NHS Digital Data Release Register - reformatted

Royal Brompton And Harefield NHS Trust projects

47 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


Epidemiology and Prognosis in Acute Myocarditis — DARS-NIC-144568-D7G6V

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (NHS Trust Site, NHS Trust)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2019-10-15 — 2020-10-14 2019.01 — 2022.11.

Access method: One-Off, Ongoing

Data-controller type: GSTT @ ROYAL BROMPTON HOSPITAL, ROYAL BROMPTON HOSPITAL, GUY'S AND ST THOMAS' NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Civil Registration - Deaths
  3. HES:Civil Registration (Deaths) bridge
  4. Civil Registration (Deaths) - Secondary Care Cut
  5. COVID-19 Hospitalization in England Surveillance System
  6. COVID-19 Second Generation Surveillance System
  7. HES-ID to MPS-ID HES Admitted Patient Care
  8. Civil Registrations of Death - Secondary Care Cut
  9. Hospital Episode Statistics Admitted Patient Care (HES APC)
  10. COVID-19 Second Generation Surveillance System (SGSS)
  11. COVID-19 SGSS First Positives (Second Generation Surveillance System)

Objectives:

Royal Brompton and Harefield NHS Trust aims to describe the longitudinal epidemiological trends of acute myocarditis to provide a contemporary, population-level assessment of the burden of disease and how this may have changed over the last 20 years. National data is therefore required over a 20 year period under this agreement recognising changes and variation arising from medical, biological, geographical and social factors.

Myocarditis means inflammation of the heart muscle and is known to predominantly affect young adults aged between 19-35 years. It is usually related to a recent viral infection. Patients often present with severe, sudden-onset chest pain mimicking a heart attack, difficulty breathing due to weakened heart muscle, and/or palpitations due to electrical rhythm disturbances within the heart. However, myocarditis also affects infants and older adults where causative factors and clinical outcomes are poorly characterised. In the long-term, up to one third of patients are at risk of developing heart failure, known as dilated cardiomyopathy, or experiencing a sudden cardiac arrest.

Few studies have investigated the epidemiology of myocarditis on a population level, and there is NO data on the incidence and prevalence of myocarditis within the UK. Historical studies focused on small cohorts, such as Finnish military conscripts in Helsinki. The WHO Global Burden of Disease study was not directly relevant to the UK and provided no data on patient prognosis. Whilst there are a growing number of clinical research studies investigating new diagnostic tools and treatments in myocarditis, these small groups of recruited study participants represent the 'tip of an iceberg.'

The Trust seeks to obtain all available data on hospital admissions specifically due to 'myocarditis' (I40, I51.4, I01.2, I09.0) in all age groups across England/Wales over the last 20 years. Data on age, sex, ethnicity, length of admission, method of admission, Intensive Therapy Unit (ITU) bed days and specific cardiac procedures (including cardiac catheterisation, endomyocardial biopsy, pacemaker/implantable cardioverter defibrillator (ICD)/ ventricular assist device (VAD) implantation and cardiac transplantation) would be important to record. Data on readmission would be useful to understand predictors of disease recurrence, and ultimately, linkage to mortality data with cause of death would provide new insights into clinical outcomes in a real-world setting. Geographical data may be helpful to understand whether social deprivation or pollution levels are implicated.

The Trust also seeks to obtain the same depth of HES and linked mortality information on hospital admissions due to pericarditis and myocardial infarction. Myocarditis overlaps with pericarditis (inflammation of the adjacent lining of the heart; collectively referred to as myopericarditis) and again there are no data on the incidence, prevalence or prognosis of pericarditis within the UK. Myocardial infarction represents a distinct disease process due to restriction in coronary blood supply but also presents with sudden-onset, severe chest pain. There are many published studies and national audits on myocardial infarction within the UK. Within this application, data on myocardial infarction is requested to allow accurate understanding and comparison across the same HES data elements on the scale and scope of myocarditis.

Up to one third of patients with myocarditis develop heart failure and dilated cardiomyopathy (DCM). DCM is the leading cause for needing a heart transplant in the UK. The Trust seeks to obtain the same depth of HES and linked mortality information on these hospital admissions to allow epidemiological and prognostic assessment of myocarditis relative to heart failure and dilated cardiomyopathy overall. Furthermore, it is expected that myocarditis may be recorded as a secondary diagnosis in a significant but yet unknown number of these admissions. Failing to detect these cases would lead to underestimation of the burden of myocarditis.

Based on extrapolation from published data (Papadakis et al, 2009), the Trust estimates that myocarditis accounts for one sudden cardiac death each week in an individual aged <35 years of age in the UK. From a mechanistic perspective, this occurs due to electrical disturbances within the heart due to the initial myocardial injury. The Trust seeks to obtain the same depth of HES and linked mortality information in order to understand the true burden of myocarditis resulting in sudden cardiac arrest with or without successful resuscitation.

Data is requested over a 20 year period to study the longitudinal epidemiological trends linked to medical (e.g. technological advances in troponin assays, echocardiography, cardiac MRI for improved detection), social (e.g. increasing population density, pollution levels, changing work patterns) and biological (e.g. viral aetiology, drug and toxin use) changes over this time period. Twenty years allows for optimal longitudinal assessment based on published literature although the applicant is aware of the reduced depth of data in the earlier years. Data is requested for all age groups recognising that while myocarditis predominantly affects young adults, it remains an important cause for heart failure in young infants and older age groups due to altered immune responses and overlap with other systemic inflammatory conditions - the understanding of myocarditis in these groups is particularly limited. National data is requested in order to remove geographical bias due to regional differences in viral aetiology and healthcare systems, ultimately informing changes to clinical guidelines and policies on a national level.

Given the growing public interest in sudden cardiac deaths and cardiac transplantation amongst young individuals, there is a pressing need to improve the understanding of the epidemiology and prognosis of myocarditis. Early detection through improved awareness would make a significant contribution to individual patient care in all age groups, including infants and elderly patients, where understanding is further limited. Looking back to understand unique features of patients that subsequently suffered disease recurrence or death will enable clinicians to better identify these high-risk individuals at initial presentation.

Yielded Benefits:

Analyses of epidemiological trends in myocarditis admissions and outcomes were presented by the Study Lead at the American Heart Association Annual Scientific Session in November 2019 in Philadelphia, USA, and subsequently published in the medical journal, ‘Circulation’. This is available online to the public at the following address: https://www.ahajournals.org/doi/10.1161/circ.140.suppl_1.11463. This has been highlighted by Cardiomyopathy UK and the Janson’s Myocarditis Foundation (the two leading patient charitable organisations) to clinicians and patients across the UK. This data has been presented to myocarditis patient groups hosted at the Royal Brompton Hospital and organised by Cardiomyopathy UK (https://www.cardiomyopathy.org/information-events-myocarditis-information-evening/myocarditis-information-evening-for-parents-and-relatives-1). The project and findings have been made publicly available on a dedicated webpage (https://www.rbht.nhs.uk/research/our-research/active-research-studies/epidemiology-and-prognosis-acute-myocarditis). Further analyses were subsequently conducted by the Study Lead and presented in their PhD, which was recently awarded by Imperial College London on 1st October 2020. These findings were compiled into a scientific manuscript over the 2019 Winter period but this was not submitted for publication due to the emergence of the COVID-19 pandemic and ensuing rise in myocarditis cases earlier in 2020. The latest evidence from cardiac MRI studies of patients that have recovered from COVID-19 has yielded conflicting findings. In one study, up to 60% of individuals with prior COVID-19 infection had undiagnosed features of ongoing inflammation within the heart consistent with myocarditis (https://jamanetwork.com/journals/jamacardiology/fullarticle/2768916). This work has had major public health implications; for example, in the US all college sports were stopped for a period due to concern about myocarditis and high-level sports post-COVID (https://www.theatlantic.com/health/archive/2020/09/covid-19-heart-pandemic-coronavirus-myocarditis/616420/). However, subsequently there has been strong divergent opinion suggesting a much lower prevalence. In order that the study team firstly better assess the prevalence but also help guide national policy, better quality data from across England will be very important. This project extension seeks to strengthen and build upon the initial body of research epidemiology by including the impact of COVID-19 on myocarditis and its related conditions (heart failure, pericarditis, sudden cardiac death and myocardial infarction), both in the period before and during the initial peak and potentially any future surges over the next 12 months to improve understanding of disease trends, regional prevalence, severity and clinical management.

