Echocardiographic Heart of England Screening (ECHOES) - Survive study

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Datasets: + Civil Registrations of Death

Objective for processing

[1 paragraph unchanged] The aim of ECHOES-Survive is to estimate the long-term survival of patients following a diagnosis of HF, explore the main causes of death and identify prognostic factors associated with long-term survival. Civil Registry mortality data are required for individual participants to calculate the survival time in days from HF diagnosis to death and to identify the main causes of death and facilitate prognostic modelling. The University of Birmingham is processing data under the General Data Protection Regulation (GDPR) Articles 6(1)(e) 'task in the public interest' and 9(2) (j) 'research' Article 6(1)(e): The sharing of information will allow estimation of survival time following a HF diagnosis. Decisions based on the results of the study are likely to benefit society by providing GPs and medical professionals the information to inform patients following a HF diagnosis of their likely prognosis; and by identifying risk factors, medical staff have potential to treat those at high risk, with potential to prolong the lifespan and quality of life of patients. Article 9(2)(j): Processing is necessary for statistical purposes to ensure accurate estimation of survival can be calculated to enable research into the long-term prognosis of persons following a HF diagnosis. The research will be carried out by an educational establishment in the area of primary care health research, to ensure high standards of quality and safety of health care. By sharing mortality data with the University of Birmingham, the proposed analyses, researching the relationship between HF and long term survival and likely cause of death, will identify causes that may be treatable thus improving survival and impacting on the quality and safety of health care. ECHOES-Survive will link the NHS Digital's civil registration death data to the ECHOES cohort study data, using a set of identifiers (name, date of birth, sex, NHS Number) to calculate survival time from diagnosis to death. Researchers will report the survival rates, mortality rates and cause of death, for the whole cohort in aggregated form, following ONS recommendations on small sample sizes avoiding potential identification of individuals. This work will determine how long people live for following a diagnosis of HF, and whether they die from heart-related problems or something else, to help doctors and patients understand more about the condition. The original short-term follow-up found a higher risk of death from heart failure than expected in the general population and recommended preventative treatment for patients following a HF diagnosis. Research into the longer term outcomes by estimating mortality rates from different causes is now warranted to further benefit treatment of patients. This long-term survival analysis has not been undertaken yet. Date and cause of death are required in order to calculate survival time in days and associated cause of death. This information cannot be obtained elsewhere. Participants of ECHOES were recruited during the period 1995- 1999, therefore data linkage from this date until the last participant has died will enable calculation of long-term survival - estimates of which cannot be obtained elsewhere. The geographical spread of the data requested relates to the West Midlands Region from where the participants were recruited. Confidential patient information items retained for patients who are deceased will be reduced to a less identifiable format. - Date of death will be replaced by survival time in days to facilitate ongoing survival analysis. - Patient ID will be deleted from the record thus removing the link with name, NHS number, address, postcode and date of birth. The data are held, managed and analysed at the University of Birmingham with one permanent member of staff and others of the team as honorary members of UoB. Several of the ECHOES Team are now based at the University of Oxford, however the University of Oxford is not a data controller or processor; all processing decisions are collaboratively made by the ECHOES Team under membership of UoB [1 paragraph unchanged] Between 1995 and 1999, 6,162 patients participated in a research study at their GP’s Surgery – Screening the Heart of England, where they saw a University Doctor, had a heart scan (Echocardiogram), an electrical recording of their heart (ECG), a blood test, and answered questions about their health. ECHOES-Survive is a long-term follow-up of the ECHOES cohort study, an historic cohort of 6162 participants recruited between 1995 and 1999 from 16 general practices in the West Midlands. It is not part of a wider project or collaboration. The same team of health researchers, from the University of Birmingham (UoB) and University Hospitals NHS Foundation Trust, with the help of the participant's GP, invited people who participated in the original study to participate in this update study to see how their hearts have changed over the years. This follow-up screening will also help UoB to answer an important research question and it will help UoB understand which type of patients are at risk of developing heart disease, and how early blood tests can help UoB identify these patients. Therefore, civil registration mortality data and detail over exits and re-entries from NHS Digital is vital for this study. Patients participated in the research study at their GP’s Surgery – Screening the Heart of England, where they saw a University Doctor, had a heart scan (Echocardiogram), an electrical recording of their heart (ECG), a blood test, and answered questions about their health.

Processing activities

[1 paragraph unchanged] HRA approval under ‘Section 251’ of the NHS Act 2006 has been given to allow ongoing processing of confidential information by NHS Digital to facilitate linkage with ONS mortality data and onward disclosure of date and cause of death. The ECHOES study dataset, held at University of Birmingham, will be linked with the civil registration mortality data via NHS Digital. The primary care team at University of Birmingham have previously sent NHS Digital - name, date of birth, sex, NHS number and the pseudonymised study ID for all ECHOES study participants. NHS Digital will match and flag the cohort and return mortality data linked to the study ID to the University of Birmingham. These data will be linked into the main ECHOES study database at University of Birmingham which only contains the clinical data (i.e. information collected at the screening appointment such as outcomes of echocardiographs, blood tests and self-reporting information). ECHOES identifiers are stored separately. The data will not be linked with any other data and only the linkages described above are permitted under this Agreement. Following the receipt of death data, the patient’s survival time (in days) will be calculated. The patient’s date of death and pseudonymised ID will then be deleted from the patient record. No attempt will be made to re-identify the individuals. Data processing is only carried out by substantive employees of, or persons holding honorary contracts with, the data processor(s) and or data controller(s) who have been appropriately trained in data protection and confidentiality. The data will be stored on a restricted access network drive, with access restricted by password to the authorised user of the data only. Both the PC and network drive are on a secure part of the University network, monitored and secured by the University Information Security team. The Information Security and Management Policy, compatible with ISO27001 and ISO27002, has been formally adopted and is reviewed annually and approved by the University Executive Board. Data are accessed both locally and remotely using University of Birmingham encrypted PCs and laptops. The combined dataset is not copied or transferred from the University of Birmingham network. Data will be held securely in accordance with the University’s policies and procedures. The data will be used exclusively for the purposes of the study specified hereby at University of Birmingham only. The data will not be made accessible to any other third parties, including the University of Oxford. The Data will only be used for the purposes described in this Agreement. [2 paragraphs unchanged] Identifying data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at the University of Birmingham of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in December 2016. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at the University of Birmingham of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in December 2016.

