The Digital Imaging versus Ophthalmoscopy (DIvO) study

The Data will be used for the purpose of a clinical trial: The Digital Imaging versus Ophthalmoscopy (DIvO) Study.

The purpose of the clinical trial is to confirm or refute the hypothesis that the sensitivity and specificity of screening with digital imaging (DI) using the Neocam device is superior to the standard ophthalmoscopic red-reflex (O) test.

The objectives of the clinical trial are to:

1. Determine the relative and absolute sensitivity and specificity of the standard test and Neocam imaging: comparison of accuracy with each test overall.

2. Determine the effect of subject’s ethnicity or screener experience on screening accuracy with each test. Assess usability and preference.

The Data will be used to answer the following question:

1. Can the diagnostic accuracy of newborn eye screening for congenital cataract be improved with digital dual light source imaging?

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 HES datasets to Cambridge University Hospital NHS Foundation Trust (CUHFT). 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 CUHFT. The data will not be stored at any other location.

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

The Controller 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 but will be used for comparison with the DIvO trial cohort data provided under a separate DSA (Ref: DARS-NIC-792991-W4Z6B).

The expected outputs of the processing will be:

• A report of findings to the regulatory authorities with as Medicines and Healthcare Regulatory Authority (MHRA).

• A epidemiological study using the data from the SDE in 2026 and the study findings (Nature, Eye) following the final analysis towards the end of 2027 after the data linkage analysis.

• Presentations are expected at the following conferences in 2027/28:

• Association for Research in Vision and Ophthalmology conference

• American Paediatric Ophthalmology Society

• World Society of Paediatric Ophthalmology and Strabismus conference.

• Congress of the European Paediatric Academic Society

• Royal College of Paediatrics and Child Health Congress

• Royal College of Ophthalmologists Congress

• British Paediatric Ophthalmology and Strabismus Association Conference

• The results will be presented to the National Screening Committee in 2027 to determine if a change in national neonatal screening policy is required

• Publication on Data Controllers website.

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:

• Social media - The Patient Advisory Group will be able to support members of the PPI group or recruited families who may be emotionally affected by participation in the study. Members of the PPI group have agreed to disseminate information about the study and its results on social media platforms.

The findings of this clinical trial are expected to contribute to evidence-based decision-making for policy-makers, 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. This trial also has the potential to enable the baby to have their congenital cataracts detected earlier, leading to more successful long-term visual outcomes than would have otherwise be possible. The results of this trial may inform national Health and Government guidelines and impact standard care in this field both nationally and internationally.

The use of the data could:

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

• Lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

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

• Inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• Provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

• Support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

Yielded Benefits is not a requirement for new applications.