Patients, the public and the uses of big data; practical engagement, education, scrutiny and leadership
Lead Research Organisation:
University of Leeds
Department Name: School of Medicine
Abstract
The types and extent of health data that exist are growing rapidly, as are the methods via which these disparate sources can be linked and used to generate new insights and understanding. As a result, the potential of big data and analytics to improve lives is also increasing exponentially. But alongside this growing potential there are also growing challenges around the legality, legitimacy and understanding of what is done with the data, how it is done, and how it is controlled.
There is also an ever-increasing interest in the media about big data. The media tend to focus on the risks of health data, with stories which are largely based on the negative aspects which increased data and usage brings, such as risks, threat, exploitation, hacking, theft and loss. However, these largely negative messages in the media are targeted at the public, whereas health data is about patients. This contrasts strongly with the views, particularly of patients, that there are significant benefits which need to be equally well argued, so that patients and the public can make informed, balanced choices about the uses of health data for individual and societal benefit.
Currently little work has been undertaken to quantify the views of patients and the public and this poses a major risk to all work undertaken in LIDA. This is exemplified by the care.data debacle where major public disquiet about the use of health records without adequate public consultation and understanding of views on how data should, and should not, be used led to a significant freeze in health data research. Although data are now moving more readily within the research system, concerns remain and there is a growing risk that public fear about how their data are used may again halt big data health research. These concerns are likely to increase with the planned implementation of the National Data Opt-Out scheme from March 2018 and the adoption of the General Data Protection Regulation (GDPR) in May 2018.
My programme of work will seek to redress this balance by undertaking research into public views on the use of 'big data'. I will then use the evidence generated to inform the development of a well-informed and coherent, but independent, patient voice that will oversee all work undertaken in LIDA spanning the priority areas of Health Data Research UK The informed and independent body of patient and public representatives that I will develop will then have direct involvement in steering and overseeing research within the LIDA portfolio and seek to mitigate any risks that public concern may bring to the big data analytics.
This Fellowship would allow me to extend and build on the work I am already undertaking at the University of Leeds. For example, I am already leading work seeking to put patients at the centre of the UK Colorectal Cancer Intelligence Hub programme (funded by a £3.4 million grant on which I am a Co-Investigator). This Hub involves the creation and exploitation of a large repository of all the UK data relevant to colorectal cancer. Given the volume and scope of the data held on this population we believe it is absolutely fundamental that individuals either at risk of, or diagnosed with the illness are at its heart.
There is also an ever-increasing interest in the media about big data. The media tend to focus on the risks of health data, with stories which are largely based on the negative aspects which increased data and usage brings, such as risks, threat, exploitation, hacking, theft and loss. However, these largely negative messages in the media are targeted at the public, whereas health data is about patients. This contrasts strongly with the views, particularly of patients, that there are significant benefits which need to be equally well argued, so that patients and the public can make informed, balanced choices about the uses of health data for individual and societal benefit.
Currently little work has been undertaken to quantify the views of patients and the public and this poses a major risk to all work undertaken in LIDA. This is exemplified by the care.data debacle where major public disquiet about the use of health records without adequate public consultation and understanding of views on how data should, and should not, be used led to a significant freeze in health data research. Although data are now moving more readily within the research system, concerns remain and there is a growing risk that public fear about how their data are used may again halt big data health research. These concerns are likely to increase with the planned implementation of the National Data Opt-Out scheme from March 2018 and the adoption of the General Data Protection Regulation (GDPR) in May 2018.
My programme of work will seek to redress this balance by undertaking research into public views on the use of 'big data'. I will then use the evidence generated to inform the development of a well-informed and coherent, but independent, patient voice that will oversee all work undertaken in LIDA spanning the priority areas of Health Data Research UK The informed and independent body of patient and public representatives that I will develop will then have direct involvement in steering and overseeing research within the LIDA portfolio and seek to mitigate any risks that public concern may bring to the big data analytics.
This Fellowship would allow me to extend and build on the work I am already undertaking at the University of Leeds. For example, I am already leading work seeking to put patients at the centre of the UK Colorectal Cancer Intelligence Hub programme (funded by a £3.4 million grant on which I am a Co-Investigator). This Hub involves the creation and exploitation of a large repository of all the UK data relevant to colorectal cancer. Given the volume and scope of the data held on this population we believe it is absolutely fundamental that individuals either at risk of, or diagnosed with the illness are at its heart.
