Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.
Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.
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DOI：
10.1016/j.cct.2022.106703
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发表时间：
2022-04
影响因子：
2.2
通讯作者：
Magnus, David
中科院分区：
文献类型：
--
作者：
Federico, Carole A.;Heagerty, Patrick J.;Lantos, John;O'Rourke, Pearl;Rahimzadeh, Vasiliki;Sugarman, Jeremy;Weinfurt, Kevin;Wendler, David;Wilfond, Benjamin S.;Magnus, David
逐步楔形簇随机试验（SW-CRT）设计越来越多地采用务实的研究，他们不同于传统的平行集群随机试验中，干预措施是提供给一个子集的集群，但不是所有。在SW-CRT中，所有群集在研究结束时接受研究中的干预。这种方法被认为是为了避免对控制组参与者拒绝期望的干预的伦理问题。文献中引用了此类问题作为选择SW-CRT设计的主要动机，但是SW-CRT引起了与延迟实施干预和知情同意相关的其他伦理问题。然而，PCT研究者可能仅仅因为担心其他研究设计不可行而选择SW-CRT设计。在本文中，我们研究的理由，使用SW-CRT研究设计，在其他设计，通过借鉴美国国立卫生研究院的卫生保健系统研究合作实验室（NIH合作实验室）的经验与五个务实的SW-CRT。我们发现，使用SW-CRT设计的决定是合理的实际和认识的原因，而不是道德的。这些问题包括对可行性的关注，集群特性的异质性，以及同时进行临床评估和实施的愿望。在本文中，我们比较了SW-CRT的潜在利益对设计所带来的道德和认识的挑战，并建议选择SW-CRT设计必须平衡认识，可行性和道德的理由。此外，鉴于其复杂性，此类研究需要严格和知情的道德监督。
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.
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