Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory
Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory
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DOI：
10.1186/s12874-017-0420-7
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发表时间：
2017-09-18
影响因子：
4
通讯作者：
Curtis, Lesley H.
中科院分区：
文献类型：
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作者：
Weinfurt, Kevin P.;Hernandez, Adrian F.;Curtis, Lesley H.
背景：临床研究企业没有及时且具有成本效益的方式提供决策者可能需要的证据；目前的研究涉及使用与临床护理分开的劳动密集型并行系统。实用临床试验（PCT）的出现提出了一个可能的解决方案：这些大规模试验嵌入常规临床护理中，通常涉及医院、诊所、初级保健提供者等的整群随机化。卫生系统人员可以通过常用的沟通渠道和质量改进基础设施以及作为常规临床护理一部分收集的数据来实施干预措施。然而，这些试验的经验刚刚起步，设计、操作、分析和报告方法方面的最佳实践尚未开发。方法：为了加强国家实施具有成本效益的大规模 PCT 的能力，美国国立卫生研究院共同基金创建了卫生保健系统研究合作实验室（合作实验室），以支持使用务实的研究设计设计、执行和传播一系列示范项目。结果：在本文中，我们将介绍该合作实验室，重点介绍一些迄今为止遇到的挑战和制定的解决方案，并讨论使用 PCT 进行大规模证据生成的剩余障碍和机遇。结论：规划阶段至关重要，即使进行了仔细的规划，执行过程中也会出现新的挑战；由于意外的变化，武器之间的比较可能会变得复杂。与医疗保健系统领导者和一线临床医生的早期和持续接触对于成功至关重要。将现有的道德和监管框架应用于 PCTS 时也存在明显的不确定性，并且使用现有的电子健康记录进行数据采集会增加复杂性。
Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.