Effective Treatments for Thoracic Aortic Aneurysms (ETTAA)

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

Datasets: − HES:Civil Registration (Deaths) bridge

Objective for processing

Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) are requesting Hospital Episodes Statistics [7 words unchanged] the Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) study. The ETTAA study (The NIHR grant reference is: HTA Project:11/147/03 - Effective Treatments for Thoracic Aortic Aneurysms) is a prospective cohort study which commenced in 2014. (National Institute for Health and Care Research (NIHR) grant reference: Health Technology Assessment (HTA) Project: 11/147/03 - Effective Treatments for Thoracic Aortic Aneurysms). The intent is to link the study cohort to the NHS Digital England data to facilitate complete patient follow up and ensure that any key events (death and/or admission to hospital) and key resources used in hospital have not been missed. Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) RPHNHSFT are the sole Data Controller who also process the data. The lawful basis for processing personal data for ETTAA is Article 6(1)(e) and Article 9(2)(j): Performance is in the public interest because, because NIHR (HTA) commissioned the ETTAA study to try and identify Effective Treatments for Thoracic Aortic Aneurysms. such Such research is part of the official business of the hospital. Processing under [40 words unchanged] funded research and the data requested is proportionate to the study objectives. The proposed project data will allow Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) RPHNHSFT to validate the existing ETTAA study data (collected by local study coordinators), ensuring that dates and causes of death are complete and accurate by linking to Civil Registration Deaths Registrations of Death data, and by linking to the HES Admitted Patient Care data, so [30 words unchanged] receiving a procedure in the latter months of the study observation period. The incidence of chronic thoracic aortic aneurysm (CTAA) is rising as the [15 words unchanged] policy-makers. Based on an estimated incidence of 6-16 affected/100,000 people-year, there are 3000 – 8000 3000–8000 new cases per year. These patients are at risk of both fatal [69 words unchanged] these two factors alone are not sufficient to predict risk of rupture, dissection dissection, or death, since fatal complications occur even while the aneurysm is small. Control of blood pressure and smoking cessation help to reduce the risk of rupture or dissection dissection, but there is a greater risk reduction after endovascular stent grafting (ESG) or open surgical repair (OSR). Both ESG and OSR are known to be effective effective, but each has limitations and cannot always be offered to all patients. [36 words unchanged] and aneurysm factors must be considered jointly while deciding upon a treatment. Data Subjects are patients with Chronic Thoracic Aortic Aneurysm (CTAA) CTAA referred to each collaborating centre who have consented to participate in the ETTAA study. [2 paragraphs unchanged] • Had a Chronic Thoracic Aortic Aneurysm (CTAA) CTAA larger than or equal to 4cm on the arch or descending aorta [5 paragraphs unchanged] • ESG: Endovascular repair of the aneurysm via transluminal introduction of a stent-graft under X-ray guidance. Hybrid procedures that comprise a combination of a conventional surgical component and a transluminal repair are to be included in this group. • OSR: Replacement of the aneurysmal aorta with prosthetic conduit via a surgical incision with circulatory support. Hybrid procedures that comprise a combination of a conventional surgical component and a transluminal repair are included in this group. • CM: These patients have aneurysms that merit procedural intervention; however however, this is not planned either due to patient choice, co-morbidities co-morbidities, or risk assessment. This refers to lifestyle modification (smoking cessation and dietary [11 words unchanged] patients who are considered unsuitable for, or who refuse, OSR / ESG. • WW: Patients with small aneurysms considered to be at low risk of rupture will remain under surveillance with annual CT / MRI scans and MDT multidisciplinary team (MDT) review (as per local practice). These patients’ data will contribute to the natural history component of the study. [1 paragraph unchanged] 1. To follow patients with CTAA referred to each collaborating multidisciplinary team (MDT), MDT, prospectively recording management, medical events, Quality of Life (QoL) (QoL), and use of health and social services throughout the duration of the study. [1 paragraph unchanged] 3. To identify patient -specific patient-specific or aneurysm-specific features that might predict poor outcome in each treatment group by risk-modelling methods. [1 paragraph unchanged] Data required includes: date of death, cause of death, dates of admission to and discharge from hospital. hospital, information about the clinical events associated with the hospital admission admission, and key resources used in hospital and on discharge. Civil registration deaths Registrations of Death data is requested to provide mortality data. [1 paragraph unchanged] Study Number, NHS number number, and Date of Birth are were provided, with patient consent for identification purposes. NHS Digital will provide England provided pseudo-anonymised data identified by study number only. Data is was requested from 2014 to 2020. 2023. This is was to maximise the number of patient years of follow up, to get closer to the original study plan whilst staying within the resources of the original grant. When the study was planned planned, the ETTAA study team predicted that a maximum of 2200 participants would [20 words unchanged] end of 2014, more centres were opened to boost recruitment. By July 2016 2016, the ETTAA team reported to the HTA Monitoring Group that there were 26 UK centres open to recruitment and 402 patients had been recruited. The Health Technology Assessment (HTA) HTA gave permission to continue to open new centres to recruit to ETTAA. [23 words unchanged] or cardiac surgery, many centres recruited patients to all four management groups. [5 paragraphs unchanged] This is the most non-intrusive, scientifically valid valid, and cost effective way to ensure complete patient follow up and to validate the existing ETTAA study data set. [1 paragraph unchanged]

