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Drugs to delay preterm birth are safe for global reduction in neonatal death

Women around the world should be able to access the best drug treatments that help to delay preterm births and improve outcomes for newborns, suggests new research.

Researchers from BHP founder-member the University of Birmingham worked with colleagues from the World Health Organization to review 122 randomised trials – published between 1966 and 2021, involving 13,697 women and conducted in 39 countries including high, middle and low-income states. The study, published in Cochrane Reviews, has allowed researchers to create a league table of drugs that delay birth, called tocolytics, based on their effectiveness and side effects.

Women benefitted from all preterm delay treatments included in the meta-analysis of studies, although the research team noted that the effectiveness of different drugs was less clear in some of the studies. The team also looked at the side effects of different drugs and combinations, including the likelihood of having to stop treatment.

The team have bought together the evidence on the benefits as well as the harms of these treatments (compared to no treatment or placebo), to arm clinicians and policy makers around with world with the information to decide upon the best treatment for the women in their care in their specific setting.

Dr Amie Wilson, Research Fellow Global Maternal Health at the University of Birmingham said: “The findings show that the benefits of these drugs outweigh any risks associated with unwanted side effects. These treatments are leading to a significant reduction in the number of deadly preterm births, and we now need to further understand the effectiveness of tocolytics for specific groups depending on pregnancy length.

“Our previous research has led to the improvement of guidelines for use of tocolysis drug use to delay preterm birth in the UK. Knowing that this paper helped to inform the forthcoming recommendations of the World Health Organization on the use of tocolytics, we hope that many more women around the globe will have access to these drugs, and have healthier births.”

Dr Victoria Hodgetts Morton, NIHR Clinical Lecturer in Obstetrics at the University of Birmingham and co-author of the paper said: “Preterm birth is the most common reason why a newborn baby may die, and the leading cause of death in children under five years of age.

“Tocolytics aim to delay preterm birth and allow time for the women to receive medicines that can help with baby’s breathing and feeding if born preterm, and medicines that lower the chance of cerebral palsy of the infant. Crucially, a short delay in preterm birth can enable women to reach specialist care.”

    New research collaboration will develop precision cell therapies for blood disorders

    The Universities of Birmingham and Oxford are to take part in one of five NHS Blood and Transplant (NHSBT) research units launched today.

    The £20m programme, co-funded by the National Institute for Health and Care Research (NIHR) and NHSBT – is aimed at providing new technologies, techniques or insights that will benefit donation, transfusion, and transplantation. The NIHR BTRUs are partnerships between universities and NHSBT.

    Many of the work strands in the new units could result in new technologies and practices that can then be delivered at scale by NHSBT, helping to save and improve even more lives. Much of the work will be aimed at reducing health disparities and improving access to new treatments.

    Researchers at the Universities of Birmingham (UoB) and Oxford are part of the NIHR BTRU in Precision Cellular Therapeutics – also working in collaboration with University Hospitals Birmingham (UHB) NHS Foundation Trust. UoB and UHB are both founding members of BHP, with a long history of collaborative research and development.  

    The aim is to develop new kinds of cell therapies for blood disorders and blood cancer, and improved systems for following up patients receiving treatment to better support their care.

    There is a wide range of work in the package but examples include:

      • Transplants work in blood cancer patients because some of the donor immune cells attack and eliminate the cancer, but these cells can also attack the donors own cells and cause a complication called graft versus host disease (GvHD).  The team will seek to identify and clone the receptors that enable the T cells to target the cancer cells while reducing the toxicity due to GvHD seen in patients. The ultimate aim of this research is develop a novel clinical trial, with NHSBT, via its cell therapy manufacturing infrastructure, expanding these cancer specific T cell receptors for use in patients.
      • There is a shortage of suitable cell donors for minority communities.  Cord blood units from babies may be a match but not have enough cells to be successful in adults. The team will seek to expand and gene edit the stem cells in cord blood, so they could be used with increased safely in a wider range of adults.  NHSBT will support the translation of this research through to early phase clinical trials, providing process development, manufacturing and quality control expertise.  This initiative will drive wider access to cord blood transplant.
      • It is important that patients from all communities benefit from cell therapies.  The team will seek to better understand how patients access the newer cell therapies and how they perceive the benefits of treatment.  The team will develop new digital technologies that improve care by enhancing interactions between the patients and their doctors and nurses.

