NHS Digital Data Release Register - reformatted
St George's, University of London
Opt outs honoured: Yes - patient objections upheld (Section 251)
When: 2018/10 — 2018/12.
Legal basis: Health and Social Care Act 2012 – s261(7)
- MRIS - Flagging Current Status Report
Around 400 young people die from sudden cardiac death (SCD) each year in the UK. The majority of these events are due to inherited abnormalities of the heart muscle or electrical systems and are often silent until they present with a cardiac arrest. It was first reported in 2008 that individuals who suffered a cardiac arrest were more likely to have a particular pattern on their resting electrocardiogram (ECG); the Early Repolarisation Pattern (ERP). Subsequent large population cohort studies showed that individuals with the ERP had an increased risk of sudden cardiac death over long-follow up periods. The excess of sudden cardiac deaths occurred in the sixth decade of life and onwards. These studies led to great concern over the significance of the ERP in the general population. Meanwhile the ERP is known to be common in young adults, particularly those who take part in high volumes of regular exercise. There have been no large-scale studies to date in cohorts of young adults with ERP. The intention of this study was firstly to identify the prevalence of the ERP in a large cohort of physically active young adults and to identify whether those with ERP have an increased risk of sudden cardiac death in the short to medium-term. Central to answering this question is to reliably identify those who have suffered sudden cardiac death and correlate these deaths with the presence of the ERP on the ECG. This study forms part of a larger research project, "EVALUATION OF THE 12 LEAD ECG AS A USEFUL TOOL IN IDENTIFYING YOUNG APPARENTLY HEALTHY INDIVIDUALS WITH CARDIAC DISEASE" (REC Ref MH532A) undertaken by clinical researchers at St. George’s Hospital Medical School Research Dept. who have published extensively in the field of ECG screening, sudden cardiac death risk and ECG patterns. The purpose of this larger study is to identify a cost-effective screening method of identifying young individuals with cardiac disease who may be at risk of sudden cardiac death. As described above, sudden cardiac death may occur in individuals with previously asymptomatic heart muscle or electrical diseases. These diseases may be diagnosed with a 12-lead ECG which therefore may be considered as a potential screening tool. This particular application utilises the demographic and ECG data collected to assess the significance of the ERP as described above. Results from this study will then feed back in to the ongoing larger study by determining whether ERP constitutes a significant marker of risk that could be screened for with a 12 lead ECG. This research analyses multiple features of an individuals ECG, looks for the prevalence of known abnormalities associated with conditions that may pose an increased risk of sudden cardiac death and also for novel features which may be associated independently with increased risk. The project has been funded by Cardiac Risk in the Young (CRY), a charitable organisation offering cardiac screening to athletes and young people with the aim of reducing rates of sudden deaths in the young. CRY funded the research for this project as well as providing the infrastructure for collection of data. This data will not form part of any other research project nor be shared with any outside parties. No part of the work is being carried out outside of the UK.
The research output will help inform the cardiology community regarding the risk of the ERP in young adults. The hypothesis is that there will be no increased risk in young adults with ERP. If this is proven, the research will lead to a reduction of unnecessary investigations of asymptomatic individuals with ERP and reduce patient and family anxieties in individuals where ERP is found incidentally. Based upon current knowledge there is confusion amongst practicing cardiologists, sports physicians and general practitioners as to the significance of the ERP in young adults. Consequently individuals can be restricted from physical activity and referred to specialist centres for further investigation. Such investigation uses health resources and can cause significant anxiety to the affected individual. Furthermore, restriction from physical activity can have a wide range of detrimental physical and psychological effects. Publication of the research in high impact medical journals will allow it's wide international circulation. Future studies in this area will also reference the work in subsequent investigations. Through academic publication and presentation it is expected that the findings of the research, if significant, will inform future national and international guidelines on the assessment and management on individuals at risk of sudden death and regarding pre-participation cardiac screening of athletes. Such guideline documents are widely circulated and advertised within clinical service. They inform the basis of clinical practice of cardiologists, sports physicians and general practitioners looking after such individuals. In many cases, guidelines are adopted or endorsed by the National Institute for Clinical Excellence (NICE) and therefore effectively become mandatory for NHS physicians.
The research output will be submitted to peer-reviewed cardiology and/or general medical journals in the form of an original research article. It is expected that the work will be accepted for publication in a high-impact cardiology-specific journal, such as Circulation, the Journal of the American College of Cardiology (JACC) or the European Heart Journal (EHJ). These journals are widely read amongst the clinical and academic cardiology community worldwide. Articles published in these journal therefore frequently inform clinical practice and are often cited in national and international guideline documents. Only aggregated data, with small number suppressed in line with HES guidance, will be included in any research output. No patient level data will be included. It is expected that the research article will be submitted for peer review within 3 months of receipt of the data from NHS digital. In addition to the written outputs, the research data will be submitted for oral presentation at national and international cardiology conferences such as the British Cardiac Society annual conference, British Heart Rhythm Congress, Euoropean Heart Rhythm Association conference and Heart Rhythm Congress in the USA. Similarly to the journal listed above, these conferences serve to dissipate cutting edge clinical research findings to leading clinical and academic cardiologists. Through this network of academic research presentations the findings, if significant, will lead to changes in national and international guidance on the assessment and management of young adults at apparent risk of sudden cardiac death or undergoing pre-participation ECG screening in the context of elite or amateur sport. Such guideline documents are widely circulated and advertised within clinical service. They inform the basis of clinical practice of cardiologists, sports physicians and general practitioners looking after such individuals. Summaries of the research findings will also be published by Cardiac Risk in the Young including on their website, via twitter and at the annual CRY International Conference on Sports Cardiology.
Completion of the medical questionnaire and acquisition of the ECG were performed by CRY at various sites throughout England and Wales at the time of cardiac screening events. All participants gave written informed consent for their data to be stored and used for research purposes by CRY. Researchers at St. George’s Hospital Medical School Research Dept used this primary source data (i.e. medical questionnaire responses and ECG) were used to construct two databases. The first containing the participants demographic details and the second containing data from the medical questionnaire and ECG. The databases are linked by unique ID numbers and are password protected. These databases are stored at St. George’s Hospital Medical School Research Dept. Access to the local network is via a unique login ID and password protected. St. George’s Hospital Medical School Research Dept. is IG toolkit compliant. Storage of data acquired from CRY medical questionnaires and ECGs at St. George's is covered by the original research protocol and consent process which were agreed by the local REC (ref MH532A)). These databases are not accessible to CRY staff. Data in the demographic database will be provided to NHS Digital with the intention of identifying any member of the cohort who has died and to identify the cause of death in each case if applicable. Data provided will be organised in to three groups; those individuals with no ERP; those with low risk form of ERP and those with the high risk form of ERP. Data flow between St. George’s Hospital Medical School Research Dept. and NHS Digital is covered by section 251 and has been approved both by the local REC and by the confidential advisory group (CAG). St. George’s Hospital Medical School Research Dept. request the numbers of deaths within each group as well as the cause of death as per the death certificate for any deceased individual. Mortality data will be analysed at St. George’s Hospital Medical School Research Dept by an ONS accredited researcher. Final data will be aggregated to prevent the identification of any individual within the study. All research outputs will include aggregated data only suppressed in line with the HES analysis guide. Aggregated data small numbers will be suppressed in line with the HES analysis guidelines. No data will be shared with third parties. Data will not be accessed from outside the UK. 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). ONS Terms and Conditions will be adhered to. The data controller must ensure that there are appropriate contracts and controls in place between the organisation and all persons accessing NHS Digital disseminated data. NHS Digital have the right to audit the controls in place under the data sharing agreement.