Handling baselines in repeated measures analyses with missing data at random. 2011

Phillip Dinh, and Peiling Yang
Division of Biometrics 1, Office of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Phillip.Dinh@fda.hhs.gov

In longitudinal clinical studies, after randomization at baseline, subjects are followed for a period of time for development of symptoms. A mixed model for repeated measures (MMRM) can be used to analyze data from such studies. Fitzmaurice et al. (2004) outlined five approaches for handling baseline responses in an MMRM analysis. They are: (1) Retain the baselines as part of the outcome vector and make no assumptions about group differences in the mean response at baseline. (2) Retain the baselines as part of the outcome vector and assume the group means are equal at baseline. (3) Subtract the baselines from all of the remaining post-baseline responses, and analyze the differences from baseline. (4) Use the baselines as a covariate in the analysis of the post-baseline responses, assuming homogeneous regression slopes. (5) Use the baselines as a covariate in the analysis of the post-baseline responses, allowing different regression slopes. In this paper, we evaluate these five approaches in the presence of data missing at random. We evaluate the approaches based on the bias of the estimate and the coverage accuracy of the confidence interval. The results suggest that strategies 2 and 5 are recommended.

UI MeSH Term Description Entries
D008137 Longitudinal Studies Studies in which variables relating to an individual or group of individuals are assessed over a period of time. Bogalusa Heart Study,California Teachers Study,Framingham Heart Study,Jackson Heart Study,Longitudinal Survey,Tuskegee Syphilis Study,Bogalusa Heart Studies,California Teachers Studies,Framingham Heart Studies,Heart Studies, Bogalusa,Heart Studies, Framingham,Heart Studies, Jackson,Heart Study, Bogalusa,Heart Study, Framingham,Heart Study, Jackson,Jackson Heart Studies,Longitudinal Study,Longitudinal Surveys,Studies, Bogalusa Heart,Studies, California Teachers,Studies, Jackson Heart,Studies, Longitudinal,Study, Bogalusa Heart,Study, California Teachers,Study, Longitudinal,Survey, Longitudinal,Surveys, Longitudinal,Syphilis Studies, Tuskegee,Syphilis Study, Tuskegee,Teachers Studies, California,Teachers Study, California,Tuskegee Syphilis Studies
D010352 Patient Dropouts Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease. Dropout, Patient,Dropouts, Patient,Patient Dropout
D003198 Computer Simulation Computer-based representation of physical systems and phenomena such as chemical processes. Computational Modeling,Computational Modelling,Computer Models,In silico Modeling,In silico Models,In silico Simulation,Models, Computer,Computerized Models,Computer Model,Computer Simulations,Computerized Model,In silico Model,Model, Computer,Model, Computerized,Model, In silico,Modeling, Computational,Modeling, In silico,Modelling, Computational,Simulation, Computer,Simulation, In silico,Simulations, Computer
D003627 Data Interpretation, Statistical Application of statistical procedures to analyze specific observed or assumed facts from a particular study. Data Analysis, Statistical,Data Interpretations, Statistical,Interpretation, Statistical Data,Statistical Data Analysis,Statistical Data Interpretation,Analyses, Statistical Data,Analysis, Statistical Data,Data Analyses, Statistical,Interpretations, Statistical Data,Statistical Data Analyses,Statistical Data Interpretations
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical

Related Publications

Phillip Dinh, and Peiling Yang
April 2010, Heart (British Cardiac Society),
Phillip Dinh, and Peiling Yang
December 2005, Research in nursing & health,
Phillip Dinh, and Peiling Yang
July 2022, American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics,
Phillip Dinh, and Peiling Yang
February 2022, Neuro-oncology practice,
Phillip Dinh, and Peiling Yang
January 2014, Multivariate behavioral research,
Phillip Dinh, and Peiling Yang
December 2023, Psychometrika,
Phillip Dinh, and Peiling Yang
April 2000, Statistics in medicine,
Copied contents to your clipboard!