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



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.



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.



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.
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania.
Ashley
A
Kraybill
Department of Medicine, University of Pennsylvania.
Laura M
LM
Dember
Department of Medical Ethics and Health Policy, University of Pennsylvania.
Steven
S
Joffe
Department of Medicine, University of Pennsylvania; Department of Medical Ethics and Health Policy, University of Pennsylvania; Leonard Davis Institute of Health Economics Center for Health Incentives and Behavioral Economics, at the Perelman School of Medicine, University of Pennsylvania.
Jason
J
Karlawish
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania; Department of Biostatistics and Epidemiology.
Susan S
SS
Ellenberg
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania.
Vanessa
V
Madden
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania; Department of Medicine, University of Pennsylvania; Department of Medical Ethics and Health Policy, University of Pennsylvania; Leonard Davis Institute of Health Economics Center for Health Incentives and Behavioral Economics, at the Perelman School of Medicine, University of Pennsylvania; Department of Biostatistics and Epidemiology.
Scott D
SD
Halpern
D000328:Adult; D000368:Aged; D001291:Attitude of Health Personnel; D002985:Clinical Protocols; D057186:Comparative Effectiveness Research / Q000941:ethics; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000523:psychology; D007407:Interviews as Topic; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010358:Patient Participation; D010361:Patients / Q000523:psychology*; D010820:Physicians / Q000523:psychology*; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D006435:Renal Dialysis / Q000523:psychology* / Q000592:standards; D059039:Standard of Care
Comparative Effectiveness Research; Ethics; Pragmatic Clinical Trials; Qualitative Research