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 Lecky; Geoffrey T. Manley; Sean Hill; Valerie Legrand; Annina Sorgner; Nada Andelic; Lasse Andreassen; Peter Andrews; Gérard Audibert; Anke Audny; Philippe Azouv; Pál Barzó; Ronny Beer; Bo Michael Bellander; Antonio Belli; Habib Benali; Maurizio Berardino; Luigi Beretta; Alexandra Bražinová; Harald Binder; Felix Brehar; Andras Buki; Monika Bullinger; Ela Cakmak; Ina Callebaut; Peter Cameron; Guillermo Carbayo Lozano; Keri L H Carpenter; Arturo Chieregato; Mark Coburn; Jonathan P. Coles; Jamie Cooper; Maryse Cnossen; Nicola Curry; Endre Czeiter; Marek Czosnyka; Claire Dahyot-Fitzelier; François Damas; Helen Dawes; Véronique De Keyser; Alessandra De Luca; Godard C W De Ruiter; Olivier De Witte; Francesco Della Corte; Béla Demeter; Bart Depreitere; Diederik W J Dippel; Kemal Dizdarevic; Jens P. Dreier; George Eapen; Ari Ercole; Patrick Esser; Martin Fabricius; Len Feremans; Valery L. Feigin; Francesca Fossi; Faye Forsyth; Stefan Florian; Shirin Kordasti Frisvold; Caterina Frosini; Alex Furmanov; Janek Frantzén; Davide Gadda; Pablo Gagliardo; Damien Galanaud; Guoyi Gao; Alexandre Ghuysen; Alison Godbolt; Veronika Gonšorová; Zapulih Grigore; Russel Gruen; Juanita A. Haagsma; Giorgio Hallaert; Ermin Hadzic; Ian Haitsma; Jed A. Hartings; Raimund Helbok; Eirik Helseth; Stefan Hoefer; Markus Holling; Maaike Hunfeld; Peter J. Hutchinson; Robert Illéš; Koen Janssens; Thamar J H Bovend'Eerdt; Ji Yao Jiang; Kelly M. Jones; Jean Pierre Kalala; Ferenc Kalovits; Gregor Kasprian; Ari Katila; Naomi Ketharanathan; Angelos G. Kolias; Felix Kolibay; Daniel Kondziella; Lars Owe Koskinen; Alfonso Lagares; Linda Lanyon; Steven Laureys; Rolf Lefering; Leon Levi; Roger Lightfoot; Hester F. Lingsma; Dirk Loeckx; Laura Nanna Lohkamp; Jyrki Lötjönen; Christianto Lumenta; Mark Lyttle; Marc Maegele; Marek Majdan; Alex Manara; Hugues Maréchal; Costanza Martino; Luciana Mascia; Walter Mauritz; Catherine McMahon; Tomas Menovsky; Patrick Mitchell; Nikolay Mladenov; Cristina Morganti-Kossmann; David Nelson; Eddy Neugebauer; Virginia F. Newcombe; Mauro Oddo; Matej Oresic; Vanni Orzalesi; Joanne G. Outtrim; Aarno Palotie; Paul Parizel; Jean François Payen; Vincent Perlbarg; Wilco Peul; Nicolas Pichon; Anna Piippo; Sébastien Pili Floury; Horia Ples; Suzanne Polinder; Aidanas Preiksaitis; Marek Psota; Pim Pullens; Louis Puybasset; Arminas Ragauskas; Rahul Raj; Michael Reiner; Jonathan K J Rhodes; Sylvia Richardson; Samuli Ripatti; Saulius Rocka; Jeffrey Roosenfeld; Jonathan Rosand; Christina Rosenlund; Guy Rosenthal; Rolf Rossaint; Sandra Rossi; Daniel Rueckert; Martin Rusnák; Michal A. Rynkowski; Juan Sahuquillo; Oliver Sakowitz; Janos Sandor; Silke Schmidt; Herbert Schoechl; Rico Schou; Toril Skandsen; Morten Sonne; Elisabeth Schwendenwein; Dirk Smeets; Peter Smieleweski; Jeannette Söderberg; Emmanuel Stamatakis; Simon Stanworth; Roberto Stefini; Robert Stevens; William Stewart; Nino Stocchetti; Walter Stummer; József Szabó; Alexandru Tascu; Olli Tenovuo; Alice Theadom; Dick Tibboel; Christos M. Tolias; Andreas Unterberg; Peter Vajkoczy; Alessia Vargiolu; Joukje Van Der Naalt; Thomas Van Essen; Wim Van Hecke; Dominique Van Praag; Dirk Van Roost; Tim Vandenbulcke; Luc Vande Hauwe; Mathieu Van Der Jagt; Emmanuel Vega; Jan Verheyden; Vishwajit Verma; Paul M. Vespa; Anne Vik; Rimantas Vilcinis; Nicole Von Steinbüchel; Peter Vulekovic; Kevin K W Wang; Eno Wildschut; Guy Williams; Mark Wilson; Lindsay Wilson; Stefan Wolf; Peter Ylén; Menashe Zaaroor; Parjam Zolfaghari; Didier Martin; Vincenzo D'Orio; Pierre Damas; Jean Flory Luaba Tshibanda

doi:10.1227/NEU.0000000000000575

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 Lecky, Geoffrey T. Manley, Sean Hill, Valerie Legrand, Annina Sorgner, Nada Andelic, Lasse Andreassen, Peter Andrews, Gérard Audibert, Anke Audny, Philippe Azouv, Pál Barzó, Ronny Beer, Bo Michael Bellander, Antonio Belli, Habib BenaliMaurizio Berardino, Luigi Beretta, Alexandra Bražinová, Harald Binder, Felix Brehar, Andras Buki, Monika Bullinger, Ela Cakmak, Ina Callebaut, Peter Cameron, Guillermo Carbayo Lozano, Keri L H Carpenter, Arturo Chieregato, Mark Coburn, Jonathan P. Coles, Jamie Cooper, Maryse Cnossen, Nicola Curry, Endre Czeiter, Marek Czosnyka, Claire Dahyot-Fitzelier, François Damas, Helen Dawes, Véronique De Keyser, Alessandra De Luca, Godard C W De Ruiter, Olivier De Witte, Francesco Della Corte, Béla Demeter, Bart Depreitere, Diederik W J Dippel, Kemal Dizdarevic, Jens P. Dreier, George Eapen, Ari Ercole, Patrick Esser, Martin Fabricius, Len Feremans, Valery L. Feigin, Francesca Fossi, Faye Forsyth, Stefan Florian, Shirin Kordasti Frisvold, Caterina Frosini, Alex Furmanov, Janek Frantzén, Davide Gadda, Pablo Gagliardo, Damien Galanaud, Guoyi Gao, Alexandre Ghuysen, Alison Godbolt, Veronika Gonšorová, Zapulih Grigore, Russel Gruen, Juanita A. Haagsma, Giorgio Hallaert, Ermin Hadzic, Ian Haitsma, Jed A. Hartings, Raimund Helbok, Eirik Helseth, Stefan Hoefer, Markus Holling, Maaike Hunfeld, Peter J. Hutchinson, Robert Illéš, Koen Janssens, Thamar J H Bovend'Eerdt, Ji Yao Jiang, Kelly M. Jones, Jean Pierre Kalala, Ferenc Kalovits, Gregor Kasprian, Ari Katila, Naomi Ketharanathan, Angelos G. Kolias, Felix Kolibay, Daniel Kondziella, Lars Owe Koskinen, Alfonso Lagares, Linda Lanyon, Steven Laureys, Rolf Lefering, Leon Levi, Roger Lightfoot, Hester F. Lingsma, Dirk Loeckx, Laura Nanna Lohkamp, Jyrki Lötjönen, Christianto Lumenta, Mark Lyttle, Marc Maegele, Marek Majdan, Alex Manara, Hugues Maréchal, Costanza Martino, Luciana Mascia, Walter Mauritz, Catherine McMahon, Tomas Menovsky, Patrick Mitchell, Nikolay Mladenov, Cristina Morganti-Kossmann, David Nelson, Eddy Neugebauer, Virginia F. Newcombe, Mauro Oddo, Matej Oresic, Vanni Orzalesi, Joanne G. Outtrim, Aarno Palotie, Paul Parizel, Jean François Payen, Vincent Perlbarg, Wilco Peul, Nicolas Pichon, Anna Piippo, Sébastien Pili Floury, Horia Ples, Suzanne Polinder, Aidanas Preiksaitis, Marek Psota, Pim Pullens, Louis Puybasset, Arminas Ragauskas, Rahul Raj, Michael Reiner, Jonathan K J Rhodes, Sylvia Richardson, Samuli Ripatti, Saulius Rocka, Jeffrey Roosenfeld, Jonathan Rosand, Christina Rosenlund, Guy Rosenthal, Rolf Rossaint, Sandra Rossi, Daniel Rueckert, Martin Rusnák, Michal A. Rynkowski, Juan Sahuquillo, Oliver Sakowitz, Janos Sandor, Silke Schmidt, Herbert Schoechl, Rico Schou, Toril Skandsen, Morten Sonne, Elisabeth Schwendenwein, Dirk Smeets, Peter Smieleweski, Jeannette Söderberg, Emmanuel Stamatakis, Simon Stanworth, Roberto Stefini, Robert Stevens, William Stewart, Nino Stocchetti, Walter Stummer, József Szabó, Alexandru Tascu, Olli Tenovuo, Alice Theadom, Dick Tibboel, Christos M. Tolias, Andreas Unterberg, Peter Vajkoczy, Alessia Vargiolu, Joukje Van Der Naalt, Thomas Van Essen, Wim Van Hecke, Dominique Van Praag, Dirk Van Roost, Tim Vandenbulcke, Luc Vande Hauwe, Mathieu Van Der Jagt, Emmanuel Vega, Jan Verheyden, Vishwajit Verma, Paul M. Vespa, Anne Vik, Rimantas Vilcinis, Nicole Von Steinbüchel, Peter Vulekovic, Kevin K W Wang, Eno Wildschut, Guy Williams, Mark Wilson, Lindsay Wilson, Stefan Wolf, Peter Ylén, Menashe Zaaroor, Parjam Zolfaghari, Didier Martin, Vincenzo D'Orio, Pierre Damas, Jean Flory Luaba Tshibanda

Research output: Contribution to journal › Article › peer-review

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 language	English
Pages (from-to)	67-80
Number of pages	14
Journal	Neurosurgery
Volume	76
Issue number	1
DOIs	https://doi.org/10.1227/NEU.0000000000000575
Publication status	Published - 2015

Keywords

Clinical study
Comparative effectiveness research
Protocol
Traumatic brain injury

ASJC Scopus subject areas

Clinical Neurology
Surgery
Medicine(all)

Access to Document

10.1227/NEU.0000000000000575

Cite this

Maas, A. I. R., Menon, D. K., Steyerberg, E. W., Citerio, G., Lecky, F., Manley, G. T., Hill, S., Legrand, V., Sorgner, A., Andelic, N., Andreassen, L., Andrews, P., Audibert, G., Audny, A., Azouv, P., Barzó, P., Beer, R., Bellander, B. M., Belli, A., ... Luaba Tshibanda, J. F. (2015). Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI): A prospective longitudinal observational study. Neurosurgery, 76(1), 67-80. https://doi.org/10.1227/NEU.0000000000000575

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, Barzó, P, Beer, R, Bellander, BM, Belli, A, Benali, H, Berardino, M, Beretta, L, Bražinová, 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, Frantzén, J, Gadda, D, Gagliardo, P, Galanaud, D, Gao, G, Ghuysen, A, Godbolt, A, Gonšorová, 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, Illéš, R, Janssens, K, Bovend'Eerdt, TJH, Jiang, JY, Jones, KM, Kalala, JP, Kalovits, F, Kasprian, G, Katila, A, Ketharanathan, N, Kolias, AG, Kolibay, F, Kondziella, D, Koskinen, LO, Lagares, A, Lanyon, L, Laureys, S, Lefering, R, Levi, L, Lightfoot, R, Lingsma, HF, Loeckx, D, Lohkamp, LN, Lötjönen, J, Lumenta, C, Lyttle, M, Maegele, M, Majdan, M, Manara, A, Maréchal, 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, JF, 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, Rusnák, 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, Söderberg, J, Stamatakis, E, Stanworth, S, Stefini, R, Stevens, R, Stewart, W, Stocchetti, N, Stummer, W, Szabó, 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 Steinbüchel, N, Vulekovic, P, Wang, KKW, Wildschut, E, Williams, G, Wilson, M, Wilson, L, Wolf, S, Ylén, P, Zaaroor, M, Zolfaghari, P, Martin, D, D'Orio, V, Damas, P & Luaba Tshibanda, JF 2015, 'Collaborative European neurotrauma effectiveness research in traumatic brain injury (CENTER-TBI): A prospective longitudinal observational study', Neurosurgery, vol. 76, no. 1, pp. 67-80. https://doi.org/10.1227/NEU.0000000000000575

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

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.",

keywords = "Clinical study, Comparative effectiveness research, Protocol, Traumatic brain injury",

