VISION Magazine - Spring 2023

VISI N

Public health research in Wessex

Using digital technology to improve Dementia care

WELCOME TO VISI N MAGAZINE

"From creating new pathways for research in local authorities, to expanding our connections with organisations across the region, I hope this latest issue of our magazine showcases the strong collaborative spirit which has enabled the greater integration of research into health and care pathways across the region."

Dr Patrick Moore Associate Clinical Director NIHR Clinical Research Network (CRN) Wessex

BY

“It has been inspiring to see everyone working together across organisational and geographical boundaries in order to increase access to research for people living in Wessex.”

FOREWORD

DR PATRICK MOORE CRN Wessex Associate Clinical Director

Last year was another exceptionally busy year for research teams in Wessex, and we can all feel incredibly proud of what has been achieved.

Much of the year was spent building on our shared successes and learnings from the COVID-19 pandemic, as well as growing our partnerships and collaborations across the region.

It has been inspiring to see everyone working together across organisational and geographical boundaries in order to increase access to research for people living in Wessex.

Through the new Clinical Research Network (CRN) Wessex Clinical Delivery Team (CDT), we have built a highly skilled and flexible workforce with the ability to deliver research in a broad range of settings.

In this issue of Vision, you’ll hear from the CDT, who have been taking studies out into the community with the aim of increasing representation in research from under-served groups.

With additional research buses due late 2023 and the launch of a new research hub in Dorset in early 2023, we hope to make strides towards improving the health of our local population and reducing health inequalities.

We continue to explore new models for research delivery, such as the CRN Wessex-funded Primary Care Network (PCN) initiative, which has seen general practices across the region coming together to deliver studies and grow a research culture within their local area.

In this issue, some of the participating PCNs will share the opportunities and challenges of the model, as well as their exciting vision for the expansion of research within primary care.

It is clear that Wessex continues to be a place of innovation. In this issue, we’ll hear from the research team at Hampshire Hospitals NHS Foundation Trust, who are leading a world-first artificial intelligence study to improve the diagnosis of prostate cancer, alongside launching their new research strategy.

We’ll also hear from the asthma team at Portsmouth Hospitals University NHS Trust, who are collaborating with the Wessex Asthma Network to look at ways to reduce the carbon footprint of inhalers. Research of this kind will be important for helping us achieve a sustainable and resilient health and care system.

In April 2022, the NIHR changed its name to emphasise its commitment to social care, and locally, we continue to build capacity and capability in this area. This issue of Vision features an interview with Dr Michelle Heward from Bournemouth University, who is exploring if digital innovation and technology can improve engagement between people with dementia living in care homes, and their relatives and care staff.

From creating new pathways for research in local authorities, to expanding our connections with organisations across the region, I hope this latest issue of our magazine showcases the strong collaborative spirit which has enabled the greater integration of research into health and care pathways.

I also hope that you enjoy reading this issue, hearing from your colleagues and seeing how our Wessex research teams continue to go from strength to strength.

“With additional research buses due late 2023 and the launch of a new research hub in Dorset in early 2023, we hope to make more strides towards improving the health of our local population and reducing health inequalities.”

PUBLIC HEALTH RESEARCH IN WESSEX:

AN INTERVIEW WITH CIARA MCGEE, PHD

Ciara is an Embedded Research Associate within Southampton City Council, currently employed by the Clinical Research Network Wessex.

Tell me a little about you?

I completed my PhD in 2015 at Liverpool John Moores University which involved developing and evaluating a primary school physical activity intervention, using sport and physical activity to deliver smoke free messages to Year 5 children.

After my PhD, I worked as a Research Assistant within the Public Health department at the University.

A year later, I relocated to the South of England with family and started working for CRN Wessex. My role initially involved undertaking a scoping study to map the public health research landscape across local authorities and academia in the Wessex region.

Following this scoping study,

the NIHR pledged to support public health research in non-NHS settings such as local authorities. This led to a unique opportunity to work within Southampton City Council public health team as an embedded researcher and I’ve been doing this role since April 2019.

What does your role involve?

Wessex CRN was one of the first networks to have an embedded researcher within local authority public health. When I started, there was no blueprint for the role and over time my role evolved.

Broadly, it involves raising awarness of CRN Wessex's support for public health research, and supporting the development of research funding

applications and facilitating links with local academics.

As part of my role, I work very closely with Becky Wilkinson, Consultant in Public Health at Southampton City Council, who provides the strategic direction from a local authority perspective. We both work closely with our Public Health Speciality Lead, Professor Julie Parkes, who provides expert advice, support, and guidance for the role.

What projects have you been involved with?

In collaboration with Professor Julie Parkes and other senior academics at the Universities of Southampton and Bournemouth, we were one of 14 NIHR Local Authority Research Systems projects commissioned in 2020. We undertook a rapid qualitative study to better understand Southampton City Council’s response to COVID-19 and childhood obesity

and the infrastructure needed to support and enable research within a local authority environment (McGee et al., 2022).

Through another successful application to the NIHR Public Health Intervention Responsive Studies Team (PHIRST), the public health team are working collaboratively with the University of Hertfordshire to conduct a realist evaluation to distil learning about programme theories, facilitators, and barriers of Southampton’s COVID-19 Champions network, Vaccine Champions programme, and its Community Participatory Action Research. Findings from this evaluation will be used to inform the development of Southampton’s future champion and community participation programmes.

Building on our previous work (McGee et al., 2022), we have recently undertaken a mixed methods study with council staff and elected members

whose role impacts on the wider determinants of health. The aim is to find out who's involved in research, how data and evidence is used to inform decisions and what support teams and individuals would need to strengthen a more evidence-based approach. The analysis is underway and key findings will be shared later.

“Through this event and our mixed methods study, we have established a network of staff who are interested in being more involved in research and helping Southampton City Council to make better use of research evidence when making decisions.”

“One of its goals is to be a more intelligence-led authority, which means using good quality data and evidence to inform decisions. We are contributing to that with our recent mixed-methods study with staff and elected members.”

Ciara McGee

What is the council doing to encourage a culture of research within the local authority?

Southampton City Council has a new corporate plan which includes a transformation programme. One of its goals is to be a more intelligence-led authority, which means using good quality data and evidence to inform decisions. We are contributing to that with our recent mixed-methods study with staff and elected members. In addition to that, we held an informal research engagement drop-in event for colleagues across the council to come along and find out more about what opportunities there are to get involved in research.

Through this event and our mixed methods study, we have established a network of staff who are interested in being more involved in research and helping Southampton City Council to make better use of research evidence when making decisions. Through

these developments and engagment across wider council directorates, it strengthens our position to collaboratively apply for funding to undertake research that is needed to better inform local decision making.

USEFUL LINKS:

NIHR PHIRST: Local government expressions of interest available at: https://www.nihr.ac.uk/documents/2214-phirst-local-governmentexpressions-of-interest/31639

NIHR PHIRST: Southampton Covid Participatory Action Research and Champions initiative Evaluation (CoPACT) available at:

http://phirst.nihr.ac.uk/evaluations/copact/

McGee CE, Barlow-Pay M, Vassilev I, Baird J, Fenge LA, Chase D & Parkes J. Supporting and enabling research in a local authority (SERLA): an exploratory study. BMC Public Health, 22:1316. DOI

https://doi.org/10.1186/s12889-022-13396-2

“We undertook a rapid qualitative study to better understand Southampton City Council’s response to Covid-19 and childhood obesity.”

Develop your career and improve patient care

Everyone’s path in research is different, but it only takes minutes to start and can make a lifetime of difference. Clinical research is essential to our NHS. Whatever your role, you can be part of it.

For more information please visit

www.nihr.ac.uk/yourpath

USING DIGITAL TECHNOLOGY TO IMPROVE DEMENTIA CARE

Michelle is a recipient of an Individual Research Career Development Award from the NIHR School for Social Care Research, given to individuals committed to developing the evidence base to improve adult social care practice in England. We caught up with her to see how the award is helping to shape her research and the future of dementia care.

DEMENTIA RESEARCH

INTERVIEWEE:

MICHELLE HEWARD –Post Doctoral Research Fellow & Service User and Carer Involvement Lead at the Ageing and Dementia Research Centre (ADRC), Bournemouth University

My role at Bournemouth University is varied. I manage several ageing and dementia research projects, support patient and public involvement and contribute to teaching. My research is about improving the care and support of older people and people with dementia. I have been interested in digital technology since my Doctoral study which focused on technology, mobility and independence in later life. Recently I’ve been working on several research projects looking at innovative approaches to dementia education. I have been working with

Health Education England (HEE) to develop the Dementia Education and Learning Through Simulation

2 programme. We have used a simulation approach to place staff in acute care settings into the shoes of a person with dementia and now have a toolkit for trainers delivering dementia training, free to download from the HEE website. We feel that this approach will enable staff to make positive changes to how they care and support people with dementia and are evaluating whether the training is making a difference in practice.

During the COVID-19 pandemic we developed the e-DEALTS2 toolkit which can be used by trainers to support the delivery of online dementia training through platforms such as Teams or Zoom. Taking this forward, we are exploring how these toolkits might be used in social care settings and would be delighted to hear from anyone that might be interested in doing so.

