• Stuart G Nicholls, Kelly Carroll, Charles Weijer, Cory E Goldstein, Jamie Brehaut, Manish M Sood, Ahmed Al-Jaishi, Erika Basile, Jeremy M Grimshaw, Amit X Garg, and Monica Taljaard.
• Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
• Can J Kidney Health Dis. 2020 Jan 1; 7: 2054358120964119.

BackgroundPragmatic cluster randomized trials (CRTs) offer an opportunity to improve health care by answering important questions about the comparative effectiveness of treatments using a trial design that can be embedded in routine care. There is a lack of empirical research that addresses ethical issues generated by pragmatic CRTs in hemodialysis.ObjectiveTo identify stakeholder perceptions of ethical issues in pragmatic CRTs conducted in hemodialysis.DesignQualitative study using semi-structured interviews.SettingIn-person or telephone interviews with an international group of stakeholders.ParticipantsStakeholders (clinical investigators, methodologists, ethicists and research ethics committee members, and other knowledge users) who had been involved in the design or conduct of a pragmatic individual patient or cluster randomized trial in hemodialysis, or their role would require them to review and evaluate pragmatic CRTs in hemodialysis.MethodsInterviews were conducted in-person or over the telephone and were audio-recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts and field notes were analyzed using a thematic analysis approach.ResultsSixteen interviews were conducted with 19 individuals. Interviewees were largely drawn from North America (84%) and were predominantly clinical investigators (42%). Six themes were identified in which pragmatic CRTs in hemodialysis raise ethical issues: (1) patients treated with hemodialysis as a vulnerable population, (2) appropriate approaches to informed consent, (3) research burdens, (4) roles and responsibilities of gatekeepers, (5) inequities in access to research, and (6) advocacy for patient-centered research and outcomes.LimitationsParticipants were largely from North America and did not include research staff, who may have differing perspectives.ConclusionsThe six themes reflect concerns relating to individual rights, but also the need to consider population-level issues. To date, concerns regarding inequity of access to research and the need for patient-centered research have received less coverage than other, well-known, issues such as consent. Pragmatic CRTs offer a potential approach to address equity concerns and we suggest future ethical analyses and guidance for pragmatic CRTs in hemodialysis embed equity considerations within them. We further note the potential for the co-creation of health data infrastructure with patients which would aid care but also facilitate patient-centered research. These present results will inform planned future guidance in relation to the ethical design and conduct of pragmatic CRTs in hemodialysis.Trial RegistrationRegistration is not applicable as this is a qualitative study.© The Author(s) 2020.

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