TY - JOUR
T1 - Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI)
T2 - A prospective longitudinal observational study
AU - CENTER-TBI Participants and Investigators
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 - Depreitere, Bart
AU - Dippel, Diederik W.J.
AU - Dizdarevic, Kemal
AU - Dreier, Jens P.
AU - Eapen, George
AU - Ercole, Ari
AU - Esser, Patrick
AU - Fabricius, Martin
AU - Feremans, Len
AU - Feigin, Valery L.
AU - Fossi, Francesca
AU - Forsyth, Faye
AU - Florian, Stefan
AU - Frisvold, Shirin Kordasti
AU - Frosini, Caterina
AU - Furmanov, Alex
AU - Frantzén, Janek
AU - Gadda, Davide
AU - Gagliardo, Pablo
AU - Galanaud, Damien
AU - Gao, Guoyi
AU - Ghuysen, Alexandre
AU - Godbolt, Alison
AU - Gonšorová, Veronika
AU - Grigore, Zapulih
AU - Gruen, Russel
AU - Haagsma, Juanita A.
AU - Hallaert, Giorgio
AU - Hadzic, Ermin
AU - Haitsma, Ian
AU - Hartings, Jed A.
AU - Helbok, Raimund
AU - Helseth, Eirik
AU - Hoefer, Stefan
AU - Holling, Markus
AU - Hunfeld, Maaike
AU - Hutchinson, Peter J.
AU - Illéš, Robert
AU - Janssens, Koen
AU - Bovend'Eerdt, Thamar J.H.
AU - Jiang, Ji Yao
AU - Jones, Kelly M.
AU - Kalala, Jean Pierre
AU - Kalovits, Ferenc
AU - Kasprian, Gregor
AU - Katila, Ari
AU - Ketharanathan, Naomi
AU - Kolias, Angelos G.
AU - Kolibay, Felix
AU - Kondziella, Daniel
AU - Koskinen, Lars Owe
AU - Lagares, Alfonso
AU - Lanyon, Linda
AU - Laureys, Steven
AU - Lefering, Rolf
AU - Levi, Leon
AU - Lightfoot, Roger
AU - Lingsma, Hester F.
AU - Loeckx, Dirk
AU - Lohkamp, Laura Nanna
AU - Lötjönen, Jyrki
AU - Lumenta, Christianto
AU - Lyttle, Mark
AU - Maegele, Marc
AU - Majdan, Marek
AU - Manara, Alex
AU - Maréchal, Hugues
AU - Martino, Costanza
AU - Mascia, Luciana
AU - Mauritz, Walter
AU - McMahon, Catherine
AU - Menovsky, Tomas
AU - Mitchell, Patrick
AU - Mladenov, Nikolay
AU - Morganti-Kossmann, Cristina
AU - Nelson, David
AU - Neugebauer, Eddy
AU - Newcombe, Virginia F.
AU - Oddo, Mauro
AU - Oresic, Matej
AU - Orzalesi, Vanni
AU - Outtrim, Joanne G.
AU - Palotie, Aarno
AU - Parizel, Paul
AU - Payen, Jean François
AU - Perlbarg, Vincent
AU - Peul, Wilco
AU - Pichon, Nicolas
AU - Piippo, Anna
AU - Floury, Sébastien Pili
AU - Ples, Horia
AU - Polinder, Suzanne
AU - Preiksaitis, Aidanas
AU - Psota, Marek
AU - Pullens, Pim
AU - Puybasset, Louis
AU - Ragauskas, Arminas
AU - Raj, Rahul
AU - Reiner, Michael
AU - Rhodes, Jonathan K.J.
AU - Richardson, Sylvia
AU - Ripatti, Samuli
AU - Rocka, Saulius
AU - Roosenfeld, Jeffrey
AU - Rosand, Jonathan
AU - Rosenlund, Christina
AU - Rosenthal, Guy
AU - Rossaint, Rolf
AU - Rossi, Sandra
AU - Rueckert, Daniel
AU - Rusnák, Martin
AU - Rynkowski, Michal A.
AU - Sahuquillo, Juan
AU - Sakowitz, Oliver
AU - Sandor, Janos
AU - Schmidt, Silke
AU - Schoechl, Herbert
AU - Schou, Rico
AU - Skandsen, Toril
AU - Sonne, Morten
AU - Schwendenwein, Elisabeth
AU - Smeets, Dirk
AU - Smieleweski, Peter
AU - Söderberg, Jeannette
AU - Stamatakis, Emmanuel
AU - Stanworth, Simon
AU - Stefini, Roberto
AU - Stevens, Robert
AU - Stewart, William
AU - Stocchetti, Nino
AU - Stummer, Walter
AU - Szabó, József
AU - Tascu, Alexandru
AU - Tenovuo, Olli
AU - Theadom, Alice
AU - Tibboel, Dick
AU - Tolias, Christos M.
AU - Unterberg, Andreas
AU - Vajkoczy, Peter
AU - Vargiolu, Alessia
AU - Van Der Naalt, Joukje
AU - Van Essen, Thomas
AU - Van Hecke, Wim
AU - Van Praag, Dominique
AU - Van Roost, Dirk
AU - Vandenbulcke, Tim
AU - Vande Hauwe, Luc
AU - Van Der Jagt, Mathieu
AU - Vega, Emmanuel
AU - Verheyden, Jan
AU - Verma, Vishwajit
AU - Vespa, Paul M.
AU - Vik, Anne
AU - Vilcinis, Rimantas
AU - Von Steinbüchel, Nicole
AU - Vulekovic, Peter
AU - Wang, Kevin K.W.
AU - Wildschut, Eno
AU - Williams, Guy
AU - Wilson, Mark
AU - Wilson, Lindsay
AU - Wolf, Stefan
AU - Ylén, Peter
AU - Zaaroor, Menashe
AU - Zolfaghari, Parjam
AU - Martin, Didier
AU - D'Orio, Vincenzo
AU - Damas, Pierre
AU - Luaba Tshibanda, Jean Flory
PY - 2015/1/1
Y1 - 2015/1/1
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
VL - 76
SP - 67
EP - 80
JO - Neurosurgery
JF - Neurosurgery
SN - 0148-396X
IS - 1
ER -