Dementia

David Woodstoke - £24,087 “Developing a holistic support program for people with Mild Cognitive Impairment to reduce dementia risk and improve brain health (MCI-Active)” 

New approaches to the prevention of dementia are urgently needed. One under-explored approach is to provide people at greatest risk of dementia with a targeted support program to improve their brain health. There is a growing number of people (around 6% of people over 60 years) living with Mild Cognitive Impairment (MCI). People with MCI have problems with memory and thinking skills that are greater than expected for the normal ageing process, but do not have major problems with day-to-day tasks. Not everyone with MCI will progress to dementia, but many do (around 5-15% per year). People can be helped to reduce their dementia risk by improving their brain health. This can be achieved through changes in lifestyle, tackling physical and mental health conditions, and training thinking skills. At present, there are no approved programs for people with MCI offered within the NHS, and people are usually discharged quickly with limited advice. In this project we will adapt and trial a new group program to address this important gap.

Clinical researchers at The University of Sydney developed the Healthy Brain Ageing program to help people improve their thinking skills and wellbeing, with the aim of delaying progression to dementia. Sessions offered a mix of health education, group discussions and thinking skills training. People attending this program demonstrated significant improvements in their thinking skills, mood and sleep quality, and valued attending the group. We plan to adapt the Australian program to use within the NHS. To do this we will adjust the program materials so that they are relevant to a UK audience, and complete training to deliver the program effectively. This work will be guided by the findings from our recent Patient and Public Involvement (PPI) project, which involved meeting with MCI patients, family members, and expert clinicians. 

We will then test the adapted program by delivering it to 3 groups of patients with MCI within our clinic. We will deliver the program to group 1 and evaluate their feedback. We will use this to update and improve the program for group 2, and repeat this process again for group 3. In total, we will deliver the program to 24 patients. We will meet with our PPI group throughout the project to help guide the improvements we make to the program. A range of questionnaires will be completed before and after the group program, and 3 months later. These will capture changes in thinking skills, wellbeing, lifestyle, dementia risk, and feedback on the program. We will use these to assess whether the program is feasible, well-received, and whether the outcomes show promise. The results will support an application for more funding to carry out a full trial of the new group program. 

Lastly, our PPI group will support us with sharing the project findings. We will present at local public events and research forums within the hospital and University of Bristol, and at national brain health / dementia conferences. We will also publish our work in a scientific journal.

Maternity

Jo Crofts - £24,844 “Cell Salvage at Assisted Vaginal birth Evaluation study - A Feasibility Study: Investigating the feasibility, safety and acceptability of collecting and processing blood lost vaginally following childbirth using cell salvage (Cell SAVE)” 

Background

Blood loss is sadly a leading cause of maternal death. Significant blood loss is more common in births requiring medical intervention, such as caesarean sections or the use of forceps. This can lead to anaemia and the need for blood transfusions. Donor blood is a scarce resource and carries risks, including infections (as highlighted in the 2024 Blood Scandal Inquiry), reduced immunity, lung injury, intensive care admissions, and prolonged hospital stays.

Cell Salvage

At Southmead Hospital a process called Intraoperative Blood Cell Salvage (IOCS, or “cell-salvage”) is used during caesarean births to reduce the need for women needing a transfusion of donor blood. Cell salvage allows a patient's own blood to be collected, cleaned, and returned during surgery, reducing both risks and costs associated with donor blood transfusions. Women who have an assisted vaginal birth with forceps of ventouse often lose more blood than women having caesareans, but cell salvage is not routinely used in these cases due to concerns about bacterial contamination of the blood and a lack of research on its feasibility and safety.

The Cell-SAVE Study

This study will look at whether it’s possible, safe, and acceptable to use cell salvage (a method to collect and clean blood) for blood lost during assisted vaginal births.

We will collect any bleeding following 77 assisted vaginal births using a small suction tube (this blood is normally disposed of in clinical waste). If enough blood is collected it will pass it through the cell salvage machine to clean and concentrate it. A small amount of the cleaned blood will be sent to the laboratory to be tested for bacteria.

During an emergency caesarean birth blood will be collected and passed through the cell salvage, as is normal practice at Southmead Hospital. If recycled blood is generated by the machine, the blood will be given back to the woman, minus a small sample which will be tested for bacterial contamination.

We will ask participants to complete two short questionnaires after they have been discharged from Hospital.

How will women be approached?

All women who are planning to have their baby at Southmead will be sent the Cell-SAVE information at 36 weeks of pregnancy. If an emergency caesarean or assisted vaginal birth in theatre is needed, women/pregnant people will be asked if they are aware of the study and can opt out if they wish. Women in which cell salvage has been used in theatre will be asked for their written consent for the research team to send them two online questionnaires in the first month following the baby’s birth and for the research team to send a small sample of blood for bacteria testing.

Public Engagement

To keep the study patient-focused, a panel will be formed, including those who have given birth, experienced significant blood loss, or received blood transfusions. Experts in transfusion and blood conservation, as well as representatives from maternal health charities, will also participate. This panel will help guide the study's design and execution.

Future Plans

If we demonstrate that we can collect enough blood vaginally to create recycled blood and that blood does not have a significantly higher level of bacteria in it compared to blood collected during caesarean births, we will apply for funding for a larger trial to assess whether cell salvage benefits women wo give birth vaginally.

Vascular

Kitty Wong - £24,965 “Effectiveness of intensive care for patients undergoing carotid surgery, lower limb bypass, or major lower limb amputation” 

Background

Every year, over 12,000 people in the UK undergo major surgery to treat narrowing or blockages of the blood vessels. These operations are high risk and outcomes are poor, especially as these patients are often frail with many medical conditions. Consequently, patients often need to go to intensive care to as part of their recovery. These are specialist wards with teams that provide intensive monitoring and treatment, which help to treat serious post-operative complications that are difficult to manage on the ward. However, invasive tests in intensive care can be traumatic for patients. The lack of intensive bed space currently leads to cancellation of 347 urgent operations per month, which could negatively impact people’s lives due to progression of untreated disease, and it is not feasible for all patients to go to intensive care. There are currently no guidelines to tell us who is best treated in intensive care, and who can recover safely on a normal ward without impacting their recovery.

Aims

Our study will look at how intensive care beds are being used currently for people having major surgery on the blood vessels across the UK, and find out who may benefit from intensive care versus normal ward-based care. This will help us to understand the benefits and risks in each situation. 

Design and methods

Information routinely collected in the NHS about people who had major surgery on the blood vessels from 2014 to 2023 will be used to:

• Find out how many people went to intensive care after surgery
• Compare patients who went to intensive care after surgery with those who went to a normal ward
• Look at what happened to each group afterwards, such as if there were any deaths and complications from surgery and how quickly patients left the hospital.

We will assess which groups of patients, for example based on age or type of operation, would benefit more from intensive care or ward-based care. The study will only use older existing data and will not compromise current patient care while it is being conducted.

Patient and public involvement

We approached the Bristol Vascular Patient Advisory Group (PAG) who helped write the lay summary, and advised they would prefer the term ‘intensive care’ and that important outcomes include death and quality of life measures. The Royal College of Anaesthesia (RCoA) patients, carers and public group (PCPIE) were also involved in study design. Patient representatives and members of the public will be invited to a steering group to help further refine our study design and decide what outcomes are the most important, and advise on how best to explain the study and its results to patients and the public.

Dissemination

Our study group has links with key organistions to develop recommendations and guidelines based on our results.  We  will discuss and share our findings with patient, public, and clinical representatives, present at national and international conferences, and publish in research journals.

Dementia

Laura Hanley - £24,799 “Exploring differences in the clinical presentation of dementia in men and women and the potential role of inflammation” 

More women are diagnosed with dementia than men and women have worse performance on tests of their thinking skills when they have dementia. It is not fully understood why there are these differences between men and women.  Understanding why these differences occur could help us to improve the diagnosis of dementia, for women in particular, and allow better treatments for dementia to be developed.

