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Author: Louise Stanley

Learning from the pandemic: Birmingham Health Partners publishes rapid evaluation study of remote outpatient appointments

Birmingham Health Partners (BHP), the second city’s University-NHS partnership, has called for greater engagement with clinicians and a deeper understanding of patient experience when considering the continued use of remote outpatient appointments post-Covid.

A new report, ‘Learning from the pandemic shift of outpatient services to a remote footing: a rapid evaluation study’, has been published by researchers and clinicians from across the three founding members of BHP (University of Birmingham, Birmingham Women’s and Children’s NHS Foundation Trust and University Hospitals Birmingham NHS Foundation Trust), and offers advice about how remote outpatient consultations might best be used as we ‘return to normal’.  The authors set out a suggested approach to making decisions about when a remote outpatient consultation might be appropriate or not; explore the issues facing patients, carers and health professionals; and point to the many operational issues that need to be addressed as new care pathways that embrace both remote and in-person consulting are developed.

The report was co-ordinated by Birmingham Health Partners’ new Rapid Evaluation Service and comprised interviews with a range of BHP staff involved in remote consultations as well as health data gathered on the use of these appointments across both Trusts, and a pragmatic literature review.

Lead author Dr Richard Lewis, Senior Associate at the University of Birmingham’s Health Services Management Centre commented: “While the shift from face-to-face to remote consultations occurred quickly in both Trusts – reaching around half of all consultations at its peak – the proportion of remote consultations has, to some extent, fallen back from pandemic lockdown levels.  This research is intended to inform clinicians and managers as they plan how best to organise outpatient services beyond the pandemic, with a mix of in-person and remote consultation offers.  There is a risk of missing a unique opportunity to draw on experience of sudden and unplanned changes in outpatient consultations to apply these lessons to more sustained reform of how at least some appointments might be delivered longer term.”

Matt Boazman, Interim Chief Executive of Birmingham Women’s and Children’s NHS Foundation Trust, added: “This study has demonstrated the significant potential for continued innovation in how we deliver care to patients, particularly across outpatients. It also serves to illustrate the importance of ensuring that we fully consider the views of patients and carers who will have different views on consultation formats depending on their personal circumstances. The authors are right to point out the need to pay careful attention to any potential unintended consequences, including the impact on patient-clinician relationships and ensuring that there are robust mechanisms in place to continue to support safeguarding.”

The report can be downloaded here: 

The BHP Rapid Evaluation Service was established in 2022 to provide time-sensitive, formative evidence on innovations in healthcare and capacity building. It carries out rapid and effective service evaluations, often running in parallel with service implementation; helps spread learning to other sites; and helps build local capacity for in-house evaluations.

The Health Services Management Centre (HSMC) at the University of Birmingham is one of the UK’s foremost centres for research, evaluation, teaching and professional development for health and social care organisations. HSMC has established a unique reputation as a ‘critical friend’ of the healthcare community and strives constantly to bridge the gap between research and practice.

New drug can lower brain pressure and treat blinding IIH headaches, finds trial

Patients with Idiopathic Intercranial Hypertension (IIH) – a condition which causes raised brain pressure and debilitating headaches – could be treated with an injectable peptide used for type 2 diabetes, a new trial has found.

The study, published in the journal Brain, reports on a phase two trial of a drug called exenatide, a GLP-1 receptor agonist, as a potential treatment for IIH.

The IIH Pressure Trial led by a team of neurologists from BHP founder-members the University of Birmingham and University Hospitals Birmingham found that the seven patients who received regular injections of the drug, currently approved for use in Type 2 Diabetes, experienced a drop in pressure in the brain during both short (2.5hrs and 24hrs) and long term (12 weeks) measurements.

The trial also saw significant reductions in the numbers of headaches across the 12 weeks that participants took part, with an average of 7.7 fewer days per month of headaches compared to the baseline, compared to only 1.5 fewer days in the placebo arm.

Alex Sinclair is Professor of Neurology in the Institute of Metabolism and Systems Research at the University of Birmingham, an Honorary Consultant Neurologist at University Hospitals Birmingham NHS Foundation Trust, and Principal Investigator of the study, said: “This is a major trial for the rare and debilitating condition IIH that can lead to people, usually women, going blind and suffering disabling daily headaches. There are no current licenced drugs to treat IIH and hence this result is a major step forward for IIH patients.

“We are delighted to see that the phase two trial resulted in our treatment group having lower brain pressure both immediately and after 12 weeks and nearly 8 fewer headache days across the 12-week period, and that all the women were able to continue the treatment throughout with few adverse effects. We now hope to see a much larger trial of exenatide to literally ease the pressure for the many people around the world suffering with IIH.”

Dr James Mitchell, Lecturer in Neurology at the University of Birmingham and first author of the paper said: “The results of this clinical trial are a shot in the arm for finding clinical treatments for IIH. While we need to do further trials before such a treatment could be available for patients in the future, we are encouraged by the significant results from this trial that made a real difference for those in the treatment arm and this treatment may prove relevant for other conditions resulting in raised brain pressure.”

