Title: Optimising evidence-based decision-making for young people with burns by the development of a core outcome set and the identification of outcome measurement tools (COSBy).
Funder: Department of Health and Social Care

Abstract: In England and Wales, over 7,500 children and young adults receive specialist burn care annually; many more are managed in secondary care and Emergency Departments. Mortality, has decreased significantly, thus more attention has to be paid to additional outcomes. Short-term outcomes include healing time, infection rates and NHS costs. Longer-term term outcomes include functional, cosmetic and psychological issues and are more related to patient satisfaction. Healthcare policy challenges come with establishing relevant outcomes to allow evidence synthesis and inform clinical decisions. In burns, this is hampered by varying clinical practice, and missing data related to lack of patient involvement. Many researchers use clinical and patient-reported outcomes. However, there is a lack of consensus and consistency in outcome and measurement tool choice. Without agreement, comparing trials and evaluating treatment is difficult. Without patient input, measured outcomes may not be relevant. A core outcome set (COS) is a minimum group of scientific outcomes agreed, defined, measured and reported in a standardised way. This doesn't prevent researchers reporting other outcomes, but ensures a core' set. A COS will reduce outcome reporting bias, common in clinical research. A COS will improve trial design and better inform professionals and patients about treatment impact. A burn COS will improve evidence synthesis, technology assessment and effective use of NHS research funding to benefit patients. My aim is to optimise patient outcomes by developing a COS to improve evidence-based decision-making in healthcare for children and young people with burns.I will develop a COS reflecting professionals and patients' views, to allow better reporting of short and long-term outcomes in research, service evaluation and clinical decision-making. I will explore how age affects outcome importance. I will identify, from those available, accurate, reproducible measures to assess the core outcomes. Research questions:What clinical and patient reported outcomes have been reported?What short-term (clinical efficacy) and longer-term outcomes (patient-centred, clinical effectiveness) are most important to burned patients, professionals and the NHS?How should these be measured?Objectives:Produce a COS relevant to patients, professionals and NHS commissioners considering short and longer-term outcomes.Identify valid, reliable outcome measures.Disseminate the COS and measurement tools. Plan of Investigation Outcome Long-list: I will Identify all possible outcomes and measurement tools through two systematic reviews (patient reported, clinical) and interviewing professionals and patients to understand the important outcomes at different times after injury.COS. I will use the long-list to develop a questionnaire. I will use this questionnaire to undertake up to three rounds of professional and patient outcome prioritising surveys (Delphi process). I will hold two consensus meetings of professionals and patients/families to finalise the COS.Outcome Measurement Tools. An assessment framework developed by Consensus-based Standards for selection of health Measurement Instruments (COSMIN) initiative' will allow me to determine the quality of my previously identified outcome measurement tools. I will incorporate quality outcome measures into the final COS. Dissemination: I aim to achieve professional endorsement to use the COS in research and service evaluation. The British Burn Association has formally supported this work. I will submit publications to relevant high impact journals.Benefits to Patients and NHS Co-developing a COS with professionals and patients, to reflect short and long-term outcomes after burns, will improve research quality, and through this, improve evidence-based clinical practice and patient care. By enabling effective trial comparison, patient involvement will not be wasted. By ensuring patients contribute to outcome choice, research will be relevant. NHS quality assurance initiatives will be consistent and better reflect stakeholder priorities. Use of comparable research evidence will ultimately allow standardisation of care and national policy-making.

Lay abstract: Burns are the fourth most common reason why children go to hospital after an accident. Many are managed in local hospitals and A&Es, and 7,500 children and young adults in England and Wales require specialist care each year. Improved burn care has meant that fewer patients die, so we cannot use this alone to measure how good care is. We need additional measures of recovery to improve care further. Currently, researchers use different endpoints to assess care quality and new treatments. This makes it difficult to compare research. Previous work to agree clinical outcomes has had limited professional and no patient involvement. Using the same endpoints that are important to patients is vital, to allow clinicians to be able to compare research. If we can compare research clearly, then clinicians can determine the best care for patients. Without patient input, measured recovery endpoints may be less relevant.Early measures of recovery include length of hospital stay, infection and healing time.Longer-term endpoints include problems with movement (contractures), cosmetic issues (scarring), pain and psychological health. Burns can affect friendships, schooling, employability, confidence and quality of life.The importance of different outcomes may vary with time after injury and possibly with the patient's age. AimsTo establish the most important recovery endpoints for burned patients, families, professionals and NHS for use in research.To determine how to measure these endpoints in a practical and reliable way. A Core Outcome Set (COS) is a minimum set of recovery endpoints that are agreed, defined, measured and reported in a standard way. I will also identify available tools that are useable and practical, to measure these outcomes. This might include, for example, a current scoring system that measures scar quality. Method To develop a COS, I will need to understand what patients, families, doctors, nurses, therapists and NHS think are the most important burn recovery endpoints. I will:Agree a recovery endpoint long-list by:Reviewing burn research to find all recovery endpoints and measurement tools that have been used.Interviewing patients (differing ages and burn size) or parents of burned children, and staff (of different disciplines) about what matters during recovery from a burn and if this changes over time. I will turn this long-list into a shorter questionnaire. This will be sent to 150 patients and 200 professionals and scored for importance. The results will be summarised and fed-back to participants who will be asked to complete it again taking into account the other group's views. This is called a Delphi survey. The highest scoring items will be kept and less important items (pre-defined criteria) will be discarded. If patients or professionals feel differently and strongly about an item, it will be retained. The survey will be undertaken up to three times. A shorter list will finally be produced of the most important recovery endpoints.This shorter list will be taken to two meetings with professionals, and patients and families separately, to agree the final COS using anonymised voting methods.I will then work with patients and professionals, using known techniques, to analyse the recovery endpoint measurement tools identified in my previous literature review (in 1a). I will only choose tools that have been shown to be reliable.Patients and the public: Patients are at the centre of this project. Theyhave edited this application and will produce the study protocol with me.will be Steering Group members ensuring study aims are met and relevant.will check patient literature is understandable.are a vital part of the Delphi survey and will check the questionnaire before use.Burn support groups (Frenchay after Burns', Welsh Dragons') and patient representatives will help me spread knowledge about my findings. Publication: It is important that new knowledge is used as soon as possible. I willpublish my findings in medical journals and at conferences.work with the COS methodology team, professional burn associations and NHS to publicise the findings.ask patient groups (as above) and charities (Children's Burns Trust) to display new knowledge on-line and through social media.Benefits: The COS willimprove patient care by making burn research comparable, allowing effective testing of new technology and care and making the most worthwhile use of scarce NHS research funding. allow clear and consistent comparison of burn service quality of care for patients and NHS. The comparison will be understandable and relevant to patients, families, the public and professionals.enable us to be consistent when counselling patients about psychological and physical recovery.benefit other similar research, eg trauma..

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: INJURIES AND ACCIDENTS