Survival bias associated with time-to-treatment initiation in drug effectiveness evaluation: A comparison of methods
Survival bias associated with time-to-treatment initiation in drug effectiveness evaluation: A comparison of methods
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DOI：
10.1093/aje/kwi307
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发表时间：
2005-11-15
影响因子：
5
通讯作者：
Pilote, L
中科院分区：
文献类型：
--
作者：
Zhou, Z;Rahme, E;Pilote, L
作者使用加拿大魁北克省的医疗管理数据库（1996-2002 年），在药物有效性研究中比较了研究与开始治疗时间相关的生存偏差的五种方法。前两种方法说明了如何引入生存偏差。考虑了另外三种方法来控制这种偏差。在评估他汀类药物对出院后 90 天内开始服用他汀类药物和未服用他汀类药物的老年急性心肌梗死患者的二级预防方面的方法进行了比较。方法 1 在出院时将患者分为使用者和非使用者，导致对获益的高估（1 年相对风险降低 38%）。在方法 2 中，从第一次处方时起跟踪使用者，并从 0 至 90 天之间随机选择的时间中跟踪非使用者，将效果减弱至零（相对风险降低 10%）。方法 3 通过从 90 天时间窗口结束时跟踪患者来控制生存偏差；然而，它在统计效率和精确度方面遭受了重大损失。方法 4 在队列进入时匹配使用者和非使用者之间的处方时间分布。方法 5 使用时间相关变量来启动治疗。方法 4 和 5 更好地控制了生存偏差，并产生了相似的结果，表明复发性心肌梗塞或死亡事件的风险降低了 20%。
The authors compared five methods of studying survival bias associated with time-to-treatment initiation in a drug effectiveness study using medical administrative databases (1996-2002) from Quebec, Canada. The first two methods illustrated how survival bias could be introduced. Three additional methods were considered to control for this bias. Methods were compared in the context of evaluating statins for secondary prevention in elderly patients post-acute myocardial infarction who initiated statins within 90 days after discharge and those who did not. Method 1 that classified patients into users and nonusers at discharge resulted in an overestimation of the benefit (38% relative risk reduction at 1 year). In method 2, following users from the time of the first prescription and nonusers from a randomly selected time between 0 and 90 days attenuated the effect toward the null (10% relative risk reduction). Method 3 controlled for survival bias by following patients from the end of the 90-day time window; however, it suffered a major loss of statistical efficiency and precision. Method 4 matched prescription time distribution between users and nonusers at cohort entry. Method 5 used a time-dependent variable for treatment initiation. Methods 4 and 5 better controlled for survival bias and yielded similar results, suggesting a 20% risk reduction of recurrent myocardial infarction or death events.