BREATHE - The Health Data Research Hub for Respiratory Health
Lead Research Organisation:
University of Edinburgh
Abstract
What is the problem?
Everyone in the UK will have a respiratory illness at some point in their life. We have the best datasets in the world – which should be used to improve respiratory health – but these are currently very difficult to find, access and use.
What do we want to do?
People in the UK deserve the best respiratory health. We want to make respiratory health better by changing the way the NHS, pharmaceutical companies, charities and researchers use data.
How will we do it?
We will create a Hub (called BREATHE) where trained, approved experts can access respiratory data to benefit patients and the public. We will make it easier for experts to use data in safe and secure ways.
How will this benefit patients?
BREATHE will support high quality research and cutting-edge innovation that will improve the lives of people living with respiratory conditions in the UK. It is important that patients and the public are involved with this project throughout, including from the very start. This is why there are patient and public members living with respiratory conditions who have worked with us on developing this proposal and who are committed to delivering BREATHE’s goals."
Everyone in the UK will have a respiratory illness at some point in their life. We have the best datasets in the world – which should be used to improve respiratory health – but these are currently very difficult to find, access and use.
What do we want to do?
People in the UK deserve the best respiratory health. We want to make respiratory health better by changing the way the NHS, pharmaceutical companies, charities and researchers use data.
How will we do it?
We will create a Hub (called BREATHE) where trained, approved experts can access respiratory data to benefit patients and the public. We will make it easier for experts to use data in safe and secure ways.
How will this benefit patients?
BREATHE will support high quality research and cutting-edge innovation that will improve the lives of people living with respiratory conditions in the UK. It is important that patients and the public are involved with this project throughout, including from the very start. This is why there are patient and public members living with respiratory conditions who have worked with us on developing this proposal and who are committed to delivering BREATHE’s goals."
Technical Summary
Approximately 12.7 million people report a history of long-standing respiratory illness and respiratory disorders are the third leading cause of death. Lung diseases account for 10% of all inpatient bed-days, cost the NHS £11billion/year and society over £70billion/year. Despite having the richest respiratory datasets in the world, data are fragmented, inconsistently structured and cumbersome to access, severely limiting their utility.
Our vision is to transform the UK’s respiratory health through creating Findable, Accessible, Interoperable and Reusable (FAIR) respiratory rich datasets; providing expert support to catalyse their responsible use in respiratory research and innovation. We will position the UK at the forefront of data driven innovation; creating a ‘one-stop’ service for trustworthy, multi-stakeholder utilisation of curated respiratory data for public, private and third sector benefit. Our UK-wide consortium provides the necessary expertise. Our priorities have been co-developed with patients, the public, industry and med-tech partners; together we have identified
major opportunities for early, high-profile, case studies.
BREATHE will initially focus on asthma and COPD, including respiratory infections, addressing three main themes of crucial importance to the UK life sciences sector:
1) Drug discovery and pharmacogenetics;
2) RWE to improve healthcare systems;
3) Digitally enabled trials
New data assets will be made available to the UK Health Data Research (HDR) Alliance and through the HDR Research Innovation Gateway. We will create a UK Respiratory Data Library (with metadata catalogue), curate and link data, and provide open-source algorithms to support secure analyses thereby enhancing the interoperability of datasets. This expandable platform will for example, enable the incorporation of data from wearable sensors into NHS apps to transform respiratory health, supporting rapid evaluation of new drugs and devices in real-world settings, and yielding evidence to underpin policy initiatives.
BREATHE will support stakeholders to securely use data to meet their diverse needs. We will work proactively with other Digital Innovation Hubs (DIH) to enhance the UK’s competitiveness.
"
Our vision is to transform the UK’s respiratory health through creating Findable, Accessible, Interoperable and Reusable (FAIR) respiratory rich datasets; providing expert support to catalyse their responsible use in respiratory research and innovation. We will position the UK at the forefront of data driven innovation; creating a ‘one-stop’ service for trustworthy, multi-stakeholder utilisation of curated respiratory data for public, private and third sector benefit. Our UK-wide consortium provides the necessary expertise. Our priorities have been co-developed with patients, the public, industry and med-tech partners; together we have identified
major opportunities for early, high-profile, case studies.
BREATHE will initially focus on asthma and COPD, including respiratory infections, addressing three main themes of crucial importance to the UK life sciences sector:
1) Drug discovery and pharmacogenetics;
2) RWE to improve healthcare systems;
3) Digitally enabled trials
New data assets will be made available to the UK Health Data Research (HDR) Alliance and through the HDR Research Innovation Gateway. We will create a UK Respiratory Data Library (with metadata catalogue), curate and link data, and provide open-source algorithms to support secure analyses thereby enhancing the interoperability of datasets. This expandable platform will for example, enable the incorporation of data from wearable sensors into NHS apps to transform respiratory health, supporting rapid evaluation of new drugs and devices in real-world settings, and yielding evidence to underpin policy initiatives.
BREATHE will support stakeholders to securely use data to meet their diverse needs. We will work proactively with other Digital Innovation Hubs (DIH) to enhance the UK’s competitiveness.