Many factors play a role in a person developing dementia.  Neuroinflammation (inflammation in the brain and nervous system) is one such factor. In women, the reproductive hormone oestrogen is known to help protect against neuroinflammation.  At the time of menopause (when a woman has stopped having periods), levels of the reproductive hormone oestrogen fall.  This means that as a women ages, the brain may not have the same levels of protection from neuroinflammation as it did before.  It is not known whether this change in the brain’s protection from neuroinflammation is one of the reasons why more women develop dementia.

In this study, we aim to investigate potential differences in the clinical presentation of men and women diagnosed with dementia.  We will begin to explore if neuroinflammation could explain some of these differences. It will also highlight important questions that still need to be answered about the links between menopause, neuroinflammation and dementia.

What is the study going to do?

The first part of the proposed research study aims to summarise all the published research findings on differences between men and women who have dementia, which will highlight what is still not known about the differences between men and women. We will identify key questions for future research to fill these gaps in our knowledge.

In the second part of the study, we will use a research database from an existing study called DREAMS-AD. The DREAMS-AD database will contain clinical measures from 395 participants when our proposed study starts.  All participants in DREAMS-AD have given consent for their clinical measures, which include biomarkers for dementia and cognitive test scores, to be used in other research studies that have ethical approval. 

We will explore potential differences in the clinical measures from men and women.  In addition, we will also begin to explore if there are differences between men and women in measures associated with neuroinflammation. 

In the final part of the study, we will review and summarise what is already known about neuroinflammation at the time of menopause.  We will explore how inflammation may be linked to menopausal symptoms, particularly those associated with our cognition (thinking skills).  We will identify gaps in our knowledge and makes suggestions for future research to fill these gaps.

Why is this study Important?

The proposed study is the first step in exploring potential differences in neuroinflammation between women and men diagnosed with dementia and whether neuroinflammation could be a link to understanding why women are more at risk of developing dementia.

Breast Care

Katherine Klimczak £19,991 – FAST MRI OPERA

Optimisation of the FAST MRI protocol: an evaluation and analysis of what makes a good breast MRI through detailed analysis of scans from multiple NHS sites contributing to the FAST MRI Programme Finding breast cancer early saves lives.  The NHS Breast Screening Programme (NHSBSP) uses mammograms to detect early breast cancers. However, not all cancers show on a mammogram so a cancer can be missed and continue to grow until the woman finds it herself.  Magnetic Resonance Imaging (MRI) scans are better at detecting cancers than mammograms.  However, MRI is expensive, and the NHS only uses it to screen women classed as high risk (women with a 4 out of 10 chance of developing breast cancer during their lifetime, almost 3 times the chance of most women (average = 1 out of 7 chance).  

Recent studies have shown that using only part of the full breast MRI scan detects cancer equally well as the full scan but is a much quicker scan with lower costs. This technique is called FAST-MRI and has the potential to save more women’s lives by finding breast cancers earlier than a mammogram and providing value for money for the NHS.  A group of research studies led by North Bristol NHS Trust aim to develop a better breast screening programme using FAST-MRI for women who currently have mammograms to screen for breast cancer.

How easy it is to see a breast cancer on an MRI scan depends on the scan quality and the technical details of the scan, known as the protocol. Quality control is therefore crucial for breast screening to optimise the detection of cancers.  This pilot study will develop a standardised and optimised protocol to be used in a separate multicentre trial of FAST-MRI for women having their first screening mammogram (current shortlisted application to NIHR by the NBT-led FAST-MRI programme). 

Neurology

Richard Ibitoye £17,550 - Detecting Cerebral Venous Thrombosis: An Artificial Intelligence Approach

Clots in veins are an uncommon but important cause of stroke in younger adults (under 50 years old). Unlike arterial strokes, cerebral venous thrombosis is far more difficult to diagnose. Prompt diagnosis and treatment is however key to minimising the risk of disability and death. Patients present with a range of symptoms, meaning stroke may be unsuspected. Furthermore, the initial plain head CT scan is often ‘normal’ – so the problem may be missed. Additional scanning of the brain’s veins (venography) is essential to diagnosing cerebral venous thrombosis. Additional scans however cost time and radiology resources, and may expose patients to unnecessary risk through X-rays and contrast injections. It is not clear which patients should be offered venography in addition to a plain head CT, particularly when headache is the presenting symptom. As over 60,000 people are admitted with headaches each year in England, the challenge is significant.

Many studies have shown that plain CT scans contain useful information about the chance of cerebral venous thrombosis. Even with the best reporting by a radiologist, 1 in 4 cases of cerebral venous thrombosis are missed. A quick and accurate way to decide who will benefit from venography does not exist. Machine learning – the use of advanced computation to learn patterns in images – may help. Machine learning benefits from large amounts of data on patients with cerebral venous thrombosis to be used to train a decision-maker/classifier. Lack of access to such clinical and scan data has previously made such work impossible. A recent collaboration between North Bristol NHS Trust (NBT) and University of Bristol - the Stroke Imaging and Clinical Database for AI (artificial intelligence) – for the first time provides access to the large amount of anonymised imaging and diagnostic data necessary for this type of work.

This proposal aims to use machine learning to support decisions in diagnosing cerebral venous thrombosis. This will involve selecting pre-existing anonymised data in the Stroke Imaging and Clinical Database for AI from patients with cerebral venous thrombosis and controls, then applying machine learning. If successful, an ‘AI classifier’ would be a critical step towards supporting clinicians in making more rapid, and more accurate diagnostic decisions in cerebral venous thrombosis. Unnecessary tests can be avoided – saving patients both time and risk, while simultaneously supporting the earlier detection of cerebral venous thrombosis. A successful outcome has the potential to transform the diagnosis of cerebral venous thrombosis across the NHS with better outcomes for patients.

Intensive Care Medicine

Matt Thomas £17,686.86 - DINE-N - Does Intermittent Nutrition Enterally Normalise hormonal and metabolic responses to feeding in critically ill adults? 

Everyone needs food but many people don’t eat well enough, and especially those with illnesses are often malnourished. For example, up to half of intensive care patients are malnourished on admission to hospital. Malnourished patients are less resilient and consequently suffer more complications and are less likely to survive. 

When patients can’t eat enough, while on intensive care, we put a tube through their nose into their stomach (a nasogastric (NG) tube). We give liquid food through the tube, hour after hour, day and night, minimising breaks – we call this continuous feeding. The idea is to correct the harmful effects of malnutrition. 

This is a very abnormal way to provide feed. It has unpleasant side effects like nausea, diarrhoea and insomnia.  It often does not give enough calories. Importantly it also changes the way the nutrients are used by the body. This could mean the food does not correct the harmful effects of malnutrition. It could even mean continuous feeding makes the problem worse.   

This study aims to assess the response of critically ill adults to intermittent daytime feeding and overnight fasting. We know critically ill patients are all at high risk of malnutrition, have NG feed routinely, and are very closely monitored. The response will be assessed clinically (calories delivered) and with multiple laboratory measures (for example blood insulin levels).   

Respiratory

Geraldine Lynch £19,644 - REPLICA  - Can performing extra tests on non-diagnostic biopsy samples avoid the need for further invasive biopsies in people with suspected cancer of the lung lining? 

Pleural mesothelioma (PM) is a cancer that affects the outside lining of the lung, caused by asbestos exposure. The UK has the highest rate of PM in the world, but despite recent treatment advances, average life expectancy remains under a year from diagnosis. Prompt diagnosis is therefore vital. 

People with suspected PM usually require a biopsy of the lung lining to confirm the diagnosis, guide treatment and assist with compensation claims. However, some people need multiple biopsies which increases the risk of biopsy-related complications and prolongs the diagnostic process, causing additional stress and anxiety.

We previously conducted a study of people with suspected PM who required further biopsies as their first biopsy did not diagnose the condition. All patients consented to be in this trial and an application is underway for approval to perform additional tests on the trial samples. We want to re-test their original and follow-up biopsy samples for BAP1, p16 and MTAP to see whether this would have made the diagnosis sooner and removed the need for further biopsies. We will investigate how many biopsies could have been avoided, how much time would have been saved, and what cost-savings this would have offered the NHS. 

