Citation

Bagiella E, Novack TA, Ansel B, Diaz-Arrastia R, Dikmen S, Hart T, Temkin N. J. Head Trauma Rehabil. 2010; 25(5): 375-382.

Affiliation

Department of Biostatistics, Mailman School of Public Health, Columbia University, New York; Physical Medicine and Rehabilitation, University of Alabama at Birmingham; National Center for Medical Rehabilitation Research, National Institute of Child Health and Human Development, Bethesda, Maryland; Department of Neurology, University of Texas, Southwestern Medical Center, Dallas; Departments of Rehabilitation Medicine, Division of Clinical Psychology and Neuropsychology, School of Medicine and Neurological Surgery and Biostatistics, University of Washington, Seattle; and Moss Rehabilitation Research Institute, Philadelphia, Pennsylvania.

Copyright

(Copyright © 2010, Lippincott Williams and Wilkins)

DOI

10.1097/HTR.0b013e3181d27fe3

PMID

20216459

PMCID

PMC2939167

Abstract

BACKGROUND: Traumatic brain injury (TBI) involves several aspects of a patient's condition, including physical, mental, emotional, cognitive, social, and functional changes. Therefore, a clinical trial with individuals with TBI should consider outcome measures that reflect their global status. METHODS: We present the work of the National Institute of Child Health and Development-sponsored Traumatic Brain Injury Clinical Trials Network Outcome Measures subcommittee and its choice of outcome measures for a phase III clinical trial of patients with complicated mild to severe TBI. RESULTS: On the basis of theoretical and practical considerations, the subcommittee recommended the adoption of a core of 9 measures that cover 2 different areas of recovery: functional and cognitive. These measures are the Extended Glasgow Outcome Scale; the Controlled Oral Word Association Test; the Trail Making Test, Parts A and B; the California Verbal Learning Test-II; the Wechsler Adult Intelligence Scale-III Digit Span subtest; the Wechsler Adult Intelligence Scale-III Processing Speed Index; and the Stroop Color-Word Matching Test, Parts 1 and 2. CONCLUSIONS: The statistical methods proposed to analyze these measures using a global test procedure, along with research and methodological and regulatory issues involved with the use of multiple outcomes in a clinical trial, are discussed.

Language: en