Mortality and morbidity outcomes after aortovascular surgery in patients with Marfan Syndrome

Barts Health NHS Trust requires access to NHS England data for the purpose of the following research project: Mortality and morbidity outcomes after aortovascular surgery in patients with Marfan Syndrome.

The following is a summary of the aims of the research project provided by Barts Health NHS Trust:

“This study aims to undertake a 10-year secondary analysis of linked national data (National Institute of Cardiovascular Outcome Research (NICOR), and NHS England Civil Registration death and Hospital Episode Statistics (HES) data) to identify the UK incidence and outcome of aortovascular surgery in patients with Marfan syndrome (MFS). This includes associated hospital length of stay, mortality and morbidity rates.

To achieve this aim, we will request mortality / morbidity outcome data of the identified MFS patients in the HES and Civil Registration death datasets.

Cardiovascular manifestations of MFS are the most serious and life-threatening of all the clinical manifestations. There is not enough evidence on post-operative complications and general recovery of MFS patients. Literature indicates that up to 36% of general cardiac surgical patients experience in-hospital post-operative morbidity, it could be expected that MFS patients would experience more due to the complexity of their condition as well as their cardiac surgical needs.”

The following NHS England data will be accessed:

- Hospital Episode Statistics Admitted Patient Care (APC) – In each identified MFS participant, Barts Health NHS Trust will request the following for each episode from time of surgery: 1.Date of each Finished Consultant Episode 2.Primary and secondary diagnostic codes, 3.Primary procedural codes, 4.Hospital episode length of stay.

- Civil Registration Mortality – date of death, place of death and cause of death relating to MFS aorto-vascular surgery participants

The incidence of aortovascular surgery in MFS patients is unknown as MFS is not always documented in the NICOR dataset and therefore, there is currently no mechanism for exploring the aortovascular outcomes for this patient group. Linked HES and mortality data will permit analysis of postoperative mortality and morbidity outcomes in MFS patients, which should significantly contribute to the UK and international evidence-base.

The level of the data will be identifiable – this is necessary to enable linkage of the data with the NICOR dataset. Personally identifiable data needed includes NHS number and date of birth. These data will only be used for data linkage with the NICOR dataset and will all be immediately destroyed after data linkage. A unique pseudonymised identifier code will be assigned to each participant to ensure anonymity during data analysis.

NHS England data needs to be sent to Barts Health NHS Trust in the first instance in order to identify the overall incidence of MFS, and to ensure that all relevant episodes of vascular surgery are captured. Surgical episodes are only captured within the NICOR data if considered a 'cardiac case'. This means that some aortovascular surgery cases may only be reflected in HES and not NICOR data.

The data will be minimised as follows:

- Limited to data for a study cohort identified by NHS England as MFS in the HES database using the International Classification of Diseases (ICD) diagnosis code Q874 between January 2010- December 2019

- Limited to hospital episodes which occur on or after the diagnosis date.

Barts Health NHS Trust will assess the overall incidence of MFS in the population.

Barts Health NHS Trust will send cohort identifiers to NICOR. NICOR data will help indicate which cohort members have had a relevant aortovascular surgery.

Barts Health NHS Trust will subsequently further minimise the data to:

- Exclude individuals who did not have aortovascular surgery

- Exclude individuals who were less than 18 years old at time of surgery

- Remove identifiable information

Barts Health NHS Trust will be identifying mortality outcomes within one year of the date of aortovascular surgery. Barts Health NHS Trust will look at longer term outcomes in HES APC, beyond date of aortovascular surgery.

Barts Health NHS Trust is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

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 is expected to provide evidence as to the aortovascular outcomes of patients with MFS that have additional complexity due to their conditions and require longer term support.

The funding is provided by Barts Charity. The funding is for a programme of work and is not specifically limited to the study described. Funding is in place until 5 April 2024.

NHS Arden & Gem Commissioning Support Unit (CSU) is a processor who hosts NICOR, acting under the instructions of Barts Health NHS Trust. NHS Arden & Gem CSU’s role is limited to providing cardiac specific surgery data for the cohort of MFS patients provided by Barts Health NHS Trust, as identified by NHS England. NHS Arden & Gem CSU will be processing only NHS number, date of birth and a pseudonymised ID for MFS patients.

Microsoft Limited provide Cloud hosting services to Barts Health NHS Trust and will store the data as contracted by Barts Health NHS Trust.

Data will be accessed by an individual with an honorary contract with Barts Health NHS Trust.

Barts Health NHS Trust developed a patient notification poster with Aortic Dissection Awareness UK (ADUK) and a patient and public involvement (PPI) group. The poster includes the information about the study as well as information on how patients can dissent to the inclusion of their data in this study. ADUK provide advice and guidance to the study as a PPI partner.

Patient associations and charities including ADUK, Marfan Trust and The Aortic Dissection Charitable Trust (TADCT) have all agreed to display this poster to their websites once data access requests from NHS England are granted.

The Society of Cardiothoracic Surgery (SCTS) also agreed to help send the poster to the audit leads of each cardiac centre in England and Wales to be displayed in the clinical area.

Patient and public involvement plans for the study will follow National Institute for Health and Care Research (NIHR) INVOLVE guidance.

A cohort will not be flowed into NHS England for the purposes of this Agreement.

NHS England will provide the relevant records from the HES and mortality datasets to Barts Health NHS Trust. The data will contain directly identifying data items including NHS Number and Date of Birth which are required to link the data at record level with NICOR data.

