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Take a look at a selection of our recent media coverage:
25th April 2024
The cystic fibrosis (CF) medication ivacaftor (brand name Kalydeco) is safe and effective in infants aged four weeks and over, paving the way for earlier initiation of therapy for newborns diagnosed with the condition, a phase 3 open-label study has found.
Ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy, was originally approved for use in adults but has since been shown to be safe and efficacious in children as young as four months.
The therapy increases channel gating activity at the cell surface in patients with CTFR gating mutations. These mutations, which prevent chloride from moving in and out of cells, are thought to cause approximately 4% of CF cases worldwide.
The latest study involved the youngest cohort treated with any CTFR modulator to date, researchers reported in the Journal of Cystic Fibrosis, with infants aged from one month to less than four months old.
Seven infants with mean age at baseline of 1.9 months with CF and an ivacaftor-responsive CTFR variant were enrolled in the phase 3 open-label trial, receiving an initial low dose of ivacaftor based on age and weight.
‘Because ivacaftor is a sensitive CYP3A substrate and CYP3A maturation is uncertain in this age group, an innovative study design was developed wherein each infant initially received a low dose of ivacaftor that was subsequently adjusted based on individual pharmacokinetic results to ensure safe dosing,’ researchers wrote.
They observed a mean decrease in sweat chloride concentration of -40.3 mmol/L from baseline through Week 24, which was generally comparable to the decreases previously reported in children aged four months to less than six months (-50 mmol/L) and in children aged six months to less than 12 months (-58.6 mmol/L).
Infants also had improvements in pancreatic function, intestinal inflammation and growth parameters, according to the study, which was sponsored by the ivacaftor manufacturer Vertex Pharmaceuticals and conducted at four medical centres in the US and Ireland.
The researchers reported ivacaftor was generally safe and well tolerated, with all adverse events being mild in severity and non-serious and generally consistent with common manifestations of CF.
‘One infant discontinued ivacaftor due to an adverse event of elevated alanine aminotransferase/aspartate aminotransferase concentration more than eight times the upper limit of normal that was not considered by the site investigator to be related to be related to ivacaftor and occurred in the context of recurrent viral illnesses in the infant,’ they added.
‘Since pharmacokinetics were predictable, an ivacaftor dosing regimen in infants one to under four months of age based on weight and age is proposed.’
Lead author Professor Paul McNally, associate professor at the Royal College of Surgeons in Ireland and consultant in respiratory medicine at Children’s Health Ireland, said the study findings were a ‘huge moment’ in CF.
‘Over the years ivacaftor… has been put through clinical trials in younger and younger children. Now, through this study, it has been shown to be safe and effective all the way down to four weeks of age,’ Professor McNally said.
Almost all children were diagnosed through newborn screening at around this time, he noted.
‘The availability of a treatment that targets the underlying cause of the disease in newborns and can be started immediately at diagnosis will provide a huge sense of reassurance and hope for families,’ Professor McNally added.
Vertex Pharmaceuticals is applying to the European Medicines Agency for an extension to the marketing authorisation for ivacaftor to infants aged one month.
Last year the UK’s Medicines and Healthcare Products Regulatory Agency extended the licence of another CF medication ivacaftor-tezacaftor-elexacaftor (brand name Kaftrio) in combination with ivacaftor to include children aged two to five years old.
The monoclonal antibody tislelizumab has been approved by the European Commission (EC) for use in patients with treatment-naive and relapsed non-small cell lung cancer (NSCLC), its manufacturer BeiGene has announced.
This follows its positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2024.
The approval of tislelizumab (under the brand name Tizveni, but also known as Tevimbra) is across three indications, including first- and second-line use, which are:
Tislelizumab, which is a PD-1 inhibitor, is also approved in the European Union for the treatment of locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) after prior chemotherapy.
The NSCLC indications were approved under the brand name Tizveni. However, BeiGene plans to combine the NSCLC indications with the second-line OSCC indication under the brand name Tevimbra, which will launch in the first EU countries later in 2024.
