Lecture notes on

epidemiological
studies for
undergraduates
 Dr Omran S Habib
Professor of epidemiology and health care
Department of Community Medicine
College of Medicine
University of Basrah
omran49_basmed@yahoo.com
Mobile: 00964 780 1 367 538
Classification of Epidemiological
studies
:Observational .1
a. Descriptive- observe and describe.
.No controls no intervention
b. Analytical- observe (measure) and
interpret. Controls are used but no
.intervention
Interventional (experimental)- .2
Interfere, observes and analyze
(interpret)
Evaluational: Can use combination .3
of observational descriptive, analytical
and interventional approaches.
Observational descriptive studies
Observational descriptive .1
epidemiological studies(surveys or
household surveys)
These surveys are specially designed
and carried out for answering specific
questions. They include different types
of epidemiological studies but two
.main types are commonly used
.Cross-sectional surveys or studies
These are based on a single observation usually carried
: out in a short time and characterized by
a. They usually measure prevalence of disease
b. Based on aggregated evidence, they suggest
.hypotheses
c. They are not useful for diseases of short duration. A
.single observation may miss cases
d. Their results are difficult to interpret
because of seasonal variation and
.cohort effect
e. They are relatively quicker and cheaper to
.do compared to follow up studies
f. They can be modified to estimate
incidence of disease and to test hypotheses.
A case-control design can also be made
.within the context of a cross-sectional study
Longitudinal or follow up surveys
.or studies
These are based on repeated
observation of the study population
over a defined period of time. They
start with a base-line data provided by
.initial cross-sectional study
a. They measure incidence of disease
.or related outcome
b. Based on aggregated evidence, they
.suggest hypotheses
c. They are relatively more expensive
.and difficult to organize
d. They are not useful for diseases of
.rare occurrence
.e. The results are easier to interpret
f. They can be useful to determine
.seasonal variation of disease
 Both cross-sectional and
longitudinal studies can be
population-based (household
(surveys
2. Observational analytical studies

Definition of basic terms

Risk:
Risk A probability that an individual
will become ill or die within a specified
period of time or age. It is used to
denote incidence rate (risk of acquiring
disease) or mortality rate (risk of
dying).
Risk factor:
factor It can be defined as:
a. Risk marker. An attribute or an
exposure that is associated with an
increased risk of disease or other
specific outcome.
b. Determinant. An attribute or
exposure that increases the risk of
disease or other specific outcome
among population groups.
Risk factors might be
a.. Modifiable risk factors. Changeable
by intervention like body weight
d. Non-modifiable risk factors: Not
changeable like gender (sex)
Relative risk or Risk Ratio (RR): is a
measure of strength of association
between an exposure (risk factor) and
an outcome (disease).
 Incidence rate among exposed
Relative risk (RR) = ----------------------------------------------------
Incidence rate among non exposed
RR =1 No association
RR >1 Positive association (Risk factor)
RR<1 Negative association (protective factor)
Attributable risk (AR): It refers to the
fraction of the incidence rate of the
disease that can be attributed to the
exposure to the risk factor. It is
calculated by the following formula:
Attributable risk (AR)=
IR among exposed – IR among non exposed
 IR among exposed – IR among non exposed
% reduction = ------------------------------------------------------X 100

IR among exposed
Association (going together or
opposite to each other): A statistical/
quantitative (relationship) between two
or more variables. When variables tend
to occur together more frequently than
could be explained by chance, they are
described as being associated with
each other.
Types of statistical association
a. Non causal when the apparent
association is due to confounding
process, when a third factor is related
both to the risk factor (the cause) and
the outcome or effect (the disease).
b. Causal which is either:
direct (A B)
or indirect (A  B C)
The factor B is an intervening cause between the
factor A and the outcome C. More than one
intervening factor may exist in any causal pathway.
Causal association

