Classification of Study

Designs
 Non- Interventional
Studies
1. Exploratory Studies
A small study of relatively short duration,
which is carried out when little is known about a
situation.
2. Descriptive Studies
Involves systematic collection and
presentation of data to give a clear picture of a
particular situation.
3. Analytical Studies
An analytical study attempts to establish
causes or risk factors for a certain problem. This is
done by comparing two or more groups some of
which have the problem and some do not.
 Descriptive Studies
Descriptive studies describe the
pattern of disease in relation to
Person, Place and Time.
Descriptive studies use information
from diverse sources like clinical
records of hospital or private
practices as well as national figures.
these studies are very useful to
describe the pattern of disease
occurrence as well as formulate
research questions.
 Descriptive studies
• Describe only; do NOT examine associations
between Exposure (E) and health Outcome (O).
• Generally the purpose is to describe the
variability in a health outcome and/or formulate
hypotheses.
• A descriptive study involves describing the
characteristics of a particular situation event or
case.
• Descriptive studies can be carried out on a small
or larger scale.
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 Types of Descriptive Studies
1. Case Study or Case Report:
– A single patient’s clinical history is described
in detail, and then discussed in relation to the
literature. Almost always a rare unusual, or
atypical case.
2. Case Series
– Two or more patients with similar diagnoses
are described. These can be either unusual
cases or a consecutive series of a more
common diagnosis in which efforts are made
to characterize the series (e.g. the male
female ratio, the age distribution)
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3. Registry Summaries
– Data from disease registries are summarized and
examined to describe variability by geographical
area, within subgroups of a population, and /or
overtime. When denominator data available,
disease rates are sometimes utilized rather than
simple counts.
4. Surveys
– Subjects or institutions are surveyed in order to
describe the prevalence of health outcomes
and /or characteristics of a population
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 Small scale, descriptive case studies
• It describes in-depth the characteristics of one or a
limited number of ‘cases’. A case may be, for
example, a patient, a health centre, or a village.
• Such a study can provide quite useful insight into a
problem.
• Case studies are common in social sciences,
management sciences, and clinical medicine.
• For example, in clinical medicine the characteristics
of an un-recognized illness may be documented as
a case study. This is often the first step toward
building up a clinical picture of that illness.

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 Larger scale, cross sectional surveys
• Cross-sectional surveys aim at describing and
quantifying the distribution of certain variables in a study
population at one point of time. They may cover, eg:
• Physical characteristics of people, materials or the
environment, as in
– prevalence surveys (of diabetes, obesity, HIV), or
– evaluation of coverage (of immunization, latrines, etc.),
• Socio-economic characteristics of people such as their
age, education, marital status, number of children and
income,
• The behavior or practices of women and the knowledge,
attitudes, beliefs, opinions which may help to explain that
behavior (KAP studies)

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Types of analytical studies

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 Comparison
Comparison is a fundamental research
strategy to identify variables that help
explain why one group of persons or
objects differs from other.

We could, for example, compare

 A new drug with an old drug
 A new treatment with placebo.
 Analytical Studies
An analytical study attempts to
establish causes or risk factors for
diseases (problems).

This is done by comparing two or more

groups, some of which have or
develop disease (problem) and some of
which do not.
 Analytical Studies
Comparative Cross Sectional Studies

Case Control Studies

Cohort Studies
 Cross sectional studies
Cross sectional studies describe as well as
compare various groups.

Cross sectional studies cover a sample of

population

Because all subjects represent existing

cases, both the disease as well as risk
factors are ascertained at the same time.

Cross sectional studies determine the

Prevalence of a disease and not the
incidence.
 1. Cross-sectional studies
• Investigator begins with a sample from a
specified population and then ascertains
both E and O at roughly the same time for
each subject in that sample
• Examples:

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 Example 1
• Stool samples of all new patients admitted
to hospital A in a calendar year were
tested for intestinal parasites. The
patients heights and weights at admission
were taken from their charts. Thin patients
were more likely to test positive for
intestinal parasites than patients of
average or above average weight for
height.
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 Example 2
• Chest x-rays were taken of granite workers at
site A; at the same time the investigators took
an occupational history on each worker. From
the occupation history, an exposure index was
developed consisting of the number of years
the worker had worked in a shed that had dust
levels above a pre-set level. The longer the
workers had worked in dusty granite sheds, the
higher their rates of chest abnormalities

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• Many cross-sectional surveys focus on
describing as well as comparing groups.
• For example, a survey on malnutrition may wish
to establish:
– The percentage of malnourished children in a
certain population;
– Socio-economic, physical, political variables
that influence the availability of food;
– Feeding practices; and
– The knowledge, beliefs, opinions that
influence these practices.

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• Cross-sectional comparative
• The researcher will not only describe
these variables but, by comparing
malnourished and well-nourished children,
researcher will try to determine which
socio-economic, behavioral and other
independent variables may have
contributed to malnutrition.

