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systemic

research means to search again and defined as a quest for knowledge

diligent search, investigation, experimentation.

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identify the problem and its impact

urgent solution need
relevant
chances of success
successfully expected impact
spin off in terms of training of staff and other research capabilities strengthening elements.

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24 Research Methodology
Research is a systematic process aimed at obtaining new
knowledge through verifiable examination of data and
empirical testing of hypothesis. Research activities are
directed towards finding answers, seeking solutions or
looking for improved designs of functioning. Very often,
no positive results emerge and a probable hypothesis
may be negated. This in no way undermines the effort.
In general, research activities in community medicine are
more concerned with ‘applied’ aspects but basic research
can also be undertaken.
As against research in many subjects which are
undertaken on a philosophical or intellectual level, i.e.
concerned with knowledge for its own sake, research in
community medicine is warranted only for the purpose
of gathering knowledge or information for improving the
health of the community or for improving the service
delivery network, i.e. operations research. This research
should not be carried out just for the sake of collecting
data. Medical sciences in general, and community
medicine in particular, deal with human beings. Hence
ethical considerations demand that research procedures
are benign and harmless. The importance of ensuring
this will be obvious if one remembers that very often the
subjects are diseased people in their natural community
environs.
The basic unit of interest in community medicine is
the community or a population group. This implies that
research priorities and interests often centeron health
problems and perceptions of population groups. In
contrast, hospital or laboratory data are sufficient for
designing research related to other medical disciplines.
Critical thinking, the quality of inquisitiveness, a desire
to examine and verify statements rather than accepting
everything at face value as true and correct, are crucial
for undertaking research in all fields. It should also be
remembered that there is no end point or finite limit
for research horizons. Science is a logical discipline and
unravels the rationale of phenomena. Thus each
research solution throws up new challenges. As Max
Webber said, ‘Every scientific fulfilment raises new
questions—it asks to be surpassed and outdated’. A
research scientist should always keep his third eye open;
he should be observing even when asleep.
Why should anybody concerned with the health of
population groups bother himself about research
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activities? Because, health is serious business and a
costly one. Interventions related to people’s health
must be based upon sound principles and practices
which must be continuously and critically evaluated.
Knowledge of research methodology is important for
a doctor because in his professional career at a later
date, he is often called upon to evaluate and sit in
judgment whether in a teaching role, services role or
administrative role.
Research tends to minimize or negate bias. Scientific
techniques help one to perceive the true dimensions
of a problem or a situation. Research pinpoints
reasons for observed differences between two
populations or groups. Research provides answers to
questions relevant to daily living. Is there any danger
if I consume iodised salt everyday? What should be
the level of fluoridation of water supplied? Can I have
two pegs of whisky every evening? At what age should
my daughter be given a dose of MMR? Is there any
benefit of substituting coconut oil with cotton seed oil
for my cooking? And many more. There is no end to
research applications.
Purpose of Research and
Broad Areas of Research
As already mentioned, the reasons for undertaking
research are manifold. The broad research area is
determined by the purpose of undertaking research.
Generally speaking, there are two broad areas of medical
research.
Exploratory Research
Exploratory research is undertaken to gain new insights
or to standardize procedures for more widespread
application. This is often undertaken to formulate a more
precise research problem or to develop a hypothesis.
Examples of such types of research in medical sciences
are standardization of reagents, chemicals, procedures
(Fluorescein angiography in diabetic retinopathy, Sputum
microscopy in tuberculosis, Standardization of OPV),
etc. where the accent is on augmenting skills or
procedures.
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Observational Research
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This is a broad area of major concern in routine
research activities. It may be of three types:
PURE OBSERVATIONAL TYPE
In social sciences, a group of people can be kept under
observation to study their culture or daily routine. Here
the social investigator can either participate in the group
activities (participant observation) or may just make notes
on what is unraveled in front of his eyes (nonparticipant
observation). In medical sciences such ‘true’ observation
without any interrogation, interview or examination is
usually not undertaken. The rigorous definition may be
applicable to observing the number and type of people
frequenting a health setup or clinic, breastfeeding
practices, delivery practices of ‘dais’, etc.
OBSERVATIONAL INTERVIEW TYPE
These research techniques are useful in the following
situations:
• When it is sought to accurately portray the charac-
teristics of an individual, situation or a group. For
example, community participation in eye camps;
sexual behavior of adolescents, etc.
• When it is sought to determine frequency of occur-
rence of a disease, e.g. prevalence of leprosy, preva-
lence of smoking, prevalence of risk factors for
cardiovascular disease, etc. Descriptive studies in
epidemiology which are concerned with the
distribution of disease in time, place and person fall
in this category. Such research is generally
undertaken to generate hypotheses which can then
be validated by analytical techniques.
