Comparison of Investigator-Reported and Clinical Event Committee–Adjudicated Outcome Events in GLASSY

Background: Event adjudication by a clinical event committee (CEC) provides standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in subset open-label, investigator-reported (IR) GLOBAL trial, an process reported and unreported potential events (triggers). We describe metrics feasibility efficiency, diagnostic accuracy IR events, their concordance with corresponding CEC-adjudicated events. Methods: report proportion myocardial infarction, bleeding, stroke, stent thrombosis triggers sufficient evidence for assessment (feasibility) that were adjudicated as (efficiency), stratified source (IR or non-IR). Using criterion standard, we sensitivity, specificity, positive negative predictive value, global Gwet AC coefficient, examine between IR- triggers. There was 2592 (98.3%) 2636 Results: Overall, end point-to-trigger ratio high similar (88%) non-IR–reported (87%) The IR-reported 0.70 (95% CI, 0.65–0.74) 0.54 0.45–0.62), respectively, infarction; 0.77 0.75–0.79) 0.71 0.68–0.74) bleeding; 0.62–0.79) 0.59 0.43–0.74) stroke; 0.52–0.66) 0.39 0.25–0.53) thrombosis. For bleedings, on type generally weak. Conclusions: Implementing pragmatic open-label trial is feasible efficient. Our findings modest weak support role such settings. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03231059.