Neonatal outcome measures of maternity care

The purpose of this Data Sharing Agreement (DSA) is to authorise the provision of 'bridging files' required to link maternity data from the National Maternity and Perinatal Audit (NMPA) with neonatal data from the National Neonatal Audit Programme (NNAP).

The Healthcare Quality Improvement Partnership (HQIP) has commissioned the Royal College of Obstetricians and Gynaecologists (RCOG) to undertake the NMPA, and Royal College of Paediatrics and Child Health (RCPCH) to undertake the NNAP as part of the HQIP National Clinical Audit and Patient Outcomes Programme (NCAPOP).

The NMPA reports on care processes and outcomes related to birth events and births among NHS Trust and Health Board maternity units across England, Wales and Scotland. The NNAP assess whether babies admitted to neonatal units in England, Wales and Scotland receive consistent high-quality care and identify areas for quality improvement.

The NNAP and NMPA have long aimed to link maternity and neonatal data, and recent national reviews have reinforced the urgency of doing so. The NMPA previously tested data linkage using maternity system data that included NHS identifiers, but both programmes now use different data sources, and the NMPA no longer holds identifiers. As a result, NHS England is required to create a bridging file to enable this linkage.

HQIP and NHS England (NHSE) already access NHS England Data for the purpose of the National Maternity and Perinatal Audit (NMPA) under a separate Data Sharing Agreement (DSA) ref: DARS‑NIC‑44356‑Y8N6R.

The aim of the NMPA is to collect Data which will provide a framework for the continuous monitoring of processes and outcomes of NHS Trust and Health Board maternity services using a comprehensive set of measures.

The following is a summary of the aims of the audit covered under DSA ref: DARS‑NIC‑44356‑Y8N6R:

• To create and maintain a nationwide database containing all delivery events and births to enable the development of robust and clinically meaningful quality indicators for maternity care. These indicators facilitate the comparison of antenatal, intrapartum, and postnatal care patterns and identify determinants of variation in maternity services at the national, regional and provider levels.

• To enable NHS maternity care providers to benchmark themselves against their peers using a set of quality indicators that the NMPA has developed.

• To enable clinicians, NHS managers, and policy makers to examine the extent to which current practice meets the array of guidelines and standards, and to compare services and maternal and perinatal outcomes among maternity units.

• To enable pregnant women and their families to make a more informed choice between the services available to them.

• To provide a balanced set of quality indicators that are meaningful, valid, fair, have sufficient statistical power and precise technical specification. This enables NHS maternity care providers to understand how to compare the care they deliver and identify what constitutes as best practice.

• To produce a range of measures that will be published on the NMPA website through accessible and interactive tables and charts.

• To produce a 'snapshot audit' as a core deliverable which will link the data of the NMPA with the National Neonatal Audit Programme (NNAP), the audit will provide important data for stakeholders on the neonatal outcomes of maternity care which have previously gone unreported. This is with a view to providing this data in the annual clinical report outputs of both NMPA & NNAP audits.

The following NHS England Data are accessed under DSA ref: DARS‑NIC‑44356‑Y8N6R:

• Maternity Services Data Set (MSDS) – necessary as the main source of maternity data for reporting on births in English maternity units from 2017/18 onwards.

• Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary to provide additional information on mothers and babies (e.g. socio-demographic characteristics), the care received (e.g. procedures that took place during delivery) and pregnancy risk factors or outcomes (e.g. diagnoses recorded) that complement the information provided in maternity datasets. These additional information shed light on the characteristics (“case-mix”) of the population accessing each provider, which is essential in performing risk-adjustment of the audit results (and enable a fair comparison between providers). HES APC also provides historical/future care records for mothers and babies, which is essential to identify risk factors and co-morbidities (e.g. outcomes of previous deliveries) and measure outcomes that are not observed immediately during or shortly after delivery (e.g. complications that require readmission to hospital).

• Office for National Statistics (ONS) register of live births and stillbirths, and the Personal Demographics Service (PDS) birth notification dataset which together form the “Birth Notification Data” - necessary for linkage of mother and baby records, case ascertainment and validation of key variables in maternity datasets.

• Civil registration of deaths - necessary to identify maternal and neonatal mortality cases in the cohort.

• Mental Health Data Sets (MHMDS, MHSDS) – necessary for the purposes of a snapshot audit on perinatal mental health services.

Collectively, the Births Notification Data, MSDS and HES APC Data are used to identify all delivery and birth episodes in English NHS maternity units for cohorts relating to each financial year from 2017/18 onwards.

Only data items which are necessary for the Audit are requested, with one or more of the following purposes:

• to determine which provider or maternity unit administered the care

• to determine the quality of care for the service user

• to determine the nature of the episode and diagnosis

• to determine the case-mix of service users with a particular provider or maternity unit

• to determine the health outcomes for the service user

The level of the Data will be identifiable, due to the inclusion of one identifiable variable: Baby date and time of birth. This information is necessary to derive audit measures such as readmission within 6 weeks of delivery (which requires comparing hospital episode dates with the date of delivery); to validate other data fields that have date/time of procedures or stages of labour and delivery; to derive other time dependent measures such as duration of labour, time between decision to delivery; and to assist with determining whether there has been a multiple birth, or whether records are duplicates.

The Data will be minimised as follows:

• Limited to cohorts identified by NHS England as 1) women who gave birth and babies whose birth was registered in English maternity units from 2017/18 onwards, and 2) women who gave birth in English maternity units from 2004/05 – 2017/18. The latter cohort enables the obstetric history of women in the former cohort to be determined.

• The RCOG holds cohort data for women who gave birth and babies whose birth was registered in English maternity units from 2015/16 – 2016/17, as collected directly from maternity units. Limited analysis variables are retained for this cohort.

NHSE are the funders of the work for the English aspect of both audit programmes. HQIP and NHSE are the controllers as the organisations 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 for HQIP and NHSE 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 for HQIP is:

Article 9(2)(i) - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

The lawful basis for processing special category data under the UK GDPR for NHSE is:

Article 9(2)(h) - processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3.

The processing is in the public interest because the audits aim to drive improvements in the quality and safety of care and to improve outcomes for all deliveries and births occurring in maternity units.

RCOG, London School of Hygiene and Tropical Medicine (LSHTM) and RCPCH are processors acting under the instructions of HQIP and NHSE. The role of both RCOG and LSHTM is limited to maintaining and analysing the database of deliveries and births in English NHS Trusts, and admissions to neonatal care to enable the development of robust and clinically meaningful quality indicators for maternity care and generate outputs aligned with the aims of the NMPA. The role of RCPCH is limited to maintaining and analysing the database of births in English NHS Trusts where a baby is admitted to neonatal care, to enable the development of robust and clinically meaningful quality indicators for neonatal care and generate outputs aligned with the aims of the NNAP.

The NMPA is carried out by RCOG in partnership with LSHTM, Royal College of Midwives (RCM), and Royal College of Paediatrics and Child Health (RCPCH). The RCOG is the host organisation of the audit, with the LSHTM, RCM and RCPCH being represented on the project board to provide clinical and methodological direction for the audit.

The selection of measures for the NMPA was guided by a panel of clinical and academic experts from RCOG, RCM, RCPCH and LSHTM, including obstetricians, midwives, neonatologists, statisticians, methodologists and health service researchers, as well as the NMPA Women and Families Involvement Group (WFIG), and organisations and charities representing maternity and neonatal service users. The WFIG in particular provide regular input on all outputs of the audit, including deciding on the measures of the audit, choosing recommendations and ensuring clearly accessible language is used throughout the NMPA’s work. A range of measures is available and reported via accessible and interactive tables/charts on the NMPA website and in the clinical reports.

The Royal College of Paediatrics and Child Health (RCPCH) will provide NHS England with identifiers (specifically NHS Number, Date of Birth and Gender) for each mother and baby included in the NNAP. This includes their NHS numbers and a NNAP pseudonymised identifier. NHS England will then use these identifiers to produce a bridge file that links each NNAP pseudo ID to the corresponding NMPA pseudo ID.

NHS England already holds pseudonymised data for the NMPA, so they can identify which NMPA records match the people in the NNAP group sent by RCPCH. After making these matches, NHS England will remove the identifiers and return only the two coded IDs (the NNAP and NMPA pseudo IDs) to RCPCH.

The Data will be stored and backed up on the RCPCH Azure tenant, provisioned by Microsoft Ltd.

Once returned, RCPCH can share this bridging file with RCOG. This will allow the two audits to share pseudonymised data between them.

The Data will also be stored and backed up on the RCOG’s Azure tenant, provisioned by Microsoft Ltd.

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 the UK. The Data will not leave the UK at any time.

Access is restricted to substantive employees of RCOG or LSHTM (who are named NMPA staff and have permission from the NMPA lead). Separately, substantive employees Royal College of Paediatrics & Child Health (RCPCH) are permitted to access a subset of the NMPA data.

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

The aggregated information derived from the Data may be combined with aggregated data from other sources.

Statisticians/methodologists from the NMPA at the RCOG, LSHTM and separately Royal College of Paediatrics & Child Health (RCPCH) will process and analyse the Data for the purposes described in ‘Objective for Processing’. The audit will produce performance indicators that will be used to compare maternity services at site, trust, regional and national level.

The expected outputs of the processing will be:

• Annual Clinical Reports. These are used by NHS Trusts and Health Boards to monitor the quality of maternity care they provide, maternal and perinatal outcomes, and trends over time and include the following:

- A full report, written by clinicians and statisticians to provide key insights into the data with key messages and recommendations provided, aimed at clinicians and decision makers.

