Title: Learning to transform prioritisation into practice changing clinical research to deliver international surgical trials
Funder: Department of Health and Social Care

Abstract: Aims Fellowship aim: Train to become an expert in the design and delivery of high quality international randomised controlled trials. Primary research aim: To test whether separate, sterile gloves and instruments to close wounds at the end of abdominal surgery can reduce surgical site infections. Background Many clinical problems for patients needing surgery in lower income countries are common to those in higher income settings, including the NHS, meaning that expert researchers for international trials need to be trained. The recently funded NIHR Global Health Research Unit on Global Surgery is the learning platform for this Fellowship. Primary clinical problem addressed Surgical Site Infection (SSI) is a major yet modifiable problem for patients worldwide, including patients within the NHS. It is the most common postoperative complication and the third most common nosocomial infection, affecting both adults and children. MethodsWorkstream 1: CHEETAH pilot cluster randomised controlled trial CHEETAH will test whether separate, sterile gloves and instruments to close wounds at the end of contaminated abdominal surgery can reduce surgical site infection. The pilot will randomise 10 international centres (7 low/middle income, 3 NHS) and recruit 910 patients. The primary aim is to assess the feasibility of undertaking a full phase III study, and to adjust the sample size/recruitment rate ahead of an external funding application. Workstream 2: Making future trials more efficient through Studies Within A Trial (SWATs)Using the already funded factorial FALCON trial (testing triclosan coated sutures and alcoholic chlorehexidine skin preparation to reduce surgical site infections), SWAT-I will identify methods to maximise follow-up after surgery in diverse settings. SWAT-II will test whether assessment point of discharge or telephone assessment can act as surrogate markers for in-person follow-up. Workstream 3: Future prioritisation I will optimise annual, international Delphi Cycles including stakeholders and patients, ensuring patient relevant research questions are developed to drive sustainability. Workstream 4: Using education to make the wider network sustainable Learning from experts, I will develop online open access toolkits for international Patient and Public Involvement, trainee led research collaboratives, recruitment to trials courses (GRANULE), and a light surgery-specific adaptation of the NIHR's Good Clinical Practice. Workstream 5: Transition to Leadership Under mentorship, I will use FALCON/CHEETAH RCTs, the prioritisation Workshops, and pilot projects to develop leadership skillsets to engage funders, industry, and the public. Patient and Public InvolvementPatients are the primary recipients of benefits from this Fellowship. I am already collaborating with patient representatives and have a plan to embed PPI within prioritisation and dissemination. I will learn to engage the public to explain the importance of global surgery to the British taxpayer and NHS patients. Impact and NHS benefits I will learn to leverage change with policy makers through the Policy Consortium. Current NICE guidelines do not make recommendations on the type of skin preparation, the use of triclosan sutures, or change of gloves/instruments prior to wound closure. Recent WHO guidelines are based on weak or moderate evidence. I expect the results of the RCTs to input directly into future guidelines.

Lay abstract: Aims: This fellowship is designed to train me to become recognised as an expert in high quality research trials that can benefit patients needing surgery anywhere in the world. This includes patients both within the NHS and also in lower income countries. The main research within this application, called the CHEETAH study, is intended to test ways to reduce wound infections after surgery. How global research can benefit NHS patients and the British public: The NIHR has recently funded research into Global Health, focusing on patients in lower income countries. I am applying from within the NIHR funded Global Health Research Unit on Global Surgery, which will be my learning platform. Many problems that exist for patients needing surgery in lower income countries are common to those undergoing surgery in the NHS. This means that NHS experts in international research need to be trained. For example, reducing wound infections and preventing death after an operation will benefit patients around the world. If the CHEETAH trial reduces wound infections, the results will impact on guidelines both within the NHS (e.g. NICE) and beyond (e.g. World Health Organisation). Design and methods of proposed research: I will design and deliver the first part of the CHEETAH research study (a 'pilot') that will test whether using a fresh pair of gloves and equipment to close the wound at the end of an operation can reduce wound infection rates; this is not done routinely in our hospital network. CHEETAH will include 10 hospitals with 910 patients undergoing surgery on their abdomen. This type of study will change practice across the whole hospital and is called a 'cluster randomised trial'. I will use an already funded trial (FALCON) to develop methods to make future research more efficient. For example, I will test whether a telephone review can act in place of an in-person review, thereby increasing follow-up and reducing cost. I will train to become an expert in designing new surgical research addressing questions with international importance, through an annual 'Prioritisation Cycle'. This will include stakeholders (patients, surgeons and health providers) from involved countries. A thorough Patient and Public Involvement plan is a key component of this application. This research is focussed around a training plan, under mentorship of two senior and successful NIHR investigators, to train me to lead the research Unit in the future.Patient and public involvement (PPI) I have already paired a professional UK patient representative to Rwanda's first surgical patient representative, who have attended and influenced our initial planning meetings since 2016. I will work alongside them to: Develop a light, feasible, free to access, online toolkit that can be used by research teams to develop their own PPI. Build this PPI into the 'Prioritisation Cycles', to ensure future research topics are relevant to patients. Produce lay summaries to support workshops that will engage patients and boost recruitment to future trials. Use annual public events to engage the British general public, explaining the importance of overseas research to the NHS.Dissemination I expect the results of this research to have an impact on patients around the world. There will be financial benefits to hospitals and the community, with fewer complications to tackle and quicker return to working life. There will also be benefit to patients in the NHS and other high income countries, as internationally relevant questions can be rapidly answered. I expect the results of the big trials to be published in major medical journals. I will learn to work with policy makers to create impact from this research and influence guidelines.

Research activity codes: 6.4 SURGERY
Health categories: GENERIC HEALTH RELEVANCE