Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer.

Journal Article (Journal Article;Multicenter Study)

CONTEXT: The 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. OBJECTIVES: This 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. METHODS: From 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. RESULTS: In 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. CONCLUSION: This 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.

Full Text

Duke Authors

Cited Authors

  • Reeve, BB; McFatrich, M; Pinheiro, LC; Freyer, DR; Basch, EM; Baker, JN; Withycombe, JS; Sung, L; Mack, JW; Waldron, MK; Mowbray, C; Palma, D; Hinds, PS

Published Date

  • April 2017

Published In

Volume / Issue

  • 53 / 4

Start / End Page

  • 759 - 766

PubMed ID

  • 28062347

Pubmed Central ID

  • PMC5374011

Electronic International Standard Serial Number (EISSN)

  • 1873-6513

Digital Object Identifier (DOI)

  • 10.1016/j.jpainsymman.2016.11.006


  • eng

Conference Location

  • United States