Royal College Of Obstetricians And Gynaecologists (rcog) projects
COVID Maternity Equalities Project
NMPA: ONS-PDS-HES-MSDS-MIS-Mental Health and ONS-PDS-PEDW-NCCHDS-MIds Linked Datasets
🚩 Royal College Of Obstetricians And Gynaecologists (rcog) was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Royal College Of Obstetricians And Gynaecologists (rcog) may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.
COVID Maternity Equalities Project — DARS-NIC-461283-Q3R7K
Purposes: (Agency/Public Body)
Data-controller type: ROYAL COLLEGE OF OBSTETRICIANS AND GYNAECOLOGISTS (RCOG)
Purpose and Background of the Project:
Prior to the COVID-19 pandemic, there were already deep inequalities in maternity care and outcomes in England. Black women were already five times more likely to die during pregnancy, birth and the postpartum period, and Asian women three times more likely, than white women. During the pandemic there have been substantial shifts in the way that maternity care is delivered in Britain. However, the effects of these changes on maternity outcomes have not been measured, and it is also unclear whether these changes have widened or narrowed existing inequality gaps. There is an opportunity to learn lessons about how services may mitigate existing inequalities through service innovation.
The purpose of this project is to identify the impact of COVID-19 and associated modifications to maternity care (such as the use of remote consultations, changes to process of diagnosis of gestational diabetes, and reduction in appointments) on inequalities in maternity care (in stillbirth, preterm birth, mode of birth such as caesarean section, and postpartum complications), and learn lessons to inform recommendations regarding ongoing modifications and changes to maternity care in the future.
Rationale for the project:
This is a new project first funded by the Health Foundation in 2021 which proposes to use data from NHS Digital and subsequent qualitative analysis to understand the impact of the COVID-19 pandemic on inequalities in maternity care.
During the COVID-19 pandemic maternity units have had to modify care provision rapidly and have faced staffing challenges. There are concerns that the service modifications have introduced new forms of inequalities, such as digital (where access to care via digital means disadvantages to those without devices or internet access). Initial results from the pandemic are heterogeneous: a possible increase in the rate of stillbirth in a single London unit (Khalil et al. JAMA 2020) not mirrored in national figures for the 'first wave' of the COVID-19 pandemic in the UK (ONS 2021); an observed reduction in extreme prematurity in Denmark (Hedermann et al. Archives of Disease in Childhood Fetal and Neonatal 2020). Women of ethnic minority groups have been disproportionally affected by COVID-19 infection (Knight M et al, BMJ 2020), but it is unclear whether ethnicity directly, or marginalisation and disadvantage or inequality in accessing care has contributed to this disparity.
This project speaks explicitly to recommendation 7 of Public Health England (PHE) report "Beyond the data: Understanding the impact of COVID-19 on BAME groups" (PHE 2020) in that it seeks to 'Ensure that COVID-19 recovery strategies actively reduce inequalities caused by the wider determinants of health to create long term sustainable change.'
Restoration of services is currently heterogeneous and there is an urgent need for information to guide prioritisation of services both in this restoration phase and in any future peak. This is to ensure that modifications to services are justified, do not worsen maternal or fetal outcomes, and look to narrow existing inequalities.
The study team are aware of the sensitivity of investigating maternity outcomes by ethnic group. The study team do not intend to produce results published by trust name and do not intend to negatively identify maternity units or produce any sort of ranking. The study team have been careful to include a wide range of stakeholders and experts in the Steering Group, together with a Women's Reference Group which represents the diverse population accessing maternity care. The investigator group includes two lay coinvestigators from RCOG's Women's Network and the Caribbean and African Health Network who are able to directly represent women from diverse backgrounds. Statisticians from Bristol University are advisory to the data processing methodology. Neither the lay coinvestigators nor individuals from Bristol University will be determining the purposes or the means of data processing. Outputs, using aggregated data with small numbers suppressed, will be co-produced as a team in order to respect the sensitivity of this topic.
Project plan:
This project aims to answer three questions using routinely collected maternity data:
i) How have the COVID-19 driven modifications to maternity services impacted on maternity outcomes overall, and on the inequality gap in these outcomes?
ii) To what extent has ethnicity contributed to the inequality gap in maternity outcomes before and during the pandemic?
iii) Which units have narrower inequality gaps in maternity outcomes during the pandemic?
