Proxy- and Patient-Reported Outcome Measures in Cleft Lip and/or Palate Under 8 Years of Age: A Scoping Review

ObjectiveThis scoping review aimed to identify patient-reported outcome (PRO) and proxy-report outcome (ProxRO) measures administered to children under 8 years of age with cleft lip and/or palate (CL/P) and to describe the age at which proxy or self-report measures were used.DesignScoping ReviewSettingWhen children are unable to self-report, PROs and ProxROs can be used. The age at which proxy-report is appropriate has not been described in patients with CL/P.Patients, ParticipantsChildren born with CL/P.InterventionsOvid MEDLINE, EMBASE, PsycINFO, the Cochrane Register, and Web of Science were searched from inception until July 2024. Title and abstract screening, full text review, and data extraction were done independently in duplicate. Measures were categorized as PROs, ProxROs, or "MultiROs," where both caregivers and children responded. A narrative synthesis was performed to describe the identified measures.Main Outcome MeasuresPRO or ProxRO measures in children with CL/P less than 8 years old.ResultsOf 7001 publications identified, 57 studies met the inclusion criteria. Fifty-six measures were identified, of which 43 had at least 1 published psychometric property. Thirteen studies used ad hoc measures. Most measures were not condition-specific to CL/P. ProxROs were more commonly utilized than PROs. Parent-proxy tools were used from birth to 8 years, while self-report was used in patients as young as 3 years old.ConclusionsThere is a paucity of cleft-specific ProxRO measures that assess outcomes of cleft care in patients under 8 years of age. Work to develop and validate ProxRO measures for CL/P is needed.