Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial (OPUS [TIMI-16]).
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.
Matheny
Michael E
ME
Decision Systems Group, Brigham & Women's Hospital, Boston, MA, USA.
Morrow
David A
DA
Ohno-Machado
Lucila
L
Cannon
Christopher P
CP
Resnic
Frederic S
FS
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D001499:Bayes Theorem; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003627:Data Interpretation, Statistical; D006801:Humans; D016015:Logistic Models; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000592:standards; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D016032:Randomized Controlled Trials as Topic; D055502:Secondary Prevention
D019039:Platelet Glycoprotein GPIIb-IIIa Complex