Involving patients in all stages of health data research is a noble aim; however, there are not too many examples of it being successfully put into practice—particularly not in real-time pandemic surveillance. In November, 2020, the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) team created a unique collaboration, inviting a Public Advisory Group (PAG) of 15 patient and public contributors to work alongside university and Public Health Scotland staff to provide vital perspectives of the public on all areas of their COVID-19 research.
“Our PAG has played a crucial role in shaping key aspects of our research into COVID-19, asking questions, and often providing answers to issues that our researchers or analysts might never have thought of”, explains Dr Lana Woolford of the University of Edinburgh, Patient and Public Involvement (PPI) Coordinator for EAVE II (figure ), to The Lancet Respiratory Medicine. “The relevance of research to the public and how it is communicated is absolutely essential. Some members of the advisory group have had COVID-19, some are shielding, some live with multiple health conditions or disabilities—and their unique insights have helped develop EAVE II and subsequent studies in a way that would not have been possible otherwise.”
Figure.
EAVE II patient and public involvement co-lead David Weatherill (far left) and Lana Woolford (second from right) with University of Edinburgh Press and communications staff
© 2023 University of Edinburgh
The original EAVE project took place more than a decade ago during the H1N1 swine flu pandemic that gripped the world. Back then, Scottish researchers used data from almost 250 000 patients to track that pandemic. EAVE II has massively scaled up this research to track COVID-19 outcomes in almost the entire Scottish population (5·4 million people). The project has identified population groups most at risk from SARS-CoV-2 infection and COVID-19 hospital admission and death, and monitors the effectiveness and safety of population-wide vaccination.
“Working meaningfully alongside patients and the public is at the core of our work”, says Sir Aziz Sheikh, principal investigator for EAVE II, and Professor of Primary Care Research and Development at the University of Edinburgh, UK. “Bridging the gap between the pandemic experiences of people in Scotland and the UK, and the data we analyse, helps to ensure that the evidence we offer is relevant, understandable, acceptable, and accountable to real people in a real-world setting”, adds Sheikh, whose other roles include Director of the Usher Institute and Director of the Asthma UK Centre for Applied Research.
Woolford explains that EAVE II originally advertised for nine members of the PAG, expanding to 15 in October, 2021, to further increase their diversity and capacity for input. They meet online every 4–6 weeks, carrying out more work by email in between. Staff engage with individual members to ensure their access needs are met, including providing software, stationery, large-print documents, or the ability to provide input by phone. Getting used to meeting online has also improved collaboration and has allowed people from across the UK to take part. The group includes two co-leads—Sandra Jayacodi (based in London) and David Weatherill (based in Dundee)—who also represent the PAG in each steering group meeting.
David is a retired chartered engineer and company director who has had more than 10 years of PPI experience, including as a lay member of the Royal College of Anaesthetists and Royal College of Surgeons. As a patient, he has had three separate cancers that have greatly impacted him, creating a concern to “give something back” to the UK's National Health Service. He explains: “My role as a PPI Lead provides me with the opportunity to contribute to the work of medical researchers and statisticians. I feel privileged to act as a public voice representing the concerns of people. Monitoring the work of researchers at all stages of their work from initial concept to delivery of research papers is amazing...we, the PAG, are welcomed by all of the researchers and are considered as full members of their team.”
Jayacodi left her profession as a solicitor due to ill health and has since used her lived experience to help improve care services, including with the Imperial Biomedical Research Centre Public Advisory Panel, and as an improvement research fellow with the Applied Research Collaboration Collaborative Leadership in northwest London. Sandra explains: “Being part of an elite team of researchers advising the UK Government on COVID-19 has been a privilege. EAVE II is a study I felt has had truly meaningful input from us. I am particularly proud of how PAG members pushed the team to get permissions for ethnicity data.”
Despite the best intentions of the EAVE II investigators, the rate at which the COVID-19 pandemic disrupted the UK meant that the full PAG was not properly in place until November, 2020, and thus was not able to play as key a part in some of the collaboration's earlier projects as had been hoped. However, working together with researchers, Public Health Scotland, and other relevant agencies, they are now full participants in key COVID-19 research. “One of the first things the PAG felt it was important to work on was our communications activities”, explains Woolford. “This included a focus on our public-facing materials, such as research summaries, infographics, and animations, advising on rewriting where appropriate and making them more easily understandable.”
