학술논문
An international, prospective observational study on traumatic brain injury epidemiology study protocol: GEO-TBI: Incidence [version 1; peer review: 2 approved]
Document Type
article
Author
David Clark; Tommi Kalevi Korhonen; Sara Venturini; Sujit Gnanakumar; Thomas Bashford; Midhun Mohan; Indira Devi Bhagavatula; Ronnie Baticulon; Rocío Fernández-Méndez; Ignatius Esene; Deepak Gupta; Anthony Figaji; Tsegazeab Laeke; Tariq Khan; David Menon; Michael Martin; Kee B. Park; Wellingson Paiva; Andres M. Rubiano; Jogi V. Pattisapu; Hamisi Shabani; Vijaya Sekhar; Davi Solla; Kachinga Sichizya; Manjul Tripathi; Abenezer Tirsit; Bart Depreitere; Carole Turner; Laura Lippa; Corrado Iaccarino; Gail Rosseau; Andrew Reisner; Rikin Trivedi; Franco Servadei; Angelos Kolias; Vicknes Waran; Peter Hutchinson; Alexis Joannides
Source
NIHR Open Research, Vol 3 (2023)
Subject
Language
English
ISSN
2633-4402
Abstract
Background: The epidemiology of traumatic brain injury (TBI) is unclear – it is estimated to affect 27–69 million individuals yearly with the bulk of the TBI burden in low-to-middle income countries (LMICs). Research has highlighted significant between-hospital variability in TBI outcomes following emergency surgery, but the overall incidence and epidemiology of TBI remains unclear. To address this need, we established the Global Epidemiology and Outcomes following Traumatic Brain Injury (GEO-TBI) registry, enabling recording of all TBI cases requiring admission irrespective of surgical treatment. Objective: The GEO-TBI: Incidence study aims to describe TBI epidemiology and outcomes according to development indices, and to highlight best practices to facilitate further comparative research. Design: Multi-centre, international, registry-based, prospective cohort study. Subjects: Any unit managing TBI and participating in the GEO-TBI registry will be eligible to join the study. Each unit will select a 90-day study period. All TBI patients meeting the registry inclusion criteria (neurosurgical/ICU admission or neurosurgical operation) during the selected study period will be included in the GEO-TBI: Incidence. Methods: All units will form a study team, that will gain local approval, identify eligible patients and input data. Data will be collected via the secure registry platform and validated after collection. Identifiers may be collected if required for local utility in accordance with the GEO-TBI protocol. Data: Data related to initial presentation, interventions and short-term outcomes will be collected in line with the GEO-TBI core dataset, developed following consensus from an iterative survey and feedback process. Patient demographics, injury details, timing and nature of interventions and post-injury care will be collected alongside associated complications. The primary outcome measures for the study will be the Glasgow Outcome at Discharge Scale (GODS) and 14-day mortality. Secondary outcome measures will be mortality and extended Glasgow Outcome Scale (GOSE) at the most recent follow-up timepoint.