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CENTER-TBI Report Summary

Project ID: 602150
Funded under: FP7-HEALTH
Country: Belgium

Periodic Report Summary 3 - CENTER-TBI (Collaborative European NeuroTrauma Effectiveness Research in TBI)

Project Context and Objectives:
Traumatic Brain Injury (TBI) is a major cause of death and disability, causing great personal suffering to victims and relatives as well as huge direct and indirect costs to society. Recent data show that approximately 2.5 million people in Europe suffer a TBI, of whom 1.5 million are admitted to hospital and 53,000 die. TBI is a complex disease, but strong evidence in support of treatment recommendations is lacking and approaches seldom adequately targeted. Conventionally, clinical TBI research has involved reductionist attempts to isolate out single factors for treatment. These approaches do not account for the complexity of TBI, nor do they reflect the clinical reality of TBI heterogeneity, and lack generalisability. Modern computational techniques and the availability of robust risk adjustment models facilitate more holistic approaches, such as Comparative Effectiveness Research (CER). CER makes use of differences in treatment and outcome, rather than attempting to exclude these. A specific feature of TBI that favours CER is the large between-centre and between-country differences in management and outcome. CENTER-TBI is a large scale CER project, aiming to (1) improve characterization and classification of TBI and (2) identify the most effective clinical care and to provide high quality evidence in support of treatment recommendations and guidelines. It brings together clinicians and researchers from 20 countries in Europe and Israel (Figure 1) with leading experts from 47 scientific institutes worldwide. CENTER-TBI is part of the International Initiative on TBI Research (InTBIR -, a collaboration of funding agencies (National Institutes of Health (NIH) in the US, the European Commission, Canadian Institutes of Health Research (CIHR) in Canada, the non-profit organization One Mind (OM), and the US Department of Defense (DoD). CENTER-TBI is an integrative project that will optimize existing knowledge and merge this with new evidence generated from a prospective observational Core Study and a Registry. Extensive profiling of participating centers will be performed. In the Core Study, the consortium will collect detailed data on approximatively 5400 patients across all severities of TBI. Enrolment will be in three strata, differentiated by care path: (1) patients seen in the emergency room and discharged (ER stratum); (2) patients admitted to hospital, but not to the intensive care unit (admission stratum); (3) patients admitted to the Intensive Care Unit (ICU) (ICU stratum). Participating centers will also maintain a Registry of basic data on all patients presenting with TBI (CENTER-TBI Registry), aiming to assess representativeness of the Core Study and to analyse effects of structural parameters (e.g. organisational) in greater numbers (15,000 – 25,000 patients). The Core Study will combine emerging techniques (e.g. biomarkers, advanced Magnetic resonance (MR) imaging, genomics), with innovative approaches to analysis, including state-of-the-art biostatistics and neuroinformatics. Repositories will be created to allow 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), the CENTER-TBI consortium will analyse the effects of structure and processes of care at both the organisational (country, region) and at the individual patient level. 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 harmonised recommendations for the treatment of TBI. CENTER-TBI wishes to break with past dogmas and restrictive traditions. As such the consortium will seek global collaborations, include emergent technologies, involve non-medical scientists, in particular bio-informatics specialists, and seek collaborative data sharing initiatives. The project duration is 6.5 years, including at least 1.5 years for recruitment, and up to an additional 2 years for follow up.

Figure 1: Distribution of centers across Europe

Project Results:
The CENTER-TBI project consists of three main components: 1) Evidence generation, 2) Evidence synthesis, 3) Evidence dissemination and knowledge transfer. During the third year of the project lifetime, activities carried out related to the three domains with substantial progress and accomplishments, as detailed hereafter.
Evidence generation
The main activities during the period have focussed on the phased initiation of centers and on recruitment for the CENTER-TBI Core Data collection and Registry. The final participation of sites across Europe and Israel was determined as indicated in Figure 2.

Figure 2: CENTER-TBI final participation of sites across Europe and Israel
Recruitment in both the Core Data Study and Registry has been steady (see Figure 3). As per October 1th a total of 3,291 patients have been recruited in the Core Data Study (62% of target) while a total of 14,195 patients have been enrolled in the Registry. The ratio between Registry and Core Data recruitment is 4.3, as expected. The enrolment in the ICU stratum has been faster than in the Admission and ER strata and it is expected to reach the target number of 1,800 patients for this stratum in December 2016. Preliminary analysis has shown a relatively high number of patients with mild TBI admitted to the ICU (30%). Substantial initiatives have been implemented towards data curation, including the set-up of a Data Curation Task Force (DCTF) which has been organised as a joint effort between several participants (i.e. UZA, UCAM, KI-INCF and EMC). As reported in the second period, the high age in subjects recruited in the Core Data and the Registry compared to previous studies has been consistent and the median age remains around 50. This reflects a clear change in epidemiologic pattern, an observation which has important consequences for healthcare planning and prevention programs.

Figure 3: Current recruitment in Core Data Study and Registry

Evidence Synthesis
Substantial progress has also been made in synthesising available evidence, both in the context of analysing results of provider profiling (PP) (characterization of structural and process related characteristics of participating sites) and in the organisation as well as in the conduct of living systematic reviews. The results of the extensive provider profiling are being collated in multiple publications, one of which has already been published. A formal agreement was established with the Journal of Neurotrauma to publish the Living Systematic Reviews (LSRs) in open-access and have them labelled as a separate manuscript category. Moreover, regular updates will be published as appendix to the online version of the manuscript.

Evidence dissemination and knowledge transfer
CENTER-TBI is already productive in dissemination and publication of the results. A total of 24 manuscripts have now been published and many more are in preparation.
The work on the publication of The Commissioned Issue on TBI in The Lancet Neurology has continued. In January 2016 a draft manuscript was submitted; positive comments from the editors and reviewers were received in April, together with suggestions for improvements. Work on revising the manuscript is in progress and we anticipate submission of the final version by the end of the year. Launch of the issue has provisionally been scheduled for April the 6th 2017 at the UN Mission of New York.

Potential Impact:
CENTER-TBI is a project that will last 6.5 years. Improvement of treatment and outcome for TBI is expected to result from 3 main pathways:
• A better characterisation of TBI, facilitating Precision Medicine approaches
• The identification of best practices by Comparative Effectiveness Research
• Improved prognostic models which may be used for benchmarking quality of care

These pathways are summarized in Figure 4.

Figure 4: CENTER-TBI expected outcomes (Reproduced with permission from Maas et al Neurosurgery, 2015.)

In addition, the extensive network developed within and beyond the CENTER-TBI participants and investigators are expected to yield great benefits far outside of the European CENTER-TBI context. Collaboration within the InTBIR framework will permit transatlantic comparative analysis, and meta-analysis of individual patient data in larger numbers. The linked projects with observational data collection have been initiated in China and India, and plans are in place to initiate data collection modelled on that of CENTER-TBI in South-Africa.

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