TY - JOUR
T1 - Biomarkers for Traumatic Brain Injury
T2 - Data Standards and Statistical Considerations
AU - Huie, J. Russell
AU - Mondello, Stefania
AU - Lindsell, Christopher J.
AU - Antiga, Luca
AU - Yuh, Esther L.
AU - Zanier, Elisa R.
AU - Masson, Serge
AU - Rosario, Bedda L.
AU - Ferguson, Adam R.
AU - Adeoye, Opeolu
AU - Badjatia, Neeraj
AU - Boase, Kim
AU - Bodien, Yelena
AU - Bullock, M. Ross
AU - Chesnut, Randall
AU - Corrigan, John D.
AU - Crawford, Karen
AU - Diaz-Arrastia, Ramon
AU - Dikmen, Sureyya
AU - Duhaime, Ann Christine
AU - Ellenbogen, Richard
AU - Feeser, V. Ramana
AU - Foreman, Brandon
AU - Gardner, Raquel
AU - Gaudette, Etienne
AU - Giacino, Joseph
AU - Goldman, Dana
AU - Gonzalez, Luis
AU - Gopinath, Shankar
AU - Gullapalli, Rao
AU - Hemphill, J. Claude
AU - Hotz, Gillian
AU - Jain, Sonia
AU - Korley, Frederick
AU - Kramer, Joel
AU - Kreitzer, Natalie
AU - Levin, Harvey
AU - Machamer, Joan
AU - Madden, Christopher
AU - Manley, Geoffrey T.
AU - Martin, Alastair
AU - McAllister, Thomas
AU - McCrea, Michael
AU - Merchant, Randall
AU - Mukherjee, Pratik
AU - Nelson, Lindsay
AU - Ngwenya, Laura B.
AU - Noel, Florence
AU - Okonkwo, David
AU - Gruen, Russell L.
N1 - Publisher Copyright:
© Copyright 2021, Mary Ann Liebert, Inc., publishers 2021.
PY - 2021/9/15
Y1 - 2021/9/15
N2 - Recent biomarker innovations hold potential for transforming diagnosis, prognostic modeling, and precision therapeutic targeting of traumatic brain injury (TBI). However, many biomarkers, including brain imaging, genomics, and proteomics, involve vast quantities of high-throughput and high-content data. Management, curation, analysis, and evidence synthesis of these data are not trivial tasks. In this review, we discuss data management concepts and statistical and data sharing strategies when dealing with biomarker data in the context of TBI research. We propose that application of biomarkers involves three distinct steps - discovery, evaluation, and evidence synthesis. First, complex/big data has to be reduced to useful data elements at the stage of biomarker discovery. Second, inferential statistical approaches must be applied to these biomarker data elements for assessment of biomarker clinical utility and validity. Last, synthesis of relevant research is required to support practice guidelines and enable health decisions informed by the highest quality, up-to-date evidence available. We focus our discussion around recent experiences from the International Traumatic Brain Injury Research (InTBIR) initiative, with a specific focus on four major clinical projects (Transforming Research and Clinical Knowledge in TBI, Collaborative European NeuroTrauma Effectiveness Research in TBI, Collaborative Research on Acute Traumatic Brain Injury in Intensive Care Medicine in Europe, and Approaches and Decisions in Acute Pediatric TBI Trial), which are currently enrolling subjects in North America and Europe. We discuss common data elements, data collection efforts, data-sharing opportunities, and challenges, as well as examine the statistical techniques required to realize successful adoption and use of biomarkers in the clinic as a foundation for precision medicine in TBI.
AB - Recent biomarker innovations hold potential for transforming diagnosis, prognostic modeling, and precision therapeutic targeting of traumatic brain injury (TBI). However, many biomarkers, including brain imaging, genomics, and proteomics, involve vast quantities of high-throughput and high-content data. Management, curation, analysis, and evidence synthesis of these data are not trivial tasks. In this review, we discuss data management concepts and statistical and data sharing strategies when dealing with biomarker data in the context of TBI research. We propose that application of biomarkers involves three distinct steps - discovery, evaluation, and evidence synthesis. First, complex/big data has to be reduced to useful data elements at the stage of biomarker discovery. Second, inferential statistical approaches must be applied to these biomarker data elements for assessment of biomarker clinical utility and validity. Last, synthesis of relevant research is required to support practice guidelines and enable health decisions informed by the highest quality, up-to-date evidence available. We focus our discussion around recent experiences from the International Traumatic Brain Injury Research (InTBIR) initiative, with a specific focus on four major clinical projects (Transforming Research and Clinical Knowledge in TBI, Collaborative European NeuroTrauma Effectiveness Research in TBI, Collaborative Research on Acute Traumatic Brain Injury in Intensive Care Medicine in Europe, and Approaches and Decisions in Acute Pediatric TBI Trial), which are currently enrolling subjects in North America and Europe. We discuss common data elements, data collection efforts, data-sharing opportunities, and challenges, as well as examine the statistical techniques required to realize successful adoption and use of biomarkers in the clinic as a foundation for precision medicine in TBI.
KW - biomarkers
KW - data sharing
KW - traumatic brain injury
UR - http://www.scopus.com/inward/record.url?scp=85115647552&partnerID=8YFLogxK
U2 - 10.1089/neu.2019.6762
DO - 10.1089/neu.2019.6762
M3 - Review article
C2 - 32046588
AN - SCOPUS:85115647552
SN - 0897-7151
VL - 38
SP - 2514
EP - 2529
JO - Journal of Neurotrauma
JF - Journal of Neurotrauma
IS - 18
ER -