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临床试验中的盲法:见大图景。

Blinding in Clinical Trials: Seeing the Big Picture.

机构信息

Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.

Division of Cardiovascular Medicine, Department of Medicine, SUNY Downstate Health Sciences University, Brooklyn, NY 11203, USA.

出版信息

Medicina (Kaunas). 2021 Jun 24;57(7):647. doi: 10.3390/medicina57070647.

Abstract

Blinding mitigates several sources of bias which, if left unchecked, can quantitively affect study outcomes. Blinding remains under-utilized, particularly in non-pharmaceutical clinical trials, but is often highly feasible through simple measures. Although blinding is generally viewed as an effective method by which to eliminate bias, blinding does also pose some inherent limitations, and it behooves clinicians and researchers to be aware of such caveats. This article will review general principles for blinding in clinical trials, including examples of useful blinding techniques for both pharmaceutical and non-pharmaceutical trials, while also highlighting the limitations and potential consequences of blinding. Appropriate reporting on blinding in trial protocols and manuscripts, as well as future directions for blinding research, will also be discussed.

摘要

盲法可以减轻多种可能会对研究结果产生定量影响的偏倚来源。盲法的应用仍然不足,特别是在非药物临床试验中,但通过简单的措施通常就可以实现高度盲法。尽管盲法通常被视为消除偏倚的有效方法,但盲法本身也存在一些固有局限性,因此临床医生和研究人员有必要了解这些注意事项。本文将回顾临床试验中盲法的一般原则,包括药物和非药物试验中有用的盲法技术示例,同时还强调盲法的局限性和潜在后果。本文还将讨论试验方案和手稿中盲法报告的适当性,以及盲法研究的未来方向。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70a3/8308085/2530ec8ec94d/medicina-57-00647-g001.jpg

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