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骨科等效性试验是否优于传统的比较性研究方法?

Do Equivalence Trials Display Superiority Over the Traditional Comparative Study Methods in Orthopedic Surgery?

机构信息

National Spinal Injuries Unit, Department of Trauma & Orthopaedic Surgery, Mater Misericordiae University Hospital.

School of Medicine, Trinity College Dublin.

出版信息

Clin Spine Surg. 2020 Jun;33(5):201-204. doi: 10.1097/BSD.0000000000000978.

Abstract

Superiority and equivalence trials are 2 commonly encountered methods of designing randomized controlled trials. Traditionally, the goal of a randomized controlled trial is to show superiority. However, in more recent times, there has been a tendency to show equivalence in clinical randomized trials. These differing conclusions at first glance seem to be drawn on the basis of the results of the respective trials. However, to accurately reach these conclusions, there are stark contrasts in the methodologies of these different study types. This article provides a brief overview of superiority and equivalence trials, highlights the differences between the 2, and their relevance to orthopedic surgery.

摘要

优效性和等效性试验是设计随机对照试验中两种常见的方法。传统上,随机对照试验的目的是显示优越性。然而,在最近的一段时间里,在临床随机试验中出现了等效性的趋势。乍一看,这些不同的结论似乎是基于各自试验的结果得出的。然而,为了准确得出这些结论,这些不同研究类型的方法学存在着明显的差异。本文简要概述了优效性和等效性试验,强调了两者之间的差异及其与骨科手术的相关性。

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