ArticleClinical trials (London, England)2015
Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.
Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.
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
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: A systematic review.PloS one · 2019Pooled it
- Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.Journal of medical ethics · 2018Trial
- Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.Trials · 2018Trial
- PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.Clinical trials (London, England) · 2017Trial
- Cluster-Randomized Trials in Emergency Care Research.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026Review
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
- Article
- 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
- Article
- Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions.Journal of empirical research on human research ethics : JERHRE · 2022Article
- Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.Contemporary clinical trials · 2022Article
- A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing.Journal of clinical epidemiology · 2021Review
- Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021Article
- Partnering with healthcare facilities to understand psychosocial distress screening practices among cancer survivors: pilot study implications for study design, recruitment, and data collection.BMC health services research · 2021Article
- Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia.Journal of the American Geriatrics Society · 2020Article
- Ethics and Collateral Findings in Pragmatic Clinical Trials.The American journal of bioethics : AJOB · 2020Article
- Awareness, Knowledge, and Utility of RCT Data vs RWE: Results From a Survey of US Cardiologists: Real-world Evidence in Clinical Decision Making.Clinical Medicine Insights. Cardiology · 2020Article
- Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: Race as an example.Contemporary clinical trials · 2020Article
- Article
- Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency.Trials · 2019Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings.
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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.