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

CENTER-TBI Participants and Investigators

Research output: Contribution to journalArticle

104 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

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Observational Studies
Longitudinal Studies
Comparative Effectiveness Research
Research
Benchmarking
Precision Medicine
Quality of Health Care
Israel
Neuroimaging
Registries
Traumatic Brain Injury
Biomarkers
Tomography
Quality of Life
Outcome Assessment (Health Care)
Clinical Trials
Prospective Studies
Technology
Wounds and Injuries
Therapeutics

Keywords

  • Clinical study
  • Comparative effectiveness research
  • Protocol
  • Traumatic brain injury

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery
  • Medicine(all)

Cite this

Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI) : A prospective longitudinal observational study. / CENTER-TBI Participants and Investigators.

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

Research output: Contribution to journalArticle

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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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AU - Maas, Andrew I R

AU - Menon, David K.

AU - Steyerberg, Ewout W.

AU - Citerio, Giuseppe

AU - Lecky, Fiona

AU - Manley, Geoffrey T.

AU - Hill, Sean

AU - Legrand, Valerie

AU - Sorgner, Annina

AU - Andelic, Nada

AU - Andreassen, Lasse

AU - Andrews, Peter

AU - Audibert, Gérard

AU - Audny, Anke

AU - Azouv, Philippe

AU - Barzó, P.

AU - Beer, Ronny

AU - Bellander, Bo Michael

AU - Belli, Antonio

AU - Benali, Habib

AU - Berardino, Maurizio

AU - Beretta, Luigi

AU - Bražinová, Alexandra

AU - Binder, Harald

AU - Brehar, Felix

AU - Büki, A.

AU - Bullinger, Monika

AU - Cakmak, Ela

AU - Callebaut, Ina

AU - Cameron, Peter

AU - Lozano, Guillermo Carbayo

AU - Carpenter, Keri L H

AU - Chieregato, Arturo

AU - Coburn, Mark

AU - Coles, Jonathan P.

AU - Cooper, Jamie

AU - Cnossen, Maryse

AU - Curry, Nicola

AU - Czeiter, Endre

AU - Czosnyka, Marek

AU - Dahyot-Fitzelier, Claire

AU - Damas, François

AU - Dawes, Helen

AU - De Keyser, Véronique

AU - De Luca, Alessandra

AU - De Ruiter, Godard C W

AU - De Witte, Olivier

AU - Corte, Francesco Della

AU - Demeter, Béla

AU - Sándor, J.

PY - 2015

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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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KW - Clinical study

KW - Comparative effectiveness research

KW - Protocol

KW - Traumatic brain injury

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