Evaluation of aid to diagnosis for congenital dysplasia of the hip in general practice: controlled randomised trial

Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) requires access to NHS England data for the purpose of the following research project: Hip Dysplasia Screening Programme (HipDys study)

The following is a summary of the aims of the research project provided by GOSH:

“Developmental dysplasia of the hip (DDH) is one of the most common congenital abnormalities and early diagnosis is key for successful treatment. Infant hips are initially examined at birth; however, this cannot always detect cases of DDH, therefore all infants undergo a second examination with their General Practitioner (GP) at 6-8 weeks of age. Despite both of these hip checks, 1-2 in 1000 children are still diagnosed late with DDH. As a result, more than 2000 hip replacements are performed every year in the UK because of DDH. It can be harmful both to miss DDH and to incorrectly diagnose infants as having DDH.

“It is not well understood why children that do not have DDH are incorrectly diagnosed as having DDH and why some who actually have DDH are not detected early enough. Studies suggest that this may be related to the examiner’s knowledge, skills and/or the way the hip check consultation is conducted. The Hip Dysplasia Screening Programme (HipDys study) seeks to address these disparities to improve the ability of GPs in evaluating infants’ hips using a diagnostic aid, which in turn could yield a financial benefit to the NHS by way of eliminating unnecessary referrals to secondary care, appointments and subsequent treatments for DDH. More specifically, the main aim of this randomised control trial is to determine whether the diagnostic aid for DDH reduces the number of clinically insignificant referrals from primary to secondary care, as well as reduce the number of DDH cases diagnosed late.

“GPs from 172 GP practices across England, who carry out the 6-week hip check on infants between 42 and 70 days old, will be divided into two groups. Eligible participants will be identified by general practice patient registers and infants will be invited to attend a 6-week check at the practice. One group of GP practices will be given the diagnostic aid, comprising of a video tool and a checklist (HipDyS checklist) to use in all hip checks they carry out. The other group will screen for DDH as normal, without the use of the HipDyS checklist. The two groups will then be compared to see if the first group better identified infants with DDH than the second group. Researchers from the study will also evaluate whether using the checklist reduces costs for families around trips to doctors or hospitals, and costs to the NHS.”

The following NHS England data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care – necessary because inpatient data will provide details of any inpatient procedures conducted by orthopaedics (e.g. surgery) following the 6-week hip check for infants who have undergone their 6-week check.

The level of the data will be:

• Identifiable – necessary because although the applicant will pseudonymise the data before analysis, Date of Birth is required to ensure that the data received is matched to the correct infant.

The data will be minimised as follows:

• Limited to a study cohort of approximately 16,720 infants between 42 and 70 days old, invited for the 6-week hip check at participating GP surgeries in England.

• Limited to data between 1st December 2020 to June 2026. For each individual patient, data will only be provided from the provided hip check date and will be restricted up to the 2nd anniversary of said hip check date.

The study has received Section 251 support from the Confidentiality Advisory Group (CAG) (19/CAG/0198) to access information on the 6-week hip check for infants who meet that criteria. The study team seek to get this information through the HES inpatient (admitted patient care) data set, as well as through central monitoring. The alternative to following up with these infants would be to visit all 172 practices and the hospitals that infants have been referred to and going through the records of at least 110 infants per GP practice, at 2 years however, the study does not have the resources (e.g. staffing or financial) to achieve this.

GOSH is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The study is in the public interest as it aims to reduce unnecessary costs to the NHS (thus enabling the NHS to relocate investment) and it aims to reduce unnecessary stress on affected infants and their parents/guardians.

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the HipDyS study as described.

University College London (UCL) is a processor acting under the instructions of GOSH. UCL’s role is limited to storing and processing the data in line with the study protocol (as determined by GOSH).

Amazon Web Services (AWS) is a processor acting under the instructions of UCL. AWS’ role is limited to secure back-up of data stored in UCL’s Data Safe Haven.

Under the HipDyS study umbrella, a qualitative study will examine the effects of implementing the trial intervention in practice and includes interviews and non-participant observations with a sample of GPs, parents/carers of infants and hospital consultants by a researcher from Kings College London (KCL), who is leading the qualitative study with the University of Bedfordshire. The qualitative study does not include data from NHS England and neither KCL nor University of Bedfordshire have any influence over the NHS England data under this Data Sharing Agreement.

Data will only be accessed by individuals who are substantive employees of UCL.

GOSH will take advice from patient and public involvement (PPI) groups as to the best way to disseminate results to relevant service users. The PPI group are comprised of professionals and parents from GOSH and the STEPs charity (https://www.stepsworldwide.org/). The PPI group have played a vital role in designing the trial. They advised and collaborated with the study to put together the ethics application and developed study materials including the on-line training video for GPs (part of the diagnostic aid), the study questionnaires and the interview schedules for parents/carers and GPs. The PPI group were also involved in the review of the findings from prior research linked to this randomised controlled trial. The PPI group meet with the study team at various points throughout the trial with the outcome of these meetings feeding into the trial’s steering group meetings.

