Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial (OPUS [TIMI-16])

AMIA Annu Symp Proc. 2007 Oct 11:1043.

Abstract

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.

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

  • Adverse Drug Reaction Reporting Systems* / standards
  • Bayes Theorem
  • Cardiovascular Diseases / prevention & control*
  • Data Interpretation, Statistical*
  • Humans
  • Logistic Models
  • Outcome Assessment, Health Care / methods*
  • Outcome Assessment, Health Care / standards
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
  • Randomized Controlled Trials as Topic
  • Secondary Prevention

Substances

  • Platelet Glycoprotein GPIIb-IIIa Complex