Department of Ophthalmology, Casey Eye Institute, Oregon Health and Science University, Portland.
Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
JAMA Ophthalmol. 2018 Jun 1;136(6):648-655. doi: 10.1001/jamaophthalmol.2018.1195.
Presence of plus disease in retinopathy of prematurity is the most critical element in identifying treatment-requiring disease. However, there is significant variability in plus disease diagnosis. In particular, plus disease has been defined as 2 or more quadrants of vascular abnormality, and it is not clear whether it is more reliably and accurately diagnosed by eye-based assessment of overall retinal appearance or by quadrant-based assessment combining grades of 4 individual quadrants.
To compare eye-based vs quadrant-based diagnosis of plus disease and to provide insight for ophthalmologists about the diagnostic process.
DESIGN, SETTING, AND PARTICIPANTS: In this multicenter cohort study, we developed a database of 197 wide-angle retinal images from 141 preterm infants from neonatal intensive care units at 9 academic institutions (enrolled from July 2011 to December 2016). Each image was assigned a reference standard diagnosis based on consensus image-based and clinical diagnosis. Data analysis was performed from February 2017 to September 2017.
Six graders independently diagnosed each of the 4 quadrants (cropped images) of the 197 eyes (quadrant-based diagnosis) as well as the entire image (eye-based diagnosis). Images were displayed individually, in random order. Quadrant-based diagnosis of plus disease was made when 2 or more quadrants were diagnosed as indicating plus disease by combining grades of individual quadrants post hoc.
Intragrader and intergrader reliability (absolute agreement and κ statistic) and accuracy compared with the reference standard diagnosis.
Of the 141 included preterm infants, 65 (46.1%) were female and 116 (82.3%) white, and the mean (SD) gestational age was 27.0 (2.6) weeks. There was variable agreement between eye-based and quadrant-based diagnosis among the 6 graders (Cohen κ range, 0.32-0.75). Four graders showed underdiagnosis of plus disease with quadrant-based diagnosis compared with eye-based diagnosis (by McNemar test). Intergrader agreement of quadrant-based diagnosis was lower than that of eye-based diagnosis (Fleiss κ, 0.75 [95% CI, 0.71-0.78] vs 0.55 [95% CI, 0.51-0.59]). The accuracy of eye-based diagnosis compared with the reference standard diagnosis was substantial to near-perfect, whereas that of quadrant-based plus disease diagnosis was only moderate to substantial for each grader.
Graders had lower reliability and accuracy using quadrant-based diagnosis combining grades of individual quadrants than with eye-based diagnosis, suggesting that eye-based diagnosis has advantages over quadrant-based diagnosis. This has implications for more precise definitions of plus disease regarding the criterion of 2 or more quadrants, clinical care, computer-based image analysis, and education for all ophthalmologists who manage retinopathy of prematurity.
早产儿视网膜病变中的“+”病是识别需要治疗的疾病的最关键因素。然而，“+”病的诊断存在显著的差异。特别是，“+”病被定义为 2 个或更多象限的血管异常，目前尚不清楚是通过对整个视网膜外观的眼部评估，还是通过结合 4 个象限的分级进行的象限评估更可靠和准确地诊断“+”病。
比较眼部和象限诊断“+”病，并为眼科医生提供有关诊断过程的见解。
设计、地点和参与者：在这项多中心队列研究中，我们从 9 个学术机构的新生儿重症监护病房的 141 名早产儿中开发了一个包含 197 张广角视网膜图像的数据库（招募时间为 2011 年 7 月至 2016 年 12 月）。每个图像都根据共识的基于图像和临床的诊断被分配了一个参考标准诊断。数据分析于 2017 年 2 月至 2017 年 9 月进行。
6 名分级员分别对 197 只眼（象限诊断）的 4 个象限（裁剪图像）和整个图像（眼部诊断）进行独立诊断。图像单独随机显示。象限的“+”病诊断是通过事后结合各个象限的分级来诊断 2 个或更多象限存在“+”病。
与参考标准诊断相比，比较分级员内和分级员间的可靠性（绝对一致和κ统计）和准确性。
在纳入的 141 名早产儿中，65 名（46.1%）为女性，116 名（82.3%）为白人，平均（标准差）胎龄为 27.0（2.6）周。6 名分级员中，眼部和象限诊断之间存在不一致（Cohen κ 范围，0.32-0.75）。与眼部诊断相比，4 名分级员的象限诊断存在“+”病漏诊（McNemar 检验）。象限诊断的分级员间一致性低于眼部诊断（Fleiss κ，0.75[95%CI，0.71-0.78] vs 0.55[95%CI，0.51-0.59]）。与参考标准诊断相比，眼部诊断的准确性为高到近乎完美，而象限“+”病诊断的准确性仅为中度到高度，每位分级员的情况均如此。
使用象限分级结合各个象限的分级进行诊断时，分级员的可靠性和准确性均低于眼部诊断，这表明眼部诊断优于象限诊断。这对“+”病的定义有影响，特别是对于 2 个或更多象限的标准，临床护理、基于计算机的图像分析以及管理早产儿视网膜病变的所有眼科医生的教育。