Processing activities

A cohort list of all Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) participants will be provided to NHS Digital, the ETTAA study will include Study ID number, Date of Birth and NHS number to identify the patients. The study ID will allow NHS Digital to flow back pseudonymised data to Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT). Once this is received, Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) will link NHS Digital data to the ETTAA study and will only use the study ID for linkage, there will be no attempt to re identify. RPHNHST transferred data to NHS England. The data consisted of identifying details (specifically NHS Number, Date of Birth, and a Study ID) for the cohort to be linked with NHS England data. Along with the study ID, pseudo-anonymised Hospital Episodes Statistics (HES) Identifiable HES Admitted Patient Care (APC) and Mortality identifiable mortality data linked to the study cohort will be was provided by NHS Digital England to Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) as detailed above, this will include - RPHNHSFT. This included, where applicable - applicable, date of death, date of admission and discharge from hospital, reason for [12 words unchanged] Resource Group (HRG) spells, dates and discharge details matched by Date of Birth Birth, and NHS number. Royal Papworth Hospital NHS Foundation trust (RPHNHST) will RPHNHST then match matched the data received from NHS Digital England with the current ETTAA data set using the Study ID, this will then be used [18 words unchanged] or health economists will only have access to pseudo-anonymised datasets for analysis. Royal Papworth Hospital NHS Foundation trust (RPHNHST) will provide the cohort data, provided from the existing study spreadsheet, and will be submitted to NHS Digital with NHS number and Date of Birth and Study ID. Variables provided by NHS England will be matched to existing variables in the ETTAA data set and the data will be compared. Where the data confirms existing information, this will be noted, and no further actions is required. Where information is additional to existing study data this will be provided as a separate variable for the analysts to use as they consider most appropriate after discussion with the study Working group, which consists of the Royal Papworth Hospital NHS Foundation Trusts, Trials Unit. NHS Digital will provide linkage of the (RPHNHST) cohort to HES APC and Mortality data and return data extracts containing Study ID only, the Study ID will allow NHS Digital to flow back pseudonymised data to (RPHNHST). Variables provided by NHS Digital will be matched to existing variables in the ETTAA data set and the data will be compared. Where the data confirms existing information, this will be noted, and no further actions is required. Where information is additional to existing study data this will be provided as a separate variable for the analysts to use as they consider most appropriate after discussion with the study Working group, which consists of the Royal Papworth Hospital NHS Foundation Trusts, Trials Unit, including a former researcher of Royal Papworth Hospital NHS Foundation Trust, working on the ETTAA study, who has recently moved to the London School of Hygiene and Tropical Medicine. An honorary contract is in place for this user only and there will be no other access to the data by LSHTM. [1 paragraph unchanged] NHS Digital England data will only be linked to the ETTAA data set and no other linkage will be permitted. NHS Digital will remove NHS number and Date of Birth and will only provide the Study ID back to (RPHNHST) which will then be returned to the ETTAA team. There will be no requirement and no attempt to reidentify individuals when using the Data. The only exception to the above is if the ETTAA study follow up is formally extended in the future with HRA/REC approval and with an approved amendment to the DARS Data sharing Agreement. NHS England will remove NHS number and Date of Birth and will only provide the Study ID back to RPHNHST which will then be returned to the ETTAA team. Data processing NHS Digital data will only be carried out by substantive employees of Royal Papworth Hospital NHS Foundation Trust who have been appropriately trained in data protection and confidentiality. The only exception to the above is if the ETTAA study follow up is formally extended in the future with Health Research Authority/Research Ethics Committee approval and with an approved amendment to the Data sharing Agreement. Data is stored on a secure NHS hospital server with access only available to substantive employees of the data processor(s) / data controller(s). Data processing of NHS England data will only be carried out by substantive employees of Royal Papworth Hospital NHS Foundation Trust who have been appropriately trained in data protection and confidentiality. NHS Digital reminds all organisations party to this agreement of the need to 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). Data is stored on a secure NHS hospital server with access only available to substantive employees of the processor(s) / controller(s).

