Measuring outcome in traumatic brain injury treatment trials: recommendations from the traumatic brain injury clinical trials network.
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.
Bagiella
Emilia
E
Department of Biostatistics, Mailman School of Public Health, Columbia University, New York 10032, NY 10032, USA.
Novack
Thomas A
TA
Ansel
Beth
B
Diaz-Arrastia
Ramon
R
Dikmen
Sureyya
S
Hart
Tessa
T
Temkin
Nancy
N
D001930:Brain Injuries / Q000534:rehabilitation*; D017326:Clinical Trials, Phase III as Topic; D023261:Glasgow Outcome Scale; D006801:Humans; D009483:Neuropsychological Tests; D014888:Wechsler Scales