How data provided by NHS Digital will be used in the study:
This study will use Hospital Episode Statistics (HES) Admitted Patient Care (APC) data on mother and child provided by NHS Digital to describe national trends and unit-level differences in key maternity outcomes by ethnic and socioeconomic group. The team will then seek to identify maternity units where there is evidence of good practice (a narrowing in inequalities in maternity outcomes) during the pandemic and approach these units to obtain consent to investigate these further through service-level interviews (i.e. interviews with clinicians and women's representatives in order to identify service changes in these units during the pandemic). There has been no engagement with these units prior to this request, as data is required to identify participant units, but preliminary approaches to three units to assess feasibility suggested that being approached as a 'positive deviant' (i.e. a unit where changes in practice during the COVID-19 pandemic narrowed existing gaps in outcomes between women from different ethnic groups, or if these do not exist, a unit where the impact on existing inequalities was as small as possible) would be viewed favourably.
Through use of the HES data from NHS Digital and the subsequent service-level interviews, the project will provide recommendations regarding which service modifications (for example, types of telephone clinics; use of remote blood pressure monitoring) will provide a positive impact on equality in maternity care. These can then inform rapidly implemented change, improve the quality and safety of maternity care and ensure that all women, irrespective of their background or place of residence, have access to safe maternity care. Data from NHS Digital on maternity care and outcomes is not currently published by hospital by ethnic and socioeconomic group and thus pseudonymised data is required in order to generate these totals and enable further investigation. Requesting HES data minimises the data burden on NHS staff by ensuring we use routinely collected data.
Data will be restricted to a cohort for births from 1st January 2018 to 31st March 2021 that is derived from hospital admissions records that contain valid information about either mode of birth or outcome of delivery. The study team estimate that this will be approximately 1.8 million women and their babies (approximately 1.8 million births). All historic admissions episodes from 2000-2017 should be provided for all individuals with a record in this cohort. By looking at women's previous admissions in HES, it is possible to derive their previous medical and maternity history, as well as use ethnicity as recorded in a previous admission if it is missing from the birth record; these processes have been used by other researchers. Since this is a national project, data from all English NHS trusts is required.
The organisations involved in data processing for the study are the Royal College of Obstetricians and Gynaecologists (RCOG), supported by researchers from Queen Mary University of London (QMUL). The project was commissioned by the Health Foundation and The Healthcare Improvement Studies (THIS) Institute to understand the impact of COVID-19 on maternity outcomes and health inequalities. The RCOG is leading and hosting the project and is the sole data controller.
The RCOG has a secure data access environment (hosted by RedCentric PLC) which is where the data will be kept and used by both employees of the RCOG and of Queen Mary (any individuals involved in the data processing who are not substantively employed by the RCOG or by QMUL have an RCOG honorary contract). QMUL is the primary employer of the principal investigator. This project has been co-developed with two lay co-investigators in order to ensure it encompasses the concerns of women and particularly women from ethnic minority groups.
RCOG's legal bases for processing the requested data are GDPR Article 6(1)(f) - legitimate interests, and Article 9(2)(h)- health care. This project has completed a legitimate interests assessment, and the balancing test shows that the individual's interests do not override the legitimate interests of RCOG in undertaking the project. Article 9(2)(h) applies because the processing will support the management of health care systems to provide equitable outcomes to women and babies from all ethnic backgrounds. This project supports the need for the healthcare system to reflect upon the impact of service changes made during the pandemic and assess the equity of their impact.
Khalil A, von Dadelszen P, Draycott T et al. Change in the Incidence of Stillbirth and Preterm Delivery During the COVID-19 Pandemic. JAMA 2020;324(7):705-706. doi:10.1001/jama.2020.12746
ONS. Provisional births in England and Wales: 2020. 2021. Available from https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/livebirths/articles/provisionalbirthsinenglandandwales/2020andquarter1jantomar2021
Hedermann G, Hedley P, Baekvad-Hansen M et al. Danish premature births during the COVID-19 lockdown. Archives of Disease in Childhood - Fetal and Neonatal Edition 2021;106:93-95.
Knight M, Bunch K, Vousden N et al. Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study. BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2107
Public Health England. Beyond the Data: Understanding the impact of COVID-19 on BAME communities. 2020. Available from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/892376/COVID_stakeholder_engagement_synthesis_beyond_the_data.pdf
It is anticipated that the results of this project will be used to inform development of guidance for
(1) reducing inequalities in maternity services
(2) modifications to services in response to any further peak of the COVID-19 pandemic or other national emergency.
Results from this project will be directly fed back to the team who have been responsible for the production of clinical guidance on behalf of the RCOG and the Royal College of Midwives (RCM) throughout the pandemic (known as the 'RCOG/RCM COVID guidance cell' this is a team of up to 20 individuals which includes obstetricians, midwives, public health professionals and representatives of policy, media, and guidance teams). The RCOG/RCM guidance for COVID-19 has been downloaded over a million times, has been widely implemented in clinical care (Jardine et al, BJOG 2020) and has been cited across all forms of media and in peer-reviewed publications.
The expected measurable benefits are hoped to include:
- A set of recommendations regarding which modifications to services (eg remote consultation) should be retained and which should revert to usual care in order to mitigate ethnic and socioeconomic inequalities in maternal and neonatal outcomes (target date Q2 2022). To be implemented by the RCOG/RCM 'COVID guidance cell'.
- A synthesis of 'lessons learned' from units with narrower or no differences in outcomes between women from different ethnic and socioeconomic groups (target date Q2 2022); implementable by the RCOG and NHS organisations.
- A lay and policy summary of 'lessons learned' regarding guidance production and implementation, for use in any future emergency (target date Q2 2022) to be implemented by the 'RCOG/RCM COVID guidance cell'. This offers potential significant measurable benefits in any future emergencies.
- The above benefits are expected to contribute to a reduction in adverse outcomes including stillbirth, and a reduction in the inequalities in care experienced by women from ethnic minority groups. In England, over 1 in 10 stillbirths is directly attributable to ethnic inequality (Jardine et al, Lancet 2021 accepted/in press) – i.e. if women from ethnic minority groups had the same rates of stillbirth as white women, more than 1 in 10 stillbirths in England would be prevented (approximately 250 stillbirths based on 2019 figures from ONS). Despite this, there is a relative paucity of clear evaluation of specific interventions for women from ethnic minority groups (Garcia et al, BMC Pregnancy and Childbirth 2015). In a time of unprecedented change to maternity services, such an evaluation is necessary in order to understand the impact of service change by ethnic minority group but also to identify changes which, if made across the whole system, could contribute to the prevention of up to 250 stillbirths per year.
Jardine J, Relph S, Magee LA et al. Maternity services in the UK during the coronavirus disease 2019 pandemic: a national survey of modifications to standard care. BJOG 2020. https://doi.org/10.1111/1471-0528.16547
Jardine J, Walker K, Gurol-Urganci I et al. Adverse pregnancy outcomes attributable to socioeconomic and ethnic inequalities in England: a national cohort study. Lancet 2021 accepted/in press
Garcia, R., Ali, N., Papadopoulos, C. et al. Specific antenatal interventions for Black, Asian and Minority Ethnic (BAME) pregnant women at high risk of poor birth outcomes in the United Kingdom: a scoping review. BMC Pregnancy Childbirth 15, 226 (2015). https://doi.org/10.1186/s12884-015-0657-2
ONS. Stillbirths. Available at https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/stillbirths
The Hospital Episode Statistics (HES) data provided by NHS Digital will enable the following outputs:
(1) Peer-reviewed publications (to be submitted to journals including the British Medical Journal, BJOG: An International Journal of Obstetrics and Gynaecology, PLoS Medicine, PLoS One) supplemented with online resources detailing
(a) national and regional changes to maternity outcomes by ethnic and socioeconomic group during the pandemic: target date late 2021/ early 2022 (aimed at academic and policy audience).
(b) associations between service changes and maternity outcomes by ethnic group: target date March 2022 (aimed at an academic and policy audience).
(2) A list of units to be approached for further qualitative analysis. Units which constitute 'positive deviants' (i.e. any units where changes in practice during the COVID-19 pandemic narrowed existing gaps in outcomes between women from different ethnic groups, or if these do not exist, units where the impact on existing inequalities was as small as possible) in their approach to ethnic and socioeconomic inequality during the pandemic will be chosen in consultation with a lay group. Ten such units are anticipated to be identified on the basis of maternity care and outcomes (eg differences in stillbirth, preterm birth, and caesarean section rates).
