Simulation Exercise in Days Alive and Out of Hospital (DAOH) Endpoint

• Activity Number: 297
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Peter Lam*+ and Songtao Jiang and Jian Huang
• Companies: Boston Scientific and Boston Scientific and Medtronic
• Keywords: Days Alive and Out of Hospital Endpoint ; Simulation Exercise

Abstract

Days alive and out of hospital (DAOH) endpoint is an alternative clinical endpoint incorporating mortality and all hospitalizations into a single measure, compared the conventional approach of event rate or event time to cardiac death and time to first hospitalization or count of recurrent hospitalization for heart failure patients. DAOH can be used to summarize the overall treatment effect on mortality and morbidity. A simulation exercise to assess the impact of the DAOH endpoint using various assumptions of survival rates, hospitalization rates, and length of stay in the setting of 2 arm superiority trial design setting will be presented. Other related outcome measures, such as %DAOH, survival time, time in hospital will be discussed.