Death: The Simple Clinical Trial Endpoint.

Death, as a biological phenomenon, is well understood and a commonly employed endpoint for clinical trials. However, death identification and adjudication may be difficult for pragmatic clinical trials (PCT) that rely upon electronic health record and patient reported data. We propose a novel death identification and verification approach that is being used in the ToRsemide compArisoN with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) PCT. We describe our hybrid approach that includes gathering information from clinical trial sites, a centralized call center, and National Death Index searches. Our methods detail how a possible death is triggered from each of these components and the types of information we require to verify a triggered death. Our different trigger/verification elements collectively define the TRANSFORM-HF PCT's definition of a death event.

Duke Scholars

Author Kevin J. Anstrom Biostatistics & Bioinformatics, Division of Biostatistics

Author Eric Leo Eisenstein Medicine, Cardiology

Author Stephen Greene Medicine, Cardiology

Author Robert John Mentz Medicine, Cardiology