COHORT STUDY

-- B.ARCHANA,
ROLL NO- 23,
2004 BATCH.
 INTRODUCTION
 DEFINITION OF EPIDEMIOLOGY :
Study of distribution and determinants of health-
related states or events in specified populations and
the application of this study to the control of health
problems.
 ANALYTICAL EPIDEMIOLOGY :

Subject of interest is the “individual” within

population. It comprises of:
(1) Case control study
(2) Cohort study

 One can determine the following :

(a) Whether or not a statistical association exists
between a disease and a suspected factor.
(b) If such a one exists, strength of association.
 COHORT STUDY
 OBJECTIVE : Is to obtain additional evidence to refute
or support the existence of an association between
suspected cause and disease.

 SYNONYMS :
Prospective study
Longitudinal study
Incidence study
Forward looking study
 CONCEPT OF COHORT STUDY
 Term cohort is defined as a group of people who share a
common characteristic or experience within a definite
period of time.
Ex : Exposure cohort

DISTINGUISHING FEATURES :
(a) The cohorts are identified prior to the appearance of the
disease under investigation.
(b) The study groups, so defined, are observed over a
period of time to determine the frequency of disease
among them.
(c) The study proceeds from cause to effect.
 INDICATIONS FOR COHORT STUDIES :
(1) Evidence of an association between risk factor and
the disease.
(2) When exposure is rare, but incidence of
disease is high among exposed.
(3) When attrition of study population can be minimized.
(4) When ample funds are available.

COHORT- STUDY group

CONTROL- general population from

which cohort is drawn (or) can be
from another cohort of persons
who had little or no exposure to the
risk factor.
 GENERAL CONSIDERATIONS :
(a) The cohorts must be free from the disease under study.
(b) Both the groups, should be equally susceptible to the
disease under study.
(c) Both the groups should be comparable in respect of all
the possible variables, which may influence the
frequency of the disease.
(d) The diagnostic and the eligibility criteria of the disease
must be defined before hand.
 PROCEDURE
 ELEMENTS OF 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 – Geographically defined.
The exposed and unexposed segments of the
population to be studied should be representative of the
corresponding segments of the general population.
Ex : – The Framingham Heart Study.
(b) Special groups:
(1)Select groups: Professional groups. These group
are usually homogenous. Also offer advantages of
accessibility and easy follow-up for a protracted period.
Ex: Doll and Hill Prospective Cohort Study.
(2)Exposure groups: Cohorts are selected based on
special exposure to physical, chemical and other disease
agents. In this, the exposure may be rare but the
incidence of disease is high among the exposed.
Ex: Radiologists exposed to X-rays.
 OBTAINING DATA ON EXPOSURE :
(1) Information available from records.
(2) Information that can be supplied by individual cohort
members.
(3) Information that can be obtained by medical
examination or special testing of the cohort members.
(4) Information that requires testing or evaluation of
environment within which the study members have lived
or worked.
 REASSIGNMENT OF THE COHORT GROUPS :
(1) According to whether or not they have been exposed to
the suspected factor.

(2) According to the level or degree of exposure.

SELECTION OF COMPARISON GROUPS:

(1) Internal comparisons
(2) External comparisons or Comparison cohorts
(3) Comparison with general population rates

 INTERNAL COMPARISONS :
No outside comparison group is required.
Comparison groups are in-built.
Classified into several comparison groups based on
levels of exposure.
 Classification No. of deaths Death rate
of exposure
½ Pack 24 95.2
1-2 Packs 90 229.2
2 Packs + 97 264.2
 EXTERNAL COMPARISONS:
When information on degree of exposure is not
available, an external control, which is similar in
demographic and other variables with the study group
is selected to evaluate the degree of exposure.
Ex: Smokers and non-smokers
 COMPARISON WITH GENERAL POPULATION RATES:
If none is available, the mortality experience of the
exposed group is compared with the mortality
experience of the general population in the same
geographic area as the exposed group.
Ex: Comparison of frequency of lung cancer among
uranium mine workers with lung cancer mortality in the
general population where the miners resided.
 LIMITING FACTORS:
(1) Non-availability of population rates for the
outcome required.
(2) Difficulties in selecting the study and
comparison groups which are representative of the
exposed and non-exposed of the general population.
FOLLOW-UP:
(A) Periodic medical examination of each member of the
cohort.
(B) Reviewing physician and hospital records
(C) Routine surveillance of death-records
(D) Mailed questionnaires, telephone calls, periodic
home-visits.
 The groups are then followed, under the same identical
conditions, over a period of time to determine the
outcome of exposure i.e., onset of disease or disability
or death in both the groups.

