Matheny, M. E., Morrow, D. A., Ohno-Machado, L., Cannon, C. P., Resnic, F. S. Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial (OPUS [TIMI-16]) AMIA Annu Symp Proc. 2007;NA(NA):1043.

We sought to validate an automated outcomes surveillance system (DELTA) using OPUS (TIMI-16), a multi-center randomized, controlled trial that was stopped early due to elevated mortality in one of the two intervention arms. Methodologies that were incorporated into the application (Statistical Process Control [SPC] and Bayesian Updating Statistics [BUS]) were compared with standard Data Safety Monitoring Board (DSMB) protocols.

Trial: OPUS-TIMI 16