UCL will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth) and a unique person ID for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the HES Admitted Patient Care dataset to UCL. The data will contain directly identifying data items (Date of Birth) which are required to confirm the correct link at record level with data already held by the recipient. Additionally, the data flow from NHS England will contain a unique person ID which can be used to link the data with other record level data already held by the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at UCL.

Amazon Web Services provides cloud hosting services to UCL and will store the data as contracted by UCL.

UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The data will not leave England at any time.

Access is restricted to individuals within the department of UCL who have authorisation from the study team. All such individuals are substantive employees of UCL.

GOSH is not permitted to access the data.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will be linked at person record level with the reported study data obtained from GPs.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the PRIMENT Clinical Trials Unit (https://www.ucl.ac.uk/priment/home/priment-clinical-trials-unit) within UCL will process the data for the purposes described above.

Trial findings will be disseminated in the following ways:

1. Presentations at national and international academic conferences to ensure members of the academic community within paediatrics, orthopaedic and behavioural psychology (regarding the qualitative and Health Economics studies) are informed These conferences include; The European Paediatric Orthopaedic Society conference, British Society for Children’s Orthopaedic Surgery, Paediatric Orthopaedic Society of North America, International Society of Behavioural Medicine conference and International Society of Behavioural Medicine conference

2. Publication in biomedical journals: the trial will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) statement (www.consort-statement.org). GOSH aim to publish its results in a high-impact general medical journal. GOSH will also contact the free publications received by most UK GPs to ask them to publicise the results. These journals include: The Journal of Bone & Joint Surgery, Journal of Children’s Orthopaedics, Lancet, British Medical Journal, The Journal of Pediatrics, Translational Behavioural Medicine, Implementation Science Journal and British Journal of Health Psychology

3. Royal Colleges: GOSH will ensure the primary care community, physicians and nurses are informed of the results through links with the Royal Colleges of General Practitioners; Surgeons; Paediatrics & Child Health.

4. NHS: All results will be communicated to NHS England and to local Integrated Care Boards, especially the Clinical Reference Orthopaedics and Paediatrics, of which the chief investigator is a member.

5. National Institute for Health and Clinical Excellence (NICE), Clinical Reference Group Orthopaedics NHS England, British Society of Childrens Orthopaedics: All will be aware of trial results.

6. Service Users: GOSH will actively communicate with patient and public involvement (PPI) groups

7. Press: UCL and Great Ormond Street have press offices, which connect medical journalists throughout the global media.

8. Websites: GOSH will publicise results on the UCL website. GOSH will also approach Great Ormond Street Hospital Childrens Charity to link to other web sites.

9. Support groups such as STEPs or MumsNet to make members of the public who have an interest or are affected by hip problems aware of the trial results and their care could be impacted.

10. Several co-applicants have international reputations and may be asked to lecture on various aspects of primary care, paediatric orthopaedics, and research methodology, thus introducing new practices into the relevant medical curriculum.

The specific journals and conferences mentioned will allow for coverage of key stakeholders in the setting of primary care, clinical trial design and clinicians involved in orthopaedics research. The aim is to begin presenting results and submitting papers to journals within months of trial results being established, approx. December 2026.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

At present, the number of referrals that are deemed clinically insignificant are higher than those deemed clinically significant. In addition, every 1-2 in 1000 children are lately diagnosed with DDH. The primary aim of this trial is to reduce the number of clinically insignificant referrals to secondary care (referrals that result in immediate discharge and no diagnosis). Additionally, the trial aims to reduce the number of late diagnoses of DDH and increase the accuracy of clinically significant referrals (referrals that result in treatment/monitoring), to improve health outcomes for infants found to have DDH.

Having access to HES data will allow the study team to track children that were assessed using the HipDyS trial checklist and compare their data to those who were not assessed using the checklist. This comparison will allow the trial team to assess whether the diagnostic aid reduces the number of insignificant and or/ late referrals to secondary care. As such, the diagnostic aid will provide a structured approach for GPs to the examination of infants within primary care, thus utilising the referral pathways for those truly in need, with the potential of allocating NHS resources more efficiently in the long term and relieving the impact on the already strained NHS service.

Similarly, the intended benefit to infants and their parent/carers are:

• Alleviate unnecessary worry for infants that would have otherwise been incorrectly diagnosed as having DDH

• Improve health outcomes of infants who do truly have DDH, as they’re able to be seen and treated by a specialist quicker

• Reduction or elimination of travel costs, to unnecessary hospital appointments, for parent/carers of infants that would have otherwise been incorrectly diagnosed.

The use of routine electronic health records within multicentre trials has the potential to both reduce the impact of additional trial-specific GP Practice visits for both clinical research teams and, significantly reduce the costs of central trial coordination and data collection.

If the results of the study are favourable, the team hope to make the diagnostic aid available to GPs by mid 2027 for use when conducting 6-week checks, alongside other current government guidance they may use on conducting these checks.

Yielded Benefits is not a requirement for new applications.