author = "Maas, {Andrew I R} and Menon, {David K.} and Steyerberg, {Ewout W.} and Giuseppe Citerio and Fiona Lecky and Manley, {Geoffrey T.} and Sean Hill and Valerie Legrand and Annina Sorgner and Nada Andelic and Lasse Andreassen and Peter Andrews and G{\'e}rard Audibert and Anke Audny and Philippe Azouv and P{\'a}l Barz{\'o} and Ronny Beer and Bellander, {Bo Michael} and Antonio Belli and Habib Benali and Maurizio Berardino and Luigi Beretta and Alexandra Bra{\v z}inov{\'a} and Harald Binder and Felix Brehar and Andras Buki and Monika Bullinger and Ela Cakmak and Ina Callebaut and Peter Cameron and Lozano, {Guillermo Carbayo} and Carpenter, {Keri L H} and Arturo Chieregato and Mark Coburn and Coles, {Jonathan P.} and Jamie Cooper and Maryse Cnossen and Nicola Curry and Endre Czeiter and Marek Czosnyka and Claire Dahyot-Fitzelier and Fran{\c c}ois Damas and Helen Dawes and {De Keyser}, V{\'e}ronique and {De Luca}, Alessandra and {De Ruiter}, {Godard C W} and {De Witte}, Olivier and Corte, {Francesco Della} and B{\'e}la Demeter and Bart Depreitere and Dippel, {Diederik W J} and Kemal Dizdarevic and Dreier, {Jens P.} and George Eapen and Ari Ercole and Patrick Esser and Martin Fabricius and Len Feremans and Feigin, {Valery L.} and Francesca Fossi and Faye Forsyth and Stefan Florian and Frisvold, {Shirin Kordasti} and Caterina Frosini and Alex Furmanov and Janek Frantz{\'e}n and Davide Gadda and Pablo Gagliardo and Damien Galanaud and Guoyi Gao and Alexandre Ghuysen and Alison Godbolt and Veronika Gon{\v s}orov{\'a} and Zapulih Grigore and Russel Gruen and Haagsma, {Juanita A.} and Giorgio Hallaert and Ermin Hadzic and Ian Haitsma and Hartings, {Jed A.} and Raimund Helbok and Eirik Helseth and Stefan Hoefer and Markus Holling and Maaike Hunfeld and Hutchinson, {Peter J.} and Robert Ill{\'e}{\v s} and Koen Janssens and Bovend'Eerdt, {Thamar J H} and Jiang, {Ji Yao} and Jones, {Kelly M.} and Kalala, {Jean Pierre} and Ferenc Kalovits and Gregor Kasprian and Ari Katila and Naomi Ketharanathan and Kolias, {Angelos G.} and Felix Kolibay and Daniel Kondziella and Koskinen, {Lars Owe} and Alfonso Lagares and Linda Lanyon and Steven Laureys and Rolf Lefering and Leon Levi and Roger Lightfoot and Lingsma, {Hester F.} and Dirk Loeckx and Lohkamp, {Laura Nanna} and Jyrki L{\"o}tj{\"o}nen and Christianto Lumenta and Mark Lyttle and Marc Maegele and Marek Majdan and Alex Manara and Hugues Mar{\'e}chal and Costanza Martino and Luciana Mascia and Walter Mauritz and Catherine McMahon and Tomas Menovsky and Patrick Mitchell and Nikolay Mladenov and Cristina Morganti-Kossmann and David Nelson and Eddy Neugebauer and Newcombe, {Virginia F.