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

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...

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Autores principales: Courtright, Katherine R., Halpern, Scott D., Joffe, Steven, Ellenberg, Susan S., Karlawish, Jason, Madden, Vanessa, Gabler, Nicole B., Szymanski, Stephanie, Yadav, Kuldeep N., Dember, Laura M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5637128/
https://www.ncbi.nlm.nih.gov/pubmed/29020994
http://dx.doi.org/10.1186/s13063-017-2217-8
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author Courtright, Katherine R.
Halpern, Scott D.
Joffe, Steven
Ellenberg, Susan S.
Karlawish, Jason
Madden, Vanessa
Gabler, Nicole B.
Szymanski, Stephanie
Yadav, Kuldeep N.
Dember, Laura M.
author_facet Courtright, Katherine R.
Halpern, Scott D.
Joffe, Steven
Ellenberg, Susan S.
Karlawish, Jason
Madden, Vanessa
Gabler, Nicole B.
Szymanski, Stephanie
Yadav, Kuldeep N.
Dember, Laura M.
author_sort Courtright, Katherine R.
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2217-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-56371282017-10-18 Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach Courtright, Katherine R. Halpern, Scott D. Joffe, Steven Ellenberg, Susan S. Karlawish, Jason Madden, Vanessa Gabler, Nicole B. Szymanski, Stephanie Yadav, Kuldeep N. Dember, Laura M. Trials Research 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2217-8) contains supplementary material, which is available to authorized users. BioMed Central 2017-10-11 /pmc/articles/PMC5637128/ /pubmed/29020994 http://dx.doi.org/10.1186/s13063-017-2217-8 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Courtright, Katherine R.
Halpern, Scott D.
Joffe, Steven
Ellenberg, Susan S.
Karlawish, Jason
Madden, Vanessa
Gabler, Nicole B.
Szymanski, Stephanie
Yadav, Kuldeep N.
Dember, Laura M.
Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
title Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
title_full Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
title_fullStr Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
title_full_unstemmed Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
title_short Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
title_sort willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5637128/
https://www.ncbi.nlm.nih.gov/pubmed/29020994
http://dx.doi.org/10.1186/s13063-017-2217-8
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