A. Epidemiological criteria (Bradford Hill criteria):

1. Strength of association.
     2. Dose-response relationship.
     3. Time sequence.
     4. Experimental evidence.
5. Consistency.
6. Coherence/ Biological plausibility
7. Specificity.
8. Analogy
B. Biological criteria ( Koch's Postulates).
Applicable mainly to  biological agents.
1. Agent is regularly found in the lesion
of each case
2. Agent is isolated in pure culture.
3. Agent causes similar disease in
experimental animals
4. Agent is recovered from lesions in
experimental animal.
 ANALYTICAL STUDIES
They attempt to answer the
questions Why? And How?
1. They test hypothesis
2. They help in determination of risk
factors (causes)
3. They involve the use of comparison
or control groups
4. They need sound study design and
high epidemiological expertise.
 COHORT STUDIES
A cohort is a group of individuals who
share common characteristics or
experience, e.g., birth cohort which
.represents all live births in one year
In cohort studies
1. Select people who are free from
the disease.
2. At least two groups are used
(exposed versus non-    exposed)
3. The two groups are followed up for a
period of time)
4. Events (new cases or deaths ) are
recorded.
5. Results are analyzed to test the
hypothesis.
Example
A study was carried out to ascertain
the relationship of parental smoking to
the risk of ARI among children aged <5
years. A total of 800 children of
smoking parents and 1200 of
nonsmoking parents were followed up
for six months. During the follow up
period, 592 of the first group and 636 of
the second group developed at least
one attack of ARI.
The analysis
1. Tabulate the data
2. Calculate the incidence rates
3. Calculate the relative risk
4. Calculate the attributable risk
5. Perform a statistical test.
 Note: In case of multiple
exposures (the disease is related to
multiple risk factors) a more sophisticated
analysis is carried out to determine the
relative effect or contribution of each risk
factor. Logistic regression analysis and
stepwise multiple regression analyses are
commonly used. Computerized statistical
packages (such as SPSS) are available for
such sophisticated analyses.
CASE-CONTROL STUDIES
In case-control studies:
1. Both exposure and outcome or
disease have occurred before the
start  of the  study.
2. The study proceeds backwards from
outcome to cause (retrospective).
3. Controls are used to support or
refute any inference.
    The basic design steps
1. Selection of cases (persons with
definite disease) and controls (persons
definitely free from the disease at the
time of the study).

2. Matching for known confounding

variables (at least age and sex).
3. Measurement of past exposure in
both groups.
4. Analysis and interpretation.
Example
To illustrate the study design, we
identify a number of children who are
suffering from ARI (say pneumonia).
Suppose we identified 240 with ARI 380
of children matched for age and sex
but free from ARI. Suppose we found
that the parents of 170 cases and 200
controls were smokers.
The analysis and interpretation
1. Tabulation of the data
Total Children Children History of
without with smoking
pneumonia pneumonia
370 200 170 Positive
250 180 70 Negative
620 380 240 Total
2. Calculation of the % of smokers
(exposed) among parents of cases and
controls.      

3. Calculation of the % of smokers

among parents of controls
4. Measurement of the strength of
association between parental smoking
and acute respiratory infection. This is
achieved by calculating a proxy measure
to the relative risk. This measure is called
the Odds ratio.
Cases exposed X Controls not exposed
The Odds Ratio =----------------------------------------------------------------------
Cases not exposed X Controls exposed
5. Perform a suitable statistical test to
ascertain any significant association.
6. Calculation of the attributable risk

b ( r - 1)
    Attributable risk = -----------------------

b(r–1)+1
Where
r = Odds ratio
b = the proportion of people in the
general population with the risk factor.
SOURCES OF CONTROLS IN ANALTICAL
STUDIES
In case control studies, the main sources
are:
1. The total population in a given area, on the
assumption that we know the extent of
exposure in the general population.
Otherwise, a population-based sample of
controls can be drawn. This is the best
source of controls but probably difficult in
logistics terms.
2. Relatives and neighbours. This is
useful to control for genetics and
 immediate environment
3. Hospital patients other than those
with the disease under study.
4. Associates of cases in place of
residence, schools, place of work.
In cohort studies the main sources are:
1. Built in comparative cohorts as for
example in studying the relationship of
lung cancer to smoking, people may be
categorized into subgroups of heavy
smokers, moderate smokers, light
smokers and nonsmokers. Thus we
have four (heavy, moderate, light and
non) instead of just two (smokers
versus non-smokers).
2. Relatives and neighbors.
3. The total population provided that
the level of exposure is ascertained at
population level at the start of the
study.
4. Special occupational groups.
Questions
1. What are the main differences between
case-control and cohort studies?
2. Which of these two designs fits
Clinical controlled trials?
3. What types of bias might be
encountered in each of these two
desins?