increase in the font size, area of pack devoted to the message, and any contrasting
background will facilitate readability.
All photos and visuals need to be clear and recognizable to enable smokers to easily identify
with the health issue concerned.
Accompanying text messages need to be brief and as simple as possible to enable ease of
comprehension.
Measure What message is this warning trying to get across? (Open ended)
Anything else its trying to say? (Open ended)
What changes would you make to this warning to make it easier to understand? (Open
ended)
Outcome Pictures played the key role in understanding the message, and tended to override the
meaning conveyed by the words in the headline. Some participants tended to take the words
in the headline literally, and often failed to read in-between the lines or to derive an implicit
message.
450
Appendix 10
Appendix 10.
Measure Are [the warnings] interesting and informative? Helpful? Why/why not? (Open ended)
How likely are [you] to read the explanatory messages? Is it curiosity? Information
seeking? (Open ended)
Do the labels raise the salience of health concerns? (Open ended)
Which health topics/issues to do with smoking are smokers most concerned about? Why?
(Open ended)
Outcome Health messages impact increases with participants age. Messages about children and
babies effective in middle age range. Recommend including both factual and personalised
Measure Did you learn something while looking at these warnings? What? (Open ended)
Are these warnings a good way to make you think? Why? Do they inform you? (Open
ended)
Do you take into account what is being said in the warnings? (Open ended)
Measure What does this warning tell you about the effects of smoking? (Open ended)
Anything new here? (Open ended)
After looking at these warnings, what do you remember about what you saw or read?
(Open ended)
Is there anything else? (Open ended)
Outcome Overall, people's attitude towards new information was positive and was sometimes related
to a warning's noticeability. If presented effectively (impactful picture and clear headline),
most wanted more information.
Measure Three standard readability tests: Flesch, Gunnings Fog, Dale/Chall
Source Malouff et al., 1992
Outcome All three methods produced similar results: each of the four US warnings required a reading
level typical of college students/graduates; the three smokeless tobacco warnings required
middle/high school reading levels.
Measure Participants were asked to look at their cigarette packages and instructed to offer what
knowledge they had about each listed ingredient and how it can affect ones health. (Open
ended)
Outcome Low knowledge of health effects
451
Appendix 10.
Focus Groups - Likelihood of Quitting
Measure Do you agree or disagree that this packet (including the warning, picture and text) is likely
to encourage [target group] to quit smoking or think about quitting? (1-Strongly disagree, 2-
Disagree, 3-Neither agree nor disagree, 4-Agree, 5-Strongly agree, 6-Dont know)
Outcome Question was used to evaluate message targeting similar themes (e.g. the risks of smoking
while pregnant).
452
workingproceduresjanvier13:Layout 1 13/01/2009 14:30 Page 453
Working Procedures for the IARC Handbooks of

