A modified self-controlled case series method to examine association between multidose vaccinations and death
A modified self-controlled case series method to examine association between multidose vaccinations and death
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DOI：
10.1002/sim.4120
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发表时间：
2011-03-15
影响因子：
2
通讯作者：
Farrington, C. Paddy
中科院分区：
文献类型：
--
作者：
Kuhnert, Ronny;Hecker, Hartmut;Farrington, C. Paddy
自我对照病例序列方法(SCCS)被用来分析时变暴露与结果事件之间的关联。我们认为五价或六价疫苗接种是暴露，不明原因的意外死亡(USUD)是事件。多次曝光和终端事件的特殊情况要求采用标准的SCCS方法。本文提出了一种新的自适应方法，即根据疫苗接种计划截断观察期。新方法利用已知的连续疫苗剂量之间的最小间隔。它的优点是，它的应用比最近引入的审查、干扰或减少事后曝光的方法简单得多。本文通过仿真研究和在实际数据集上的应用，对这两种SCCS方法进行了比较。在模拟研究中，年龄分布和假设的疫苗接种时间表是基于真实数据。两种SCCS方法之间只观察到很小的差异，尽管50%的病例不能包括在截断观察期的SCCS方法的分析中。通过一项包括300 uSUD的研究，可以检测到在第四次注射后风险增加16倍，威力至少为90%。接种疫苗后风险一般增加2倍，可检测到80%的威力。对德国婴儿猝死病例对照研究(GeSID)病例的数据进行重新分析后，使用SCCS方法得出的点数估计值略高于病例对照分析得出的优势比。版权所有(C)2010 John Wiley&Sons，Ltd.
The self-controlled case series method (SCCS) was developed to analyze the association between a time-varying exposure and an outcome event. We consider penta-or hexavalent vaccination as the exposure and unexplained sudden unexpected death (uSUD) as the event. The special situation of multiple exposures and a terminal event requires adaptation of the standard SCCS method. This paper proposes a new adaptation, in which observation periods are truncated according to the vaccination schedule. The new method exploits known minimum spacings between successive vaccine doses. Its advantage is that it is very much simpler to apply than the method for censored, perturbed or curtailed post-event exposures recently introduced. This paper presents a comparison of these two SCCS methods by simulation studies and an application to a real data set. In the simulation studies, the age distribution and the assumed vaccination schedule were based on real data. Only small differences between the two SCCS methods were observed, although 50 per cent of cases could not be included in the analysis with the SCCS method with truncated observation periods. By means of a study including 300 uSUD, a 16-fold risk increase after the 4th dose could be detected with a power of at least 90 per cent. A general 2-fold risk increase after vaccination could be detected with a power of 80 per cent. Reanalysis of data from cases of the German case-control study on sudden infant death (GeSID) resulted in slightly higher point estimates using the SCCS methods than the odds ratio obtained by the case-control analysis. Copyright (C) 2010 John Wiley & Sons, Ltd.