Technical Summary
I will build the evidence base to inform best practice in this area. I will undertake research (using methods such as discrete choice experiments) to generate a better understanding of the views of patients and the public about how data are used.
A significant benefit of the links to the use MY data patient movement is that we will have a range of patients and advocates who have already been through a range of training and education (which will continue). Their skills, experience and views will be a unique resource to the project, providing ready access to a specialist advisory and reference group. Using real life examples and clinical scenarios I will ask patient groups to look at the types and levels of data required, and how they would need to be used, to answer specific research questions. This will generate evidence to strengthen our understanding of what the public would, and would not, be happy for data to be used for. Key points here are that the scenarios would be based on actual patient experience, and the process would be patient-led and reported so ensuring the public credibility and maximum impact of research work across HDR-UK.
Much of the research will be qualitative in nature, with a key focus on the development of lay summaries to encapsulate and communicate learning.
A significant benefit of the links to the use MY data patient movement is that we will have a range of patients and advocates who have already been through a range of training and education (which will continue). Their skills, experience and views will be a unique resource to the project, providing ready access to a specialist advisory and reference group. Using real life examples and clinical scenarios I will ask patient groups to look at the types and levels of data required, and how they would need to be used, to answer specific research questions. This will generate evidence to strengthen our understanding of what the public would, and would not, be happy for data to be used for. Key points here are that the scenarios would be based on actual patient experience, and the process would be patient-led and reported so ensuring the public credibility and maximum impact of research work across HDR-UK.
Much of the research will be qualitative in nature, with a key focus on the development of lay summaries to encapsulate and communicate learning.
People |
ORCID iD |
| Christopher Carrigan (Principal Investigator / Fellow) |
Publications
Affleck P
(2018)
Sharing patient data: understanding anonymisation.
in BMJ (Clinical research ed.)
| Title | Patient voice videos |
| Description | Filmed patients giving their views around the use of data, either for themselves or for the benefit of others. Filming was to produce short, snappy views from patients which could be used across social media and at larger events. |
| Type Of Art | Film/Video/Animation |
| Year Produced | 2018 |
| Impact | Videos have been used across a range of social media platforms. One of the videos has been used at the ABPI Annual Conferenvce to an audience of severak hundred, and others have been used at other national and regional events. Several of the videos have also been adopted and used by international organisations (EU), including the EU data saves lives campaign. |
| Description | National Colorectal Cancer Intelligence Patient Group |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | As Chair of the Patient Involvement Group for the UK Colorectal Cancer Intelligence programme my role is to bring together a variety of patient and carer voices to oversee the programme, which uses data from colorectal cancer patients from the mid-1990s to 2018. The work includes agreeing governance processes with the patient group, and working across the programme with the programme leads to ensure these are implemented. The work also requires the increased education of group members to allow them to effectively critique the programme as a whole, and to input where necessary. |
| Description | OSCHR Informatics Committee |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Represented patient voice on the OSCHR Informatics Group. This included representation to senior leaders from NHS England and the Department of Health, covering areas of public concern including the National Data Opt-out, the planning for the new GP Contract and the work of NHS Digital in providion of data access for research. |
| Description | PPIE Lead, HDR-UK DATA-CAN Hub |
| Geographic Reach | National |
| Policy Influence Type | Participation in a guidance/advisory committee |
| Impact | DATA-CAN is a UK-wide partnership that aims to unlock the power of health data to improve cancer care. Working in partnership with patients and the public, we make high-quality health data more accessible for cancer researchers, clinicians and other health professionals. My work with patients and the public who help ensure that health data is used transparently and responsibly, and that the benefits are returned to the NHS and the wider UK community. Patients are involved in DATA-CAN's decision-making process. Our patient group helps ensure we act fairly and openly, in the best interests of patients. By working together, we are able to ensure that health data is used responsibly, and that the benefits of improved access to data for researchers are returned to the NHS and the wider UK community. Our core principle is that patients are active participants and leaders in all that we do. We ensure this by: - Having an engaged patient advocate group to represent our national ambition - Engaging with and representing the diverse cancer population of the UK - Engaging with existing patient advocacy champions - Recruiting patient and public participants in an open manner - Having a patient advocate/citizen lead on every DATA-CAN project We operate by the principles of transparency developed by use MY data. Our patient and public members are proactively offered training to empower them in their role with DATA-CAN. The potential benefits to patients include: - Optimising patient care - Supporting drug discovery - Better diagnostics - Faster access to clinical trials - Better treatment - for example via improved access to personalised medicine - Better prevention - Developing new artificial intelligence solutions to accelerate understanding of diseases |
