Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK)

Cardiff University requires access to NHS England data for the purpose of the following research project:

Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK)

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

Bleeding is the most common complication of childbirth. Every year about 50,000 women in the UK lose 1L (2 pints) of blood or more. Many women develop post-traumatic stress disorder, need blood transfusion or admission to intensive care, often developing mental health issues after having their baby. Women from minority ethnic backgrounds and more socioeconomically deprived areas are also disproportionately affected. The optimum treatment of bleeding after childbirth is not known and outcomes have not improved over the last 10 years despite comprehensive national guidelines.

Cardiff University have developed a care bundle for treating bleeding during childbirth in Wales called the ‘Obstetric Bleeding Strategy’ (OBS). The care bundle is: 1) Assessment of every woman’s bleeding risk, 2) Real-time measurement of blood loss after all births, 3) A consistent approach to managing excess bleeding and involving more senior clinicians, 4) Bedside tests to rapidly identify and treat abnormal blood clotting. This contrasts with current UK guidelines which recommend measuring blood loss only after excess bleeding is identified. The Obstetric Bleeding Strategy (OBS) bundle was associated with a reduction in major bleeding and blood transfusion but do not know whether the improved outcomes were due to the OBS programme- This national study follows on from a pilot study in which it was found that the OBS care bundle could be successfully adopted by maternity units. The results from the OBS pilot were encouraging, but since this was a small study with limited data, it is not known whether the improvements seen were due to the change in care, or whether the care bundle is value for money. To find this out, this study will compare clinical outcomes, psychological wellbeing and cost of care for women and birthing people in maternity units that use the care bundle with patients receiving standard care.

The study is a stepped wedge cluster randomised trial. Thus each site are providing comparator data during the period of standard care and the maternity unit is the unit of randomisation. Maternity units have been randomised to one of six sequences, so there are 6 maternity units in each sequence. Maternity units initially collect data during a period of standard postpartum hemorrhage (PPH) care for between 3 and 18 months, depending upon the outcome of randomisation. In the first sequence, 6 maternity units collect standard care data for 3 months. They will then undertake the 9-month implementation period. Following this, maternity units will undertake a period of data collection whilst providing the OBS UK care bundle. This will last between 18 (first sequence) and 3 (last sequence) months depending on the randomisation. Data is also being collected between months 5 and 9 of the implementation period. The Data Controller will compare the rate of blood transfusion after childbirth before and after the OBS was introduced. The effect of the OBS on the psychological well-being of women and birth partners and its financial cost will also be studied. Data linkage using national data sets will be used for follow-up of all women in this study.

The Data Controller are recruiting approximately 189,000 women from 36 UK NHS maternity units, including 32 NHS sites in England, over 30-months between 1st February 2024 and 31st August 2026. There are also 3 sites in Scotland and 1 in Northern Ireland. All women giving birth in these units will be included, whether they have excess bleeding or not. The Data Controller will also collect data about ethnicity and multiple deprivation to see whether outcomes are affected by these variables.

The Initial cohort provided to NHS England in 2025 will be used by the applicant to act as a proof of concept and allow them to ensure the Data selected allows the Controller to assess the above. An updated cohort with around 4000 extra participants will be provided in 2026 to NHS England and the same data sets will be provided again, this will act as the main body of the study using the Data from the DSA.

The following NHS England Data will be accessed:

> Hospital Episode Statistics (HES) Admitted Patient Care (APC) – necessary to capture hospital admissions related to the participants’ condition by evaluating the frequency and type of attendances and bookings made during the antenatal, intrapartum and postnatal care periods and the cost-effectiveness of the intervention.

> Hospital Episode Statistics (HES) Critical Care (CC) – necessary to track any instances where participants required critical care and the duration and frequency, a potential outcome of severe PPH after childbirth. This will help in evaluating the effectiveness of the OBS intervention in preventing severe complications that necessitate intensive treatment and enable the cost effectiveness evaluation.

- Hospital Episode Statistics (HES) Outpatients (OP) – necessary to track outpatient attendance to examine attendances and bookings made during the antenatal, intrapartum and postnatal care periods for secondary outcome and cost analyses.

> Emergency Care Data Set (ECDS) – necessary to track emergency department visits when participants experience complications / require emergency care and the duration. Analysing emergency care usage will provide insight into the frequency of urgent care needs for secondary outcomes and cost-effectiveness evaluation.

>Maternity Services Data Set (MSDS) - necessary to enable evaluation of all women giving birth at the OBS UK maternity sites by providing demographic and obstetric outcomes for secondary and cost analyses. By accessing detailed records of maternity care, we can assess the direct impact of the OBS intervention on the frequency and type of attendances and bookings made during the antenatal, intrapartum and postnatal care periods, providing insight into its effect on reducing the need for acute care.

