The 3rd Sprint National Anaesthesia Project (SNAP 3) Consent

The University of Nottingham requires access to NHS England data for the purpose of the following research project: The 3rd Sprint National Anaesthesia Project (SNAP 3)_Consent (participants under MCA05 are covered by DARS-NIC-796147-S7T1T-v0.2)

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

“The Sprint National Anaesthesia Projects (SNAPs) examine commonly occurring events related to anaesthesia and surgery which affect a large number of patients. Each SNAP is conducted within a short data collection window of a few days at most, though their planning and analysis take much longer. Two SNAPs have been completed to date, with this the third SNAP underway.

SNAP1 focused on Patient-reported outcomes after anaesthesia and was a research project which involved a two-day evaluation of patient-reported outcomes after anaesthesia. SNAP2 focused on the Epidemiology of Critical Care Services after Surgery.

The 3rd Sprint National Anaesthesia Project (SNAP 3) is an observational cohort study that aims to describe the impact of frailty and delirium whilst finding associations between frailty, comorbidity, multimorbidity, and delirium and their management, with outcomes following surgery in older people. In common with SNAP 1 and SNAP 2 it will consist of a short period of data collection from potentially every eligible patient having surgery in a defined period. It is estimated that approximately 6,500 individuals will take part.”

The following NHS England data will be accessed:

• Hospital Episode Statistics (HES) Admitted Patient Care (APC) – The SNAP 3 records relate only to an individual admission, and by linking to inpatient HES data, the study will be able to provide more precise and relevant information to NHS hospitals by allowing the research team to describe longer-term outcomes (e.g., readmission rates) and to improve the SNAP 3 team's understanding of risk attributed to frailty, multimorbidity, and delirium.

• Civil Registration Mortality – The SNAP 3 Team also wishes to link the cohort of patients with mortality data, this will enable the study to detect the consequences of both short and longer-term mortality for those patients. Access to this linked information will support this national research project to improve the quality of care within NHS hospitals for a high-risk patient group.

The level of data will be identifiable, necessary because although the University of Nottingham will receive pseudonymised data (along with their study ID) from NHS England, the University of Nottingham hold the cohort identifiers.

The data will be minimised as follows:

• Limited to a study cohort of approx. 6093 participants identified by the University of Nottingham

• Limited to data 12 months prior to recruitment and 4 months after recruitment for HES APC and Mortality data for the first year and second year after recruitment.

The University of Nottingham is the controller, as the organisation responsible for ensuring that the data will only be processed for the purpose described above. The SNAP 3 Team seeks guidance from a clinical reference group made up of representatives from key stakeholders (see below). Neither these individuals nor their organisations have access to SNAP 3 data or NHS England data.

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.

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

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users, and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the Royal College of Anaesthetists and the Frances and Augustus Newman Foundation. The funding is specifically for the project described.

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

The funders will have no ability to suppress or otherwise limit the publication of findings.

Microsoft Limited provides IT hosting services to University of Nottingham and will store the Data as contracted by University of Nottingham.

The following organisations are involved in the SNAP 3 project as co-investigators but will not access the data and they do not determine the purposes and means of the processing of personal data under this agreement:

Guys and St Thomas’s Hospital London

Royal Devon and Exeter Hospital NHS Trust

University of Oxford and Oxford University Hospitals NHS Trust

A senior clinical fellow in Australia

University College London

Data will be accessed by:

A PhD student enrolled with University of Nottingham. The individual has completed mandatory data protection and confidentiality training and is subject to University of Nottingham’s policies on data protection and confidentiality. The individual accessing the data will do so under the supervision of a substantive employee of University of Nottingham. University of Nottingham’ would be responsible and liable for any work carried out by the individual. The PhD student would only work on the data for the purposes described in this Data Sharing Agreement (DSA).

A Public and Patient Involvement and Engagement (PPIE) group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above.

PPIE has been and will continue to be embedded within the project. The study budget includes appropriate funding for PPIE activity in accordance with NIHR Centre for Engagement and Dissemination guidance (2021).

The study topic itself was chosen by a panel including members of the Patient, Carer and Public Involvement and Engagement Committee at the Royal College of Anaesthetists panel.

PPI work has been completed prior to this study looking at consent processes.

Participant/consultee information sheets have been co-produced with PPI representatives.

Two PPIE representatives are full members of the study steering committee and the study management group. Committee chairs will be briefed to ensure that PPIE voices are welcomed and heard at all times.

The University of Nottingham 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) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES APC and Civil Registration Mortality datasets to the University of Nottingham. 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 University of Nottingham.

The data will not be transferred to any other location.

The data will be stored on servers at the University of Nottingham.

