TBI Research at NIH. Ramona Hicks, PhD NIH/NINDS
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1 TBI Research at NIH Ramona Hicks, PhD NIH/NINDS
2 Objectives 1. Overview of TBI research opportunities at NIH 2. Highlight a few projects Common Data Element Project Federal Interagency TBI Research Informatics System International TBI Research Initiative NFL donation to the Sports and Health Research Program Disclosure: I have no real or perceived conflicts of interest that relate to this educational activity.
3 NIH Turning Discovery Into Health NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit
4 Scope: TBI Research at NIH All ages, types, severities, and acute and chronic TBI Basic, translation, and clinical research Training and career development NINDS is the lead, but many other NIH Institutes also fund TBI research Funded research abstracts available at NIH Reporter Funding: FY 2011 $81M
5 Website:
6 Project Overview
7 TBI Common Data Elements Interagency workshop Mar 2009 Goal was to standardize TBI research to enable data sharing Working groups: Clinical Assessment Biomarkers Neuroimaging Outcomes Plus 4 PH groups
8 What are Common Data Elements? Standardized definitions, methods, and codes Patient-Specific Factors Treatment-Specific Factors Outcomes
9 How are the TBI common data elements organized? Core a minimal set of data to characterize a broad spectrum of subjects Basic a larger set of essential data to provide greater depth and breadth for specific research studies Supplemental optional data elements to provide greater depth and breadth as needed Treatments Patient Outcomes
10 Results:
11 : Number of CDEs Across Disease Areas by Classification (version 1) Disease Core Supplemental Exploratory Area Total CDEs CDEs CDEs CDEs General Epilepsy PD SCI Stroke TBI* TOTAL
12 From Good to Great: Version 2.0 Objectives Decrease core items, organize into modules based on sample and study type, fill gaps New working groups Epidemiology Concussion/Mild TBI Acute Hospitalization Rehab and Post-Acute
13 : Number of TBI CDEs Across Subdomains Disease Area Total CDEs Core CDEs Basic CDEs Supplemental CDEs Epidemiology Concussion Acute Hospital Rehab TOTAL
14 Conclusions about CDEs Dynamic and collaborative process Imperfect but still worthwhile Success depends upon the experts who make the recommendations and the community of users put them into practice Necessary for sharing data, but not sufficient
15
16 Federal Interagency TBI Research Informatics System is a DoD-NIH Collaboration to: Facilitate meta-analysis severity Enable new analyses Link seemingly disparate research age time
17 How? Capitalize on success National Database for Autism Research (NDAR) National Institute for Disability and Rehabilitation Research (NIDRR Models Systems) Alzheimer s Disease Neuroimaging Initiative Use the TBI Common Data Elements as the data dictionary Build what the investigator s want and need Ensure rigorous standards for data quality Provide user-friendly interfaces and operational support Focus on high priority research questions - Data output just as important as data input Promote team science
18 Hybrid Model Collaboration Principal Investigator General Data Submission Federated Data Data Submission Research Site FITBIR Collaboration Genomics Images Phenotype Query GUID Server Collaboration Researcher
19 FITBIR Timeline April 2012 Public Website July 2012 FITBIR v1.0 Nov 2012 FITBIR v Public Website Live Data Dictionary Tool Data Validation Tool GUID Tool Data Contribution NIH Single Sign-On NINDS TBI Version 2.0 Electronic Form Capture (ProFoRM) Query Tool Data Download Tool Data Attribution Outreach/Training for Grantees Federation Advanced Query Functionality Outreach/Training for Grantees and Other Submitters Meta-Study Analysis
20 Towards an International Initiative for Traumatic Brain Injury Research Brussels, October 2011
21 What are the priorities? Integrate TBI research across the continuum of age, care and injury severity. Increase the precision of diagnosis and classification. Identify biomarkers to predict outcomes and to monitor injury and recovery. Comparative effectiveness research to determine which treatments work and for whom and under what conditions
22 INJURY SEVERITY Figure 4: Treatment System Transitions and Injury Severity INJURY DEATH INJURY ED HOSPITAL DEATH INJURY ED HOSPITAL SUB-ACUTE INJURY ED HOSPITAL REHAB SUB-ACUTE COMMUNITY INJURY ED HOSPITAL REHAB COMMUNITY INJURY ED HOSPITAL COMMUNITY INJURY ED COMMUNITY INJURY COMMUNITY MD Office COMMUNITY PRE- INJURY INJURY COMMUNITY INJURY HOUR DAY WEEK MONTH YEAR DECADE LIFETIME John Whyte Need to study TBI across the injury severity, timecourse, and lifespan
23 Towards an International Initiative for Traumatic Brain Injury Research Should we do it? Yes How? Governance Participation Standardization Data sharing
24 Sept. 5, 2012 The National Football League Commits $30 Million Donation to the Foundation for the National Institutes of Health to Support Medical Research The NFL is the founding donor to a new Sports and Health Research Program Specific plans for the research to be undertaken remain to be developed, but potential areas include: chronic traumatic encephalopathy; concussion; understanding the potential relationship between traumatic brain injury and late life neurodegenerative disorders, especially Alzheimer's disease; chronic degenerative joint disease; the transition from acute to chronic pain; sudden cardiac arrest in young athletes; and heat and hydration-related illness and injury.
25 TBI Research at NIH: Summary NIH supports research and training on TBI through grants, cooperative agreements and contracts NIH strives to communicate, coordinate, and collaborate on TBI research across funding agencies and other stakeholders
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