Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI): a prospective longitudinal observational study

Andrew I R Maas, David K Menon, Ewout W Steyerberg, Giuseppe Citerio, Fiona E Lecky, Geoffrey T Manley, Sean Hill, Valerie Legrand, Annina Sorgner, Peter Cameron, Russell Lindsay Gruen, Maria Cristina Morganti-Kossmann, Jeffrey Victor Rosenfeld

Research output: Contribution to journalArticleOther

119 Citations (Scopus)

Abstract

BACKGROUND: Current classification of traumatic brain injury (TBI) is suboptimal, and management is based on weak evidence, with little attempt to personalize treatment. A need exists for new precision medicine and stratified management approaches that incorporate emerging technologies. OBJECTIVE: To improve characterization and classification of TBI and to identify best clinical care, using comparative effectiveness research approaches. METHODS: This multicenter, longitudinal, prospective, observational study in 22 countries across Europe and Israel will collect detailed data from 5400 consenting patients, presenting within 24 hours of injury, with a clinical diagnosis of TBI and an indication for computed tomography. Broader registry-level data collection in approximately 20 000 patients will assess generalizability. Cross sectional comprehensive outcome assessments, including quality of life and neuropsychological testing, will be performed at 6 months. Longitudinal assessments will continue up to 24 months post TBI in patient subsets. Advanced neuroimaging and genomic and biomarker data will be used to improve characterization, and analyses will include neuroinformatics approaches to address variations in process and clinical care. Results will be integrated with living systematic reviews in a process of knowledge transfer. The study initiation was from October to December 2014, and the recruitment period was for 18 to 24 months. EXPECTED OUTCOMES: Collaborative European NeuroTrauma Effectiveness Research in TBI should provide novel multidimensional approaches to TBI characterization and classification, evidence to support treatment recommendations, and benchmarks for quality of care. Data and sample repositories will ensure opportunities for legacy research. DISCUSSION: Comparative effectiveness research provides an alternative to reductionistic clinical trials in restricted patient populations by exploiting differences in biology, care, and outcome to support optimal personalized patient management
Original languageEnglish
Pages (from-to)67 - 80
Number of pages14
JournalNeurosurgery
Volume76
Issue number1
DOIs
Publication statusPublished - 2015

Cite this

Maas, Andrew I R ; Menon, David K ; Steyerberg, Ewout W ; Citerio, Giuseppe ; Lecky, Fiona E ; Manley, Geoffrey T ; Hill, Sean ; Legrand, Valerie ; Sorgner, Annina ; Cameron, Peter ; Gruen, Russell Lindsay ; Morganti-Kossmann, Maria Cristina ; Rosenfeld, Jeffrey Victor. / Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI): a prospective longitudinal observational study. In: Neurosurgery. 2015 ; Vol. 76, No. 1. pp. 67 - 80.
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abstract = "BACKGROUND: Current classification of traumatic brain injury (TBI) is suboptimal, and management is based on weak evidence, with little attempt to personalize treatment. A need exists for new precision medicine and stratified management approaches that incorporate emerging technologies. OBJECTIVE: To improve characterization and classification of TBI and to identify best clinical care, using comparative effectiveness research approaches. METHODS: This multicenter, longitudinal, prospective, observational study in 22 countries across Europe and Israel will collect detailed data from 5400 consenting patients, presenting within 24 hours of injury, with a clinical diagnosis of TBI and an indication for computed tomography. Broader registry-level data collection in approximately 20 000 patients will assess generalizability. Cross sectional comprehensive outcome assessments, including quality of life and neuropsychological testing, will be performed at 6 months. Longitudinal assessments will continue up to 24 months post TBI in patient subsets. Advanced neuroimaging and genomic and biomarker data will be used to improve characterization, and analyses will include neuroinformatics approaches to address variations in process and clinical care. Results will be integrated with living systematic reviews in a process of knowledge transfer. The study initiation was from October to December 2014, and the recruitment period was for 18 to 24 months. EXPECTED OUTCOMES: Collaborative European NeuroTrauma Effectiveness Research in TBI should provide novel multidimensional approaches to TBI characterization and classification, evidence to support treatment recommendations, and benchmarks for quality of care. Data and sample repositories will ensure opportunities for legacy research. DISCUSSION: Comparative effectiveness research provides an alternative to reductionistic clinical trials in restricted patient populations by exploiting differences in biology, care, and outcome to support optimal personalized patient management",
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Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI): a prospective longitudinal observational study. / Maas, Andrew I R; Menon, David K; Steyerberg, Ewout W; Citerio, Giuseppe; Lecky, Fiona E; Manley, Geoffrey T; Hill, Sean; Legrand, Valerie; Sorgner, Annina; Cameron, Peter; Gruen, Russell Lindsay; Morganti-Kossmann, Maria Cristina; Rosenfeld, Jeffrey Victor.

In: Neurosurgery, Vol. 76, No. 1, 2015, p. 67 - 80.

Research output: Contribution to journalArticleOther

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AU - Menon, David K

AU - Steyerberg, Ewout W

AU - Citerio, Giuseppe

AU - Lecky, Fiona E

AU - Manley, Geoffrey T

AU - Hill, Sean

AU - Legrand, Valerie

AU - Sorgner, Annina

AU - Cameron, Peter

AU - Gruen, Russell Lindsay

AU - Morganti-Kossmann, Maria Cristina

AU - Rosenfeld, Jeffrey Victor

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N2 - BACKGROUND: Current classification of traumatic brain injury (TBI) is suboptimal, and management is based on weak evidence, with little attempt to personalize treatment. A need exists for new precision medicine and stratified management approaches that incorporate emerging technologies. OBJECTIVE: To improve characterization and classification of TBI and to identify best clinical care, using comparative effectiveness research approaches. METHODS: This multicenter, longitudinal, prospective, observational study in 22 countries across Europe and Israel will collect detailed data from 5400 consenting patients, presenting within 24 hours of injury, with a clinical diagnosis of TBI and an indication for computed tomography. Broader registry-level data collection in approximately 20 000 patients will assess generalizability. Cross sectional comprehensive outcome assessments, including quality of life and neuropsychological testing, will be performed at 6 months. Longitudinal assessments will continue up to 24 months post TBI in patient subsets. Advanced neuroimaging and genomic and biomarker data will be used to improve characterization, and analyses will include neuroinformatics approaches to address variations in process and clinical care. Results will be integrated with living systematic reviews in a process of knowledge transfer. The study initiation was from October to December 2014, and the recruitment period was for 18 to 24 months. EXPECTED OUTCOMES: Collaborative European NeuroTrauma Effectiveness Research in TBI should provide novel multidimensional approaches to TBI characterization and classification, evidence to support treatment recommendations, and benchmarks for quality of care. Data and sample repositories will ensure opportunities for legacy research. DISCUSSION: Comparative effectiveness research provides an alternative to reductionistic clinical trials in restricted patient populations by exploiting differences in biology, care, and outcome to support optimal personalized patient management

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