Who Should Fill Out a Pediatric PROM? Psychometric Assessment From a Clinical Perspective in 567 Children With a Cleft

Background:The CLEFT-Q is a questionnaire developed for patients with a cleft lip and/or palate (CL/P). Numerous scales have been implemented as part of the ICHOM Standard Set for CL/P. Although validated for completion by patients only, clinicians noted that caregivers are often involved in completion of the scales. Aim of the study was to promote further standardization of Patient Reported Outcome Measures (PROMs) in pediatric patients by examining the preferences of patients and parents concerning the reporter type. Moreover, possible discrepancies in outcomes between reporter types were explored. Methods: Data from 567 patients with CL/P and their caregivers that completed scales of the CLEFT-Q questionnaire were collected. Reporter group sizes and proportions were examined at the ages of 8, 12, and 15 years to determine the preferred manner of completion. Mean outcomes were analyzed per scale at the 3 ages, and compared between the 3 reporter groups: "patient," "caregiver," and "together." Results: In all age-groups, the majority completed the PROMs together. Concerning the reporter types per age-group, an upward trend was seen in the proportion of patients that completed the scales alone. In the caregiver group, a downward trend was observed, and the highest proportion of parents that completed the scales was found at age 8. No significant differences were found between the reporter types in any of the scales. Conclusion: Even if a PROM questionnaire is validated for patient report only, it is recommended to record the reporter type when a pediatric PROM is completed. In order to capture outcomes that represent the patient's voice validly and reliably, though with support of the caregiver, a pediatric PROM should be filled out by the patient alone and thereafter evaluated with the caregiver(s). Concerning the CLEFT-Q, there seems to be demand for a validated parent-version of the scales.