These are just some of the ways in which questions highlighted as important by James Lind Alliance Priority Setting Partnerships (PSPs) are being, or have been, addressed. This is research that we know has come about as a direct result of a PSP. We know that other research will be taking place that answers PSP questions, perhaps having been suggested already for other reasons. We’re keen to hear from you if you know of studies that we haven’t mentioned that directly result from a PSP. Please get in touch.
In September 2019 Professor Hywel Williams, Director of the National Institute for Health Research Health Technology Assessment Programme, issued a video message about how researchers can make the most of PSP priorities when applying for funding to research them.
Addressing priority 3: A Cochrane Review was published in April 2016. The team reviewed 24 previous trials to pull together the evidence that already exists about interventions for acne scars, and to highlight where further research is needed.
Background Acne is very common and, although thought of as a teenage condition, it often continues into adulthood where impact on quality of life can be significant. The most commonly used treatment for acne is long courses of antibiotics but concerns about antibiotic resistance mean we need to find alternatives. Spironolactone reduces hormones called androgens that are implicated in acne as these increase grease production and cause changes in follicles in the skin making them prone to acne. This study will measure whether spironolactone helps adult women with persistent moderate-severe facial acne.
This study explores how self-neglect is experienced by people who are homeless, and how this can be addressed through strengthening local adult safeguarding responses.
Addressing priority 7: Commissioning brief advertised to researchers by the NIHR Health Services and Delivery Research Programme
More than 1.5 million patients require general anaesthesia for major surgery each year in the NHS. General anaesthesia is most commonly maintained with inhalational anaesthesia where the patient breathes anaesthetic gas through a breathing tube whilst asleep. However, some patients receive an alternative called total intravenous anaesthesia, or 'TIVA'. During a TIVA anaesthetic, the patient breathes oxygen through a breathing tube but is kept asleep by drugs given into a vein. Many anaesthetic doctors believe patients recover more quickly after TIVA, and small studies suggest patients prefer this technique. Some anaesthetists are enthusiastic about TIVA because very early research suggests better survival for patients undergoing cancer surgery. However, this has not been proven and others are worried about possible risks including excess deaths and waking up during surgery. The evidence for TIVA has been positive so far but the clinical trials were very small and the results are not reliable. This trial aims to find out which technique is better in terms of getting patients home earlier, patient survival and avoiding any accidental awareness under anaesthesia.
Surgery through the side of the chest (thoracotomy), usually to treat lung cancer, can cause pain post-operatively that can last months or years in up to half of patients. This Chronic Post-Thoracotomy Pain (CPTP) can be severe and debilitating to patients, leading to more frequent GP visits, anxiety, depression, time off sick and unemployment. This study is trying to find out which of two common pain relief techniques results in less incidence of chronic pain at six months after surgery.
Addressing priority 7: NIHR research published. Many people with asthma are interested in non-drug treatments, particularly in breathing exercises. Teaching these breathing exercises face to face works well. This study showed that breathing retraining exercises improve quality of life in adults with asthma and at lower cost than usual care, with delivery by DVD having equivalent outcomes with lower cost than face-to-face training.
“It has been a great privilege to be involved in a research project like BREATHE, which had its roots firmly embedded in the wishes and priorities of patients with asthma and their families. We knew from the work of the James Lind Alliance, and our own clinical experience, that breathing techniques were of great interest to people with asthma.
We also knew that there were not enough NHS physiotherapists with the specialist skills needed to teach these techniques. BREATHE was developed out of these two key facts – and has resulted in a trial assessing the effect of physiotherapy breathing retraining learned through two different delivery methods – a) face to face with a physio, and b) digitally using a DVD plus booklet at home. We have found that both delivery methods were equally effective for our participants.
The interventions were developed iteratively with feedback from patients and clinicians, and this has helped to make sure they are not only effective, but also acceptable, and therefore more likely to be used in practice. We can honestly say that without the input of clinicians, patients and their families, we would not have been able to design, develop, test, and now implement, our new digital intervention.”
Anne Bruton, Co-investigator of the BREATHE study
Commissioning brief advertised to researchers by the NIHR HTA programme.
This study aims to find out whether the drug Sertraline is an effective treatment for anxiety in adults with a diagnosis of autism. Sertraline is a commonly prescribed antidepressant and is also recommended for the treatment of anxiety problems. The use of Sertraline will be compared with the use of a placebo, a non-active identical capsule. Anxiety is common in autistic adults and can be more disabling than the core features of autism. Medications for anxiety are often prescribed for autistic adults but their effectiveness or side effects in this population are not well known. The trial is to be run in five centres in England and Western Australia.
There are high levels of mental health difficulties in parents of children with Autism Spectrum Disorder (ASD). The period following their child's diagnosis can be particularly challenging. Groups that educate parents about ASD are often used in the NHS but have not been evaluated and we do not know if they help parents' mental health. An intervention called Acceptance and Commitment Therapy (ACT) has been used with parents of children with disabilities with some evidence of success. It uses problem solving, mindfulness, and practical exercises to help people reflect on their current situation and manage any distressing experiences and thoughts. The EMPOWER-ASD programme combines education about autism with ACT. This research aims to find out if EMPOWER-ASD benefits parents and their families when delivered as part of NHS care, using a randomised controlled trial.
Challenging restricted repetitive behaviours (RRB) such as repetitive movements, routines, restricted interests, and resistance to change can interfere with an autistic child's ability to engage in everyday living activities, reduce social opportunities and prevent learning new skills. Parents report they need strategies and advice on how to manage their child's challenging RRB. This study will assess the effectiveness of a Managing Repetitive Behaviours intervention.
Autism is a complex life-long condition that impacts on development in different areas including intellectual, communication, social, emotional, and adaptive skills for daily living. The proportion of children diagnosed with autism has increased considerably over the last two decades, and it now affects approximately 3 in 200 children born in the UK. This study aims to find out whether or not intensive early interventions based on applied behaviour analysis (ABA) can help young children with autism, and whether it represents good value for money.
Addressing all priorities: A broad commissioning brief advertised to researchers by the NIHR HTA Programme, asking for proposals for the evaluation of interventions to improve the detection, management or treatment or people across the whole age range with symptoms of bipolar disorder, a diagnosis of bipolar disorder or at risk of bipolar disorder.
A humeral shaft fracture is a break in the long bone of the upper arm. It occurs mainly in two groups of individuals; young men and older women, as their bones are more fragile. Currently, the most common treatment (approximately 70%) for these fractures is non-operative -using a cast for two weeks and then a brace until the bone begins to heal properly - although there is large variation in treatments between and in hospitals. The risk of complications is low and the cost also relatively low at £1,100. The disadvantages are that the patient is immobilised for a prolonged period and the cumbersome cast can lead to significant pain and discomfort in some patients. There is also a 20% chance that the break will not heal. This then requires surgery and involves additional costs of approximately £15,500. There appears to be a worldwide trend towards treating these fractures with surgery (rather than a cast and brace), however there is no high quality evidence that this is indeed a better option. Surgery is the more expensive route, and has a higher risk of complication e.g. infection and nerve damage. However there is a better chance of the bone healing successfully and the patient is likely to recover more quickly allowing them to regain their independence sooner. This study aims to directly compare these two methods.
In standard practice in the UK, about one fifth of people with cavernomas have 'active treatment' with either brain surgery to remove a cavernoma or stereotactic radiosurgery to treat it with radiation. These treatments themselves can cause death, disability, and handicap. The pros and cons of active treatment or avoiding it by just treating the symptoms (also known as 'conservative management') are finely balanced. The most reliable way of finding out which management is best is to do a randomised trial, in which suitable patients are allocated to active treatment or conservative management at random. This has never been done with cavernomas. This pilot study aims to find out whether enough patients can be found for a randomised trial comparing 'active treatment' with 'conservative management' of symptomatic cavernomas.