CAREER DEVELOPMENT AWARD

In my work and personal life, I have discovered that communication with people who have dementia can become increasingly difficult as the condition progresses. Many relatives of people with dementia that I have spoken to say that they find it hard to know what to say to the person with dementia – they feel they lose the connection they once had.

Care staff have suggested that they find it equally as complex to get

to know residents with dementia, particularly once verbal communication becomes more tricky. With the NIHR award funding, I want to explore if digital innovation and technologies could improve engagement between people with dementia living in care homes, their relatives, and the care staff. I’m particularly interested in memories and reminiscence and exploring the potential of virtual reality. I want to reflect on the lessons learnt during the COVID-19 pandemic. I have some questions that I would like to understand more about. Why did care homes use technology at this time? Was technology use continued after the pandemic? What were the barriers faced by those who did not use technology? What difference did it make to residents to have access to digital technology to maintain contact with relatives?

There’s a real drive with this project to gain contacts, I’m looking to develop a network to understand

“With the NIHR award funding, I want to explore if digital innovation and technologies could improve engagement between people with dementia living in care homes, their relatives, and the care staff.”

the research gaps, exchange ideas and co-produce a list of priority areas of focus. Specifically, people with lived experience design backgrounds, care home staff and researchers already working in this area, but I would love to hear from anyone interested in this topic. I am aiming to produce several outputs that contribute to the social work evidence base, including journal articles and an application for further funding to take forward the digital reminiscence research.

“I’m looking to develop a network to understand the research gaps, exchange ideas and co-produce a list of priority areas of focus."

At this stage my project is based in care homes, but there may be scope to broaden the remit to include home care and domiciliary care staff in the future too.

This is the second time I’ve applied for the Career Development Award. First time round, I was unsuccessful but I used the feedback from the panel to work on my application and make it stronger. I applied again and was awarded 12 months of funding, which began on the 1st November 2022 and funds me for two days a week.

THE VALUE OF SOCIAL CARE RESEARCH

Dementia is a condition that affects people differently and for the person with dementia and their families, this experience can be very lonely and isolating. A lot of the things that help might help one day and not the next. Care staff can often feel overwhelmed and may not know how to approach situations. There is value in toolkits and interventions that can be applied appropriately, but we must undertake research to ensure we understand how and why they make a difference.

My research draws on co-production methods to ensure continual involvement of key stakeholders, including experts-byexperience. I feel that educating staff and relatives can improve the care they provide, and that evaluating toolkits and interventions can make a real difference in shaping a positive care culture. Ultimately, I am passionate about improving adult social care and I want my research to make a difference in practice.

I do feel that there is still a lot of stigma around dementia and gaps in the social care research evidence base, so there’s a lot of potential opportunities for collaboration. I hope that people will start to see the importance of social care research. The inclusion of social care in the NIHR title and the development of the NIHR School for Social Care Research are huge steps forwards.

Please do email me if you wish to discuss anything raised in this article: mheward@bournemouth.ac.uk

For current publications please view my staff profile pages: https://staffprofiles.bournemouth.ac.uk/display/mheward

For updates on the ADRC: https://www.bournemouth.ac.uk/research/centres-institutes/ageingdementia-research-centre

For updates on DEALTS2: https://www.bournemouth.ac.uk/research/centres-institutes /ageing-dementia-research-centre/innovative-education

"I do feel that there is still a lot of stigma around dementia and gaps in the social care research evidence base, so there’s a lot of potential opportunities for collaboration."

BRINGING

SEXUAL HEALTH RESEARCH INTO THE COMMUNITY

Evaluation of Home-based Intervention Strategy (HIS-UK) is a Wessex-led and NIHR-funded multi-site condom education study. The team at Dorset HealthCare has been driving recruitment to the study through outreach visits to Weymouth College, Bournemouth University and Bovington Army Camp alongside in-clinic recruitment. We caught up with them to hear about their experience of research in sexual health.

EVALUATION OF THE HIS-UK STUDY

INTERVIEWEES:

KASIA MALCZUK, Research Practitioner and Study Coordinator, Dorset HealthCare University Foundation Trust (DHC)

JULIE HYDE, Research Nurse & Study Coordinator, DHC

IAN LEADBITTER, Research Nurse, DHC

KASIA: HIS-UK is an education and training programme about condom use. The aim is to help young people find condoms more enjoyable and pleasurable to use, in turn helping to reduce the risk of Sexually Transmitted Infections (STIs).

We want young people to move away from thinking ‘condoms aren’t for me’ if ones they've tried previously don't fit or aren’t comfortable, and to explore all the options available. The hope is that it will reduce STIs and the risks, we want to know if this approach works.

The study has three arms. In the control arm, participants receive the standard condom education

you currently get at sexual health clinics and free condoms, which are usually 10 of the same type.

Then there is the pro HIS-UK training, which is delivered by a member of the research team, where we talk participants through all the different condoms, sizes and materials. We educate on how to put them on, take them off, how to use lubricants and why to use them – focussing on the safety as well as the pleasure aspect. Participants receive a kit full of different types of condoms to try out.

Then there is e-HIS which is the same education programme but online. We want to see how those three groups compare and which has better outcomes.

Will the online delivery be sufficient,

or will we need the face-to-face approach? The study team will also need to analyse the cost effectiveness of these approaches.

THE RECRUITMENT CHALLENGE

KASIA: It seemed like a good opportunity to further integrate our research team with the Sexual Health team, so that we could work together and build a stronger partnership. The Sexual Health team was actively involved in research at both University Hospitals Dorset and Dorset County Hospital (where they were based before) and we were keen to continue this when the service moved over to us at Dorset HealthCare. However, we did find screening and introducing the study to eligible patients a big challenge.

IAN: We worked closely with clinicians to identify eligible patients, maintaining confidentiality and sensitivity, to ensure that those we do approach are happy for the research team to speak with them about opportunity to get involved in the study.

KASIA: Twice a week, we screened the patient list with a member of clinic staff to identify patients who might be eligible. We would then come into the clinic when the potentially eligible patients had their appointment and be available to speak to them if they were interested in taking part. The change in provision with sexual health clinics during COVID-19 was probably our biggest challenge because there used to be more face-to-face opportunities. The pandemic resulted in more phone appointments and a lot

of the asymptomatic STI screening was diverted online, where people would carry out their tests at home. This decreased the pool of eligible people we could speak to. This resulted in reduction of potential participants to the study, so we decided to take recruitment out of the clinical setting.

A NEW APPROACH

KASIA: We took the recruitment out of the clinical context, into universities and freshers’ fairs, and quickly found that the environments were much more open and fun. People were keen to talk and curious to find out more.

IAN: The participants were approaching us on their own terms outside of the clinical area. It made a big difference to this type of research.

KASIA: I’m new to the NHS and research and this was the first study I’ve overseen. I wonder if that was a benefit because when you don’t know how things typically work, you think of what else could work. It wasn’t

“We want more young people to move away from thinking ‘condoms aren’t for me'...”

“It was good to build relationships within our trust but also outside the NHS. That’s something we hope to keep growing so that we can do more studies of this nature and make research accessible and available to everyone."

working in clinic, due to COVID-19, so we asked what else we could do. We were open to changing the recruitment process.

We’re targeting 16–25-year-olds so naturally that’s people at universities, colleges etc. So I emailed Bournemouth University and that began to change how we recruited to the study.

JULIE: We also started working with the Sexual Health Targeted Outreach team who were happy for us to accompany them to a variety of events including the Weymouth College Equality and Diversity Fair. They helped us network and introduced us to other services who we would have not otherwise been aware of. The Outreach Team's experience of working across different sectors with young people completely changed the success we had in our recruitment.

KASIA: We then went on to visit Bournemouth University, Bovington Army Barracks and Hamworthy Marine Barracks.

JULIE: With a mixture of networking, making contacts with external

services and following up these leads, resulted in finding new opportunities to outreach.

IAN: This approach was new for me as I came from an acute clinical background. I really enjoyed the experience of going out and talking to people in the community. It was much nicer taking it to them, rather than people coming to our hospital clinic and not expecting to see us or be involved.

KASIA: Going outside of the clinics and having exciting display boards with freebies such as sweets and condoms to demonstrate the study – it opened the channels of communication. Talking to young people in an environment that's familiar to them removed barriers and we found that people were up for a chat. It was nice to be able to be so open with them. We gave out posters, leaflets and business cards with QR codes. The study is also regularly advertised on Twitter and in our internal comms and newsletters. We had a target

of 25 people to recruit and we are currently on 57, so we’ve managed to more than double this. It was good to build relationships within our Trust but also outside the NHS. That’s something we hope to keep growing so that we can do more studies of this nature and make research accessible, inclusive and available to everyone, including those who may find it more difficult to engage with research opportunities.

The study, which is running at sites across Wessex, is sponsored by the University of Southampton and funded by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC).

The study closed to recruitment at the end of February 2023, with results expected in by December 2023.

“Talking to young people in an environment that's familiar to them removed barriers and we found that people were up for a chat. It was nice to be able to be so open with them."

BRINGING RESEARCH BACK TO THE

EMERGENCY DEPARTMENT

INTERVIEWEE:

REBECCA MILN

Senior Research Nurse, Division 6, Poole Hospital, University Hospitals Dorset NHS Foundation Trust.

