Neurosurgeons’ experiences of conducting and disseminating clinical research in low- and middle-income countries: a qualitative study protocol

Low-income and middle-income countries (LMICs) face the greatest burden of neurotrauma. However, most of the research published in scientific journals originates from high-income countries, suggesting those in LMICs are either not engaging in research or are not publishing it. Evidence originating in high-income countries may not be generalisable to LMICs; therefore, it is important to nurture research capacity in LMICs so that a relevant evidence base can be developed. However, little is published about specific challenges or contextual issues relevant to increasing research activity of neurosurgeons in LMICs. Therefore, the aim of this study was to understand neurosurgeons’ experiences of, aspirations for and ability to conduct and disseminate clinical research in LMICs.Methods and analysisThis is a pragmatic qualitative study situated within the naturalistic paradigm using focus groups and interviews with a purposive sample of neurosurgeons from LMICs. First, we will conduct asynchronous online focus groups with 36 neurosurgeons to broadly explore issues relevant to the study aim. Second, we will select 20 participants for follow-up semistructured interviews to explore concepts in more depth and detail than could be achieved in the focus group. Interviews will be audio-recorded and transcribed verbatim. A thematic analysis will be conducted following Braun and Clarke’s six stages and will be supported by NVIVO software.Ethics and disseminationThe University of Cambridge Psychology Research Ethics Committee reviewed this study and provided a favourable opinion in January 2020 (REF PRE.2020.006). Participants will provide informed consent, be able to withdraw at any time and will have their contributions kept confidential. The findings of the study will be shared with relevant stakeholders and disseminated in conference presentations and journal publications.</jats:sec

Task-Shifting and Task-Sharing in Neurosurgery: An International Survey of Current Practices in Low- and Middle-Income Countries.

BACKGROUND: Because nearly 23,000 more neurosurgeons are needed globally to address 5 million essential neurosurgical cases that go untreated each year, there is an increasing interest in task-shifting and task-sharing (TS/S), delegating neurosurgical tasks to nonspecialists, particularly in low- and middle-income countries (LMICs). This global survey aimed to provide a cross-sectional understanding of the prevalence and structure of current neurosurgical TS/S practices in LMICs. METHODS: The survey was distributed to a convenience sample of individuals providing neurosurgical care in LMICs with a Web-based survey link via electronic mailing lists of continental societies and various neurosurgical groups, conference announcements, e-mailing lists, and social media platforms. Country-level data were analyzed by descriptive statistics. RESULTS: The survey yielded 127 responses from 47 LMICs; 20 countries (42.6%) reported ongoing TS/S. Most TS/S procedures involved emergency interventions, the top 3 being burr holes, craniotomy for hematoma evacuation, and external ventricular drain. Most (65.0%) believed that their Ministry of Health does not endorse TS/S (24.0% unsure), and only 11% believed that TS/S training was structured. There were few opportunities for TS/S providers to continue medical education (11.6%) or maintenance of certification (9.4%, or receive remuneration (4.2%). CONCLUSIONS: TS/S is ongoing in many LMICs without substantial structure or oversight, which is concerning for patient safety. These data invite future clinical outcomes studies to assess effectiveness and discussions on policy recommendations such as standardized curricula, certification protocols, specialist oversight, and referral networks to increase the level of TS/S care and to continue to increase the specialist workforce

Requirements and Recommendations for IoT/IIoT Models to automate Security Assurance through Threat Modelling, Security Analysis and Penetration Testing

The factories of the future require efficient interconnection of their physical machines into the cyber space to cope with the emerging need of an increased uptime of machines, higher performance rates, an improved level of productivity and a collective collaboration along the supply chain. With the rapid growth of the Internet of Things (IoT), and its application in industrial areas, the so called Industrial Internet of Things (IIoT)/Industry 4.0 emerged. However, further to the rapid growth of IoT/IIoT systems, cyber attacks are an emerging threat and simple manual security testing can often not cope with the scale of large IoT/IIoT networks. In this paper, we suggest to extract metadata from commonly used diagrams and models in a typical software development process, to automate the process of threat modelling, security analysis and penetration testing, without detailed prior security knowledge. In that context, we present requirements and recommendations for metadata in IoT/IIoT models that are needed as necessary input parameters of security assurance tools.Comment: 8 pages, Proceedings of the 14th International Conference on Availability, Reliability and Security (ARES 2019) (ARES '19), August 26-29, 2019, Canterbury, United Kingdo

International Neurotrauma Training Based on North-South Collaborations: Results of an Inter-institutional Program in the Era of Global Neurosurgery.

