Patients treated by the Duke Cleft & Craniofacial Center are being actively recruited for participation in the CleftKit project in order to look at long-term, comprehensive, and holistic outcomes associated with cleft care.
The CleftKit project is officially listed in ClinicalTrials.gov as “Prospective Data-collection System for the Comprehensive Appraisal of Cleft Care” (#NCT02702869). This project is a longitudinal observational study. There are no changes to clinical care based on participation in CleftKit.
CleftKit is a specific implementation of the ICHOM standard set for cleft lip/palate and other related outcome measures and process metrics. The database frontend and management system is a relational database design using REDCap. Data analytical algorithms are coded in Python. The code repository for this implementation will be maintained on GitHub. You can find the database schema, codebooks, and analytical code here. No patient data are publicly reported.
If you are a clinician or researcher at a Cleft Team and would like for your center to collaborate with Duke on this project, please contact me.