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Ethical Issues in Pragmatic Cluster-Randomized Trials in Dialysis Facilities
Cory E Goldstein1, Charles Weijer1, Monica Taljaard2
1Rotman Institute of Philosophy, Western University, London.
Summary
This study addresses ethical considerations for pragmatic cluster-randomized trials (CRTs) in dialysis care. It outlines key ethical domains and discusses their application in the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial.
Area of Science:
- Clinical Trials
- Bioethics
- Nephrology
Background:
- Pragmatic cluster-randomized trials (CRTs) are valuable for testing interventions in dialysis care.
- Existing ethical guidelines for CRTs require adaptation for the unique dialysis setting.
Purpose of the Study:
- To identify and outline ethical issues specific to pragmatic CRTs conducted in dialysis facilities.
- To inform the ethical design and conduct of future dialysis-focused CRTs.
Main Methods:
- Review of ethical domains relevant to CRTs in dialysis.
- Case illustration using the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial.
- Identification of ethical challenges and areas of uncertainty.
Main Results:
- Seven key ethical domains were identified: justification of cluster randomization, standard of care adoption, benefit-harm analysis, gatekeeper roles, informed consent, patient notification, and inclusion of vulnerable participants.
- The TiME trial served as a model for addressing these ethical considerations.
- Specific ethical uncertainties remain for pragmatic CRTs in dialysis.
Conclusions:
- Ethical guidance for pragmatic CRTs in dialysis requires careful consideration of specific domains.
- Further interdisciplinary research is needed to refine ethical frameworks for these trials.
Keywords:
IRBPragmatic trialsbiascluster-randomized trialsdialysis caredialysis facilitiesend-stage renal disease (ESRD)ethical issuesgatekeeperinformed consentintergroup contaminationnephrology researchpatient adherencepatient autonomypatient protectionsrandomization typeresearch ethicsreviewstudy designwaiverMore Related Videos
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