When I began my career as a nurse, I worked in the Emergency Department (ED) for six years then went into haematology and oncology, then oncology research.

When I side-stepped into oncology research, I really enjoyed the exposure I had to research but over time I missed acute medicine – emergency care and acute treatment has always been my passion. During the pandemic, I had the opportunity to step up as a Senior Research Nurse and was involved in public health research with the RECOVERY trial, which gave me the opportunity to blend research with acute treatment.

I was on the lookout for other studies and approached the NIHR, who were funding the PRONTO trial and put it on my radar. The EDs at Poole and Royal Bournemouth Hospital hadn’t run research for a number of years, so I knew it would be a challenge to get the study up and running because EDs are always so busy. However, I have a good relationship with the consultant

there and he was interested in the study, so we decided to give it a go.

THE PRONTO STUDY

Currently in ED, we use a tool called the NEWS2 score to aid early recognition of seriously unwell patients. Those who have a high NEWS2 score could be at greater risk of sepsis but it’s important to know that you can have a high NEWS2 score for multiple reasons, it doesn't always suggest a patient has sepsis. In some people it can be perfectly normal to have a high NEWS2 score. What we worry about is either missing sepsis or overtreating when it’s not necessary. Further down the line, when the blood results have been analysed, you find there are a lot of patients that aren’t actually septic. If we continue to overtreat,

are people going to be resistant to broad-spectrum antibiotics in ten years’ time? It also costs the trust a lot of money, so if we can more accurately diagnose and treat sepsis then it helps everyone.

The PRONTO study uses a blood test called PROcalcitonin which gives us a much clearer indication of bacterial infection. The result combined with the NEWS2 score provides more information to support clinicians to treat appropriately early on in the patient’s journey.

From the moment we think a patient might have sepsis, we enrol them into the study. We first randomise them via an iPad, which selects which arm of the trial they go into. For patients selected to receive the PROcalcitonin test, we take a blood sample and get the results in 20 minutes. With the NEWS2 score alone, we can’t tell if there is a viral or bacterial infection, or something else, it’s just numbers.

Because of the nature of sepsis and the need to diagnose and treat

quickly, we use a deferred consent process. When I’m with the patient, I talk them through what we’re doing and why but as you can imagine, these patients are quite unwell and unable to take in lots of information. Most patients who have then been diagnosed with sepsis have been so grateful to have had the test and be part of the research.

PRONTO opened at Royal Bournemouth Hospital in April 2021 and currently has over 100 participants enrolled into the study. In Poole, we have recruited more than 50 participants since the study opened in July 2022. PRONTO is due to end around May 2023, with the results expected shortly after.

GETTING ENGAGEMENT

Getting engagement from busy EDs can be difficult. When I taught initially at the hospital to establish the study, I made it really clear that there would be no additional

workload for the emergency care teams. The trial team would be there to assess patients, randomise and carry out any related tasks.

It took about six months to set up the study and get it ready to accept patients. The first two months of the study being open were tricky and I needed to be very present which was a challenge at times. It was important for me to be available to answer any questions that helped people to engage and understand, and for me to teach during quiet moments. I’ve had to wear a lot of hats!

“Of course, the trial has huge benefits for our patients. But what we're also doing is raising awareness of research and inspiring staff to get involved.”

“It was important to share the motivation for the trial – this could be something that shapes the future of emergency care and how we diagnose and treat sepsis.”

I am really lucky to have engaged Principal Investigators (PI) at Bournemouth and Poole, who do a wonderful job at raising the profile of the study and disseminating information about it. It wouldn’t have been as successful without them.

The engagement has been amazing since opening. People were so keen to be involved and asked for extra training sessions to know more. The staff now get in touch with the research team if they have any patients who may be eligible which is fantastic and a positive step forward for embedding research in ED.

CHALLENGING THE STATUS-QUO

Of course, the trial has huge benefits for our patients. But what we're also doing is raising awareness of research and inspiring staff to get involved. We're showing that even in a busy department, there is still time for

research and research active hospitals are generally safer and deliver better care.

It's important to share the motivation for the trial – this could be something that shapes the future of emergency care and how we diagnose and treat sepsis. Not only does the work we’re doing help guide potential diagnoses, but it also helps to refresh people’s knowledge on sepsis. The guidelines change all the time so it keeps people up-to-date.

Research is really on the map because of the pandemic and PRONTO is part of the NIHR’s Associate PI scheme, which helps to embed research within clinical settings by providing practical experience for healthcare professionals starting their research career. I think previously, people assumed that research nurses sat at desks and wrote up lots of reports on trials – but now they can see that we’re incredibly patient-facing. We’re able to offer patients treatments and investigations that they wouldn’t

normally have access to, which can help to deliver better care.

After the study was established at both hospitals, I was invited to give a talk to advanced nurse practitioners. It was fantastic that they had thought about research – they were so engaged. Someone at that talk now works at Poole Hospital and wants to be involved with research.

I really hope that the results of the PRONTO trial show a positive impact and that we could potentially influence standard emergency care across the country. That’s a really exciting prospect.

I hope that people will begin to approach us to see what else we can do and change. Even if the outcome is that it doesn’t work, we still need to know that – it’s important to know what doesn’t work just as much as what does work.

“We’re able to offer patients treatments and investigations that they wouldn’t normally have access to, which can help to deliver better care.”

For better public health, add research to your career

Develop your career as a public health practitioner by engaging with research. You will shape and promote practical interventions based on evidence. Research is essential to healthy communities. Find out how NIHR can support your career progression.

For more information please visit

www.nihr.ac.uk/yourpath YOUR PATH

AN INSIGHT INTO CRN WESSEX'S

CLINICAL DELIVERY TEAM

AND THEIR CURRENT KEY STUDIES

INTERVIEWEES:

Kirsty Gladas, Senior Research Nurse Manager, CRN Wessex

Michelle Just, Senior Clinical Trials Assistant, CRN Wessex

Kerry Gunner, Ruth Jackson and Kate Battley, Research Nurses at CRN Wessex

Alice Jenden, Research Midwife at CRN Wessex

Tell us about the CDT

The CDT consists of our original CRN Wessex core nursing team who originally had a focus on primary care, and the new Direct Delivery Team (DDT) which has now been established for 18 months.

The DDT was set up when funding came through from the NIHR Transformation of Delivery Initiative to enable an agile workforce to better support and deliver research in public health, social care and under-served communities.

My role is to manage and support the team to deliver research day to day across the Wessex region.

What contribution has the CDT team made to research delivery in Wessex?

We've helped support a lot of the COVID-19 vaccine research locally. I don't think that that would have been possible on the scale we have seen without the support from the CDT and the wider CRN Wessex team.

We have also been able to support partner organisations to either sustain their research portfolio or increase recruitment.

I think our contribution is to highlight and actively promote research opportunities to future participants within the region and

Kirsty Gladas, Senior Research Nurse Manager, provides an overview of the Clinical Delivery Team (CDT) and her role in supporting them.

engage them in some small way. This will ultimately help the Wessex wide community and contribute evidence towards clinical practice that can be shared with colleagues, the UK and further afield.

What is their skill set?

The CDT team has a wide variety of backgrounds and skills that contribute to the new areas that we will be supporting and delivering research within. These include a midwife, a paramedic and people who have worked in pharmacies, laboratories, the blood service, patient transport services and care homes to name a few.

How will the CDT benefit patients and the public?

We are expecting two new research buses to be in use by late 2023.

I think this will pave the way for how we look at bringing research to patients and the public in non-NHS settings.

We currently have research hubs in Bournemouth, Portsmouth and Southampton, with a new hub in Weymouth due to open later this year. Our hubs allow us to bring studies to the community and will help improve access to research for people living in Wessex.

What’s next for the CDT?

Consolidating the knowledge and experience that we've gained so far will be important. I think it would be particularly useful to grow our understanding of how research can be delivered in public health and social care.

Things like being aware of the

different terminology will be useful as we go forward, for example, most clinical staff who have been working in a hospital setting use the word ‘patient’, whereas in a social care setting you should use the term ‘service user’ or ‘client’. We have much to learn from the new settings and look forward to working side by side delivering research for community benefit.

I've really enjoyed leading the team and I'm looking forward to seeing where we can take research in the community next and the relationships we can build with organisations in the region. I hope our research passion rubs off onto others and they too see the benefit research can bring to individuals and their communities.

"I think being adaptable in our work and our approach is one of the biggest strengths of the CDT.”

Kirsty Gladas

One of our research buses

ATTACK study

The CDT is currently supporting the Wessex-led ATTACK study, which is investigating whether people living with Chronic Kidney Disease (CKD) should take a low-dose of aspirin daily to help reduce their risk of a first heart attack or stroke.

CKD is a common long term condition where the kidneys do not work as well as they should. People living with CKD are often at greater risk of other health conditions, such as Cardiovascular Disease (CVD).

Previous studies have shown that aspirin can reduce the risk of further heart attacks or strokes in people living with CVD, and that these benefits are greater than the increased risk of bleeding caused by taking aspirin.

However, before aspirin can be recommended as a preventative measure for people with CKD who have not yet developed CVD, there is a need to find out whether the benefits of daily aspirin outweigh any long-term risks.

