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Sample size calculations for cluster randomised controlled trials with a fixed number of clusters
Karla Hemming1, Alan J Girling, Alice J Sitch
1Department of Public Health, Epidemiology and Biostatistics, University of Birmingham, UK. k.hemming@bham.ac.uk
Sample size calculations for cluster randomised controlled trials (CRCTs) with a fixed number of clusters are essential. If the number of clusters is insufficient, the study may not be feasible, impacting detectable differences and power.
Area of Science:
- Health Services Research
- Biostatistics
- Clinical Trials
Background:
- Cluster randomised controlled trials (CRCTs) are common in health service evaluations.
- Standard sample size calculations assume average cluster sizes.
- Formulas for CRCTs with a fixed number of clusters and variable individuals per cluster are less studied.
Purpose of the Study:
- To systematically outline sample size formulae for CRCTs with a fixed number of clusters.
- To provide a concise summary for both binary and continuous outcomes.
- To address extensions for unequal cluster sizes.
Main Methods:
- Systematic outlining of sample size formulae.
- Inclusion of required number of randomisation units, detectable difference, and power.
- Consideration of both binary and continuous outcomes.
Main Results:
- Trial feasibility requires the number of clusters to exceed a threshold related to individuals needed for individual randomisation and intra-cluster correlation.
- A formula is provided to assess cluster sufficiency.
- If insufficient, investigators can determine maximum power or minimum detectable difference.
Conclusions:
- CRCT design with a fixed cluster number may lead to infeasibility.
- Minimum detectable difference or maximum achievable power may be constrained, regardless of individuals per cluster.
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