Expected Benefits:

Heart failure and sudden cardiac death are two separate but important worldwide health problems with high morbidity and mortality that can both arise from acute myocarditis at any age. Heart failure is reported to occur in up to one third of patients with acute myocarditis and has a major global economic burden through healthcare costs and lost productivity through heart failure hospitalisations. Based on published data from ONS, myocarditis is thought to account for approximately 1 sudden cardiac death under 35 years of age each week in the UK. Such events commonly feature in the media headlines and understandably generate considerable anxiety and questions.

By accruing data on the real-world burden of acute myocarditis resulting in hospital admission, relative to other similarly presenting conditions, and its downstream consequences in terms of recurrence, DCM and mortality, the Trust hopes to greatly enhance the understanding of this poorly characterised disease and dispel the old myth that myocarditis is; (i) rare and (ii) benign. Specific outputs and further details are include below:

1. Accurate and contemporary data on incidence and prevalence within the UK would reveal health trends over time and support national service planning and provision. Early detection through improved recognition and awareness arsing from this study both amongst the public and medical staff would make a significant contribution to individual patient care and healthcare resource allocation.

2. Reductions in length of hospital admission due to defined diagnostic pathways from the Consensus pathway may both reduce hospital expenditure and employment productivity loss. Improved diagnostic confidence amongst clinicians with published data to support their clinical-decision making will improve the patient journey and outcome.

3. Better risk stratification of those patients at great risk of subsequent DCM and sudden cardiac arrest may provide a window to intervene at a much earlier stage in the disease where therapy is far more likely to make a difference. Once the disease has occurred and resulted in a complication, intervention is always more complicated, costly and less likely to deliver favourable results.

4. The findings from this study will form the basis of the researcher's PhD and be published in high-impact medical journals with guidance from the Public Health Department at Imperial College. This work is expected to be completed within 6-12 months of receiving the data within the time-scale of a higher research degree. The outputs will be supported and promoted through the British Heart Foundation Press Office, with whom the lead researcher has worked previously (https://www.bhf.org.uk/news-from-the-bhf/news-archive/2017/june/heart-scans-reveal-cause-of-sudden-cardiac-arrests-in-the-young), as well as Cardiomyopathy UK and the Alexander Janson Fund for publicising the results and conveying these findings to patients and their families. This is exemplified by the 3rd annual myocarditis patient and relatives evening due to be held at the Trust on 14th November 2018 (details of previous events found here: http://www.rbht.nhs.uk/research/research-news-2/patients-share-experiences-of-myocarditis-at-information-day/, https://www.cardiomyopathy.org/news--media/latest-news/post/268-myocarditis-patient-and-relatives-information-evening, http://www.rbht.nhs.uk/research/research-news-2/charity-funding-boosts-myocarditis-research-and-patient-support/, http://alexanderjansonsfund.org/wp-content/uploads/2017/01/patient-information-slides.pdf).

5. Data generated from this study in all its forms (incidence, prevalence, age groups, gender differences, geographical variation, viral aetiology, social deprivation status, length of admission, investigations, treatments, recurrences, sudden death, heart failure and mortality) will be compiled into an epidemiological high-impact paper and a Consensus statement paper, both of which will be publicised and promoted through Imperial College, the BHF and Cardiomyopathy UK. Based on this evidence demonstrating the scope of the problem and the need for improved UK guideline support, the Trust intends to propose the development of NICE guidelines for managing patients with myocarditis. These will be proposed to the NICE Committee through established links within the Trust.

6. Ultimately, better evidence and information on the scale and scope of myocarditis will highlight and inform future directions for medical research, including the design of large multi-centre studies to evaluate new emerging immunological therapies. The overall aim is to improve patient outcomes.

