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, Nick Freemantle, Irwin Nazareth, Andreas Roposch, Kaltuun Warsame, Angel Chater, Judith Green, Rachael Hunter, John Wood, Nick Freemantle, Irwin Nazareth

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 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.

Keywords: paediatric orthopaedics; paediatrics; primary care; public health.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart demonstrating pathways and principal endpoints and their collection. DDH, developmental dysplasia of the hip; GP, general practitioner; HES, Health Episodes Statistic.

References

    1. Bialik V, Bialik GM, Blazer S, et al. . Developmental dysplasia of the hip: a new approach to incidence. Pediatrics 1999;103:93–9. 10.1542/peds.103.1.93
    1. Public Health England Newborn and infant physical examination (NIPE) sceening Handbook. Available: [Accessed 27 Aug 2019].
    1. Clarke NMP, Reading IC, Corbin C, et al. . Twenty years experience of selective secondary ultrasound screening for congenital dislocation of the hip. Arch Dis Child 2012;97:423–9. 10.1136/archdischild-2011-301085
    1. NJR Editorial Board 10Th annual report: national joint Registry for England, Wales and Northern Ireland, 2013.
    1. Davies R, Talbot C, Paton R. Evaluation of primary care 6- to 8-week hip check for diagnosis of developmental dysplasia of the hip: a 15-year observational cohort study. Br J Gen Pract 2020;70:e230–5. 10.3399/bjgp20X708269
    1. Sanghrajka AP, Murnaghan CF, Shekkeris A, et al. . Open reduction for developmental dysplasia of the hip: failures of screening or failures of treatment? Ann R Coll Surg Engl 2013;95:113–7. 10.1308/003588413X13511609957137
    1. Price KR, Dove R, Hunter JB. Current screening recommendations for developmental dysplasia of the hip may lead to an increase in open reduction. Bone Joint J 2013;95-B:846–50. 10.1302/0301-620X.95B6.31461
    1. Roposch A, Liu LQ, Hefti F, et al. . Standardized diagnostic criteria for developmental dysplasia of the hip in early infancy. Clin Orthop Relat Res 2011;469:3451–61. 10.1007/s11999-011-2066-9
    1. Roposch A, Liu LQ, Protopapa E. Variations in the use of diagnostic criteria for developmental dysplasia of the hip. Clin Orthop Relat Res 2013;471:1946–54. 10.1007/s11999-013-2846-5
    1. Roposch A, Protopapa E, Cortina-Borja M. Weighted diagnostic criteria for developmental dysplasia of the hip. J Pediatr 2014;165:1236–40. 10.1016/j.jpeds.2014.08.023
    1. Roposch A, Protopapa E. Testing newly developed standardized diagnostic criteria for DDH in consecutive patients referred to a paediatric orthopaedic unit. Pediatric Orthopedic Society of North America, 2013.
    1. El-Kareh R, Hasan O, Schiff GD. Use of health information technology to reduce diagnostic errors. BMJ Qual Saf 2013;22 Suppl 2:ii40–51. 10.1136/bmjqs-2013-001884
    1. Croskerry P. Clinical cognition and diagnostic error: applications of a dual process model of Reasoning. Adv Health Sci Educ Theory Pract 2009;14 Suppl 1:27–35. 10.1007/s10459-009-9182-2
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Woolacott NF, Puhan MA, Steurer J, et al. . Ultrasonography in screening for developmental dysplasia of the hip in newborns: systematic review. BMJ 2005;330:1413. 10.1136/bmj.38450.646088.E0
    1. Clinical practice guideline: early detection of developmental dysplasia of the hip. Committee on quality improvement, Subcommittee on developmental dysplasia of the hip. American Academy of pediatrics. Pediatrics 2000;105:896–905. 10.1542/peds.105.4.896
    1. ICH Steering Committee Ich harmonised tripartite guideline: statistical principles for clinical trials. Available: [Accessed 5 Feb 1998].
    1. NHS Digital National clinical coding standards OPCS-2 (2018). Norwich, England: TSO Shop, 2018.
    1. MacArthur C, Jolly K, Ingram L, et al. . Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial. BMJ 2009;338:b131. 10.1136/bmj.b131
    1. Stevens K. Assessing the performance of a new generic measure of health-related quality of life for children and refining it for use in health state valuation. Appl Health Econ Health Policy 2011;9:157–69. 10.2165/11587350-000000000-00000
    1. Powell AA, Bloomfield HE, Burgess DJ, et al. . A conceptual framework for understanding and reducing overuse by primary care providers. Med Care Res Rev 2013;70:451–72. 10.1177/1077558713496166
    1. Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait anxiety inventory (STAI). Br J Clin Psychol 1992;31:301–6. 10.1111/j.2044-8260.1992.tb00997.x
    1. Gardner F, Dezateux C, Elbourne D, et al. . The hip trial: psychosocial consequences for mothers of using ultrasound to manage infants with developmental hip dysplasia. Arch Dis Child Fetal Neonatal Ed 2005;90:F17–24. 10.1136/adc.2002.025684
    1. Wensing M. EUROPEP 2006: revised EUROPEP instrument and user manual, 2006. Available: [Accessed 06 Jun 2014].
    1. Department of Health National Schedule of Reference Costs - Year 2011-12 - NHS Trusts and NHS Foundation Trusts: NHS own costs, 2015.
    1. Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ 1997;6:327–40. 10.1002/(SICI)1099-1050(199707)6:4<327::AID-HEC282>;2-W
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. McIntosh E. Using discrete choice experiments within a cost-benefit analysis framework: some considerations. Pharmacoeconomics 2006;24:855–68. 10.2165/00019053-200624090-00004
    1. Oakley A, Strange V, Bonell C, et al. . Process evaluation in randomised controlled trials of complex interventions. BMJ 2006;332:413–6. 10.1136/bmj.332.7538.413
    1. Michie S, Richardson M, Johnston M, et al. . The behavior change technique taxonomy (V1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013;46:81–95. 10.1007/s12160-013-9486-6
    1. Murray E, Treweek S, Pope C, et al. . Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med 2010;8:63. 10.1186/1741-7015-8-63
    1. Roposch A, Moreau NM, Uleryk E, et al. . Developmental dysplasia of the hip: quality of reporting of diagnostic accuracy for US. Radiology 2006;241:854–60. 10.1148/radiol.2413051358
    1. Elbourne D, Dezateux C, Arthur R, et al. . Ultrasonography in the diagnosis and management of developmental hip dysplasia (UK hip trial): clinical and economic results of a multicentre randomised controlled trial. Lancet 2002;360:2009–17. 10.1016/S0140-6736(02)12024-1

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj