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The first step to integrating the child's voice in adverse event reporting in oncology trials: A content validation study among pediatric oncology clinicians
Author(s) -
Reeve Bryce B.,
Withycombe Janice S.,
Baker Justin N.,
Hooke Mary C.,
Lyons Jessica C.,
Mowbray Catriona,
Wang Jichuan,
Freyer David R.,
Joffe Steven,
Sung Lillian,
Tomlinson Deborah,
Gold Stuart H.,
Hinds Pamela S.
Publication year - 2013
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.24463
Subject(s) - common terminology criteria for adverse events , medicine , adverse effect , pediatric oncology , clinical trial , documentation , terminology , childhood cancer , medline , content validity , family medicine , medical physics , cancer , clinical psychology , psychometrics , linguistics , philosophy , computer science , political science , law , programming language
Purpose Children with cancer experience significant toxicities while undergoing treatment. Documentation of adverse events (AEs) in clinical trials is mandated by federal agencies. Although many AEs are subjective, the current standard is clinician reporting. Our long‐term goal is to create and validate a self‐report measure of subjective AEs for children aged 7 years and older that will inform AE reporting for the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). This content validation study aimed to identify which of the AEs in the current CTCAE should be included in a pediatric self‐report measure. Methods We sought expert panel review and consensus among 187 pediatric clinicians from seven Children's Oncology Group institutions to determine which of the 790 AEs are amenable to child self‐report. Two survey iterations were used to identify suitable AEs, and clinician agreement estimated by the content‐validity ratio (CVR) was assessed. Results Response rates for surveys 1 and 2 were 72% and 67%, respectively. After the surveys, 64 CTCAE terms met the criteria of being subjective, relevant for use in pediatric cancer trials, and amenable to self‐report by a child. The most frequent reasons for removal of CTCAE terms were that they relied on laboratory or clinical measures or were not applicable to children. Conclusion The 64 CTCAE terms will be translated into child‐friendly terms as the basis of the child‐report toxicity measure. Ultimately, systematic collection of these data will improve care by enhancing the accuracy and completeness of treatment toxicity reports for childhood cancer. Pediatr Blood Cancer 2013; 60: 1231–1236. © 2013 Wiley Periodicals, Inc.