BACKGROUND There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes. METHODS We use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration's Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials. RESULTS Information is available for research on more than 75 million people with commercial or Medicare Advantage health plans. We describe three studies that have used or plan to use the Network, as well as a single health plan study, from which we glean our lessons learned. CONCLUSIONS Studies that are conducted in health plans provide much-needed evidence to drive clinically meaningful changes in care. However, there are many unique aspects of these trials that must be considered in the planning, implementation, and analytic phases. The type of trial best suited for studies embedded in health plans will be those that require large sample sizes, simple interventions that could be disseminated through health plans, and where data available to the health plan can be leveraged. These trials hold potential for substantial long-term impact on our ability to generate evidence to improve care and population health.

中文翻译：

---

将实用临床试验纳入健康计划的实用指南：大型简单试验并不那么简单。

背景 存在与健康保险计划中嵌入的实用试验的设计和进行相关的独特机会，这些试验具有关于会员/患者人口统计、承保日期和报销医疗护理的纵向数据，包括处方药配药、疫苗接种、行为医疗保健遭遇，以及一些实验室结果。此类试验可以是大规模且高效的，利用这些数据来识别符合试验资格的患者并确定结果。方法 我们主要利用美国国立卫生研究院实用性试验合作分布式研究网络（该网络包括参与美国食品和药物管理局哨兵系统的健康计划）的经验来描述从嵌入式实用性试验的实施和规划中吸取的经验教训。结果 信息可用于对超过 7500 万名拥有商业或 Medicare Advantage 健康计划的人进行研究。我们描述了三项已经使用或计划使用该网络的研究，以及一项健康计划研究，我们从中吸取了教训。结论 在健康计划中进行的研究提供了急需的证据，以推动护理方面发生具有临床意义的变化。然而，这些试验有许多独特的方面，必须在规划、实施和分析阶段予以考虑。最适合嵌入健康计划的研究的试验类型是那些需要大样本、可以通过健康计划传播的简单干预措施以及可以利用健康计划可用数据的试验类型。这些试验有可能对我们生成证据以改善护理和人口健康的能力产生重大长期影响。