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Author: Louise Stanley

New Inflammatory Bowel Disease testing protocol could speed up diagnosis

Written by Louise Stanley on . Posted in Early diagnosis and detection, Inflammation and chronic disease.

Patients with suspected inflammatory bowel disease (IBD) could benefit from improved testing protocols that could reduce the need (and lengthy wait) for potentially unnecessary colonoscopies, a new study has found.

In a paper published in Frontline Gastroenterology, researchers from the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC) tested a new protocol to improve IBD diagnosis combining clinical history with multiple home stool tests.

In the two-year study involving 767 participants, patients were triaged and had repeated faecal calprotectin (FCP) tests. The research team found that the use of serial FCP tests were able to strongly predict possible IBD as well as Crohn’s Disease and Ulcerative Colitis, and observed that a second FCP test was a strong indicator of a potential need for further investigation including colonoscopy; although the researchers observed that only 20% of patients had two samples submitted prior to referral to secondary care.

Dr Peter Rimmer from the NIHR Birmingham Biomedical Research Centre and corresponding author of the study said: “Patients who experience symptoms associated with inflammatory bowel diseases often have a long wait until getting a diagnosis, and current testing is under immense strain.

“Using a comprehensive 13-point symptom checker and multiple FCP tests, we have been able to identify much more accurately patients who had IBD and other diseases. The rollout of this protocol could reduce the time taken to get a diagnosis and start treatment for IBDs as much more of the screening and testing can be done through primary care. The sensitivity of multiple FCP tests can be used to flag those patients who urgently need referral into secondary care.”

Dr Rachel Cooney, Consultant Gastroenterologist at University Hospitals Birmingham NHS Foundation Trust, researcher at the NIHR Birmingham BRC and co-author of the study, added: “In its simplest form, this study may help improve referral triage for IBD patients.

“But as we plan new care pathways, it could open up new exciting possibilities: with the growing availability of home FCP testing, these tests’ results combined with simple symptom questionnaires could feed into algorithms that allow patients to self-refer to secondary care services, reducing strain on primary care.

“This is something we’re going to explore in a large follow-up study we’re currently initiating.”

The NIHR Birmingham Biomedical Research Centre is hosted by BHP founder-member University Hospitals Birmingham NHS Foundation Trust in partnership with fellow BHP founder-member the University of Birmingham. Its roster of partner organisations also includes BHP members Birmingham Women’s and Children’s NHS Foundation Trust; Sandwell and West Birmingham NHS Trust; and Aston University. 

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Objective biomarker test could predict heart disease risk for patients with common arrhythmia

Written by Louise Stanley on . Posted in Early diagnosis and detection, Inflammation and chronic disease.

Patients with atrial fibrillation (AF) – a common heart arrhythmia – could have one blood test to assess their risk of cardiovascular events in the following five years, new research has found.

Published in Cardiovascular Research and presented at the Frontiers in CardioVascular BIology Congress 2024 conference in Amsterdam, the research suggests that a blood-based biomolecule test alone could assess the risk of having a cardiovascular event in the next five years.

The study of 1,586 AF patients found that a cluster of high-risk patients who recorded high levels of 13 biomolecules had five times more cardiovascular events than those in the low-risk cluster.

Professor Larissa Fabritz, from the Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg Eppendorf and an Honorary Professor at BHP founder-member the University of Birmingham said: “These validated findings show that one blood test could be used to help predict the risk of cardiovascular events for patients with atrial fibrillation, helping to differentiate healthcare where it’s most needed. Through a further validation study carried out in Birmingham, we are confident that the blood test can give a useful understanding of those in greatest need of interventions to avoid strokes, acute heart failure and death.”

The international team developed a profile of 13 specific biomarkers that were used to differentiate risk in atrial fibrillation. Using samples from AF patients, they analysed likely target biomarkers and through the trial and validation in the Birmingham BBC-AF registry found that a combination of elevated biomarkers corresponded with risk variation in patients.

The findings are taken from a subset of the EAST – AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention) trial which demonstrated that early rhythm control – with antiarrhythmic drugs or atrial fibrillation ablation – delivered within one year after AF diagnosis improves outcomes in 2,789 patients with early AF and cardiovascular risk factors compared to usual care (UC) over a 5-year follow-up time.

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Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Maternal health.

During pregnancy, women and pregnant individuals who do not identify as women* can develop a range of pregnancy-specific conditions, such as preeclampsia and gestational diabetes, that can adversely affect both their own health and that of the developing foetus during the pregnancy. These conditions can affect the lifelong health of both mother and child. Despite the danger that these conditions present to mother and baby, there are few approved, safe and effective medicines to treat them, and limited investment in novel therapy development.

To map out key barriers and potential enablers of preclinical research and experimental medicine to support the development of new medicines for pregnancy-specific conditions, the Academy of Medical Sciences, Birmingham Health Partners, and Concept Foundation organised a multi-sectoral FORUM workshop in September 2023. People with lived experience joined representatives from academia, the commercial sector, clinical practice (including doctors and midwives), regulatory authorities, funding bodies, charities, and patient advocacy groups at the meeting.

