Project Overview

In October 2011 the DG Health of the European Commission and NIH/NINDS hosted a workshop in Brussels on "feasibility and benefits of international collaboration in the field of TBI research". This workshop brought together over 60 policy makers, scientists, clinicians and patient and industry representatives from the EU, USA, Canada, China and Australia.The workshop identified gaps in our knowledge and summarized research priorities for the near future. Major gaps identified included: understanding different responses to similar injuries, the importance of pre-morbid factors and co-morbidities, antiquated and insensitive approaches to classification of initial severity and of outcome, lack of strong evidence for treatment recommendations, lack of mechanistic targets and early endpoints and absence of standardized approaches to track service utilization and outcome following acute care discharge.

Research priorities identified included:

• Comparative effectiveness research to determine the benefits of current and new treatments
• Prediction of outcome and how this is affected by patient injury and the quality of general and specific management across the continuum of care
• Development and validation of surrogate markers of injury and recovery
• A patho-anatomical and mechanistic patient classification system to enable targeted therapies

These research priorities are embodied in the CENTER-TBI project. CENTER-TBI represents a focused European effort to advance the care of patients with TBI, within the broader international framework of InTBIR (International Initiative for Traumatic Brain Injury Research). We expect profound impacts in terms of treatment provision (Precision Medicine and personalized management), health care policy (improved organisation and quality assessment), economy (improved cost-effectiveness), and most importantly, improved health, quality of life, and social integration for patients. International collaborations with other InTBIR partners and external institutes will help increase generalizability of our study findings, and ensure a global impact.

The CENTER-TBI project is designed as a comparative effectiveness research (CER) study with a strong emphasis on evidence translation and communication, aiming to achieve optimal dissemination of results.

We will hereto conduct a prospective longitudinal observational study in 68 centers from 20 countries including approximately 4,500 patients (CENTER-TBI Core Study). We will obtain detailed data on the entire clinical course on injury details, treatment, outcome and health costs, collecting all relevant core Common Data Elements (TBI-CDEs).

Data collection will be in 3 strata, differentiated by care path:

1. Patients seen in the emergency room (ER) and discharged (ER stratum)
2. Patients admitted to hospital, but not to the intensive care unit (admission stratum)
3. Patients admitted to the ICU (ICU stratum)

Participating centers will also maintain a registry with observational data on all patients presenting with TBI (CENTER-TBI Registry), aiming to assess representativeness of the CENTER-TBI Core Study and to analyze effects of structural parameters (e.g. organizational) in even greater numbers (15,000 – 25,000 patients). To improve characterization of TBI, we will include the most promising emerging techniques (e.g. biomarkers, advanced MR imaging, genomics), with innovative approaches to analysis, including state-of-the-art biostatistics and neuroinformatics. Repositories will be created to allow for legacy research with future technologies, benefitting from the extensive and systematic data collection in CENTER-TBI, including long-term outcome.

To identify (cost-)effective medical care (both acute and post-acute), we will exploit the inherent heterogeneity of TBI with its great variability in disease, treatment and outcome using a comparative effectiveness research (CER) approach. We will obtain information on provider profiles for analysis of organizational aspects, processes of care, and to identify best practice. The large-scale standardized clinical data acquisition will enable the characterization of TBI by multidimensional clinical characteristics and outcomes, and the identification of effective medical care at an unprecedented scale. Improved disease characterization and CER results will aid Precision Medicine, and help provide individually targeted care. Research results will be integrated with systematic reviews in a process of knowledge transfer and disseminated to patients, health care professionals and policy makers, thus contributing to improved and harmonized clinical guidelines for the treatment of TBI.

The integrated results of the project will be brought together in a process of translational outputs. We aim for real world approaches to translating research outputs into practical information for patients, healthcare professionals and policy makers. We will develop and sustain an international TBI knowledge community that integrates results of the project with high quality 'living evidence reviews' of the current state of knowledge, aiming to continuously provide evidence to underpin guidelines and treatment recommendations.

The impact of CENTER-TBI will be enhanced by international collaborations within and beyond InTBIR. TBI is a global problem and requires a global approach. The CENTER-TBI database and repositories will be an invaluable resource for further research which we wish to encourage. Data sharing policies, providing open access, modelled on the Alzheimer‘s Disease Neuro-imaging Initiative (ADNI) concept, aim to encourage academic productivity and accelerate TBI research.