    The BRTUs are funded by £16m from the NIHR and £4m from NHSBT, with research goals set to meet NHSBT’s requirements, to be delivered between 2022 and 2027.

    The products could be manufactured at the latest NHSBT sites including major new centres such as the new cellular therapies laboratories in Barnsley and the forthcoming Clinical Biotechnology Centre in Bristol.

    Dr Gail Miflin, Chief Medical Officer for NHSBT, said: “By collaborating with academia, these five new Blood and Transplant Research Units will help us to deliver on our mission to ‘save and improve even more lives’ and drive innovation to inform future clinical practice and improve patient outcomes.

    “For example, the supply-demand gap for solid organs continues to grow. We will explore the use of organ perfusion technologies to maintain and enhance the quality of organs, improve organ preservation and increase organ utilisation. This will enable more patients to receive the transplant they need.

    “And by building and analysing new data sets to track and demonstrate the impact of our interventions will lead to better understanding and improved outcomes. We already do this well for solid organs, but do not currently understand the outcomes for people who receive blood or stem cells. We will work with partners to build integrated data sets for these patients, focusing on the multi-transfused, especially those with sickle cell disease where a clear health inequity exists.

    “To maximise the value and impact from our research, we will accelerate the translation of innovation into practice. The NIHR BTRUs will be an important vehicle for this in the longer term.”

    Improving access to quality post-injury care can save lives

    A major study led by BHP founder-member the University of Birmingham will help reduce unnecessary deaths in developing countries from injuries caused by accidents or violence.

    Every year five million people die due to injuries like road traffic accidents, burns, falls, or violence – with 90% of these deaths in Low- or Middle-income Countries (LMICs).

    Backed by £2.9 million of NIHR funding, University of Birmingham (UK) and University of Stellenbosch (South Africa) researchers will build on partnerships with experts in Ghana, South Africa, Rwanda, and Pakistan to explore how to overcome barriers to accessing quality care after injury and reduce the likelihood of death or disability.

    Experts will use a ‘four delays framework’, which looks at where delays occur in people seeking, reaching, receiving, and remaining in good quality care after injuries, to collect information on delays and their effects on patient outcomes. They will develop visualisations for policy makers to see where to intervene to reduce delays suffered after injury and produce maximum health benefits.

    The project builds on a recent study funded by the NIHR led by University of Birmingham and experts in Rwanda which identified 121 barriers to access to quality injury care in three countries across sub-Saharan Africa: Ghana, South Africa and Rwanda.

    Researchers discovered that whilst there were a large number of barriers in total, only 31 (25.6%) of these were shared across all three countries, suggesting that solutions to improve access to quality care after injuries may be highly contextually dependent.

    Also, only just over half of these common factors (18/31, 58%) were related to delays in receiving quality care at the healthcare facility, suggesting that investment needs to be made in overcoming delays in seeking or reaching care.

    Justine Davies, Professor of Global Health Research at the University of Birmingham, explained: “Injuries in LMICs are common and their number is expected to increase, but death and disability after injury can be substantially reduced if people reach healthcare facilities in a timely manner. Understanding access to quality injury care is critical to improving patient outcomes. By partnering with organisations in Ghana, South Africa, Rwanda, and Pakistan, we will develop solutions for future study in these, and similar countries. Our research has already identified many barriers to quality care in Rwanda, Ghana and South Africa. However, as few of these are shared across countries, solutions to reduce the risk of post-injury death and disability will need to reflect circumstances in each country.”

    The diversity of cultures, economies, and injuries in partner countries will allow researchers to identify delays and solutions that can be applied across different settings and others that are transferable outside of the four countries of this study.

    Study leaders will also train four PhD students and 14 junior researchers in countries with low resources. Training will be done through the development of research hubs in partner countries – these hubs will continue and train future LMIC researchers beyond the project’s end.

    Researchers will also work closely with patients, community members and leaders, healthcare providers, and policy makers to understand how to translate the findings of the study into real world solutions.