"
Organisations
- University of Edinburgh, United Kingdom (Lead Research Organisation)
- University of Oxford, United Kingdom (Collaboration)
- GE (General Electric Company) UK (Collaboration)
- Respiri Limited (Collaboration)
- Diveplane Corporation (Collaboration)
- Office for National Statistics, United Kingdom (Collaboration)
- Queen's University of Belfast, United Kingdom (Collaboration)
- Smart Respiratory Products Ltd (Collaboration)
- University of Strathclyde, United Kingdom (Collaboration)
- University of Birmingham, United Kingdom (Collaboration)
- Royal College of General Practioners (RCGP) (Collaboration)
- SAIL Databank (Collaboration)
- Novartis (Collaboration)
- Swansea University, United Kingdom (Collaboration)
- Cystic Fibrosis Trust (Collaboration)
- Tiny Medical Apps (Collaboration)
- Savana (Collaboration)
- Asthma UK (Collaboration)
Publications
Adeloye D
(2022)
Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis
in The Lancet Respiratory Medicine
Bachtiger P
(2020)
Belief of having had unconfirmed Covid-19 infection reduces willingness to participate in app-based contact tracing.
in NPJ digital medicine
Bloom CI
(2020)
Health and cost impact of stepping down asthma medication for UK patients, 2001-2017: A population-based observational study.
in PLoS medicine
Clift AK
(2020)
Living risk prediction algorithm (QCOVID) for risk of hospital admission and mortality from coronavirus 19 in adults: national derivation and validation cohort study.
in BMJ (Clinical research ed.)
Dogar O
(2020)
Cytisine for smoking cessation in patients with tuberculosis: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.
in The Lancet. Global health
Drake T
(2020)
The effects of physical distancing on population mobility during the COVID-19 pandemic in the UK
in The Lancet Digital Health
Fry R
(2021)
Real-time spatial health surveillance: Mapping the UK COVID-19 epidemic.
in International journal of medical informatics
Gruer L
(2022)
Complex differences in infection rates between ethnic groups in Scotland: a retrospective, national census-linked cohort study of 1.65 million cases
in Journal of Public Health
Han Q
(2022)
Long-Term Sequelae of COVID-19: A Systematic Review and Meta-Analysis of One-Year Follow-Up Studies on Post-COVID Symptoms.
in Pathogens (Basel, Switzerland)
| Description | All-Party Parliamentary Group for Respiratory Health - Improving Asthma Outcomes Consultation. Asthma UK Centre for Applied Research Response |
| Geographic Reach | National |
| Policy Influence Type | Gave evidence to a government review |
| URL | https://www.ed.ac.uk/usher/breathe/latest/appg-respiratory-health-asthma-report |
| Description | Contribution to Scottish Government reports on modelling of the pandemic |
| Geographic Reach | Local/Municipal/Regional |
| Policy Influence Type | Citation in other policy documents |
| Impact | This is evidence of EAVE II findings being used directly by the Director-General Health and Social Care in Scotland, in terms of spread of the disease and demands on the system e.g. in terms of healthcare |
| URL | https://www.ed.ac.uk/usher/eave-ii/key-outputs/scottish-government-reports |
| Description | Member of DHSC/UKRI COVID-19 College of Experts |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Aziz Sheikh is a member of the DHSC/UKRI COVID-19 College of Experts. The EAVE-II activities, as well as studies using this resource such as DaCVaP, QCOVID and National Core Studies, have ensured that data for the whole Scottish population are included in the UK Government's COVID-19 disease and vaccination forecasting efforts, and supported identification of individuals at particularly high risk of serious COVID-19 outcomes. |
| Description | Member of Scottish Government's Silver Group for Data & Intelligence and Chair of Task Force: 3 Priority Questions |
| Geographic Reach | Local/Municipal/Regional |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Professor Aziz Sheikh is a Member of Scottish Government's Silver Group for Data & Intelligence and Chair of Task Force: 3 Priority Questions. The EAVE II research has improved the Scottish Government's COVID-19 forecasting capability and supported identification of individuals at particularly high risk of serious COVID-19 outcomes. |
| Description | Member of the Academy of Medical Science's Winter Scenarios Group |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Aziz Sheikh is a member of the Academy of Medical Science's Winter Scenarios Group. This policy related work has resulted in use of the EAVE-II national data platform for COVID-19 surveillance and the UK's main risk prediction algorithms for identifying risk factors for serious COVID-19 outcomes. |
| URL | https://acmedsci.ac.uk/more/news/prepare-now-for-a-winter-covid-19-peak-warns-academy-of-medical-sci... |
| Description | Member of the Royal Society's Data Evaluation and Learning for Viral Epidemics (DELVE) Group |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Aziz Sheikh is a member of the Royal Society's Data Evaluation and Learning for Viral Epidemics (DELVE) Group. This policy related work has amongst other things resulted in the use of the EAVE-II national data platform for COVID-19 surveillance and the UK's main risk prediction algorithms for identifying risk factors for serious COVID-19 outcomes. |
| URL | https://rs-delve.github.io/ |
| Description | Member of the Scottish Government's Chief Medical Officer's COVID-19 Advisory Group, and its Data Task Force and Ethnicity Groups |
| Geographic Reach | Local/Municipal/Regional |
| Policy Influence Type | Participation in a advisory committee |
| Impact | Professor Aziz Sheikh is a member of the Scottish Government's Chief Medical Officer's COVID-19 Advisory Group, and its Data Task Force and Ethnicity Groups, and also serves on the New and Emerging Respiratory Virus Threats (NERVTAG) Risk Stratification Subgroup. This policy-related work has benefited from creation of the EAVE-II national data platform for COVID-19 surveillance, and linkage to other health and research datasets, enabling the UK's main risk prediction algorithms for identifying risk factors for serious COVID-19 outcomes. |