Objective: Shortage of general neurosurgery and specialized neurotrauma care in low resource settings is a critical setback in the national surgical plans of low and middle-income countries (LMIC). Neurotrauma fellowship programs typically exist in high-income countries (HIC), where surgeons who fulfill the requirements for positions regularly stay to practice. Due to this issue, neurosurgery residents and medical students from LMICs do not have regular access to this kind of specialized training and knowledge-hubs. The objective of this paper is to present the results of a recently established neurotrauma fellowship program for neurosurgeons of LMICs in the framework of global neurosurgery collaborations, including the involvement of specialized parallel education for neurosurgery residents and medical students. Methods: The Global Neurotrauma Fellowship (GNTF) program was inaugurated in 2015 by a multi-institutional collaboration between a HIC and an LMIC. The course organizers designed it to be a 12-month program based on adapted neurotrauma international competencies with the academic support of the Barrow Neurological Institute at Phoenix Children's Hospital and Meditech Foundation in Colombia. Since 2018, additional support from the UK, National Institute of Health Research (NIHR) Global Health Research in Neurotrauma Project from the University of Cambridge enhanced the infrastructure of the program, adding a research component in global neurosurgery and system science. Results: Eight fellows from Brazil, Venezuela, Cuba, Pakistan, and Colombia have been trained and certified via the fellowship program. The integration of international competencies and exposure to different systems of care in high-income and low-income environments creates a unique environment for training within a global neurosurgery framework. Additionally, 18 residents (Venezuela, Colombia, Ecuador, Peru, Cuba, Germany, Spain, and the USA), and ten medical students (the United Kingdom, USA, Australia, and Colombia) have also participated in elective rotations of neurotrauma and critical care during the time of the fellowship program, as well as in research projects as part of an established global surgery initiative. Conclusion: We have shown that it is possible to establish a neurotrauma fellowship program in an LMIC based on the structure of HIC formal training programs. Adaptation of the international competencies focusing on neurotrauma care in low resource settings and maintaining international mentoring and academic support will allow the participants to return to practice in their home-based countries

Consensus-based recommendations for diagnosis and surgical management of cranioplasty and post-traumatic hydrocephalus from a European panel

Introduction: Planning cranioplasty (CPL) in patients with suspected or proven post-traumatic hydrocephalus (PTH) poses a significant management challenge due to a lack of clear guidance. Research question: This project aims to create a European document to improve adherence and adapt to local protocols based on available resources and national health systems. Methods: After a thorough non-systematic review, a steering committee (SC) formed a European expert panel (EP) for a two-round questionnaire using the Delphi method. The questionnaire employed a 9-point Likert scale to assess the appropriateness of statements inherent to two sections: “Diagnostic criteria for PTH” and “Surgical strategies for PTH and cranial reconstruction.” Results: The panel reached a consensus on 29 statements. In the “Diagnostic criteria for PTH” section, five statements were deemed “appropriate” (consensus 74.2−90.3 %), two were labeled “inappropriate,” and seven were marked as “uncertain.” In the “Surgical strategies for PTH and cranial reconstruction” section, four statements were considered “appropriate” (consensus 74.2−90.4 %), six were “inappropriate,” and five were “uncertain.” Discussion and conclusion: Planning a cranioplasty alongside hydrocephalus remains a significant challenge in neurosurgery. Our consensus conference suggests that, in patients with cranial decompression and suspected hydrocephalus, the most suitable diagnostic approach involves a combination of evolving clinical conditions and neuroradiological imaging. The recommended management sequence prioritizes cranial reconstruction, with the option of a ventriculoperitoneal shunt when needed, preferably with a programmable valve. We strongly recommend to adopt local protocols based on expert consensus, such as this, to guide patient care

Informing efficient randomised controlled trials: Exploration of challenges in developing progression criteria for internal pilot studies

Objectives: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. Design: A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. Results: There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decisionmaking process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. Conclusions: Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials

Neurosurgeons' experiences of conducting and disseminating clinical research in low-income and middle-income countries: a reflexive thematic analysis.

