Mapping the local and regional characteristics of maternity population in England

King’s College London (KCL) requires access to NHS England data for the purpose of the following research project:

Mapping the local and regional characteristics of maternity population in England.

Higher risk of maternal morbidity and mortality amongst non-white ethnic groups in the United Kingdom was widely reported. Studies have not been able to identify causes for differences across ethnic groups, and the increased risk of maternal morbidity among Black Minority Ethnic groups. The total population of Black Minority Ethnic groups has the potential to increase from 13% in 2006 to 28% in 2031, and up to 44% by 2056, as projected by the Office for National Statistics.

This study is motivated by the observation of how maternity outcomes vary across trusts, and no clear explanation as to what contributes to these differences. Be it to what extent patients’ characteristics play or to what extent do trusts and geographical location have an influence.

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

• To quantify the risks of maternal morbidity, such as eclampsia, caesarean section use, and babies adverse outcomes including death, and Fetal Growth Restriction (FGR) for individual ethnic groups in the UK.

• To provide summary estimates of a range of maternity outcomes adjusting for patient characteristics, such as pre-existing medical conditions, past and current pregnancy problems, and healthcare utilization and trust influence.

• To provide policymakers with essential information on ways to provide more equitable and equal interventions for negative maternal outcomes, understanding differences between trusts’ services and geographical areas is important. This will be confined to adequate numbers that would not expose any patient to being identified.

The aims specific to this study are:

• To examine risk factors of maternity outcomes by region independently.

• To examine associations of risk factors including ethnicity, and maternity negative outcomes.

• To compare different statistical methods and their capability to provide meaningful summaries of outcome measures.

The following NHS England Data will be accessed:

• Maternity Services Data Set (MSDS) – necessary because it contains mother and baby maternity episodes relevant to the study outcomes of interest.

• Civil Registration of Deaths – necessary because the study will consider mortality outcomes during pregnancy or post-maternity episode

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

• Limited to a study cohort identified by NHS England as meeting the following criteria: mothers/ expectant mothers/ babies involved in maternity episodes

• Limited to data between 2017/18 and 2022/23

KCL 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 is provided by KCL. The funding is for the department/programme of work and is not specifically limited to the study described.

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

Data will be accessed by:

Substantive employees of KCL and 3 Masters and/or 3 PhD students enrolled with KCL. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to KCL’s policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of KCL. KCL would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this DSA.

The study ensures the involvement of members of the public and seeks advice at early stages via the ongoing Public and Patient Involvement and Engagement (PPIE) Advisory Group for RESILIENT and for ELIXIR (Early Life Cross Linkage in Research) Programme. ELIXIR is a research programme using linked resources of data to help understand the early origins of disease and provide novel strategies for prevention. This DSA was discussed with the RESILIENT PPIE Advisory Group, and there were no objections in consideration of diverse public views which have contributed to the design of the proposed use of the data. There is a dissemination plan for RESILIENT, with listening Events for regional discussion and a national Policy Lab. King’s College London has guidelines for handing media coverage and these will be observed.

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 and Civil Registration of Deaths datasets to KCL. 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 KCL.

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).

Remote processing will be from secure locations within England/Wales. The data will not leave England/Wales at any time.

Access to the core dataset is restricted to substantive employees of KCL who have authorisation from the Principal Investigator. They will produce subsets of the Data that will be accessed by the students.

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.

Researchers from KCL will process the Data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer reviewed journals (such as Women and Birth; British Medical Journal, BioMed Central).

• Presentations at appropriate conferences (such as UKIMS Perinatal Mental Health Conference, Royal College of Paediatrics and Child Health Conference, Royal Statistical Society annual conference)

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.

• Summaries of each journal publication for patients and the public interested in research on maternal and child health, based at King’s Health Partners (KHP) and nationally.

• Conferences and societies.

• Social media via the Kings School of Life Course and Population Sciences account.

• Listening Events for regional discussion and a national Policy Lab.

The production and dissemination of the outputs are expected to take place from 2025 onwards and continue throughout the lifetime of the agreement.

The findings of this research study 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.

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.

• Advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions relevant to the subject matter of the study.

• 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).

This study is believed to be the largest study undertaken to determine the associations between risk factors and a range of maternity adverse outcomes, considering trusts and geographical regions’ characteristics.

The study is expected to have direct implications for the way that care to pregnant women is managed, delivered, and its potential benefit to patients. Policymakers and health practitioners including clinicians and managers require this research to determine whether a service tailored to different subgroups (possibly ethnic minorities) is warranted to avoid more negative maternity outcomes. The study will identify differences in care access across different ethnic groups and different regions. Models will be used to adjust for confounders. The study will provide evidence of care equity and identify groups that may benefit from tailored services and follow up.

This study is anticipated to provide evidence to inform shared decision-making related to mothers’ and babies’ unfavourable maternity outcomes, helping the system to better understand the health and care needs of populations, and advance understanding of regional and national trends in health and social care needs.

This project is expected to help to inform a reduction in unwarranted variation in current negative maternity outcomes. It is intended to support the promotion of high standards of quality health care that can address potential health issues that would be identified on inequities in access to care, pre and during pregnancy and after childbirth. It is planned to identify patient groups with differing risks of poor maternity outcomes, to enable better tailored maternity care.

As a result of this study, KCL expect to provide the information and evidence needed to promote polices that would result in reduction in deaths/ eclampsia complications/ death in childbirth for certain populations.

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.

Members of the public will be engaged in many pieces of KCL research through ongoing public and patients' involvement (PPI) groups. The PPI groups will be updated with findings and will be invited to share interpretations and results at earlier stages before dissemination, to be able to accommodate adverse all potential opinions and views.

This project provides an opportunity to collaborate with NMPA that will advance clinical, academic, and methodological knowledge more than either NMPA or KCL can achieve working in isolation of each other. From KCL's end, the project facilitates capacity building including training master’s, Fellows, and PhD students, supporting methodology development to refine estimations of outcomes and statistical adjustments.

These refined estimates would support The NHS with quality information to empower future decision making for the better outcomes of patients. Progress can be measured by assessing trends of outcomes on regular basis using appropriate methodology and suitable adjustments. The NMPA fully endorses this project and highlights that the collective body of research proposed, will add clinical and methodological value to maternity

KCL also aim to be inclusive of relevant charities and societies, to enable wide advertisement of key findings, for example KCL engage Tommy's Baby Charity - Baby Loss Research.

Yielded Benefits is not a requirement for new applications.