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The association between multidose vaccinations and death: comparing case series methods when the first exposure changes the general risk of an event

机译：多剂量疫苗接种与死亡之间的关联：首次暴露改变事件总体风险时比较病例系列方法

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Many case-control studies have shown a protective effect of vaccinations on the risk of sudden unexplained death (SUD). In this paper we compare the properties of different statistical methods in this situation, when the first vaccination appears to reduce the overall risk of an event (SUD). The first method is the self controlled case series (SCCS) method, which considers only subjects with an event during the observation time. This method yields unbiased estimates in the situation of non-censoring events. We show by simulation studies that the second method considered, the adjusted SCCS method, underestimates the parameter of interest, the effect of the first dose, when the general risk of SUD is lower in control periods after the first vaccination than in the period before vaccination. This type of bias could be eliminated by considering only cases who had received at least one vaccination. Additionally, we compare the adjusted SCCS method with the Cox model as a third method. Cox regression can take into account the time before the first vaccination, and this method yields unbiased estimates at modest effect sizes and short risk periods. We applied the SCCS method and Cox regression to data from the German study on sudden infant death (GeSID) and to a case series study from Italy (the HERA study) examining sudden unexpected deaths and vaccinations during the first 2 years of life. We show that the adjusted SCCS analysis with all cases underestimates the vaccination effect, as expected from the simulation analyses. Using Cox regression, we examined the general risk reduction after vaccination, as was the focus of the above mentioned studies. With a relative incidence of 0.8, our results were less pronounced than in the case-control analysis of the GeSID study (adjusted odds ratio: 0.51). SCCS analyses of both the GeSID and HERA studies yielded very similar estimates for the first and second vaccine doses.
机译：许多病例对照研究表明，疫苗接种对猝死原因不明（SUD）的风险具有保护作用。在本文中，当首次接种疫苗似乎可以降低事件的总体风险（SUD）时，我们将比较这种情况下不同统计方法的特性。第一种方法是自控案例系列（SCCS）方法，该方法仅考虑观察期内发生事件的受试者。在非审查事件的情况下，此方法得出无偏估计。我们通过仿真研究表明，当在第一次疫苗接种后的控制期内SUD的一般风险低于疫苗接种前的时期时，所考虑的第二种方法（调整后的SCCS方法）低估了相关参数，第一剂的效果。通过仅考虑至少接受过一次疫苗接种的病例，可以消除这种偏见。此外，我们将调整后的SCCS方法与Cox模型作为第三种方法进行比较。 Cox回归可以考虑第一次疫苗接种之前的时间，并且该方法在中等效应量和短风险期的情况下得出无偏估计。我们将SCCS方法和Cox回归应用于来自德国婴儿猝死研究（GeSID）的数据以及来自意大利的案例研究（HERA研究），以检查出生后头两年的意外意外死亡和接种疫苗的情况。我们显示，根据模拟分析的预期，在所有情况下进行的调整后的SCCS分析都会低估疫苗接种的效果。使用Cox回归，我们检查了接种疫苗后总体风险的降低，这是上述研究的重点。相对发生率为0.8，我们的结果不如GeSID研究的病例对照分析（校正后的优势比：0.51）明显。对GeSID和HERA研究的SCCS分析得出的第一剂和第二剂疫苗的估计值非常相似。

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