CASP Checklist Systematic Reviews Observational Studies Checklist 2024
CASP Checklist Systematic Reviews Observational Studies Checklist 2024
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Appraisal
Date:
During critical appraisal, never make assumptions about what the researchers
have done. If it is not possible to tell, use the “Can’t tell” response box. If you
can’t tell, at best it means the researchers have not been explicit or transparent,
but at worst it could mean the researchers have not undertaken a particular task
or process. Once you’ve finished the critical appraisal, if there are a large
number of “Can’t tell” responses, consider whether the findings of the study are
trustworthy and interpret the results with caution.
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Section A: Is the basic study design valid for a systematic review?
CONSIDER:
Did the researchers state a research question and a null hypothesis?
For a systematic review of observational studies, a research question can be
‘formulated’ in terms of the PECOT(S) framework:
Population
Exposure/Risk factor
Detection of a beneficial or harmful effect
Comparator/Controls
Outcome/s or Event/s
Time, e.g., length of time in which to detect outcomes or events, or time of
exposure
Setting
2. Did the researchers search for Yes No Can’t Tell
appropriate study design(s) to
answer the research question? Studi menggunakan pendekatan
systematic review yang sesuai untuk
menganalisis bukti dari berbagai
sumber penelitian primer
CONSIDER:
If the research question is concerned with the identification of risk factors or
exposures associated with a particular event or outcome, observational studies
are appropriate study designs to address the research question in a systematic
review, for example:
Cohort studies follow a group of people who share a common characteristic or
exposure over time and compare them with another group who do not have
that characteristic or exposure.
Case-control studies compare a group of people who have a specific outcome
or condition (cases) with a group of people who do not have it (controls) and
look for differences in their past exposures or risk factors.
Cross-sectional studies measure the prevalence of a characteristic, outcome,
or exposure in a population at a single point in time or over a short period.
Notes to support interpretation of Section A, Questions 1 and 2:
If you answered “No” to both these questions:
It is likely that the researchers did not clearly formulate the fundamental
aspects of the research question, and the most appropriate way of answering
it. If this is the case, it is likely other problems will arise during the conduct of
the systematic review
Consider whether it would be useful to continue with the critical appraisal
process
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Section B: Is the systematic review methodologically sound?
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berbagai sumber dan lokasi yang
berbeda, memberikan variasi dalam
konteks penelitian.
CONSIDER:
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Lack of methodological rigour in the individual primary research studies can affect
the validity and interpretation of the findings of the systematic review with meta-
analysis.
• Did the researchers use a validated tool to assess the methodological rigour
of the primary research studies included in the systematic review?
• Was the tool appropriate to assess the type(s) of study design(s) included in
the systematic review? For example, for case-control and cohort studies, the
Newcastle-Ottawa Scale or the ROBINS-E tool.
• Did the researchers present the findings from their quality assessment in
sufficient detail, and interpret them accurately?
5. Did the researchers extract, and Yes No Can’t Tell
present information from the
individual primary research studies Para peneliti menggunakan proses
appropriately and transparently? yang sistematis dan jelas dalam
mengekstraksi data dari penelitian
(a) Extraction of data primer.
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• Did the researchers present the key characteristics of the individual
primary research studies, e.g., in a table? For instance, the number of
participants, the profile of participants (age, sex), the intervention, the
comparator, the outcome/s evaluated, and the study timeframe.
• Did the researchers present the results of the individual primary research
studies in a Forest plot or combination of table and Forest plot? For
instance, the effect size/s, the confidence-interval ranges, and the P values.
NB: The Forest plot should also show the overall result from the meta-
analysis
Notes to support the interpretation of Section B, Questions 3-5:
If you answered “No” to these questions, it is likely that there is a lack of
methodological rigour in the conduct of the systematic review, which means it is
best to interpret the results with caution, and to assess how those aspects of poor
methodology will have an impact on the results of the systematic review.
For Question 3, a “No” response indicates that this systematic review may
have missed primary research studies that could have contributed to
answering the research question; in a systematic review with meta-analysis,
the results of any missing primary research studies could have altered the
effect estimate for the systematic review.
For Question 4, a “No” response indicates that the researchers did not identify
any systematic bias or confounding factors in the primary research studies that
could have affected the results of the systematic review; in the absence of this
information, it is not possible for you to assess in what ways the results of the
systematic review could have been affected, and it is best to be cautious when
interpreting the results.
For Question 5, a “No” response indicates that the researchers did not organise
the data from the primary research studies in a coherent way such that it could
analysed appropriately, and thereby reliable conclusions drawn from it.
If you answered “No” to all three questions in Section B, consider whether it would
be useful to continue with the critical appraisal process.
CONSIDER:
• Did the researchers undertake a sample-size estimation during the design
and planning of the systematic review?
• Did the number of participants whose outcomes were entered into the
analysis meet that estimation, i.e., was the sample size sufficient to detect
any effect on the outcomes of interest?
