Evidence map›Paper›PMID 40528254›Full record

ArticleResearch integrity and peer review2025

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.

Cory E Goldstein, Jessica du Toit, Nicholas B Murphy, Stuart G Nicholls, Julia F Shaw, Fernando Althabe, Ariella Binik, Jamie Brehaut, Sandra Eldridge, Rashida A Ferrand and 17 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Research integrity and peer review, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Cory E GoldsteinMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada. cogoldstein@ohri.ca.ORCID http://orcid.org/0000-0002-0229-5039
Jessica du ToitDepartment of Clinical and Organizational Ethics, The University Health Network, Toronto, ON, Canada.
Nicholas B MurphyDepartment of Medicine, Western University, London, ON, Canada.
Stuart G NichollsMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Julia F ShawMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Fernando AlthabeInstituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina.
Ariella BinikDepartment of Philosophy, McMaster University, Hamilton, ON, Canada.
Jamie BrehautMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Sandra EldridgePragmatic Clinical Trials Unit, Barts and The London, School of Medicine and Dentistry, Blizard Institute, Queen Mary University of London, London, UK.
Rashida A FerrandClinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.
Katie GilliesAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
Bruno GiraudeauUniversité de Tours, Université de Nantes, INSERM SPHERE U1246, Tours, France.
Rieke van der GraafDepartment of Bioethics and Health Humanities, University Medical Center Utrecht, Utrecht, The Netherlands.
Lars G HemkensPragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel, University of Basel, Basel, Switzerland.
Karla HemmingInstitute of Applied Healthcare Research, University of Birmingham, Birmingham, UK.
Mira JohriCentre de Recherche du CHUM, Montreal, QC, Canada.
Scott Y H KimDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Emily LargentDepartment of Medical Ethics and Health Policy, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.
Alex John LondonDepartment of Philosophy, Carnegie Mellon University, Pittsburgh, PA, USA.
Lawrence MbuagbawBiostatistics Unit, St Joseph's Healthcare, Hamilton, ON, Canada.
Susan L MitchellMarcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, USA.
Maureen SmithDalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Peter TugwellMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Shaun TreweekAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
Vivian A WelchSchool of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Monica TaljaardMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Charles WeijerDepartment of Medicine, Western University, London, ON, Canada.

Funding

CIHR PJT-479757
6 · The paper itself

Abstract

backgroundAlthough commonly used to evaluate health interventions, cluster randomized trials raise difficult ethical issues. Recognizing this, the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues across seven domains. But due to several developments in the design and implementation of cluster randomized trials, there are new issues requiring guidance. To inform the forthcoming update of the Ottawa Statement, we aimed to identify any gaps in the Ottawa Statement discussed within the literature.

methodsWe searched Google Scholar, Scopus, and Web of Science using the 'cited by' function on 11 November 2022.We included all types of publications, including articles, book chapters, commentaries, editorials, ethics guidelines, theses and trial-related publications (i.e., primary reports, protocols, and secondary analyses), that cited and engaged with the Ottawa Statement, the Ottawa Statement précis, or one or more of its four background papers. Data were extracted by four reviewers working in rotating pairs. Reviewers captured relevant text verbatim and recorded whether it reflected a gap relating to one or more of the Ottawa Statement domains. Using a thematic analysis approach, semantic coding was used to summarize the content of the data into distinct gaps within the Ottawa Statement domains, which was subsequently expanded in an inductive manner through discussion.

resultsThe qualitative analysis of the text from 53 articles resulted in the identification of 24 distinct gaps in the Ottawa Statement: 4 gaps about justifying the cluster randomized design; 2 gaps about research ethics committee review; 3 gaps about identifying research participants; 4 gaps about obtaining informed consent; 3 gaps about gatekepeers; 6 gaps about assessing benefits and harms; 1 gap about protecting vulnerable participants; and 1 gap about equity-related issues in cluster randomized trials.

conclusionIdentifying 24 gaps reveals a need to update the Ottawa Statement. Alongside additional gaps identified in ongoing empirical work and through engagement with our patient and public partners, the gaps identified through this citation analysis should be considered in the forthcoming Ottawa Statement update.

Indexed as

Benefit-harm assessmentCitation analysisEthics guidelinesInformed consentResearch ethicsResearch ethics committee reviewVulnerability

Identifiers

PMID40528254
PMCPMC12175472

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.