Funding Agency:

National Institute of Health

Total Project Period:

10/1/09 - 8/31/12

Total Project Award:

$760,656

Initiating Principal Investigator:

Geoff Manley, MD (University of California, San Francisco)

Participating Principal Investigators:

David O. Okonkwo, MD, PhD; Alex Valadka, MD (University of Texas, Houston)

Co-Investigator:

Ava M. Puccio, PhD

Project Summary:

Traumatic Brain Injury (TBI) remains one of the greatest unmet needs in medicine and public health. Advances in basic science research in the past 20 years have created new opportunities for targeted therapies for TBI. However, these advances have failed to translate into a successful clinical trial or a new treatment for TBI. Two recent workgroups identified important reasons for the failure in translation that include lack of standardization in data collection, outdated approaches to TBI classification and outcome. There was consensus that the selection of variables in TBI studies should be standardized across studies and a strong recommendation was made to develop novel and improved approaches to TBI classification. The application of emerging technologies was also recommended. With broad agency support, a multidisciplinary group of thought leaders was brought together to draft a proposal for standardization of data collection across TBI studies with an emphasis on demographics, neuroimaging, outcome measures, biomarkers, and psychological health, referred to as the TBI Common Data Elements (TBI-CDE). This now provides a potential framework for all future TBI research, but it was acknowledged that a web-based data entry format and further refinement and testing of the beta-version in clinical practice would be required for implementation and widespread adoption of the TBI-CDE.

The global aims of this proposal are to test and refine standards for data collection in TBI studies suitable for use across the broad spectrum of TBI, and to explore novel approaches for TBI classification and outcome after TB, making use of emerging technology. In addition, we aim to develop a pilot set of performance indicators for assessment of the health care quality and effectiveness in TBI. Testing and validating the TBI-CDE will be performed in a multicenter observational study with 3 TBI Centers (UCSF, UPMC, UT Houston) and a TBI Rehabilitation Center (Mount Sinai). A unique feature is that it will span the entire spectrum of TBI from mild to severe, from early to late presentation and from infancy to the age of seniors. For the first time, the development of TBI specific performance indicators will be explored. Taken in combination, the deliverables of this project have the potential to transform TBI research and clinical care.