Estimating sample size in critical care clinical trials

J Crit Care. 2005 Mar;20(1):6-11. doi: 10.1016/j.jcrc.2005.02.002.


Estimating the required sample size for a study is necessary during the design phase to ensure that it will have maximal efficiency to answer the primary question of interest. Clinicians require a basic understanding of the principles underlying sample size calculation to interpret and apply research findings. This article reviews the critical components of sample size calculation, including the selection of a primary outcome, specification of the acceptable types I and II error rates, identification of the minimal clinically important difference, and estimation of the error associated with measuring the primary outcome. The relationship among confidence intervals, precision, and study power is also discussed.

Publication types

  • Review

MeSH terms

  • Bias
  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / statistics & numerical data*
  • Confidence Intervals
  • Critical Care*
  • Humans
  • Research Design
  • Sample Size