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Trials. 2017 Oct 11;18(1):474. doi: 10.1186/s13063-017-2217-8.

Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach.

Author information

1
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
2
Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.
3
Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA.
4
Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.
5
Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
6
Division of Geriatrics, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
7
Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA. ldember@upenn.edu.
8
Renal-Electrolyte and Hypertension Division, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA. ldember@upenn.edu.

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 < 0.001 for each 2-way comparison). Among the physicians, similar proportions were willing to participate in trials with high and low physician autonomy (61% and 61%, respectively, p = 0.96) or with low and high burden (60 and 61%, respectively, p = 0.79). However, as for the patients, the consent approach influenced trial acceptability with 77%, 69%, and 62% willing to participate using opt-in, opt-out, and notification-only, respectively, compared to no notification (36%) (p < 0.001 for each 2-way comparison).

CONCLUSIONS:

Curtailing physician's treatment autonomy and increasing the burden associated with participation did not influence patients' or physicians' willingness to participate in the hypothetical research, suggesting that pragmatic dialysis trials are generally acceptable to patients and physicians. Both patients and physicians preferred consent approaches that include at least some level of patient notification, but the majority of patients were still willing to participate in trials that did not notify patients of the research.

KEYWORDS:

Autonomy; Comparative effectiveness research; Ethics; Informed consent; Pragmatic clinical trial; Standard of care

PMID:
29020994
PMCID:
PMC5637128
DOI:
10.1186/s13063-017-2217-8
[Indexed for MEDLINE]
Free PMC Article

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