>Community Services Data Set (CSDS) – necessary to enable evaluation of breastfeeding exclusivity at 6 weeks during the 6-8 week visit (secondary outcome).

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

·Limited to a study cohort identified by Cardiff University of 8031 patients in the first year of the agreement with an updated cohort of approximately 12,000 to be provided by the Controller in 2026.

· Limited to data between 2023/24 to 2024/25. For each individual patient, data will only be provided from the date they joined the trial.

Cardiff University is the research sponsor and the 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.

This research serves the public interest by potentially improving maternal and clinical outcomes and informing more cost-effective healthcare strategies for the NHS.

Furthermore, the study’s findings will contribute to evidence gaps in current clinical guidelines, directly impacting public health policy and healthcare provision.

The funding is provided by National Institute for Health and Care Research (NIHR). The funding is specifically for the study described. Funding is in place until 01/01/2027.

Public Heath Scotland is a processor acting under the instructions of University of Cardiff. Public Heath Scotland's role is limited to providing the National Safe Haven environment.

Public Health Scotland provides IT hosting services to Controller and will store the Data as contracted by Controller.

A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group strongly supported the collection of the data for the purposes described above. A PPI plan will be published.

Throughout the study the Data Controller will be utilising the expertise and support of Egality Health. Egality is a community engagement agency, addressing health inequalities by improving inclusion in research. They work with the network of community organisations, connecting the groups most impacted by health inequalities with the health and life sciences sector. Together, the PPIE group will collaborate to bring new insights, new ways of working, and deliver creative campaigns and strategies, that increase diversity in research and improve health inequalities. Their EDI strategy spans all under-represented groups in health research, including according to ethnicity, gender, disabilities and socio-economic status. While Egality’s initial work mainly focused on improving diversity in terms of ethnicity, they are continuing to expand their networks and are connecting with community organisations who work with the LGBQIA+ community, women’s health, and disabled people. Organisations already in their network, such as HAREF Connected Voice, have the reach into these communities through its network in the North East.

Cardiff University will transfer data to NHS England.

The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode and Study ID) for the cohort to be linked with NHS England data.

• NHS England will provide the relevant records from the Hospital Episode Statistics (HES) Admitted Patient Care (APC), Hospital Episode Statistics (HES) Critical Care (CC), Hospital Episode Statistics (HES) Outpatients (OP), Hospital Episode Statistics (HES) Emergency Care Data Set (ECDS), Maternity Services Data Set (MSDS), Community Services Data Set (CSDS) datasets to Public Health Scotland's National Safe Haven.

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 Public Health Scotland. These servers are located in the National Safe Haven secure infrastructure which is operated by the University of Edinburgh and the servers are controlled by Public Health Scotland (PHS) with the oversight of Scotland's Public Benefit and Privacy Panel which is a department within PHS.

Data will be accessed by an individual with an honorary contract with University of Cardiff. The individual will act as an employee of University of Cardiff at all times under supervision from employees of University of Cardiff. Aside from this individual, access is restricted to employees of University of Cardiff who have authorisation from the Chief Investigator.

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).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to employees of Cardiff University who have authorisation from 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 the University of Cardiff will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to the Funder (NIHR) as per the trial's publication policy, this will be at the end of the trial in early 2027.

• Submissions to peer reviewed journals at the end of the trial in early 2027

• Presentations to NHS health boards, the public, Health and Care Research Wales events

• Presentations at appropriate conferences

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:

• Workshops involving healthcare professionals, specifically NHS maternity staff

• Social media

• Public events like public engagement events to showcase the use of routine data in trials

• Posters displayed at hospital sites covering the results of the trial

• Press/media engagement

• Public promotion of the research on our trial website

• Reports aimed at the public in plain English language (and translated versions), the Funder, NHS health boards, national data providers

The target dates for production and dissemination of the outputs are between 30/11/2026-30/11/2027.

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 or conditions such as obesity and diabetes.

• 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).

The aim of evaluating to drive quality improvement will be a benefit to patients. The prime benefit of the work is to improve care for all pregnant women who have excess bleeding by making the results more generalizable and accessible to policy and decision makers to enable improvements in care and treatment for patients.

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.

Three charities have been engaged to co produce plans with PPI members and the controller. The PPIE group will confirm they find the results in a format that's suitable for other members of the public and that it is targeted at the right audiences results demanding.

Yielded Benefits is not a requirement for new applications.