} and Mauro Oddo and Matej Oresic and Vanni Orzalesi and Outtrim, {Joanne G.} and Aarno Palotie and Paul Parizel and Payen, {Jean Fran{\c c}ois} and Vincent Perlbarg and Wilco Peul and Nicolas Pichon and Anna Piippo and Floury, {S{\'e}bastien Pili} and Horia Ples and Suzanne Polinder and Aidanas Preiksaitis and Marek Psota and Pim Pullens and Louis Puybasset and Arminas Ragauskas and Rahul Raj and Michael Reiner and Rhodes, {Jonathan K J} and Sylvia Richardson and Samuli Ripatti and Saulius Rocka and Jeffrey Roosenfeld and Jonathan Rosand and Christina Rosenlund and Guy Rosenthal and Rolf Rossaint and Sandra Rossi and Daniel Rueckert and Martin Rusn{\'a}k and Rynkowski, {Michal A.} and Juan Sahuquillo and Oliver Sakowitz and Janos Sandor and Silke Schmidt and Herbert Schoechl and Rico Schou and Toril Skandsen and Morten Sonne and Elisabeth Schwendenwein and Dirk Smeets and Peter Smieleweski and Jeannette S{\"o}derberg and Emmanuel Stamatakis and Simon Stanworth and Roberto Stefini and Robert Stevens and William Stewart and Nino Stocchetti and Walter Stummer and J{\'o}zsef Szab{\'o} and Alexandru Tascu and Olli Tenovuo and Alice Theadom and Dick Tibboel and Tolias, {Christos M.} and Andreas Unterberg and Peter Vajkoczy and Alessia Vargiolu and {Van Der Naalt}, Joukje and {Van Essen}, Thomas and {Van Hecke}, Wim and {Van Praag}, Dominique and {Van Roost}, Dirk and Tim Vandenbulcke and {Vande Hauwe}, Luc and {Van Der Jagt}, Mathieu and Emmanuel Vega and Jan Verheyden and Vishwajit Verma and Vespa, {Paul M.} and Anne Vik and Rimantas Vilcinis and {Von Steinb{\"u}chel}, Nicole and Peter Vulekovic and Wang, {Kevin K W} and Eno Wildschut and Guy Williams and Mark Wilson and Lindsay Wilson and Stefan Wolf and Peter Yl{\'e}n and Menashe Zaaroor and Parjam Zolfaghari and Didier Martin and Vincenzo D'Orio and Pierre Damas and {Luaba Tshibanda}, {Jean Flory}",

year = "2015",

doi = "10.1227/NEU.0000000000000575",

language = "English",

volume = "76",

pages = "67--80",

journal = "Neurosurgery",

issn = "0148-396X",

publisher = "Lippincott Williams and Wilkins",

number = "1",

}

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 - 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

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

UR - http://www.scopus.com/inward/citedby.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 -

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

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