Simulation-Based Training Tools for Cleft Lip Repair: A Systematic Review

Background: Simulation may supplement operative exposure in cleft lip surgery, but the strength and clinical relevance of evidence remain uncertain. This systematic review evaluated cleft lip repair simulators, focusing on characteristics, validity evidence, educational effectiveness, and implementation. Methods: PubMed, Scopus, Web of Science, and Embase were searched on 1 August 2026. Eligible studies were original English-language studies published in 2016-2026 evaluating cleft lip repair simulators for training or assessment. Non-original reports and studies without an eligible training or assessment component were excluded. Two reviewers independently selected studies and extracted data. Validity evidence was assessed using Messick's framework, educational effectiveness using an adapted McGaghie framework, and methodological quality using the Mixed Methods Appraisal Tool (MMAT) 2018. Findings were synthesized narratively. The protocol was submitted to PROSPERO on 5 August 2026, and registered on 11 August 2026 (CRD420261469105). Results: Twenty-four publications were included. Two publications (8.3%) were categorized as educational effectiveness not evaluated, 14 (58.3%) as McGaghie Level 1, and eight (33.3%) as Level 2; none reached Levels 3-5. Eight publications demonstrated objectively measured improvement in knowledge or performance following an educational intervention or repeated simulation. Response Process validity evidence was identified in 19 publications (79.2%), whereas Content-related validity evidence was identified in 13 publications (54.2%). Internal Structure and Relations to Other Variables were less frequently supported, and Consequences evidence was absent. Evidence was limited by small samples, heterogeneous designs, and frequent reliance on subjective outcomes. Conclusions: Cleft lip simulation can produce measurable educational benefits, but evidence of transfer to clinical performance or patient outcomes is lacking. Future studies should prioritize objective assessment, stronger validity and reliability evidence, accessible task-specific models, and evaluation of clinical transfer. No external funding was received.