| Description | BREATHE: The Health Data Research Hub for Respiratory Health |
| Amount | £4,670,992 (GBP) |
| Funding ID | MC_PC_19004 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2019 |
| End | 08/2022 |
| Description | Data and Connectivity: Vaccine Pharmacovigilance |
| Amount | £203,919 (GBP) |
| Funding ID | HDRUK2020.146 |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 01/2021 |
| End | 06/2021 |
| Description | Developing and validating a risk prediction model for long COVID-19 |
| Amount | £189,659 (GBP) |
| Organisation | Chief Scientist Office |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2021 |
| End | 02/2023 |
| Description | National Core Studies - Longitudinal Health & Wealth |
| Amount | £9,862,000 (GBP) |
| Funding ID | MC_PC_20030 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2020 |
| End | 03/2021 |
| Description | Post-hospitalisation COVID-19 study (PHOSP-COVID): a national consortium to understand and improve long-term health outcomes |
| Amount | £8,532,683 (GBP) |
| Organisation | Department of Health (DH) |
| Sector | Public |
| Country | United Kingdom |
| Start | 06/2020 |
| End | 01/2022 |
| Description | QCOVID Covid Risk Stratification Tool. Development and evaluation of a tool for predicting risk of short-term adverse outcomes due to COVID-19 in the general UK population |
| Amount | £1,285,333 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 04/2020 |
| End | 05/2022 |
| Description | Rapid Outcomes of COVid therapeutics in Eave II (ROCOVE) |
| Amount | £113,580 (GBP) |
| Organisation | United Kingdom Research and Innovation |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 03/2022 |
| Description | SME Access to Healthcare Data: AI Generated Synthetic Data |
| Amount | £30,000 (GBP) |
| Organisation | Innovate UK |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 05/2022 |
| Description | SyntheticData Guidance |
| Amount | £80,000 (GBP) |
| Funding ID | 4050856767 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2022 |
| End | 03/2023 |
| Description | What is the uptake, safety and effectiveness of COVID-19 vaccines in: a. pregnancy; b. children and young people; c. those receiving booster doses; d. those co-administered COVID-19 and influenza vaccines? |
| Amount | £249,775 (GBP) |
| Funding ID | 2021.0158 |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 09/2021 |
| End | 09/2022 |
| Title | Sharing code on github |
| Description | We regularly update code (https://github.com/EAVE-II). Health data for our research is stored securely but separately in Trusted Research Environments in England, Scotland, Wales and Northern Ireland. By pooling the number of cases across different parts of the UK, we can create a big enough dataset to analyse rare events. Shared code facilitates common data analysis protocols across different Trusted Research Environments which means that we can perform analyses using much larger samples but without sharing actual data between research teams. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Our recent paper PLOS Medicine paper (doi.org/10.1371/journal.pmed.1003927) "First dose ChAdOx1 and BNT162b2 COVID-19 vaccinations and cerebral venous sinus thrombosis" is an example of impact from this method. There were not enough people in Scotland who had experienced CVST after a first dose of vaccine for us to analyse the data in a reliable way for this condition. By pooling the data across Scotland, England and Wales to form a sample of £11.6m people, we could create a big enough dataset to analyse possible links with vaccination, without sharing individual data between countries. We were able to show that there is a very small increased risk of CVST for people who had a first dose of the Oxford-AstraZeneca vaccine. We did not find any link between CVST and the Pfizer-BioNTech vaccine. |
| URL | https://github.com/EAVE-II |
| Title | HDRUK Innovation Gateway - BREATHE Collection Page |
| Description | Health Data Research UK is enabling researchers to discover and request access to data via the Innovation Gateway. The Gateway does not hold or store any datasets or patient or health data but allows users to see descriptions of the different types of datasets in the UK to enable researchers to see what's available and how they can access it. A dataset is a collection of related individual pieces of data but in the case of health data, identifiable information (e.g. name or NHS number) is removed and data is de-identified where possible.If a researcher wants to access a dataset, they can send a request via the Innovation Gateway and this will be considered by the organisation that looks after that dataset. The HDRUK Innovation Gateway has created a 'collections page' for each of the 7 Hubs. BREATHE's collection page is a tool to showcase the data the Hub has access to, plus allows the Hub to make the datasets visable and facilitates a process to request access more simply. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2020 |
| Provided To Others? | No |
| Impact | The BREATHE collections page will allow anyone to see what data assets are collected by BREATHE and makes them easy to find, access and use. At the time of submission, BREATHE signposts to ~90 respiratory datasets. |
| URL | https://web.www.healthdatagateway.org/collection/420201816349588 |
| Title | Work with Public Health Scotland to make data available to other researchers |
| Description | eDRIS has developed a COVID-19 Research Database as a direct output from the EAVE II study. This is a reduced set of key datasets and fields to support urgent COVID Research. |
| Type Of Material | Data handling & control |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | This makes some of the EAVE II data available to a wider group of researchers, in line with Public Benefit and Privacy Panel (PBPP) approvals. |
| URL | https://www.isdscotland.org/Products-and-Services/eDRIS/COVID-19/index.asp |
| Description | Asthma UK British Lung Foundation |