Addressing priority 1: NIHR Health Technology Assessment Programme commissioning brief advertised to researchers
Families and professionals agree that there needs to be more research on therapy interventions (physiotherapy, occupational therapy and speech and language therapy) for children with neurodisabilities. To aid decisions about what, or whether, to fund research on this topic, the National Institute for Health Research commissioned a small scoping study.
It’s a challenge to identify suitable communication aids and language representation systems for each child, and getting it right means that long-term successful use is much more likely. This team of researchers explored current provision of symbol communication aids in order to provide guidance to support clinicians, parents and others in their selection of the most appropriate aids.
This project will estimate the costs and benefits of providing very young disabled children (under 5 years) with powered mobility aids (e.g. mini wheelchairs, ride-on-cars). To do this the team will combine the results of existing research and use a technique called economic modelling to predict how cost-effective it is to provide powered mobility aids from a very early age. More than 70,000 children in the UK use special equipment, such as wheelchairs, to help them move around. Helping children under the age of 5 to move around on their own can have long-lasting benefits, including physical and mental development, increased independence and more participation in everyday life. These benefits can also have positive impacts on the physical and mental health of children's parents, and may reduce later health, social care and education costs. What is currently unknown is whether providing powered mobility aids for very young children provides more benefits than waiting until after the child is aged 5.
Learning to manage going to the toilet independently is an important milestone in growing up. Children with special educational needs and disabilities may be slower to learn to manage going to the toilet, or they may need extra help. Many children with special educational needs and disabilities can become continent with training. Various things can influence if and when toilet training starts. A key issue is whether families and professionals think a child is ready and able to begin toilet training. Interventions that professionals recommend to improve continence include toilet training programmes, nappies and other products, aids and equipment, medicines and surgery. Currently it is uncertain which ways to assess and treat children with special educational needs and disabilities are best. This study will describe the variety of current practice in the NHS and summarise the evidence available for interventions.
Bryony Beresford and her team brought together the evidence which already exists from lots of previous studies about sleep disturbance, to determine how well different treatments work. The review showed that it was not possible to draw conclusions about the effectiveness of non-pharmacological interventions for managing sleep disturbance and although there was some benefit with melatonin, the degree of benefit is uncertain.
Autism Spectrum Disorder is a common lifelong condition affecting 1 in 100 people. A team based at Cardiff University is investigating whether Sensory Integration Therapy, provided by trained occupational therapists, improves a child’s behaviour, socialisation and daily functioning, compared with the usual care they’d receive.
Autism is a complex life-long condition that impacts on development in different areas including intellectual, communication, social, emotional, and adaptive skills for daily living. The proportion of children diagnosed with autism has increased considerably over the last two decades, and it now affects approximately 3 in 200 children born in the UK. This study aims to find out whether or not intensive early interventions based on applied behaviour analysis (ABA) can help young children with autism, and whether it represents good value for money.
About 1-2% of the population have a Learning (also called intellectual) Disability (LD). This is a lifelong condition characterised by an IQ less than 70, general developmental delay and limitations in day to day activities. There is significant evidence from research in the general population that parenting groups which support parents in developing skills to manage challenging behaviours such as temper tantrums, aggression or self injury in their child can be helpful. These programmes, if offered to parents early on, may reduce and even prevent serious emotional problems and possible criminality from developing in the child later in life. This study team will evaluate a programme called level 4 Stepping Stones Triple P (SSTP) delivered by trained practitioners to groups of parents of young children aged 30-59 months with moderate to severe LD.
Young children with developmental difficulties may also have eating, drinking and swallowing problems. Eating and drinking difficulties may lead to a restricted diet, poor growth, and impact on development, in addition to general physical health risks such as choking or chest infections. This research team wants to find out what treatments are currently recommended by health professionals. They will then decide which of these potentially useful treatments should be tested in a future study.
Addressing one of the top priorities: Commissioning brief advertised to researchers by the NIHR HTA Programme.
Dupuytren's contractures are scar-like tissue that form under the skin of the palm of the hand, causing one or more fingers to bend into the palm (www.nhs.uk/conditions/dupuytrens-contracture/). They prevent them from straightening fully which causes difficulty with many everyday tasks. It is common: in 2016 NHS England spent £36M treating 16,700 patients with Dupuytren's contractures. Dupuytren's contractures are most commonly treated using one of two procedures and we don't know which is best. The problem can come back after either treatment. This study aims to determine which is best at preserving hand function and which treatment offers best value for money.
A fracture of the proximal phalanx shaft finger is a common type of bone break in the section of the finger closes to the knuckle. A team at the University of Nottingham is investigating which treatment is better for the patient - surgery using metalwork to fix the fracture or treatment using finger splints applied in clinic. The team will also look at which treatment option represents best value for money.
This research was informed by a number of service uncertainties throughout the whole list of questions identified by this PSP: NIHR research published.
Numbers of people with dementia who are admitted to general hospitals are increasing. This research team aims to help us understand what works best in hospitals when providing quality care for people with dementia.
Gillian Parker and her team looked at an example of providing specialist nursing support to carers of people with dementia, to assess the costs and benefits.
Research has given us a growing list of things that can be done to improve dementia care, but there is a gap between what we know and what actually happens. This project looks at how we can best communicate the practices that have been shown to improve care.
Addressing priority 10: Commissioning brief advertised to researchers by the NIHR HTA Programme.
Depression in adolescents is a serious problem that can lead to poor mental health and stigma throughout a person's life. Depression is reported in around 20% of young people by the time they are 18 years of age. Over half continue to be depressed into adulthood, with many attempting suicide. Problems include difficulties at home and school, maintaining friendships and taking part in social activities, including exercise. Young people with depression often delay seeking psychological support. Antidepressants can help some, but they have negative side effects. Research shows that adults with depression benefit from exercise, but it is not known whether exercise is helpful for young people who are depressed. The aim of this research is to find out whether exercise is an effective treatment for young people with depression and whether it is good value for money for the NHS.
Addressing priority 1: Commissioning brief advertised to researchers by the NIHR HTA Programme.
1 in 5 children in the UK have eczema There are many different emollients (moisturising treatments applied directly to the skin) to relieve skin dryness and hardly any research comparing them. This research team wants to do a fair test of the four most commonly used types of emollients. Read more about the BEE study in this BMJ article from 24 October 2019.
Addressing one of the top Health Professional priorities: This NIHR-funded research compares the cost effectiveness of two drug treatments for children who have severe eczema. 102 children aged 2 to 16 years will be randomly chosen to be given either Ciclosporin or Methotrexate for a 36 week treatment period with 24 weeks further follow-up. An economic evaluation is required, as it is currently uncertain which drug represents best value-for-money for the UK National Health Service (NHS).
In cases of severe damage where daily activities are difficult and some people cannot work, hip or knee joint replacement often works well, with many people having a good result. However when the damage within the joint is less severe, (known as 'early osteoarthritis'), joint replacement might to be less effective and other surgical treatments can be used. At present it is not clear which procedures are best for the patient. This presents a problem for the NHS because it means that some patients with osteoarthritis may miss out on helpful surgery whilst others may undergo treatment, which brings little benefit The purpose of this research therefore is to look for the best evidence available to support decisions on surgical treatment for each individual patient with early osteoarthritis.
About 20-30% of patients with anorexia nervosa need intensive treatment (day patient or inpatient treatment or both) to help them improve or recover. We do not know whether either of these two intensive treatment approaches has advantages/disadvantages for patients, families, the NHS and wider society. Ulrike Schmidt is leading a team which will compare the following approaches: (a) specialist inpatient treatment as usual and (b) specialist day patient treatment (either immediately or, if needed, after brief inpatient treatment to medically stabilise the patient), which we call 'stepped care'. The team will assess how effective and acceptable these two approaches are and whether they provide value for money.
