CASP Checklist: 11 questions to help you make sense of a Randomised Controlled Trial

How to use this appraisal tool: Three broad issues need to be considered when appraising a
trial:

Are the results of the study valid? (Section A)

What are the results? (Section B)
Will the results help locally? (Section C)

The 11 questions on the following pages are designed to help you think about these issues
systematically. The first three questions are screening questions and can be answered
quickly. If the answer to both is “yes”, it is worth proceeding with the remaining questions.
There is some degree of overlap between the questions, you are asked to record a “yes”,
“no” or “can’t tell” to most of the questions. A number of italicised prompts are given after
each question. These are designed to remind you why the question is important. Record your
reasons for your answers in the spaces provided.

About: These checklists were designed to be used as educational pedagogic tools, as part of a
workshop setting, therefore we do not suggest a scoring system. The core CASP checklists
(randomised controlled trial & systematic review) were based on JAMA 'Users’ guides to the
medical literature 1994 (adapted from Guyatt GH, Sackett DL, and Cook DJ), and piloted with
health care practitioners.
For each new checklist, a group of experts were assembled to develop and pilot the checklist
and the workshop format with which it would be used. Over the years overall adjustments
have been made to the format, but a recent survey of checklist users reiterated that the basic
format continues to be useful and appropriate.
Referencing: we recommend using the Harvard style citation, i.e.: Critical Appraisal Skills
Programme (2018). CASP (insert name of checklist i.e. Randomised Controlled Trial) Checklist.
[online] Available at: URL. Accessed: Date Accessed.

©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial-
Share A like. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-
sa/3.0/ www.casp-uk.net

Critical Appraisal Skills Programme (CASP) part of Oxford Centre for Triple Value Healthcare Ltd www.casp-uk.net
Paper for appraisal and reference:
Section A: Are the results of the trial valid?

1. Did the trial address a clearly Yes ✔ HINT: An issue can be ‘focused’ In terms of
focused issue? • the population studied
Can’t Tell • the intervention given
• the comparator given
No
• the outcomes considered

Comments: P: women with an ectopic pregnancy or a pregnancy of unknown location (PUL) with low and
plateauing serum hCG concentrations (haemodynamically stable women .18 years old with both an
ectopic pregnancy visible on transvaginal sonography and a plateauing serum hCG concentration
<1500 IU/l or with a PUL and a plateauing serum hCG concentration <2000 IU/l were eligible)
I: systemic methotrexate (MTX), single dose injection, 1 mg/kg body weight i.m. with a maximum of
100 mg, within 24 h of randomization
C: expectant management
2. Was the assignment of Yes HINT: Consider
O: treatment success rate (The primary outcome ✔ measure was an uneventful decline of serum hCG
patients to
toan
treatments • how outcome
undetectable level (<2 IU/l) by the initial intervention strategy. Secondary this was measures
carried out
randomised? Can’t Tell
included additional treatment, side effects and serum hCG • was the allocation
clearance time) sequence concealed
from researchers and patients
No

Comments:
web-based randomization program, block randomization with stratification
for hospital and serum hCG concentration (,1000 versus 1000–2000 IU/l)

3. Were all of the patients Yes HINT: Consider

✔
who entered the trial • was the trial stopped early
properly accounted for at Can’t Tell • were patients analysed in the groups to
its conclusion? which they were randomised
No

Comments: trial was completed

patients were analysed in the groups to which they were randomised (intention-to-treat analysis)
(*41 were allocated single-dose systemic MTX and 32 expectant management, however 2
declined and had expectant management instead, researchers performed a per protocol
analysis) --> see Figure 1

Is it worth continuing?

2
4. Were patients, health Yes
workers and study personnel
‘blind’ to treatment? Can’t Tell

No
✔

Comments:
open trial, not placebo-controlled

5. Were the groups similar at Yes HINT: Consider

the start of the trial • other factors that might affect the
Can’t Tell outcome, such as; age, sex, social class
✔

No

Comments: similar demographics, but risk factors (previous EP, tubal pathology) may
be significantly diff?
(see Table 1)

6. Aside from the experimental Yes

intervention, were the groups
treated equally?
Can’t Tell
✔

No

Comments: both outpatient setting, surgical intervention as indicated

?MTX both groups: warned of interactions with alcohol, non-steroidal anti-inflammatory drugs, aspirin
and antibiotics, and received advice on fluid intake, buccal hygiene and exposure to sun- light. They
were advised to use adequate contraception during a period of 3 months after the last injection of MTX

Section B: What are the results?

3
7. How large was the treatment effect? HINT: Consider
• what outcomes were
measured
• Is the primary outcome clearly
specified
• what results were found for
each outcome

Comments: Primary outcome measure: an uneventful decline of serum hCG to an undetectable level (<2 IU/l) by the
initial intervention strategy
- Intervention/MTX group: RR 1.3; 95% CI 0.9–1.8
Secondary outcome measures: additional MTX injections, surgical procedures, treatment complications (i.e.
haemorrhage, severe allergic reaction to MTX), mild-to-moderate side effects of MTX treatment (i.e. nausea,
diarrhoea, vomiting, buccositis and conjunctivitis), clinical symptoms and serum hCG clearance time.

8. How precise was the estimate of the treatment HINT: Consider

effect? • what are the confidence limits

Comments: All CIs cross 1, thus no sig diff

Section C: Will the results help locally?

9. Can the results be applied to Yes HINT: Consider whether

the local population, or in • the patients covered by the trial are
your context? Can’t Tell similar enough to the patients to whom
you will apply this
No • how they differ

Comments:
plateauing serum hCG in women with an ectopic pregnancy or a PUL is
not a very common condition

10. Were all clinically important Yes HINT: Consider whether

outcomes considered? • there is other information you would
Can’t Tell like to have seen
✔
• if not, does this affect the decision
No

Comments:

4
11. Are the benefits worth the Yes ✔
HINT: Consider
harms and costs? • even if this is not addressed by the
Can’t Tell trial, what do you think?

No

Comments: MTX, a potentially harmful drug, can be withheld in these women.