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

Katherine R Courtright,Jason Karlawish,Stephanie Szymanski,Susan S Ellenberg,Nicole B Gabler,Vanessa Madden,Kuldeep N Yadav,Laura M Dember,Steven Joffe,Scott D Halpern

doi:10.1186/s13063-017-2217-8

Katherine R Courtright, Jason Karlawish + Show 8 more

Open Access

https://doi.org/10.1186/s13063-017-2217-8

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Abstract

BackgroundPragmatic 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.MethodsWe 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.ResultsSimilar 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).ConclusionsCurtailing 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.

Highlights

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
The benefits of trials embedded in clinical care must be considered in the context of the loss of patient and physician autonomy that they may impose especially if entire hospitals or clinics are randomized as a cluster to a specific treatment approach
Several ethicists have noted that standard informed consent procedures may not be applicable in pragmatic trials comparing interventions that fall within the “standard of care” [16,17,18,19] because such trials do not increase risk to patients beyond the risk of usual care

Summary

Introduction

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. The benefits of trials embedded in clinical care must be considered in the context of the loss of patient and physician autonomy that they may impose especially if entire hospitals or clinics are randomized as a cluster to a specific treatment approach Such trials may be conducted with waivers of informed consent. Several ethicists have noted that standard informed consent procedures may not be applicable in pragmatic trials comparing interventions that fall within the “standard of care” [16,17,18,19] because such trials do not increase risk to patients beyond the risk of usual care Such trials alter the process by which an individual’s care is selected, thereby limiting patients’ and physicians’ decisional autonomy [20]

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