Does additional confounder information alter the estimated risk of bleeding associated with phenprocoumon use—results of a two‐phase study

Does additional confounder information alter the estimated risk of bleeding associated with phenprocoumon use—results of a two‐phase study
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额外的混杂信息是否会改变与苯丙香豆素使用相关的估计出血风险——两阶段研究的结果

DOI:
10.1002/pds.3193
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发表时间:
2012
影响因子:
2.6
通讯作者:
Pigeot
Pigeot
中科院分区:
医学4区
文献类型:
--
作者:
Schill;Pigeot

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目的索赔数据库是药物流行病学研究的重要来源,但它们往往缺乏一些混杂因素的信息。两阶段的方法被用来估计出血风险与苯丙香豆素治疗的索赔数据结合额外的信息,身体质量指数(BMI)和smoking.MethodsWe进行了巢式病例对照研究,使用索赔数据从2004年至2007年(第1阶段)。从对505名被保险人的访谈中获得了更多信息(第2阶段)。使用来自完整病例对照数据集的数据,使用logistic回归计算校正的出血OR。此外,进行了两个阶段的分析,考虑到第2阶段的数据BMI和smoking.ResultsThe阶段1样本包括1248例和24 960对照。在第1阶段,我们观察到55岁男性受试者服用苯丙香豆素的校正出血OR为3.93(95%CI:2.75-5.61)。与苯丙香豆素使用相关的出血风险随着年龄的增加而降低。两阶段分析显示吸烟和高BMI是出血的风险因素。从两阶段分析中获得的苯丙香豆素的OR与第一阶段估计值的大小相似。Discussion 2阶段数据增加了有关吸烟和BMI的有价值信息。然而,在考虑了2期信息后,1期结果没有显著变化,这对数据库研究的有效性是令人放心的。版权所有© 2012约翰威利父子有限公司.
PurposeClaims databases are an important source for pharmacoepidemiological studies although they often lack information on some confounders. Two‐phase methodology was used to estimate the bleeding risk in patients treated with phenprocoumon from claims data combined with additional information on body mass index (BMI) and smoking.MethodsWe conducted a nested case–control study using claims data from 2004 to 2007 (phase 1). Additional information was obtained from interviews in a subset of 505 insurants (phase 2). Adjusted bleeding OR were calculated using logistic regression using data from the complete case–control dataset. Furthermore, a two‐phase analysis was conducted, taking into consideration phase 2 data on BMI and smoking.ResultsThe phase 1 sample included 1248 cases and 24 960 controls. In phase 1, we observed an adjusted bleeding ORs of 3.93 (95%CI: 2.75–5.61) for male subjects aged 55 years taking phenprocoumon. The bleeding risk associated with phenprocoumon use decreased with increasing age. The two‐phase analysis revealed smoking and a high BMI as risk factors for bleeding. The OR for phenprocoumon obtained from the two‐phase analysis was of similar size as the phase 1 estimate.DiscussionPhase 2 data added valuable information on smoking and BMI. However, phase 1 results did not change dramatically after accounting for phase 2 information, which is reassuring for the validity of database studies. Copyright © 2012 John Wiley & Sons, Ltd.
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