Rose Sherri, Normand Sharon-Lise
Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, U.S.A.
Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, U.S.A.
Biometrics. 2019 Mar;75(1):289-296. doi: 10.1111/biom.12927. Epub 2018 Jul 13.
Postmarket comparative effectiveness and safety analyses of therapeutic treatments typically involve large observational cohorts. We propose double robust machine learning estimation techniques for implantable medical device evaluations where there are more than two unordered treatments and patients are clustered in hospitals. This flexible approach also accommodates high-dimensional covariates drawn from clinical databases. The Massachusetts Data Analysis Center percutaneous coronary intervention cohort is used to assess the composite outcome of 10 drug-eluting stents among adults implanted with at least one drug-eluting stent in Massachusetts. We find remarkable discrimination between stents. A simulation study designed to mimic this coronary intervention cohort is also presented and produced similar results.
治疗性治疗的上市后比较有效性和安全性分析通常涉及大型观察性队列。我们提出了双稳健机器学习估计技术,用于可植入医疗设备评估,其中存在两种以上无序治疗且患者在医院中聚类。这种灵活的方法还适用于从临床数据库中提取的高维协变量。马萨诸塞州数据分析中心经皮冠状动脉介入治疗队列用于评估马萨诸塞州至少植入一个药物洗脱支架的成年人中10种药物洗脱支架的复合结局。我们发现支架之间存在显著的区分度。还介绍了一项旨在模拟该冠状动脉介入治疗队列的模拟研究,并得出了类似的结果。