Purpose: To validate the international chronic ocular graft-versus-host disease (GVHD) diagnostic criteria (ICCGVHD) compared to the National Institute of Health diagnostic criteria 2014 (NIH2014) for chronic ocular GVHD. Methods: Between 2013 and 2019, the study enrolled 233 patients with or without chronic ocular GVHD combined with the presence or absence of systemic chronic GVHD in an internationally prospective multicenter and observational cohort from 9 institutions. All patients were evaluated for four clinical parameters of ICCGVHD. Results: The relation between the ICCGVHD score (0-11) and NIH2014 eye score (0–4) was relatively high (r = 0.708, 95% CI: 0.637–0.767, p < 0.001). The sensitivity and specificity of ICCGVHD for NIH 2014 for 233 patients were 94.3% (95% CI: 89.6%–98.1%) and 71.7% (95% CI: 63.0–79.5%), respectively (cutoff value of the ICCGVHD score = 6). The positive predictive value was 77.1% (95% CI: 71.1%–82.1%), and the negative predictive value was 87.0% (95% CI:81.6–92.5%). For the patients with systemic GVHD (n = 171), the sensitivity and specificity were 94.2% and 67.2%, respectively (ICCGVHD-score cutoff value = 6). By receiver operating characteristic (ROC) curve analysis, the area under the curve (AUC) was 0.903 (95% CI: 0.859–0.948). For patients without systemic GVHD (n = 62), the sensitivity and specificity were 100% and 76.7%, respectively (ICCGVHD-score cutoff value = 6). The AUC was 0.891 (95% CI 0.673–1.000). Conclusions: Good sensitivity, specificity, predictive value and correlation were found between ICCGVHD and NIH2014. ICCGVHD scores ≥6 can be useful to diagnose ocular GVHD with or without systemic GVHD for clinical research.
|Number of pages||9|
|Publication status||Published - 2022 Oct|
Bibliographical noteFunding Information:
This research was supported by the grant for Global Clinical Research Center Program at Keio University from the Japanese Ministry of Health , Labor, and Welfare 2011, Japanese Ministry of Education , Science, Sports, and Culture, to Y.O.
E.M.R. has a patent in Brazil (Patent: PI 0401186-4, title: "Formulation of Insulin eye drop for dry eye”, application number: PI 0401186-4, published in Revista de Propriedade Industrial 2356 on March 01, 2016, and patent application number: BR102015005856-0, title:”Microparticles of insulin, method of production and ophthalmic composition and use”. E.M.R. receive research grant form the Brazilian National Council for Scientific and Technological Development (CNPq) number: 1C 302355/2017-0.
E.S. has grant from Japanese Ministry of Education, Science, Sports, and Culture 21K18394 and the Bristol Myers Squibb. The other authors received no financial support or other supportedthe authors have no financial interests that may create a potential conflict or the appearance of conflict of interest regarding this work.
M.A. receives research grant from FAPESP number: 2021/04045-5.
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