The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting

Cory E Goldstein; Monica Taljaard; Stuart G Nicholls; Mary Beaucage; Jamie Brehaut; Charles L Cook; Brenden B Cote; Jonathan C Craig; Stephanie N Dixon; Jessica Du Toit; Catherine C S Du Val; Amit X Garg; Jeremy M Grimshaw; Shasikara Kalatharan; Scott Y H Kim; Austin Kinsella; Valerie Luyckx; Charles Weijer

doi:10.1016/j.kint.2024.03.001

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting

Kidney Int. 2024 May;105(5):898-911. doi: 10.1016/j.kint.2024.03.001.

Authors

Cory E Goldstein¹, Monica Taljaard², Stuart G Nicholls³, Mary Beaucage⁴, Jamie Brehaut², Charles L Cook⁵, Brenden B Cote⁵, Jonathan C Craig⁶, Stephanie N Dixon⁷, Jessica Du Toit⁸, Catherine C S Du Val⁹, Amit X Garg¹⁰, Jeremy M Grimshaw¹¹, Shasikara Kalatharan⁵, Scott Y H Kim¹², Austin Kinsella⁵, Valerie Luyckx¹³, Charles Weijer¹⁴

Affiliations

¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: [email protected].
² Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
³ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Office for Patient Engagement in Research Activities, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁴ CanSOLVE CKD Network, Vancouver, British Columbia, Canada; Canadian Donation and Transplantation Research Program, Edmonton, Alberta, Canada.
⁵ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁶ College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
⁷ Lawson Research Institute and London Health Sciences Centre, London, Ontario, Canada; ICES, Burnaby, British Columbia, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
⁸ Department of Philosophy, Western University, London, Ontario, Canada.
⁹ Lawson Research Institute and London Health Sciences Centre, London, Ontario, Canada.
¹⁰ Lawson Research Institute and London Health Sciences Centre, London, Ontario, Canada; ICES, Burnaby, British Columbia, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada; Department of Research Methods, Evidence and Uptake, McMaster University, Hamilton, Ontario, Canada.
¹¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹² Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
¹³ Renal Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa; Department of Public and Global Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
¹⁴ Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Department of Philosophy, Western University, London, Ontario, Canada; Department of Medicine, Western University, London, Ontario, Canada.

PMID: 38642985
DOI: 10.1016/j.kint.2024.03.001

Abstract

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Keywords: cluster randomized trial; ethics guidance implementation; in-center maintenance hemodialysis; informed consent; patient and public involvement; research ethics committee.

MeSH terms

Ethics, Research
Humans
Informed Consent*
Randomized Controlled Trials as Topic
Renal Dialysis
Research Design*