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Study protocol for evaluation of aid to diagnosis for developmental dysplasia of the hip in general practice: controlled trial randomised by practice

  • Andreas Roposch
    ,
  • Kaltuun Warsame
    ,
  • Angel Chater
    ,
  • Judith Green
    ,
  • Rachael Hunter
    ,
  • John Wood
Research Output: Contribution to journal Article Peer-review

Open access

Abstract

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 useof the study diagnostic aid and/or as per usual practice. The total number of infants seen during a15-month recruitment period will be 110 per practice. Two years after the 6-week hip check, we willmeasure 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.

Publication Information

Output type

Research Output: Contribution to journal Article Peer-review

Original language

English

Pages from-to (Number of pages)

Pages e041837

Journal (Volume, Issue Number)

BMJ Open (Volume 10, Issue 12)

Publication milestones

  • Accepted/In press - 21/11/2020
  • Published - 02/12/2020

Publication status

Published - 02/12/2020

External Publication IDs

  • handle.net: 10547/624722
  • Scopus: 85097124656

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