Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, United States.
Vaccine. 2012 Dec 17;31(1):271-7. doi: 10.1016/j.vaccine.2012.07.024. Epub 2012 Jul 24.
In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic plausibility considering features of the AEFI, presumed or known pathologic mechanism, and the vaccine. Misspecification of the length and timing of these intervals may result in introducing bias in epidemiologic and clinical studies of immunization safety. To date, little work has been done to formally assess and determine biologically plausible and evidence-based risk intervals in immunization safety research. In this report, we present a systematic process to define biologically plausible and evidence-based risk interval estimates for two specific AEFIs, febrile seizures and acute disseminated encephalomyelitis. In addition, we review methodologic issues related to the determination of risk intervals for consideration in future studies of immunization safety.
在免疫接种安全性研究中，个体在特定时间段内被认为存在发生某些特定不良反应（AEFI）的风险，该时间段被称为风险间隔。这些间隔时间应根据生物合理性来确定，考虑 AEFI 的特征、推测或已知的病理机制以及疫苗的特征。这些间隔时间的长度和时间的指定不当可能会导致在免疫接种安全性的流行病学和临床研究中引入偏倚。迄今为止，在免疫接种安全性研究中，很少有工作专门用于正式评估和确定基于生物学合理性和基于证据的风险间隔。在本报告中，我们提出了一种系统的方法来定义两种特定 AEFI（热性惊厥和急性播散性脑脊髓炎）的基于生物学合理性和基于证据的风险间隔估计值。此外，我们还回顾了与确定免疫接种安全性研究中风险间隔相关的方法学问题。