Expected output

The study will culminate in a HTA monograph describing the study and its results in detail, which will allow the Trust to make recommendations for practice and policy in the UK. allow the Trust to make recommendations for practice and policy in the UK. The findings from this study will continue to be reported locally, nationally, and internationally in the form of presentations and journal articles to medical professionals and, where appropriate, patient groups. The findings from this study will also be reported locally, nationally and internationally in the form of presentations and journal articles to medical professionals and patient groups. This information will also be available via patient information leaflets and the study website which will be designed with the help of the patient representatives. Presentations may need to be online as medical conferences and public meetings are currently limited due to COVID-19. It is anticipated that there will be a number of publications describing: • Changes in aneurysm size over time • Clinical events and relationship to aneurysm size • Selection criteria for ESG, OSR and CM • Factors affecting outcomes after ESG and OSR • Comparative clinical outcomes after ESG and OSR in those patients that were eligible for both treatments • QoL and cost-effectiveness in patients for whom more than one treatment is appropriate. An analysis of patient specific and aneurysm specific factors (if there are any) which predict good or poor outcome will be provided. This will allow draft guidelines to be prepared regarding indications for ESG or OSR in patients with CTAA. [1 paragraph unchanged] Open Access articles will be made available whenever possible. The ETTAA study has a publication committee and publication plan and the exact journals will be chosen when the papers have been drafted - however these are likely to be chosen from a drafted. Example of journals include general medical journal (Lancet, BMJ) or journals (e.g., Lancet, BMJ), Cardiac surgery or Vascular surgery specialist journals as well as journals, and Statistical or Heath Economic publications. Open Access articles will be made available whenever possible. (RPHNHST) PPI representative will be invited to present, or arrange for ETTAA team members to present, the results to Aortic Aneurysm groups and the study team will arrange presentations for study participants. Due to Covid 19 these are likely to be online presentations but face to face meetings may be considered it the situation changes and funding is available to complete these safely. The following outputs are expected to be produced: Title/subject: The cost of providing surgery for CTAA: a micro costing study of OSR and ESG. By Gray et al. on behalf of the ETTAA Collaborative Group. Target date: Winter 2023/24. Destination: Submitted for publication. Title/subject: Investigation of differences in management and outcomes between men and women. Target date: Winter 2023/24. Destination: Presented at British Society of Endovascular Therapy (June 2023). Journal article submitted to European Heart Journal Title/subject: Analysis of health-related quality of life dimensions: detailed analysis of EQ-5D-5L dimensions. Target date: Spring 2024 Destination: Journal article Title/subject: Comparison of data collection methodology: Hospital Episode Statistics and hospital research staff records: assessment of accuracy and completeness of HES. Target date: Summer 2024 Destination: Journal article Title/subject: Planned re-analysis of patient survival using final HES data download for updated survival analysis (to March 2023). Target date: Autumn 2024 Destination: Journal article More detailed analysis of CT scans may be linked to outcome data from NHS England in 2024/2025. Scans are being prepared for additional analysis

