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Applied an Integrated Efficacy Outcome to Post-Surgical Pain Trials (302844)

Keywords: Integrated analgesic efficacy, post-surgical pain trial examples

Analgesic efficacy often involves testing for multiple hypotheses. The approaches used to adjust for the type 1 error rate usually decrease the power of declaring trial success for the need to meet two or more endpoints. A new approach of building and applying an integrated outcome, the SIA (Score of Integrated Analgesic) to the acute pain trials suggest two major advantages of the approach. One is more statistical power when compared to testing each endpoint separately; the other is to discover patients present with differential treatment effects on outcome variables. Application of this method to simulated post-surgical pain trials were performed where two co-primary endpoints, pain, and morphine consumption with Hochberg adjustment to the type 1 error rate were pre-specified. Comparison of the statistical properties, graphical display of the outcome(s), and their impact on the conclusion from the two approaches will be illustrated and discussed.