Objective To develop and validate an international set of classification criteria for primary Sjögren’s Syndrome (pSS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria target individuals with signs/symptoms suggestive of SS. Methods We assigned preliminary importance weights to a consensus list of candidate criteria items using multi-criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on pSS cases and non-SS controls, with case/non-case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients. Results The final classification criteria are based on the weighted sum of 5 items: anti-SSA(Ro) antibody positivity and focal lymphocytic sialadenitis with a focus score ≥ 1 foci/mm2, each scoring 3; an abnormal ocular staining score ≥ 5 (or van Bijsterveld score ≥ 4), a Schirmer test ≤ 5 mm/5 min, and an unstimulated salivary flow rate ≤ 0.1 mL/min, each scoring 1. Individuals (with signs/symptoms suggestive of SS) who have a total score ≥ 4 for the items above, meet the criteria for pSS. Sensitivity and specificity against clinician-expert derived case/non-case status in the final validation cohort were high: 96% (95% CI: 92%, 98%), and 95% (95% CI: 92%, 97%), respectively. Conclusion Using methodology consistent with other recent ACR/EULAR-approved classification criteria, we developed a single set of data-driven consensus classification criteria for pSS, that performed well in validation, and are well-suited as entry criteria for clinical trials.

Objectives We propose new classification criteria for Sjögren’s Syndrome (SS), which are needed considering the emergence of biological agents as potential treatments and their associated co-morbidity. These criteria target individuals with signs/symptoms suggestive of SS. Methods Criteria are based on expert opinion elicited using the Nominal Group Technique, and analyses of data from the Sjögren’s International Collaborative Clinical Alliance. Preliminary criteria validation included comparisons with classifications based on the American-European-Consensus-Group (AECG) criteria, a model-based “gold standard” obtained from Latent Class Analysis (LCA) of data from a range of diagnostic tests, and a comparison with cases and controls collected from sources external to the population used for criteria development Results Validation results indicate high levels of sensitivity and specificity for the criteria. Case definition requires at least 2 out of the following 3: Positive serum anti-SSA and/or anti-SSB or [positive rheumatoid factor and ANA ≥ 1:320]; Ocular staining score ≥ 3; Presence of focal lymphocytic sialadenitis with focus score ≥ 1 focus/4mm2 in labial salivary gland biopsies. Observed agreement with the AECG criteria is high when these are applied using all objective tests. However, AECG classification based on allowable substitutions of symptoms for objective tests results in poor agreement with the proposed and LCA-derived classifications. Conclusion These classification criteria developed from registry data collected using standardized measures are based on objective tests. Validation indicates improved classification performance relative to existing alternatives, making them more suitable for application in situations where misclassification may present health risks.

Using methodology consistent with other recent ACR/EULAR-approved classification criteria, we developed a single set of data-driven consensus classification criteria for primary SS, which performed well in validation analyses and are well suited as criteria for enrolment in clinical trials.

No abstract

No abstract

SummaryBackground-Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe.

Background Hepatitis C virus (HCV) infection, clearance and reinfection are best studied in injection drug users (IDU) who have the highest incidence and are representative of most infections. Methods A prospective cohort of HCV negative young IDU was followed from 2000 to 2007, to identify acute and incident HCV and prospectively study infection outcomes. Results Among 1,191 young IDU screened, 731 (61.4%) were HCV negative, and 520 (71.1%) were enrolled into follow-up. Cumulative HCV incidence was 26.7 per 100 person years of observation (PYO) (95% CI, 21.5, 31.6). 95 (70.4%) of 135 acute/incident HCV infections were followed; 21% cleared HCV. Women had a significantly higher incidence of viral clearance compared to men (age-adjusted relative hazard 2.91, 95% CI, 1.68, 5.03) and also showed a significantly faster rate of early HCV viremia decline. Estimated reinfection rate was 24.6 per 100 PYO (95% CI, 11.7, 51.6). Among seven individuals, multiple episodes of HCV reinfection and re-clearance were observed. Conclusions In this large sample of young IDU, females show demonstrative differences in their rates of viral clearance and kinetics of early viral decline. Recurring reinfection and re-clearance suggest possible protection against persistent infection. These results should inform HCV clinical care and vaccine development.

No abstract