(3) A final report on service changes associated with adverse outcomes and ethnic inequality to inform policy and guideline changes. This will have a supplementary lay and policy briefing to enable change (aimed at the public and at policymakers).
All outputs will be coproduced with patients and the public (including academic outputs). The report and supplementary lay briefing will be freely available. We will make every effort within funding constraints to enable published papers to be open access.
All published outputs will be aggregated with small number suppression in line with the HES analysis guide.
Note on patient and public involvement (PPI): This project is supported by a Women's Reference Group. This group, which will have 5-6 meetings throughout the year, is made up of 25 women chosen from over 200 who applied, who together represent a diverse range of experience (diversity of ethnicity, socioeconomic group, birth experience, parity, geography) supported by the PPI team at the RCOG and a qualitative researcher. This group will provide direct input into the selection criteria for units identified for qualitative investigation and a framework of lived experience of the pandemic, as well as ensuring that what is important to women is highlighted in the recommendations made. The team also has two lay co-investigators who each lead representative networks of women, who have provided direct input into the conduct of the study, the desired outputs, and the design of the qualitative aspects of the study in which they have expertise.
A wide network of stakeholders has formally committed to the project including the Royal College of Midwives (RCM), NHS England, the Care Quality Commission (CQC), the Governments of the devolved nations of the UK, charities and National Maternity Voices. This network will facilitate bi-directional dissemination, mobilising outputs down to practitioners and end users and up to policy makers. Dissemination of the key findings via social media will enable us to reach women directly, drawing specifically on the RCOG's Women's Network and Voices panels.
Data request:
NHS Digital will identify a cohort of approximately 1.8 million women and babies from delivery and birth records between 1st January 2018 to 31st March 2021.
NHS Digital will return pseudonymised record level data to the Royal College of Obstetricians and Gynaecologists (RCOG) via secure file transfer. The Hospital Episode Statistics (HES) Admitted Patient Care (APC) extract will contain delivery and birth episodes for the identified cohort, containing valid information about either mode of birth or outcome of delivery. RCOG will provide the data specification in terms of appropriate episode type, OPCS-4 procedure and ICD10 diagnosis codes to identify delivery and birth episodes for data extraction. All historical and future (i.e. following delivery) HES APC records for mothers and babies identified in the previous step will also be included within the files.
RCOG will use the data from 2018-2019 as a historical comparison cohort to establish baseline rates of measures both overall and by hospital trust, and then interrogate data for 2020-2021 to understand changes during the COVID period.
Historical hospital admissions episodes (2000-2017) will enable the derivation of previous birth history and previous significant medical history relating to the hospital admission episode, and allow RCOG to augment ethnic coding using historical codes. Once the variables required (parity, previous caesarean, previous preterm birth, previous stillbirth, previous ethnicity, previous diagnoses, previous procedures) have been derived, these historical records will be destroyed and the main cohort will be kept: i.e. all admissions which are not the index admission will be deleted. A data destruction certificate will be made available to NHS Digital on request.
Episodes of care after the delivery episode will allow the identification of re-admissions of mothers and babies after birth.
Only data items which are necessary for the project 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.
Pseudonymised patient level data from NHS Digital will be held within RCOG's secure data environment. This pseudonymised data will be processed within RCOG's secure data environment by both substantive employees of and honorary contract holders with the RCOG, and substantive employees of Queen Mary University of London (QMUL) who have been appropriately trained in data protection and confidentiality. All honorary contract holders have a primary employment contract at either a University or with the NHS which also holds them to account regarding data processing. The secure research environment is accessed by two factor authentication.
The data will only be used to calculate by ethnic and socioeconomic group the rates and trends of key maternity safety measures prior to and during the COVID-19 pandemic. The selection of measures used to evaluate the quality of maternity care in this project will be guided by a Steering Group (a panel of clinical and academic experts, including obstetricians, midwives, statisticians and health service researchers, listed here https://www.rcog.org.uk/en/guidelines-research-services/audit-quality-improvement/cmep/) as well as a Women's Reference Group with researchers representing women's groups who are coinvestigators to the project (see details in 'Objectives for Processing'). The measures used will be informed by expertise available from existing published research in this area using HES and from the National Maternity and Perinatal Audit, also based at the RCOG. These are anticipated to include:
- Induction of labour
- Mode of birth
- Severe Maternal morbidity
- Obstetric anal sphincter injury
- Preterm birth
- Stillbirth
- Babies born small for gestational age (SGA <10th centile of birthweight; fetal growth restriction <3rd centile of birthweight)
- Maternal readmission following birth
Redcentric PLC supply IT infrastructure and Cloud Services for the RCOG and are therefore listed as a data processor. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.