Tobacco Control
Starting in 2006, the series of undesired health effect. However, evidence on the role of chemical
International Agency for Research in this series of Handbooks compounds, biological and phar-
on Cancer (IARC) Handbooks of dedicated to the evaluation of the maceutical products, behaviours,
Cancer Prevention added tobacco preventive effects of compounds, programmes and interventions in
control as a new area of pre- biological or pharmaceutical pro- reducing tobacco use and de-
vention for their reviews. When ducts, behaviours, programmes creasing tobacco-associated mor-
appropriate, in addition to cancer, and interventions, the traditional bidity and mortality. The aim of the
other health outcomes preven- meaning of the term exposure is Handbook series is to provide the
table by avoiding tobacco use may unfitting. Therefore in several scientific community, policy-
be included for evaluation in a instances the term intervention, makers and governing bodies of
Handbook. which lacks a hazardous con- IARC member states as well as of
The text that follows is notation, is preferred. Examples of other countries with evidence-
organised in two principal parts. interventions with expected based assessments of these
The first addresses the general benefits in the area of tobacco interventions at the individual and
scope, objectives and structure of control are smoking cessation, population levels, with the ultimate
the Handbooks of Tobacco Con- banning of smoking in public goal of assisting in the global
trol. The second describes the places and taxation on cigarettes. implementation of tobacco control
scientific procedures for evalu- The evaluation of their health provisions within national and
ating cancer-preventing agents or effects may be the focus of future international programmes aimed
interventions. Handbooks. at reducing tobacco-related mor-
The Working Procedures bidity and mortality.
described herein are largely taken Part one: General Principles
from the Handbooks of Cancer Objectives
Prevention devoted to Chemo- General Scope
prevention and Screening, and The objective of the programme is
from the IARC Monograph Prea- The prevention and control of to prepare, and to publish in the
mble (updated in January 2006). cancer are the strategic objectives form of Handbooks, critical
The term exposure appears of the International Agency for reviews and consensus evalu-
repeatedly in these procedures, Research on Cancer. Cancer ations of evidence on the pre-
borrowed from the IARC Mono- prevention may be achieved at the ventive effect or risk reduction
graphs devoted to the evaluation individual level by avoiding resulting from interventions fo-
of carcinogenicity. Epidemiological cancer-causing agents and at the cusing on tobacco control, with the
studies conducted to assess the population level by adopting pro- help of an internationally formed
association between exposure to grammes, legislation and regu- Working Group of experts. The
a given hazard and disease lations to reduce exposure to Handbooks may also indicate
outcome are based on the cancer-causing agents. where additional research efforts
meaning of the term exposure The Handbooks of Tobacco are needed, specifically when
implying increased risk to an Control will evaluate the available data immediately relevant to an
453
evaluation are not available. The lished significant research related 2. Invited Specialists are experts
evaluations in the Handbooks are to the topic being reviewed or in who also have critical know-
scientific and qualitative judge- tobacco control in particular. ledge and experience but have
ments of the peer-reviewed pub- Consideration is also given to a real or apparent conflict of
lished data, conducted during a demographic diversity and ba- interest. These experts are
week-long meeting of peer review lance of area of expertise. All invited when necessary to
and discussions by the Working participants are listed, with their assist in the Working Group by
Group. addresses and principal affilia- contributing their unique know-
tions, at the beginning of each ledge and experience during
Topic for the Handbook Handbook volume. subgroup and plenary dis-
cussions. They may also
The topic to be evaluated in a 1. The Working Group is contribute text on the inter-
Handbook is selected approxi- responsible for the critical vention being evaluated.
mately twelve months prior to the reviews and evaluations that Invited Specialists do not serve
meeting by the head of the are developed during the as meeting chair or subgroup
Lifestyle, Environment and Cancer meeting. The tasks of the chair, or participate in the
Group after consultation with Working Group are: (i) to evaluations.
IARC scientists involved in tobac- ascertain that all appropriate
co research. A Handbook may data have been collected; (ii) to 3. Representatives of national
cover a single topic or a group of select the data relevant for the and international health agen-
related topics in the area of evaluation on the basis of cies may attend meetings
Tobacco Control. scientific merit; (iii) to prepare because their agencies are
accurate summaries of the interested in the topic of a
Meeting Participants data to enable the reader to Handbook. Representatives do
follow the reasoning of the not serve as meeting chair or
Soon after the topic of a Working Group; (iv) to critically subgroup chair, draft any part
Handbook is chosen, international evaluate the results of of a Handbook, or participate in
scientists with relevant expertise epidemiological, clinical, and the evaluations.
are identified by IARC staff, in other type of studies; (v) to
consultation with other experts. prepare recommendations for 4. Observers with relevant scien-
IARC uses literature searches to research and for public health tific credentials may be
identify most experts. Each action; and (vi) if the topic admitted to a meeting by IARC
participant serves as an inde- being reviewed so permits, to in limited numbers. Priority will
pendent scientist and not as a make an overall evaluation of be given to achieving a
representative of any organi- the evidence of a protective balance of Observers from
sation, government or industry. effect or reduced risk asso- constituencies with differing
Five categories of participants ciated with the exposure or perspectives. They are invited
can be present at Handbook intervention focus of the to observe the meeting and
meetings: Working Group Mem- evaluation. Working Group should not attempt to influence
bers, Invited Specialists, Rep- members are selected based it. Observers serve as sources
resentatives of national and on knowledge and experience of first-hand information from
international health agencies, pertinent to the topic evaluated the meeting to their sponsoring
Observers and the IARC and absence of real or ap- organisations. Observers also
Secretariat. Participants in the first parent conflicts of interest. can play a valuable role in
two groups generally have pub- ensuring that all published
454
Working Procedures
information and scientific conflict of interest is identified, Inclusion of a study does not
perspectives are considered. then the expert is asked to attend imply acceptance of the adequacy
Observers will not serve as as an Invited Specialist. The of the study design or of the
chair or subgroup chair, draft declarations are updated and analysis and interpretation of the
any part of a Handbook, or reviewed again at the opening of results, and limitations identified
