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Activity Number: 186
Type: Contributed
Date/Time: Monday, August 4, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #313466
Title: Joint Hypothesis Testing Application
Author(s): Jing You*+ and Edward Mascha
Companies: Cleveland Clinic and Cleveland Clinic
Keywords: multiple outcomes ; Joint hypothesis testing ; noninferiority ; superiority
Abstract:

Clinical studies often have multiple outcomes. Joint hypothesis testing1 is easy to implement and can improve interpretation for such studies while protecting type I error. An intervention might be deemed better than its comparators if it meets an a priori set of criteria, for example, (1) superiority(SUP) on all outcomes, or (2) noninferiority (NI) on all, SUP on at least one. Inthe DeLiT trial 2,we assessed effects of light anesthesia on pain and opioids. It would be deemed better if found NI on both outcomes and SUP on at least one. Overall significance level was 0.05; in each direction, 0.025 was used for NI and SUP overall. Bonferroni correction for 2 outcomes was made only for SUP, since NI was required for both. The estimated upper limits of 95% confidence intervals for ratio of medians of opioids (0.51, 1.08) and mean difference in pain (-0.46, 0.47) were below NI criteria of 1.15 and 1. The estimated upper limits of 97.5% confidence intervals (0.48, 1.14) and (-0.53, 0.54) were above SUP criteria of 1 and 0. Light anesthesia was NI on both outcomes, but not SUP on either, failing to reject the joint null hypothesis.


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