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

ABSTRACT:

Background

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.

Objective

To identify stakeholder perceptions of ethical issues in pragmatic CRTs conducted in hemodialysis.

Design

Qualitative study using semi-structured interviews.

Setting

In-person or telephone interviews with an international group of stakeholders.

Participants

Stakeholders (clinical investigators, methodologists, ethicists and research ethics committee members, and other knowledge users) who had been

SUBMITTER: Nicholls SG 

PROVIDER: S-EPMC7597560 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature