Measuring outcome in traumatic brain injury treatment trials: recommendations from the traumatic brain injury clinical trials network

J Head Trauma Rehabil. Sep-Oct 2010;25(5):375-82. doi: 10.1097/HTR.0b013e3181d27fe3.

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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Brain Injuries / rehabilitation*
  • Clinical Trials, Phase III as Topic*
  • Glasgow Outcome Scale*
  • Humans
  • Neuropsychological Tests*
  • Wechsler Scales*