TY - JOUR
T1 - Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI)
T2 - A prospective longitudinal observational study
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, Pál
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 - Buki, Andras
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 - Gruen, Russel
N1 - Publisher Copyright:
Copyright © 2014 by the Congress of Neurological Surgeons.
PY - 2015
Y1 - 2015
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.
AB - 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.
KW - Clinical study
KW - Comparative effectiveness research
KW - Protocol
KW - Traumatic brain injury
UR - http://www.scopus.com/inward/record.url?scp=84925936260&partnerID=8YFLogxK
U2 - 10.1227/NEU.0000000000000575
DO - 10.1227/NEU.0000000000000575
M3 - Article
C2 - 25525693
AN - SCOPUS:84925936260
SN - 0148-396X
VL - 76
SP - 67
EP - 80
JO - Neurosurgery
JF - Neurosurgery
IS - 1
ER -