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Month: June 2024

Behind the scenes – meet the ROH research team

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Experimental medicine.

Written for BHP by Ellie Keeling, Lead Research Nurse at the Royal Orthopaedic Hospital

Birmingham is a major research hub with a thriving collaborative ecosystem convened by Birmingham Health Partners. Within this alliance, the Royal Orthopaedic Hospital (ROH) is leading the way in orthopaedic research, conducting clinical trials, observational studies, and laboratory research. Our work focuses on enhancing physiotherapy rehabilitation, developing therapies for bone tissue regeneration, and creating pharmaceutical treatments to reduce invasive surgeries and speed up recovery. ROH’s research aims to improve patient care, facilitate early diagnosis, support new drug development, and offer alternative treatments, consistently contributing new findings to the field.

The majority of this work happens behind the scenes. And the roles that make up this team are varied. They include our lab manager who oversees the management of the Dubrowsky Lab; research nurses; a research tissue bank co-ordinator; study co-ordinators; assistant clinical research practitioners; data managers; and a healthcare technician.

Research nurses play a vital role in delivering clinical research, guiding the patient as they go through the clinical research process and ultimately improving patient care and treatment pathways. It’s an incredibly diverse role, from recruiting patients for studies to collecting and tracking samples, and developing pathways to improve the delivery of trials. Because many clinical trials run over the course of several years, research nurses get to work with the same patients regularly and are able to build up a rapport with them.

Our research tissue bank co-ordinator manages our research tissue bank, which was established over thirty years ago and contains the world’s largest archive of frozen bone tumour samples – currently numbering 32,000 – including all orthopaedic malignancies as well as other benign and non-tumour tissue types. The research tissue bank is used by researchers across the globe who need access to bone and tissue samples that they can’t get elsewhere, with the samples supporting clinical projects to better understand cancers like chondrosarcomas (cancer of the cartilage cells) or develop new treatments for primary bone cancer.

The team is involved in a number of clinical trials, including the BASIS study and the RACER Hip and Knee studies. We are one of the main recruiting centres for the BASIS study, which is trying to find out which type of back brace is best for treating children and young people with scoliosis. The RACER Hip and Knee studies are exploring clinical effectiveness of robotic assisted hip and knee replacement. Pivotal to the success of these studies is patient recruitment – working closely with patients and recruiting them onto these clinical trials with empathy. Our assistant clinical research practitioners (ACRPs) are critical here, as this research couldn’t happen without the generosity of patient donations and their time. In this role, ACRPs work closely with patients to explain what research we are doing, explore how the patient could potentially participate in this research and support them through the process.

It’s essential that patient donations are viable and there are several steps required to ensure this. The role of the healthcare technician is a rare role, but a key one at ROH as it enables a clear and consistent pathway for the effective collection and packaging of patient bone and tissue samples.

Finally, our data managers keep all this work running smoothly by supporting the team with the collection and storing of patient data. This support helps our researchers identify what patient data could support new and existing clinical research as well as retrospective data-led research, all the while ensuring compliance and confidentiality.

While many research roles, especially in hospitals, are perceived as being behind the scenes, they are incredibly important bringing unique skills and knowledge and their contribution is crucial in making breakthroughs that can improve lives.

For more information on The Royal Orthopaedic Hospital’s research activities, visit Royal Orthopaedic Hospital – Research (roh.nhs.uk).

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a woman injects insulin into her abdomen

Patients with recent onset diabetes fast-tracked more effectively for pancreatic cancer screening

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

A recent study, funded by Pancreatic Cancer UK and conducted by researchers at BHP’s University of Birmingham, in collaboration with University of Oxford, University of Nottingham and fellow BHP founder-members University Hospitals Birmingham NHS Foundation Trust, developed a new prediction model as an effective way of identifying individuals suitable for fast-track abdominal imaging.

Weight loss and glycaemic control are known biomarkers that can indicate pancreatic cancer risk and in, accordance with NICE recommendations, people over the age of 60 years with recent onset diabetes and weight loss currently undergo urgent abdominal CT imaging to assess for pancreatic cancer.

Pancreatic cancer is known for its poor prognosis, with less than a quarter of patients surviving past one year after diagnosis. Early detection is important as patients with early-stage disease are more likely to be able to tolerate chemotherapy and therefore have an improved 5-year survival rate, but most patients are not diagnosed until the later stages of the disease. One way of detecting pancreatic cancer patients sooner is through screening patients with diabetes as there is a known association.

