Updating the OMERACT Systemic Lupus Erythematosus Core Outcome Set

Objectives 1. Generate a list of preliminary Systemic Lupus Erythematosus (SLE) domains in consideration for the SLE Core Outcome Set (COS). 2. Winnow and bin the preliminary domains into a final list of candidate domains with agreed upon definitions. Methods 1. Preliminary Domain Generation a) In order to review the continued importance of known SLE domains and generate novel candidate domains, a survey assessing the importance of known SLE domains and asking respondents to recommend additional domains was conducted. The survey was administered to 100 patients from the University of Toronto Lupus Clinic and 175 members of the Outcome Measures in Rheumatology (OMERACT) SLE Working Group. b) To identify preliminary domains from the literature, a scoping literature review of SLE clinical trials and systematic reviews since 2010 was conducted extracting domains, definitions, and methods of assessment (measurement tools). c) Domains important to patients living with SLE were identified through focus groups held with 36 SLE patients representing 5 continents. Patients were asked a wide variety of questions to identify all manners of domains and transcripts from interviews were thematically coded. 2. Candidate Domain Sorting a) The OMERACT SLE Advisory Group met regularly to winnow and bin the preliminary SLE domains. b) Definitions for the candidate domains were retrieved from the scoping literature review and from additional literature searches. Definitions were reviewed, modified, and agreed upon by the OEMRACT SLE Advisory Group. Results The domain survey, the scoping literature, and the focus groups generated many preliminary domains which was winnowed and binned into 25 candidate: Adverse Events, Anxiety, Cognition Impact, Cognitive Function, Depression, Economic Cost Impact, Emotional Health, Fatigue, Flares, Frailty, Health-Related Quality of Life, Pain Intensity, Pain Interference, Participation, Patient Global Assessment of Disease Activity, Physical Function, Physician Global Assessment of Disease Activity, Reproductive Health, Sexuality, SLE Disease Activity, Sleep, Stress, Tissue/Organ Damage, Treatment Satisfaction, and Use of Glucocorticoids Including Tapering. Definitions for the 25 candidate domains have been agreed upon (Table 1). Conclusion The domain generation stage of updating the SLE COS is complete. The next stage involves achieving consensus on the core domains to form the SLE COS through a 4-round Delphi consensus exercise with international collaborators (patients, clinicians, researchers, pharmaceutical representatives, and more) beginning in January 2025. Following the establishment of the core domains will be measurement instrument selection where candidate instruments will be identified and appraised for each core domains, yielding the final SLE COS.

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