Background/Purpose: Systemic lupus erythematosus (SLE) is clinically heterogeneous. ACR and/or SLICC classification criteria provide homogeneous populations for research purposes, but studies differ in selection and exclusion criteria and in definitions of SLE. We examine recent publications to determine how consistently they characterize SLE patients.

Methods: We reviewed English-language studies, using “systemic lupus erythematosus” as the search term, and filtering for full text availability, publication dates 4/2//2013-4/2/2018, and human. We excluded reviews, letters, and papers from <2 impact factor journals and/or irrelevant to the question and classified papers as translational if they examined pathophysiology or biological factors that lead to treatment interventions or clinical/epidemiological if patients or populations were studied. We evaluated these papers for inclusion and exclusion criteria, disease activity, overlap syndrome (SLE coexisting with another rheumatic illness), disease stability (defined as no change in treatment regimen for a specified duration), diagnostic antibody status (including antinuclear (ANA), anti-double stranded DNA (anti-dsDNA) and/or anti-Smith (anti-Sm) antibodies), and disease duration.

Results: 402 of 732 papers were suitable for analysis, of which 80 were translational and 322 clinical/epidemiological. 71% of translational studies and 66% of clinical/epidemiological studies used only ACR and/or SLICC classification criteria to define SLE, of which only 9% of translational and 7% of clinical/epidemiological studies specified requirement for both ACR and/or SLICC criteria and diagnostic antibodies. 30% of clinical/epidemiological and only 16% of translational studies specified exclusion criteria. Of the 402 studies overall, only 6% specified exclusion of patients with overlap syndrome, 14% specified disease activity using either SLEDAI score or BILAG index, and 8% specified disease stability. 2% of clinical/epidemiological studies, but no translational studies, specified disease duration.

Conclusion: Although translational and clinical/epidemiological studies all use the term SLE, only 67% specify use of ACR and/or SLICC criteria, 27% specify exclusion criteria; ≤15% of both types of studies exclude patients with overlap syndromes, specify SLE-specific autoantibodies, disease activity, or duration. Improved consistency in the use of these study characteristics might better standardize current literature on SLE.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/how-consistently-do-publications-define-sle-a-systematic-review/