OMERACT systemic lupus erythematosus domain survey

Area of Science:

• Rheumatology
• Patient-Reported Outcomes
• Clinical Trial Methodology

Background:

• The existing Systemic Lupus Erythematosus (SLE) Core Outcome Set (COS) was established in 1998.
• Numerous new SLE domains and outcome measures have emerged since its development.
• An update is necessary to reflect current understanding and research in SLE.

Purpose of the Study:

• To evaluate existing candidate domains for the updated SLE COS.
• To identify and generate novel candidate domains for SLE outcome assessment.
• To involve SLE patients and collaborators in the COS development process.

Main Methods:

• A survey was developed by the OMERACT SLE Working Group steering committee.
• Patients with SLE and OMERACT SLE Working Group collaborators were invited to participate.
• Surveys were administered between August 2022 and February 2023.

Main Results:

• 100 out of 175 invited patients and 145 out of 178 collaborators completed the survey.
• Patients prioritized life-impact domains, while collaborators focused on clinical domains.
• Both groups recommended additional domains beyond the 1998 SLE COS and research agenda.

Conclusions:

• Patient and collaborator priorities differ, necessitating the inclusion of both perspectives for a holistic SLE assessment.
• The study identified domains with high agreement for inclusion, those needing further clarification, and novel domains for consideration.
• This research is vital for updating the SLE COS to better capture the multifaceted nature of the disease.