Transforming Traumatic Brain Injury Research and Clinical Care

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Investigator: Geoffrey Manley, MD, PhD
Sponsor: NIH National Institute of Neurological Disorders and Stroke

Location(s): United States

Description

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 workshops sponsored by NINDS, NIDRR, DVBIC, and DCOE identified important reasons for the failure in translation that include lack of standardisation in data collection, outdated approaches to TBI classification and outcome.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 standardisation 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 aim of this proposal is to test and refine standards for data collection in TBI studies, suitable for use across the broad spectrum of TBI (Aim 1), and to explore novel approaches for TBI classification (Aim 2) and outcome after TBI (Aim 3), 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 (Aim 4). 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). These Centers have multicenter TBI research experience and existing infrastructure to rapidly and successfully complete the study. We will create, or expand existing, data repositories for patient demographics, neuroimaging, serum biomarkers and genomics thereby providing researchers and clinicians with the infrastructure to develop the TBI field in a concerted multidisciplinary effort. The project is aimed at developing infrastructure, collaborations, and tools. It will build bridges across disciplines, break down artificial constructs and barriers that have slowed progress and facilitate comparison and meta-analyses of individual patient data across studies. It represents one of the most integrative TBI efforts to date. 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. Traumatic Brain Injury (TBI) remains one of the greatest unmet needs in medicine and public health. The overall goal of this proposal is to test and refine standards for data collection in TBI studies in order to improve classification, outcome assessment, and healthcare quality and effectiveness research Together, the deliverables of this project have the potential to transform TBI research and clinical care.