CASP Checklist:
For Randomised Controlled Trials (RCTs)
Reviewer
Name:
Paper
Title:
Author:
Web Link:
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 randomised controlled
trial?
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1. Did the study address a Yes No Can’t Tell
clearly formulated
research question?
CONSIDER:
Was the study designed to assess the outcomes of an intervention?
Is the research question ‘formulated’ in terms of:
• Population studied
• Intervention given
• Comparator chosen
• Outcomes measured?
2. Was the assignment of Yes No Can’t Tell
participants to
interventions
randomised?
CONSIDER:
• How was randomisation carried out? Was the method appropriate?
• Was randomisation sufficient to eliminate systematic bias?
• Was the allocation sequence concealed from investigators and
participants?
3. Were all participants Yes No Can’t Tell
who entered the study
accounted for at its
conclusion?
Intent-to-treat analysis
CONSIDER:
• Were losses to follow-up and exclusions after randomisation accounted
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for?
• Were participants analysed in the study groups to which they were
randomised (intention-to-treat analysis)?
• Was the study stopped early? If so, what was the reason?
Section B Was the study methodologically sound?
4. (a) Were the Yes No Can’t Tell
participants ‘blind’ to
intervention they were
given?
Emergency situation –
cannot blind anyone
because they wouldn’t
know what to do in case
of emergency
(b) Were the Yes No Can’t Tell
investigators ‘blind’ to
the intervention they
were giving to
participants?
(c) Were the people Yes No Can’t Tell
assessing/analysing
outcome/s ‘blinded’?
5. Were the study groups Yes No Can’t Tell
similar at the start of
the randomised
controlled trial?
CONSIDER:
Were the baseline characteristics of each study group (e.g. age, sex, socio-
economic group) clearly set out?
Were there any differences between the study groups that could affect the
outcome/s?
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6. Apart from the Yes No Can’t Tell
experimental
intervention, did each
study group receive the
same level of care (that
is, were they treated
equally)?
CONSIDER:
Was there a clearly defined study protocol?
If any additional interventions were given (e.g. tests or treatments), were
they similar between the study groups?
Were the follow-up intervals the same for each study group?
Section C: What are the results?
7. Were the effects of Yes No Can’t Tell
intervention reported
comprehensively?
Presentation of results
were clear
Magnitude of effect was
presented
CONSIDER:
• Was a power calculation undertaken?
• What outcomes were measured, and were they clearly specified?
• How were the results expressed? For binary outcomes, were relative and
absolute effects reported?
• Were the results reported for each outcome in each study group at each
follow-up interval?
• Was there any missing or incomplete data?
• Was there differential drop-out between the study groups that could affect
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the results?
• Were potential sources of bias identified?
• Which statistical tests were used?
• Were p values reported?
8. Was the precision of the Yes No Can’t Tell
estimate of the
intervention or
treatment effect
reported?
95% confidence interval
CONSIDER:
• Were confidence intervals (CIs) reported?
9. Do the benefits of the Yes No Can’t Tell
experimental
intervention outweigh
the harms and costs?
The results do not support the use of
Conclusion of the study: lopinavir-ritonavir over standard care
no significant benefit
compared to standard
therapy
CONSIDER:
What was the size of the intervention or treatment effect?
Were harms or unintended effects reported for each study group?
Was a cost-effectiveness analysis undertaken? (Cost-effectiveness
analysis allows a comparison to be made between different interventions
used in the care of the same condition or problem.)
Section D: Will the results help locally?
10. Can the results be Yes No Can’t Tell
applied to your local
population/in your
context? The study was conducted in one
province in China.
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The participants were a homogenous
Only if they are ethnic group and likely to be similar
severely ill with COVID- genetically.
19 in China; may not be It is hard to tell whether these
useful in mild COVID-19 factors would affect the efficacy of
or for people in other the treatment
cultures and diversity
Trial group tested on
patients that are
severely ill with COVID-
19
CONSIDER:
• Are the study participants similar to the people in your care?
• Would any differences between your population and the study participants
alter the outcomes reported in the study?
• Are the outcomes important to your population?
• Are there any outcomes you would have wanted information on that have
not been studied or reported?
• Are there any limitations of the study that would affect your decision?
11. Would the Yes No Can’t Tell
experimental
intervention provide
greater value to the Not likely
people in your care The authors concluded that the
than any of the results do not support the use of
existing interventions? lopinavir-ritonavir over standard care
CONSIDER:
What resources are needed to introduce this intervention taking into
account time, finances, and skills development or training needs?
Are you able to disinvest resources in one or more existing interventions in
order to be able to re-invest in the new intervention?
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/ Negative/Relatively poor Unknowns
Methodologically methodology
sound
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Referencing recommendation:
CASP recommends using the Harvard style referencing, which is an author/date
method. Sources are cited within the body of your assignment by giving the
name of the author(s) followed by the date of publication. All other details about
the publication are given in the list of references or bibliography at the end.
Example:
Critical Appraisal Skills Programme (2024). CASP (insert name of checklist i.e.
randomised controlled trials (RCTs) Checklist.) [online] Available at: insert URL.
Accessed: insert date accessed.
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