Title: Improving outcomes in trauma patients with open fractures: proving the utility of a national audit dataset.
Funder: Department of Health and Social Care

Abstract: BACKGROUND Open fractures, where the soft tissue envelope is breached, are major injuries with an annual UK incidence of 11.5 per 100,000 adults. Health-related quality-of-life falls by one half and only half of patients return to work. Lifelong healthcare costs are estimated between GBP160,000 and GBP500,000 per patient. Few randomised studies of treatments for these devastating injuries exist. A recent randomised trial took 5 years to complete and cost GBP2.4 million. More cost and time efficient means to conduct interventional studies in this area are urgently needed.AIM To establish a research framework which can facilitate cost and time efficient embedded randomised trials about the treatments for patients with open fractures.OBJECTIVES Explore how fracture treatment and outcomes have changed over time to develop hypotheses for future testing. Develop core outcome and instrument sets for this inury. Test the feasibility of a comprehensive cohort collecting this dataset within an existing routinely collected national database. WORKSTREAMS A natural experimental study of outcomes after treatment of open fracture in Major Trauma Centres (MTCs) in the UK The Trauma Audit and Research Network (TARN) collects information on all patients that are severely injured and receiving hospital care in England. We will link this routinely collected dataset with Hospital Episode Statistics database (HES) which contains data on all NHS hospital admissions. The study will assess the effect of the introduction of MTCs in 2012, explore variation in outcomes between centres and possible causes of variation. Outcomes will include death, length of stay, complications, need for re-operation or re-admission to hospital, and quality-of-life. 2.Development of core outcome and core instrument sets for future trials with patients sustaining open fracture Core outcome sets and their associated instrument set, are an agreed minimum set of outcomes and instruments that should be measured and reported in all trials. Using established COMET methodology we will develop core outcome and core instrument sets for patients with this injury. Patient perspectives will be gathered through interpretation of existing one-to-one interviews, with iterative feedback to focus groups with patients and professionals. A systematic review of outcomes reported in the existing literature will be performed. Outcomes derived from each of these streams will be mapped to the International Classification Functioning, Disability and Health to generate a longlist of outcomes. Consensus for a shortlist and core set will be achieved using a three-round Delphi survey followed by an independently chaired consensus meeting. We will perform a systematic review of the available instruments used to measure each of the outcomes of the core set and their clinimetric properties using the COSMIN methodology. A second round consensus meeting with methodological, clinical and measurement experts will determine the appropriate core instrument set.3.Testing a national framework of outcome collection using the national trauma database There is precedent for including additional limited questions in the TARN database. We will incorporate the agreed instruments from Workstream 2 into the TARN dataset which is mandatory for all Major Trauma hospitals. We will use the routine collection systems already in place for a period of 12 months. We will define success as 90% collection of the primary outcome data.IMPACT This programme of work will set the conditions for future high quality studies for this important injury. With appropriate outcomes defined and agreed with patients, a cost and time efficient framework for recruitment and followup of patients, future research will be able to develop current practice and innovations in care for these patients. Without this work it is unlikely, given recent experience from similar studies, that future high quality studies will be feasible.

Lay abstract: SCALE OF THE PROBLEM An open fracture is a break of a bone where part of the bone comes out through the skin. Approximately 7,500 people in the UK will suffer an open fracture every year. Open fractures are a life-changing event; they cause a significant loss in quality-of-life, indeed often worse than if the person had a stroke. The treatment of these injuries is complex, requiring different surgeons to repair the bones, skin and in severe cases the blood vessels and nerves; costing between GBP160,000 and GBP500,000. Surprisingly, the most effective way of treating these devastating injuries is not proven. Clinical practice guidelines have been issued by specialists but these are based only on opinion rather than evidence. The best quality studies in this field are very expensive and lengthy so that new evidence is produced very slowly. A more efficient way is needed to deliver high quality work in this area to help develop better care for patients sustaining this life-changing injury.PATIENT INVOLVEMENT This programme of work is not possible without partnering with patients. Patients will: be members of the Study Steering Group. lead on the development of a patient-focused means of measuring outcomes. lead the publicising of this research beyond the scope of routine scientific dissemination. AIM To establish a research framework which can facilitate multiple cost and time efficient research studies about the treatments for patients with open fractures.OBJECTIVES Explore how fracture treatment and outcomes have changed over time to develop ideas for future effective treatments. Reach an agreed method to measure outcomes following injury that are important to patients and other stakeholders. Test the feasibility of a comprehensive system of collection of these agreed outcomes from all patients with open fractures within an existing national database. WORKSTREAMS Analysis of treatments and outcomes for open fractures from the Trauma Audit and Research Network (TARN) TARN collects information on all patients who are severely injured and taken to hospital in England. The Hospital Episode Statistics database (HES) collects data on all NHS hospital admissions. This study will identify all cases of open fracture recorded by TARN and link these to data for the same patients in HES. The outcomes from the combined databases that will be used are death, length of stay, complications, disability level, need for re-operation or re-admission to hospital, and quality-of-life. We will review how each identified patient was treated. We will then link the care received to the outcomes achieved. In this way we will be able to understand how national best practice guidelines influence clinical outcomes across England. 2.Development of an agreed method to measure outcome after open fracture Currently there is no agreement on which outcomes are important to patients after an open fracture. This is because the issues which are truly important to patients and professionals are currently unknown. For the NHS to decide if one type of treatment is better than another, it is essential to measure patients' experiences and outcomes important to people's recovery. We will carry out focus groups with patients and professionals to gather and interpret the reported experience and recovery from this injury. We will use online surveys and seminars to shortlist and then reach agreement for a core set of outcomes which are important for all future studies in this field to report. Finally, we will work with experts using this core set to select a group of measurements which can be used in future research to record these agreed important outcomes.3.Testing a national framework of outcome collection using the national trauma database (TARN) There is precedent for including additional limited questions into the TARN database. We will incorporate the agreed measurements from Workstream 2 into the TARN dataset which is mandatory for all Major Trauma hospitals. We will use the routine collection systems already in place for a period of 12 months. We will define success as 90% collection of the required data.IMPACT This programme of work will set the conditions for multiple future high quality studies for this important injury. Investing in this programme will establish appropriate outcomes, defined and agreed with patients, that are embedded within a cost and time efficient framework for recruitment and followup of patients. In this way future research studies can be much better value-for-money. Without this work it is unlikely, given recent experience from similar studies, that future high quality studies will be considered feasible or affordable.

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: INJURIES AND ACCIDENTS