【摘要】目的：观察糖尿病视网膜病变(DR)眼底彩色照片读片结果的可信度及其影响因素，评价眼底彩色照片读片在DR诊断中的意义.方法：以13名无眼科知识及眼科临床工作经验者为普通读片人,1名DR专科教授为专业读片人,参考DR早期治疗研究组的读片法，13名读片人分别采用盲法对50张50°4个视野彩色眼底照片进行前后2次读片（前后读片），确认并记录11项眼底病变（毛细血管瘤和/或视网膜点状出血、线状和/或火焰状出血、硬性渗出、轮状硬性渗出、软性渗出、视网膜内细小血管异常、视网膜动脉白线化、静脉数珠状扩张、静脉襻形成、静脉白鞘化、新生血管）。对比分析13 名读片人之间前后读片结果的异同，运用κ、加权κ(κｗ)统计值及级内相关系数（ICC）方法评价普通读片人读片结果的可信赖性。结果：每一普通读片人前后2次读片结果比较，11项眼底病变κ为0.49～1.00(平均0.81～0.93);13个普通读片人之间读片结果比较，前读片κ为0.41～1.00(平均0.70～0.90)、后读片κ为0.37～1.00(平均0.63～0.89);普通读片人与专业读片人之间11项异常指标的读片结果比较，前读片κ为0.45～1.00(0.79～0.95)、κｗ为0.52～1.00（平均0.86～0.98）;后读片κ为0.37～1.00(平均0.79～0.95)、κｗ为0.43～1.00（平均0.84～0.98）.结论： 眼底彩色照片读片在DR眼底异常的判断普查和随访观察中有较高的可信赖性；读片标准和读片方法是否统一是影响读片可信度的重要因素。
【关键词】 糖尿病视网膜病变 眼底照片读片 读片者 标准照片 信赖性 κ统计值
Reliability of evaluating grade of diabetic retinopathy from non-stereoscopic color fundus photographs
Zhe Chen1, Nikawa Tatsuya1, Ping Xu2, Hirosaki Shinji1, Hao Yan1
Foundation item: Project of Science Investigation of Ministry of Health, Labour and Welfare, Japan
1Fundus Photograph Reading Center, The Clinical Service Provider,EPS Co.,Ltd., Japan; 2EPS China Co., Ltd., Shanghai 200030, China
Correspondence to: Zhe Chen . Fundus Photograph Reading Center, The Clinical Service Provider,EPS Co.,Ltd., Japan. [email protected]
Received: 2006-12-29 Accepted: 2007-01-29
Abstract
· AIM: To determine the reliability of evaluating grading for diabetic retinopathy (DR) from color fundus photographs and related factors.
· METHODS: The raters consisted of 13 graders were non-ophthalmologists who had been trained extensively to assess diabetic retinopathy and one senior grader was a professor of DR. The intra- observer, inter-observer and accuracy reliability of stage-evaluation for DR using ETDRS's classification was assessed by theκcoefficient. Intraclass correlation coefficient. The study was a double-blind, randomized trial, presenting the methodology for 4-fields 500 fundus photography and details for the assessment of DR. This system provided more steps in the grading scale for 11 characteristics (Haemorrhages and Micro-Aneurysms, Hard Exudates, and so on).
· RESULTS: Retinopathy data from completed grading forms were computerized at the Coordinating Centre using SAS (should give version number). Theκcoefficient was calculated to evaluate the intra- observer reliability, was 0.49 to 1.00(Mean value:0.81-0.93).Theκto evaluate the inter-observer for the 1st was 0.41 to 1.00(Mean value:0.70-0.90)and that for the 2nd time was 0.37 to 1.00(Mean value:0.63-0.89); The κ of Accuracy reliability for the 1st was 0.45 to 1.00(Mean value: 0.79-0.95),κｗ:0.52-1.00（Mean value 0.86-0.98）and that for the 2nd was 0.37 to 1.00(Mean value: 0.79-0.95), κｗ:0.43-1.00（Mean value 0.84-0.98）.
· CONCLUSION: Our results suggest high reliability of evaluation grade of DR and the necessarily of the standardization of DR using fundus photographs.
· KEYWORDS: diabetic retinopathy; agreement of evaluation of fundus; grader; standard photograph; reliability; κ coefficient
Chen Z, Tatsuya N, Xu P, Shinji H, Yan H. Reliability of Evaluating grade of diabetic retinopathy from non-stereoscopic color fundus photographs.Int J Ophthalmol(Guoji Yanke Zazhi) ,2007;7(1):112-116
0引言
糖尿病视网膜病变（DR）的主要眼底改变是毛细血管瘤、出血、硬性渗出、软性渗出毛细血管闭塞、新生血管形成甚至玻璃体积血、视网膜脱离等[1]。对DR的病变分析、进展状况的追踪以及药物疗效的判断，目前主要依据病历记录、眼底以及荧光素眼底血管造影（FFA）检查来收集数据进行分析。然而，FFA检查不便于DR普查或多次随访检查；并且，这些方法均存在诊断标准、不同的医院、不同的医师、同一医师的不同检查时间等不同所导致的诊断结果差异。采用眼底彩色照片进行DR的分级观察，是DR防盲和流行病学研究中的简单易行的方法之一；以无眼科知识及眼科临床工作经验者为读片者通过眼底彩色照片进行DR早期筛选，有利于DR的早期发现和早期诊断。 为了详细、精确地观察糖尿病的病程发展中视网膜微循环的变化,近年来美国、欧洲及日本等国家都相继展开了对DR追踪眼底照片的读片研究[2-5],。建立一套规范的读片系统,对DR病变分类标准化、数据采集方法的统一化以及眼底照片读片结果的信赖性评估具有重要价值。为此，我们对DR眼底彩色照片的读片可信度进行了研究，现将结果报道如下。
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