Epidemiology V

Today’s Topics

 Cohort Studies
 Definition
 Features
 Design
 Steps
Cohort study
 Cohort study is another type of analytical
(observational) study which is usually undertaken
to obtain additional evidence to refute or support
the existence of an association between suspected
cause and disease.

 Cohort study is known by a variety of names:

prospective study, longitudinal study, incidence
study, and forward – looking study.
Cohort study
 Concept of cohort:
In epidemiology, the term “cohort” is defined as a
group of people who share a common characteristic
or experience within a defined time period, (e.g. age,
sex, occupation, exposure to drug or vaccine,
pregnant, etc.)
 The distinguished features of cohort studies are:
 The cohorts are identified prior to the appearance of
the disease under investigation.
 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.
Cohort study
 The basic design of Cohort study:
Cohort Diseases +ve Disease -ve Total

Exposed to factor a b a+b

Not exposed to factor c d c+d

 Here a group of cohort (a+b) is exposed to the factor and

another group of cohort is not exposed to the factor (c+d).
The former is known a study cohort and the latter is known
as control cohort.
 These group are then followed under the same identical
conditions, over a period of time to determine the outcome
of exposure. (e.g. onset of diseases, disability or death, etc)
 Among the study cohort (a+b) which are exposed to factor,
‘a’ developed diseases during the follow up period; among
control cohort (c+d) which are not exposed to factor, ‘c’ of
which become diseased.
Cohort Study
 The basic design of Cohort study:
Cohort Diseases +ve Disease -ve Total
Exposed to factor a b a+b
Not exposed to factor c d c+d

 After the follow up incidence rate in both groups are

determined.
 If it is found a/ (a+b) i.e. incidence of the diseases in
the exposed group is higher than c/ (c+d) i.e. incidence
rate in the non exposed group, it would suggest that the
diseases and suspected cause are associated.
Steps of Cohort Study
1. Identification/Selection of exposure cohort:
Cohort is selected from
I. General population; residing in well defined
geographical, administrative area.
II. Special groups; Select groups (Doctors, Nurses,
Lawyers, Teachers, etc), exposure groups (X-ray
technician, Uranium miners, Asbestos miners, etc)
2. Obtaining data exposure: Information about
exposure may be obtained by; direct interview, mail
questionnaire, review of hospital records, medical
examination, surveys, etc.
3. Selection of control or comparison groups: This
cohort should be similar to exposure cohort as
possible in demographic and other relevant
characteristics but not exposed to risk factor.
Steps of Cohort Study
4. Follow up: Periodic medical
examination, hospital records, mailed
questionnaire, telephone calls, periodic
home visits, etc.
5. Analysis: The data are analyzed by
a. Incidence rates of outcome among
exposed cohort and non-exposed
cohort
b. Estimation of risk: Relative risk and
Attributable risk.
Steps of Cohort Study
 Incidence rate can directly be determined-
Example

Cigarette Lung Cancer Lung cancer Total

Smoking Developed not developed
Yes 70 (a) 6930 (b) 7000 (a+b)
No 3 (c) 2997 (d) 3000 (c+d)

 Incidence rate of lung cancer among smoker=

a/ (a+b) =70/7000= 10 per 1000
 Incidence rate of lung cancer among non-smoker=
c/ (c+d) =3/3000= 1 per 1000
 Relative risk is the ratio of incidence of the diseases or death
among exposed cohort & the incidence among non-exposed cohort.
 Estimation of relative risk measures the strength of the association
between suspected cause and effect.
 A relative risk of 1 indicates no association, relative risk greater than
1 suggest that a positive association.
Cigarette Lung Cancer Lung cancer Total
Smoking Developed not developed
Yes 70 (a) 6930 (b) 7000 (a+b)
No 3 (c) 2997 (d) 3000 (c+d)
Incidence of disease among exposed
 RR = ---------------------------------------------------------------
Incidence of disease among non-exposed
 = 10/1 =10
 It shows that a smoker are 10 times more prone to develop lung
cancer than non-smokers.
Attributable risk
Attributable risk or excess risk is the difference in
rate of a condition between an exposed population and
an unexposed population.
Investigators count the occurrence of the diseases.
The cohort is then subdivided by the level of exposure
and the frequency of disease is compared between
subgroups. One is considered exposed and another
unexposed.
The formula attributable risk is
Once the AR is calculated, then the AR percent can be determined,
which is calculated as 100*(Ie –Iu) / Ie

What is the difference between relative risk and attributable risk?

