Mark is Operational Lead for Gut Reaction; a role that involves all stages of the project, from developing the initial funding application for Gut Reaction to working alongside the data management teams, communications and our Patient Advisory Committee.
Mark, you have several complicated job titles! Please can you tell us a bit about your roles at Eastern AHSN and Cambridge University Health Partners?
I am Director of Health Informatics for Cambridge University Health Partners (CUHP) and the Eastern AHSN (Academic Health Science Network). CUHP and Eastern AHSN support other organisations, including hospitals, research groups and commercial organisations to adopt new innovations and ways of working together to improve patient care. My focus on health informatics means that I am involved in looking at how data from medical records and other sources can improve patient care, and facilitate health data research for the benefit of patients and the wider NHS.
I have spent the last 25 years working in and around health data, predominantly for the NHS, in a range of positions; from my initial role as an analyst to several years in operational, contract and change management, and system redesign. For the last five years or so, I have focused on creating new opportunities for health data research at Eastern AHSN and CUHP.
I often get asked what health informatics is, and for me it is an approach to improving outcomes for patients that combines expertise from information technology, data science, social science, and health and social care professionals. It is a challenging but exciting field, with technical and legal issues to consider when using and organising data from different places to make it Findable, Accessible, Interoperable and Re-usable (FAIR)1. It is important that these challenges are met to allow researchers to improve our understanding of the mechanisms of diseases, and develop new products and treatments, while also protecting the privacy of participants, providing value to the NHS and ensuring that any research is acceptable to patients and the public.
As the Operational Lead for Gut Reaction, my role has been to organise and support interactions between partner organisations to jointly design and build a model for health data research in inflammatory bowel disease (IBD). Through Gut Reaction we have shown how NHS, academia, industry and charity organisations can work alongside patients to securely bring large amounts data together as a health data research ‘Hub’, creating new opportunities for research and innovation that will improve the lives of people living with IBD.
We can see that you have lots of experience in managing NHS data and large-scale projects, but how did this lead you to Gut Reaction?
Before the national Digital Innovation Hub programme, which Gut Reaction is part of, Health Data Research UK (HDR UK) launched a competition for Sprint Innovation Exemplar Projects to help inform the development of larger HDR UK Hubs. Led by Cambridge University Hospitals, the NIHR BioResource, AIMES (a trusted host for NHS data), and Privitar (specialists in data privacy), we worked with clinical research teams specialising in rare diseases to develop a proof-of-concept secure cloud-based (stored safely on the internet) research environment for combining and analysing NHS, research and genomic data.
This proved to be a very successful model for data access, combining information from medical records with lifestyle, genomic and study data in a secure cloud to support research initiatives.2 The team was recognised as ‘HDR UK Team of the Year’, and the model paved the way for the Gut Reaction Hub. IBD was selected as the fastest growing area of the NIHR BioResource, and there are now 36,000 patients enrolled from more than 100 hospitals UK-wide who have given consent for their health data to be used to support academic and commercial research. IBD is a chronic condition, with no cure, and it can have a huge impact on quality of life. Patients respond differently to treatments, so research is urgently needed to develop more personalised approaches. Ultimately our aim is to make IBD a ‘manageable long-term condition’ rather than one that can have such a negative effect on day-to-day life, work and relationships.
What is a typical day on Gut Reaction like for you, and are there any aspects of the work that you particularly enjoy?
Essentially, my role is to help coordinate activities across the workstreams and organisations involved in Gut Reaction, working with patients so that their views shape how this is achieved. A lot of my time is spent talking with people, listening, and ‘brokering’! From discussions about overcoming technical challenges and ensuring we meet all legal requirements for data use (often known as ‘information governance’), to working with NHS Trusts providing data and commercial organisations who are interested in accessing it, I oversee the collaboration between many expert partners. Health data research is certainly a complex area to be working in, but I admit I really quite enjoy trying to find solutions that work – and then coordinating activities to help make them happen.
One of the most rewarding elements of the project has been working with patients through our Patient Advisory Committee (PAC) on models for data access and sharing, and developing a sustainable business model for the Hub that has patient decision-making about how data are used as a central component.
From your description, it’s clear that this is a busy, and potentially challenging, role. Can you tell us about any of the issues that you have faced on this project, and how they have been overcome?
