Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury

Abstract

Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide, with enormous negative social and economic impacts. The heterogeneity of TBI combined with the lack of precise outcome measures have been central to the discouraging results from clinical trials. Current approaches to the characterization of disease severity and outcome have not changed in more than three decades. This prospective multicenter observational pilot study aimed to validate the feasibility of implementing the TBI Common Data Elements (TBI-CDEs). A total of 650 subjects who underwent computed tomography (CT) scans in the emergency department within 24 h of injury were enrolled at three level I trauma centers and one rehabilitation center. The TBI-CDE components collected included: 1) demographic, social and clinical data; 2) biospecimens from blood drawn for genetic and proteomic biomarker analyses; 3) neuroimaging studies at 2 weeks using 3T magnetic resonance imaging (MRI); and 4) outcome assessments at 3 and 6 months. We describe how the infrastructure was established for building data repositories for clinical data, plasma biomarkers, genetics, neuroimaging, and multidimensional outcome measures to create a high quality and accessible information commons for TBI research. Risk factors for poor follow-up, TBI-CDE limitations, and implementation strategies are described. Having demonstrated the feasibility of implementing the TBI-CDEs through successful recruitment and multidimensional data collection, we aim to expand to additional study sites. Furthermore, interested researchers will be provided early access to the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) data set for collaborative opportunities to more precisely characterize TBI and improve the design of future clinical treatment trials. (ClinicalTrials.gov Identifier NCT01565551.)

Apolipoprotein E epsilon 4 (APOE‐ε4) genotype is associated with decreased 6‐month verbal memory performance after mild traumatic brain injury

“…The TRACK‐TBI Pilot study is a multicenter prospective observational study conducted at three Level I Trauma Centers in the U.S.—San Francisco General Hospital (SFGH), University of Pittsburgh Medical Center (UPMC), and University Medical Center Brackenridge (UMCB) in Austin, Texas—using the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) TBI Common Data Elements (CDEs) (Yue et al., 2013; Maas et al., 2010; Duhaime et al., 2010; Manley et al., 2010; Wilde et al., 2010). Inclusion criteria for TRACK‐TBI Pilot were external force trauma to the head presenting to Level I trauma center, and clinically indicated head CT scan within 24 hr of injury.…”

“…Specimen acquisition was performed as previously described (Yue et al., 2013). In brief, blood samples were collected via peripheral venipuncture or existing peripheral venous or arterial indwelling catheters within 24 hr of injury for DNA genotyping.…”

“…For the current analysis, we utilized data from the prospective multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot (TRACK‐TBI Pilot) study (Yue et al., 2013) to explore associations between APOE and components of 6‐month verbal memory postinjury. We demonstrate that the APOE‐ ε 4 carrier status is specifically associated with decreased performance on long‐delay recall trials, without effects on immediate recall or short‐delay recall trials.…”

Global neurotrauma research challenges and opportunities

“…Research will focus on new trends for TBI care, including, but not limited to, the use of hyperosmolar fluids, blood components for early resuscitation and other strategies aimed at improving resuscitation in patients with multiple injuries, including TBI [29][30][31] . Additional aspects that are more applicable to LMICs, such as the importance of data collection (neurotrauma registries), capacity building for advanced education in neurotrauma-care provision and research, and integration of teams within a trauma-care system have been recently proposed 32,33 .…”

Mind the gaps—advancing research into short-term and long-term neuropsychological outcomes of youth sports-related concussions

“…New APOE studies should standardize research methodologies and reporting measures, including the collection of 'common data elements' , to ensure valid comparison across studies. 110,115 The APOE genotype is not neces sarily a non-modifiable risk factor for concussion recovery: therapies being developed for AD include drugs that modify the interaction between the ApoE4 protein and Aβ, which might also be applicable to paediatric concussion. 116,117 Other genetic risk factors The Val66Met polymorphism in the gene encoding brain-derived neurotrophic factor has been linked to better outcomes after mTBI, 118 but worse outcomes after focal penetrating brain injury.…”