OBJECTIVES: 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. DESIGN: 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. PARTICIPANTS: 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). RESULTS: 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. CONCLUSION: 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

Management and outcomes following emergency surgery for traumatic brain injury - A multi-centre, international, prospective cohort study (the Global Neurotrauma Outcomes Study).

Introduction:Traumatic brain injury (TBI) accounts for a significant amount of death and disability worldwide and the majority of this burden affects individuals in low-and-middle income countries. Despite this, considerable geographical differences have been reported in the care of TBI patients. On this background, we aim to provide a comprehensive international picture of the epidemiological characteristics, management and outcomes of patients undergoing emergency surgery for traumatic brain injury (TBI) worldwide. Methods and analysis:The Global Neurotrauma Outcomes Study (GNOS) is a multi-centre, international, prospective observational cohort study. Any unit performing emergency surgery for TBI worldwide will be eligible to participate. All TBI patients who receive emergency surgery in any given consecutive 30-day period beginning between 1st of November 2018 and 31st of December 2019 in a given participating unit will be included. Data will be collected via a secure online platform in anonymised form. The primary outcome measures for the study will be 14-day mortality (or survival to hospital discharge, whichever comes first). Final day of data collection for the primary outcome measure is February 13th. Secondary outcome measures include return to theatre and surgical site infection. Ethics and dissemination:This project will not affect clinical practice and has been classified as clinical audit following research ethics review. Access to source data will be made available to collaborators through national or international anonymised datasets on request and after review of the scientific validity of the proposed analysis by the central study team

Trial of Dexamethasone for Chronic Subdural Hematoma

BACKGROUND: Chronic subdural hematoma is a common neurologic disorder that is especially prevalent among older people. The effect of dexamethasone on outcomes in patients with chronic subdural hematoma has not been well studied. METHODS: We conducted a multicenter, randomized trial in the United Kingdom that enrolled adult patients with symptomatic chronic subdural hematoma. The patients were assigned in a 1:1 ratio to receive a 2-week tapering course of oral dexamethasone, starting at 8 mg twice daily, or placebo. The decision to surgically evacuate the hematoma was made by the treating clinician. The primary outcome was a score of 0 to 3, representing a favorable outcome, on the modified Rankin scale at 6 months after randomization; scores range from 0 (no symptoms) to 6 (death). RESULTS: From August 2015 through November 2019, a total of 748 patients were included in the trial after randomization - 375 were assigned to the dexamethasone group and 373 to the placebo group. The mean age of the patients was 74 years, and 94% underwent surgery to evacuate their hematomas during the index admission; 60% in both groups had a score of 1 to 3 on the modified Rankin scale at admission. In a modified intention-to-treat analysis that excluded the patients who withdrew consent for participation in the trial or who were lost to follow-up, leaving a total of 680 patients, a favorable outcome was reported in 286 of 341 patients (83.9%) in the dexamethasone group and in 306 of 339 patients (90.3%) in the placebo group (difference, -6.4 percentage points [95% confidence interval, -11.4 to -1.4] in favor of the placebo group; P = 0.01). Among the patients with available data, repeat surgery for recurrence of the hematoma was performed in 6 of 349 patients (1.7%) in the dexamethasone group and in 25 of 350 patients (7.1%) in the placebo group. More adverse events occurred in the dexamethasone group than in the placebo group. CONCLUSIONS: Among adults with symptomatic chronic subdural hematoma, most of whom had undergone surgery to remove their hematomas during the index admission, treatment with dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo at 6 months, but fewer repeat operations were performed in the dexamethasone group. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Dex-CSDH ISRCTN number, ISRCTN80782810.)