The result of this workshop is a new report – Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions – which highlights the need to raise awareness of the importance of research in pregnancy, and give women opportunities to participate.

> Understanding pregnancy: Accelerating the development of new therapies for pregnancy-specific conditions – view and download the report here

This work builds upon the BHP-led Pregnancy Policy Commission which in 2022 published its Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe, Effective and Accessible Medicines for Use in Pregnancy report, proposing a clear roadmap to improve the lives of millions of people, not just for women while they are pregnant, but for future generations.

Professor Peter Brocklehurst, Emeritus Professor at BHP founder member the University of Birmingham, commented: “We need to better understand the biological mechanisms of pregnancy-specific conditions so that we can develop therapies that target these processes. To do this, we need more health data and biological samples from women with those conditions.”

Forum participants identified the following six priority areas for next steps:

    1. A cross-sectoral and cross-speciality network or coalition, including women with lived experience, to provide a platform for collaboration and to coordinate efforts to promote the development of new medicines for pregnancy-specific conditions.
    2. Additional interdisciplinary research and cross-sector collaboration to address key knowledge gaps (including the biology of the placenta, of the early stages of pregnancy, and of pregnancy-specific conditions), to enable appropriate use of animal models and physiologically based pharmacokinetic (PBPK) modelling, and to leverage routinely collected health data and patient samples.
    3. The establishment of a more enabling environment for research in pregnancy, for example through development of a stronger research base and a more supportive regulatory environment.
    4. Greater engagement with women to raise awareness of the importance of research into pregnancy and of opportunities to participate in this research, including when women contact the healthcare system.
    5. Education and training of healthcare professionals, including midwives, to promote research in pregnancy.
    6. Advocacy to secure greater prioritisation of research in pregnancy (and women’s health more generally) by policymakers, funders, and higher education institutions.

The workshop was chaired by Professor Peter Brocklehurst FMedSci, Emeritus Professor of Women’s Health at the University of Birmingham, and Dr Pauline Williams CBE FMedSci, an independent pharmaceutical medicine consultant and former Senior Vice-President and Head of Global Health R&D at GlaxoSmithKline.

* The Academy acknowledges that not all pregnant people identify as women. While the terms ‘woman’ and ‘mother’ are used here, many of the learnings from the workshop about obstetric/pregnancy-specific conditions are expected to be widely applicable. It is recognised that there will be specific experiences and challenges associated with obstetric conditions among pregnant individuals who do not identify as women that were not explored at the workshop given the lack of specific research in this area. 

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Birmingham scientists win funding to develop ‘lollipops’ for mouth cancer diagnosis

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

A ‘lollipop’ that can diagnose mouth cancer early could become a reality, thanks to a pioneering project funded by Cancer Research UK and the Engineering and Physical Sciences Research Council (EPSRC).

Scientists at BHP founder-member the University of Birmingham have been awarded £350,000 over the next three years to develop a prototype flavoured ‘lollipop’ from a material called a smart hydrogel.

Smart hydrogels – previously developed by the University’s Dr Ruchi Gupta and her team – work a bit like a fishing net: they absorb large quantities of water while ‘catching’ larger molecules, such as proteins. The ‘net’ can then be cut open to release the larger molecules for analysis in the lab. The idea is that patients suck on the lollipop, transferring a saliva sample into the hydrogel. Scientists can then release the ‘caught’ proteins by blasting the hydrogel with UV light and then analyse the liquid for saliva proteins which indicate the early stages of mouth cancer.

Around 12,400 people are diagnosed with cancers of the head and neck in the UK every year*. Currently, diagnosing mouth cancer can involve putting a flexible camera on the end of a tube through the nose or mouth and taking a biopsy for testing. This procedure is invasive, time-consuming and requires an endoscopist.

Mum of five, Rachel Parsons, needed a biopsy after being referred to Coventry University Hospital with a lump on her cheek in 2008. She admits she was unprepared for the procedure which, in her case, turned out to be painful.

“I had no idea what a biopsy really was,” said Rachel, from Coventry. “I had the kind of injection you get at the dentists and, when it wore off, it was really sore because I’d needed stitches.”

That was just the beginning of a 12-month nightmare for Rachel who ended up needing a nine-and-a-half-hour operation to remove a cancerous tumour from her cheek and replace the skin with tissue and veins from her forearm.

“The thought of putting a lollipop round your mouth instead of having a biopsy in the first instance is amazing,” said Rachel who has spent years as a patient ambassador, campaigning for more awareness of mouth cancer. “I wish something like that had existed when I was diagnosed.”

Dr Ruchi Gupta, Associate Professor of Biosensors at the University of Birmingham, said she was thrilled to receive funding to begin the next phase of the project: “Smart hydrogels have really exciting potential for diagnosing mouth cancer,” she said. “They can be easily moulded into shapes as a solid to ‘catch’ proteins in saliva.

“We’re really excited to start the next phase of this project. We’re hoping that we can be the first to make a device which is much kinder for diagnosing mouth cancer for patients and easier for GPs to use.”

