Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice

Summary

Developmental dysplasia of the hip (DDH) is one of the most common inborn diseases. Early diagnosis of this condition is very important and it can be harmful both to miss DDH and label normal infants as having DDH. Why DDH can be missed or labelled to normal children is not well understood but can be related to the doctor's knowledge, skill and the way the hip consultation is conducted. This research aims to help overcome these issues and proposes the use of a diagnostic aid (checklist) for DDH in general practices (GP).

The Investigator will divide general practices (GP) in England into two groups. One group will use our checklist for all hip checks they carry out. The other group will work as they usually do, without the aid. The study wishes to compare if GPs who use the checklist will do better in identifying babies with DDH than those who do not use our checklist. The Investigator will also evaluate whether using the checklist reduces costs for families around trips to doctors or hospitals, and costs to the NHS (National Health Service). In addition The Investigators will interview general practitioners, health visitors and carers of infants to elicit their perceptions about the intervention.

The study will include GPs registered in England who carry out the 6-week hip check and agree to being randomised and to hospitals releasing data on infants they had examined during the study period. Practices planning to close within 12 months of the start of the study are not eligible. Eligible infants will be identified by general practice patient registers and infants will be invited to attend a 6-week check at their local practices, the research sites. The study plans to include a total of 152 practices in this study and will collaborate with 15 NIHR (National Institute of Health Research) CRNs (Clinical Research Network) to recruit GP practices with efficient and existing infrastructure.

Conditions

• Developmental Dysplasia of the Hip

Interventions

DIAGNOSTIC_TEST

The 6-week Hip Checklist

Comprehensive 9-item structured guide to aid in correct diagnosis of developmental dysplasia of the hip.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• University of Bedfordshire

  collaborator OTHER

• King's College London

  collaborator OTHER

• Steps Charity Worldwide

  collaborator UNKNOWN

• Longrove Surgery

  collaborator UNKNOWN

• Great Ormond Street Hospital for Children NHS Foundation Trust

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

11 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-06

Primary Completion

2025-06-30

Completion

2027-02-15

Countries

• United Kingdom

Study Locations