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随机临床试验与观察性研究:评估各自优势与局限性的指南

Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations.

作者信息

Hannan Edward L

机构信息

SUNY University at Albany, School of Public Health, Rensselaer, New York 12144-3456, USA.

出版信息

JACC Cardiovasc Interv. 2008 Jun;1(3):211-7. doi: 10.1016/j.jcin.2008.01.008.

DOI:10.1016/j.jcin.2008.01.008
PMID:19463302
Abstract

The 2 primary types of studies that are used to test new drugs or procedures or compare competing drugs or types of procedures are randomized clinical trials (RCTs) and observational studies (OS). Although it would appear that RCTs always trump OS because they eliminate selection bias, there are many possible limitations to both types of studies, and these limitations must be carefully assessed when comparing the results of RCTs and OS. This state-of-the art review describes these limitations and discusses how to assess the validity of RCTs and OS that yield different conclusions regarding the relative merit of competing treatments/interventions.

摘要

用于测试新药或新程序或比较竞争性药物或程序类型的两种主要研究类型是随机临床试验(RCT)和观察性研究(OS)。尽管似乎随机临床试验总是胜过观察性研究,因为它们消除了选择偏倚,但这两种研究类型都有许多可能的局限性,在比较随机临床试验和观察性研究的结果时,必须仔细评估这些局限性。这篇前沿综述描述了这些局限性,并讨论了如何评估随机临床试验和观察性研究的有效性,这些研究对于竞争性治疗/干预措施的相对优点得出了不同的结论。

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