VA Boston Healthcare System, Center for Healthcare Organization and Implementation Research (CHOIR), United States Department of Veterans Affairs, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI, USA; Survey Research Center, Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.
Psychiatry Res. 2020 Jan;283:112452. doi: 10.1016/j.psychres.2019.06.027. Epub 2019 Jun 20.
Implementation science is focused on maximizing the adoption, appropriate use, and sustainability of effective clinical practices in real world clinical settings. Many implementation science questions can be feasibly answered by fully experimental designs, typically in the form of randomized controlled trials (RCTs). Implementation-focused RCTs, however, usually differ from traditional efficacy- or effectiveness-oriented RCTs on key parameters. Other implementation science questions are more suited to quasi-experimental designs, which are intended to estimate the effect of an intervention in the absence of randomization. These designs include pre-post designs with a non-equivalent control group, interrupted time series (ITS), and stepped wedges, the last of which require all participants to receive the intervention, but in a staggered fashion. In this article we review the use of experimental designs in implementation science, including recent methodological advances for implementation studies. We also review the use of quasi-experimental designs in implementation science, and discuss the strengths and weaknesses of these approaches. This article is therefore meant to be a practical guide for researchers who are interested in selecting the most appropriate study design to answer relevant implementation science questions, and thereby increase the rate at which effective clinical practices are adopted, spread, and sustained.
实施科学专注于在真实临床环境中最大限度地采用、适当使用和维持有效的临床实践。许多实施科学问题可以通过完全的实验设计来合理回答，通常采用随机对照试验（RCT）的形式。然而，以实施为重点的 RCT 通常在关键参数上与传统的以疗效或有效性为导向的 RCT 有所不同。其他实施科学问题更适合准实验设计，这些设计旨在在没有随机分组的情况下估计干预措施的效果。这些设计包括具有非等效对照组的前后设计、中断时间序列（ITS）和逐步楔形设计，最后一种设计要求所有参与者都接受干预，但以交错的方式进行。本文回顾了实验设计在实施科学中的应用，包括最近在实施研究方面的方法学进展。我们还回顾了准实验设计在实施科学中的应用，并讨论了这些方法的优缺点。因此，本文旨在为有兴趣选择最合适的研究设计来回答相关实施科学问题的研究人员提供实用指南，从而提高有效临床实践的采用、传播和维持速度。