The ATTACK study, which is sponsored by the University of Southampton and funded by the NIHR and the British Heart Foundation, aims to answer this important research question and will inform National Institute for Health and Care Excellence (NICE) guidelines on the management of CKD going forward.

KERRY GUNNER, CRN Wessex Research Nurse, who has been working in research for a decade, explains her role in delivering the study:

“As a research nurse within the CDT, I support research across a range of different settings, although my main remit has always been the set up and delivery of research in primary care.

“When we first started recruiting to ATTACK in 2019, the study was being delivered in a face-to-face format. As a team, we were going into general practices to run the study, carrying out activities such as receiving consent, confirming study eligibility and collecting blood and urine samples from our participants. Recruitment was going very well, but the study had to pause following the outbreak of coronavirus.

“As soon as it was safe to do so, everyone was keen to get the study up and running again as it’s such an

important research question. Patients living with CKD have always been very interested in the study and eager to help, even though it may not benefit them directly.

“The study team were very pragmatic and managed to adapt the study and train nurses to deliver it remotely, which was safe for us and our patients.

“It’s been fantastic to see the study recruiting participants again, despite all of the clinical pressures in general practice post pandemic. This is something we are very aware of as a team, and we will continue to be versatile and flexible to support practices.

“Our primary aim is to ensure that patients and the public have access to research opportunities. Within primary care, I find it particularly interesting that we are often trialling existing therapies and treatments but in a new way for different conditions or for a different cohort of patients.

“Whether they’re positive or negative, the results of the ATTACK study will guide future practice by supporting GPs and patients with the management of CKD.”

"The study team were very pragmatic and managed to adapt the study and train nurses to deliver it remotely, which was safe for us and our patients."

Kerry Gunner

Treat to Target (T2T)

Gout is a type of arthritis that causes sudden and severe joint pain. An attack of gout will usually last up to a week, and additional attacks are common, particularly if not treated.

Current treatment for gout aims to reduce pain and swelling. It can include anti-inflammatory medication such as ibuprofen or steroids and it is also possible to make lifestyle changes which can stop or reduce further flare ups.

The CRN Wessex Clinical Delivery Team (CDT) is supporting an NIHRfunded study which aims to improve the future treatment of gout.

The Treat to Target (T2T) gout study, sponsored by the University of Nottingham, will test whether a new gout medication strategy can help to reduce both the number and severity of gout attacks compared to usual care.

RUTH JACKSON, CRN Wessex

Research Nurse, is part of the team supporting T2T. Here, she explains its importance and why she enjoys working in research.

“The study is really important for helping people living with gout. Often, patients have been struggling with gout for a long time and haven’t really been able to find the ideal treatment that works for them”.

“This study is trying to identify a

better way of treating and managing gout for people experiencing recurrent flare ups, and will explore the clinical and cost effectiveness of Allopurinolbased T2T urate lowering therapy.

“Although Allopurinol is well known and has been used to treat gout for many years, we need to improve our understanding around the effectiveness

Allopurinol works best for them.

“We then follow up with participants after one and then two years. It’s been a valuable experience going back and seeing how they’re getting on. Lots of patients have fed back that they’ve enjoyed being part of the study and have found it straightforward and not a burden which is positive.

“Most of the study appointments are face to face and could not be carried out remotely. Whilst this did mean we had to pause recruitment to the study during the pandemic, it’s great to be open again now and we’re halfway to our recruitment target.

of different doses, so the T2T study will compare whether tailoring the dose to each patient is more effective than standard GP care for gout.

“Since the study opened in 2019, I have been supporting general practices across Wessex with setting it up. Once a practice is on board, we have been getting in touch with patients who might be eligible to see if they’d like to take part.

“Once participants have joined the study, they are randomised to the treatment arm or standard care. Those in the treatment arm of the study will then have regular blood tests to help decide what dose of

"I enjoy working clinically and seeing the participants, and that's the rewarding and enjoyable element of my role. I also love knowing that research is there to improve healthcare and future treatments; it can be exciting working on studies knowing they will make a difference.

“As a team, the CDT is here to give patients the opportunity to take part in research and ensure that studies are carried out efficiently across all settings.

“We work in so many different environments, on various studies for a vast range of conditions, which is fantastic. We’re very supportive of research and evolving our healthcare knowledge base to improve the treatments and care we offer patients.

"I enjoy working clinically and seeing the participants, that's the rewarding and enjoyable element of my role."

Bryony Marks, Kate Battley, Michelle Just, Sophie Hutin

Ruth Jackson

iDx study

This iDx Lung trial is funded by UK Research and Innovation, with funding support from Cancer Research UK. It is taking place in collaboration with the Southampton Clinical Trials Unit at the University of Southampton, the University of Leeds and healthcare and diagnostic companies. The study is piloting new diagnostic tests that aim to find ways to detect lung cancer at an early stage when it is more treatable.

We speak to members of the CDT team, Alice Jenden, Michelle Just and Kate Battley, who have been working on the study at sites across Hampshire.

Please tell us what’s involved in the study

Alice: Any patients aged 55 to 74 who have ever smoked are invited to a Lung Health Check, providing their smoking status is correctly recorded in their GP record. The lung health check is a two staged process, firstly involving a telephone call with a specialist nurse, then if they are deemed high risk they are given an appointment for a CT scan. Any people attending their CT scan as part of their lung health check are eligible for the research study. If they are happy to take part, we take

them from the CT scanner to our dedicated research van. Here we take blood samples and tissue from inside of the nose.

All samples are taken to the Southampton Tissue Bank for processing and then sent to partner laboratories for biomarker analysis. The participants will be followed up remotely for at least three years using their health records. This clinical data will then be reviewed in line with the samples taken by the study doctors.

The data will help to assess whether adding biomarker samples to CT scanning for at risk populations can improve early diagnosis for lung cancer.

Can you tell us more about the iDx van?

Michelle: The research van enables the CDT to follow the scanner locations. Excitingly, it means we can take research out into the community to make it more accessible.

Kate: It poses different challenges to working in a hospital or clinic setting but I think that's what makes it really interesting.

What are your roles in the delivery of this study?

Michelle: We're really flexible as a team. There are specific guidelines around who can consent but otherwise we rotate all the jobs. We all do everything from setting up the bus to nasal brushing and taking bloods.

Kate: From a practical level, it's very much about teamwork. No one person carries out the same job each time. We take it in turns to do things like driving the bus, filling up the petrol, setting up the steps, all those jobs that as a research nurse you may never have come across.

How long has the study run for and what were your target recruitment figures?

Alice: The study started in May 2021 in Southampton and it's due to finish by the end of March 2023. We have a national target of 7,000 participants.

How have you found recruiting to the study?

Alice: The radiographers who work with the CT scanner have been a big part of us recruiting because they are

“We also have a research bus that team members use to take studies into the community, which is really exciting!”

the first people that participants see. Early into the study, an idea was suggested about using a walkie talkie to communicate. We have one on the research bus and they have one on the CT scanner, they let us know that there's an eligible participant and we can meet them or know to expect them. That has really helped with recruitment, it's just sometimes thinking outside the box.

in all kinds of roles, from facilities managers to site contractors.

What have been your highs and lows of the study?

Michelle: Our participants have been a high for me. They’re from all walks of life and are often happy to share personal stories about family members and their experiences with cancer. They are more than willing to help if it means that they are helping future generations.

Alice: I think from a staff perspective, a real high is how the study has pulled us all together. Teams from Southampton, Portsmouth and Bournemouth, pharmacy teams, radiographers and of course research teams.

Michelle: Where the study has meant so much to us all, we are elated when we get good figures and things are going well but can also feel really disappointed when we have a bad day.

Has this study involved much cross-team collaboration?

Michelle: Absolutely it has! We have been working with staff from different trusts and in a variety of roles. And not only people in the NHS – because of the van, we’ve got to know people

Alice: I agree with that. We have a WhatsApp Group for those of us working on the study, where we communicate any updates. Quite a lot of the time, people share how their day has been as well. You can definitely feel that team happiness when things are going well and there’s a lot of support when you’re struggling which has been amazing.

Kate: This was our first study as the CDT too, which was quite an achievement. It was probably the first research study that some of our team had worked on, they've been able to get involved from the get go and use some practical skills as well.

“Our participants have been a high for me. They’re from all walks of life and are often happy to share personal stories about family members and their experiences with cancer.”

“As a team, the CDT is here to give patients the opportunity to take part in research and ensure that studies are carried out efficiently across all settings."

Fran Terry and Alice Jenden

“We have a WhatsApp Group for those of us working on the study, where we communicate any updates. Quite a lot of the time, people share how their day has been as well.”

SHARING A FAMILY’S STORY

AND RAISING AWARENESS THROUGH PRESS COVERAGE

The team at University Hospital Southampton (UHS) explored an exciting avenue to boost study participation, by raising awareness of a leading cause of serious infections in babies and a vaccine being tested to combat it.

ABOUT THE STUDY

INTERVIEWEE:

DR CHRISSIE JONES –Southampton study lead

In July 2022, a study was launched at UHS to test a vaccine to guard against Group B strep and look at the best time to offer this vaccine to pregnant women. Group B strep infection is responsible for nearly half of all life-threatening infections during the first three months of life. It also sometimes causes miscarriages, premature births and stillbirths.