OBSERVATIONAL ANALYTICAL TYPE
Such research is undertaken to test the hypothesis of
a causal relationship between a set of input and outcome
variables such as hypertension and ocular pressure,
smoking and lung cancer, unsafe sexual practices and
AIDS, deficient dietaries and malnutrition, etc. Analytical
epidemiological studies like case control and cohort
studies fall in this category.
Research Approaches in
Public Health
There are two broad areas of research in public health.
These are:
1. Quantitative research methods
2. Qualitative research methods.
Quantitative Research Methods
These are the traditional methods used in epidemiology
and clinical medicine. These are also called evidence
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based research methods. Epidemiological studies, which
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CHAPTER 24: Research Methodology
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Cohort Studies, and Cross Sectional Studies are quanti-
tative methods. Intervention studies like Community
Trials and Vaccine Trials or Drug Trials are also quanti-
tative methods. The hallmark of quantitative methods
is the collection of information, which can be generalized
to the population where the study has been conducted.
Therefore probability sampling and determination of
sample size, which will yield a statistically valid result,
is of prime concern.
Surveys are an epidemiological study based on the
cross sectional approach. They will be explained in
greater detail in this chapter.
Qualitative Research Methods
These methods were traditionally used in behavioral
sciences for a long time and have recently found appli-
cation in health sciences. The common feature of these
methods is that they do not primarily seek to provide
quantified answers (like prevalence rates, odds ratio,
etc.) to research questions. They help in understanding
social phenomenon as they occur in their natural
settings without any intervention. An example is to
understand why and how health education messages
on stopping smoking can be well known to teenagers
but still they fail to give up smoking. With increasing
prevalence of diseases concerned with lifestyle and
behavior, there is an urgent need to understand and
study these aspects in greater detail. Diabetics may
continue to eat excess calories despite knowing about
the need for diet control in management. Persons
continue to go to commercial sex workers and have sex
without a condom even after knowing that such risk
behavior can result in HIV infection or STD. What
characteristics lead to such behavior can be answered
by qualitative research.
Since qualitative research seeks to explain social
phenomenon, it is not unduly concerned with sample
size and type of sampling. In fact, purposive sampling
is used expensively in qualitative research. The exact
expressions used by patients to describe their problems
are more important than counting age, gender,
socioeconomic status, frequencies, etc.
There are many types of qualitative methods. The case
study, interview and observational techniques are also
used in qualitative methods. Other methods like focus
group discussions, consensus methods (Delphi technique),
etc. are specifically used only in qualitative research.
Recently a combination of qualitative and quantitative
methods is being increasingly used in health.
Case Studies
The case study approach is extensively used in behavioral 451
and medical sciences. This approach involves an in
depth and intensive evaluation of one or a few cases
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considered as typical or representative of a larger
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investigation may be a few characteristic individuals, a
family, a community, a specific group of interest or an
institution. Case studies conducted in clinics, which are
so commonly utilized in medical practice, also fall in this
category. The method entails a comprehensive work-
up. The quantum of details collected can be
phenomenal. Such detailed investigation is generally not
possible in survey techniques where a large number of
units are examined at the same time. The biggest
drawback of this method is its inability to generalise
findings on a wider scale or to a bigger group. However,
the method can be effectively utilized to pinpoint data
or to suggest hypotheses, which can then be tested by
other more encompassing methods.
Surveys
Surveys constitute the basic tool of research in commu-
nities. There are many types of surveys such as social
surveys, Gallup polls, utilisation surveys, health surveys,
morbidity surveys, etc. The factor common to all surveys
is that they are concerned with groups or populations
rather than a few individuals. Outcome analysis in
surveys represents the sum total of the group and cannot
reflect each individual’s concern or interests. The
coverage of a survey can vary from a few individuals
to a complete enumeration of the population.
Surveys provide a denominator which enables
comparison, which is not possible in case studies. The
denominator refers to the total number of units in which
the survey was carried out such as 100,000 population;
50,000 males; 10,000 drug addicts; 5000 prostitutes;
1000 medical students, etc. There are three basic types
of surveys that can be undertaken in the health sector:
1. Health surveys: A health survey is basically a program
for studying a population or a particular segment of
a population in order to assess its health problems
or to detect conditions to which preventive measures
may be applied. A health survey has a much wider
connotation compared to a morbidity survey.
2. Morbidity surveys: A morbidity survey is a specific
survey dealing with only one element in the full range
of possible components of a health survey. They are
concerned with disease states and their distribution
in population groups.