As part of the overall project, RCOG will derive a further database from Maternity Information System (MIS) data to capture information on the mother's care from the first antenatal appointment until the postnatal discharge. The MIS will be linked to an extract from BadgerNet neonatal detailing the characteristics of babies admitted to neonatal units, their care and outcomes. The MIS derived database will not be linked to patient-level data records provided by NHS Digital. No other data will be linked to patient level NHS Digital data. Maternity Information System (MIS) data contains information about each woman's pregnancy, booking and birth, and early postnatal care, including information about the baby. BadgerNet neonatal is a nationally used computer system which contains information about neonatal care for the 10% of babies admitted to neonatal units.
There will be no requirement or attempt to reidentify the individuals involved in the data collection.
NMPA: ONS-PDS-HES-MSDS-MIS-Mental Health and ONS-PDS-PEDW-NCCHDS-MIds Linked Datasets — DARS-NIC-44356-Y8N6R
Opt outs honoured: Yes - patient objections upheld, No - data flow is not identifiable, Anonymised - ICO Code Compliant, Identifiable, Yes, No (Section 251, Section 251 NHS Act 2006)
Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261 - 'Other dissemination of information'; National Health Service Act 2006 - s251 - 'Control of patient information'.
Data-controller type: HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), HEALTHCARE QUALITY IMPROVEMENT PARTNERSHIP (HQIP), NHS ENGLAND (QUARRY HOUSE)
MSDS (Maternity Services Data Set)
MRIS - Bespoke
Birth Notification Data
The majority of women giving birth and babies born in the UK receive safe and effective care. However, the stillbirth rate is higher in the UK than in many other European countries.[http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(10)62310-0.pdf] There is also evidence of substantial variation in the maternity care received by women during pregnancy and delivery across hospitals, as well as the outcomes. These patterns of variation are also not the same for women from different socio-economic and ethnic backgrounds. [Patterns of Maternity Care in English NHS Hospitals 2013/14. Royal College of Obstetricians and Gynaecologists.
London, 2016: https://www.rcog.org.uk/globalassets/documents/guidelines/research--audit/maternity-indicators-2013-14_report2.pdf]
To address these issues, high quality information on the processes and outcomes of care is required so that clinicians, NHS managers and policy makers can examine the extent to which current practice meets the array of guidelines and standards, and to compare services and maternal and neonatal outcomes among maternity units. Pregnant women and their families also require this information to enable them to make a more informed choice between the services available to them.
Maternity care is becoming increasingly high profile and is a subject of great public interest. The introduction of the Safer Maternity Care Action Plan in October 2016, which includes the National Maternity and Perinatal Audit (NMPA) , highlights that maternity care is a priority area for the Secretary of State for Health.
The aim of this new National Clinical Audit and Patient Outcomes Programme (NCAPOP) Audit is to deliver a clinically meaningful and methodologically robust audit of all NHS maternity services in England, Scotland and Wales, to inform decision making by CCGs, policy makers and clinicians, and support maternity services to improve the quality of care and outcomes for mothers and newborns. The NMPA is commissioned by the Health Quality Improvement Partnership (HQIP) on behalf of the English and Welsh Governments and the Health Department of the Scottish Government. It is being carried out by the Royal College of Obstetricians and Gynaecologists (RCOG), in partnership with the Royal College of Midwives (RCM), Royal College of Paediatrics and Child Health (RCPCH) and the London School of Hygiene and Tropical Medicine (LSHTM), all of which are registered charities.
Under this agreement RCOG and LSHTM are data processors and will be the only parties accessing the record level data. RCPCH and RCM will provide expert clinical advice on high-level decisions regarding the Audit, help facilitate engagement from clinicians and organise quality improvement programmes and regional meetings where the Audit's findings and recommendations will be disseminated.
One of the key aims of the Audit is to create a nationwide database containing all births to enable the development of robust and clinically meaningful quality indicators for maternity care. The Audit will develop a set of performance indicators to allow maternity units to benchmark themselves against their peers. The indicators will facilitate the comparison of antenatal, intrapartum and postnatal care patterns and identify determinants of variation both regionally and nationally.
