The Outcome Measures in Rheumatology (OMERACT) Systemic Lupus Erythematosus (SLE) Working Group is endeavoring to update the OMERACT SLE Core Domain Set and their measurement instruments. The previous OMERACT SLE Core Domain Set was developed in 1998, and since then, many novel pertinent domains in SLE have been identified creating a need to update the OMERACT SLE Core Domain Set. A new OMERACT SLE Working Group was established in 2018 which currently has over 150 stakeholders representing 5 continents and 25 countries. Domain Generation is being accomplished by a Scoping Literature Review, SLE Patient Focus Groups, SLE Patient Interviews, and a Qualitative SLE Research Scoping Literature Review. Consensus on domains for the Core Domain Set will be achieved through a 4-round DELPHI consensus exercise with the OMERACT SLE Working Group. A final Vote held by OMERACT will determine the implementation of the OMERACT SLE Core Domain Set. Once the Core Domain Set is established, measurement instruments for each core domain will be selected based on the OMERACT 2.1 Instrument Selection Filter.
AimTo update the OMERACT SLE Core Domain Set and their measurement instruments.
ContributorsWils Nielsen(1), Vibeke Strand(2), Lee S. Simon(3), Julian Thumboo(4), Marta Mosca(5), Martin Aringer(6), Sindhu Johnson(7), Aaron M. Drucker(8), Eric Morand(9), Ian Bruce(10), Zahi Touma(1)
1. University of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada.
2. Division of Immunology/Rheumatology, Stanford U, Palo Alto, California, USA.
3. SDG, LLC, Cambridge, Massachusetts, USA.
4. Department of Rheumatology and Immunology, Singapore General Hospital, Singapore.
5. Department of Clinical and Experimental Medicine, University of Pisa, Italy.
6. Division of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine TU Dresden, Dresden, Germany.
7. Toronto Western Hospital, Mount Sinai Hospital, and University of Toronto, Toronto, Ontario, Canada.
8. Division of Dermatology, Department of Medicine, University of Toronto and Women’s College Hospital.
9. Centre for Inflammatory Disease, Monash University, Melbourne, Australia.
10. Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
Disease Category: Rheumatology
Disease Name: Systemic lupus erythematosus (SLE)
Age Range: 18
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Governmental agencies
- Journal editors
- Methodologists
- Pharmaceutical industry representatives
- Researchers
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Systematic review
Domains in consideration for the Outcome Measures in Rheumatology (OMERACT) Systemic Lupus Erythematosus (SLE) Core Domain Set are generated through a scoping literature review of SLE clinical trials and systematic reviews of the last 10 years as well as qualitative research. The qualitative research includes a SLE qualitative research scoping literature review of the past 10 years, interviews with 23 SLE patients, and focus groups with SLE patients from around the world. The domains generated from this research will be consolidated and prioritized using a 4 Round DELPHI Consensus method with the OMERACT SLE Working Group that consist of over 100 patient research partners and 100 non-patient SLE stakeholders such as clinicians and researchers.