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Assessing outcome in head injury trials
1Department of Psychology, University of Stirling, Stirling FK9 4LA, United Kingdom. j.t.l.wilson@stir.ac.uk
Current Pharmaceutical Design
|September 20, 2001
Summary
Outcome measures in neuroprotection trials for head injury are often insensitive. This review examines assessment tools, highlighting the Glasgow Outcome Scale (GOS) and neuropsychological tests for improved trial sensitivity.
Area of Science:
- Neuroscience
- Clinical Trials
- Traumatic Brain Injury
Background:
- Neuroprotection trials for head injury often fail due to insensitive outcome measures.
- Effective assessment requires measures sensitive to outcome differences and influenced by brain injury.
Purpose of the Study:
- To review the strengths and weaknesses of various outcome assessment approaches in head injury trials.
- To identify sensitive and relevant measures for determining treatment response in neuroprotection studies.
Main Methods:
- Review of existing literature on outcome measures for head injury trials.
- Analysis of scales of disability, handicap, and neuropsychological impairment.
- Evaluation of the Glasgow Outcome Scale (GOS) as a primary endpoint.
Main Results:
- The Glasgow Outcome Scale (GOS) is a popular, simple endpoint capable of detecting outcome changes with adequate sample sizes.
- Neuropsychological tests offer potential for hypothesis testing but face practical challenges.
- Other scales and questionnaires provide limited advantages over the GOS but can supplement data.
Conclusions:
- Current outcome measures for head injury trials have limitations.
- The choice of endpoint depends on measure properties and anticipated treatment effects.
- Improving outcome measure sensitivity is crucial for successful neuroprotection trials.