participate in the evaluations. the meeting, approximately 8 by the Working Group are clearly
At the meeting, the chair and months later. Interests related to outlined in square brackets (ie, [ ] ).
subgroup chairs may grant the subject of the meeting are The reasons for not giving further
Observers the opportunity to disclosed to the meeting par- consideration to an individual
speak, generally after they ticipants and in the published study are also indicated in square
have observed a discussion. volume (Cogliano et al., 2004). brackets. Important aspects of a
study, directly impinging on its
5. The IARC Secretariat consists Data for the Handbooks interpretation, are brought to the
of scientists who have relevant attention of the reader. In general,
expertise and who are desig- The Handbooks review all numerical findings are indicated
nated by the Agency to attend pertinent studies on the inter- as they appear in the original
a meeting. They serve as vention to be evaluated. Only report; units are converted when
rapporteurs and participate in those data considered relevant to necessary for easier comparison.
all discussions. When re- evaluate the evidence are in- The Working Group may conduct
quested by the meeting chair cluded and summarized. Those additional analyses of the pub-
or subgroup chair, they may judged inadequate or irrelevant to lished data and use them in their
also draft text or prepare tables the evaluation may be cited but assessment of the evidence.
and analyses. not summarized. If a group of These analyses and their results
similar studies is not reviewed, the are outlined in square brackets or
The WHO Declaration of reasons are indicated. in italics in the Handbook.
Interest form is sent to each With regard to reports of basic
prospective participant at the first scientific research, epidemiological Working Procedures
contact, with the preliminary letter studies and clinical trials, only
presenting the Handbook meeting. studies that have been published or (a) Literature to be reviewed
Before an official invitation is accepted for publication in the
extended, each potential parti- openly available scientific literature After the topic of the Handbook is
cipant, including the IARC are reviewed. In certain instances, chosen, pertinent studies are
Secretariat, completes the WHO government agency reports that identified by IARC from recog-
Declaration of Interests to report have undergone peer review and nized sources of information such
financial interests, employment are widely available can be as PubMed and made available to
and consulting, and individual and considered. Exceptions may be Working Group members and
institutional research support made ad hoc to include unpub- Invited Specialists to prepare the
related to the topic of the meeting. lished reports that are in their final working papers for the meeting.
IARC assesses the declared form and publicly available, if their Meeting participants are invited to
interests to determine whether inclusion is considered pertinent to supplement the IARC literature
there is a conflict that warrants making an evaluation. Abstracts searches with their own searches.
some limitation on participation. from scientific meetings and other Studies cited in the working
Working Group Members are reports that do not provide sufficient papers are available at the time of
selected based on the absence of detail upon which to base an the meeting.
real or apparent conflicts of assessment of their quality are
interest. If a real or apparent generally not considered.
455
(b) Chair of the Meeting Acknowledgement of significant the evaluation may be available
contributions to the chapters by on the IARC website (http://www.
The chair of the Handbook colleagues of the invited experts, iarc.fr) soon after the meeting, and
meeting is identified among either at their home institution or a short report may be published in
leading international experts soon elsewhere, can be included in the the international literature.
after the topic of a Handbook is Handbook under an acknow-
chosen. The chair will help de- ledgement paragraph to be shown
velop an outline for the Handbook following the listing of the meeting Part two: Scientif ic Review
early on, participate on conference participants. of the Evidence and Evalua-
calls with Working Group tion
members and Invited Specialists (d) Meeting
in preparing for the meeting, 1. Scientific Review
provide early feedback on working The Working Group members
papers and chair the meeting. meet at IARC for seven to eight The results of the studies
days to discuss and finalize the reviewed will constitute the
(c) Working papers texts of the Handbook and to evidence forming the foundation
formulate the evaluations. The of the evaluation. The validity of
Working papers are due about 6 Working Group members and these studies should be examined
to 8 months after original contact Invited Specialists are grouped critically to determine the weight of
of invited experts. The first version into sub-groups according to their the studies contributing to the
of the working papers is compiled area of expertise. Sub-groups assessment. This will entail
and formatted by IARC staff about meet during the first three to four judging the appropriateness of
two months prior to the meeting, days to review in detail the first study design, data collection
or as soon as they are received, versions of their working papers, (including adequate description of
and made available ahead of time develop a joint subgroup draft, the intervention and follow-up),
through IARCs Internet to all and write summaries. Scheduling data analysis, and ultimately
Working Group members, Invited of plenary and sub-group time deciding if chance, bias, con-
Specialists and the IARC Sec- may change from one Handbook founding or lack of statistical
retariat. Reception of working meeting to another. During the last power may account for the
papers ahead of the established few days the participants meet in observed results. The experts will
deadline is encouraged, as it plenary session to review the ascertain how the limitations of the
allows review of their content, subgroup working papers, sum- studies affect the results and
facilitating identification of infor- maries and to develop the conclusions reported. The criteria
mation gaps early enough. When consensus evaluations. that follow apply to epide-
possible or when deemed miological and clinical studies and
necessary, some working papers (e) Post-Meeting therefore may not be as relevant
may be discussed early on among to studies where other quality
experts to expedite the review After the meeting, the draft of the criteria would be indicatedfor
process to be accomplished Handbook composed during the example, those assessing the
during the meeting. A conference meeting is verified (by consulting impact of economic policies.
call will be scheduled after the original literature), edited and
reception of all working papers prepared for publication by IARC (a) Quality of studies considered
and prior to the meeting, with the staff. The aim is to publish
aim of identifying areas deserving Handbooks within twelve months It is necessary to take into account
additional work by experts before of the meeting. If applicable, the possible roles of bias,
the meeting. summaries reporting the results of confounding and chance in the
456
Working Procedures
interpretation of epidemiological interest. Potential confounding by These methods have been

