Traumatic Brain Injury (TBI) Common Data Element (CDE) recommendations

The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) is requesting your input on version 2 of the Traumatic Brain Injury (TBI) Common Data Element (CDE) recommendations.  

The TBI CDEs were developed as the result of a U.S. multiagency collaboration between the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Disability and Rehabilitation Research (NIDRR), the Department of Veterans Affairs (VA), and the Defense Centers of Excellence (DCoE).  This collaboration previously resulted in the development of Version 1.0 of the TBI CDEs. For Version 2.0, the CDEs have been organized according to type of TBI study (Concussion/mild TBI studies, Acute Hospitalized studies, Moderate/Severe TBI: Rehabilitation studies, and Epidemiology studies), the list of “Core” CDEs required for NINDS-funded studies has been reduced, and some gaps from Version 1.0 have been addressed. We hope you will take the time to review the CDEs. 

The NINDS CDE Web site fully describes the NINDS CDE Project and its goals.  In summary, the CDE Project aims to develop content standards, both generic and disease-specific, to enable clinical investigators to systematically collect, analyze, and share data across the research community.  Beginning in November 2011, a Working Group of over 50 TBI experts convened to work on refining the TBI CDEs for Version 2.0.  Investigators can choose from this catalog of CDEs when assembling their clinical study materials.  The TBI CDE Working Group has not attempted to define the complete universe of variables a clinical study might collect but rather to identify elements that will be useful across clinical studies. The TBI CDEs are being incorporated into the Federal Interagency Traumatic Brain Injury Research (FITBIR) database (http://fitbir.nih.gov/), which will further enable researchers to share data across the entire TBI research field.

The public review period for the TBI CDEs will take place through June 15, 2012.  During this time, Version 2.0 of the TBI CDEs will be publically available on the NINDS CDE Web site.  To access and review the TBI CDE recommendations, please follow the steps below:

1.       Navigate to http://www.commondataelements.ninds.nih.gov/TBI.aspx#tab=Data_Standards

2.       From the TBI CDE Standards page, on the Data Standards Tab, download the zip file containing the review package

3.       Unzip the zip file and read the “Overview document” for tips on how to conduct the review and submit your comments

The TBI CDE review package is categorized into the four different types of studies included above. Please feel free to provide comments on as many of the recommendations as you wish.  We look forward to your feedback and ask that you please submit your comments by Friday, June 15, 2012.  Please note, the CDEs will require refinement and validation, and the Call for Public Review is an important step in that ongoing process.  

Thank you in advance for taking the time to review the TBI CDEs. We hope that you will share this announcement with your colleagues and encourage them to provide feedback as well.

Sincerely,

This email address is being protected from spambots. You need JavaScript enabled to view it.
Program Director, Repair and Plasticity 
NIH/NINDS
301-496-1447