By looking at further potential biomarkers to determine which patients would benefit from referral for abdominal imaging, there is a chance of picking more cancers and reducing the cost of imaging those who are not so high-risk.

Dr Shivan Sivakumar, Associate Professor in oncology, specialising in pancreatic, liver and biliary tract cancer, said: “One in ten pancreatic cancer patients have new-onset diabetes and we know that some patients with newly diagnosed diabetes are worth exploring further to improve early detection of pancreatic cancer. We need to more accurately predict which of those patients should be referred for further investigation. We used health data records, from a larger patient population than has previously been studied, to develop a more nuanced method of stratification that could improve referral pathways.”

This study used large-scale, population-representative, linked electronic health data records to develop and evaluate a new prediction model that can be used to predict risk of developing pancreatic cancer within two years of a diabetes diagnosis. The new models used a variety of potential markers and were able to predict pancreatic cancer risk in patients aged between 30 and 85 years, rather than relying on the 60+ rule of thumb.

This study was the largest of its kind and offers improved accuracy compared to previous prediction models as it used a larger data set. The new prediction model could be more effective than current ‘rules-based’ referral guidelines. Further external validation and health economic assessment is recommended.

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Lower risk of caesarean births after COVID vaccination

Written by Louise Stanley on . Posted in Maternal health.

Pregnant women who have received a Covid-19 vaccination are less likely to require a caesarean section or experience hypertension, according to new research.

A meta-analysis – funded by the NIHR Birmingham Biomedical Research Centre (BRC) – of 67 studies which included more than 1.8m women found that being fully vaccinated against Covid-19 had a protective benefit against infection and hospitalisation, while vaccination with at least one dose lowered the risk of adverse pregnancy-related and neonatal outcomes. The BRC is hosted by University Hospitals Birmingham in partnership with the University of Birmingham – both founding members of BHP.

Drawing on data from December 2019 to January 2023, the PregCOV study published in BMJ Global Health assessed evidence from global studies to evaluate the effectiveness of Covid vaccinations for pregnant women, who had increased risks associated with the virus.

The study found that women involved in the studies who had been fully vaccinated had a 61% reduction in the likelihood of getting Covid, and 94% reduced odds of hospital admission. Moreover, the meta-analysis suggests that vaccination leads to a 9% reduction in caesarean section risk, 12% reduction in hypertensive disorders in pregnancy; and an 8% reduction in the risk of intensive care unit admission for newborn babies born to vaccinated mothers.

Professor Shakila Thangaratinam, Dame Hilda Lloyd Chair of Maternal and Perinatal Health at the University of Birmingham and lead author of the PregCOV study said: “Our findings show how beneficial the vaccination programme against Covid-19 has been for pregnant women. As well as the expected benefits from reduced infections, we have also seen a significant reduction in pregnancy complications including hypertension and caesarean sections. This underlines the importance of a systems approach to maternal health and the need to ensure that future healthcare policy, including pandemic preparedness, takes into account how connected natal care is for our healthcare.

“Pregnant women were unfortunately neglected during the heights of the Covid-19 pandemic, especially when it came to a robust understanding of the impact of vaccinations for expectant mothers. PregCOV was launched during the pandemic to conduct a series of reviews to pull together the best evidence possible to support informed policy making for pregnant and postnatal women.”

Evidence from the meta-analysis of studies has been able to draw robust conclusions about the reduction in risk of several pregnancy-related conditions, including less common outcomes such as neonatal intensive care unit admissions.

The research team however note that there have been too few cases and studies relating to adverse impacts such as thrombotic events or Guillain–Barré syndrome from Covid-19 vaccination to draw any meaningful results, and that cases of several known impacts are very low. In addition, the team note that studies have drawn on evidence across multiple waves of the Covid-19 pandemic and weren’t able to differentiate potential changes in the effects caused by new variants of concern.

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Clinical trials programme kicks off with pulse survey

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

As part of our ‘Reducing Bureaucracy in Clinical Trials’ programme, Birmingham Health Partners is seeking the views of research-active colleagues from across the research partnership to help inform our strategy and ensure patients get access to clinical trials, quicker.

BHP’s Clinical Trials working group – established in 2018 by Professor Pam Kearns – has highlighted a number of opportunities to increase efficiency and allow us to build on the growing national momentum to improve clinical trials delivery. Now, with the ultimate aim of reducing the overall time taken to set up academic clinical trials led within BHP, we are working to improve the experience of colleagues facilitating and navigating the set-up process and welcome views from Chief and Principal Investigators, trial management teams, R&D and support staff.

