Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events

• Type of Material: Article
• Authors: Meaghann Weaver, St Jude Childrens Res Hosp; Bryce Reeve, University of North Carolina; Justin Baker, St Jude Childrens Res Hosp; Christa Martens, University of North Carolina; Molly McFatrich, University of North Carolina; Catriona Mowbray, Childrens Natl Hlth Syst; Diana Palma, Childrens Hosp Los Angeles; Lillian Sung, Hosp Sick Children; Deborah Tomlinson, Hosp Sick Children; Janice Withycombe, Emory University; Pamela Hinds, Childrens Natl Hlth Syst
• Language: English
• Date: 2016-01-01
• Publisher: Wiley: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2015 American Cancer Society.
• Final Published Version (URL): http://dx.doi.org/10.1002/cncr.29702
• Title of Journal or Parent Work: Cancer
• ISSN: 0008-543X
• Volume: 122
• Issue: 1
• Start Page: 141
• End Page: 148
• Grant/Funding Information: Clinical and Translational Research Center grant support (1UL1TR001111) from the Clinical and Translational Science Award program of the National Center for Advancing Translational Sciences, National Institutes of Health. Funding provided through Grant 1R01CA175759-01 “Creating and Validating Child Adverse Event Reporting in Oncology Trials”.
• Keywords: QUALITY-OF-LIFE; EVALUATING CONTENT VALIDITY; adverse events; Life Sciences & Biomedicine; SELF-REPORT; TASK-FORCE; CLINICIAN; instrument development; CANCER; INSTRUMENTS; qualitative research; patient-reported outcomes; Oncology; pediatric oncology; PARENT-CHILD AGREEMENT; PROXY; INSTITUTE; Science & Technology; symptoms; patient communication
• Research Categories: Health Sciences, Nursing; Health Sciences, Oncology; Health Sciences, Health Care Management

Abstract

BACKGROUND: Symptoms arising from disease or treatment are subjective experiences. Insight into pediatric oncology treatment side effects or symptoms is ideally obtained from direct inquiry to the ill child. A concept-elicitation phase in a patient-reported outcome (PRO) instrument design provides an opportunity to elicit children's voices to shape cancer symptom selection and terminology. METHODS: Through semistructured, one-on-one, voice-recorded interviews, symptom data were collected from 96 children with cancer between the ages of 7 and 20 years who were undergoing oncologic treatment at 7 pediatric oncology sites in the United States and Canada. RESULTS: The mean number of symptoms reported per child over the prior 7 days was 1.49 (range, 0-7; median, 1; standard deviation, 1.56). The most common symptoms across all age groups were tiredness or fatigue, nausea or vomiting, aches or pains, and weakness. There was not a statistically significant correlation between self-reported wellness and the number of reported symptoms (r = -0.156, n = 65, P =.215) or the number of symptoms reported by age group or diagnosis type. Forty participants reported experiencing a change in their body in the past week, with one-third of these changes unanticipated. Only through direct questions about feelings were emotional symptoms revealed because 90.6% of interviewees who discussed feelings (48 of 53) did so only in the context of direct questioning on feelings. Adolescents were more likely than younger children to discuss feelings as part of the interview. CONCLUSIONS: Concept elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative PRO measures. Cancer 2016;122:141-148. This article presents the findings of semistructured concept-elicitation adverse event interviews with 96 children and adolescents undergoing treatment for cancer between the ages of 7 and 20 years. Treatment symptom elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative patient-reported outcome measures.