Award Title: Optimising the efficiency and value of burn care research; prioritising evidence uncertainties and embedding agreed core outcomes to enable focussed registry-based RCTs.
Funder: Department of Health and Social Care

Abstract: Background: World-wide burns affect 11 million people annually of whom 140,000 are in England. Most burns result in scarring which has life-long functional, psychological, and cosmetic consequences for patients. Management strategies and outcomes after burns varies between services. A contributing factor is a lack of quality evidence. Most burn randomised controlled trials (RCTs) are small, single-site and report different outcomes, limiting evidence synthesis. RCTs do not often reflect patient need and evidence gaps. Observational studies lack the strengths gained from randomisation. Although more and better RCTs are needed, they are expensive and challenging to conduct. Innovative registry-based randomised trials (R-RCTs) collecting the Core Outcome Set (COS) items are proposed as a solution. Before these are undertaken, feasibility work is required to optimise main trial design and conduct. Aim: To improve the burn care evidence base by identifying and prioritising evidence uncertainties and optimising the design and conduct of registry-based RCTs to assess core outcomes of relevance to patients, clinicians, and NHS. Objectives:	Establish the evidence uncertainties and agree priorities for future burn research. 	Develop the final measures of the burn COS, and novel methods for embedding data collection within existing registries. 	Evaluate the feasibility of conducting an R-RCT in a pilot case-study of a prioritised evidence uncertainty.Methods: Three phases will be undertaken in partnership with patients. Phase 1: identify a long-list of evidence uncertainties through an umbrella review, patient and staff interviews and on-line survey. Prioritisation will be through collaboration with the James Lind Alliance (JLA) to achieve a 'top-ten'. One research question will be developed into a pilot RCT. Phase 2: develop and finalise core measures for the agreed burn COS using Core Outcome Set Measurement Instrument (COSMIN) methodology and embed data collection within existing UK and Australian registries. Phase 3: conduct a pilot R-RCT within the registries to establish if a main trial is feasible. Throughout will be the development of an international burn registry research group. Timelines for delivery: Phases 1 and 2 will be completed in two years. The remainder of the time will be spent undertaking the pilot. A dissemination plan, co-developed with patients, will engage clinicians, researchers, funders, and editors through professional organisations, conferences, delivery networks, COS organisations, registry reports and international webinars. Papers reporting literature reviews, interview and survey data, top-ten clinical uncertainties, core measures and R-RCT pilot will be published. Patient involvement will be through steering group membership, project co-delivery and dissemination through support groups, charities, and social media. Impact: The pilot work will demonstrate how to conduct an efficient R-RCT trial which will impact evidence-based NHS care. Methods will be relevant to other clinical specialties. Measures of the agreed COS will lead to improved evidence synthesis. The JLA work will identify important patient-centred research questions for others to use. Efficient evidence development will ultimately impact international guidelines and training, enabling standardised care and improved patient outcomes and NHS productivity. Global burn registry audit and research will increase equity of care. Public understanding of efficient quality research will be important.

Lay Abstract: Background: Burns affect 11 million people world-wide and 140,000 patients in England each year. Many burn patients have difficulties affecting daily life, such as walking, dressing, poor mental health and living with scars. Burn care is expensive due to operations, long hospital stays, and scar treatment. Despite the importance of these issues, there is limited research available to inform hospital staff how to make treatment decisions. Without strong evidence, staff will use their own preferences and do what they have always done. This limits progress, results in care that varies between hospitals, and means patients may not get the best results. The best evidence for doctors to use to make decisions, is from more than one trial. Evidence put together from several trials is much stronger. To do this, we need all trials to use the same measures of recovery (also called outcomes). Our earlier research with 700 patients and international staff, agreed upon seven important burn outcomes. These are: survival, wound infection, daily living activities, wound healing, long-term pain and itch, psychological problems, and time to return to school or work. We also need our trials to answer questions that are important. We need to do research to understand which clinical questions, patients and hospital staff think are the most important to answer and will most improve recovery. Trials also need to be designed and conducted efficiently. One way is to use routinely-collected data. In burn care, every hospital enters patient details into a database known as a registry. We intend to use this registry data to make trials easier and cheaper. Aims: 1.Agree with patients and hospital staff the top-ten burn care clinical questions lacking evidence. 2.Ensure the agreed outcomes can be routinely collected through burn registries. 3.Test the possibility of doing a large trial using data from UK and Australian registries. Methods: We will work with patients and staff through interviews, and using published research, to agree a list of clinical questions that have not been answered with previous trials. These questions will be ranked through a survey. The top 30 questions will be taken to a meeting with patients, and staff, to agree the top-ten. We will then make sure that we can routinely collect the chosen outcomes from two registries. Finally, we will run a small trial over five UK and Australian hospitals to see if we can test one research question using registry data. The results will show us if patients, doctors, and nurses are happy to take part, if we can collect outcome data from registries and if a larger trial is possible and worthwhile. Patient involvement: Patients will work in a partnership with researchers. Patients have helped to write this application and fully support this research. They will be involved through interviews, surveys, consensus meetings and communication of the results. Patients will benefit the research by drawing on their rich experiences and ensuring the work remains patient-focused. A patient group will advise on project design, progress and the feasibility of a large registry trial. An expert in patient involvement will provide support. Dissemination: The project results will be shared through published papers, conference presentations, newsletters, patient support groups, charities, and social media. Impact: This research will make sure that we use research funding and staff time to answer the most important questions in burn care, that we use the same agreed outcomes to assess patient recovery and that we do trials in the cheapest way. This will ensure evidence is produced more quickly and decision-making about treatment is based on evidence to benefit patients, not on localised historical practice.

Research Activity Codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES);7.3 MANAGEMENT AND DECISION MAKING
Health Categories: INJURIES AND ACCIDENTS