OPEN IN READ APP
JOURNAL ARTICLE

Sample size determination for testing equality in a cluster randomized trial with noncompliance

Kung-Jong Lui, Kuang-Chao Chang
Journal of Biopharmaceutical Statistics 2011, 21 (1): 1-17
21191850
For administrative convenience or cost efficiency, we may often employ a cluster randomized trial (CRT), in which randomized units are clusters of patients rather than individual patients. Furthermore, because of ethical reasons or patient's decision, it is not uncommon to encounter data in which there are patients not complying with their assigned treatments. Thus, the development of a sample size calculation procedure for a CRT with noncompliance is important and useful in practice. Under the exclusion restriction model, we have developed an asymptotic test procedure using a tanh(-1)(x) transformation for testing equality between two treatments among compliers for a CRT with noncompliance. We have further derived a sample size formula accounting for both noncompliance and the intraclass correlation for a desired power 1 - β at a nominal α level. We have employed Monte Carlo simulation to evaluate the finite-sample performance of the proposed test procedure with respect to type I error and the accuracy of the derived sample size calculation formula with respect to power in a variety of situations. Finally, we use the data taken from a CRT studying vitamin A supplementation to reduce mortality among preschool children to illustrate the use of sample size calculation proposed here.

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Available on the App Store

Available on the Play Store
Remove bar
Read by QxMD icon Read
21191850
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"