The commissioned audit programme consists of three phases of work:
- An 'organisational survey' to collect provider-level information on service delivery and the organisation of maternity care, which will contribute to a better understanding of the care provided to pregnant women;
- A continuous clinical audit that produces information for maternity units to monitor patterns of care and maternal and perinatal outcomes;
- A series of in-depth topic-specific, time-limited audits ('sprint audits'), predominantly focusing on specific types of maternal and neonatal outcomes.
The continuous clinical audit will use the following sources of patient-level maternity data:
• Data extracted from NHS hospitals' electronic maternity record systems/maternity information systems (MISs) in England and Wales, for which Section 251 approval has been gained. These databases include information along the complete care pathway, from antenatal booking through to postnatal care. The applicants are currently requesting data extracts from individual providers in England and Wales, which will be sent to the applicant directly via secure file transfer. This protocol will eventually be replaced by the use of national maternity datasets. For England this will be the new Maternity Services Data Set (MSDS), once the submission rate, data quality and completeness are sufficiently high, and data is available from NHS Digital. HQIP has specified within the NMPA contract that the Audit should not become dependent on the flow of processed data from the MSDS until this flow is established and access to it does not introduce additional risk or delay to the analysis and reporting of the Audit. Similarly, in Wales a new Maternity Indicators Data Set is being implemented, with regular submissions now achieved by four of the Welsh Health Boards.
• The Scottish Birth Record (SBR), which contains data from providers' MISs, and already has a high data quality and completeness, covering over 98% of Scottish births. The Audit will use this national data source rather than requesting separate extracts from each provider.
• The Audit will also use data from routine hospital episode datasets such as Hospital Episode Statistics (HES) in England (pending DARS approval), Patient Episode Data for Wales (PEDW) in Wales and the Scottish Morbidity Record 02 (SMR-02) in Scotland (pending approval from the Information Services Division (ISD), Scotland), which contain administrative information about each hospital admission, including deliveries. This data is necessary to the Audit for several reasons. Firstly, knowledge of hospital admissions and diagnoses during and after delivery will allow the understanding of maternal and neonatal outcomes, and provides a greater level of detail on treatments that took place during delivery. Secondly, knowledge of diagnoses before delivery will shed light on case-mix, which is essential in performing risk-adjustment of the Audit results (which enables a fair comparison between providers). Finally, the completeness of routine hospital episode datasets is very high, and thus it can be used to validate data from other sources such as the data extracts from providers' MISs. The datasets will be linked at a patient level to produce:
• MIS-HES linked database for England;
• MIS-PEDW linked database for Wales;
• SMR-02/SBR-NRS linked database for Scotland.
A dataset linked at a patient level has several advantages for the Audit. It will:
1) minimise – if not eliminate – the burden on clinical staff of data collection for the sole purpose of the Audit;
2) enable information to be provided on longitudinal patterns of care, for example, hospital readmission following delivery,
(3) enable validation of data from each source, and
(4) enable information to be collected on the clinical history of the women before pregnancy, and their health service use during pregnancy which is important for case-mix adjustment.
A similar methodology was found to be effective in a pilot study conducted by the RCOG in 2013/14, which involved 18 NHS hospitals across the UK supplying MIS data to create a database consisting of 120,000 delivery records from 2012/13, which was then linked to the HES database. The study positively demonstrated the feasibility of this approach and showed a very high level of completeness of essential data items (>98%) and data linkage.
The Audit will provide all NHS providers, commissioners and clinical networks with individualised and timely feedback on the quality of care provided and maternal and neonatal outcomes. Patients and the wider public will have access to lay summaries of all Audit outputs.
The audit's first annual report was published on 9th November 2017. This report was written in lay language, accessible to those working in all areas of the NHS and also to women giving birth and their families. The first annual stakeholder meeting was held on 9th November 2017, which further helped disseminate the audit results to a variety of stakeholders. An online reporting system was launched at the same time as the first annual report, enabling clinicians, maternity care providers, commissioners and managers to compare the quality of care provided at their maternity unit with others within England, Scotland and Wales on a wide variety of measures. A large number of clinicians and methodologists have contributed towards the derivation of these measures, ensuring they are clinically meaningful and methodologically robust. The audit team have already received feedback from a number of maternity units detailing how initiatives have been set up to improve the quality of care provided in terms of specific measures published by the audit. Subsequent audit outputs will include examples and case studies of how clinical practice has been improved based on the audit results.
