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首页> 外文期刊>Journal of biopharmaceutical statistics >Discussion of: Statistical and Regulatory Issues with the Application of Propensity Score Analysis to Nonrandomized Medical Device Clinical Studies
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Discussion of: Statistical and Regulatory Issues with the Application of Propensity Score Analysis to Nonrandomized Medical Device Clinical Studies

机译:讨论:倾向得分分析在非随机医疗器械临床研究中的统计和监管问题

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摘要

Lilly Yue's article on Statistical and Regulatory Issues with the Application of Propensity Score Analysis to nonrandomized Medical Device Clinical Studies provides a nice overview of some of the issues that are confronted when using propensity scores in regulatory applications. There has been much written about propensity scores (D'Agostino Jr., 1998; D'Agostino Jr. and Rubin, 2000; Rosenbaum and Rubin, 1983, 1984), but this article addresses an important application of the technique in a field where its use is continuing to grow. This discussion will focus on several issues that were raised in the article. In particular, we will discuss (1) the implications of having nonoverlapping covariate (or propensity score) distributions between treatment groups, (2) some additional issues to consider when covariates included in the propensity score model have missing data; and (3) the possibility of using propensity score approaches even in randomized clinical trials.
机译:Lilly Yue的文章将倾向得分分析应用于非随机医疗器械临床研究中的统计和监管问题,很好地概述了在监管应用中使用倾向得分时遇到的一些问题。关于倾向得分的文献很多(D'Agostino Jr.,1998年; D'Agostino Jr.和Rubin,2000年; Rosenbaum和Rubin,1983年,1984年),但本文探讨了该技术在以下领域的重要应用:它的使用正在继续增长。讨论将集中在文章中提出的几个问题上。特别是,我们将讨论(1)在治疗组之间具有不重叠的协变量(或倾向得分)分布的含义,(2)当倾向得分模型中包含的协变量缺少数据时要考虑的其他一些问题; (3)即使在随机临床试验中也可能使用倾向评分法。

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