We hope our research will show how useful these tests are and how much benefit they offer to patients and NHS services, so they can be used more widely in routine care. Ultimately, we expect our research to be included in national guidelines and change clinical practice across the UK and worldwide.

Breast Care

Katherine Klimczak £19,366.00 - FAST MRI ENAID - Selection for personalised screening with FAST MRI: Evaluation of an Artificial Intelligence (AI) tool, developed within and owned by the NHS to accurately measure mammographic breast density 

Finding breast cancer early saves lives. The NHS uses mammograms to try and detect early breast cancers. However, as mammograms do not show some cancers very well, a cancer can be missed and continue to grow until the woman finds it for herself. MRI (Magnetic Resonance Imaging) is a test that can find cancers better than mammograms, but it is expensive and so the NHS only uses it to screen women at very high risk of breast cancer. A quicker, shorter MRI test is now available called FAST MRI. Not only might this test benefit more women, it may also provide better value for money for the NHS to find breast cancers early and save lives. 

Every woman’s breasts are different. One way they differ is in their composition, which affects how they look on mammograms. Women with denser breasts can have their cancers missed on mammograms, as the dense normal tissue can hide the cancer. FAST MRI is better at finding these cancers.

To find out which women have dense breasts and could benefit from a FAST MRI, the mammograms need to be studied and measured. Currently, breast density is looked at and estimated by the radiologist but as each radiologist might view images slightly differently, results for breast density might not always be correct. There are now better systems to do this using (expensive) technology.

The research aims to evaluate the accuracy and reliability of a breast density measurement tool. This will provide the National Breast Screening Programme (NHSBSP) with the ability to describe a woman’s breast density. If this tool is successful, it will further enable the North Bristol NHS Trust led FAST MRI research programme to develop a better breast screening programme.

Respiratory

Rahul Bhatnagar £19,919 – SPOTLight - A study to better understand and diagnose patients with conditions which affect the lining of the lungs 

The pleural membranes are two thin layers of tissue which cover the outside of the lungs. The pleura are vulnerable to many different diseases, which can cause them to become inflamed (leading to excess fluid buildup, called an effusion), or to become filled with trapped air (called a pneumothorax). In both situations, this can cause severe breathlessness. Unfortunately, a general lack of research means there are many unanswered questions when choosing how to best diagnose and manage pleural diseases.

At Southmead Hospital, since 2008, we have created the largest collection of pleural fluid samples and data in the world, involving over 1500 people. Using this resource, we have been able to help patients and doctors better understand pleural effusions. However, with science rapidly evolving, it is unlikely that this resource will be able to meet the needs of the next generation of NBT researchers. We therefore plan to create a new, long-term study to replace and improve on the current one, allowing us to help more types of patient; apply more cutting-edge tests; and improving patient involvement in our research. 

We plan to invite every patient who attends Southmead hospital with a pleural condition to take part in a simple follow-up study. We hope to involve at least 1200 people over 10 years, although this application only asks for support to help establish the study over the first 2 years. We would ask participants for permission to record data about their health, and to store small amounts of blood and fluid for future laboratory tests. This study would not require any additional visits to hospital as we would only collect information about what happens to them during their usual care. We would also ask patients to fill out a brief questionnaire about how they are affected by their condition. 

After 4 and months 12 months, we would send an email to the patient with the same symptom survey, so we can monitor the results over time. We would also check their medical records to confirm their diagnosis and to see how their disease was affecting them.

We hope that this project will allow us to improve our understanding of patients with pleural diseases, leading to better medical tests, while also ensuring NBT remains at the forefront of research in this area.

Women’s & Children’s

Katherine Lattey & Abi Merriel £7,990 - In preterm birth does vaginal delivery or caesarean section lead to the best outcomes?

60,000 babies are born early, before 37 weeks’ gestation (preterm) every year in the UK. These preterm births contribute to half of the 25,000 baby deaths in England and Wales each year. Of the babies that survive being born early, some have long-term health problems, which impacts the baby and their families for life and has far-reaching implications for the NHS and society. Currently, we do not know the safest way to help deliver these high-risk babies. Birth options include a vaginal birth or a caesarean section. It has been argued that caesarean section can be safer for preterm babies, however some doctors disagree and highlight that a caesarean section is more risky for the mother, for example bleeding, infections and future risk of stillbirth. 

The aim of this project is to carry out an in-depth review of the existing evidence about ways to deliver preterm babies (the “mode of birth”), to see if, when we combine all of the available research, we have enough evidence to support doctors and women in making this difficult decision.

We will identify all the research studies, based in wealthy countries since 1990, looking at outcomes for both the baby and the mother. We will combine this evidence, to see if there is a clear answer. We will look at short-term problems for the babies, such as being born unwell, but also assess longer term health. The main outcomes will be birth injury and starvation of oxygen to the babies’ brain and for the mother admission to intensive care.

Our evidence search will use electronic databases for research and then two members of our team will assess and select the research studies to be included. With the support of a statistician we will analyse the data to bring together many different studies that have been designed in different ways.

Infectious Diseases and Microbiology

Maha Albur £5,650 - CHARM - Comparing heat -moisture exchange filter (HMEF) and Lower Respiratory Tract (LRT) microbiomes in mechanically ventilated adult patients by using advanced molecular techniques.  

Despite extensive infection-control efforts, hundreds of millions of patients become infected in hospitals every year around the world. Of particular concern is pneumonia developing during artificial ventilation or ‘life support’ (using a machine called ventilator and breathing tube containing a filter) to support the lungs in critically ill patients admitted to an intensive care unit. This is called ventilator associated pneumonia (VAP). VAP is the leading cause of death from infections acquired in the Intensive Care Unit. There is, at best guess, an extra cost of at least £10,000 per patient with VAP in the UK.

Trauma & Orthopaedics 

Emma Clark £11,787 - Testing Vfrac in men: A osteoporotic vertebral fracture screening tool for use in older people with back pain

Having a broken bone in your back (vertebral fracture) is a marker of weaker bones (osteoporosis) and greatly increases the chances of having another broken bone, including hip fracture. Vertebral fractures are common, with approximately 12% of adults aged over 50 years having at least one. Quality of life in people with vertebral fracture is hugely reduced: they experience more pain and are unable to do things they used to, so are more likely to be socially isolated. Our experienced PPI group feel this is a very important area that needs researching to improve patient care.

The aim of this project is to test our Vfrac checklist in men. Although all development work for Vfrac has been carried out in women, men also get vertebral fractures. There is clear evidence that vertebral fractures in men predict future hip fractures in a similar way to women, and medications for osteoporosis work equally well in men and women in protection against future fractures. However, specific questions remain: 

• Do men with vertebral fractures describe their back pain similarly to women?

• Does our checklist work equally well in men or do we need a new checklist specifically for men?

We hope to address these questions with this study.  

Respiratory

James Dodd £17,273 - BRistol Evaluation of novel Airways diagnostics, Therapies & Healthcare outcomEs: BREATHE study

The team at Southmead complex airways clinic specialise in helping patients with problems of wheeze, shortness of breath, cough, and chest-tightness. We diagnose some people with Asthma or chronic obstructive pulmonary disease, but these symptoms may also be caused or made worse by other conditions. For example, problems with the voice box, referred to as Inducible Laryngeal Obstruction (ILO) and Breathing Pattern Disorders (BPD). Both ILO and BPD cause significant symptoms and distress and are often mis diagnosed. What is Inducible laryngeal obstruction (ILO)? ILO occurs when the vocal cords tighten in response to harmless triggers such as perfume or exercise, making it difficult for to breathe. The best way to diagnose ILO is to pass a small flexible camera into the back of the mouth to examine the vocal cords. This is known as a Continuous Laryngoscopy during Exercise/Provocation (CLE/P). Southmead is the only hospital in the Southwest of England that performs CLE/P and access to the test is limited with long waiting lists. What is a breathing pattern disorder (BPD)? Patients with BPD have developed abnormal breathing patterns e.g. hyperventilation. During these episodes patients experience shortness of breath and noisy breathing, which can be hard to distinguish from asthma/COPD. BPD is diagnosed through a medical history and observed breathing during CLE/P. There are effective treatments for ILO and BPD, including exercises & support from specialist therapists.

