Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria

Yoko Ogawa; Reza Dana; Stella Kim; Sandeep Jain; Mark I. Rosenblatt; Victor L. Perez; Janine A. Clayton; Monica Alves; Eduardo Melani Rocha; Francisco Amparo; Kyoung Yul Seo; Yan Wang; Joanne Shen; Joo Youn Oh; Murugesan Vanathi; Sridevi Nair; Kyung Sun Na; Anjo Riemens; Kimberly Sippel; Matias Soifer; Shudan Wang; Marilia Trindade; Mee Kum Kim; Chang Ho Yoon; Ryuichiro Yagi; Ryo Hiratsuka; Mamoru Ogawa; Eisuke Shimizu; Yasunori Sato; Stephen Pflugfelder; Kazuo Tsubota

doi:10.1016/j.jtos.2022.09.002

Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria

Yoko Ogawa, Reza Dana, Stella Kim, Sandeep Jain, Mark I. Rosenblatt, Victor L. Perez, Janine A. Clayton, Monica Alves, Eduardo Melani Rocha, Francisco Amparo, Kyoung Yul Seo, Yan Wang, Joanne Shen, Joo Youn Oh, Murugesan Vanathi, Sridevi Nair, Kyung Sun Na, Anjo Riemens, Kimberly Sippel, Matias SoiferShudan Wang, Marilia Trindade, Mee Kum Kim, Chang Ho Yoon, Ryuichiro Yagi, Ryo Hiratsuka, Mamoru Ogawa, Eisuke Shimizu, Yasunori Sato, Stephen Pflugfelder, Kazuo Tsubota

Department of Ophthalmology

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	200-208
Number of pages	9
Journal	Ocular Surface
Volume	26
DOIs	https://doi.org/10.1016/j.jtos.2022.09.002
Publication status	Published - 2022 Oct

Bibliographical note

Funding 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.

Funding Information:
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.

Funding Information:
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.

Funding Information:
M.A. receives research grant from FAPESP number: 2021/04045-5.

Publisher Copyright:
© 2022

All Science Journal Classification (ASJC) codes

Ophthalmology

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10.1016/j.jtos.2022.09.002

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Ogawa, Y., Dana, R., Kim, S., Jain, S., Rosenblatt, M. I., Perez, V. L., Clayton, J. A., Alves, M., Rocha, E. M., Amparo, F., Seo, K. Y., Wang, Y., Shen, J., Oh, J. Y., Vanathi, M., Nair, S., Na, K. S., Riemens, A., Sippel, K., ... Tsubota, K. (2022). Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria. Ocular Surface, 26, 200-208. https://doi.org/10.1016/j.jtos.2022.09.002

@article{713dfcfe87ae49048a8efa6da2142608,

title = "Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria",

abstract = "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.",

author = "Yoko Ogawa and Reza Dana and Stella Kim and Sandeep Jain and Rosenblatt, {Mark I.} and Perez, {Victor L.} and Clayton, {Janine A.} and Monica Alves and Rocha, {Eduardo Melani} and Francisco Amparo and Seo, {Kyoung Yul} and Yan Wang and Joanne Shen and Oh, {Joo Youn} and Murugesan Vanathi and Sridevi Nair and Na, {Kyung Sun} and Anjo Riemens and Kimberly Sippel and Matias Soifer and Shudan Wang and Marilia Trindade and Kim, {Mee Kum} and Yoon, {Chang Ho} and Ryuichiro Yagi and Ryo Hiratsuka and Mamoru Ogawa and Eisuke Shimizu and Yasunori Sato and Stephen Pflugfelder and Kazuo Tsubota",

note = "Funding 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. Funding Information: 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. Funding Information: 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. Funding Information: M.A. receives research grant from FAPESP number: 2021/04045-5. Publisher Copyright: {\textcopyright} 2022",

year = "2022",

month = oct,

doi = "10.1016/j.jtos.2022.09.002",

language = "English",

volume = "26",

pages = "200--208",

journal = "Ocular Surface",

issn = "1542-0124",

publisher = "Ethis Communications, Inc.",

}

Ogawa, Y, Dana, R, Kim, S, Jain, S, Rosenblatt, MI, Perez, VL, Clayton, JA, Alves, M, Rocha, EM, Amparo, F, Seo, KY, Wang, Y, Shen, J, Oh, JY, Vanathi, M, Nair, S, Na, KS, Riemens, A, Sippel, K, Soifer, M, Wang, S, Trindade, M, Kim, MK, Yoon, CH, Yagi, R, Hiratsuka, R, Ogawa, M, Shimizu, E, Sato, Y, Pflugfelder, S & Tsubota, K 2022, 'Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria', Ocular Surface, vol. 26, pp. 200-208. https://doi.org/10.1016/j.jtos.2022.09.002

TY - JOUR

T1 - Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria

AU - Ogawa, Yoko

AU - Dana, Reza

AU - Kim, Stella

AU - Jain, Sandeep

AU - Rosenblatt, Mark I.

AU - Perez, Victor L.

AU - Clayton, Janine A.

AU - Alves, Monica

AU - Rocha, Eduardo Melani

AU - Amparo, Francisco

AU - Seo, Kyoung Yul

AU - Wang, Yan

AU - Shen, Joanne

AU - Oh, Joo Youn

AU - Vanathi, Murugesan

AU - Nair, Sridevi

AU - Na, Kyung Sun

AU - Riemens, Anjo

AU - Sippel, Kimberly

AU - Soifer, Matias

AU - Wang, Shudan

AU - Trindade, Marilia

AU - Kim, Mee Kum

AU - Yoon, Chang Ho

AU - Yagi, Ryuichiro

AU - Hiratsuka, Ryo

AU - Ogawa, Mamoru

AU - Shimizu, Eisuke

AU - Sato, Yasunori

AU - Pflugfelder, Stephen

AU - Tsubota, Kazuo

N1 - Funding 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. Funding Information: 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. Funding Information: 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. Funding Information: M.A. receives research grant from FAPESP number: 2021/04045-5. Publisher Copyright: © 2022

PY - 2022/10

Y1 - 2022/10

N2 - 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.

AB - 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.

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U2 - 10.1016/j.jtos.2022.09.002

DO - 10.1016/j.jtos.2022.09.002

M3 - Article

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SN - 1542-0124

VL - 26

SP - 200

EP - 208

JO - Ocular Surface

JF - Ocular Surface

ER -

Multicenter prospective validation study for international chronic ocular graft-versus-host disease consensus diagnostic criteria

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