    Patient symptom and quality of life assessments must be inclusive and equitable

    Information reported directly by patients can be invaluable for assessing the impact of disease and treatment on patients’ symptoms and quality of life -but more needs to be done to include under-served groups to avoid rising inequalities in healthcare, say experts at BHP founder-member the University of Birmingham.

    The information is commonly collected in both clinical trials and clinical practice and ensures that the patient’s perspective is at the heart of decision making. As use of these data become more commonplace, however, researchers in the University’s Centre for Patient-Reported Outcomes Research are calling for more to be done to ensure such information can be provided by everybody.

    In an article published 5 May 2022 in Nature Medicine, researchers in collaboration with patients, regulators and international experts identify some of the barriers to participation such as access to technology, disability, language and cultural requirements and call for these to be addressed.

    Lead author, Professor Melanie Calvert, said: “When we start to embrace new approaches to healthcare, such as use of patient-reported outcomes, we need to make sure that barriers to participation are addressed at an early stage. If we don’t do this, the gaps between advantaged and disadvantaged populations will only get worse.

    “Representative diversity in clinical trials is vital to ensure new medicines and technologies are applicable to the population they are intended to serve. Targeted initiatives are needed to ensure that no groups are excluded from participation in patient-reported outcome data collection, both in research settings and routine clinical care.”

    Specific recommendations in the article include:

        • Improve diversity by involving individuals who represent target populations when designing patient questionnaires.
        • Consider the type and severity of disease when seeking patient views, including cognitive or functional impairment that would limit participation.
        • Be aware of cultural needs or languages that might be a barrier, and address these sensitively and appropriately.
        • Include individuals with all levels of reading, writing and problem solving abilities by ensuring material is accessible and that assistance is available, if required.
        • Provide alternative methods of participation to promote digital inclusion
        • Where information is being used in drug development, make sure inclusivity is included early on in discussions about data collection.

    Rav Verdi, a patient partner who co-authored the work, said: “As a patient and living in a cosmopolitan society it’s encouraging to see that all walks of life have been considered and a means of communication thought about to glean information from the patient and to provide information to the patient regarding their care and treatment. As worldwide issue, information could be shared with treatment centres to provide better care and understanding of different groups of the population.”

    Roger Wilson, a patient partner adds: “Listening to patients reveals the range of diversity which must be understood and allowed for by careful design if a study is to offer benefits to society equitably.”

    Professor Calvert adds: “Patient-reported outcome measures and data collection must be reflective of diverse and multicultural societies, to improve research and promote equitable clinical care for the benefit of all patients and the public as a whole.”

    The team are supported by a number of funders including the National Institute for Health and Care Research (NIHR) Biomedical Research Centre Birmingham and Applied Research Collaboration West Midlands, Health Data Research UK and UK SPINE.

    Funding boost to help improve ovarian cancer survival rates

    BHP’s newest member NHS Trust has been given a charity grant of £100,000 to help improve survival rates of women with ovarian cancer.

    The Pan-Birmingham Gynaecological Cancer Centre, based at SWBH’s City Hospital, is working jointly with University of Cambridge to boost the uptake in genetic testing, especially in Black, Asian and Minority Ethnic communities (BAME) where survival rates are low.

    The project, called the Demonstration of Improvement for Molecular Ovarian cancer testing (DEMO), will create information about genetic testing in various languages both in leaflet and video format. The project will also improve the quality of the sample taken to aid diagnosis when there is suspicion of ovarian cancer by establishing a guidance document for all healthcare professionals involved in the process.

    Dr Elaine Leung, Clinical Lecturer and Specialist Registrar at the Pan-Birmingham Gynaecological Centre which is run by Sandwell and West Birmingham NHS Trust, said: “This is a much-needed project reaching those diverse communities in the area.

    “With the support of our patient representatives, the materials we co-create will be in an easy-to-understand format in both written and video form, which will give women a better understanding of the link between cancer and genetic testing.

    “It’s important to ensure women know that genetic testing is similar to early detection and can help prolong life – we have already seen evidence of this through other studies.

    “It helps to provide tailored treatments for patients and ultimately can mean surviving an ovarian cancer diagnosis.

