Do outcomes in orthodontic research of cleft lip and palate patients reflect patient values?

Objectives: The aim of this systematic review was to identify existing outcomes used in studies of orthodontic treatment in children with cleft lip and palate. The objectives were to categorize research outcomes into outcome domains and to explore whether any relevant outcome domains were underrepresented.
Methods: The following electronic databases and grey literature were searched until March 2015 to identify all studies of orthodontic treatment interventions in children with cleft lip and palate: MEDLINE, EMBASE, CENTRAL, CDSR, PsycINFO, LILACS, BBO, ClinicalTrials.gov. Abstracts and subsequently eligible full-text articles were screened independently and in duplicate by two reviewers using systematic review methodology. Outcome measures were identified and categorised into six pre-determined outcome domains: morphological changes of treatment; adverse effects of treatment; quality of life; health resource utilisation; physical consequence of malocclusion; and functional status.
Results: The search identified 665 abstracts, of which 53 eligible articles were retrieved in full. Forty two studies met the inclusion criteria and were included in the review. Morphological features of treatment were measured in the majority of studies, whereas the remaining five outcome domains were infrequently evaluated. A diverse range was outcomes was used with little consistency in the outcomes selected amongst studies of similar context to measure these domains.
Conclusions: Most of the outcomes used in orthodontic research involving young people with cleft lip and palate are concerned with measuring morphological changes of treatment and do not reflect patient perspectives. Outcomes between studies were varied and heterogenous. Developing a core standardised set of outcomes reflecting the perspectives of all stakeholders will help to inform patients, parents, clinicians and commissioners about the effects of orthodontic treatment on young people with cleft lip and palate and would help overcome these issues.