E. Basch|B. B. Reeve|Sandra A. Mitchell|Steven B. Clauser|Lori M. Minasian|Amylou C. Dueck|Tito R. Mendoza|Jennifer L. Hay|Thomas M. Atkinson|A. P. Abernethy|Deborah Watkins Bruner|Charles S. Cleeland|Jeff A. Sloan|Ram Chilukuri|P. Baumgartner|Andrea Denicoff|D. St. Germain|Ann M. O’Mara|Allen M. Chen|Joseph Kelaghan|Antonia V. Bennett|Laura Sit|Lauren J. Rogak|Allison Barz|Diane ?. Paul|Deborah Schrag
Development of the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill
standard approach documenting symptomatic adverse events aes cancer clinical trials involves investigator reporting using national cancer institutes ncis common terminology criteria adverse events ctcae approach underdetects symptomatic aes nci issued two contracts create patientreported outcome pro measurement system companion ctcae called proctcae commentary describes development proctcae group multidisciplinary investigators patient representatives provides overview qualitative quantitative studies measurement properties systematic evaluation 790 aes listed ctcae identified 78 appropriate patient selfreporting proctcae plain language term english one three items characterizing frequency severity andor activity interference ae created rendering library 124 proctcae items items refined cognitive interviewing study among patients active cancer treatment diverse educational racial geographic backgrounds favorable measurement properties items including construct validity reliability responsiveness betweenmode equivalence determined prospectively demographically diverse population patients receiving treatments many different tumor types software platform built administer proctcae items clinical trial participants via internet telephone interactive voice response refined usability testing work ongoing translate proctcae multiple languages determine optimal approach integrating proctcae clinical trial workflow ae analyses envisioned proctcae enhance precision patientcenteredness adverse event reporting cancer clinical research