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Randomized controlled trials (RCTs) remain the gold standard for assessing the efficacy or safety of a given medication or intervention, with RCT data at the top of the hierarchy of evidence. By design, the randomization process eliminates the risk of selection bias and ensures that RCTs are unconfounded, thereby avoiding important sources of bias that are particularly challenging to control for in observational studies.

随机对照试验（RCT）仍然是评估给定药物或干预措施的有效性或安全性的金标准，RCT数据处于证据层次的顶部。通过设计，随机化过程消除了选择偏倚的风险，并确保随机对照试验不受限制，从而避免了观察性研究中特别难以控制的重要偏倚来源。

However, conducting an RCT might not always be feasible owing to various constraints — the study might be unethical, too expensive, or too complex to design and monitor. RCTs might also lack generalizability, which is an important barrier in nephrology because patients with reduced kidney function are often excluded from trials.

然而，由于各种限制，进行随机对照试验可能并不总是可行的-这项研究可能不道德，成本过高，或者设计和监测过于复杂。随机对照试验也可能缺乏普遍性，这是肾脏病学的一个重要障碍，因为肾功能降低的患者通常被排除在试验之外。

In these situations, observational studies represent an alternative, making use of the increasing amount of routinely collected administrative and health-care data and benefiting from the advantage of being implemented in real-world settings, thereby increasing their generalization potential. However, observational studies are more susceptible to confounding effects and bias than RCTs.By applying the design of an RCT to observational data, the target trial emulation (TTE) framework aims to get the best of both worlds and limit the introduction of biases that often affect observational research, such as the prevalent-user bias and immortal-time biases.

在这些情况下，观察性研究是一种替代方法，它利用了越来越多的常规收集的行政和保健数据，并受益于在现实环境中实施的优势，从而增加了它们的推广潜力。然而，观察性研究比随机对照试验更容易受到混杂效应和偏倚的影响。通过将随机对照试验的设计应用于观测数据，目标试验模拟（TTE）框架旨在充分利用两个世界，并限制引入经常影响观测研究的偏见，例如普遍存在的用户偏见和不朽的时间偏见。

This approach is being increasingly and successfully used, including in kidney research1,2. Emulating a trial from observational data essentially involves writing the protocol of a hypothetical trial that would answer the research question, explicitly specifying each one of its components (for instance, eligibility criteria, treatment strategies and modalities of treatment assignme.

这种方法正在越来越多地成功使用，包括在肾脏研究中1,2。从观察数据模拟试验基本上涉及编写一个假设试验的方案，以回答研究问题，明确指定其每个组成部分（例如，资格标准，治疗策略和治疗分配方式）。

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Fig. 1: The clone–censor–weight approach within the target trial emulation.

图1:target试验仿真中的克隆-审查-权重方法。

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Download referencesAuthor informationAuthors and AffiliationsHoriana, Bordeaux, FranceEmilie LambourgDivision of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, UKEmilie LambourgAuthorsEmilie LambourgView author publicationsYou can also search for this author in.

下载参考文献作者信息作者和附属机构波尔多，弗朗西埃米莉·兰堡，邓迪大学医学院，人口健康与基因组学系，邓迪，UKEmilie LambourgAuthorsEmilie LambourgView作者出版物您也可以在中搜索这位作者。

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Rights and permissionsReprints and permissionsAbout this articleCite this articleLambourg, E. Improving the quality of pharmacoepidemiological studies using the target trial emulation framework.

权利和许可打印和许可本文引用本文Lambourg，E。使用target试验模拟框架提高药物流行病学研究的质量。

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