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年龄相关性黄斑病变临床分期系统的评估

Evaluation of the clinical age-related maculopathy staging system.

作者信息

Seddon Johanna M, Sharma Sanjay, Adelman Ron A

机构信息

Epidemiology Unit, Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts 02114, USA.

出版信息

Ophthalmology. 2006 Feb;113(2):260-6. doi: 10.1016/j.ophtha.2005.11.001.

DOI:10.1016/j.ophtha.2005.11.001
PMID:16458093
Abstract

OBJECTIVE

To evaluate a clinical classification system, the Clinical Age-Related Maculopathy Staging (CARMS) system, for age-related maculopathy (ARM) using a simple grading scale designed for clinical practice and clinical research protocols.

PARTICIPANTS

Two hundred forty-six male and female participants with various stages of ARM who were enrolled during the first 4 years of a longitudinal study were selected for the evaluation of the CARMS system.

DESIGN

Cross-sectional comparison study.

METHODS

The CARMS system divides patients into 5 mutually exclusive categories based on slit-lamp assessment of drusen, retinal pigment epithelial irregularities, geographic atrophy, retinal pigment epithelial detachment, and choroidal neovascularization. Fundus photographs and clinical data of the subjects were used to evaluate this scale. Clinical grades assigned for 492 eyes of 246 patients with varying stages of ARM were compared with grades obtained from photographs evaluated by a reading center. To compare grades obtained from an inexperienced grader with those of an experienced grader, observations based on photographs from 50 randomly selected patients were reviewed. To quantify intraobserver agreement for photographic grades, observations from one observer were compared with those made at a later date by the same observer.

MAIN OUTCOME MEASURES

Reliability and validity of the CARMS system in grading various stages of ARM based on clinical examination and photography.

RESULTS

The degree of overall agreement between the clinically assigned grade and photographic assessment for 492 eyes was substantial (exact overall agreement, 75%; unweighted kappa, 0.63; weighted kappa, 0.78). For advanced age-related macular degeneration, the sensitivity was 0.83, and specificity was 0.97. When assessing photographic grades, the degree of agreement between an inexperienced and an experienced grader was very high (unweighted kappa, 0.79; weighted kappa, 0.86), and the degree of intraobserver agreement was excellent (unweighted kappa, 0.92; weighted kappa, 0.97).

CONCLUSIONS

The CARMS system, a 5-level clinical scale, is a valid and reliable staging system that can be used in both clinical practice and in clinical research protocols involving patients with all stages of ARM.

摘要

目的

使用一种为临床实践和临床研究方案设计的简单分级量表,评估一种临床分类系统——年龄相关性黄斑病变临床分期(CARMS)系统,用于年龄相关性黄斑病变(ARM)。

参与者

在一项纵向研究的前4年中招募的246名处于不同ARM阶段的男性和女性参与者被选来评估CARMS系统。

设计

横断面比较研究。

方法

CARMS系统根据对玻璃膜疣、视网膜色素上皮不规则、地图样萎缩、视网膜色素上皮脱离和脉络膜新生血管的裂隙灯评估,将患者分为5个相互排斥的类别。受试者的眼底照片和临床数据用于评估该量表。将246例不同阶段ARM患者的492只眼睛的临床分级与由一个阅片中心评估照片得出的分级进行比较。为了比较无经验分级者与有经验分级者得出的分级,对基于50例随机选择患者照片的观察结果进行了回顾。为了量化观察者自身对照片分级的一致性,将一名观察者的观察结果与该观察者在稍后日期的观察结果进行比较。

主要观察指标

CARMS系统基于临床检查和摄影对ARM不同阶段进行分级的可靠性和有效性。

结果

492只眼睛的临床分级与照片评估之间的总体一致程度很高(精确总体一致性,75%;未加权kappa值,0.63;加权kappa值,0.78)。对于晚期年龄相关性黄斑变性,敏感性为0.83,特异性为0.97。在评估照片分级时,无经验分级者与有经验分级者之间的一致程度非常高(未加权kappa值,0.79;加权kappa值,0.86),观察者自身的一致程度极佳(未加权kappa值,0.92;加权kappa值,0.97)。

结论

CARMS系统,一种5级临床量表,是一种有效且可靠的分期系统,可用于临床实践以及涉及所有阶段ARM患者的临床研究方案。

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