title: Measuring continuous baseline covariate imbalances in clinical trial data.
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.
authors.affiliation: Division of Biostatistics and Epidemiology, 135 Cannon Street, Suite 303, Medical University of South Carolina, Charleston, SC, USA. jodycio@gmail.com.
authors.forename: Jody D
authors.initials: JD
authors.lastname: Ciolino
authors.affiliation: Division of Biostatistics and Epidemiology, 135 Cannon Street, Suite 303, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Reneé H
authors.initials: RH
authors.lastname: Martin
authors.affiliation: Division of Biostatistics and Epidemiology, 135 Cannon Street, Suite 303, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Wenle
authors.initials: W
authors.lastname: Zhao
authors.affiliation: Department of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, AB, Canada.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
authors.affiliation: Department of Emergency Medicine, Medical University of South Carolina, Charleston, USA.
authors.forename: Edward C
authors.initials: EC
authors.lastname: Jauch
authors.affiliation: Division of Biostatistics and Epidemiology, 135 Cannon Street, Suite 303, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Yuko Y
authors.initials: YY
authors.lastname: Palesch
mesh_terms: D019540:Area Under Curve; D015982:Bias; D056808:Biostatistics; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D013269:Stochastic Processes; D020521:Stroke / Q000188:drug therapy; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use
chemical_list: D010959:Tissue Plasminogen Activator