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 Case Control Study
Risk Factor Present

Risk Factor Absent

Cases

Comparison

Risk Factor Present

Controls
Risk Factor Absent

Past Present
 Retrospective
Retrospect (Noun)
• Looking back at the past events.
• View of past events.

Retrospection (Noun)
• Act of looking back at past events.

Retrospective (Adjective)
• Related to retrospection.
• Looking back at past events.
(Oxford dictionary)
 2. Case control studies

• In a CASE-CONTROL STUDY the

investigator compares one group among
whom the problem that he wishes to
investigate is present (e.g. malnutrition)
and another group called a control or
comparison group, where the problem is
absent, in order to find out what factors
have contributed to the problem.

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 Example 1
• Study question: Does a high fat diet risk
increase risk for prostate cancer?
• Complete diet histories were taken on 103
men with prostate cancer and 264 men
with benign prostate conditions diagnosed
at the same medical center. The prostate
cancer cases consumed more of their
calories from fat than did the men without
prostate cancer, after adjustment for age
and race.
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 Example 2
• Study question: Do OCs increase the risk of
myocardial infarction (MI)?
• Contraceptive histories were taken on 500
women hospitalized for MI and 1500 women
hospitalized for non-heart related conditions who
were individually matched (in a 3 to 1 ratio) to
the MI patient on race and age (within one year).
• Prior use of OCs was not associated with an
increased risk of MI (OR=1.1, 95% CI= 0.9, 1.6)

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 Major advantages
1. Efficiency: Easiest and least expensive type
of study
2. Early Warning: Can alert colleagues to
unusual information
3. Generates Hypotheses: Can serve as a
basis for generating testable hypotheses

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 Major Disadvantages
1. Cannot test hypotheses: since descriptive studies lack
comparison groups (either non-cases or non-exposed), they
do not provide evidence regarding causes-effect
relationships.
2. Generalizability may be limited:
– Case reports may describe exceptions rather than the
general situation.
– Case series often make no effort to select a representative
sample of cases.
– Surveys often suffer from high rates of non-response.
– Generalizability is increased when a consecutive (or
complete) series is used.

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 Cohort
A cohort is a group of people, who
share some common characteristics or
pass through the same experience.

Born in the same year.

Eating same type of food

Exposed to a risk factor.

 Prospection

Hoped for

Looked forward to.

Which is one day to be.

(Oxford dictionary)
Adjective: Prospective
 Cohort Study
Problem Developed
Exposed to
Risk factor
Problem Not developed

Comparison

Problem Developed

Not Exposed
To Risk
Problem Not developed

Present Future
 Cohort Studies
• Investigator begins with a sample of persons
without O, ascertain E status on these subjects
at enrolment, and then follows both groups over
time and compares the occurrence of the
problem that he expects to be related to the risk
factor in the two groups to determine whether a
greater proportion of those with the risk factor
are indeed affected.

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 Example
• Study Question: Does night shift work effect
illness rates.
• A cohort of 200 night-shift workers was
followed for 6 months for absence due to
illness. The same information was
collected at the same times on two
additional cohorts of 200 day-shift an 200
swing shift workers. Both night-shift
workers and swing-shift workers were more
likely to have high rates of absenteeism,
compared to day-shift workers. 30
 Example
• If you assume there is a causal
relationship between the use of a
certain water source and the
incidence of diarrhea among children
under five in a village with different
water sources:

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• You may use any of the three types of
analytical studies (cross-sectional
comparison, case-control or cohort) to
investigate possible causes of a
problem.
 A Cohort study
• You can select a group of children under
five years and check at regular intervals
(e.g., every two weeks) whether the
children have had diarrhea and how
serious it was. Children using the
suspected water source and those using
other sources of water supply will be
compared with regard to the incidence of
diarrhea.

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 A case-control study
• You may compare children who present
themselves at a health centre with
diarrhea (cases) during a particular period
of time with children presenting
themselves with other complaints of
roughly the same severity, for example
acute respiratory infections (controls)
during the same time, and determine
which source of drinking water they had
used.
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A cross-sectional comparative study

• You could interview mothers to determine

how often their children have had diarrhea
during, for example, the past month,
obtain information on their source of
drinking water, and compare the source of
drinking water of children who did and did
not have diarrhea.

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 Assumptions of Valid Case-Control
Studies
• Cases and controls come from the same
population.
• Cases are representative of all cases, and
controls are representative of all non-
cases.

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 Comparison
Case Control Cohort
Retrospective Prospective/
Hospital Based Longitudinal
Quick Community based
Easy to conduct Time consuming
Small sample size Logistically difficult
Less expensive Large sample size
Rare diseases Very expensive
None Common disease
Incidence
 Case Control
Cause Disease
Retrospective

Or Or

Risk Cohort
Factors Prospective Effect