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. 2016;7(2):106-115.
doi: 10.1080/23294515.2015.1111272. Epub 2015 Oct 23.

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care

Ashley Kraybill  1 , Laura M Dember  2 , Steven Joffe  3 , Jason Karlawish  4 , Susan S Ellenberg  5 , Vanessa Madden  1 , Scott D Halpern  6
Affiliations

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care

Ashley Kraybill et al. AJOB Empir Bioeth. 2016.

Abstract

Background: Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care.

Methods: We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice.

Results: A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients' concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating.

Conclusions: This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials.

Keywords: Comparative Effectiveness Research; Ethics; Pragmatic Clinical Trials; Qualitative Research.

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Figures

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Figure 1
Directional Response to Research and Clinical Care Scenarios
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References

    1. Anderson ML, Califf RM, Sugarman J. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems. Clinical Trials. 2015;12(3):276–86. - PMC - PubMed
    1. Cho MK, Magnus D, Constantine M, et al. Attitudes toward risk and informed consent for research on medical practices: A cross-sectional survey. Annals of Internal Medicine. 2015;162(10):690–6. - PMC - PubMed
    1. Department of Health and Human Services (DHHS) Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. 2011 Available at: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf.
    1. Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics. Hastings Center Report. 2013;43(1):S16–S27. - PubMed
    1. Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? New England Journal of Medicine. 2009;360(19):1925–1927. - PubMed

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