Journal
BIOSTATISTICS
Volume 11, Issue 1, Pages 1-17Publisher
OXFORD UNIV PRESS
DOI: 10.1093/biostatistics/kxp046
Keywords
Analysis of covariance; Causal pathway; Covariance structure; Cross-level bias; Experimental design; REML; Restricted maximum likelihood
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It is our experience that in many settings, crossover trials that have within-period baseline measurements are analyzed wrongly. A conventional analysis of covariance in this setting uses each baseline as a covariate for the following outcome variable in the same period but not for any other outcome. If used with random subject effects such an analysis leads to biased treatment comparisons; this is an example of cross-level bias. Using a postulated covariance structure that reflects the symmetry of the crossover setting, we quantify such bias and, at the same time, investigate potential gains and losses in efficiency through the use of the baselines. We then describe alternative methods of analysis that avoid the cross-level bias. The development is illustrated throughout with 2 example trials, one balanced and orthogonal and one highly unbalanced and nonorthogonal.
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