CASP Randomised Controlled Trial Standard Checklist:

11 questions to help you make sense of a randomised controlled trial (RCT)

Main issues for consideration: Several aspects need to be considered when appraising a
randomised controlled trial:

Is the basic study design valid for a randomised

controlled trial? (Section A)
Was the study methodologically sound? (Section B)
What are the results? (Section C)
Will the results help locally? (Section D)

The 11 questions in the checklist are designed to help you think about these aspects
systematically.

How to use this appraisal tool: The first three questions (Section A) are screening questions
about the validity of the basic study design and can be answered quickly. If, in light of your
responses to Section A, you think the study design is valid, continue to Section B to assess
whether the study was methodologically sound and if it is worth continuing with the appraisal by
answering the remaining questions in Sections C and D.

Record ‘Yes’, ‘No’ or ‘Can’t tell’ in response to the questions. Prompts below all but one of the
questions highlight the issues it is important to consider. Record the reasons for your answers
in the space provided. As CASP checklists were designed to be used as educational/teaching
tools in a workshop setting, we do not recommend using a scoring system.

About CASP Checklists: The CASP RCT checklist was originally based on JAMA Users’ guides to the
medical literature 1994 (adapted from Guyatt GH, Sackett DL and Cook DJ), and piloted with
healthcare practitioners. This version has been updated taking into account the CONSORT 2010
guideline ([Link] accessed 16 September 2020).

Citation: CASP recommends using the Harvard style, i.e. Critical Appraisal Skills Programme
(2020). CASP (insert name of checklist i.e. Randomised Controlled Trial) Checklist. [online]
Available at: insert URL. Accessed: insert date accessed.

©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial- Share
A like. To view a copy of this licence, visit [Link]

Critical Appraisal Skills Programme (CASP) part of OAP Ltd [Link]

 Effectiveness of Group Wheelchair Skills Training for People With Spinal Cord Injury: A Randomized Controlled Trial
Study and citation: ........................................................................................................................

Section A: Is the basic study design valid for a randomised controlled trial?

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

research question? o
✔ o
CONSIDER: Population: wheel chair users (18-75 years
Was the study designed to assess the outcomes independent users)
of an intervention?
Intervention: 8 weekly 90-minute WSTP
Is the research question ‘focused’ in terms of:
• Population studied classes
• Intervention given Comparator: waitlist control group
• Comparator chosen Outcomes measured: Wheelchair Skills Test
• Outcomes measured? Questionnaire & Goal Attainment scale score

2. Was the assignment of participants to Yes No Can’t tell

interventions randomised? o
✔ o o
CONSIDER: - Randomisation: stratified by site and completed using
• How was randomisation carried out? Was per-mutated blocks of 2 or 4 based on level of injury
the method appropriate? - It is sufficient as it can reduce the effect due to
• Was randomisation sufficient to eliminate different level of injury
systematic bias? - Allocation was concealed with study members at
• Was the allocation sequence concealed individual sites
from investigators and participants?

3. Were all participants who entered the study Yes No Can’t tell
accounted for at its conclusion? o✔ o o
CONSIDER:
• Were losses to follow-up and exclusions
- There are losses after the interventions
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. Yes No Can’t tell

• Were the participants ‘blind’ to
intervention they were given? o
✔
o o
• Were the investigators ‘blind’ to the o o
✔
intervention they were giving to
participants?
• Were the people assessing/analysing o
✔ o o
outcome/s ‘blinded’?

5. Were the study groups similar at the start of Yes No Can’t tell
the randomised controlled trial? o✔ o o
CONSIDER: There is standardised age group,
• Were the baseline characteristics of each
study group (e.g. age, sex, socio-economic wheelchair users etc.
group) clearly set out?
• Were there any differences between the
study groups that could affect the
outcome/s?

2
6. Apart from the experimental intervention, did Yes No Can’t tell
each study group receive the same level of o o o✔

care (that is, were they treated equally)?

Cannot show how they treat the subject.
CONSIDER: Some subject may receive different
• Was there a clearly defined study protocol? paces of treatment
• 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?

Yes No Can’t tell

7. Were the effects of intervention reported
o
✔ o o
- underpowered
comprehensively?
- WST-Q capacity total score
CONSIDER: - The chi-square/p value and effect size
• Was a power calculation undertaken? are reported
• What outcomes were measured, and were - a graph is used to report the score in
they clearly specified? two intervals
• How were the results expressed? For
binary outcomes, were relative and - there is missing data
absolute effects reported? - there is more drop-out in the
• Were the results reported for each
outcome in each study group at each intervened group which may affect the
follow-up interval? power
• Was there any missing or incomplete data? - Kolmogorov-Smirnov
• Was there differential drop-out between the
study groups that could affect the results? test,Mann-Whitney U test and
• Were potential sources of bias identified? chi-square test are used
• Which statistical tests were used?
• Were p values reported?

8. Was the precision of the estimate of the Yes No Can’t tell

intervention or treatment effect reported? o o
✔
o
CONSIDER:
• Were confidence intervals (CIs) reported?

9. Do the benefits of the experimental Yes No Can’t tell

intervention outweigh the harms and costs? o
✔ o o
There is no harm reported in this study.
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.)

3
 Section D: Will the results help locally?

10. Can the results be applied to your local Yes No Can’t tell
population/in your context? o✔ o o
- wheel chair users are the potential
CONSIDER:
• Are the study participants similar to the patient I may need to face while some
people in your care? of them should have spinal cord
• Would any differences between your injuries
population and the study participants alter - The level of the wheelchair users
the outcomes reported in the study?
• Are the outcomes important to your should be much lower
population? - quality of life
• Are there any outcomes you would have - the general goal people want to
wanted information on that have not been achieve, reason of drop-out
studied or reported?
• Are there any limitations of the study that - power of the study, did not go for the
would affect your decision? follow-up (tedious, salience?)xf
11. Would the experimental intervention provide Yes No Can’t tell
greater value to the people in your care than o o o
✔
any of the existing interventions?

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: Record key points from your critical appraisal in this box. What is your
conclusion about the paper? Would you use it to change your practice or to recommend changes to
care/interventions used by your organisation? Could you judiciously implement this intervention
without delay?