Andrews Nick
Statistics Modelling and Economics Department, Health Protection Services, Health Protection Agency, 61 Colindale Avenue, London, NW9 5EQ, UK.
Biologicals. 2012 Sep;40(5):389-92. doi: 10.1016/j.biologicals.2011.08.010. Epub 2011 Oct 8.
Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues.
三种常用于疫苗上市后安全性评估的设计是队列研究、病例对照研究和自我对照病例系列研究。这些方法经常与常规健康数据库和免疫登记系统一起使用。本文探讨了在设计流行病学研究时可能出现的问题，例如理解疫苗安全性问题、病例定义与发现、数据来源的局限性、未控制的混杂因素以及适用于个别设计的陷阱。文中给出了麻疹、腮腺炎和风疹联合疫苗（MMR）与自闭症关系的例子，在该例子中这三种设计都曾被使用，以此来帮助思考这些问题。
