Abstract
Purpose: To compare Early Treatment Diabetic Retinopathy Study (ETDRS) severity levels between two digital fundus imaging protocols for research studies of diabetic retinopathy: the gold standard 7-field (7F) imaging and the more recent 4-widefield (4W) imaging. Methods: Two hundred twenty-two participants enrolled in the Diabetes Prevention Program Outcomes Study underwent concurrent 7F and 4W imaging. The ETDRS levels from 220 paired gradable images were determined by masked graders. Each image was graded by two independent graders with adjudication by a senior grader, if necessary. Percent agreement between graders and between imaging protocols was evaluated with kappa statistics and weighted kappa statistics. Results: Of 220 gradable eyes, diabetic retinopathy was seen in 11.8%; this was mild in 10.4% and more than mild in 1.4% using 7F imaging. The ETDRS levels showed exact agreement of 95% between 7F and 4W imaging (weighted kappa 0.86). Intergrader agreement for each modality had exact agreement of 89% (weighted kappa of 0.73) for 7F and 91% (weighted kappa 0.77) for 4W. Conclusions: There is substantial agreement in the ETDRS severity level between the 7F and 4W digital imaging protocols, demonstrating that the two imaging protocols are interchangeable. Both 4W and 7F digital imaging protocols can be used for assessing ETDRS levels, even in populations with minimal diabetic retinopathy. Translational Relevance: The 4W protocol requires fewer images than the 7F, is more comfortable for the patients, is easier for photographic capture, and provides diabetic retinopathy data that is equivalent to the 7F imaging protocol.
| Original language | English |
|---|---|
| Article number | 13 |
| Journal | Translational Vision Science and Technology |
| Volume | 11 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2022 |
Keywords
- Diabetic retinopathy
- Digital imaging
- ETDRS grading
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In: Translational Vision Science and Technology, Vol. 11, No. 1, 13, 01.2022.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Comparison of ETDRS 7-Field to 4-Widefield Digital Imaging in the Evaluation of Diabetic Retinopathy Severity
AU - Blodi, Barbara A.
AU - Domalpally, Amitha
AU - Tjaden, Ashley H.
AU - Barrett, Nancy
AU - Chew, Emily Y.
AU - Knowler, William C.
AU - Lee, Christine G.
AU - Pi-Sunyer, Xavier
AU - Wallia, Amisha
AU - White, Neil H.
AU - Temprosa, Marinella
N1 - Funding Information: The DPP Research Group gratefully acknowledges the commitment and dedication of the participants of the DPP and DPPOS. BAB, AD, and NB were supported in part by an unrestricted grant from Research to Prevent Blindness, Inc., to the University of Wisconsin Madison Department of Ophthalmology and Visual Sciences. Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) under award numbers U01 DK048339, U01 DK048377, U01 DK048349, U01 DK048381, U01 DK048468, U01 DK048434, U01 DK048485, U01 DK048375, U01 DK048514, U01 DK048437, U01 DK048413, U01 DK048411, U01 DK048406, U01 DK048380, U01 DK048397, U01 DK048412, U01 DK048404, U01 DK048387, U01 DK048407, U01 DK048443, U01 DK048400, and U01 DK048489, which provided funding during DPP and DPPOS to the clinical centers and the Coordinating Center for the design and conduct of the study, as well as the collection, management, analysis, and interpretation of the data. Funding was also provided by the National Institute of Child Health and Human Development, National Institute on Aging, National Eye Institute, National Heart Lung and Blood Institute, National Cancer Institute, Office of Research on Women’s Health, National Institute on Minority Health and Health Disparities, Centers for Disease Control and Prevention, and American Diabetes Association. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The Southwestern American Indian Centers were supported directly by the NIDDK, including its Intramural Research Program, and the Indian Health Service. The General Clinical Research Center Program, National Center for Research Resources, and the Department of Veterans Affairs supported data collection at many of the clinical centers. Merck KGaA provided medication for DPPOS. DPP and DPPOS have also received donated materials, equipment, or medicines for concomitant conditions from Bristol Myers Squibb, Parke-Davis, LifeScan, Health-o-Meter, Hoechst Marion Roussel, Merck-Medco Managed Care, Merck & Co., Nike Sports Marketing, SlimFast, and Quaker Oats. McKesson BioServices, Matthews Media Group, and the Henry M. Jackson Foundation provided support services under subcontract with the Coordinating Center. The sponsor of this study was represented on the Steering Committee and played a part in the study design, how the study was done, and its publication. All authors in the writing group had access to all data. The opinions expressed are those of the study group and do not necessarily reflect the views of the funding agencies. A complete list of centers, investigators, and staff can be found in the online supplemental file. Funding Information: The DPP Research Group gratefully acknowledges the commitment and dedication of the participants of the DPP and DPPOS. BAB, AD, and NB were supported in part by an unrestricted grant from Research to Prevent Blindness, Inc., to the University of Wisconsin Madison Department of Ophthalmology and Visual Sciences. Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) under award numbers U01 DK048339, U01 DK048377, U01 DK048349, U01 DK048381, U01 DK048468, U01 DK048434, U01 DK048485, U01 DK048375, U01 DK048514, U01 DK048437, U01 DK048413, U01 DK048411, U01 DK048406, U01 DK048380, U01 DK048397, U01 DK048412, U01 DK048404, U01 DK048387, U01 DK048407, U01 DK048443, U01 DK048400, and U01 DK048489, which provided funding during DPP and DPPOS to the clinical centers and the Coordinating Center ETDRS report number 12. Early Treatment for the design and conduct of the study, as well as Diabetic Retinopathy Study Research Group. the collection, management, analysis, and interpre-Ophthalmology. 1991;98(5 suppl):823–833. tation of the data. Funding was also provided by 2. Early Treatment Diabetic Retinopathy Study the National Institute of Child Health and Human Research Group. Grading diabetic retinopathy Development, National Institute on Aging, National from stereoscopic color fundus photographs–an Eye Institute, National Heart Lung and Blood Insti-extension of the modified Airlie House classifica-tute, National Cancer Institute, Office of Research tion. ETDRS report number 10. Early Treatment on Women’s Health, National Institute on Minority Diabetic Retinopathy Study Research Group. Health and Health Disparities, Centers for Disease Ophthalmology. 1991;98(5 suppl):786–806. Control and Prevention, and American Diabetes 3. Bressler SB, Odia I, Glassman AR, et al. Changes Association. The content is solely the responsibil-in diabetic retinopathy severity when treating dia-ity of the authors and does not necessarily repre-betic macular edema with ranibizumab: DRCR.net sent the official views of the National Institutes of Protocol I 5-year report. Retina. 2018;38(10):1896– Health. The Southwestern American Indian Centers 1904. were supported directly by the NIDDK, including 4. Klein R, Klein BE, Moss SE, Cruickshanks KJ. its Intramural Research Program, and the Indian The Wisconsin Epidemiologic Study of diabetic Health Service. The General Clinical Research Center retinopathy. XIV. Ten-year incidence and progres-Program, National Center for Research Resources, and sion of diabetic retinopathy. Arch Ophthalmol. the Department of Veterans Affairs supported data 1994;112(9):1217–1228. collection at many of the clinical centers. Merck KGaA 5. Zoungas S, Arima H, Gerstein HC, et al. Effects provided medication for DPPOS. DPP and DPPOS of intensive glucose control on microvascular have also received donated materials, equipment, or outcomes in patients with type 2 diabetes: a medicines for concomitant conditions from Bristol meta-analysis of individual participant data from Myers Squibb, Parke-Davis, LifeScan, Health-o-Meter, randomised controlled trials. Lancet Diabetes Hoechst Marion Roussel, Merck-Medco Managed Endocrinol. 2017;5(6):431–437. Care, Merck & Co., Nike Sports Marketing, SlimFast, 6. Sadda SR. Assessing the severity of diabetic and Quaker Oats. McKesson BioServices, Matthews retinopathy: Early Treatment Diabetic Retinopa-Media Group, and the Henry M. Jackson Foundation thy Study report number 10. Ophthalmology. provided support services under subcontract with the 2020;127(4S):S97–S98. Coordinating Center. The sponsor of this study was 7. Ip MS, Domalpally A, Hopkins JJ, et al. Long-represented on the Steering Committee and played a term effects of ranibizumab on diabetic retinopa-part in the study design, how the study was done, and thy severity and progression. Archives of Ophthal- its publication. All authors in the writing group had mology. 2012;130(9):1145–1152. access to all data. The opinions expressed are those of 8. Gangaputra S, Almukhtar T, Glassman AR, et al. the study group and do not necessarily reflect the views Comparison of film and digital fundus pho-of the funding agencies. A complete list of centers, tographs in eyes of individuals with diabetes mel-investigators, and staff can be found in the online litus. Invest Ophthalmol Vis Sci. 2011;52(9):6168– supplemental file. 6173. Publisher Copyright: © 2022 The Authors.
