Development and validation of the Iranian Minimum Data Set for Epidermolysis Bullosa: A mixed method approach

Minimum Data Set (MDS) enables integration in data collection, uniform data reporting, and data exchange across clinical and research information systems. The current study was conducted to determine a comprehensive national MDS for the Epidermolysis Bullosa (EB) information management system in Iran. This cross-sectional descriptive study consists of three steps: systematic review, focus group discussion, and the Delphi technique. A systematic review was conducted using relevant databases. Then, a focus group discussion was held to determine the extracted data elements with the help of contributing multidisciplinary experts. Finally, MDSs were selected through the Delphi technique in two rounds. The collected data were analyzed using Microsoft Excel 2019. In total, 103 data elements were included in the Delphi survey. The data elements, based on the experts' opinions, were classified into two main categories: administrative data and clinical data. The final categories of data elements consisted of 11 administrative items and 92 clinical items. The national MDS, as the core of the EB surveillance program, is essential for enabling appropriate and informed decisions by healthcare policymakers, physicians, and healthcare providers. In this study, a MDS was developed and internally validated for EB. This research generated new knowledge to enable healthcare professionals to collect relevant and meaningful data for use. The use of this standardized approach can help benchmark clinical practice and target improvements worldwide.