Once data are received from NHS England, Barts Health NHS Trust will calculate the overall incidence of MFS in the population, and will send the NHS number, date of birth and a unique pseudonymised ID to NICOR (based at NHS Arden and Greater East Midlands (GEM) Commissioning Support Unit (CSU)) for these patients via secure transfer system.

NICOR will obtain the surgery specific data for these patients if available. NICOR will then transfer this data to Barts Health NHS Trust using secure electronic transfer.

Upon receipt of the data from NICOR, Barts Health NHS Trust will link the mortality and morbidity data (from NHS England) and surgery specific data (from NICOR) at person record level.

Barts Health NHS Trust and NICOR will destroy all identifiers, and Barts Health NHS Trust will destroy all details of cohort members who did not have a relevant aortovascular surgery or were <18 years old at time of surgery as soon as possible following linkage to ensure anonymity during data analysis and dissemination.

The data will be stored on servers at Barts Health NHS Trust and NHS Arden & GEM CSU. Barts Health NHS Trust will store data on Microsoft Azure cloud servers.

The data will be accessed both onsite at the premises of Barts Health NHS Trust and NHS Arden & GEM CSU, and by authorised personnel via remote access. The data will remain on the servers at Barts Health NHS Trust, NHS Arden & GEM CSU and Microsoft Limited at all times.

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

Access is restricted to employees of Barts Health NHS Trust and NHS Arden & GEM CSU, and an honorary contract holder at Barts Health NHS Trust. The research team will determine the individuals who can access NHS England data. The individual with an honorary contract will act as an agent of Barts Health NHS Trust at all times under supervision from employees at Barts Health NHS Trust.

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

Following destruction of the identifiable data by Barts Health NHS Trust, all subsequent analyses will use a pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Barts Health NHS Trust will analyse the data for the purposes described in ‘Objective for Processing’.

The expected outputs of the processing will be:

• A PhD thesis by April 2024

• Submissions to peer reviewed journals by April 2024

• Presentations to local, national and international conferences in 2023 and 2024

• The use of (i) social media (twitter, Facebook, blogs, YouTube), (ii) filming research findings for those who prefer not to read, (iii) seminars and workshops, (iv) newsletters, (v) linking with relevant charities will all be considered.

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.

Dissemination of the work undertaken will be tailored by stakeholder group:

a) Academia: the primary academic output is a PhD thesis. The PhD student is the principal investigator (PI) and is expected to (i) present at annual local student meetings, (ii) publish the research results in high quality peer-reviewed papers in the highest impact journals achievable and in accordance with open access policies proposed by the leading research funding bodies and (iii) present at national and international scientific meetings.

b) Clinical: dissemination is planned to occur (i) locally: at cardiac specialty meetings (Surgical, Peri-Operative Surgical, Nursing), inclusion in existing research newsletters, summary on the nursing research online pages, (ii) nationally: at annual cardiac surgical scientific meeting of the Society of Cardiothoracic Surgery and (iii) Internationally: Houston Aortic Symposium or Barts Aortic Symposium.

c) Patients/public: The PI expects to participate in newsletters and attend talks at the local and national patient forums. Aortic Dissection Awareness UK will be involved in developing the patient and public dissemination strategy.

This study is expected to describe for the first time, the incidence of aortovascular surgery in patients with Marfan Syndrome (MFS) in England, including the associated hospital length of stay, morbidity and mortality rates.

Although the results of this study may not be directly beneficial to participants, it is expected to be beneficial to future MFS aorto-vascular surgery patients. Understanding mortality alongside morbidity could enable further study of the burdens that aorto-vascular manifestations may place on the MFS population. This is anticipated to create better understanding of the condition and potentially guide the development of a holistic and comprehensive service for this patient group, based upon a better understanding of their health and care needs.

This study could also help identify those patients who may benefit from targeted interventions, and potentially evaluate the efficacy of an implemented intervention in place. This could enable research to improve those interventions which may result in an improvement of health care outcomes for aortovascular surgery in MFS patients.

The results of this study are expected to be useful for the stakeholders to effectively prioritise which complications to tackle and to allocate resources towards, as well as proactively manage, the potential onset of a health event.

As the first work in this area in the UK, there is a potential to influence national practice and policy in the care of MFS patients.

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

The use of the data could:

• 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.

If MFS patients who had aortovascular surgery are found to be at higher risk of developing certain complications (i.e renal failure, stroke, etc) postoperatively, then patients can perhaps benefit from prehabilitation intervention to avoid these complications.

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.

Patient and public involvement and engagement (PPIE) plans for the study will follow National Institute for Health and Care Research INVOLVE guidance. Aortic Dissection Awareness UK (ADUK) have provided insights on the significance of the study and the acceptability of the use of patient’s identifiable information without consent. They will also be involved in developing the patient and public dissemination strategy. The study’s local PPIE group has also supported the use of patients’ identifiable information without consent for research purposes only.

One of the expected outputs of this work is to participate in newsletters of certain organisations and charities such as the ADUK, Marfan Foundation, The Aortic Dissection Charitable Trust and Society of Cardiothoracic Surgery as well as present results in local and national patients’ forum to increase patients’ awareness on the outcomes of aortovascular surgery in MFS. This will potentially help them make an informed decision about their treatment. The use of social media (i.e. Twitter, LinkedIn) will also be explored for potential dissemination.

Yielded Benefits is not a requirement for new applications.