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Author: Louise Stanley

Fitness app could transform care of rheumatoid arthritis patients

Written by Louise Stanley on . Posted in Clinical trials, Inflammation and chronic disease.

Researchers at BHP members Sandwell and West Birmingham NHS Trust and the University of Birmingham aim to transform the care of rheumatoid arthritis (RA) patients by developing an app which links to the Fitbit – a popular activity tracker.

The rheumatology medical team and researchers are leading the groundbreaking clinical trial to create the app which they hope will ease the pain of patients suffering from the crippling disease and provide extra support.

It’s called MISSION-RA which stands for MovIng to Support Sustained Improvement of Outcomes iN Rheumatoid Arthritis.

Sally Fenton, Chief Investigator for the study, said: “The app will be specifically designed for and by people with RA.

“This will be done in two ways. Firstly, a series of interviews, co-design studies and workshops will be carried out to develop the app. Then, artificial intelligence will be used within the app to provide personalised support for people living with RA, based on symptoms such as pain, fatigue and mobility. It is expected the app will be available to download for free so it can be used on a Fitbit in the future.”

RA leads to inflammation of the joints and surrounding tissues which causes flare ups – this is when symptoms become worse. One of the ways to help ease these episodes of pain can be through exercise, physiotherapy and occupational therapy.

Dr Sangeetha Baskar, Clinical Specialty Lead for Rheumatology and Principal Investigator for MISSION-RA explained: “Rheumatoid arthritis is an extremely painful, tiring, psychological and physically debilitating disease. Patients face countless challenges while doing basic daily activities such as dressing, cooking and walking and often become dependent on family members to perform some of their daily tasks. Through this innovative study and the mobile app, we are hoping to help patients increase their physical activity tailored for them and improve their quality of life.”

The first patient from the Trust has already been recruited into the study.

Ana Duarte, Clinical Research Practitioner (CRP) and also Associate Principal Investigator, said: “Overall, the MISSION-RA study has overcome our initial expectations. Patients are very keen and have enjoyed their experience so far. This has also been a great opportunity for the study staff which has led to progression in their careers. Most importantly, this we hope will place SWB’s R&D department and rheumatology team as international leaders in healthcare AI and machine learning.”

MISSION-RA is being delivered in partnership with the National Institute for Health and Care Research (NIHR) and National Rheumatoid Arthritis Society (NRAS).

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Researchers at the Royal Orthopaedic Hospital and Aston University explore novel bone cancer therapy

Written by Louise Stanley on . Posted in Cancer outcomes, Experimental medicine.

Lucas Souza, Research Laboratory Manager for the Dubrowsky Regenerative Medicine Laboratory at the Royal Orthopaedic Hospital (pictured), is partnered with Professor Richard Martin, director of the Advanced Materials Research Centre at Aston University to explore a new way to treat bone cancer.

As bone cancer researchers, we are seeking to tackle the problem of bone tumours across all fronts. We are currently exploring how the metal element gallium could be used to support the treatment of bone tumours due to its cancer-killing properties.

Bone tumours can be either primary (originated in the bone tissue) or secondary (originated in another tissue and metastasise to bone tissue). We have already proved in a previous study that primary bone cancer cells are four times more sensitive to gallium than normal cells. In that study we wanted to understand if doping bioactive glasses, used in orthopaedic and dental surgeries for its bone forming properties, with gallium would support positive outcomes for bone cancer patients. We were able to show that the use of gallium embedded in bioactive glasses is an excellent strategy to support bone repair whilst selectively killing bone cancer cells which can potentially culminate with better treatment outcomes and reduced cancer recurrence rates.

The next phase of this study is exploring the use of gallium against bone metastases – cancer that originated in another tissue before spreading to bone. The ultimate goal is to prove whether cells from bone metastases also have greater sensitivity to gallium so it could be used as an adjuvant medicine to control metastatic growth in the treatment of other types of cancer that usually metastasise to bone, such as breast, lung, and prostate cancer.

If successful, we will combine the gallium-doped bioactive glass powder with biodegradable polymers to make a minimally invasive injective gel that surgeons can use to treat both primary and secondary bone tumours. This gel will have the potential to reduce cancer recurrence and implant failure rates, leading to reduced time in hospital beds, reduced use of antibiotics, fewer revision surgeries, and increased survival rates.

It is also hoped that this innovation could be used to improve outcomes for patients with vertebral metastases and other types of primary bone tumours where surgery and radiation is less effective due to their proximity to the spinal cord.

The safety and effectiveness of these biomaterials will need to be tested further, but the initial results are really promising. Treatments for a bone cancer diagnosis remain very limited and there’s still much we don’t understand. Research like this is vital to support in the development of new drugs and new methodologies for treatment options.

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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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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.