ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022
Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
26 citing papers in PubMed, 58 citations in OpenAlex.
- Parent Views on Parent and Child-reported Outcomes in Pediatric Advanced Cancer: A Qualitative Study.Journal of pain and symptom management · 2025Trial
- A dyadic approach to understanding anxiety and child overall health in pediatric oncology: insights from an actor-partner interdependence model.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Harm to Children from Prescribing and Administration Errors in Acute Care: A Multidisciplinary Panel Assessment.Drug safety · 2026Article
- Defining and measuring tolerability in pediatric, adolescent, and young adult oncology: The essential voices.Cancer · 2025Review
- Incorporation of patient-reported outcomes in pediatric cancer clinical trials: design, implementation, and dissemination.Journal of the National Cancer Institute · 2025Article
- Benchmarking the pediatric quality of life (PedsQL) cancer module in a large Dutch national cohort of childhood cancer patients.BMC cancer · 2025Article
- Sarcoma Assessment Measure-Paediatric Version (SAM-Paeds): development of a disease-specific patient reported outcome measure for children with sarcoma.Journal of patient-reported outcomes · 2025Article
- Incorporating patient-reported outcome measures into routine paediatric pharmacovigilance: opportunities for safety monitoring with practical use scenarios from paediatric oncology.Frontiers in pharmacology · 2025Review
- Assessing Fears of Negative Consequences in Children With Symptoms of Avoidant Restrictive Food Intake Disorder.The International journal of eating disorders · 2024Article
- Article
- mHealth Apps in the Digital Marketplace for Pediatric Patients With Cancer: Systematic Search and Analysis.JMIR pediatrics and parenting · 2024Article
- Household income and health-related quality of life in children receiving treatment for acute myeloid leukemia: Potential impact of selection bias in health equity research.Cancer medicine · 2024Article
- Article
- Agreement and disagreement between child-caregiver symptom and function reports in pediatric oncology.Pediatric blood & cancer · 2024Article
- From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments.Drug design, development and therapy · 2024Review
- Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study.Journal of medical Internet research · 2023Article
- A comprehensive analysis of adverse events in the first 30 days of phase 1 pediatric CAR T-cell trials.Blood advances · 2023Article
- Developing Angelman syndrome-specific clinician-reported and caregiver-reported measures to support holistic, patient-centered drug development.Orphanet journal of rare diseases · 2023Article
- Combination Early-Phase Trials of Anticancer Agents in Children and Adolescents.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Review
- A joint international consensus statement for measuring quality of survival for patients with childhood cancer.Nature medicine · 2023Review
Corrections and comments
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Authors and funding
14 authors at 9 institutions in 2 countries.
Funding
Abstract
purposeTo examine concordance in symptomatic adverse event (AE) grading using the Common Terminology Criteria for Adverse Events (CTCAE 4.0) for clinicians and its patient-reported outcome (PRO) versions for children (Ped-PRO-CTCAE) and caregivers (Ped-PRO-CTCAE [Caregiver]).
methodsChildren age 7-18 years with a first cancer diagnosis, their clinicians, and caregivers completed CTCAE-based measures before starting a treatment course (T1) and after the treatment (T2). Grades (0-3) were assigned by each reporter for 15 core AEs spanning physical and mental health. Mean grades were compared between reporters using two-sample
resultsThere were 438 child-clinician-caregiver triads with complete data at either T1 or T2. For children, the mean age was 13 years (standard deviation = 3.4), 53.7% were male, 32.6% non-White, and 56.4% had leukemia/lymphoma. At T1, clinician mean AE grades were significantly lower (ie, better) than children for all AEs and remained significantly lower at T2 except for constipation, nausea, anorexia, neuropathy, and anxiety. Caregiver mean AE grades were similar to children at T1 and significantly higher (ie, worse) at T2 for nausea, vomiting, anorexia, pain, fatigue, anxiety, and depression. Agreement for child-clinician grading was poor-to-fair at T1 (κ range, 0.08-0.34) and T2 (0.11-0.35), and for child-caregiver, was fair-to-good at T1 (0.34-0.65) and T2 (0.24-0.60). No factors were consistently associated with reporter concordance across AEs.
conclusionCompared 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.