| Organisation | Asthma UK |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | BREATHE is able to support the Asthma UK and British Lung Foundation Partnership to understand data needs for the charity to support the questions they wish to address, in some cases to inform policy making decisions. |
| Collaborator Contribution | Asthma UK and British Lung Foundation Partnership are a powerful voice for all respiratory diseases in the UK and BREATHE has been able to tap into the expertise within this group in an advisory capacity. |
| Impact | Ongoing collaboration, no formal impact to report yet. |
| Start Year | 2019 |
| Description | Can we enable harmonised, real-time, pharmacovigilance of COVID-19 vaccine(s) using routinely collected linked national data across the UK? |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We led this partnership to access routine healthcare data and use common protocols to understand how safe COVID-19 vaccines are and how well they work across the UK |
| Collaborator Contribution | Our partners looked for patterns in health records for the populations of England, Northern Ireland and Wales relating to COVID-19 vaccines, and we worked together to develop common data analysis protocols. |
| Impact | We were the first group in the world to show using national routinely collected health data that having a first vaccine dose gives very good protection against COVID-19 hospital admission. Between 8 December 2020 and 15 February 2021, we studied over 1.3 million vaccinated people in Scotland. In a follow-on analysis, we found that between 8 December 2020 and 14 April 2021, less than one in 2000 vaccinated people in Scotland had severe COVID-19. This is despite high background levels of infection. Using common analysis protocols, we were able to coordinate a UK-wide analysis with our partners to understand how long vaccine protection lasts. At the request of one of the UK's Chief Scientific Advisers, we used data to look at side effects in the blood from the first dose of a COVID-19 vaccines. We did not find any link between the Pfizer-BioNTech vaccine and bleeding or blood-clotting side effects. We did find in some people given the Oxford-AstraZeneca vaccine a slightly increased risk of a condition known as 'idiopathic thrombocytopenic purpura' (ITP) which increases the risk of bleeding disorders. In our Scottish analysis, we were not able to find a link between the COVID-19 vaccines and a very rare side effect in the brain called 'cerebral venous sinus thrombosis' (CVST). This may have been because the number we studied in Scotland was too small to find such a rare event. To address this, we repeated the analysis in England and Wales and brought results together with the Scottish data into a single analysis of 11.6 million people. We found a slightly increased risk of CVST (0.25 extra cases of clots per million people) in the 28 days after a first dose of the Oxford-AstraZeneca vaccine. This is very, very low compared with the risk of COVID-19 hospitalisation and death in people who have not been vaccinated. We did not find any link between CVST and the Pfizer-BioNTech vaccine. In Northern Ireland, our partners looked at vaccine uptake in people having treatment for mental health disorders. When looking at their healthcare records, it seemed that adults taking medication to aid sleep, anxiety or psychosis were less likely to be vaccinated than the general adult population. We also looked at whether healthcare staff in Wales had been vaccinated. We found that overall, a high number of staff did have their vaccines but the numbers vaccinated depended on their age and what jobs they did. We have shown that vaccines prevent or shorten COVID-19 outbreaks in care home residents in Northern Ireland. We are looking at how well and for how long vaccines protect healthcare professionals in Wales, and are currently coordinating a UK-wide analysis to understand how long vaccine protection lasts. |
| Start Year | 2021 |
| Description | Can we enable harmonised, real-time, pharmacovigilance of COVID-19 vaccine(s) using routinely collected linked national data across the UK? |
| Organisation | Swansea University |
| Department | Swansea University Medical School |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We led this partnership to access routine healthcare data and use common protocols to understand how safe COVID-19 vaccines are and how well they work across the UK |
| Collaborator Contribution | Our partners looked for patterns in health records for the populations of England, Northern Ireland and Wales relating to COVID-19 vaccines, and we worked together to develop common data analysis protocols. |
| Impact | We were the first group in the world to show using national routinely collected health data that having a first vaccine dose gives very good protection against COVID-19 hospital admission. Between 8 December 2020 and 15 February 2021, we studied over 1.3 million vaccinated people in Scotland. In a follow-on analysis, we found that between 8 December 2020 and 14 April 2021, less than one in 2000 vaccinated people in Scotland had severe COVID-19. This is despite high background levels of infection. Using common analysis protocols, we were able to coordinate a UK-wide analysis with our partners to understand how long vaccine protection lasts. At the request of one of the UK's Chief Scientific Advisers, we used data to look at side effects in the blood from the first dose of a COVID-19 vaccines. We did not find any link between the Pfizer-BioNTech vaccine and bleeding or blood-clotting side effects. We did find in some people given the Oxford-AstraZeneca vaccine a slightly increased risk of a condition known as 'idiopathic thrombocytopenic purpura' (ITP) which increases the risk of bleeding disorders. In our Scottish analysis, we were not able to find a link between the COVID-19 vaccines and a very rare side effect in the brain called 'cerebral venous sinus thrombosis' (CVST). This may have been because the number we studied in Scotland was too small to find such a rare event. To address this, we repeated the analysis in England and Wales and brought results