Expected output

[2 paragraphs unchanged] The study research team plan will use the linked civil registration mortality data to report the 20-year survival rates and associated causes of death from of participants in the original cohort by 31st December 2021. cohort. The study team also plan to report longer term survival rates when all study participants have died. The team will present the results at academic conferences such as the European Society of Cardiology Congress and submit findings to a peer-reviewed journal for publication such as the European Heart Journal or British Medical Journal. The team hope to have successfully published the work by July 2022. The target audience will be cardiologists and family doctors caring for patients with heart failure (HF) and policymakers responsible for developing HF guidelines. The team will also work with their patient and public involvement (PPI) representatives to disseminate the findings to the public through PPI newsletters, charity websites and social media when the paper is published. All output data will be aggregated with small numbers supressed in line with the ONS guidelines. [1 paragraph unchanged] UoB's 5 and 10-year prognosis papers (listed below) have been reported in peer-reviewed journals and widely cited. The NHS Digital audit team commented on the importance of this prognostic research and were keen for the study to continue and further this work. This type of long-term mortality data from a well-established cohort is not available by any other means. Hobbs FD, Roalfe AK, Davis RC, Davies MK, Hare R; Midlands Research Practices Consortium (MidReC). Prognosis of all-cause all cause heart failure and borderline left ventricular systolic dysfunction: 5 year mortality follow-up of the Echocardiographic Heart of England Screening Study (ECHOES). Eur Heart J. 2007;28(9):1128-34. [1 paragraph unchanged]

Expected measurable benefits

[1 paragraph unchanged] In England, approximately one million people are living with heart failure and 200,000 are newly diagnosed each year. The natural history of heart failure detected by screening is poorly understood. [72 words unchanged] without heart failure are currently unknown. This information is vital to further UoB's UoB’s knowledge of the natural course of screen detected heart failure and for patients to understand their outlook following a diagnosis.

Benefits reported

The previously published data has benefited patients, clinicians and healthcare commissioners. The [12 words unchanged] cause of death following a diagnosis for people with heart failure. The UoB team have heard from clinicians that they have used the survival rate [34 words unchanged] the need to commission appropriate healthcare services, including provision of palliative care. A better understanding of long-term prognosis could help inform patients, clinicians and commissioners. The limited data on long-term survival can make discussions between patients and clinicians more challenging. Accurate mortality data linked to a well-phenotyped cohort could improve clinicians understanding of likely survival rates and causes of death for people with heart failure. Commissioners of healthcare are also likely to be interested in the findings to allow them to appropriate surgical and palliative care services for this population. Identification of risk factors for death in people with heart failure may allow targeted treatment of modifiable risk factors. The findings from the study are likely to be relevant to other European countries where the prevalence of heart failure and risk factors for death are similar. Further scientific benefits include the contribution to future systematic reviews and meta-analysis of risk factors for the prognosis of heart failure. The findings of the study may also lead to future randomised trials of treatments, aimed to target risk factors, to improve the long-term prognosis of these patients. The previous DSA prohibited data processing and receipt of additional mortality data due to delays in honorary contract renewals and gaining Section 251 approval therefore planned benefits not achieved. This application to renew the DSA follows renewal of honorary contracts and S251 approval by the HRA. We anticipate presentation of UoB’s proposed analyses at academic conferences such as the European Society of Cardiology Congress and publication in a peer-reviewed journal such as the European Heart Journal or British Medical Journal.

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Expected output

[2 paragraphs unchanged] The study team plan to report 20-year survival rates and associated causes of death from the original cohort by 31st May December 2021. The study team also plan to report longer term survival rates when all study participants have died. [4 paragraphs unchanged]

Unchanged: Objective for processing, Processing activities, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

Mortality and Exit/Re-entry data were supplied to the University of Birmingham by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to Echocardiographic Heart of England Screening (ECHOES) study. This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the University of Birmingham to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. The following provides background information on the purpose of the original study: Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required. The following information provides background information on the purpose of the original study: [2 paragraphs unchanged]

Processing activities

[1 paragraph unchanged] The study data, including data provided by NHS Digital under previous agreements, are currently held by the University of Birmingham. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the University of Birmingham storage address specified in this Agreement. The following provides background on the processing activities undertaken for the original study: prior to this Agreement: [1 paragraph unchanged]

Expected output

This Agreement permits the secure retention of the data only and no other processing. [1 paragraph unchanged] In any future application, the applicant will be required to provide details of any future outputs planned. The study team plan to report 20-year survival rates and associated causes of death from the original cohort by 31st May 2021. The study team also plan to report longer term survival rates when all study participants have died. [1 paragraph unchanged] UoB's 5 and 10-year prognosis papers (listed below) have been reported in peer-reviewed journals and widely cited. UoB plan to report 20-year survival rates from the original cohort. The NHS Digital audit team commented on the importance of this prognostic [18 words unchanged] data from a well-established cohort is not available by any other means. [2 paragraphs unchanged]

Expected measurable benefits

This Agreement permits the secure retention of the data only and no other processing. [1 paragraph unchanged]

Unchanged: Benefits reported.