studies. Bias is the operation of such variables should have been reviewed for case-control studies
factors in the study design or dealt with either in the design of (Breslow & Day, 1980) and for
execution that lead erroneously to the study, such as by matching, or cohort studies (Breslow & Day,
a stronger or weaker association in the analysis, by statistical 1987).
than in fact exists between the adjustment. In cohort studies, Aspects that are particularly
exposure/intervention being eval- comparisons with local rates of the important in evaluating experi-
uated and the outcome. Con- disease may or may not be more mental studies are: the selection
founding is a form of bias that appropriate than those with na- of participants, the nature and
occurs when the association with tional rates. Internal comparisons adequacy of the randomisation
the disease is made to appear of disease frequency among procedure, evidence that ran-
stronger or weaker than it truly is individuals at different levels of the domisation achieved an adequate
as a result of an association intervention are also desirable in balance between groups, the
between the apparent causal cohort studies, since they mini- exclusion criteria used before and
factor and another factor that is mize the potential for confounding after randomisation, compliance
associated with either an increase related to difference in risk factors with the intervention in the
or decrease in the incidence of the between an external reference intervention group, and contami-
disease. The role of chance is group and the study population. nation with the intervention in the
related to biological variability and Third, the authors should have control group. Other consi-
the influence of sample size on the reported the basic data on which derations are the means by which
precision of estimates of effect. the conclusions are founded, even the end-point was determined and
In evaluating the extent to if sophisticated statistical analyses validated, the length and com-
which these factors have been were employed. They should have pleteness of follow-up of the
taken into account in an individual given the numbers of exposed and groups, and the adequacy of the
study, the Handbook considers a unexposed cases and controls in analysis. Detailed analyses of
number of aspects of design and a case-control study and the both relative and absolute risks in
analysis as described in the report numbers of cases observed and relation to temporal variables,
of the study. expected in a cohort study. such as age at first exposure, time
First, the study population, Further tabulations by time since since first exposure, duration of
disease (or diseases) and expo- exposure began and other exposure, cumulative exposure,
sure/intervention should have temporal factors are also impor- peak exposure (when appropriate)
been well defined by the authors. tant. In a cohort study, data on all and time since exposure ceased,
Cases of disease in the study cancer sites and all causes of will be reviewed and summarized
population should have been death should have been given to when available.
identified independently of the reveal the possibility of reporting Independent population-based
intervention of interest, and the bias. In a case-control study, the studies of the same exposure or
intervention should have been effects of investigated factors intervention may lead to am-
assessed in a way that was not other than the exposure of interest biguous results. Combined anal-
related to disease status. should have been reported. yses of data from multiple studies
Second, the authors should Finally, the statistical methods may be a means of resolving this
have taken into accountin the used to obtain estimates of ambiguity. There are two types of
study design and analysisother relative risk, absolute rates of combined analysis: The first
variables that can influence the cancer, confidence intervals and involves combining summary sta-
risk of disease or impact of an significance tests, and to adjust for tistics such as relative risks from
intervention, and that may have confounding should have been individual studies (meta-analysis),
been related to the intervention of clearly stated by the authors. and the second involves a pooled
457
analysis of the raw data from the (b) Criteria for causality association between an inter-
individual studies (pooled anal- vention and cancer prevention,
ysis). After the quality of each study has the judgement may be made that,
The advantages of combined been summarized and assessed, in the aggregate, they show
analyses include increased pre- a judgement is made concerning evidence of lack of effect. The
cision due to increased sample the strength of evidence that the possibility that bias, confounding
size as well as the opportunity to exposure or intervention in ques- or misclassification of exposure or
explore potential confounders, tion reduces the risk of disease or outcome that could explain the
interactions and modifying effects is protective for humans. Hill observed results should be con-
that may explain heterogeneity (1965) lists areas for evaluating sidered and excluded with
