학술논문

Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
Document Type
article
Source
Trials, Vol 18, Iss 1, Pp 1-10 (2017)
Subject
Pragmatic clinical trial
Ethics
Informed consent
Autonomy
Standard of care
Comparative effectiveness research
Medicine (General)
R5-920
Language
English
ISSN
1745-6215
Abstract
Abstract Background Pragmatic clinical trials embedded in routine delivery of clinical care can lead to improvements in quality of care, but often have design features that raise ethical concerns. Methods We performed a discrete choice experiment and used conjoint analysis to assess how specific attributes of pragmatic dialysis trials influenced patients’ and physicians’ willingness to have their dialysis facility participate in a hypothetical trial of hypertension management. Electronic survey data were collected from 200 patients enrolled from 11 outpatient hemodialysis units and from 203 nephrologists. The three attributes studied were physicians’ treatment autonomy, participants’ research burden, and the approach to consent. The influence of each attribute was quantified using mixed-effects logistic regression. Results Similar proportions of patients were willing to have their facilities participate in a trial with high vs. low physician autonomy (77% vs. 79%; p = 0.13) and research burden (76% vs. 80%; p = 0.06). Opt-in, opt-out, and notification-only consent approaches were acceptable to most patients (84%, 82%, and 81%, respectively), but compared to each of these consent approaches, fewer patients (66%) were willing to have their facility participate in a trial that used no notification (p