Cardiovascular risk prediction in the Emergency Department has previously been focused upon short term outcomes, however we collect data which could be used to inform long term outcomes. The efficient use of data and NHS-patient interactions will be key in preventative medicine strategies. A group of researchers, with the support of a Royal College of Emergency Medicine project grant, plans to investigate this by conducting a systematic review of the existing evidence for long term cardiovascular risk prediction in the acute care setting. There will be subsequent qualitative studies including patients, emergency physicians and general practitioners to ascertain the feasibility and barriers to implementation that this may face.
The anticipated outcome is a long term cardiovascular risk prediction strategy for acute care. The hope is that it can be used to enhanced shared decision making in patients presenting with chest pain, aligning with the James Lind Alliance priority six.
The optimal treatment for sepsis includes early recognition, prompt antibiotics and fluids into a vein (intravenous/IV). Currently, clinicians assess severity in patients in the Emergency Department with a scoring system based on simple to measure observations: the National Early Warning Score (NEWS). NEWS helps clinicians identify the sickest patients. It is not specific and tends to over-diagnose sepsis leading to over prescribing of antibiotics, thus promoting antimicrobial resistance. It is currently used in over 70% of English hospitals. Procalcitonin (PCT), a blood test not widely used in the NHS, helps to identify bacterial infection. The primary aim of this study is to compare PCT- supported assessment with standard care of suspected sepsis in adults presenting to the ED, and measure whether this approach reduces prescriptions of antibiotics without increasing mortality by decreasing uncertainty in the group who may not need IV antibiotics urgently within 1 hour, or not need antibiotics at all. The evaluation will be done via a randomised controlled trial in ten hospitals. If the study shows that PCT-supported assessment is superior to current practice, then it will lead to better outcomes in sepsis, improved care and a reduction in inappropriate antibiotics prescriptions.
Addressing priority 9: Commissioning brief advertised to researchers by the NIHR HTA programme
There is a good evidence base that a CT within 6 hours is sensitive enough to rule-out subarachnoid haemorrhage without the need for a lumbar puncture. However, this has not been universally adopted in UK practice. This is emphasised by the fact that the Emergency Medicine PSP priority 11 directly highlighted this question. The Trainee Emergency Research Network is currently in the advanced stages of planning a prospective observational cohort study aimed at validating this question. The study will start in the summer of 2019, with results published in the summer of 2020.
Pulmonary embolism (PE) is a potentially serious condition, whereby blood clots cause a blockage of the blood supply to the lungs. PEs are often caused by blood clots in the legs and occasionally the arms (deep vein thrombosis (DVT)) breaking off and travelling to the lungs. The treatment of PE includes anticoagulant medication (blood thinners) that are taken over months. This study aims to find out more about smaller clots, where it is unclear whether anticoagulant treatment is required or whether they may be removed by the body's own mechanisms for dissolving clots without needing anticoagulants, which can cause side effects in some patients.
Addressing priority 27: Commissioning brief advertised to researchers by the NIHR HS&DR programme
Sepsis is a life-threatening condition caused by the body having an abnormal response to infection that leads to heart, lung and kidney failure. People with sepsis need urgent treatment with antibiotics and intravenous fluids, and may need treatment in intensive care. However, some features of sepsis may be seen with uncomplicated infections or other illnesses, particularly in people with underlying diseases. This can make it difficult to correctly identify who has sepsis and needs urgent treatment, and who does not. Early warning scores can be used to identify patients with sepsis and prioritise their treatment in a busy emergency department. This research aims to determine how accurately existing and potential new early warning scores identify cases of sepsis that need urgent treatment. It also aims to determine the likely impact of paramedics using early warning scores to (a) alert the emergency department so they are seen immediately on arrival, or (b) provide treatment for sepsis in the ambulance.
Previous research done by this team in a busy London hospital has already shown that the introduction of a digital sepsis alert is associated with more patients receiving antibiotics in the target of one hour after identification and fewer patients dying. The team wants to expand this work to include sites from other areas of the UK. Different hospitals have used different methods of creating a score and introduced the digital alerting systems in different ways, some of which include details on a patient's clinical history. They want to establish which method works best, and how. This research will assess whether different digital alerts, and the way in which they were introduced results in better outcomes for patients.
Community acquired pneumonia (CAP) is one of the commonest serious bacterial infections in children worldwide. It is an important cause of childhood illness and a frequent cause of emergency department visits and hospitalisation. There is currently no evidence-based, validated tool to help health professionals make decisions about how to manage childhood CAP. The objective of this study is to develop a clinical prediction rule to accurately identify children with CAP who are at risk for low, moderate, and severe disease. Under questions 31-72 identified by the PSP, there is a stated need for meaningful research around clinical decision making to target interventions and improve the diagnostic process. It will also help to decrease over-investigation of patients, which is a particularly important goal in paediatric emergency departments.
Addressing a range of the priorities: Commissioning brief advertised to researchers by the NIHR EME Programme
Repeat surgery for endometriosis is invasive, expensive and risky, without guaranteeing a cure. A less invasive way of shrinking endometriosis is to use a drug called gonadotrophin releasing hormone analogue (GnRHa) which temporarily stops the ovaries from producing oestrogen (the female hormone that endometriosis depends on for growth). While very effective in terms of reducing pain, this treatment is generally only used for 6 months to a year because of side effects such as hot flushes and night sweats caused by the lack of oestrogen, and concerns about osteoporosis (thinning of the bones). Recent research has shown that adding small doses of hormone replacement therapy (HRT) in women on GnRHa reduces the risk of side effects and osteoporosis whilst controlling the pain. To date there have been no attempts to compare long-term use (more than 1 year) of GnRHa with HRT to further key hole surgery to treat endometriosis. This research team will compare long-term (2 years) GnRHa with added HRT to key hole surgery to destroy or remove endometriosis in women who experience recurrence of pain after endometriosis surgery but wish to preserve their fertility.
The Canadian Frailty Network funded 12 projects in 2018 after advertising a call for research proposals that directly addressed one or more of the PSP priorities.
Robotic systems are increasingly being used to help surgeons perform knee replacements. They are expensive, but we do not know if they provide any benefit for patients. This research team wants to find out if total knee replacement performed with the help of a robot is better than using the standard technique.
We want to find out whether treatments used for diarrhoea in people with irritable bowel syndrome (IBS) can help people with stable ulcerative colitis (UC) and diarrhoea, with no sign of active bowel inflammation. In IBS, a low FODMAP diet improves diarrhoea, because some poorly absorbed sugars (FODMAPs) increase small intestinal water content. Drugs like ondansetron (an anti-sickness drug), amitriptyline (an old-fashioned anti-depressant drug), or loperamide (an anti-diarrhoeal drug) can also be effective in IBS with diarrhoea. This is because they change bowel activity, and can relieve tummy pain. These treatments may therefore help people with UC with diarrhoea who have no active bowel inflammation, but we are unsure as there are no large studies. This project is due to commence April 2019 and end December 2022
Addressing priority 5: Commissioning brief advertised to researchers by the NIHR HTA Programme.
Addressing any of the relevant priorities in the Top 10: forCrohns and Core announced a joint call for research projects on Crohn’s Disease in 2018, asking that researchers focus on once of the priorities identified by the PSP. More information about the two projects they funded is shown at the weblink.
Addressing priority 2: In 2015 the Intensive Care Foundation gave a £50,000 ‘JLA Award’ to Dr Brenda O’Neill and Dr Bronagh Blackwood of Queen’s University Belfast, who led a UK-wide collaborative project proposal aiming to improve the assessment of ICU survivor’s support needs across the continuum of care.
