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