In this study the drug was given as a twice daily injection into the subcutaneous tissue. To reduce the need for frequent injection in the future, a once-weekly subcutaneous injection called Presendin will be trialled though University of Birmingham Start-up company, Invex Therapeutics.

Shelly Williamson, the Chair of patient charity IIH UK said: “This is such exciting progress. New drug options is vitally important for IIH and this trial brings hope to the millions of patients living with the condition. We very much look forward to the next steps and seeing the drug tested in two large Phase 3 clinical trials.”

The IIH Advance is a Phase 3 clinical trial in Adolescents run in the UK, sponsored by the University of Birmingham and IIH Evolve is running in adults internationally sponsored by Invex Therapeutics. Ultimately the aim is to gain enough evidence to allow the drug to be licensed for use in IIH patients in the future.

Funding boost for Birmingham rare disease research

BHP founder-member the University of Birmingham has been awarded a £500k Pathfinder Award from the medical research charity LifeArc which will support early-stage projects with a focus on translational development in rare diseases.

The successful projects have now been announced following an internal selection process. Research, conducted by the University of Birmingham and working across Birmingham Health Partners, will begin this spring.

Professor Timothy Barrett, Director of the Centre for Rare Disease Studies (CRDS) Birmingham, commented: “I am thrilled that our Centre for Rare Disease Studies at the University of Birmingham has been successful in securing a LifeArc Pathfinder Award. We are working closely with other organisations from Birmingham Health Partners; Birmingham Children’s and Women’s Hospital and University Hospitals Birmingham; to fund a number of impactful translational research projects through the fund. Our uniquely diverse patient population, and strength in partnership ensures that we are in the best possible position to drive forward research in rare diseases to accelerate progress and ultimately improve patients’ lives.”

Around the world, approximately 300 million people are living with a rare disease. A disease is considered rare if it affects less than 1 in 2000 people. Around 80% of rare diseases have a genetic component. They are often chronic, progressive, degenerative and frequently life-threatening with no existing cure.

Owing to the nature of rare disease, small patient populations make research challenging. Lack of scientific knowledge and quality of information on rare diseases can mean that misdiagnosis is common and treatment options may be limited.

The Centre for Rare Disease Studies supports basic and applied research, in order to build a pipeline of translational research from gene discovery to improving the diagnosis, clinical management and treatment of these disorders.

Research projects that will benefit from the Pathfinder Award include:

      • The NEEDED Study (NanoporE Enhances Diagnosis in rarE Disease), led by Dr Hannah Titheradge, which will investigate the effectiveness of a new type of genome sequencing to identify rare diseases.
      • A proof-of concept study, led by Dr Nekisa Zakeri, which aims to develop a novel ‘off-the-shelf’ T cell immunotherapy capable of providing more effective treatment for patients with a rare liver cancer.
      • The CATCH Study (CArbalivefor the Treatment of CHoleastic Disease), led by Dr Palak Trivedi, looks into whether a new medical device can absorb toxins from the gut to reduce inflammation and scarring in primary sclerosing cholangitis; a rare progressive liver disorder for which no medical treatment has been shown to slow disease progression.
      • Dr Richard Tuxworth and Professor Zubair Ahmed, whose research in DNA damage in nerve cells has already resulted in patent applications covering pathways and mechanisms that could provide new therapies for neurological conditions and spinal cord injury, will now work with Professor Andrew Beggs and Dr Chiara Bardella to investigate the potential for one of these pathways (the ATM-Chk-2 pathway) as a basis for therapies to tackle rare neurological conditions that appear early in childhood.
      • Dr Sovan Sarkar’s study aims to improve the health of patients with rare childhood-onset forms of neurodegeneration by correcting the process of autophagy that normally removes undesirable cellular materials which is detrimental to brain cells called neurons.

Dr Hannah Titheradge, a Consultant in Clinical Genetics at Birmingham Women’s and Children’s NHS Foundation Trust, will investigate the effectiveness of nanopore sequencing – a new type of real time genome sequencing – on a larger group of patients. Previously tested on a very small sample, this new technology showed promise for improving our capability to diagnose rare diseases.

Nanopore sequencing reads more letters in an individual’s genome than the standard sequencing method used to diagnose rare genetic disorders. The NEEDED Study (NanoporE Enhances Diagnosis in rarE Disease) will explore a more detailed approach that could improve the percentage of patients who receive an important genetic diagnosis, which can help those patients and their families face their challenges feeling better informed.

Dr Hannah Titheradge commented: “Receiving a diagnosis can be an uphill challenge for patients with rare diseases and their families. These individuals often wait years for a final diagnosis, having undergone multiple tests and procedures. Having a diagnosis is very important because it helps these individuals better understand their health problems and plan for the future. Some genetic conditions are treatable, and a diagnosis is the first step towards accessing these treatments. We can also understand whether any other family members’ health may be affected. For these reasons, any advance that can be made in improving rare disease diagnostics is invaluable.”

