A pilot study to evaluate the incidence, distribution and referral pathways for Post Infarction Ventricular Septal Defect in England using NHS Hospital Episode Statistics

The Data will be used for the purpose of a research project:

A pilot study to evaluate the incidence, distribution and referral pathways for Post Infarction Ventricular Septal Defect in England

The objective of this study is to understand then incidence and pattern of presentation, together with the pathway through care of patients with Post Infarction Ventricular Septal Defect.

Post Infarction Ventricular Septal Defect is a rare complication of an acute myocardial infarction (heart attack). It is a tear between the two main pumping chambers of the heart and without repair is associated with a 94% chance of death within 1 month. Even with repair the chance of surviving to hospital discharge is only around 50%. Evaluating the best option for improving survival including aspects of care such as timing of surgery, mode of surgery and appropriate supportive treatments require prospective studies including registries and clinical trials.

In order to evaluate whether these clinical studies are feasible, it is important to understand the current pattern of disease and pathways for treatment in England. In particular the demographics of patients presenting to acute hospitals, and the numbers transferred to adult cardiac surgery centres are important to evaluate whether a registry of patients with PIVSD is feasible to be conducted in UK surgical centres only. Accurate data for the portion of patients managed conservatively and their outcomes is not available on a national basis, since previous attempts at retrospective data analysis have only been able to identify individual who have had surgical treatment. Previous applications for grants to enable registries and clinical trials have resulted in reviewer comments that suggest a deeper understanding of presentation patterns to UK hospitals and numbers of patients managed conservatively, together with an understanding of their age and comorbidity would improve the planning of future clinical trials.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide access to the relevant records from the Data to authorised users from Liverpool Heart and Chest Hospital NHS Foundation Trust. The Data will contain no direct identifying data items.  The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the Recipient.

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform.  It allows approved researchers with approved projects access to pseudonymised data and industry leading analytics tools.

The Data will not be transferred to any other location.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA.  The access and use of the system is fully auditable and all users must comply with the use of the Data as specified in this DSA.

Users will be authorised to access the data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

Remote processing will be from secure locations within England & Wales.

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).

The expected outputs of the processing will be:

- A report of findings to relevant stakeholders including the British Heart Foundation clinical research collaborative, the British Cardiovascular Intervention Society (BCIS), and the Society of Cardiothoracic Surgeons of Great Britain and Ireland (SCTS) [one report at the end]

- Manuscript submissions to peer reviewed journals [one manuscript at the end expected]

- Presentations at relevant specialist conferences in the form of posters and oral presentation

- Generation of pilot data to inform future peer review of grant applications and improve the design of upcoming clinical trials

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 outputs will be communicated to relevant recipients through the following dissemination channels:

- Journals

- Oral presentations at conferences

- Reports to stakeholders

- Posters displayed at conferences

- Findings will also be shared with colleagues and relevant patient groups as part of the planning process for an upcoming clinical registry

This study will provide better quality information regarding the incidents and demographic distribution of post infarction ventricular septal defect in England. Currently there is extremely high mortality associated with this condition, even with surgical intervention, and a lack of broad agreement in how to improve clinical care of these patients. This study is an important first step in understanding the nature of the problem on a country wide level in order to develop better grant applications for clinical trials and prospective registries.

This study will also provide detailed data to understand the impact of the pandemic on the pattern of presentation of the condition. It will allow cardiologists to understand the distribution of patients between secondary and tertiary care facilities. Clinical trials that could follow may include the nature of the intervention (surgical or percutaneous intervention), optimization of the timing treatment, and the use of supportive therapies such as intra-aortic balloon pump or mechanical circulatory support. Clinical trials may also identify a subset of patients where intervention is inappropriate and futile, and assist with clinical decision making regarding patient transfer and treatment.

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.

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

Yielded Benefits is not a requirement for new applications.