National Maternity Research Database pilot

Imperial College London (ICL) requires access to NHS England data for the purpose of the following research project: National Maternity Research Database (NMRD) Pilot.

UK NMRD (National maternity research database) was established at ICL in 2007, collecting 400 routine data fields on babies admitted to UK neonatal units. The NNRD team has developed unique expertise in establishing high quality data for the purpose of service evaluations, quality improvement projects, and ethically approved research. The UK has a wealth of data on outcomes and treatments in pregnancy and breastfeeding. Much of it is fragmented across different datasets according to care setting, outcome, and UK nation. There are gaps in the available data with some variables either missing completely or poorly recorded presenting opportunities to optimise data collection and access.

The broad aims of the NMRD are:

• To create a UK maternity dataset to include outcomes from all stages of pregnancy, the postnatal period, and for neonates not admitted to neonatal units.

• To support local, regional, and national service improvement and audit in maternity services to improve pregnancy outcomes in the UK.

• To facilitate participation of women in pregnancy in local, regional, and national clinical and epidemiological observational research and Randomised Controlled Trial (RCTs) using routinely collected clinical outcomes.

The aims of the NMRD Pilot research project are:

• To evaluate key variables in maternity care delivery contributing to pregnancy outcome disparities by ethnicity on a national level.

• To evaluate these disparities by ethnicity over time to analyse what factors in maternity care delivery contribute to disparities in pregnancy outcome by ethnicity.

The requested data will be processed to investigate the following primary outcomes:

• Attributable risk for factors in maternity care delivery for a composite of mortality outcomes (maternal, fetal, neonatal death) by ethnicity category.

• Attributable risk for factors in maternity care delivery for individual mortality outcomes in pregnancy by ethnicity.

This research project also aims to assess the completeness and quality, by field and maternity care provider, of the Maternity Services Dataset (MSDS) for the purpose of linkage within the NMRD. The objectives of this processing are:

• To form a pilot national maternity research database from pseudonymised MSDS data.

• To assess the quality & completeness of MSDS data by field and maternity provider.

• To feedback results from secondary objectives to NHS England and work with national stakeholders on a strategy to improve the data.

The following NHS England Data will be accessed:

• MSDS v1.5 and v2.0 - necessary to assess patient records at each stage of the maternity service care in NHS-funded maternity services to evaluate factors in care delivery which may be linked to disparities of outcome. The data will provide information on differential outcomes for patients during pregnancy and on patient pathways including utilisation of antenatal and intrapartum care. This will inform analysis on which factors in maternity care delivery contribute to disparities and whether these outcomes are attributable to deprivation and ethnicity.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

• Limited to data from 2015-2023

• Data is requested from all available non-identifiable & sensitive fields within the MSDS datasets. All records within the given timeframe are requested.

- It is not suitable to narrow the data by geography as the quality and completeness for each English maternity trust will vary.

- It is not suitable to narrow the data by demography as the outcome disparity by ethnicity may vary by geography, age, and other demographic factors.

- It is not suitable to narrow the data by clinical factor or episodes as the factors in maternity care delivery associated with pregnancy outcome disparity by ethnicity are yet unknown.

ICL is the research sponsor and the controller who also processes the data 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.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding was provided by the National Institute for Health and Care Research Imperial Biomedical Research Centre. Funding was was provided up to 30/11/2022 and has been retained for the project described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

Public and Patient Involvement and Engagement (PPIE) groups helped refine the purpose of the research. The group supported the collection of the data for the purposes described above.

The project initially involved the Royal College of Obstetricians and Gynaecologists Women’s Voices panel, a North West London women’s health PPIE group, the Maternity Voices Partnership, and Baby Lifeline (a leading maternity Safety charity). These organisations/groups helped in developing the concept of the NMRD and in defining initial use cases for the data.

ICL will recruit a funded NMRD steering group consisting of mothers and a representative from a leading maternity safety organisation on the steering committee for the NMRD to develop governance, manage access and consult on use of the database.

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 MSDS v1.5 and v2.0 datasets to ICL. 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 ICL.

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/Wales at any time.

Access is restricted to substantive employees of ICL who have authorisation from the Chief Investigator.

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

The Data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts from ICL will process the Data for the purposes described above.

The expected outputs of the processing will be:

• Biannual internal and external reports for ICL to assess the disparities in clinical care and common morbidities between all women of different ethnicities giving birth in England.

• Submissions to peer reviewed journals (such as British Journal of Obstetrics and Gynaecology, British Medical Journal).

• Presentations at public engagement and NHS events (such as local and national Maternity Voices Partnership meetings [service user groups]).

• Presentations at appropriate conferences (such as National Maternity Safety Conference).

• Supporting analysis of the suitability of MSDS for developing the NMRD as a database to be utilised as a resource for health research.

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:

• Journals

• Presentations at events and conferences

• Webinars organised by the Imperial College Women's Health Network

• The Bridge (London Women's health PPIE group)

• Imperial Policy Forum (https://www.imperial.ac.uk/the-forum/)

• Imperial College and NHS social media channels (@imperialcollege and @UKNMRD).

The production and dissemination of the outputs are expected to begin at 12 months following receipt of the data and will target an audience of researchers, scientists, policy makers, research participants, and maternity service users.

The findings of this research study 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.

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.

• inform decisions on how to effectively allocate and evaluate funding according to health needs.

• 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).

Impact on data quality and completeness:

By evaluating the quality and completeness of data, the feasibility of the use of MSDS for research and service improvement can be demonstrated. Ongoing work to improve data quality and completeness can be supported and targeted at units and data flows which are currently supplying data of low quality or completeness. There are 122 maternity trusts in England. The data outputs, by field and by maternity service provider, will be disseminated to NHS England and all maternity NHS trusts, guided by the project steering group. This dissemination will support the utilisation of additional maternity safety funding announced after the recent Ockendon enquiry for these purposes targeted to the geographical areas and populations identified as at risk of poor pregnancy outcomes in the data. Dissemination through NHS England might support prioritisation of routine data entry by NHS Trusts.

Impact on maternity services through research and service improvement:

By evaluating the factors in maternity service delivery which are associated with disparities in pregnancy outcome by ethnicity, service improvement and further research can be designed by a range of stakeholders in order to address the maternity service delivery factors associated with disparities in pregnancy outcome by ethnicity and evaluate the effect of these on excess mortality in non-white women. NHS England has launched successive care bundles to reduce stillbirth, which affects over 2000 women a year in England. This processing is hoped to support the assessment of the effects of these care bundles in women of different ethnicities and different geographical locations to evaluate areas where improvements can be made to care services provided to these women.

Impact on mortality in women and babies:

The outputs are hoped to inform maternity service improvement, locally and nationally, and further research to reduce excess mortality by ethnicity in maternity. If disparities in maternal mortality can be addressed, it is highly plausible that the UK can reduce its maternal, fetal and neonatal mortality.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations, and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Yielded Benefits is not a requirement for new applications.