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Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials.

Publication ,  Journal Article
Freyer, DR; Lin, L; Mack, JW; Maurer, SH; McFatrich, M; Baker, JN; Jacobs, SS; Lucas, N; Withycombe, JS; Tomlinson, D; Villabroza, KR ...
Published in: J Clin Oncol
May 20, 2022

PURPOSE: To 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]). METHODS: Children 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 t-tests; agreement was estimated using weighted kappa (κ) statistics. Multivariable mixed regression models were used to evaluate associations of clinical factors with AE reporting concordance. Significance was set at α = .05 (two-sided). RESULTS: There 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. CONCLUSION: 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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 20, 2022

Volume

40

Issue

15

Start / End Page

1623 / 1634

Location

United States

Related Subject Headings

  • Patient Reported Outcome Measures
  • Oncology & Carcinogenesis
  • Neoplasms
  • Nausea
  • Male
  • Humans
  • Female
  • Child
  • Caregivers
  • Anorexia
 

Citation

APA
Chicago
ICMJE
MLA
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Freyer, D. R., Lin, L., Mack, J. W., Maurer, S. H., McFatrich, M., Baker, J. N., … Reeve, B. B. (2022). Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials. J Clin Oncol, 40(15), 1623–1634. https://doi.org/10.1200/JCO.21.02669
Freyer, David R., Li Lin, Jennifer W. Mack, Scott H. Maurer, Molly McFatrich, Justin N. Baker, Shana S. Jacobs, et al. “Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials.J Clin Oncol 40, no. 15 (May 20, 2022): 1623–34. https://doi.org/10.1200/JCO.21.02669.
Freyer DR, Lin L, Mack JW, Maurer SH, McFatrich M, Baker JN, et al. Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials. J Clin Oncol. 2022 May 20;40(15):1623–34.
Freyer, David R., et al. “Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials.J Clin Oncol, vol. 40, no. 15, May 2022, pp. 1623–34. Pubmed, doi:10.1200/JCO.21.02669.
Freyer DR, Lin L, Mack JW, Maurer SH, McFatrich M, Baker JN, Jacobs SS, Lucas N, Withycombe JS, Tomlinson D, Villabroza KR, Waldron MK, Hinds PS, Reeve BB. Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials. J Clin Oncol. 2022 May 20;40(15):1623–1634.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 20, 2022

Volume

40

Issue

15

Start / End Page

1623 / 1634

Location

United States

Related Subject Headings

  • Patient Reported Outcome Measures
  • Oncology & Carcinogenesis
  • Neoplasms
  • Nausea
  • Male
  • Humans
  • Female
  • Child
  • Caregivers
  • Anorexia