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.).

FIG. 1.

Traumatic brain injury (TBI) common data elements for Transforming Research and Clinical Knowledge in TBI (TRACK-TBI).

FIG. 2.

Three levels of detail for classification of version 1.0 of the common data elements (CDEs) that correspond to the International Mission for Prognosis and Analysis of Clinical Trials (IMPACT) CDE levels of basic, intermediate, and advanced. Core CDEs represent data relevant to all traumatic brain injury (TBI) patients and studies. Supplemental CDEs capture increased data granularity and clinical detail for examination or for specific types of injuries or care delivery settings. The emerging CDEs represent measures on which consensus has not been achieved because they are of a more exploratory nature, are not widely available, and/or are not validated and correlated with outcome measures.

FIG. 3.

Data management flow chart for acquisition and sharing of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) common data elements (CDEs).

FIG. 4.

Workflow and estimated time on task for patient screening, enrollment and collection of data for each common data element (CDE) domain.

FIG. 5.

Monthly (bars) and cumulative (line) enrollment rates for Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK TBI) patients at all study sites and age ranges (3–94 years old).

FIG. 6.

Overall age and gender distributions. Males accounted for 64–85% of patients between 16 and 69 years of age. Among those between 70 and 89 years of age, males accounted for 42–50% of patients. The mean (SD) age was 43±18.

FIG. 7.

Effects of different blood specimen processing methods on patient (PT) plasma glial fibrillary acidic protein (GFAP) concentrations. Comparisons were made for fresh blood samples processed immediately after blood was drawm by the research associate (RA) and the clinical laboratory (Lab) versus add-on samples that were collected from ordered blood draws that were kept at room temperature for <4 h and processed by the clinical laboratory.