ReviewBMJ open2021
Informed consent in cluster randomised trials: a guide for the perplexed.
Review in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07580781 (Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation), which is not on this map. Cited by 15 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.
Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation (ECMO) Patients
Who cites it
15 citing papers in PubMed.
- Informed Consent for Placebo-Controlled Trials: Do Ethics and Science Conflict?Ethics & human research · 2022Trial
- Does Waiver of Informed Consent in Low-Risk Randomised Controlled Trials Improve Research Inclusion? Insights from a Review of the UK Health Research Authority Confidentiality Advisory Group Register.Journal of empirical research on human research ethics : JERHRE · 2026Review
- Practical guide for determining whether healthcare providers are research participants in cluster randomised trials.BMJ open · 2026Review
- Effect of eHealth intervention (ADHERE) on adherence to partograph and WHO safe childbirth checklist in intrapartum care: implementation research in Ethiopia.Reproductive health · 2026Article
- Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials.Journal of medical ethics · 2025Article
- Review
- Strengthening research preparedness for crises: lessons from Norwegian government agencies in using randomized trials and quasi-experimental methods to evaluate public policy interventions.Health research policy and systems · 2025Article
- Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration.BMJ (Clinical research ed.) · 2025Article
- An online clinical decision tool to screen for vertebral fragility fractures (Vfrac) in older women presenting with back pain in general practice: protocol for a feasibility study in preparation for a future cluster randomised controlled trial.Archives of osteoporosis · 2024Article
- Article
- 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
- Key considerations for designing, conducting and analysing a cluster randomized trial.International journal of epidemiology · 2023Article
- Optimizing patient recruitment into clinical trials of antimicrobial-resistant pathogens.JAC-antimicrobial resistance · 2023Review
- Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.Contemporary clinical trials · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
In a cluster randomised trial (CRT), intact groups-such as communities, clinics or schools-are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention-not the unit of randomisation-that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.
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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.