Cohort Study

Definition

A study design where one or more samples (called cohorts) are followed prospectively and
subsequent status evaluations with respect to a disease or outcome are conducted to
determine which initial participants exposure characteristics (risk factors) are associated
with it. As the study is conducted, outcome from participants in each cohort is measured
and relationships with specific characteristics determined

Advantages

 Subjects in cohorts can be matched, which limits the influence of confounding

variables
 Standardization of criteria/outcome is possible
 Easier and cheaper than a randomized controlled trial (RCT)

Disadvantages

 Cohorts can be difficult to identify due to confounding variables

 No randomization, which means that imbalances in patient characteristics could
exist
 Blinding/masking is difficult
 Outcome of interest could take time to occur

Design pitfalls to look out for

The cohorts need to be chosen from separate, but similar, populations.

How many differences are there between the control cohort and the experiment cohort? Will
those differences cloud the study outcomes?

Fictitious Example

A cohort study was designed to assess the impact of sun exposure on skin damage in beach
volleyball players. During a weekend tournament, players from one team wore waterproof,
SPF 35 sunscreen, while players from the other team did not wear any sunscreen. At the end
of the volleyball tournament players' skin from both teams was analyzed for texture, sun
damage, and burns. Comparisons of skin damage were then made based on the use of
sunscreen. The analysis showed a significant difference between the cohorts in terms of the
skin damage.
 Lesson 9: Cohort Study Design; Sample Size and Power Considerations for Epidemiologic
Studies

Cohort Study Design

A cohort study is useful for estimating the risk of disease, the incidence rate and/or relative
risks.

Types of Cohort Studies

The simplest cohort design is prospective, i.e., following a group forward in time, but a cohort
study can also be 'retrospective'. In general, the descriptor, ’prospective’ or 'retrospective',
indicates when the cohort is identified relative to the initiation of the study.

1. Prospective cohort (concurrent; longitudinal study) - An investigator identifies the study

population at the beginning of the study and accompanies (সসসসস সসসস) the subjects
through time. In a prospective study, the investigator begins the study at the same time as
the first determination of exposure status of the cohort. When proposing a prospective
cohort study, the investigator first identifies the characteristics of the group of people he/she
wishes to study. The investigator then determines the present case status of individuals,
selecting only non-cases to follow forward in time. Exposure status is determined at the
beginning of the study.
 Problems: loss to follow up; differential nonresponse; loss of funding support; continually
improving methods for detecting exposure (leading to greater misclassification than would
be expected in current practice)
 Examples: Framingham Study; Nurses Health Study; National Health and Nutrition
Examination Study Follow up Study. These are all studies where case status was determined
at the beginning of the cohort and cases eliminated from the study. Exposure was then
measured who were followed over a period of time until reaching the study endpoint. A
member of the cohort reaches the endpoint either by dying, becoming a case, or reaching the
end of the study period. A subject can also be lost to follow-up over the course of the study.
The investigator progresses through time with the subjects in a prospective cohort study.
Such a study may also be called a longitudinal or a concurrent study, as opposed to a
retrospective cohort study.
2. Retrospective cohort study (historical cohort; non-concurrent prospective cohort) - An
investigator accesses a historical roster of all exposed and nonexposed persons and then
determines their current case/non-case status. The investigator initiates the study when the
disease is already established in the cohort of individuals, long after the original measurement
of exposure. Doing a retrospective cohort study requires good data on exposure status for
both cases and noncases at a designated earlier timepoint.
Think About It!
Come up with an answer to this question and then click on the icon to the left to
reveal the answer.
How does a retrospective cohort study differ from a case-control study? Suppose you are
investigating the possibility of an environmentally-linked cancer among students at a
university. How would the sample selected for a case-control study differ from those
included in a retrospective cohort study?
Potential problems with the retrospective cohort approach include selection bias and
misclassification bias because of the retrospective nature of the study. However, the
retrospective cohort design can be useful when reliable records are available, such as in
occupational studies where levels of exposure to environmental exposures are monitored and
recorded in a database. Investigators can determine the case status of the entire group at
the present time, then use the exposure records to assess the relationship between exposure
and disease. To make the terminology even more confusing, these types of designs can also
be labeled historical cohort studies or non-concurrent prospective cohort studies.

Think About It!

Come up with an answer to this question and then click on the icon to the left to reveal
the answer.
Is a panel study the same as a cohort study?