among studies in more detail. A the strength of epidemiological reasonable certainty.
disadvantage of combined anal- associations used in the review of
yses is the possible lack of human data when assessing 2. Summary of the data
compatibility of data from various carcinogenesis. These criteria, in reviewed (evidence)
studies due to differences in many instances, will apply to the
subject recruitment, data col- assessment included in a This section summarizes the
lection procedures, measurement Handbook results of the evidence presented
methods and effects of un- in the preceding sections in a
measured covariates that may Consistency of observed Handbook in a concise manner.
differ between studies. associations across studies Traditionally, this section does not
Meta-analyses may be and populations; include citation of literature as do
conducted by the Working Group Magnitude of the reported preceding sections presenting and
during the course of preparing a association; discussing the evidence covered
Handbook and are identified as Temporal relationship between in a Handbook.
original calculations by placement exposure/intervention and
of the results in square brackets or change in disease;
in italics. These may be de-novo Exposure-response biologic 3. Evaluation of the evidence
analyses or updates of previously gradient;
conducted analyses that incor- Biological plausibility; An evaluation of the strength of
porate the results from new Coherence of results across the evidence for disease
studies. Whenever possible, other lines of evidence; and prevention or reduction in mor-
however, such analyses are Analogy present in related bidity and mortality is made using
preferably conducted prior to the exposures and their effects on standard terms. It is conceivable
Handbook meeting. Publication of health. that not every exposure/
the results of such meta-analyses If the results are inconsistent intervention reviewed in a Hand-
prior to or concurrently with the among investigations, possible book of tobacco control will permit
Handbook meeting is encouraged reasons (such as differences in a formal evaluation of the
for purposes of peer review. The level of exposure/intervention) are evidence, as traditionally done in
same criteria for data quality that sought, and results of studies other Handbooks of Cancer
would be applied to individual judged to be of high quality are Prevention and in the Mono-
studies must be applied to given more weight than those of graphs. In evaluating the strength
combined analyses, and such studies judged to be metho- of the evidence, a topic may allow
analyses must take into account dologically less sound. a more formal evaluation (i.e.
heterogeneity between studies. When several studies show assigning causality or a protective
little or no indication of an effect in the prevention of cancer).
458
Working Procedures
If assignment of causality is tion under consideration and a limited to the disease sites,
pertinent and possible, the reduction in disease morbidity and conditions and levels of control,
possible outcomes of an evalu- mortality for which a causal and length of observation covered
ation can include: interpretation is considered by the by the available studies.
Working Group to be credible, but
Sufficient evidence of a reduction chance, bias or confounding could 4. Overall evaluation
in risk: The Working Group not be ruled out with reasonable
considers that a causal relation- confidence. The overall evaluation, usually in
ship has been established the form of a narrative, will include
between the intervention under Inadequate evidence of a a summary of the body of
consideration and a reduction in reduction in risk: The available evidence considered as a whole
morbidity and mortality. That is, a studies are of insufficient quality, and summary statements made
relationship has been observed consistency or statistical power to about the strength of the evidence
between the exposure/inter- permit a conclusion regarding the for a health protective or pre-
vention and disease morbidity and presence or absence of a causal ventive effect, or adverse effects,
mortality in studies in which association between the expo- as appropriate.
chance, bias and confounding sure/intervention and a reduced
could be ruled out with reasonable morbidity and mortality. Alter- 5. Recommendations
confidence. A statement that there natively, this category is used
is sufficient evidence should be when no data are available. After reviewing the data and
followed by a separate sentence deliberating on them, the Working
that identifies the types of cancer Evidence suggesting lack of Group may formulate recom-
and other diseases where a effect: There are several adequate mendations, where applicable, for
decreased morbidity and mortality studies that are mutually con- further research and public health
was observed in humans. sistent in not showing an action.
association between the expo-
Limited evidence of a reduction in sure/intervention and disease
risk: morbidity and mortality. A con-
An association has been observed clusion of evidence suggesting
between the exposure/interven- lack of risk reduction is inevitably
459