Commenting on the approval, Dr Luis Paz-Ares, head of the medical oncology service at University Hospital October 12 in Madrid, Spain, said: ‘Non-small cell lung cancer remains one of the most common and deadly cancers in Europe, with 50% of patients diagnosed already progressed to advanced stages, making it difficult to treat.
‘Across three phase 3 studies, tislelizumab has been shown to improve outcomes for patients with certain types of NSCLC, providing a new option for those facing the disease.’
The positive opinion for these indications is based on the results of three Phase 3 trials which demonstrated the benefit of tislelizumab as a first- and second-line treatment for patients with NSCLC: RATIONALE 307 and RATIONALE 304, which both looked at first-line treatment in combination with chemotherapy for various types of NSCLC, and RATIONALE 303, which looked at tislelizumab as second- and third-line treatment compared with docetaxel.
24th April 2024
Patients with suspected inflammatory bowel disease (IBD) could avoid unnecessary colonoscopy tests and speed up diagnosis by using multiple home testing kits, a new study has found.
Researchers from the University of Birmingham, UK, have developed a unique testing protocol to improve IBD referral triage by combining a new 13-point symptom checker with the results of multiple faecal calprotectin (FCP) tests.
Obtaining a second FCP result prevented patients from undergoing unnecessary colonoscopies. The findings could reduce the need for expensive and intrusive investigations, speed up diagnosis for many IBD patients, and support self-diagnosis to secondary care. This would, in turn, reduce the burden on primary care.
The study, published in the journal Frontline Gastroenterology, is the first in the UK to prospectively examine the symptoms of IBD and levels of faecal calprotectin (FCP) from the onset of the condition.
Patients with IBD, including Crohn’s disease and ulcerative colitis, often have a long wait until diagnosis, and the researchers note that the current testing system is under immense strain. Diagnostic delays for IBD can result in adverse outcomes for patients.
The two-year study, which took place between January 2021 and August 2023, involved 767 participants. Over half of those who took part (n=423, 55%) were diagnosed with IBD: 208 with Crohn’s disease and 215 with ulcerative colitis.
A 13-point symptom history was taken prediagnosis, and clinical indices such as repeat FCP were collected prospectively.
The most common symptoms, which were not always easily distinguished from non-IBD symptoms, were abdominal pain (84%), looser stools (84%) and fatigue (79%) for Crohn’s disease and per-rectal bleeding (94%), urgency of stools (82%), and looser stools (81%) for ulcerative colitis.
The researchers found blood in the stools and weight loss to be the strongest predictors of IBD. The results showed that a person with blood in their stools was over four times more likely than those without to have Crohn’s disease (based on a measurement of an odds ratio (OR) of 4.38 with a 95% confidence interval and a range of 2.40 to 7.98) and over three times more likely to have weight loss (OR 3.39; 2.14–5.38).
Patients diagnosed with ulcerative colitis were 33 times more likely to experience blood in their stools and over two times more likely to have weight loss (OR 33.68; 15.47–73.33 and OR 2.33; 1.37–4.00, respectively).
Serial FCP measurements were found to be more useful than a single test for predicting IBD accurately.
Two FCP measurements, where one is greater than 100 µg/g and the other greater than 200 µg/g, were shown to be associated with the diagnosis of IBD. However, a second result, ≥220 µg/g, when considered alone and regardless of the first result, was more accurate at predicting IBD.
Some patients with elevated FCP levels and were suspected of having IBD were re-tested and showed a reduction in levels since the first measurement, indicating the initial elevated levels of FCP were not due to IBD.
Using the findings, the researchers have developed a rapid-access pathway for suspected IBD patients outside of the urgent ‘two-week wait’ criteria, with patients triaged by utilising a combination of FCP results and symptom history.
