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

被引:26
|
作者
Freyer, David R. [1 ,2 ]
Lin, Li [3 ]
Mack, Jennifer W. [4 ,5 ]
Maurer, Scott H. [6 ,7 ]
McFatrich, Molly [8 ]
Baker, Justin N. [9 ]
Jacobs, Shana S. [10 ,11 ]
Lucas, Nicole [12 ]
Withycombe, Janice S. [13 ]
Tomlinson, Deborah [14 ]
Villabroza, Katie Rose [15 ]
Waldron, Mia K. [16 ]
Hinds, Pamela S. [16 ]
Reeve, Bryce B. [3 ,17 ]
机构
[1] Univ Southern Calif, Canc & Blood Dis Inst, Childrens Hosp Los Angeles, Los Angeles, CA USA
[2] Univ Southern Calif, Keck Sch Med, Los Angeles, CA USA
[3] Duke Univ, Sch Med, Dept Populat Hlth Sci, Durham, NC USA
[4] Dana Farber Canc Inst, Boston, MA 02115 USA
[5] Boston Childrens Hosp, Boston, MA USA
[6] UPMC, Childrens Hosp, Pittsburgh, PA USA
[7] Univ Pittsburgh, Sch Med, Pittsburgh, PA USA
[8] Duke Univ, Sch Med, Durham, NC USA
[9] St Jude Childrens Res Hosp, Div Qual Life & Palliat Care, Memphis, TN 38105 USA
[10] Childrens Natl Hosp, Div Oncol, Washington, DC USA
[11] George Washington Univ, Sch Med & Hlth Sci, Washington, DC 20052 USA
[12] Duke Univ, Durham, NC USA
[13] Clemson Univ, Sch Nursing, Clemson, SC USA
[14] Hosp Sick Children, Peter Gilgan Ctr Res & Learning, Toronto, ON, Canada
[15] Childrens Hosp Los Angeles, Los Angeles, CA 90027 USA
[16] George Washington Univ, Sch Med & Hlth Sci, Dept Nursing Sci, Childrens Natl Hosp, Washington, DC 20052 USA
[17] Duke Univ, Sch Med, Dept Pediat, Durham, NC USA
基金
美国国家卫生研究院;
关键词
QUALITY-OF-LIFE; COMMON TERMINOLOGY CRITERIA; OUTCOMES VERSION; PEDIATRIC ONCOLOGY; PATIENT; PARENT; PRO; AGREEMENT; ADOLESCENTS; RELIABILITY;
D O I
10.1200/JCO.21.02669
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 (kappa) statistics. Multivariable mixed regression models were used to evaluate associations of clinical factors with AE reporting concordance. Significance was set at alpha = .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 (kappa 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. (C) 2022 by American Society of Clinical Oncology
引用
收藏
页码:1623 / +
页数:17
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