Evaluating Cardiovascular Devices Using Observational Analyses.

With the proliferation of large electronic databases, there has been increasing interest in using observational analyses to also examine the comparative effectiveness of devices.

随着大型电子数据库的激增，人们越来越有兴趣使用观察性分析来研究设备的比较有效性。

However, these analyses are often met with skepticism because of concerns about whether they can generate credible evidence about causal effects.

然而，这些分析常常受到怀疑，因为人们担心它们是否能够产生关于因果效应的可信证据。

This is in part a result of the difficulty in meeting the assumptions necessary to interpret observational associations as causal effects and of the wide variability in analytic rigor.

这在一定程度上是由于难以满足将观察性关联解释为因果效应所必需的假设，以及分析严谨性存在巨大差异。

In this review, we outline frameworks and review methods for using observational analyses to answer questions about the effectiveness and safety of cardiovascular devices.

在这篇综述中，我们概述了使用观察性分析回答有关心血管设备有效性和安全性问题的框架和审查方法。

We highlight the target trial framework as a practical tool for guiding observational comparative effectiveness analyses.

我们强调了目标试验框架作为指导观察性比较有效性分析的实用工具。

We illustrate how the framework allows investigators planning and conducting observational analyses to organize their activities as responses to 3 prompting questions.

我们展示了该框架如何允许研究人员规划和进行观察性分析，将他们的活动组织为对3个提示性问题的回应。

First, what is the research question of the study (ie, "What do we want?")?

首先，研究的研究问题是什么（即，“我们想要什么？”）？

Second, what are the resources-including background knowledge, research concepts, principles and methods, and available data-that can be brought to bear on the research question (ie, "What do we have?")?

其次，哪些资源——包括背景知识、研究概念、原则和方法以及可用数据——可以用来解决研究问题（即“我们拥有什么？”）？

And third, what specific steps should be taken to use the available resources to answer the research question (ie, "What do we do?")?

第三，应该采取哪些具体步骤来使用可用资源回答研究问题（即“我们该怎么做？”）？

We focus our exposition on the evaluation of cardiovascular devices, for which randomized trial data are often limited and there is a strong need for real-world evidence.

我们将重点阐述心血管器械的评估，对于这些器械，随机试验数据往往有限，而真实世界证据的需求非常强烈。

In this setting, real-world evidence is usually derived from observational comparisons of the treatment of interest with relevant comparator groups using data captured during routine care.

在这种情况下，真实世界证据通常来源于使用常规护理过程中捕获的数据，对感兴趣的治疗与相关对照组进行观察性比较。

A principled approach to the planning and conduct of observational analyses can improve the quality of real-world evidence generation and ensure that the results of observational studies on medical devices can support meaningful conclusions about the risks and benefits of new devices.

通过有原则地规划和执行观察性分析，可以提高真实世界证据生成的质量，并确保关于医疗器械的观察性研究结果能够支持关于新设备风险和益处的有意义结论。