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德国视网膜网早产儿视网膜病变(ROP)登记处和欧盟-ROP 登记处输入参数的可比性——2011 年至 2021 年的示例比较。

Comparability of input parameters in the German Retina.net ROP registry and the EU-ROP registry - An exemplary comparison between 2011 and 2021.

机构信息

Department of Ophthalmology, University Medicine Greifswald, Greifswald, Germany.

Department of Ophthalmology, Vivantes Klinikum Neukoelln, Berlin, Germany.

出版信息

Acta Ophthalmol. 2024 May;102(3):e314-e321. doi: 10.1111/aos.15753. Epub 2023 Sep 19.

DOI:10.1111/aos.15753
PMID:37725047
Abstract

PURPOSE

The German Retina.net ROP registry and its Europe-wide successor, the EU-ROP registry, collect data from patients treated for ROP. This analysis compares input parameters of these two registries to establish a procedure for joint analyses of different registry data using exemplary datasets from the two registries.

METHODS

Exemplary datasets from the two databases over a 1-year period each (German Retina.net ROP Registry, 2011, 22 infants; EU-ROP Registry, 2021, 44 infants) were compared. The parameters documented in the two databases were aligned and analysed regarding demographic parameters, treatment modalities, complications within first 24 h and retreatments.

RESULTS

The current analysis showed that data can be aligned for joint analyses with some adjustments within the data structure. The registry with more detailed data collection (EU-ROP) needs to be reduced regarding granularity in order to align the different registries, as the registry with lower granularity determines the level of analyses that can be performed in a comparative approach. In the exemplary datasets, we observed that the overall most common ROP severity in both registries was zone II, 3+ (2011: 70.5%; 2021: 65%), with decreasing numbers of clock hours showing preretinal neovascularisations (2011: 10-12 clock hours in 29% of cases, 2021: 4-6 clock hours in 38%). The most prevalent treatment method was laser coagulation in 2011 (75%) and anti-VEGF therapy in 2021 (86.1%). Within the anti-VEGF group, all patients were treated with bevacizumab in 2011 and with ranibizumab in 2021. Retreatment rates were comparable in 2011 and 2021.

CONCLUSION

Data from two different ROP registries can be aligned and jointly analysed. The analysis reveals a paradigm shift in treatment modalities, from predominantly laser to anti-VEGF, and within the anti-VEGF group from bevacizumab to ranibizumab in Germany. In addition, there was a trend towards earlier treatment in 2021.

摘要

目的

德国视网膜病变网络(Retina.net ROP)登记处及其在欧洲范围内的后续项目欧盟-ROP 登记处收集了接受 ROP 治疗的患者的数据。本分析比较了这两个登记处的输入参数,以建立使用这两个登记处的示例数据集联合分析不同登记处数据的程序。

方法

比较了这两个数据库中各为期一年的示例数据集(德国视网膜病变网络 ROP 登记处,2011 年,22 例婴儿;欧盟-ROP 登记处,2021 年,44 例婴儿)。比较了两个数据库中记录的参数,分析了人口统计学参数、治疗方式、24 小时内的并发症和再治疗。

结果

本分析表明,可以通过在数据结构中进行一些调整来对齐数据,以便进行联合分析。数据采集更详细的登记处(欧盟-ROP)需要在粒度方面进行缩减,以便对齐不同的登记处,因为粒度较低的登记处决定了在比较方法中可以进行的分析水平。在示例数据集中,我们观察到两个登记处中最常见的 ROP 严重程度均为二区 3+(2011 年:70.5%;2021 年:65%),随着视网膜前新生血管数量的减少(2011 年:29%的病例中有 10-12 个时钟小时,2021 年:38%的病例中有 4-6 个时钟小时)。最常见的治疗方法是 2011 年的激光凝固术(75%)和 2021 年的抗血管内皮生长因子治疗(86.1%)。在抗血管内皮生长因子组中,2011 年所有患者均接受贝伐单抗治疗,2021 年均接受雷珠单抗治疗。2011 年和 2021 年的再治疗率相似。

结论

来自两个不同 ROP 登记处的数据可以对齐并联合分析。该分析揭示了治疗方式的范式转变,从主要的激光治疗转变为抗血管内皮生长因子治疗,在抗血管内皮生长因子组中,从贝伐单抗转变为雷珠单抗。此外,2021 年的治疗开始时间呈提前趋势。

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