Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, WA, USA.
Department of Veterans Affairs, Health Systems Research, Center of Innovation for Veteran-Centered and Value-Driven Care, Seattle, WA, USA.
J Gen Intern Med. 2024 Jul;39(9):1735-1743. doi: 10.1007/s11606-024-08747-1. Epub 2024 Apr 16.
Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).
临床试验中的实用主义侧重于增加研究结果在常规临床护理环境中的可推广性。临床试验中的混合方法（即评估临床效果和实施成功）侧重于加速循证实践的发展和纳入常规临床护理的过程。尽管实用试验方法和实施科学来自非常不同的学科，但实用试验和混合有效性-实施试验具有许多相似的设计特征。事实上，这些类型的试验很容易混淆，从而导致研究人员错误地标记他们的试验类型或错误地使用错误的试验类型来回答他们的研究问题。试验类型之间的界限模糊会阻碍对资助申请的评估、对研究结果的科学解释和决策制定。承认大多数试验既不是纯粹的实用试验，也不是纯粹的混合有效性-实施试验，这些试验类型之间存在关键差异，它们回答的是非常不同的研究问题。本文的目的是为资助者、研究人员和决策者澄清这些试验类型的相似点和不同点。此外，还提出了建议，以帮助研究人员选择、标记和实施最合适的试验类型来回答他们的研究问题。这些建议补充了现有的临床效果试验（TIDieR）和实施试验（StaRI）报告指南。
