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Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): A Prospective Longitudinal Observational Study

Lookup NU author(s): Patrick Mitchell

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


Abstract

Copyright © 2014 by the Congress of Neurological Surgeons. 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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Author(s): Maas AIR, Menon DK, Steyerberg EW, Citerio G, Lecky F, Manley GT, Hill S, Legrand V, Sorgner A, Andelic N, Andreassen L, Andrews P, Audibert G, Audny A, Azouv P, Barzo P, Beer R, Bellander B-M, Belli A, Benali H, Berardino M, Beretta L, Brazinova A, Binder H, Brehar F, Buki A, Bullinger M, Cakmak E, Callebaut I, Cameron P, Lozano GC, Carpenter KLH, Chieregato A, Coburn M, Coles JP, Cooper J, Cnossen M, Curry N, Czeiter E, Czosnyka M, Dahyot-Fitzelier C, Damas F, Dawes H, De Keyser V, De Luca A, De Ruiter GCW, De Witte O, Corte FD, Demeter B, Depreitere B, Dippel DWJ, Dizdarevic K, Dreier JP, Eapen G, Ercole A, Esser P, Fabricius M, Feremans L, Feigin VL, Fossi F, Forsyth F, Florian S, Frisvold SK, Frosini C, Furmanov A, Frantzen J, Gadda D, Gagliardo P, Galanaud D, Gao G, Ghuysen A, Godbolt A, Gonsorova V, Grigore Z, Gruen R, Haagsma JA, Hallaert G, Hadzic E, Haitsma I, Hartings JA, Helbok R, Helseth E, Hoefer S, Holling M, Hunfeld M, Hutchinson PJ, Illes R, Janssens K, Bovend'Eerdt TJH, Jiang J-Y, Jones KM, Kalala J-P, Kalovits F, Kasprian G, Katila A, Ketharanathan N, Kolias AG, Kolibay F, Kondziella D, Koskinen L-O, Lagares A, Lanyon L, Laureys S, Lefering R, Levi L, Lightfoot R, Lingsma HF, Loeckx D, Lohkamp L-N, Lotjonen J, Lumenta C, Lyttle M, Maegele M, Majdan M, Manara A, Marechal H, Martino C, Mascia L, Mauritz W, McMahon C, Menovsky T, Mitchell P, Mladenov N, Morganti-Kossmann C, Nelson D, Neugebauer E, Newcombe VF, Oddo M, Oresic M, Orzalesi V, Outtrim JG, Palotie A, Parizel P, Payen J-F, Perlbarg V, Peul W, Pichon N, Piippo A, Floury SP, Ples H, Polinder S, Preiksaitis A, Psota M, Pullens P, Puybasset L, Ragauskas A, Raj R, Reiner M, Rhodes JKJ, Richardson S, Ripatti S, Rocka S, Roosenfeld J, Rosand J, Rosenlund C, Rosenthal G, Rossaint R, Rossi S, Rueckert D, Rusnak M, Rynkowski MA, Sahuquillo J, Sakowitz O, Sandor J, Schmidt S, Schoechl H, Schou R, Skandsen T, Sonne M, Schwendenwein E, Smeets D, Smieleweski P, Soderberg J, Stamatakis E, Stanworth S, Stefini R, Stevens R, Stewart W, Stocchetti N, Stummer W, Szabo J, Tascu A, Tenovuo O, Theadom A, Tibboel D, Tolias CM, Unterberg A, Vajkoczy P, Vargiolu A, Van Der Naalt J, Van Essen T, Van Hecke W, Van Praag D, Van Roost D, Vandenbulcke T, Vande Hauwe L, Van Der Jagt M, Vega E, Verheyden J, Verma V, Vespa PM, Vik A, Vilcinis R, Von Steinbuchel N, Vulekovic P, Wang KKW, Wildschut E, Williams G, Wilson M, Wilson L, Wolf S, Ylen P, Zaaroor M, Zolfaghari P, Martin D, D'Orio V, Damas P, Luaba Tshibanda J-F

Publication type: Article

Publication status: Published

Journal: Neurosurgery

Year: 2015

Volume: 76

Issue: 1

Pages: 67-80

Online publication date: 24/09/2014

Acceptance date: 02/09/2014

ISSN (print): 0148-396X

ISSN (electronic): 1524-4040

Publisher: Lippincott Williams and Wilkins

URL: http://doi.org/10.1227/NEU.0000000000000575

DOI: 10.1227/NEU.0000000000000575

PubMed id: 25525693


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