3. Utilization surveys: These demonstrate how many
people are utiliing services provided by specific
facilities.
Uses of Surveys
Surveys are extremely useful in community medicine
and help in the following ways:
452 • To assess the magnitude of a specific disease condi-
tions or health-related events in specified. Commu-
nities or well-defined geographic areas.
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• To guide planning of national, regional or local
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• To evaluate control activities or national health
programs.
• To study community perceptions and attitudes
related to health and disease.
• To evaluate degree of utilization of health care
facilities.
• To provide data for planning and evaluation of
community intervention and health educational
activities.
• To suggest and test hypotheses on health-related
events and disease conditions.
The above are only the major uses. There can be
many more. However, it would be clear by now that
surveys are useful for research, training, planning and
evaluation.
Planning for Surveys
Large scale surveys are expensive propositions. Hence
they should not be undertaken unless there are
compelling reasons. Before embarking on a survey, one
should be reasonally sure that the information that is
being sought is not available from any source. Many a
time data may have been collected but it may not have
been compiled or analyzed. Minimal effort to retrieve
such data may be a better and cost-effective strategy than
carrying out a full-scale survey.
Meticulous planning would obviate several problems
that may crop up at a later stage. The planning process
should carefully consider and satisfactorily answer the
following questions:
• Why is the survey being undertaken?
• Where will it be carried out?
• Who all will be covered by the survey?
• When will the survey be carried out?
• What variables are to be addressed in a survey?
• Why are certain variables included and others
excluded from purview?
• What instruments will be used?
• How will the survey instruments be standardised and/
or validated?
• How will the survey activities be scheduled?
• What are the training needs of personnel to be
involved in data collection?
• What cross-checks or supervisory modes will be used?
• How is the data to be analyzed?
If these problems are addressed at the planning stage
itself, unnecessary hurdles will be avoided during the
execution of the survey. It is important to remember the
adage—well begun is half done.
Essential Prerequisites for Surveys
The following requirements must be fulfilled before
starting a survey:
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• It is essential that the permission of the appropriate
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before starting the survey.
• The objectives of the survey should be precise and
clear. These should be defined beforehand in
unambiguous terms.
• The community leaders should be contacted and all
aspects of the survey should be explained to them
and their cooperation solicited.
• Community health surveys should always be planned
with the intent of carrying out an appropriate action
program. Needless to say that a community which
cooperates in a health survey legitimately expects
some health benefits to accrue to its members. These
could be limited to examination and referral or could
also include provision of treatment facilities.
• The members of the community should preferably
be told about the subsequent plan of action or
follow-up activities after completion of the survey.
• As much background data as possible should be
collected regarding the community where the survey
is to be undertaken. This data can include demo-
graphic particulars, health facilities available, leader-
ship patterns, other agencies working in the area, etc.
• The available resources should be carefully
scrutinised. This should include money, manpower,
materials, time, etc.
Survey Instruments
These can be classified into two groups:
1. Data collection instruments
• Observation
• Interview
• Questionnaires and schedules
• Projective techniques.
2. Supplementary diagnostic instruments such as
hemoglobinometer, infantometer, microscope, ECG
and X-ray machines, etc.
In this chapter we are only concerned with the data
collection instruments.
OBSERVATION
Observation is an effective tool in social sciences. The
major advantage of observation is that there is no
necessity to depend on memory recall as one can
record events as they unfold. In medical sciences,
observation is akin to inspection procedures. They can
be used to study breastfeeding or weaning practices,
types of individuals frequenting STD clinics, infant
behavior, time and motion studies, etc. One should be
clear as to what should be observed, and how it should
be recorded.
• Unstructured observation: Here the ground rules on
how to observe and what all needs to be observed
cannot be laid down in exacting terms. This generally
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activities of the group under observation. This is
most useful in sociological enquiries where cultural
aspects can be the focus of attention.
• Structured observation: This is a more systematic
method and the investigator clearly knows what to
observe and how to record. This method is mainly
useful in situations where specific hypothesis or
procedures are known beforehand.
Advantages of Observation Techniques
Observation techniques are useful as they do not
depend on recall of memory. If what is to be observed
is explicit, a good deal of information will be available.
This can be coupled with supplementary data gathered
from other sources.
Disadvantages
Not everything is amenable to observation. Discreet
data, e.g. sexual behavior, cannot be observed. The
time frame involved can be taxing. To observe many
facets of rare occurrences may consume a lot of time.
At the same time, not every group may like to be
observed and the events that one wants to observe may
occur too spontaneously. Climatic conditions, terrain,
etc. may all interfere with undisturbed observation.
These techniques cannot provide information on events
which have already occurred. An individual’s beliefs and
perceptions cannot be adequately represented.
