Designs and methods for implementation research: Advancing the mission of the CTSA program

Designs and methods for implementation research: Advancing the mission of the CTSA program
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DOI:
10.1017/cts.2020.16
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发表时间:
2020-06-01
影响因子:
2.6
通讯作者:
Smith, Justin D.
Smith, Justin D.
中科院分区:
其他
文献类型:
--
作者:
Hwang, Soohyun;Birken, Sarah A.;Smith, Justin D.

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简介:美国国立卫生研究院 (NIH) 设立了临床和转化科学奖 (CTSA) 计划,以应对将生物医学和行为干预措施从发现转化为实际使用的挑战。为了应对将循证干预措施 (EBI) 转化为实践的挑战,实施科学领域已成为一门独特的学科。 EBI 有效性研究和实施研究之间的区别带来了研究设计和方法的差异,将重点从临床结果转移到支持忠实采用和交付 EBI 的系统。方法:实施研究设计共享功效/效果研究的许多基本要素和假设。目前应用于实施研究的设计和方法包括实验、准实验、观察、混合有效性实施、模拟建模和配置比较方法。结果:具体研究设计和方法的示例说明了它们在实施科学中的用途。我们建议 CTSA 计划通过三种方式利用该领域能力建设的势头:1)将最先进的实施方法和设计融入其现有的研究体系中; 2) 通过与其他具有共同推进实施科学目标的 NIH 机构合作,将自己定位在推进实施科学的前沿; 3) 提供充分的实施科学培训。结论:随着实施方法的成熟,实施科学和 CTSA 计划都将从交叉专业知识和共享基础设施中受益匪浅,这些知识旨在促进美国和世界各地的医疗保健。
Introduction: The US National Institutes of Health (NIH) established the Clinical and Translational Science Award (CTSA) program in response to the challenges of translating biomedical and behavioral interventions from discovery to real-world use. To address the challenge of translating evidence-based interventions (EBIs) into practice, the field of implementation science has emerged as a distinct discipline. With the distinction between EBI effectiveness research and implementation research comes differences in study design and methodology, shifting focus from clinical outcomes to the systems that support adoption and delivery of EBIs with fidelity. Methods: Implementation research designs share many of the foundational elements and assumptions of efficacy/effectiveness research. Designs and methods that are currently applied in implementation research include experimental, quasi-experimental, observational, hybrid effectiveness-implementation, simulation modeling, and configurational comparative methods. Results: Examples of specific research designs and methods illustrate their use in implementation science. We propose that the CTSA program takes advantage of the momentum of the field's capacity building in three ways: 1) integrate state-of-the-science implementation methods and designs into its existing body of research; 2) position itself at the forefront of advancing the science of implementation science by collaborating with other NIH institutes that share the goal of advancing implementation science; and 3) provide adequate training in implementation science. Conclusions: As implementation methodologies mature, both implementation science and the CTSA program would greatly benefit from cross-fertilizing expertise and shared infrastructures that aim to advance healthcare in the USA and around the world.