Dataset Information

Pre-Clinical Common Data Elements for Traumatic Brain Injury Research: Progress and Use Cases.

ABSTRACT: Traumatic brain injury (TBI) is an extremely complex condition due to heterogeneity in injury mechanism, underlying conditions, and secondary injury. Pre-clinical and clinical researchers face challenges with reproducibility that negatively impact translation and therapeutic development for improved TBI patient outcomes. To address this challenge, TBI Pre-clinical Working Groups expanded upon previous efforts and developed common data elements (CDEs) to describe the most frequently used experimental parameters. The working groups created 913 CDEs to describe study metadata, animal characteristics, animal history, injury models, and behavioral tests. Use cases applied a set of commonly used CDEs to address and evaluate the degree of missing data resulting from combining legacy data from different laboratories for two different outcome measures (Morris water maze [MWM]; RotorRod/Rotarod). Data were cleaned and harmonized to Form Structures containing the relevant CDEs and subjected to missing value analysis. For the MWM dataset (358 animals from five studies, 44 CDEs), 50% of the CDEs contained at least one missing value, while for the Rotarod dataset (97 animals from three studies, 48 CDEs), over 60% of CDEs contained at least one missing value. Overall, 35% of values were missing across the MWM dataset, and 33% of values were missing for the Rotarod dataset, demonstrating both the feasibility and the challenge of combining legacy datasets using CDEs. The CDEs and the associated forms created here are available to the broader pre-clinical research community to promote consistent and comprehensive data acquisition, as well as to facilitate data sharing and formation of data repositories. In addition to addressing the challenge of standardization in TBI pre-clinical studies, this effort is intended to bring attention to the discrepancies in assessment and outcome metrics among pre-clinical laboratories and ultimately accelerate translation to clinical research.

SUBMITTER: LaPlaca MC

PROVIDER: S-EPMC8082734 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Pre-Clinical Common Data Elements for Traumatic Brain Injury Research: Progress and Use Cases.

LaPlaca Michelle C MC Huie J Russell JR Alam Hasan B HB Bachstetter Adam D AD Bayir Hűlya H Bellgowan Patrick F PF Cummings Diana D Dixon C Edward CE Ferguson Adam R AR Ferland-Beckham Chantelle C Floyd Candace L CL Friess Stuart H SH Galanopoulou Aristea S AS Hall Edward D ED Harris Neil G NG Hawkins Bridget E BE Hicks Ramona R RR Hulbert Lindsey E LE Johnson Victoria E VE Kabitzke Patricia A PA Lafrenaye Audrey D AD Lemmon Vance P VP Lifshitz Carrie W CW Lifshitz Jonathan J Loane David J DJ Misquitta Leonie L Nikolian Vahagn C VC Noble-Haeusslein Linda J LJ Smith Douglas H DH Taylor-Burds Carol C Umoh Nsini N Vovk Olga O Williams Aaron M AM Young Margaret M Zai Laila J LJ

Journal of neurotrauma 20210224 10

Traumatic brain injury (TBI) is an extremely complex condition due to heterogeneity in injury mechanism, underlying conditions, and secondary injury. Pre-clinical and clinical researchers face challenges with reproducibility that negatively impact translation and therapeutic development for improved TBI patient outcomes. To address this challenge, TBI Pre-clinical Working Groups expanded upon previous efforts and developed common data elements (CDEs) to describe the most frequently used experime ...[more]

PMID: 33297844

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Project description:Standardization and harmonization of data collection in studies on traumatic brain injury (TBI) is of paramount importance for meta-analyses across studies. Nearly 10 years ago, the first set of Common Data Elements for TBI (TBI-CDEs v1) were introduced to achieve these goals. The TBI-CDEs version 2 were developed in 2012 to broaden the approach to all ages, injury severity, and phases of recovery. We aimed to quantify the degree of harmonization of these data elements in three large, prospective multi-center studies conducted within the International Initiative for TBI Research (InTBIR). Data variables of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI; adult and pediatric patients in Europe and Israel), Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI; adult and pediatric patients in the U.S.), and Approaches and Decisions in Acute Pediatric TBI (ADAPT; international study on severe pediatric TBI) studies were indexed and matched to the second version of the TBI CDEs. We focused on the CDE sub-categories of "Acute Hospitalized" (AH) and "Moderate/Severe TBI: Rehabilitation (Rehab). All "Core" and "Basic" level CDEs were considered. Closely related elements were reduced to one variable to prevent over-representation. Categorical elements and text elements for the same variable were likewise merged to one element for analysis. Following reduction and merging of related elements, 21 Core, 46 Basic AH, and 50 Basic Rehab elements were deemed harmonizable across studies. Gaps in global applicability were identified for four of the TBI CDEs and many of the outcome instruments, which are only available in the English language. Agreements of Core and Basic study CDEs for the AH domain with the TBI CDEs were respectively 81% and 91% for CENTER-TBI, 76% and 93% for TRACK-TBI, and 85% in ADAPT for both domains. For the domain Rehab, agreement with Basic TBI CDEs was 84% for CENTER-TBI, 94% for TRACK-TBI, and 71% for ADAPT. Non-harmonization was largely caused by absence of the elements in the studies. For elements present, the compatibility of coding with TBI CDEs was 90-99%. The degree of harmonization was greatest between CENTER-TBI and TRACK-TBI with 81-87% overlap within the TBI CDE sub-categories. The high degree of harmonization of study variables among these studies demonstrates the importance and utility of common data elements in TBI research. It also confirms the potential for future meta-analyses across these large studies, especially for CENTER TBI and TRACK TBI. The global applicability of the TBI CDEs needs to be improved for them to become a global standard for TBI research. CENTER-TBI, TRACK-TBI, and ADAPT, along with other studies within the InTBIR Initiative, provide a platform to inform further refinement and internationalization for the next version of the TBI CDEs.

