Validation of the Hubli Grading System for Assessing Unilateral and Bilateral Cleft Lip Outcomes

Background: When determining whether a cleft lip repair outcome is acceptable, the severity of a patient's cleft at initial presentation must be considered. Currently, there is not a widely agreed upon scale for grading the pre-operative severity or post-operative surgical outcome for patients with unilateral and/or bilateral cleft lip. The aim of this study is to validate the Hubli grading system as a reliable and reproducible system for characterizing cleft lip repair outcomes. Methods: Craniofacial surgeon graders independently evaluated 2489 patients from 56 different countries undergoing both unilateral and bilateral cleft lip repair from April 2004 to December 2018. Preoperative severity and postoperative surgical results were assessed, and these grades were combined to determine surgical outcome acceptability based on initial cleft severity. Intrarater and interrater reliability were calculated as percentages of agreement. Results: Intrarater and interrater acceptability scores had an agreement of 94.50% and 87.04%, respectively. These results indicate that using the Hubli grading system, independent raters are able to reliably and reproducibly measure the acceptability of a cleft lip repair. Conclusions: This study validates the use of the Hubli grading system to evaluate the acceptability of unilateral and bilateral cleft lip repairs. This is the largest study to date to evaluate cleft lip severity and repair outcomes, and the Hubli grading system is the only scale to determine the acceptability of surgical outcomes based on initial cleft severity. This system is designed to identify surgeons with sub-optimal outcomes in order to implement timely, individualized training on a global scale.