Title: Improving outcomes for patients having shoulder replacements: guiding patient selection, evaluating cost-effectiveness and informing NHS provision.
Funder: Department of Health and Social Care

Abstract: Background Osteoarthritis of the shoulder is debilitating and increasing in prevalence. Despite the incidence of shoulder replacements rising rapidly every year, there is ongoing treatment uncertainty with no high-quality evidence to guide the use of the different types of shoulder replacement. This topic has been identified as a research priority by patients, carers and clinicians through the 2015 James Lind Alliance Priority Setting Partnership. Five years later, the 2020 National Institute for Health and Care Excellence guidelines and a 2020 Cochrane Review confirm an ongoing lack of evidence and a requirement for further research on this topic. With substantial complications and high rates of revision surgery, shoulder replacements are not without risk. In the NHS, certain low volume procedures are currently undergoing service provision changes through centralisation. With national registry data revealing considerable volume variation for shoulder replacements in the UK, and volume-outcome studies inconclusive, there is a pressing need to improve the available evidence. Objectives 1. Compare patient outcomes after different commonly used shoulder replacements 2. Estimate the cost-effectiveness of different shoulder replacement procedures and the projected burden of shoulder replacements to the NHS 3. Examine the surgeon and hospital volume-outcome relationship to inform service provision of shoulder replacements in the NHS Methods Design: Population-based cohort study and cost-effectiveness analysis using linked and unlinked data from the National Joint Registry (NJR) and Hospital Episode Statistics (HES). Work Packages (WP): WP 1- Outcomes after shoulder replacement I will compare patient outcomes including revision and reoperation, mortality and other serious adverse events (SAEs), and patient-reported Oxford Shoulder Scores (OSS), after different commonly used shoulder replacements. I will develop and validate models to predict these outcomes. WP 2- Health Economics I will estimate incremental quality-adjusted life years and healthcare costs, using these to calculate the incremental cost-effectiveness ratio comparing different shoulder replacement procedures to conventional total shoulder replacement. I will investigate temporal shoulder replacement health costs, projected future costs and burden on the NHS over the next 25 years. WP 3- Volume-outcome analysis I will investigate the volume-outcome relationship of shoulder replacements by analysing between- and within-surgeon effects of surgical volume on revision and reoperation, SAEs, OSS and length of hospital stay. Anticipated impact and dissemination This study will deliver high-quality evidence on shoulder replacements to inform and guide patients and surgeons and make cost-effectiveness recommendations for the NHS. The results will help the NHS by informing any national guideline changes on the commissioning of shoulder replacements though the Getting It Right First Time Programme. I will work with my Patient Advisory Group and the British Elbow and Shoulder Surgeons Expert Patient Group to co-produce patient-friendly summaries, including patient perspectives of the results. I will collaborate with the NIHR Oxford Biomedical Research Centre and my University communications teams to effectively disseminate through the press, media and musculoskeletal charities. I will publish the results in high impact open-access journals and deliver national and international presentations at scientific meetings.

Lay abstract: Shoulder arthritis Shoulder arthritis is a painful and disabling condition affecting up to a third of adults over the age of 60, as well as younger people. Pain and disability in working age people can be so severe it prevents them from being able to work. Around 1 in 3 people receiving benefits in the UK record problems such as bone and joint arthritis as their primary disabling condition. Shoulder replacement operations have the potential to relieve pain and improve shoulder movement. Around the world, annual shoulder replacements have increased by a factor of 17 over the last 10 years. There are now nearly 7000 shoulder replacements carried out each year in the UK alone. At present, there are many different designs and types of shoulder replacement, as well as different surgical techniques. Which is the best shoulder replacement? Shoulder replacements can work well. Most people report reduced pain and improved function within 6 months after surgery. However, some patients report problems after surgery and need another operation to change their shoulder replacement. This major surgery is required by as many as 1 in 4 men aged under 60 having shoulder replacements. We do not know which type of shoulder replacement is best for different age groups or different people, and patients have decided this is a priority for researchers to address. Research is needed to help patients and doctorsPatients needing a shoulder replacement vary in many ways such as age, sex and size. They also vary in the demands they would put on a shoulder replacement. These are all factors that might affect their result. The UK is lucky to have one of the largest databases of shoulder replacements in the world (National Joint Registry (NJR)). This database alongside another NHS database called Hospital Episode Statistics (HES) offer the perfect means to address this pressing issue. I plan to use these databases to urgently answer the questions that patients and doctors have asked about shoulder replacements. How will the study be done? I plan to use routinely collected data by the NJR and HES, and use statistical methods to answer the following questions: 1. What are the results for patients after different types of shoulder replacement? 2. Which types of shoulder replacement represent the best value for money, and how much will this cost the NHS over the next 25 years? 3. Does the number of shoulder replacements a surgeon and hospital perform each year have any effect on the results for patients? Patient Involvement In 2015, through a James Lind Alliance Priority Setting Partnership, patients identified the need for urgent research to guide the choice of shoulder replacements. I have worked with patients from the North East Shoulder Research Group, the National Institute for Health and Care Excellence, as well as local patients in Oxford to improve this project proposal. I will continue to work closely with these patients, and with the new British Elbow and Shoulder Society Expert Patient Group, to manage the research, gain feedback on the data analysis and aid dissemination of the study's findings to the public. Dissemination I plan to disseminate the results of the study widely through research publications, scientific conferences, the media and health charities, and use the evidence to improve patient care pathways. This will include providing evidence to doctors working in primary care (your local GP), hospital health workers and health service commissioners, all aimed to achieve the best results possible for patients having shoulder replacement surgery.

Research activity codes: 6.4 SURGERY;8.2 HEALTH AND WELFARE ECONOMICS
Health categories: MUSCULOSKELETAL