The effectiveness of modern day cardiac rehabilitation: A study from the National Audit of Cardiac Rehabilitation

The University of York is permitted to obtain and link the following datasets: National Audit for Cardiac Rehabilitation (NACR) Data, HES Data and Civil Registration Data for a specific project: The effectiveness of Modern Day Cardiac Rehabilitation: A study from the National Audit of Cardiac Rehabilitation. This is an extension to the work already undertaken by the NACR.

The overall aim of the National Audit of Cardiac Rehabilitation (NACR) is to collect comprehensive audit data to improve local cardiac rehabilitation services to patients, in terms of access, equity, quality and clinical outcomes.

Cardiac rehabilitation (CR) has been shown, through systematic reviews and meta-analyses, to reduce premature cardiovascular death, all-cause mortality and improve health related quality of life following an acute myocardial infarction (AMI) or after coronary re-vascularisation. As such National, European and International guidelines recommend the provision of prevention and rehabilitation programmes.

In recent years the evidenced benefits of CR have been challenged. The RAMIT study, a pragmatic multi-centre randomised controlled trial (RCT) in the UK, questioned the value of CR when no effect on mortality, morbidity risk factors, health related quality of life or activity was found following UK based CR. Although the validity of the trial was questioned the results of this study in addition to the aging evidence base supporting CR means an important issue has been raised. Namely whether the efficacy demonstrated in historic CR RCTs is evident in modern day CR practice.

Purpose:

To investigate the effects of modern CR in routine practice an observational approach is required. The objectives of the project are as follows:

* To characterise eligible CR attenders and non-attenders

* To determine mortality rates (all cause and cardiovascular related) over a 5-year period for eligible CR attenders and nonattenders

* To determine healthcare utilisation, through re-admission, for eligible CR attenders and non-attenders

* To compare health care costs associated with re-admission in CR attenders and non-attenders and estimate the costs of providing CR

* To determine re-occurrence of AMI over a 5-year period for eligible CR attenders and non-attenders

* To investigate the role of co-morbidity on death, hospital re-admission and re-occurrence of heart attack

* To identify the characteristics of successful CR programmes.

The results of this project will address an important issue in terms of future commissioning of cardiac care in the NHS i.e. whether CR in its current format should continue to be funded. With over 80,000 patients in the UK accessing CR services each year the findings of this project could have a profound impact on future patient care.

The project aims to answer whether modern day cardiac rehabilitation as delivered in routine practice across the UK remains beneficial for patients. The project will achieve this aim by investigating whether mortality, re-admission and re-occurrence significantly differs between cardiac rehabilitation attenders versus non-attenders. The results of this project will address an important issue in terms of future commissioning in the NHS for cardiac care i.e. whether cardiac rehabilitation in its current format should continue to be funded. With over 80,000 patients in the UK accessing cardiac rehabilitation services each year the findings of this project could have a profound impact on future patient care.

To answer this question an observational approach is required to accurately investigate the effects of CR delivered in routine practice. In addition a new RCT of routine CR practice could not be tested when CR is standard therapy and thus withholding such care from a control group would be unethical.

In line with the University charter. which states the aim is to advance learning and knowledge by teaching and research, the University processes personal data for research purposes under:

The University of York are using the following Lawful Basis for processing data: Article 6 (1) (e) of the GDPR:

Processing is necessary for the performance of a task carried out in the public interest. University of York is a public authority and is bound by it's charter to carry out research.

Special category data is processed under Article 9 (2) (j) of the GDPR:

Processing is necessary for archiving purposes in the public interest, or scientific and historical research purposes or statistical purposes. Research will only be undertaken where there is a clear public interest and where appropriate safeguards have been put in place to protect data. Health data provided by NHS Digital will be processed as part of this research project.

Data Controller/Processor:

University of York is both the data controller and the data processor for this study.

Data Minimisation:

Hospital Episode Statistics Admitted Patient Care Data is requested from the years 2010 to 2018.

The data requested will be pseudonymised data and will only relate to cardiac diagnosis and treatments and no other records relating to other conditions. Mortality data is requested for only those patients who are included in the NACR dataset.

The audit data is collected by over 200 rehabilitation programmes based in both primary and secondary trusts located across the UK. The patients come from UK routine care centres; patients in England are collected without consent under Section 251 exemption, which is renewed annually. This is a continuously recruiting audit. Approximately 100,000 events are received per year. In total, 940,000 records have been obtained from the beginning of the audit.

No exclusion criteria are applied during data collection to the audit, the data is collected routinely. All patients going through the service are eligible to be entered. No age limits are applied to the data being entered; however, the data is cleaned to remove patients < 18 years for reporting purposes. The gender split in the care, depending on reporting, is 70-30% split Male-Female.

There are no additional commissioners involved in this project.

The British Heart Foundation has historically provided funding to help University of York with the delivery of the audit. However they do not act in a data controller or data processor capacity in regards to the NHS Digital data - they provide funding only.

