PMID- 23335328
OWN - NLM
STAT- MEDLINE
DCOM- 20130723
LR  - 20210715
IS  - 1545-5017 (Electronic)
IS  - 1545-5009 (Linking)
VI  - 60
IP  - 7
DP  - 2013 Jul
TI  - The first step to integrating the child's voice in adverse event reporting in 
      oncology trials: a content validation study among pediatric oncology clinicians.
PG  - 1231-6
LID - 10.1002/pbc.24463 [doi]
AB  - 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.
CI  - Copyright (c) 2013 Wiley Periodicals, Inc.
FAU - Reeve, Bryce B
AU  - Reeve BB
AD  - 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
FAU - Withycombe, Janice S
AU  - Withycombe JS
FAU - Baker, Justin N
AU  - Baker JN
FAU - Hooke, Mary C
AU  - Hooke MC
FAU - Lyons, Jessica C
AU  - Lyons JC
FAU - Mowbray, Catriona
AU  - Mowbray C
FAU - Wang, Jichuan
AU  - Wang J
FAU - Freyer, David R
AU  - Freyer DR
FAU - Joffe, Steven
AU  - Joffe S
FAU - Sung, Lillian
AU  - Sung L
FAU - Tomlinson, Deborah
AU  - Tomlinson D
FAU - Gold, Stuart H
AU  - Gold SH
FAU - Hinds, Pamela S
AU  - Hinds PS
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20130117
PL  - United States
TA  - Pediatr Blood Cancer
JT  - Pediatric blood & cancer
JID - 101186624
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Antineoplastic Agents/adverse effects
MH  - Child
MH  - *Clinical Trials as Topic
MH  - Data Collection
MH  - Female
MH  - Humans
MH  - Neoplasms/therapy
MH  - Pediatrics/*methods
MH  - Radiotherapy/adverse effects
MH  - *Research Design
MH  - *Self Report
EDAT- 2013/01/22 06:00
MHDA- 2013/07/24 06:00
CRDT- 2013/01/22 06:00
PHST- 2012/10/07 00:00 [received]
PHST- 2012/12/10 00:00 [accepted]
PHST- 2013/01/22 06:00 [entrez]
PHST- 2013/01/22 06:00 [pubmed]
PHST- 2013/07/24 06:00 [medline]
AID - 10.1002/pbc.24463 [doi]
PST - ppublish
SO  - Pediatr Blood Cancer. 2013 Jul;60(7):1231-6. doi: 10.1002/pbc.24463. Epub 2013 
      Jan 17.