Théophile Hélène, Moore Nicholas, Robinson Philip, Bégaud Bernard, Pariente Antoine
Département de Pharmacologie médicale, Centre Régional de Pharmacovigilance, CHU Bordeaux, Hôpital Pellegrin-Bât. 1A Zone Nord, 33076, Bordeaux Cedex, France.
INSERM CR 1219, 146 rue Léo Saignat, Case 121, 33076, Bordeaux Cedex, France.
Drug Saf. 2016 Dec;39(12):1197-1209. doi: 10.1007/s40264-016-0449-2.
The case-population approach compares exposure among cases to that of their source population. By using aggregated data to estimate the denominator, this approach can provide a real-time estimate of an association that could be particularly valuable to explore urgent vaccine safety concerns and to generate signals during a vaccine campaign.
Our objective was to present the vaccine case-population method, a method derived from the case-population approach and adapted for vaccine safety surveillance, and to test it using several published examples.
For the vaccine case-population method, exposure in the population is estimated from the sum of at-risk periods using the number of vaccinated individuals, or data of vaccine sales, and the at-risk period considered for the vaccine-event pair. The vaccine case-population method was applied to data from published case-control studies retrieved from the MEDLINE database and having quantified risks associated with vaccines. Odds ratios derived from the vaccine case-population method were compared with those from published case-control studies.
A total of 20 vaccine-event pairs were retrieved in which the vaccine case-population method could be applied. For all identified vaccine-event pairs, when a significant association was found using the vaccine case-population method, a significant association was also found in the corresponding case-control study. Conversely, when no association was found by the vaccine case-population method, no association was found in the corresponding case-control study.
These results suggest that the vaccine case-population method can produce coherent conclusions and may be used in the future for prospective investigation of urgent vaccine safety concerns or for the prospective generation of vaccine safety signals. This method could also be used to identify selection bias from cases excluded from the case-control study.
病例-人群方法将病例组的暴露情况与其源人群的暴露情况进行比较。通过使用汇总数据来估计分母，这种方法可以提供关联的实时估计值，这对于探索紧急疫苗安全性问题以及在疫苗接种活动期间生成信号可能特别有价值。
我们的目的是介绍疫苗病例-人群方法，这是一种源自病例-人群方法并适用于疫苗安全性监测的方法，并使用几个已发表的例子对其进行测试。
对于疫苗病例-人群方法，根据接种疫苗个体的数量或疫苗销售数据以及针对疫苗-事件对考虑的暴露期，从暴露期总和估计人群中的暴露情况。将疫苗病例-人群方法应用于从MEDLINE数据库检索到的已发表病例对照研究的数据，并对与疫苗相关的风险进行了量化。将疫苗病例-人群方法得出的比值比与已发表病例对照研究得出的比值比进行比较。
总共检索到20对疫苗-事件对，其中可以应用疫苗病例-人群方法。对于所有确定的疫苗-事件对，当使用疫苗病例-人群方法发现显著关联时，在相应的病例对照研究中也发现了显著关联。相反，当疫苗病例-人群方法未发现关联时，在相应的病例对照研究中也未发现关联。
这些结果表明，疫苗病例-人群方法可以得出一致的结论，未来可用于对紧急疫苗安全性问题进行前瞻性调查或前瞻性生成疫苗安全信号。该方法还可用于识别病例对照研究中排除病例所导致的选择偏倚。