A panel study is a longitudinal study of a cohort of people with multiple measures over
time. They are a cohort because they share something in common (e.g, employment,
retirement). There is generally limited sampling with respect to exposure, and there is no
assurance of not being diseased (or having a specific outcome) when they enter the study. A
disease or outcome of interest is not specified... The panel study is a group of people who
share a characteristic and they are progressing through time together to undetermined
outcomes.

3. Investigator enters well-after cohort is enrolled, but well-before case determination

Sometimes investigators enter into an ongoing prospective cohort study before the cases are
determined. An investigator may pose a new question during an intermediate time period of
an ongoing study. The cohort is already determined. Exposure and case status information
are available from the beginning of the ongoing study; subjects can be followed forward to
collect cases. For example, suppose genotyping is performed in a cohort study. Later, an
investigator may decide to use these data and subsequent case status to consider the
relationship of a genetic factor to a particular disease. The investigator may wish to follow the
subjects several more years to ascertain more cases. This would be a mixture of a prospective
and retrospective cohort.

A cohort study is a particular form of longitudinal study (panel study) that sample a cohort (a
group of people who share a defining characteristic, typically who experienced a common
event in a selected period, such as birth or graduation), performing a cross-section at intervals
through time. A cohort study is a panel study, but a panel study is not always a cohort study
as individuals in a panel study do not always share a common characteristic. [1]
A cohort study is a quasi-experiment used in medicine, nursing, psychology, social
science, actuarial science, business analytics, and ecology. For instance: in medicine, it is an
analysis of risk factors and follows a group of people who typically do not have a given
disease, and uses correlations to determine the absolute risk of subject contraction. It is one
type of clinical study design and should be compared with a cross-sectional study. Cohort
studies are largely about the life histories of segments of populations, and the individual
people who constitute these segments.[2][3]
A cohort is a group of people who share a common characteristic or experience within a
defined period (e.g., are currently living, are exposed to a drug or vaccine or pollutant, or
undergo a certain medical procedure). Thus a group of people who were born on a day or in
a particular period, say 1948, form a birth cohort. The comparison group may be the general
population from which the cohort is drawn, or it may be another cohort of persons thought
to have had little or no exposure to the substance under investigation, but otherwise similar.
Alternatively, subgroups within the cohort may be compared with each other.
Indicators of cohort study:

1. When there is a strong association between cause and effect, established by any
observational study
2. When the exposure is rare, but incidence of disease among exposed is high
3. When people's attrition can be minimized
4. When resources are ample
Cohort studies can be retrospective (looking back in time, thus using existing data such as
medical records or claims database) or prospective (requiring the collection of new data).[4]

Application
In medicine, a cohort study is often undertaken to obtain evidence to try to refute the
existence of a suspected association between cause and effect; failure to refute a hypothesis
often strengthens confidence in it. Crucially, the cohort is identified before the appearance of
the disease under investigation. The study groups follow a group of people who do not have
the disease for a period of time and see who develops the disease (new incidence). The cohort
cannot therefore be defined as a group of people who already have the disease. Prospective
(longitudinal) cohort studies between exposure and disease strongly aid in studying causal
associations, though distinguishing true causality usually requires further corroboration from
further experimental trials.
The advantage of prospective cohort study data is that it can help determine risk factors for
contracting a new disease because it is a longitudinal observation of the individual through
time, and the collection of data at regular intervals, so recall error is reduced. However, cohort
studies are expensive to conduct, are sensitive to attrition and take a long follow-up time to
generate useful data. Nevertheless, the results that are obtained from long-term cohort
studies are of substantially superior quality to those obtained from retrospective/cross-
sectional studies. Prospective cohort studies are considered to yield the most reliable results
in observational epidemiology. They enable a wide range of exposure-disease associations to
be studied.
Some cohort studies track groups of children from their birth, and record a wide range of
information (exposures) about them. The value of a cohort study depends on the
researchers' capacity to stay in touch with all members of the cohort. Some studies have
continued for decades.
In a cohort study, the population under investigation consists of individuals who are at risk
of developing a specific disease or health outcome.[5]
Examples
An example of an epidemiological question that can be answered using a cohort study is
whether exposure to X (say, smoking) associates with outcome Y (say, lung cancer). In 1951
commenced the British Doctors Study, a cohort that included both smokers (the exposed
group) and non-smokers (the unexposed group). The study continued through 2001. By 1956,
the study provided convincing proof of the association of smoking with the incidence of lung
cancer. In a cohort study, the groups are matched in terms of many other variables such as
economic status and other health status so that the variable being assessed, the independent
variable (in this case, smoking) can be isolated as the cause of the dependent variable (in this
case, lung cancer). In this example, a statistically significant increase in the incidence of lung
cancer in the smoking group as compared to the non-smoking group is evidence in favor of
the hypothesis. However, rare outcomes, such as lung cancer, are generally not studied with
the use of a cohort study, but are rather studied with the use of a case-control study.

