Design of a dual randomized trial in a type 2 hybrid effectiveness-implementation study.
Design of a dual randomized trial in a type 2 hybrid effectiveness-implementation study.
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DOI：
10.1186/s13012-023-01317-9
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发表时间：
2023-11-23
影响因子：
7.2
通讯作者：
Leeman, Jennifer
中科院分区：
文献类型：
--
作者：
Stevens, June;Mills, Sarah Denton;Millett, Thomas J.;Lin, Feng-Chang;Leeman, Jennifer
双随机对照试验(DRCT)是包括两个随机试验的第二类混合研究：一个测试实施策略，另一个测试干预。我们认为，这种研究设计通过在一项研究中提供对实施和干预的严格调查来提供效率，并有可能加速生成将有效干预转化为现实世界实践所需的证据。然而，使用这种设计的研究在文献中并不多见。我们构建了一个范例，分解了DRCT的组件，并提供了设计功能的逐步解释和使用建议。对测试执行和干预的双线进行了明确的区分，并主张至少有三个随机武器。我们建议一个积极的治疗部门，既包括实施战略，也包括假定优越的干预措施。我们建议两个比较/控制武器：一个用来测试执行策略，另一个用来测试干预。此外，我们建议选择两个对照药物的标准，强调最大限度地提高研究设计的效用以促进公共卫生实践。从表面上看，DRCT的设计看起来很简单，但实际应用却很复杂。我们认为，正是这种复杂性限制了它在文学中的使用。我们希望本文能让不熟悉实现科学的实现科学家和试验人员更好地理解DRCT设计，并鼓励他们使用它。网上版载有补充材料，可在10.1186/s13012-023-01317-9查阅。
Dual randomized controlled trials (DRCT) are type 2 hybrid studies that include two randomized trials: one testing implementation strategies and one testing an intervention. We argue that this study design offers efficiency by providing rigorous investigation of both implementation and intervention in one study and has potential to accelerate generation of the evidence needed to translate interventions that work into real-world practice. Nevertheless, studies using this design are rare in the literature. We construct a paradigm that breaks down the components of the DRCT and provide a step-by-step explanation of features of the design and recommendations for use. A clear distinction is made between the dual strands that test the implementation versus the intervention, and a minimum of three randomized arms is advocated. We suggest an active treatment arm that includes both the implementation strategy and intervention that are hypothesized to be superior. We suggest two comparison/control arms: one to test the implementation strategy and the second to test the intervention. Further, we recommend selection criteria for the two control arms that place emphasis on maximizing the utility of the study design to advance public health practice. On the surface, the design of a DRCT can appear simple, but actual application is complex. We believe it is that complexity that has limited its use in the literature. We hope that this paper will give both implementation scientists and trialists who are not familiar with implementation science a better understanding of the DRCT design and encouragement to use it. The online version contains supplementary material available at 10.1186/s13012-023-01317-9.
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DOI：
10.1177/1740774520941419
发表时间：
2020-10
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Parker RA;Weir CJ
通讯作者：
Weir CJ
影响因子：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
Boles, SM
影响因子：
4
作者：
McCarney, Rob;Warner, James;Fisher, Peter
通讯作者：
Fisher, Peter
影响因子：
5.7
作者：
Esmail LC;Barasky R;Mittman BS;Hickam DH
通讯作者：
Hickam DH
DOI：
10.1016/j.jclinepi.2010.03.004
发表时间：
2010-01-01
期刊：
Open medicine : a peer-reviewed, independent, open-access journal
影响因子：
--
作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
通讯作者：
Moher, David