Author: Louise Stanley

Eye-safe laser technology to diagnose traumatic brain injury

Written by Louise Stanley on 01/12/2023. Posted in Early diagnosis and detection.

Researchers from BHP founder-member the University of Birmingham have designed and developed a novel diagnostic device designed for the early detection of traumatic brain injury (TBI), which works by shining a safe laser into the eye.

Described in Science Advances, the technique is dramatically different from other diagnostic methods and is now expected to be developed into a hand-held device for use in the crucial ‘golden hour’ after TBI, when life-critical decisions on treatment must be made.

The device incorporates a class 1, CE-marked, eye-safe laser and a unique Raman spectroscopy system, which uses light to reveal the biochemical and structural properties of molecules by detecting how they scatter light, to detect the presence and levels of known biomarkers for brain injury.

There is an urgent need for new technologies to improve the timeliness of TBI diagnosis, which is a leading cause of death worldwide. TBI is caused by sudden shock or impact to the head, which can cause mild to severe injury to the brain, and although it needs diagnosis and treatment as soon as possible to prevent further irreversible damage, it is hard to diagnose at the point of injury. Additionally, radiological investigations such as X-ray or MRI are very expensive and slow to show results.

Birmingham researchers, led by Professor Pola Goldberg Oppenheimer from the School of Chemical Engineering, designed and developed the novel diagnostic hand-held device to assess patients as soon as injury occurs. It is fast, precise and non-invasive for the patient, causing no additional discomfort, can provide information on the severity of the trauma, and will be suitable to be used on-site – at the roadside, on the battlefield or on the sports pitch – to assess TBI.

The device works by scanning the back of the eye where the optic nerve sits. Because this nerve is so closely linked to the brain, it carries the same biological information in the form of protein and lipid biomarkers. These biomarkers exist in a very tightly regulated balance, meaning even the slightest change may have serious effects on brain health. TBI causes these biomarkers to change, indicating that something is wrong.

Previous research has demonstrated the technology can accurately detect the changes in animal brain and eye tissues with different levels of brain injuries – picking up the slightest changes.

The device detailed in the current paper detects and analyses the composition and balance of these biomarkers to create ‘molecular fingerprints’. The study details the development, manufacture, and optimisation of a proof-of-concept prototype, and its use in reading biochemical fingerprints of brain injury on the optic nerve, to see whether it is a viable and effective approach for initial ‘on-scene’ diagnosis of TBI.

The researchers constructed a phantom eye to test its alignment and ability to focus on the back of the eye, used animal tissue to test whether it could discern between TBI and non-TBI states, and also developed decision support tools for the device, using AI, to rapidly classify TBIs.

The device is now ready for further evaluation including clinical feasibility and efficacy studies, and patient acceptability.

The researchers expect the diagnostic device to be developed into a portable technology which is suitable for use in point-of-care conditions capable to rapidly determine whether TBI occurs as well as classify whether it is mild, moderate or severe, and therefore, direct triage appropriately and in timely manner.

Rare disease trials to develop playbook for testing new treatments

Written by Louise Stanley on 17/11/2023. Posted in Clinical trials.

Patients with rare diseases could benefit from a ‘revolution’ in clinical trials that could see one-stop studies designed to provide robust results even with small numbers of participants.

The CAPTIVATE node is part of the recently introduced UK Rare Disease Research Platform established as part of a £14 million investment over five years by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR).

Led by BHP founder-member the University of Birmingham along with collaborators at the Universities of Sheffield and Liverpool, the CAPTIVATE node will be developing a methodology to run a ‘one-stop-study’, which would encompass all phases of clinical trials to enable the efficient evaluation of treatments for rare diseases.

The CAPTIVATE node will bring together the UK’s leading trial experts with hospital researchers experienced in rare diseases, industry partners, policy makers and patient partners, and the resulting designs could speed up the approval of medicines for use in rare diseases.

Professor Lucinda Billingham at the University of Birmingham is the lead academic for the CAPTIVATE node of the MRC-NIHR UK Rare Disease Research Platform. She explained: “One of the biggest challenges with developing new treatments or improving existing ways of treating rare diseases is that the model of clinical trial that is used as standard is incredibly difficult to run where there may be only hundreds of people around the world at any one time with that disease.

