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. 2017 Mar;64(3):10.1002/pbc.26261.
doi: 10.1002/pbc.26261. Epub 2016 Sep 21.

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

Bryce B Reeve  1   2 , Molly McFatrich  1 , Laura C Pinheiro  1   2 , Meaghann S Weaver  3 , Lillian Sung  4   5 , Janice S Withycombe  6 , Justin N Baker  3 , Jennifer W Mack  7 , Mia K Waldron  8 , Deborah Gibson  3 , Deborah Tomlinson  4 , David R Freyer  9 , Catriona Mowbray  10 , Shana Jacobs  10 , Diana Palma  9 , Christa E Martens  1 , Stuart H Gold  1 , Kathryn D Jackson  1 , Pamela S Hinds  8   11
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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

Bryce B Reeve et al. Pediatr Blood Cancer. 2017 Mar.

Abstract

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.

Keywords: adverse events; cancer; cognitive interviews; patient-reported outcomes.

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Conflict of interest statement

The authors declare that there is no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flow of cognitive interviews for participants
See this image and copyright information in PMC

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