The University of Nottingham stores and backs up data on the Cloud provided by Microsoft Limited.

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

The University of Nottingham 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 and Wales.

The data will not leave England and Wales at any time.

Access is restricted to employees or agents of the University of Nottingham who have authorisation from the Principal Investigator.

For Clarity, the following organisations are not permitted to access the data:

Guys and St Thomas’s Hospital London

Royal Devon and Exeter Hospital NHS Trust

University of Oxford and Oxford University Hospitals NHS Trust

The senior clinical fellow in Australia mentioned within the protocol.

University College London

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

The data will be linked at person record level with the cohort’s pseudonymised clinical dataset held by the University of Nottingham.

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.

Researchers from the organisation will analyse the data for the purposes described above.

The SNAP 3 study group anticipate that the data processed will allow for the following to be produced:

a. Reports

b. Submissions to peer-reviewed journals

c. Presentations

d. Conferences

The study group will ensure that the results are disseminated widely across clinicians, hospital management groups, health policymakers, patients and our participants. The study’s results will be promoted via email to those participants who have opted in to email updates. Email, social media, podcasts, journals, conferences, websites and established relationships will allow for communication with healthcare professionals and policymakers. Interested members of the public will receive information via newsletters through relevant charities and other organisations such as Age UK. The SNAP 3 team will provide participants with emailed updates as milestones are achieved such as the total number of participants recruited, useful analysis outcomes and publication dates.

One intended output of this research is the creation of a tool which can be used to detect those patients who are at risk of delirium postoperatively. If a successful tool is created, then the knowledge ownership will be shared between the University of Nottingham and the Royal College of Anaesthetists. The Royal College of Anaesthetists have not had any involvement in determining the mean and purpose of the processing (specifically for this tool).

It is anticipated that the initial publication of results in a scientific journal will occur in March 2024, this will be open source. The results of the study will also be disseminated at professional medical conferences and in peer-reviewed journals. Other newsletters and conference presentations will occur prior to and after March 2024. The results will be provided in report form and briefings will be given to interested and influential organisations such as the Royal College of Anaesthetists, Centre for Perioperative Care, British Geriatrics Society and NHS England. A comprehensive list of all bodies for dissemination of results will be produced by the SNAP 3 Study Management and Steering Committee.

The SNAP 3 dataset will be analysed comprehensively as part of a PhD project and a thesis finalised in 2025.

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.

The findings of this research study are expected to contribute to evidence-based decision-making for policymakers, and local decision-makers such as doctors, and patients to inform best practices to improve the care, treatment, and experience of healthcare users relevant to the subject matter of the study.

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.

• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions.

• 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.

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

Understanding how current clinical practice influences the outcomes of older surgical patients is crucial to improving the design and funding of these complex, multi-specialty pathways. At present the services available to older surgical patients are hugely variable, with different structures, personnel, and resources available. SNAP 3 may determine which elements of perioperative care are essential to the effective management of older patients and ensure that these findings are disseminated at the trust and NHS level. The implementation of alterations to the perioperative medicine services will be measured by repeating an organisational survey which initially was conducted in October 2021. The use of data from the survey’s before and after picture may demonstrate the influence of SNAP 3’s recommendations. The efficacy of these interventions are more complex to measure. Ongoing projects such as the National Emergency Laparotomy Audit (NELA) and the Perioperative Quality Improvement Programme (PQIP) will track outcomes for older surgical patients with frailty and multimorbidity, allowing the detection of the efficacy of new interventions.

In high-risk surgery, such as trauma and cardiac surgery, 36-40% of adult patients develop postoperative delirium, whereas in lower-risk surgery, such as elective arthroplasty, the prevalence of delirium is 5-10%. At present there is no commonly used delirium risk prediction tool which is applicable across all surgical specialties. The production of a risk prediction tool for postoperative delirium may provide an opportunity to screen patients and direct preventative measures toward those at greatest risk of this common complication. Delirium is commonly preventable and is a reversible condition in approximately 40% of cases. Identifying those at risk may have positive effects on patients and healthcare services eg. reduced length of stay, reduced distress for patients, relatives and staff, fewer falls, fewer pressure sores, less functional decline, less incontinence, reduced readmission rates, increased probability of discharge to original address, less worsening of cognitive trajectory and less in-hospital mortality. The estimated date for production of this validated risk prediction score is March 2024.

Frailty, multimorbidity, and delirium in older surgical patients are common problems that effect the public both directly, as patients and relatives, and indirectly through the increased resources required to manage resulting complications. The greater the understanding of these widespread problems, the more refined and effective our surgical pathways may become. The dissemination of this work may also aid the integration and growth of perioperative medicine within UK hospital practice.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations, and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Not stated in the register.