“Added to this fact, in the UK three quarters of rare diseases affect children and more than 30% of children with a rare disease die before their fifth birthday.

“The CAPTIVATE node is looking to scale a revolutionary model of clinical trial that runs all the phases together and can get clinically significant results even with very small numbers of patients. We want to find ways that need as few people to take part as possible, that are quicker and that provide all the information needed for the authorities to approve a new medicine to be prescribed to people with rare diseases from one single trial.”

Bringing together strengths in rare diseases

The MRC-NIHR UK Rare Disease Research Platform is now getting up and running and will bring together UK strengths in rare diseases research to improve diagnosis and treatment through better understanding of the disease.

It is made up of a central coordination and administrative hub and 11 specialist nodes based at universities across the UK, including the CAPTIVATE node at the University of Birmingham.

The aim of the platform is to bring together expertise from across the UK rare disease research system to foster new and innovative treatments for those directly and indirectly impacted by rare conditions.

Professor Lucy Chappell, Chief Executive of the NIHR, commented: “The UK Rare Disease Platform marks a significant advance in accelerating rare disease research, supported through NIHR funding and our partners the Medical Research Council. The platform will enable greater collaboration between patients and those working across academic, clinical and industry research. By bringing the right people and expertise together, we will be able to provide better care more quickly to those living with rare diseases.

“The NIHR continues to lead essential ongoing research into rare diseases, including through our Biomedical Research Centres, and we are making it easier for people with rare diseases to take part in research opportunities via our Be Part of Research Service, which can now be accessed through the NHS app in England. We look forward to working with our partners further to accelerate our understanding and treatment of rare diseases affecting millions of people across the UK.”

Giving progesterone in early pregnancy may reduce preeclampsia risk – preliminary study

Written by Louise Stanley on 17/11/2023. Posted in Maternal health.

Prescribing vaginal progesterone treatment early in pregnancy appears to reduce risk of developing preeclampsia – a potentially fatal condition – by approximately 39%, a recent research review suggests.

Collaborating through the Tommy’s National Centre for Miscarriage Research, Dr Pedro Melo from the University of Oxford, and Dr Adam Devall and Professor Arri Coomarasamy from BHP member the University of Birmingham have analysed the findings of 11 recent studies involving 11,640 women.

These studies were originally designed to explore the impact of progesterone on reducing miscarriage or preterm birth rates. In every study, data were also collected on whether the same treatment affected rates of preeclampsia or other high blood pressure (hypertensive) disorders in women during pregnancy.

The review, published in the British Journal of Obstetrics and Gynaecology, concludes that vaginal progesterone appears to reduce risk of hypertensive disorders in pregnancy, but only when treatment is started in the first trimester.

The review showed that, compared to a placebo, 400 mg of vaginal progesterone used twice a day was associated with a 39% reduction in preeclampsia and a 29% reduction in the rate of other hypertensive disorders such as gestational hypertension.

Starting progesterone early in pregnancy appears to be critical: no clear evidence was found through this review to suggest that starting progesterone in the second or third trimesters had an effect.

Frequency, quantity, and method of use are also important: 400 mg used twice daily as a vaginal capsule showed a benefit in reducing risk of preeclampsia and other hypertensive disorders but using 400 mg once a day did not.

“The recent PROMISE and larger PRISM trials led to an exciting breakthrough in finding evidence that progesterone can reduce miscarriage risk in some women when used in the first trimester. This evidence led to updated NICE guidelines in 2021 recommending its use. But the signal we found in the data for progesterone’s effectiveness in reducing hypertensive disorders had not previously been demonstrated.

“These are exciting preliminary findings, but it must be stressed that they were secondary results of trials focusing on the use of progesterone for the prevention of miscarriage and preterm birth, not preeclampsia. We need a large randomised controlled trial focusing specifically on women and birthing people at risk of preeclampsia to confirm our hypothesis that progesterone supplementation may tackle abnormal implantation in this subgroup of people” said Dr Pedro Melo, lead author of the study at the Tommy’s National Centre for Miscarriage Research at the University of Birmingham and the Nuffield Department of Women’s and Reproductive Health at the University of Oxford.