 The need for research ILO and BPD diagnoses are often missed or delayed it and is not clear exactly how common they are, or the best way to select patients for testing with CLE/P. The dangers of delayed diagnosis of ILO & BPD include inappropriate treatment for asthma/COPD, medication side effects, excess hospital appointments and A&E visits and inappropriate NHS costs.

Women’s & Children’s

Anna Davies £19,185 - Identifying barriers to taking low-dose aspirin in pregnancy, to prevent pre-eclampsia.

Pre-eclampsia (PET) is high blood pressure and protein in urine, and is a common, serious pregnancy complication. PET causes growth restriction, pre-term birth, and serious illness for mother(fits, organ problems, cardiac disease, death), with substantial NHS care-related costs for mother and baby.

Daily low-dose aspirin (LDA) can prevent PET in women with risk and is safe. At-risk women are prescribed LDA or asked to buy it(approximately £0.25p), depending on midwifery hub attended. Importantly, 40-60% of women do not take LDA as recommended(called non- or sub-optimal adherence), making it less effective. 

Women less likely to take it are smokers, younger, Black or Asian, and less affluent. No studies have investigated the reasons for this. By understanding what prevents adherence in these women, we can identify solutions to support them to take LDA, reducing PET risk. This is particularly important in these groups, who have higher risk of pregnancy-related complications and death. 

We interviewed non-adherent pregnant women, to identify adherence barriers. These women were largelyWhite/University-educated. They reported that healthcare professionals(HCPs) did not explain their PET risk, what LDA prevents, and could not answer questions. No studies have investigated HCP’s experiences of informing women about PET and LDA. In our evidence review we found no studies reporting effective interventions to support adherence to LDA or other medications. Therefore, we need to develop an effective intervention to support LDA adherence.

Women’s & Children’s

Jo Crofts £19,045 - A study investigating the feasibility of a ‘Time to Transition Caesarean section’

In the womb, a baby’s lungs are filled with fluid, which helps them develop. During labour and birth, most of this fluid goes away, and the baby adapts to breathing air.

When babies are born quickly by caesarean, they may not have enough time to clear the fluid, so the lungs remain “wet”, making it harder to breathe. They breathe faster and shallower, a condition called Transient Tachypnea of the Newborn (TTN), and often need antibiotics, breathing support, and a stay in a Neonatal Intensive Care Unit.

Reducing TTN could reduce the need for this extra care. This study will assess a new ‘Time-to-Transition Caesarean Birth’. 

Rather than being born rapidly after opening the womb, the doctor will deliver the baby’s head, keeping the body inside the womb until the baby starts to cry (for a maximum of 2 minutes). This extra time may help the baby transition to breathing air and reduce the risk of TTN.

As with any caesarean, the mother and baby will be closely monitored. If there are any concerns the baby will be immediately delivered. Everything else about the birth and recovery remain unchanged.

Urology

Jonathan Aning £18,781 – MUTO - A qualitative evaluation of patient, carer and clinician perspectives on Percutaneous Nephrostomy and Ureteric Stenting for malignant upper tract obstruction towards the end of life.

Advanced cancer can block the ureter, of one or both kidneys, preventing urine flow and causing kidney failure. This commonly happens in people approaching the end-of-life. Blockage symptoms may include pain, feeling sick/tired and suffering infections. 

There are two treatments available:

1. Percutaneous Nephrostomy(PCN): the doctor places a tube through the patient’s skin into the kidney whilst awake using local anaesthetic. Urine then drains into a collection bag outside the body.
2. Retrograde Ureteric Stent insertion(RUS): the doctor places a tube through the bladder into the kidney whilst the patient is asleep. Urine then drains through the ureter.

It’s not known whether these treatments improve quality-of-life or increase length of life beyond a few weeks/days for people with advanced cancer and we may be doing harm without knowing. These treatments can be troublesome for patients, causing long term pain, inconvenience to daily life including multiple additional hospital and/or GP visits. Over 2900 PCNs are inserted each year for this condition in England. This number is increasing and inter-hospital variation has been demonstrated.  

Limited information exists to help people decide between PCN/RUS/no surgical intervention. Most people with these blockages are treated as an emergency which usually doesn’t allow time to fully consider options. This study aims to investigate the degree to which patients, carers and HCPs value these treatments and their information needs.

The questions the research looks to answer are:

What are the experiences of patients with kidney blockages due to cancer and of the healthcare professionals(HCPs) responsible for treating them in hospitals with differing first-line treatment approaches(PCN/RUS)?

How do patients view the information they receive before making their treatment decision?

Infection Sciences

Fergus Hamilton £16,640 - Scavenge sampling for optimising antibiotic dosing in critically unwell patients

Antibiotic therapy is a critical component of modern medicine, but it is increasingly recognised that dosing of antibiotics in the critically ill is imprecise. For our commonly used antibiotics, actual drug levels after the same dose are very variable, with up to 500-fold variation in drug levels. This means around 15-20% of patients in intensive care do not achieve adequate drug concentrations to effectively kill bacteria, and these patients have a significantly increased mortality.  Alongside this, there is a potential for sub-optimal therapy to lead to antimicrobial resistance as we do not adequately treat infections. Currently, international guidance recommends measurement of antibiotic drug concentrations during therapy in the critically ill in order to ensure the correct dosing of the drug. 

However, this guidance is not currently widely followed as taking drug levels requires a specific sample, taken and placed immediately on ice, both before and shortly after the drug is given, between the hours the laboratory is open. This complexity precludes widespread adoption of this policy, despite supporting guidance.

This complexity often means the real turn-around time is often 48-72hrs; during which time the patient is on potentially the incorrect dose.

In this study, we want to investigate whether we can use already taken ‘scavenged’ blood samples taken as part of routine care to measure these drug levels and get reliable results on same day samples. In all unwell intensive care patients, a blood sample is taken routinely at around 4am for monitoring of biochemistry. After this analysis has been performed, we will then ‘scavenge’ the left-over sample from the biochemistry department and perform testing on this sample. This means we will get an antibiotic drug level result by midday on the day after the drug is started, improving the turnaround time by > 24hrs. This has the potential to improve antimicrobial treatment in the critically unwell and allow us to provide precision dosing to many more patients with critical infection.

Renal

Maria Pippias £6,365.56 - Incidence and outcomes of in-hospital cardiac arrest in the United Kingdom kidney replacement therapy population.

When a person’s kidneys fail, they may start kidney replacement therapy by means of dialysis or receive a kidney transplant. Although these replace some of the kidney’s functions, individuals living with kidney failure are at high risk of serious health problems, including sudden death (1-3, 7-17). Cardiopulmonary resuscitation (CPR – heart massage) can prevent death for a small number of people whose hearts stop beating (cardiac arrest). Several research studies have tried to understand how often cardiac arrest happens in people with kidney failure, how likely they are to survive, and what quality of life they are left with. However, the findings of these studies are not always in agreement with each other and none of them come from the UK.

To understand which treatments someone would or would not want in the future, healthcare professionals need to discuss these situations ahead of time. This process is called advance care planning. It gives the patient and their loved ones the opportunity to consider their wishes about care and health outcomes that they would find acceptable. However, we do not have enough information about how many people survive and what quality of life they have after having a cardiac arrest and receiving cardiopulmonary resuscitation. 

