RESEARCH DESIGN
 Primary: original research
publications
 Quantitative: hypothesis
testing; establishing cause
and effect; data reported
mathematically
 Qualitative research:
exploratory; why and how of
decision making; data
reported in narrative terms
 Secondary: filtered or
synthesized publication
of the primary/original
research
 Systematic reviews
 Meta-analyses
 Evidence-based article
reviews
 Evidence-based clinical
practice guidelines
QUANTITATIVE PRIMARY RESEARCH:
EXPERIMENTAL STUDIES
 Researcher controls or manipulates the variables under
investigation, such as in testing the effectiveness of a treatment.
 These studies are the most complex and include randomized
controlled trials and controlled clinical trials.
 The Randomized Controlled Trial (RCT) provides the strongest
evidence for demonstrating cause and effect, i.e., the treatment
has caused the effect, rather than it happening by chance.
VARIABLES IN EXPERIMENTAL STUDIES: RCT

 All experiments have at least 1 independent and 1 dependent

variable.
 Concurrent enrollment of subjects and follow-up of subjects
in experimental and control groups
 Assignment of subjects through random process

 Purpose of experiments is to estimate the extent to which the

independent variable causes changes in the dependent
variables.
 Physically manipulate independent variable
 Giving experimental group new drug and control group a placebo
 Teaching 1 class with computers and 1 without
 KEY CHARACTERISTICS OF RCTS
 Ability to randomly assign subjects to either the experimental or
control group and to randomly allocate treatments
 Prospective in nature and can include blind or double-blind
strategies
 A double-blind RCT is one in which neither the patient nor
the investigator knows whether the patient is receiving the
experimental treatment or the control treatment, e.g., studies
involving therapies (pills/liquids/pastes).
 More difficult to double blind studies when testing a new
treatment, technique, or procedure where the investigator or
patient can distinguish a difference.
EXPERIMENTAL RESEARCH

 Random assignment – equal chance of being in the experimental

group or control group
 Double-blind – investigators or examiners are not aware of which
group the subjects are assigned
 Inter-rater reliability – degree to which examiners are calibrated;
achieve same results (e.g., 8 of 10 times)
 Intra-rater reliability – degree to which an examiner achieves the
same results with himself
QUANTITATIVE PRIMARY RESEARCH:
NONEXPERIMENTAL RESEARCH
 Studies in which the researcher does not give a treatment, give an
intervention, or provide an exposure, i.e., data are gathered without
intervening to control variables
 Includes cohort studies, case control studies, case series, and case
reports
 Descriptive: used to systematically describe and interpret conditions or
relationships that already exist
 In experimental studies, the intervention is under the control of the
researcher, Observational studies, the researcher observes patients at a
point in time (cross-sectional studies) or over time (longitudinal studies). If
the observations are made by looking forward and gathering new data, the
study is prospective; if the data already exist (for instance, in dental records
or as census data), the studies are retrospective.
WHAT IS A COHORT STUDY?

 Makes observations about the association between a particular

exposure or risk factor (tobacco) and the development of a
disease (e.g., lung cancer)
 Patients/subjects have been exposed to tobacco but do not
have lung cancer
 Followed over time and compared with a similar group that has
not been exposed to the risk factor
 Again, a treatment/intervention is not given by the investigator.
 PROSPECTIVE COHORT STUDY DESIGN

Exposed Unexposed

Disease No Disease Disease No Disease

Persons with and without the exposure of interest (e.g., tobacco) are identified at
the initiation of the study. Information is then collected looking forward in time to
identify disease outcomes. At the start of the study, neither group has the disease.
 WHAT IS A CASE CONTROL STUDY?
 Patients who already have a certain condition are compared with people
who do not
 For example, lung cancer patients are asked how much they smoked
in the past
 Answers are compared with those from a matching sample without
the condition
 Less reliable than either RCTs or Cohort Studies. Statistical relationship
between two conditions does not mean that one condition actually
caused the other.
 E.g., lung cancer rates are higher for people who earn less than
$50,000 (who tend to smoke more), but this does not mean that
they can reduce their cancer risk by getting a salary increase to over
$50,000.
Guide to Research Methods http://library.downstate.edu/ebm/2100.htm
CROSS-SECTIONAL STUDIES

 This design attempts to establish an association

between a possible causal factor and a condition,
by determining an exposure to the factor and
“caseness” at the same time.
For instance, a large cross-section of women might be
interviewed to determine if they had given birth to a
baby with a cleft palate and if they had taken a
particular drug during pregnancy.
o Although this type of study is relatively easy and
inexpensive to carry out and ethically acceptable, it can
only establish an association, not a cause and effect
relationship.
 CASE CONTROL STUDY DESIGN

Disease No Disease

Exposed Unexposed Exposed Unexposed

Persons with and without the disease of interest (caries, cancer) are identified at the
initiation of the study. Information is then collected looking backward in time to identify
potential exposures (sugar, tobacco) that could have contributed to getting the disease.
QUALITATIVE PRIMARY RESEARCH
 Nonexperimental in that it conducts studies in
natural settings in an attempt to understand an event
from the point of view of the participants
 It seeks to provide depth of understanding.
 It answers questions such as what, how, and why.
 It explores issues in more depth with those
experiencing the issue, rather than testing a
hypothesis to answer questions such as how many
or what proportion.
 Can generate new theory
QUALITATIVE PRIMARY RESEARCH (CONT.)
 Compliments quantitative research by attempting to
clarify the meaning of how many or by providing a
greater understanding of why an intervention works
 Quantitative research may ask, "How many smokers
have tried to quit?" whereas qualitative research
explores "What stops smokers from quitting?"
 The most important consideration in designing a
study is to use the right methodology to answer the
question.
Table 3-1: Characteristics
of Quantitative Research
Approaches6,7
SECONDARY RESEARCH: SYSTEMATIC
REVIEWS AND META-ANALYSIS
 Secondary research is filtered or synthesized
publications of the primary research literature.
 Systematic reviews (SRs) and meta-analyses,
evidence-based article reviews of already conducted
research, and evidence-based clinical practice
guidelines
 Provides a way of managing large quantities of
information by providing a summary of primary
research studies that have investigated the same
question
 Uses explicit predefined criteria for retrieval of
studies, assessment, and synthesis of evidence from
individual RCTs and other well-controlled methods
SECONDARY RESEARCH: EVIDENCE-BASED
JOURNALS AND ARTICLE REVIEWS
 New evidence-based resources are being developed for
practitioners to facilitate integrating evidence into their
clinical decision making, e.g., Journal of Evidence-Based
Dental Practice (JEBDP), Evidence-Based Dentistry
(EBD).
 Provide concise and easy-to-read summaries of original
and review articles selected from the biomedical
literature based on specific inclusion criteria
 Article reviews of already conducted research often
consist of a 1- to 2-page structured abstract along with
an expert commentary highlighting the most relevant
and practical information of the study being reviewed.
SECONDARY RESEARCH: PRACTICE
GUIDELINES
 Growing source of synthesized information on a
specific topic
 Guidelines are “systematically developed
statements to assist practitioner and patient
decisions about appropriate health care for
specific clinical circumstances.”
 The inclusion of scientific evidence within
clinical practice guidelines has now become the
standard, in that guidelines should incorporate
the best available scientific evidence. SRs
support this process by putting together all that
is known about a topic in an objective manner.
SECONDARY RESEARCH: PRACTICE
GUIDELINES (CONT.)

Examples of clinical practice guidelines

 ADA’s clinical recommendations on professionally
applied topical fluoride
 AHA’s guidelines on antibiotic premedication
 ADHA guidelines on polishing procedures