The University of York has determined that there are no alternative, less intrusive ways of achieving the purpose without obtaining the HES data from NHS Digital.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

The NACR team at the University of York (UoY) manages the audit on a day to day basis and are the Data controllers for the audit. University of York have contracted NHS Digital to provide the technical platform of informatics and data management services. This platform, a legacy Lotus Notes-based system, is currently under review with the aim of a transition to NHS Digital’s new Clinical Audit Platform (CAP). The NHS Digital CAP team collect and process the audit data as instructed by the UoY. As part of this agreement UoY have instructed the NHS Digital Audit CAP team to share the clinical audit data with the NHS Digital DARS team for the purpose of linkage to HES and Civil Registration data. This is covered explicitly in the s251 approvals for this linkage.

Therefore, The University of York (via the Clinical Audit Team at NHS Digital) provided NHS Digital Data Access Request Service (via the Clinical Audit Team at NHS Digital) with the following identifiers:

• Study ID

• NHS number

• Sex

• Postcode

The identifiers above were used to enable accurate data linkage to HES and mortality data. This formed a part of the cohort. These identifiers are of people who are in the NACR audit.

NHS Digital DARS Team then additionally created a HES cohort. This was based on distinctive diagnosis and Operating codes. Therefore this produced a single cohort containing individuals in the Clinical Audit cohort (done by the transfer of identifiers) as well as additional people found in the HES data-set with relevant procedure codes.

A pseudonymised data set will was released to and accessed by University of York. The data will be linked to the clinical audit data by the University of York via a study ID. Within that data set there will be no held identifiers.

Data analysis will be conducted at University of York.

Data will also be stored at University of York.

Only those with substantive employment at the University of York will have access to patient level data.

Co-investigators from the University of Leeds and the Farr Institute will be providing support in terms of assisting with the project and supporting the development of the analysis. They do not have any influence of the direction of the work. They are acting in an advisory capacity only and have no controls over the manner by which the data is being used. No record level data supplied under this agreement will be accessed by the University of Leeds or The Farr Institute.

Only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide, will be shared with the co investigators at University of Leeds and The Farr Institute.

All outputs will be restricted to aggregate data with small numbers suppressed in line with the HES Analysis Guide.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement.

There will be no additional data linkages with the NHS Digital provided data permitted other than what is described in this agreement.

There will be no attempt or requirement to re-identify individuals in the dataset.

Several outputs are expected from this project. Various routes will be used to permit free access to the findings for both clinicians, policy makers and patients as follows:

• Cardiac support Groups:

The research team at the University of York, University of Leeds and The Farr Institute have established links to numerous regional cardiac support groups for patients. The project team will be liaising with these groups to decide an appropriate route to present the findings of this project to patients i.e. attendance at support groups, dissemination through newsletters. In addition, the British Heart Foundation Health Service Engagement teams will also be involved in dissemination of aggregated results and information.

• Journal publications:

The authors will be targeting leading cardiac journals. Depending on when access to the data is achieved publications are anticipated during 2021 and onwards.

• Conferences:

Cardiac related conferences will be targeted regarding the results of this project such as the British and European cardiology Congress. Conference attendance is anticipated during 2021 and onwards.

Through the outputs listed above, findings of this study shall be communicated to researchers, clinicians and commissioners to encourage beneficial dialogue on CR. Findings of this study will be extensively utilised for the period of access to the data, but also after to help inform and guide new studies. This research will be the largest study of CR, in terms of attenders and non-attenders. This research is novel in terms of linking multiple data sources and generating new results for UK cardiac rehabilitation services.

The aim of dissemination is:

• To facilitate impact through engagement with the policy making communities and commissioners of cardiac rehabilitation.

• To ensure knowledge developed by the research is available to the public and used to improve service delivery.

The results of this project will address an important issue in terms of future commissioning of cardiac care in the NHS i.e. whether CR in its current format should continue to be funded. With over 80,000 patients in the UK accessing CR services each year the findings of this project could have a profound impact on future patient care.

The findings of this research will either provide ‘current’ and clear support for the continued investment in cardiac rehabilitation services. It is apparent from data in the NACR statistical report and dialogue with national CR services that this extended period of austerity has impacted CR services, i.e. running shorter programmes which are not evidence supported. Thus, it is vital that relevant and current knowledge is obtained to remove doubts of efficacy and support evidence-based practices. If more negative results are found, significant changes to CR service provision may be required. The next step in CR research would be to identify effectiveness of modern CR programmes.

The last Randomised Controlled Trial (RCT) (RAMIT study) tested the efficacy of routine CR and was commissioned due to doubts that ‘modern’ CR was effective; given

- advances in medicine,

- changes to how CR programmes are run

- and changes in the patient profile receiving care.

The results of this RCT were contentious in that no benefits were found, however, the RCT was heavily criticised which led to doubts over the validity of the study findings. As the RCT could not adequately address the question of efficacy and a new trial of routine CR could not be run as CR is a routine therapy and could not be withheld from a control group.

A different approach is therefore required, and it is proposed that an analysis of observational data be used to address this issue.

The Principal Investigator (PI) will oversee that the benefits described will be achieved, by both the PI and the associated researchers in the research team at the University of York. The University will act as a data processor and will adhere to the processing agreement between NHS Digital.

Not stated in the register.