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?

1. Did the study address a clearly Yes No Can’t Tell

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 who Yes No Can’t Tell

entered the study accounted
for at its conclusion?

Intent-to-treat analysis

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CONSIDER:
• Were losses to follow-up and exclusions after randomisation accounted 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 participants Yes No Can’t Tell

‘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 investigators Yes No Can’t Tell

‘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 similar Yes No Can’t Tell

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?

6. Apart from the experimental Yes No Can’t Tell

intervention, did each study

3
 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 the results?
• Were potential sources of bias identified?
• Which statistical tests were used?
• Were p values reported?

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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 lopinavir-ritonavir over
Conclusion of the study: no standard care
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 applied to Yes No Can’t Tell

your local population/in your
context?
• The study was conducted in one province in China.
• The participants were a homogenous ethnic group
Only if they are severely ill with and likely to be similar genetically.
COVID-19 in China; may not be • It is hard to tell whether these factors would affect
useful in mild COVID-19 or for the efficacy of the treatment
people in other cultures and
diversity

5
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 experimental Yes No Can’t Tell

intervention provide greater
value to the people in your
care than any of the existing • Not likely
interventions? • The authors concluded that the results do not
support the use of 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/Methodologically Negative/Relatively poor Unknowns
sound methodology

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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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