Discordance in Symptomatic Adverse Event Reports by Clinicians, Children in Cancer Clinical Trials


Adverse event (AE) reports from pediatric cancer patients participating in clinical trials often do not match AE reports from their clinicians or their caregivers, according to research published in the Journal of Clinical Oncology.

To compare AE reporting across these groups, researchers surveyed 438 child-clinician-caregiver triads.

The recognized standard for reporting adverse outcomes in oncology trials is the Common Terminology Criteria for Adverse Events (CTCAE); however, it relies on clinician assessment.

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This study used the CTCAE-linked patient-reported outcome (PRO) measures to compare responses from children undergoing cancer treatment (Ped-PRO-CTCAE) with those of their clinicians (CTCAE) and caregivers (Ped-PRO-CTCAE [Caregiver]).

Responses from 2 analysis points were compared: within 72 hours prior to initiation of a treatment course and approximately 1 to 4 weeks later.

Before starting a treatment course, the clinicians’ mean AE scores were lower than the children’s. The clinicians’ scores also remained lower at the second analysis point (posttreatment), except for nausea, anorexia, constipation, anxiety, and neuropathy. The agreement between the clinicians’ AE scores and the children’s AE scores was poor to fair at both analysis points.

The caregivers’ scores were more closely aligned with the children’s scores prior to treatment, but caregivers’ scores were significantly higher for nausea, vomiting, pain, fatigue, anxiety, anorexia, and depression after treatment.

The researchers suggested that both the clinician’s report and the child’s report need to be included when assessing symptomatic AEs to get the most complete version.

“Our finding that clinicians consistently underreport symptomatic AEs compared with children using CTCAE-based measures provides compelling evidence for routinely incorporating child report in formal toxicity monitoring on pediatric cancer clinical trials,” the researchers wrote, noting that the child’s report complements but does not replace the clinician’s report.

A few study limitations could affect the applicability of these results. The study had a relative lack of patients who had undergone bone marrow transplant, and clinician and child reports may have been submitted on different days. The researchers also noted that the sample was limited to English-speaking participants, with modest representation of the Hispanic population.

Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Freyer DR, Lin L, Mack JW, et al. Lack of concordance in symptomatic adverse event reporting by children, clinicians, and caregivers: Implications for cancer clinical trials. J Clin Oncol. 2022;40(15):1623-1634. doi:10.1200/JCO.21.02669

This article originally appeared on Oncology Nurse Advisor

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