How to use CONSORT (Consolidated Standards of Reporting Trials) Checklist

How to Use the CONSORT Checklist for Reporting RCTs

The CONSORT (Consolidated Standards of Reporting Trials) checklist ensures transparent and complete reporting of randomized controlled trials (RCTs). It is used by researchers, peer reviewers, and journal editors to assess whether an RCT’s methodology and results are clearly documented.

1. Understand the CONSORT Checklist Structure

The CONSORT 2010 Checklist has 25 items grouped into:

• Title & Abstract (1)
• Introduction (2)
• Methods (3–12)
• Results (13–19)
• Discussion (20–22)
• Other (23–25)

Each item corresponds to a critical element of an RCT report (e.g., randomization, blinding, participant flow).

🔗 Download the checklist: www.consort-statement.org

2. Step-by-Step Application

For Authors Writing an RCT Report

1. Follow the Checklist While Drafting
   • Ensure each CONSORT item is addressed in your manuscript.
   • Use the CONSORT Flow Diagram to illustrate participant enrollment, allocation, follow-up, and analysis.
2. Key Items to Include
   • Item 3a (Trial Design): Specify if parallel, factorial, crossover, etc.
   • Item 8a (Randomization): Describe the method (e.g., computer-generated sequence).
   • Item 10 (Blinding): State who was blinded (participants, investigators, outcome assessors).
   • Item 17a (Outcomes): Report results for all pre-specified primary and secondary outcomes.
   • Item 19 (Harms): Report adverse events (even if none occurred).
3. Use the CONSORT Flow Diagram
   • Visualize:
     • Enrollment → Randomization → Intervention → Follow-up → Analysis.
     • Number of dropouts/exclusions at each stage.

   Example Flow Diagram:

   Copy

   Assessed for eligibility (n=500)  
     ↓  
   Excluded (n=200)  
     ↓  
   Randomized (n=300)  
     ↓  
   Allocated to Treatment (n=150) → Lost to follow-up (n=10) → Analyzed (n=140)  
   Allocated to Control (n=150) → Lost to follow-up (n=15) → Analyzed (n=135)

For Reviewers/Readers Assessing an RCT

1. Check if All CONSORT Items Are Reported
   • If an item is missing, the study may have reporting biases (e.g., selective outcome reporting).
2. Focus on Critical Items
   • Randomization (Items 8–9): Was allocation truly random and concealed?
   • Blinding (Item 10): Could bias have influenced results?
   • Outcomes (Item 17): Were all pre-registered outcomes reported?
   • Harms (Item 19): Were adverse events documented?
3. Compare with Study Protocol
   • Check ClinicalTrials.gov or other registries for discrepancies.

3. Example Checklist Evaluation

Conclusion: The study has major reporting gaps (randomization method, secondary outcomes).

4. When to Use CONSORT

✔ Writing an RCT manuscript (required by most medical journals).
✔ Peer-reviewing an RCT (to assess completeness).
✔ Systematic reviews (to evaluate risk of reporting bias).

5. Comparison with Other Tools

Final Tips

✅ Use the CONSORT Extension for:

• Cluster RCTs (CONSORT-Cluster)
• Pragmatic Trials (CONSORT-Pragmatic)
• Non-Pharmacologic Treatments (CONSORT-NPT)

❌ Avoid:

• Omitting the flow diagram.
• Ignoring negative/harm outcomes.

Would you like a filled-in CONSORT checklist example for an RCT paper?