| Description | Patient Data Citation |
| Geographic Reach | National |
| Policy Influence Type | Contribution to a national consultation/review |
| Impact | Designed and tested a "patient data citation", to recognise the use of patient data in research and analysis. Developed and tested with patients, ensuring the citation was what patients wanted. Hosted a public consultation to choose a citation from a list of five options that were suggested by patient advocates. After a period of voting, the most popular choice was: "This work uses data provided by patients and collected by the NHS as part of their care and support." The citation has been adopted by UK cancer registries and by Public Health England, who have the usage of the citation as a condition of data release. The citation has also been adopted by Understanding Patient Data and as a standard across Health Data Research UK. It has also been used by the ONS and by several commercial data services companies that use NHS data. |
| Description | Policy Research Unit Scientific Advisory Committee, Queen Mary University of London |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | The role of the advisory committee is to provide advice to the Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis (PRU 2.0) in support of the development of strategy, policy and research activity. This will include the identification of future priorities and opportunities to be pursued, and the development of clear plans of action to address research and policy priorities, including identification of appropriate collaborators and partners. The scientific advisory committee will also keep the PRU 2.0 apprised of the bigger picture, in terms of both the clinical and policy contexts in relation to cancer diagnosis. Composition The committee will comprise independent members approved by the Executive Committee of PRU 2.0. Members of the committee will be chosen to represent a broad spectrum of skills and experience related to screening for and diagnosis of cancer. The Chair of the PPI committee may attend the Scientific Advisory Committee in his/her role as a member of the PRU executive committee, or appoint a substitute if necessary. Committee role The advisory committee will: • advise on current and likely future cancer policy issues • advise on priority areas for research • advise on research approaches and methods • advise on bigger picture issues, including social and ethical implications of research and policy • assist with advice when problems arise within the programme • Advise on strategic direction of the PRU • Suggest new projects • Where possible view and advise on project proposals before these go to the oversight committee The committee will meet twice per year and may be consulted between meetings by the directorial team of the PRU 2.0 (Stephen Duffy, Rosalind Raine, Peter Sasieni). At least one member of the directorial team will attend advisory committee meetings, and members of the PRU 2.0 executive are entitled to attend if they wish. The chair of the committee may request PRU 2.0 directors and executive to leave the meeting for discussion of specific items (although it is anticipated that this will be rare). Advice of the committee may be sought by email between meetings. |
| Description | Low use of Tissue |
| Organisation | Medicines Discovery Catapult |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Coordinated a workshop, campaign and report around the low use of tissues donated by patients. Request was made by patients following a use MY data workshop. Provisiojof expert advice, design of patient workshop and editing of the final report with partners. |
| Collaborator Contribution | MDC provided co-funding along with Roche to enable a patient workshop to take place, and for the production of a final report. Report include key recommendations for national bodies across the UK and is being taken forward by MDC, UKCRC and others. |
| Impact | Collaborative report with MDC and use MY data describing the actions needed at national and local level to improve the low usage of tissue samples donated by patients for research. |
| Start Year | 2019 |
| Description | use MY data patient movement |
| Organisation | use MY data |
| Sector | Charity/Non Profit |
| PI Contribution | Expert data advice to the use MY data movement. Provision of secretariat to the movement. |
| Collaborator Contribution | use MY data members are patient, families and carers who have in interest in the wider use of patient data for research. All patient members give their time for free. Ten members comprise a national Advisory Group for the movement, all of whom give their time for free. |
| Impact | Need to add these later: Workshops National Panels Consultation Responses Citizens Jury NDG Review of Caldicott |
| Start Year | 2018 |
| Description | "Emerging technologies: what does the future of health care look like?" |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Briefed and accompanied patient member to be part of a panel of senior experts to assess the promise and dangers of emerging technologies. The panel explored topical issues at the intersection of AI, data and health care, separating myth from reality and giving practical examples of how emerging technologies might be used. |
