This article summarizes the selection of outcome measures by the interagency Traumatic Brain Injury (TBI) Outcomes Workgroup to address primary clinical research objectives, including documentation of the natural course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies. Consistent with other Common Data Elements Workgroups, the TBI Outcomes Workgroup adopted the standard 3-tier system in its selection of measures. In the first tier, core measures included valid, robust, and widely applicable outcome measures with proven utility in TBI from each identified domain, including global level of function, neuropsychological impairment, psychological status, TBI-related symptoms, executive functions, cognitive and physical activity limitations, social role participation, and perceived health-related quality of life. In the second tier, supplemental measures were recommended for consideration in TBI research focusing on specific topics or populations. In the third tier, emerging measures included important instruments currently under development, in the process of validation, or nearing the point of published findings that have significant potential to be superior to some older ("legacy") measures in the core and supplemental lists and may eventually replace them as evidence for their utility emerges.
ContributorsWilde, E. A. Whiteneck, G. G. Bogner, J. Bushnik, T. Cifu, D. X. Dikmen, S. French, L. Giacino, J. T. Hart, T. Malec, J. F. Millis, S. R. Novack, T. A. Sherer, M. Tulsky, D. S. Vanderploeg, R. D. von Steinbuechel, N.
Disease Category: Neurology
Disease Name: Brain injury (traumatic)
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Not specified
- Clinical experts
- Researchers
- Recommendations for outcome measures (measurement/how)
- COS for clinical trials or clinical research
- Semi structured discussion
Semi structured discussion: meeting
Other: teleconferences