together with the Scottish data into a single analysis of 11.6 million people. We found a slightly increased risk of CVST (0.25 extra cases of clots per million people) in the 28 days after a first dose of the Oxford-AstraZeneca vaccine. This is very, very low compared with the risk of COVID-19 hospitalisation and death in people who have not been vaccinated. We did not find any link between CVST and the Pfizer-BioNTech vaccine. In Northern Ireland, our partners looked at vaccine uptake in people having treatment for mental health disorders. When looking at their healthcare records, it seemed that adults taking medication to aid sleep, anxiety or psychosis were less likely to be vaccinated than the general adult population. We also looked at whether healthcare staff in Wales had been vaccinated. We found that overall, a high number of staff did have their vaccines but the numbers vaccinated depended on their age and what jobs they did. We have shown that vaccines prevent or shorten COVID-19 outbreaks in care home residents in Northern Ireland. We are looking at how well and for how long vaccines protect healthcare professionals in Wales, and are currently coordinating a UK-wide analysis to understand how long vaccine protection lasts. |
| Start Year | 2021 |
| Description | Can we enable harmonised, real-time, pharmacovigilance of COVID-19 vaccine(s) using routinely collected linked national data across the UK? |
| Organisation | University of Oxford |
| Department | Nuffield Department of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We led this partnership to access routine healthcare data and use common protocols to understand how safe COVID-19 vaccines are and how well they work across the UK |
| Collaborator Contribution | Our partners looked for patterns in health records for the populations of England, Northern Ireland and Wales relating to COVID-19 vaccines, and we worked together to develop common data analysis protocols. |
| Impact | We were the first group in the world to show using national routinely collected health data that having a first vaccine dose gives very good protection against COVID-19 hospital admission. Between 8 December 2020 and 15 February 2021, we studied over 1.3 million vaccinated people in Scotland. In a follow-on analysis, we found that between 8 December 2020 and 14 April 2021, less than one in 2000 vaccinated people in Scotland had severe COVID-19. This is despite high background levels of infection. Using common analysis protocols, we were able to coordinate a UK-wide analysis with our partners to understand how long vaccine protection lasts. At the request of one of the UK's Chief Scientific Advisers, we used data to look at side effects in the blood from the first dose of a COVID-19 vaccines. We did not find any link between the Pfizer-BioNTech vaccine and bleeding or blood-clotting side effects. We did find in some people given the Oxford-AstraZeneca vaccine a slightly increased risk of a condition known as 'idiopathic thrombocytopenic purpura' (ITP) which increases the risk of bleeding disorders. In our Scottish analysis, we were not able to find a link between the COVID-19 vaccines and a very rare side effect in the brain called 'cerebral venous sinus thrombosis' (CVST). This may have been because the number we studied in Scotland was too small to find such a rare event. To address this, we repeated the analysis in England and Wales and brought results together with the Scottish data into a single analysis of 11.6 million people. We found a slightly increased risk of CVST (0.25 extra cases of clots per million people) in the 28 days after a first dose of the Oxford-AstraZeneca vaccine. This is very, very low compared with the risk of COVID-19 hospitalisation and death in people who have not been vaccinated. We did not find any link between CVST and the Pfizer-BioNTech vaccine. In Northern Ireland, our partners looked at vaccine uptake in people having treatment for mental health disorders. When looking at their healthcare records, it seemed that adults taking medication to aid sleep, anxiety or psychosis were less likely to be vaccinated than the general adult population. We also looked at whether healthcare staff in Wales had been vaccinated. We found that overall, a high number of staff did have their vaccines but the numbers vaccinated depended on their age and what jobs they did. We have shown that vaccines prevent or shorten COVID-19 outbreaks in care home residents in Northern Ireland. We are looking at how well and for how long vaccines protect healthcare professionals in Wales, and are currently coordinating a UK-wide analysis to understand how long vaccine protection lasts. |
| Start Year | 2021 |
| Description | Cystic Fibrosis Trust |
| Organisation | Cystic Fibrosis Trust |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | The partnership will aim to raise awareness of the UK CF Registry amongst new audiences, improving access and stimulating research. The Hub has contributed financially to allow the data linkage. |
| Collaborator Contribution | The Cystic Fibrosis Trust (CFT) is working with BREATHE to link data from its national UK Cystic Fibrosis (UK CF) registry to NHS patient records. The aim of the collaboration is to establish a UK-wide linked data asset for the UK CF registry and to support the community of patients living with cystic fibrosis by stimulating research and innovation in this somewhat neglected disease area. BREATHE is working with CFT to engage patients whose data are collected as part of this registry and involve them in the future scientific direction of our collaboration. |
| Impact | Ongoing collaboration. |
| Start Year | 2020 |
| Description | Development and evaluation of a tool for predicting risk of short-term adverse outcomes due to COVID-19 in the general UK population |
| Organisation | University of Oxford |
| Department | Nuffield Department of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The EAVE II team has validated the QCovid algorithm with Scottish health data, including conceptualising the study, developing a protocol, carrying out the analysis and publishing the results. |
