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临床研究中用于白内障硬度分级的简单术前核分级评分(SPONCS)

A Simple Pre-Operative Nuclear Classification Score (SPONCS) for Grading Cataract Hardness in Clinical Studies.

作者信息

Mandelblum Jorge, Fischer Naomi, Achiron Asaf, Goldberg Mordechai, Tuuminen Raimo, Zunz Eran, Spierer Oriel

机构信息

Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv 6243906, Israel.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.

出版信息

J Clin Med. 2020 Oct 29;9(11):3503. doi: 10.3390/jcm9113503.

Abstract

BACKGROUND

The aim of this study was to evaluate whether a simplified pre-operative nuclear classification score (SPONCS) was valid, both for clinical trials and real-world settings.

METHODS

Cataract classification was based on posterior nuclear color: 0 (clear), 1 (subcapsular/posterior cataract with clear nucleus), 2 (mild "green nucleus" with plus sign for yellow reflection of the posterior cortex), 3 (medium "yellow nucleus" with plus sign for brown/red posterior cortex reflection), 4 (advanced with 4 being "red/brown nucleus" and 4+ white nucleus), and 5 (hypermature/Morgagnian nucleus). Inter- and intra-observer validity was assessed by 30 Ophthalmologists for 15 cataract cases. The reliability of the cataract grading score in a surgical setting was evaluated. Correlation of nuclear scores was compared with phacoemulsification cumulative dissipated energy (CDE) in 596 patients.

RESULTS

Analysis of mean intra-observer Cohen kappa agreement was 0.55 with an inter-observer score of 0.54 for the first assessment and 0.49 for the repeat assessment one week later. When evaluating results by nuclear color alone, there was a substantial agreement for both the intra-observer (0.70) and inter-observer parameters: 0.70 for the first test, and 0.66 on repetition with randomization of the cases after a week. CDE levels were found to be significantly different between all SPONCS score groups (p < 0.001), with a lower CDE related to a lower SPONCS score. A strong correlation was found between the SPONCS score and CDE (Spearman's rho = 0.8, p < 0.001).

CONCLUSION

This method of grading cataract hardness is both simple and repeatable. This system can be easily incorporated in randomized controlled trials to lower bias and confounding effects regarding nuclear density along with application in the clinical setting.

摘要

背景

本研究的目的是评估简化术前核分级评分(SPONCS)在临床试验和实际应用场景中是否有效。

方法

白内障分级基于晶状体后核颜色:0(透明)、1(晶状体后囊下/后发性白内障且核透明)、2(轻度“绿色核”,后皮质有黄色反光且有“+”号)、3(中度“黄色核”,后皮质有棕色/红色反光且有“+”号)、4(重度,4级为“红色/棕色核”,4+级为白色核)以及5(过熟期/莫尔加尼氏核)。30位眼科医生对15例白内障病例评估了观察者间和观察者内的有效性。评估了白内障分级评分在手术场景中的可靠性。比较了596例患者的核分级与超声乳化累积耗散能量(CDE)之间的相关性。

结果

首次评估时,观察者内平均科恩kappa一致性分析为0.55,观察者间评分为0.54;一周后的重复评估中,观察者间评分为0.49。仅根据核颜色评估结果时,观察者内(0.70)和观察者间参数(首次测试为0.70,一周后病例随机化重复测试为0.66)均有高度一致性。发现所有SPONCS评分组之间的CDE水平存在显著差异(p < 0.001),CDE越低,SPONCS评分越低。SPONCS评分与CDE之间存在强相关性(斯皮尔曼相关系数rho = 0.8,p < 0.001)。

结论

这种白内障硬度分级方法既简单又可重复。该系统可轻松纳入随机对照试验,以降低核密度相关的偏倚和混杂效应,并可应用于临床环境。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/917d/7694099/e9c3a0a0b715/jcm-09-03503-g001.jpg

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