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Am J Kidney Dis. 2019 Nov;74(5):659-666. doi: 10.1053/j.ajkd.2019.04.019. Epub 2019 Jun 19.

Ethical Issues in Pragmatic Cluster-Randomized Trials in Dialysis Facilities.

Author information

1
Rotman Institute of Philosophy, Western University, London. Electronic address: cgoldst2@uwo.ca.
2
Rotman Institute of Philosophy, Western University, London.
3
Clinical Epidemiology Program, Ottawa Hospital Research Institute; School of Epidemiology and Public Health, University of Ottawa, Ottawa.
4
Institute for Clinical Evaluative Sciences, Toronto; Department of Health and Research Methods, Evidence, and Impact, McMaster University, Hamilton.
5
Office of Research Ethics, Western University.
6
Patient partner with the SPOR Innovative Clinical Trials Initiative, London.
7
Clinical Epidemiology Program, Ottawa Hospital Research Institute; Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
8
Dialysis Clinic, Inc, Nashville, TN; Tufts University School of Medicine, Boston, MA.
9
The George Institute for Global Health, University of New South Wales; Department of Renal Medicine, Concord Repatriation General Hospital and University of Sydney, Sydney, NSW, Australia.
10
Renal, Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
11
Institute for Clinical Evaluative Sciences, Toronto; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton; Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.

Abstract

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.

KEYWORDS:

IRB; Pragmatic trials; bias; cluster-randomized trials; dialysis care; dialysis facilities; end-stage renal disease (ESRD); ethical issues; gatekeeper; informed consent; intergroup contamination; nephrology research; patient adherence; patient autonomy; patient protections; randomization type; research ethics; review; study design; waiver

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