Towards a minimal core dataset for systemic lupus erythematosus studies

Stephen McDonald; Jialin Teng; Chengde Yang; Michelle Barraclough; Graciela S Alarcon; Anca D Askanase; Sasha Bernatsky; Ann Elaine Clarke; Nathalie Costedoat-Chalumeau; Qiang Fu; Dafna D Gladman; John G Hanly; Alexandra C Legge; David Isenberg; Kenneth Kalunian; Diane L Kamen; Michelle A Petri; Anisur Rahman; Chuanyin Sun; Ting Li; Murray Urowitz; Alexandre Voskuyl; Daniel J Wallace; Juan Zhang; Ian N Bruce

doi:10.1136/lupus-2025-001595

Towards a minimal core dataset for systemic lupus erythematosus studies

Lupus Sci Med. 2025 Sep 22;12(2):e001595. doi: 10.1136/lupus-2025-001595.

Authors

Stephen McDonald^{1

2}, Jialin Teng^{1

3}, Chengde Yang⁴, Michelle Barraclough⁵, Graciela S Alarcon^{6

7}, Anca D Askanase⁸, Sasha Bernatsky⁹, Ann Elaine Clarke¹⁰, Nathalie Costedoat-Chalumeau¹¹, Qiang Fu¹², Dafna D Gladman^{13

14}, John G Hanly¹⁵, Alexandra C Legge¹⁵, David Isenberg¹⁶, Kenneth Kalunian¹⁷, Diane L Kamen¹⁸, Michelle A Petri¹⁹, Anisur Rahman¹⁶, Chuanyin Sun²⁰, Ting Li²¹, Murray Urowitz^{22

23}, Alexandre Voskuyl²⁴, Daniel J Wallace²⁵, Juan Zhang²⁶, Ian N Bruce^{27

28}

Affiliations

¹ NIHR Manchester Biomedical Research Centre, Manchester Foundation Trust, Manchester Royal Infirmary Kellgren Centre for Rheumatology, Manchester, UK.
² Rheumatology, HSC Western Health and Social Care Trust, Londonderry, UK.
³ School of Medicine, Department of Rheumatology and Immunology, Shanghai Jiao Tong University, Shanghai, China.
⁴ Rheumatology and Immunology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, China.
⁵ Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
⁶ Marnix E Heersink School of Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
⁷ Universidad Peruana Cayetano Heredia, Lima District, Peru.
⁸ Division of Rheumatology, Columbia University Irving Medical Center, New York City, New York, USA.
⁹ Division of Rheumatology and Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
¹⁰ Division of Rheumatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
¹¹ Service de Médecine Interne, Centre de référence des maladies auto-immunes et auto-inflammatoires systémiques rares d'Ile-de-France, de l'Est et de l'Ouest, Hopital Cochin, Paris, France.
¹² The First Affiliated Hospital of Nanchang Medical College, Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China.
¹³ Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁴ Schroeder Arthritis Institute, Krembil Research Institute, Toronto, Ontario, Canada.
¹⁵ Division of Rheumatology, Department of Medicine, Queen Elizabeth II Science Centre & Dalhousie Univeristy, Halifax, Nova Scotia, Canada.
¹⁶ Centre for Rheumatology, University College London, London, UK.
¹⁷ San Diego School of Medicine, Division of Rheumatology, Autoimmunity and Inflammation, University of California San Diego, La Jolla, California, USA.
¹⁸ Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
¹⁹ Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
²⁰ Department of Rheumatology, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
²¹ Department of Rheumatology, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
²² Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
²³ Schroeder Arthritis Institute, Toronto Western Hospital, Toronto, Ontario, Canada.
²⁴ Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.
²⁵ Rheumatology, Cedars-Sinai Medical Center, West Hollywood, California, USA.
²⁶ Department of Rheumatology, Lanzhou University Second Hospital, Lanzhou, Gansu, China.
²⁷ Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK ian.bruce@manchester.ac.uk.
²⁸ Faculty of Medicine, Health and Life Sciences, Queen's University Belfast, Belfast, UK.

Abstract

Objective: SLE is a complex, heterogenous autoimmune disease. SLE researchers do not always collect the same data, making comparative studies difficult. We aimed to ascertain what variables SLE clinical researchers commonly collect for SLE research. Our ultimate goal is to generate a minimal core dataset for future SLE studies.

Methods: In 2020, we designed and distributed a questionnaire to members of the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) as well as additional active research centres in China. Our survey included 26 questions about the types of data that are routinely collected for research. Variables collected by ≥75% of participating respondents were used as a threshold for inclusion.

Results: 18 of 36 invited respondents replied (8 from USA/Canada, 5 from China and 5 from Europe). Many key variables in the domains of sociodemographics, SLE specific, comorbidities, baseline haematology/biochemistry/immunology and treatment data were collected by ≥75% respondents including the 1997 American College of Rheumatology (ACR) Classification Criteria (83%), SLE Disease Activity Index-2000 (82%), current treatment (100%), drug name, dose, frequency and start date (75-100%) and complement C3/4 (94%). A range of other items was collected by 50-<75% of respondents including SLICC 2012 Criteria (67%), SLICC/ACR Damage Index (68%) and Short Form Health Survey-36 (53%). Less than 50% of respondents collect certain items including European Alliance of Associations for Rheumatology/ACR 2019 criteria (33%), British Isles Lupus Assessment Group scores (12%) and pneumococcal vaccine status (39%).

Conclusions: The frequency with which an initial set of variables is collected in SLE cohorts globally was identified and can form the basis from which to develop a core minimum dataset for SLE. Further refinement and common definitions will be needed to finalise a minimal core dataset suitable for widespread use.

Keywords: Clinical Trial; Lupus Erythematosus, Systemic; Lupus Nephritis.

MeSH terms

Adult
Biomedical Research*
Canada
China
Datasets as Topic*
Europe
Female
Humans
Lupus Erythematosus, Systemic* / diagnosis
Male
Middle Aged
Surveys and Questionnaires
United States

Abstract

MeSH terms

Grants and funding