The vaccine is being developed by the Danish company MinervaX. The hope is

that, by giving it to women at the right time in their pregnancy, it will protect their baby during pregnancy and birth.

RECRUITMENT

Participants were required to start the study at around 20 weeks of pregnancy and were followed up with for six months after delivery. There were 12 hospital visits in total including a screening visit.

Dr Chrissie Jones, Southampton study lead, said: “Media coverage of this trial helped to raise awareness of the importance of Group B strep infection in young infants. This is crucial to recruitment as we were inviting women to take part in study to test a vaccine against an infection that they might not have heard about before.”

Iwan and Teddy Thomas

PRESS COVERAGE

In 2018, Olympic sprinter Iwan Thomas nearly lost his son Teddy to Group B strep. He was admitted to Princess Anne Hospital based at UHS where he stayed for 10 days while being looked after by staff.

To support recruitment, teams at UHS arranged for Iwan to return to the Princess Anne Hospital with his son Teddy. He featured on BBC Morning Live in Autumn 2022, speaking about his support for the study.

In the clip, Iwan spoke to researchers leading the study and interviewed Jen Dawkins, one of Southampton’s first participants in the new research.

“It’s hugely exciting to see the progress of this new vaccine,” Iwan said.

“If this work saves just one family from losing a child to this awful infection, then it will all have been worth it.”

STUDY TEAM COMMENTS

Dr Jones added: “A safe and effective Group B Strep vaccine would be a game-changer for newborn infants, both in the UK and globally.

“This is a significant infection in newborn babies, that can be life-threatening and also cause long-term problems in those babies who recover from the infection.

“A vaccine against Group B Strep would be a massive step forward in our ability to protect newborn infants from serious infection.”

CONCLUSION

The study was delivered at the NIHR Southampton Clinical Research Facility, part of University Hospital Southampton NHS Foundation Trust, and St George's University Hospitals NHS Foundation Trust in London. Results of the study are expected in 2023.

“A safe and effective Group B Strep vaccine would be a gamechanger for newborn infants, both in the UK and globally.”

Teddy Thomas Iwan being interviewed

RESEARCH IN PRIMARY CARE NETWORKS: HOW GP SURGERIES ARE MAKING ACCESS TO RESEARCH EASIER FOR PATIENTS

Research across Primary Care Networks (PCNs) has been going from strength-to-strength with many sharing resources and knowledge to improve patient access to research. We caught up with the Abbeywell Surgery, part of Romsey & North Baddesley PCN, to see how their approach is improving patient access to research within Primary Care.

INTERVIEWEES:

NICOLA LESTER, Research Clinical Lead, Abbeywell Surgery

LIANE ARMSTRONG, Senior Research Nurse, Abbeywell Surgery

TRACY WHITFIELD, Administration Research

Facilitator, Abbeywell Surgery

NICOLA: We began looking at research across the Primary Care Network (PCN) as part of the PCN Incentivisation Scheme where additional funding is given to help networks improve their services to patients. We were already research active at Abbeywell but the Alma Road and North Baddesley Surgeries weren’t. I wanted to increase opportunities for the community to be involved in research, so I approached the practices and asked if they wanted to be part of the scheme.

LIANE: Research in any setting is really important but in my view it’s especially important in Primary Care and GP surgeries. We’re the first port of call for most patients so it's a great way of embedding research somewhere familiar with people they already trust. It’s also important to provide them with the opportunity that lots of hospitals have, offering research locally so that patients don’t have to go to a specialist centre.

A PERSONAL APPROACH TO RESEARCH

LIANE: One study that we’re working on at the moment is the HARMONIE study, which is the first commercial study within the PCN and our surgeries. The study is aimed at immunising babies against RSV through an antibody injection. Respiratory Syncytial Virus (RSV) has high hospitalisation rates, babies can get really poorly and there’s currently no treatment for it – just best supportive care.

Our recruitment began in October and we’re currently the third top recruiter in Wessex – we’re a small team of three, so we’re doing really well. We have 64 babies signed up and it’s a great study to offer parents here at the surgery. They’re already coming in for immunisations and eight week checks, so they know our team and trust us.

NICOLA: Liane calls all the patients personally before she sends out information on the study, then carries out follow up calls which help with recruitment. Having someone like Liane that they can contact directly for questions and queries gives much more direct support compared with bigger study models. It’s much more personalised and helps recruitment numbers. We operate on a hub & spoke model for our trials, which means that the team is based at Abbeywell and if required, patients attend clinics there, but patients from any of our PCN surgeries can take part. It makes it easier to run studies and opens the door for lots of opportunities because we have a larger recruitment pool of patients across the three surgeries. We can offer studies to another potential 25,000 patients.

LIANE: I’ve had patients specifically say they prefer being involved in research at the GP surgery rather than going to hospital, for practical reasons and also emotionally. It feels safer for them.

TRACY: As a small team, we work well together and good communication is essential for this work.

“We have 64 babies signed up, it’s a great study to offer parents here at the surgery.”

“I wanted to increase opportunities for the community to be involved in research, so I approached the practices and asked if they wanted to be part of the scheme..”

Nicola, Tracy and Liane

OVERCOMING CHALLENGES

NICOLA: We found our learning around the finances quite a challenge – Tracy has been instrumental in helping us establish how the money is coming in and working with the Clinical Research Network (CRN) and the trials’ office so that we have a clear picture. Research finance can be tricky to understand but we needed to know how it worked so that we could plan effectively.

TRACY: Research is full of abbreviations and acronyms which can also be a challenge. The CRN team is really helpful in clarifying what certain terms were as this can be time consuming for a small or inexperienced team.

NICOLA: Negotiating how studies work across the three practices has taken time. Things like using different computer systems has been a challenge, when you’re

used to a certain system it can be difficult to use another.

When we first started as a PCN, we found communicating between the three surgeries challenging. To overcome this, we now have a nominated colleague in each of our spoke sites that can raise awareness of research in their own surgery and be approached to signpost any questions to us as the hub team. We also send a quarterly PCN newsletter to staff members across the three surgeries to keep everyone up to date with current research. Making use of poster boards at the surgeries to promote active studies has also been useful, so that the patients know what they can access.

TRACY: It can be such a minefield. There’s a lot to pick up and learn, so to be able to offer our expertise across three sites is really good and helps hugely. As we grow, hopefully we will take on more staff and share our expertise which will enable research involvement to expand.

NICOLA: Research can be difficult, possibly even off-putting, so it would be nice to inspire and motivate other practices to do it too.

TRACY: The CRN has been really supportive; providing a bank of research nurses and clinical trials assistants when needed. They have been extremely helpful in answering any questions and finding solutions to any problems we have had

THE OPPORTUNITIES FOR PCN RESEARCH

NICOLA: The great thing about PCN research is that we can pick studies that are directly relevant to our local community.

So far, we’ve been involved in the initial arm of the PANORAMIC study where we recruited 114 patients that would otherwise not have had the opportunity to receive COVID-19 treatment.

Other studies include WAVE, which looks to see if vocational interventions for people off on

“I think that PCN research could pave the way for all GP surgeries to have access to research opportunities.”

long-term sick leave might help them get back to work quickly and Active Brains, which looks at the use of computer-based activities to see if they can prevent dementia in the long-term.

Alongside these, there is STATIC, which looks at different options for Crohn’s medication. We’re also currently getting set up for Treat to Target gout which will look at the recurrence of gout if you can get uric acid levels to a certain level and maintain it.

LIANE: With PCN research, we have an increased recruitment pool of patients and we also have an increased awareness of research. Word of mouth between patients is powerful in PCN research.

I think that PCN research could pave the way for all GP surgeries to have access to research opportunities because this model allows access at other sites when it’s not possible to have an in-house research team.

USEFUL LINKS TO STUDIES

HARMONIE: https://www.nihr.ac.uk/news/research-begins-totackle-rsv-infections-in-infants/31312

PANORAMIC: https://www.panoramictrial.org

STATIC: https://www.bsg.org.uk/clinical-resource/static-clinicaltrial/

Active Brains: https://www.hra.nhs.uk/planning-and-improvingresearch/application-summaries/research-summaries/activebrains-study/

WAVE: https://www.hra.nhs.uk/planning-and-improvingresearch/application-summaries/research-summaries/wave-trial

Treat to Target: https://academic.oup.com/rheumatology/ article/57/suppl_1/i20/4762109

Abbeywell Surgery, Romsey

GROWING PRIMARY CARE RESEARCH

INTERVIEWEES:

DR ALEX TODD, GP Partner & Research

Lead, Shore Medical Partnership

BECCA MILNE, Research

Nurse, Shore Medical Partnership

SHIRLEY-ANN CLIMIE, Research Administrator, Shore Medical Partnership

ALEX: I’ve always fostered an interest in research which was sparked by my time at Nottingham University when I worked with the Anaesthetic research team. I worked on a study looking at the effects of topical local anaesthetics and we presented our findings in Porto at the European Society of Regional Anaesthesia and were published in Regional Anaesthesia and Pain Management. Since then, I have been keeping an eye out for opportunities to get involved with research and when I joined Shore in 2021, we had the perfect opportunity to start.

