Rheumatology (Oxford). 2014 Jul 3. pii: keu271. [Epub ahead of print] Validation of the classification criteria for cryoglobulinaemic vasculitis. Quartuccio L1, Isola M1, Corazza L1, Ramos-Casals M1, Retamozo S1, Ragab GM1, Zoheir MN1, El-Menyawi MA1, Salem MN1, Sansonno D1, Ferraccioli G1, Gremese E1, Tzioufas A1, Voulgarelis M1, Vassilopoulos D1, Scarpato S1, Pipitone N1, Salvarani C1, Guillevin L1, Terrier B1, Cacoub P1, Filippini D1, Saccardo F1, Gabrielli A1, Fraticelli P1, Sebastiani M1, Tomsic M1, Tavoni A1, Mazzaro C1, Pioltelli P1, Nishimoto N1, Scaini P1, Zignego AL1, Ferri C1, Monti G1, Pietrogrande M1, Bombardieri S1, Galli M1, De Vita S2. Abstract OBJECTIVE: The aim of this study was to validate the classification criteria for cryoglobulinaemic vasculitis (CV). METHODS: Twenty-three centres were involved. New patients with CV (group A) and controls, i.e. subjects with serum cryoglobulins but lacking CV based on the gold standard of clinical judgment (group B) and subjects without cryoglobulins but with clinical features that can be observed in the course of CV (group C), were studied. Positivity of serum cryoglobulins was necessary for CV classification. Sensitivity and specificity of the criteria were calculated by comparing group A vs group B. The group A vs group C comparison was done to demonstrate the possible diagnostic utility of the criteria. RESULTS: The study included 268 patients in group A, 182 controls in group B and 193 controls in group C (small vessel vasculitis, 51.8%). The questionnaire (at least 2/3 positive answers) showed 89.0% sensitivity and 93.4% specificity; the clinical item (at least 3/4 clinical involvement) showed 75.7% sensitivity and 89.0% specificity and the laboratory item (at least 2/3 laboratory data) showed 80.2% sensitivity and 62.4% specificity. The sensitivity and specificity of the classification criteria (at least 2/3 positive items) were 89.9% and 93.5%, respectively. The comparison of group A with group C demonstrated the clinical utility of the criteria in differentiating CV from CV mimickers. CONCLUSION: Classification criteria for CV were validated in a second, large, international study confirming good sensitivity and specificity in a complex systemic disease.
Posted on: Wed, 09 Jul 2014 11:47:37 +0000
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