Thousands of individuals sustain traumatic brain injury (TBI) each year, resulting in permanent disability for an estimated 5.3 million Americans in 1999. The primary objective of this project is to develop strategies to improve outcome from TBI.
Specific aims of this project will be to (1) aid in the development of standard terminology and data collection tools for the conduct of clinical research for TBI, (2) continue development of information technology systems to facilitate multicenter clinical research on TBI, (3) determine appropriate outcome measures for distinguishing efficacy of TBI therapies, and (4) conduct multidisciplinary, multicenter research into therapeutic interventions regarding their safety and effects upon outcome after TBI. Central to the goals of any multicenter trial is accurate, complete, and appropriate data collection. In addition, reliable follow-up must be ensured. The present proposal aims to facilitate this center's participation in a TBI clinical research network by promoting both. It further seeks to develop improved tools to be shared with other network centers and ultimately non-network centers. The PIs propose an organizational model for conducting TBI research to insure collection of a wide variety of data, including electronic images and continuous monitoring data, in addition to traditionally collected data points. Furthermore, they propose a database design which includes information from the entire continuum of care, ranging from available pre-morbid information and field assessments and treatments through the acute care phase into the long-term follow-up periods. Finally, the data is collected in an ongoing, prospective manner in the proposed model to insure accuracy. In order to accomplish the level of detail necessary to glean significant information relevant to outcomes from TBI, the treatment of which is often lengthy and complicated, the PIs assert that individuals certified in the management of health information will be crucial. Individuals with expertise in the management of medical information are well suited not only to collect the information, but also to collate data for subsequent interpretation. Nurse coordinators who are knowledgeable about the treatment and special needs of TBI patients are also a vital part of the research team. The model proposed will facilitate the cooperative involvement of multiple disciplines and centers in the conduct of clinical TBI research. ? ?
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| Zafonte, Ross D; Bagiella, Emilia; Ansel, Beth M et al. (2012) Effect of citicoline on functional and cognitive status among patients with traumatic brain injury: Citicoline Brain Injury Treatment Trial (COBRIT). JAMA 308:1993-2000 |
| Bagiella, Emilia; Novack, Thomas A; Ansel, Beth et al. (2010) Measuring outcome in traumatic brain injury treatment trials: recommendations from the traumatic brain injury clinical trials network. J Head Trauma Rehabil 25:375-82 |
| Zafonte, Ross; Friedewald, William T; Lee, Shing M et al. (2009) The citicoline brain injury treatment (COBRIT) trial: design and methods. J Neurotrauma 26:2207-16 |
