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Ethical Issues in Pragmatic Cluster-Randomized Trials in Dialysis Facilities
American Journal of Kidney Diseases ( IF 13.2 ) Pub Date : 2019-06-19 , DOI: 10.1053/j.ajkd.2019.04.019
Cory E. Goldstein , Charles Weijer , Monica Taljaard , Ahmed A. Al-Jaishi , Erika Basile , Jamie Brehaut , Charles L. Cook , Jeremy M. Grimshaw , Eduardo Lacson , Craig Lindsay , Meg Jardine , Laura M. Dember , Amit X. Garg

A pragmatic cluster-randomized trial (CRT) is a research design that may be used to efficiently test promising interventions that directly inform dialysis care. While the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides general ethical guidance for CRTs, the dialysis setting raises additional considerations. In this article, we outline ethical issues raised by pragmatic CRTs in dialysis facilities. These issues may be divided into 7 key domains: justifying the use of cluster randomization, adopting randomly allocated individual-level interventions as a facility standard of care, conducting benefit-harm analyses, gatekeepers and their responsibilities, obtaining informed consent from research participants, patient notification, and including vulnerable participants. We describe existing guidelines relevant to each domain, illustrate how they were considered in the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial (a prototypical pragmatic hemodialysis CRT), and highlight remaining areas of uncertainty. The following is the first step in an interdisciplinary mixed-methods research project to guide the design and conduct of pragmatic CRTs in dialysis facilities. Subsequent work will expand on these concepts and when possible, argue for a preferred solution.



中文翻译:

透析设施中的实用集群随机化试验中的伦理问题

实用的整群随机试验(CRT)是一项研究设计,可用于有效测试直接为透析治疗提供帮助的有希望的干预措施。虽然在伦理设计群随机试验的行为和渥太华声明提供了有关CRT的一般道德指导,透析设置提出了更多注意事项。在本文中,我们概述了实用的CRT在透析设施中提出的道德问题。这些问题可以分为7个关键领域:证明使用聚类随机化的合理性,采用随机分配的个体水平干预措施作为护理标准,进行利益-损害分析,看门人及其职责,获得研究参与者,患者的知情同意通知,包括弱势参与者。我们描述了与每个领域相关的现有指南,阐明了如何在“降低末期肾脏疾病死亡率”(TiME)试验(一种典型的实用性血液透析CRT)中考虑这些指南,并强调了尚不确定的领域。以下是跨学科混合方法研究项目的第一步,旨在指导透析设施中实用CRT的设计和进行。随后的工作将在这些概念上扩展,并在可能的情况下争辩出首选的解决方案。

更新日期:2019-11-18
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