The Center for Health Research, Kaiser Permanente, Portland, Oregon, USA.
Pharmacoepidemiol Drug Saf. 2013 Jan;22(1):1-6. doi: 10.1002/pds.3334. Epub 2012 Oct 1.
Comparative effectiveness research includes cohort studies and registries of interventions. When investigators design such studies, how important is it to follow patients from the day they initiated treatment with the study interventions? Our article considers this question and related issues to start a dialogue on the value of the incident user design in comparative effectiveness research. By incident user design, we mean a study that sets the cohort's inception date according to patients' new use of an intervention. In contrast, most epidemiologic studies enroll patients who were currently or recently using an intervention when follow-up began. We take the incident user design as a reasonable default strategy because it reduces biases that can impact non-randomized studies, especially when investigators use healthcare databases. We review case studies where investigators have explored the consequences of designing a cohort study by restricting to incident users, but most of the discussion has been informed by expert opinion, not by systematic evidence.
比较有效性研究包括队列研究和干预措施的登记。当研究人员设计此类研究时，从患者开始使用研究干预措施的那一天起对他们进行随访有多重要？我们的文章探讨了这个问题和相关问题，以就比较有效性研究中事件使用者设计的价值展开对话。通过事件使用者设计，我们指的是根据患者对干预措施的新使用来确定队列起始日期的研究。相比之下，大多数流行病学研究在开始随访时招募的是当前或最近正在使用干预措施的患者。我们将事件使用者设计作为一种合理的默认策略，因为它可以减少可能影响非随机研究的偏差，尤其是当研究人员使用医疗保健数据库时。我们回顾了一些案例研究，研究人员通过限制事件使用者来探索设计队列研究的后果，但大多数讨论都是基于专家意见，而不是系统证据。