INTERVIEW
This is a very popular method of data collection. This
method involves juxtaposition of the interviewer and the
interviewee. If the interviewee does not understand a
question, it can be explained to him. If more details are
desired, additional queries can be posed. However,
interviewing is an art. What is to be asked and how to
proceed are crucial to the success of this method. Inter-
view can be either structured or unstructured. In
unstructured interviews, the interrogator has the
freedom and leeway to proceed in any manner that he
may deem judicious. In structured interviews the format
and order of investigation is set out right at the
beginning.
Interviews can be conducted irrespective of the
literacy level of the interviewee. Complex psychosocial
problems are better addressed by interviews. The
biggest disadvantage of the interview is the probable
lack of confidentiality and trust. The interviewee may
be ill at ease because of the presence of the interro-
gator. When objectivity is crucial, standardized interviews
are conducted, where the same wording and same order
is retained for all respondents. Verbal method in an 453
interview can be supplemented by visual aids.
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Questionnaires are the most commonly used survey
instruments. A questionnaire is a document where
questions are set out in a predetermined fashion which
is filled in by the respondent himself. Questionnaires can
either be administered in person or sent by post (mailed
questionnaires). Mailed questionnaires are easy to
administer and do not call for special skills. How the
questionnaire is to be filled up is indicated in a covering
note. Mailed questionnaires generally lead to a poor yield
as it needs a lot of motivation to respond to the
document.
Questionnaires are less expensive than other methods
and a large number of respondents can be contacted in
a short span of time.
The disadvantages of the questionnaire are:
1. A high level of literacy of the respondents is
necessary. Illiterate respondents cannot be
administered a questionnaire.
• The set questions may connot different meanings to
different respondents and no explanation is possible.
• The respondents need to be highly motivated and
must have patience to properly record statements.
• To improve yield, questionnaires need to be
attractive and eye-catching.
Schedules are a recording device where the interro-
gator asks questions and records the respondent’s
answers on a document. This method is used for illiterate
audiences. A set of questions are posed as in a question-
naire but the responses are filled in by the interrogator
himself.
Types of Questionnaires/Schedules
Unstructured questionnaire: This is also called the
interview schedule and has the advantage of greater
degree of flexibility in administration. It usually contains
open-ended questions so that information is provided
by the respondent spontaneously in an unhindered
manner. The only problem is that some respondents
may not know when to stop.
Structured questionnaire/schedule: Here the
sequencing and contents of the questions are decided
well in advance. The respondent has to proceed in an
orderly fashion. The questions can either be open or
closed-ended. Open-ended questions have already been
described. Closed-ended questions are those where the
respondent has to select an appropriate response from
among the given responses. The number of responses
provided can vary from two to ‘n’. Generally, not more
than 4 to 5 responses are included. For example:
The objective(s) of studying community medicine
is (are):
454 • Teaching assignments are easy
• Provides a proper perspective of communities
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• Enables one to discharge social obligations
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of approaches is also possible. One can use a semi
open-ended or semi closed-ended format where, if
the respondent does not agree with any of the stated
responses, he can cite his own reason. For example,
in the above question, another option could be:
• “Any other (please specify).”
In framing questionnaires or schedules, care should
be taken to carefully formulate the questions and
responses. Questions should be clear and unambiguous
and should consider the sociocultural background of the
respondents. Simpler and noncontroversial questions,
such as those about demographic data, should be asked
in the beginning. There should be a logical sequence.
Questions should not be repetitive. The respondent
should be able to fully answer the questionnaire in 15
to 30 minutes. It is best to avoid leading questions. As
far as possible, controversial questions should be
avoided. Closed-ended questions facilitate analysis.
PROJECTIVE METHODS
The major use of projective methods is in the field of
psychiatry. In these methods, the framed question is
designed to act as a stimulus to elicit more complex
emotional information. The stimuli are capable of
eliciting varied responses. For example, a rope may be
perceived differently by different respondents. Similarly,
an ink blot or a picture of red sauce may evoke
different responses. Each type of response has a
different meaning attached to it. The responses are
interpreted as indicative of the respondents personality.
The responses are not taken at face value but are
interpreted in some form of preestablished
psychological conceptualization of what the responses
to the specific test situation mean.