Outputs:

In this study, the Trust aims to investigate the following features with definable outputs as detailed below:

1. Incidence and prevalence of myocarditis– there are no studies published to date that have examined the incidence and prevalence of acute myocarditis (or myopericarditis) on a national level. Estimates from the WHO Global Burden of disease study of 2013 suggest myocarditis affects 23 out of 100,000 people. However, there is a wide spectrum of clinical presentation and disease detection. In the wake of a number of sudden cardiac deaths due to myocarditis (http://www.bbc.co.uk/news/health-40408536; http://www.bbc.co.uk/news/health-11542429; http://www.bbc.co.uk/news/entertainment-arts-39193367; http://www.bbc.co.uk/news/uk-england-birmingham-41988846), there is a need for improved understanding of disease epidemiology and in turn, awareness and recognition. At present, there is no understanding of whether the number of cases of myocarditis is increasing or decreasing within the UK. The Trust will analyse and write up this data for publication in a high-impact medical journal, such as the Lancet or British Medical Journal (BMJ). Data will also be circulated widely through our partners, the British Heart Foundation and Cardiomyopathy UK.

2. Long-term complications and prognosis of myocarditis – published studies investigating long-term outcome are subject to bias amongst recruited individuals and provide a narrow window into possible outcomes. Most of these studies have been performed on patients with biopsy-proven myocarditis in Germany and study outcomes may not be reflective of UK practice given geographical variation, for example, in viral aetiology. The Trust will analyse and write up this data for publication in a high-impact medical journal, such as the Lancet or BMJ.

3. Gender differences – no studies have specifically investigated age and sex differences in patients affected by acute myocarditis. There is evidence that myocarditis typically affects young men from 19-35 years of age. By studying all age groups across the county, the Trust will generate up-to-date knowledge of this within the NHS - this will improve treating clinicians’ understanding and awareness of who is typically affected by myocarditis.

4. Seasonal variation – from the Trust's experience of recruiting patients from across South East England into a genetics myocarditis research study based within the Trust, the number of new cases appears to be greatest during the Winter months. The Trust aims to explore this on a national level through the HES dataset. This will again be published in a high-impact medical journal providing new insights into seasonal variation. This could have a significant impact on health-care resource utilisation.

5. Geographical variation – the Trust hypothesises that myocarditis is predominantly a disease of major towns and cities rather than rural or coastal areas. Given that viral infection remains the leading aetiology, geographical differences are likely, in addition to differences depending on socio-economic status. These findings will again be published and circulated widely through the BHF and Cardiomyopathy UK.

6. Diagnostic approaches – there are currently no clinical recommendations to guide patient diagnosis and management in the UK. Individual practice varies between clinicians and hospitals, which has again been clear from the researcher's myocarditis research experience. As a result, there appears to be a postcode lottery for length of hospital admissions, investigations and treatments. By studying the national trends in length of admission, diagnostic tests performed (cardiac MRI, coronary angiogram, cardiac biopsy) and treatments delivered (pacemaker/ICD implantation, cardiac transplantation), the Trust aims to write-up and publish a Consensus statement paper supported by the BHF and co-authored by leading Cardiology consultants with expertise in myocarditis from across the country to unify and guide the way in which patients with myocarditis are diagnosed and treated in future. Such a UK-centric document is greatly needed. Improved diagnostic confidence and approaches to management will translate in improved patient experience and clinical outcomes, which can be reassured after an interval.

7. Recurrence rates and prognosis – there are no published studies that have examined the real-world risks of recurrence following an acute episode of myocarditis. This is one of the most common questions asked by patients, and at present, the Trust is unable to base a response on any published evidence. HES data will allow the Trust to estimate how many patients are readmitted, and whether this typically occurs in the short or long-term. Such data would be useful from a healthcare economics perspective, and again alleviate patient concerns if appropriate to do so.

8. Mortality rate – the number of patients that die as a result of acute myocarditis or related complications within the UK remains unknown. Whilst clinical outcomes in patients suffering a heart attack have vastly been improved in recent years due to developments and advances in service provision and coronary angioplasty, the Trust expects that the mortality rate from myocarditis is likely to be: (i) underestimated and (ii) unchanged over the last 20 years despite advances in other areas. Knowledge of this information once disseminated through high-impact publications, the BHF and Cardiomyopathy UK will likely spur further public interest, funding and research into the condition.

