Title: NIHR Global Health Research Group on Global Surgical Technologies, University of Leeds
Funder: Department of Health and Social Care

Abstract: The University of Leeds (UoL) is a research-intensive university, voted University of the Year in 2016. The Faculty of Medicine and Health (FMH) has a research strategy that promotes excellence in Clinical Trials, Social Sciences, and Biomedical Technologies. It has a strong commitment to global health through the Nuffield Centre for International Health and Development, including an 11-year DfID-funded programme in Africa and Asia. Engineering in Leeds is a particular strength with the Faculty rated in the top 10 in the UK and top 100 in the world. The University’s partner NHS organisation is Leeds Teaching Hospitals NHS Trust (LTHT), the 2nd largest healthcare provider and 3rd largest Major Trauma Centre in the UK. Surgery in Leeds has an international reputation for excellence in research and NHS service provision. Surgical Technologies is a central tenant of research, supported by strong collaborations with engineering and formalized in the EPSRC Leeds Innovation in Surgical Technologies (LIST). Close collaborations with Leeds Clinical Trials and Research Unit (CTRU) and Applied Health Sciences bring expertise in clinical evaluation of surgical technologies. The strength of this collaboration is evidenced by a portfolio of NIHR trials: MRC/NIHR GLiSteN, HTA/NIHR SaFaRI, MRC/NIHR IntAct, and MRC/NIHR ROLARR trial - a pan-World randomised evaluation of robotic surgery for rectal cancer, and the award of Royal College of Surgeons of England Surgical Trials Centre in 2016. This is complemented by NIHR infrastructure - Leeds boasts both an NIHR Healthcare Technologies Co-operative (HTC) and an NIHR Diagnostic Evaluation Centre (DEC) – which brings national academic and industry engagement. Programme of research. We will focus on 2 LMICs, Sierra Leone and India, chosen because of the strength of existing connections and the pressing need to address surgical inequalities. India has a more developed healthcare system than Sierra Leone, but both countries face similar challenges, particularly in rural communities, from lack of resource, expertise and infrastructure. General Surgery, Emergency Surgery and Trauma Surgery are priority areas. Through an integrated research programme we will identify barriers to surgical care and unmet surgical needs, develop and implement technological solutions, and evaluate the benefits for wider adoption. Our research aligns to priority areas of the global health agenda, including: strengthening health systems and equitable access; harnessing knowledge, sciences and technology; strengthening governance, leadership, and accountability. It aligns with the Lancet Commission on Global Surgery to provide all people with access to safe, high quality surgical care, with financial protection. Research strategy WS1: Building networks. UK Lead: D. Jayne. We will work with LIMC leads to form strong links to local health networks, connecting local researchers, healthcare providers, and policy makers with UK collaborators. Our main partner in Sierra Leone will be CapaCare, a Norweign-based NGO that runs a surgical training programme. Other NGOs active in healthcare are Medicos Del Mundo, and Scotia Aid. Engineers without Borders (EWB) in Sierra Leone will prove useful allies for our engineers. Uni. Sierra Leone and Dept. Surgery, Connaught Hospital, Freetown (Dr TB Kamara, HoD), will provide access to local researchers. In India, our partner organisations will be the Lancet Commission Centre for Innovation Excellence at Karunya University, and PSG Institute of Medical Science and Research (Dr B Vinod). Our engineers have research collaborations and joint teaching/exchange programmes with PSG College of Technology and Kamaraguru College of Technology in Coimbatore – these local research institutions have a tele-medicine link through J Gnanaraj. We will establish robust lines of communication with both institutions and their networks. WS2: Defining unmet surgical needs and health system assessment. UK Lead: T. Ensor Members of the UK team will visit Sierra Leone and India between months 6 and 12 to establish contacts, conduct baseline assessments, and lay the foundations for implementation. Research will identify and prioritise unmet surgical needs using and adapting quantitative tools, such as the Surgeons OverSeas Assessment of Surgical Need (SOSAS) survey, which was piloted in Sierra Leone in 2012 by medical students using iPads. Barriers to a safe surgical supply chain will also be assessed. Issues unpacked in the survey will be elaborated through a qualitative exploration of barriers and enablers to accessing services, and opportunity costs (e.g. time away from family and caring responsibilities) with the aim of developing an understanding of household barriers to obtaining care. This will be combined with an assessment of health system readiness to provide a safe and effective environment for surgery, mapping of services in relation to population, and identification of system modifications required. WS3: Developing solutions to unmet surgical needs. WS UK Lead: P Valdastri. We will use the strengths of Leeds Innovation in Surgical Technologies (LIST) and our NIHR infrastructure (HTC and DEC) to work with LMIC innovators/institutions to develop or re-purpose innovations to unmet surgical needs. LMICs are fertile countries for “Jugaad Innovation” – frugal creativity to develop new solutions from limited resource. The UK team has a pipeline of such technologies: i) Virtual simulator for laparoscopic surgery: laparoscopic surgery has been adopted in some LMICs (e.g. Mongolia), reducing hospital stays and the need for follow-up. Our cheap, portable simulator will facilitate training and dissemination, ii) Ultra low cost endoscopy: an ultra low cost, portable, endoscopy has been developed for use in areas where endoscopy is not available, iii) Surgical training models: vascular training models are available to address the increasing demand for trauma services due to previous conflict or motor vehicle accidents, iv) Magnetic surgical instruments: have been developed to reduce incisions in laparoscopic surgery and minimise postoperative infections. Interventions will be developed in close consultation with local care providers and government officials to ensure strategic and regulatory appropriateness and sustainability within the local health system. WS4: Clinical evaluation and health economics to inform wider adoption. WS Lead J. Brown. We will appoint researchers in each country, embed them in our partner organisations, and equip them with the training and resources to undertake qualitative and clinical evaluation studies. We will evaluate surgical interventions developed in WS3, including safety, efficacy, and cost effectiveness. Using a staged approach, we will begin in central institutions (Freetown and Karunya) in Year 1 and roll out the programme to more rural areas in Years 2 & 3. Early health economic modelling will be integral to informing wider adoption, providing estimates of the potential to enhance the value of care for patients and identifying the priorities for further evidence development and efficient designs for future research. Process evaluation will be undertaken to understand intervention fidelity, unintended consequences, causal mechanisms and factors facilitating or impeding positive outcomes. Matched funding from UoL will be used to employ a social scientist in the UK. Trainee surgeons taking “Out of Programme Experience” and medical students undertaking “Elective Placements” will be used to increase UK and LMIC capacity, collaborating with existing UK programmes, such as NHS Education England "Global Health Exchange". WS 5: Advocacy programme & Impact. WS Leads: J Scott & G Toogood We will engage with global health and charitable organisations to increase awareness of health inequalities and promote our research. We will host an annual GHRG scientific meeting, rotating between the UK, Sierra Leone, and India, to share knowledge, widen participation, and celebrate successes. 6-month delivery targets: i) functioning GHRG office, Management Team, and Steering Committee. ii) research contracts with LMIC institutions and stakeholders. iii) web site and IT research and training platforms iv) Stakeholder launch meeting, including key researchers and representatives from NGOs, government agencies, and private health providers etc. Medium-term objectives (1-2 years): i) research strategy based on a clear understanding of the unmet surgical needs ii) development of new innovations to unmet needs iii) at least 2 projects initiated in each country ii) Advocacy Programme, including exchange programmes and engagement with global health organisations. Long-term objectives: (2-3 years): i) at least 2 projects completed in each country ii) tangible growth in UK and LMIC research capacity iii) dissemination of outputs through publications and conferences iv) strong Advocacy programme v) exerting impact through local government and charitable groups to influence healthcare policy. There will be a focus on capacity building and sustainability: i) attracting industry investment by promoting our work and the advantages of working in LMICs, ii) promoting wider engagement and ownership by local and UK organisations, iii) developing a “young innovators” global health platform to facilitate overseas placements and exchanges, iv) profiling our work on the global health stage, and v) securing charitable and governmental funding to develop and expand our programme. By the end of Year 3, we aim to be in a strong position to bid for a Global Health Research Unit.