| Year(s) Of Engagement Activity | 2019 |
| Description | "Say what you do, do what you say - trust and transparency around patient data" |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | This workshop followed our May 2019 workshop "Patient data - balancing access and protection; All talk and no access?" which highlighted the number of organisations who already play a part in the management, access and release of our patient data. The organisations gave specific commitments to improve access to patient data. Since then we had the launch of the Health Data Research Hubs, charged with a priority to make patient data available for innovative commercial uses. The general focus on commercial use of patient data is increasing significantly. The Office for Life Sciences has ambitious plans to seek new insights about public views on what constitutes a "fair deal" for patients. Our workshop examined what is happening in all these areas of data access, what do patients think is fair and how informed are the public? We asked how the different custodians of patient data fit together and work together. We also explored which bodies have patient/public representatives sitting on decision-making committees/boards, and examined how they fit together. |
| Year(s) Of Engagement Activity | 2019 |
| Description | "The Issue with Tissue" |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | Coordinating a campaign to increase the use of tissue samples held in UK biobanks. As a key part of the preparations for this we organised a small stakeholder workshop, in partnership with the Medicines Discovery Catapult, and facilitated by Incisive Health. We received a grant from Roche to support the costs of the work. When a person makes a donation of a tissue sample, they expect it to be used to help accelerate the discovery and development of better diagnostics and treatments, so that future patients will experience better outcomes. Feedback from researchers suggests that too often there are unnecessary barriers to the use of tissue, resulting in missed opportunities for research and frustrating donors' wishes. This issue was first raised at our workshop in 2018, "Your data, your control" and, since then, we have been discussing with key partners how we might address it. The workshop was to discuss the key steps that should be taken to improve and accelerate the use of human tissue samples in research, unblocking barriers and ensuring that the wishes of patients are respected. We hope to identify a series of recommendations, which can then be used to develop a 'manifesto' to support engagement with key decision-makers, ensuring that discussion is translated into action. Workshop attendees comprised representatives from use MY data, Medicines Discovery Catapult, UK biobanks, the Medical Research Council, the Human Tissue Authority, the Health Research Authority, charities and academia. A report was published in January 2020. |
| Year(s) Of Engagement Activity | 2019 |
| Description | "The ethics and regulation of innovation" |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Industry/Business |
| Results and Impact | The Research, Medical & Innovation and Legal teams at the ABPI ran an event for their regulatory/medical and legal colleagues across our membership. Invited speaker and took part in a senior leaders panel session looking at the regulation of patient data. |
| Year(s) Of Engagement Activity | 2019 |
| Description | ABPI Annual Conference - Keynote presentation |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Industry/Business |
| Results and Impact | Keynote presentation to the Association of British Pharmaceutical Industry - "Embracing the data opportunity for better patient care" Presentation about the power of the patient voice in the development and delivery of real-world evidence and real-world trials. Event was attended by several hundred from the pharmaceutical industry and beyond and was also distributed by electronic media. I was also on the expert panel, chaired by Jonathan Dimbleby, looking at how big-pharma can better engage with patients about the benefits of real-world data. One outcome was the ABPI hearing that their current ABPI Code of Practice was now a barrier to better patient involvement, an action which the ABPI CEO agreed to take away and address. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Biobank Webinar |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Webinar to discuss the low usage of tissue samples in biobanks. Joint project with TDCC, MDC and Incisive health, with patient members from use MY data |
| Year(s) Of Engagement Activity | 2020,2021 |
| Description | COGX Panel Member |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Industry/Business |
