Department of Mathematics and Statistics, The Open University, Milton Keynes, UK.
Epidemiol Infect. 2011 Dec;139(12):1805-17. doi: 10.1017/S0950268811001531. Epub 2011 Aug 18.
The self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995-2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.
自身对照病例系列研究方法最初是为了调查疫苗与不良事件之间的潜在关联而开发的，现在常用于此目的。本研究回顾了 1995 年至 2010 年间该方法在疫苗安全性研究中的应用。共审查了 40 项研究。本文批判性地审查了这些研究中自身对照病例系列研究方法的应用，特别参考了观察期和风险期的定义、混杂因素的控制、假设和潜在偏倚、方法学和报告问题、功效和样本量以及软件。还突出了与综述论文中进行的其他研究设计的比较。提出了一些建议，重点是促进良好实践。
