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

Autor: LaPlaca MC; Department of Biomedical Engineering, Georgia Institute of Technology/Emory University, Atlanta, Georgia, USA.; San Francisco Veterans Affairs Health Care System, San Francisco, California, USA., Huie JR; Brain and Spinal Injury Center, Department of Neurological Surgery, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, California, USA., Alam HB; Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA., Bachstetter AD; Department of Neuroscience, University of Kentucky, Lexington, Kentucky, USA., Bayir H; Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA., Bellgowan PF; National Institutes of Health, Bethesda, Maryland, USA., Cummings D; National Institutes of Health, Bethesda, Maryland, USA., Dixon CE; Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA., Ferguson AR; Brain and Spinal Injury Center, Department of Neurological Surgery, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, California, USA., Ferland-Beckham C; Cohen Veterans Bioscience, Cambridge, Massachusetts, USA., Floyd CL; Department of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah, USA., Friess SH; Division of Critical Care Medicine, Washington University in St. Louis, St. Louis, Missouri, USA., Galanopoulou AS; Department of Neuroscience, Albert Einstein College of Medicine, Bronx, New York, USA., Hall ED; Department of Neuroscience, University of Kentucky, Lexington, Kentucky, USA., Harris NG; Department of Neurosurgery, University of California, Los Angeles, Los Angeles, California, USA., Hawkins BE; Department of Anesthesiology, University of Texas Medical Branch, Galveston, Texas, USA., Hicks RR; One Mind, Rutherford, California, USA., Hulbert LE; Department of Animal Sciences and Industry, Kansas State University, Manhattan, Kansas, USA., Johnson VE; Department of Neurosurgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Kabitzke PA; Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA., Lafrenaye AD; Department of Anatomy and Neurobiology, Virginia Commonwealth University, Richmond, Virginia, USA., Lemmon VP; Department of Neurological Surgery, University of Miami, Miami, Florida, USA., Lifshitz CW; Department of Child Health, University of Arizona College of Medicine Phoenix, Phoenix, Arizona, USA., Lifshitz J; Department of Child Health, University of Arizona College of Medicine Phoenix, Phoenix, Arizona, USA., Loane DJ; School of Biochemistry and Immunology, Trinity College Dublin, Dublin, Ireland., Misquitta L; National Institutes of Health, Bethesda, Maryland, USA., Nikolian VC; Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA., Noble-Haeusslein LJ; Departments of Psychology and Neurology, University of Texas at Austin, Austin, Texas, USA., Smith DH; Department of Neurosurgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Taylor-Burds C; National Institutes of Health, Bethesda, Maryland, USA., Umoh N; Department of Defense, U.S. Army Medical Research and Materiel Command, Fort Detrick, Frederick, Maryland, USA., Vovk O; National Institutes of Health, Bethesda, Maryland, USA., Williams AM; Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA., Young M; Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA., Zai LJ; Lucent Neuroscience, Parker, Colorado, USA.
Jazyk: angličtina
Zdroj: Journal of neurotrauma [J Neurotrauma] 2021 May 15; Vol. 38 (10), pp. 1399-1410. Date of Electronic Publication: 2021 Feb 24.
DOI: 10.1089/neu.2020.7328
Abstrakt: 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.
Databáze: MEDLINE