FOCUS GROUP DISCUSSIONS
Focus group discussions refer to a form of group inter-
view, which capitalizes on the interactions of the
members of the group to a question. For example, in
a group of 8 visually impaired males aged 50+ years,
the moderator asks people to comment on their
experiences regarding interpersonal relationships within
the family after becoming blind. All the 8 people may
have something to say about their sons, daughter-in-
laws, spouses, etc. and an answer given by one person
may prompt another person to respond more
emotionally. This is the strength of a focus group,
which is not possible to capture in a one-to-one
interview. The method is particularly useful for
exploring people’s knowledge and experiences and can
be used to examine not only what people think but
how they think and why they think that way.1
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A number of focus group discussions (FGDs) can be
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conducted for a problem. Each FGD should not consist
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of more than 6 to 8 people who are not known to each
other earlier. An FGD should not last more than 1 –
1½ hours. All members of the FGD should share similar
characteristics—Gender/Age/Social Status, etc. If there
is too much disparity, interaction will not be good. If
males are present, females may not speak, especially on
sensitive topics. Analysis of FGD is cumbersome, as a
complete record of what each person has stated has to
be recorded. Even nonverbal communication is
recorded. Commonly FGDs are audio taped and
transcripts are then prepared and analyzed for content.
The frequency with which a particular issue has been
mentioned and the exact expressions used are all
analyzed.
DELPHI TECHNIQUE
This is a consensus method. Such methods determine
to what extent a group of experts or lay people agree
or disagree on a particular topic. The Delphi technique
has been used widely in health research within the fields
of technology assessment, education and training, priority
setting and information. It enables a large group of
experts to be contacted cheaply, usually by mail with a
self-administered questionnaire.
Typically, the process takes a number of ‘rounds’. In
the first round, a knowledgeable group expresses
opinions on a specific subject and selects suitable experts
to participate in the subsequent rounds. Their comments
are put in the form of a questionnaire and in the second
round, the experts are asked to rank the comments given
in the first round. This is then summarized and sent back
to the experts in the third round to rethink on the subject.
The rerankings are then analyzed for consensus. If there
is no consensus, the process of repeat rounds is continued
till consensus emerges.
The nominal group technique is also a consensus
method. Unlike the Delphi technique, here, a highly
structured meeting is planned with 9 to 12 relevant
experts and decisions are taken on a specific subject of
concern. A lot of groundwork needs to be done before
the Nominal Group meets, unlike the Delphi technique
where the initial round may have very little structuring.
The following steps are used in the Nominal Group.2
• Participants in the group spend several minutes
writing down their views about the topic in question.
• Each participant contributes one idea to the facilitator
who records it on a flip board.
• Similar suggestions are grouped together wherever
appropriate. There is group discussion to clarify and
evaluate each idea.
• Each participant privately ranks each idea.
• The ranking is tabulated and presented.
• The overall ranking is discussed and reranked.
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• The final rankings are tabulated and the results fed
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Designing Research Protocol
It is essential to formulate a detailed research protocol
so that the research effort is meaningful and productive.
The research protocol should follow a systematic format.
This does not mean that the subsequent step can only
be undertaken after completion of the preceding step,
because there is often an overlap. However, following
the format ensures that every aspect is carefully
addressed. The essential steps are given below.
Selecting a Researchable Topic
A general topic of study or broad area of research may
present itself in relation to some practical concern or a
scientific or intellectual interest. The decision-making
process may be guided by the following:
• Need for additional information on some specific
disease, health care facility or service.
• Need for evaluation of the effects of a particular
component of health care facilities or services.
• Need for comparing alternative treatment modalities.
• Need for future projections of the magnitude of
specific health problems or health care infrastructure
or services.
Formulating the Research Problem
Once the research topic is selected, the research
problem needs to be formulated in detail. The following
steps are useful for this purpose and have been
abridged from the WHO/WPRO format:1
• Statement of the problem: The first step in the
development of a research project is a clear enunci-
ation of the research problem. The statement of the
problem is essential for constructing a research
protocol. It guides and puts into sharper focus the
research design being considered for solving the
problem. It allows the investigator to describe the
problem systematically and to reflect on its
importance, its priority in the country or region and
the rationale for undertaking the research.
• Relevance of the problem: It should be ensured that
the problem to be researched is relevant to national,
regional or local health needs and activities. It should
preferably fall under the priority areas in reference
to national health.
• Field of application: One must clearly spell out how
the findings of the proposed research would benefit
policy makers, health administrators or health services
research scientists. It should also be indicated as to 455
how the results would be transmitted to them.
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Search for Related Work • To provide vitamin A supplementation to all under-
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A thorough scan of all available literature or information
on the research problem should be undertaken. A review
of existing information is important for the following
reasons:
• It helps in further understanding of the proposed
research problem and may lead to refining of the
statement of the problem.
• It helps in identifying the study variables and
conceptualizing their relationships.
• It helps in the formulation and selection of research
hypotheses.
• It helps in finding out what others have already
reported on the topic, so that account can be taken
of this in the design of research.