Relative risk estimates the magnitude of an

association between exposure and disease, based on the incidence
of disease in the exposed group relative to the unexposed group.
... Attributable risk, or risk difference, is the absolute
difference in incidence between an exposed and unexposed group.
Population attributable risk (PAR)

It is the proportion of the incidence of a

disease in the population (exposed and
unexposed) that is due to exposure. It is the
incidence of a disease in the population that
would be eliminated if exposure were
eliminated.
 Experimental Studies:
 Treatment and exposures occur in a
“controlled” environment
 planned research designs
 clinical trials are the most well known
experimental design. Clinical trials use
randomly assigned data.
 Community trials use nonrandom data.
 Observational Studies

 non-experimental
 observational because there is no
individual intervention
 treatment and exposures occur in a “non-
controlled” environment
 individuals can be observed prospectively,
retrospectively, or currently
 Cross-sectional studies
 An “observational” design that surveys
exposures and disease status at a single point
in time (a cross-section of the population)

time
Study only exists at this point in time
Cross-sectional Design
factor present
No Disease
factor absent
Study
population
factor present
Disease
factor absent

time
Study only exists at this point in time
Cross-sectional Studies

 Often used to study conditions that are relatively

frequent with long duration of expression (nonfatal,
chronic conditions)
 It measures prevalence, not incidence of disease
 Example: community surveys
 Not suitable for studying rare or highly fatal diseases
or a disease with short duration of expression
 Cross-sectional studies

Disadvantages
Weakest observational design,
(it measures prevalence, not incidence of
disease). Prevalent cases are survivors
The temporal sequence of exposure and effect
may be difficult or impossible to determine
Usually don’t know when disease occurred
Rare events a problem. Quickly emerging
diseases a problem
Epidemiologic Study Designs

Case-Control Studies
an “observational” design comparing
exposures in disease cases vs. healthy
controls from same population
exposure data collected retrospectively
most feasible design where disease
outcomes are rare
 Case-Control Study
 Strengths
 Less expensive and time consuming
 Efficient for studying rare diseases
 Limitations
 Inappropriate when disease outcome for a specific
exposure is not known at start of study
 Exposure measurements taken after disease
occurrence
 Disease status can influence selection of subjects
 Epidemiologic Study Designs
 Cohort Studies
 an “observational” design comparing
individuals with a known risk factor or exposure
with others without the risk factor or exposure
 looking for a difference in the risk (incidence) of
a disease over time
 best observational design
 data usually collected prospectively (some
retrospective)
 Timeframe of Studies
 Prospective Study - looks forward, looks
to the future, examines future events,
follows a condition, concern or disease
into the future

time

Study begins here

 Prospective Cohort study

Exposed Outcome

Measure exposure
and confounder
variables

Baseline Non-exposed Outcome

time

Study begins here

 Timeframe of Studies

 Retrospective Study - “to look back”,

looks back in time to study events that
have already occurred

time
Study begins here
 Retrospective Cohort study

Exposed Outcome

Measure exposure
and confounder
variables

Baseline Non-exposed Outcome

time
Study begins here
 Cohort Study
 Strengths
 Exposure status determined before disease detection
 Subjects selected before disease detection
 Can study several outcomes for each exposure

 Limitations
 Expensive and time-consuming
 Inefficient for rare diseases or diseases with long
latency
 Loss to follow-up
 Experimental Studies
 Investigator can “control” the exposure
 Similar to laboratory experiments except
living populations are the subjects
 Generally involves random assignment to
groups
 Clinical trials are the most well known
experimental design
 The ultimate step in testing causal
hypotheses
Experimental Studies

 In an experiment, we are interested in the

consequences of some treatment on some
outcome.
 The subjects in the study who actually receive the
treatment of interest are called the treatment
group.
 The subjects in the study who receive no treatment
or a different treatment are called the comparison
group.
 Epidemiologic Study Designs
 Randomized Controlled Trials (RCTs)
a design with subjects randomly assigned to
“treatment” and “comparison” groups

 provides
most convincing evidence of relationship
between exposure and effect

 notpossible to use RCTs to test effects of

exposures that are expected to be harmful, for
ethical reasons
Steps in RCT
1. Drawing up a protocol
2. Selecting reference and experimental populations
3. Randomization
4. Manipulation or intervention
5. Follow-up
6. Assessment of outcome
 BIAS
 It arises from errors of assessment of the outcome due to
human element.
 Three sources of bias:
 1. Bias may be on the part of the participant who may
subjectively feel better or report improvement if they
knew they were receiving a new form of treatment. This
is known as subject variation.
 2. There may be observer bias that is the investigator
measuring the outcome of a therapeutic trial maybe
influenced if he knows beforehand the particular
procedure or therapy to which the patient has been
subjected. This is known as observer bias.
 3.May be bias in evaluation that is the investigator may
subconsciously give a favorable report of the outcome
of the trial. Randomization cannot control against the
source of bias nor the size of the sample.
 In order to reduce these problems, blinding is done.
 BLINDING
 SINGLE BLIND TRIAL—The trial is so planned that the
participant is not aware whether he belongs to the study
group or control group.

 DOUBLE BLIND TRIAL—The trial is so planned that

neither the doctor not the participant is aware of the group
allocation and the treatment received.

 TRIPLE BLIND TRIAL– This goes one step further. The

participant, investigator and the person analyzing the data
are all blind.