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Study protocol for evaluation of aid to diagnosis for developmental dysplasia of the hip in general practice:
Andreas Roposch1,2, Kaltuun Warsame3, Angel Chater4
1Great Ormond Street Institute of Child Health, UCL, London, UK a.roposch@ucl.ac.uk.
Insights
A new diagnostic aid for developmental dysplasia of the hip (DDH) aims to improve the accuracy of the UK's 6-week hip check. This study will assess if the aid reduces unnecessary referrals and late diagnoses of DDH.
Area of Science:
- Pediatric Orthopedics
- Diagnostic Accuracy Studies
- Primary Care Medicine
Background:
- The UK's routine 6-week hip check for developmental dysplasia of the hip (DDH) faces challenges with missed diagnoses and over-referrals.
- Current practice lacks standardized tools, potentially leading to adverse outcomes for infants and increased healthcare costs.
Purpose of the Study:
- To evaluate a novel 9-item diagnostic aid for developmental dysplasia of the hip (DDH) in primary care.
- To determine if the aid reduces clinically insignificant referrals and late diagnoses of DDH compared to standard care.
Main Methods:
- A practice-randomized controlled trial involving 152 general practitioner practices in England.
- Comparison of a standardized diagnostic aid against usual care for the 6-week hip check.
- Primary outcomes measured two years post-check: clinically insignificant referrals and appropriate referrals for DDH.
Main Results:
- Study is currently in the pre-results phase (NCT04101903).
- A qualitative process evaluation, professional behavioral change assessment, and health economic evaluation are included.
Conclusions:
- The developed diagnostic aid, based on international consensus, has the potential to improve non-expert diagnosis of DDH.
- Findings will inform national guidelines and improve the efficiency and accuracy of infant hip screening programs.
Introduction:
In the UK, a compulsory '6-week hip check' is performed in primary care for the detection of developmental dysplasia of the hip (DDH). However, missed diagnoses and infants incorrectly labelled with DDH remain a problem, potentially leading to adverse consequences for infants, their families and the National Health Service. National policy states that infants should be referred to hospital if the 6-week check suggests DDH, though there is no available tool to aid examination or offer guidelines for referral. We developed standardised diagnostic criteria for DDH, based on international Delphi consensus, and a 9-item checklist that has the potential to enable non-experts to diagnose DDH in a manner approaching that of experts.
Methods And Analysis:
We will conduct a controlled trial randomised by practice that will compare a diagnostic aid against standard care for the hip check. The primary objective is to determine whether an aid to the diagnosis of DDH reduces the number of clinically insignificant referrals from primary care to hospital and the number of late diagnosed DDH. The trial will include a qualitative process evaluation, an assessment of professional behavioural change and a full health economic evaluation. We will recruit 152 general practitioner practices in England. These will be randomised to conduct the hip checks with use of the study diagnostic aid and/or as per usual practice. The total number of infants seen during a 15-month recruitment period will be 110 per practice. Two years after the 6-week hip check, we will measure the number of referred infants that are (1) clinically insignificant for DDH and (2) those that constitute appropriate referrals.
Ethics And Dissemination:
This study has approval from the Health Research Authority (16/1/2020) and the Confidentiality Advisory Group (18/2/2020). Results will be published in peer-reviewed academic journals, disseminated to patient organisations and the media.
Trial Registration Number:
NCT04101903; Pre-results.
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