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IARC HANDBOOKS OF CANCER PREVENTION

Vol 12: Methods for Evaluating Tobacco Control Policies

Methods for Evaluating

IARC HANDBOOKS OF CANCER PREVENTION

International Agency for Research on Cancer

Methods for Evaluating

This Handbook was made

International Agency for Research on Cancer

IARC Handbooks of Cancer Prevention

Published by the International Agency for Research on Cancer,

International Agency for Research on Cancer, 2008

Format for bibliographic citation:

IARC Library Cataloguing in Publication Data

(IARC Handbooks of Cancer Prevention ; 12)

1. Health Policy 2. Neoplasms - prevention & control 3. Program Evluation

ISBN 978-92-832-3012-0 (NLM Classification QZ 39)

List of participants ....................................................vi

Ron Borland (Co-Chair) Carolyn Dresler (not attending) Prakash C. Gupta

Alan Lopez, (not attending) Megan E. Piper Martina Potschke-Langer

IARC Handbooks of Cancer Prevention

Introduction to the disseminated programmes of Lopez, 2003). If current trends

IARC Handbooks of Cancer Prevention

Ensuring effective evaluation of tobacco control interventions

Environment: Physical, institutional, communication, policy, legal, scientific,

Tobacco Cues Tobacco

Tobacco People: Awareness, appraisals, Host

Active and passive exposures Socio-economic effects

Figure 1.1 Major influences on tobacco use and its consequences

IARC Handbooks of Cancer Prevention

Ensuring effective evaluation of tobacco control interventions

IARC Handbooks of Cancer Prevention

Where does th is volume f it

This Handbook is not intended to

Ensuring effective evaluation of tobacco control interventions

development, intervention deploy- cochrane.org, for reviews) pro- 1. A research design

IARC Handbooks of Cancer Prevention

Ensuring effective evaluation of tobacco control interventions

IARC Handbooks of Cancer Prevention

Ensuring effective evaluation of tobacco control interventions

IARC Handbooks of Cancer Prevention

Policy Policy- specific General Policy

Figure 1.3 A generalised model of mediation

Ensuring effective evaluation of tobacco control interventions

Policy as Policy- specific General Policy

IARC Handbooks of Cancer Prevention

Policy as Policy- specific General Targeted policy

Ensuring effective evaluation of tobacco control interventions

IARC Handbooks of Cancer Prevention

Ensuring effective evaluation of tobacco control interventions

IARC Handbooks of Cancer Prevention

Tobacco in dustry controls

Tobacco industry controls are

Ensuring effective evaluation of tobacco control interventions

Policy-related Other Tobacco

Propositions about Sensory stimuli Tobacco

Tobacco use Tobacco

Passive Patterns of Toxin exposure

IARC Handbooks of Cancer Prevention

Tobacco Industry Control

Tobacco Price controls and taxes

Passive Rules on use, e.g.

Tobacco users and

Ensuring effective evaluation of tobacco control interventions