Cohort Studies

Introduction
All studies involve some descriptive or
analytic type of comparison of
exposure and disease status.
Analytical study design options include:
observational or interventional (which
one is based on the role of the investigator) .
There are three basic types of
observational analytical study designs:
Cohort studies
Case-control studies
Cross-sectional studies

Introduction
Specific epidemiological study designs can be
used to reveal etiologic (causal) relationships

First, using observational analytical studies :

Determine whether there is an association
between a factor or a characteristic and the
development of disease

Second:
From these associations, derive appropriate
inferences regarding a possible causal
relationship

Analytical Studies
Control and experimental groups
Randomized groups
data collected without bias

Dependent and independent factors

Cohort Studies
Group by common characteristics
Start with a group of subjects who lack a
positive history of the outcome of interest
yet are at risk for it (cohort).
Think of going from cause to effect.

The exposure of interest is determined for

each member of the cohort and the group
is followed to document incidence in the
exposed and non-exposed members.

When is a cohort
study warranted?
When good evidence suggests an
association of a disease with a
certain exposure or exposures.

Cohort Effect
Changes and variation in the disease or
health status of a study population as
the study group moves through time.
Generation effect

Types of Cohort Studies

Prospective (concurrent)
Retrospective (historical)
Restricted (restricted exposures)

Types of Cohort Studies

Prospective cohort characterized by
determination of exposure levels (exposed
vs. not exposed) at baseline (present) and
followed for occurrence of disease in future
Groups move through time as they age

Retrospective - makes use of historical

data to determine exposure level at some
baseline in the past and then determine
subsequent disease status in the present.
Restricted - limited exposure, narrow
behavior (military, long shore men)

Prospective Studies
Also called
longitudinal
concurrent
incidence studies

Looking into the future

Example:
Framingham Study of coronary heart
disease (CHD)

Design of a Cohort Experiment

The essential characteristic in the design of
cohort studies is the comparison of
outcome in an exposed group and a
nonexposed group (or a group with a certain
characteristic and a group w/o that characteristic).
A study population can be chosen by selecting
groups for inclusion in the study on the basis of
whether or not they were exposed

Selection of Cohort Groups

There are two basic ways to generate cohort
groups.
Select a cohort (defined population) BEFORE
any of its members become exposed or before
the exposures are identified.
Select a cohort on the basis of some factor
(e.g., where they live) and take histories (e.g.,
blood tests) on the entire population to separate
into exposed and non-exposed groups.

Regardless of which selection approach is

used, we are comparing exposed and nonexposed persons.

Design of a Cohort Experiment

Design of a Prospective
Cohort Experiment

Major problem with a prospective cohort design is that

the cohort must be followed up for a long period of time.

Framingham Study
Designed to study the effect of multiple
factors on coronary heart disease (CHD):
age
hypertension
elevated blood cholesterol
tobacco smoking
increased physical activity
increase in body weight
diabetes mellitus

Framingham Study Design

Framingham, Massachusetts population
was 28,000
Study design called for a random
sample of 6,500
Enrollment questionnaire form targeted
age range 30-59 years
No clinical evidence of atherosclerotic
cardiovascular disease
Cohort re-examined every two years
Problems: white, middle class

Hypothetical Cohort Study Approach

1. Examine people over their life times for
contraction of diseases. In meantime,
ask questions concerning diet,
lifestyle,habits, work, etc.
2. Take blood and do lab tests (as many
as possible).
3. Do same tests every year for a period
of years.
Interventional aspect: If positive findings occur, they
refer you to a specialist. By screening, they may have
prolonged a life.

Sampling
Valid, reliable surveys
Critical number of subjects

Garbage in,
garbage out

the more, the better

Randomize
random selection
random assignment

Rule out bias

For example, degree of accuracy with which
subjects have been classified with respect to
their exposure.
For example, individuals who are sick may be
more likely to give the kind of responses that
they believe the investigator wants to hear

Data Gathering

Person - to - person
Drop off questionnaire
Mailed to people
Telephone interview
Newsletter or magazine

Potential Biases in
Cohort Studies

Information bias
Bias in estimation of the outcome
Bias from non-response
Bias from losses to follow-up
Analytic bias
Your assignment:
Describe and
differentiate between
these types of biases.

Advantages of
Prospective Cohort Studies

Captive groups
Large sample sizes
Certain diseases or risk factors targeted
Can be used to prove cause-effect
Assess magnitude of risk
Baseline of rates
Number and proportion of cases that can
be prevented

Advantages of
Prospective Studies (contd)
Completeness and accuracy
Opportunity to avoid condition being
studied
Quality of data is high
Considers seasonal and other
variations over a long period
Tracks effects of aging process

Disadvantages of
Prospective Cohort Studies
Large study populations required
not easy to find subjects

Expensive
Unpredictable variables
Results not extrapolated to general
population
Study results are limited
Time consuming/results are delayed
Requires rigid design and conditions

Disadvantages of
Prospective Studies (contd)

Subjects lost over time (dropouts)

Costs are high
Logistically demanding
Maintaining quality, validity, accuracy
and reliability can be a problem

Survivorship Studies
Survivorship is the number of persons out of a
study population who would survive until a
certain time interval has been reached
Shows the chance that an event (such as death
from cancer) will occur in successive intervals
of time once a diagnosis has been made
Analysis yields a cumulative probability of
surviving the projected time period
For infectious diseases, we use case fatality rate
to assess survival
For chronic diseases, we use cohort life tables

(Cohort) Life Tables

Charts which summarize the patterns
of survival and death in study groups
of certain types of disease (chronic)
Insurance companies study these
charts very closely.

Survival curves and risk of death for males vs.

females based on life tables in California for 1980.
Dip at beginning of
life is due to infant
mortality rate.
As one reaches the
later years of life, the
survival curve goes
down and the risk of
death goes up.

Is the Association Causal?

To be continued