| Collaborator Contribution | Researchers in our team have carried out validation |
| Impact | QCovid was developed as a model to estimate a person's risk of being hospitalised or dying due to catching coronavirus. |
| Start Year | 2020 |
| Description | Diveplane Corp. |
| Organisation | Diveplane Corporation |
| Country | United States |
| Sector | Private |
| PI Contribution | Access to secure Trusted Research Environment through partnership with SAIL Databank. |
| Collaborator Contribution | A synthetic data engine will utilise respiratory data to enable the creation of accurate specific respiratory synthetic data sets. Diveplane have become a Supporting Partner to BREATHE. Diveplane will deploy the GEMINAI synthetic data engine using BREATHE respiratory data, in partnership with SAIL, to enable the creation of accurate specific respiratory synthetic data sets, without risk of exposing any confidential data. |
| Impact | Ongoing collaboration. |
| Start Year | 2021 |
| Description | GE Healthcare |
| Organisation | GE Healthcare Life Sciences |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | BREATHE is offering GE Healthcare Partners the opportunity to provide expertise in the delivery of respiratory health services, and identify opportunities where GE Healthcare Partners can service the scale-up and delivery of those services. For example through BREATHE's support in their Accelerator Programme. |
| Collaborator Contribution | GE Healthcare Partners are significantly involved in the delivery of healthcare services in the NHS and globally. Their expertise is supporting the scale-up of Hub services to ensure its sustainability. |
| Impact | No impact to report yet, collaboration ongoing. |
| Start Year | 2019 |
| Description | Novartis |
| Organisation | Novartis |
| Country | Global |
| Sector | Private |
| PI Contribution | Novartis is involved with two HDR Hubs which, along with other UK investments (e.g. new headquarters in White City and partnership Oxford's Big Data Institute), is indicative of their commitment to the UK Life Sciences sector. Novartis can contribute to the development of UK respiratory capabilities and gain insight in the UK offering amongst UK and Global colleagues. |
| Collaborator Contribution | Novartis bring pharmaceutical industry expertise and perspective to the activities of the Hub, one of their representatives sits as co-chair on the BREATHE Industry Forum. Novartis can provide use case projects that highlights the benefit of the Health Data Research Hub projects and are supporting the development of the sustainability model of the Hub through identifying Hub activities that resonate with industry. |
| Impact | Ongoing collaboration. |
| Start Year | 2019 |
| Description | Oxford Royal College of General Practitioners Research and Surveillance Centre |
| Organisation | Royal College of General Practitioners |
| Department | RCGP Research and Surveillance Centre |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | As a partner, the Oxford-RCGP RSC will work collaboratively with BREATHE and across the Hub network to drive the use of health data in respiratory research and innovation |
| Collaborator Contribution | The Oxford-RCGP RSC is an internationally renowned source of information, analysis and interpretation of primary care data. Established in 1957, the RSC collects and monitors data from over 1700 general practices across England and Wales. Through its weekly upload of pseudonymised data, it is the principal primary care surveillance system across England. |
| Impact | Collaboration ongoing |
| Start Year | 2020 |
| Description | Rapid Outcomes of COVid therapeutics in Eave II |
| Organisation | University of Strathclyde |
| Department | Mathematics and Statistics Strathclyde |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We are leading this piece of work, which seeks to: 1. estimate the proportion of the population that might be eligible for MAb therapy according to current guidelines, 2. estimate the uptake of MAbs by demographics and risk group, 3. investigate the effectiveness of these treatments (alone and in combination) in real world settings, stratified by viral strain, 4. identify factors associated with severe outcomes in those treated with MAbs, 5. determine the safety profile of MAb therapies. |
| Collaborator Contribution | Our partners at Strathclyde are providing high level statistical input and pharmacy expertise to this study. |
| Impact | This work has only just started. |
| Start Year | 2022 |
| Description | Respiri |
| Organisation | Respiri Limited |
| Country | Australia |
| Sector | Private |
| PI Contribution | Respiri are an Australia-based company. Its involvement with the BREATHE Hub highlights its interest in raising its profile in the UK and potentially scaling the use of its products to support respiratory health. |
| Collaborator Contribution | Respiri are providing an early test project utilising its smart tools to empower people with asthma and improve outcomes. Respiri are providing insight based on data already collected to support asthma management. A representative from Respiri sits on the BREATHE Industry Forum and contributes to the Hub viability with industry. |
| Impact | No formal impact to record yet, collaboration ongoing. |
| Start Year | 2019 |
| Description | SAIL Databank |
| Organisation | SAIL Databank |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | BREATHE facilitates the depositing of data into the SAIL Databank to be stored in a safe trusted environment. The BREATHE Hub will encourage partners, collaborations and customers to make use of the data solutions within BREATHE and will drive the use of the respiratory data assets held. |
