NHS Digital Data Release Register - reformatted
Epsom And St Helier University Hospitals NHS Trust projects
9 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Maternal and fetal variables associated with term stillbirths — DARS-NIC-239092-Q9Q3X
Type of data: information not disclosed for TRE projects
Opt outs honoured: Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)
Legal basis: Health and Social Care Act 2012 s261(2)(a)
Purposes: No (NHS Trust)
Sensitive: Sensitive, and Non-Sensitive
When:DSA runs 2023-01-25 — 2025-03-31 2023.04 — 2024.02.
Access method: One-Off
Data-controller type: EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST
Sublicensing allowed: No
Datasets:
- Maternity Services Data Set (MSDS) v1.5
- Maternity Services Data Set (MSDS) v2
Objectives:
Epsom and St Helier University Hospitals NHS Trust requires access to NHS England data for the purpose of the following research project:
Maternal and fetal variables associated with term stillbirths
The following is a summary of the aims of the research project provided by Epsom and St Helier University Hospitals NHS Trust:
The aim of the study is improving outcomes for women and babies from black, Asian and minority ethnic (BAME) backgrounds. Previous studies have shown differences in stillbirth rates for women and babies from BAME backgrounds and differences in gestational age duration between different ethnic groups, as a possible contributor to term stillbirths.
This study aims to add to the existing MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK) work by looking specifically into stillbirths and identify risk factors cohort. The focus of this study is more precise than other dataset studies to enable informed decision-making processes by analyses of parameters that have not been addressed in other studies.
The following NHS England data will be accessed:
Maternity Services Data Set (MSDS) necessary because this dataset will enable the study team to analyse risk indicators, and also, to specifically identify outcomes for women and babies from BAME backgrounds. The data will include all records for the most recent 5 years. As part of the study the research term will need to compare all stillbirths (from 24 weeks to 42+ weeks with a specific focus on term stillbirths >37 weeks gestation) with all births (as a control group).
The level of the data will be pseudonymised.
The data will be minimised as follows:
Limited to data between 2017/18 and 2021/22
Epsom and St Helier University Hospitals NHS Trust is the data 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.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients treatments or care.
The funding is provided by Epsom and St Helier University Hospitals NHS Trust. The funding is specifically for the project. Funding is in place until March 2024.
In addition to the team at Epsom and St Helier University Hospitals NHS Trust, data will be accessed by an individual with an honorary contract with Epsom and St Helier University Hospitals NHS Trust. The individual is a clinician from an NHS trust who will be supporting the data analysis.
There has been no direct patient and public involvement and engagement (PPIE) for this specific study, as this study is to complement the MBRRACE-UK work previously completed. The MBRRACE-UK work has had extensive PPIE.
Expected Benefits:
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.
advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations
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.
support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).
The results of the study may potentially identify differences in stillbirth rates at different gestations, dependant on ethnicity and if the study hypothesis is proved in the results, then management of pregnancies may need to be modified. Examples of potential impact of the study could include follow up of small for gestational age babies, recommendations for mode and timing of delivery in such high-risk pregnancies, especially those from ethnic minorities and the management of pregnancies after 40 weeks. Tailoring the care needed for specific groups may eventually lead to overall reduction of pregnancy complications but especially in the reduction of term stillbirths. Stillbirths have a significant impact on maternal health, physical and mental health of the individual, with a significant impact on future pregnancies.
It is hoped the benefits gained from the study may also be to improve the evidence base and support the wider teams looking after pregnant individuals. It will be one part of a wider move towards supporting women and staff. Management of such poor outcomes in pregnancies involves multiple agencies (counsellors/bereavement midwives/ general practitioners/obstetricians) and staff groups. Stronger evidence to enable more informed decision making may support everyones role.
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.
Outputs:
The expected outputs of the processing will be:
Submissions to peer reviewed journals (For example, the British Journal of Obstetrics and Gynaecology)
Presentations
- Local via the Maternity Voices Partnerships (MVP)
- Regional by the local Maternity & Neonatal Services (LMNS)
- National via organisations working in the field - for example, Stillbirth and Neonatal Death Charity (SANDS).
Presentations at international conferences. For example:
- The Royal College of Obstetricians and Gynaecologists Annual World Conference
- Society for Maternal and Fetal Medicine, United States
- International Federation of Gynaecology and Obstetrics (FIGO) World Congress
Production of a risk assessment tool which may be made available for clinicians and the public to use at the start of pregnancy or even pre-pregnancy. The aim is to develop risk calculators based on certain variables. This tool will be available free of charge.
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 from which the information was derived.
The outputs will be communicated to relevant recipients through the following dissemination channels:
Journals
Workshops involving doctors and midwives
Social media
Briefing documents provided to the Royal College Of Obstetricians & Gynaecologists (RCOG)
Relevant charities (for example, SANDS)
The target date for publication of the results and development of the risk assessment tool is summer 2024.
Processing:
No data will flow to NHS England for the purposes of this Agreement.
NHS England data will provide the relevant records from the MSDS dataset to Epsom and St Helier University Hospitals NHS Trust. 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 Epsom and St Helier University Hospitals NHS Trust.
The data will be accessed onsite at the premises of Epsom and St Helier University Hospitals NHS Trust only.
Personnel are prohibited from downloading or copying data to local devices.
The data will not leave England and Wales at any time.
Data will be accessed by an individual with an honorary contract with Epsom and St Helier University Hospitals NHS Trust. The individual will act as an agent of Epsom and St Helier University Hospitals NHS Trust at all times under supervision from employees of Epsom and St Helier University Hospitals NHS Trust. Aside from this individual, access is restricted to employees of Epsom and St Helier University Hospitals NHS Trust who have authorisation from the Principal 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.
Researchers from the research and study team will process the data for the purposes described above.