• J Pain Symptom Manage · Apr 2017

    Multicenter Study

    Cognitive Interview-based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Adolescents with Cancer.

    • Bryce B Reeve, Molly McFatrich, Laura C Pinheiro, David R Freyer, Ethan M Basch, Justin N Baker, Janice S Withycombe, Lillian Sung, Jennifer W Mack, Mia K Waldron, Catriona Mowbray, Diana Palma, and Pamela S Hinds.
    • Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA. Electronic address: bbreeve@email.unc.edu.
    • J Pain Symptom Manage. 2017 Apr 1; 53 (4): 759-766.

    ContextThe National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials.ObjectivesThis study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version.MethodsFrom seven pediatric cancer hospitals, 51 adolescents (13-20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive interviews with retrospective probing were completed in age groups of 13-15 and 16-20 year olds. Proxies were interviewed independently.ResultsIn general, the 16-20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13-15 year olds had greater challenges completing the PRO-CTCAE.ConclusionThis study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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