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- Timmers, Marjolein, et al.
(författare)
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How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? : Experiences from the CENTER-TBI study
- 2020
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Ingår i: BMC Medical Ethics. - : BioMed Central (BMC). - 1472-6939 .- 1472-6939. ; 21:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: 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.
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- van Veen, Ernest, et al.
(författare)
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Brain death and postmortem organ donation : report of a questionnaire from the CENTER-TBI study.
- 2018
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Ingår i: Critical Care. - : Springer Science and Business Media LLC. - 1364-8535 .- 1466-609X. ; 22:1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: We aimed to investigate the extent of the agreement on practices around brain death and postmortem organ donation.METHODS: Investigators from 67 Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study centers completed several questionnaires (response rate: 99%).RESULTS: Regarding practices around brain death, we found agreement on the clinical evaluation (prerequisites and neurological assessment) for brain death determination (BDD) in 100% of the centers. However, ancillary tests were required for BDD in 64% of the centers. BDD for nondonor patients was deemed mandatory in 18% of the centers before withdrawing life-sustaining measures (LSM). Also, practices around postmortem organ donation varied. Organ donation after circulatory arrest was forbidden in 45% of the centers. When withdrawal of LSM was contemplated, in 67% of centers the patients with a ventricular drain in situ had this removed, either sometimes or all of the time.CONCLUSIONS: This study showed both agreement and some regional differences regarding practices around brain death and postmortem organ donation. We hope our results help quantify and understand potential differences, and provide impetus for current dialogs toward further harmonization of practices around brain death and postmortem organ donation.
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- Van den Bulcke, Bo, et al.
(författare)
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Ethical climate and intention to leave among critical care clinicians: an observational study in 68 intensive care units across Europe and the United States.
- 2020
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Ingår i: Intensive care medicine. - 1432-1238. ; 46:1, s. 46-56
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Tidskriftsartikel (refereegranskat)abstract
- Apart from organizational issues, quality of inter-professional collaboration during ethical decision-making may affect the intention to leave one's job. To determine whether ethical climate is associated with the intention to leave after adjustment for country, ICU and clinicians characteristics.Perceptions of the ethical climate among clinicians working in 68 adult ICUs in 12 European countries and the US were measured using a self-assessment questionnaire, together with job characteristics and intent to leave as a sub-analysis of the Dispropricus study. The validated ethical decision-making climate questionnaire included seven factors: not avoiding decision-making at end-of-life (EOL), mutual respect within the interdisciplinary team, open interdisciplinary reflection, ethical awareness, self-reflective physician leadership, active decision-making at end-of-life by physicians, and involvement of nurses in EOL. Hierarchical mixed effect models were used to assess associations between these factors, and the intent to leave in clinicians within ICUs, within the different countries.Of 3610 nurses and 1137 physicians providing ICU bedside care, 63.1% and 62.9% participated, respectively. Of 2992 participating clinicians, 782 (26.1%) had intent to leave, of which 27% nurses, 24% junior and 22.7% senior physicians. After adjustment for country, ICU and clinicians characteristics, mutual respect OR 0.77 (95% CI 0.66- 0.90), open interdisciplinary reflection (OR 0.73 [95% CI 0.62-0.86]) and not avoiding EOL decisions (OR 0.87 [95% CI 0.77-0.98]) were all associated with a lower intent to leave.This is the first large multicenter study showing an independent association between clinicians' intent to leave and the quality of the ethical climate in the ICU. Interventions to reduce intent to leave may be most effective when they focus on improving mutual respect, interdisciplinary reflection and active decision-making at EOL.
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| 5. |
- van Veen, Ernest, et al.
(författare)
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End-of-life practices in traumatic brain injury patients : Report of a questionnaire from the CENTER-TBI study
- 2020
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Ingår i: Journal of critical care. - : Elsevier. - 0883-9441 .- 1557-8615. ; 58, s. 78-88
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: We aimed to study variation regarding specific end-of-life (EoL) practices in the intensive care unit (ICU) in traumatic brain injury (TBI) patients.Materials and methods: Respondents from 67 hospitals participating in The Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study completed several questionnaires on management of TBI patients.Results: In 60% of the centers, ≤50% of all patients with severe neurological damage dying in the ICU, die after withdrawal of life-sustaining measures (LSM). The decision to withhold/withdraw LSM was made following multidisciplinary consensus in every center. Legal representatives/relatives played a role in the decision-making process in 81% of the centers. In 82% of the centers, age played a role in the decision to withhold/withdraw LSM. Furthermore, palliative therapy was initiated in 79% of the centers after the decision to withdraw LSM was made. Last, withholding/withdrawing LSM was, generally, more often considered after more time had passed, in a patient with TBI, who remained in a very poor prognostic condition.Conclusion: We found variation regarding EoL practices in TBI patients. These results provide insight into variability regarding important issues pertaining to EoL practices in TBI, which can be useful to stimulate discussions on EoL practices, comparative effectiveness research, and, ultimately, development of recommendations.
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| 6. |
- van Veen, Ernest, et al.
(författare)
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Occurrence and timing of withdrawal of life-sustaining measures in traumatic brain injury patients : a CENTER-TBI study
- 2021
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Ingår i: Intensive Care Medicine. - : Springer Science+Business Media B.V.. - 0342-4642 .- 1432-1238. ; 47:10, s. 1115-1129
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In patients with severe brain injury, withdrawal of life-sustaining measures (WLSM) is common in intensive care units (ICU). WLSM constitutes a dilemma: instituting WLSM too early could result in death despite the possibility of an acceptable functional outcome, whereas delaying WLSM could unnecessarily burden patients, families, clinicians, and hospital resources. We aimed to describe the occurrence and timing of WLSM, and factors associated with timing of WLSM in European ICUs in patients with traumatic brain injury (TBI).METHODS: The CENTER-TBI Study is a prospective multi-center cohort study. For the current study, patients with traumatic brain injury (TBI) admitted to the ICU and aged 16 or older were included. Occurrence and timing of WLSM were documented. For the analyses, we dichotomized timing of WLSM in early (< 72 h after injury) versus later (≥ 72 h after injury) based on recent guideline recommendations. We assessed factors associated with initiating WLSM early versus later, including geographic region, center, patient, injury, and treatment characteristics with univariable and multivariable (mixed effects) logistic regression.RESULTS: A total of 2022 patients aged 16 or older were admitted to the ICU. ICU mortality was 13% (n = 267). Of these, 229 (86%) patients died after WLSM, and were included in the analyses. The occurrence of WLSM varied between regions ranging from 0% in Eastern Europe to 96% in Northern Europe. In 51% of the patients, WLSM was early. Patients in the early WLSM group had a lower maximum therapy intensity level (TIL) score than patients in the later WLSM group (median of 5 versus 10) The strongest independent variables associated with early WLSM were one unreactive pupil (odds ratio (OR) 4.0, 95% confidence interval (CI) 1.3-12.4) or two unreactive pupils (OR 5.8, CI 2.6-13.1) compared to two reactive pupils, and an Injury Severity Score (ISS) if over 41 (OR per point above 41 = 1.1, CI 1.0-1.1). Timing of WLSM was not significantly associated with region or center.CONCLUSION: WLSM occurs early in half of the patients, mostly in patients with severe TBI affecting brainstem reflexes who were severely injured. We found no regional or center influences in timing of WLSM. Whether WLSM is always appropriate or may contribute to a self-fulfilling prophecy requires further research and argues for reluctance to institute WLSM early in case of any doubt on prognosis.
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