Objective: To qualitatively assess surgeons decision making for lip surgery in patients with cleft lip/palate (CL/P). Design: Prospective, non-randomized, clinical trial. Setting: Clinical data institutional laboratory setting. Patients, Participants: The study included both patient and surgeon participants recruited from four craniofacial centers. The patient participants were babies with a CL/P requiring primary lip repair surgery (n=16) and adolescents with repaired CL/P who may require secondary lip revision surgery (n=32). The surgeon participants (n=8) were experienced in cleft care. Facial imaging data that included 2D images, 3D images, videos, and objective 3D visual modelling of facial movements were collected from each patient, and compiled as a collage termed the Standardized Assessment for Facial Surgery (SAFS) for systematic viewing by the surgeons. Interventions: The SAFS served as the intervention. Each surgeon viewed the SAFS for six distinct patients (two babies and four adolescents) and provided a list of surgical problems and goals. Then an in-depth-interview (IDI) was conducted with each surgeon to explore their decision-making processes. IDIs were conducted either in person or virtually, recorded, and then transcribed for qualitative statistical analyses using the Grounded Theory Method. Results: Rich narratives/themes emerged that included timing of the surgery; risks/limitations and benefits of surgery; patient/family goals; planning for muscle repair and scarring; multiplicity of surgeries and their impact; and availability of resources. For diagnoses/treatments, surgeons agreed, and level of surgical experience was not a factor. Conclusions: The themes provided important information to populate a checklist of considerations to serve as a guide for clinicians. Key Words: Cleft lip/palate decision-making clinical trial lip repair lip revision qualitative

The authors have declared no competing interest.

NCT03537976

This study was funded by NIH/NIDCR Grant# U01DE024503 awarded to Principal Investigator Dr. Carroll Ann Trotman

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The study protocol and consent and HIPAA documents were approved by the Tufts Health Sciences and University of North Carolina Biomedical Human Subjects Institutional Review Boards.

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