COHORT STUDY

Dr. Rahul Netragaonkar

Associate Professor

Epidemiology
Defined by John M. Last in 1988
Study of Distribution and Determinants of health
related state or event in a specified population
and the application of this study to the control of
health problem.
We measure
Disease frequency
Diseases distribution
Determinants of disease.

TYPES OF EPIDEMIOLOGICAL STUDIES

1.

OBSERVATIONAL STUDIES
A.

DESCRIPTIVE STUDY
DESCRIBE DIESEASE BY
TIME
PLACE
PERSON

B.

ANALYTICAL STUDIES
ECOLOGICAL STUDY
CROSS SECTIONAL STUDY
CASE-CONTROL STUDY
COHORT STUDY

2.

EXPEREMENTAL STUDIES
RANDOMIZED CONTROLLED TRIAL (RCT)
FIELD TRIAL
COMMUNITY TRIAL

Descriptive Epidemiology

Describe the disease by

Time
Place
Person

ANALYTICAL EPIDEMIOLOGY
To test the hypothesis
a. case control study
b. cohort study
a. Whether a statistical association between
a disease and a suspected factor exists or
not
b. If it exists, the strength of the Association

 To obtain additional evidence to

refute or support the existence of an
association between suspected
cause and disease.
Also called as Prospective study,
Longitudinal study, Incidence study,
and Forward-looking study.

 Cohort study is undertaken to support the existence of

association between suspected cause and disease
A major limitation of cross-sectional surveys and casecontrol studies is difficulty in determining if exposure or risk
factor preceded the disease or outcome.
Cohort Study:

Key Point:
Presence or absence of risk factor is
determined before outcome occurs.

COHORT STUDY
Features

The cohorts are identified prior to the appearance of

the disease
The study groups, so defined, are observed over a
period of time to determine the frequency of disease
among them
The study proceeds forward from cause to effect.
Individual Exposed to
PROSPECTIVE (Cohort)
Particular Factor(s)
STUDY
Individual
Presence or absence of
Unexposed to
Particular disease
Particular factor(s)

Cohort

Cohort" is a group of people who

share a common characteristic or
experience within a defined time
period (e.g., age, occupation,
exposure to a drug or vaccine,
pregnancy, insured persons, etc).

Indications for cohort studies

(a) when there is good evidence of an
association between exposure and disease
(b) when exposure is rare, but the incidence
of disease high among exposed
(c) when attrition of study population can be
minimised,
(d) when ample funds are available.

Framework of a cohort study

The basic approach in cohort

studies is to work from "cause to
effect.
In a cohort study, the exposure
has occurred, but the disease
has not.

a. The cohorts must be free from the

disease under study.
b. Both the groups (i.e., study and
control cohorts) should be equally
susceptible to the disease under
study,
c. They should efficiently reflect any
difference in disease

Both the groups should be

comparable
e. The diagnostic and
eligibility criteria of the
disease must be defined
beforehand
d.

Types of cohort studies

1. Prospective cohort studies
2. Retrospective cohort studies
3. A combination of retrospective
and prospective cohort studies

Prospective cohort study

A prospective cohort study (or

"current" cohort study) is one which
the outcome (e.g., disease) has not
yet occurred at the time the
investigation begins.
Most prospective studies begin in
present and continue into future.

Types of cohort study

Prospective cohort study/current
Doll and Hills prospective study on
smoking and lung cancer
Framingham Heart Study of U.S
Public Health Services.
Uranium miners and lung cancer.

Retrospective cohort studies

A retrospective cohort study (or "historical" cohort
study) is one in which the outcomes have all
occurred before the start of the investigation.
The investigator goes back in time, to select his
study groups from existing records of past
employment, medical or other records and traces
them forward through time, from a past date fixed
on the records, usually up to the present.

Retrospective cohort study Historical cohort

study (Economical)

Electronic fetal monitoring and neonatal

deaths.
Arsenic in carcinogenesis.
Uranium miners and lung cancer
Angiosarcoma of liver in those who use
PVCs

. Combination of retrospective and prospective

cohort studies

The cohort is identified from past

records, and is assessed of date for
the outcome.
The same cohort is followed up
prospectively into future for further
assessment of outcome.

Combination of retrospective and

prospective study

Court Brown and Doll in the

effects of radiation ( for
ankylosing spondilitis) outcome
was death or aplastic anemia

ELEMENTS OF A COHORT STUDY

1. Selection of study subjects

2. Obtaining data on exposure
3. Selection of comparison groups
4. Follow-up
5. Analysis

Selection of study subjects

(a) General population : When the

exposure or cause of death is fairly
frequent in the population,
(b) Special groups : These may be
special groups or exposure groups
that can readily be studied:

 (i) Select groups: Professional groups (e.g.,

doctors, nurses, lawyers, teachers, civil
servants), insured persons, obstetric
population, college alumni, government
employees, volunteers, etc.
(ii) Exposure groups : If the exposure is
rare, a more economical procedure is to
select a cohort of persons known to have
experienced the exposure.

