Scoping literature review to identify candidate domains for the OMERACT Systemic Lupus Erythematosus core outcome set.

Yvonne Enman, Lee Simon, Dennisse Bonilla, Danaë Papachristos, Alberta Hoi, Lai Shan Tam, Oshrat E Tayer-Shifman, Kimberly Trotter, Yashaar Chaichian, Alfred Kim, Maya Desai, Wils Nielsen, Marta Mosca, Amita Aggarwal, Julian Thumboo, Melanie Anderson, Victoria P Werth, Juanita Romero-Diaz, Luís Sousa Inês, Michelle Barraclough, Jose A Gómez-Puerta, Patti Katz, Behdin Nowrouzi-Kia, Fadi Kharouf, Carolina Munoz Grajales, Aarabi Thayaparan, Elektra J Papadopoulos, Laura Patricia Whitall-Garcia, Cheryl F Rosen, Alexandra Legge, Kathleen Bingham, Sindhu Johnson, Aaron Drucker, Vibeke Strand, Eric Morand, Ann Elaine Clarke, Keishi Fujio, Alí Duarte-García, Zahi Touma, Meggan Mackay, Laurent Arnaud, Karina D Torralba, Rosalind Ramsey-Goldman, Reinhard E Voll, Dafna D Gladman, Martin Aringer, Ian Bruce, Irene E M Bultink, Manuel F Ugarte-Gil, Simone Appenzeller, John A Reynolds, Guillermo J Pons-Estel, Chrisanna Dobrowolski, Diane L Kamen, Chiara Tani, Stephanie Finzel, Mandana Nikpour, Ioannis Parodis, Beverley Shea, Daniel J Wallace, Anca D Askanase, Chi Chiu Mok, Guillermo Ruiz-Irastorza, Cynthia Aranow, Sandra Navarra

Journal: Seminars in arthritis and rheumatism 2025;72():152684

PMID: 40056477

Abstract

OBJECTIVE

To identify candidate Systemic Lupus Erythematosus (SLE) domains from the literature for consideration towards the development of the SLE Core Outcome Set.

METHODS

This was a comprehensive scoping literature review of SLE clinical trials and systematic reviews published since 2010. Studies were identified from 5 databases and were screened for eligibility. Candidate domains were extracted from the included studies. Candidate domains were winnowed and binned by the Outcome Measures in Rheumatology (OMERACT) SLE Advisory Group.

RESULTS

Of the 4063 studies identified, 507 met inclusion criteria and proceeded to data extraction. Multiple domains and items were extracted, which winnowing and binning reduced to 25 candidate domains.

CONCLUSION

The 25 candidate domains cover the important aspects of SLE and the 4 core areas of disease impact according to OMERACT framework. The 25 candidate domains constitute a feasible and manageable number of domains to proceed with to the core domain consensus stage that covers the wide range of impact of SLE. The candidate domains will be supplemented by ongoing qualitative research with patients living with SLE to identify additional domains before proceeding to the consensus stage.

Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.

