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Seasides of Byzantium: harbours and anchorages of a mediterranean empire
In: Byzanz zwischen Orient und Okzident 21
In: Interdisziplinäre Forschungen zu den Häfen von der Römischen Kaiserzeit bis zum Mittelalter in Europa Band 9
An exploratory qualitative study of the prevention of road traffic collisions and neurotrauma in India: perspectives from key informants in an Indian industrial city (Visakhapatnam)
BACKGROUND: Despite current preventative strategies, road traffic collisions (RTCs) and resultant neurotrauma remain a major problem in India. This study seeks to explore local perspectives in the context within which RTCs take place and identify potential suggestions for improving the current status. METHODS: Ten semi-structured interviews were carried out with purposively selected key informants from the city of Visakhapatnam, Andhra Pradesh. Participants were from one of the following categories: commissioning stakeholders; service providers; community or local patient group/advocacy group representatives. Transcripts from these interviews were analysed qualitatively using the Framework Method. RESULTS: Participants felt RTCs are a serious problem in India and a leading cause of neurotrauma. Major risk factors identified related to user behaviour such as speeding and not using personal safety equipment, and the user state, namely drink driving and underage driving. Other reported risk factors included poor infrastructure, moving obstacles on the road such as other vehicles, pedestrians and animals, overloaded vehicles and substandard safety equipment. Participants discussed how RTCs affect not only the health of the casualty, but are also a burden to the healthcare system, families, and the national economy. Although there are ongoing preventative strategies being carried out by both the government and the community, challenges to successful prevention emerged from the interviews which included resource deficiencies, inconsistent implementation, lack of appropriate action, poor governance, lack of knowledge and the mindset of the community and entities involved in prevention. Recommendations were given on how prevention of RTCs and neurotrauma might be improved, addressing the areas of education and awareness, research, the pre-hospital and trauma systems, enforcement and legislation, and road engineering, in addition to building collaborations and changing mindsets. CONCLUSIONS: RTCs remain a major problem ...
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Neurosurgeons' experiences of conducting and disseminating clinical research in low-income and middle-income countries: a reflexive thematic analysis
Low-income and-middle-income countries (LMICs) are increasing investment in research and development, yet there remains a paucity of neurotrauma research published by those in LMICs. The aim of this study was to understand neurosurgeons' experiences of, aspirations for, and ability to conduct and disseminate clinical research in LMICs. This was a two-stage inductive qualitative study situated within the naturalistic paradigm. This study committed to an interpretivist way of knowing (epistemology), and considered reality subjective and multiple (ontology). Data collection used online methods and included a web-based survey tool for demographic data, an asynchronous online focus group and follow-up semistructured interviews. Data were analysed using Braun and Clarke's Reflexive Thematic Analysis supported by NVivo V.12. Setting LMICs. In April–July 2020, 26 neurosurgeons from 11 LMICs participated in this study (n=24 in the focus groups, n=20 in follow-up interviews). The analysis gave rise to five themes: The local landscape; creating capacity; reach and impact; collaborative inquiry; growth and sustainability. Each theme contained an inhibitor and stimulus to neurosurgeons conducting and disseminating clinical research, interpreted as 'the neurosurgical research potential in LMICs'. Mentorship, education, infrastructure, impact and engagement were identified as specific accelerators. Whereas lack of generalisability, absence of dissemination and dissemination without peer review may desensitise the impact of research conducted by neurosurgeons. The geographical, political and population complexities make research endeavour challenging for neurosurgeons in LMICs. Yet in spite of, and because of, these complexities LMICs provide rich opportunities to advance global neurosurgery. More studies are required to evaluate the specific effects of accelerators of research conducted by neurosurgeons and to understand the effects of desensitisers on high-quality, high-impact clinical research. ; National Institute for Health Research
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Neurotrauma clinicians' perspectives on the contextual challenges associated with long-term follow-up following traumatic brain injury in low-income and middle-income countries: a qualitative study protocol
Traumatic brain injury (TBI) is a global public health concern; however, low/middle-income countries (LMICs) face the greatest burden. The WHO recognises the significant differences between patient outcomes following injuries in high-income countries versus those in LMICs. Outcome data are not reliably recorded in LMICs and despite improved injury surveillance data, data on disability and long-term functional outcomes remain poorly recorded. Therefore, the full picture of outcome post-TBI in LMICs is largely unknown. This is a cross-sectional pragmatic qualitative study using individual semistructured interviews with clinicians who have experience of neurotrauma in LMICs. The aim of this study is to understand the contextual challenges associated with long-term follow-up of patients following TBI in LMICs. For the purpose of the study, we define 'long-term' as any data collected following discharge from hospital. We aim to conduct individual semistructured interviews with 24–48 neurosurgeons, beginning February 2020. Interviews will be recorded and transcribed verbatim. A reflexive thematic analysis will be conducted supported by NVivo software. The University of Cambridge Psychology Research Ethics Committee approved this study in February 2020. Ethical issues within this study include consent, confidentiality and anonymity, and data protection. Participants will provide informed consent and their contributions will be kept confidential. Participants will be free to withdraw at any time without penalty; however, their interview data can only be withdrawn up to 1 week after data collection. Findings generated from the study will be shared with relevant stakeholders such as the World Federation of Neurosurgical Societies and disseminated in conference presentations and journal publications. ; This research was supported by the National Institute for Health Research (NIHR) Global Health Research Group on Neurotrauma (grant number 16/137/105) using UK aid from the UK government.
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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
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. ; Peer reviewed
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Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study
Purpose: Enrolling traumatic brain injury (TBI) 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. ; Peer reviewed
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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
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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