NHS Digital Data Release Register - reformatted
Royal College of Obstetricians and Gynaecologists (RCOG)
Project 1 — DARS-NIC-44356-Y8N6R
Opt outs honoured: Yes - patient objections upheld, No - data flow is not identifiable (Section 251)
Sensitive: Sensitive, and Non Sensitive
When: 2017/06 — 2018/12.
Repeats: One-Off, Ongoing
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)
Categories: Anonymised - ICO code compliant, Identifiable
- Hospital Episode Statistics Admitted Patient Care
- Hospital Episode Statistics Critical Care
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Outpatients
- HES:Civil Registration (Deaths) bridge
- Civil Registration (Deaths) - Secondary Care Cut
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 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 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.