Premium
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
Author(s) -
Reeve Bryce B.,
McFatrich Molly,
Pinheiro Laura C.,
Weaver Meaghann S.,
Sung Lillian,
Withycombe Janice S.,
Baker Justin N.,
Mack Jennifer W.,
Waldron Mia K.,
Gibson Deborah,
Tomlinson Deborah,
Freyer David R.,
Mowbray Catriona,
Jacobs Shana,
Palma Diana,
Martens Christa E.,
Gold Stuart H.,
Jackson Kathryn D.,
Hinds Pamela S.
Publication year - 2017
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.26261
Subject(s) - common terminology criteria for adverse events , medicine , adverse effect , cognitive interview , proxy (statistics) , terminology , pediatric cancer , cognition , medline , family medicine , pediatrics , clinical psychology , psychiatry , cancer , linguistics , philosophy , machine learning , computer science , political science , law
Background 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. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent‐proxies. The Pediatric PRO‐CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were interviewed independently. Results Two rounds of interviews involved 81 children and adolescents and 74 parent‐proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO‐CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO‐CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO‐CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.