This project addresses the priority "What is the best way of preventing damage to the lungs of patients receiving respiratory support (ventilation)?". It aims to find out whether keeping oxygen saturations at lower levels (conservative oxygen therapy) is better than the higher level that is currently being used in the NHS to treat patients in ICU needing help from a ventilator.
Addressing one of the Top 10 priorities: This NIHR-funded trial in UK patients with acute antibody mediated rejection will test the most promising two treatments. It has been designed with input from patients, the UK Kidney Research Consortium, leading transplant specialists, and experts in clinical trials.
Addressing a range of the priorities: Commissioning brief advertised to researchers by the NIHR EME programme
The CONFIRM trial was selected as a “Stand Up 2 Cancer” trial and was highlighted on the Channel 4 SU2C funding event in 2019. It was one of the fastest opening Cancer Research UK trials – starting to recruit patients in less than 8 months from the decision to go ahead with the funding. The main aim of the CONFIRM trial is to evaluate the efficacy, safety and cost-effectiveness of treatment with nivolumab in patients with relapsed mesothelioma.
Find out more in these videos https://www.facebook.com/hyundaiuk/videos/283211282349766/ https://www.facebook.com/hyundaiuk/videos/293795651308209/
In the UK, over 2,000 patients are diagnosed yearly with pleural mesothelioma, a cancer of the lining of the chest wall and lung mainly due to previous (40 to 60 years ago) exposure to asbestos. This trial compares surgery (extended pleurectomy decortication) versus no surgery with respect to overall survival in patients with pleural mesothelioma.
Addressing priorities 10 and 13: This NIHR-funded small-scale research will test how feasible it is to recruit and randomise patients to a full-scale study to look at this question. The study will collect information on how common trapped lung really is and examine quality of life before and after treatment as well as safety aspects. Patients will be asked what they thought about the research in order to improve how the full-scale study might be run in future.
HypoxamiRs as a New Target for Treatment of Malignant Pleural Mesothelioma (MPM). Funded by a Mesothelioma UK/British Lung Foundation research grant
Translating BAP1 dependencies for precision therapy of mesothelioma. Funded by a British Lung Foundation project grant
Immunotherapy for mesothelioma using ErbB re-targeted CAR T-cells in combination with PD-1 checkpoint inhibition. Funded by a British Lung Foundation project grant
PRISM - Prediction of Resistance to chemotherapy using Somatic Copy Number Variation in Mesothelioma. Funded by a British Lung Foundation project grant
Gli as a novel therapeutic target in malignant mesothelioma. A PhD studentship project funded by the British Lung Foundation
Targeting BAP1 mutated mesothelioma via synthetic lethal disruption of DNA double-strand repair. A PhD studentship project funded by the British Lung Foundation
In vitro evaluation of potential new chemotherapeutic agents for the treatment of Mesothelioma. Funded by a British Lung Foundation pump priming grant
MEDUSA – Mesothelioma Evolution: Deciphering drUgable Somatic Alterations as potential targets for synthetic lethal therapy. Funded by a Mesothelioma UK/British Lung Foundation research grant
Genes in Cages. Design of Smart Capsules for the Delivery of Macromolecules. A PhD studentship project funded by the British Lung Foundation
Understanding how EKR5 signalling drives malignant mesothelioma progression. Funded by a British Lung Foundation pump priming grant
Combination treatment modelling for the immunotherapy of mesothelioma. Funded by a British Lung Foundation project grant
Immunotherapy for malignant mesothelioma using IL-6-neutralising CAR T cells. Funded by a British Lung Foundation project grant.
This ongoing research aims to identify barriers and enablers for the use of hearing technologies such as hearing aids and over-the-counter alternatives, to inform the development and feasibility of a behavioural intervention to improve use and adherence. The research draws upon audiology, health psychology and person-based intervention development expertise.
This systematic review (2018) examined the effectiveness of alternative listening devices for adults with hearing loss. Findings showed evidence for improvements in speech intelligibility, but no consistent improvements in user self-reported benefits. Much of the evidence reviewed was of low quality. Further high-quality research is needed.
In March 2017, the NIHR published the results of its horizon scanning review, which looked for new and emerging technologies for hearing loss. The review identified 55 new technologies. Patients, clinicians and researchers highlighted the technologies of interest to them which, if successful, would have the potential to change the cochlear implant landscape for patients, improve patient experience and use of hearing aids, and would affect service delivery and provision.
This Cochrane Review (2017) showed a large beneficial effect of hearing aids on hearing-specific health-related quality of life, and a small beneficial effect of hearing aids on general health-related quality of life, for adults with mild to moderate hearing loss. This evidence is compatible with the widespread provision of hearing aids as the first‐line clinical management in those who seek help for hearing difficulties.
An ongoing systematic review and meta-analysis (an update to a published 2013 systematic review: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3651281/ ) will synthesise evidence for the following:
Does evidence exist to support improvements in trained and untrained measures of speech perception, cognition, communication or quality of life as a result of individual computer-based auditory training in adults with hearing loss (with or without hearing aids or cochlear implants)?
Do any improvements in trained or untrained outcomes remain at post-training intervention follow-ups (where measured and reported)?
What are the levels of compliance with individual computer-based auditory training programs in adults with hearing loss for included studies?
This NIHR-funded feasibility study will examine the feasibility of a multicentre clinical trial to assess the clinical and cost-effectiveness of providing auditory-cognitive training to improve speech perception outcomes for first-time hearing aid users in the NHS.
This project addresses a treatment uncertainty submitted to the PSP: What are the benefits of educating people about mild to moderate hearing loss and hearing aids? A randomised controlled trial of an interactive multimedia education program for first-time hearing aid users showed evidence for improved knowledge and use of hearing aids. This study provides evidence to suggest that education in the form of Reusable Learning Objects (RLOs) may provide valuable learning and educational support for first-time hearing aid users and could be used to supplement clinical rehabilitation practice.
This study aims to find out if having hysteroscopic removal of fibroids and polyps increases the live birth rate in women with infertility and recurrent miscarriage.
In 2014, the MS-STAT1 clinical trial of 140 people with secondary progressive multiple sclerosis followed for 2 years showed promising results in those taking simvastatin (dose-80mg/day) compared to placebo (a dummy drug). This MS-STAT2 trial is based on the original MS-STAT1 trial, but is a larger clinical trial. Patients will be followed for 3 years to investigate whether there is confirmed slowing of disability progression or not.
Addressing priority 3: A Cochrane Review published in September 2015 brought together the best available evidence looking at whether exercise therapy is an effective and safe way of reducing fatigue in MS.
Read more from Evidently Cochrane.
Also read more about this study here Working in the US and the UK, DELIVER-MS aims to answer one of the biggest questions facing people diagnosed with relapsing MS: Is early treatment with an intensive but aggressive Disease-Modifying Therapy (DMT) the best option, or should you start with a DMT that has the least side effects?
Addressing all of the priorities: Commissioning brief advertised to researchers by the NIHR Health Technology Assessment, Efficacy and Mechanism Evaluation, Health Services & Delivery Research and Public Health Research programmes
Smoking is a major cause of illness and death in the UK. It affects both general and oral health. Around three-quarters of the 7200 new cases of mouth and throat cancer diagnosed in the UK each year are due to smoking. Smoking is also a big risk factor for gum disease ('periodontitis'). This affects 1 in 10 UK adults and often leads to tooth loss. Quitting smoking is an effective way to improve oral health. Helping patients to quit is one of the most important aspects of dental care. For those with gum disease, their treatments will work better if they quit. There are many ways to support smokers to quit. These include behavioural support, medications such as nicotine replacement therapy (NRT), or e-cigarettes. Dental teams currently offer 'very brief advice' (VBA) to patients who smoke. This involves a short discussion and sometimes a referral elsewhere, such as to a doctor or Stop Smoking Service, for further support. Of all healthcare providers, dental teams are probably best placed to offer extra quitting support. They see a large number of patients regularly. They notice changes in the mouth related to smoking, such as loose teeth and staining. These changes can be used as powerful prompts for a quit attempt. This study is needed to tell us: 1) Does providing extra quitting support in the dental clinic improve smoking quit rates and gum health? 2) Is providing this support good value for money?
