评估与他汀类药物使用相关的最易患II型糖尿病的亚组：来自电子健康记录数据的证据
Assessing the Most Vulnerable Subgroup to Type II Diabetes Associated with Statin Usage: Evidence from Electronic Health Record Data
摘要：
他汀类药物是治疗冠状动脉疾病最常用的处方药之一，人们越来越担心使用他汀类药物可能与新发II型糖尿病（T2D）的风险增加有关。然而，到目前为止，没有强有力的证据支持是否以及什么样的人群在服用他汀类药物后确实容易发生T2D。在本案例研究中，利用合作伙伴卫生系统中的生物库和电子健康记录数据，我们引入了一种新的数据分析管道和一种新颖的统计方法学，通过以下方式解决现有的局限性：（i）设计一个严格的因果框架，系统地检查他汀类药物使用对观察数据中T2D风险的因果影响，（ii）揭示哪个患者亚组在服用他汀类药物后最易发生T2D，以及（iii）通过自助校准程序评估最易发生亚组的可重复性和统计学显著性。我们提出的方法提供了渐近尖锐的置信区间和去偏估计的处理效应的最脆弱的亚组中存在的高维协变量。通过我们提出的方法，我们发现具有高T2D遗传风险的女性由于使用他汀类药物而患T2D的风险最高。
英文摘要：
There have been increased concerns that the use of statins, one of the most commonly prescribed drugs for treating coronary artery disease, is potentially associated with the increased risk of new-onset type II diabetes (T2D). Nevertheless, to date, there is no robust evidence supporting as to whether and what kind of populations are indeed vulnerable for developing T2D after taking statins. In this case study, leveraging the biobank and electronic health record data in the Partner Health System, we introduce a new data analysis pipeline and a novel statistical methodology that address existing limitations by (i) designing a rigorous causal framework that systematically examines the causal effects of statin usage on T2D risk in observational data, (ii) uncovering which patient subgroup is most vulnerable for developing T2D after taking statins, and (iii) assessing the replicability and statistical significance of the most vulnerable subgroup via a bootstrap calibration procedure. Our proposed approach delivers asymptotically sharp confidence intervals and debiased estimate for the treatment effect of the most vulnerable subgroup in the presence of high-dimensional covariates. With our proposed approach, we find that females with high T2D genetic risk are at the highest risk of developing T2D due to statin usage.
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