On the role of Baseline measurements for crossover designs under the self and mixed carryover effects model.
It is well known that optimal designs are strongly model dependent. In this article, we apply the Lagrange multiplier approach to the optimal design problem, using a recently proposed model for carryover effects. Generally, crossover designs are not recommended when carryover effects are present and when the primary goal is to obtain an unbiased estimate of the treatment effect. In some cases, baseline measurements are believed to improve design efficiency. This article examines the impact of baselines on optimal designs using two different assumptions about carryover effects during baseline periods and employing a nontraditional crossover design model. As anticipated, baseline observations improve design efficiency considerably for two-period designs, which use the data in the first period only to obtain unbiased estimates of treatment effects, while the improvement is rather modest for three- or four-period designs. Further, we find little additional benefits for measuring baselines at each treatment period as compared to measuring baselines only in the first period. Although our study of baselines did not change the results on optimal designs that are reported in the literature, the problem of strong model dependency problem is generally recognized. The advantage of using multiperiod designs is rather evident, as we found that extending two-period designs to three- or four-period designs significantly reduced variability in estimating the direct treatment effect contrast.
Department of Epidemiology and Biostatistics, University of Texas Health Science Center, San Antonio, USA.
Yuanyuan
Y
Liang
Keumhee Chough
KC
Carriere
D000465:Algorithms; D001499:Bayes Theorem; D001699:Biometry / Q000379:methods*; D003198:Computer Simulation; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D004812:Epidemiologic Methods; D016247:Information Storage and Retrieval / Q000379:methods*; D008137:Longitudinal Studies; D015233:Models, Statistical; D018401:Sample Size