• Ethan Basch, Bryce B Reeve, Sandra A Mitchell, Steven B Clauser, Lori M Minasian, Amylou C Dueck, Tito R Mendoza, Jennifer Hay, Thomas M Atkinson, Amy P Abernethy, Deborah W Bruner, Charles S Cleeland, Jeff A Sloan, Ram Chilukuri, Paul Baumgartner, Andrea Denicoff, Diane St Germain, Ann M O'Mara, Alice Chen, Joseph Kelaghan, Antonia V Bennett, Laura Sit, Lauren Rogak, Allison Barz, Diane B Paul, and Deborah Schrag.
• : Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC (EB, BBR, AVB); Department of Epidemiology and Biostatistics, Health Outcomes Research Group (EB, LS, LR) and Department of Psychiatry and Behavioral Sciences (JH, TMA), Memorial Sloan Kettering Cancer Center, New York, NY; Outcomes Research Branch, Applied Research Program, Division of Cancer Control and Population Sciences (SAM, SBC), Division of Cancer Prevention (LMM), NCTN Clinical Trials Operations, Cancer Therapy Evaluation Program (AD), Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention (AMO, DSG, JK), and Investigational Drug Branch, Cancer Therapy Evaluation Program (AC), National Cancer institute, Bethesda, MD;Division of Health Sciences Research, College of Medicine, Mayo Clinic - Arizona, Scottsdale, AZ (ACD); Department of Symptom Research, Division of Internal Medicine, The University of Texas Anderson Cancer Center, Houston, TX (TRM, CSC); Patient Advocate, New York, NY (DBP); Department of Medicine, Duke Center for Learning HealthCare, Duke Cancer Research Program, Duke University, Durham, NC (APA); Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute of Emory University, Emory University, Atlanta, GA (DWB); Mayo Clinic - Rochester, Rochester, MN (JAS); SemanticBits LLC, Herndon, VA (RC, PB); Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA (AB); Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA (DS). ebasch@med.unc.edu.
• J. Natl. Cancer Inst. 2014 Sep 1; 106 (9).

AbstractThe standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.© The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

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