OBSERVATIONAL ASPIRIN USE AND CVD IN THE PHS

此应用程序建议分析来自医生的现有数据 健康研究（PHS），一项低剂量的随机一级预防试验 阿司匹林和β-胡萝卜素在22,071名美国男性医生中进行， 讨论阿司匹林和心血管（CV）疾病相关问题 在随机阿司匹林治疗期间无法充分解决 期 阿司匹林部分的试验于2001年1月1日终止 25，1988年，由于阿司匹林对心肌的益处 梗塞 然而，在那个时候，中风和CV死亡的人数 试验参与者的经验不足以确定 评估这些终点。 试验中的β-胡萝卜素成分一直持续到 它计划于1996年12月结束。 在此期间 继续收集试验后阿司匹林使用的详细信息 通过年度问卷调查。 截至1995年10月， 包括心血管死亡在内的死亡人数从2000年的2000年增加了四倍， 在随机阶段，中风的数量增加了， 3.5次 因此，我们建议使用随机阿司匹林 试验后的观察期，以评估 阿司匹林使用对心血管疾病和总死亡率的影响， 阿司匹林使用对后续卒中和MI的长期影响。 拟议的方法将包括分析两种随机阿司匹林 分配和随时间变化的阿司匹林使用情况， 问卷调查 由于潜在的偏见， 阿司匹林的使用，特别是在观察期间，必须服用 的理由：建筑 分析将包括使用比例风险模型 考虑到阿司匹林使用的时变效应和控制 对于随时间变化的混杂因素，以及使用 因果建模

This application proposes to analyze existing data from the Physicians Health Study (PHS), a randomized primary prevention trial of low-dose aspirin and beta carotene conducted among 22,071 U.S. male physicians, to address questions concerning aspirin and cardiovascular (CV) disease that could not adequately be addressed during the randomized aspirin period. The aspirin component of the trial was terminated on January 25, 1988, due to a demonstrated benefit of aspirin on myocardial infarction. At that time, however, the number of strokes and CV deaths experienced by trial participants was inadequate to definitively evaluate these endpoints. The beta carotene component of the trial continued uninterrupted until its scheduled termination in December, 1996. During this period detailed information continued to be collected on post-trial aspirin use through annual questionnaires. As of October, 1995, the number of deaths, including cardiovascular deaths, had increased fourfold from that in the randomized period, and the number of strokes had increased 3.5 times. We thus propose to use data from both the randomized aspirin period and the observational period following the trial to assess the impact of aspirin use on cardiovascular and total mortality, and the long-term impact of aspirin use on subsequent stroke and MI. The proposed methods will include analyses of both randomized aspirin assignment and of time-varying aspirin use, as assessed on the annual questionnaires. Because of the potential for bias, the propensity for aspirin use, particularly during the observational period must be taken into account. Analyses will include use of proportional hazards models allowing for both time-varying effects of aspirin use and controlling for time-varying confounders, as well as more complex procedures using causal modeling.