Agreement between clinician and reading center gradings of diabetic retinopathy severity level at baseline in a phase 2 study of intravitreal bevacizumab for diabetic macular edema
Agreement between clinician and reading center gradings of diabetic retinopathy severity level at baseline in a phase 2 study of intravitreal bevacizumab for diabetic macular edema
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DOI：
10.1097/iae.0b013e31815e9385
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发表时间：
2008-01-01
影响因子：
3.3
通讯作者：
Qin, Haijing
中科院分区：
文献类型：
--
作者：
Scott, Ingrid U.;Bressler, Neil M.;Qin, Haijing
目的：在玻璃体内贝伐单抗治疗中心糖尿病性黄斑水肿的 2 期临床试验中，评估视网膜专家进行检眼镜检查与阅读中心 (RC) 对七视野立体眼底照片分级的糖尿病视网膜病变严重程度分类的一致性。方法：临床医生的分级量表使用四个级别：仅微动脉瘤、轻度/中度非增殖性糖尿病视网膜病变 (NPDR)、重度 NPDR 和增殖性糖尿病视网膜病变 (PDR) 或既往全视网膜光凝 (PRP) 或两者兼而有之。 RC量表使用八个级别：仅微动脉瘤、轻度NPDR、中度NPDR、中度重度NPDR、重度NPDR、轻度PDR、中度PDR和高风险PDR。一致性百分比和 kappa 统计量通过折叠 RC 类别来定义，以匹配临床医生使用的类别。结果：89/118 只眼睛 (75%) 的一致性为 kappa = 0.55（95% 置信区间 [0.41, 0.68]）。在六只眼睛中，分歧具有潜在的重大临床意义：五只眼睛有轻微的视网膜新生血管形成，一只眼睛有仅在照片中发现的少量视网膜前出血。结论：临床医生对视网膜病变严重程度的分级与 RC 分级具有中等程度的一致性，可能有助于将眼睛归入广泛的基线类别。
Purpose: To evaluate agreement in diabetic retinopathy severity classification by retina specialists performing ophthalmoscopy versus reading center (RC) grading of seven-field stereoscopic fundus photographs in a phase 2 clinical trial of intravitreal bevacizumab for center-involved diabetic macular edema.Methods: Clinicians' grading scale used four levels: microaneurysms only, mild/moderate nonproliferative diabetic retinopathy (NPDR), severe NPDR, and proliferative diabetic retinopathy (PDR) or prior panretinal photocoagulation (PRP) or both. The RC scale used eight levels: microaneurysms only, mild NPDR, moderate NPDR, moderately severe NPDR, severe NPDR, mild PDR, moderate PDR, and high-risk PDR. Percent agreement and kappa statistic were defined by collapsing RC categories to match those used by clinicians.Results: There was agreement in 89/118 eyes (75%) with kappa = 0.55 (95% confidence interval [0.41, 0.68]). In six eyes, disagreements were of potential substantial clinical importance: five eyes with subtle retinal neovascularization and one with a small preretinal hemorrhage identified only in photographs.Conclusions: Clinician grading of retinopathy severity had moderate agreement with RC grading and might be useful for placing eyes into broad baseline categories.