ArticleClinical trials (London, England)2015
Harms, benefits, and the nature of interventions in pragmatic clinical trials.
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 19 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
19 citing papers in PubMed.
- Optimizing clinical scientific research: the cohort intervention random sampling study with historical controls.Journal of comparative effectiveness research · 2025Article
- Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements.Learning health systems · 2024Article
- Protocol of a patient randomized clinical trial to improve medication adherence in primary care.Contemporary clinical trials · 2024Article
- Ethics challenges in sharing data from pragmatic clinical trials.Clinical trials (London, England) · 2022Article
- Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.Contemporary clinical trials · 2022Article
- Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.Learning health systems · 2022Article
- Practical steps to identifying the research risk of pragmatic trials.Clinical trials (London, England) · 2022Article
- Pragmatic clinic randomized trial to improve chronic kidney disease care: Design and adaptation due to COVID disruptions.Contemporary clinical trials · 2021Article
- COVID-19 Challenges Confronted by Smoking Cessation Clinical Trials for People Living With HIV: The Experience of Grantees of the US National Cancer Institute.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2021Article
- Article
- The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care.BMC pediatrics · 2019Article
- Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?BMC medicine · 2018Article
- Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.BMC medical ethics · 2018Review
- Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.BMC medical research methodology · 2017Article
- Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs.Trials · 2016Article
- Personalized prescription feedback to reduce antibiotic overuse in primary care: rationale and design of a nationwide pragmatic randomized trial.BMC infectious diseases · 2016Article
- Oversight on the borderline: Quality improvement and pragmatic research.Clinical trials (London, England) · 2015Article
- Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.Clinical trials (London, England) · 2015Article
- Exploring the ethical and regulatory issues in pragmatic clinical trials.Clinical trials (London, England) · 2015Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems.
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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.