Francis I. Proctor Foundation, University of California San Francisco, San Francisco, CA.
Department of Ophthalmology, University of California San Francisco, San Francisco, California.
Cornea. 2020 Aug;39(8):1013-1016. doi: 10.1097/ICO.0000000000002311.
To evaluate the ocular signs and tests for keratoconjunctivitis sicca (KCS) in the absence of a gold standard.
Cross-sectional study of participants from the Sjögren's International Collaborative Clinical Alliance (SICCA) registry. Participants had oral/ocular/rheumatologic examinations, blood/saliva samples collected, and salivary gland biopsy. Latent class analysis (LCA) identified clusters of patients based on 3 to 4 predictor variables relating to signs or tests of KCS. The resulting model-based "gold standard" classification formed the basis for estimated sensitivity and specificity associated with these predictors.
A total of 3514 participants were enrolled into SICCA, with 52.9% classified as SS. LCA revealed a best-fit model with 2 groups. For the gold standard-positive group, an abnormal tear breakup time, ocular staining score (OSS), and Schirmer I had a sensitivity of 99.5%, 91.0%, and 47.4%, respectively. For the gold standard-negative group, an abnormal tear breakup time, OSS, and Schirmer I had a specificity of 32.0%, 84.0%, and 88.5%, respectively. OSS components (fluorescein and lissamine staining), exhibited a sensitivity of 82.6% and 90.5%, respectively, in the gold standard-positive group, whereas these signs in the gold standard-negative group had a specificity of 88.8% and 73.0%, respectively.
OSS and its components (fluorescein and lissamine staining) differentiated 2 groups from each other better than other KCS parameters and had relatively high sensitivity and specificity.
在缺乏金标准的情况下,评估干燥性角结膜炎(KCS)的眼部体征和检查。
对干燥综合征国际协作临床联盟(SICCA)登记处的参与者进行横断面研究。参与者接受了口腔/眼部/风湿病学检查、血液/唾液样本采集和唾液腺活检。潜在类别分析(LCA)根据与 KCS 的体征或检查相关的 3 到 4 个预测变量,对患者进行聚类。由此产生的基于模型的“金标准”分类为这些预测因子相关的估计敏感性和特异性提供了基础。
共有 3514 名参与者被纳入 SICCA,其中 52.9%被分类为 SS。LCA 显示出最佳拟合模型有 2 个组。对于金标准阳性组,异常泪膜破裂时间、眼染色评分(OSS)和 Schirmer I 的敏感性分别为 99.5%、91.0%和 47.4%。对于金标准阴性组,异常泪膜破裂时间、OSS 和 Schirmer I 的特异性分别为 32.0%、84.0%和 88.5%。OSS 成分(荧光素和丽丝胺染色)在金标准阳性组中的敏感性分别为 82.6%和 90.5%,而在金标准阴性组中的特异性分别为 88.8%和 73.0%。
OSS 及其成分(荧光素和丽丝胺染色)比其他 KCS 参数更好地将两组区分开来,具有相对较高的敏感性和特异性。