@article{3047909, title = "Assessment of the European classification criteria for Sjogren's syndrome in a series of clinically defined cases: Results of a prospective multicentre study", author = "Vitali, C and Bombardieri, S and Moutsopoulos, HM and Coll, J and Gerli, and R and Hatron, PY and Kater, L and Konttinen, YT and Manthorpe, R and and Meyer, O and Mosca, M and Ostuni, P and Pellerito, RA and Pennec, Y and and Porter, SR and Richards, A and Sauvezie, B and Schiodt, M and Sciuto, M and and Shoenfeld, Y and Skopouli, FN and Smolen, JS and Soromenho, F and and Tishler, M and Tomsic, M and vandeMerwe, JPV and Yeoman, CM and and Wattiaux, MJ and Hitzelhammer, J and Petera, P and Hietanen, J and and Malmstrom, M and Youniou, P and Grossin, M and Kahn, MF and Ehrenfeld, M and and Ianniello, A and Sfriso, P and Ercolani, R and Muscat, C and and DeGiovanni, R and Rizzi, L and vandenHoogen, FHJ and Hoodkaas, H and and Kruize, AA and Alves, J and Presetnik, M and Rozman, B and Axell, T and and Larsson, A and Tabety, H and Maddison, PJ and Mutlu, S and Scully, C and and Franklin, CD and Nelson, M", journal = "Annals of the Rheumatic Diseases", year = "1996", volume = "55", number = "2", pages = "116-121", publisher = "BMJ Publishing Group", issn = "0003-4967, 1468-2060", doi = "10.1136/ard.55.2.116", abstract = "Objective-To assess the recently proposed preliminary criteria for the classification of Sjogren’s syndrome (SS) in a multicentre European study of a new series of clinically defined cases. Methods-The criteria included six items: I = ocular symptoms; II = oral symptoms; III = evidence of keratoconjunctivitis sicca; IV = focal sialoadenitis by minor salivary gland biopsy; V = instrumental evidence of salivary gland involvement; VI = presence of autoantibodies. Each centre was asked to provide five patients with primary SS, dive with secondary SS, five with connective tissue diseases (CTD) but without SS, and five controls (patients with ocular or oral features that may simulate SS). The preliminary six item classification criteria set was applied to both the SS patients and the non-SS controls, and the performance of the criteria in terms of sensitivity and specificity was tested. Results-The criteria set was tested on a total of 278 cases (157 SS patients and 121 non-SS controls) collected from 16 centres in 10 countries. At least four of the six items in the criteria set (Limiting item VI to the presence of Ro(SS-A) or La(SS-B) antibodies) were present in 79 of 81 patients initially classified as having primary SS (sensitivity 97.5%), but in only seven of 121 non-SS controls (specificity 94.2%). When the presence of item I or II plus any two of items III-V of the criteria set was considered as indicative of secondary SS, 97.3% (71 of 73) of the patients initially defined as having this disorder and 91.8% (45 of 49) of the control patients with CTD without SS were correctly classified. Conclusion-This prospective study confirmed the high validity and reliability of the classification criteria for SS recently proposed by the European Community Study Group." }