The SMARTIE Study: SMART4NIPE Integrating Evidence Study

The Data will be used for the purpose of a service evaluation: The SMARTIE Study: SMART4NIPE Integrating Evidence Study.

Overarching Aim - The data will be used to describe the frequency, variation, and outcomes of Developmental Dysplasia of the Hip (DDH) within the NHS England NIPE screening programme, using the Smart4NIPE national dataset.

DDH screening and treatment represents the most fundamental and highest-volume function in children's orthopaedic surgery in England. Despite this, no national audit/ or service evaluation. currently describes the outcomes of the pathway - only the referral process. Clinicians, commissioners, and NHS England cannot currently determine whether the programme is working, where variation exists, or whether outcomes differ between providers and regions.

This gap has important patient safety considerations. Recent independent reviews within paediatric orthopaedic services have highlighted the risks associated with the absence of systematic outcome monitoring and consistent national oversight. These findings have led to increased scrutiny of children’s orthopaedic care at a national level and emphasised the need for robust data to identify variation in practice and outcomes.

The SMARTIE audit directly addresses this gap by establishing, for the first time, a comprehensive national picture of developmental dysplasia of the hip (DDH) outcomes. This will enable variation to be identified, understood, and acted upon in a timely and evidence-based manner.

The findings will be shared with relevant professional and clinical communities, including national clinical improvement programmes, to support service development and quality improvement. The service evaluation has been developed with engagement from senior clinical leadership within children’s orthopaedics, including representation from national clinical directors, clinical leads for trauma and orthopaedics improvement programmes, and expert advisors in paediatric hip screening and surveillance. This ensures alignment with current national priorities for improving outcomes in children and young people.

The data will not be used for any experimental purpose. No hypothesis is tested. No patient care is altered. The sole purpose is to describe current NHS practice to support national oversight, identify unwarranted variation, and directly improve the safety and quality of DDH care in England.

The objectives of the service evaluation is to:

• Describe the frequency of DDH in England identified through the NIPE screening programme, exploring the different disease severities and diagnostic definitions used by doctors.

• Describe the frequency of DDH in England identified after the initial NIPE screening period, identified by reporting clinicians initiating treatment.

• Describe the frequency of True Positives screens and False Positive screens, using varying ultrasound diagnostic thresholds.

• Describe variations in the treatment pathways for DDH (i.e. differences in diagnostic thresholds for treatment, differences in timing of treatments, differences in the types of splint used, differences in duration of treatment, differences in treatment discontinuation pathways).

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the NHS England NIPE (Newborn and Infant Physical Examination) hip screening pathway to University of Liverpool.

The Data will:

• Contain no direct identifying data items.

• The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at University of Liverpool and on the Cloud provided by Microsoft Ltd.

The Data will be accessed onsite at the premises of University of Liverpool and via remote access.

For 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 be linked with any other data outside of this agreement.

The expected outputs of the processing will be:

Expected submissions

• Presentations to NIPE programme (NHS England), British society of orthopaedic surgery, midwives and paediatricians.

• Publication in journals.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Peer review scientific journals

• STEPS charity, who support the audit and PPIE partners. STEPS is a UK based national charity that supports children and adults affected by childhood lower limb conditions, including developmental dysplasia of the hip (DDH).

• Social media STEPS charity, Mumsnet.

• Public reports NHSE and NIPE programme

• Public promotion of the audit [Mumsnet and STEPS charity]

• Participant newsletters [Mumsnet and STEPS charity].

Outputs target 2027-2028

In 2024, the Smart4NIPE team (Perry et al.) updated the National Screening Database within Smart4NIPE to introduce new SCREENING fields, developed through a formal core measurement set, to improve the quality and consistency of data captured within the national pathway – moving from a process monitoring tool, to a tool with clinical value. These additions were to support national audit of pathway delivery, identify variation between centres, and highlight areas where greater standardisation may be needed. These fields were rolled out nationally.

In addition, hospitals were able to opt in to provide supplementary treatment fields, capturing information on how infants were managed following screening. This enables the NIPE programme to assess the downstream clinical consequences of screening, including variation in diagnostic thresholds, treatment decisions, and treatment pathways.

This national service evaluation will use routinely collected Smart4NIPE NIPE screening data to describe the frequency of developmental dysplasia of the hip (DDH) identified through screening, examine variation in recorded diagnostic thresholds and early management pathways, and report practice patterns across centres. The findings will support quality improvement by strengthening the value of Smart4NIPE beyond process monitoring alone, identifying unwarranted variation, and highlighting potential areas of over-treatment or under-treatment. The work will also help inform NHS policy and future guidance relating to screening and early management of DDH.

In the longer term, these analyses may also provide important feasibility information for future large-scale clinical trials evaluating screening and treatment strategies for DDH. Such trials could potentially be embedded within routine care through further development of the Smart4NIPE pathway, with the database providing an efficient mechanism for structured data capture.

The use of the data could:

• help the system to better understand the health and care needs of populations.

• highlight variation in care, concerning the screening and treatment of hip dysplasia in babies.

system design to improve health and care outcomes or experience.

• advance understanding of regional and national trends in health and social care needs.

• advance understanding of the need for, or effectiveness of, preventative health and care

The findings of this service evaluation are expected to contribute to evidence-based decision-making for policymakers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

Yielded Benefits is not a requirement for new applications.