Addressing priority 1: Research grant awarded to Dr Felicity Hasson, Ulster University, by Marie Curie.
Addressing priority 1: Research grant awarded to Professor Richard Harding, Kings College London, and Dr Fliss Murtagh, Hull York Medical School, by Marie Curie.
Addressing priority 1: One of two joint Royal College of GPs/Marie Curie Palliative Care Research Fellowships. Awarded to Dr Huw Williams, Cardiff University, 1 January 2017 to 30 April 2019.
Addressing priority 1: One of two joint Royal College of GPs/Marie Curie Palliative Care Research Fellowships. Awarded to Dr Sarah Hoare, 1 April 2019 to 31 March 2020.
Addressing priority 1 and 4: NIHR research published Most people want to be cared for and die at home. As people get weaker in the last weeks or days of life, they usually can’t swallow. In the UK, when this happens, it is standard practice for medicines to be given by a drip under the skin to relieve symptoms. If, despite a drip being in place, distressing symptoms still occur, a family member is advised to call a healthcare professional to give the patient an injection under the skin. This can take time. In Australia, family members are trained to give such an injection. This feasibility study aims to find out more about how acceptable and effective this would be in the UK and how feasible a large-scale trial would be.
Addressing priority 4: Research grant awarded to Dr Nathan Davies, University College London, by Marie Curie
Addressing PSP priorities 6 and 8 from the Top 10: Research grant awarded to Dr Christopher McDermott, University of Sheffield, in March 2017, by Marie Curie and the Motor Neurone Disease Association.
Addressing PSP priority 6 from the Top 10 and number 33 from the long list of questions identified: Research grant awarded to Dr Kate Flemming, University of York, in March 2017, by Marie Curie and the Motor Neurone Disease Association.
Addressing PSP priorities 4, 8, and 10 from the Top 10 and numbers 36, 37, 42 and 45 from the long list of questions identified: Research grant awarded to Professor Gunn Grande, University of Manchester and Dr Gail Ewing, University of Cambridge, in March 2017, by Marie Curie and the Motor Neurone Disease Association.
Addressing priority 8: NIHR research in progress Much effort has been invested in health services to support care at home, including services called Hospice at Home (HAH) which aim to offer hospice care in the individual's home. The aim of hospice care is to improve the quality of life of people who have an incurable illness up to the point of death. This includes medical, emotional, social, practical, psychological, and spiritual care, as well as addressing the needs of the person's family and carers. Currently a range of different HAH services exist in the UK and it is unclear which features of these services enable better care and outcomes at the end of life for patients and families. Therefore the research question being asked by this project is: What are the features of Hospice at Home service models that work, for whom, and under what circumstances?
Addressing PSP numbers 18, 21, and 73 from the long list of questions identified: Research grant awarded to Professor Marie Fallon and Dr Barry Laird, University of Edinburgh, in March 2017, by Marie Curie and the Chief Scientist Office Scotland.
Addressing priority 19: Research grant awarded to Professor Marie Fallon, University of Edinburgh, by Marie Curie
Addressing priority 19: Research grant awarded to Professor Simon Noble, Cardiff University and Dr Jason Boland, Hull York Medical School, by Marie Curie
Addressing numbers 47, 48, 49 and 50 from the long list of questions identified: Research grant awarded to Dr Richard Harding and Dr Katherine Bristowe, King’s College London, in March 2017, by Marie Curie.
Addressing priority 28: Research grant awarded to Dr Sally Wheelwright, University of Southampton, by Marie Curie.
Addressing number 80 from the long list of questions identified: Research grant awarded to Dr Bridget Candy, University College London, in March 2017, by Marie Curie.
Addressing PSP priorities 2 and 6 from the Top 10 and number 64 from the long list of questions identified: Research grant awarded to Dr Morag Farquhar, University of East Anglia, in March 2017, by Marie Curie.
Addressing PSP priorities 3 and 4 from the Top 10: Research grant awarded to Dr Karen Shaw, University of Birmingham, in March 2017, by Marie Curie.
Addressing priority 1 NIHR research in progress to determine whether a drug, known as a cholinesterase inhibitor, can prevent falls in Parkinson's. The effect of these drugs on falls in Parkinson's has been tested in 3 small trials showing that treatment has the potential to reduce the number of falls and this study will provide better evidence for this.
Addressing priority 1: This Parkinson's UK-funded study aimed to shed new light on the complex relationship between physical activity and falls in Parkinson’s, hoping that this new knowledge will empower people with the condition to manage their condition more effectively and reduce their risk of falling.
Addressing priority 2: In this Parkinson’s UK-funded study, the team has tested a mindfulness course to assess how helpful it is.
Addressing priority 2: In this project, the team hopes to test the reason behind anxiety in Parkinson’s and a technique to reduce anxiety using simple online exercises.
Addressing priority 2: Researchers investigated whether anxiety in Parkinson’s is similar to anxiety in people without the condition and then tested whether this anxiety could be reduced with a simple computer training task in this Parkinson’s UK-funded study.
Addressing priority 3: In another Parkinson’s UK-funded study, a team looked at what makes nerve cells become overactive when taking Levodopa, resulting in uncontrollable movements.
Addressing priorities 4 and 7: At the end of the project, this research team hopes to be able to accurately calculate risk based on a number of factors and be able to predict people who will develop Parkinson’s in the future.
Addressing priority 4 and 7: This research team is interested in finding out how people’s genetic makeup may influence the progression of Parkinson’s.
Addressing priority 5: In this Parkinson’s UK-funded study the team worked to further understand the changes that happen in the brain if people with Parkinson’s go on to develop dementia so that new treatments may be developed in future.
Addressing priority 5: This Parkinson’s UK-funded study aimed to find biomarkers that predict the risk of a person with Parkinson’s developing dementia.
Addressing priority 5: Researchers are looking at the gene activity in different parts of the brain in people affected by dementia with Lewy bodies and with Parkinson’s. They will then compare gene activity levels to those found in healthy people to understand the differences in this Parkinson’s UK-funded study.
Addressing priorities 5 and 6: The main goal of this is to better understand the early signs of dementia in people with Parkinson’s.
Addressing priority 6: This Parkinson’s UK-funded project looked for ways to improve the long term benefits of therapies where people with Parkinson’s learn new movements.
Addressing priority 6: The team is studying people with REM sleep behaviour disorder, who are at high risk of developing Parkinson’s, to identify areas of the brain affected early on.
Addressing priority 7: This research grant given by Parkinson’s UK brings together a world-class team of researchers to better understand Parkinson’s.
Addressing priority 9: Symprove is an oral probiotic that can reach the lower gut and has been seen to improve symptoms in conditions such as irritable bowel syndrome. The research team has some evidence that Symprove may be able to reduce motor and non-motor symptoms in people with Parkinson’s. Now they want to test its potential.
Addressing priority 10: Urinary problems are one of the top research priorities for improving quality of life for people with Parkinson’s. This project is looking to test a new bladder training programme for people with Parkinson’s in a pilot study.
