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E-MOTIVE wins prestigious Trial of the Year Award

The landmark E-MOTIVE study, led by University of Birmingham researchers and coordinated by the Birmingham Clinical Trials Unit, as been awarded ‘David Sackett Trial of the Year Award’ by the Society of Clinical Trials, recognising the importance of the findings and the potential impact as the simple, low-cost approach is rolled out around the world, dramatically improving maternal health across the globe. The trial tested a package of low-cost interventions that resulted in a 60% reduction in heavy bleeding following childbirth.

Each year the award goes to a randomized, controlled trial published in the previous calendar year that is considered to improve the lot of humankind and provide the basis for substantial, beneficial change in healthcare, amongst other criteria.

“This has been the largest set of nominations for the Trial of the Year Award in all my time on the committee. We received numerous nominations for worthy trials, from around the world and across a large number of clinical disciplines – including obstetrics, emergency medicine, infectious disease, and cancer. We had a challenging time as a committee to choose a winner” said Andrew Cook, Chair of the SCT David Sackett Trial of the Year Committee.

Postpartum haemorrhage (PPH), or severe bleeding after birth, is the leading cause of maternal deaths worldwide. It affects an estimated 14 million women each year and results in around 70 000 deaths – mostly in low and middle-income countries – equivalent to 1 death every 6 minutes. The E-MOTIVE study found that objectively measuring blood loss using a simple, low-cost collection device called a ‘drape’ and bundling together WHO-recommended treatments – rather than offering them sequentially – reduced severe bleeding by 60%, and women were less likely to lose their life.

Dr Adam Devall collected the award, on behalf of the E-MOTIVE team, from the Society of Clinical Trials 45th Annual Meeting, in Boston, USA, and said: “I’m honoured to accept the Trial of the Year Award on behalf of the E-MOTIVE project. E-MOTIVE was a huge international team effort, and this award speaks to the dedication of teams at each of our 80+ sites. More high-quality clinical trial evidence is desperately needed for pregnancy and maternal health so we’re delighted to receive this recognition of our work and the impact it will have on deaths from PPH.”

Professor Arri Coomarasamy, who led the E-MOTIVE trial and is the Co-Director of the WHO Collaborating Centre on Global Women’s Health at the University of Birmingham said: “This new approach to treating postpartum haemorrhage could radically improve women’s chances of surviving childbirth globally, helping them get the treatment they need when they need it”.

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Birmingham Health Partners announces theme leads to drive strategy

The second city’s clinical-academic alliance, Birmingham Health Partners, has appointed three strategic theme leads to support the implementation of its new five-year mission: to work together, transforming Birmingham’s healthcare through high impact innovation.

Taking the new role of Health Inequalities Lead, Dr Joht Singh Chandan is a Clinical Associate Professor in Public Health at the University of Birmingham where his research focuses on identifying and addressing health inequalities – with a particular interest in abuse and violence prevention inspired by many years of working as a voluntary police officer.

As the UK’s third-poorest city, with a diverse ethnic profile and socioeconomic demographics, Birmingham experiences significant health disparities. Joht will develop a detailed action plan for improving population health in the city, underpinned by his experience of issues that impact widely on health and wellbeing; factors that prevent early detection; and barriers to accessing healthcare.

Joht said: “We shouldn’t see reducing health inequality as just the responsibility of public health bodies. The determinants of inequality are so interlinked that not only can we not tackle issues in isolation, we can’t tackle them as one institution. Working across the partnership and linking health data platforms, we’ll be able to work in a much more representative and inclusive way to improve physical and mental health outcomes for our local communities.”

Tasked with optimising data integration across the partnership, Professor Simon Ball has been appointed Academic Lead for Data. A Consultant Nephrologist, Simon has had various roles in developing electronic health care records and using data to improve patient care and support research. His other roles currently include Associate Director for the Midlands Health Data Research UK and Senior Responsible Officer for the West Midlands Secure Data Environment (WMSDE).

