TY - JOUR
T1 - Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI
T2 - a European prospective, multicentre, longitudinal, cohort study
AU - Steyerberg, Ewout W.
AU - Wiegers, Eveline
AU - Sewalt, Charlie
AU - Buki, Andras
AU - Citerio, Giuseppe
AU - De Keyser, Véronique
AU - Ercole, Ari
AU - Kunzmann, Kevin
AU - Lanyon, Linda
AU - Lecky, Fiona
AU - Lingsma, Hester
AU - Manley, Geoffrey
AU - Nelson, David
AU - Peul, Wilco
AU - Stocchetti, Nino
AU - von Steinbüchel, Nicole
AU - Vande Vyvere, Thijs
AU - Verheyden, Jan
AU - Wilson, Lindsay
AU - Maas, Andrew I.R.
AU - Menon, David K.
AU - Ackerlund, Cecilia
AU - Amrein, Krisztina
AU - Andelic, Nada
AU - Andreassen, Lasse
AU - Anke, Audny
AU - Antoni, Anna
AU - Audibert, Gérard
AU - Auslands, Kaspars
AU - Azouvi, Philippe
AU - Azzolini, Maria Luisa
AU - Badenes, Rafael
AU - Bartels, Ronald
AU - Barzó, Pál
AU - Beauvais, Romuald
AU - Beer, Ronny
AU - Bellander, Bo Michael
AU - Belli, Antonio
AU - Benali, Habib
AU - Berardino, Maurizio
AU - Beretta, Luigi
AU - Blaabjerg, Morten
AU - Bragge, Peter
AU - Brazinova, Alexandra
AU - Brinck, Vibeke
AU - Brooker, Joanne
AU - Brorsson, Camilla
AU - Bullinger, Monika
AU - Cabeleira, Manuel
AU - Ylén, Peter
AU - CENTER-TBI participants and investigators
N1 - Funding Information:
CENTER-TBI was supported by the European Union 7th Framework programme (EC grant 602150 ). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA), and from Integra LifeSciences Corporation (USA). We gratefully acknowledge interactions and support from the InTBIR funders and investigators. We are grateful to our patients with TBI for helping us in our efforts to improve care and outcome for TBI.
Funding Information:
DKM reports grants from the UK National Institute for Health Research, during the conduct of the study; grants, personal fees, and non-financial support from GlaxoSmithKline; personal fees from Neurotrauma Sciences, Lantmaanen AB, Pressura, and Pfizer, outside of the submitted work. AIRM declares consulting fees from PresSura Neuro, Integra Life Sciences, and NeuroTrauma Sciences. GM reports grants from the US National Institute of Neurological Disorders and Stroke and the US Department of Defense, during the conduct of the study. WP reports grants from the Netherlands Brain Foundation. ES reports personal fees from Springer, during the conduct of the study. NvS reports grants from the European Union, during the conduct of the study. All other authors declare no competing interests.
Funding Information:
CENTER-TBI was supported by the European Union 7th Framework programme (EC grant 602150). Additional funding was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA), and from Integra LifeSciences Corporation (USA). We gratefully acknowledge interactions and support from the InTBIR funders and investigators. We are grateful to our patients with TBI for helping us in our efforts to improve care and outcome for TBI.
Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/10
Y1 - 2019/10
N2 - Background: The burden of traumatic brain injury (TBI) poses a large public health and societal problem, but the characteristics of patients and their care pathways in Europe are poorly understood. We aimed to characterise patient case-mix, care pathways, and outcomes of TBI. Methods: CENTER-TBI is a Europe-based, observational cohort study, consisting of a core study and a registry. Inclusion criteria for the core study were a clinical diagnosis of TBI, presentation fewer than 24 h after injury, and an indication for CT. Patients were differentiated by care pathway and assigned to the emergency room (ER) stratum (patients who were discharged from an emergency room), admission stratum (patients who were admitted to a hospital ward), or intensive care unit (ICU) stratum (patients who were admitted to the ICU). Neuroimages and biospecimens were stored in repositories and outcome was assessed at 6 months after injury. We used the IMPACT core model for estimating the expected mortality and proportion with unfavourable Glasgow Outcome Scale Extended (GOSE) outcomes in patients with moderate or severe TBI (Glasgow Coma Scale [GCS] score ≤12). The core study was registered with ClinicalTrials.gov, number NCT02210221, and with Resource Identification Portal (RRID: SCR_015582). Findings: Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study and from 22 782 patients in the registry. In the core study, 848 (19%) patients were in the ER stratum, 1523 (34%) in the admission stratum, and 2138 (47%) in the ICU stratum. In the ICU stratum, 720 (36%) patients had mild TBI (GCS score 13–15). Compared with the core cohort, the registry had a higher proportion of patients in the ER (9839 [43%]) and admission (8571 [38%]) strata, with more than 95% of patients classified as having mild TBI. Patients in the core study were older than those in previous studies (median age 50 years [IQR 30–66], 1254 [28%] aged >65 years), 462 (11%) had serious comorbidities, 772 (18%) were taking anticoagulant or antiplatelet medication, and alcohol was contributory in 1054 (25%) TBIs. MRI and blood biomarker measurement enhanced characterisation of injury severity and type. Substantial inter-country differences existed in care pathways and practice. Incomplete recovery at 6 months (GOSE <8) was found in 207 (30%) patients in the ER stratum, 665 (53%) in the admission stratum, and 1547 (84%) in the ICU stratum. Among patients with moderate-to-severe TBI in the ICU stratum, 623 (55%) patients had unfavourable outcome at 6 months (GOSE <5), similar to the proportion predicted by the IMPACT prognostic model (observed to expected ratio 1·06 [95% CI 0·97–1·14]), but mortality was lower than expected (0·70 [0·62–0·76]). Interpretation: Patients with TBI who presented to European centres in the core study were older than were those in previous observational studies and often had comorbidities. Overall, most patients presented with mild TBI. The incomplete recovery of many patients should motivate precision medicine research and the identification of best practices to improve these outcomes. Funding: European Union 7th Framework Programme, the Hannelore Kohl Stiftung, OneMind, and Integra LifeSciences Corporation.
