National Emergency Laparotomy Audit (NELA)

BACKGROUND AND PURPOSE

The National Emergency Laparotomy Audit (NELA) was commissioned in 2011 by the Healthcare Quality Improvement Partnership (HQIP) and is funded by NHS England and the Welsh government. NELA first began collecting data in 2013 and has continued to do so on a regular basis ever since. NELA’s aims are to collect and publish high-quality comparative information from all hospitals in England and Wales at which emergency laparotomies (an emergency laparotomy is a major operation where the surgeon has to cut open the abdomen) are performed, in order to drive quality improvement in the care of these patients. It was established in response to the comparatively high death rate after emergency laparotomy, and the substantial variation in this rate between hospitals.

Throughout the Agreement NELA, the NELA team, and the NELA project team are interchangeable terms used and refer to the core NELA team that manage the day-to-day operations and analysis. The NELA team comprises substantive employees of both the Royal College of Surgeons of England (RCS) and Royal College of Anaesthetists (RCoA) as well as members who hold a signed memorandum of understanding with RCoA. Only substantive employees of the RCoA or RCS or non-substantive employees who hold honorary contracts with the RCoA will access the NHS England data disseminated.

The objectives of the Audit are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing emergency laparotomy using information produced by the audit.

2. To provide comparative information on the organisation of care by providers of emergency laparotomy.

3. To provide comparative information on patient outcomes following surgery for emergency laparotomy.

4. To facilitate the development of effective change (quality improvement) initiatives and thereby spread examples of best practice to help local providers make the best possible use of audit results.

NELA audits care provided by participating hospitals against a set of key standards including:

• Case Ascertainment

• Computerised tomography (CT) scans reported by an in-house consultant radiologist before surgery

• Access to theatres within a time frame appropriate for the urgency of surgery

• Documented assessment, before surgery, of the risks of surgery

• Review before surgery by consultant surgeon, anaesthetist, and intensivist for high-risk patients

• Presence of consultant surgeon and anaesthetist in theatre for high-risk patients

• Admission to critical care after surgery for high-risk patients

• Assessment by a care of the older person specialist for those aged 65+ and frail or aged 80+

• 30-day mortality

DATA SUMMARY

NELA holds data from 2012/13 and requires Demographics and Civil Registration (deaths) data (on a quarterly basis) and Hospital Episode Statistics (HES) Admitted Patient Care and Critical Care data (on an annual basis) over the course of this Agreement.

NELA supplies a cohort to NHS England on an annual basis. The cohort submitted to NHS England is different each year - all patients over the age of 18 years who, in the most recent NELA-defined audit year, have had a general surgical emergency laparotomy in any NHS hospital in England including emergency gastrointestinal procedures on the stomach, large and small bowel, for conditions such as perforation, bleeding, abdominal abscess or obstruction, via open or laparoscopic approaches. It is expected that there will be around 25,000 - 30,000 such patients each year. To address the UK GDPR Principle of Data Minimisation the data requested has been limited to this cohort of patients.

Each year NELA also requires NHS England to provide the previous three years’ worth of HES data for the new cohort which is submitted annually. No historic data is released for cohorts submitted in previous audit years; only those who have undergone an emergency laparotomy procedure within the most recent NELA year. There are therefore no duplications of data. The retained data and additional data requested under this iteration of the Agreement will be used to enrich the data submitted by hospitals for the purposes of the audit.

The data required is pseudonymised data. No direct patient identifiers are needed for analysis, however the information needs to be on an individual level in order to link NHS England data to the NELA data set for analysis in line with the audit’s aims.

NELA is a national audit that includes all eligible patients of emergency laparotomy in England and Wales. Therefore, the audit requires data for the whole of England.

Given the size and scope of the audit, the NELA team feel that requesting data from NHS England is the most efficient way to obtain the data required.

NELA is only requesting data required for the purposes of the audit and only for eligible emergency bowel surgeries. The audit already collects an extensive dataset directly from hospitals—no data that can be obtained from the hospitals is required from NHS England. As aforementioned, the NHS England data supplements and enhances the data the audit dataset already holds.

NELA has received Section 251 NHS Act 2006 support (reference - CAG 5-07(d)/2013) from the Health Research Authority (HRA) Confidential Advisory Group (CAG) to cover access to identifiable data on patients aged 18 and over undergoing emergency laparotomy in England and Wales from December 2013 onwards and linkage of this data to HES, ONS mortality data and Intensive Care National Audit and Research Centre (ICNARC) data (ICNARC data facilitated under a separate Agreement between ICNARC and the RCoA, not an Agreement with NHS England).

Support has also been received from HRA CAG to defer the application of the National Data Opt-Out (NDO) in relation to NELA. There are two points of rationale: (1) patient safety – if the NDO is implemented, clinicians may be unable to use the NELA webtool to obtain patient risk scores. Several clinical teams have flagged the risk to NELA data entry with the NELA study team due to the increased workload related to checking for the NDO prior to data entry in real-time, or fear of data breaches to diminished engagement with the audit; (2) introduction of bias – the case ascertainment to NELA is over 85%. Figures from NHS England show that rates of registration with the National Data Opt-Out vary, exceeding 10% in one in twenty GP practices. The Care Quality Commission uses information from NELA to inform their surveillance approach and to plan and support inspections. Missing information may bias the results. The data quoted is derived from data available here: https://digital.nhs.uk/data-and-information/publications/statistical/national-data-opt-out/april-2022.

NELA applied for, and received, exemption from applying the national data-opt. Therefore, data from anyone on the opt-out register can continue to be entered and used as part of NELA. NELA will continue to remove any individual patient who get in touch with NELA or their care team indicating that they do not wish to have their data included in NELA, as per the CAG conditions of support. Therefore, local opt-outs will be applied.

JUSTIFICATION FOR DATA

- Demographics data and Civil Registration (deaths) data:

The above datasets help ensure that the audit has accurate information on mortality outcomes, including information on diagnoses associated with the death. This allows NELA to compute deaths within 30- and 90- days of surgery, a key metric for the audit.

- Hospital Episode Statistics (HES) Critical Care data:

This data allows for an investigation of the patterns of critical care across NHS Hospitals and for an examination of whether patients with similar conditions and risk of death are being treated in a consistent way that is compatible with guideline recommendations. In line with the NELA team’s desire to continue to look for ways to enhance the audit, participants and stakeholders fed back to the NELA team that information about the delivery of critical care to emergency laparotomy patients would help to inform the development of local Quality Improvement initiatives. To this end, the project uses Critical Care data to develop performance indicators to provide hospitals with this information.

- HES Admitted Patient Care data:

This data is required to provide information on the number of expected emergency laparotomy procedures in any given audit year (case ascertainment). This is critical information and allows NELA to compute case ascertainment rates for each participating hospital - a metric needed to determine the level of completeness of reporting for each hospital and to provide an insight into the representativeness of the audit population. Information from this dataset is also required to examine data by deprivation score, which can provide important information on equity of services in different regions. Other variables from this dataset are also needed to provide information on key measures like patient comorbidities and longer-term outcomes like readmission rates.

The data from HES Critical Care and Admitted Patient Care also helps the NELA team to improve risk-adjustment models by using extensive information on comorbid conditions held within HES (eg. to calculate the Charlson Comorbidity score - predicts 10-year survival in patients with multiple comorbidities).

DATA CONTROLLERS / DATA PROCESSORS

HQIP and NHS England are joint data controllers for the purposes of this Data Sharing Agreement. RCoA, RCS, Bluesource Information Limited and Harbor Solutions Limited are data processors.

Funders include NHS England and the Welsh government. While the audit is commissioned by HQIP, HQIP themselves are commissioned by NHS England to commission the Audit. HQIP and NHS England provide general oversight for the audit but are not involved in the day-to-day management and do not have access to NHS England data.

The RCoA were commissioned by HQIP to deliver the audit. As commissioners, HQIP ensure that the RCoA deliver contracted elements of the audit on time and within budget, in addition to serving as data controllers. HQIP, NHS England, and the Welsh government receive copies of NELA-generated reports for review and approval. Where the reports contain NHS England data, the data is aggregated with small numbers suppressed in line with the HES analysis guide. The audit’s contract with HQIP specifies how data should be protected and processed.

The RCoA also work with the Clinical Effectiveness Unit (CEU) at the RCS to support the delivery of the audit. RCS have a role in developing the audit methodology and analysis of the audit data. The NHS England data is also stored and processed on servers located at the RCS CEU. Both the RCoA and RCS however have no role in determining the purposes and means of the processing of the NHS England data requested under this Agreement. That responsibility lies solely with NHS England and HQIP.

The RCoA have employed Bluesoure Information Limited to provide secure back-up storage of the data. In turn Bluesource have contracted Harbor Solutions Limited to provide these services. Per Part 1, Section 3(4)(a) of the Data Protection Act 2018, as the storage of data is considered to be a type of processing, Harbor Solutions Limited and Bluesource Information Limited are considered data processors. No patient identifiable data is stored on the back-up servers provided by Harbor Solutions Limited. The terms of the contract Bluesource Information Limited has with Harbor Solutions Limited mirror the terms agreed between Bluesource Information Limited and the RCoA.

NELA also seeks guidance from a clinical reference group made up of representatives from key stakeholder organisations. Neither these individuals nor their organisations have access to NELA data or NHS England data; they also do not determine the purpose or means of the processing of personal data.

WIDER PROGRAMMES

NELA forms part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). HQIP, as commissioner of the NCAPOP, are responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England are responsible for determining which projects/topics are included in the NCAPOP and, as a funder, participate in specification development, procurement and project extension activities and authorises, as chair of the specification development meetings, the publication of project outputs. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are also a representative on the HQIP Data Access Request Group which authorises data sharing applications from third parties.

Other than the NCAPOP, NELA is not part of any wider projects. From time to time however, NELA collaborates with external researchers by allowing access to NELA data via an application process. Only data collected as part of the audit (not data from NHS England) are shared.

PATIENT AND PUBLIC INVOLVEMENT (PPI)

The NELA study team collaborates with its patient and families involvement group (PAFIG) which serves to provide insight and accountability to the NELA project team. The PAFIG are a group of individuals with lived experience of an emergency laparotomy. The core responsibilities of the PAFIG are to: (1) provide the lay perspective on the NELA, representing the views of patients and their families with experience of emergency laparotomy surgery; (2) ensure that positive outcomes for the end user, the emergency laparotomy patient, remains a key focus of the work; (3) provide feedback on materials related to the NELA including providing comments from a lay perspective into final reports; (4) advise on any additional patient and public involvement that may strengthen the project.

An information leaflet, outlining in lay person terms the objectives of NELA, was published in October 2018. The information leaflet has since been reviewed and simplified by the Patient and Public Involvement Manager at the RCoA. This has been shared once more with the PAFIG for their thoughts. Upon finalization, this document will be posted to the NELA website and shared with the PAFIG and participating sites for wider distribution (the patient information leaflet can be found on the following webpage: https://www.nela.org.uk/Patient-Information#pt)

NELA convened a meeting with its patient and families involvement group (PAFIG) on 27th July 2022 to discuss the deferral of the national data opt-out. The opt-out legislation was reviewed in general and an overview of the NELA exemption application was provided as a basis for discussion.

One member noted that the information collected as part of NELA was really important in that it improves surgery; she thought it was strange that anyone would want to opt-out of such a programme. She also noted that the information about mortality risk was particularly important as this impacts all care received subsequently. One of the members asked if there was still an option for patients to withdraw after the exemption comes into place and the NELA team indicated that there was, through previously established withdrawal procedures. When specifically asked if members had any objections to the exemption being applied, no objections were received.

In the 27th of July meeting of the PAFIG, other modes of communication were discussed. A video was also suggested. The NELA team will look to produce a video and/or poster regarding the opt-out which can be posted to the website and distributed to local NELA leads within participating hospitals which can be further distributed to patients.

LEGAL BASIS FOR PROCESSING

HQIP and NHS England both rely on Article 6 (1) (e) of the General Data Protection Regulation as their lawful basis for processing personal data - "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". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care servicTo process special categories of personal data, HQIP rely on 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". This is justified as the data is required for audit purposes - for improvement and ensuring high standards and quality/safe care. The Secretary of State has a legal duty under section 2 of the Health and Social Care Act 2012 to continuously improve the quality of health care services. NHS England has a legal duty under the NHS Act 2006 section 13e to improve quality of healthcare services . The Secretary of State and NHS England exercise these duties through the NHS England contract with HQIP to commission NELA and the NHS standard contract with NHS providers of services to mandate participation within NCAPOP audits.

Recital 54 of GDPR explains that:

The processing of special categories of personal data may be necessary for reasons of public interest in the areas of public health without consent of the data subject. Such processing should be subject to suitable and specific measures so as to protect the rights and freedoms of natural persons. In that context, ‘public health’ should be interpreted as defined in Regulation (EC) No 1338/2008 of the European Parliament and of the Council, namely all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care expenditure and financing, and the causes of mortality. Such processing of data concerning health for reasons of public interest should not result in personal data being processed for other purposes by third parties such as employers or insurance and banking companies.

To process special categories of personal data, NHS England rely on 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". This is justified as NHS England are responsible for the provision of health and social care, and the management of systems and compliance. Members of the NELA project team employed by the NHS will be subject to standard NHS confidentiality agreements.

NELA is commissioned to produce a ‘state of the nation’ annual report each year. Reports utilising patient level information have been published in June 2015, July 2016, October 2017, November 2018, December 2019, November 2020 and November 2021 - these are available to view on the NELA website (https://www.nela.org.uk/). Subsequent reports are scheduled to be published yearly, while ad hoc interim reports may also be published. These reports provide updates on standards of care for emergency bowel surgery patients. The reports provide aggregated information on key metrics like case ascertainment, mortality, timeliness to operating theatre, consultant delivered care, and risk assessment among others. The reports also produce this information at hospital-level and red, amber, green (RAG) rate the success of each hospital in meeting each metric.

In order to more widely disseminate the findings of the audit, additional scientific publications hope to be produced. These outputs are anticipated to be in the form of peer-reviewed articles and conference presentations e.g. the British Medical Journal (BMJ), British Journal of Anaesthesia (BJA), Association of Surgeons of Great Britain and Ireland (ASGBI) journal, and Association of Anaesthetists of Great Britain and Ireland (AAGBI) journal. Publications related to the audit methods (e.g. a risk-adjustment model) rather than information of clinical practice and outcomes are to be published on an ad hoc basis.

Publications are also anticipated to be / have been distributed via social media (@NELANews on Twitter), newsletters, and website updates (https://www.nela.org.uk/reports).

So far, 7 peer-reviewed publications that used combined NELA data and data from NHS England have been produced by the NELA project team.

All outputs and publications contain / will contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

For each annual report, the NELA team develop a communication plan that is agreed with NELA’s commissioner, HQIP. Once approved, the report is a publicly available document. Methods of communication for the annual report include social media (Twitter posts), website updates to the both the RCoA and NELA websites, newsletter distribution to various audiences, including the RCoA members and NELA participating hospitals, webinars, and infographics designed for a lay audience. The report is also shared with NELA’s clinical reference group for distribution through their networks, as well as NELA’s funders—NHS England and the Welsh government. Ad hoc interim reports are communicated and disseminated in similar ways.

Update under v10:

The data received under this DSA will contribute to upcoming NELA state of the nation reports. An addendum to NELA's 8th annual report is expected shortly, which includes data from NHS England to support the case ascertainment figures and mortality and outlier analyses. The 9th annual report, which also relies on data from NHS England, is pending receipt of the data being requested under v10 of the DSA.

The NELA audit is highly relevant to current clinical practice and publications have allowed for widespread dissemination of the findings amongst healthcare professionals. Linkage to the HES/Mortality data has allowed the Audit to report more extensively on patterns of care beyond the initial hospital admission and longer-term outcomes, such as 90-day mortality. The Audit is able to examine issues such as readmission rates and the most common reasons for these post-discharge complications - e.g. respiratory complications and anastomotic leaks. Data provided by the audit has an impact on provision of care for patients undergoing emergency bowel surgery and as noted below there have been tangible improvements in patient care since the audit's inception. Based on the NELA key metrics, the audit can see that patients now benefit from consultant-delivered care more than in earlier years of the audit, receive computerised tomography (CT) scans before surgery more often, have a pre-operative documentation of risk more often, and a higher percentage of high-risk patients are admitted directly to critical care after surgery than previously.

The NELA team have produced a quality improvement (QI) plan, approved by NELA’s commissioner, HQIP, which includes tools that the NELA team can offer to participating hospitals to improve patient care based on data produced by the audit. Ultimately, it is up to the participating hospitals to implement QI initiatives locally.

The NELA team have seen promising trends on a national level in most key metrics since the start of the audit. In the most recent report, five metrics achieved compliance on a national level, while progress was also seen in relation to most other metrics. Different hospitals have different levels of compliance with each metric. The time it takes to achieve compliance across all metrics will vary by trust but the NELA team are encouraged by the progress seen since inception.

NHS England data is being used by the Care Quality Commission (CQC) on their Dashboard (hospital-level data - includes data derived from NHS England data, including case ascertainment and 30-day mortality, with small numbers suppressed), on the MyNHS website (no record level data - all aggregated with small numbers suppressed) and as part of the NHS England Best Practice Tariff.

In terms of exploitation of results, there may be instances where data gathered as part of NELA is used for further research and the creation of new tools. An example of such development is the creation of the NELA risk prediction algorithm, which was developed to facilitate risk-adjusted comparisons of 30-day mortality rates between hospitals. It was brought about because other risk prediction tools were limited as they did not specifically focus on our patient population. Mortality data were used to develop the model so that 30-day postoperative mortality could be derived. The model is not intended to be used in isolation but as part of the overall clinical decision making process. All of the audit data is owned by HQIP as the audit commissioner, but the audit acknowledges all those that contribute including NHS England. The coefficients and calculations used are open to all and published on the NELA website so anyone can make use of it.

The audit has made recommendations in annual reports for local participating sites to follow. Includes recommendation for NELA Local Leads, Clinical Directors, Commissioners, Medical Directors, Multidisciplinary Teams, Royal Colleges and other professional stakeholders.

The audit has run regional NELA Quality Improvement workshops to assist hospital sites in using their local data to improve patient care

In addition, peer-reviewed publications have added to literature on emergency bowel surgery. For example, NELA data have been combined with death data to demonstrate that patients with anaemia are at a higher risk of mortality and morbidity following surgery. Data from NELA and NHS England-held HES/Mortality datasets have also been published showing that older emergency bowel surgery patients (aged 65+) experience worse outcomes in terms of mortality, length of stay, and discharge to care-home accommodation than younger patients.

Statistics:

Nearly 30,000 patients undergo emergency bowel surgery each year in England and Wales. Since NELA’s inception:

- Length of hospital stay after emergency bowel surgery has decreased from 19.3 days in NELA’s first year to 15.1 days in the most recent report. In addition to getting patients home quicker this also represents a cost-savings of around £42.4 million to participating trusts.

- In NELA’s first year of reporting, only 44% of hospitals had case ascertainment of 85% or higher. In the most recent NELA report, this increased to 58% of hospitals.

- More than 90% of high-risk patients now have a consultant surgeon and consultant anaesthetist present in theatre during surgery. This is an improvement from 82.3% in 2016/17.

- 85% of patients now have an assessment of mortality risk documented preoperatively. This is an improvement from 74.5% in 2016/17.

On 1 February 2023, NHS Digital merged with NHS England. NHS England DARS has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England and is referred to as NHS England DARS.

BACKGROUND AND PURPOSE

The National Emergency Laparotomy Audit (NELA) was commissioned in 2011 by the Healthcare Quality Improvement Partnership (HQIP) and is funded by NHS England and the Welsh government. NELA first began collecting data in 2013 and has continued to do so on a regular basis ever since. NELA’s aims are to collect and publish high-quality comparative information from all hospitals in England and Wales at which emergency laparotomies (an emergency laparotomy is a major operation where the surgeon has to cut open the abdomen) are performed, in order to drive quality improvement in the care of these patients. It was established in response to the comparatively high death rate after emergency laparotomy, and the substantial variation in this rate between hospitals.

Throughout the Agreement NELA, the NELA team, and the NELA project team are interchangeable terms used and refer to the core NELA team that manage the day-to-day operations and analysis. The NELA team comprises substantive employees of both the Royal College of Surgeons of England (RCS) and Royal College of Anaesthetists (RCoA) as well as members who hold a signed memorandum of understanding with RCoA. Only substantive employees of the RCoA or RCS or non-substantive employees who hold honorary contracts with the RCoA will access the NHS England’s DARS data disseminated.

The objectives of the Audit are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing emergency laparotomy using information produced by the audit.

2. To provide comparative information on the organisation of care by providers of emergency laparotomy.

3. To provide comparative information on patient outcomes following surgery for emergency laparotomy.

4. To facilitate the development of effective change (quality improvement) initiatives and thereby spread examples of best practice to help local providers make the best possible use of audit results.

NELA audits care provided by participating hospitals against a set of key standards including:

• Case Ascertainment

• Computerised tomography (CT) scans reported by an in-house consultant radiologist before surgery

• Access to theatres within a time frame appropriate for the urgency of surgery

• Documented assessment, before surgery, of the risks of surgery

• Review before surgery by consultant surgeon, anaesthetist, and intensivist for high-risk patients

• Presence of consultant surgeon and anaesthetist in theatre for high-risk patients

• Admission to critical care after surgery for high-risk patients

• Assessment by a care of the older person specialist for those aged 65+ and frail or aged 80+

• 30-day mortality

DATA SUMMARY

NELA holds data from 2012/13 and requires Demographics and Civil Registration (deaths) data (on a quarterly basis) and Hospital Episode Statistics (HES) Admitted Patient Care and Critical Care data (on an annual basis) over the course of this Agreement.

NELA supplies a cohort to NHS England’s DARS on an annual basis. The cohort submitted to NHS England’s DARS is different each year - all patients over the age of 18 years who, in the most recent NELA-defined audit year, have had a general surgical emergency laparotomy in any NHS hospital in England including emergency gastrointestinal procedures on the stomach, large and small bowel, for conditions such as perforation, bleeding, abdominal abscess or obstruction, via open or laparoscopic approaches. It is expected that there will be around 25,000 - 30,000 such patients each year. To address the UK GDPR Principle of Data Minimisation the data requested has been limited to this cohort of patients.

Each year NELA also requires NHS England’s DARS to provide the previous three years’ worth of HES data for the new cohort which is submitted annually. No historic data is released for cohorts submitted in previous audit years; only those who have undergone an emergency laparotomy procedure within the most recent NELA year. There are therefore no duplications of data. The retained data and additional data requested under this iteration of the Agreement will be used to enrich the data submitted by hospitals for the purposes of the audit.

The data required is pseudonymised data. No direct patient identifiers are needed for analysis, however the information needs to be on an individual level in order to link NHS England’s DARS data to the NELA data set for analysis in line with the audit’s aims.

NELA is a national audit that includes all eligible patients of emergency laparotomy in England and Wales. Therefore, the audit requires data for the whole of England.

Given the size and scope of the audit, the NELA team feel that requesting data from NHS England’s DARS is the most efficient way to obtain the data required.

NELA is only requesting data required for the purposes of the audit and only for eligible emergency bowel surgeries. The audit already collects an extensive dataset directly from hospitals—no data that can be obtained from the hospitals is required from NHS England’s DARS. As aforementioned, the NHS England’s DARS data supplements and enhances the data the audit dataset already holds.

NELA has received Section 251 NHS Act 2006 support (reference - CAG 5-07(d)/2013) from the Health Research Authority (HRA) Confidential Advisory Group (CAG) to cover access to identifiable data on patients aged 18 and over undergoing emergency laparotomy in England and Wales from December 2013 onwards and linkage of this data to HES, ONS mortality data and Intensive Care National Audit and Research Centre (ICNARC) data (ICNARC data facilitated under a separate Agreement between ICNARC and the RCoA, not an Agreement with NHS England’s DARS).

Support has also been received from HRA CAG to defer the application of the National Data Opt-Out (NDO) in relation to NELA. There are two points of rationale: (1) patient safety – if the NDO is implemented, clinicians may be unable to use the NELA webtool to obtain patient risk scores. Several clinical teams have flagged the risk to NELA data entry with the NELA study team due to the increased workload related to checking for the NDO prior to data entry in real-time, or fear of data breaches to diminished engagement with the audit; (2) introduction of bias – the case ascertainment to NELA is over 85%. Figures from NHS England’s DARS show that rates of registration with the National Data Opt-Out vary, exceeding 10% in one in twenty GP practices. The Care Quality Commission uses information from NELA to inform their surveillance approach and to plan and support inspections. Missing information may bias the results. The data quoted is derived from data available here: https://digital.nhs.uk/data-and-information/publications/statistical/national-data-opt-out/april-2022.

NELA applied for, and received, exemption from applying the national data-opt. Therefore, data from anyone on the opt-out register can continue to be entered and used as part of NELA. NELA will continue to remove any individual patient who get in touch with NELA or their care team indicating that they do not wish to have their data included in NELA, as per the CAG conditions of support. Therefore, local opt-outs will be applied.

JUSTIFICATION FOR DATA

- Demographics data and Civil Registration (deaths) data:

The above datasets help ensure that the audit has accurate information on mortality outcomes, including information on diagnoses associated with the death. This allows NELA to compute deaths within 30- and 90- days of surgery, a key metric for the audit.

- Hospital Episode Statistics (HES) Critical Care data:

This data allows for an investigation of the patterns of critical care across NHS Hospitals and for an examination of whether patients with similar conditions and risk of death are being treated in a consistent way that is compatible with guideline recommendations. In line with the NELA team’s desire to continue to look for ways to enhance the audit, participants and stakeholders fed back to the NELA team that information about the delivery of critical care to emergency laparotomy patients would help to inform the development of local Quality Improvement initiatives. To this end, the project uses Critical Care data to develop performance indicators to provide hospitals with this information.

- HES Admitted Patient Care data:

This data is required to provide information on the number of expected emergency laparotomy procedures in any given audit year (case ascertainment). This is critical information and allows NELA to compute case ascertainment rates for each participating hospital - a metric needed to determine the level of completeness of reporting for each hospital and to provide an insight into the representativeness of the audit population. Information from this dataset is also required to examine data by deprivation score, which can provide important information on equity of services in different regions. Other variables from this dataset are also needed to provide information on key measures like patient comorbidities and longer-term outcomes like readmission rates.

The data from HES Critical Care and Admitted Patient Care also helps the NELA team to improve risk-adjustment models by using extensive information on comorbid conditions held within HES (eg. to calculate the Charlson Comorbidity score - predicts 10-year survival in patients with multiple comorbidities).

DATA CONTROLLERS / DATA PROCESSORS

HQIP and NHS England are joint data controllers for the purposes of this Data Sharing Agreement. RCoA, RCS, Bluesource Information Limited and Harbor Solutions Limited are data processors.

Funders include NHS England and the Welsh government. While the audit is commissioned by HQIP, HQIP themselves are commissioned by NHS England to commission the Audit. HQIP and NHS England provide general oversight for the audit but are not involved in the day-to-day management and do not have access to NHS England’s DARS data.

The RCoA were commissioned by HQIP to deliver the audit. As commissioners, HQIP ensure that the RCoA deliver contracted elements of the audit on time and within budget, in addition to serving as data controllers. HQIP, NHS England, and the Welsh government receive copies of NELA-generated reports for review and approval. Where the reports contain NHS England’s DARS data, the data is aggregated with small numbers suppressed in line with the HES analysis guide. The audit’s contract with HQIP specifies how data should be protected and processed.

The RCoA also work with the Clinical Effectiveness Unit (CEU) at the RCS to support the delivery of the audit. RCS have a role in developing the audit methodology and analysis of the audit data. The NHS England’s DARS data is also stored and processed on servers located at the RCS CEU. Both the RCoA and RCS however have no role in determining the purposes and means of the processing of the NHS England’s DARS requested under this Agreement. That responsibility lies solely with NHS England and HQIP.

The RCoA have employed Bluesoure Information Limited to provide secure back-up storage of the data. In turn Bluesource have contracted Harbor Solutions Limited to provide these services. Per Part 1, Section 3(4)(a) of the Data Protection Act 2018, as the storage of data is considered to be a type of processing, Harbor Solutions Limited and Bluesource Information Limited are considered data processors. No patient identifiable data is stored on the back-up servers provided by Harbor Solutions Limited. The terms of the contract Bluesource Information Limited has with Harbor Solutions Limited mirror the terms agreed between Bluesource Information Limited and the RCoA.

NELA also seeks guidance from a clinical reference group made up of representatives from key stakeholder organisations. Neither these individuals nor their organisations have access to NELA data or NHS England’s DARS data; they also do not determine the purpose or means of the processing of personal data.

WIDER PROGRAMMES

NELA forms part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). HQIP, as commissioner of the NCAPOP, are responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England are responsible for determining which projects/topics are included in the NCAPOP and, as a funder, participate in specification development, procurement and project extension activities and authorises, as chair of the specification development meetings, the publication of project outputs. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are also a representative on the HQIP Data Access Request Group which authorises data sharing applications from third parties.

Other than the NCAPOP, NELA is not part of any wider projects. From time to time however, NELA collaborates with external researchers by allowing access to NELA data via an application process. Only data collected as part of the audit (not data from NHS England’s DARS) are shared.

PATIENT AND PUBLIC INVOLVEMENT (PPI)

The NELA study team collaborates with its patient and families involvement group (PAFIG) which serves to provide insight and accountability to the NELA project team. The PAFIG are a group of individuals with lived experience of an emergency laparotomy. The core responsibilities of the PAFIG are to: (1) provide the lay perspective on the NELA, representing the views of patients and their families with experience of emergency laparotomy surgery; (2) ensure that positive outcomes for the end user, the emergency laparotomy patient, remains a key focus of the work; (3) provide feedback on materials related to the NELA including providing comments from a lay perspective into final reports; (4) advise on any additional patient and public involvement that may strengthen the project.

An information leaflet, outlining in lay person terms the objectives of NELA, was published in October 2018. The information leaflet has since been reviewed and simplified by the Patient and Public Involvement Manager at the RCoA. This has been shared once more with the PAFIG for their thoughts. Upon finalization, this document will be posted to the NELA website and shared with the PAFIG and participating sites for wider distribution (the patient information leaflet can be found on the following webpage: https://www.nela.org.uk/Patient-Information#pt)

NELA convened a meeting with its patient and families involvement group (PAFIG) on 27th July 2022 to discuss the deferral of the national data opt-out. The opt-out legislation was reviewed in general and an overview of the NELA exemption application was provided as a basis for discussion.

One member noted that the information collected as part of NELA was really important in that it improves surgery; she thought it was strange that anyone would want to opt-out of such a programme. She also noted that the information about mortality risk was particularly important as this impacts all care received subsequently. One of the members asked if there was still an option for patients to withdraw after the exemption comes into place and the NELA team indicated that there was, through previously established withdrawal procedures. When specifically asked if members had any objections to the exemption being applied, no objections were received.

In the 27th of July meeting of the PAFIG, other modes of communication were discussed. A video was also suggested. The NELA team will look to produce a video and/or poster regarding the opt-out which can be posted to the website and distributed to local NELA leads within participating hospitals which can be further distributed to patients.

LEGAL BASIS FOR PROCESSING

HQIP and NHS England both rely on Article 6 (1) (e) of the General Data Protection Regulation as their lawful basis for processing personal data - "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". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care servicTo process special categories of personal data, HQIP rely on 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". This is justified as the data is required for audit purposes - for improvement and ensuring high standards and quality/safe care. The Secretary of State has a legal duty under section 2 of the Health and Social Care Act 2012 to continuously improve the quality of health care services. NHS England has a legal duty under the NHS Act 2006 section 13e to improve quality of healthcare services . The Secretary of State and NHS England exercise these duties through the NHS England contract with HQIP to commission NELA and the NHS standard contract with NHS providers of services to mandate participation within NCAPOP audits.

Recital 54 of GDPR explains that:

The processing of special categories of personal data may be necessary for reasons of public interest in the areas of public health without consent of the data subject. Such processing should be subject to suitable and specific measures so as to protect the rights and freedoms of natural persons. In that context, ‘public health’ should be interpreted as defined in Regulation (EC) No 1338/2008 of the European Parliament and of the Council, namely all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care expenditure and financing, and the causes of mortality. Such processing of data concerning health for reasons of public interest should not result in personal data being processed for other purposes by third parties such as employers or insurance and banking companies.

To process special categories of personal data, NHS England rely on 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". This is justified as NHS England are responsible for the provision of health and social care, and the management of systems and compliance. Members of the NELA project team employed by the NHS will be subject to standard NHS confidentiality agreements.

NELA is commissioned to produce a ‘state of the nation’ annual report each year. Reports utilising patient level information have been published in June 2015, July 2016, October 2017, November 2018, December 2019, November 2020 and November 2021 - these are available to view on the NELA website (https://www.nela.org.uk/). Subsequent reports are scheduled to be published yearly, while ad hoc interim reports may also be published. These reports provide updates on standards of care for emergency bowel surgery patients. The reports provide aggregated information on key metrics like case ascertainment, mortality, timeliness to operating theatre, consultant delivered care, and risk assessment among others. The reports also produce this information at hospital-level and red, amber, green (RAG) rate the success of each hospital in meeting each metric.

In order to more widely disseminate the findings of the audit, additional scientific publications hope to be produced. These outputs are anticipated to be in the form of peer-reviewed articles and conference presentations e.g. the British Medical Journal (BMJ), British Journal of Anaesthesia (BJA), Association of Surgeons of Great Britain and Ireland (ASGBI) journal, and Association of Anaesthetists of Great Britain and Ireland (AAGBI) journal. Publications related to the audit methods (e.g. a risk-adjustment model) rather than information of clinical practice and outcomes are to be published on an ad hoc basis.

Publications are also anticipated to be / have been distributed via social media (@NELANews on Twitter), newsletters, and website updates (https://www.nela.org.uk/reports).

So far, 7 peer-reviewed publications that used combined NELA data and data from NHS England’s DARS have been produced by the NELA project team.

All outputs and publications contain / will contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

For each annual report, the NELA team develop a communication plan that is agreed with NELA’s commissioner, HQIP. Once approved, the report is a publicly available document. Methods of communication for the annual report include social media (Twitter posts), website updates to the both the RCoA and NELA websites, newsletter distribution to various audiences, including the RCoA members and NELA participating hospitals, webinars, and infographics designed for a lay audience. The report is also shared with NELA’s clinical reference group for distribution through their networks, as well as NELA’s funders—NHS England and the Welsh government. Ad hoc interim reports are communicated and disseminated in similar ways.

The NELA audit is highly relevant to current clinical practice and publications have allowed for widespread dissemination of the findings amongst healthcare professionals. Linkage to the HES/Mortality data has allowed the Audit to report more extensively on patterns of care beyond the initial hospital admission and longer-term outcomes, such as 90-day mortality. The Audit is able to examine issues such as readmission rates and the most common reasons for these post-discharge complications - e.g. respiratory complications and anastomotic leaks. Data provided by the audit has an impact on provision of care for patients undergoing emergency bowel surgery and as noted below there have been tangible improvements in patient care since the audit's inception. Based on the NELA key metrics, the audit can see that patients now benefit from consultant-delivered care more than in earlier years of the audit, receive computerised tomography (CT) scans before surgery more often, have a pre-operative documentation of risk more often, and a higher percentage of high-risk patients are admitted directly to critical care after surgery than previously.

The NELA team have produced a quality improvement (QI) plan, approved by NELA’s commissioner, HQIP, which includes tools that the NELA team can offer to participating hospitals to improve patient care based on data produced by the audit. Ultimately, it is up to the participating hospitals to implement QI initiatives locally.

The NELA team have seen promising trends on a national level in most key metrics since the start of the audit. In the most recent report, five metrics achieved compliance on a national level, while progress was also seen in relation to most other metrics. Different hospitals have different levels of compliance with each metric. The time it takes to achieve compliance across all metrics will vary by trust but the NELA team are encouraged by the progress seen since inception.

NHS England’s DARS data is being used by the Care Quality Commission (CQC) on their Dashboard (hospital-level data - includes data derived from NHS England’s DARS data, including case ascertainment and 30-day mortality, with small numbers suppressed), on the MyNHS website (no record level data - all aggregated with small numbers suppressed) and as part of the NHS England Best Practice Tariff.

In terms of exploitation of results, there may be instances where data gathered as part of NELA is used for further research and the creation of new tools. An example of such development is the creation of the NELA risk prediction algorithm, which was developed to facilitate risk-adjusted comparisons of 30-day mortality rates between hospitals. It was brought about because other risk prediction tools were limited as they did not specifically focus on our patient population. Mortality data were used to develop the model so that 30-day postoperative mortality could be derived. The model is not intended to be used in isolation but as part of the overall clinical decision making process. All of the audit data is owned by HQIP as the audit commissioner, but the audit acknowledges all those that contribute including NHS England’s DARS. The coefficients and calculations used are open to all and published on the NELA website so anyone can make use of it.

The audit has made recommendations in annual reports for local participating sites to follow. Includes recommendation for NELA Local Leads, Clinical Directors, Commissioners, Medical Directors, Multidisciplinary Teams, Royal Colleges and other professional stakeholders.

The audit has run regional NELA Quality Improvement workshops to assist hospital sites in using their local data to improve patient care

In addition, peer-reviewed publications have added to literature on emergency bowel surgery. For example, NELA data have been combined with death data to demonstrate that patients with anaemia are at a higher risk of mortality and morbidity following surgery. Data from NELA and NHS England’s DARS-held HES/Mortality datasets have also been published showing that older emergency bowel surgery patients (aged 65+) experience worse outcomes in terms of mortality, length of stay, and discharge to care-home accommodation than younger patients.

Statistics:

Nearly 30,000 patients undergo emergency bowel surgery each year in England and Wales. Since NELA’s inception:

- Length of hospital stay after emergency bowel surgery has decreased from 19.3 days in NELA’s first year to 15.1 days in the most recent report. In addition to getting patients home quicker this also represents a cost-savings of around £42.4 million to participating trusts.

- In NELA’s first year of reporting, only 44% of hospitals had case ascertainment of 85% or higher. In the most recent NELA report, this increased to 58% of hospitals.

- More than 90% of high-risk patients now have a consultant surgeon and consultant anaesthetist present in theatre during surgery. This is an improvement from 82.3% in 2016/17.

- 85% of patients now have an assessment of mortality risk documented preoperatively. This is an improvement from 74.5% in 2016/17.

1. The objectives of the Audit are:

• To enable secondary care providers to improve the delivery of care to patients undergoing emergency laparotomy using information produced by the audit

• To provide comparative information on the organisation of care by providers of Emergency Laparotomy.

• To provide comparative information on patient outcomes following surgery for Emergency Laparotomy.

• To facilitate the development of effective change (quality improvement) initiatives and thereby spread examples of best practice and help local providers make the best possible use of audit results

a. HQIP has put forward article 6(1)(e) ‘…for the performance of a task carried out in the public interest or in the exercise of official authority…’ article 9(2)(i) ‘…processing is necessary for reasons of public interest in the area of public health, such as ......... ensuring high standards of quality and safety of health care and of medicinal products or medical devices.…’ as the legal basis most appropriate for clinical audit.

b. Emergency abdominal surgery (or emergency laparotomy) is associated with significant morbidity and mortality worldwide. The aim of the National Emergency Laparotomy Audit (NELA) is to enable the improvement of the quality of care of patients undergoing emergency laparotomy by providing high quality comparative information of the clinical practice and outcomes of all NHS providers of emergency laparotomy in England and Wales. NELA is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical and Patient Outcomes Programme (NCAPOP).

i. The audit has Section 251 approval to collect information on emergency laparotomy patients. Patients who do not want their data included can opt-out by emailing the NELA team or through the National Data Opt-Out portal.

2. The analysis by the NELA project team will only involve pseudonymised datasets that link information submitted by NHS hospitals and data supplied by NHS Digital. Date of death (mortality data) comes from the hospitals if it occurs during the hospital admission. For deaths outside hospital, NELA uses the NHS Digital mortality data which is linked along with the NELA audit data to NHS Digital data and then analysed by substantive employees of the Royal College of Surgeons (RCS) and substantive or contracted employees of the Royal College of Anaesthetists (RCoA).

The RCoA and RCS wish to link the patient records submitted to NELA with the Hospital Episode Statistics (HES) records for those patients. The NELA records relate only to an individual admission, and by linking to inpatient HES data, the Audit will be able to provide more precise and relevant information to NHS hospitals by allowing the RCoA and RCS to describe longer term outcomes (e.g., readmission rates) and to improve RCoA’s and RCS’s risk-adjustment models by using the extensive information on comorbid conditions held within HES (eg to calculate the Charlson Comorbidity score).

The RCoA and RCS also wish to link the patient records submitted to NELA with the Mortality Data on a quarterly basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

3. HQIP have commissioned the RCoA to deliver the audit. RCoA are working in partnership with the Clinical Effectiveness Unit of the RCS and therefore make up the NELA project team. There are no other organisations involved. HQIP act as data controllers for the national clinical audit but do not have access to any data collected or analysed by the RCoA and RCS who are the data processors. NELA began in 2013 and the requested historic data provides important data when looking to improve mortality and length of stay.

4. As noted above, the RCoA and the RCS collaborate on NELA; no other organisations are involved. NELA’s primary purpose is to provide quality data to be used for clinical audit purposes; inclusion of HES and ONS mortality data help ensure the accuracy of the information. From time to time, NELA collaborate with external researchers by allowing access to NELA data after an application process. Only data collected as part of the audit (and not data from NHS Digital) are provided.

5. All patients over the age of 18 years, having a general surgical emergency laparotomy in all NHS hospitals in England and Wales are eligible for the audit and trusts/hospitals will submit their records. The aim is to include all emergency gastrointestinal procedures on the stomach, large and small bowel, for conditions such as perforation, bleeding, abdominal abscess or obstruction, via open or laparoscopic approaches. Emergency laparotomies following elective surgical complications will also be included in the NELA. The NELA includes all NHS hospitals in England and Wales that carry out emergency laparotomy. This includes any hospitals with acute admission, emergency departments, or specialist centres which carry out emergency laparotomy as a complication of other types of surgery.

6. NELA are requesting the following datasets:

a. Demographic data: data on date of death so as to ensure the audit has accurate information on this key outcome

b. Civil registration: as mortality is a key outcome measure of the audit, it is important to have accurate information, including information on diagnoses associated with the death

c. Critical care data: These specific data would allow investigation of the patterns of critical care across NHS Hospitals and examine whether patients with similar conditions and risk of death are being treated in a consistent way that is compatible with guideline recommendations. The NELA team continue to look for ways in which to enhance the audit. The NELA team has received feedback from participants and stakeholders that information about the delivery of critical care to Emergency Laparotomy patients would help to inform the development of local Quality Improvement initiatives, and the project would use the Critical Care data to develop performance indicators to provide hospitals with this information.

d. Admitted patient care data: this data is being requested to provide information on the number of expected emergency laparotomy procedures in any given audit year. This is critical information and allows NELA to compute case ascertainment rates for each participating hospital. Information from this dataset also allows us to examine data by deprivation score, which can provide important information on equity of services in different regions. Other variables from this dataset provide information on key measures like patient comorbidities and longer-term outcomes like readmission rates.

All data requested is at record level in order to link cases within NELA to the NHS Digital datasets. Data requested is pseudonymised as no direct patient identifiers are needed for analysis. We are requesting data for all of England as NELA is a national audit. NELA do not believe there are less intrusive alternatives to collecting this data, but are committed to only requesting that data which is necessary for the purposes of the audit. Data are only being requested for those patients with emergency laparotomy and only for those variables that cannot be reliably or easily obtained through hospital medical records.

7. HQIP act as data controllers and commissioners for the audit as noted above. NELA seek guidance from a clinical reference group made up of representatives from key stakeholder organisations. Neither these individuals or their organisations have access to NELA data or NHS Digital data. Funders include NHS England and the Welsh government. They provide general oversight for the audit but are not involved in the day-to-day management and do not have access to data.

The linked dataset will be a product of this process and will enhance the quality of the comparative data for the audit in subsequent years.

The NELA is commissioned to produce a "State of the Nation" annual report each year. Reports utilising patient level information have been published in June 2015, July 2016, October 2017, November 2018, December 2019, and November 2020; these are available to view on the NELA website. Subsequent reports are scheduled to be published yearly, while ad hoc interim reports may also be published.

In order to more widely disseminate the findings of the audit, additional scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BMJ (British Medical Journal), BJA (British Journal of Anaesthesia), ASGBI (Association of Surgeons of Great Britain and Ireland) journal, and AAGBI (The Association of Anaesthetists of Great Britain and Ireland) at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk-adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

In response to participant feedback a Quality Improvement Report Dashboard has been created on the NELA Online Web Tool to assist sites with audit data collection and to promote local Quality Improvement work (Local hospital data can only be viewed by registered local hospital participants). The Quality Improvement Report Dashboard will only provide local units with aggregated information to compare their performance against a national average. The figures available to each unit will be based on their own local data (supplied by the units) and the Dashboard may therefore present small numbers on some occasions. Each individual user has their own login to the webtool which gives them access to only their own hospital local data. To access the webtool they require a username and password. No data supplied from NHS Digital is held or accessed here.

The following Reports and Publications have been created:

- 6 National Patient Audit Reports published in 2015, 2016, 2017, 2018, 2019, and 2020

- 2 Organisational Audit reports published in 2014 and 2017

- Quarterly hospital reports provided to participants since the start of 2017 and ongoing

- Quarterly Reports at AHSN level provided since Year 4 Quarter 3

In addition,

- Data is being used by CQC on their Dashboard (no record level data - all aggregated with small numbers suppressed)

- Data being used on MyNHS website (no record level data - all aggregated with small numbers suppressed)

- Data being used as part of the NHS England Best Practice Tariff.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

There will be no requirement nor attempt to re-identify individuals from the data.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

RCoA/RCS have requested permission to release a small number of items from HES data back to participating hospitals sites. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it to HES in the first place.

RCoA/RCS have requested permission to release a small number of items – unsuppressed, at record-level – from HES data back to participating hospitals sites, to enable clinicians to explore and understand low-volume activity in their Trusts, to understand case ascertainment and - specifically - identify which patients have not had their data uploaded to NELA. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it – originally as SUS, then transformed by NHS Digital into HES – in the first place.

Benefits derived from the research so far:

Headlines from reports of the last 6 years:

> national 30-day mortality rate falling from 11.8 per cent to 9.3 per cent over six years

> Average length of stay has fallen to 15.4 days from 19.2 days in year one.

> Making recommendations in the reports for local participating sites to follow. Includes recommendation for NELA Local Leads, Clinical Directors, Commissioners, Medical Directors, Multidisciplinary Teams, Royal Colleges and other professional stakeholders.

> Running regional NELA Quality Improvement workshops to assist hospital sites in using their local data to improve patient care

HQIP has put forward Article 6(1)(e) as their legal basis under GDPR. However, HQIP are currently seeking legal advice on whether this is the most appropriate legal basis. Further to receipt of that legal advice, the stated GDPR lawful basis may change, and the NHS Digital data release register would be updated to reflect this.

Emergency abdominal surgery (or emergency laparotomy) is associated with significant morbidity and mortality worldwide. The aim of The National Emergency Laparotomy Audit (NELA) is to enable the improvement of the quality of care of patients undergoing emergency laparotomy by providing high quality comparative information of the clinical practice and outcomes of all NHS providers of emergency laparotomy in England and Wales. NELA is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Anaesthetists (RCoA) to deliver the audit. RCoA are working in partnership with the Clinical Effectiveness Unit of the Royal College of Surgeons (RCS) and therefore make up the NELA project team. There are no other organisations involved. HQIP act as data controllers for the national clinical audit but do not have access to any data collected or analysed by the RCoA and RCS who are the data processors.

The analysis by the NELA project team will only involve pseudonymised datasets that links information submitted by NHS hospitals and data supplied by NHS Digital. Date of death (mortality data) comes from the hospitals if it occurs during the hospital admission. For deaths outside hospital, NELA uses the NHS Digital mortality data which is linked along with the NELA audit data to NHS Digital data and then analysed by substantive employees of RCS and substantive or contracted employees of RCoA.

The RCoA and RCS wish to link the patient records submitted to NELA with the Hospital Episode Statistics (HES) records for those patients. The NELA records relate only to an individual admission, and by linking to inpatient HES data, the Audit will be able to provide more precise and relevant information to NHS hospitals by allowing the RCoA and RCS to describe longer term outcomes (e.g., readmission rates) and to improve RCoA’s and RCS’s risk-adjustment models by using the extensive information on comorbid conditions held within HES. (eg to calculate the Charlson Comorbidity score)

The RCoA and RCS also wish to link the patient records submitted to NELA with the Mortality Data on a quarterly basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

All patients over the age of 18 years, having a general surgical emergency laparotomy in all NHS hospitals in England and Wales are eligible for the audit and the trusts/hospitals will submit their records.

The aim is to include all emergency gastrointestinal procedures on the stomach, large and small bowel, for conditions such as perforation, bleeding, abdominal abscess or obstruction, via open or laparoscopic approaches.

Emergency laparotomies following elective surgical complications will also be included in the NELA.

The Project is requesting a three year DSA as this covers the length of the current National Audit contract with HQIP (NHS England & Welsh Government).The NELA includes all NHS hospitals in England and Wales that carry out emergency laparotomy. This includes any hospitals with acute admission, emergency departments, or specialist centres which carry out emergency laparotomy as a complication of other types of surgery.

NELA began in 2013 and the requested historic data provides important data when looking to improve mortality and length of stay.

The objectives of the Audit are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing emergency laparotomy using information produced by the audit;

2. To provide comparative information on the organisation of care by providers of Emergency Laparotomy.

3. To provide comparative information on patient outcomes following surgery for Emergency Laparotomy.

4. To facilitate the development of effective change (quality improvement) initiatives and thereby spread examples of best practice and help local providers make the best possible use of audit results

In summary, the purpose of this request is to support national clinical audit, quality improvement within hospitals, and research on methods to monitor surgical outcomes.

The request for the addition of the HES Critical Care Data is for similar reasons to those for why the RCoA/RCS are requesting other data sets. These specific data would allow investigation of the patterns of critical care across NHS Hospitals and examine whether patients with similar conditions and risk of death are being treated in a consistent way that is compatible with guideline recommendations. The NELA team continue to look for ways in which to enhance the audit. The NELA team has received feedback from participants and stakeholders that information about the delivery of critical care to Emergency Laparotomy patients would help to inform the development of local Quality Improvement initiatives, and the project would use the Critical Care data to develop performance indicators to provide hospitals with this information.

The linked dataset will be a product of this process and will enhance the quality of the comparative data for the audit in subsequent years.

The NELA is commissioned to produce a "State of the Nation" annual report each year. The first 4 reports utilising patient level information were published in June 2015, July 2016, October 2017 & 2018 and are available to view on the NELA website. Subsequent reports are scheduled to be published yearly.

In order to more widely disseminate the findings of the audit, additional scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BMJ (British Medical Journal), BJA (British Journal of Anaesthesia), ASGBI (Association of Surgeons of Great Britain and Ireland) journal, and AAGBI (The Association of Anaesthetists of Great Britain and Ireland) journal at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk-adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

In response to participant feedback a Quality Improvement Report Dashboard has been created on the NELA Online Web Tool to assist sites with audit data collection and to promote local Quality Improvement work (Local hospital data can only be viewed by registered local hospital participants). The Quality Improvement Report Dashboard will only provide local units with aggregated information to compare their performance against a national average. The figures available to each unit will be based on their own local data (supplied by the units) and the Dashboard may therefore present small numbers on some occasions. Each individual user has their own login to the webtool which gives them access to only their own hospital local data. To access the webtool they require a username and password. No data supplied from NHS Digital is held or accessed here.

The first phase of the Dashboard which has now been launched focuses on Case Ascertainment and Patient Demographics. The Patient Demographics section allows local participants to view some basic information on their hospital's population of patients undergoing emergency laparotomy, and how it compares to the audit-wide average. It focuses on characteristics such as patient age and operative urgency.

The Case Ascertainment aims at increasing case completeness and submission by providing a monthly list of cases entered/completed/not completed.

The next phase of the Dashboard will focus much more on Quality Improvement, feeding back key QI indicators and comparing hospital's local data with national audit-wide averages. Some of the measures reported back will include; Documentation of risk, Direct Admission to critical care etc.

The Royal College of Anaesthetists are currently in the process of developing the QI dashboard and hope to make further additions in the next few months.

The following Reports and Publications have been created:

- 4 National Patient Audit Reports published in 2015, 2016, 2017, 2018

- 2 Organisational Audit reports published in 2014 and 2017

- Quarterly hospital reports provided to participants since the start of 2017 and ongoing

- Quarterly Reports at AHSN level provided since Year 4 Quarter 3

In addition,

- Data is being used by CQC on their Dashboard (no record level data - all aggregated with small numbers suppressed)

- Data being used on MyNHS website (no record level data - all aggregated with small numbers suppressed)

- Work has started on introducing a BPT for Emergency Laparotomy using the audit data. NHS England are looking to introduce this BPT in 2019. The BPT will be using audit data to ensure compliance.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

There will be no requirement nor attempt to re-identify individuals from the data.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

RCoA/RCS have requested permission to release a small number of items from HES data back to participating hospitals sites. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it to HES in the first place.

RCoA/RCS have requested permission to release a small number of items – unsuppressed, at record-level – from HES data back to participating hospitals sites, to enable clinicians to explore and understand low-volume activity in their Trusts, to understand case ascertainment and - specifically - identify which patients have not had their data uploaded to NELA. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it – originally as SUS, then transformed by NHS Digital into HES – in the first place.

Benefits derived from the research so far:

Headlines from reports of the last 4 years:

> national 30-day mortality rate falling from 11.8 per cent to 9.5. per cent over four years, represents around 700 lives saved each year in comparison 2013-2014.

> Average length of stay has fallen to 15.6 days from 19.2 days in year one.

> Making recommendations in the reports for local participating sites to follow. Includes recommendation for NELA Local Leads, Clinical Directors, Commissioners, Medical Directors, Multidisciplinary Teams, Royal Colleges and other professional stakeholders.

> Running regional NELA Quality Improvement workshops to assist hospital sites in using their local data to improve patient care

Peer Reviewed Papers Published:

- C.M. Oliver, M.G. Bassett, T.E. Poulton, I.D. Anderson, D.M. Murray, M.P. Grocott, S.R. Moonesinghe for the National Emergency Laparotomy Audit collaborators. Organisational factors and mortality after an emergency laparotomy: multilevel analysis of 39 903 National Emergency Laparotomy Audit patients. BJA. 2018 Dec;121(6):1346-1356

- N. Eugene, C.M. Oliver, M.G. Bassett, T.E. Poulton, A. Kuryba, C. Johnston, I.D. Anderson, S.R. Moonesinghe, M.P. Grocott, D.M. Murray, D.A. Cromwell, K. Walker on behalf of the NELA collaboration§ Development and internal validation of a novel risk adjustment model for adult patients undergoing emergency laparotomy surgery: the National Emergency Laparotomy Audit risk model. BJA 2018 Oct;121(4):739-748

- O. Peacock, M. G. Bassett, A. Kuryba, K. Walker, E. Davies, I. Anderson et al. Thirty‐day mortality in patients undergoing laparotomy for small bowel obstruction. BJS March 2018; 105: 1006-1013.

Non-peer reviewed paper published:

- ‘NELA; Engaging with emergency laparotomy patients’ - RCoA Bulletin March 2018.

- Using data to improve care: NELA regional workshops - RCoA Bulletin July 2018

- Leeds Teaching Hospitals NHS Trust - NELA Nurse Leads - Blog for RCoA Website - July 2018

- NELA: more than just another audit - Sarah Hare Blog for RCoA Website - November 2018

Conferences/Presentations Attended:

There are multiple as the NELA Project Team attend many meetings throughout the year. The meetings listed below have taken place in the last 6 months (July - December 2018)

- National Clinical Audit Summit - London

- AAGBI Congress - London

- NELA London QI Workshop

- ICNARC Conference -London

- South East Thames Society of Anaesthetics - Maidstone

- NAP 6 Launch – London

- ELC Welsh Meeting - Cardiff

- ASGBI Congress - Liverpool

- Age Anaesthesia Conference - London

- RCoA Anaesthesia 2018 - London

- AAGBI Conference – Telford

- RCoA College Tutors – Leeds

- NENC AHSN Meeting – Newcastle

- Ebpom – London

- AAGBI Meeting – London

- NELA meets NASBO – Birmingham

- South West ELC Meeting - Bath

- Local/Regional Trainee FFICM Meeting – Bristol

HQIP has put forward Article 6(1)(e) as their legal basis under GDPR. However, HQIP are currently seeking legal advice on whether this is the most appropriate legal basis. Further to receipt of that legal advice, the stated GDPR lawful basis may change, and the NHS Digital data release register would be updated to reflect this.

Emergency abdominal surgery (or emergency laparotomy) is associated with significant morbidity and mortality worldwide. The aim of The National Emergency Laparotomy Audit (NELA) is to enable the improvement of the quality of care of patients undergoing emergency laparotomy by providing high quality comparative information of the clinical practice and outcomes of all NHS providers of emergency laparotomy in England and Wales. NELA is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Anaesthetists (RCoA) to deliver the audit. RCoA are working in partnership with the Clinical Effectiveness Unit of the Royal College of Surgeons (RCS) and therefore make up the NELA project team. There are no other organisations involved. HQIP act as data controllers for the national clinical audit but do not have access to any data collected or analysed by the RCoA and RCS who are the data processors.

The analysis by the NELA project team will only involve pseudonymised datasets that links information submitted by NHS hospitals and data supplied by NHS Digital. Date of death (mortality data) comes from the hospitals if it occurs during the hospital admission. For deaths outside hospital, NELA uses the NHS Digital mortality data which is linked along with the NELA audit data to NHS Digital data and then analysed by substantive employees of RCS and substantive or contracted employees of RCoA.

The RCoA and RCS wish to link the patient records submitted to NELA with the Hospital Episode Statistics (HES) records for those patients. The NELA records relate only to an individual admission, and by linking to inpatient HES data, the Audit will be able to provide more precise and relevant information to NHS hospitals by allowing the RCoA and RCS to describe longer term outcomes (e.g., readmission rates) and to improve RCoA’s and RCS’s risk-adjustment models by using the extensive information on comorbid conditions held within HES. (eg to calculate the Charlson Comorbidity score)

The RCoA and RCS also wish to link the patient records submitted to NELA with the Mortality Data on a quarterly basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

All patients over the age of 18 years, having a general surgical emergency laparotomy in all NHS hospitals in England and Wales are eligible for the audit and the trusts/hospitals will submit their records.

The aim is to include all emergency gastrointestinal procedures on the stomach, large and small bowel, for conditions such as perforation, bleeding, abdominal abscess or obstruction, via open or laparoscopic approaches.

Emergency laparotomies following elective surgical complications will also be included in the NELA.

The Project is requesting a three year DSA as this covers the length of the current National Audit contract with HQIP (NHS England & Welsh Government).The NELA includes all NHS hospitals in England and Wales that carry out emergency laparotomy. This includes any hospitals with acute admission, emergency departments, or specialist centres which carry out emergency laparotomy as a complication of other types of surgery.

NELA began in 2013 and the requested historic data provides important data when looking to improve mortality and length of stay.

The objectives of the Audit are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing emergency laparotomy using information produced by the audit;

2. To provide comparative information on the organisation of care by providers of Emergency Laparotomy.

3. To provide comparative information on patient outcomes following surgery for Emergency Laparotomy.

4. To facilitate the development of effective change (quality improvement) initiatives and thereby spread examples of best practice and help local providers make the best possible use of audit results

In summary, the purpose of this request is to support national clinical audit, quality improvement within hospitals, and research on methods to monitor surgical outcomes.

The request for the addition of the HES Critical Care Data is for similar reasons to those for why the RCoA/RCS are requesting other data sets. These specific data would allow investigation of the patterns of critical care across NHS Hospitals and examine whether patients with similar conditions and risk of death are being treated in a consistent way that is compatible with guideline recommendations. The NELA team continue to look for ways in which to enhance the audit. The NELA team has received feedback from participants and stakeholders that information about the delivery of critical care to Emergency Laparotomy patients would help to inform the development of local Quality Improvement initiatives, and the project would use the Critical Care data to develop performance indicators to provide hospitals with this information.

The linked dataset will be a product of this process and will enhance the quality of the comparative data for the audit in subsequent years.

The NELA is commissioned to produce a "State of the Nation" annual report each year. The first 4 reports utilising patient level information were published in June 2015, July 2016, October 2017 & 2018 and are available to view on the NELA website. Subsequent reports are scheduled to be published yearly.

In order to more widely disseminate the findings of the audit, additional scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BMJ (British Medical Journal), BJA (British Journal of Anaesthesia), ASGBI (Association of Surgeons of Great Britain and Ireland) journal, and AAGBI (The Association of Anaesthetists of Great Britain and Ireland) journal at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk-adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

In response to participant feedback a Quality Improvement Report Dashboard has been created on the NELA Online Web Tool to assist sites with audit data collection and to promote local Quality Improvement work (Local hospital data can only be viewed by registered local hospital participants). The Quality Improvement Report Dashboard will only provide local units with aggregated information to compare their performance against a national average. The figures available to each unit will be based on their own local data (supplied by the units) and the Dashboard may therefore present small numbers on some occasions. Each individual user has their own login to the webtool which gives them access to only their own hospital local data. To access the webtool they require a username and password. No data supplied from NHS Digital is held or accessed here.

The first phase of the Dashboard which has now been launched focuses on Case Ascertainment and Patient Demographics. The Patient Demographics section allows local participants to view some basic information on their hospital's population of patients undergoing emergency laparotomy, and how it compares to the audit-wide average. It focuses on characteristics such as patient age and operative urgency.

The Case Ascertainment aims at increasing case completeness and submission by providing a monthly list of cases entered/completed/not completed.

The next phase of the Dashboard will focus much more on Quality Improvement, feeding back key QI indicators and comparing hospital's local data with national audit-wide averages. Some of the measures reported back will include; Documentation of risk, Direct Admission to critical care etc.

The Royal College of Anaesthetists are currently in the process of developing the QI dashboard and hope to make further additions in the next few months.

The following Reports and Publications have been created:

- 4 National Patient Audit Reports published in 2015, 2016, 2017, 2018

- 2 Organisational Audit reports published in 2014 and 2017

- Quarterly hospital reports provided to participants since the start of 2017 and ongoing

- Quarterly Reports at AHSN level provided since Year 4 Quarter 3

In addition,

- Data is being used by CQC on their Dashboard (no record level data - all aggregated with small numbers suppressed)

- Data being used on MyNHS website (no record level data - all aggregated with small numbers suppressed)

- Work has started on introducing a BPT for Emergency Laparotomy using the audit data. NHS England are looking to introduce this BPT in 2019. The BPT will be using audit data to ensure compliance.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

There will be no requirement nor attempt to re-identify individuals from the data.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

RCoA/RCS have requested permission to release a small number of items from HES data back to participating hospitals sites. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it to HES in the first place.

RCoA/RCS have requested permission to release a small number of items – unsuppressed, at record-level – from HES data back to participating hospitals sites, to enable clinicians to explore and understand low-volume activity in their Trusts, to understand case ascertainment and - specifically - identify which patients have not had their data uploaded to NELA. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it – originally as SUS, then transformed by NHS Digital into HES – in the first place.

Benefits derived from the research so far:

Headlines from reports of the last 4 years:

> national 30-day mortality rate falling from 11.8 per cent to 9.5. per cent over four years, represents around 700 lives saved each year in comparison 2013-2014.

> Average length of stay has fallen to 15.6 days from 19.2 days in year one.

> Making recommendations in the reports for local participating sites to follow. Includes recommendation for NELA Local Leads, Clinical Directors, Commissioners, Medical Directors, Multidisciplinary Teams, Royal Colleges and other professional stakeholders.

> Running regional NELA Quality Improvement workshops to assist hospital sites in using their local data to improve patient care

Peer Reviewed Papers Published:

- C.M. Oliver, M.G. Bassett, T.E. Poulton, I.D. Anderson, D.M. Murray, M.P. Grocott, S.R. Moonesinghe for the National Emergency Laparotomy Audit collaborators. Organisational factors and mortality after an emergency laparotomy: multilevel analysis of 39 903 National Emergency Laparotomy Audit patients. BJA. 2018 Dec;121(6):1346-1356

- N. Eugene, C.M. Oliver, M.G. Bassett, T.E. Poulton, A. Kuryba, C. Johnston, I.D. Anderson, S.R. Moonesinghe, M.P. Grocott, D.M. Murray, D.A. Cromwell, K. Walker on behalf of the NELA collaboration§ Development and internal validation of a novel risk adjustment model for adult patients undergoing emergency laparotomy surgery: the National Emergency Laparotomy Audit risk model. BJA 2018 Oct;121(4):739-748

- O. Peacock, M. G. Bassett, A. Kuryba, K. Walker, E. Davies, I. Anderson et al. Thirty‐day mortality in patients undergoing laparotomy for small bowel obstruction. BJS March 2018; 105: 1006-1013.

Non-peer reviewed paper published:

- ‘NELA; Engaging with emergency laparotomy patients’ - RCoA Bulletin March 2018.

- Using data to improve care: NELA regional workshops - RCoA Bulletin July 2018

- Leeds Teaching Hospitals NHS Trust - NELA Nurse Leads - Blog for RCoA Website - July 2018

- NELA: more than just another audit - Sarah Hare Blog for RCoA Website - November 2018

Conferences/Presentations Attended:

There are multiple as the NELA Project Team attend many meetings throughout the year. The meetings listed below have taken place in the last 6 months (July - December 2018)

- National Clinical Audit Summit - London

- AAGBI Congress - London

- NELA London QI Workshop

- ICNARC Conference -London

- South East Thames Society of Anaesthetics - Maidstone

- NAP 6 Launch – London

- ELC Welsh Meeting - Cardiff

- ASGBI Congress - Liverpool

- Age Anaesthesia Conference - London

- RCoA Anaesthesia 2018 - London

- AAGBI Conference – Telford

- RCoA College Tutors – Leeds

- NENC AHSN Meeting – Newcastle

- Ebpom – London

- AAGBI Meeting – London

- NELA meets NASBO – Birmingham

- South West ELC Meeting - Bath

- Local/Regional Trainee FFICM Meeting – Bristol

HQIP has put forward Article 6(1)(e) as their legal basis under GDPR. However, HQIP are currently seeking legal advice on whether this is the most appropriate legal basis. Further to receipt of that legal advice, the stated GDPR lawful basis may change, and the NHS Digital data release register would be updated to reflect this.

Emergency abdominal surgery (or emergency laparotomy) is associated with significant morbidity and mortality worldwide. The aim of The National Emergency Laparotomy Audit (NELA) is to enable the improvement of the quality of care of patients undergoing emergency laparotomy by providing high quality comparative information of the clinical practice and outcomes of all NHS providers of emergency laparotomy in England and Wales. NELA is a national clinical audit commissioned by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical and Patient Outcomes Programme (NCAPOP).

HQIP have commissioned the Royal College of Anaesthetists (RCoA) to deliver the audit. RCoA are working in partnership with the Clinical Effectiveness Unit of the Royal College of Surgeons (RCS) and therefore make up the NELA project team. There are no other organisations involved. HQIP act as data controllers for the national clinical audit but do not have access to any data collected or analysed by the RCoA and RCS who are the data processors.

The analysis by the NELA project team will only involve pseudonymised datasets that links information submitted by NHS hospitals and data supplied by NHS Digital. Date of death (mortality data) comes from the hospitals if it occurs during the hospital admission. For deaths outside hospital, NELA uses the NHS Digital mortality data which is linked along with the NELA audit data to NHS Digital data and then analysed by substantive employees of RCS and substantive or contracted employees of RCoA.

The RCoA and RCS wish to link the patient records submitted to NELA with the Hospital Episode Statistics (HES) records for those patients. The NELA records relate only to an individual admission, and by linking to inpatient HES data, the Audit will be able to provide more precise and relevant information to NHS hospitals by allowing the RCoA and RCS to describe longer term outcomes (e.g., readmission rates) and to improve RCoA’s and RCS’s risk-adjustment models by using the extensive information on comorbid conditions held within HES. (eg to calculate the Charlson Comorbidity score)

The RCoA and RCS also wish to link the patient records submitted to NELA with the Mortality Data on a quarterly basis to enable the Audit to monitor changes in postoperative outcomes (both short and longer-term mortality) for those patients. Access to this linked information will support this national clinical audit to improve the quality of care within NHS hospitals for a high-risk patient group.

All patients over the age of 18 years, having a general surgical emergency laparotomy in all NHS hospitals in England and Wales are eligible for the audit and the trusts/hospitals will submit their records.

The aim is to include all emergency gastrointestinal procedures on the stomach, large and small bowel, for conditions such as perforation, bleeding, abdominal abscess or obstruction, via open or laparoscopic approaches.

Emergency laparotomies following elective surgical complications will also be included in the NELA.

The Project is requesting a three year DSA as this covers the length of the current National Audit contract with HQIP (NHS England & Welsh Government).The NELA includes all NHS hospitals in England and Wales that carry out emergency laparotomy. This includes any hospitals with acute admission, emergency departments, or specialist centres which carry out emergency laparotomy as a complication of other types of surgery.

NELA began in 2013 and the requested historic data provides important data when looking to improve mortality and length of stay.

The objectives of the Audit are:

1. To enable secondary care providers to improve the delivery of care to patients undergoing emergency laparotomy using information produced by the audit;

2. To provide comparative information on the organisation of care by providers of Emergency Laparotomy.

3. To provide comparative information on patient outcomes following surgery for Emergency Laparotomy.

4. To facilitate the development of effective change (quality improvement) initiatives and thereby spread examples of best practice and help local providers make the best possible use of audit results

In summary, the purpose of this request is to support national clinical audit, quality improvement within hospitals, and research on methods to monitor surgical outcomes.

The request for the addition of the HES Critical Care Data is for similar reasons to those for why the RCoA/RCS are requesting other data sets. These specific data would allow investigation of the patterns of critical care across NHS Hospitals and examine whether patients with similar conditions and risk of death are being treated in a consistent way that is compatible with guideline recommendations. The NELA team continue to look for ways in which to enhance the audit. The NELA team has received feedback from participants and stakeholders that information about the delivery of critical care to Emergency Laparotomy patients would help to inform the development of local Quality Improvement initiatives, and the project would use the Critical Care data to develop performance indicators to provide hospitals with this information.

The linked dataset will be a product of this process and will enhance the quality of the comparative data for the audit in subsequent years.

The NELA is commissioned to produce a "State of the Nation" annual report each year. The first 4 reports utilising patient level information were published in June 2015, July 2016, October 2017 & 2018 and are available to view on the NELA website. Subsequent reports are scheduled to be published yearly.

In order to more widely disseminate the findings of the audit, additional scientific publications will be produced. These outputs will be in the form of peer-review articles and conference presentations.

The results of the audit will also be disseminated at professional medical conferences and in peer-reviewed journals e.g. BMJ (British Medical Journal), BJA (British Journal of Anaesthesia), ASGBI (Association of Surgeons of Great Britain and Ireland) journal, and AAGBI (The Association of Anaesthetists of Great Britain and Ireland) journal at the time of the launch of the report or shortly after. Publications related to the Audit methods (e.g., a risk-adjustment model) rather than information of clinical practice and outcomes will be published on an ad hoc basis.

In response to participant feedback a Quality Improvement Report Dashboard has been created on the NELA Online Web Tool to assist sites with audit data collection and to promote local Quality Improvement work (Local hospital data can only be viewed by registered local hospital participants). The Quality Improvement Report Dashboard will only provide local units with aggregated information to compare their performance against a national average. The figures available to each unit will be based on their own local data (supplied by the units) and the Dashboard may therefore present small numbers on some occasions. Each individual user has their own login to the webtool which gives them access to only their own hospital local data. To access the webtool they require a username and password. No data supplied from NHS Digital is held or accessed here.

The first phase of the Dashboard which has now been launched focuses on Case Ascertainment and Patient Demographics. The Patient Demographics section allows local participants to view some basic information on their hospital's population of patients undergoing emergency laparotomy, and how it compares to the audit-wide average. It focuses on characteristics such as patient age and operative urgency.

The Case Ascertainment aims at increasing case completeness and submission by providing a monthly list of cases entered/completed/not completed.

The next phase of the Dashboard will focus much more on Quality Improvement, feeding back key QI indicators and comparing hospital's local data with national audit-wide averages. Some of the measures reported back will include; Documentation of risk, Direct Admission to critical care etc.

The Royal College of Anaesthetists are currently in the process of developing the QI dashboard and hope to make further additions in the next few months.

The following Reports and Publications have been created:

- 4 National Patient Audit Reports published in 2015, 2016, 2017, 2018

- 2 Organisational Audit reports published in 2014 and 2017

- Quarterly hospital reports provided to participants since the start of 2017 and ongoing

- Quarterly Reports at AHSN level provided since Year 4 Quarter 3

In addition,

- Data is being used by CQC on their Dashboard (no record level data - all aggregated with small numbers suppressed)

- Data being used on MyNHS website (no record level data - all aggregated with small numbers suppressed)

- Work has started on introducing a BPT for Emergency Laparotomy using the audit data. NHS England are looking to introduce this BPT in 2019. The BPT will be using audit data to ensure compliance.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

There will be no requirement nor attempt to re-identify individuals from the data.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

RCoA/RCS have requested permission to release a small number of items from HES data back to participating hospitals sites. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it to HES in the first place.

RCoA/RCS have requested permission to release a small number of items – unsuppressed, at record-level – from HES data back to participating hospitals sites, to enable clinicians to explore and understand low-volume activity in their Trusts, to understand case ascertainment and - specifically - identify which patients have not had their data uploaded to NELA. This would be provided only to hospitals via the online webtool so they could see which patients have been coded as Emergency Laparotomies in HES. RCoA/RCS would not be releasing information that the hospital does not already have, as they submitted it – originally as SUS, then transformed by NHS Digital into HES – in the first place.

Benefits derived from the research so far:

Headlines from reports of the last 4 years:

> national 30-day mortality rate falling from 11.8 per cent to 9.5. per cent over four years, represents around 700 lives saved each year in comparison 2013-2014.

> Average length of stay has fallen to 15.6 days from 19.2 days in year one.

> Making recommendations in the reports for local participating sites to follow. Includes recommendation for NELA Local Leads, Clinical Directors, Commissioners, Medical Directors, Multidisciplinary Teams, Royal Colleges and other professional stakeholders.

> Running regional NELA Quality Improvement workshops to assist hospital sites in using their local data to improve patient care

Peer Reviewed Papers Published:

- C.M. Oliver, M.G. Bassett, T.E. Poulton, I.D. Anderson, D.M. Murray, M.P. Grocott, S.R. Moonesinghe for the National Emergency Laparotomy Audit collaborators. Organisational factors and mortality after an emergency laparotomy: multilevel analysis of 39 903 National Emergency Laparotomy Audit patients. BJA. 2018 Dec;121(6):1346-1356

- N. Eugene, C.M. Oliver, M.G. Bassett, T.E. Poulton, A. Kuryba, C. Johnston, I.D. Anderson, S.R. Moonesinghe, M.P. Grocott, D.M. Murray, D.A. Cromwell, K. Walker on behalf of the NELA collaboration§ Development and internal validation of a novel risk adjustment model for adult patients undergoing emergency laparotomy surgery: the National Emergency Laparotomy Audit risk model. BJA 2018 Oct;121(4):739-748

- O. Peacock, M. G. Bassett, A. Kuryba, K. Walker, E. Davies, I. Anderson et al. Thirty‐day mortality in patients undergoing laparotomy for small bowel obstruction. BJS March 2018; 105: 1006-1013.

Non-peer reviewed paper published:

- ‘NELA; Engaging with emergency laparotomy patients’ - RCoA Bulletin March 2018.

- Using data to improve care: NELA regional workshops - RCoA Bulletin July 2018

- Leeds Teaching Hospitals NHS Trust - NELA Nurse Leads - Blog for RCoA Website - July 2018

- NELA: more than just another audit - Sarah Hare Blog for RCoA Website - November 2018

Conferences/Presentations Attended:

There are multiple as the NELA Project Team attend many meetings throughout the year. The meetings listed below have taken place in the last 6 months (July - December 2018)

- National Clinical Audit Summit - London

- AAGBI Congress - London

- NELA London QI Workshop

- ICNARC Conference -London

- South East Thames Society of Anaesthetics - Maidstone

- NAP 6 Launch – London

- ELC Welsh Meeting - Cardiff

- ASGBI Congress - Liverpool

- Age Anaesthesia Conference - London

- RCoA Anaesthesia 2018 - London

- AAGBI Conference – Telford

- RCoA College Tutors – Leeds

- NENC AHSN Meeting – Newcastle

- Ebpom – London

- AAGBI Meeting – London

- NELA meets NASBO – Birmingham

- South West ELC Meeting - Bath

- Local/Regional Trainee FFICM Meeting – Bristol