| Collaborator Contribution | SAIL Databank provides a technology platform to store the data, link datasets together and allow users secure access to different views of the data. This is administered by the SAIL Databank / Secure Research Platform (SeRP) teams at Swansea University. They provide an information governance and data security model which sets out the rules under which data within the platform is held and made available to researchers. The established SAIL Databank independent Information Governance Review Panel reviews all applications to use data. They contribute their well established contractual / operational model which governs the day to day administration of the platform. And finally, data linkage services for health records for linked data projects. SAIL Databank's relationship with NHS bodies who regularly share data for research across the UK means that studies interested in accessing anonymised NHS data for research, or linking their own data to such records, can do so with the support of SAIL |
| Impact | See publications section for full list. |
| Start Year | 2019 |
| Description | Savana Med |
| Organisation | Savana |
| Department | Savana, UK |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Clinical expertise and advice, access to secure research environment through partnered TRE SAIL Databank. Mechanism to validate algorithm. Access to data. |
| Collaborator Contribution | Savana team expertise and time invested in BREATHE meetings, events and collaborative opportunities. Training of the COVID algorithms by applying NLP (natural language processing) and Machine learning to anonymised electronic health records (EHR's) from participating UK sites. Collaboration involves support for Covid-19 clinical trial. The project will engage with 20 or more NHS sites to develop a new way of accessing and 'reading' patient data. The commercial partner is contributing cash to cover each site on boarding and data management costs. The subsequent database generated by the work will become a sharable BREATHE resource. |
| Impact | Ongoing collaboration. |
| Start Year | 2020 |
| Description | Smart Respiratory Products |
| Organisation | Smart Respiratory Products Ltd |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | BREATHE has worked with Smart Respiratory Products (SRP) as a partner on an Innovate UK Fund (Tiny Medical Apps led grant, with SRP to provide devices for work). |
| Collaborator Contribution | SRP are providing support via the BREATHE Industry Forum and have provided over 1-million Peak Flow readings from their devices to the SAIL database, which will shortly be available on the HDRUK Gateway. |
| Impact | Provision of Peak Flow reading data to SAIL environment |
| Start Year | 2020 |
| Description | Tiny Medical Apps |
| Organisation | Tiny Medical Apps |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | BREATHE has supported Tiny Medical Apps to secure funding from Innovate UK's Sustainable Innovation Fund to develop a fast, developer-friendly, secure, consent-driven, and cost-effective digital platform that aims to facilitate access to patient records across England. |
| Collaborator Contribution | Tiny Medical Apps are providing support via the BREATHE industry forum and may provide consented patient reported data, in the future, for use in research. |
| Impact | Funding secured for TinyMedical Apps from Innovate UK's Sustainable Innovation Fund to develop a fast, developer-friendly, secure, consent-driven, and cost-effective digital platform that aims to facilitate access to patient records across England. |
| Start Year | 2019 |
| Description | Uptake, safety and effectiveness of COVID-19 vaccines |
| Organisation | Office for National Statistics |
| Department | Health Statistics |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | We are leading the team to analyse linked datasets across the UK, to address questions about COVID-19 vaccines that are the most important to the public, namely what is the uptake, safety and effectiveness of vaccines in pregancy, in children and young people, when given as booster doses, and against new variants. We are also leading on Patient and Public Involvement, and on Engagement and Dissemination of this work. |
| Collaborator Contribution | Each partner is leading on an analysis question: Wales on Children & Young People, England on booster doses and Northern Ireland on new varants. |
| Impact | Protocols have been published for analysis of COVID-19 in pregnancy, and for the uptake, effectiveness and safety of vaccines in children and young people in Scotland. Additional work is underway to finalise protocols for a UK meta analysis. |
| Start Year | 2021 |
| Description | Uptake, safety and effectiveness of COVID-19 vaccines |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We are leading the team to analyse linked datasets across the UK, to address questions about COVID-19 vaccines that are the most important to the public, namely what is the uptake, safety and effectiveness of vaccines in pregancy, in children and young people, when given as booster doses, and against new variants. We are also leading on Patient and Public Involvement, and on Engagement and Dissemination of this work. |
| Collaborator Contribution | Each partner is leading on an analysis question: Wales on Children & Young People, England on booster doses and Northern Ireland on new varants. |
| Impact | Protocols have been published for analysis of COVID-19 in pregnancy, and for the uptake, effectiveness and safety of vaccines in children and young people in Scotland. Additional work is underway to finalise protocols for a UK meta analysis. |
| Start Year | 2021 |
| Description | Uptake, safety and effectiveness of COVID-19 vaccines |
| Organisation | Swansea University |
| Department | Swansea University Medical School |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We are leading the team to analyse linked datasets across the UK, to address questions about COVID-19 vaccines that are the most important to the public, namely what is the uptake, safety and effectiveness of vaccines in pregancy, in children and young people, when given as booster doses, and against new variants. We are also leading on Patient and Public Involvement, and on Engagement and Dissemination of this work. |
| Collaborator Contribution | Each partner is leading on an analysis question: Wales on Children & Young People, England on booster doses and Northern Ireland on new varants. |
