Department of Clinical Pharmacology, IST, University of Southern Denmark, Odense, Denmark.
J Intern Med. 2014 Jun;275(6):581-9. doi: 10.1111/joim.12186.
Self-controlled observational study designs, such as the case-crossover design and the self-controlled case series, are reviewed, and their respective rationale, strengths and limitations are compared. Although no single design is generally superior to the others, they share the trait of being robust towards confounders that are stable over time. The self-controlled designs can be particularly useful when using secondary healthcare data for pharmacoepidemiological research and might be useful in screening for adverse drug effects. The main limitations of self-controlled designs are that they are amenable only to transient effects; some may be inefficient with long-term exposure; and they may be sensitive towards trends in exposure.
本文回顾了自我对照观察性研究设计,如病例交叉设计和自身对照病例系列设计,并比较了它们各自的原理、优势和局限性。虽然没有一种设计通常优于其他设计,但它们都具有对随时间稳定的混杂因素具有稳健性的特点。自我对照设计在使用二级医疗保健数据进行药物流行病学研究时特别有用,并且可能有助于筛选药物不良反应。自我对照设计的主要局限性是它们只能适用于瞬时效应;有些设计可能对长期暴露效率不高;并且它们可能对暴露趋势敏感。