Format

Send to

Choose Destination
See comment in PubMed Commons below
Neurosurgery. 2015 Jan;76(1):67-80. doi: 10.1227/NEU.0000000000000575.

Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study.

Collaborators (216)

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, Brazinová A, Binder H, Brehar F, Buki A, Bullinger M, Cakmak E, Callebaut I, Cameron P, Lozano GC, Carpenter KL, Chieregato A, Citerio G, 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 GC, De Witte O, Della Corte F, Demeter B, Depreitere B, Dippel DW, 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, Hill S, Hoefer S, Holling M, Hunfeld M, Hutchinson PJ, Illéš R, Janssens K, Bovend'Eerdt TJ, 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, Lecky F, Lefering R, Levi L, Lightfoot R, Lingsma HF, Loeckx D, Lohkamp LN, Lötjönen J, Lumenta C, Lyttle M, Maas A, Maegele M, Majdan M, Manara A, Manley GT, Maréchal H, Martino C, Mascia L, Mauritz W, McMahon C, Menon DK, 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 JK, 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, Steyerberg EW, 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 KK, Wildschut E, Williams G, Wilson M, Wilson L, Wolf S, Ylén P, Zaaroor M, Zolfaghari P, Martin D, D'Orio V, Damas P, Tshibanda JF.

Author information

1
*Department of Neurosurgery, Antwerp University Hospital and University of Antwerp, Edegem, Belgium; ‡Division of Anaesthesia, University of Cambridge/Addenbrooke's Hospital, Cambridge, UK; §Department of Public Health, Center for Medical Decision Making, Erasmus MC-University Medical Center Rotterdam, Rotterdam, The Netherlands; ¶Department of Health Science, University of Milan-Bicocca; NeuroIntensive Care, Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy; ‖Emergency Medicine Research in Sheffield, Health Services Research Section, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; #Department of Neurological Surgery, University of California, San Francisco, California; **International Neuroinformatics Coordinating Facility, Karolinska Institutet, Stockholm, Sweden; ‡‡ICON plc, VP Global project management, Dublin, Ireland; §§GABO:mi, International projects management, Munich, Germany.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02210221.

PMID:
25525693
DOI:
10.1227/NEU.0000000000000575
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Silverchair Information Systems
    Loading ...
    Support Center