Senior Programme Lead Amy Smith said: “Input from colleagues across the BHP research community will be vital for our programme. By understanding your current experiences, we’ll be able to identify areas for improvement and ensure the right support is in place at every stage of the process.”

Sir David Nicholson, BHP board member and sponsor of the project, said: “This pivotal initiative is based on BHP’s shared belief that all patients should have the opportunity to take part in research, and the knowledge that research-active healthcare organisations perform better. We are all committed to working together to reduce bureaucracy and duplication of effort in clinical trials through this project, which will offer patients access to trials sooner and ensure innovations reach the clinic more quickly. The fantastic diversity of our regional population also means that our research, and the commercial innovations which result from it, will be applicable nationally and globally.”

The survey can be accessed at the following link – Reducing Bureaucracy Programme: Experience Survey – and is open to employees of any BHP member organisation involved in research delivery. The deadline for responses is Monday 12 August 2024.

The programme has been established to respond the challenges identified in recent reviews by Professor Adam Tickell and Lord O’Shaughnessy.

Children’s brain tumours could be diagnosed with 10-minute scan

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

Children with the most common malignant form of brain cancer could see diagnostic wait times dramatically reduced thanks to new research that trialled a quicker and less invasive way of determining which type of tumour they have. 

The study, published in eBioMedicine, was conducted by a team of researchers led by the University of Birmingham (UoB) and Newcastle University, with Birmingham Children’s Hospital as the lead clinical centre, and funded by Children with Cancer UK and Cancer Research UK. UoB and Birmingham Women’s and Children’s NHS Foundation Trusts are both founding members of BHP.

The collaborative team identified how the four different groups of medulloblastoma, a malignant children’s brain tumour, had a specific profile based on their individual metabolism. Taking cell samples from 86 tumours, a laboratory test was used to accurately identify metabolic markers including chemicals specific to the different tumour groups.  

The study also validated previous research that found that glutamate, a metabolite present across all of the tumour cells, is linked closely with tumour prognosis. 

Significantly, the research could pave the way for using MRI scanning combined with machine learning to assess medulloblastomas for their ‘signature’ metabolic profiles without the need for invasive biopsy and could rapidly reduce the current 3-4 week wait from presentation to full diagnosis. 

Andrew Peet, Emeritus Professor of Clinical Paediatric Oncology at the University of Birmingham and an Honorary Consultant at Birmingham Women’s and Children’s NHS Foundation Trust, who is lead author of the study said: “Time is so important in cancer diagnosis so our findings on different types of medulloblastoma having a detectable signature metabolism could be game changing for quickly diagnosing, and then offering the best possible treatment for children.”

Professor Steve Clifford, Chair of Molecular Paediatric Oncology at the Newcastle University Centre for Cancer, who jointly led the study said: “Providing a rapid diagnosis using innovative scanning and AI (artificial intelligence) techniques, has the potential to revolutionise patient management, allowing early non-invasive diagnosis, tailoring of treatment decisions and reducing the period of uncertainty for patients and parents while awaiting a full diagnosis. Further, our biological findings provide critical new insights into the metabolism underpinning these tumours, and the potential to exploit these therapeutically.”

The latest findings could be game changing for children like Jack Bourne, aged six, from Birmingham who was diagnosed with medulloblastoma in March 2023.

Jack’s dad Tom said: “We’ve been through 13 months of treatment but six weeks of that was just waiting to find out what type of tumour he had. We were so scared.”

Within weeks of starting school, Jack had started experiencing sickness and headaches which doctors put down to possible separation anxiety or vertigo. But when parents Tom and Tom and Suzanna noticed that he was struggling to walk, they sought a second opinion and Jack was referred to Birmingham Children’s Hospital the same day.

“When they told me the results of the MRI scan, I didn’t know what to feel,” said Tom. “As we were trying to digest everything, they were asking us to sign consent forms because they wanted to operate first thing the next morning. You’re reading these forms and all you see is – he might not make it out alive. It’s heartbreaking, it really is.”

Jack pulled through the ten-hour operation to remove the tumour, but it would take more than four weeks for doctors to figure out what specific type of medulloblastoma he had in order to effectively treat it.

“The research that’s going into diagnosing tumours is really important,” said Tom. “In Jack’s case there was quite a delay while they sent his tumour to Great Ormond Street to be analysed. During that time Jack was given some chemo just to start things off because they just wanted to do something rather than just wait. But all you want is for your child to be given the best possible treatment right from the start.” 

