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Should we adjudicate outcomes in stroke trials? A systematic review
Peter J Godolphin1, Philip M Bath2,3, Alan A Montgomery4
1MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.
Summary
Central outcome adjudication in stroke trials is often costly and may not change results, especially with blinded assessments. However, it becomes crucial if site investigators introduce bias, particularly in open-label studies.
Area of Science:
- Clinical Trials
- Neurology
- Evidence-Based Medicine
Background:
- Central adjudication of outcomes is standard in stroke randomized clinical trials (RCTs) to minimize errors.
- Despite clear rationale, central adjudication introduces trial complexity and significant costs.
Approach:
- Systematic review of 12 studies on central adjudication in stroke trials.
- Analysis focused on impact on trial results and cost-effectiveness.
- Simulation used to model bias impact on adjudication necessity.
Key Points:
- Most studies showed adjudication did not alter trial outcomes, even without full blinding.
- Greatest discrepancies between site and central assessment occurred for subjective outcomes like adverse event causality.
- Adjudication costs can exceed £100,000 for medium to large prevention trials.
Conclusions:
- Central adjudication may be unnecessary in stroke trials with blinded outcome assessment.
- For open-label stroke trials, central adjudication gains importance to mitigate potential bias.
- The cost-benefit of central adjudication requires careful consideration based on trial design and blinding.