Addressing priority 10: Transcutaneous electrical stimulation involves using a device to deliver small electrical impulses to the skin. This approach is sometimes used to address pain but has not been used to treat bladder problems before. This project will test if the treatment can improve bladder symptoms in people with Parkinson’s.
Addressing priority 20: Delirium is difficult to diagnose in people with Parkinson’s. This is because it has similar symptoms to Parkinson’s and dementia – such as confusion, hallucinations and sleep disturbances. But people will often make a full recovery from delirium if it is recognised and treated early enough. The findings from this study will be used to help develop and evaluate a new tool to identify delirium in people with Parkinson’s, so that it can be treated better. This project will investigate delirium in people with Parkinson’s admitted to hospital, which could help better identify and treat the condition.
Addressing priority 23: More than half of all people with Parkinson’s experience chronic pain. This Parkinson’s UK-funded study aimed to increase our understanding of this symptom.
Addressing priority 24: This project looked at three different techniques for treating swallowing problems in this Parkinson’s UK-funded study.
Addressing priority 25: This Parkinson’s UK-funded research aimed to find out if people with Parkinson’s will recover more quickly and spend less time in hospital if they are given their medication on time.
In July 2019, the Chartered Society of Physiotherapy Charitable Trust launched a special one-off call for research, offering up to £295,00 to fund research into one of the Physiotherapy PSP top priorities.
Addressing priority 11: Commissioning brief advertised to researchers by the NIHR HTA Programme.
Addressing priority 8: A Cochrane Review published in June 2017 brought together the best available evidence to help health professionals and people with pressure ulcers make decisions about the use of dressings or topical agents as treatments.
Around 12% of preterm infants are born between 30-33 weeks gestation forming 42% of routine admissions to neonatal units. Most are started on intravenous (IV) fluids and milk feeds are slowly introduced via gastric feeding tube. Clinicians are wary of milk feeding due to a potentially life-threatening condition called necrotising enterocolitis (NEC). Evidence suggests that feeding preterm infants earlier and faster does not increase NEC and could reduce the risk of infection and death. Full milk feeding and avoiding of IV fluids may have other benefits: less pain from interventions like IV drips, reduced medicalisation of care, greater parental involvement, and parent-infant bonding. This study investigates the hypothesis that in infants born at 30-33 weeks gestational age, starting full milk feeds from day 1 when compared to current practice of parenteral nutrition/IV fluids with gradual milk feeding will reduce length of hospital stay by 2 days.
This review looked at the effects of lifestyle changes for psoriasis, including weight reduction, alcohol abstinence, smoking cessation, dietary modification, exercise, and other lifestyle change interventions.
Several studies have demonstrated that smokers are at increased risk of psoriasis. At the same time, it is not clear whether giving up cigarettes can improve disease symptoms. This study looks at this question by identifying the changes that occur in the skin of smokers affected by psoriasis, and demonstrating that these alterations can be reversed by quitting smoking
There are a range of medicines available to treat psoriasis. These therapies work in many but not all patients and some patients have to stop medication due to side effects. Unfortunately, we still do not have tests available to tell us which therapy works best for which patient so being able to predict a person's response to a medicine is of high importance.
In order to prescribe the best possible drug to each individual with psoriasis, doctors need to be able to categorise people according to specific biological markers (“biomarkers”) that predict the likelihood that the drug will work. This Psoriasis Association-endorsed Psoriasis Stratification to Optimise Relevant Therapy (PSORT) is a multicentre study aimed at identifying biomarkers predictive of response to biologic drugs.
The overall goal of this project is to characterise the biological significance of mast cells-CD8 T cell interactions and how these may contribute to the development of psoriasis and their response to treatment. It will also study how their activities are affected by biologic therapy targeting a key immune system molecule – interleukin (IL) 17. This knowledge will suggest novel strategies for therapeutic intervention, e.g. by manipulating mast cell mediators in psoriatic plaques so as to block the activation of CD8 T cell and thus reduce skin inflammation.
Patients with psoriasis appear to have higher rates of liver fibrosis in comparison to the general population. The prevalence of liver fibrosis in the psoriasis population in the UK has not been defined. The higher rates of risk factors for liver fibrosis such as obesity, alcohol and diabetes are important; however there have been concerns that methotrexate can contribute to liver fibrosis. Despite the increasing importance of biologic therapies, methotrexate remains the most commonly used systemic agent in the UK. The majority of patients needing systemic therapy will try methotrexate first. This study aims to investigate the prevalence of liver fibrosis in a group of patients with psoriasis and then go on to determine the number of participants required to conduct a study to determine which factors can predict the risk of liver fibrosis.
Researchers at the Centre for Appearance Research at the University of the West of England in Bristol explored the impact flare-ups can have on the people with psoriasis. They interviewed 18 Psoriasis Association members about their experiences.
Schizophrenia usually starts in the twenties but it can begin during childhood or adolescence, when it is often more severe, causing many problems for the person and their family. The main treatment for it is antipsychotic medication. If not treated, symptoms typically carry on for many years, so it is vital to get effective treatment as soon as possible. Research shows that one antipsychotic, clozapine, works better than any other antipsychotics, and that clozapine has the best chance of working if people start it early on in treatment. On the other hand, clozapine has more side effects than some other antipsychotics, so doctors only use it when other drugs haven't helped. For this reason, almost all research on clozapine was done with adults for 25 and over who had already taken several other antipsychotic medications over the years. Because the illness so often starts in the teens or early twenties, we need to get a better understanding of what could help younger people. Three well designed studies suggest that clozapine works better than other antipsychotics in children and young people, but the studies were too small to be conclusive. This study will look at clozapine as a treatment for schizophrenia and similar illnesses in young people. It will recruit only people under twenty five years old.
Addressing priority 2: Joint research through NIHR and the Australian National Health and Medical Research Council in progress
Relapse in schizophrenia is a major cause of distress and disability among patients and their families. Teams based in the UK and Australia are working together to build an intervention that refines existing smartphone technology for the monitoring of early warning signs. They will assess the acceptability of this to service users, carers and health professionals and look at the feasibility of a larger scale trial of its acceptability and safety.
Addressing priority 2: A Cochrane Review was published in February 2013. It looked at all previous evaluations of how effective early warning signs interventions are and what kind of future research we need in this area.
A number of drugs improve the mental health of people with psychosis; these are called 'antipsychotic' drugs. Up to a half of people who take them experience sexual side effects including reduced desire for and pleasure from sex. These side effects lead some to stop taking their medication making a relapse more likely. This study will compare the effects of switching a person's medication to an equivalent dose of an alternative antipsychotic drug that is believed to result in fewer sexual side effects. This study started in May 2018 and is due to end in January 2021.
Addressing priority 4: A Cochrane Review was published in May 2013. It looked at the results of previous studies around this relatively common side effect of antidepressant medication to find out what management strategies are effective and what the adverse effects and acceptability of them are.
Obesity and problems with weight are two to three times more common in people with schizophrenia. This project created a lifestyle education programme (based on an existing one for Diabetes around diet and physical activity) and evaluated how it could support weight loss in around 5,000 adults, within 10 mental health trusts across the UK. Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia.
Scoliosis is a condition that affects children where the spine twists and curves to the side. It develops when the child is growing, usually between the ages of 10 and 15 years. There are different types of brace worn in order to stop the curve worsening. The most common type of brace is recommended to be worn for at least 20 hours a day, known as full-time brace . This holds the spine in its current position to prevent it worsening and there is good evidence that it works. The alternative is a night-time brace , which is only worn in bed at night. Night-time braces push the curve to make it straighter overnight, though the evidence for its benefit is less clear. Adolescents do not like wearing braces, as they interfere with activities and are uncomfortable, so there are advantages to wearing a brace just at night. This study will investigate if a night-time brace is as good as the full-time brace and will find out patient's experiences of the two braces.
