ArticleTrials2011
Ethical issues posed by cluster randomized trials in health research.
Article in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 6 of them syntheses 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
65 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs).Trials · 2025Guideline
- Pooled it
- Effectiveness of mobile application-based perinatal interventions in improving parenting outcomes: A systematic review.Midwifery · 2022Pooled it
- A systematic review of factors affecting children's right to health in cluster randomized trials in Kenya.Trials · 2014Pooled it
- Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document.Trials · 2014Guideline
- The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials.PLoS medicine · 2012Guideline
- Effectiveness of a game-based educational strategy e-EDUCAGUIA for implementing antimicrobial clinical practice guidelines in family medicine residents in Spain: a randomized clinical trial by cluster.BMC medical education · 2022Trial
- Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial.BMC pregnancy and childbirth · 2021Trial
- Trial
- Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.BMC medical ethics · 2016Trial
- Trial
- Restrictive vs liberal blood transfusion for acute upper gastrointestinal bleeding: rationale and protocol for a cluster randomized feasibility trial.Transfusion medicine reviews · 2013Trial
- Trial
- Trial
- Cluster minimal sufficient balance (CMSB): an efficient covariate balancing randomization method for cluster randomized trials.BMC medical research methodology · 2026Article
- Ethical considerations in implementation research: a scoping review of key principles, unintended consequences, and emerging ethical guidance.Implementation science communications · 2025Review
- 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
- Review article: Primer for clinical researchers on innovative trial designs for emergency medicine.Emergency medicine Australasia : EMA · 2025Review
- Article
- Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1.Pilot and feasibility studies · 2024Article
5 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.
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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.