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Recommended Scoring Approach for the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
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  • Pamela Hinds,
  • Laura Pinheiro,
  • Molly McFatrich,
  • Mia Waldron,
  • Justin Baker,
  • Catriona Mowbray,
  • Scott Maurer,
  • Yao Cheng,
  • Bryce Reeve,
  • Jichuan Wang
Pamela Hinds
Children's National Medical Center
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Laura Pinheiro
Well Cornell Medicine
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Molly McFatrich
Duke University School of Medicine
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Mia Waldron
Children\'s National Health System
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Justin Baker
St. Jude Children's Research Hospital
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Catriona Mowbray
Children's National Medical Center
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Scott Maurer
Children's Hospital of Pittsburgh of UPMC
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Yao Cheng
Children's National Medical Center
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Bryce Reeve
Duke University School of Medicine
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Jichuan Wang
Children's National Medical Center
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Abstract

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 Scoring approaches compared were 1) at the AE attribute (frequency, severity, interference) using ordinal and dichotomous measures, 2) a weighted composite AE item score by AE attribute (0.5 - frequency; 1.0 - severity; 1.5 - interference), and 3) overall number of AEs endorsed. Associations of each AE attribute, AE item score and overall AE score with the PROMISĀ® Pediatric measures of anxiety, depressive symptoms, and fatigue 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. 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 clinical care and research.
02 Sep 2021Submitted to Pediatric Blood & Cancer
02 Sep 2021Submission Checks Completed
02 Sep 2021Assigned to Editor
08 Sep 2021Reviewer(s) Assigned
23 Sep 2021Review(s) Completed, Editorial Evaluation Pending
24 Sep 2021Editorial Decision: Revise Minor
10 Oct 2021Submission Checks Completed
10 Oct 2021Assigned to Editor
10 Oct 20211st Revision Received
13 Oct 2021Reviewer(s) Assigned
23 Oct 2021Review(s) Completed, Editorial Evaluation Pending
25 Oct 2021Editorial Decision: Accept
Jun 2022Published in Pediatric Blood & Cancer volume 69 issue 6. 10.1002/pbc.29452