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Abstract Number: 0644

Scoping Literature Review to Identify Candidate Domains for the SLE OMERACT Core Outcome Set

Wils Nielsen1, Fadi Kharouf2, Carolina Munoz-Grajales3, Aarabi Thayaparan4, Melanie Anderson5, Lee Simon6, Maya Desai7, Ioannis Parodis8, Alfred Kim9, Yvonne Enman10, Kathleen Bingham11, Dennisse Bonilla11, Julian Thumboo12, Marta Mosca13, Martin Aringer14, Eric Morand15, Ian Bruce16, Vibeke Strand17 and Zahi Touma4, 1University of Toronto, Markham, ON, Canada, 2University Health Network and University of Toronto, Toronto, ON, Canada, Toronto, ON, Canada, 3UHN/TWH, Toronto, ON, Canada, 4University of Toronto, Toronto, ON, Canada, 5The Institute for Education Research, Library and Information Services, University Health Network, Toronto, ON, Canada, 6SDG LLC, West Newton, MA, 7Ontario College of Art and Design University, Toronto, ON, Canada, 8Karolinska Institutet, Karolinska University Hospital; Örebro University, Solna, Sweden, 9Washington University School of Medicine, Division of Rheumatology, Department of Medicine, St Louis, MO, 10Karolinska Institutet, Stockholm, Sweden, 11University Health Network, Toronto, ON, Canada, 12Singapore General Hospital, Singapore, Singapore, 13University of Pisa, Department of Clinical and Experimental Medicine - Rheumatology Unit, Pisa, Italy, 14University Medical Center and Faculty of Medicine TU Dresden, Dresden, Germany, 15School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, 16Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, United Kingdom, 17Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA

Meeting: ACR Convergence 2024

Keywords: , , ,

Session Information

Date: Saturday, November 16, 2024

Title: SLE – Diagnosis, Manifestations, & Outcomes Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: The Outcome Measures in Rheumatology (OMERACT) Systemic Lupus Erythematosus (SLE) Working Group was re-established in 2018 to update the SLE Core Outcome Set (COS) and includes over 260 members representing 6 continents and over 30 countries. A COS is a fundamental list of outcomes to standardize the measurement and reporting of domains/outcomes in SLE trials. The first SLE COS was developed in 1998, thus there is a need to update the SLE COS. Three years ago, the OMERACT SLE Working Group embarked on multiple projects to generate an extensive list of potential candidate domains to be included in the SLE COS. In this study, we specifically report on the scoping literature review results.

Methods: Scoping Review: We searched 5 databases (Medline, Embase, Cochrane, CINALH, PsycINFO) for SLE systematic reviews and clinical trials since 2010. 3 reviewers performed an agreement test on 100 articles for title and abstract screening using Covidence with a 98% agreement. Due to the large volume of studies, the 1st screening of title and abstract was conducted by a single reviewer. A 2nd agreement test on 100 articles was performed for full-text screening with the same reviewers with a 99% agreement. The 2nd screening of full-texts and data extraction of domain items consisted of 2 reviewers per article.

Advisory Group: An advisory group was established with OMERACT SLE Working Group Steering Committee members, Patient Research Partners, and additional SLE Expert Collaborators. This group reviewed all domain items generated from the scoping literature review, winnowing any domain items deemed too broad, narrow, multivariable, non-specific, or contextual factors, and binning the remaining domain items into preliminary candidate domains.

Results: The scoping literature review search yielded 4033 articles which title and abstract screening reduced to 605 (Figure 1). Article retrieval and full-text review further reduced the number of articles to 437. All domain items were extracted and winnowed and binned along with the results of other domain generation projects into 25 preliminary candidate domains. Related themes/domains were grouped and contextual factors were removed yielding a preliminary list of 25 domains (Table 1).

Conclusion: This scoping review identified multiple domain items expanding the list of preliminary candidate domains to 25. Future steps for SLE COS development include further generation of potential domains from qualitative research, to be followed by definition development for candidate domains in preparation for the final step in domain selection – the Delphi consensus exercise to vote on the final SLE COS.

Supporting image 1

Figure 1. PRISMA flow diagram of scoping literature review search strategy.

