Wisconsin Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Biostatistics Center and Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA.
Transl Vis Sci Technol. 2022 Jan 3;11(1):13. doi: 10.1167/tvst.11.1.13.
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.
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.
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.
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.
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.
比较两种糖尿病视网膜病变研究用数字眼底成像方案（黄金标准的 7 视野（7F）成像和较新的 4 宽视野（4W）成像）之间的早期治疗糖尿病视网膜病变研究（ETDRS）严重程度分级。
222 名参加糖尿病预防计划结局研究的参与者同时接受了 7F 和 4W 成像。220 对可分级图像的 ETDRS 分级由盲法分级员确定。如果需要，每个图像由两名独立的分级员进行分级，并由一名资深分级员进行裁决。使用 Kappa 统计和加权 Kappa 统计评估分级员之间和成像方案之间的百分比一致性。
在 220 个可分级的眼中，有 11.8%出现糖尿病视网膜病变；使用 7F 成像，轻度病变占 10.4%，中重度病变占 1.4%。7F 和 4W 成像的 ETDRS 分级显示出 95%的完全一致性（加权 Kappa 0.86）。两种成像方案的分级员之间的一致性为 7F 为 89%（加权 Kappa 0.73），4W 为 91%（加权 Kappa 0.77）。
7F 和 4W 数字成像方案之间的 ETDRS 严重程度分级具有实质性的一致性，表明两种成像方案是可互换的。4W 和 7F 数字成像方案均可用于评估 ETDRS 分级，即使在糖尿病视网膜病变患者较少的人群中也是如此。
杨硕
