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Abstract Details

Activity Number: 663
Type: Contributed
Date/Time: Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306712
Title: Multiple Testing in Patient-Reported Symptom Data with Application to the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Author(s): Amylou C Dueck*+ and Sandra A. Mitchell and Tito R Mendoza and Pamela J Atherton and Daniel V Satele and Antonia V Bennett and Yuelin Li and Thomas M Atkinson and Bryce B Reeve and Steven B Clauser and Jeff A Sloan and Ethan Basch
Companies: Mayo Clinic and National Cancer Institute and MD Anderson Cancer Center and Mayo Clinic and Mayo Clinic and Memorial Sloan-Kettering Cancer Center and Memorial Sloan-Kettering Cancer Center and Memorial Sloan-Kettering Cancer Center and The University of North Carolina at Chapel Hill and National Cancer Institute and Mayo Clinic and Memorial Sloan-Kettering Cancer Center
Address: 6945 E. Osborn Rd., Scottsdale, AZ, 85251, United States
Keywords: patient-reported outcomes ; symptoms ; multiple testing ; proc multtest ; cancer clinical trials ; psychometrics
Abstract:

Symptom adverse events in cancer clinical trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). NCI contracted to create a patient-reported outcomes companion tool (PRO-CTCAE) consisting of 124 items reflecting 78 symptoms to incorporate the patient perspective into AE reporting. The PRO-CTCAE validation study (N=869 patients receiving treatment for a range of cancer types) revealed many challenges in the analysis/interpretation of multi-symptom patient-reported outcomes in cancer trials. One challenge is multiple testing as when comparing scores for multiple symptoms between arms in a randomized trial. In this paper, we describe common methods for handling multiplicity including alpha adjustment methods (Bonferroni, Holm-Bonferroni step-down, Hochberg step-up), resampling methods and methods for large-scale testing (false discovery rate). Depending on the method, the number of significant results when comparing 124 PRO-CTCAE items between patients with low vs high performance status ranged from 32 to 55. Interpretation of results under each method are compared and contrasted.


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