After three months, we started to have discussions with the Clinical Research Network (CRN) for possible

funding models and support. We started on the Research Sites Initiative (RSI) scheme in October 2021 as a sessional practice at Primary Care Network level. The funding from the CRN has allowed us to cover most of the costs of staff and enabled us to engage with research studies.

Initially, we focused our work on vaccine and pandemic related studies acting as a Patient Identification Centre (PIC). This included working on studies such as PANORAMIC, PRINCIPLE, REGAIN, COV-BOOST and COVID Vaccine Monitor.

Slowly over time we started to grow the team, with Shirley-Ann doing a day a week on the administration and

As Primary Care research opportunities expand, we speak to the research team at Shore Medical Partnership in Dorset, to see how they’re approaching research across the six GP Practices within their network.

Shirley-Ann, Alex & Rebecca

then earlier this year Rebecca came on board for one day a week, which has allowed us to engage with more in-depth studies.

We’ve since taken on ATTACK, which looks at Chronic Kidney Disease (CKD) and aspirin use, then subsequently ATHENA, looking at amitriptyline in treatment of longterm pain from shingles and now DEFINE, which explores fractional exhaled nitric oxide (FeNO) guided asthma management that Becca has taken the lead on.

BECCA: It’s very different working in a primary care setting but in a small amount of time we are now in a position to take on more exciting studies. And that’s where DEFINE comes in, it’s the first interventional in-house study. It’s a big learning curve, but everyone is so on-board

with research and willing. There’s a synergy there between me and the nurses here that are interested in research and it makes it much easier to share the work between us, it's great for our future.

SHIRLEY-ANN: This role has many similarities with my previous role as a Senior Project Manager, such as the attention-to-detail required and the project set up – in both roles it is important to ensure that all administration is tightly controlled.

A NEW MODEL FOR PRIMARY CARE RESEARCH

ALEX: Shirley-Ann dedicates one day a week to research administration and four to the practice reception. Study administration needs more time than she has at the moment, it really

snowballs once you start taking on extra projects.

The sheer scale of it can make it challenging. We have found it’s easier running a trial within one site, then we expand and grow once we know how the study works and how we best can run them. We’re slowly learning and developing the best ways that fit our model.

Another challenge has been communicating studies to 200 staff members. It can be difficult to keep awareness up when there are so many studies ongoing but to help, we’ve produced laminated sheets about each study that’s running and given them to staff and relevant teams. I also try to send regular updates by email or WhatsApp to point staff in the right direction.

“I’ve attended the NIHR course which is a great networking opportunity because everyone is really motivated and keen to help – it’s a joy to be part of the research community.”

Dr Alex Todd

SHIRLEY-ANN: I’m keen to expand my research role and take on more hours as I really enjoy the time that I spend on research, it’s a constant learning curve. With my experience on reception, I’m able to ensure that the team is aware of everything we are doing at a grassroots level.

their rash. That can be difficult if we only have one day a week allocated towards research and the patient comes through on day four of their rash when we’re not available. That’s where the CRN support has been invaluable, the CRN nurses can consent on days that we can’t and their experience has helped us hugely. We’ve had lots of help from other, more experienced, sites locally too. The Adam Practice has been really helpful in supporting us and Oaks Healthcare in Portsmouth have kindly given up their time to work with us and guide us.

CREATING IMPACT THROUGH PCN RESEARCH

primary care is very busy, through research they’re able to access additional intervention and potential investigation more easily.

BECCA: It’s been really positive. People are really willing to help and like to know they are helping.

ALEX: We’ve tried to take on studies that we think are of real value and to answer important questions. If you relay that to patients, they see the benefits and value of building that evidence base in primary care for the future.

ALEX: All our cases come through an external care navigation unit, engagement from them is needed to identify suitable patients quickly. With ATHENA, identifying patients with shingles needed to be done within five days of the onset of

ALEX: We have around 58,000 patients across our six sites which makes it possible to run wide searches across our patch and engage patients with research.

I’ve found the response from patients positive. I think they really value the contact they get from clinicians during a time when

BECCA: People here are excited about research. Post-COVID, people are really willing to be engaged –especially staff. Having a dedicated research team helps to reassure people that their workload won’t be drastically increased or become a burden and we’re potentially changing medicine for the future. Most people go into this sort of profession because they care and want to make things better. By being a part of research,

“I’ve found the response from patients positive. I think they really value the contact they get from clinicians during a time when primary care is very busy."

you’re doing that and it's something you can see in front of your eyes.

SHIRLEY-ANN: We are planning a presentation to the board at the end of Q1/Q2 which will hopefully show that we have the appetite and the capacity to take on more projects.

ALEX: I wasn’t sure how patients would react with us contacting them with research opportunities, but it’s been really nice to see that they do want to engage. Most want to take part and have been very grateful for the opportunity.

It’s important to have protected time for research, especially as a GP because otherwise it can be difficult to fit in. I hope over time, as our reputation builds, we’ll be able to take on more studies, both commercial and non-commercial.

Ideally the future would involve practices working collaboratively at scale to deliver high-quality research, more awareness that funding is available will help enable them.

It can seem daunting to start up

without much research experience but you can start slowly with support from the CRN and engage with light studies – acting as a PIC site for example. Then it can grow gradually over time without much risk. Just getting started is the biggest step.

BECCA: Knowing that there is support out there, especially from the network, is so important.

USEFUL LINKS TO STUDIES

As is communicating with other practices to gain as much experience and knowledge as you can.

SHIRLEY- ANN: We’ve had a positive response from the CRN team. I’ve attended the NIHR course which is a great networking opportunity because everyone is really motivated and keen to help – it’s a joy to be part of the research community.

PANORAMIC: https://www.panoramictrial.org/

PRINCIPLE: https://www.principletrial.org/

REGAIN: https://trialsjournal.biomedcentral.com/articles/10.1186/ s13063-020-04978-9

COV-BOOST: https://covboost.web.ox.ac.uk/home

COVID Vaccine Monitor: https://vaccinemonitor-yellowcard.mhra.gov.uk/

ATTACK: https://www.southampton.ac.uk/attack-trial/index.page

ATHENA: https://www.phc.ox.ac.uk/research/infectious-diseases/ current-projects/athena-preventing-long-term-pain-from-shingles

DEFINE: https://www.phctrials.ox.ac.uk/studies/define

“That’s where the CRN support has been invaluable, the CRN nurses can consent on days that we can’t and their experience has helped us hugely.”

STRENGTHENING RESEARCH

WITHIN HAMPSHIRE HOSPITALS NHS FOUNDATION TRUST

INTERVIEWEES:

NATASHA CHIGBO, Head of Research & Development, Hampshire Hospitals NHS Foundation Trust (HHFT)

EMMA LEVELL, Research Nurse, HHFT

DR LARA ALLOWAY, Chief Medical Officer said: “This is an exciting time for Hampshire Hospitals, our staff and our local population, as we work towards delivering our Modernising our Hospitals and Health services programme (MOHHS). Research is a core theme in our Trust and clinical strategies, as a key enabler for delivering outstanding care to our patients, today and tomorrow. Our patients’ and staffs’ impressive involvement in research throughout the COVID-19 pandemic has reminded us of the value of clinical research, helping us understand diagnosis, treatment and prevention of COVID-19. This strategy uses our experience as a basis to further develop the scope of the research we can offer in the Trust.

We aim to empower, train and support our staff to be engaged in research and collaborate with our partners to achieve

this. We want to increase our capacity to offer our patients access to research, across all services and truly embed a research culture.”

In 2022, we were asked to develop a new strategy to sit alongside the overarching clinical strategy at HHFT. The research team here is quite small, but we want to grow, and we needed to show how we we're going to advance and develop a strong research culture within the trust.

We hope that our four key strategy themes will help us to achieve this:

PATIENTS, PUBLIC & STAFF

We hope to embed research among all the people that we work with, and for, at HHFT. We are developing a network of Public Research Ambassadors

who will help us reach out to the communities we serve and our staff, alongside promoting opportunities for people to get involved in research (patients, public and staff) across multiple platforms and creating a network of Research Link Champions who can help us disseminate research information to all.

SUSTAINABLE GROWTH

We want to ensure that we can build on what we are good at and be truly innovative in our approach to research. This means increasing our capacity to host commercial trials and sponsoring trials too. We will explore areas that are already a natural fit for us, with the expertise we have, and assist our clinicians to make grant applications that will support our work and strategy goals.

WORKFORCE AND INFRASTRUCTURE

Growing our research workforce also means that we need to have the facilities in place to be able to support them. We’ve been working alongside the teams planning the new hospital in Hampshire to ensure that purposebuilt research facilities are embedded within the development. We also hope to develop clinical and academic pathways to build the depth and breadth of research among clinicians from all backgrounds and specialities.

COLLABORATION AND PARTNERSHIP

Working alongside others is an important part of growing our research capabilities and expanding who we can reach with our research opportunities. We already host

student nurses, physiotherapists and dietitians from the University of Winchester so that we can embed research within their training and grow our partnerships with organisations, but we are also expanding the ways we can do this with fellow research organisations, companies and services.

Read on to discover how one of these partnerships, the PAIR1 Study, is already producing results for prostate cancer diagnosis.

“Research is a core theme in our Trust and clinical strategies, as a key enabler for delivering outstanding care to our patients, today and tomorrow.”

