SynthesisClinical trials (London, England)2018
Reporting non-adherence in cluster randomised trials: A systematic review.
Synthesis in Clinical trials (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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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
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic review of simulation studies which compare existing statistical methods to account for non-compliance in randomised controlled trials.BMC medical research methodology · 2023Pooled it
- Failure to rescue the trial: lessons from a randomised antibiotic treatment trial in the acute care setting.Trials · 2026Trial
- Trial
- Safe birth in cultural safety in southern Mexico: a pragmatic non-inferiority cluster-randomised controlled trial.BMC pregnancy and childbirth · 2022Trial
- Preference-Informed Cluster Randomized Design for Pragmatic Clinical Trials.Statistics in medicine · 2026Article
- Article
- Impact of Fortified Malt-Based Food on Immunity Outcomes in School Children in India: Cluster Randomized Controlled Trial.Interactive journal of medical research · 2025Article
- Practical design considerations for cluster randomized controlled trials: lessons learned in community oncology research.Journal of the National Cancer Institute. Monographs · 2025Article
- Influential methods reports for group-randomized trials and related designs.Clinical trials (London, England) · 2022Article
- Review
- Tobacco-Free Duo Adult-Child Contract for Prevention of Tobacco Use Among Adolescents and Parents: Protocol for a Mixed-Design Evaluation.JMIR research protocols · 2020Article
- What are the statistical implications of treatment non-compliance in cluster randomized trials: A simulation study.Statistics in medicine · 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
2 authors.
Funding
Abstract
backgroundTreatment non-adherence in randomised trials refers to situations where some participants do not receive their allocated treatment as intended. For cluster randomised trials, where the unit of randomisation is a group of participants, non-adherence may occur at the cluster or individual level. When non-adherence occurs, randomisation no longer guarantees that the relationship between treatment receipt and outcome is unconfounded, and the power to detect the treatment effects in intention-to-treat analysis may be reduced. Thus, recording adherence and estimating the causal treatment effect adequately are of interest for clinical trials.
objectivesTo assess the extent of reporting of non-adherence issues in published cluster trials and to establish which methods are currently being used for addressing non-adherence, if any, and whether clustering is accounted for in these.
methodsWe systematically reviewed 132 cluster trials published in English in 2011 previously identified through a search in PubMed.
resultsOne-hundred and twenty three cluster trials were included in this systematic review. Non-adherence was reported in 56 cluster trials. Among these, 19 reported a treatment efficacy estimate: per protocol in 15 and as treated in 4. No study discussed the assumptions made by these methods, their plausibility or the sensitivity of the results to deviations from these assumptions. LIMITATIONS: The year of publication of the cluster trials included in this review (2011) could be considered a limitation of this study; however, no new guidelines regarding the reporting and the handling of non-adherence for cluster trials have been published since. In addition, a single reviewer undertook the data extraction. To mitigate this, a second reviewer conducted a validation of the extraction process on 15 randomly selected reports. Agreement was satisfactory (93%).
conclusionDespite the recommendations of the Consolidated Standards of Reporting Trials statement extension to cluster randomised trials, treatment adherence is under-reported. Among the trials providing adherence information, there was substantial variation in how adherence was defined, handled and reported. Researchers should discuss the assumptions required for the results to be interpreted causally and whether these are scientifically plausible in their studies. Sensitivity analyses to study the robustness of the results to departures from these assumptions should be performed.
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