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Comparison of Film and Digital Fundus Photographs in Eyes of Individuals with Diabetes Mellitus

机译：糖尿病人眼中胶片和数字眼底照片的比较

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Purpose.: 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. Methods.: 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 ?o statistics. Results.: 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 ?o statistic of 0.82 (95% confidence interval [CI], 0.71a??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 ?o statistic, 0.44 [95% Cl, 0.34a??0.54] and 0.72 [95% Cl, 0.55a??0.90], respectively). Conclusions.: 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.)
机译：目的：比较从立体电影中获得的糖尿病性视网膜病（DR）和糖尿病性黄斑水肿（DME）与从部分糖尿病性视网膜病临床研究网络（DRCR.net）参与者那里获得的立体数字照片的等级。方法：在这项照相媒体比较研究中，通过一次研究访问就从积极参加DRCR.net临床研究方案的一些受试者获得了数字和胶片图像。数码相机系统以及数码和胶卷摄影师被认证可以按照标准程序获取图像。图像由Fundus Photograph Reading Center（威斯康星州麦迪逊）的分级人员以遮罩的方式对DR严重性和DME进行了分级。等级之间的一致性是通过计算一致性百分比和整个统计数据来评估的。结果：通过电影和数字媒体获得的图像被提交给96位研究参与者的155眼。在一项9步糖尿病视网膜病变早期治疗研究中，DR严重程度量表的评分准确度在74％内一致，并且在93％的一致性内仅一步之遥，加权fo统计量为0.82（95％置信区间[CI]，0.71） a≤0.92）。在9步DME严重程度量表和3步临床上显着的黄斑水肿（CSME）量表上，分级分别准确地分别达到39％和88％，一步之内达到70％和92％（加权统计量，0.44）。分别为[95％Cl，0.34a≤0.54]和0.72 [95％Cl，0.55a≤0.90]。结论：在参与DRCR.net的临床站点中，胶片和数字图像之间的一致性对于DR严重性水平是基本达到或几乎是完美的，而对于DME和CSME严重性水平则是中等至基本。用数字图像代替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。 （ClinicalTrials.gov编号，NCT00367133，NCT00369486，NCT00444600，NCT00445003，NCT00709319。）

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