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Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events.

Publication ,  Journal Article
Hinds, PS; Pinheiro, LC; McFatrich, M; Waldron, M; Baker, JN; Mowbray, C; Maurer, SH; Cheng, Y; Reeve, BB; Wang, J
Published in: Pediatr Blood Cancer
June 2022

BACKGROUND: Collecting symptom, function, and adverse event (AE) data directly from children and adolescents undergoing cancer care is more comprehensive and accurate than relying solely on their caregivers or clinicians for their interpretations. We developed the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) measurement system with input from children, parents, and clinicians. Here, we report how we determined the recommended Ped-PRO-CTCAE item scoring approach. METHODS: Data from 271 patients were analyzed using three scoring approaches: (a) at the AE attribute (frequency, severity, interference) using ordinal and dichotomous measures; (b) a weighted composite AE item score by AE attribute (0.5 - frequency; 1.0 - severity; 1.5 - interference); and (c) overall number of AEs endorsed. Associations of each AE attribute, AE item score, and overall AE score with the Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric measures were examined. The ability of the overall Ped-PRO-CTCAE AE score to identify patients with PROMIS symptom T-scores worse than reference population scores was assessed. Clinician preference for score information display was elicited through interviews with five pediatric oncology clinical trialists. RESULTS: The diverse scoring approaches yielded similar outcomes, including positive correlations of the Ped-PRO-CTCAE attributes, AE item score, and the overall AEs score with the PROMIS Pediatric measures. Clinicians preferred the most granular display of scoring information (actual score reported by the child and corresponding descriptive term). CONCLUSIONS: Although three scoring approaches yielded similar results, we recommend the AE attribute level of one score per Ped-PRO-CTCAE AE attribute for its simplicity of use in care and research.

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Published In

Pediatr Blood Cancer

DOI

EISSN

1545-5017

Publication Date

June 2022

Volume

69

Issue

6

Start / End Page

e29452

Location

United States

Related Subject Headings

  • Patient Reported Outcome Measures
  • Parents
  • Oncology & Carcinogenesis
  • Neoplasms
  • Medical Oncology
  • Humans
  • Child
  • Caregivers
  • Adolescent
  • 3213 Paediatrics
 

Citation

APA
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Hinds, P. S., Pinheiro, L. C., McFatrich, M., Waldron, M., Baker, J. N., Mowbray, C., … Wang, J. (2022). Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events. Pediatr Blood Cancer, 69(6), e29452. https://doi.org/10.1002/pbc.29452
Hinds, Pamela S., Laura C. Pinheiro, Molly McFatrich, Mia Waldron, Justin N. Baker, Catriona Mowbray, Scott H. Maurer, Yao Cheng, Bryce B. Reeve, and Jichuan Wang. “Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events.Pediatr Blood Cancer 69, no. 6 (June 2022): e29452. https://doi.org/10.1002/pbc.29452.
Hinds PS, Pinheiro LC, McFatrich M, Waldron M, Baker JN, Mowbray C, et al. Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events. Pediatr Blood Cancer. 2022 Jun;69(6):e29452.
Hinds, Pamela S., et al. “Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events.Pediatr Blood Cancer, vol. 69, no. 6, June 2022, p. e29452. Pubmed, doi:10.1002/pbc.29452.
Hinds PS, Pinheiro LC, McFatrich M, Waldron M, Baker JN, Mowbray C, Maurer SH, Cheng Y, Reeve BB, Wang J. Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events. Pediatr Blood Cancer. 2022 Jun;69(6):e29452.
Journal cover image

Published In

Pediatr Blood Cancer

DOI

EISSN

1545-5017

Publication Date

June 2022

Volume

69

Issue

6

Start / End Page

e29452

Location

United States

Related Subject Headings

  • Patient Reported Outcome Measures
  • Parents
  • Oncology & Carcinogenesis
  • Neoplasms
  • Medical Oncology
  • Humans
  • Child
  • Caregivers
  • Adolescent
  • 3213 Paediatrics