Session (CTI)

Purpose: Traditional analyses of randomized clinical trials (RCTs) or other comparative effectiveness studies do not routinely incorporate patient preferences. This workshop will provide participants with a step-by-step approach to eliciting preference weights and applying them to data from RCTs using novel methodologies—Win Statistics and Weighted Composite Endpoints (WCE)—to enable patient-centered comparative effectiveness research. Description: Dr. Gouda will review newer analytic approaches, including win statistics and weighted-composite endpoints (WCE), designed to address limitations of conventional analytic methods for treatment comparisons in RCTs. Dr. Reed will review alternative stated-preference methods that can be used to quantify the relative importance of various medical events for incorporation in these analytic methods. The audience will participate in a Case-1 best-worst scaling exercise used to generate weights for medical events relevant to benefit-risk evaluations of anticoagulants in a survey of 1028 patients with atrial fibrillation. Dr. Shoji will demonstrate how these patient-preference weights can be applied in win statistics and WCE approaches using a worked example from a patient-level analysis of 58,541 individuals across four RCTs of direct oral anticoagulants versus warfarin. The audience answer polling questions about their interpretation of findings from different approaches.