Failure of the Proportional Odds is the Result

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Elizabeth Lorenzi systematically examine the analytic pitfalls in recent acute ischemic stroke trials, especially the implications of violating the proportional odds assumption on the modified Rankin Scale. The discussion draws on the DISCOUNT, INSTANT, ESCAPE-MeVo, and ORIENTAL-MeVo trials, spotlighting frequent reactive shifts to proportional odds violations. Scott and Liz detail how such approaches obscure clinically relevant heterogeneity and react by creating analysis methods that obscure the clinical relevance of a violation of proportional odds. The episode underscores the necessity for trial designs that explicitly address heterogeneity of treatment effect. Listeners gain an unvarnished critique of prevailing reporting practices and an actionable vision for future stroke trial designs. Key Highlights DISCOUNT trial’s interim analysis and futility stopping. Issues with endpoint dichotomization after proportional odds violations. Comparison across multiple recent stroke trials with inconsistent endpoint definitions. Obscuring of proportional odds violations, which may be the most important result of the trial. Adaptive strategies in STEP platform. For more, visit us at https://www.berryconsultants.com/