Expected measurable benefits

It is hoped that the ETTAA study will directly address the research question specified in the NIHR HTA brief ‘What brief: 'What is the clinical and cost-effectiveness of various management strategies for chronic thoracic aortic aneurysm (CTAA)?’ The aim is to produce robust information to answer this question and, in the process, 1) assist clinical decision making by individual patients and healthcare professionals; and, 2) inform NHS Policy and resource allocation. Any assessment of the clinical and cost-effectiveness of various management strategies for chronic thoracic aortic aneurysm (CTAA) are of public interest as the costs are funded from public funds and it is members of the public who develop aortic aneurysms that requires NHS treatment. The aim is to produce robust information to answer this question and, in the process, 1) assist clinical decision making by individual patients and healthcare professionals; and 2) inform NHS Policy and resource allocation. • The disseminated results (reports, publications and presentations) will provide the current background, descriptive evidence based on the ETTAA study results and assessment of how the findings of this observational study add to the evidence available to answer the above question. Any assessment of the clinical and cost-effectiveness of various management strategies for CTAA are of public interest as the costs are funded from public funds and it is members of the public who develop aortic aneurysms that requires NHS treatment. Discussion within and around the research publications and presentations will inform the DoH, aortic specialists and the public on what has been observed and what this might mean for future practice and future research. The disseminated results (reports, publications, and presentations) will provide the current background, descriptive evidence based on the ETTAA study results, and assessment of how the findings of this observational study add to the evidence available to answer the above question. ETTAA will provide published cost-effectiveness analyses and general published literature (e.g. journal articles) and the ETTAA team will work with clinicians and professional bodies across the UK to revise clinical guidelines – should the study provide strong enough evidence to warrant changes. Discussion within and around the research publications and presentations will inform the Department of Health, aortic specialists, and the public on what has been observed and what this might mean for future practice and future research. ETTAA will provide published cost-effectiveness analyses and general published literature (e.g. journal articles), and the ETTAA team will work with clinicians and professional bodies across the UK to revise clinical guidelines should the study provide strong enough evidence to warrant changes. [2 paragraphs unchanged] The longer the patients are followed up, the more reliable long term outcome predictions and estimates of event free survival and resource use will be. The requested data will improve the quality of information provided to patients, the NHS, and those responsible for patients national and the NHS. international guidelines for treatment of chronic thoracic aortic aneurysms. The HTA monograph will include an overview of all the study outputs which will subsequently be prepared as journal articles and presentations for publication/delivery in Spring 2021. Further work on aneurysm growth and longer term follow up outcomes (if funding allows) will be reported in 2024. [6 paragraphs unchanged]

Benefits reported

Yielded Benefits is not a requirement for new applications. Publications and conclusions: 1. Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study. Sharples et al. Health Technology Assessment Volume: 26, Issue: 6, January 2022. https://doi.org/10.3310/ABUT7744 Conclusion: Small (4–6 cm) aneurysms require close observation. Larger (> 6 cm) aneurysms require intervention without delay. Endovascular stent grafting and open surgical replacement were successful for carefully selected patients, but cost comparisons were unfeasible. The choice of intervention is well established, but the timing of intervention remains challenging. 2. Aneurysm growth, survival, and quality of life in untreated thoracic aortic aneurysms: the effective treatments for thoracic aortic aneurysms study. Sharples et al. on behalf of the ETTAA Collaborative Group. European Heart Journal, Volume 43, Issue 25, 1 July 2022. https://doi.org/10.1093/eurheartj/ehab784 Conclusion: International guidelines should consider increasing monitoring intervals to 12 months for small aneurysms and increasing intervention thresholds. Individualized decisions about surveillance/intervention should consider age, sex, size, growth, patient characteristics, and surgical risk 3. Inequalities for women diagnosed with thoracic aortic aneurysms, results from the Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) cohort study. Pouncey et al. Submitted for publication in the European Heart Journal, September 2023 Conclusions: Guidelines for referral to specialist services should be based on ASI rather than diameter to reduce inequity due to patient sex.