title: The first step to integrating the child's voice in adverse event reporting in oncology trials: a content validation study among pediatric oncology clinicians.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina 27599-7411, USA. bbreeve@email.UNC.edu
authors: Bryce B
authors: BB
authors: Reeve
authors: Janice S
authors: JS
authors: Withycombe
authors: Justin N
authors: JN
authors: Baker
authors: Mary C
authors: MC
authors: Hooke
authors: Jessica C
authors: JC
authors: Lyons
authors: Catriona
authors: C
authors: Mowbray
authors: Jichuan
authors: J
authors: Wang
authors: David R
authors: DR
authors: Freyer
authors: Steven
authors: S
authors: Joffe
authors: Lillian
authors: L
authors: Sung
authors: Deborah
authors: D
authors: Tomlinson
authors: Stuart H
authors: SH
authors: Gold
authors: Pamela S
authors: PS
authors: Hinds
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000970:Antineoplastic Agents / Q000009:adverse effects; D002648:Child; D002986:Clinical Trials as Topic; D003625:Data Collection; D005260:Female; D006801:Humans; D009369:Neoplasms / Q000628:therapy; D010372:Pediatrics / Q000379:methods*; D011878:Radiotherapy / Q000009:adverse effects; D012107:Research Design; D057566:Self Report
chemical_list: D000970:Antineoplastic Agents