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

Kariym Joachim ^1,2, Alexandra D'Souza ², Jessie Howard ^2,3

⁰Institute of Medical Science, University of Toronto, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada.

The Cleft Palate-Craniofacial Journal : Official Publication of the American Cleft Palate-Craniofacial Association +

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December 16, 2025

View abstract on PubMed

Summary

This review found few specific outcome measures for young children with cleft lip/palate (CL/P). More research is needed to develop and validate patient-reported outcome (PRO) and proxy-report outcome (ProxRO) tools for this population.

Area Of Science

Pediatric Health Outcomes Research
Cleft Lip and Palate Care
Measurement Science

Background

Patient-reported outcomes (PROs) and proxy-report outcomes (ProxROs) are crucial for assessing care effectiveness, especially when children cannot self-report.
The appropriate age for utilizing proxy versus self-report measures in children with cleft lip and/or palate (CL/P) remains underexplored.
Existing literature lacks a comprehensive overview of available PROs and ProxROs for young CL/P patients.

Purpose Of The Study

To identify existing PRO and ProxRO measures used in children under 8 years with CL/P.
To determine the age at which proxy or self-report measures are applied in this pediatric population.
To highlight gaps in current outcome measurement for young CL/P patients.

Main Methods

A scoping review was conducted using major databases (Ovid MEDLINE, EMBASE, PsycINFO, Cochrane, Web of Science) up to July 2024.
Studies were screened, and data were extracted independently by duplicate reviewers.
Identified measures were categorized as PROs, ProxROs, or MultiROs, with narrative synthesis of findings.

Main Results

Of 7001 identified publications, 57 studies met inclusion criteria, yielding 56 distinct measures.
Most identified measures (43/56) had published psychometric properties, but few were CL/P-specific.
Proxy-report outcome (ProxRO) measures were more common than PROs; parent proxies were used from birth to 8 years, while self-report began at age 3.

Conclusions

There is a significant lack of condition-specific ProxRO measures for assessing cleft care outcomes in children under 8 years.
Development and validation of specialized ProxRO tools are urgently needed for the CL/P population.
Current measurement practices highlight a need for age-appropriate and condition-specific outcome assessment in pediatric cleft care.

Keywords:

cleft lip cleft palate outcomes pediatrics quality of life systematic review