Supporting image 2

Disclosures: W. Nielsen: None; F. Kharouf: None; C. Munoz-Grajales: None; A. Thayaparan: None; M. Anderson: None; L. Simon: None; M. Desai: None; I. Parodis: Amgen, 5, 6, AstraZeneca, 1, 2, 6, Aurinia, 1, 5, 6, Bristol-Myers Squibb(BMS), 2, 5, Eli Lilly, 5, GlaxoSmithKlein(GSK), 1, 2, 5, 6, Janssen, 2, 6, Novartis, 1, 2, Otsuka Pharma, 1, 2, 5, 6, Roche, 2, 5, 6; A. Kim: Amgen, 2, ANI Pharmaceuticals, 2, AstraZeneca, 5, Atara Bio, 2, Aurinia Pharmaceuticals, 2, Cargo Therpeutics, 2, Exagen Diagnostics, 2, 6, GSK, 2, 5, 6, Kypha, 2, 4, 10, Miltenyi Biotech, 2, Novartis, 5, Pfizer, 2, Synthekine, 2, Techtonic Therapeutics, 2, The Rheumatology Education Group, 6; Y. Enman: None; K. Bingham: None; D. Bonilla: None; J. Thumboo: None; M. Mosca: AbbVie, 2, 6, AstraZeneca, 2, 6, GSK, 2, 5, 6, Idorsia, 2, Janssen, 6, Lilly, 6, Otsuka, 2, 6, UCB, 2; M. Aringer: GlaxoSmithKlein(GSK), 1, 6; E. Morand: AbbVie, 5, Amgen, 5, AstraZeneca, 1, 2, 5, 6, Biogen, 2, 5, Bristol Myers Squibb, 2, 5, Dragonfly, 2, Eli Lilly, 5, EMD Serono, 2, 5, Genentech, 2, 5, Gilead, 2, GSK, 2, 5, Janssen, 5, Novartis, 2, 5, RemeGen, 2, Roche, 5, 6, Takeda, 2, 5, UCB, 5, Zenas, 2; I. Bruce: AstraZeneca, GSK and UCB, 6, Genzyme/Sanofi, GSK, Roche, Novartis, Janssen, UCB, 5; V. Strand: AbbVie, 1, 2, Alpine Immune Sciences, 1, 2, Alumis, 1, 2, Amgen, 1, 2, AstraZeneca, 1, 2, Bayer, 1, 2, Blackrock Pharmaceuticals, 1, 2, Boehringer Ingelheim, 1, 2, Bristol Myers Squibb, 1, 2, Celltrion, 1, 2, Citryll, 1, 2, Contura, 1, 2, Equillium, 1, 2, Fortress Biotech, 1, 2, Genentech/Roche, 1, 2, GSK, 1, 2, Inmedix, 1, 2, Janssen, 1, 2, Kiniksa, 1, 2, Lilly, 1, 2, Novartis, 1, 2, Omeros, 1, 2, Pfizer, 1, 2, Priovant Therapeutics, 1, 2, Rapt Therapeutics, 1, 2, Regeneron, 1, 2, R-Pharm, 1, 2, Samsung, 1, 2, Sandoz, 1, 2, Sanofi, 1, 2, Scipher, 1, 2, SetPoint Medical, 1, 2, Sobi, 1, 2, Spherix, 1, 2, SynAct Pharma, 1, 2, Takeda Pharmaceuticals, 1, 2; Z. Touma: None.

To cite this abstract in AMA style:

Nielsen W, Kharouf F, Munoz-Grajales C, Thayaparan A, Anderson M, Simon L, Desai M, Parodis I, Kim A, Enman Y, Bingham K, Bonilla D, Thumboo J, Mosca M, Aringer M, Morand E, Bruce I, Strand V, Touma Z. Scoping Literature Review to Identify Candidate Domains for the SLE OMERACT Core Outcome Set [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/scoping-literature-review-to-identify-candidate-domains-for-the-sle-omeract-core-outcome-set/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/scoping-literature-review-to-identify-candidate-domains-for-the-sle-omeract-core-outcome-set/