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Measuring continuous baseline covariate imbalances in clinical trial data

  • Jody D. Ciolino*
  • , Reneé H. Martin
  • , Wenle Zhao
  • , Michael D. Hill
  • , Edward C. Jauch
  • , Yuko Y. Palesch
  • *Corresponding author for this work
  • Medical University of South Carolina
  • University of Calgary

Research output: Contribution to journalArticlepeer-review

30 Scopus citations

Abstract

This paper presents and compares several methods of measuring continuous baseline covariate imbalance in clinical trial data. Simulations illustrate that though the t-test is an inappropriate method of assessing continuous baseline covariate imbalance, the test statistic itself is a robust measure in capturing imbalance in continuous covariate distributions. Guidelines to assess effects of imbalance on bias, type I error rate and power for hypothesis test for treatment effect on continuous outcomes are presented, and the benefit of covariate-adjusted analysis (ANCOVA) is also illustrated.

Original languageEnglish
Pages (from-to)255-272
Number of pages18
JournalStatistical Methods in Medical Research
Volume24
Issue number2
DOIs
StatePublished - 23 Apr 2015
Externally publishedYes

Keywords

  • baseline
  • clinical trial
  • covariate
  • imbalance

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