Recommended Scoring Approach for the Pediatric Patient-Reported Outcomes
version of the Common Terminology Criteria for Adverse Events
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.