Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials.
David R FreyerLi LinJennifer W MackScott H MaurerMolly McFatrichJustin N BakerShana S JacobsNicole LucasJanice S WithycombeDeborah TomlinsonKatie Rose VillabrozaMia K WaldronPamela S HindsBryce B ReevePublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2022)
Compared with children, symptomatic AEs were consistently under-reported by clinicians with low agreement and over-reported by caregivers with low-moderate agreement. Direct reporting by children using Ped-PRO-CTCAE or similar measures should be routinely incorporated for toxicity assessment in clinical trials.