ArticleJournal of medical ethics2021
Informed consent in pragmatic trials: results from a survey of trials published 2014-2019.
Article in Journal of medical ethics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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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
18 citing papers in PubMed.
- Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.Diabetes care · 2024Trial
- Practical guide for determining whether healthcare providers are research participants in cluster randomised trials.BMJ open · 2026Review
- Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study.Clinical trials (London, England) · 2026Article
- Systematic review of approaches to informed consent in recent high-impact clinical trials.Journal of clinical and translational science · 2026Article
- Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials.Journal of medical ethics · 2025Article
- Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines.Research integrity and peer review · 2025Article
- The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research.Clinical trials (London, England) · 2025Article
- Are pragmatism and ethical protections in clinical trials a zero-sum game?Clinical trials (London, England) · 2025Article
- Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.JMIR formative research · 2024Article
- Design, implementation, and inferential issues associated with clinical trials that rely on data in electronic medical records: a narrative review.BMC medical research methodology · 2023Review
- Waivers of informed consent in research with competent participants and the Declaration of Helsinki.European journal of clinical pharmacology · 2023Review
- Article
- Ethics challenges in sharing data from pragmatic clinical trials.Clinical trials (London, England) · 2022Article
- Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey.Alzheimer's & dementia (New York, N. Y.) · 2022Article
- Pilot and feasibility studies for pragmatic trials have unique considerations and areas of uncertainty.Journal of clinical epidemiology · 2021Article
- Article
- Exception from Informed Consent and Waiver of Informed Consent for Comparative Effectiveness Trials in Emergency Care Research.Ethics & human researchArticle
- Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
objectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.
methodsSurvey of primary trial reports, published 2014-2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.
resultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001). DISCUSSION: Not obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public's trust in research.
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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.