Title: CORE-Kids: What are the most important outcomes to measure following childhood fractures?
Funder: Department of Health and Social Care

Abstract: Research Question What are the most important outcomes that need to be measured in all trials of fractures sustained by children and how is best to measure them? Background Fractures are common in children with 1/3 children suffering a fracture before their 17th birthday1. The estimated cost of childhood injuries to the NHS is more than 275million2 with additional indirect costs to families and impacts on childhood participation and opportunities. There is a lack of evidence to guide the management of childhood fractures. It will be impossible to address this without first developing a core outcome set to guide researchers in designing and delivering the necessary high quality trials that can be combined into meta-analyses. Aims and Objectives The aim of this project is to deliver a core outcome set for childhood fractures and evaluate the outcome measures including clinimetric properties of available outcome instruments using a validation cohort of children with lower-limb fractures. MethodsThe project will be divided into two phases to achieve the sub-objectives of the project: Phase 1: Core outcome set Prior work Identify a list of candidate outcomes through systematic review and qualitative interviews (completion due June 2019) Formal agreement of outcomes Reduce the candidate outcomes into a core outcome set through a Delphi survey and a consensus meeting including members of the multidisciplinary team, parents and children Phase 2: Validation and investigation of outcome tools Cohort study An observational cohort study of 300 children with lower limb fractures from three centres (Nottingham, Oxford and Liverpool) will be recruited to test outcome measures Children will be reviewed at 2 weeks, 6 weeks and 12 weeks following fractures and scores collated A pre-specified sub-group analysis of ankle fractures is built into the sample size calculation Clinimetric analysis Content validity, internal consistency, reliability, responsiveness, criterion validity and measurement error will be calculated using the results from the cohort study Minimal important clinical difference will be calculated using an anchor method Item response theory will be applied to the components of each outcome tool to establish the measurement characteristics of the components contained within the tool. This will be used to explore if a composite outcome is required Timeline for delivery Phase 1: Trial development and core outcome set - 6 monthsPhase 2: Setup -h; 3 months Recruitment -h; 6 months Follow up -h; 3 months Data analysis and reporting -h; 4 months Dissemination -h; 2 monthsTotal study time = 24 months Anticipated impact and dissemination Immediate impact This project will provide immediate impact by providing outcome domains that can be adopted by all future trials in childhood fractures and routine clinical care. These domains will be communicated through conferences, journal articles and through public engagement with our study group. Long term impact The long-term impact is to harmonise the outcome reporting in clinical trials, and clinical research in children's trauma to enable synthesis of results -h; i.e. to facilitate metanalyses and reliable conclusions to be drawn between studies.

Lay abstract: Broken bones are common in children, but there is a lack of scientific evidence to help families and doctors select the best treatments. This is a significant problem, as we know around 1 in 10 children do not make a full recovery following an injury. We need to know what are the best treatments to help children recover. The NHS spends 275 million on treating childhood injuries, and when children break a bone, their families have to take time off work, attend clinic appointments and the children miss opportunities to learn and play. This research will investigate the most important outcomes to measure when completing studies involving children with broken bones. This is vital, as without it, researchers may measure things that are not important to parents and children or produce studies that are not useful in deciding on the best treatments. The most important areas to measure will be selected using international standard techniques. This involves developing a long-list of ways to measure outcomes through a review of previously published studies and family interviews. Using an online survey technique, the long-list is reduced to a shorter list. A meeting of parents, children, surgeons and other stakeholders will decide on the final list of outcomes to measure in all future studies. Once the most important outcome areas have been identified, we will recruit a group of children with broken legs to establish what the current outcomes are following this injury. This group have been selected as our parent and patient involvement group have told us this is an important area, and there are many different possible treatments that are commonly provided to children in the UK. Children with broken legs will be treated by the doctors in clinic and be asked to complete outcome scores at 2, 6, and 12 weeks following their injury. The results from this study will provide important information in preparation for a full trial. These include: how good are the outcome measures, how easy are they to fill in and are the outcomes following treatments similar or is a more complex study called a randomised trial needed in the future? As part of this fellowship, ongoing parent, public and patient involvement is critical. Two parent representatives will sit on the study management panel to provide oversight throughout the whole project. Our parent and patient focus groups will meet regularly throughout the project to manage study literature, optimise study recruitment and maximise study impact through production of plain-English summaries for the website and social media. This fellowship will deliver a list of the most important outcomes that can be used immediately to help clinicians identify what to monitor in follow up clinics and in the design of future trials. The results from the children with broken legs will be presented at the annual scientific meeting for children's orthopaedic surgeons and published in scientific literature. A regular newsletter will be distributed to all participants, who want to receive it, and the publicly available website will be updated on a monthly basis to keep patients, participants and the public informed. The fellowship will also develop the skills and experience of the applicant towards a career as an academic children's orthopaedic surgeon. This is an area of medicine with few high-quality studies and an area that needs development in the number of research surgeons in the U.K. The fellowship will also equip the applicant with skills for use in study management, understanding outcomes and statistics that are applicable and needed in many surgical and medical specialities.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: INJURIES AND ACCIDENTS