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These criteria were developed for use in individuals with signs and\/or symptoms suggestive of SS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We assigned preliminary importance weights to a consensus list of candidate criteria items, using multi\u2010criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non\u2010SS controls, with case\/non\u2010case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The final classification criteria are based on the weighted sum of 5 items: anti\u2010SSA\/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of \u22651 foci\/4 mm\n                      <jats:sup>2<\/jats:sup>\n                      , each scoring 3; an abnormal ocular staining score of \u22655 (or van Bijsterveld score of \u22654), a Schirmer's test result of \u22645 mm\/5 minutes, and an unstimulated salivary flow rate of \u22640.1 ml\/minute, each scoring 1. Individuals with signs and\/or symptoms suggestive of SS who have a total score of \u22654 for the above items meet the criteria for primary SS. Sensitivity and specificity against clinician\u2010expert\u2013derived case\/non\u2010case status in the final validation cohort were high, i.e., 96% (95% confidence interval [95% CI] 92\u201398%) and 95% (95% CI 92\u201397%), respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Using methodology consistent with other recent ACR\/EULAR\u2010approved classification criteria, we developed a single set of data\u2010driven consensus classification criteria for primary SS, which performed well in validation analyses and are well\u2010suited as criteria for enrollment in clinical trials.<\/jats:p>\n                  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