Demand for glaucoma care is increasing (and will continue to do so) due to our aging population. Recent advances in technology mean it is now possible for glaucoma patients to monitor eye pressure and visual fields in their own home. The main aim of this study is assess acceptability and feasibility of home monitoring, and to make recommendations about future research to test how the NHS could use home monitoring.
Read more information about this study. Mark Wilkins, consultant ophthalmologist at Moorfields Eye Hospital, is leading a team comparing two forms of cataract surgery. The trial will include more than 800 people, from Moorfields Eye Unit at St Ann’s Hospital in North London, and Wolverhampton Infirmary. They’re looking at the benefits of making some of the steps of surgery more robotic.
AMD typically leads to loss of central vision and low vision aids can be successful in some users however limitations include small field of view and difficulties with hand-eye co-ordination. Recently a novel approach has been the use of an implantable magnifying lens into the eye. This is often described as an intraocular telescope. The aim of this trial is to provide good quality evidence around the use of this.
Assessing retinal structure and function in Stargardt’s disease using advanced phenotyping in preparation for planned therapeutic intervention
Dr Michel Michaelides from University College London Institute of Ophthalmology, and colleagues, were awarded funding to look at the observable characteristics of eyes with Stargardt’s to determine how retinal pigment epithelium (RPE) cells and photoreceptor cells are involved in various forms of Stargardt’s disease.
Does higher macular pigment density preserve visual function in intermediate AMD?
Dr Raymond Beirne from the University of Ulster was awarded funding to research the relationship between macular pigment density and visual function in AMD to understand the role that the macular pigment plays in keeping retinal rods healthy and maintaining dark adaption.
How eccentric viewing training may help wayfinding and outdoor mobility in the built environment for people with AMD
Josie Grant at Heriot Watt University was awarded funding to look at how we navigate the built environment and whether eccentric viewing training (Skills for seeing) makes this easier for people with AMD. The research also measures whether the training improves people’s self-confidence and has a positive impact on physical activity levels and quality of life.
Establishment of a national eye tissue archive for AMD research
Professor Paul Bishop from the University of Manchester was awarded funding to retrieve tissue from 1,000 pairs of eyes and make it available to researchers in the UK for at least the next 10 years to provide a unique and important resource for future research into new treatments for AMD.
Using induced pluripotent stem cells to investigate Best’s associated macular degeneration
Dr Amanda Carr from University College London Institute of Ophthalmology was awarded funding to create models of Best’s disease using induced pluripotent stem cells (iPSCs) to define the role of the gene BEST1 in the progression of Best’s disease, and potentially identify new treatment pathways. The Macular Society have funded the first year of this study.
Read more information about this study. Chronic eye diseases are a major cause of visual impairment and blindness in the UK. The need for long-term monitoring of these diseases, with frequent, time-consuming visits to hospital eye clinics, places a huge burden on both patients and the NHS. A new form of medical imaging device, termed binocular optical coherence tomography (OCT) has the potential to reinvent the eye examination for the 21st Century, and thus greatly improve the care of patients with these conditions. This research tests the effectiveness of this device in hospital eye clinics in the NHS.
Read more information about this study. Keratoconus is a long term eye disorder that impairs the ability of the eye to focus and reduces vision. Frank Larkin, a consultant at Moorfields Eye Hospital, and his co-investigators will test a treatment known as ‘collagen cross-linking to find out if it’s safe and whether it works in children and young people.
Addressing priority 1 in Inherited Retinal Disease: In June 2014, the NIHR published the results of its 'horizon scanning review', which looked for any new and emerging technologies for inherited retinal disease. The review found 40 new and emerging technologies.
Addressing priority 1 in Corneal and external eye conditions: In September 2016, the NIHR published the results of its horizon scanning review, which looked for any new and emerging technologies for the treatment of corneal disorders. The review identified 130 new and emerging technologies and procedures.
Addressing ocular inflammatory priority 1: Participants in this study are given a course of experimental light therapy in one eye only, in addition to their existing treatment, to see if this can reduce inflammation in the eye caused by auto-immune activity.
Addressing ocular inflammatory priority 5: This biobank of samples from patients with birdshot will ultimately enable a great variety of statistically-valid studies to be performed on large numbers of patient samples.
Addressing ocular inflammatory priority 7: Omar Mahroo and colleagues test a portable device that measures electroretinogram activity to find out whether it can reliably monitor Birdshot’s progress.
Addressing ocular inflammatory priority 3 and 5: In this project, a research team from Birmingham explores a machine learning method known as ‘supercell analysis’ to see if it can help speed up diagnosis and ultimately lead to a reliable diagnostic test.
Addressing ocular inflammatory priority 3: In this project, Mark Westcott and team at Moorfields Eye Hospital look for which clinical signs that appear early in the condition are good predictors of poor prognosis later on.
Addressing ocular inflammatory priority 3 and 5: This team based at Queen Elizabeth Hospital Birmingham tests a light-based imaging device to see how good it is at detecting ‘flare-ups’.
Addressing ocular inflammatory priority 7: This project is a 2-year national survey of the demographics, signs and symptoms of each new case of birdshot in the UK.
Addressing ocular inflammatory priority 1 and 5: It would help our understanding of birdshot to study cells and tissue from patients, but donor tissue is in short supply. This team aims to develop a suitable layer of tissue from certain stem cells that come from patients.
Addressing ocular inflammatory priority 5: This research team studies genes to find out whether iron overload is related to birdshot and can therefore be helped by standard therapy for iron overload.
Addressing priority 4: NIHR research complete. There is no clear agreement among experts on how to detect urinary tract infection in people who have loss of bladder control. Also many scientific studies disagree on the correct definition of a urinary tract infection. Stoke Mandeville National Spinal Injuries Centre is seeking to answer these questions by working with patients and reviewing the current evidence. The results will help doctors better understand how to treat these infections.
Currently, women are offered a scan at 20 weeks, but are not offered any scans after that unless a problem is identified. It is currently known that some babies with problems are not picked up by the usual abdominal examinations during antenatal check-ups. As babies that are small, large or not head first prior at birth are more likely to be sick at birth or not survive, it is thought an extra scan in late pregnancy may be helpful and improve outcomes for babies. The trial will evaluate existing evidence, consider and determine the level of appropriate support for women for whom a late scan identifies a problem, evaluate financial costs vs benefit of a screening programme and finally, taking into account all the evidence, design a study of scanning in late pregnancy. HTA will then be able to judge whether or a not a trial of scanning in late pregnancy for all women should go ahead.
Addressing priority 7: Commissioning brief advertised to researchers by the NIHR HTA Programme.
This trial tests whether planned delivery at 38 weeks is better than monitoring women and babies until at least 40 weeks. The WILL trial will run for 3 years in about 30 UK hospitals. We will ask women to take part if they have reached 36 or 37 weeks of pregnancy and have high blood pressure and no other current problems. This trial started in June 2018.
In the last months of pregnancy, babies who are smaller or who grow more slowly than expected are at higher risk of dying in the mother's womb. Some of these smaller babies who survive may have developmental problems later in infancy. Doctors have many ways to monitor such babies in the womb but, until the baby is born, the only treatment available is to deliver the baby. If the pregnancy has reached its full term, induction of labour is the usual option. If the baby is preterm (before 37 weeks of pregnancy) the right course of action is less clear. Delivering the baby early, as soon as there are signs of problems, will minimise any damage due to lack of oxygen in the womb, but the baby may suffer harm as a result of being born prematurely. This research team is looking at the balance of risks linked with continuing the pregnancy a little longer or delivering the baby early.
