Traumatic brain injury – A clinical study
TBI is a major cause of death and disability. Both victims and relatives experience suffering, and the associated direct and indirect costs to society are huge. Currently, up-to-date evidence-based TBI treatment guidelines do not exist. Moreover, recently emerged technologies such as biomarkers, diffusion tensor imaging and genomics have not been considered in older studies. The CENTER-TBI(opens in new window) (Collaborative European neurotrauma effectiveness research in TBI) project will employ comparative effectiveness research (CER) to identify the most effective clinical care approach. This 6.5-year project is part of The International Initiative for Traumatic Brain Injury Research (InTBIR)(opens in new window). CENTER-TBI is a large-scale observational study that will attempt to improve TBI classification and characterisation. Using CER, project members will determine between-centre and between-country differences in TBI management and outcome. A total of 78 sites from 21 countries in Europe and Israel will participate. During the first year of the project, project members laid the foundation for conducting the study and ensuring smooth and harmonised data collection. Over 280 participants attended the training meeting. Already, the study protocol has been registered and accepted for publication in the prestigious Neurosurgery journal. They finalised the case report forms (CRFs), developed a web-based data entry format (e-CRF), finalised outcome instruments and summarised the study procedures in a trial manual. CENTER-TBI successfully completed the linguistic validation of multiple outcome instruments in many languages. They also established a knowledge commons and obtained an overview of existing knowledge in the literature concerning TBI treatments. The first patients were enrolled in December 2014. Project members established close collaboration within and outside InTBIR with similar research endeavours such as TRACK-TBI in the United States and ADAPT, a study on severe TBI in children. Project activities were widely disseminated via presentations at scientific meetings, media publications and interviews. This has attracted global interest, with China and India also setting up similar studies that will be linked to CENTER-TBI. Transatlantic comparative analysis and meta-analysis of individual patient data in larger numbers will provide a truly global perspective. Identification and implementation of best practices will improve patient outcomes while reducing the immense socioeconomic burden of TBI.