Shorter term studies are commonly used in medical research as a form of clinical trial, or
means to test a particular hypothesis of clinical importance. Such studies typically follow two
groups of patients for a period of time and compare an endpoint or outcome measure
between the two groups.
Two examples of cohort studies that have been going on for more than 50 years are
the Framingham Heart Study and the National Child Development Study (NCDS), the most
widely researched of the British birth cohort studies. Key findings of NCDS and a detailed
profile of the study appear in the International Journal of Epidemiology.[6]
The Dunedin Longitudinal Study, started in 1975, has been studying the thousand people born
in Dunedin, New Zealand in 1972-73. The subjects are interviewed regularly, with Phase 45
starting in 2017.
The largest cohort study in women is the Nurses' Health Study. Started in 1976, it is tracking
over 120,000 nurses and has been analyzed for many different conditions and outcomes.
The largest cohort study in Africa is the Birth to Twenty Study, which began in 1990 and tracks
a cohort of over 3,000 children born in the weeks following Nelson Mandela's release from
prison.
Other famous examples are the Grant Study tracking a number of Harvard graduates from ca.
1950.77, the Whitehall Study tracking 10,308 British civil servants, and the Caerphilly Heart
Disease Study, which since 1979 has studied a representative sample of 2,512 men, drawn
from the Welsh town of Caerphilly.
Current and historical cohorts
A current cohort study represents a true prospective study where the data concerning
exposure are assembled prior to the occurrence of the fact to be studied, for instance a
disease. An example of a current cohort study is the Oxford Family Planning Association Study
in the United Kingdom, which aimed to provide a balanced view of the beneficial and harmful
effects of different methods of contraception. This study has provided a large amount of
information on the efficacy and safety of contraceptive methods, and in particular oral
contraceptives (OCs), diaphragms and intrauterine device (IUDs).
In a historical cohort study the data concerning exposure and occurrence of a disease, births,
a political attitude or any other categorical variable are collected after the events have taken
place, and the subjects (those exposed and unexposed to the agent under study) are
assembled from existing records or health care registers.
A "prospective cohort" defines the groups before the study is done, while historical studies,
which are sometimes referred to as "retrospective cohort", defines the grouping after the
data is collected. Examples of a retrospective cohort are Long-Term Mortality after Gastric
Bypass Surgery[9] and The Lothian Birth Cohort Studies.[10]
Though historical studies are sometimes referred to as retrospective study, it a misnomer as
the methodological principles of historical cohort studies and prospective studies are the
same.

Cohort Study (Retrospective, Prospective): Definition, Examples

A Cohort study, used in the medical fields and social sciences, is an observational study used
to estimate how often disease or life events happen in a certain population. “Life events”
might include: incidence rate, relative risk or absolute risk.

A cohort is a defined group, like “nurses,” “10-19 year-olds,” or “college students.”

Participants are chosen for a reason, rather than randomly.

Image: SUNY Downstate

The study usually has two groups: exposed and not exposed. If the exposure is rare (for
example, exposure to an industrial solvent), then the cohort is called a “special exposure
cohort.” Both groups are followed to see who develops a disease and who does not. For
example, you could look at cigarette smokers to see who gets breast cancer and who does
not. The study would include a group of smokers, and a group of non-smokers.

Cohort Study Classification: Prospective, Retrospective, Case

Cohort studies can be grouped in several ways:

 Prospective: none of the subjects have the disease (or other outcome) being measured
when the study commences; data analysis happens after a period of time has elapsed.
 Retrospective (Historical): the researcher looks at historical data for a group. Some of
the people in this group have developed the disease, and some have not. This can
result in finding out who has the disease and when they developed it.
 Case-control nested within a cohort: a smaller group is chosen from within the cohort
for a deeper look. These investigations may include genotyping, collecting tissue samples
or other factors.
 Case-cohort: similar to case-control nested within a cohort. The difference is that in a
case-cohort study, participants are evaluated for outcome risk factors at any time before
the first outcome (i.e. the first incidence of disease).

What is a Prospective Cohort Study?

