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Barbhaiya, M; Zuily, S; Naden, R; Hendry, A; Manneville, F; Amigo, MC; Amoura, Z; Andrade, D; Andreoli, L; Artim-Esen, B; Atsumi, T; Avcin, T; Belmont, HM; Bertolaccini, ML; Branch, DW; Carvalheiras, G; Casini, A; Cervera, R; Cohen, H; Costedoat-Chalumeau, N; Crowther, M; de, Jesus, G; Delluc, A; Desai, S; De, Sancho, M; Devreese, KM; Diz-Kucukkaya, R; Duarte-Garcia, A; Frances, C; Garcia, D; Gris, JC; Jordan, N; Leaf, RK; Kello, N; Knight, JS; Laskin, C; Lee, AI; Legault, K; Levine, SR; Levy, RA; Limper, M; Lockshin, MD; Mayer-Pickel, K; Musial, J; Meroni, PL; Orsolini, G; Ortel, TL; Pengo, V; Petri, M; Pons-Estel, G; Gomez-Puerta, JA; Raimboug, Q; Roubey, R; Sanna, G; Seshan, SV; Sciascia, S; Tektonidou, MG; Tincani, A; Wahl, D; Willis, R; Yelnik, C; Zuily, C; Guillemin, F; Costenbader, K; Erkan, D, , ACR/EULAR, APS, Classification, Criteria, Collaborators.
The 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria.
Arthritis Rheumatol. 2023; 75(10):1687-1702
Doi: 10.1002/art.42624
Web of Science
PubMed
FullText
FullText_MUG
- Co-Autor*innen der Med Uni Graz
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Mayer-Pickel Karoline Ilse
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- 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.
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