A follow up study
(also called cohort study, incident study, prospective study, or longitudinal study), compares disease in exposed to disease
in non-exposed groups after a period of follow-up. It can be prospective (forward), retrospective (backward), or ambispective
(both forward and backward) follow-up. In a nested case control design, a case control study is carried out within a larger
follow up study. The follow-up cohorts may be closed (fixed cohort) or open (dynamic cohort). Analysis of fixed cohorts is
based on CI and that of open cohorts on IR.
and DATA COLLECTION
The study population
is divided into the exposed and unexposed populations. A sample is taken from the exposed and another sample is taken from
the unexposed. Both the exposed and unexposed samples are followed for appearance of disease. The study may include matching,
(one-to-one or one-to-many), pre and post comparisons, multiple control groups, and stratification. The study cohort is from
special exposure groups, such as factory workers, or groups offering special resources, such as health insurance subscribers.
Information on exposure can be obtained from the following sources: existing records, interviews/questionnaires, medical examinations,
laboratory tests for biomarkers, testing or evaluation of the environment. The time of occurrence of the outcome must be defined
precisely. The ascertainment of the outcome event must be standardized with clear criteria. Follow-up can be achieved by letter,
telephone, surveillance of death certificates and hospitals. Care must be taken to make sure that surveillance, follow-up,
and ascertainment for the 2 groups are the same.
non-response on exposure, the risk ratio is valid but the distribution of exposure in the community is not valid. In non-random
non-response on outcome, the odds ratio is valid but the disease incidence rate is not valid. There is a more complex situation
when there is non-response on both exposure and outcome. In general random non-response is better than non-random or differential
non-response. Loss to follow-up can be related to the outcome, the exposure and to both outcome and exposure. The consequences
of loss to follow-up are similar to those of non-response. In cases of regular follow-up, it is assumed that the loss occurred
immediately after the last follow-up. If the loss to follow-up is related to an event such as death, it can be assumed that
the loss was half-way between the last observation and the death.
of bias can arise in follow-up studies. Selection bias arises when the sample is not representative of the population. Follow-up
bias arises when the loss to follow-up is unequal among the exposed and the unexposed, when disease occurrence leads to loss
to follow up, when people may move out of the study area because of the exposure being studied, and when the observation of
the two groups is unequal. Information/misclassification bias arises due to measurement error or misdiagnosis. Confounding
bias arises usually due to age and smoking because both are associated with many diseases. Post-hoc bias arises when cohort
data is used to make observations that were not anticipated before.
3.0 STATISTICAL PARAMETERS
and risk statistics can be computed. The incidence statistics are the incidence
rate and the cumulative incidence. The risk statistics are either the risk difference or the various ratio statistics (risk
ratio, the rate ratio, the relative risk, or the odds ratio).
4.0 STRENGTHS and WEAKNESSES
The cohort design
has 4 advantages: it gives a true risk ratio based on incidence rates, the time sequence is clear since exposure precedes
disease, incidence rates can be determined directly, and several outcomes of the same exposure can be studied simultaneously.
It has 5 disadvantages: loss to subjects and interest due to long follow-up, inability to compute prevalence rate of the risk
factor, use of large samples to ensure enough cases of outcome, and high cost. The cost can be decreased by using existing
monitoring/surveillance systems, historical cohorts, general population information instead of studying the unexposed population,
and the nested case control design. Follow-up studies are not suitable for study of diseases with low incidence.
5.0 SAMPLE SIZE COMPUTATION
are considered: the estimated proportion of the risk factor in the general unexposed population, the minimum detectable difference
in outcome between the exposed and unexposed groups. Sample size computations are usually made assuming 95% confidence intervals.