ReviewBMJ (Clinical research ed.)2011
Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials.
Review in BMJ (Clinical research ed.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 5 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
31 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Pooled it
- A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality.BMC medical research methodology · 2013Pooled it
- How transparent is behavioral intervention research on pathological gambling and other gambling-related disorders? A systematic literature review.Addiction (Abingdon, England) · 2012Pooled it
- The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials.PLoS medicine · 2012Guideline
- Reporting of Research Ethics in Studies Focusing on Foot Health in Patients with Rheumatoid Arthritis - A Systematic Review.Journal of empirical research on human research ethics : JERHREPooled it
- Ethical implications of excessive cluster sizes in cluster randomised trials.BMJ quality & safety · 2018Trial
- A focus group study to understand biases and confounders in a cluster randomized controlled trial on low back pain in primary care in Norway.BMC family practice · 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
- Trial
- Research waste of randomized controlled trials related to deep brain stimulation: a cross-sectional analysis.Frontiers in aging neuroscience · 2026Article
- Ethical challenges in contemporary psychiatry: an overview and an appraisal of possible strategies and research needs.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2024Article
- Article
- Stakeholders' experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis.Research ethics · 2024Article
- Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.International journal for equity in health · 2023Article
- Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.Critical care explorations · 2022Review
- A review identified challenges distinguishing primary reports of randomized trials for meta-research: A proposal for improved reporting.Journal of clinical epidemiology · 2022Review
- Reporting of health equity considerations in equity-relevant observational studies: Protocol for a systematic assessment.F1000Research · 2022Article
- Ethics issues identified by applicants and ethics experts in Horizon 2020 grant proposals.F1000Research · 2021Article
- Article
- The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009-2013.Science and engineering ethics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
objectivesTo investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices.
designReview of a random sample of published cluster randomised trials from an electronic search in Medline.
settingCluster randomised trials in health research published in English language journals from 2000 to 2008. Study sample 300 cluster randomised trials published in 150 journals.
results77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001).
conclusionsReporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for.
Indexed as
Identifiers
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.