A Road Map to Creating a High-Quality Clinical Database in Plastic Surgery

Area of Science:

• Medical Informatics
• Surgical Research
• Clinical Data Management

Background:

• In-house databases are vital for surgical research and clinical guideline development.
• Limited literature exists on the creation and management of such databases.
• This article presents a stepwise process for developing a clinical facial fracture database at a single institution.

Purpose of the Study:

• To outline the development of a large, single-institution clinical pediatric facial fracture database.
• To highlight critical steps including conception, regulatory approval, data integrity, resource allocation, collection, quality assurance, and error remediation.

Main Methods:

• Utilized Research Electronic Data Capture (REDCap) for recording patient data, fracture details, treatments, and outcomes.
• Established protocols for data quality assurance and control.
• Conducted error identification analysis to assess database completeness and accuracy.

Main Results:

• Compiled a database with 4451 records from 3334 patients (2006-2021).
• Achieved a 99.8% data completion rate.
• Reported a low error rate of 0.216% (259 incorrect entries out of 120,177 total).

Conclusions:

• Clinical research quality is directly tied to data collection accuracy.
• Rigorous quality control is essential throughout database setup.
• More research on database design processes is needed to enhance research transparency and reproducibility.