Rachel, who still has numbness around her face and can’t open her mouth wide enough to eat a burger, added: “I’m so grateful for the research and treatment that saved my life. Things have improved immensely since then but what’s happening now could be absolutely brilliant for people diagnosed in future.”

Executive Director of Research and Innovation at Cancer Research UK, Dr Iain Foulkes, said: “Biopsies and nasoendoscopy are the gold standard for diagnosing mouth cancer, but it requires great skill to carry out and can feel unpleasant for patients. We want an accurate, faster and kinder alternative test which can help us diagnose cases of mouth cancer sooner.

“This project is an exciting first step towards an entirely new way to identify mouth cancers earlier. Research like this is guiding us towards a future where people can live longer, better lives, free from the fear of cancer.”

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Revolutionising diagnosis and management of cartilage tumours

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

The musculoskeletal radiology department at BHP member the Royal Orthopaedic Hospital (ROH) has developed a new website designed to enhance the diagnosis and management of cartilage tumours.

bactip.co.uk is a platform that equips healthcare professionals with the tools and knowledge to navigate the complexities of central cartilage tumours. By offering drawings and real case examples, it serves as a valuable resource for interpreting musculoskeletal radiology imaging findings related to these tumours, ensuring their accurate and consistent reporting. Developed collaboratively by experts in the field, bactip.co.uk offers an approach for assessing, diagnosing and monitoring these lesions.

A standout feature of bactip.co.uk is its integrated calculator, which streamlines the grading process based on tumour characteristics, like size and aggressiveness. This innovative tool aims to simplify decision making processes for healthcare professionals dealing with cartilage tumours. This advanced tool also standardises the reporting of central cartilage tumours, reducing subjective differences and improving patient care.

bactip.co.uk enables radiologists and clinicians to make informed decisions by offering an imaging follow up plan. Whether it involves suggesting a referral to an oncology specialist or safely discharging a patient from surveillance monitoring, the protocol provides a detailed framework customised for each unique case.

As a leading authority in orthopaedic excellence, the ROH musculoskeletal radiology department is proud to share its expertise through bactip.co.uk, an open-source free resource.

Dr A. Mark Davies, consultant radiologist at the ROH commented: “This initiative reflects our commitment to openness making sure that healthcare professionals worldwide can access our cutting-edge knowledge and best practices without any barriers. Our dedication to spreading knowledge and best practices aligns with our shared goal of enhancing patient outcomes on a global scale.”

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Birmingham researchers receive prestigious NIHR award

Written by Louise Stanley on . Posted in Birmingham Health Partners.

Professors Melanie Calvert and Richard Riley – both of BHP founder-member the University of Birmingham – have been recognised with a National Institute for Health and Care Research (NIHR) Senior Investigator Award.

Melanie Calvert – Director of the Centre for Patient Reported Outcomes Research and Professor of Outcomes Methodology – has been reappointed NIHR Senior Investigator for a second term and said: “I am delighted and honoured to receive this prestigious award for a second term. It is important recognition, not only of my work, but that of my brilliant team at the University of Birmingham, our international collaborators and wonderful patient partners. I look forward to providing senior leadership within the NIHR and building capacity for patient centred research.”

Melanie leads the Patient-reported Outcomes research theme at the NIHR Birmingham Biomedical Research Centre (BRC) and has led international initiatives to improve the design, analysis and reporting of patient-reported outcomes (PROs) in clinical trials and works with the Health Research Authority to improve ethical and inclusive PRO collection. Through global leadership and collaboration she has engaged patients and professionals, developing international guidelines which informed European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidance and are used by pharmaceutical companies, patient-partners and trialists worldwide. Her work has helped ensure that patient quality of life and symptom data is captured and reported in a rigorous way that can meaningfully inform patient care, regulatory decision-making, clinical guidelines and health policy.

Richard Riley, who has been newly awarded the accolade, is Professor of Biostatistics at the Institute of Applied Health Research and a researcher within the NIHR Birmingham BRC’s Data, Diagnostics and Decision tools research theme. He leads a team of statisticians undertaking applied and methodology research for healthcare, especially in regard to prognosis, prediction models, and evidence synthesis. He is Deputy Chief Statistics Editor for The BMJ and was named as a ‘Highly Cited Researcher’ in 2023. He works passionately to improve medical research by developing, promoting and educating about the importance of high methodology standards in study design, analysis and reporting.

He commented: “I am delighted to receive this award from the NIHR. Statisticians and methodologists play a critical role in undertaking and improving medical research, and having my contributions recognised by the NIHR is truly humbling. I would like to thank the many research collaborators and mentors who have supported my career, and I look forward to further championing methodology and guiding the NIHR community in the coming years.”

NIHR Senior Investigators are among the most prominent researchers funded by the NIHR. This award is presented to outstanding researchers developing health and care research capability to improve the future health of the nation, with reach into both academia and the health and care system.

Senior Investigators play an important role in guiding research capacity development and strengthening the career paths of NIHR researchers, which includes participating as mentors in the NIHR mentoring programme.

In addition to the title, Senior Investigators also receive an award of £20,000 per year of appointment to fund activities that support their research. They are usually appointed for 4 years, for a maximum of two terms to ensure turnover.