PMID- 28062347 OWN - NLM STAT- MEDLINE DCOM- 20171227 LR - 20220317 IS - 1873-6513 (Electronic) IS - 0885-3924 (Print) IS - 0885-3924 (Linking) VI - 53 IP - 4 DP - 2017 Apr TI - Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer. PG - 759-766 LID - S0885-3924(16)31216-7 [pii] LID - 10.1016/j.jpainsymman.2016.11.006 [doi] AB - 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. CI - Copyright (c) 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved. FAU - Reeve, Bryce B AU - Reeve BB AD - 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. FAU - McFatrich, Molly AU - McFatrich M AD - Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA. FAU - Pinheiro, Laura C AU - Pinheiro LC AD - 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. FAU - Freyer, David R AU - Freyer DR AD - Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California, USA. FAU - Basch, Ethan M AU - Basch EM AD - Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA. FAU - Baker, Justin N AU - Baker JN AD - Division of Quality of Life and Palliative Care, Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA. FAU - Withycombe, Janice S AU - Withycombe JS AD - Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA. FAU - Sung, Lillian AU - Sung L AD - Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada; Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada. FAU - Mack, Jennifer W AU - Mack JW AD - Dana-Farber Cancer Institute, Boston, Massachusetts, USA. FAU - Waldron, Mia K AU - Waldron MK AD - Department of Nursing Research and Quality Outcomes, Children's National Health System, Washington, District of Columbia, USA. FAU - Mowbray, Catriona AU - Mowbray C AD - Department of Oncology, Children's National Health System, Washington, District of Columbia, USA. FAU - Palma, Diana AU - Palma D AD - Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California, USA. FAU - Hinds, Pamela S AU - Hinds PS AD - Department of Nursing Research and Quality Outcomes, Children's National Health System, Washington, District of Columbia, USA; Department of Pediatrics, George Washington University, Washington, District of Columbia, USA. LA - eng GR - R01 CA175759/CA/NCI NIH HHS/United States GR - U54 HD090257/HD/NICHD NIH HHS/United States PT - Journal Article PT - Multicenter Study PT - Validation Study DEP - 20170103 PL - United States TA - J Pain Symptom Manage JT - Journal of pain and symptom management JID - 8605836 SB - IM MH - Adolescent MH - Age Factors MH - Comprehension MH - Female MH - Humans MH - Interviews as Topic MH - Male MH - National Cancer Institute (U.S.) MH - Neoplasms/*diagnosis/psychology MH - Parents MH - *Patient Reported Outcome Measures MH - Proxy MH - Retrospective Studies MH - Terminology as Topic MH - United States MH - Young Adult PMC - PMC5374011 MID - NIHMS843708 OTO - NOTNLM OT - Patient-reported outcomes OT - adolescents OT - adverse events (AEs) OT - cancer OT - cognitive interviews EDAT- 2017/01/08 06:00 MHDA- 2017/12/28 06:00 PMCR- 2018/04/01 CRDT- 2017/01/08 06:00 PHST- 2016/08/24 00:00 [received] PHST- 2016/10/24 00:00 [revised] PHST- 2016/11/03 00:00 [accepted] PHST- 2017/01/08 06:00 [pubmed] PHST- 2017/12/28 06:00 [medline] PHST- 2017/01/08 06:00 [entrez] PHST- 2018/04/01 00:00 [pmc-release] AID - S0885-3924(16)31216-7 [pii] AID - 10.1016/j.jpainsymman.2016.11.006 [doi] PST - ppublish SO - J Pain Symptom Manage. 2017 Apr;53(4):759-766. doi: 10.1016/j.jpainsymman.2016.11.006. Epub 2017 Jan 3.