| Results and Impact | Each panellistto speak for 5-7 minutes on the following themes: Kerry: What has your experience of the rapid online pilot been like? What are the key themes that emerged? How should technologists and policymakers involve people? How were issues of social solidarity, personal agency and trust examined? Simon: Why is public engagement important? What are the challenges for PE at this moment in time? How do we address these challenges and build collaborations that ensure citizens can be heard? Is COVID19 changing how PE is done and if so how? Chris: What role can and do people play in shaping the terms on which their data can be used for beneficial social impact? Can you provide some examples through Use My Data and other similar movements? Anja: What can, and do technology companies do to ensure citizen voice is heard and responded to? Again - please provide some clear examples, and it would be good if you could be fairly balanced (what has worked? But also where is there scope for improvement?) Questions forwider discussion / thought - likely to come up on the day. Do use your ownjudgement though as news stories are very quickly evolving at the moment. Why is it important that we engage the public on these questions? What is the value of public engagement? How is COVID-19 changing the nature of public engagement and approaches to it? Questions of systemic injustice (racial injustice, for instance) have dominated the headlines in recent days. To what extent can public engagement help address some of these challenges? Is there a limit to what PE can claim to do? What types of decisions and approaches have left people out of decisions about tech, and what has been the effect and impact of that? How do we work together to democratise decisions about tech? What's one practical next step that could be undertaken towards that goal? |
| Year(s) Of Engagement Activity | 2020 |
| Description | Harnessing the potential of patient-generated data to shape population health & genomics |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Industry/Business |
| Results and Impact | Briefed and accompanied patient member to take part in the panel session 'Harnessing the potential of patient-generated data to shape population health & genomics' at this event. The event was being run by Healthcare Excellence Through Technology (HETT) and ran on 01 & 02 October in London. |
| Year(s) Of Engagement Activity | 2019 |
| Description | Interview around research access to data |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Interview for later recorded broadcast by M2 |
| Year(s) Of Engagement Activity | 2020 |
| Description | National Data Guardian, Invited workshop |
| 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 | Requested by the National Data Guardian to participate in a workshop to seek your views on steps that Dame Fiona Caldicott, the National Data Guardian for Health and Social Care (NDG), is considering to ensure that the patient and service user's perspective is securely established as a guiding factor in decisions to share health and adult social care data. In particular to discuss a proposal that the Caldicott Principles could be revised and/or augmented and issued as statutory guidance to foreground the importance of ensuring that where such data is shared, steps are taken to make sure that this aligns with what people would reasonably expect. |
| Year(s) Of Engagement Activity | 2019 |
| Description | Patient workshop - The patient voice in the expanding data world |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | The workshop examined the latest patient data initiatives and how (or whether) the patient voice is being incorporated into these. The programme featured: - Do we need opt-outs, active data donation or just a new NHS social contract? - The Local Health and Care Record Exemplars (LHCRE) programme - Auditing your own health record - how, what, why? - GDPR, Common Law, Consent. Where are researchers struggling and how could the patient voice help? Delegates heard the latest thinking from experts on different aspects of the uses of patient data. They also heard about some of the challenges and were asked for their thoughts and suggestions throughout the day. The workshop was interactive and discussive and was an opportunity for delegates to feed their views directly into several developing areas. The workshop was aimed at patients, relatives and carers, the public and professionals. It was open to all who are interested and was free to attend. Expenses were covered for delegates who are patients, relatives and carers. |
| Year(s) Of Engagement Activity | 2018 |
| URL | http://www.usemydata.org/resources/The%20patient%20voice%20in%20the%20expanding%20data%20world_use%2... |
| Description | Patient workshop - Your data, your control |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | A use MY data workshop to examine and discuss the ways in which patient data is being used, how patients are being involved and how they can play a stronger part. The programme featured: - Machine learning and patient inclusion - Microsoft Research - Patient Data Choices project and primary care preparations for the National Data Opt-out - Royal College of General Practitioners - How patients, who want to be more active in biobanking, can ensure their biobank data is used - Catapult Medicines Discovery - A facilitated session to find out the questions that patients still need answers to, about how their data is used and shared |
| Year(s) Of Engagement Activity | 2018 |
| URL | http://www.usemydata.org/resources/Your%20data,%20your%20control_use%20MY%20data%20workshop%20020518... |
| Description | Swiss National Science Foundation - invited speaker |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Considering clinical research data governance: a case study of good practice from the UK Learn from the UK about data governance, balancing the technical and the human: using big data for real-world evidence to serve the public well-being, integrated public and patient engagement the challenges, limitations, and benefits associated with this real-life case study |
| Year(s) Of Engagement Activity | 2018 |
| Description | Training Workshop |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | Development of a training programme about patient data, for patients. |
| Year(s) Of Engagement Activity | 2020,2021 |
| URL | http://www.usemydata.org.uk/training.php |