Towards a minimal core dataset for systemic lupus erythematosus studies

Area of Science:

• Rheumatology
• Autoimmune Diseases
• Clinical Research

Background:

• Systemic Lupus Erythematosus (SLE) is a complex autoimmune disease with heterogeneous presentation.
• Inconsistent data collection across SLE research studies hinders comparative analysis and collaboration.
• Establishing a standardized dataset is crucial for advancing SLE research.

Purpose of the Study:

• To identify variables commonly collected by SLE clinical researchers globally.
• To establish a foundation for a minimal core dataset for future SLE studies.
• To improve data comparability and facilitate multi-center SLE research.

Main Methods:

• A questionnaire was distributed in 2020 to international SLE research centers, including SLICC members and Chinese research centers.
• The survey comprised 26 questions on routinely collected research data.
• Variables collected by at least 75% of respondents were prioritized for the core dataset.

Main Results:

• Sociodemographics, SLE-specific data (e.g., ACR 1997 criteria, SLEDAI-2K), treatment details, and complement levels (C3/C4) were frequently collected (≥75%).
• Other items like SLICC 2012 criteria and SLICC/ACR Damage Index were collected by 50-75% of respondents.
• Less than 50% of respondents collected newer criteria (e.g., EULAR/ACR 2019) or specific vaccine status.

Conclusions:

• The study identified frequently collected variables in global SLE cohorts, providing a basis for a minimal core dataset.
• Further refinement and standardization of definitions are necessary to finalize a widely applicable minimal core dataset for SLE research.
• This initiative aims to enhance the consistency and comparability of SLE data worldwide.