    “The lack of informed decision-making resources for women whose first language is not English could be a contributor to the low rates of testing within these communities. The team will co-produce information in multiple languages, as well as exploring why some groups of women are more likely to decline genetic testing.”

    The project has been funded by health charity Ovarian Cancer Action and is part of a wider national initiative which includes funding for five other NHS cancer centres.

    The Pan-Birmingham Gynaecological Cancer Network delivers cancer care to more than two million people in the West Midlands.

    The project also builds on the team’s previous experience with the genetic testing studies, looking at BRCA testing in women with a new diagnosis of ovarian cancer before it became mainstream practice.

    Lisa Bird, a former cancer patient who is part of the project, said: “When I was in my thirties I was diagnosed with ovarian cancer, which was a large shock.  My first line treatment successfully got me into remission but I wanted to know what options would be available to me if I came out of remission.

    “I investigated treatment options and found that there were some treatments only available to those that have the BRCA 1 and 2 genes.  I also wanted to know if other family members were at an increased genetic risk of also getting ovarian cancer, so that I could warn them of the symptoms and ensure that they received better monitoring by their GPs.

    “I’m really pleased to be part of the DEMO project team that will encourage more patients to have these same tests. I’m passionate that anyone affected by ovarian cancer should be able to have this genetic knowledge so that their healthcare teams can give them the best treatments available to them as quickly as possible. I really believe that the results of this project will help to provide patients with ovarian cancer, with a greater chance of an extended life.”

    £7m funding boost for world-leading surgical research team

    A world-leading global surgical research team led from BHP founder member the University of Birmingham has received £7 million of funding to continue its life-saving work in developing countries – finding ways of increasing surgical capacity and preventing post-operative complications.

    The NIHR Global Health Research Unit on Global Surgery (NIHR GSU) will focus on training non-surgeons to perform essential hernia operations – hernias posing a major problem with five million patients awaiting surgery in sub-Saharan Africa, stopping young men from providing for their families.

    The team will also continue its work in boosting post-operative recovery in Low- and Middle-income Countries (LMICs) – testing simple innovations such as the use of high-dose oxygen, mouthwashes and inhalers.

    Researchers are also looking to bring innovation back into the health systems of high-income countries by piloting innovative practices in LMICs – proving their worth ahead of wider roll-out.

    Established in 2017, the new NIHR funding will allow the GSU to continue its global research for at least a further five years. The Unit co-ordinates a global network of surgeons that includes over 20,000 clinicians from over 100 countries.

    Based at the University of Birmingham, it is co-directed by Professor Dion Morton OBE, Barling Chair of Surgery and Professor Stephen Tabiri, Dean of the Medical School at University for Development Studies in Tamale, Ghana.

    Professor Dion Morton commented: “Delivering safe and effective surgical care across the world is one of the greatest challenges facing global health today. Our work impacts the most disadvantaged and vulnerable populations of the world – we are training surgeons in these countries to continue the research drive that is helping to save lives.

    “Surgical capacity is a critical issue – a matter of life and death. In many developing countries, there are simply not enough surgeons to deliver the operations that are needed – there are less than 100 general surgeons working in the Benin health service to serve a population of 12 million people.

    “Equally, it’s no use performing more operations if patients are at risk of dying from post-operative complications. Simple but effective steps in reducing risks such as surgical site infection (SSI) – the most common post-surgical complication – will be vital in ensuring improved health outcomes for people living in LMICs.”

    The GSU’s international cohort studies are open to all collaborators – whether medical students, clinical officers, doctors, nurses or researchers. The team works across clinical disciplines with healthcare professionals, policy makers, epidemiologists, economists, patients and community members.

    The GSU provides the tools and infrastructure to help surgeons around the world to sustain the research drive that will increase surgical capacity in LMICs.

    A ‘hub and spoke model’ helps the GSU co-ordinate surgical research globally in seven LMICs: India, South Africa, Rwanda, Nigeria, Benin, Ghana and Mexico. Each hub acts as an independent research centre for conducting clinical trials and cohort studies, as well as supporting local and international research training and education. The network consists of more than 100 urban and rural hospitals in these seven countries, some in the most remote parts of the world.

    The GSU runs a range of cohort studies, qualitative research and clinical trials aimed at: