NELA NoLap

The Healthcare Quality Improvement Partnership (HQIP) requires access to NHS England data for the purpose of the following audit:

National Emergency Laparotomy Audit (NELA)

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

The NoLap audit has been established with the aim to better understand patients who need emergency laparotomy but do not undergo the procedure. Emergency laparotomy (EL) is a major surgical procedure that involves opening the abdomen. It is usually done urgently after the doctor has made a diagnosis of a serious condition in the abdomen. However, deciding whether to proceed with surgery is a challenging decision, as EL is a high-risk surgery due to the potential for serious complications with prolonged recovery time.

Sometimes, despite the need for surgery, a decision can be made by the doctor or jointly between the patient and their doctor, not to proceed with surgery. This decision is known as a NoLap decision. It may be based on individual's preferences, their overall health status, or severity of their health-related problems. The process of making this decision is challenging when time is limited, or the patient is too unwell to express their wishes. The challenge with these decisions is that, often, they are made under pressure and when the patient may be too ill to express their wishes clearly. Very little is known about patients who had a NoLap decision made and what their expectations are about their care.

The goal with this audit is to gain insights into these patients’ needs, preferences, and outcomes. By gathering this information, we aim to improve the way these decisions are made and ensure better care and support for patients in similar situations. This project is expected help inform better practices in emergency care and guide healthcare providers in delivering more tailored, compassionate treatment for these individuals.

NHS England and HQIP have commissioned the National Emergency Laparotomy Audit (NELA) team to include in their audit a group of patients with pathologies indicative for emergency laparotomy, but who do not undergo surgery, known as the ‘no-lap’ cohort. As such, the purpose of the audit will be expanded to include this cohort, with the aim of identifying best practice for this cohort of patients to reduce morbidity and mortality. Standards of care will be defined for this cohort and associated questions will be drafted and implemented in the data collection instrument. As with the current cohort of surgical patients, information on process and outcome measures will be published by the NHS trust/health board to support benchmarking and quality improvement.

While the audit is commissioned by HQIP, HQIP themselves are commissioned by NHS England to commission the Audit. 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 employees or honorary contract holders of both the Royal College of Surgeons of England (RCS) and Royal College of Anaesthetists (RCoA).

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary to provide information on the number of expected patients 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, ethnicity and longer-term outcomes like readmission rates.

> Civil Registration Mortality – necessary to 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 after hospital discharge, a key metric for the audit.

The level of the Data will be:

> For the NHS England generated cohort: Pseudonymised

> For the RCoA supplied cohort: Identifiable

Although the Data received from NHS England contains no directly identifying information, for a short time period while cleaning and uploading the data for linkage, the data analyst has access to both the NHS England pseudonymised Data and the cohort identifiers. Therefore, there exists the technical means to reidentify participants of the RCoA supplied cohort.

The Data will be minimised as follows:

> Limited to a study cohort (NELA cohort) identified by HQIP (cohort size: estimated at approximately 1200-5000 per year) – data subjects include anyone aged 18 or over seeking care in an NHS setting in England or Wales where emergency surgery for bowel pathologies is indicated but not undertaken.

> Data on a separate population defined based on a series of ICD10 codes will also be provided. This unlinked data is necessary to know how many patients are eligible for the audit; this forms the denominator of one of our key audit metrics--case ascertainment. Case ascertainment compares the number of cases submitted to the audit to the number that should have been submitted based on the HES data.

> Whole of England data is required as the audit is national and includes all patients indicated for surgery but who do not undergo a procedure in England and Wales. Only data relating to England will flow under this Agreement.

> Limited to data between 2023/24 to latest available.

The full date of death is required to be able to calculate survival at multiple time points (30-day, 90-day, etc.)

NHS England has commissioned HQIP to commission the audit and is involved in decisions about the processing of the data. As such, NHS England is a joint controller.

NHS England and HQIP are the organisations responsible for ensuring that the Data will only be processed for the purpose described above. 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.

HQIP has commissioned the Royal College or Anaesthetists (RCoA) to undertake the work. RCoA does not specify what data are required to deliver the work nor how the data shall be processed to achieve that purpose. Such decisions are taken by HQIP and NHS England. As commissioners, HQIP ensure that the RCoA deliver contracted elements of the audit on time and within budget.

For HQIP and NHS England:

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

For HQIP:

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

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

This is justified as the data is required for audit purposes, specifically, for improvement of care and ensuring high standards of 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.

For NHS England:

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.

The funding comes from multiple sources. Current funders include:

> NHS England.

> Welsh Government

Funding to continue the work described will be sought on an ongoing basis.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

RCoA is a processor acting under the instructions of HQIP. RCoA’s role is limited to delivering the audit.

The Royal College of Surgeons of England (RCS) is a processor acting under the instructions of HQIP. RCS’s role is limited to 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 Clinical Effectiveness Unit (CEU).

Bluesource Information Limited provides IT hosting and back up services to RCoA and will store copies of the Data as contracted by RCoA. In turn Bluesource have contracted Harbor Solutions Limited to provide these services. The terms of the contract Bluesource Information Limited has with Harbor Solutions Limited mirror the terms agreed between Bluesource Information Limited and the RCoA.

The back-up servers that are owned and managed by Harbor Solutions Limited are held at locations owned by IOMart and Cyxtera respectively. IOMart and Cyxtera do not have access to the servers that hold the data disseminated under this Agreement.

The audit 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 audit data or NHS England's DARS data; they also do not determine the purpose or means of the processing of personal data.

Data will be accessed by:

> Substantive employees of RCoA and RCS

> Individuals holding an honorary contract under the supervision of a substantive employee of RCoA for the purposes described in this DSA only. RCoA must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

There is a patient representative on the project team who is privy to discussions around linkage. This individual has not posed any concerns about the proposes linkage.

The NELA No-Lap team at RCoA will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID (NELA ID)) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES and mortality datasets to RCoA. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

RCoA will then securely transfer a copy of the Data to the RCS CEU.

The Data will be stored on servers at RCoA and RCS.

RCoA uses Cloud and offsite back-up services provided by Bluesource Information Limited. In turn Bluesource have contracted Harbor Solutions Limited to provide these services.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England/Wales. The data will not leave England/Wales at any time.

Data will be accessed by individuals with an honorary contract with RCoA. The individuals will act as agents of RCoA at all times under supervision from employees of RCoA. Aside from these individuals, access is restricted to employees or agents of RCoA and RCS.

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

The Data will be linked at person record level with NELA data obtained from participating hospital; data collected includes information on demographics, hospital admission, clinician review and decision making, elements of care like CT scans and antibiotic administration, risk assessment, patient care plans/advanced care plans, and patient outcomes like death and length of stay.

The Data will not be linked with any other data.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Analysts from RCoA and RCS who form part of the NELA project team will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> An annual ‘state of the nation’ report, made publicly available via RCoA’s website. Ad hoc interim reports may also be published. These reports provide updates on standards of care for patients in the audit. The reports provide aggregated information on key metrics like case ascertainment, mortality, 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.

> Submissions to peer reviewed journals, 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.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

For each annual report, the NELA team develop a communication plan that is agreed with NELA's commissioner, HQIP. The outputs will then be communicated to relevant recipients through the following dissemination channels:

> Journals

> Social media (@NELANews on Twitter/X)

> Newsletters tothe RCoA members and NELA participating hospitals

> RCoA and NELA Website updates

> Webinars

> 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.

Quality improvement work on NoLap allows the NELA team to understand this group of patients in more detail, identify variability in care across hospitals and provide improvement in management and aid shared decision making between clinicians and patients.

Inclusion of NoLap patients in the audit for the long term allows the NELA team to perform analysis on both short-term and long-term outcomes such as:

- mortality

- length of stay in hospital

- rate of readmission to hospital

- patient-centric measures such as days alive out of hospital (DAOH), health-related quality of life

The use of the data could:

> help the system to better understand the health and care needs of populations.

> lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

> advance understanding of regional and national trends in health and social care needs.

> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

> inform decisions on how to effectively allocate and evaluate funding according to health needs.

> provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

> support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The overall goal is to improve the care that this group of patients receive.

NoLap patients represent one of the most complex and challenging groups to manage in surgical care. These patients are typically older, exhibit higher levels of frailty, and present with more challenging medical needs. As the population ages, gaining a comprehensive understanding of their demographics and the care they receive is increasingly crucial.

Including NoLap patients in the audit is essential for several reasons:

- Insight into Care Processes

Data collected from this audit allows the study team to assess and report on strengths, weaknesses and any variability in care processes at hospital-level. This information can guide the development of quality improvement resources to ensure standardised and good quality care for this vulnerable group.

- Promoting Quality Improvement

By focusing on NoLap patients, the study team can identify and address variability in care across hospitals, leading to improvements in patient management. Furthermore, the study team hope that this work will support shared decision-making between clinicians and patients, enhancing the overall care experience in future.

- Focus on Meaningful Outcomes

Unlike short-term studies, the long-term inclusion of NoLap patients in the audit enables the study team to examine both immediate and longer-term outcomes, such as health-related quality of life which are more meaningful for patients and their families.

Yielded Benefits is not a requirement for new applications.