• It provides familiarity with various methods that
might be used in research. The search can be under-
taken in the following ways:
– Thorough literature scan for related work.
– Discussion with experts in the specific area of
interest.
– First hand experience or observation.
The sources of information include:
i. Library catalogues, literature.
ii. Indices (e.g. Index Medicus and Excerpta
Medica, which identify articles appearing in
selected journals by subject, author and title),
computer search facilities (such as Medline,
Medlar, Popline).
iii. Bibliographies (e.g. current contents).
iv. Statistical reports.
Statement of Objective
Before undertaking any research investigation, its
purpose should be clearly spelled out in the research
protocol in terms of goals, objectives and targets. A goal
is a broad definition of policy, not constrained by time.
For example, an applied research project related to school
health may state its goal as: “Health care facilities will
be provided to maintain and improve health status of
preschool children”. No mention need be made as to
how the goal is to be fulfiled. This is addressed by the
objectives. Objectives are defined more precisely than
the goal. An objective is a broad statement of purpose
reflecting the conditions one wants at some future time.
The relationship between goals and objectives is that
objectives are essentially steps towards a goal.
The specific objectives are the specific aims of the
research project. What is to be accomplished is often
broken down into smaller logical components. Specific
objectives relate to specific research questions, which the
investigator wants to answer through the proposed
456 research. For example, the general objective “To
improve ocular health of preschool children” may have
the following specific objectives:
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• To screen eyes of preschool children at ‘anganwadis’
at six monthly intervals
• To provide nutrition education to mothers.
A target is an indicator with a magnitude. It points
out what should be realised by a specific date. Targets
should be quantitatively measurable. They represent the
measurable and attainable aims directed towards
objectives which, in turn, are directed towards the
ultimate goal. For example, a target may be “100 percent
coverage of preschool children by vitamin A prophylaxis.”
At this stage, while objectives and targets, etc. are
outlined by the investigator, it is also necessary to clarify
the concepts related to the study and to give working
definitions of the terms used.
It should be borne in mind that each study rests on
earlier ones and provides a basis for future research
efforts. More the links that can be established between
a given study and other studies or a body of theory,
greater the probable contribution of the study.
Selection of Variables
Variables that are sought to be measured should be
clearly spelled out. The different types of variables are:
• Independent variables (Input, antecedent, etc):
These are manipulated under study conditions to see
what effect differences in them will have on those
variables proposed as being dependent on them.
• Dependent variables (Outcome, effect, etc):
These are the ones in which changes result due to
the effect of the independent variables.
• Confounding variables (Intervening variables):
These should be studied because they may influence
or confound the effect of the independent variables
on the dependent variable.
• Background variables: Variables like sex, age,
race, literacy, SES, marital status, etc. are so often
of relevance in investigations of groups or
populations that they should be considered for
possible inclusion in all studies.
The variables in a study should be clearly identi-
fied and their method of measurement as well as the
unit of measurement should be cleary indicated.
Formulation of Research Hypothesis
A hypothesis can be defined as a tentative prediction
or explanation of the relationship between two or more
variables. Formulation of hypothesis requires the investi-
gator to predict an answer to the research question based
on knowledge of the field and logical analysis. The
formulation of a hypothesis should:
• Suggest explanations for certain facts
• Guide in investigation of related facts
• Investigate characteristics that determine the
occurrence of disease.
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A hypothesis translates the problem statement into
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A hypothesis is not meant to be a haphazard guess.
Rather, it should reflect the depth of knowledge, imagi-
nation and experience of the investigator.
The formulation and verification of a hypothesis is
the major goal of scientific enquiry. The researcher should
try to identify alternative competing or rival hypotheses
which should then be carefully considered. Purely
descriptive studies do not need a formal hypothesis.
Research Methodology
This is the most important section of the research
protocol as it explicitly sets out how the protocol is to
be implemented. The following items of research design
have to be carefully addressed:
SELECTION OF RESEARCH STRATEGIES
This is probably the single most important decision that
has to be made. Various strategies are described below.
The appropriateness of a particular strategy will depend
upon the problem to be researched.
Descriptive Strategies
These generate hypotheses rather than test them. Their
nature will become clear by having a look at the
following examples:
• Descriptive cross sectional surveys including KAP
studies.
• Disease description by time, place and person.
Changing patterns of health and disease over time.
• Community diagnosis of a health problem.
• Assessment of community perceptions and needs.
• Studies of existing data—case series, disease
registries, surveillance records, hospital inpatient
data, etc.
• Studies on the natural history of disease.