Project description:Properties of the human neck such as range and resistance to motion are considered important determinants of the kinematic response of the head pre, during and post-impact. Mechanical surrogate necks (i.e., anthropomorphic test device necks), have generally been limited to a single anatomical plane of motion and an artificially high resistance to motion. The aim of this study was to present the Loughborough University Surrogate Neck that is representative of the 50th percentile human male neck, developed for motion in and between each of the anatomical planes with inertial and flexural stiffness properties matching those of a passive elastic (i.e., negligible active tension) neck muscle state. The complex intervertebral joints were reduced to three encapsulated ball joints with appropriate locations, orientations and distributed range of motion to precisely position and orientate the head with respect to the torso at the neutral position and end range of motion. A plain bearing sub-assembly was incorporated at the C1-C2 vertebral level to permit 50% of the axial rotation with negligible resistance to motion, as exhibited by humans. Detachable elastomeric elements provided resistance to motion across each ball joint and permit any orientation of the head within the physiological range of motion of the joints. The mass of the surrogate neck (1.62 Kg) was in agreement with the typical human range and similar agreement was found for the principal moments of inertia (Ixx 26.8 kg cm2, Iyy 20.5 kg cm2 and Izz 14.3 kg cm2). Quasi-static bending moment and dynamic torque tests characterised the surrogate neck in flexion/extension, lateral flexion and axial rotation. With respect to commercial surrogate necks, the surrogate neck presented here was in closer agreement to the reported human responses, for equivalent loading conditions. The applications of a surrogate neck that can appropriately constrain the head relative to the torso are far reaching in the areas of brain injury mechanism research, and for the development and assessment of protective equipment to reduce the risk of such injuries.

Project description:ObjectiveTo summarize the current literature to identify what research has been conducted, examine the approaches used, and determine what is presently known about prescription and nonprescription opioid receipts and use among individuals with traumatic brain injury (TBI).Data sourcesThe search strategy included the following: opioid; opiate; analgesics, opioid; opiate alkaloids; or opioid-related disorders; AND brain injury; brain injuries; brain injuries, traumatic; head injury; head injuries; head injuries, closed; head injuries, penetrating; brain concussion; diffuse axonal injury; diffuse axonal injuries; brain trauma/s; head trauma/s; concussion; craniocerebral trauma/s; or TBI. Filters included English and Adults (19+ years). Study Selection: Inclusion: English language, adults with stable TBI, and prescription opioid receipt or use after TBI. Exclusion: Animal models, populations with other acquired brain injury, acute TBI management, and non-peer-reviewed articles, theses, or conference abstracts. Multiple reviewers screened abstracts and full-text articles for eligibility. In total, 771 abstracts were screened, 183 full texts were reviewed, and 21 met eligibility criteria. Data Extraction: Relevant content was independently extracted by multiple observers, including authors, design, sample identification and data source/s, TBI severity, TBI assessment, opioid assessment, study population (demographics, N), military affiliation, comparison groups, date of data collection, and summary of findings.ResultsStudies were published between 1987 and 2019; most data were collected prior to 2015. The majority utilized administrative and electronic medical record data from the Department of Veterans Affairs and retrospective cohort designs, and most focused on prescription opioids. There were no studies evaluating interventions to reduce use of opioids in TBI populations. Preliminary findings suggest that prescription opioid receipt is strongly related to psychological symptoms, including comorbid depression, anxiety, and posttraumatic stress disorder.ConclusionsDespite increased awareness of opioid receipt and use following TBI, there is limited investigation on the examination of this issue. Future studies should include more varied patient populations as well as evaluate interventions to reduce opioid use following TBI.

Dataset Information

Pre-Clinical Common Data Elements for Traumatic Brain Injury Research: Progress and Use Cases.

Publications

Pre-Clinical Common Data Elements for Traumatic Brain Injury Research: Progress and Use Cases.

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