Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders

Canadian Journal of Kidney Health and Disease
Stuart G NichollsMonica Taljaard

Abstract

Pragmatic 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. To identify stakeholder perceptions of ethical issues in pragmatic CRTs conducted in hemodialysis. Qualitative study using semi-structured interviews. In-person or telephone interviews with an international group of stakeholders. Stakeholders (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. Interviews 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. Sixteen interviews were conducted with 19 individuals. Interviewees were largely drawn from ...Continue Reading

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Citations

May 22, 2021·Nature Reviews. Nephrology·An S De VrieseFernando C Fervenza

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