Simon said: “NHS Trusts in Birmingham were among the first to adopt electronic health records systems, meaning we have access to a wealth of data – including blood tests, scans and biopsies – spanning several decades. This can provide valuable insight into an array of diseases, health conditions and care pathways – but only if it is integrated. Working together, BHP and the WMSDE can ensure our data is analysed, learnt from and used to optimise healthcare across our region.”

Leading the ‘Reducing Bureaucracy in Clinical Trials’ programme is Amy Smith, an experienced Senior Programme Lead with considerable experience in clinical trials across multiple BHP NHS Trusts and NIHR infrastructure. The programme responds to the challenges identified by Professor Adam Tickell and Lord O’Shaughnessy, ensuring patients in Birmingham get access to clinical trials more quickly. 

Amy said: “I am very proud to be leading this exciting project which showcases BHP as a leader in clinical trials.  Through trust, transparency, and collaboration we will harness the extensive knowledge and expertise within BHP, delivering improved setup times. Ultimately our aim is to make trials accessible to a diverse range of patients, quicker – increasing our attractiveness to funders and industry partners.”

Improving screening in underrepresented groups for genetic condition with heart complications

Researchers from across BHP are collaborating with community groups and Amicus Therapeutics to improve screening and diagnosis of Fabry disease, a rare and inherited condition where complications affect the heart muscle, and can lead to premature death.

Through the project, the team – from University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham – has begun to build advisory groups in collaboration with community leaders, healthcare professionals and patients from black, South Asian and other minority ethnic groups. These advisory groups will support researchers to understand patient perspectives on possible barriers to diagnosis, as well as possible approaches to breaking down these barriers. Once further funding is secured, these approaches will be trialled locally in Birmingham, a super-diverse city.

The incidence rate of Fabry disease in the general population is reportedly around 1 in 100,000, although this is likely an underestimate of its true prevalence. Although Fabry disease is very rare, as a genetic condition, patient’s family members have a higher likelihood of the disease that the wider population. Therefore, family screening and mapping is an important tool to identify more cases.

Identifying Fabry disease is important, since the earlier that a patient is diagnosed the better the prognosis for treatment. There are several therapies available, including enzyme replacement and methods to make the faulty enzyme that causes Fabry disease work better, all of which are more effective if started earlier. Without treatment, patients may develop significant cardiac, renal and cerebrovascular complications.

Project lead Richard Steeds, Honorary Professor of Cardiovascular Medicine and Deputy Director of Clinical Research within the Institute of Cardiovascular Sciences at the University of Birmingham and Consultant in Cardiovascular Imaging at University Hospitals Birmingham, explained: “Previous work has shown that Black, South Asian, and other minority ethnic groups, as well as patients from lower socioeconomic groups, are underrepresented in our clinic in Birmingham, despite it being a very diverse city. This knowledge helped us to identify a need for further research to understand and overcome specific barriers to family screening that are more prevalent within minority ethnic groups. If we can address these barriers, then we can support more people to benefit from beginning treatment for this rare condition sooner. Working with members of different community groups is essential to making this work.”

It is well established that minority ethnic groups face health inequalities from language barriers, lower health literacy and cultural difference that contribute to stigma and fear of discrimination that can impact on help seeking behaviours. These inequalities can lead to poorer health outcomes, so addressing them is vital.

Fabry disease can often take many years and several doctors’ appointments to diagnose because many of the symptoms are also attributed to more common causes. Family screening has the potential to help identify more cases sooner.

Some of this work has been funded through a collaboration project with Amicus Therapeutics.

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AI – safe and effective for everyone: new standards released by BHP members

An international initiative called STANDING Together – led by BHP founder-members University Hospitals Birmingham NHS Foundation Trust, and the University of Birmingham – has released new standards ensuring that medical artificial intelligence (AI) systems are developed with appropriate health datasets.