Addressing one of the Top 10 priorities: Commissioning brief advertised to researchers by the NIHR HTA Programme
Rotator cuff tears are tendon tears in the shoulder that cause pain, weakness and loss of movement. People affected have problems with day to day activities, work, recreation and sleep. These tears can be full tears through the whole tendon or only part way through - a partial tear. Partial tears are treated in the NHS first with physiotherapy and a steroid injection. Patients who do not get better with these treatments may then choose to have surgery. The aim of this study is to assess if surgical repair of partial tears, in patients with persistent pain despite physiotherapy, is effective. The study is important because, even though rotator cuff problems are the most common cause of shoulder pain and disability, it remains unknown how best to treat them and whether surgery has any extra value.
Breaking (fracturing) the upper part of the arm at the shoulder (proximal humerus) most commonly occurs in people over 65 years old after a simple fall. Fractures are considered more serious & complex when the bone is broken into more than 2 parts or are widely separated This study will assess which is the most effective treatment for these more severe fractures.
Addressing priority 1: Research in progress, supported by The British Tinnitus Association Head of Research.
Currently available tinnitus apps suggest a range of ways in which they might be effective for managing and treating tinnitus, including masking, neuromodulation, relaxation etc. Many allow customisation and personalisation of sounds used. Despite increasing popularity of apps it is unclear what proportion of people use apps for tinnitus management and which apps are the most popular. Also deeper and independent assessment of tinnitus apps that would assess quality of apps (including accuracy of content and usability) and mechanisms of action is lacking. In this ‘horizon scanning’ study, Magdalena Sereda at the NIHR Nottingham Hearing Biomedical Research Unit will identify apps that people use for tinnitus management, evaluate their content, and assess their potential strengths and limitations through an online survey.
In the UK, emphasis is placed on audiologists meeting tinnitus patient needs but few receive the necessary training to provide patient counselling and few audiology departments have counselling-trained audiologists. In this feasibility study, NIHR Nottingham Hearing Biomedical Research Unit staff led by Derek Hoare will develop a manual for audiologists which defines standard care and counselling. Feasibility study objectives include evaluating acceptability of the counselling intervention, compliance, and whether there is sufficient interest and need for a randomised controlled trial.
Sleep disturbance is one of the most common complaints from people with tinnitus affecting between 50-70% of people attending tinnitus clinics. Cognitive Behavioural Therapy (CBT) is a psychological talking therapy which has been shown to help manage insomnia. CBTi is now part of the NICE guidelines for the management of long term insomnia (NICE 2014). This study, led by Dr Laurence McKenna and Dr Liz Marks, University College London, will investigate the effectiveness of CBTi as a treatment of tinnitus-related insomnia. Sleep Hygiene (an approach commonly used in the tinnitus clinics) will be used as a control.
Addressing priority 4: NIHR research was funded through the NIHR Nottingham Hearing Biomedical Research Unit PhD studentship.
Until a cure for tinnitus is found, people need support to manage their tinnitus and reduce its impact on their everyday lives. Self-help programmes provide one way of achieving this. A systematic review was published in May 2016 which identified the self-help techniques used in self-help interventions for adults with chronic tinnitus and assessed their effectiveness. From 5 previous studies 15 behaviour change techniques and eight self-management components were identified but confident conclusions could not be drawn regarding efficacy. The PhD project has also evaluated the Tinnitus E-Programme (www.tinnituseprogramme.org), an internet-based self-help programme for people with tinnitus.
Addressing priority 5: A Cochrane Review was published in January 2014. The team reviewed one previous trial to pull together the evidence that already exists about hearing aid interventions for tinnitus and co-existing hearing loss, and to highlight where further research is needed.
The British Tinnitus Association is funding a Head of Research fellowship that addresses priorities 1, 4, 5 and 9. Research is in progress. Dr Magdalena Sereda hopes her funded research will shed new light on the clinical efficacy and cost-effectiveness of NHS contracted sound therapy options for tinnitus including hearing aids and combination hearing aids.
Addressing priority 5: Research in progress. Supported by the British Society of Audiology Tinnitus and Hyperacusis Special Interest Group Part-funded by a BSA Applied Research Grant.
Combination hearing aids are devices which amplify sounds in the same way as hearing aids, but also can create sounds such as white noise. They are used to manage tinnitus and are a fairly new addition to use in the UK. Many audiology clinics can offer combination aids. However, there is no standard guide to help audiologists decide on who to offer the devices to or how to fit them to best meet the needs of each patient with hearing loss and tinnitus. Ongoing research led by Dr Magdalena Sereda is conducting a series of surveys to 1) identify where there is and is not clinical consensus on who should be recommended combination hearing aids (candidacy) and how those devices should be fitted; 2) explore expectations and experiences of people with tinnitus who have used combination hearing aids.
Addressing priority 6: In March 2015, the Paediatric Audiology Interest Group (PAIG) of the British Society of Audiology published practice guidance – a project that was undertaken by a working party of national specialists in paediatric tinnitus. The guidance offers child-friendly, practical advice for those wanting to develop their skills in the management of children with tinnitus. It is intended for a multidisciplinary audience including audiologists, medical professionals, school nurses, teachers of the deaf, and psychologists. This project was supported by the British Tinnitus Association.
Addressing priority 7: People who are deaf or have profound hearing loss are often marginalised by both their tinnitus and hearing loss. The British Tinnitus Association commissioned The Ear Foundation to investigate people's experiences with different degrees of hearing loss and tinnitus (supported by the James Tudor Foundation). The report was launched in September 2015 and presents the views of 1432 participants on the treatment they have received, what helped, what didn't and their hopes for the future.
Addressing priority 10: In 2015, Autifony Therapeutics Ltd sponsored a Phase IIa tinnitus clinical trial in the UK, funded by Innovate UK. Professor Jaydip Ray, Consultant Ear, Nose and Throat (ENT) surgeon at Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children’s Hospital NHS Foundation Trust was the national Coordinating Investigator and Professor Deborah Hall, University of Nottingham and NIHR Nottingham Hearing Biomedical Research Unit (BRU), was the academic partner. The main aim was to try to demonstrate an improvement in the severity of tinnitus symptoms and impact after 28 days of treatment with the study medicine compared to placebo. Findings from the planned interim analysis of completed participants led to the closure of recruitment due to lack of efficacy. On a statistical basis, it would not be possible to reach the magnitude of change needed to show improvement over the placebo. Nevertheless, the team gained many valuable insights about trial design and patient recruitment.
Accidental leakage of urine is a distressing problem that affects about one in three women and the NHS spends considerable amounts of money treating it. Biofeedback equipment allows women to see their pelvic floor muscles working as they exercise. This study compares exercise with this equipment with standard exercises in around 600 women.
Addressing priority 2: Research complete. This article describes a randomised controlled trial to inform the initial development of a psychosocial self-help intervention designed to reduce social anxiety associated with vitiligo.
Addressing priority 2: Research complete. Psychological interventions are recommended as part of routine management of vitiligo. However, the development and effectiveness of such interventions have been rarely addressed. This study aimed to identify key components for a psychological intervention for people with vitiligo.
Addressing priority 4: NIHR Research complete. Read more information about this study. Vitiligo can have a devastating effect on the quality of life of those who have it, particularly where it is easily seen by others, for example on the face or hands. Over 440 people with vitiligo were involved in this study which looks at combinations of light therapy delivered at home, with steroid ointment. See a short animated video about the results.
Addressing priority 1: This review published in December 2016 discusses a prediction model for identifying women at high risk of endometrial cancer who may therefore benefit from prevention strategies.
Addressing priority 10: Cochrane Review published in February 2018. This review looked at the impact of weight loss interventions, in addition to the standard management of womb cancer, on overall survival and frequency of adverse events.