Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research

Title

Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research

Creator

McFatrich M; Brondon J; Lucas N R; Hinds P S; Maurer S H; Mack J W; Freyer D R; Jacobs S S; Baker J N; Mowbray C; Wang M; Castellino S M; Barz Leahy A; Reeve B B

Identifier

Publisher

Cancer

Date

2019

Subject

adverse events; patient-reported outcomes; pediatric oncology; toxicity grading

Description

BACKGROUND: Clinicians are the standard source for adverse event (AE) reporting in oncology trials, despite the subjective nature of symptomatic AEs. The authors designed a pediatric patient-reported outcome (PRO) instrument for symptomatic AEs to support the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) (the Pediatric PRO-CTCAE). The current study developed a standardized algorithm that maps all possible Pediatric PRO-CTCAE response patterns to recommended CTCAE grades to improve the accuracy of AE reporting in pediatric oncology trials. METHODS: Two rounds of surveys were administered to experienced cancer clinicians across 9 pediatric hospitals. In round 1, pediatric oncologists assigned CTCAE grades to all 101 possible Pediatric PRO-CTCAE response patterns. The authors evaluated clinician agreement of CTCAE grades across response patterns and categorized each response pattern as having high or low agreement. In round 2, a survey was sent to a larger clinician group to examine clinician agreement among a select set of Pediatric PRO-CTCAE response patterns, and the authors examined how clinical context influenced grade assignment. RESULTS: A total of 10 pediatric oncologists participated in round 1. Of the 101 possible patterns, 89 (88%) had high agreement. The Light weighted kappa was averaged across the 10 oncologists (Light kappa = 0.73; 95% CI, 0.66-0.81). A total of 139 clinicians participated in round 2. High clinician agreement remained for the majority of generic response patterns and the clinical context did not typically change grades but rather improved agreement. CONCLUSIONS: The current study provides a framework for integrating child self-reported symptom data directly into mandated AE reporting in oncology trials. Translating Pediatric PRO-CTCAE responses into clinically meaningful metrics will guide future cancer care and toxicity grading.

Rights

Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).

Citation List Month

Oncology 2019 List

Collection

Citation

McFatrich M; Brondon J; Lucas N R; Hinds P S; Maurer S H; Mack J W; Freyer D R; Jacobs S S; Baker J N; Mowbray C; Wang M; Castellino S M; Barz Leahy A; Reeve B B, “Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research,” Pediatric Palliative Care Library, accessed July 24, 2021, https://pedpalascnetlibrary.omeka.net/items/show/16955.

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