Observational Analytical Strategies
These are useful in testing formulated hypotheses. These
may be of the following types:
• Prospective study (cohort study)
• Historical cohort study
• Retrospective study (casecontrol study)
• Analytical cross-sectional studies
• Follow-up studies (either longitudinal studies or
cross-sectional studies repeated at intervals).
Experimental Strategies
The experimental setting may vary from a closed
laboratory background to an open-field background as
listed below:
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as randomized clinical trials (RCT). They may be
diagnostic (such as comparison of barium meal and
endoscopy for diagnosing peptic ulcer), therapeutic
(such as comparison of a new antihypertensive drug
with the current one)
• Field trials: e.g. vaccine trials
• Quasi-experimental studies: (e.g. intervention studies,
health systems research, etc.).
Operational Strategies
These relate to operational aspects of a health program
or facility. Observational element is an important aspect
of these. Time-motion studies are a good example.
SELECTION OF RESEARCH SETTING
This includes all pertinent aspects such as characteristics
of the study population, the place and time of the study
and the ethical considerations. The latter are described
a little later.
SAMPLING CONSIDERATIONS
The best method of studying a population is by complete
enumeration of all units. This is not operationally feasible
because of financial and time constraints. Hence
adequate samples are drawn which are representative
of all units in a population. A consideration of sampling
techniques deals with the following:
• Selection of appropriate sampling methods: Simple,
random, systematic or stratified random sampling,
multiphase, multistage, cluster sampling, etc.
• Determination of appropriate sample size: It is the
smallest number of units that is required to be
studied for getting statistically valid results. Sample
size depends upon the parameter measured and the
research design chosen. As a general rule more the
variance or standard deviation, more the sample size.
• Minimizing sampling errors: By ensuring represen-
tativeness and reliability of the sample.
CONTROLS
Controls are used to increase the validity of results.
Controls are comparable units drawn from similar popu-
lation groups which are similar in most respects except
that exposure to the risk factor or disease condition is
lacking. Controls should be matched on as many of the
confounding variables as possible. For example, they
may be drawn from the general population, other family
members or hospitalized patients not afflicted by the
same disease.
In experimental situations, “controls” are those indi- 457
viduals who are not administered an experimental
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stimulus (for example, individuals given placebo in A pilot study can also be utilised for determining the
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constitute the experimental group). When cause and prevalence and other variables of a disease (which is
effect relationships are not being considered, there is essential for determining the sample size) is not available.
no need for a control group. The pilot study can be used to obtain such information.
If a pilot study shows that certain components are
DESCRIPTION OF STUDY INSTRUMENTS not feasible, a modification should be incorporated in
the research design. The modified research plan should
The study instruments used in research protocols have again be validated through a pilot study before the
already been discussed. The questionnaires, interview main research protocol is implemented.
schedules, other methods of observation and the
recording forms, etc. should be explained in detail. DESCRIPTION OF PLANS FOR DATA ANALYSIS
AND INTERPRETATION OF RESULTS
DESCRIPTION OF DATA COLLECTION
The plan for analysis of data is an integral part of the
The method of collection of data should also be spelled research design and should be incorporated into the
out in full detail. How the community would be research proposal itself. Preparing such plan helps the
approached, how investigators would be selected, how investigator in avoiding several pitfalls, such as,
their training needs would be assessed and how they discovering at the end of the study that some needed
would be trained — all these aspects need to be information has not been collected, or that the
described. So also, there is a need to specify job information collected is not appropriate for statistical
responsibilities of each member of the data collection
analysis. The description should include the following:
team, methods of supervision and cross checking and
• Design of the forms for data processing.
the logistic support and supplies. Persons responsible for
• Overall data processing plan and a statement
field verification of data should be identified. Large
whether the data will be processed by hand or by
studies should be preceded by a pilot study which
computer.
should include pretesting of forms and schedules.
• Pretests: Pretesting is the system of validating the • Coding plan in case of computer processing.
study instruments and procedures. It is a method of • Personnel to be involved in verification of data, data
standardization of the instrument as well as the entry and handling and data retrieval.
personnel who will administer the instrument. • Choice of statistical methods to be employed.
Pretesting helps in the following ways:
– It tests the clarity of the framed questions. It REPORTING AND PUBLISHING OF RESULTS
examines whether the questions in the form are The prime aim of undertaking research is to validate
understood similarly by many people or whether selected hypotheses and to disseminate information
their perceptions vary greatly. In India, question- which will be useful for future research. The scientific
naires and schedules have often to be translated community at large should be able to benefit from the
into local languages. Hence it is desirable to see research results. Hence a comprehensive report is
whether the translation agrees with the original. desirable and wide dissemination, using all available
– It tests acceptability of the questions. It looks into channels of communication, is essential.
whether people answer the questions happily or
whether they take offence to some questions.