The STANDING Together recommendations ensure that the full diversity of people that AI systems will be used for, is represented in health datasets. This is imperative as AI systems are less likely to work well for people who aren’t properly represented in datasets – and may even be harmful. People who are in minority groups are particularly likely to be under-represented in datasets.

The recommendations provide guidance on collecting and reporting details such as age, sex, gender, race, ethnicity, and other important characteristics, and have been developed following a two-year research study involving over 350 people from 58 countries, including patients, researchers, healthcare professionals, industry experts, and regulators. They also recommend that any limitations of the dataset should be transparently reported to ensure that developers creating AI systems can choose the best data for their purpose. Guidance is also given on how to identify those who may be harmed when medical AI systems are used, allowing this risk to be reduced.

The research has been conducted with collaborators from over 30 institutions worldwide, including universities, the UK medicines regulator (the Medicines and Healthcare products Regulatory Agency, MHRA), patient groups and charities, and small and large health technology companies. The work has been funded by The Health Foundation and the NHS AI Lab and supported by the National Institute for Health and Care Research (NIHR).

Lead researcher Dr Xiaoxuan Liu, Clinical Scientist in AI and Digital Health Technologies at the University of Birmingham, explained: “AI models are underpinned by data, which captures a wealth of information. When dealing with health data, this information can unfortunately include existing health inequalities. These inequalities can come about in many ways, including underrepresentation of particular groups, or as a reflection of structural biases within wider society. It is vital that anyone using data to develop new innovations (including AI) are aware of any biases, and that they are accounted for. As we move towards an AI-enabled future, we can ensure these technologies don’t just work on average, but that they work for all.”

Dominic Cushnan, Director AI, Imaging & Deployment at the NHS AI Lab, said: “The lack of diversity and inclusivity in our current datasets are major challenges in our ability to ensure AI in health and care works for everyone. These standards are an important step towards transparent and common documentation of represented groups in our data, which can support the responsible and fair development and use of AI.”

The recommendations are available open access at to support the development of safe, effective and equitable AI tools for healthcare.

Review of 25 years reveals AI healthtech is beginning to listen to patients

Patients experiences of their health conditions are slowly being integrated into AI studies, a review of 25 years of healthcare publications has found.

Published in the Lancet Digital Health, the new study saw experts from BHP members the University of Birmingham and University Hospitals Birmingham look at more than 600 interventional studies on AI healthcare technologies.

While the team, funded by the National Institute for Health and Care Research (NIHR), found that only 24% of studies have a patient reported outcome element included in their study, there has been an increase in the number in recent years with 2021 and 2022 seeing nearly two thirds of all studies included.

Dr Samantha Cruz Rivera from the Centre for Patient Reported Outcomes Research at the University of Birmingham said: “The opportunities for AI to revolutionise healthcare are only going to make patients’ lives better if those models consider how patients actually feel and respond to healthcare interventions. Our review shows that patient reported outcomes, such as measures of symptom burden and quality of life, are increasingly being incorporated into AI studies which is very encouraging.

“The future could see AI healthcare tech analysing and raising an alert if a patient’s health is declining, but such a future is going to depend on having large-scale patient reported outcome datasets so that AI can support or drive care in a specific condition, and incorporate patient experience. Integrating PROs within AI can support the humanisation of AI for health and ensure that the patient’s voice is not lost in a rush to digitise and automate health care.”

Melanie Calvert, Professor of Outcomes Methodology at the University of Birmingham said: “Managing long term health conditions places a huge burden on patients and their families, but also the NHS and social care system. AI systems can help support patients and healthcare systems to aid decision-making, improve workflow and lead to more efficient care with improved outcomes.

“Encouragingly, we are seeing more research into AI tech solutions for chronic conditions incorporating patient reported outcomes.

“It’s clear that having technology that can analyse and predict patient outcomes to help prioritise care is going to be a part of healthcare’s future. However, we must ensure that the patient reported outcome data used to train the AI systems are applicable to the population they are intended to serve. If we don’t do this, the gaps between advantaged and disadvantaged populations will only get worse.”

