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2019 OMIG Abstract

Ocular Clinical Signs and Diagnostic Tests Most Compatible with Keratoconjunctivitis Sicca: A Latent Class Approach

John A. Gonzales, MD^1,2, Stephen C. Shiboski³, Vatinee Y. Bunya⁴, Esen K. Akpek^5,6,
Jennifer Rose-Nussbaumer^1,7, Gerami Seitzman, MD^1,2, Lindsey A. Criswell^8,9,
Caroline H. Shiboski⁹, Thomas M. Lietman^1,2
1Francis I. Proctor Foundation, University of California, San Francisco; ²Department of Ophthalmology, University of California, San Francisco; ³Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA; ⁴Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania; ⁵Ocular Surface Diseases and Dry Eye Clinic, The Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD; ⁶The Johns Hopkins Jerome L. Greene Sjögren's Syndrome Center, Baltimore, MD, sup>7Kaiser Permanente, Redwood City, CA; ⁸Department of Medicine, University of California, San Francisco, ⁹Department of Orofocial Sciences, School of Dentistry, University of California, San Francisco, San Francisco, CA

Design: Cross-sectional study of participants enrolled into the Sjögren's International Collaborative Clinical Alliance (SICCA) registry from 9 international research sites.

Methods: At baseline, participants who met enrollment criteria had oral/ocular/rheumatologic examinations, blood and saliva samples collected, and labial salivary gland biopsy. We used latent class analysis to identify clusters of patients based on three to four predictor variables relating to the signs or tests of KCS. The resulting model-based "gold standard" classification formed the basis for estimated sensitivity and specificity associated with these predictors.

Results: A total of 3,514 participants from 9 international sites were enrolled into SICCA. Latent class analysis revealed a best fit model with two groups. For the gold standard positive group, an abnormal TBUT, OSS, and Schirmer 1 had a sensitivity of 99.5%, 91.0%, and 47.4%, respectively. In the gold standard negative group, an abnormal TBUT, OSS, and Schirmer 1 had a specificity of 32.0%, 84.0%, and 88.5%, respectively. OSS component parts (fluorescein staining of the cornea and lissamine staining of the conjunctiva), exhibited a sensitivity of 82.6% and 90.5%, respectively, in the gold standard positive group, while these signs in the gold standard negative group had a specificity of 88.8% and 73.0%, respectively.

Conclusion: The OSS differentiated two groups from each other better than other KCS parameters and had relatively high sensitivity and specificity.

Disclosure: S: JAG, VYB, CHS

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