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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: *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.
authors.forename: Andrew I R
authors.initials: AI
authors.lastname: Maas
authors.forename: David K
authors.initials: DK
authors.lastname: Menon
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Citerio
authors.forename: Fiona
authors.initials: F
authors.lastname: Lecky
authors.forename: Geoffrey T
authors.initials: GT
authors.lastname: Manley
authors.forename: Sean
authors.initials: S
authors.lastname: Hill
authors.forename: Valerie
authors.initials: V
authors.lastname: Legrand
authors.forename: Annina
authors.initials: A
authors.lastname: Sorgner
mesh_terms: D000328:Adult; D001930:Brain Injuries / Q000145:classification* / Q000175:diagnosis* / Q000628:therapy; D002648:Child; D057186:Comparative Effectiveness Research; D005060:Europe; D005260:Female; D006801:Humans; D007557:Israel; D008137:Longitudinal Studies; D008297:Male; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012107:Research Design; D014057:Tomography, X-Ray Computed