Alpha Testing of a Patient-Centered Decision Aid for Cleft Revision Procedures.

Cleft lip and palate is the most common craniofacial anomaly. Primary repair occurs in the first year of life, with elective revision procedures becoming available in later childhood and adolescence. This study aims to evaluate the usability and acceptability of a decision aid designed to support shared decision-making for cleft-related revision surgery. This was accomplished with a mixed-method design at a single academic research setting. Participants included craniofacial surgeons, parents of children with cleft lip, and children with isolated cleft palate who were not actively considering revision surgery. Participants engaged with our decision aid while verbalizing feedback during think-aloud interviews. After completing all sections of the decision aid, participants completed the System Usability Scale, the Decision Aid Acceptability Scale, and the Single-Item Literacy Screener. Participants reported excellent usability. Acceptability scores indicated the decision aid was useful, unbiased, and appropriately informative. Qualitative analysis identified 3 key themes surrounding the importance of affirming and neutral language, improving visual appeal and usability, and clarifying realistic expectations regarding surgical outcomes. This is the first decision aid developed for cleft-related revision surgery. Feedback will inform refinements to optimize the language, visual aspects, and information included. Our findings support progression to beta testing and demonstrate potential for future integration into clinical practice as a tool that promotes shared decision-making for patients and families considering cleft revision procedures.