| Impact | Protocols have been published for analysis of COVID-19 in pregnancy, and for the uptake, effectiveness and safety of vaccines in children and young people in Scotland. Additional work is underway to finalise protocols for a UK meta analysis. |
| Start Year | 2021 |
| Description | Uptake, safety and effectiveness of COVID-19 vaccines |
| Organisation | University of Oxford |
| Department | Nuffield Department of Clinical Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We are leading the team to analyse linked datasets across the UK, to address questions about COVID-19 vaccines that are the most important to the public, namely what is the uptake, safety and effectiveness of vaccines in pregancy, in children and young people, when given as booster doses, and against new variants. We are also leading on Patient and Public Involvement, and on Engagement and Dissemination of this work. |
| Collaborator Contribution | Each partner is leading on an analysis question: Wales on Children & Young People, England on booster doses and Northern Ireland on new varants. |
| Impact | Protocols have been published for analysis of COVID-19 in pregnancy, and for the uptake, effectiveness and safety of vaccines in children and young people in Scotland. Additional work is underway to finalise protocols for a UK meta analysis. |
| Start Year | 2021 |
| Description | Uptake, safety and effectiveness of COVID-19 vaccines |
| Organisation | University of Strathclyde |
| Department | Mathematics and Statistics Strathclyde |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We are leading the team to analyse linked datasets across the UK, to address questions about COVID-19 vaccines that are the most important to the public, namely what is the uptake, safety and effectiveness of vaccines in pregancy, in children and young people, when given as booster doses, and against new variants. We are also leading on Patient and Public Involvement, and on Engagement and Dissemination of this work. |
| Collaborator Contribution | Each partner is leading on an analysis question: Wales on Children & Young People, England on booster doses and Northern Ireland on new varants. |
| Impact | Protocols have been published for analysis of COVID-19 in pregnancy, and for the uptake, effectiveness and safety of vaccines in children and young people in Scotland. Additional work is underway to finalise protocols for a UK meta analysis. |
| Start Year | 2021 |
| Description | Use of national linked healthcare, serology and viral genomic data to identify and characterise post-third and -booster dose vaccine breakthroughs at a population level |
| Organisation | University of Birmingham |
| Department | School of Immunity and Infection |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Our primary aim is to investigate COVID infection breakthrough after third and booster vaccination and the potential influence of viral variants. This includes post-vaccine re-infection with prior history of COVID-19 illness. |
| Collaborator Contribution | The University of Birmingham (UoB) has been awarded up to £6,674,199 on behalf of UKRI, funded as part of the COVID-19 National Core Studies (NCS), for "Phase 1 COVID-19 Immunity - National Core Study (Phase 1 IMM-NCS)" to coordinate research programmes and infrastructure to ensure key questions on immunity are being answered from basic understanding of the immune response, through duration and nature of natural infection and vaccine induced immunity in clinically at risk and general populations. By working collaboratively we draw fresh insights and increase our collective understanding of how to accelerate control of the COVID-19 pandemic. |
| Impact | This work is at an early stage, having only began in December 2021. Our objectives are to: 1) Estimate the frequency of post-vaccine breakthroughs from linked electronic health records and viral genomic data in Scotland in near real-time. 2) Characterise the demographic, ethnic, socio-economic, immunological and clinical features of post-vaccine breakthroughs. 3) Investigate how these risks vary by vaccine dose, vaccine type, and viral variants. 4) Develop and internally validate a prediction model to assess predictors for post-vaccine breakthroughs. 5) Analyse viral variants, mutations and lineages in post-vaccine breakthroughs, and compare these to viruses in the general population over the same time interval. 6) Replicate the above findings using research-ready national linked surveillance datasets across the other UK nations. |
| Start Year | 2021 |
| Description | Media briefing events and working extensively with journalists on their stories |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | Presentation of information about safety and effectiveness of COVID-19 vaccines |
| Year(s) Of Engagement Activity | 2021,2022 |
| Description | Presentation on Health Data at a Research Insights event |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Public/other audiences |
| Results and Impact | The Research Insights series are free online public events exploring the science and research taking place in our College. Prof Sheikh and Dr Vasileiou presented about health data, how it is kept safe and secure, and how information about people's health helps to inform public health policy decisions. They explained how health data helped scientists to figure out how the effectiveness of the first doses of Covid-19 vaccine, and how health data are being used to track the Covid-19 pandemic. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentations to government bodies, including GO-Science, JCVI, MHRA, National Core Studies |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Presentation of data summarising safety and effectiveness of COVID-19 vaccines |
| Year(s) Of Engagement Activity | 2021,2022 |
| Description | Presentations to inter-governmental bodies e.g. WHO |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Presentation of data summarising safety and effectiveness of COVID-19 vaccines |
| Year(s) Of Engagement Activity | 2021,2022 |