How to use Joanna Briggs Institute (JBI) Critical Appraisal Checklist for RCTs
The JBI Checklist for RCTs is a widely used tool to assess the methodological quality of randomized controlled trials. It helps determine if a study’s design, conduct, and analysis minimize bias and ensure reliable results.

? Step 1: Access the JBI Checklist

  • Download the checklist from the official JBI website: ? https://jbi.global/critical-appraisal-tools
  • The RCT checklist consists of 13 questions covering randomization, blinding, outcomes, and statistical analysis.

? Step 2: Appraise the Study Using the 13 Key Criteria

1. Was true randomization used?

  • ✔ Look for:
    • Computer-generated randomization
    • Random number tables
    • Block randomization
  • ❌ If non-random (e.g., alternation, date of birth), mark as high risk of bias.

2. Was allocation concealment maintained?

  • ✔ Accepted methods:
    • Sealed opaque envelopes
    • Centralized randomization
  • ❌ If allocation was predictable (e.g., open list), mark as flawed.

3. Were groups similar at baseline?

  • ✔ Compare demographics, disease severity, and prognostic factors.
  • ❌ Major imbalances suggest selection bias.

4. Were participants blinded?

  • ✔ Check if patients knew their treatment group.
  • ❌ If unblinded (e.g., surgery vs. pill), note performance bias.

5. Were care providers blinded?

  • ✔ Were doctors/nurses unaware of treatment allocation?
  • ❌ If unblinded, risk of differential care.

6. Were outcome assessors blinded?

  • ✔ Were researchers measuring outcomes unaware of group assignments?
  • ❌ If not, risk of detection bias.

7. Were all participants analyzed in their original groups? (ITT analysis)

  • ✔ Intention-to-treat (ITT) analysis preserves randomization.
  • ❌ Per-protocol analysis (excluding dropouts) inflates bias.

8. Was follow-up complete and attrition reported?

  • ✔ Acceptable if ≤20% dropout with reasons explained.
  • ❌ >20% loss to follow-up threatens validity.

9. Were participants analyzed in the groups they were allocated to?

  • ✔ Crossovers or contamination should be minimal.
  • ❌ High crossover (e.g., control group taking treatment) biases results.

10. Were outcomes measured consistently?

  • ✔ Same assessment tools and timing for all groups.
  • ❌ Inconsistent methods introduce measurement bias.

11. Were outcomes measured reliably?

  • ✔ Were validated scales/instruments used?
  • ❌ Subjective measures increase variability.

12. Was statistical analysis appropriate?

  • ✔ Check:
    • Correct tests for data type (e.g., t-tests for continuous data)
    • Adjustment for multiple comparisons
  • ❌ Misuse of statistics (e.g., p-hacking) invalidates results.

13. Was the trial design appropriate?

  • ✔ Parallel, crossover, or factorial design should fit the research question.
  • ❌ Poor design (e.g., no control group) limits conclusions.

? Step 3: Score and Interpret the Appraisal

  • Answer each question: Yes (✔), No (✖), Unclear (?), or Not Applicable (NA).
  • Overall rating:
    • Low risk of bias (≥10 ✔) → High-quality study
    • Moderate risk (6-9 ✔) → Some concerns
    • High risk (≤5 ✔) → Significant flaws

? Example JBI Appraisal

Question Response Comments
1. True randomization? ✔ Yes Computer-generated sequence
2. Allocation concealed? ✔ Yes Sealed opaque envelopes
3. Groups similar at baseline? ✔ Yes Balanced age, gender, severity
4. Participants blinded? ✖ No Open-label trial
5. Care providers blinded? ✖ No Clinicians knew treatment
6. Outcome assessors blinded? ✔ Yes Independent blinded assessor
7. ITT analysis? ✔ Yes All randomized participants analyzed
8. Follow-up complete? ✔ Yes 88% retention, dropouts explained
9. Minimal crossovers? ✔ Yes <5% contamination
10. Consistent outcome measures? ✔ Yes Standardized lab tests
11. Reliable outcomes? ✔ Yes Validated depression scale
12. Appropriate stats? ✔ Yes Adjusted for covariates
13. Appropriate design? ✔ Yes Parallel-group RCT
Final Rating: Moderate risk of bias (due to lack of participant/care provider blinding).

? When to Use the JBI Checklist?

✔ Systematic reviews (PRISMA, Cochrane) ✔ Meta-analyses (assessing included study quality) ✔ Clinical guideline development ✔ Journal clubs & peer review

? Comparison with Other Tools

Tool Best For Key Difference
JBI RCT Checklist Detailed methodological quality Focuses on RCT conduct
Cochrane RoB 2 Bias risk assessment More granular bias domains
CASP RCT Quick clinical appraisal Simpler, 11 questions

Final Tips

✅ Use alongside CONSORT to check reporting completeness. ✅ Combine with GRADE to assess evidence certainty. ✅ Involve ≥2 reviewers for objectivity. Would you like a blank JBI checklist template for your review?