Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review
Abstract
Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any re…
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The most common reasons for adopting cluster randomization were due to either a concern over contamination or for practical reasons; and this echoes what others have found.
“Finally, we identified that the most common reasons for adopting cluster randomization were due to either a concern over contamination or for practical reasons; and this echoes what others have found [30].”
From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [30]
No citation lists for this paper
No citation lists for this paper yet — checked again daily.
References 22 · Cited by 41
- Authors
- Taljaard, M., Hemming, K., Shah, L., Giraudeau, B., Grimshaw, J. M., & Weijer, C.
- Affiliations
- University of Ottawa (CA)
- University of Birmingham (GB)
- McGill University (CA)
- Université de Tours (FR)
- Western University (CA)
- Corresponding author
- Taljaard, Monica
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2017-04-08
- Volume
- 14
- Issue
- 4
- Pages
- 333-341
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- OpenAlex
- W2604399020
- Cited by
- 41
- References
- 22
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 4 · 2023: 2 · 2022: 7 · 2021: 3 · 2020: 5 · 2019: 7 · 2018: 4 · 2017: 1
- FWCI
- 0.76
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- stepped-wedge cluster randomized trial, research ethics review, informed consent, waiver of consent, research ethics committees, trial reporting quality
- MeSH terms
- Data Collection, Humans, Informed Consent, Research Design, Research Personnel, Randomized Controlled Trials as Topic, Ethics Committees, Research, Ethics, Research
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
