Common Data Elements in Radiologic Imaging of Traumatic Brain Injury
Massachusetts General Hospital, Boston, USA.Archives of physical medicine and rehabilitation (Impact Factor: 2.57). 11/2010; 91(11):1661-6. DOI: 10.1016/j.apmr.2010.07.238
Radiologic brain imaging is the most useful means of visualizing and categorizing the location, nature, and degree of damage to the central nervous system sustained by patients with traumatic brain injury (TBI). In addition to determining acute patient management and prognosis, imaging is crucial for the characterization and classification of injuries for natural history studies and clinical trials. This article is the initial result of a workshop convened by multiple national health care agencies in March 2009 to begin to make recommendations for potential data elements dealing with specific radiologic features and definitions needed to characterize injuries, as well as specific techniques and parameters needed to optimize radiologic data acquisition. The neuroimaging work group included professionals with expertise in basic imaging research and physics, clinical neuroradiology, neurosurgery, neurology, physiatry, psychiatry, TBI research, and research database formation. This article outlines the rationale and overview of their specific recommendations. In addition, we review the contributions of various imaging modalities to the understanding of TBI and the general principles needed for database flexibility and evolution over time to accommodate technical advances.
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- "In response to the 2007 workshop recommendations, the Interagency Common Data Elements Project for TBI was launched in 2008 and the first set of recommendations for CDEs for TBI in adults was published (Version 1 [V1]) in 2010. CDEs V1 included various domains for data collection including demographics and clinical assessment , trial protocols, outcome, neuroimaging, and biomarkers (Haacke et al., 2010; Maas et al., 2010, 2011; Manley et al., 2010). The primary emphasis of V1 was the coding of data. "
ABSTRACT: Despite increased attention to traumatic brain injury (TBI), there remains no specific treatment and available interventions focus rather on the prevention of secondary injury. One of the reasons posited for the lack of a successful therapy is the amalgamation of various types of injuries under the same severity category in clinical trials. Informatics approaches have been suggested as a means to develop an improved classification system for TBI. As a result of federal interagency efforts, common data elements (CDEs) for TBI have now been developed. Further, the Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR) has been created and is now available for TBI researchers to both add and retrieve data. This chapter will discuss the goals, development, and evolution of the CDEs and FITBIR and discuss how these tools can be used to support TBI research. A specific exemplar using the CDEs and lessons learned from working with the CDEs and FITBIR are included to aid future researchers.
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- "We collect baseline data regarding demographics, socioeconomic status, medical history, medication use, and injury characteristics and severity, according to the common data elements for TBI advocated by multiple agencies, including the National Institute of Neurological Disorders and Stroke. Also, we collect pathoanatomic data elements that encompass the Marshall CT classification, Rotterdam CT score, and other consensus-derived data elements [45,46]. "
ABSTRACT: Background Severe TBI, defined as a Glasgow Coma Scale ≤ 8, increases intracranial pressure and activates the sympathetic nervous system. Sympathetic hyperactivity after TBI manifests as catecholamine excess, hypertension, abnormal heart rate variability, and agitation, and is associated with poor neuropsychological outcome. Propranolol and clonidine are centrally acting drugs that may decrease sympathetic outflow, brain edema, and agitation. However, there is no prospective randomized evidence available demonstrating the feasibility, outcome benefits, and safety for adrenergic blockade after TBI. Methods/Design The DASH after TBI study is an actively accruing, single-center, randomized, double-blinded, placebo-controlled, two-arm trial, where one group receives centrally acting sympatholytic drugs, propranolol (1 mg intravenously every 6 h for 7 days) and clonidine (0.1 mg per tube every 12 h for 7 days), and the other group, double placebo, within 48 h of severe TBI. The study uses a weighted adaptive minimization randomization with categories of age and Marshall head CT classification. Feasibility will be assessed by ability to provide a neuroradiology read for randomization, by treatment contamination, and by treatment compliance. The primary endpoint is reduction in plasma norepinephrine level as measured on day 8. Secondary endpoints include comprehensive plasma and urine catecholamine levels, heart rate variability, arrhythmia occurrence, infections, agitation measures using the Richmond Agitation-Sedation Scale and Agitated Behavior scale, medication use (anti-hypertensive, sedative, analgesic, and antipsychotic), coma-free days, ventilator-free days, length of stay, and mortality. Neuropsychological outcomes will be measured at hospital discharge and at 3 and 12 months. The domains tested will include global executive function, memory, processing speed, visual-spatial, and behavior. Other assessments include the Extended Glasgow Outcome Scale and Quality of Life after Brain Injury scale. Safety parameters evaluated will include cardiac complications. Discussion The DASH After TBI Study is the first randomized, double-blinded, placebo-controlled trial powered to determine feasibility and investigate safety and outcomes associated with adrenergic blockade in patients with severe TBI. If the study results in positive trends, this could provide pilot evidence for a larger multicenter randomized clinical trial. If there is no effect of therapy, this trial would still provide a robust prospective description of sympathetic hyperactivity after TBI. Trial registration ClinicalTrials.gov NCT01322048
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- "Emerging neuroimaging tools with the potential to inform TBI research have been previously identified, both by the original Neuroimaging Workgroup (Duhaime et al., 2010; Haacke et al., 2010) and the Pediatric Neuroimaging Workgroup (Duhaime, 2011). The recommendations for core and supplemental CDEs from the original Neuroimaging Workgroup were generally focused on conventional imaging, largely because of the need to establish radiological definitions for forms of injury identifiable on conventional imaging sequences , and also because these techniques are widely available in many TBI-related studies and across centers. "
ABSTRACT: This article identifies emerging neuroimaging measures considered by the inter-agency Pediatric Traumatic Brain Injury (TBI) Neuroimaging Workgroup. This article attempts to address some of the potential uses of more advanced forms of imaging in TBI as well as highlight some of the current considerations and unresolved challenges of using them. We summarize emerging elements likely to gain more widespread use in the coming years, because of 1) their utility in diagnosis, prognosis, and understanding the natural course of degeneration or recovery following TBI, and potential for evaluating treatment strategies; 2) the ability of many centers to acquire these data with scanners and equipment that are readily available in existing clinical and research settings; and 3) advances in software that provide more automated, readily available, and cost-effective analysis methods for large scale data image analysis. These include multi-slice CT, volumetric MRI analysis, susceptibility-weighted imaging (SWI), diffusion tensor imaging (DTI), magnetization transfer imaging (MTI), arterial spin tag labeling (ASL), functional MRI (fMRI), including resting state and connectivity MRI, MR spectroscopy (MRS), and hyperpolarization scanning. However, we also include brief introductions to other specialized forms of advanced imaging that currently do require specialized equipment, for example, single photon emission computed tomography (SPECT), positron emission tomography (PET), encephalography (EEG), and magnetoencephalography (MEG)/magnetic source imaging (MSI). Finally, we identify some of the challenges that users of the emerging imaging CDEs may wish to consider, including quality control, performing multi-site and longitudinal imaging studies, and MR scanning in infants and children.
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