 In spite of best efforts, certain percentage of losses to

follow-up are inevitable due to death, change of residence,
migration or withdrawal of occupation resulting in bias in
the results.
FRAME WORK OF COHORT STUDY

DISEASE
COHORT YES NO TOTAL
EXPOSED a b a+b
NOT c d c+d
EXPOSED
 ANALYSIS: The data are analyzed in terms of :
(a) Incidence rates.
(b) Estimation of risk.
 Incidence rates :
Incidence rate is defined as “ the number of NEW cases
occurring in a defined population during a specified
period of time”.

Number of new cases

of specific disease during a given
time period Incidence =
×1000
Population at risk during that period
 Cigarette Developed Did not Total
Smoking develop
lung cancer lung cancer
Yes 70 6930 7000
(a) (b) (a+b)
No 3 2997 3000
(c) (d) (c+d)

 Incidence rates among smokers and non-smokers

are calculated
as following : Among
smokers:70/7000*1000=10 per 1000
Among non-smokers:3/3000*1000=1 per 1000

 a/a + b > c/ c + d
 ESTIMATION OF RISK:

(A) Relative risk

(B) Attributable risk
(C) Population attributable risk
(A) RELATIVE RISK:
Relative risk is the ratio of the incidence of the disease
among exposed and the incidence among non-exposed.
Incidence of disease among exposed
RR =
Incidence of disease among non-exposed

 In our example RR of lung cancer = 10/1 = 10

 A relative risk of one indicates no association; relative
risk greater than one suggests “positive” association
between exposure and the disease under study.

 A relative risk of 0.25 indicates a 75% reduction in the

incidence rate in exposed individuals as compared
with the unexposed.
 The larger the RR, the greater the “strength” of the
association between the suspected factor and disease.
(B) ATTRIBUTABLE RISK OR RISK DIFFERENCE :
It is the difference in incidence
rates of disease between an exposed group and non-
exposed group.
Incidence of disease rate among exposed-Incidence
of disease rate among non-exposed
= ×100
Incidence rate among exposed

 Attributable risk in the example : 10-1/10×100 =90

It indicates to what extent the disease under study can
be attributed to the exposure.
(C)POPULATION ATTRIBUTABLE RISK :

It is the incidence of the disease in the total

population minus the incidence of the disease among
those who were not exposed to the suspected causal
factor.
 The concept of population attributable risk is useful in
that it provides an estimate of the amount by which the
disease could be reduced in that population if the
suspected
Smokers factor was eliminated
224 or modified.
Exposed (a)
Non Smokers 10 Non-exposed (b)
Death in total 74(c)
population