PY - 2022/1
Y1 - 2022/1
N2 - Purpose: To compare Early Treatment Diabetic Retinopathy Study (ETDRS) severity levels between two digital fundus imaging protocols for research studies of diabetic retinopathy: the gold standard 7-field (7F) imaging and the more recent 4-widefield (4W) imaging. Methods: Two hundred twenty-two participants enrolled in the Diabetes Prevention Program Outcomes Study underwent concurrent 7F and 4W imaging. The ETDRS levels from 220 paired gradable images were determined by masked graders. Each image was graded by two independent graders with adjudication by a senior grader, if necessary. Percent agreement between graders and between imaging protocols was evaluated with kappa statistics and weighted kappa statistics. Results: Of 220 gradable eyes, diabetic retinopathy was seen in 11.8%; this was mild in 10.4% and more than mild in 1.4% using 7F imaging. The ETDRS levels showed exact agreement of 95% between 7F and 4W imaging (weighted kappa 0.86). Intergrader agreement for each modality had exact agreement of 89% (weighted kappa of 0.73) for 7F and 91% (weighted kappa 0.77) for 4W. Conclusions: There is substantial agreement in the ETDRS severity level between the 7F and 4W digital imaging protocols, demonstrating that the two imaging protocols are interchangeable. Both 4W and 7F digital imaging protocols can be used for assessing ETDRS levels, even in populations with minimal diabetic retinopathy. Translational Relevance: The 4W protocol requires fewer images than the 7F, is more comfortable for the patients, is easier for photographic capture, and provides diabetic retinopathy data that is equivalent to the 7F imaging protocol.
AB - Purpose: To compare Early Treatment Diabetic Retinopathy Study (ETDRS) severity levels between two digital fundus imaging protocols for research studies of diabetic retinopathy: the gold standard 7-field (7F) imaging and the more recent 4-widefield (4W) imaging. Methods: Two hundred twenty-two participants enrolled in the Diabetes Prevention Program Outcomes Study underwent concurrent 7F and 4W imaging. The ETDRS levels from 220 paired gradable images were determined by masked graders. Each image was graded by two independent graders with adjudication by a senior grader, if necessary. Percent agreement between graders and between imaging protocols was evaluated with kappa statistics and weighted kappa statistics. Results: Of 220 gradable eyes, diabetic retinopathy was seen in 11.8%; this was mild in 10.4% and more than mild in 1.4% using 7F imaging. The ETDRS levels showed exact agreement of 95% between 7F and 4W imaging (weighted kappa 0.86). Intergrader agreement for each modality had exact agreement of 89% (weighted kappa of 0.73) for 7F and 91% (weighted kappa 0.77) for 4W. Conclusions: There is substantial agreement in the ETDRS severity level between the 7F and 4W digital imaging protocols, demonstrating that the two imaging protocols are interchangeable. Both 4W and 7F digital imaging protocols can be used for assessing ETDRS levels, even in populations with minimal diabetic retinopathy. Translational Relevance: The 4W protocol requires fewer images than the 7F, is more comfortable for the patients, is easier for photographic capture, and provides diabetic retinopathy data that is equivalent to the 7F imaging protocol.
KW - Diabetic retinopathy
KW - Digital imaging
KW - ETDRS grading
UR - http://www.scopus.com/inward/record.url?scp=85123459649&partnerID=8YFLogxK
U2 - 10.1167/tvst.11.1.13
DO - 10.1167/tvst.11.1.13
M3 - Article
C2 - 35015059
AN - SCOPUS:85123459649
SN - 2164-2591
VL - 11
JO - Translational Vision Science and Technology
JF - Translational Vision Science and Technology
IS - 1
M1 - 13
ER -