The researchers suggest that the results from home FCP testing can be coupled with a review of symptoms to form the foundation of effective self-referral pathways. Based on the study findings, patients with two FCPs >200 µg/g could be streamed directly to colonoscopy, while those with two FCPs >100 µg/g could be reviewed in clinic.
A second result ≥220 µg/g is deemed more accurate than dual-result thresholds and can indicate that a patient should be referred directly for a colonoscopy. The researchers observed that only 20% of patients had two samples submitted before referral to secondary care.
Dr Peter Rimmer, academic clinical lecturer in gastroenterology at the University of Birmingham’s National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC) and corresponding author of the study said: ‘Using a comprehensive 13-point symptom checker and multiple FCP tests, we have been able to identify much more accurately patients who had IBD and other diseases.
‘The rollout of this protocol could reduce the time taken to get a diagnosis and start treatment for IBDs as much more of the screening and testing can be done through primary care. The sensitivity of multiple FCP tests can be used to flag those patients who urgently need referral into secondary care.’
The researchers hope the study will improve referral triage for IBD patients and open new care pathways for them. A large follow-up study will explore the latter.
Efficiencies in the diagnosis of Barrett’s oesophagus have also recently been identified with a successful pilot project using a capsule sponge test found to reduce the need for invasive endoscopy.
23rd April 2024
A type II variation of ciltacabtagene autoleucel (cilta-cel; brand name Carvykti) has been approved by the European Commission (EC) for use in the treatment of eligible patients with multiple myeloma, its manufacturer Janssen has announced.
Cilta-cel has been recommended for adult patients with relapsed and refractory (R/R) multiple myeloma, who have received at least one prior therapy including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
Cilta-cel is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA) and is the first BCMA CAR-T therapy approved in Europe for the treatment of eligible patients as early as first relapse.
The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2024.
Professor Jesús San Miguel, director of clinical & translational medicine at the University of Navarra in Pamplona, Spain, said: ‘Patients with lenalidomide-refractory multiple myeloma tend to experience early resistance to standard treatments and their disease worsens exponentially with each additional line of therapy.
‘A single infusion of cilta-cel has been shown to significantly lower the risk of progression or death compared to current treatment options, as early as after first relapse.’
The EC approval was based on the results of a phase 3 CARTITUDE-4 clinical trial evaluating the efficacy and safety of cilta-cel in patients with relapsed and lenalidomide-refractory multiple myeloma.
Data from the study were previously published in the New England Journal of Medicine.
The primary endpoint was progression-free survival (PFS), defined as the time from randomisation to the first documentation of disease progression or death.
In total, 419 patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy underwent randomisation.
Patients were randomised to receive either a sequence of apheresis, bridging therapy, lymphodepletion and cilta-cel (n=208) or standard of care, which included daratumumab, pomalidomide and dexamethasone (DPd) or pomalidomide, bortezomib and dexamethasone (PVd) (n=211).
At a median follow-up of 15.9 months, a single infusion of cilta-cel gave rise to a significantly lower risk of disease progression or death compared to standard care (hazard ratio, HR = 0.26, 95% CI 0.18 – 0.38, p < 0.001).
The median duration of PFS was not reached in the cilta-cel arm and was 11.8 months in the standard care arm (95% CI, 10-14).
After 12 months, PFS was 75.9% (95% CI 69.4 – 81.1) in the cilta-cel group and 48.6% (95% CI 41.5 – 55.3) in the standard care group. In addition, a higher proportion of patients in the cilta-cel group had an overall response (84.6% vs. 67.3%), a complete response or better (73.1% vs 21.8%) and an absence of minimal residual disease (60.6% vs. 15.6%).
In terms of safety, Grade 3 or 4 adverse events occurred in a similar proportion of participants in the two groups (96.6% vs 94.2%, cilta-cel vs standard care).
Many people with breast cancer are not receiving the treatment they should, with inequalities in care leading to many groups being ‘systematically left behind, ignored and forgotten’, according to a new report.
This comes despite considerable advances in breast cancer research and treatment over the last three decades, which has led to a more than 40% reduction in breast cancer mortality in some high-income countries.