Christiana Ogunbote, Head of Research at Children with Cancer UK said: “We are incredibly proud to help fund this innovative medulloblastoma research and are excited to see how it could change the experiences of children diagnosed with this disease and their families. Discovering new ways to improve outcomes for children with cancer is at the heart of what we are trying to achieve. Through continued and sustained investments in research we look forward to a day where every child can survive their cancer diagnosis.” 

Dr Laura Danielson, Children’s and Young People’s Research Lead at Cancer Research UK, said:  “Developing quicker, less invasive ways to accurately diagnose the different types of medulloblastoma, the most common malignant brain tumour in children, is a crucial step in improving outcomes for young patients. 

“This important study has identified a new way to distinguish between the four subgroups of medulloblastoma. This discovery paves the way for the development of simple imaging tests that could quickly and accurately diagnose the different types of medulloblastoma. 

“This kind of discovery research is important to drive new and improved ways to better detect and treat cancers affecting children and young people.”

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Statisticians call for rigour and transparency in the evaluation of diagnostic tests

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

Recommendations – developed by a working group of statisticians – on reframing the evaluation of in vitro diagnostic tests have been published today by the Royal Statistical Society in its Series A journal. The group was co-chaired by Professor Jon Deeks, at BHP founder-member the University of Birmingham and former RSS President, Professor Deborah Ashby, at Imperial College London.

The report, which will be submitted to the UK Covid-19 Inquiry, is intended to help prevent future scenarios in which IVDs are marketed widely, but later attract serious concerns about the standards applied to their evaluation. Its co-authors include statisticians from the Universities of Oxford, Cambridge, Edinburgh, Birmingham and the London School of Hygiene and Tropical Medicine.

The research was prompted by concerns about the standards applied to the evaluation of diagnostic tests during the Covid-19 pandemic – particularly lateral flow tests – however the recommendations cover all new tests, especially those designed to detect infectious diseases.

It is published today in the RSS’s Series A journal and also presented at the Evidence Based Early Diagnosis conference at St Andrews.

The RSS Working Group on Diagnostic Tests set out 22 recommendations, designed to ensure that in vitro diagnostic (IVD) tests – which typically test samples of fluids such as blood, urine or saliva – are statistically robust and fit for purpose. The RSS Working Group identified Study-Design matters (10 recommendations); Regulation matters (6 recommendations); Transparency matters (6 recommendations).

Jon Deeks, Professor of Biostatistics at the University of Birmingham, said: “The Covid-19 pandemic provided a microcosmic insight into inadequacies in current processes to evaluate and regulate diagnostic tests. It’s important that we learn from these failures and establish robust processes that can be applied broadly across diagnostic tests.”

The report covers three areas of diagnostic testing: study-design of evaluations; regulation of tests; and transparency of test evaluations.

Key recommendations included:

  • Evaluation needs to take into account each specific intended use of the test, including the person being tested, the target condition and even the facilities where the testing will be done. Field or clinical evaluation studies should be carried out for each intended use.
  • Direct comparison of alternative IVDs and testing strategies should be available to inform clinical and public health decision-making.
  • The Medicines and Healthcare products Regulatory Agency (MHRA) should collaborate with independent experts to revise the national licensing process for IVDs. This will ensure public safety is protected. Protocols and reports for test evaluations should be publicly available to ensure transparency in all planning and decision-making.

The publication of the report is relevant for the opening of the ‘Test, Trace and Isolate’ module of the UK Covid-19 Inquiry. It also coincides with the MHRA’s recently-launched consultation on improved safety for high-risk diagnostic devices.

Professor Sheila Bird at the MRC Biostatistics Unit at the University of Cambridge, said: “Past Royal Statistical Society Working Party reports on matters which affect the public health have had enduring impact. Official Statistics – Counting with Confidence led to the UK Statistic Act of 2007; Statistics and Statisticians in Drug Regulation led to the appointment of professional statisticians by the UK, and later, European drug regulator; Statistical Issues in First-in-Man Studies led to safety-enhanced study-designs with open protocols. I hope that this month’s consultation by MHRA is indicative that Diagnostic Tests is making its mark already.”

Dr Andrew Garrett, President of the Royal Statistical Society, said: “The report provides a thorough evaluation of both diagnostic tests and diagnostic testing. It addresses how to develop, regulate, and use diagnostic tests in the future – a subject that is of increasing importance to individual and public health.”

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