Dr Adam Devall, Institute of Metabolism and Systems Research, University of Birmingham, added: “The preliminary finding from this study suggests vaginal micronised progesterone might reduce the risk of preeclampsia. The researchers are calling for a large multi-centre clinical trial to explore the effects of progesterone in women at risk of preeclampsia.”

The 11 studies analysed focused on groups of pregnant women who either had a history of recurrent pregnancy loss or had a threatened miscarriage (i.e., they were experiencing early pregnancy bleeding). The review recommends that future studies are needed to explore the link further, to find out whether the reductions of 29-39% are relevant to all women and birthing people and whether the effect could be larger for those who have risk factors for preeclampsia.

Preeclampsia is a condition that affects some pregnant women, usually during the second half of pregnancy or soon after their baby is delivered. Preeclampsia can lead to fetal growth restriction which can cause premature birth. If severe, it can be dangerous, sometimes even fatal, for mothers.

Progesterone plays an important role in implantation of the embryo as it helps make the tissue lining the uterus receptive to implantation. By giving vaginal progesterone, researchers believe it is possible to combat problems with the lining of the womb and partly correct abnormal implantation, helping support successful development of the blood vessels in the placenta. This would reduce the chance of developing conditions such as preeclampsia.

“This research further supports Tommy’s calls for women with a history of miscarriage and pregnancy bleeding to be given progesterone in the early stages of pregnancy. We must continue to keep exploring progesterone’s potential and improve understanding of what it can be used for, who it works best for, when, and how” explained Kate Davies, Research Director at Tommy’s.

High-profile appointee heightens ambition for Birmingham Health Partners

Written by Louise Stanley on 16/11/2023. Posted in Birmingham Health Partners.

The second city’s strategic University-NHS alliance, Birmingham Health Partners (BHP) has announced the appointment of experienced business leader Jonathan Pearson as its new Chair, tasked with implementing an ambitious new strategy.

Bringing extensive experience as a management consultant and a profound understanding of the health and life sciences sector, Jonathan has established and guided numerous healthcare enterprises, spearheaded significant growth, and led large-scale transformation and technology programmes. He has also served within the NHS as Independent Chair of the Sandwell and West Birmingham Health System, bringing together a unique blend of high-level industry and health service expertise.

Jonathan’s contributions to the sector have earned him several prestigious accolades throughout his career. Notably, he was honoured with the Healthcare Deal of the Year award in 2014 by Acquisition International, recognised by the Management Consultancy Association in 2015 for thought leadership, and received the HSJ award for Analytic Provider of the Year in 2019. His exceptional leadership in the Sandwell ICP’s Covid vaccination program was further acknowledged with the Local Government Association award in 2021.

BHP is a strategic alliance uniting two renowned Universities, five NHS Trusts and Health Innovation West Midlands, with the shared aim of transforming healthcare across our region by leveraging collective strengths in clinical and technological innovation, research, and education.

Commenting on his appointment, Jonathan said: “Birmingham Health Partners is a powerhouse of research at the heart of an ambitious city and region, with a strong track record of scaling innovation from the bench to the bedside at pace. Together with its wider regional partners, BHP is already working to address pressing health challenges and deliver economic growth and this work will only be enhanced by the imminent launch of our new strategy which will benefit our communities, region and workforce. It is an incredibly exciting time to join the partnership.”

Spinal injury model funding awarded to BHP members

Written by Louise Stanley on 07/11/2023. Posted in Birmingham Health Partners.

BHP members the Royal Orthopaedic Hospital and Aston University – working with the University of Edinburgh – have been awarded a joint research fellowship to develop a working 3D model of the spinal cord, to improve understanding of the management of compressive spinal cord pathology.

The fellowship is funded by Orthopaedic Research UK (ORUK), the British Association of Spine Surgeons (BASS) and the British Scoliosis Society (BSS) and the project will run for three years. The team is led by Professor Adrian Gardner – consultant spine surgeon at the Royal Orthopaedic Hospital and Jean-Baptiste Souppez – senior lecturer mechanical, biomedical and design engineering at Aston University.

The idea for the project came about following a discussion between colleagues about a patient presenting with a multi-level degenerative cervical spine with multi-level spondylolisthesis. Multiple vertebra in the patient’s neck were compressing on each other and several of these vertebra were pushed forwards creating an unstable spine.

