Validity and Reliability of the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

Reeve, Bryce B.; McFatrich, Molly; Mack, Jennifer W.; Maurer, Scott H.; Jacobs, Shana; Freyer, David R.; Withycombe, Janice S.; Baker, Justin N.; Castellino, Sharon M.; Lin, Li; Lucas, Nicole; Hinds, Pamela S.

doi:10.1093/jnci/djaa016

Cited by 61 publications

(64 citation statements)

References 33 publications

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“…It is advisable to use patient reported tools to measure their severity and their impact on QoL[93,94]. Notably, their frequency and severity may be associated with clinical benefit from anticancer therapies, so mitigating these events is of importance to maintaining dose intensity and QoL.…”

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confidence: 99%

Prevention and management of dermatological toxicities related to anticancer agents: ESMO Clinical Practice Guidelines☆

et al. 2021

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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confidence: 99%

Prevention and management of dermatological toxicities related to anticancer agents: ESMO Clinical Practice Guidelines☆

et al. 2021

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“…Data were collected and stored electronically via the PRO Core System at the University of North Carolina. Details describing the study design have been published 17 …”

Section: Methodsmentioning

confidence: 99%

“…We also examined results at T1 to make sure that findings were consistent. We provide results by age group (7‐12, 13‐15, and 16‐18 years) whenever possible 17 . Analyses focused on 15 symptom AEs captured by Ped‐PRO‐CTCAE [Caregiver] that were most prevalent in children with cancer.…”

Section: Methodsmentioning

confidence: 99%

“…The Pediatric PRO‐CTCAE (Ped‐PRO‐CTCAE) was designed to extend the PRO‐CTCAE measurement system to children and adolescents between 7 and 17 years of age. Evidence for the validity of the self‐report version of the Ped‐PRO‐CTCAE has been previously documented 14‐17 . Concurrently, a caregiver‐reported version of the Ped‐PRO‐CTCAE (Ped‐PRO‐CTCAE [Caregiver]) was designed to parallel the self‐report version with the expectation that it may be used in research and health care settings to complement the child's self‐reported data or to inform the AE assessment when the child is unable or unwilling to self‐report.…”

Section: Introductionmentioning

confidence: 99%

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Validation of the caregiver Pediatric Patient‐Reported Outcomes Version of the Common Terminology Criteria for Adverse Events measure

Reeve

McFatrich

Lin

et al. 2020

Cancer

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Background Despite improvements in survival rates, cancer treatments have significant side effects that affect the quality of life of children and their families. When an ill child cannot self‐report symptoms (eg, he or she is too ill), caregiver (parent) reporting becomes critical. This study evaluates the validity and reliability of the caregiver‐reported Pediatric Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped‐PRO‐CTCAE [Caregiver]) measure. Methods A diverse sample of caregivers with children receiving treatment at 9 oncology centers completed the Ped‐PRO‐CTCAE [Caregiver] measure, the Patient‐Reported Outcomes Measurement Information System® (PROMIS®) Parent Proxy measures, the Lansky Play‐Performance Scale (PPS), medication use questions, and Global Impressions of Change (GIC). Construct validity (including convergent, discriminant, and known groups validity and responsiveness over time) and reliability (stability) were examined. Results A majority of the 473 caregivers were female (85%), non‐Hispanic White (61%), and married (75%). Symptoms assessed with the Ped‐PRO‐CTCAE [Caregiver] and PROMIS Parent Proxy measures were strongly correlated (e.g., r for pain = 0.78; r for fatigue = 0.78; and r for depression = 0.83). Most of the Ped‐PRO‐CTCAE [Caregiver] item mean scores distinguished among PPS function levels and between children who did take medications for symptom control and children who did not. Changes in Ped‐PRO‐CTCAE [Caregiver] item mean scores were responsive to GIC over time. Test‐retest evaluation found moderate to high agreement (57.8%‐93.3%) over time. Conclusions This study found strong evidence for the convergent and discriminant validity, known groups validity, responsiveness, and stability of the Ped‐PRO‐CTCAE [Caregiver] measure in a large and diverse sample of caregivers. The caregiver perspective provides a valuable and unique insight into the experiences of children and adolescents undergoing cancer treatment. Lay Summary Despite advances in cancer treatments, children and adolescents continue to suffer from treatment side effects, including pain, nausea, fatigue, and emotional distress, that can adversely affect quality of life for children and their families. Although it is best for children to report how they are feeling, there are times when a child may be too young or too ill to self‐report. This study provides critical evidence for a new type of questionnaire that allows the caregiver or parent to report accurately what the child is experiencing. This measure can be used to improve adverse event reporting and child cancer care.

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“…15 These scales are commonly used to assess the functional status of patients with brain tumors. 16,17…”

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confidence: 99%

Behavior Disorder and Social Function Impairment in Children with Basal Ganglia Germ Cell Tumors

Jin

Chen

et al. 2021

NDT

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Purpose: Basal ganglia intracranial germ cell tumors (iGCTs) can specifically destroy the basal ganglia network, leading to several cognitive, learning, behavioral, and social impairments. This study aimed to investigate the behavior and social disorders of patients with basal ganglia iGCTs. Patients and Methods: We recruited 30 newly diagnosed iGCTs patients (and their parents) for the current study. The Child Behavior Checklist/6-18 was used to evaluate emotional and behavioral problems. The Conner's Parent Rating Scales was used to assess symptoms of hyperactivity/impulsivity and conduct problems. The health-related quality of life (HRQoL) was assessed using the Pediatric Quality of Life Inventory 4.0 Generic Core Scale. Performance status was assessed using the Lansky play-performance scale and Karnofsky performance scale. The effects of basal ganglia lesions on these scores were examined. Results: Patients with basal ganglia iGCTs (n = 10) had more behavioral problems (attention problems, aggressive behavior, learning problems, hyperactivity index), social function impairment, anxiety/depression, and poorer HRQoL compared to patients with non-basal ganglia iGCTs (n = 20). There was no significant difference in the Lansky play-performance /Karnofsky performance scale scores. Conclusion: This study demonstrates the effects of basal ganglia lesions on behavioral and emotional outcomes, social functions, and HRQoL of patients with iGCTs. The results may help to understand the function of basal ganglia and provide evidence for the benefit of early psychological intervention to improve the treatment for this rare disease.

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Validity and Reliability of the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

Cited by 61 publications

References 33 publications

Prevention and management of dermatological toxicities related to anticancer agents: ESMO Clinical Practice Guidelines☆

Prevention and management of dermatological toxicities related to anticancer agents: ESMO Clinical Practice Guidelines☆

Validation of the caregiver Pediatric Patient‐Reported Outcomes Version of the Common Terminology Criteria for Adverse Events measure

Behavior Disorder and Social Function Impairment in Children with Basal Ganglia Germ Cell Tumors

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