Effectiveness of intensive care for patients undergoing vascular surgery in the UK

This study uses routinely-collected data in the NHS on patients undergoing major surgery on the blood vessels in the last 10 years. We will use this data to understand how intensive care is used and what happens to patients admitted to intensive care or a normal ward after surgery. The results will tell us which patients will benefit more from intensive care or ward-based care.

This leaflet tells you about our study and the data collected through NHS data registries, how the data is kept secure, and what to do if you wish to opt-out of your data being used for research.

_______________________________________________________________________________________________

Every year, over 12,000 people in the UK undergo major surgery to treat narrowing or blockages of the blood vessels. These operations are high risk and outcomes are poor, especially as these patients are often frail with many medical conditions. Consequently, patients often need to go to intensive care to as part of their recovery. These are specialist wards with teams that provide intensive monitoring and treatment, which help to treat serious post-operative complications that are difficult to manage on the ward. However, invasive tests in intensive care can be traumatic for patients. The lack of intensive bed space currently leads to cancellation of 347 urgent operations per month, which could negatively impact people’s lives due to progression of untreated disease, and it is not feasible for all patients to go to intensive care. There are currently no guidelines to tell us who is best treated in intensive care, and who can recover safely on a normal ward without impacting their recovery.

Our study will look at how intensive care beds are being used currently for people having major surgery on the blood vessels across the UK, and find out who may benefit from intensive care versus normal ward-based care. This will help us to understand the benefits and risks in each situation.

Information routinely collected in the NHS (through the NHS England database, National Vascular Registry, Intensive Care National Audit and Research Centre) about people who had major surgery on the blood vessels from 2014 to 2024 will be used to:

· Find out how many people went to intensive care after surgery

· Compare patients who went to intensive care after surgery with those who went to a normal ward

· Look at what happened to each group afterwards, such as if there were any deaths and complications from surgery and how quickly patients left the hospital.

We will assess which groups of patients, for example based on age or type of operation, would benefit more from intensive care or ward-based care. The study will only use older existing data and will not compromise current patient care while it is being conducted. The

results of this study has potential to improve outcomes for people having these surgeries in the future, and to ensure NHS resources are being used efficiently.

What would taking part involve? What are the risks and benefits?

We will identify eligible patients through existing NHS data registries. This information is routinely collected by hospital staff when you undergo vascular surgery in the NHS. The study will only use data from the past, and will not impact the care you receive in any way. You will not need to attend any extra appointments or tests. There are no immediate benefits or risks to you by using the data for this study, but we hope the results will contribute to better healthcare in the future by providing clarity on the use of intensive care for patients undergoing major vascular surgery.

What NHS research registries are used?

This study involves national data registries including NHS England Hospital Episodes Statistics (HES), the National Vascular Registry (NVR), and the Intensive Care National Audit and Research Centre (ICNARC). Hospitals send data to these registries in order to provide information on their standard of clinical care and patient outcomes. This allows hospitals to know what they are doing well, and highlights areas for improvement. If you have had a vascular surgery operation in the UK for blocked arteries, your data may be included in this study.

This study has approval from the Health Research Authority (HRA) for processing health care information under Section 251 following advice from the Confidentiality Advisory Group, and has a favourable ethics opinion from the NHS REC. Stringent approvals processes are in place for each registry to access the data.

What information is collected on me?

The registries collect information about the vascular surgery you have whilst in hospital. Information about you and your medical background (such as your sex, age, and medical conditions) and information related to your surgery (such as the severity of your condition, the types of investigations and treatments you received) will be collected. We will not access any information on any care that does not relate to your vascular surgery.

In order to get an in-depth picture of the care you received around your vascular surgery, three national databases as mentioned above (HES, NVR, ICNARC) links your information together. In order to do this, the registries will access details such as your full name, NHS number, date of birth, and postcode. This will be performed by experienced registry staff with the necessary training and confidentiality protocols. Once the data is linked, only pseudonymised data (that is, with no personally identifiable information such as NHS number and date of birth) is released to the research team for analysis. The data will not be shared with any third party outside of the research team for this study.

If the data required is regarding a patient who is deceased, additional “Date of Death” is provided to the research team to understand how many days the patient survived after

their operation. This is considered identifiable information and the legal basis for this is outlined below. To avoid prolonged access to this information, the research team will delete this data from the University of Bristol secure data storage system as soon as the number of days alive is calculated, within 3 months of receiving the data.

Legal basis for collecting and processing personal patient data

The research team has approval for data linkage and analysis of this specific dataset under Section 251 (reference number: 25/CAG/0055). More information on section 251 is available. This study has also received a favourable ethical opinion from the Health Research Authority (HRA) Research Ethics Committee (Ref 25/NE/0088).

The research team processes data under articles 6(1)(e) “Public task” and 9(2)(i) “Public health”, as the research is being carried out by healthcare professionals and addresses important areas of public interest in the area of public health. This is demonstrated by an expressed need for research in intensive care in surgery nationally in the UK, due to a lack of detailed national guidelines to inform selection of patients for intensive care. A number of commissioned national initiatives including the Getting It Right First Time (GIRFT) programme, National Confidential Enquiry into patient Outcomes and Death (NCEPOD), and NIHR James Lind Alliance (JLA) priority setting partnership in anaesthesia, perioperative care, and vascular surgery have all highlighted this as a top 10 national research priority. Further information on GDPR compliance by University of Bristol researchers are outlined here: https://www.bristol.ac.uk/secretary/data-protection/gdpr/gdpr-details-for-researchers/

How will your information be kept safe?

NHS registries have strict data security measures to keep the information held on you confidential and conforms to the confidentiality rules established by the General Data Protection Regulation 2018 (GDPR), the Data Protection Act 2018, and the Health and Social Care Act 2008. Your personal data is needed under the legal basis of legitimate

interest to ensure high standards of quality and safety of healthcare and will not be shared with anyone outside of the healthcare system. More information about how each individual data registry involved in this research handles your data can be found on their respective websites below: - NVR: https://www.vsqip.org.uk/resource/nvr-privacy-notice/ - ICNARC: https://www.icnarc.org/privacy-notice/

The research team at the University of Bristol will similarly ensure strict data security measures, adhering to GDPR, the Data Protection Act 2018, and Health and Social Care Act 2008. This is under the legal basis of ‘research’. Data will be kept in a secure storage system within the University of Bristol. Only the immediate study research staff will be able to access the data and it will not be shared to any other third parties. All members of the research group will demonstrate compliance with legal, data protection, and ethical guidelines as set out in the University of Bristol Research Governance and Integrity (https://www.bristol.ac.uk/research/environment/governance/)and Data Protection (https://www.bristol.ac.uk/secretary/data-protection/policy/) policies. Upon completion of

the data retention period, data will be removed from the University of Bristol servers and disposed of securely in accordance with the University of Bristol Data Security Policy (https://www.bristol.ac.uk/infosec/data-security/).

NHS registries have strict data security measures to keep the information held on you confidential and conforms to the c

Pseudonymised patient data will be analysed by the research team according to the research aims set out above. Only information describing the care received by groups of similar patients will be published. We will not publish information on individuals, and your personal details will not be made public. We will not share data with any third parties.