ArticleMedical care2017
Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices.
Article in Medical care, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Impact of Legal Perceptions and Disclosure on Willingness to Undergo HIV Antiretroviral Resistance Testing Among Men Who Have Sex with Men: A Brief Report.AIDS and behavior · 2026Trial
- An Intervention to Increase Advance Care Planning Among Older Adults With Advanced Cancer: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
- Methodology and predictive accuracy of the prospective preference assessment for randomized trial enrollment: A literature review.Osteoarthritis and cartilage open · 2025Review
- Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements.Learning health systems · 2024Article
- Ethics challenges in sharing data from pragmatic clinical trials.Clinical trials (London, England) · 2022Article
- Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.Clinical trials (London, England) · 2021Article
- 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
- Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States.Clinical trials (London, England) · 2019Article
- Reframing Recruitment: Evaluating Framing in Authorization for Research Contact Programs.AJOB empirical bioethicsArticle
- Research Use of Electronic Health Records: Patients' Views on Alternative Approaches to Permission.AJOB empirical bioethicsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundFor pragmatic clinical research comparing commonly used treatments, questions exist about if and how to notify participants about it and secure their authorization for participation.
objectiveTo determine how patients react when they seek clinical care and encounter one of several different pragmatic clinical research studies. RESEARCH
designIn an online survey using a between-subjects experimental design, respondents read and responded to 1 of 24 hypothetical research scenarios reflecting different types of studies and approaches to notification and authorization (eg, general notification, oral consent, written consent). SUBJECTS: English-speaking US adults 18 years and older. MEASURES: Willingness to participate in the hypothetical study, acceptability of the notification and authorization approach, understanding of the study, perceptions of benefit/harm, trust, and perception of amount of study information received.
resultsWillingness to participate did not differ by notification and authorization approach. Some (21%-36%) of the patients randomized to general notification with an explicit opt-out provision were not aware they would be enrolled by default. Acceptability was greatest for and similar among notification and authorization approaches that actively engaged the patient (eg, oral or written consent) and lower for approaches with less engagement (eg, general notification). Problems of understanding were found among 20%-55% of respondents, depending on the particular scenario. Most respondents (77%-94%) felt that participation in the hypothetical study posed no risks of harm to their health or privacy.
conclusionsCurrent attitudes about notification and authorization approaches and difficulties understanding pragmatic clinical research pose significant challenges for pragmatic research. Data from this study provide a starting point to developing solutions to these surprisingly complex issues.
Indexed as
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What OpenQuestion holds
Registered trials
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.