First Midlands research collaboration to focus on patient safety

Expectant mums and anyone needing emergency treatment will both benefit from funding for new research to improve patient safety and reduce the risk of harm.

BHP founder-members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust will be establishing the first research collaboration focused on patient safety based in the Midlands, thanks to new funding from the National Institute for Health and Care Research. The announcement made today by the Department for Health and Social Care will see £3.4m invested in world-leading research that supports patient safety in maternal and acute care settings.

The newly announced NIHR Midlands Patient Safety Research Collaboration (PSRC) will bring together NHS trusts, universities, and private business to evaluate how digital tools can support clinical decision making and reduce risks for patients.

Professor Alice Turner is a Professor of Respiratory Medicine in the Institute for Applied Health Research at the University of Birmingham, Honorary Consultant Respiratory Physician at University Hospitals Birmingham, and Co-Director of the NIHR Midlands Patient Safety Research Collaboration along with Professor Richard Lilford, Professor of Public Health at the University of Birmingham.

She commented: “Patient safety is at the forefront of every clinician’s mind and runs at the heart of the whole healthcare system. The power of new technology available to us means that we can address one of the ongoing areas of risk for patients, which is effective communication and clinical decision making.

“Thanks to the new funding from NIHR and with the support of partners, the new collaboration will be looking at how digital tools can make a real difference to reduce risks and support patient safety in the key areas of acute medicine and maternal health.”

Acute Care

Patients requiring emergency medical care in acute services will benefit as new digital decision-making tools could improve prescribing and personalised management.

Thanks to the funding, the NIHR Midlands PSRC will trial digital clinical decision support tools which will provide smoother flow of information between healthcare professionals in acute care. Working with acute care hospitals, primary care providers and the West Midlands Ambulance Service, the researchers will review how the digital tools can reduce risks of patient harm at key points in acute care management.

Professor Elizabeth Sapey, Director of the Institute of Inflammation and Ageing at the University of Birmingham and an Honorary Respiratory Consultant at the University Hospitals Birmingham said: “The vision is that every healthcare professional involved in a patients journey in acute care has access to the same information, the same decision-making support, and is able to both spot and flag any point where patients might be at increased risk of harm.

“We know that a disproportionate number of medical errors happen in acute services, and around half of patients experience a clinical error in what can be a complex journey. As acute care becomes more heavily relied on, it is critical that we use technology available to us to ensure that our patients are kept safe and risk is managed.”

Maternal Health

Mothers and babies will benefit from the new research collaboration to look at how digital tools can support antenatal decision making.

The collaboration will examine the effectiveness of clinical decision-making tools to recognise risks among expectant mothers, particularly among marginalised groups who experience worse outcomes and quality of care compared to the general population.

Professor Shakila Thangaratinam, Co-Director of WHO Collaborating Centre for Global Women’s Health at the University of Birmingham and Consultant Obstetrician at the Birmingham Women’s Hospital said: “Maternal and perinatal mortality reports in the UK have highlighted that there are real issues when it comes to identifying and responding to risk. One of the key priorities is identifying early in pregnancy those mothers who need the extra support and care, thereby ensuring that women receive individualised care during pregnancy.

“With this new funding from the NIHR, we can evaluate how digital tools can help clinicians ensure that no mum falls ‘through the net’ in identifying risk, and ensure every family receives the right level of support.”

Partners involved in the NIHR Midlands Patient Safety Research Collaboration

  • University Hospitals Birmingham NHS Foundation Trust (BHP)
  • University of Birmingham (BHP)
  • Birmingham Women’s and Children’s NHS Foundation Trust (BHP)
  • Health Innovation West Midlands (BHP)
  • NHS Birmingham and Solihull Integrated Care Board
  • University of Warwick
  • University of Aberdeen
  • Clevermed Limited
  • West Midlands Ambulance Service University NHS Foundation Trust
  • Shrewsbury and Telford Hospital NHS Trust