For the NIHR, research impact is about making a meaningful difference to people’s lives through the research we fund and support.
Read how our work influences care and makes a positive difference to people and the economy in the impact stories below.
The children’s allergy NATASHA study
University Hospitals of Leicester NHS Trust, through the NIHR Leicester CRF was the joint second highest recruiting site overall for the NATASHA study.
We were the highest recruiting site for two out of the three arms: the peanut arm for children and young people over 6 years of age, and the peanut arm for 2-3 year olds.
NATASHA is an oral immunotherapy trial for children with peanut or milk allergy. As food allergies are increasingly common; can have potentially serious consequences; and have no specific treatments except avoidance of the allergen, it is vitally important to offer children the opportunity to take part in research. Involvement in peanut immunotherapy studies could have a huge impact on many patients’ lives, from a clinical viewpoint and the improved quality of life and increased freedom this can provide.
This was a complex trial to deliver. It was the first children’s research study at UHL using real word foods. Many considerations were required around safe preparation and use of foods. The study requires a double blind placebo controlled food challenge using either a peanut based or placebo product. Consultation was required with Dieticians, Infection Prevention, Education, Allergy Specialists, and R&I to plan which staff roles could be involved in the unblinded food preparation, what training was required, where this could be undertaken and what safeguards needed to be in place to mitigate risks.
Logistically the food challenge visits are lengthy, complex and require the coordination of a high number of different members of unblinded and blinded teams. The Children’s Research Team work hand-in-hand with the Paediatric Allergy Team to safely support the visits, and include clinicians, research nurses, specialist nurses, and research practitioners. All staff undertake annual anaphylaxis training and emergency scenario training, in addition to their Trust required mandatory life-support training.
Allergy research is a high-risk area – giving children who are allergic to peanut, a peanut product at increasing doses over time with the aim of desensitising them.
Although families are keen to have the opportunity to take part in allergy research, participation can cause anxiety and concern because the young people involved are going to have allergic reactions. The team go the extra mile to ensure that the participants are cared for inside and outside of research visits, and can personally call on them if the family have any fears or concerns especially during home dosing.
This focus on putting patients has helped to build good relationships and increase retention. The delivery team have received excellent feedback about their kindness and care.
New Elective Research Placements for University of Leicester nursing students
The Leicester CRF student nurse elective placement – in conjunction with delivering a lecture to the student cohort – has created an opportunity for University of Leicester nursing students to access clinical research as part of their course.
A student nurse who had undertaken the placement noted a gap in continuous updating and collaborating with our local R&I department, and felt there should be some process for keeping students informed up to completion of their course and into preceptor-ship.
With support and experience gained during their CRF placement, they developed the concept of a ‘Student Ambassador’ for which the student was a finalist in the Nursing Times ‘Student Nurse or Midwife of the Year: Clinical Research’ award.
The main impact of this work is to show a viable route into research delivery for graduate nurses and provide a platform for further collaborative work with universities, so that the next generation of nurses are inspired to work and develop their careers in this area.
The RECONNECT Trial Fragile X National Hub/Centre of Excellence
Fragile X syndrome is a genetic condition that can cause a wide range of difficulties with learning, as well as social, language, attentional, emotional, and behavioural problems. Some may also experience connective tissue issues such as difficulty breast-feeding, hypotonia, hyperflexibility, flat feet, recurrent ear infections and mitral valve prolapse.
Fragile X is the most common inherited cause of learning disability and is often misdiagnosed. There is currently no treatment for behavioural issues that arise from this condition, hence the concept of the RECONNECT trial.
This trial has the potential to change the quality of life for both children suffering from Fragile X and their families, and hopefully provide a more holistic approach to caring for these children and young adults.
Local parents have also reported struggles with getting the right diagnosis, treatment and support and the impact this has on day-to-day family life.
From all of the work we have undertaken we are developing plans to establish a national holistic and integrated clinic and research hub for Fragile X Syndrome that involves a care assessment including access to Relate family counselling, a medical assessment, genetic counselling, occupational therapy, educational psychology and speech and language therapy.
