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用于新生血管性年龄相关性黄斑变性阿柏西普服务提供的有意义的中心间比较的质量标准的适宜性。

Appropriateness of quality standards for meaningful intercentre comparisons of aflibercept service provision for neovascular age-related macular degeneration.

作者信息

Talks J S, James P, Sivaprasad S, Johnston R L, McKibbin M

机构信息

Newcastle Eye Centre, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.

Institute of Health and Society, Newcastle University, Newcastle Upon Tyne, UK.

出版信息

Eye (Lond). 2017 Nov;31(11):1613-1620. doi: 10.1038/eye.2017.86. Epub 2017 Jun 23.

DOI:10.1038/eye.2017.86
PMID:28643799
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5684460/
Abstract

PurposeReal-world data give different information on health-care delivery compared with randomised controlled trials. We aimed to evaluate the appropriateness of possible quality standards for intersite comparisons of outcomes of providing Aflibercept for neovascular age-related macular degeneration (nAMD) in clinical practice.Patients and methodsRetrospective data analysis from an electronic medical record. A consecutive series of treatment-naive patients initiated on aflibercept for nAMD, in the UK from March 2013 to October 2015. Age, visual acuity (VA) at baseline and 1 year, and injection episodes were remotely extracted in an anonymised format.ResultsThe mean baseline VA was 54.3 letters, ranging from 51.3 to 58.1 between different centres, in 5620 eyes taken from 12 centres. Out of these, 3360 were initiated on treatment more than a year before. The percentage with <35 letters at baseline was 19.9-3% and that with >70 letters was 24.8-10.7%. Eyes with ≥70 letters at 1 year ranged from 20.2 to 42.9% and those with <35 ranged from 4.5 to 21.6% across different sites. Injection rates in 1 year varied from 5.5 to 8.6, and data available at 1 year also varied from 82.3 to 46.4%.ConclusionsSignificant variation was found between sites attempting to provide the same therapeutic regime. For fair comparisons between sites, we recommend that both VA measures and process measures, such as injection numbers, retention rates, and discharge policies, are used. More work is required to explain the differences. Such real-world data are not generated in the same way as a randomised clinical trial, and maybe best used to help improve service provision.

摘要

目的

与随机对照试验相比,真实世界数据能提供有关医疗服务的不同信息。我们旨在评估在临床实践中对新生血管性年龄相关性黄斑变性(nAMD)使用阿柏西普治疗的不同地点间结局进行比较时,可能的质量标准是否恰当。

患者和方法

对电子病历进行回顾性数据分析。2013年3月至2015年10月在英国,对一系列连续的初治nAMD患者开始使用阿柏西普治疗。以匿名形式远程提取年龄、基线和1年时的视力(VA)以及注射次数。

结果

来自12个中心的5620只眼中,平均基线VA为54.3字母,不同中心之间范围为51.3至58.1字母。其中,3360只眼在一年多以前开始治疗。基线时VA<35字母的比例为19.9 - 3%,VA>70字母的比例为24.8 - 10.7%。不同地点1年时VA≥70字母的眼比例为20.2%至42.9%,VA<35字母的眼比例为4.5%至21.6%。1年的注射率从5.5至8.6不等,1年时可用数据也从82.3%至46.4%不等。

结论

在尝试提供相同治疗方案的不同地点之间发现了显著差异。为了在不同地点之间进行公平比较,我们建议同时使用VA测量和过程测量,如注射次数、留存率和出院政策。需要做更多工作来解释这些差异。此类真实世界数据的产生方式与随机临床试验不同,可能最适合用于帮助改善服务提供。

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Real-World Evidence - What Is It and What Can It Tell Us?真实世界证据——它是什么以及能告诉我们什么?
N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216.
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Twelve-Month Outcomes of Ranibizumab vs. Aflibercept for Neovascular Age-Related Macular Degeneration: Data from an Observational Study.雷珠单抗与阿柏西普治疗新生血管性年龄相关性黄斑变性的 12 个月疗效观察:一项观察性研究数据。
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The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care.英国新生血管性年龄相关性黄斑变性数据库报告3:视力结果的中心间差异及确立实际护理指标
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Ranibizumab for the treatment of wet AMD: a summary of real-world studies.雷珠单抗治疗湿性年龄相关性黄斑变性:真实世界研究综述
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Two-year outcomes of "treat and extend" intravitreal therapy for neovascular age-related macular degeneration.“治疗与扩展”玻璃体腔注射治疗新生血管性年龄相关性黄斑变性的两年疗效。
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Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration.抗血管内皮生长因子疗法治疗湿性年龄相关性黄斑变性的多国真实世界经验
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A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study.一项在常规临床实践中对新生血管性年龄相关性黄斑变性患者使用0.5毫克雷珠单抗的为期2年的IV期多中心观察性研究:EPICOHORT研究。
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