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Reporting non-adherence in cluster randomised trials: A systematic review
Schadrac C Agbla1, Karla DiazOrdaz1
1Department of Medical Statistics, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.
Clinical Trials (London, England)
|April 3, 2018
Summary
Treatment non-adherence in cluster randomized trials is under-reported, with varied methods for handling it. Researchers must clearly state assumptions and perform sensitivity analyses for causal interpretation.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Epidemiology
Background:
- Treatment non-adherence in randomized trials occurs when participants deviate from their assigned intervention.
- In cluster randomized trials, non-adherence can happen at the cluster or individual level, potentially confounding treatment-outcome relationships.
- Adequate recording of adherence and estimation of causal treatment effects are crucial for clinical trial validity.
Purpose of the Study:
- To evaluate the reporting of non-adherence in published cluster randomized trials.
- To identify methods used to address non-adherence and assess if clustering was considered.
- To determine the extent to which adherence issues are reported in cluster trials.
Main Methods:
- Systematic review of 132 cluster randomized trials published in English in 2011.
- PubMed database search for relevant trials.
- Data extraction by a single reviewer, with validation on a subset of reports.
Main Results:
- Out of 123 included trials, non-adherence was reported in 56.
- Only 19 trials reported a treatment efficacy estimate using per-protocol (15) or as-treated (4) methods.
- No studies discussed the assumptions, plausibility, or sensitivity analyses related to their adherence handling methods.
Conclusions:
- Treatment adherence is under-reported in cluster randomized trials, despite existing reporting guidelines.
- Significant variation exists in how adherence is defined, handled, and reported.
- Researchers should transparently discuss assumptions for causal interpretation and conduct sensitivity analyses.
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