Additional advice can include support from Neurology, CAMHS and the Rutland Rotoract Family Support Centre on request. The clinic would be run over a day face-to-face with additional discussions pre and post the clinic day with a requested involvement of a day a week for a year as part of a pilot to assess family experience and how helpful they find it.
Professor Barwell is a consultant Clinical Geneticist at the University Hospitals of Leicester NHS Trust and in partnership with the Clinical Research Facility, is the largest recruiter in Europe to a cannabinoid gel based study called RECONNECT.
Through the University of Leicester and as part of an engagement with local communities portfolio of genomic activities, we have run two conferences and have built a close relationship with the Fragile X Society and have a co-creation partnership with parents of children with Fragile X Syndrome (Chris and Alex McQuade) with a long-term aim of establishing a national hub, underpinned by holistic and integrated care and research.
Professor Barwell runs community health and social support for families with additional needs as part of the Rutland Rotoract Family Support Centre, which was recently presented with a community charitable organisation MBE equivalent Queen’s Award.
PHOSP-COVID
The Post Hospitalisation Covid-19 study (PHOSP-COVID) is a national consortium led by Leicester, working together to undertake research to better understand the symptoms and organ damage in people that were hospitalised with the COVID-19 infection and those now experiencing long-COVID.
PHOSP-COVID combines expertise from doctors, nurses, AHPs, sociologists, scientists, statisticians, and data scientists across 24 universities and 83 hospitals, together with charities and public patient groups. The PHOSP-COVID team have recruited over 7,000 participants, obtaining 16 million data points and collecting more than 100,000 samples.
The resulting research, of which many papers have been published in world leading journals, has highlighted large ongoing health impairments and provided insight into possible biological mechanisms underpinning long-COVID, informing further research into potential treatments and patient care.
From this, two clinical trials for long-COVID are now underway led by Leicester. PHOSP-R is a rehabilitation trial, which was completed in Spring 2024 and findings submitted for publication. PHOSP-I is for long-COVID participants with persistent inflammation. This is a phase IIa double blind, randomised placebo-controlled trial of Tocilizumab to investigate the effect on health-related quality of life. This is the first drug intervention trial for long-COVID.
Foundation Year 2 doctor rotation at the Clinical Research Facility
In the CRF we identified a gap in availability of medical cover for studies due to current Principal Investigator workload being at saturation point, a notable downturn in interest from junior clinicians and a lack of opportunities for clinical academics in research.
This is not just a local issue, as highlighted at a recent BMA/BMJ clinical academic conference themed “Where are all the clinical academics going?”.
This affects our ability to expand our research portfolio and increase our early phase work, due to lack of clinical cover. We also had concerns about the succession of PIs and how we could build an appetite and commitment to research for the future.
Our concept for the FY2 CRF clinical research rotation is to offer exposure and opportunity to people who otherwise wouldn’t commit to a period of time dedicated to research.
The NIHR Leicester CRF was added into the Foundation year 2 training in August 2023, as a rolling four-month rotation. This was co-ordinated by the CRF training lead, and the rotation was set out and mapped to allow trainees to specifically support the earlier phase studies so they gained exposure of higher risk, clinical trials. This was balanced by ensuring they were also supported to work in research projects in an elective speciality of their choosing and by introducing them to the NIHR Associate PI scheme.
The feedback from the trainees, local PIs and CRF staff has been universally positive.
Each FY2 was surveyed and gave feedback: there was a 75 % increase in understanding of research delivery after the placement compared to before, they felt much more confident in working in this area and had a greater understanding of the processes involved.
We also had a 100% response of “definitely will” on the metric question: ‘How likely are you to want to be part of research in your future career?’
The CRF has also been able to consider higher intensity and more complex trials with the presence of an FY2, as well as trials which require more invasive sampling (e.g. skin biopsies).
The CRF infrastructure has directly provided a training opportunity for trainee medical staff, with positive feedback to the regional training lead, and we are anticipating a second FY2 doctor from 2024 as a result. This has increased our capacity and improved research awareness, which will hopefully inspire future clinical academics.
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