Data generated through this application will be analysed within the Trust and disseminated widely through a number of channels within the year. These will include scientific publication in high-impact medical journals, such as the Lancet and BMJ, as well as lay summaries for communication with patient and public groups through established links with the British Heart Foundation, Imperial College London, Cardiomyopathy UK and Alexander Jansons Fund. Of note, the Trust has arranged it's 3rd annual myocarditis patient and relatives information evening on 14th November 2018 in partnership with Cardiomyopathy UK with the specific aim of providing support and education to individuals affected by myocarditis. Through the planned Consensus statement paper and other established links with guideline committees such as NICE, the Trust hopes to improve and standardise the diagnosis, treatment and surveillance of patients with myocarditis.

Processing:

In summary, the Trust is seeking HES and linked mortality data on a population level for acute myocarditis to investigate the changing epidemiological trends and long-term prognosis of this disease. The Trust does NOT require patient identifiable information.

The Trust would like to obtain all available (pseudonymised) data on hospital admissions specifically due to 'myocarditis' (I40, I51.4, I01.2, I09.0 – full list of diagnostic codes copied below) in all age groups across England over the last 20 years. Data on age, sex, ethnicity, length of admission, method of admission, ITU bed days, specific cardiac procedures (including cardiac catheterisation, endomyocardial biopsy, pacemaker/ICD/VAD implantation and cardiac transplantation) and discharge medication (if available) would be important to record. Geographical data may be helpful to understand whether social deprivation or pollution levels are implicated.

Readmission data is requested in order to understand the likelihood of myocarditis recurrence over the study period as it is recognised that a subset of patents will suffer a recurrence many years later. At present, there are few tools to identify such patients at the time of index presentation. Alternative diagnoses made at the time of readmission may also be due to complications, such as heart failure and cardiac arrhythmia as described above.

To facilitate accurate comparisons with other conditions of overlapping biology (pericarditis), clinical presentation (myocardial infarction) and better understanding of long-term complications (sudden cardiac arrest and dilated cardiomyopathy), the Trust seeks the same depth of HES and mortality linked data on these linked diagnoses (codes listed below).

All data received would be subject to protection and storage within Royal Brompton Hospital's restricted swipe card access department on restricted file servers operating behind an NHS specification firewall. All data stored on or transmitted by a computer of any sort at any location will be encrypted with password protected, 256 bit AES standard encryption. The data will be analysed by the researcher and the chief/principal investigator, who are both employed by Royal Brompton and Harefield NHS Foundation Trust. This analysis will only take place at the Royal Brompton Hospital.

The data will not be linked with any record level data other than that which is described in this agreement. There will be no requirement nor attempt to re-identify individuals from the data. The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

The diagnostic codes required relate to:
(i) Myocarditis:
(ii) Pericarditis
(iii) Dilated cardiomyopathy and heart failure
(iv) Cardiac arrest
(v) Myocardial infarction.

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 i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).


MR1004 - ARTERIAL REVASCULARISATION TRIAL ( ART ) — DARS-NIC-147755-C5H4X

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Identifiable (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive, and Non Sensitive, and Non-Sensitive

When:DSA runs 2019-09-01 — 2020-08-31 2017.12 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF OXFORD

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Members and Postings Report
  4. MRIS - Scottish NHS / Registration
  5. MRIS - Flagging Current Status Report
  6. Civil Registrations of Death
  7. Demographics
  8. Emergency Care Data Set (ECDS)
  9. Hospital Episode Statistics Accident and Emergency (HES A and E)
  10. Hospital Episode Statistics Admitted Patient Care (HES APC)
  11. Hospital Episode Statistics Critical Care (HES Critical Care)
  12. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The data supplied by the NHS IC to Royal Brompton Hospital and Harefield Trust will be used only for the approved Medical Research project.

Yielded Benefits:

The study has provided unique long term information on the efficacy and safety of bilateral internal thoracic artery grafts for CABG, as well as a valuable high quality database to understand factors that influence long term outcomes after CABG and how these may be improved.

Expected Benefits:

The ART study will provide evidence from the first randomised trial for the use of bilateral IMA during CABG surgery. It will provide evidence for patients, doctors and policy-decision makers on the optimum treatment for patients undergoing CABG surgery.