Securely organising and linking the large volumes of patient data that Gut Reaction brings together has been a huge challenge for everyone involved. Reaching the point where information is available for vital research was (and continues to be) a team effort, working with data experts from our partner organisations including AIMES, Privitar and the NIHR BioResource to ensure that the Gut Reaction data meets the needs of researchers, while also being acceptable for the patients who generously donated their information. I hope that our efforts will not only support future research through Gut Reaction, but also other initiatives using patient information.
The number of partner organisations involved within the Gut Reaction Hub means that finding a viable value proposition (i.e. what’s in it for me?) that works for everyone can be difficult. Working through these issues has meant a lot of listening, and helping each to understand the needs and priorities of others to try to find an acceptable route through. Ultimately everyone agrees on our aim of improving treatment options for patients, and keeping these benefits central to our decision-making has been key to the finding solutions and agreeing the compromises that have made this project successful.
You mentioned that you work closely with the Patient Advisory Committee. Could you explain their role in Gut Reaction please?
It has been great to watch the role of the PAC evolve and grow. We are working in a really complex area, with complicated rules about what can be done with data, and different priorities about how people want to use it. Maximising the use of data while protecting individual privacy means finding a balance to ensure technical controls, contracts and project design that are acceptable for everyone involved. The PAC’s use and understanding of the Five Safes model (safe people, safe projects, safe data, safe settings, safe outputs) has really supported our work.
This approach has been particularly important when we have worked with the PAC to co-develop an approach to collaborating with commercial organisations. This is a complex area given the sometimes conflicting needs, concerns and priorities of patients, NHS organisations, academic researchers, and industry. Developing a model that works for everyone took a lot of time and discussion – but the result is one of the greatest successes of this programme of work, and it is great to see some high-profile commercial research going ahead with understanding and backing from our highly-engaged and informed PAC. You can see some of our approved studies on the HDR UK data use register.
Working together in this way has shown how important is it to support individuals learning about health data. We have recently developed training materials for patient representatives involved in health data research activities with our PAC and partner organisations. This is another benefit of the programme, and will support future initiatives like Gut Reaction.
Gut Reaction is nearing the end of the initial funding period. What can you tell us about the future plans for the Hub, and what this will mean for the patients who have contributed to Gut Reaction?
We had three initial aims for Gut Reaction: to build on the research data already held in the NIHR BioResource with information from NHS Trusts, the IBD Registry and other nationally available data; to develop a secure cloud-based trustworthy research environment; and to develop a model for sustainability, allowing the Hub to support research in the longer-term. I’m delighted to say that we have now met those aims.
We have just completed our third and final Milestone assessment with our funders HDR UK, and as part of that process we have provided a business case for sustainability that secures the future of Gut Reaction under the umbrella of the NIHR BioResource, through a mix of academic and commercial activities. Patients will continue to be integral to decision-making as part of the Data Access Committee (DAC) and the Patient and Public Review Group (PPRG).
While significant progress has been made over the last three years, there is still much to do so that we can maximise the use of the data collated so far, and with data still coming in further curation will mean yet more scope for research.
Gut Reaction is possible because of the generosity of patients living with IBD who have consented to their data being used for research. How important do you think this contribution is for the future?
The contribution of these patients has been crucial! What makes Gut Reaction unique, and unlocks new opportunities for research, is the fact that data from different sources can be linked – for example, allowing researchers to look at genomic information alongside lifestyle and longitudinal health record data. This would not be possible without the permission and generosity of participants who have given their consent for their data to be used to benefit others.
Finally, can you update us on what we should look out for from the Gut Reaction this year?
One of the exciting things to look out for will be the development of a new participant portal, which is being explored at the moment as a great way to enable NIHR BioResource volunteers to engage further with research. It will offer individuals opportunities to opt in or out of particular studies, access insights from their own data, and see which research studies their data has been used to support.
You can find out more about the role of the patient advisory committee here and our data safety processes here. For any further questions, please contact us at gutreaction@bioresource.nihr.ac.uk.
- Wilkinson et al., 2016; https://www.force11.org/group/fairgroup/fairprinciples
- https://www.hdruk.ac.uk/case-studies/rare-diseases-sprint-project-why-it-was-voted-team-of-the-year/