AB - Background: The burden of traumatic brain injury (TBI) poses a large public health and societal problem, but the characteristics of patients and their care pathways in Europe are poorly understood. We aimed to characterise patient case-mix, care pathways, and outcomes of TBI. Methods: CENTER-TBI is a Europe-based, observational cohort study, consisting of a core study and a registry. Inclusion criteria for the core study were a clinical diagnosis of TBI, presentation fewer than 24 h after injury, and an indication for CT. Patients were differentiated by care pathway and assigned to the emergency room (ER) stratum (patients who were discharged from an emergency room), admission stratum (patients who were admitted to a hospital ward), or intensive care unit (ICU) stratum (patients who were admitted to the ICU). Neuroimages and biospecimens were stored in repositories and outcome was assessed at 6 months after injury. We used the IMPACT core model for estimating the expected mortality and proportion with unfavourable Glasgow Outcome Scale Extended (GOSE) outcomes in patients with moderate or severe TBI (Glasgow Coma Scale [GCS] score ≤12). The core study was registered with ClinicalTrials.gov, number NCT02210221, and with Resource Identification Portal (RRID: SCR_015582). Findings: Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, were analysed in the core study and from 22 782 patients in the registry. In the core study, 848 (19%) patients were in the ER stratum, 1523 (34%) in the admission stratum, and 2138 (47%) in the ICU stratum. In the ICU stratum, 720 (36%) patients had mild TBI (GCS score 13–15). Compared with the core cohort, the registry had a higher proportion of patients in the ER (9839 [43%]) and admission (8571 [38%]) strata, with more than 95% of patients classified as having mild TBI. Patients in the core study were older than those in previous studies (median age 50 years [IQR 30–66], 1254 [28%] aged >65 years), 462 (11%) had serious comorbidities, 772 (18%) were taking anticoagulant or antiplatelet medication, and alcohol was contributory in 1054 (25%) TBIs. MRI and blood biomarker measurement enhanced characterisation of injury severity and type. Substantial inter-country differences existed in care pathways and practice. Incomplete recovery at 6 months (GOSE <8) was found in 207 (30%) patients in the ER stratum, 665 (53%) in the admission stratum, and 1547 (84%) in the ICU stratum. Among patients with moderate-to-severe TBI in the ICU stratum, 623 (55%) patients had unfavourable outcome at 6 months (GOSE <5), similar to the proportion predicted by the IMPACT prognostic model (observed to expected ratio 1·06 [95% CI 0·97–1·14]), but mortality was lower than expected (0·70 [0·62–0·76]). Interpretation: Patients with TBI who presented to European centres in the core study were older than were those in previous observational studies and often had comorbidities. Overall, most patients presented with mild TBI. The incomplete recovery of many patients should motivate precision medicine research and the identification of best practices to improve these outcomes. Funding: European Union 7th Framework Programme, the Hannelore Kohl Stiftung, OneMind, and Integra LifeSciences Corporation.
KW - Adult
KW - Aged
KW - Brain Injuries, Traumatic/classification
KW - Cohort Studies
KW - Critical Care Outcomes
KW - Critical Pathways
KW - Diagnosis-Related Groups
KW - Europe
KW - Female
KW - Glasgow Coma Scale
KW - Glasgow Outcome Scale
KW - Humans
KW - Intensive Care Units
KW - Israel
KW - Longitudinal Studies
KW - Male
KW - Middle Aged
KW - Patient Admission
KW - Prognosis
KW - Prospective Studies
KW - Registries
UR - http://www.scopus.com/inward/record.url?scp=85071987996&partnerID=8YFLogxK
U2 - 10.1016/S1474-4422(19)30232-7
DO - 10.1016/S1474-4422(19)30232-7
M3 - Article
C2 - 31526754
AN - SCOPUS:85071987996
SN - 1474-4422
VL - 18
SP - 923
EP - 934
JO - The Lancet Neurology
JF - The Lancet Neurology
IS - 10
ER -