Samira Fakire, Business Manager at LifeArc, added: “We hope that the Pathfinder Award will encourage more researchers to move into the rare disease space and promote the development of a translational culture – pushing more discoveries from the lab into meaningful real-world benefits for patients.”

BHP invests £300k in innovative service improvement projects

Birmingham Health Partners (BHP), the second city’s University-NHS partnership, has announced the inaugural recipients of its Seed Fund programme, awarding more than £300,000 to four projects across physiotherapy, drug delivery, perinatal care and ophthalmology.

Launched in 2022, the BHP Seed Fund is designed to support clinical academics and early-career researchers to develop, refine and implement projects which address local health burdens or system challenges. The fund enables interdisciplinary research, aiming to develop service improvements which can have rapid impact on patient experience and outcomes, and which can also be rolled out to other NHS Trusts. With funding contributed by its three founding members – the University of Birmingham, Birmingham Women’s and Children’s Hospitals, and University Hospitals Birmingham – the Seed Fund supports BHP’s culture of embedding research into everyday clinical and healthcare practice.

The successful projects are:

      • Testing a variety of interventions to reduce avoidable readmission to acute hospital care after hip fracture;
      • Developing a novel drug delivery device to reduce recurrence of sarcoma (bone and soft tissue cancer);
      • Reducing racial and ethnic inequalities and improving perinatal outcomes using health data;
      • Developing an Ocular Infection reference database to deal with common eye conditions.

The judging panel were impressed by the scope and variety of all the proposals submitted, noting the particular benefits of the successful projects in terms of patient outcome and cost-effectiveness for the NHS. The projects also demonstrated a clear link back to the five priority themes which have been identified for the West Midlands by BHP in collaboration with local NHS Trusts, namely: health data and AI; engineering into health settings; sustainability; health inequalities; and health systems and evaluation.

Dr Emma Sutton, a clinical-academic physiotherapist at BHP founder-member University Hospitals Birmingham NHS Foundation Trust is one of the awardees and commented: “I am absolutely thrilled to be conducting this important piece of work alongside a fantastic steering group which includes orthogeriatricians, geriatricians, surgeons, methodologists, nurses, physiotherapists, pharmacists, data experts, quality improvement experts and patients. We are all passionate about the care of older people, and we are driven to improve care so that when a person who experiences a hip fracture goes home, they only return to hospital within the first month if it is appropriate and necessary. Working out which re-admissions to hospital are avoidable is crucial, because when an older person is re-admitted to hospital, they are at risk of much poorer outcomes (such as being discharged to residential care instead of their own home). We hope to find a way to identify which readmissions are avoidable, and identify which systems and support could be put in place to ensure that the root causes of these avoidable re-admissions can be tackled.”

Tim Pile, Chair of BHP member the Royal Orthopaedic Hospital, led the judging panel and commented: “In its inaugural year, the BHP Seed Fund received a very high standard of applications, attracting a wide range of proposals from across the partnership. Our awardees all demonstrated tangible patient benefit and excellent potential to scale up and roll out to other Trusts. As each project now begins to move from proof-of-concept through to implementation, we’ll be on hand to provide support and mentoring throughout.”

Applications for future rounds of the Seed Fund and key dates will be posted at www.birminghamhealthpartners.co.uk/bhp-seed-fund/

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.”

Leukaemia trial tests Covid vaccine strategies to combat immune suppression

Patients with the most common form of leukaemia – Chronic Lymphocytic Leukaemia (CLL) – are being invited to take part in a trial that could help them build Covid-19 antibodies following vaccination, when they previously have had poor responses.

Blood cancer patients are known to be at high risk of Covid-19 and many are part of the ‘forgotten 500k’ who are not well protected by Covid-19 vaccination and are therefore still very cautious going about their daily lives in contrast to those who are not immunocompromised.

Research has found that CLL patients who take either ibrutinib or acalabrutinib over the long term are not responding to Covid vaccination as well as those who are not taking the drug. Their antibody response is usually much lower, meaning the vaccine is not as effective in protecting against the disease.

Dr Helen Parry, Associate Professor at the Institute of Immunology and Immunotherapy at the University of Birmingham, is leading the IMPROVE trial and explained: “This study aims to determine if it is possible to improve the immune response by pausing ibrutinib or acalabrutinib treatment for a short period around the time of vaccination. It will also monitor whether pausing this treatment is well tolerated by patients by looking for symptom flare.

“At present there is no advice for CLL patients regarding whether pausing their treatment is the safest approach to vaccination, but anyone who participates in the trial will help to build a vital evidence base so that appropriate advice can be given in future.”

Patients interested in participating must be able to travel to one of the six trial sites: Birmingham, Stoke on Trent, London, Dudley, Oxford or Nottingham.

Anyone interested in taking part in the trial can email the trial team or call 0808 175 1455, and further information is available on the IMPROVE trial website.