Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital & Harvard Medical School, Boston, MA 02120, USA.
Pharmacoepidemiol Drug Saf. 2010 Aug;19(8):858-68. doi: 10.1002/pds.1926.
Active drug safety monitoring based on longitudinal electronic healthcare databases (a Sentinel System), as outlined in recent FDA-commissioned reports, consists of several interlocked processes, including signal generation, signal strengthening, and signal evaluation. Once a signal of a potential drug safety issue is generated, signal strengthening and signal evaluation have to follow in short sequence in order to quickly provide as much information about the triggering drug-event association as possible. This paper proposes a basic study design based on the incident user cohort design for expedited signal evaluation in longitudinal healthcare databases. It will not resolve all methodological issues nor will it fit all study questions arising within the framework of a Sentinel System. It should rather be seen as a guidance that will fit the majority of situations and serve as a starting point for adaptations to specific studies. Such an approach will expedite and structure the process of study development and highlight specific assumptions, which is particularly valuable in a Sentinel System where signals are by definition preliminary and evaluation of signals is time critical.
基于纵向电子医疗保健数据库（监测系统）的主动药物安全监测，如最近 FDA 委托报告中所述，包括几个相互关联的过程，包括信号生成、信号增强和信号评估。一旦发现潜在药物安全问题的信号，就必须按照短序列进行信号增强和信号评估，以便尽快提供尽可能多的关于触发药物事件关联的信息。本文提出了一种基于事件用户队列设计的基本研究设计，用于在纵向医疗保健数据库中加速信号评估。它不能解决所有方法学问题，也不能满足监测系统框架内出现的所有研究问题。它更应该被视为指导，适用于大多数情况，并作为适应特定研究的起点。这种方法将加快研究开发过程并突出特定的假设，这在监测系统中特别有价值，因为信号是初步的，并且对信号的评估是时间关键的。