Professor Gardner said: “I was able to make recommendations, however this was based on training over the years and experience. For example, there are multiple ways to approach this kind of injury – you could go in from the front (anterior) or the back (posterior), but the decision is largely down to how you’ve been trained. It occurred to me that a physical model could be used to better understand the pathology and use scientific evidence to inform surgical solutions for our patients here at the Royal Orthopaedic Hospital and across the globe.”

Professor Gardner worked through potential options with contacts at Aston University, who recommended using 3D printing to simulate the different ways spinal cord compression happens, and its management. The model would be made up of a 3D printed, fully articulated vertebral column and use tuneable pneumatic pressure to replicate the spinal cord. Adjustable to reflect various spinal conditions, the model would enable spinal teams to test the likely impact of different procedures.

Degenerative Cervical Myelopathy (DCM) is one of the most common spinal injuries, caused by severe compression in the neck. This compression can come because of inflammation, arthritis and age. It can lead to issues with balance, dexterity and control of the bowel and bladder. If left untreated, myelopathy can lead to permanent spinal cord injury and nerve damage.

Professor Gardner added: “Despite being common, DCMs are under researched. As spinal surgeons we often refer to it as a silent disease – studies show about 2% of the adult population have DCM, but the real number could be much higher. This is because patients may not be aware that they have a degenerative cervical myelopathy and will put their symptoms down to aging, never seeking out treatment.

“With this fellowship we have the chance to enhance understanding of the best way to treat this under-researched condition and better support clinicians with their management plans. Timing is key in treating people with DCM to maximise recovery and outcomes, but surgeons have always been appropriately cautious due to the lack of research in this space. Ultimately, we hope that this model will help demonstrate that earlier intervention can prevent DCM becoming a serious disability.”

The project is supported by three students from the University of Aston who sit across different engineering disciplines: Design Engineering, Biomedical Engineering and Mechanical Engineering.

Jean-Baptiste R. G. Souppez, senior lecturer in mechanical, biomedical and design engineering at Aston, co-lead on the project, commented: “The award of the inaugural ORUK/BASS/BSS fellowship has been instrumental in enabling this joint research project between the Royal Orthopaedic Hospital and Aston University’s Mechanical, Biomedical and Design Engineering department.

“It is also fantastic to see the joint effort from three engineering disciplines, coming together to strengthen our commitment to our local community partners, developing innovative solutions to real-world problems as part of our Engineering for Health research centre at Aston University.”

Our shared future – BHP publishes annual review of activity

Written by Louise Stanley on 01/11/2023. Posted in Birmingham Health Partners.

Following a year in which Birmingham Health Partners expanded its membership to eight member organisations – welcoming Aston University and Birmingham and Solihull Mental Health NHS Foundation Trust – we’re pleased to publish our second annual review of activity for the period September 2022-August 2023.

Download and read the Birmingham Health Partners Report of Activity 22-23 (PDF, 5MB)

Over the past year, BHP has demonstrated the benefits of collaboration across our organisations. The addition of new members and the emergence of integrated care systems together with changes in the funder landscape offer new opportunities for BHP to continue to develop and promote our collaborative purpose.

The year ahead will see us welcome a new Chair, new leaders at some of our Partner organisations and the publication of a strategic framework and delivery plan that reflects our ambitions for the region.

We have in our hands the tools that we need to succeed, the onus is on us to put them to work to ensure Birmingham is seen as the place where innovative research translates into improved health and economic growth.

Outgoing chair Ed Smith commented: “We were delighted to welcome Aston University and Birmingham and Solihull Mental Health NHS Foundation Trust to our membership during the year and now comprise two universities, five NHS Trusts, and the West Midlands AHSN. Our collaboration between such significant partners allows us to focus on research, innovation and health care capabilities to deal with important health issues in the region and indeed beyond through wider partnerships.

“BHP’s key activities over the last year have been a focus on women’s health; improving the environment for clinical research fellowships; and our forward strategy for the next five years – which has been approved by the BHP Board and is focussed on delivering real value to the region from collaborative and skilled contributions which, in the prioritised areas, would be less effective than those from single organisations working individually.”