To answer these questions, we have designed a study that plans to look back at data already collected and available in data registries in people receiving kidney replacement therapy between 2012 and 2021. Using statistical analysis, we will describe how often people receiving kidney replacement therapy have a cardiac arrest when in hospital. We will also describe how many people receiving kidney replacement therapy survive a cardiac arrest after receiving cardiopulmonary resuscitation, how long they live for and what quality of life they have after leaving hospital. To measure quality of life, we will use data that measures a person’s ability to work and perform activities of daily living. We will also describe how these findings change in different groups, for example if receiving dialysis or a transplant, whether the individual has diabetes or not and by their age and sex. By using already collected data, this study does not place additional burden on patients or services. Alongside statistical analysis, we will work with a group of people living with kidney disease. They will help us to better understand the information they need to decide whether they would like to receive CPR, how they would like to be told about their options and the language that is acceptable to them when discussing treatment outcomes. 

To inform patients about our findings, we will work with UK kidney charities to make information accessible and available via their websites and patient information leaflets. This will help inform advance care planning conversations and allow patients to make decisions that are in keeping with their wishes and views on living and dying with kidney failure. The improved decisions will result in less harm and more benefit for patients.

Respiratory

Shaney Barratt £8,892 - Investigating novel approaches to prognostication and disease monitoring in fibrotic interstitial lung disease

The Progressive Fibrotic Interstitial lung diseases (PF-ILD) are progressive, scarring lung conditions, affecting up to 70,000 people in the UK. They have a life expectancy of 3-5 years from diagnosis; a prognosis worse than some forms of lung cancer. PF-ILD progresses differently in individual patients, making the timing of introduction to advanced care planning or referral for lung transplantation challenging and creates barriers to drug development. We have established a multi-centre research study investigating the role of new technologies and biological markers in disease prognostication and monitoring in PF-ILD. This study, PREDICT-ILD, will examine how specialised computer software called quantitative CT (qCT) can aid patient assessment in predicting and quantifying disease progression. This feasibility study has been funded as part of Dr Giles Dixon’s 3-year PhD programme application and is due to start recruitment from June 2023. Dr Shaney Barratt, colead of the Bristol Interstitial Lung Disease service is joint academic supervisor of the study.

Respiratory

Dr. James Dodd
Award: £19,914 – Remote teaching of home spirometry in patients with respiratory symptoms

Spirometry is a breathing test performed by blowing at maximum force into a tube. This is deemed to be high risk for COVID-19 transmission. Safety measures have led to the number of patients having spirometry tests halving and a long waiting list.

Spirometry can be performed at home, and the results can be sent via email to hospital staff using an app. However, we do not know how patients can be effectively taught how to perform spirometry.

This study is to determine the most effective way of performing spirometry in patients own homes.

James and his team will find out how accurate the home spirometry is by comparing the results to spirometry performed in the hospital.

If this study shows that patients can be effectively taught to perform spirometry at home remotely, this will reduce the number of hospital visits patients have to make in a place where respiratory patients are vulnerable and at risk of contracting COVID-19, decrease the hospital waiting list and reduce the costs associated with face-to-face visits.

Mental Health

Jo Daniels
Award: £19,757 – COVID-19 clinicians cohort (CoCCo) study: trauma needs and preferences

Many frontline doctors are experiencing mental health problems due to the impact of coronavirus, particularly traumatic stress.

Doctors who struggle with their mental health are known to take time off sick, perform poorly at work and experience high levels of psychological distress. This can then have a knock-on effect in terms of their patient care.

Studies completed during COVID-19 have outlined how important it is to hear from doctors from their own individual point of view, so services are shaped around what these doctors want and need. 

Jo’s study aims to explore the key issues faced by doctors to understand the experience of working in a pandemic. Jo wants to know what treatment doctors want and how doctors want it.

The team will interview around 40 doctors from three groups (those working in emergency medicine, intensive care, anaesthetics). They will identify common themes from the interviews and note any differences between them.

The team will use their knowledge to develop treatment recommendations to professional groups, so that care for doctors is improved.

Renal and Urogenital

Nikki Cotterill
Award: £18,574 – Lower urinary tract dysfunction with SARS-CoV-2 infection

Nikki is interested if symptoms associated with bladder disorders start or worsen with the development of COVID-19 symptoms. There are very few studies that have addressed this question, and the preliminary results from these studies demonstrate a link between COVID-19 infection and bladder problems.

Nikki’s study aims to follow two groups of volunteers: those who have been infected with SARS-CoV-2 and display COVID-19 symptoms, and a comparable group who haven’t had COVID. Participants will be asked to fill out three questionnaires to document their symptoms to answer these questions:

• Has COVID-19 contributed to the development of these symptoms?
• Does COVID-19 infection alter the severity of existing symptoms?
• Do symptoms change over time: do they rise and fall with time; do they get progressively worse; do they lessen with time?

Whether COVID-19 increases the prevalence of these bladder symptoms in the population, especially in the older group, is yet unknown but could have an impact on everyday life, need for services, and how nursing homes might respond.

Early detection and any proactive easing of symptoms can have an impact. If we know that bladder symptoms are associated with COVID-19 infection we can inform healthcare staff so that they can manage these symptoms more effectively.

Respiratory

Dr Anna Bibby
Award: £19,979 – Can we diagnose cancer of the lung lining (mesothelioma) by testing cancerous fluid for a gene called BAP1?

Mesothelioma is an incurable cancer that affects the outside lining of the lung. In the UK, 2500 people die from mesothelioma every year, which is equivalent to one person dying every four hours.

Anna will use her funding to establish whether it is possible to diagnose mesothelioma on the fluid when it is first removed. This could allow us to make the diagnosis within two weeks of the patient’s first appointment. This would shorten the anxious, uncertain time and potentially mean patients didn’t need to have additional tests. 

Anna will test a gene called BAP1, which is part of the DNA building blocks found in every cell in our bodies that make up who we are and how our bodies behave. In normal cells, the role of BAP1 is to stop tumours appearing and, if they do appear, prevent them growing. However, when mesothelioma tumours take over normal cells, the BAP1 gene disappears, which is why mesothelioma tumours can grow inside the body. 

We can currently test biopsy samples for BAP1. If it has disappeared, then the diagnosis is definitely mesothelioma. We want to find out whether we can test BAP1 in fluid as well as biopsies and whether this will be a reliable test for mesothelioma. 

Respiratory

David Arnold
Award: £5000 – Rapid Diagnostics in Pleural Infection

Pleural infection is the collection of infected fluid around the lung. It affects around 15,000 adults in the UK every year. The usual length of hospital admission for this condition is over 2 weeks. Part of the need for such extended hospital stays is due to difficulty for doctors in working out which patients might get better with antibiotics alone, who will need the infected fluid draining and who will require surgery.

David is testing to see whether testing levels of a protein called suPAR in pleural fluid can help us to predict which patients will require hospital admission, a chest drain or surgery,

If this marker could show that some patients could be managed less invasively then this has the potential to reduce the need for procedures and hospital admissions which would be beneficial to patients and the health service.

Intensive Care Medicine

Matt Thomas
Award: £19,688 – Early beta-blockade in severe traumatic brain injury: a pre-randomised controlled trial qualitative study

Damage to the brain following an accident has two forms. Primary injury happens at the moment of impact and cannot be altered. Secondary injury happens in the minutes, hours and days after the event and can be improved by medical treatment. Less secondary injury means patients are more likely to survive, and to survive with less disability.

One cause of secondary injury is adrenaline, a natural hormone released at times of stress. Too much adrenaline can make blood vessels leaky. This causes brain swelling which leads to secondary brain damage.

For this funded research, Matt will be investigating the challenges that researchers face when carrying out this type of research in intensive care to ensure that future trials into beta blockers and traumatic brain injury are successful.

Vascular

Shona McIntosh
Award: £19,986 – Is prognosis discussed with adult patients who have peripheral arterial disease?

Peripheral arterial disease (PAD) is a disease of the circulatory system affecting both sexes and increases in occurrence with age. It happens when arteries narrowed by calcium, cholesterol and fat deposits prevent adequate blood flow to the legs. Patients with inadequate blood supply to limbs are also likely to have narrowed arteries in other areas of their body putting them at increased risk of stroke, heart disease and kidney disease.

Patients with PAD who are facing amputation are likely to have a reduced life expectancy: four in ten patients undergoing amputation die within a year after surgery, and approximately seven out of ten will die within five years. This is a poorer life expectancy than for many people with cancer. Physical and psychological needs may be overlooked in patients with PAD in the last 6-12 months of life by clinicians looking after them because their declining health is difficult to predict.

The aim of Shona’s research is to understand the factors affecting discussions about life expectancy for patients who have PAD, and whether the barriers to having these conversations lie with the patient, the clinician or both.

Psychology

Dr Jo Daniels
Award: £13,805 – A study establishing need and experience of high impact users in A&E with abdominal pain

People who attend the Emergency Department (ED) between 5-10 per year classed as high impact users and over 31,000 people attend ED over 10 times a year. The third most common reason for visiting the Emergency Department is abdominal pain which can be difficult to accurately diagnose or treat. Additionally, there is often no medical cause for the pain.

This is problematic for ED doctors, because although they do not want to overlook a serious medical emergency, they also want to avoid prioritising and spending excess time on patients who could be treated by GPs or self-manage at home There is no clear plan of action yet developed for doctors to treat abdominal patients effectively; there are no treatments that work and very little in terms of guidelines. This is surprising given how distressed these patients are and how much they cost the NHS.

Patients often find it difficult to hear that there is nothing medically wrong when they are in so much pain and distress. This can make them more worried (thinking perhaps something has been missed) which can cause symptoms to worsen by focussing on them, which then for some gives panicky symptoms such as feeling hot and palpitations which may be taken as evidence that something is really wrong

Jo aims to understand the needs and experiences of these patients attending A&E. She plans to use this information to help develop treatments in the future, improve quality of life for these patients and also benefit the NHS through expected cost savings.

Women's Health

Katharine Gale
Award: £19,992 – The Working Lives of Menopausal Women in the NHS

The overall aim of Katharine’s research project is to investigate the working lives of women in the NHS, focusing on the menopause to discover what women describe as supportive management and explore how the organisation can improve support & guidance for their female staff within the organisation.

The menopause is the time in every woman’s life when her periods stop and usually occurs between the ages of 45 and 55, with the UK median age of the menopause being 51. The average duration of moderate to severe hot flushes is 10 years but symptoms include night sweats, poor concentration, tiredness, poor memory and lowered confidence, with 25% of women experiencing symptoms they describe as severe. There are over 3,000 female employees in NBT aged between 41 and 60 years and therefore either likely to be affected by the menopause or have a lived experience of dealing with the impact at work.

The aims of Katharine’s research project are:

• To identify the unique health needs of menopausal women
• To explore the experiences of these working women during the menopause
• To identify any barriers to accessing health care, support and advice
• To make recommendations on how women’s working lives could be improved in our organisation

A thin flexible tube is passed gently into your nostril. You will then be asked to take small sips of water through a straw which will help move the tube down the oesophagus and into your stomach. You will feel a slight sensation at the back of your throat but it should not be painful.

Once the tube is in place you will be asked to lie down on the couch, propped up slightly by a pillow.

We will then ask you to lie still whilst we take measurement of your oesophagus. Following this you will also be asked to swallow small mouthfuls of water and sometimes food. After this, the test is complete and the tube will be carefully removed.

If you do not need a 24hr pH/impedance monitoring study, you can go about your normal daily activities and resume any medication stopped.

If you may need assistance transferring onto our procedure couch please contact the department before attending your appointment.

A thin tube will be passed into your nostril and then down your oesophagus into your stomach with the help of you sipping and swallowing on water.

The tube will be positioned in the oesophagus just above the valve and taped securely to the side of your nose and face. It is importance that this tape stays on to ensure the tube is in the correct place.

You will be asked to record your symptoms, meal times, and bedtime on the monitor throughout the 24 hours. You will also be provided with a paper diary, which should be completed and returned the following day. Symptom recording will be explained to you after your procedure.

You can eat and drink as normal and we encourage you to carry out regular daily activities as well as symptom provoking tasks.

You will be required to take out the tube at home. This will be explained to you during your appointment. Once removed, the white tube and connector can be disposed of as waste.

Please return the monitor and diary sheet to Gate 36 Reception.

Please do not take the specified medication on page 2 until the tube is removed. Once the tube is taken out you can re- continue any medication stopped. 

• If you have any problems while you have the tube in overnight, please contact the person who performed your test using the on number provided to you.
• In an emergency situation if you are feeling very unwell please go to A&E.

The benefit of having the test is to accurately measure how the muscles of your oesophagus and the valve where it joins to your stomach are working. 

There is a small risk of bleeding (in the nose) when the catheter is inserted. There is also a theoretical risk of perforation (a tear) to the oesophagus, but this has never been documented to have happened during one of these tests.

You should already have had either an upper gastrointestinal (GI) endoscopy or a barium swallow to look at the lining of your oesophagus to check for obstructions. If you have not had one of these tests in the last 2 years, please contact the department before coming to your appointment. This test, however, investigates the muscle function of your oesophagus and currently there is no alternative. 

If you feel like your symptoms have improved since your referral to us or if you require any additional information about the investigations, please contact us using the details on the back page. If unavailable, please leave a message and you will be contacted.

If you require any additional information concerning the investigations or any advice, please contact us using the details below:

• If no answer, please leave a message and you will be contacted.

Hydrogen breath tests are very safe. In some cases the test my trigger your usual symptoms. 

The hydrogen breath test is only dangerous in the following two (rare) scenarios: 

• If hereditary fructose intolerance is suspected (or known) you must not undertake the fructose load test or sorbitol load test.
• If you have postprandial hypoglycaemia (low blood sugars after eating) of unknown cause, you must not have a hydrogen breath test.

A report with your results will be sent to your referring consultant or GP. If you require treatment, your doctor will arrange this. You may be asked to return for another appointment if an additional test using a different sugar has been asked for. You will be able to resume normal activities following the test.

There are no alternative tests for diagnosis other than a trial of antibiotics in the case of suspected small bowel bacterial overgrowth, or dietary exclusion in the case of suspected sugar intolerances.

The appointment is for 2-3 hours with breath samples being taken every 20 minutes. This can feel timely and therefore please feel free to bring a book or magazine.

If you are diabetic please let our department know using the contact information below. 

Please bring the following to the appointment:

• Your blood glucose monitor (if you have one).
• Food to eat after the test.
• Insulin (if you use this).

The Bladder and Bowel Foundation 

The Bladder and Bowel Foundation is a UK wide charity dedicated to helping people manage their continence needs as a result of both bladder and bowel control problems. They can be contacted at: 

• Bladder & Bowel Foundation, SATRA Innovation Park, Rockingham Road, Kettering, Northants, NN16 9JH
• Supporting Your Bladder & Bowel Health | Bladder & Bowel Community

British Nutrition Foundation 

This organisation is a registered charity that provides information on food and nutrition. They can be contacted at: 

• Imperial House 6th Floor, 15-19 Kingsway, London, WC2B 6UN
• British Nutrition Foundation - Homepage

Allergy UK 

This organisation is a national charity that provides information and advice on allergies and intolerances. They can be contacted at: 

• Imperial House 6th Floor, 15-19 Kingsway, London, WC2B 6UN
• Allergy UK | National Charity

When you go to your GP or hospital, the doctors and others looking after you will record information about your health. This will include your health problems, and the tests and treatment you have had. They might want to know about family history, if you smoke or what work you do. All this information that is recorded about you is called patient data or patient information.

When information about your health care joins together with information that can show who you are (like your name or NHS number) it is called identifiable patient information. It’s important to all of us that this identifiable patient information is kept confidential to the patient and the people who need to know relevant bits of that information to look after the patient. There are special rules to keep confidential patient information safe and secure.

There are lots of different types of health and care research.

If you take part in a clinical trial, researchers will be testing a medicine or other treatment. Or you may take part in a research study where you have some health tests or answer some questions. When you have agreed to take part in the study, the research team may look at your medical history and ask you questions to see if you are suitable for the study. During the study you may have blood tests or other health checks, and you may complete questionnaires. The research team will record this data in special forms and combine it with the information from everyone else in the study. This recorded information is research data.