• Did the researchers use an appropriate effect measure?
• Did the researchers provide confidence-interval ranges for the effect
estimates in the systematic review?
• Did the researchers provide p values for the effect estimates in the
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systematic review?
• Did the researchers provide a minimal important difference, that is the
smallest possible difference in outcome that would be meaningful to people
experiencing the exposure or risk factor?
• Did the researchers assess the level of statistical heterogeneity (variability)
among the primary research studies? For example, using the I 2 statistic.
• Did the researchers use an appropriate model of meta-analysis for the level
of heterogeneity among the primary research studies (a random-effects
model if there was heterogeneity or a fixed-effects model if the primary
research studies were all investigating the same underlying effect)?
• Did the researchers perform any sensitivity analyses?
• Did the researchers analyse the reasons for heterogeneity using subgroup
analysis or meta-regression? For subgroup analysis, see Question 6.1, and for
meta-regression see Question 6.2.
• Did the researchers investigate the small-study-effect, and assess the
potential for publication bias in the systematic review (e.g., using a funnel
plot)?
6.1 Subgroup analysis Yes No Can’t Tell
Hasil penelitian disajikan dengan detail
yang memadai, termasuk karakteristik
studi, metode yang digunakan, serta
hasil utama dari setiap penelitian
primer.
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metodologi, karakteristik populasi, atau
ukuran sampel.
CONSIDER:
• Did the researchers comment on the size of the sample in the meta-analysis
and whether it was large enough to detect an effect of the exposure or risk
factor if there was one?
• Did the researchers consider the appropriateness of the effect measure or
measures they used?
• Did the researchers reflect on the precision of the results of the systematic
review, i.e., the confidence-interval range? The smaller the range, the
narrower the confidence intervals, meaning the result is more precise, and
closer to the true effect size.
• If relevant, did the researchers note whether the confidence-interval range
included the “line of no effect” (0 for a difference, 1 for a ratio, where the null
hypothesis holds true), or whether the lower limit of the confidence-interval
range was close to the “line of no effect”, and discuss the implications for the
results of the meta-analysis?
• If the results were statistically significant (i.e., they were less likely to be due
to chance), did the researchers discuss whether the results would be
important or meaningful for the outcomes experienced by individuals and/or
populations using a minimal important difference specific to the research
question?
• Did the researchers consider whether relevant primary research studies could
have been missed?
• Did the researchers mention any systematic bias identified during the risk-of-
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bias/quality assessment of the primary research studies, and explain how it
might have influenced the effect estimate in the meta-analysis?
• Did the researchers mention any potential sources of confounding that could
have influenced the effect estimate in the meta-analysis?
• Did the researchers discuss the implications of any sensitivity analyses?
• Did the researchers discuss the impact of the level of heterogeneity on the
results of the meta-analysis?
• Did the researchers investigate the reasons for any heterogeneity across the
primary research studies and discuss the implications? For subgroup analysis,
see Question 7.1, and for meta-regression, see Question 7.2.
• Did the researchers discuss the effect of any publication bias on the results of
the meta-analysis?
7.1 Subgroup analysis Yes No Can’t Tell
CONSIDER:
• If characteristics or effect modifiers were not pre-specified, did the
researchers address whether bias was introduced into the analysis?
• Did the researchers reflect on whether the characteristics or effect modifiers
selected were well-defined to ensure clarity about the effect being
investigated?
• If no rationale was given for the selection of specific characteristics or effect
modifiers, or the rationale was not supported by evidence or a plausible
argument of meaningfulness, did the researchers discuss whether this
affected the validity or relevance of the subgroup analysis?
• If characteristics or effect modifiers were closely related to other
characteristics, did the researchers mention the potential for confounding?
• Did the researchers outline whether the sample sizes in any subgroup
analyses were sufficient to detect an effect of the exposure or risk factor on
the primary outcome?
• If continuous data were allocated to categories, did the researchers address
whether the thresholds or cut-off points could have introduced bias into the
subgroup analysis or were not meaningful either clinically or in terms of
public and population health?
• If more than three characteristics or effect modifiers were investigated or
subgroup analyses performed, did the researchers adjust for multiple testing
and consider the potential to generate Type I errors?
• Did the researchers explain the results of any tests for interaction, and
whether they were statistically significant?
• Did the researchers discuss the implications of whether the results of tests for
interaction were quantitative or qualitative?
• If the analysis of effect modification was based on a comparison between
studies, did the researchers reflect on whether the number of studies in the
smallest subgroups was large enough for the results to be credible?
7.2 Meta-regression Yes No Can’t Tell
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CONSIDER:
• If characteristics or effect modifiers were not pre-specified, did the
researchers address whether bias was introduced into the analysis?
• If continuous data were allocated into categories, did the researchers address
whether any thresholds or cut-off points for categorisation were arbitrary and
could have introduced bias into the meta-regression or whether they were not
meaningful clinically and/or in terms of public and population health?