- Online interactive tables and graphs of the report’s results.

• Reports of periodic time-limited, topic-specific audits (“snapshot audits”). These will be predominantly focusing on specific types of maternal and neonatal outcomes.

• An online resource (the Family Gateway) which will provide printable content aimed at women and birthing people

• Lay summaries of all audit outputs (annual reports, snapshot audit) including professionally designed infographics, aimed at service users, their families and the wider public.

• Submissions to peer reviewed journals. These aim to identify determinants of variation in maternity services and methodological development work.

The outputs 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 target dates for production and dissemination of the outputs are 6-12 months following receipt of the data, and then each year in Spring for subsequent annual reports.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Main audit website (www.maternityaudit.org.uk) and on HQIP’s website (https://www.hqip.org.uk/a-z-of-nca/maternity-perinatal-audit/).

• HQIP’s National Clinical Audit Benchmarking (NCAB) online portal – https://ncab.hqip.org.uk/reports/card/audits/NMPA/.

• Social media via the NMPA and partner organisations such as the RCOG, RCM and RCPCH.

• Briefing documents and launch communications provided to stakeholder organisations represented on the NMPA Clinical Reference Group such as The Twins Trust, Maternity Voices Partnerships and Sands.

• Conferences and events where NMPA has a presence such as RCOG Congress and the BAPM Conference.

• Journals (e.g., The Lancet, British Medical Journal, PLOS Med, American Journal of Obstetrics and Gynaecology, British Journal of Obstetrics and Gynaecology, Journal of Clinical Epidemiology, and BMC Health Services Research).

The expected outputs of the processing relating to the linkage of the NNAP data will be:

A snapshot audit will be conducted by RCOG to assess the process and reportable outcomes from the initial data linkage exercise. It is anticipated that ongoing linkage of neonatal and maternity identifiers will enable continued use of the combined dataset to generate meaningful insights.

Royal College of Paediatrics and Child Health (RCPCH) will use the linked NMPA data to support their annual clinical report and to update the neonatal data dashboard. This dashboard includes publicly accessible aggregated reports, as well as a secure area where neonatal units can access their own data.

The outputs will include new findings across a range of clinical measures, such as:

• Assessing clinical activity, care processes, and outcomes for preterm babies who are not admitted to neonatal units.

• Evaluating the proportion of babies receiving therapeutic cooling among those meeting a case definition for neonatal encephalopathy.

• Timely measurement of admissions to neonatal care for late and moderate preterm babies, with a focus on alignment with NMPA denominators.

• Monitoring the proportion of term babies admitted to neonatal units at any point during the first week of life.

The evidence-based clinical indicators derived in the audit are used by maternity units to assess their performance and compare it with others. Information is made publicly available, including key results at individual maternity unit level where available. This informs decisions made by local managers on policies and procedures within maternity units, and also enables women and families using services to engage in informed conversations with health service providers regarding their care. The audit ensures that appropriate comparisons can be made to allow an assessment of whether local maternity units are meeting relevant standards of care. The findings of this audit are therefore expected to inform best practice to improve the care, treatment, and experience of women who give birth and babies who are born in NHS Trust or Health Board maternity units.

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 of 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).

Giving birth is the most common reason for admission to hospital in the UK, with approximately 700,000 births per year throughout England, Scotland, and Wales. Thus, each benefit described above has the potential to positively affect the experience of maternity care for a very large number of women and their families.

The reports produced by the NMPA and NNAP include recommendations to enable NHS Trusts and Health Boards to drive effective local quality improvement initiatives. The recommendations are aimed at the full spectrum of stakeholders (e.g., individual clinicians, maternity units, neonatal units, commissioners, or higher levels, depending on the issues).

These recommendations also feed into quality improvement programmes in maternity and neonatal care organised by the Royal College of Obstetrics and Gynaecology (RCOG), Royal College of Midwives (RCM), Royal College of Paediatrics and Child Health (RCPCH) and British Association of Perinatal Medicine (BAPM). Each runs regular regional meetings and the audit results feed into their processes with the aim of standardising the delivery of care and improving the culture of safety for service users. This would bring a clear benefit for users of maternity and neonatal services and staff by making information more easily accessible and less difficult to find. Combination of each organisation’s knowledge and expertise, and collaboration between these audits is expected to provide a stronger voice in championing tools and recommendations to improve standards of maternity and perinatal care.

The NMPA and NNAP ensure the voices of service users are heard throughout this work by incorporating women and families in the advisory groups of all the outputs. The NMPA and NNAP thread these voices though the reports in the form of qualitative quotations and photographs/art work, helping to add a contextual narrative to the findings from those who use services. This also supports quality improvement by enabling service providers and wider stakeholder groups to hear from a range of people who have accessed maternity care and neonatal care, and how they interpret and understand the findings.

Yielded Benefits is not a requirement for new applications.