A prospective cohort study takes a group of similar people (a cohort) and studies them over
time. At the time the baseline data is collected, none of the people in the study have the
condition of interest. This is in contrast to a retrospective cohort study, which takes a group
of people who already have the condition and then attempts to piece together the reasons
why. The now famous Framingham Heart Study is one example of a prospective cohort study;
the researchers have, to date, studied three generations of Framingham residents in order to
understand the causes of heart disease and stroke.
Although none of the participants actually have the disease of interest in a prospective cohort
study, some of the cohort are expected to develop the disease in the future. For example, a
cohort of thirty-year-old people in a certain town might be studied to see who develops lung
cancer. Half of the cohort might be smokers and half may not. This enables comparisons
between the two groups.

Once the prospective cohort study has been established, researchers follow up with the
participants and track their progress. Follow ups can be:

 In-person interviews.
 Imaging tests.
 Internet questionnaires.
 Lab tests.
 Mail questionnaires.
 Phone interviews.
 Physical exams.
A combination of the above methods may also be used.
Advantages and Disadvantages

Advantages
 One major advantage of a prospective cohort study is that researchers don’t have to
tackle with the ethical issues surrounding randomized control trials (i.e. who receives a
placebo and who gets the actual treatment).
 Incidence and prevalence of a disease can be easily calculated.
 Multiple diseases and outcomes can be studied at the same time.

Disadvantages
 Selection bias and confounding variables can be a problem.
 Cohort studies can be expensive and time consuming.
 Sample sizes required are usually very large.
More: Prospective Study: Definition and Examples.

What is a Retrospective Cohort Study?

A retrospective cohort study (also known as a historic study or longitudinal study) is a study
where the participants already have a known disease or outcome. The study looks back into
the past to try to determine why the participants have the disease or outcome and when they
may have been exposed. In a retrospective cohort study the researcher:
 Uses historical data to identify members of a population who have been exposed (or
not exposed) to a disease or outcome.
 Assembles a group to be studied.
 Determines the current status of the disease or outcome in the participants.

Retrospective cohort studies have led to a deeper understanding of breast cancer risk
factors.

One of the first recognized retrospective cohort studies was Lane-Claypon’s 1926 study of
breast cancer risk factors, titled “A Further Report on Cancer of the Breast, With Special
Reference to Its Associated Antecedent Conditions.” The study of 500 hospitalized patients
and 500 controls led to the identification of most of the risk factors for breast cancer that we
know today.

Prospective vs. Retrospective Cohort Study

In a retrospective cohort study, the group of interest already has the disease/outcome. In a
prospective cohort study, the group does not have the disease/outcome, although some
participants usually have high risk factors.

Retrospective example: a group of 100 people with AIDS might be asked about their lifestyle
choices and medical history in order to study the origins of the disease. A Second group of
100 people without AIDS are also studied and the two groups are compared.
Prospective example: a group of 100 people with high risk factors for AIDS are followed for
20 years to see if they develop the disease. A control group of 100 people who have low risk
factors are also followed for comparison.
A retrospective cohort study can be combined with a prospective cohort study: the researcher
takes the retrospective study groups, and then follows the cohort in the future.

What is the Cohort Effect?

Children who grew up in New Orleans during Hurricane Katrina would have vastly different
experiences than a cohort born at the same time in Seattle.

A cohort effect is the influence of a group’s life experience on the outcome of an experiment.
It’s the effect of being born at the same time (i.e. GenXer vs. Baby Boomer), or in the same
region (i.e. born in New Orleans vs. Seattle) or some other factor that makes the group
unique. Cohorts in schools are usually defined by age group, while cohorts in organizations
are defined by their date of entry into the job.

Cohort Effect Example

Lets say you were conducting cross sectional research (a method that compares different
age groups at the same point in time) to find out how basic mathematics ability improves
with age. You give the same basic math standardized test to groups of students who are 7-
years-old, 14-years-old, and 21-years-old. You get the following mean results:
 7-years-old: 24% correct
 14-years-old: 48% correct
 21-years-old: 72% correct
You might conclude that every 7 years that pass makes a difference of 24% in scores.
However, what you haven’t accounted for is the cohort effect. The students differ not only in
age, but they belong to different cohorts (in this case, groups of people born around the same
time), some of which may have grown up when basic mathematics was strongly emphasized
in schools. If the 21-year-old cohort in the above study experienced strong emphasis on basic
math, it’s a possibility that they could have achieved 72% when they were 14-years old or
even 7-years-old.
The problems associated with the cohort effect can be lessened by testing the same cohort
over a period of time, a method called longitudinal research. In the above example, you would
test a group of 7-year-olds, then test the same group every 7 years. A disadvantage to
longitudinal research is that it’s costly, and dropout rates can affect the results.