SCORE Study Report 2: Interobserver agreement between investigator and reading center classification of retinal vein occlusion type.

SCORE Study Report 2: Interobserver agreement between investigator and reading center classification of retinal vein occlusion type.
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DOI:
10.1016/j.ophtha.2008.11.015
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发表时间:
2009-04
期刊:
影响因子:
13.7
通讯作者:
SCORE Study Investigator Group
SCORE Study Investigator Group
中科院分区:
医学1区
文献类型:
--
作者:
Scott IU;Blodi BA;Ip MS;Vanveldhuisen PC;Oden NL;Chan CK;Gonzalez V;SCORE Study Investigator Group

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评价研究者和雷丁中心对视网膜静脉闭塞的分类是否一致。标准治疗与皮质类固醇治疗视网膜静脉闭塞(SCORE)研究包括两项多中心3期随机临床试验,评估玻璃体注射曲安奈德的有效性和安全性;视网膜中央静脉阻塞(CRVO)和视网膜分支静脉阻塞(BRVO)两组。半视网膜静脉闭塞(HRVO)分为BRVO。682名SCORE研究参与者,包括271名CRVO和411名BRVO。参与者根据研究者对视网膜静脉阻塞的分类被纳入每项试验。CRVO、BRVO和HRVO的定义根据临床表现在研究方案中明确。在基线时,每个参与者的研究眼上的七场彩色立体眼底照片被转发到威斯康星大学眼底照片阅读中心(阅读中心)进行评估。28只眼睛被排除在分析之外。研究者和雷丁中心视网膜静脉闭塞类型分类的一致性百分比和kappa统计。将HRVO分类为BRVO(与SCORE研究设计一致),研究者与Reading Center分类之间有98.0%的一致性(641/654只眼;kappa = 0.96; 95%可信区间:0.94,0.98)。研究者将一只眼睛分类为CRVO,而阅读中心将其分类为BRVO(7/13),反之亦然(6)。当比较所有三种疾病类别(CRVO、BRVO和HRVO)时,一致性为92.2%(603/654;未加权kappa = 0.86; 95%置信区间:0.83,0.90)。大多数分歧发生在BRVO和HRVO之间(38/51,74.5%),其中CRVO和BRVO之间有9个,HRVO和CRVO之间有4个。在单变量分析中,与差异显著相关的基线因素包括毛细血管损失面积较大和黑人种族;在多变量分析中,黑人种族是唯一重要的因素。在SCORE研究中,研究者和阅读中心的协议是优秀的;只有13只(2.0%)只眼睛的疾病分类被改变。BRVO和HRVO分类的观察者间一致性最低。
To evaluate interobserver agreement between investigator and Reading Center classification of retinal vein occlusion. The Standard Care versus Corticosteroid for Retinal Vein Occlusion (SCORE) Study includes two multicenter phase 3 randomized clinical trials evaluating efficacy and safety of intravitreal triamcinolone; one involving participants with central retinal vein occlusion (CRVO) and one involving participants with branch retinal vein occlusion (BRVO). Eyes with hemiretinal vein occlusion (HRVO) were classified as BRVO. 682 SCORE Study participants, including 271 with CRVO and 411 with BRVO. Participants were enrolled into each trial based upon investigator classification of retinal vein occlusion. Definitions of CRVO, BRVO and HRVO based on clinical findings were specified in the study protocol. At baseline, seven-field color stereoscopic fundus photographs on the study eye of each participant were forwarded to the University of Wisconsin Fundus Photograph Reading Center (Reading Center) for evaluation. 28 eyes were excluded from the analysis. Percent agreement and kappa statistics comparing investigator and Reading Center classification of retinal vein occlusion type. With HRVO categorized as BRVO (consistent with the SCORE Study design), there was 98.0% agreement between investigator and Reading Center classification (641/654 eyes; kappa = 0.96; 95% confidence interval: 0.94, 0.98). Disagreements were fairly evenly divided between classification of an eye as CRVO by the investigator and as BRVO by the Reading Center (7/13 disagreements) and vice versa (6 disagreements). When all three disease categories (CRVO, BRVO and HRVO) were compared, there was 92.2% agreement (603/654; unweighted kappa = 0.86; 95% confidence interval: 0.83, 0.90). Most disagreements (38/51, or 74.5%) were between BRVO and HRVO, with 9 between CRVO and BRVO, and 4 between HRVO and CRVO. In univariate analyses, baseline factors significantly associated with disagreement include larger area of capillary loss and black race; black race was the only significant factor in a multivariate analysis. Investigator and Reading Center agreement was excellent in the SCORE Study; in only 13 (2.0%) eyes would disease classification have been altered had Reading Center eligibility been required. Interobserver agreement was least for classification between BRVO and HRVO.
DOI: 10.1097/iae.0b013e31815e9385
发表时间: 2008-01-01
影响因子: 3.3
作者:
Scott, Ingrid U.;Bressler, Neil M.;Qin, Haijing
通讯作者: Qin, Haijing