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Central vs site outcome adjudication in the IRIS trial
Rachel Forman1, Catherine M Viscoli1, Philip M Bath2
1Yale School of Medicine, 100 York St. Suite 1N, New Haven, CT 06511, United States.
Summary
Central adjudication in the Insulin Resistance Intervention after Stroke (IRIS) trial showed mixed results. While primary outcomes were unaffected, stroke-only events lost significance, highlighting the impact of outcome definitions on clinical trial results.
Area of Science:
- Clinical trial methodology
- Neurology
- Cardiovascular research
Background:
- Central adjudication of clinical trial outcomes is standard practice.
- The Insulin Resistance Intervention after Stroke (IRIS) trial evaluated pioglitazone for secondary stroke prevention.
- This study examines how central adjudication impacts outcome assessment in IRIS, considering event definitions and characteristics.
Purpose of the Study:
- To assess the influence of central adjudication versus site adjudication on outcome event classification in the IRIS trial.
- To determine how different outcome definitions (original vs. updated stroke definition) affect the assessment of treatment effects.
- To identify specific event features that may benefit from central adjudication.
Main Methods:
- Comparison of hazard ratios (HRs) for primary and secondary outcomes using site adjudication versus central adjudication.
- Re-analysis using an updated stroke definition to evaluate its impact on treatment effect estimates.
- Analysis of agreement between adjudicators based on specific clinical and imaging features of events.
Main Results:
- Primary outcome hazard ratios were identical (0.76) and significant regardless of adjudication method.
- Stroke-only outcome hazard ratios were similar but only reached statistical significance with site adjudication (HR 0.80, p=0.049 vs. HR 0.82, p=0.09).
- An updated stroke definition yielded lower, statistically significant hazard ratios across all adjudication methods. Higher agreement was observed for certain stroke types, symptom durations, and imaging findings.
Conclusions:
- Central adjudication led to a higher hazard ratio for the stroke-only outcome, causing it to lose statistical significance compared to site review.
- Updated stroke definitions resulted in larger estimates of treatment effects.
- Central adjudication may offer benefits for specific events, particularly those with shorter symptom duration or normal brain imaging.
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