Title: Overcoming unplanned variation in children’s health (OUCH): Maximising the safety and effectiveness of orthopaedic care for children through better evidence.
Funder: Department of Health and Social Care

Abstract: Background: Until recently, children's trauma and orthopaedic surgery has been untouched by research. This is despite 250,000 childhood fractures annually in the UK and a large burden of non-traumatic disease from birth anomalies, developmental disease and infection. The absence of evidence has propagated uncertainty and widespread variation in care. It is 'normal' to encounter scenarios for which surgeons have diametrically opposed views, i.e. injuries/ disease which some surgeons advocate strongly in favour of surgery, and some strongly against.As a Clinician Scientist, I led UK-wide improvement in children's orthopaedic research. Prior to this there were no multicentre studies and no clear research direction. Now, we have a national cohort that recruited in 143 UK hospitals involving over 500 surgeons, six multicentre NIHR HTA trials, and a clear research agenda through surgeon-consensus and a James Lind Partnership. What is the value of this Professorship? This will enable me to be the international research leader through a growing series of e-Trials, and by developing digitally enabled trials to answer questions previously considered impossible to answer. In particular, this will build the foundation from which to launch data-enabled trials in routine care, to resolve three of the of the top-10 research questions from the research agenda. These questions relate to the screening and treatment of hip dysplasia in newborns. This will build on my methodological expertise, showcase the UK as a leader in trials innovation and inform policy concerning the care of almost every child born around the world.e-Trial Portfolio: Severe radius fractures (CRAFFT): Non-inferiority RCT comparing surgery to non-operative care . Medial epicondyle fractures (SCIENCE): Superiority RCT comparing surgery to non-operative care Slipped Femoral Epiphysis (Big BOSS): Superiority RCT comparing intracapsular reduction to pinning-in-situ.Data Enabled Trials In Developmental Hip Dysplasia (DDH):1 in 1000 babies are born with a completely dislocated hip, and more with minor dysplasia. Although there is a national screening programme, the national screening committee have acknowledged that two-thirds of dislocated hips are missed by current policy. Even when diagnosed, there is no agreement concerning treatment pathways. Trials are needed to develop the evidence to inform screening and treatment policy. The national screening programme in England has recently launched a database, Smart4NIPE, in which it is mandated that the details of each baby screened is recorded. I am national advisor to the hip screening programme, and have agreement from the Director of Screening at PHE, to develop research within routine care. I will enrich the dataset within Smart4NIPE to collect the key parameters of a newly defined 'core measurement set', ensure the quality of the data collected and develop a module to enable randomisation at the point of screening and treatment. This will enable world-leading observational studies and data-enabled trials through routine care, in a pathway that affects almost every baby born throughout the world.Building Capacity: I will develop the UK Trauma and Orthopaedic Trials (TOTs) for Children Collaborative, lead the development of international clinical trials, and ensure sustainability through the development of new Chief Investigators.

Lay abstract: Orthopaedic surgeons who care for children are best known for looking after broken bones. This is understandable, as 250,000 children in the UK break a bone each year, with these being three times more common in the summer. These surgeons also care for children with long-term disabling conditions of the bones, which occur through birth abnormalities, infection and the effects of poverty and obesity. Perhaps the best known of these disabling conditions is 'hip dysplasia', commonly known as 'clicky hips', for which every newborn baby is examined shortly after birth and at 6-8 weeks.Despite the frequency of children's bone injuries and disease, there is little research to test how effective orthopaedic treatments are. Currently, treatments offered to children depend on the beliefs of the individual surgeon they see. It is common for surgeons to have opposite views on treatments, even amongst common conditions - such that one surgeon may recommend major surgery, whilst the next surgeon may profoundly disagree. Parents often find variation in opinion difficult to understand, with confusion amplified through social media. There is a growing desire amongst surgeons, healthcare professionals and families to resolve these uncertainties, by generating robust evidence. Children, families, surgeons and health professionals recently met to agree a list of the most important questions which needed answers. This Professorship will enable me to deliver leadership to directly address a number of these uncertainties. In particular, this Professorship will enable me to become a world leader, encouraging and inspiring surgeons and families throughout the world to join together to engage in research. Ultimately, this will provide real benefits to children and young people, and their families. Through this Professorship, the following will be delivered:Projects relating to injuries in children: Major wrist fractures - A study asking whether surgery is as good as a plaster cast amongst children under 11-years old. Elbow (medial epicondyle) fractures - A study asking whether surgery is better that a plaster in children with this common injury. Slipped Epiphysis (a hip disease in children) - A study asking whether major surgery to correct deformity is better than minor surgery that does not correct the deformity.A new research platform to develop during this Professorship:'Developmental Hip Dysplasia (DDH)' ('clicky hips') -h; 1 in 1000 babies are born with a hip(s) completely out of the socket, and many more have minor hip problems. All UK newborn babies are part of a national DDH screening programme. However, it is recognised that this programme doesn't work, with two-thirds of dislocated hips missed by screening. Across Europe, doctors use different ways to 'screen' hips -h; though no one knows which way is most reliable. Even when diagnosed, there is no agreement on when to start treatment, how to treat it and when to stop. A series of studies is needed to determine the best treatment pathways, and then the best screening methods. The national screening programme recently started routinely recording details of each baby on a computer database. We will seek to include key aspects of care within the database and make it possible to enable high-quality research. This will allow questions to be answered quickly, by involving large numbers of babies across the UK through routine care. For example, previous studies have suggested hip screening research maybe impossible as it would need at least 100,000 babies, however if undertaken as part of routine care in England, this could be achieved in just 2 months. Through this Professorship, I will become a global leader in children's orthopaedic surgery, to improve surgical research within the UK for the benefit of children and their families.

Research activity codes: 6.4 SURGERY;7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL