Background: The rapidly increasing number of elderly (>= 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with... Show moreBackground: The rapidly increasing number of elderly (>= 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDHMethods: In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients >= 65 years with at first presentation a GCS >= 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and a midline shift > 5 mm, or a GCS < 9 with a traumatic ASDH < 10 mm and a midline shift < 5 mm without extracranial explanation for the comatose state, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024.Discussion: The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered. Show less
Mostert, C.Q.B.; Singh, R.D.; Gerritsen, M.; Kompanje, E.J.O.; Ribbers, G.M.; Peul, W.C.; Dijck, J.T.J.M. van 2022
Background: Expectation of long-term outcome is an important factor in treatment decision-making after severe traumatic brain injury (sTBI). Conclusive long-term outcome data substantiating these... Show moreBackground: Expectation of long-term outcome is an important factor in treatment decision-making after severe traumatic brain injury (sTBI). Conclusive long-term outcome data substantiating these decisions is nowadays lacking. This systematic review aimed to provide an overview of the scientific literature on long-term outcome after sTBI. Methods: A systematic search was conducted using PubMed from 2008 to 2020. Studies were included when reporting long-term outcome >= 2 years after sTBI (GCS 3-8 or AIS head score >= 4), using standardized outcome measures. Study quality and risk of bias were assessed using the QUIPS tool. Results: Twenty observational studies were included. Studies showed substantial variation in study objectives and study methodology. GOS-E (n = 12) and GOS (n = 8) were the most frequently used outcome measures. Mortality was reported in 46% of patients (range 18-75%). Unfavourable outcome rates ranged from 29 to 100% and full recovery was seen in 21-27% of patients. Most surviving patients reported SF-36 scores lower than the general population. Conclusion: Literature on long-term outcome after sTBI was limited and heterogeneous. Mortality and unfavourable outcome rates were high and persisting sequelae on multiple domains common. Nonetheless, a considerable proportion of survivors achieved favourable outcome. Future studies should incorporate standardized multidimensional and temporal long-term outcome measures to strengthen the evidence-base for acute and subacute decision-making. Show less
Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study.... Show moreHealth-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent. Show less
Wijk, R.P.J. van; Dijck, J.T.J.M. van; Timmers, M.; Veen, E. van; Citerio, G.; Lingsma, H.F.; ... ; CENTER-TB1 Investigators 2020
Purpose: Enrolling traumatic brain injury (731) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in... Show morePurpose: Enrolling traumatic brain injury (731) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice.Methods: Variation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries.Results: Variation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N 426;20%) and deferred consent (N 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%).Conclusions: Alternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers. (C) 2020 Published by Elsevier Inc. Show less
AbstractBackground: The high occurrence and acute and chronic sequelae of traumatic brain injury (TBI) cause major healthcare and socioeconomic challenges. This study aimed to describe outcome, in... Show moreAbstractBackground: The high occurrence and acute and chronic sequelae of traumatic brain injury (TBI) cause major healthcare and socioeconomic challenges. This study aimed to describe outcome, in-hospital healthcare consumption and in-hospital costs of patients with TBI.Methods: We used data from hospitalised TBI patients that were included in the prospective observational CENTER-TBI study in three Dutch Level I Trauma Centres from 2015 to 2017. Clinical data was completed with data on in-hospital healthcare consumption and costs. TBI severity was classified using the Glasgow Coma Score (GCS). Patient outcome was measured by in-hospital mortality and Glasgow Outcome Score-Extended (GOSE) at 6 months. In-hospital costs were calculated following the Dutch guidelines for cost calculation.Results: A total of 486 TBI patients were included. Mean age was 56.1 ± 22.4 years and mean GCS was 12.7 ± 3.8. Six-month mortality (4.2%-66.7%), unfavourable outcome (GOSE ≤ 4) (14.6%-80.4%) and full recovery (GOSE = 8) (32.5%-5.9%) rates varied from patients with mild TBI (GCS13-15) to very severe TBI (GCS3-5). Length of stay (8 ± 13 days) and in-hospital costs (€11,920) were substantial and increased with higher TBI severity, presence of intracranial abnormalities, extracranial injury and surgical intervention. Costs were primarily driven by admission (66%) and surgery (13%).Conclusion: In-hospital mortality and unfavourable outcome rates were rather high, but many patients also achieved full recovery. Hospitalised TBI patients show substantial in-hospital healthcare consumption and costs, even in patients with mild TBI. Because these costs are likely to be an underestimation of the actual total costs, more research is required to investigate the actual costs-effectiveness of TBI care.Keywords: Functional outcome; In-hospital costs; Mortality; Traumatic brain injury. Show less
AbstractBackground: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further... Show moreAbstractBackground: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency.Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe.Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074).Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.Keywords: CENTER-TBI; European Union; Harmonization; Health-care research; Research ethic committees. Show less
Purpose of reviewThere is an urgent need to discuss the uncertainties and paradoxes in clinical decision-making after severe traumatic brain injury (s-TBI). This could improve transparency, reduce... Show morePurpose of reviewThere is an urgent need to discuss the uncertainties and paradoxes in clinical decision-making after severe traumatic brain injury (s-TBI). This could improve transparency, reduce variability of practice and enhance shared decision-making with proxies.Recent findingsClinical decision-making on initiation, continuation and discontinuation of medical treatment may encompass substantial consequences as well as lead to presumed patient benefits. Such decisions, unfortunately, often lack transparency and may be controversial in nature. The very process of decision- making is frequently characterized by both a lack of objective criteria and the absence of validated prognostic models that could predict relevant outcome measures, such as long-term quality and satisfaction with life. In practice, while treatment-limiting decisions are often made in patients during the acute phase immediately after s-TBI, other such severely injured TBI patients have been managed with continued aggressive medical care, and surgical or other procedural interventions have been undertaken in the context of pursuing a more favorable patient outcome. Given this spectrum of care offered to identical patient cohorts, there is clearly a need to identify and decrease existing selectivity, and better ascertain the objective criteria helpful towards more consistent decision-making and thereby reduce the impact of subjective valuations of predicted patient outcome.SummaryRecent efforts by multiple medical groups have contributed to reduce uncertainty and to improve care and outcome along the entire chain of care. Although an unlimited endeavor for sustaining life seems unrealistic, treatment-limiting decisions should not deprive patients of a chance on achieving an outcome they would have considered acceptable. Show less
Veen, E. van; Jagt, M. van der; Cnossen, M.C.; Maas, A.I.R.; Beaufort, I.D. de; Menon, D.K.; ... ; CENTER-TBI Investigators 2018
