Stanford Center for Biomedical Ethics, Stanford University, Stanford, CA 94305, USA.
Department of Biostatistics, University of Washington, Seattle, WA 98185, USA.
Contemp Clin Trials. 2022 Apr;115:106703. doi: 10.1016/j.cct.2022.106703. Epub 2022 Feb 15.
Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.
阶梯式群组随机对照试验（SW-CRT）设计在实用性研究中越来越多地被采用；与传统的平行群组随机对照试验不同，后者将干预措施提供给部分群组，但并非所有群组。在 SW-CRT 中，所有群组在研究结束时都接受正在研究的干预措施。这种方法被认为避免了因拒绝对照组参与者接受所需干预而引起的伦理问题。这种担忧在文献中被认为是选择 SW-CRT 设计的主要动机之一，但是 SW-CRT 还提出了与干预措施延迟实施和同意相关的其他伦理问题。然而，PCT 研究者可能选择 SW-CRT 设计仅仅是因为他们担心其他研究设计不可行。在本文中，我们通过借鉴美国国立卫生研究院医疗保健系统研究合作组织（NIH 合作组织）在五个实用 SW-CRT 中的经验，考察了使用 SW-CRT 设计而不是其他设计的理由。我们发现，使用 SW-CRT 设计的决定是基于实际和认识论的原因，而不是伦理原因。这些原因包括对可行性、群组特征的异质性以及同时进行临床评估和实施的愿望的关注。在本文中，我们比较了 SW-CRT 的潜在好处与设计带来的伦理和认识论挑战，并建议 SW-CRT 设计的选择必须平衡认识论、可行性和伦理方面的理由。此外，鉴于其复杂性，此类研究需要严格和知情的伦理监督。
