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.
Wils Nielsen 1, Fadi Kharouf 2, Carolina Munoz Grajales 2, Aarabi Thayaparan 3, Melanie Anderson 4, Vibeke Strand 5, Lee Simon 6, Dennisse Bonilla 2, Eric Morand 7, Julian Thumboo 8, Martin Aringer 9, Marta Mosca 10, Ian Bruce 11, Elektra J Papadopoulos 12, Karina D Torralba 13, Laura Patricia Whitall-Garcia 2, Cheryl F Rosen 14, Ioannis Parodis 15, Alfred Kim 16, Maya Desai 17, Yvonne Enman 18, Beverley Shea 19, Daniel J Wallace 20, Yashaar Chaichian 5, Sandra Navarra 21, Cynthia Aranow 22, Meggan Mackay 23, Kimberly Trotter 23, Oshrat E Tayer-Shifman 24, Alí Duarte-García 25, Lai Shan Tam 26, Manuel F Ugarte-Gil 27, Guillermo J Pons-Estel 28, John A Reynolds 29, Mandana Nikpour 30, Alberta Hoi 31, Juanita Romero-Diaz 32, Amita Aggarwal 33, Danaë Papachristos 34, Chi Chiu Mok 35, Keishi Fujio 36, Rosalind Ramsey-Goldman 37, Alexandra Legge 38, Laurent Arnaud 39, Irene E M Bultink 40, Stephanie Finzel 41, Reinhard E Voll 41, Guillermo Ruiz-Irastorza 42, Luís Sousa Inês 43, Simone Appenzeller 44, Chrisanna Dobrowolski 45, Ann Elaine Clarke 46, Diane L Kamen 47, Michelle Barraclough 48, Chiara Tani 49, Jose A Gómez-Puerta 50, Victoria P Werth 51, Patti Katz 52, Anca D Askanase 53, Kathleen Bingham 54, Dafna D Gladman 3, Sindhu Johnson 55, Aaron Drucker 56, Behdin Nowrouzi-Kia 57, Zahi Touma 58; OMERACT SLE Working Group
Disease Category: Rheumatology
Disease Name: Systemic lupus erythematosus (SLE)
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Systematic review of qualitative research
- Systematic review
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.