Title: Improving the United Kingdom's Newborn Screening Pathway for Detection of Developmental Dysplasia of the Hip
Funder: Department of Health and Social Care

Abstract: Background Developmental dysplasia of the hip (DDH) is a significant public health issue and represents the largest cause of hip osteoarthritis in young adults. DDH leads to total hip replacements in around 29% of these patients. The majority (>70%) then undergo multiple hip operations and struggle with persistent pain affecting their daily lives. This can be prevented with early diagnosis and splint treatment which has a high success rate (>90%). Delayed diagnosis (after 3 months old) leads to a higher risk of surgical complications and a sevenfold increase in treatment costs. The current UK screening programme has shown no improvement in early detection of DDH since 1986. There is no national clinical consensus on ultrasound diagnostic parameters and indications for treatment; this has led to regional variation. Cochrane review has confirmed the lack of evidence to support the current programme. Objectives 1. To develop a UK consensus-based 'core measurement set' detailing ultrasound features that should inform early diagnosis and treatment in DDH, which would facilitate screening programme standardisation. 2. To investigate the potential for computer programmes to automatically identify hip features and calculate measurements from ultrasound images, allowing for improved reliability and reproducibility. Methods 1. A systematic review of studies reporting early (3 months) ultrasound features in DDH that are associated with need for treatment. This will report the predictive characteristics (e.g. sensitivity, specificity, likelihood ratios) of different scanning methods. 2. A UK-based Delphi consensus exercise to identify early ultrasound features/measurements that inform diagnosis and treatment of DDH. This will allow development of a 'core measurement set' to reduce regional variation and facilitate high-quality research. 3. Development of an artificial intelligence model to automatically delineate an 'adequate' ultrasound scan image, then reliably calculate and report the 'core measurement set'. Learning and non-learning methods will be evaluated against manual techniques. Anticipated impact This topic has been identified as a UK research priority by patients, carers and clinicians through the 2019 James Lind Alliance Priority Setting Partnership. The study aim has been supported by the UK National Screening Committee who recognise the need to improve evidence around screening for DDH. The project will deliver a multidisciplinary consensus to reduce regional variation, improve diagnosis and effectively monitor treatment outcomes. This will improve the ability of the screening programme to identify babies that will benefit from treatment. Automating the assessment of ultrasound images could lead to a cost-effective and reliable means of measuring and recording hip-specific measurements. Consistent measurements using a standardised platform are likely to improve inter-observer reliability and facilitate further research aimed at optimising the screening programme. Dissemination Findings will be published open access in appropriate high impact peer-reviewed journals aimed at an international audience. They will also be presented at international meetings of clinicians and academics in the fields of DDH and medical technology. Patients and the public will be updated via a bespoke website, social media and charity newsletters. Our experience of working with patients and the public will be published on the NIHR INVOLVE website.

Lay abstract: BackgroundDevelopmental dysplasia of the hip (DDH) refers to a range of problems in the way a baby's hip joints develop after they are born. In the United Kingdom (UK), around 1 in 200 babies are born with hip problems requiring treatment and 1 in 1000 are born with a hip that is completely out of the socket ('dislocated'). If diagnosed early (under 3 months old), DDH can be treated with a splint that the baby wears over their clothes. Delayed diagnosis often requires complex surgery with big scars, more time in hospital and a higher risk of ongoing pain as an adult. All newborn babies have their hips examined after they are born as part of a national screening programme to identify DDH early. If a baby is believed to have a hip problem during this physical examination, was born feet first or has a history of DDH in the family, an ultrasound scan is performed. Unfortunately, the UK's screening programme currently misses two-thirds of dislocated hips and the number of babies with a late diagnosis has not changed since 1986. This is partly because the examination is difficult to perform and unreliable but also because the process of ultrasound scanning could be improved. Multiple ultrasound scanning methods are currently used across the UK. The specialists also use different scan measurements when diagnosing and deciding whether or not to recommend treatment. Ultrasound requires a high degree of individual judgement and so depends a lot on the person performing the scan. For this reason, hip scans cannot be reliably repeated or interpreted to the same standards. It is likely that his problem contributes to the failure of the current screening programme. Aim To provide evidence to improve the UK's hip screening programme for DDH. MethodsI will study all published research on early ultrasound features in DDH to work out which hip measurements are most important for predicting which babies need treatment. I will ask UK experts about the hip measurements they commonly use to diagnose and recommend treatment. I will then use this information to design a national standard for ultrasound assessment of DDH. I will design an 'artificial intelligence' computer programme to help calculate hip measurements from ultrasound scans. This might be more cost-effective and consistent than the current method, which relies on the judgement of different individuals. Using 5000 ultrasound scans of babies with and without DDH, the computer programme will 'learn' which scan features it needs to identify to calculate the important measurements. It will then report these measurements in order to help clinicians determine which babies would benefit from treatment. Patient and public involvement (PPI)In 2019, patients, public and healthcare professionals identified the need for urgent research to improve DDH screening. Patients from across the UK, their carers and a charity (Steps) representative have already been involved in designing this study. As research partners, they have helped to write this application and will contribute to all future stages of this research. They will also ensure that this research meets the ideas and expectations of NHS users. To make it easier for them to participate, some PPI meetings will be done via video-calls and at charity events. We will publish our experience of working together to help future researchers.DisseminationI will publish this project's results in scientific journals and present the work at national/international meetings. The DDH community will be regularly updated via a website, social media and charity newsletters. This project will inform the national policy for hip screening and so help achieve the best results for babies undergoing hip screening.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.4 POPULATION SCREENING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;MUSCULOSKELETAL