Page 116 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 5
TBI Core study (clinicaltrials.gov NCT02210221; RRID: SCR_015582) is a prospective multicentre longitudinal observational study conducted in 65 centers across Europe and Israel. 16 The project aimed to improve TBI characterization and classification and to identify best clinical care. The responsible institutional review board (METC Leiden) approved this study (P14.222).
Patients were included in the CENTER-TBI Core study using the following criteria: (1) clinical diagnosis of TBI, (2) clinical indication for head CT scan, (3) presentation to study center within 24 hours after injury and (4) informed consent following Dutch requirements, including patient, proxy and deferred consent. Patients were excluded when they had a severe pre-existing neurological disorder that would confound outcome assessments or in case of insufficient understanding of the Dutch or English language.
Clinical data
Clinical data were prospectively collected by using a web-based electronic case report form (CRF) (QuesGen System Incorporated, Burlingame, CA, USA). Data were obtained from electronic patient files and patient interviews and when necessary initially recordedonahardcopyCRF.Datacollectionwascompletedbyalocalresearchstaffthat was specifically trained for this project. The site’s principal investigator supervised the project. Data were de-identified by using a randomly generated GUPI (Global Unique Patient Identifier) and was stored on a secure database, hosted by the International Neuroinformatics Coordinating Facility (INCF; www.incf.org) in Stockholm, Sweden.
Data was extracted in December 2019 (version 2.1) using a custom-made data access tool Neurobot (http://neurobot.incf.org), developed by INCF (RRID: SCR_01700). Extracted data included: baseline demographic, trauma and injury information, results of neurological assessments, imaging (first head CT scan) and patient outcome. This database was merged with separately collected data on in-hospital healthcare consumption and in-hospital costs, which is explained later. Discrepancies were resolved by source data verification.
Baseline Glasgow Coma Scale (GCS) Total Score, GCS Motor Score and pupillary reactivity variables were collected. TBI severity was then classified by using the GCS (GCS13-15; mild TBI, GCS9-12; moderate TBI, GCS3-8; severe TBI, GCS3-5; very severe TBI). 17 These values were derived variables that were centrally calculated using the
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