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

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
The main goal of this qualitative cognitive interview study was to establish, evaluate, and refine the PRO-CTCAE (Patient-Reported Outcomes version of the NCI's CTCAE) measures to be comprehensible to children and their caregivers, and relevant for capturing AEs, in order to improve care and precision of AE grading in trials. The study aimed to refine the measures and stratify the children into different age groups.
Children/adolescents ages 7-20 receiving treatment for cancer from 7 pediatric research hospitals and their parent-proxies were included. Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs, in child-friendly terms. First round of interviews elicited concepts and terminology from participants and was used to refine the Paediatric PRO-CTCAE questions tested in the second round to obtain specific feedback. Interviews were stratified by age group.
45 children and 42 proxies participated. Some words/stems that were found to be challenging in the first round of interviews were changed in the second round and were well understood. 7-8-year-olds had difficulty with the 7-day reference period for symptoms. Most questions in the Paediatric and Proxy PRO-CTCAE were well understood by participants and proxies. Patients who had experienced a particular AE were better able to accurately report it.
Small sample sizes for each item (although consistent with recommended guidelines). Participants likely did not represent the sickest patients. As well, some children did not feel well which may have affected their full attention during the interviews.
Development of patient reported outcome tools in pediatrics are important to improve the way adverse events are reported and graded on clinical trials. The Paediatric and Proxy PRO-CTCAE performed well, particularly among older children, who were able to read, understand, and report symptoms. The next step is to validate the tool in a longitudinal multisite study to detect changes in symptom status over time and compare self-report AEs with relevant clinical anchors.