The National Institutes of Health, in partnership with the Department of Defense, is building a central database focused on traumatic brain injuries (TBI) that officials say will aid in better prevention, diagnosis and treatment.

The Federal Interagency Traumatic Brain Injury Research (FITBIR) database, funded at $10 million over four years, is designed to accelerate comparative effectiveness research on brain injury treatment and diagnosis. It will serve as a central repository for new data, link to current databases and allow valid comparison of results across studies.

"There are many traumatic brain injury studies whose value to scientific research and clinical care could be greatly enhanced by transforming the data into a common, easily available format," said Walter Koroshetz, MD, deputy director of NIH's National Institute of Neurological Disorders and Stroke (NINDS).

The FITBIR database will collect uniform and high-quality data on traumatic brain injury, including brain imaging scans and neurological test results. The data will be obtained with informed consent and stripped of any patient-identifying information.

"Uniform data makes it much easier to compare intervention results across a broad range of studies, providing innovative and unique insights that are not possible from a single study," said Matthew McAuliffe, PhD, co-director of the FITBIR database and a member of NIH’s Center for Information Technology (CIT). "This is part of a larger effort by the government to make taxpayer-funded research more broadly available and usable."

The database is expected to aid in the development of:

• A system to classify different types of traumatic brain injury
• More targeted studies to determine which treatments are effective and for whom and under what conditions (comparative effectiveness research)
• Enhanced diagnostic criteria for concussions and milder injuries
• Predictive markers to identify those at risk of developing conditions that have been linked to traumatic brain injury, such as Alzheimer’s disease
• Clearer understanding of the effects of age, sex and other medical conditions on injury and recovery
• Improved evidence-based guidelines for patient care, from the time of injury through rehabilitation
• According to officials, NIH CIT was chosen to build the database because of its experience and success in developing the National Database on Autism Research. Reusing the database structure is expected to save 35-50 percent of the project costs and significantly reduce the time to achieve meaningful results.

The database builds upon a larger effort to create common data elements for the study of traumatic brain injury – which are essentially definitions and guidelines about the kinds of data that should be collected, and how to collect these data in clinical studies. The Common Data Elements project emerged from a collaborative interagency effort involving more than 50 American and European universities and several federal agencies, including NINDS, Defense and Veterans Brain Injury Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Department of Veterans Affairs and the National Institute on Disability and Rehabilitation Research within the Department of Education.

The Defense Health Program, through agreement with the U.S. Army Medical Research and Materiel Command (USAMRMC) is the lead DoD component funding the FITBIR database. The Division of Computational Bioscience within NIH CIT is building the database, and will provide ongoing system administration and hosting services once the database is complete in about two years. USAMRMC and NINDS will provide programmatic support and foster collaborative research to populate the database. Researchers will be given detailed information about the FITBIR database, and encouraged to participate at the time they submit proposals for new studies.

Currently about 1.7 million people in the United States sustain traumatic brain injuries each year from common causes such as auto accidents and falls. In addition, American servicemembers in Iraq, Afghanistan and other parts of the world face unique risks of traumatic brain injury from routine military operations, enemy fire and improvised explosive devices. According to the DoD, in the past 12 years, more than 200,000 servicemembers deployed worldwide have been diagnosed with traumatic brain injury, adding to the urgent need for preventive methods and treatments. Total costs of traumatic brain injury in the United States – including medical care, lost wages and other expenses – exceed $60 billion.

Treatments also remain limited despite improved surgeries and rehabilitation techniques for people with brain injuries. Cases of traumatic brain injury are highly variable, involving different causes, locations within the brain and different kinds of damage to brain tissue. Such variability makes it difficult for clinicians to treat patients, predict long-term outcomes and investigate new therapies. Also, studies often report different kinds of data on patients, obtained through various tests and measures, further impeding comparison of data across studies.

"Despite the great burden of neurotrauma incidence, developing objective diagnostics and treatments has proven especially challenging for the medical community,"  said Col. Dallas Hack, director of the U.S. Army Combat Casualty Research Program and joint chairperson for the Defense Health Program. "Only by combining efforts through initiatives such as the FITBIR database can we hope to make major progress in this field."