Primary Immunodeficiency Registry System: The Minimum Data Set Designing Phase-A Systematic Review and Quantitative...

Area of Science:

• Immunology
• Medical Informatics
• Public Health

Background:

• Registries are essential for effective data management in healthcare.
• Developing a minimum data set (MDS) is crucial for efficient and relevant data collection in registries.
• This study focused on creating an MDS for a primary immunodeficiency registry system.

Purpose of the Study:

• To develop a standardized minimum data set for primary immunodeficiency (PID) registry systems.
• To ensure the collection of relevant and efficient data for PID research and clinical practice.

Main Methods:

• A two-stage cross-sectional study was conducted in 2023.
• Stage one involved literature review to extract primary data elements.
• Stage two utilized a questionnaire and the Quantitative Delphi Method with 10 specialists to refine the MDS.

Main Results:

• The initial MDS comprised 198 data elements, categorized into administrative (demographic, patient index) and clinical (history, physical exam, tests, diagnosis).
• Through two rounds of the Delphi method, 9 elements were removed, and 13 were recommended.
• A final MDS of 202 data elements was established for primary immunodeficiency registries.

Conclusions:

• The developed MDS is expected to enhance clinical and policymaker decision-making.
• The standardized data set aims to improve the quality and efficiency of scientific research in primary immunodeficiency.