Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative
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- 作者：Bryce B. Reeve ; Molly McFatrich ; Laura C. Pinheiro ; Meaghann S. Weaver ; Lillian Sung ; Janice S. Withycombe ; Justin N. Baker ; Jennifer W. Mack ; Mia K. Waldron ; Deborah Gibson ; Deborah Tomlinson ; David R. Freyer ; Catriona Mowbray ; Shana Jacobs ; Diana Palma ; Christa E. Martens ; Stuart H. Gold ; Kathryn D. Jackson and Pamela S. Hinds
- 刊名：Pediatric Blood & Cancer
- 出版年：2017
- 出版时间：March 2017
- 年：2017
- 卷：64
- 期：3
- 全文大小：381K
- ISSN：1545-5017
文摘
Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity.