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Ethical implications of excessive cluster sizes in cluster randomised trials
Karla Hemming1, Monica Taljaard2, Gordon Forbes3
1Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
BMJ Quality & Safety
|February 22, 2018
Summary
Excessively large cluster sizes in cluster randomized trials (CRTs) may not increase statistical power and can raise ethical concerns. Researchers should carefully consider cluster size to minimize participant burden and risk.
Area of Science:
- Healthcare Research
- Clinical Trials
- Public Health Interventions
Background:
- Cluster randomized trials (CRTs) are a standard design for evaluating healthcare policy.
- Participant numbers in CRTs increase power up to a certain point, after which gains diminish.
- Excessively large cluster sizes can lead to unnecessary participant burden and potential risks.
Purpose of the Study:
- To explore the ethical implications of excessively large cluster sizes in CRTs.
- To identify when large cluster sizes may be justifiable.
- To inform researchers, funders, and ethics committees about these issues.
Main Methods:
- Analysis of ethical considerations in CRT design.
- Exploration through two distinct case studies.
- Examination of power curves and participant burden.
Main Results:
- Ethical concerns are minimal when data collection is routine, low-cost, and interventions pose low risk.
- Large cluster sizes can be justified for secondary analyses or demonstrating sustainability.
- Minimizing participant burden and risk is paramount in all randomized controlled trials.
Conclusions:
- Optimizing cluster size in CRTs is crucial for ethical research conduct.
- Awareness of ethical issues related to large cluster sizes is essential for all stakeholders.
- Balancing statistical power with participant welfare and resource allocation is key in healthcare research design.
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