Garner Bryan R
Department of Internal Medicine, The Ohio State University, Columbus, OH, United States.
Front Health Serv. 2022 Dec 6;2:1007750. doi: 10.3389/frhs.2022.1007750. eCollection 2022.
To address the enduring gap between research and practice, there is a need to improve the speed and efficiency of research across the translational research spectrum. In 2012, the effectiveness-implementation hybrid trial design (HTD) was codified as a design with the potential to improve the speed and efficiency of translation, especially as part of T2 (clinical research) translational research. Building on this and other recent efforts to stimulate greater use of this novel HTD, the current article highlights an innovative application of each effectiveness-implementation HTD type. The completed application of the Type 1 effectiveness-implementation HTD tested the effectiveness of a clinical intervention for reducing HIV viral load and retaining people with HIV in care, as well as conducted a longitudinal mixed-methods examination to test for significant changes over time in three key measures of context, and economic evaluation of the clinical intervention. The completed application of the Type 2 effectiveness-implementation HTD used a dual-randomized design to simultaneously test the effectiveness of a clinical intervention for addressing substance use disorder among people with HIV and effectiveness of a blended strategy called the Implementation and Sustainment Facilitation (ISF) Strategy. This Type 2 hybrid trial was also innovative due to its focus on both sustainment and economic outcomes. The innovative Type 3 application (funded in 2008 and completed in 2012) tested the effectiveness and cost-effectiveness of using pay-for-performance to improve both implementation outcomes and client outcomes. This article also codifies a HTD called the Dissemination, Implementation, effectiveness, Sustainment, Economics, and Level-of-scaling (DIeSEL) HTD.
为了弥合研究与实践之间长期存在的差距，有必要提高整个转化研究领域的研究速度和效率。2012年，有效性-实施混合试验设计（HTD）被编纂为一种有潜力提高转化速度和效率的设计，尤其是作为T2（临床研究）转化研究的一部分。基于此以及最近为促进更多地使用这种新型HTD所做的其他努力，本文重点介绍了每种有效性-实施HTD类型的创新应用。1型有效性-实施HTD的完整应用测试了一种临床干预措施在降低艾滋病毒病毒载量以及使艾滋病毒感染者持续接受治疗方面的有效性，还进行了纵向混合方法检查，以测试在三个关键背景指标上随时间的显著变化，并对该临床干预措施进行了经济评估。2型有效性-实施HTD的完整应用采用了双重随机设计，以同时测试一种临床干预措施在解决艾滋病毒感染者物质使用障碍方面的有效性以及一种称为实施与维持促进（ISF）策略的混合策略的有效性。这种2型混合试验还因其对维持和经济结果的关注而具有创新性。创新的3型应用（2008年获得资助并于2012年完成）测试了使用绩效薪酬来改善实施结果和客户结果的有效性和成本效益。本文还编纂了一种称为传播、实施、有效性、维持、经济学和扩展水平（DIeSEL）HTD的混合试验设计。