In other types of research, you won’t need to do anything different, but the research team will be looking at some of your health records. This sort of research may use some data from your GP, hospital or central NHS records. Some research will combine these records with information from other places, like schools or social care. The information that the researcher collects from the health records is research data.

In clinical trials, the researchers are collecting data that will tell them whether one treatment is better or worse than other. The information they collect will show how safe a treatment is, or whether it is making a difference to your health. Different people can respond differently to a treatment. By collecting information from lots of people, researchers can use statistics to work out what effect a treatment is having.

Other types of research will collect data from lots of health records to look for patterns. It might be looking to see if any problems happen more in patients taking a medicine. Or to see if people who have screening tests are more likely to stay healthier.

Some research will use blood tests or samples along with information about the patient’s health. Researchers may be looking at changes in cells or chemicals due to a disease.

All research should only use the patient data that it really needs to do the research. You can ask what parts of your health records will be looked at.

If you take part in some types of research, like clinical trials, some of the research team will need to know your name and contact details so they can contact you about your research appointments, or to send you questionnaires. Researchers must always make sure that as few people as possible can see this sort of information that can show who you are.

In lots of research, most of the research team will not need to know your name. In these cases, someone will remove your name from the research data and replace it with a code number. This is called coded data, or the technical term is pseudonymised data. For example, your blood test might be labelled with your code number instead of your name. It can be matched up with the rest of the data relating to you by the code number.

In other research, only the doctor copying the data from your health records will know your name. They will replace your name with a code number. They will also make sure that any other information that could show who you are is removed. For example, instead of using your date of birth they will give the research team your age. When there is no information that could show who you are, this is called anonymous data.

Sometimes your own doctor or care team will be involved in doing a research study. Often, they will be part of a bigger research team. This may involve other hospitals, or universities or companies developing new treatments. Sometimes parts of the research team will be in other countries. You can ask about where your data will go. You can also check whether the data they get will include information that could show who you are. Research teams in other countries must stick to the rules that the UK uses.

All the computers storing patient data must meet special security arrangements.

If you want to find out more about how companies develop and sell new medicines, visit the Association of the British Pharmaceutical Industry website.

• You can stop being part of a research study at any time, without giving a reason, but the research team will keep the research data about you that they already have. You can find out what would happen with your data before you agree to take part in a study.
• In some studies, once you have finished treatment the research team will continue to collect some information from your doctor or from central NHS records over a few months or years so the research team can track your health. If you do not want this to happen, you can say you want to stop any more information being collected.
• Researchers need to manage your records in specific ways for the research to be reliable. This means that they won’t be able to let you see or change the data they hold about you. Research could go wrong if data is removed or changed.

Researchers must make sure they write the reports about the study in a way that no-one can work out that you took part in the study.

Once they have finished the study, the research team will keep the research data for several years, in case they need to check it. You can ask about who will keep it, whether it includes your name, and how long they will keep it.

Usually your hospital or GP where you are taking part in the study will keep a copy of the research data along with your name. The organisation running the research will usually only keep a coded copy of your research data, without your name included. This is kept so the results can be checked.

If you agree to take part in a research study, you may get the choice to give your research data from this study for future research. Sometimes this future research may use research data that has had your name and NHS number removed. Or it may use research data that could show who you are. You will be told what options there are. You will get details if your research data will be joined up with other information about you or your health, such as from your GP or social services.

Once your details like your name or NHS number have been removed, other researchers won’t be able to contact you to ask you about future research.

Any information that could show who you are will be held safely with strict limits on who can access it.

You may also have the choice for the hospital or researchers to keep your contact details and some of your health information, so they can invite you to take part in future clinical trials or other studies. Your data will not be used to sell you anything. It will not be given to other organisations or companies except for research.

GDPR stands for the General Data Protection Regulation. In the UK we follow the GDPR rules and have a law called the Data Protection Act. All research using patient data must follow UK laws and rules.

Universities, NHS organisations and companies may use patient data to do research to make health and care better.

When companies do research to develop new treatments, they need to be able to prove that they need to use patient data for the research, and that they need to do the research to develop new treatments. In legal terms this means that they have a ‘legitimate interest’ in using patient data.

Universities and the NHS are funded from taxes and they are expected to do research as part of their job. They still need to be able to prove that they need to use patient data for the research. In legal terms this means that they use patient data as part of ‘a task in the public interest’.

If they could do the research without using patient data they would not be allowed to get your data.

Researchers must show that their research takes account of the views of patients and ordinary members of the public. They must also show how they protect the privacy of the people who take part. An NHS research ethics committee checks this before the research starts.

You will have a choice about taking part in a clinical trial testing a treatment. If you choose not to take part, that is fine.

In most cases you will also have a choice about your patient data being used for other types of research. There are two cases where this might not happen:

• When the research is using anonymous information. Because it’s anonymous, the research team don’t know whose data it is and can’t ask you.
• When it would not be possible for the research team to ask everyone. This would usually be because of the number of people who would have to be contacted. Sometimes it will be because the research could be biased if some people chose not to agree. In this case a special NHS group will check that the reasons are valid. You can opt-out of your data being used for this sort of research. You can ask your GP about opting-out, or you can find out more by visiting the NHS UK website.

If you want to complain about how researchers have handled your information, you should contact the research team. If you are not happy after that, you can contact the Data Protection Officer. The research team can give you details of the right Data Protection Officer.

If you are not happy with their response or believe they are processing your data in a way that is not right or lawful, you can complain to the Information Commissioner’s Office.

The BSRBR-RA study tracks the progress of people with rheumatoid arthritis (RA) who have been prescribed biologic (including biosimilar) and other targeted therapies in the UK, to monitor the long-term safety of these drugs.

Project Details
Principal Investigator: Dr Paul Creamer
Planned End Date: 30/09/2028
Local Ref: 3512

The study evaluates the long-term course of PsA and,patients are followed up annually, comprising patient and treatment characteristics, clinical parameters,patient-defined benefit, quality of life and adverse events. In addition, patients starting a boDMARD, bsDMARD, or tsDMARD agent (either at recruitment or subsequently) will be followed up three and six months after the commencement of that therapy, with the follow-up schedule being ‘reset’ in the event of switching between therapies. Questionnaire follow-up is tied to patients’ anticipated clinical visit schedule, and clinical centres are contacted regarding any patients lost-to-follow- up. Safety issues, serious adverse events and supplementary information are collected by standardised forms.

A biobank is also being created as part of the study. Where local facilities allow, participants may be asked to donate tissue samples (blood and urine) which, alongside the extensive clinical phenotyping, will help facilitate biomarker evaluation and the identification of specific bio-molecular predictors of treatment response.

Project Details
Principal Investigator: Dr Paul Creamer
Planned End Date: 30/09/2024
Local Ref: 4721

Systemic sclerosis or scleroderma is an autoimmune condition that causes thickening and hardening of the skin, but can also affect internal organs.

There are two major subsets of scleroderma: the limited cutaneous systemic sclerosis (lcSSc) that usually affects the skin of the face, neck, lower legs or lower arms, but can also lead to internal organ complications, and the diffuse cutaneous systemic sclerosis (dcSSc), that may affect blood circulation and internal organs, as well as the skin.

To date there is no drug that has been definitively proven to cure or modify the course of scleroderma. However, there is emerging evidence that immunosuppression and specifically mycophenolate mofetil (MMF) may be beneficial in lcSSc. The MINIMISE-Pilot trial would be an important first step to evaluate the risk and potential benefit to this disease group. MMF as the intervention of choice is both appropriate and timely, as it has been routinely used in the management of dcSSc.

The MINIMISE-Pilot trial aims to explore whether the immunosuppressive agent MMF at a target dose of 2g daily can slow down disease progression in patients with lcSSc compared to the current standard of care alone. This pilot trial will also provide critical information for the development of a future large trial that could potentially transform lcSSc patient management. This is an open label randomised prospective trial that will recruit 120 participants aged 18 or over across 13 sites in the UK. The trial will involve five (5) clinic visits which are expected to be carried out at the same time of the participants routine hospital appointment. In addition, they will receive four (4) routine telephone calls in between their clinic visits. Participants are expected to be followed up for a minimum of 48 weeks or a maximum of 96 weeks.

