How to Use the 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

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

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?