The Audit team will implement an active engagement strategy, communicating in a way that is accessible to all stakeholders. The Audit team are committed not just to the reporting of the results of the Audit in Annual Reports but to ensuring that the results lever local change and quality improvement.
The Audit will provide robust and rigorous evidence to CCGs, to inform decisions on prioritising services for commissioning, and advise on the most effective ways to improve access to antenatal care.
Results from the Audit will relate patterns of care to maternal and neonatal outcomes, guiding policies on, for example, the situations in which induction of labour, instrumental delivery and caesarean section lead to better or worse clinical outcomes. This will have a direct impact on clinical practice.
The evidence-based clinical indicators derived in the Audit can be used by maternity units to assess their performance and compare it with others. Information will be made publically available, including key results at both individual maternity unit level and at regional levels reflecting the various commissioning structures in England. It will be ensured that appropriate regional comparisons can be made to allow an assessment of whether local maternity units and NHS commissioners are meeting relevant standards of care, including accepted national standards issued by NICE, RCOG, RCM, the British Association of Perinatal Medicine and the Obstetric Anaesthetists' Association. This will inform decisions made by local managers on policies and procedures within maternity units.
The Audit's Annual Reports will include recommendations to enable NHS Trusts to drive effective local quality improvement initiatives. Some of these recommendations may be guided by providers who have been demonstrated to have superior performance according to the results of the Audit. The recommendations will be aimed at the full spectrum of stakeholders (e.g. individual clinicians, maternity units, commissioners or higher levels, depending on the issues at stake). These recommendations will also feed into quality improvement programmes in maternity care organised by the RCOG, RCM and RCPCH. Each College runs regular regional meetings and the Audit results will feed into their processes with the aim of standardising the delivery of care and improving the culture of safety for service users. Giving birth is the most common reason for admission to hospital in the UK, with approximately 800,000 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
From the start of the Audit, a reporting framework will be developed that produces frequent, individualised and timely output using online feedback to NHS providers, commissioners and networks. Summaries of all outputs for patients and the wider public will be produced. There will be five different approaches to report the results:
1. Annual reports (two versions – one version for providers and a lay version for patients and the public) will be used to report on adherence to national guidelines on essential aspects of maternity care, maternal and perinatal outcomes and trends over time. Variation in outcomes will be reported, carefully adjusted for differences in case-mix. The first annual reports will be published on 9th November 2017, with subsequent reports published in November 2018 and 2019.
2. Annual stakeholder meetings will be arranged to disseminate Audit findings and promote quality improvement. The first of these will be held on 9th November 2017, with subsequent events held in November 2018-January 2019 and November 2019-January 2020.
3. Online reports will be set up that allow individual providers, commissioners and relevant clinical networks to benchmark their process and outcomes indicators against care provided nationally and regionally. These reports will be designed to facilitate the use of national data for local audit activities. Moreover, the Audit will support English maternity units to contribute to the Quality Accounts. The online reporting system will be ready for use by providers by December 2017. This will be developed into a system of continuous monitoring, by December 2018, with the potential to update feedback about processes and outcomes of maternity services as soon as data become available.
4. From the Audit's second year, it is envisaged that annually at least two reports of periodic time-limited, topic-specific audits will be produced to allow more detailed analysis and reporting than in the annual reports. These reports will be published by December 2018 and December 2019.
5. The Audit team will also produce peer-reviewed publications, especially related to the additional analyses aiming to identify determinants of variation in maternity services and methodological development work (e.g. risk adjustment, handling missing data, continuous monitoring, combining multiple linked indicators to assess maternity units' performance, design of outputs that are most effective in local quality improvement). These publications will be submitted to clinical journals (e.g. British Journal of Obstetrics and Gynaecology or British Medical Journal) or methodological journals (such as the Journal of Clinical Epidemiology or the BMC Health Services Research). The submissions to journals will begin from summer 2017.
