The Joanna Briggs Institute Critical Appraisal tools

for use in JBI Systematic Reviews

Checklist for Cohort Studies

http://joannabriggs.org/research/critical-appraisaltools.html

rg

The Joanna Briggs Institute

Introduction
The Joanna Briggs Institute (JBI) is an international, membership based research
and development organization within the Faculty of Health Sciences at the
University of Adelaide. The Institute specializes in promoting and supporting
evidence-based healthcare by providing access to resources for professionals in
nursing, midwifery, medicine, and allied health. With over 80 collaborating centres
and entities, servicing over 90 countries, the Institute is a recognized global leader
in evidence-based healthcare.
JBI Systematic Reviews
The core of evidence synthesis is the systematic review of literature of a
particular intervention, condition or issue. The systematic review is essentially an
analysis of the available literature (that is, evidence) and a judgment of the
effectiveness or otherwise of a practice, involving a series of complex steps. The
JBI takes a particular view on what counts as evidence and the methods utilized to
synthesize those different types of evidence. In line with this broader view of
evidence, the Institute has developed theories, methodologies and rigorous
processes for the critical appraisal and synthesis of these diverse forms of
evidence in order to aid in clinical decision-making in health care. There now
exists JBI guidance for conducting reviews of effectiveness research, qualitative
research, prevalence/incidence, etiology/risk, economic evaluations, text/opinion,
diagnostic test accuracy, mixed-methods, umbrella reviews and scoping reviews.
Further information regarding JBI systematic reviews can be found in the JBI
Reviewers Manual on our website.
JBI Critical Appraisal Tools
All systematic reviews incorporate a process of critique or appraisal of the research
evidence. The purpose of this appraisal is to assess the methodological quality of a
study and to determine the extent to which a study has addressed the possibility
of bias in its design, conduct and analysis. All papers selected for inclusion in the
systematic review (that is those that meet the inclusion criteria described in the

Joanna Briggs Institute 2016

Critical Appraisal 2
Checklist for Cohort Studies

protocol) need to be subjected to rigorous appraisal by two critical appraisers. The

results of this appraisal can then be used to inform synthesis and interpretation of
the results of the study. JBI Critical appraisal tools have been developed by the JBI
and collaborators and approved by the JBI Scientific Committee following extensive
peer review. Although designed for use in systematic reviews, JBI critical appraisal
tools can also be used when creating Critically Appraised Topics (CAT), in journal
clubs and as an educational tool.

Joanna Briggs Institute 2016

Critical Appraisal 3
Checklist for Cohort Studies

JBI Critical Appraisal Checklist for Cohort Studies

Reviewer

Date

Author

Year
Yes

1. Were the 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 belong 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 followup utilized?
11.Was appropriate statistical analysis used?

Overall appraisal:

Include

Exclude

Record Number
No

Unclea
r

Not
applicab
le

Seek further info

Comments (Including reason for exclusion)

Joanna Briggs Institute 2016

Critical Appraisal 4
Checklist for Cohort Studies

Explanation of cohort studies critical appraisal

How to cite: The Joanna Briggs Institute. Joanna Briggs Institute Reviewers' Manual:
2016 edition. Australia: The Joanna Briggs Institute; 2016.

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 to allocate to
groups?
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
Joanna Briggs Institute 2016

Critical Appraisal 5
Checklist for Cohort Studies

include baseline characteristics,

exposures (e.g. smoking).

Joanna Briggs Institute 2016

prognostic

factors,

or

concomitant

Critical Appraisal 6
Checklist for Cohort Studies

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 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 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, its 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?

Joanna Briggs Institute 2016

Critical Appraisal 7
Checklist for Cohort Studies

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 followup 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 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.

Joanna Briggs Institute 2016

Critical Appraisal 8
Checklist for Cohort Studies

12.

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 utilising 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.

Joanna Briggs Institute 2016

Critical Appraisal 9
Checklist for Cohort Studies