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: Reeve et al.
- 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.
DOIAbstract
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
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