Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. doi: 10.1167/iovs.11-7321.
To compare grading of diabetic retinopathy (DR) and diabetic macular edema (DME) from stereoscopic film versus stereoscopic digital photographs obtained from a subset of Diabetic Retinopathy Clinical Research Network (DRCR.net) participants.
In this photographic media comparison study, digital and film images were obtained at a single study visit from some of the subjects enrolled in active DRCR.net clinical study protocols. Digital camera systems and digital and film photographers were certified to obtain images according to standard procedures. Images were graded for DR severity and DME in a masked fashion by Fundus Photograph Reading Center (Madison, WI) graders. Agreement between gradings was assessed by calculating the percentage of agreement and κ statistics.
Images obtained with both film and digital media were submitted for 155 eyes of 96 study participants. On a nine-step Early Treatment Diabetic Retinopathy study DR severity scale, grading agreed exactly in 74%, and was within one step of agreement in 93%, with a weighted κ statistic of 0.82 (95% confidence interval [CI], 0.71-0.92). On a nine-step DME severity scale and three-step clinically significant macular edema (CSME) scale, grading agreed exactly in 39% and 88%, respectively, and within one step in 70% and 92% (weighted κ statistic, 0.44 [95% Cl, 0.34-0.54] and 0.72 [95% Cl, 0.55-0.90], respectively).
Among clinical sites participating in the DRCR.net, agreement between film and digital images was substantial to almost perfect for DR severity level and moderate to substantial for DME and CSME severity levels, respectively. Replacement of film fundus images with digital images for DR severity level should not adversely affect clinical trial quality. (ClinicalTrials.gov numbers, NCT00367133, NCT00369486, NCT00444600, NCT00445003, NCT00709319.)
比较从糖尿病视网膜病变临床研究网络（DRCR.net）参与者的立体电影和立体数字照片中获得的糖尿病视网膜病变（DR）和糖尿病性黄斑水肿（DME）的分级。
在这项摄影媒体比较研究中，从参与 DRCR.net 主动临床研究方案的部分受试者中获得了数字和电影图像。数码相机系统和数字及胶片摄影师经过认证，可按照标准程序获取图像。由眼底照相阅读中心（威斯康星州麦迪逊）的阅片员以盲法对 DR 严重程度和 DME 进行分级。通过计算一致性百分比和κ统计量评估分级之间的一致性。
用胶片和数字媒体获得的图像提交给了 96 名研究参与者的 155 只眼。在一个九步早期糖尿病性视网膜病变研究 DR 严重程度分级量表中，完全一致的分级占 74%，一步之差的分级占 93%，加权κ统计量为 0.82（95%置信区间[CI]，0.71-0.92）。在一个九步 DME 严重程度分级量表和三步临床显著黄斑水肿（CSME）分级量表中，完全一致的分级分别占 39%和 88%，一步之差的分级分别占 70%和 92%（加权κ统计量，0.44[95%CI，0.34-0.54]和 0.72[95%CI，0.55-0.90]）。
在参与 DRCR.net 的临床站点中，DR 严重程度的分级结果在胶片和数字图像之间具有高度一致性，DME 和 CSME 严重程度的分级结果在胶片和数字图像之间具有中度至高度一致性。用数字图像替代 DR 严重程度的胶片眼底图像不会对临床试验质量产生不利影响。（临床试验注册号：NCT00367133、NCT00369486、NCT00444600、NCT00445003、NCT00709319。）
