Abstract
Purpose :
Making a definite diagnosis of primary Sjögren’s syndrome (pSS) is challenging as it has a diverse phenotypic expression. The aims of this study were to evaluate the most recent American College of Rheumatology (ACR, 2012) diagnostic criteria for pSS against the gold standard American-European Consensus Group (AECG, 2001) criteria and to correlate a range of objective and subjective clinical characteristics of pSS patients with quality of life (QOL) and disease evaluation tools, including the recently developed ESSDAI and ESSPRI disease indices.
Methods :
Twenty five consecutive patients attending the cornea clinic with a clinical diagnosis of pSS were assessed using the ACR and AECG criteria and those satisfying the diagnostic criteria underwent the following clinical evaluation: Schirmer’s I test, ocular surface staining (OSS), Tear break up time (TBUT); and the following disease activity indices and QOL questionnaires: OSDI, ESSDAI, ESSPRI, NEI-VFQ, and SF-36.
Results :
Twenty patients satisfied the AECG diagnostic criteria and 19 patients satisfied the ACR criteria for pSS, giving a level of agreement of 88% between the two systems using kappa statistics. Strong correlation between 3 different OSS schemes was found with Pearson’s r ranging from 0.9 – 0.99 (p<0.01). OSDI scores showed moderate to strong correlations with OSS scores for all 3 schemes with Spearman r 0.52 to 0.57 (p<0.01) but no significant correlation with the other clinical measurements or ESSDAI and ESSPRI values. Strong correlation between visual role functioning on the NEI-VFQ with the ESSDAI and OSDI was found. Role limitations due to physical problems and general health perception were significantly worse than the general population as determined by the SF-36, with strong correlations between ESSPRI and all of the SF-36 domains (p<0.01).
Conclusions :
The recently developed and simplified ACR diagnostic criteria for pSS are valid and accurate for this purpose when compared to the gold standard AECD criteria. The subjective OSDI assessment correlates highly with objective measures of OSS, and with the visual function subscales of the NEI-VFQ, thus validating its use in pSS. QOL and disease activity tools are useful methods for measuring and understanding the true impact of pSS on patient well-being and health-related quality of life to facilitate improved patient management.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.