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Evaluation Review
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Power Analysis of Cutoff-Based Randomized Clinical Trials

Joseph C. Cappelleri

New England Medical Center

Richard B. Darlington

Cornell University

William M.K. Trochim

Cornell University

A cutoff-based randomized clinical trial couples cutoff-based assignment on an appropriate covariate with random assignment to help balance ethical and scientific concerns in certain situations. A statistical power algorithm based on the Fisher Z method is developed that is particular to and inclusive of cutoff-based random clinical trials and the single cutoff-point (regression-discontinuity) design, which has no randomization. This article quantifies power and sample size estimates for varying levels of randomization and cutoff-based assignment. Although more randomization engenders greater statistical power, less randomization requires a much larger increase in sample size for small treatment effects.

Evaluation Review, Vol. 18, No. 2, 141-152 (1994)
DOI: 10.1177/0193841X9401800202


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