Address: Institute of Medical Science, University of Toronto, Toronto, Canada; Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Canada; University of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada.; Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Canada; University of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada.; Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Canada.; University Health Network, Toronto, ON, Canada.; Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.; SDG, LLC, Cambridge, MA, USA.; Centre for Inflammatory Disease, Monash University, Melbourne, Australia.; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore.; Division of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine TU Dresden, Dresden, Germany.; Department of Clinical and Experimental Medicine, University of Pisa, Italy.; Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, UK.; Patient Centered Outcomes Research, AbbVie, CA, USA.; Department of Medical Education-Basic Sciences, Loma Linda University School of Medicine, Loma Linda, CA, USA; Division of Rheumatology, Department of Medicine, University of California Riverside, Riverside, CA, USA; Global Development-Inflammation, Amgen, Inc, Thousand Oaks, CA, USA.; Division of Dermatology, University of Toronto, Toronto, Canada; Division of Dermatology, Toronto Western Hospital, Toronto, Canada.; Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden; Department of Gastroenterology, Dermatology and Rheumatology, Karolinska University Hospital, Stockholm, Sweden; Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.; Division of Rheumatology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.; Faculty of Design, OCAD University, Toronto, Ontario, Canada.; Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden; Swedish Rheumatism Association, Stockholm, Sweden.; Knowledge Synthesis Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Centre for Practice-Changing Research, 501 Smyth Road, Box 201, Ottawa, ON, K1H 8L6, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.; Division of Rheumatology, Department of Medicine, Cedars-Sinai, USA; David Geffen School of Medicine at UCLA, Cedars-Sinai Medical Center, Los Angeles, CA, USA.; Section of Rheumatology, Department of Medicine, University of Santo Tomas, Manila, Philippines.; Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases, Feinstein Institutes for Medical Research, Manhasset, NY, USA.; Section of Rheumatology and Gwen Knapp Center for Lupus and Immunology Research, University of Chicago, Chicago, IL, USA.; Rheumatology Unit, Meir Medical Center, Kfar Saba, Israel; Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.; Division of Rheumatology, Mayo Clinic, Rochester, MN, USA.; Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.; Grupo Peruano de Estudio de Enfermedades Autoinmunes Sistémicas. Universidad Cientifica del Sur, Lima, Perú; Rheumatology Department. Hospital Nacional Guillermo Almenara Irigoyen, EsSalud, Lima, Peru.; Grupo Oroño - Centro Regional de Enfermedades Autoinmunes y Reum´aticas (GO-CREAR), Rosario, Argentina.; Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.; The University of Sydney School of Public Health, Camperdown, NSW 2006, Australia.; Centre for Inflammatory Diseases, School of Clinical Sciences, Monash University, Melbourne, Australia.; Instituto Nacional de Ciencias M´edicas y Nutrici´on, M´exico City, Mexico.; Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 226014, India.; University of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada.; Department of Medicine, Tuen Mun Hospital, New Territories, Hong Kong, China.; Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, Japan.; Division of Rheumatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.; Division of Rheumatology, Department of Medicine, Dalhousie University, Halifax, NS B3H 4K4, Canada; Arthritis Research Canada, Vancouver, BC, Canada.; Department of Rheumatology, Hopitaux Universitaires de Strasbourg, INSERM UMR-S 1109, Centre National de Reference des Maladies Auto-immunes Systemiques Rares, France.; Department of Rheumatology, Amsterdam Rheumatology and immunology Center, Amsterdam University Medical Center, Amsterdam, the Netherlands.; Department of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.; Biobizkaia Health Research Institute, University of the Basque Country, Bizkaia, Spain.; Department of Rheumatology, Centro Hospitalar e Universitario de Coimbra, Unidade Local de Saúde de Coimbra, Coimbra, Portugal; School of Health Sciences, Universidade da Beira Interior, Covilha, Portugal.; Department of Orthopedics, Rheumatology and Traumatology, School of Medical Science, University of Campinas, Campinas, S˜ao Paulo, 13083881, Brazil.; Division of Rheumatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.; Division of Rheumatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.; Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.; Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Canada; Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, UK.; Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.; Rheumatology Department, Hospital Clínic, Barcelona, Spain.; Department of Dermatology, University of Pennsylvania Perelman School of Medicine and Philadelphia VA Medical Center, Philadelphia, USA.; Professor of Medicine and Health Policy, Division of Rheumatology, Department of Medicine, UCSF, Philip R. Lee Institute for Health Policy Studies, USA.; Columbia University Medical Center, New York City, NY, USA.; Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada; Centre for Addiction and Mental Health, Toronto, Canada; Centre for Mental Health, University Health Network, Toronto, Canada.; Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Canada; Division of Rheumatology, Department of Medicine, University of Toronto, Toronto Western Hospital, Toronto, ON, Canada.; Division of Dermatology, Department of Medicine, University of Toronto and Women's College Hospital, Toronto, Ontario, Canada.; Restore Lab, Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, ON M5G 1V7, Canada.; Institute of Medical Science, University of Toronto, Toronto, Canada; Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Canada; University of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada. Electronic address: [email protected].
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