Natasha Chigbo

Emma Levell

WORLD-FIRST ARTIFICIAL INTELLIGENCE STUDY

BEING DELIVERED AT HAMPSHIRE HOSPITALS NHS FOUNDATION TRUST

INTERVIEWEES:

ANTONY RIX, Chief Executive Officer and Co-Founder, Lucida Medical

STEFFI BARWICK, Study Coordinator, Lucida Medical

RICHARD HINDLEY, Principal Investigator, Basingstoke and North Hampshire Hospital (BNHH)

AARTI SHAH, Chief Investigator and Consultant Radiologist, BNHH

SOPHIE SQUIRE, Data

Collection and Radiographer, Hampshire Hospitals NHS Foundation Trust (HHFT)

CLARE ROWE JONES, Urogynaecology Clinical Coordinator, HHFT

TORY CORNER, Sponsor

Representative, HHFT

PAIR 1 is a retrospective study looking to examine the effectiveness of Artificial Intelligence (AI) software in the analysis of Magnetic Resonance Imaging (MRIs), and subsequent diagnosis, for prostate cancer. It is the first large study to be sponsored by Hampshire Hospitals NHS Foundation Trust (HHFT).

Collecting and analysing data from eight hospitals across the country, we caught up with the PAIR 1 Study Team to hear about the goals of the study and their experience of leading a multi-site trial.

DIAGNOSING PROSTATE CANCER WITH AI

ANTONY RIX: The study came about more than two years ago when we were discussing the challenge of validating the new type of AI software that Lucida Medical is developing for prostate cancer. It’s especially difficult to get hold of real-world data that’s representative of how systems like this would be used in the NHS, but crucially important that the software is validated.

Richard and Aarti suggested that HHFT would be interested in this research and might be willing to

sponsor it, with Lucida covering its costs. We supported them with the design and application process, collaborating with Tory and Clare to make use of their Research and Development Expertise. Once the study was approved, we worked with Aarti, Richard and Sophie who reviewed 300 patient cases to extract scans and data, with the other eight hospitals doing the same.

This data allows us to do a headto-head comparison between how a radiologist and the AI software score the MRI scans. We take the biopsy as the absolute truth and look at patient follow up to see if the patient

came back for further investigations. We want to know how well the AI algorithm holds up to the yardstick of the original radiologist. At the moment, the radiologist sensitivity is close to 100% and the software is around 90-95%.

AARTI: In the short time I’ve been a consultant, the way we use MRI and diagnostics for prostate cancer has changed dramatically. We have good data now that shows that you have to place MRI at the beginning of the prostate cancer diagnostic pathway for every patient with suspected prostate cancer. That’s a huge change.

RICHARD: The diagnostic pathway is complicated for prostate cancer detection and we also use MRI for monitoring. We are very busy and if we can get consistent high-quality reports in a timely manner, it will help with diagnostic pathways, treatment planning and monitoring.

If all radiologists need to do is look at a report and sign it off, that’s good all round. The software can generate a very detailed report with images and, because we don’t all have the same standard of scanner, it has the potential to turn a sub-optimal scanner into a slightly better one.

AARTI: The pressures on these pathways are immense. So that’s why we’re trying every small thing we can to speed the process up. The need to have good MR imaging and reports that help to select which patients will benefit from further investigations, including biopsies, and which would be best left alone, is crucial for us. What we’re trying to do is score each scan against a robust criteria which is central to our decision making. The thing that’s quite clever about the technology is that everyone’s populations are very different, so you can set thresholds for all the results that can flag potential cases for further investigation. So, you can decide as a

hospital whether you’re going to take a very cautious approach based on your local population data or you can decide whether you will target the more aggressive cases. We don’t want to end up over-diagnosing prostate cancer in older patients where it won’t necessarily impact on their quality of life.

RICHARD: There’s a natural variation between radiologists and their reporting so it will hopefully improve consistency, the quality of reporting and save time – potentially from 40 minutes looking at scans to just five minutes looking at the report and recommendations.

ANTONY: There’s no intention or evidence that AI will replace radiologists – this study will be one of the first in the world to evaluate how accurate the software is with real-world data. Then hopefully, on the basis of this, it will be able to set thresholds that hospitals might use

“The study came about more than two years ago when we were discussing the challenge of validating the new type of AI software that Lucida Medical is developing for prostate cancer.”

Antony Rix

Clare Rowe Jones and Aarti Shah

Richard Hindley

to speed up the diagnostic process. The study will hopefully provide us with some guidance on that, workload prioritisation and triaging driven by the algorithm.

AARTI: No scan is the same, for example people may have a hip replacement and we can’t yet use AI for this. There will always be ones that the software struggles with which will need our input.

THE CHALLENGES OF DOING A MULTI-SITE, RETROSPECTIVE STUDY

CLARE: Doing a retrospective trial has been a massive change to the usual clinical trial with patient participation. It’s allowed us to be quite functional, it allows Sophie to come in and work at weekends or at night, there’s no consent, no reassuring patients – it’s been a data gathering exercise which is really different. The biggest challenge for the

coordinating team was the variation in process between different NHS trusts, which was staggering. It was so complicated around permissions and information governance teams, R&D teams, IT teams and making sure they were transferring their Dicom images in the right format. But we got there and because there were solid processes, SOPS and instructions behind everything from Lucida, the study did then fly.

AARTI: It is not always easy to do research in the NHS particularly involving large volumes of data. But the power and the future of the NHS

is in the amount of data we generate, particularly in imaging. We are very behind in how we translate that into making research happen. A lot more could be done to help people participate in research such as this.

GAME-CHANGING RESEARCH PROCESSES

SOPHIE: We were able to get through the data quickly as it already existed. This helped hugely with the trial set up. If we’d had to collect 300 patients’ data from the start of the trial, it would have taken us a couple of years.

CLARE: We just entered date parameters and sites assessed each patient file on their suitability for the study.

ANTONY: The study isn’t complete yet but because it’s been providing progressive amounts of data, we’ve been able to do a number of interim analyses that are showing very exciting

“Doing a retrospective trial has been a massive change to the usual clinical trial with patient participation."

“The study has created a fantastic data resource across eight NHS trusts with over 2,000 patients processed."

results. I found it uplifting to be sat down at a conference a few weeks ago with one of the leading radiologists internationally in prostate MRI. He had a look at the results we were presenting and suggested that we strengthen our conclusions, as the software is matching the performance of expert radiologists. That’s quite exciting.

CLARE: It was a game-changer to realise how much you can do on Teams. I’ve spent nearly two years working with people from Cambridge, Cornwall, Oxford and London – I hadn’t met Aarti until about a month ago. The connectivity that we have achieved, I think we were all surprised at the ease with which we developed a comfortable working relationship. Taking it forward within the NHS, the fact that we’ve got Teams and NHS staff can now work from home – that is ground-breaking for hospital and multi-site studies.

AARTI: Yes, previously you’d have had to do all the site visits in person

– I think it’s the new face of how research will be done.

CLARE: This was the first study HHFT has done that had an Electronic Trial Master File so we have no paper. That gave me palpitations at first but it’s the way forward – it saves so much time. We all need to start coming up that learning curve really quickly around what is data, what will be archived and where will it be stored? I wouldn’t do another paper-based site file.

ANTONY: 18 months ago we made a decision to go for electronic CRF and electronic transfer of files. There is no way we’d go back to paper. For the NIHR, it’s a resource that everybody doing this type of work should have. We’ve created processes because there wasn’t an existing infrastructure in place that we could use. It could be easily and cost-effectively implemented on a national scale. There’s a lot that could be learned from here.

The study has created a fantastic data resource across eight NHS trusts

with over 2,000 patients processed. With this we can look at the patient journey through to diagnosis and look at a lot beyond the narrow scope of AI. We would love to see our software being used. But I hope from the clinicians’ side, it will help ease the pressures of resourcing, staffing and variations in consistency – helping with standardisation and automation and making diagnosis more accurate wherever you are.

RICHARD: If it rolled out countrywide from all our work at HHFT it would be particularly fulfilling.

The PAIR 1 study began at Basingstoke in August 2021 and data transfers concluded at the end of December 2022.

REDUCING THE CARBON EMISSIONS OF INHALERS

INTERVIEWEE:

LAURA WIFFEN, Respiratory Research Fellow, Portsmouth Hospitals University NHS Trust (PHU)

The NHS contributes around 23 million tonnes of CO2 per year, with 3% of that footprint down to inhalers. We caught up with Laura Wiffen, to discuss the research she’s conducting that will hopefully help to shape inhaler prescribing practices for the future.

Development of the REDUCE Carbon Study began just before the COVID-19 pandemic, right as the green agenda was starting to come to the fore. We recognised the significant carbon footprint of the NHS and how much of that was contributed to by inhalers. There are many different types of inhalers available to prescribe, across the UK we prescribe a higher number of metered dose inhalers which also have the highest carbon footprint. Within Wessex, we have recently updated our prescribing guidelines to include the carbon footprint information for each inhaler.

Through the REDUCE carbon study we wanted to explore prescribing behaviours to try and understand what it is that makes people

choose one inhaler over another and whether additional knowledge of the carbon footprint would impact prescribing preferences. This information would hopefully serve to support the production of more comprehensive asthma management guidelines, facilitate a drive to greener inhaler prescribing practices, support the widespread inclusion of carbon footprint data in national and regional prescribing guidelines to ensure a consistent message and highlight the need for a standardised and inclusive ‘carbon data’ value for inhaler devices.