Obtaining data on exposure

(a) Cohort members, through personal interviews
or mailed questionnaires
(b) Review of records: Certain kinds of
information (e.g., dose of radiation, or details of
medical treatment)etc.
(c) Medical examination or special tests: e.g.,
blood pressure, serum cholesterol, ECG.
(d) Environmental surveys: where the cohort lived
or worked.

Selection of comparison groups

a) Internal comparisons:
) Single cohort enters the study, and its members may,
on the basis of information obtained.
(b) External comparisons:
) To evaluate the experience of the exposed group, e.g.,
smokers and nonsmokers
(c) Comparison with general population rates:
) Experience of the exposed group is compared with the
mortality experience of the general population in the
same geographic area as the exposed people

Follow-up
Periodic medical examination of each
member of the cohort
Reviewing physician and hospital
records
Routine surveillance of death records
Mailed questionnaires, telephone calls,
periodic home visits-

Analysis
(a) Incidence rates of outcome among exposed and non exposed
(b) Estimation of risk

Cigare Develop
tte
ed lung
Smoki cancer
ng
yes
70
no
3
Incidence rates:

Did not
develop
lung
cancer
6930
2997

(a) among smokers = 70/7000 = 10 per 1000

(b) among non-smokers = 3/3000 = 1 per 1000
Statistical significance: P < 0.001

Tota
l

7000
3000

{ a/ ( a + b ) }
{ c/ ( c+ d ) }

RELATIVE RISK (Risk ratio )

It is the ratio of the incidence of the disease (or death)

among exposed and the incidence among non
exposed.

RR= Incidence of disease (or death) among

exposed /Incidence of disease (or death)
among non-exposed { a / (a+b) / c / ( c+d ) }
It is a direct measure (or index) of the "strength" of the
association between suspected cause and effect.
A RR = 1 No association;
RR > 1- suggests "positive" association between exposure and
the disease under study.

ATTRIBUTABLE RISK

Difference in incidence rates of disease (or death) between an

exposed group and non exposed group. Some authors use
the term "risk difference" to attributable risk.

AR= Incidence of disease rate among exposed

--incidence of disease rate among non exposed /
Incidence rate among exposed X 100
10 1 / 10 * 100 = 90 %
Attributable risk indicates to what extent the disease under
study can be attributed to the exposure.
This suggests the amount disease that might be eliminated if
the factor under study could be controlled or eliminated.

POPULATION ATTRIBUTABLE RISK

It is the incidence of the disease (or death)

in the total population - the incidence of
disease (or death) among those who were
not exposed to the suspected causal factor
Population attributable risk provides an
estimate of the amount by which the
disease could be reduced in that population
if the suspected factor was eliminated or
modified.

Advantages

Incidence can be calculated

Several outcomes related to exposure can
be studied
Cohort studies provide a direct estimate of
RR
Dose-response ratios can also be calculated
Bias can be minimised.

Disadvantages

Cohort studies involve a large number of people.

Unsuitable to investigate uncommon diseases
Long time to complete the study and obtain results
Attrition is possible
Cohort studies are expensive
The study itself may alter peoples behaviour.
There may be changes in the standard methods or
diagnostic criteria of the disease over prolonged
follow-up

Case control study

Cohort study

1.

Proceeds from "effect to cause

Proceeds from "cause to effect" .

2.

Starts with the disease

Starts with people exposed to risk factor or suspected

cause.

3. Tests whether the suspected cause occurs more

frequently in those with the disease than among those
without the disease.

Tests whether disease occurs more frequently in those

exposed, than in those not similarly exposed.

4. Usually the first approach to the testing of a hypothesis,

but also useful for exploratory studies.

Reserved for testing of precisely formulated hypothesis

5.

Involves fewer number of subjects

Involves larger number of subjects

6.

Yields relatively quick results

Long follow-up period often needed , delayed results.

7. Suitable for the study of rare diseases

Inappropriate when the disease or exposure under

investigation is rare.

8. Generally yields only estimate of RR (odds ratio)

Yields incidence rates, RR as well as AR.

9. Cannot yield information about diseases other than that

selected for study

Can yield information about more than one disease

outcome.

10. Relatively inexpensive

Expensive.

Some Famous studies

Smoking and lung cancer At least eight prospective studies on the
relation of smoking lung cancer had been done.
The Framingham Heart Study was initiated in 1948 by the United States
Public Health Service to study the relationship of a number of (risk)
factors (e.g., serum cholesterol, blood pressure, weight, smoking) to the
subsequent development of cardiovascular disease in the town of
Framingham
Oral contraceptives and health and health conducted by the Royal
College of General Practitioners in England
It was initiated in 1968, after 2 years of planning. 23,000 users of the pill
aged 15-49 years together with a similar number of controls using other
methods or no method of contraception were brought under observation
of 1400 general practitioners.

THANKS