ArticleTrials2017
Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach.
Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Pooled it
- Pooled it
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
- Patient engagement and shared decision-making in trial recruitment intervention studies: a systematic review.Research involvement and engagement · 2025Review
- Consent Approach and Patient Notification in Pragmatic Comparative Effectiveness Trials in Critical Care.Annals of the American Thoracic Society · 2025Article
- Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.BMC medical research methodology · 2024Article
- Article
- Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol.Annals of the American Thoracic Society · 2022Article
- Public Attitudes toward Consent When Research Is Integrated into Care-Any "Ought" from All the "Is"?The Hastings Center report · 2021Article
- Patient Partner Perspectives Regarding Ethically and Clinically Important Aspects of Trial Design in Pragmatic Cluster Randomized Trials for Hemodialysis.Canadian journal of kidney health and disease · 2021Article
- Measurement invariance of the Research Attitudes Questionnaire in an age and ethnically diverse, community-dwelling sample.Journal of Alzheimer's disease reportsArticle
- Ethical Issues in Implementation Science: A Qualitative Interview Study of Participating Clinicians.AJOB empirical bioethicsArticle
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.