临床试验中的敏感性分析教程：内容、原因、时机和方法。
A tutorial on sensitivity analyses in clinical trials: the what, why, when and how.
机构信息
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
出版信息
BMC Med Res Methodol. 2013 Jul 16;13:92. doi: 10.1186/1471-2288-13-92.
BACKGROUND
Sensitivity analyses play a crucial role in assessing the robustness of the findings or conclusions based on primary analyses of data in clinical trials. They are a critical way to assess the impact, effect or influence of key assumptions or variations--such as different methods of analysis, definitions of outcomes, protocol deviations, missing data, and outliers--on the overall conclusions of a study.The current paper is the second in a series of tutorial-type manuscripts intended to discuss and clarify aspects related to key methodological issues in the design and analysis of clinical trials.
DISCUSSION
In this paper we will provide a detailed exploration of the key aspects of sensitivity analyses including: 1) what sensitivity analyses are, why they are needed, and how often they are used in practice; 2) the different types of sensitivity analyses that one can do, with examples from the literature; 3) some frequently asked questions about sensitivity analyses; and 4) some suggestions on how to report the results of sensitivity analyses in clinical trials.
SUMMARY
When reporting on a clinical trial, we recommend including planned or posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.
背景
敏感性分析在评估临床试验中基于主要数据分析得出的结果或结论的稳健性方面起着至关重要的作用。它们是评估关键假设或变化对研究整体结论的影响、效果或影响的重要方法，例如不同的分析方法、结果定义、方案偏离、缺失数据和离群值。本文是一系列教程类型的手稿中的第二篇，旨在讨论和澄清临床试验设计和分析中关键方法学问题的各个方面。
讨论
在本文中，我们将详细探讨敏感性分析的关键方面，包括：1）什么是敏感性分析，为什么需要它们，以及它们在实践中使用的频率；2）可以进行的不同类型的敏感性分析，并举例说明文献中的例子；3）一些关于敏感性分析的常见问题；以及 4）关于如何在临床试验中报告敏感性分析结果的一些建议。
总结
在报告临床试验时，我们建议包括计划或事后敏感性分析、相应的基本原理和结果，以及讨论这些分析对研究整体结果的影响。
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