Lay abstract: The Global Health Research Group in Surgical technologies (GHRG-ST) is developing projects to address unmet surgical needs in Arunachal Pradesh (North East India) and Sierra Leone. The objectives are to improve surgical care to these populations who live in remote areas where surgical provision is limited. Our projects involve a mix of surveys to identify areas of surgical need, engineering solutions to improve surgical care, evaluation of treatments – to include health economic evaluation – and engagement and advocacy activities to promote wider adoption and sustainability. In each country we will be conducting 3 projects: Sierra Leone: i) Connaught Hospital in Freetown is the main public referral centre for major trauma in Sierra Leone. We will study lower limb fractures, which are a healthcare problem due to the use of motorbikes and poor road safety conditions. We will introduce a special external fixation device, the Ilizarov frame, which allows patients to mobilise whilst fractures are healing and compare this to the current method of skin traction and bed rest for 6-8 weeks. External fixation should allow patients to go home sooner, and reduce complications from protracted bed-rest. Fracture healing should also be better, leading to improved functional outcomes. ii) Masanga Hospital is in a remote setting in Tonkolili District. We will focus on improving the quality of lower limb amputation – a common surgical procedure. We will develop a training package for surgical operatives, to include the most advanced teaching methods in the UK – artificial reality using immersive technologies. These technologies are now affordable in LMICs and are ideally suited to long distance training. iii) We will study the cause of chronic lower limb ulcers at Masanga hospital to determine the various causes with the aim of implementing better diagnostics and diseases-specific care – we suspect that a large number of these ulcers are due to Buruli disease, which is a non-recognised entity in Sierra Leone. North East India: Our projects in NE India will be undertaken in Arunachal Pradesh, one of the most remote areas in India with the greatest surgical need. i) We will investigate gasless laparoscopy to improve surgical care across a range of conditions –will focus on female sterilisation where gasless laparoscopy can reduce the complications associated with traditional “min-lap” techniques. Gasless laparoscopy is suited to LMIC settings as it can be performed under spinal surgery, without the need for an anaesthetist. We will provide training in the technique with our country PI, Dr Gnanaraj, and the Dept. of Surgery, Uni. Calcutta. We will study the barriers to implementation, the learning curve, surgical outcomes, and cost effectiveness. ii) We will study “Diagnostic Camps” as a means of providing mobile diagnostic capability to remote primary care settings. We will investigate the impact of portable ultrasound in the Diagnostic Camps, and its influence on surgical referral practice. iii) In Itanager, the capital of Arunachal Pradesh, we have established collaborations with a new medical college that opened in August 2018 with an intake of 50 – 100 students. This provides us with a unique opportunity to share UK surgical teaching practices with the students and ultimately shape surgical practice in the longer term, providing an efficient and sustainable means for improving access to good surgical care.

Research activity codes: 6.9 RESOURCES AND INFRASTRUCTURE (TREATMENT EVALUATION);7.4 RESOURCES AND INFRASTRUCTURE (DISEASE MANAGEMENT)
Health categories: GENERIC HEALTH RELEVANCE