1. The 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria.
- Author
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Barbhaiya, Medha, Zuily, Stephane, Naden, Ray, Hendry, Alison, Manneville, Florian, Amigo, Mary‐Carmen, Amoura, Zahir, Andrade, Danieli, Andreoli, Laura, Artim‐Esen, Bahar, Atsumi, Tatsuya, Avcin, Tadej, Belmont, H. Michael, Bertolaccini, Maria Laura, Branch, D. Ware, Carvalheiras, Graziela, Casini, Alessandro, Cervera, Ricard, Cohen, Hannah, and Costedoat‐Chalumeau, Nathalie
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AUTOANTIBODY analysis , *CONSENSUS (Social sciences) , *IMMUNOGLOBULINS , *ANTIPHOSPHOLIPID syndrome , *DECISION making , *THROMBOEMBOLISM , *ENZYME-linked immunosorbent assay , *HEALTH care teams , *SENSITIVITY & specificity (Statistics) , *DELPHI method - Abstract
Objective: To develop new antiphospholipid syndrome (APS) classification criteria with high specificity for use in observational studies and trials, jointly supported by the American College of Rheumatology (ACR) and EULAR. Methods: This international multidisciplinary initiative included 4 phases: 1) Phase I, criteria generation by surveys and literature review; 2) Phase II, criteria reduction by modified Delphi and nominal group technique exercises; 3) Phase III, criteria definition, further reduction with the guidance of real‐world patient scenarios, and weighting via consensus‐based multicriteria decision analysis, and threshold identification; and 4) Phase IV, validation using independent adjudicators' consensus as the gold standard. Results: The 2023 ACR/EULAR APS classification criteria include an entry criterion of at least one positive antiphospholipid antibody (aPL) test within 3 years of identification of an aPL‐associated clinical criterion, followed by additive weighted criteria (score range 1–7 points each) clustered into 6 clinical domains (macrovascular venous thromboembolism, macrovascular arterial thrombosis, microvascular, obstetric, cardiac valve, and hematologic) and 2 laboratory domains (lupus anticoagulant functional coagulation assays, and solid‐phase enzyme‐linked immunosorbent assays for IgG/IgM anticardiolipin and/or IgG/IgM anti–β2‐glycoprotein I antibodies). Patients accumulating at least 3 points each from the clinical and laboratory domains are classified as having APS. In the validation cohort, the new APS criteria versus the 2006 revised Sapporo classification criteria had a specificity of 99% versus 86%, and a sensitivity of 84% versus 99%. Conclusion: These new ACR/EULAR APS classification criteria were developed using rigorous methodology with multidisciplinary international input. Hierarchically clustered, weighted, and risk‐stratified criteria reflect the current thinking about APS, providing high specificity and a strong foundation for future APS research. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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