Balance algorithm for cluster randomized trials.
BACKGROUND
Within cluster randomized trials no algorithms exist to generate a full enumeration of a block randomization, balancing for covariates across treatment arms. Furthermore, often for practical reasons multiple blocks are required to fully randomize a study, which may not have been well balanced within blocks.


RESULTS
We present a convenient and easy to use randomization tool to undertake allocation concealed block randomization. Our algorithm highlights allocations that minimize imbalance between treatment groups across multiple baseline covariates. We demonstrate the algorithm using a cluster randomized trial in primary care (the PRE-EMPT Study) and show that the software incorporates a trade off between independent random allocations that were likely to be imbalanced, and predictable deterministic approaches that would minimise imbalance. We extend the methodology of single block randomization to allocate to multiple blocks conditioning on previous allocations.


CONCLUSIONS
The algorithm is included as Additional file 1 and we advocate its use for robust randomization within cluster randomized trials.
South East Wales Trials Unit, Neuadd Meirionnydd, School of Medicine, Heath Park Campus, Cardiff University, CF14 4XN, UK. carterbr@cardiff.ac.uk
Ben R
BR
Carter
Kerenza
K
Hood
D000465:Algorithms; D016000:Cluster Analysis; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012984:Software