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Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria
Pamela S Hinds1,2, Laura C Pinheiro3, Molly McFatrich4
1Children's National Health System, Washington, District of Columbia, USA.
Insights
Collecting symptom data directly from pediatric cancer patients using the Ped-PRO-CTCAE system is more accurate. We recommend scoring at the AE attribute level for simplicity in care and research.
Area of Science:
- Pediatric Oncology
- Patient-Reported Outcomes
- Clinical Trials
Background:
- Direct data collection from pediatric cancer patients offers superior accuracy for symptom, function, and adverse event (AE) assessment compared to caregiver or clinician interpretations.
- The pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) was developed collaboratively with children, parents, and clinicians.
- This study details the process of determining the optimal scoring approach for the Ped-PRO-CTCAE measurement system.
Purpose of the Study:
- To evaluate and recommend a scoring approach for the Ped-PRO-CTCAE system.
- To assess the correlation between Ped-PRO-CTCAE scores and established PROMIS Pediatric measures.
- To understand clinician preferences for displaying Ped-PRO-CTCAE data.
Main Methods:
- Analysis of data from 271 pediatric cancer patients using three scoring methods: AE attribute level, weighted composite AE item score, and overall AE count.
- Examination of associations between Ped-PRO-CTCAE scores and PROMIS Pediatric measures.
- Qualitative interviews with five pediatric oncology clinical trialists to gauge preferences for score display.
Main Results:
- All three scoring approaches demonstrated similar outcomes, showing positive correlations between Ped-PRO-CTCAE scores and PROMIS Pediatric measures.
- The overall Ped-PRO-CTCAE AE score effectively identified patients with worse PROMIS symptom T-scores.
- Clinicians favored a granular display of scoring information, including the child's reported score and its descriptive term.
Conclusions:
- While multiple scoring methods yield comparable results, the AE attribute level is recommended for its user-friendliness in clinical practice and research.
- The Ped-PRO-CTCAE system provides a valuable tool for collecting patient-reported data in pediatric oncology.
- Standardizing the scoring approach enhances the utility of Ped-PRO-CTCAE in research and clinical settings.
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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