Project Details
Principal Investigator: Dr H Gunwardena
Planned End Date: TBC
Local Ref: 4766

Primary systemic vasculitidies (PSV), encompassing Anti-Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis and medium vessel vasculitis, are relatively uncommon diseases, but have a propensity for renal involvement and account for a significant number of patients with both acute and chronic kidney disease. The aetiology of PSV is unknown and current therapies are non-specific and associated with major side effects. Outcome data for such patients have comprised small cohort studies from single centres. Understanding the factors that influence disease outcome and the impact different therapies have outside of clinical trials can only be achieved using a larger number of patients, accrued from multiple different units.

We propose to establish the first pan-UK PSV dataset, which will collect regular returns regarding patient recruitment and outcome from all participating centres. This will facilitate investigation of disease associations, outcomes and demographic trends for the UK PSV population. We will test the hypothesis that disease incidence is increasing in Indo-Asians and why the outcome may be different among different ethnic groups, as well as investigating contemporary outcomes with modern immunosuppressive protocols. In addition, we will combine clinical phenotype with genetic studies. Specifically we will investigate genetic variation between ethnic groups by looking at variations in DNA sequences that can help to explain differences in disease susceptibility. These are investigated using many DNA specific markers, called single-nucleotide polymorphisms (SNPs) whose expression will be compared between patients from different ethnic groups.

Finally, we will be able to record the outcome of all patients treated with novel therapeutics, thus eliminating the significant reporting bias that exists. This will allow individual investigators to carry out particular projects mining the dataset.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 28/02/2022
Local Ref: 3724

The BILAG Biologics Prospective Cohort is a prospective observational cohort study of patients with SLE who are starting treatment with a biologic drug or a conventional, non-biologic therapy. The study aims to recruit 220 patients into the biologic treatment group and a further 220 patients into the conventional, non-biologic therapy cohort.

The aim of the BILAG BR is to ascertain whether using biologics in the routine treatment of SLE is associated with an increased risk of hospitalisation for infection, compared to SLE patients with similar disease activity receiving conventional therapies. The secondary purpose of the BILAG Biologics Prospective Cohort is to determine the long-term efficacy of biological therapies in the treatment of SLE.

This prospective cohort study will recruit an exposed cohort of patients with SLE treated with biological therapies and an unexposed cohort of patients with similar disease characteristics but exposed only to conventional non-biological therapies. Comprehensive data will be collected at baseline, from the clinic team and the patient, including data on disease diagnosis and activity, risk factors for infection and routine laboratory results. Follow-up data will be collected at 3, 6, 12, 24 and 36 months to include any changes in medications, adverse events, hospitalisations for infections, disease activity and quality of life along with biological samples for biomarker analysis.

Project Details
Principal Investigator: Dr Harsha Gunawardena
Planned End Date: 31/12/2022
Local Ref: 8251

Idiopathic Inflammatory Myopathies (IIM), also know as myositis, is a rare condition that causes inflammation of the muscles and can result in weakness, fatigue and disability. It can also affect other parts of the body including the skin, joints, heart, lungs and digestive tract. Treatment involves the suppression of inflammation using anti inflammatory medication before permanent damage results. However, the outcome for patients with myositis is not as good as it could be and needs to be improved. For this reason we are planning a research study to find better ways to diagnose, treat and improve the care of patients with myositis.

Patients wishing to take part will ideally attend for 4 study visits over the course of 12 months. If they continue to be seen at the hospital, they may also be asked to provide further blood samples and information on an annual basis for 5 years. At the initial visit they will be asked to sign a consent form, give a blood sample, undergo a clinical assessment and complete a number of questionnaires. Additionally (as part of their routine clinical care), they will be asked to undertake an MR scan of their muscle, a muscle biopsy, and be given the option of an MR contrast scan of their heart (these clinical results will be used as part of research findings. Follow up visits at 3, 6 and 12 months will involve further blood samples, clinical assessments and questionnaires. Additionally, they will be given the option of a second MR muscle scan, a repeat muscle biopsy and an MR contrast scan of their heart at the 6 month follow up visit.

It is hoped that the information gained from this study will help identify better ways to diagnose, treat and improve the care of patients with myositis.

Project Details
Principal Investigator: Dr Harsha Gunawardena
Planned End Date: 31/12/2020
Local Ref: 3793

Multiple Sclerosis (MS) is a progressive neurological disorder of the brain and spinal cord. It affects approximately 120,000 people in the UK and 2.5 million people globally. Most people with MS experience two stages of the disease:

Early MS – Relapsing-Remitting MS (RRMS), which is partially reversible.

Late MS – Secondary Progressive MS (SPMS), which affects the majority of patients, usually after 10 to 15 years after diagnosis.

SPMS results from progressive neuronal degeneration that causes accumulating and irreversible disability affecting walking, balance, manual function, vision, cognition, pain control, bladder and bowel function. The pathological process driving the accrual of disability in SPMS is not known at present.

Immunomodulatory anti-inflammatory disease modifying therapies (DMTs) are increasingly effective in reducing relapse frequency in RRMS, however, they have been unsuccessful in slowing disease progression in SPMS. This is the overwhelming conclusion from an analysis of 18 phase 3 trials (n=8500), of which 70% of the population had SPMS, all performed in the last 25 years. There is no current disease modifying treatment (DMT) for SPMS.

In an earlier study (MS-STAT1), 140 people with SPMS were randomly assigned to receive either placebo or simvastatin for a period of two years. The investigators found that the rate of brain atrophy (loss of neurons - ‘brain shrinkage’), as measured by magnetic resonance imaging (MRI), was reduced in patients receiving simvastatin compared to those taking placebo.

Several other long term studies have also reported that there might be a relationship between the rate of brain atrophy and the degree of impairment.

The study is designed to test the effectiveness of repurposed simvastatin (80mg) in a phase 3 double blind, randomised, placebo controlled trial (1:1) in patients with secondary progressive MS (SPMS), to determine if the rate of disability progression can be slowed over a 3 year period.

Project Details
Chief Investigator: Dr Claire Rice
Planned End Date: TBC
Local Ref: 4104

This pragmatic, prospective observational cohort study is planned to run for 7 years to estimate the frequency of serious adverse events with real world DMT use in routine clinical practice in the UK. It is a non-interventional cohort study. The study will recruit people with MS on treatment from major MS care clinics across the country, as well as those starting, switching or potentially eligible for treatment, but who are not currently taking DMT. This study will provide – for the first time - an estimate of overall rates of serious adverse events associated with DMT (including multiple sclerosis relapses or opportunistic infections) in the UK population with MS. It will facilitate a way of exploring related questions regarding the relative benefits vs risks of treatment and the influence of prior treatments on adverse events.

Project Details
Principal Investigator: TBC
Planned End Date: TBC
Local Ref: 4635

A phase 3 double blind, placebo-controlled study to evaluate the efficacy and safety of prophylactic Donidalorsen in HAE. Patient recruitment is closed but current and new participants may enrol to an open-label extension study. Patients need to have at least 2 HAE attacks within the last 2 consecutive months to participate. There are also other inclusion /exclusion criteria and recruitment is subject to availability.

Project Details
Principal Investigator: 
Planned End Date: 31/12/24
Local Ref: 5248

Chapter-1 is a phase 2 double-blind, placebo-controlled, randomized, dose-ranging, parallel group study to evaluate the safety and efficacy of PHA-022121 administered orally for prophylaxis against angioedema attacks in patients with HAE. Patients need to have at least 3 HAE attacks within the last 3 consecutive months to participate. There are also other inclusion /exclusion criteria and taking part in the study is subject to availability.

Project Details
Principal Investigator: 
Planned End Date: 31/12/2023
Local Ref: 5046