Individual RR a/b=224/10 =22.4

Population AR c-b/c *100=86%

 TYPES OF COHORT STUDIES
Based on the time of occurrence of disease in relation
to the time at which the investigation is initiated and
continued, (a) Prospective cohort studies
(b) Retrospective cohort studies
(c) Combination studies
At the beginning of a prospective cohort study, the
investigator is aware of a group of individuals, some of
whom have been exposed to a hazard. All members of the
cohort will be followed over time to see if those exposed
and those unexposed have different disease experiences.
Ex:
The US Public Health Service’s Framingham
Heart Study.
The Doll and Hill Prospective cohort study.
Study of oral contraceptives and health by Royal
College of general practitioners.
59,600 British doctors participated, follow-up
was done for 4 years and 5 months by obtaining
notifications of deaths from the registrar
general, the general medical council and the
British medical association.
WOMEN WITH DIABETES ARE MORE AT RISK OF FATAL CHD
THAN MEN
Type 2 diabetes increases the risk of dying from coronary heart
disease (CHD) by up to 50% more in women than in men. Huxley
and colleagues carried out 37 prospective cohort studies that
included more than 445 000 cases. In the 29 studies, they found a
relative risk (female : male) of 1.46.This may be a consequence of
diabetes inducing a more adverse cardiovascular risk profile in
women. 
 At the beginning of a retrospective cohort study, the
investigator is aware of an exposure to a hazard that
occurred at some time in the past, sufficiently long ago
 A cohort that includes the exposed individuals is
identified, and the health histories of all members
explored to identify the presence or absence of disease.
Ex: Occupational exposures, Study of role of arsenic
and uranium, Study of angiosarcoma of liver.
 To improve understanding of the epidemiology of
endemic viral hepatitis in urban India, a retrospective
analysis was conducted of the prevalence of this disease
in 69,440 residents of Alwar, Rajasthan State, in 1994. A
total of 192 cases of jaundice were detected during the 12-
month study period, for an annual incidence of 2.76/1000
population. Almost 60% of these cases occurred during
the summer and monsoon months (June-September),
suggesting a feco-oral mode of transmission.
 ATTRIBUTE PROSPECTIVE RETROSPECTIVE
Information More complete Less complete
& not accurate & accurate
Expense More costly Less costly
Completion Longer Shorter
time

Discontinued Not useful Useful

exposure
Emerging new Useful Not useful
exposures
Other names The current study The historical study
Prospective study in
retrospect
Non-concurrent study
 In combination studies, the cohort is identified from
the past records and is assessed of date for the
outcome (retrospectively). The same cohort is
followed up (prospectively) for future for further
outcome.
Ex: Court-Brown and Doll study on development
of leukemia or aplastic anaemia who received large
doses of radiation therapy for ankylosing spondylitis.
ADVANTAGES OF COHORT STUDY :
(1) Incidence can be calculated.
(2) Several possible outcomes related to exposure
can be studied simultaneously.
(3) Cohort studies provide a direct estimate to relative
risk.
(4) Dose-response ratios can also be calculated.
(5) Certain forms of bias can be minimized like
misclassification of individuals into exposed and
unexposed, since comparison groups are formed
before the onset of disease.
 DISADVANTAGES OF COHORT STUDIES :

(1) Involve large number of people.

(2) Takes long time to complete the study and obtain

results.

(3) Administrative problems such as loss of experienced

staff, loss of funding, and extensive record keeping are
inevitable.

(4) It is not unusual to lose a substantial proportion of the

original cohort.

(5) Selection of the comparison groups which are

representative of the exposed and unexposed
segments of the population is a limiting factor.
DISADVANTAGES OF COHORT STUDIES Contd.

(6) There may be changes in the standard methods or

diagnostic criteria.

(7) Cohort studies are expensive.

(8) The study itself may alter the people’s behavior.

(9) Ethical problems are present.

(10) Practical considerations that we must concentrate on a

limited number of factors possibly related to disease
outcome.
 Case control study Cohort study

(1) Proceeds from “effect to (1) Proceeds from “cause to

cause”. effect”.
(2) Starts with the disease. (2) Starts with people
exposed to risk factor.
(3) Tests whether the (3) Tests whether disease
suspected cause occurs occurs more frequently in
more frequently in those those exposed, than in
with the disease than among those not exposed.
those without the disease.
(4) The first approach is to (4) Reserve for testing
test hypothesis, but also precisely formulated
useful for exploratory hypothesis.
studies.
(5) Involves fewer number of (5) Larger number.
subjects.
 Case control study Cohort study
(6) Yields relatively quick (6) Long follow – up period
results. often needed.

(7) Suitable for the study of (7) Inappropriate when the

rare diseases. disease under investigation
is rare.
(8) Generally yields only
estimate of RR, (8) Yields incidence rates,
(odds ratio). RR as well as AR.

(9) Cannot yield information (9) Can yield information

about diseases other than about more than one disease
that selected for study. outcome.

(10) Relatively inexpensive. (10) Expensive.