CRITICAL APPRAISAL CHECKLIST FOR COHORT STUDIES

Reviewer______________________________________ Date_______________________________
Author_______________________________________ Year_________ Record Number_________
Yes No Unclear Not
applicable

1. Were the two groups similar and recruited from the

same population? □ □ □ □
2. Were the exposures measured similarly to assign
people to both exposed and unexposed groups? □ □ □ □
3. Was the exposure measured in a valid and reliable
way? □ □ □ □
4. Were confounding factors identified? □ □ □ □
5. Were strategies to deal with confounding factors
stated? □ □ □ □
6. Were the groups/participants free of the outcome
at the start of the study (or at the moment of
exposure)?
□ □ □ □
7. Were the outcomes measured in a valid and reliable
way? □ □ □ □
8. Was the follow up time reported and sufficient to be
long enough for outcomes to occur? □ □ □ □
9. Was follow up complete, and if not, were the
reasons to loss to follow up described and explored? □ □ □ □
10. Were strategies to address incomplete follow up
utilized? □ □ □ □
11. Was appropriate statistical analysis used? □ □ □ □
Overall appraisal: Include □ Exclude □ Seek further info □
Comments (Including reason for exclusion)

________________________________________________________________________________________________
________________________________________________________________________________________________
EXPLANATION OF COHORT STUDIES CRITICAL APPRAISAL
Cohort Studies Critical Appraisal Tool
Answers: Yes, No, Unclear or Not/Applicable

1. Were the two groups similar and recruited from the same population?
Check the paper carefully for descriptions of participants to determine if patients within and
across groups have similar characteristics in relation to exposure (e.g. risk factor under
investigation). The two groups selected for comparison should be as similar as possible in all
characteristics except for their exposure status, relevant to the study in question. The authors
should provide clear inclusion and exclusion criteria that they developed prior to recruitment of
the study participants.

2. Were the exposures measured similarly to assign people to both exposed and
unexposed groups?
A high quality study at the level of cohort design should mention or describe how the exposures
were measured. The exposure measures should be clearly defined and described in detail. This
will enable reviewers to assess whether or not the participants received the exposure of
interest.

3. Was the exposure measured in a valid and reliable way?

The study should clearly describe the method of measurement of exposure. Assessing validity
requires that a 'gold standard' is available to which the measure can be compared. The validity
of exposure measurement usually relates to whether a current measure is appropriate or
whether a measure of past exposure is needed.

Reliability refers to the processes included in an epidemiological study to check repeatability of

measurements of the exposures. These usually include intra-observer reliability and inter-
observer reliability.

4. Were confounding factors identified?

Confounding has occurred where the estimated intervention exposure effect is biased by the
presence of some difference between the comparison groups (apart from the exposure
investigated/of interest). Typical confounders include baseline characteristics, prognostic
factors, or concomitant exposures (e.g. smoking). A confounder is a difference between the
comparison groups and it influences the direction of the study results. A high quality study at
the level of cohort design will identify the potential confounders and measure them (where
possible). This is difficult for studies where behavioral, attitudinal or lifestyle factors may impact
on the results.
5. Were strategies to deal with confounding factors stated?
Strategies to deal with effects of confounding factors may be dealt within the study design or in
data analysis. By matching or stratifying sampling of participants, effects of confounding factors
can be adjusted for. When dealing with adjustment in data analysis, assess the statistics used in
the study. Most will be some form of multivariate regression analysis to account for the
confounding factors measured. Look out for a description of statistical methods as regression
methods such as logistic regression are usually employed to deal with confounding
factors/variables of interest.

6. Were the groups/participants free of the outcome at the start of the study (or at the
moment of exposure)?
The participants should be free of the outcomes of interest at the start of the study. Refer to
the ‘methods’ section in the paper for this information, which is usually found in descriptions of
participant/sample recruitment, definitions of variables, and/or inclusion/exclusion criteria.

7. Were the outcomes measured in a valid and reliable way?

Read the methods section of the paper. If for e.g. lung cancer is assessed based on existing
definitions or diagnostic criteria, then the answer to this question is likely to be yes. If lung
cancer is assessed using observer reported, or self-reported scales, the risk of over- or under-
reporting is increased, and objectivity is compromised. Importantly, determine if the
measurement tools used were validated instruments as this has a significant impact on
outcome assessment validity.

Having established the objectivity of the outcome measurement (e.g. lung cancer) instrument,
it’s important to establish how the measurement was conducted. Were those involved in
collecting data trained or educated in the use of the instrument/s? (e.g. radiographers). If there
was more than one data collector, were they similar in terms of level of education, clinical or
research experience, or level of responsibility in the piece of research being appraised?

8. Was the follow up time reported and sufficient to be long enough for
outcomes to occur?
The appropriate length of time for follow up will vary with the nature and characteristics of the
population of interest and/or the intervention, disease or exposure. To estimate an appropriate
duration of follow up, read across multiple papers and take note of the range for duration of
follow up. The opinions of experts in clinical practice or clinical research may also assist in
determining an appropriate duration of follow up. For example, a longer timeframe may be
needed to examine the association between occupational exposure to asbestos and the risk of
lung cancer. It is important, particularly in cohort studies that follow up is long enough to
enable the outcomes. However, it should be remembered that the research question and
outcomes being examined would probably dictate the follow up time.
9. Was follow up complete, and if not, were the reasons to loss to follow up described
and explored?
It is important in a cohort study that a greater percentage of people are followed up. As a
general guideline, at least 80% of patients should be followed up. Generally a dropout rate of
5% or less is considered insignificant. A rate of 20% or greater is considered to significantly
impact on the validity of the study. However, in observational studies conducted over a lengthy
period of time a higher dropout rate is to be expected. A decision on whether to include or
exclude a study because of a high dropout rate is a matter of judgement based on the reasons
why people dropped out, and whether dropout rates were comparable in the exposed and
unexposed groups.

Reporting of efforts to follow up participants that dropped out may be regarded as an indicator
of a well conducted study. Look for clear and justifiable description of why people were left out,
excluded, dropped out etc. If there is no clear description or a statement in this regards, this
will be a 'No'.

10. Were strategies to address incomplete follow up utilized?

Some people may withdraw due to change in employment or some may die; however, it is
important that their outcomes are assessed. Selection bias may occur as a result of incomplete
follow up. Therefore, participants with unequal follow up periods must be taken into account in
the analysis, which should be adjusted to allow for differences in length of follow up periods.
This is usually done by calculating rates which use person-years at risk, i.e. considering time in
the denominator.

11. Was appropriate statistical analysis used?

As with any consideration of statistical analysis, consideration should be given to whether there
was a more appropriate alternate statistical method that could have been used. The methods
section of cohort studies should be detailed enough for reviewers to identify which analytical
techniques were used (in particular, regression or stratification) and how specific confounders
were measured.

For studies utilizing regression analysis, it is useful to identify if the study identified which
variables were included and how they related to the outcome. If stratification was the analytical
approach used, were the strata of analysis defined by the specified variables? Additionally, it is
also important to assess the appropriateness of the analytical strategy in terms of the
assumptions associated with the approach as differing methods of analysis are based on
differing assumptions about the data and how it will respond.