The REDUCE Carbon study

The REDUCE Carbon study is online and can be completed on a computer, tablet or phone and should take no more than 10 minutes to complete. It is based on the Wessex asthma guidelines and uses case studies, asking participants to rank inhaler choices using information including, cost, dosing schedule and for some participants, the carbon footprint. The study is randomised, so half the participants will get the carbon footprint of each inhaler on their guidelines and half won’t. It is not a test of clinical practice at all and we are asking all healthcare professionals to take part.

Over 1,800 people have completed the survey so far spread across different healthcare institutions, professions and specialties within Wessex. However, our recruitment drive must continue; we would like to include as many health care professionals as possible from as

many different backgrounds and specialities to really be able to understand the drivers and factors that influence their choices.

Research for healthcare professionals

Most research studies are not usually targeted at healthcare professionals. REDUCE Carbon has given us an invaluable opportunity to target a population that is often underserved by research, giving them a voice and allowing them to be involved in change. In particular we undertook a night-time trolley dash, to capture those individuals who work night shifts, who would not generally see the research team or get the chance to be involved in research because it doesn’t often happen beyond 9-5. Making this research visible also allows for invaluable education opportunities to be delivered alongside the study. I’ve really enjoyed being able to do something

“Over 1,800 people have completed the survey so far spread across different healthcare institutions, professions and specialties within Wessex.”

for healthcare professionals, providing education opportunities and supporting development at the same time as bringing colleagues with us on our journey to influence and support change.

The challenges and opportunities

Initial engagement to the study was a challenge. We learnt early on that simply sending out emails was not going to help us achieve the participation we were hoping for. So we adapted our delivery methods,

“When it comes to the opportunities, there are some exciting ones. The REDUCE Carbon Study has given us an opportunity to build on what COVID did for research and involve as many healthcare professionals as we can across the Wessex region.”

with significant efforts from the PHU respiratory research delivery team visiting the wards. We had been kindly donated a number of seed packs by Garson’s Farm to support recruitment. This has been a huge success, however we recognise that this method of delivery is not necessarily applicable to other trusts and primary care. A challenge has been how we broaden recruitment outside of PHU and this has been something that requires new ways of thinking. We need to better understand how different sites work and how we can embed research into teams with varying levels of research delivery support. The CRN delivery teams have been pivotal in increasing recruitment across community sites and primary care.

When it comes to the opportunities, there are some exciting ones. The REDUCE Carbon study has given us an opportunity to build on what COVID-19 did

for research and involve as many healthcare professionals as we can across the Wessex region. Everyone, whether they are prescribers or not, have an impact on prescribing choices. Other regions are also including carbon footprints or recommendations for green inhalers in their guidelines, with data from the REDUCE carbon study hopefully supporting a collaborative approach to influence national guidance.

The REDUCE carbon study has also raised other important issues within the green agenda. Whilst we can encourage the prescription of ‘greener’ inhalers, most are still made from plastic and will be thrown away at the end of their use due to a current lack of recycling facilities. Patients are keen to recycle their inhalers and this study may also help to increase awareness and facilitate development of widely accessible recycling schemes.

We have an opportunity now to keep research in the limelight

after COVID-19 and maintain that momentum and enthusiasm. We are incredibly grateful to everyone who has already taken part in the REDUCE study and encourage everyone who hasn’t yet taken part to have a go- thank you!

If you are a healthcare professional and would like more information about the trial, please contact laura.wiffen@porthosp.nhs.uk

Alternatively, you can take part in the study here: https://reduce.pttu.org.uk/

“We have an opportunity now to keep research in the limelight after COVID and maintain that momentum and enthusiasm.”

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THE GROWING REACH OF RENAL RESEARCH

A small team of renal research nurses are having a big impact in Dorset. We spoke to Barbara and Laura to explore the work they’ve been doing and how they’ve been helping renal research to grow by supporting Renal Research Fellows from Southampton.

INTERVIEWEES:

BARBARA WINTERGOODWIN, Senior Research Nurse, Dorset County Hospital NHS Foundation Trust (DCHFT)

LAURA BOUGH, Senior Research Nurse, DCHFT

RENAL RESEARCH AT DORSET COUNTY HOSPITAL

BARBARA: I started as an Intensive Care Nurse and then worked as a Clinical Site Manager. I moved to renal research in 2012 where I’ve worked ever since. I’ve been lucky to have worked with really engaged Principal Investigators (PIs) while I’ve been doing renal research which has helped me to enjoy it even more. I think in the whole time I’ve been here, there has been only one study that the PIs have declined.

LAURA: I’ve been here since 2014, before this I did chemotherapy and was a Dialysis Nurse, so my background is renal. I went into haematology

when I joined research and have now come back to renal. It’s lovely to work with Dr Taylor and Dr Hateboer, our consultants. Dr Taylor in particular has championed renal research. She is an excellent consultant, the whole team is brilliant.

It’s a very supportive and trusting environment, our PIs are really engaged with what we do.

BARBARA: Having studies here also gives the patients continuity – they see us whenever they come in and we can pick up other things if something isn't right.

LAURA: A patient might have a problem that has nothing to do with the study.

If this is the case, we can recognise when things aren’t right and refer them if necessary. Sometimes, we’ve been able to get other problems diagnosed or help the patient to get additional support. That happened during an observational study for polycystic kidney disease which was a five-year study. You develop good relationships with the patients and there are so many other little things that can be picked up just through having that contact with a research nurse.

A COLLABORATIVE APPROACH

BARBARA: We’ve worked with the University of Oxford a lot, and we’ve recently worked on the EMPA-KIDNEY trial testing whether taking a single pill of Empagliflozin every day slowed the progression of kidney disease. It was a long trial, about four years, but the Oxford

team are amazing to work with. Their training on trials is very thorough and they keep you up-to-date with developments and emerging results. They respond really quickly if we have questions, and they try to make it as easy for the researchers and patients as possible.

LAURA: They gave us the chance to work with pre-screening on some trials which was new to us and helped hugely with the recruitment because we had a list of hundreds of patients we could approach as soon as the trial launched.

BARBARA: Their trial design is excellent and they try to factor in everyone’s needs and make them work for patients, doctors, PIs and trial staff.

LAURA: We were one of the first sites to set up for EMPA-KIDNEY back in 2019.

BARBARA: We consented 45 participants into that trial and our target was less than that, so we did really well to over-recruit given we are such a small team.

LAURA: Having worked with the team at Oxford before, we already had a relationship with them when COVID-19 hit. This helped us hugely when it came to the RECOVERY trial which involved different treatments for COVID-19. It was great to be working across different teams and working together in different ways but because we knew the people at the top of the trial and we were using systems that we were familiar with, we were one of the first sites in the UK to be set up despite us being quite small. At one point we had really high recruitment in proportion to our population.

“Their trial design is excellent and they try to factor in everyone’s needs and make them work for patients, doctors, PIs and trial staff.”

Barbara Winter-Goodwin

Laura Bough

BARBARA: RECOVERY was so rewarding, seeing the results come through so quickly and the changes it made. We didn’t really work alongside other colleagues in different departments before that, so we got to know our colleagues better and experience different trials in different areas of the hospital.

GROWING RENAL RESEARCH

BARBARA: Part of our work now is supporting Renal Research Fellows. Tom Phillips from University Hospital Southampton was one of the first research fellows we had worked with – we were a little apprehensive because we weren’t sure how it would work but it’s been great. We worked on a trial called Protect V, where we needed a doctor to consent the patients to the trial and were lucky that Tom was able to do this.

Now we have Keegan Lee, who comes once a month from Southampton and is new to research. We’ve been showing him how to access our systems so that he can screen participants, consent and randomise. He’s applied to be an

Associate PI on a study which is great for the region and the speciality; seeing renal research growing is very rewarding.

LAURA: Both of our renal fellows have been based in Southampton, where there isn’t a hemodialysis service, so it’s nice for them to come here and to see renal research happening in an active environment.

BARBARA: Knowing that our work will eventually benefit patients fantastic.

LAURA: Within our team, Sarah Horton is our Research Project Manager. She carries out all of our data management, supporting the team and keeping everything on track.

That involves handling all the amendments and trial set-up, liaising between trial units, us and our Research and Development (R&D) department.

BARBARA: Sarah’s knowledge is amazing and it’s so important to helping the studies run smoothly, we wouldn’t be able to grow without that support.

If you’d like to find out more about what the Renal Research Team at Dorset County Hospital are involved in, you can visit their Twitter page: twitter.com/dchft_research

USEFUL LINKS:

EMPA-KIDNEY study: https://www.empakidney.org

RECOVERY trial: https://www.recoverytrial.net

PROTECT-V: https://www.camcovidtrials.net/trials/protect.htm

“Having studies here also gives the patients continuity –they see us whenever they come in and we can pick up other things if something isn't right."

Develop your career and improve patient care.

Everyone’s path in research is different, but it only takes minutes to start and can make a lifetime of difference. Clinical research is essential to our NHS. Whatever your role, you can be part of it.

For more information, please visit