Traumatic Brain Injury

In civilian, military and Veteran populations, there is an increased recognition of the interrelationship between traumatic brain injury (TBI) and some psychological health (PH) disorders, and of the need to better understand the relationships by integrating research on these topics.

The use of different measures to assess similar study variables and/or differing metrics to assess outcomes may limit important advances in PH and TBI research. Without a common set of data elements (which include variable definitions and recommended measures), comparison of findings across studies is challenging.

To develop the TBI CDE standards a variety of Co-sponsoring Federal agencies led a scientific initiative to develop common data elements for TBI. Scientific experts were invited to participate in a Working Group to develop recommendations for specific topic-driven common data elements. The resulting TBI CDE Version 1.0 recommendations were published in the Archives of Physical Medicine and Rehabilitation in November 2010. Additional pediatric-specific recommendations were developed and published in The Journal of Neurotrama in March 2012.

The Working Group reconvened in late 2011 to refine and reorganize the CDEs according to type of TBI study around four major study types:

• Epidemiological research
• Studies on acute, hospitalized patients
• Studies of the rehabilitation for moderate/severe TBI
• Mild TBI/Concussion research

The Working Group also reduced the list of “Core” CDEs strongly recommended for NINDS-funded studies and expanded the CDEs to be more comprehensive and fill gaps. Version 2.0 of the TBI CDEs was published on this site in late June 2012 and was used to construct the Federal Interagency Traumatic Brain Injury Research informatics system, which was available for use in mid-July 2012.

The American Association of Neurological Surgeons (AANS) has stated its commitment to the NINDS Traumatic Brain Injury Common Data Element project since the development of version 1.0 and has participate in the development, organization, and distribution of version 2.0 of the Traumatic Brain Injury Common Data Elements and recently circulated a letter of support.

The American Congress of Rehabilitation Medicine (ACRM) have also recently endorsed Version 2 TBI CDEs through a letter of support.

Version 2.0 includes CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines available are organized into domains which are intuitive and common in clinical research studies. Investigators can choose from this catalog of CDEs when assembling their clinical study materials. Please note that the classifications are named differently from the other disease recommendations (e.g., classification of “Supplemental” for TBI would be “Exploratory” in all other diseases). The Version 2.0 CDEs are classified according to the following definitions:

• Core — small set of data elements that are relevant to all TBI clinical studies
• Basic (Supplemental for all other diseases) — small set of data elements, beyond the Core, that are recommended for inclusion in studies of Concussion/mild TBI, Acute Hospitalized, Moderate/Severe TBI: Rehabilitation, or Epidemiology
• Supplemental (Exploratory for all other diseases) — additional recommended data elements where inclusion depends upon the particulars of the study

Researchers working on acute hospitalized, concussion or mild TBI, rehabilitation of moderate or severe TBI, and epidemiology studies can use these classifications as guidelines to find customized sets of elements that they can incorporate into their studies.

Please note the Version 1.0 TBI CDE recommendations of the Demographics and Clinical Assessment Working Group are available on the IMPACT Web site. These CDE recommendations are presented using an alternate classification scheme of three levels of detail: Basic, Intermediate and Advanced, with the greatest level of detail in the Advanced version.

In 2017, the Biomechanical Devices in Traumatic Brain Injury (TBI) CDE Working Group was convened to develop CDE recommendations. This Working Group was divided into the following subgroups: (1) Head Accelerometry; (2) Impact Video; and (3) Blast Exposure. The recommendations were posted in February 2018 and are part of the Disease/Injury Related Events Domain/Biomechanical Devices Subdomain.