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Could real-world data replace evidence from clinical trials in surgical retinal conditions?
British Journal of Ophthalmology ( IF 4.1 ) Pub Date : 2022-08-01 , DOI: 10.1136/bjophthalmol-2022-321759
Rodrigo Anguita 1 , David Charteris 2
Affiliation  

Vitreoretinal surgeons have a range of procedures available to treat primary rhegmatogenous retinal detachment (RD) and decisions on which approach to take relate to the training and skill set of the individual surgeon and their assessment of the published literature. Randomised controlled trials (RCT) are uncommon in the surgical management of RD and most published work is on smaller, often retrospective, studies or analyses of centralised databases both of which have inherent limitations. RCT remain the gold standard for evaluating treatments and providing the highest level evidence-based medicine in clinical research; however, they are expensive, resource intensive and time-consuming.1 2 Study design, selection of the study population, compliance and, in relation to vitreoretinal surgery, the pre-existing surgical skill set and preferences of participating surgeons are of critical importance to the eventual relevance of the results of RCTs to clinical practice and the failure to adequately plan and implement these elements can lead to limitations in interpreting the data and drawing valid conclusions.1 Real-world data studies are fundamental to monitor postmarked safety and adverse events and to make regulatory decisions. They can also support clinical trials and generate observational studies to inform new treatment approaches.3 The statistical methods used in the analysis of real-world data should be considered when interpreting results. Propensity score matching is a …

中文翻译:

真实世界的数据能否取代手术视网膜疾病临床试验的证据?

玻璃体视网膜外科医生有一系列可用于治疗原发性孔源性视网膜脱离 (RD) 的程序,以及关于采取哪种方法的决定与个体外科医生的培训和技能组合以及他们对已发表文献的评估有关。随机对照试验 (RCT) 在 RD 的手术治疗中并不常见,并且大多数已发表的工作都是针对集中式数据库的较小的、通常是回顾性的研究或分析,这两者都有固有的局限性。RCT 仍然是评估治疗和在临床研究中提供最高水平循证医学的黄金标准;然而,它们价格昂贵、资源密集且耗时。1 2 研究设计、研究人群的选择、依从性以及与玻璃体视网膜手术相关的 参与外科医生的预先存在的手术技能和偏好对于 RCT 结果与临床实践的最终相关性至关重要,而未能充分规划和实施这些要素可能会导致解释数据和得出有效结论的局限性.1 真实世界的数据研究对于监测已标记的安全性和不良事件以及做出监管决策至关重要。它们还可以支持临床试验并生成观察性研究,为新的治疗方法提供信息。3 在解释结果时应考虑用于分析真实世界数据的统计方法。倾向得分匹配是一个…… 1 真实世界的数据研究对于监测已标记的安全性和不良事件以及做出监管决策至关重要。它们还可以支持临床试验并生成观察性研究,为新的治疗方法提供信息。3 在解释结果时应考虑用于分析真实世界数据的统计方法。倾向得分匹配是一个…… 1 真实世界的数据研究对于监测已标记的安全性和不良事件以及做出监管决策至关重要。它们还可以支持临床试验并生成观察性研究,为新的治疗方法提供信息。3 在解释结果时应考虑用于分析真实世界数据的统计方法。倾向得分匹配是一个……
更新日期:2022-07-21
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