Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria |
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| Affiliation: | 1. Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan;2. Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Massachusetts, USA;3. Department of Ophthalmology & Visual Science, University of Texas Health Science Center, Texas, USA;4. MD Anderson Cancer Center, Texas, USA;5. Department of Ophthalmology and Visual Sciences, Illinois University Chicago, Illinois, USA;6. Department of Ophthalmology, Bascom Parmer Institute, Miami, USA;7. Department of Ophthalmology, Duke University, North Carolina, USA;8. Department of Ophthalmology, National Institute of Health, Maryland, USA;9. Department of Ophthalmology, School of Medical Sciences University of Campinas, Campinas, Brazil;10. Department of Ophthalmology, Ribeirao Preto Medical School, Sao Paulo, Brazil;11. Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea;12. Department of Ophthalmology, Fudan University, Eye and ENT Hospital, Shanghai, China;13. Department of Ophthalmology, Mayo Clinic, Arizona, USA;14. Department of Ophthalmology, Seoul National University College of Medicine, Seoul, South Korea;15. Dr R P Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi, India;p. Department of Ophthalmology & Visual Science, Yeouido St. Mary''s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea;q. Department of Ophthalmology, University of Utrecht, Utrecht, the Netherlands;r. Department of Ophthalmology, Weill Cornell Medical School, New York, New York, USA;s. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA;t. Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan;u. Department of Ophthalmology, Baylor College of Medicine, Houston, Texas, USA;v. Tsubota Laboratory, Inc., Tokyo, Japan;1. University of Houston, College of Optometry, Houston, TX, 77204, USA;2. Department of Applied Sciences, Northumbria University, Newcastle Upon Tyne, NE1 8ST, UK;1. Department of Ophthalmology, Prince of Wales Hospital, Randwick, Australia;2. Faculty of Medicine, University of New South Wales, Kensington, Australia;3. University of Sydney Medical School, University of Sydney, Camperdown, Australia |
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| Abstract: | PurposeTo 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.MethodsBetween 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.ResultsThe 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).ConclusionsGood 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. |
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| Keywords: | Dry eye disease Chronic ocular graft-versus-host disease International chronic ocular GVHD consensus Criteria NIH diagnostic Criteria 2014 |
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