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  • Among the participants in our

    2018-11-09

    Among the 1303 participants in our study, 74% (n=964) reported xerostomia (Table 2). Xerostomia prevalence was highest among SS participants (87.4%, 95% CI: 84.8%–89.8%) followed by Sicca participants (72.4%, 95% CI: 67.4%–77.0%) and the ISS group (38.1%, 95% CI: 32.0%–44.4%). The absolute difference in xerostomia prevalence between SS and Sicca participants was significant (15.0%, 95% CI: 9.8%–20.3%, p<0.001) as was the absolute difference in prevalence between SS and ISS participants (49.4%, 95% CI: 42.9%–55.9%, p<0.001). The sensitivity of xerostomia for detecting SS among high-risk participants was 87.4% (95% CI: 84.8%–89.8%) and specificity was 41.7% (95% CI: 37.7%–45.7%) (Table 2A). SS participants were 50% more likely to have xerostomia compared to other high risk participants, namely Sicca and ISS (LR+=1.50, 95% CI: 1.39–1.61). Moreover, SS participants were 70% less likely to be without xerostomia compared to other high risk participants (LR−=0.30, 95% CI: 0.24–0.37). Further, SS participants had a 5-fold higher risk of xerostomia compared to other high-risk participants (OR=4.98, 95% CI: 3.78–6.56). Consequently, a participant with salivary gland dysfunction presenting with xerostomia is 5 times more likely to have SS than Sicca or ISS. The positive predictive value (PPV) and negative predictive value (NPV) of xerostomia indicate that levels of a high-risk participant with xerostomia has a 64% chance of having SS, and if without xerostomia, has a 74% chance of not having SS. Unlike xerostomia which is subjective, hyposalivation is a quantifiable measure. Test diagnostics indicated the sensitivity of WUS for detecting SS was 63.8% (95% CI: 56.3%–70.9%) while the specificity was 51.3% (95% CI: 43.1%–59.4%). The OR, PPV, and NPV test statistics for WUS in detecting SS were lower compared to those of xerostomia. Although SS participants were 50% more likely to have xerostomia compared to other high-risk participants, WUS as a screening test was unable to differentiate between SS and Sicca (overlapping 95% CIs, Table 2A) and test diagnostics for ISS were low. For IUS, sensitivity was 76% and specificity was 46.9% for detecting SS and SS participants were nearly 3 times more likely to have xerostomia compared to other high-risk groups (OR=2.80, 95% CI: 2.17–3.62). The inability of WUS to distinguish between SS and Sicca demonstrated by test diagnostics was corroborated by the non-statistically significant difference in median WUS between the SS and Sicca groups (Figs. 2, 3). As the test diagnostics of IUS were better than that of WUS, we also found that the median IUS was significantly different among all 3 high-risk groups. The SS group had the lowest median IUS and TSS compared to Sicca and ISS groups. Correlations between WUS, levels of IUS, TSS, and Xerostomia are shown in Table 2B. In the overall pool of high-risk participants, both unstimulated and stimulated salivary flow rates were negatively correlated with xerostomia, with WUS possessing the strongest point-biserial correlation coefficient compared to IUS and TSS (−0.49, −0.42, −0.21 respectively, p-value<0.001, without outliers). However, when stratified by high-risk groups, WUS was only significantly correlated with xerostomia in SS and Sicca groups, while IUS was significantly correlated with xerostomia in all three groups. Correlation of TSS with xerostomia was only noted in the SS group, and was weaker than that of WUS and IUS. Correlation coefficients are influenced by outliers, yielding weak correlations. In this analysis, even with the removal of outliers salivary flow rates remained weakly correlated with xerostomia in all three high-risk groups. Table 3 compares the phenotypic characteristics of those with and without xerostomia. Compared to SS participants without xerostomia (SS+X−), SS participants with xerostomia (SS+X+) had a significantly higher proportion of reporting ocular dryness lasting >3months, hyposalivation with respect to both unstimulated and stimulated salivary flow rates, and salivary gland swelling. Although subjective ocular dryness was significantly different, the proportion of objective ocular signs was similar between subgroups. In addition, though the proportion of hyposalivation (IUS, TSS) was higher in SS+X+ subgroup, the proportions of positive focus scores (≥1 per 4mm2) and autoantibodies SSA/SSB were not different between subgroups. Diabetes mellitus, thyroid disease, and other autoimmune disorders and extraglandular manifestations such as fatigue, anxiety, and pain were comparable between subgroups. Potential confounders such as cigarette smoking, alcohol intake and caffeine intake were similar in both subgroups. Various classes of medications were also similar between subgroups. Among Sicca participants, the proportions of symptomatic dry eye, salivary gland pain, thyroid disease, and caffeine intake were significantly higher among those with xerostomia than those without. Among ISS participants, the proportions of symptomatic dry eye and thyroid disease were significantly higher among those with xerostomia than those without.