The PAG subsequently moved into the other parts of the research cycle, including grant development (including shaping the project design and writing the lay research summary); analysis design, including protocols for research on COVID-19 vaccines in children and young people, and new COVID-19 treatments; and assistance throughout the actual project or study. This has included project steering, involving networks of contributors with relevant lived experience, and providing public perspectives throughout the research cycle. Where the PAG felt it did not have sufficient experience or representation for a particular issue, it sought help from outside, such as from the Long Covid Scotland Action Group for issues around long COVID.
The group also provides analysis and reflection on EAVE II's projects, in lay terms. For one study, PAG member Eve Smyth gave her perspective in a profile in The Lancet Respiratory Medicine, commenting that children with asthma should be prioritised for COVID-19 vaccination, including younger children aged 5–11 years who had just become eligible for vaccination.
Data access and quality have also been improved as a direct result of the PAG's work. After they raised concerns about the availability and quality of ethnicity data in Scottish health records, they successfully lobbied the Scottish Government and Public Health Scotland alongside researchers, enabling the EAVE II team to gain access to a wider repository of ethnicity records, which were not previously available to them. This also led to PPI representation from EAVE II on a collaboration study led by the University of Glasgow, looking at the impact of ethnicity and socioeconomic status on COVID-19 outcomes in Scotland.
A more recent example of effective PAG input is in a study by EAVE II assessing so-called breakthrough infections, in which people who are fully vaccinated still get COVID-19 and can become very ill. The study results discussed the risk of serious COVID-19 disease outcomes with omicron infection following both two vaccine doses and a subsequent booster dose. It found patients taking immunosuppressants were at 6-times higher risk of severe COVID-19 disease than those not taking them, despite being fully vaccinated. One of the vaccine breakthrough project's PPI co-leads Lynn Laidlaw, in an online interview with Sheikh, described how the study shows “how people like me who are immunosuppressed and live with multiple long-term conditions are still high risk after taking a booster vaccine…it enables me to make informed decisions about my risk and benefits.” Sheikh also explained how the study information was disseminated to key government departments and the media.
The second round of the study assesses the latest Moderna bivalent vaccine that includes additional protection against omicron variants. “One of our patient representatives pointed out that these very same patients, vulnerable to breakthrough infections, are also those eligible for COVID-19 antiviral and monoclonal antibody treatments”, explains Woolford. “We realised that the new study would be significantly more beneficial for patients if we also looked at vaccine effectiveness in the context of receiving or being eligible for COVID-19 treatments—the study design was modified to reflect this.”
EAVE II is not the only successful collaboration with strong involvement from the public, but the team hope their model can be copied as both researchers and the PAG have learned and contributed so much to the experience. Another project called CO-CONNECT, has worked on standardising data across UK institutions nationwide so that, while they will continue with their own data systems, they will also have health data that can be collected and compiled into other studies. The Public User Group, an advisory group made up of members from the general public, has advised on storing and representing patient data. And in the International Severe Acute Respiratory Infection Consortium 4C-R project, data from England and Scotland are being used to predict hospital readmission for people with COVID-19, with EAVE II's PAG being asked to contribute.
Funding for EAVE II's PAG is currently guaranteed until March, 2023, and Woolford says the team hope funding will be extended since there are many unanswered questions they want to continue working on. This includes further research into COVID-19 vaccine immune responses, and studies on long COVID that can help provide policy makers with desperately needed information. “Even diagnosis of long COVID is difficult, with it having similarities to other chronic conditions”, explains Woolford. “Another area we are collaborating on is pregnancy and COVID-19, again a very complex and delicate topic.” She adds: “The EAVE II PAG has a really strong sense that we can do more, including branching into other respiratory infections like influenza and chronic conditions, such as asthma, COPD, and even diabetes.”
© 2023 Paul Bradbury/Caia Image/Science Photo Library