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

Abstract

Introduction Cleft lip and palate are 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. The choice to undergo a cleft-related revision procedure is preference sensitive, meaning that more than one reasonable treatment option exists. Shared decision-making is standard of care for preference-sensitive decisions, and decision aids facilitate the shared decision-making process. Methods After IRB approval, surgeons, parents of children with cleft lip, and children with isolated cleft palate, none of whom were currently facing the decision to undergo a cleft-related revision procedure, were recruited for alpha testing. Think aloud interviews were conducted and their content transcribed for qualitative analysis and theme development. All participants completed a single item literacy screener, a decision aid acceptability scale, and a system usability scale. Results Participants reported an excellent level of usability and acceptability. Scores indicated that all participants found the decision aid useful in decision making. Most participants answered that the length and amount of information in the decision aid were appropriate. In analysis of qualitative data, three themes emerged: use affirming and neutral language, improve visual appeal and usability, and clarify realistic expectations. Conclusions To our knowledge this is the first decision aid to be developed and tested with the goal of helping children make informed choices about cleft-related revision surgery. Participants overwhelmingly found the tool helpful and serviceable. Participant feedback will guide revisions that ensure the final iteration meets the needs of patients and families. These results support the readiness of the decision aid for beta testing and eventual integration into clinical practice as a resource that enhances shared decision-making.