For the continuous audit in England, until such a point that the new Maternity Services Data Set is mature, maternity units will supply the NMPA team with an annual extract of patient-level data (including babies' and mothers' dates of birth, babies' and mothers' NHS numbers, mothers' postcodes and babies' genders as well as clinical information about the care received by mothers and babies) relating to the deliveries that occurred at their unit in the previous financial year period (12 months) from their MIS. However, for the first extract, recently requested from all providers, data is required that relates to deliveries between 1st April 2014 and 31st March 2016. From then on, at the end of each year, the Audit team will request data for the previous financial year (e.g. in late 2017 the Audit team will request data on deliveries between 1st April 2016 and 31st March 2017), so that the study cohort is continually updated on annual basis).
NHS Trusts will provide data from their MIS by transferring it to the NMPA's secure server within the N3 network using a Secure File Transfer Protocol. All data processing will take place on this server. The secure server is leased from RedCentric by the RCOG, and is based at the RedCentric site in Reading, with backups located at the RedCentric Harrogate site.
Data will be pseudonymised by the Audit's two data managers, who will separate the patient identifiers contained within the data extracts from maternity record and treatment MIS data. Both data managers are based at the RCOG and hold substantive contracts of employment there. No other individuals will have access to patient identifiers. The records belonging to the same individual will only be accessed by the project team with a NMPA-derived anonymised label (which will be the study ID). All individuals with access to the record level data are substantive employees of either LSHTM or RCOG.
The Audit's data managers will securely transfer the patient identifiers to NHS Digital's Data Linkage and Extract Service, where the following are being requested:
1) Linkage of the study cohort's patient identifiers plus study ID to HES Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data. This cohort will include mothers who gave birth and babies born from 1st April 2014 to 31st March 2016 (two financial years at the start) in the first instance, with the intention of updating the cohort on an annual basis (providing the latest information on those patients already linked, and the latest information with back data on new patients). The identifiers will be stripped out of the returned file and the study ID appended.
2)	An unlinked extract of HES Admitted Patient Care, Critical Care, Outpatient and Accident & Emergency data, from 2000/01 to the latest available. This will be filtered to all mothers who have given birth, and all babies born, with the output being anonymised in context.
The data will form the NMPA ID-HESdatabase, which the NMPA's data managers will link to the pseudonymised MIS data. Patient identifiers will be stored separately and only the data managers will be able to access these. English patient data will not be transferred outside of England or linked to the Scottish or Welsh data at patient level.
The linked datasets described above will provide a framework for continuous monitoring of processes and outcomes of maternity services using a comprehensive set of performance indicators linked to national standards, for example:
• Antenatal care booking by 13 weeks of gestation (NICE NG4; QS22);
• Proportion of elective caesareans performed before 39 completed weeks of gestation without a clinical indication (NICE CG132);
• Proportion of infants with Apgar score less than 7 at 5 minutes among term, normally formed, singleton infants (Standards for Maternity Care).
These indicators will be used to compare maternity services at national, regional, commissioner and unit level. The development of these indicators will be guided by criteria related to validity, statistical power, fairness and the appropriateness of the technical coding.
The historical (from 2014) and future data (up to April 2018) on the individuals in the HES-MIS study cohort described above is required for two main reasons: 1) it enables information to be provided on longitudinal patterns of care, for example, maternal or neonatal hospital readmission following delivery, and (2) it enables information to be collected on the clinical history of the women before pregnancy and their health service use during pregnancy which is important for case-mix adjustment.
The (unlinked) extract of HES data on women who gave birth in England since 1 April 2000, and babies born in this time period, allows the NMPA team to detect trends in patterns of care and in data quality over time. This is important in order to understand the Audit's results and to put them into context.
Risk adjustment approaches will be developed for the purpose of making the comparisons at the above-described levels 'fair' (as much as possible eliminating the impact of difference in case-mix). It is envisaged that the risk adjustment approach will need to vary according to the level of comparison, the type of indicators used (e.g. related to process and outcome) and the specific audit population.
The statistical techniques will depend on the type of indicator involved. Logistic regression models will be used for indicators based on categorical variables, linear regression for indicators based on continuous variables and Cox or Poisson regression for indicators based on time-to-event data. Where necessary, multiple-imputation techniques will be used to handle records of patients with missing data, as well as multi-level modelling to take into account that results may be 'clustered' within maternity units or within other relevant units of analysis.
All outputs will be aggregated and anonymised in line with the HES analysis guide.
Any references to Mortality data regards Scottish Mortality data only.