• If more than three characteristics or effect modifiers were investigated, or
meta-regression analyses performed, did the researchers adjust for multiple
testing and consider the potential to generate Type I errors?
• Did the researchers discuss the implications of any tests for interaction and
whether they were statistically significant?
• If a random-effects model was not used to account for residual heterogeneity
and/or mixed effects, which would have allowed for both within-study and
between-study variation, did the researchers outline the implications for the
results?
• If the analysis of effect modification was based on a between-study
comparison, did the researchers reflect on whether the number of primary
research studies in the meta-regression was sufficient for the results to be
credible?
8. Would the benefits of acting upon Yes No Can’t Tell
the results outweigh any potential
disadvantages, harms and/or
additional demand for resources
associated with acting on the
results?
CONSIDER:
Are you clear about the likely benefits of acting upon the results bearing in
mind the potential impacts of any study limitations?
Did the researchers identify any potential disadvantages, unwanted
outcomes, or negative impacts of acting on the results of the systematic
review?
If so, did the researchers assess any benefits against the disadvantages,
unwanted outcomes, or negative impacts, and discuss the overall balance
between benefit and harm?
Did the researchers report any information on the potential demand for
resources (e.g., cost, workforce, time, skills levels/skill mix, training needs,
data collection and analysis, IT requirements) that might be associated
with acting on the results of the systematic review?
Notes to support interpretation of Section C, Questions 6, 7 & 8: If
you answered “No” to these questions, it is likely that the researchers did
not analyse and interpret the information from the primary research studies
appropriately, nor did they discuss the limitations of the systematic review
as fully as possible so it is not possible for you to assess the trustworthiness
(validity and credibility) of the results of the systematic review. Finally, if
there is no information on the likely resource demands of intervention, it is
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not possible for you to judge whether you have the resource capacity to act
upon the results.
If you answered “No” to all three questions in Section C, consider whether it
would be useful to continue with the critical appraisal process.
CONSIDER:
• Are there differences between your local population and the participants in
the primary research studies in the systematic review that would influence
whether you would act upon the results?
• Are there differences between your local setting and the settings or contexts
in the primary research studies in the systematic review that would influence
whether you would act upon the results?
• Are there any outcomes or other factors that the researchers could have
studied that would have been useful to you bearing in mind the needs of your
local population and/or setting?
Notes to support interpretation of Section D, Question 9:
If you answered “No” to this question, it is not necessary to answer Question
10 because, irrespective of a systematic review’s methodological rigour, the
results are not applicable to the individuals or populations for whom you are
responsible.
If you answered “Yes” to Question 9, answer Question 10
CONSIDER:
Value equals the Outcome/s (Benefit minus Harm) divided by the Resources
required for implementation.
• What resources would be needed to take action on the findings of the
systematic review? Take account of various types of resource, not only
costs, but also time, skills mix, skills development or training needs, IT
requirements, and other material resources.
• If necessary, are you able to disinvest resources from other activities to be
able to re-invest in actioning the findings from the systematic review?
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Notes to support interpretation of Section E, Question 10:
If you answered “No” to this question, it is likely that the findings of the
systematic review will not confer greater or additional benefit or value on the
individuals and/or populations for whom you are responsible, despite the
systematic review’s applicability to your local setting.
If you answered “Yes” to the question, it is likely that the findings of the
systematic review will confer greater or additional benefit or value on the
individuals and/or populations for whom you are responsible, and you need to
discuss with colleagues whether it would be appropriate to implement the
findings in your local setting.
CONSIDER:
• Would you use it to change practice or to recommend changes to care policy
and procedures in your organisation?
• Could you judiciously take action on the information about the exposure or
risk factor without delay?
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6. Did the researchers analyse the results of the individual primary
research studies appropriately?
7. Did the researchers report any limitations of the systematic
review and, if so, do the limitations discussed cover all the
issues in your critical appraisal?
8. Would the benefits of acting upon the results outweigh any
potential disadvantages, harms and/or additional demand for
resources associated with acting on the results?
D. Are the results of the systematic review relevant
locally?
9. Can the results of the systematic review be applied to your local
population/in your local setting or context?
E. Will the implementation of the results represent greater value for
your service users or population?
10. If actioned, would the findings from the systematic review
represent greater or additional value for the individuals or
populations for whom you are responsible?
APPRAISAL SUMMARY: List key points from your critical appraisal that need to be
considered when assessing the validity of the results and their usefulness in
decision-making.
Positive/Methodologically Negative/Relatively poor Unknowns
sound methodology
Referencing recommendation:
Example:
Critical Appraisal Skills Programme (2024). CASP (insert name of checklist i.e.
systematic reviews with meta-analysis of observational studies Checklist.)
[online] Available at: insert URL. Accessed: insert date accessed.
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