论文标题
选择引起的对比度估计（SICE）效应：试图量化某些患者选择标准在随机临床试验中的影响
Selection Induced Contrast Estimate (SICE) Effect: An Attempt to Quantify the Impact of Some Patient Selection Criteria in Randomized Clinical Trials
论文作者
论文摘要
定义试验的包含/排除（I/E）标准是试验设计中最重要的步骤之一。越来越复杂的I/E标准可能会在设计和运行试验的人们与消耗试验所产生的信息的人之间存在信息不平衡和透明度问题。为了更好地理解和量化I/E标准对观察到的治疗效果的影响，在本文中引入并制定了一个概念，称为选择诱导的对比度估计值（SICE）效应。当治疗影响用于选择的标记与感兴趣的响应之间的相关性时，可以在对照临床试验中存在SICE效应。模拟和实际临床试验数据都证明了这种效果。尽管已经对SICE效应背后的统计要素进行了充分的研究，但是明确制定和研究这种效果可以使多个领域受益，包括在I/E标准方面提高透明度，多个临床试验的荟萃分析，现实世界中医学实践中的治疗效果解释等。
Defining the Inclusion/Exclusion (I/E) criteria of a trial is one of the most important steps during a trial design. Increasingly complex I/E criteria potentially create information imbalance and transparency issues between the people who design and run the trials and those who consume the information produced by the trials. In order to better understand and quantify the impact of a category of I/E criteria on observed treatment effects, a concept, named the Selection Induced Contrast Estimate (SICE) effect, is introduced and formulated in this paper. The SICE effect can exist in controlled clinical trials when treatment affects the correlation between a marker used for selection and the response of interest. This effect is demonstrated with both simulations and real clinical trial data. Although the statistical elements behind the SICE effect have been well studied, explicitly formulating and studying this effect can benefit several areas, including better transparency in I/E criteria, meta-analysis of multiple clinical trials, treatment effect interpretation in real-world medical practice, etc.