ART is funded by the British Heart Foundation (2004-2014), Medical Research Council (2004-2014) and National Institute of Health Research (2014-2017) to compare 10-year survival after bilateral versus single internal thoracic artery grafting, and secondary outcomes of the composite of death, myocardial infarction or stroke, quality of life and health economic measures. Follow up to ten years is expected to be completed in 2017. This study will provide unique long term information on the efficacy and safety of bilateral internal thoracic artery grafts for CABG, as well as a valuable high quality database to understand factors that influence long term outcomes after CABG and how these may be improved.

All of this information will be used directly to improve the care of patients with advanced coronary artery disease undergoing coronary artery bypass graft surgery. Since coronary artery bypass graft surgery is a common operation and if the use of bilateral internal thoracic arteries lead to improved long term survival this could offer substantial health benefits to patients. Furthermore, the health economic component of ART will provide evidence to policy makers on the relative costs and benefits of performing coronary artery bypass surgery.

Outputs:

The University of Oxford intend to publish finding in high impact and disease specific medical journals as well as present findings at scientific sessions and conferences. Safety data at one year have been published and an interim analysis of five year follow-up results was presented at the American Heart Association Scientific Sessions in November 2016 and published simultaneously in the New England Journal of Medicine.

There has also been a number of other publications, for example;

1. Taggart DP, Altman DG, Gray AM, Lees B, Nugara F, Yu LM, Campbell H, Flather M; ART Investigators. Randomized trial to compare bilateral vs. single internal mammary coronary artery bypass grafting: 1-year results of the Arterial Revascularisation Trial (ART). Eur Heart J. 2010 Oct;31(20):2470-81

2. Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather M; ART Investigators.. Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts. N Engl J Med. 2016 Dec 29;375 (26):2540-9 4. Taggart DP, Altman DG, Gray AM, Lees B, Nugara F, Yu LM, Flather M; ART Investigators.

3. Effects of on-pump and off-pump surgery in the Arterial Revascularization Trial. Eur J Cardiothorac Surg. 2015 Jun;47(6):1059- 65 5. Benedetto U, Altman DG, Gerry S, Gray A, Lees B, Pawlaczyk R, Flather M, Taggart DP; Arterial Revascularization Trial investigators.

4. Pedicled and skeletonized single and bilateral internal thoracic artery grafts and the incidence of sternal wound complications: Insights from the Arterial Revascularization Trial. J Thorac Cardiovasc Surg. 2016 Jul;152(1):270-6 6. Benedetto U, Altman DG, Gray AM, Lees B, Gerry S, Flather M, Taggart DP on behalf of the ART investigators. Impact of dual antiplatelet therapy after coronary artery bypass surgery on 1 year outcomes in the Arterial Revascularization Trial (ART). Eur J Cardiothoracic Surgery (accepted 2017) 7.

5. Taggart DP, Altman DG, Gray A M, Lees B, Gerry S, Benedetto U, Flather M,for the ART Investigators. Randomized trial of bilateral versus single internal- thoracic-artery grafts. N Engl J Med 2016;375:2540-2549

It is proposed that once all patients have completed their 10 year follow up (scheduled 2017), the survival data will be analysed and form the basis of a manuscript to be published in a peer-review medical journal(s) as soon as possible after the end of the study .

In addition to further outputs in peer review medical journals and conferences, the ART study team will prepare information for participants once the 10 year analysis has been performed and the findings published (anticipated date: end 2017/beginning 2018).

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

A cohort of 1837 patients has been flagged by NHS Digital for the ART study. The ART study has informed patient consent for their entire cohort. The data from the UK patients on date of death and cause of death will contribute towards the analysis of the primary outcome of the ART study which is survival at 10 years.

Sensitive and identifiable data (including Date of Death and Cause of Death) will be transferred from NHS Digital to the ART study on a quarterly basis.

Data will be stored by the University of Oxford (Nuffield Department of Surgical Sciences). The data will be held electronically in a file that is only accessible by nominated ART study personnel working at the University of Oxford.

Only authorised ART study personnel at the University of Oxford will have access to the patient ID and patient data from NHS Digital.

The data will not be shared with 3rd parties and will only used for the purposes described in this agreement.

All ONS terms and conditions described in the special conditions section of this agreement will be adhered to.

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).