– It tests logical sequencing of questions. Ethical Considerations in Research
After pretesting, the questionnaire should be
modified in the light of the experience gained. Any research activity conducted in a human population
• Pilot studies: A pilot study is akin to a fulldress has to be carefully reviewed in terms of ethical
rehearsal. It can be defined as a program of implications. Once a community participates in a
predetermined duration and on a restricted scale research project, it logically expects some corollary
which should serve as a model for extended or medical benefits to accrue. Some part of the budget
general application, if it proves to be feasible, should be earmarked for this purpose.
effective and sufficiently efficient. A pilot phase helps Since most persons in a general population do not
to validate whether all components of the system are suffer from a disease condition, it is essential that the
functioning smoothly or not. The pilot phase should examination procedures used in the study are completely
have a duration long enough to detect weaknesses harmless and noninvasive.
and constraints in the system. Pretesting of the A careful consideration of what is to be done for
instruments and procedures should have been those people who were not selected in the final sample
458 completed before embarking on the pilot is also important. Any intervention in the community
study. should not be restricted solely to those who were
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sampled or who participated in a trial. At the
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responsibility to share results with the community.
Ethical considerations are more rigid in intervention
studies. Informed consent must be obtained from all
participants. They must be clearly told about the objec-
tives, salient features of methodology, adverse reactions,
placebo effect, etc. Confidentiality should be ensured.
The poorer sections of the community should not be
exploited in research that will mainly benefit the more
wealthy and privileged sections. It would be unethical
to institute costly therapy in poor patients and to
discontinue treatment after completion of the research
project without providing medication for the remainder
of the course.
Every institution has an ethical committee. All pro-
posals are carefully screened by this committee. If a new
drug or dosage formulation is to be used, it should be
done only after seeking permission of the drug
controller.
Ethics committee (EC), also known as
Institutional Review Board (IRB), Institutional
Ethics Committee (IEC) and Ethics Review Board
(ERB) constituted of medical, scientific and non-scientific
members, whose responsibility is to ensure the protection
of the rights, safety and well being of human subjects
involved in a study. Among other things-reviewing,
approving and providing continuing review of study
protocol and amendments and of the methods and
material to be used in obtaining and documenting
informed consent of the study subjects.
Ethical Guidelines for Biomedical
Research on Human Subjects
In 2000 AD, ICMR has brought out guidelines for
research which need to be followed by all individuals/
institutions. ICMR has highlighted the following principles
for undertaking research:
• Principles of essentiality: Research on human
subjects should be done only if all other avenues of
research have been considered.
• Principle of voluntariness, informed consent
and community agreement: Subjects are fully
apprised of the research and the impact and risk of
participating in the research. These are cardinal
principles and must be adhered to.
• Principles of nonexploitation: Subjects should be
remunerated for their participation and complete
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CHAPTER 24: Research Methodology
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care should be provided to all subjects.
• Principles of privacy and confidentiality: Identity
and records of all subjects should be kept
confidential.
• Principle of precaution and risk minimization:
Due care and caution should be taken at all stages
of research.
• Principles of professional competence: Research
should be conducted at all times by competent and
qualified persons with total integrity and impartiality.
• Principles of accountability and transparency:
Fair and honest research is essential and if necessary,
all records should be produced in front of
appropriate legal and administrative authorities.
• Principles of maximization of public interest
and distributive justice: Research should be done
to benefit all human kind and not just those who
are socially better off. All reports and records should
be duly preserved.
• Principles of public domain: All research should
be brought into public domain and published to
share findings in scientific and other publications in
accordance with the relevant law of the country.
• Principles of totality of responsibility: Professional
and moral responsibility should be upheld and regular
monitoring done while research is being undertaken.
• Principles of compliance: The letter and spirit of
these guidelines should be followed.
These 12 principles are common to all areas of
biomedical research in the country. Every Institution
must have an Institutional Ethical Committee, which
should comprise of a minimum of 5 and maximum of
15 persons. It should have basic medical scientists,
clinicians, legal experts/retired judge, and social scientist/
representatives from NGOs, philosophers/ethicist/
theologian and, at least, one person from the lay public.
Detailed guidelines are available from ICMR and an
Ethics Committee in accordance with the principles laid
down by ICMR should clear a research proposal before
the research is initiated.
References
1. Kitzinger J. Qualitative Research: Introducing Focus
Groups. BMJ 1995;311:299-302.
2. Jones J, et al. Qualitative Research: Consensus Methods
for Medical and Health Services Research. BMJ,
1995;311:376-380.
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