People living with metastatic breast cancer are particularly disadvantaged since rates of this type of cancer are unrecorded, and the needs of this population are unmet. The findings of The Lancet Breast Cancer Commission suggested that systematic recording of cancer rates must be established and call for increased prevention strategies and personalised treatment.
Current predictions suggest there will be three million new cases a year of breast cancer worldwide by 2040 and a million deaths, with people living in low- and middle-income countries disproportionately affected.
Tackling breast cancer gaps and inequities should be achieved through ‘global collaboration, and communication and empowerment’, the researchers said, stating that The Lancet Breast Cancer Commission is a ‘forward-looking and optimistic road map’ to address urgent challenges in breast cancer care and reduce breast cancer rates.
The findings highlighted a lack of information around rates of metastatic breast cancer, despite statistics showing that 20-30% of early breast cancers experience relapse.
Often, the physical, psychological, social and financial costs of breast cancer were found to be ‘immense but under-recognised’ since current global health metrics do not capture them.
Professor Charlotte Coles, professor of breast cancer clinical oncology and deputy head of department of oncology at the University of Cambridge, said: ‘Recent improvements in breast cancer survival represent a great success of modern medicine. However, we can’t ignore how many patients are being systematically left behind.’
She added: ‘We hope that, by highlighting these inequities and hidden costs and suffering in breast cancer, they can be better recognised and addressed by healthcare professionals and policymakers in partnership with patients and the public around the world.’
In response to the findings, the researchers established a UK-based pilot study that provides a snapshot of the economic burden and care needs of people affected by breast cancer. Nearly all of the 606 people living with breast cancer and carers surveyed experienced physical or wellbeing issues related to breast cancer, such as losing a job whilst undergoing treatment or experiencing sexual dysfunction.
Many cancer patients were also found to experience financial difficulty as a result of their illness, with 27% of patients with early breast cancer and 35% with metastatic breast cancer reporting money problems. A fifth of participants with early breast cancer and a quarter of those with metastatic breast cancer reported difficulty in covering the costs of travel for treatment.
Estimates of serious health-related suffering indicated the need for palliative care. In 2020, approximately 120 million days were spent with serious health-related suffering per year for people who died of their cancer. A further 520 million days were estimated for patients living with the disease.
Dr Carlos Barrios director of the the Oncology Research Center at Hospital São Lucas, Brazil, said: ‘Even in countries with well-developed healthcare systems, patients with breast cancer experience inadequate support and care. In countries lacking affordable health care facilities, patients experience these costs more commonly and intensely, too often leading to catastrophic spending and impoverishment.’
The The Lancet Breast Cancer Commission advocates the development of new tools to estimate the hidden costs of breast cancer and better communication between healthcare workers and patients to improve the quality of life for patients and guide policymakers to invest in breast cancer prevention and interventions that relieve suffering, such as early detection, cost-effective therapy, optimal management and financial protection.
The researchers estimate that up to a quarter of breast cancer in high-income countries could be prevented by modifying risk factors for breast cancer. This involves education and awareness-raising efforts, as well as ‘bold policy changes’ that reduce the number of people exposed to these risk factors, such as alcohol consumption and being overweight.
In addition, systematic approaches that identify those at increased risk of the disease are essential to enable equitable access to personalised prevention strategies, including cheap and effective medications that can avert breast cancer for many women and early detection programmes.
Professor Benjamin Anderson, professor of surgery and global health medicine at the University of Washington, concluded: ‘Access to evidence-based prevention and care that isn’t dependent on where an individual lives or their ability to pay would reap wide-ranging benefits for patients, families and healthcare systems striving to achieve universal health coverage.’
A version of this article was originally published by our sister publication Nursing in Practice.
22nd April 2024
Bimekizumab (brand name Bimzelx) has been granted marketing authorisation by the European Commission (EC) for active moderate-to-severe hidradenitis suppurativa (HS), its manufacturer UCB has announced.
Now indicated for adults with an inadequate response to conventional systemic HS therapy, the humanised monoclonal IgG1 antibody is designed to selectively inhibit the two cytokines interleukin 17A (IL-17A) and interleukin 17F (IL-17F).
This approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2024 and makes bimekizumab the first biologic for moderate-to-severe HS to target IL-17F in addition to IL-17A.
It also marks the fourth marketing authorisation for the drug, adding to the existing indications in moderate-to-severe plaque psoriasis, active psoriatic arthritis and active axial spondyloarthritis.
Professor Christos Zouboulis, director of the departments of dermatology, venereology, allergology and immunology at Städtisches Klinikum Dessau, Brandenburg Medical School, Germany, and president of the European Hidradenitis Suppurativa Foundation, said: ‘The European Commission’s approval of bimekizumab marks a significant milestone for the EU hidradenitis suppurativa community, particularly considering the limited treatment options currently available.
‘As a community, we strive to improve the management of hidradenitis suppurativa. Bimekizumab offers a promising new therapeutic option for moderate to severe disease, supported by Phase 3 evidence that demonstrated clinically meaningful and sustained responses over 48 weeks.’
Indeed, the EC approval was based on results from the BE HEARD I and BE HEARD II studies, which evaluated the efficacy and safety of bimekizumab in the treatment of moderate-to-severe HS.
The multicentre, randomised, double-blind, placebo-controlled phase 3 trials had a combined enrolment of 1,014 adult patients with a diagnosis of moderate to severe HS.
The primary endpoint in both studies was HiSCR50 at Week 16, with HiSCR75 at Week 16 as a key secondary endpoint. These are defined as at least either a 50 or 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
A significantly higher proportion of patients treated with bimekizumab versus placebo achieved a 50% or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50.
Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16.
Responses were maintained to Week 48, and the safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.
Semaglutide could be beneficial in helping to treat patients with type 2 diabetes and obesity-related heart failure, a study has shown.
In a trial of more than 600 patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to several benefits after one year.
This included larger reductions in heart failure-related symptoms and improvement in physical limitations, researchers reported in the New England Journal of Medicine (NEJM).
It follows previous research suggesting benefit of the glucagon-like peptide-1 (GLP-1) receptor agonist in obesity-related heart failure in people without type 2 diabetes, the researchers said.
But it was not clear if the same would be true of those who also had type 2 diabetes for several reasons including that they tend to present with more advanced disease and are already likely to be receiving treatment with a sodium-glucose cotransporter-2 inhibitor for their heart disease.
After 12 months, the researchers reported that a once-weekly 2.4mg dose of semaglutide not only led to a larger reduction in heart failure symptoms in this group but also increased the six-minute walk distance.
It was also associated with fewer serious adverse events than placebo, the researchers noted.
But the trial was not designed to evaluate the number of hospitalisations or urgent doctor visits for heart failure symptoms, they added.
Those taking semaglutide lost more weight compared with placebo, but the weight reduction was 40% lower than reported in people with heart failure but not diabetes in a previous study.
Writing in the NEJM, the researchers concluded that the findings suggested ‘the mechanisms of benefit with semaglutide may extend beyond weight loss’.
This could be due to the effects of the drug on the heart and blood vessels, inflammation, insulin resistance and other factors, they said.
The consistency between the findings of this and the previous trial in patients without type 2 diabetes ‘provides greater reassurance that semaglutide is an efficacious treatment option with a favourable safety profile in a broad population of patients with obesity-related heart failure,’ they said.
Commenting on the study results, Professor Naveed Sattar, professor of cardiometabolic medicine at the University of Glasgow, said: ‘This new well conducted trial suggests once again we have underestimated the impact of excess weight in the development of heart failure with preserved ejection fraction.
‘Preventing obesity remains critically important but newer treatments that help people living with obesity lose decent amounts of weight could help improve the lives of many living with heart failure, and many other conditions associated with obesity.
‘Robust randomised trials are needed to also ensure these drugs are not only beneficial but also safe and the evidence here is also mounting and reassuring.’
Earlier this month, a review by the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee concluded that available evidence does not support a causal association between GLP-1 and suicidal and self-injurious thoughts and actions.
A version of this article was originally published by our sister publication Pulse.
18th April 2024
Over a third of patients are in favour of clinicians using artificial intelligence (AI) in consultations to improve documentation processes such as clinical letters, according to a recent white paper from the Microsoft company Nuance.
Analysing survey responses from 13,500 participants from nine European countries plus the UK and Australia, the white paper explored patients’ recent interactions with clinicians and whether they believed AI would have helped to improve their experience.
The responses highlighted five main challenges that patients felt contributed to an unsatisfactory experience with their clinician: ineffective communication, excessive waiting times, lack of personalisation, insufficient continuity of care and limited accessibility to healthcare information.
An average of 40% of respondents felt that they didn’t receive their physician’s full attention during consultations because they were focused on their computer screens. Of those, 40% said that led to feelings of frustration. In the UK, this frustration peaked at 50% of respondents.
In order to improve this interaction, an average of 34% of respondents said they felt using AI to assist in the clinical documentation process would be a good idea, ranging from 27% in Norway to 48% in Spain.
When considering the age breakdown, respondents from younger age groups were more likely to agree AI would be beneficial. The percentage decreased with each age category from 43% of 18-to-24-year-olds to 26% of those aged 65 and over.
Although the patients surveyed had not yet had any personal experience with AI in healthcare, respondents chose freeing up time for the clinician as the most compelling reason to use AI, with an average of 45% and peaking at 55% for German respondents.
While the survey respondents broadly supported the use of AI, they also raised concerns about the use of AI in clinical settings, with 50% saying they were ‘somewhat concerned’. A further 32% were ‘not very concerned’ and 10% were ‘not concerned’.
The main cause for this concern was a lack of AI regulation at 34%, which increased to 46% in Germany and 48% in the UK. Medical information being recorded was also highlighted, with 17% recording this as a concern.
In response to this, the white paper stated: ‘The regulatory aspect of AI is changing all the time, with most governing bodies in our surveyed countries working on AI roadmaps and specific legislation.
‘Healthcare organisations should ensure they implement tools that are purpose-built for clinical environments to guarantee quality and safety, and that they clearly communicate the benefits to clinicians and patients.’
Writing in the white paper, Dr David Rhew, global chief medical officer and vice president of healthcare, at Microsoft, said: ‘With AI, we can pull together more information than ever before, extracting deeper insights into patient health and treatment options. We can accelerate and automate the workflows clinicians follow, and simplify the tasks that can draw their focus away from the patient. And we can tailor care pathways and treatments to the individual patient’s unique needs.’
The white paper also stated that ‘this total focus on the most meaningful part of their role – working directly with patients – supports clinicians’ professional satisfaction and reduces the likelihood of burnout’.
Earlier this year, the EU-funded METEOR Project highlighted widespread retention issues in Europe with 9% of doctors and nearly 14% of nurses declaring an intention to leave their profession, citing low job satisfaction, growing depersonalisation and emotional exhaustion as the primary factors.
And the recent NHS staff survey revealed that 65.56% of medical and dental staff were unable to meet all the conflicting demands on their time at work.
Previous research from Nuance in 2022 revealed that NHS healthcare professionals in acute, mental and community health settings were spending an average of 13.5 hours per week generating clinical documentation – a 25% increase since 2015.
Consultants were found to spend the longest on clinical documentation at 15.1 hours per week.
A further 3.2 hours per week were spent out-of-hours by healthcare professionals on this task, according to the research.
Some 68% of respondents said they felt it likely or very likely that their notes would be more complete if they had more time to complete them.
In an attempt to help free up doctors’ time to treat more patients and reduce waiting times, the NHS has recently announced the rollout of AI software at 10 trusts in England that aims to reduce missed appointments.
17th April 2024
Supporting patients via telemedicine after experiencing acute coronary syndrome (ACS) can reduce emergency department attendance and prevent hospital readmission, according to a new study.
Published in the Journal of the American College of Cardiology and funded by the British Heart Foundation, the study involved 337 patients (86% men) who came to Hammersmith Hospital with ACS over 15 months and were randomly assigned to receive telemedicine or standard care on discharge.
The standard care group of 167 patients were discharged with medication and asked to go to their GP or hospital if they experienced any cardiac symptoms that caused concern.
The 163 patients in the telemedicine group were provided with a blood pressure monitor, a pulse oximeter and a 12-lead electrocardiogram belt device, along with training on how to use the technologies to measure their vital signs. They were told to send their vital signs to their specialist cardiology team if they identified results indicating a potential heart problem.
Using rules developed by the research team, cardiologists then performed a remote clinical assessment to determine the seriousness of the condition, with patients either being reassured, offered a non-urgent follow-up or advised to attend A&E or call 999.
Principal investigator Dr Ramzi Khamis, consultant cardiologist and BHF research fellow at the National Heart and Lung Institute, Imperial College London, said: ‘The approach we designed and tested is focused on sparing valuable time and resources while reaching a well-informed treatment plan for high-risk patients experiencing worrying symptoms.’
The primary outcome was time to first readmission at six-months, with secondary outcomes including emergency department visits, major adverse cardiovascular events and patient-reported symptoms.
The researchers found that the remote monitoring approach meant patients were 76% less likely to be readmitted to hospital within six months (hazard ratio [HR] 0.24; 95% confidence interval [CI] 0.13 to 0.44; p < 0.001) and 41% less likely to attend an emergency department (HR 0.59; 95% CI 0.59; 95% CI 0.40 to 0.89) compared to those receiving the standard care.
What’s more, patients supported via telemedicine had a 15% lower risk of repeat myocardial infarction after nine months, as well as fewer strokes and fewer unplanned coronary revascularisations (3% in telemedicine group versus 9% in standard therapy group).
The occurrence of chest pain (9% versus 24%), breathlessness (21% versus 39%) and dizziness (6% versus 18%) at six-months was lower in the telemedicine group compared to the standard care group.
For those who were readmitted to hospital, the average length of stay was half a day – a third of the average one and a half days in the standard care group.
The researchers concluded that remote monitoring after ACS could help to tackle pressure on health systems worldwide, and reduce emergency department and cardiology ward waiting lists.
Dr Khamis added: ‘The study clearly showed that sending vital information straight to cardiology teams, coupled with a consultation, led to seemingly better care, reductions in admissions, average length of stay and A&E attendance.
‘This simple strategy can potentially free up thousands of hospital beds and doctors’ hours across the country whilst keeping patients just as safe. We are now looking at working with the NHS and other healthcare systems globally to adopt this strategy and hopefully improve treatment for future patients.’
Earlier this year, an e-health programme for patients with high blood pressure, cardiac arrhythmias or heart failure was rolled out to patients at Amsterdam UMC’s Heart Centre to supplement their care and support cardiologists.
Previous research found that patients with heart failure who receive remote disease monitoring and consultations experienced short-term cardiovascular and mortality benefits.
NHS England has U-turned on plans to cut funding for a mental health support service following strong criticism from the profession, and will allow new registrations from hospital clinicians for another year.
Earlier this month, the NHS Practitioner Health service said NHS England was ‘undertaking a review’ for the support offer across all NHS staff groups, to consider ‘long term sustainable options’.
This meant that the service would not accept any new registrations from secondary care staff from 15 April, but would continue to treat existing patients, with new patients being ‘signposted’ to other services such as their GP, it said.
Justifying the decision, NHS England chief strategy officer Chris Hopson said the ‘vast majority’ of mental health support for NHS staff ‘is, and always has been, via their employer’s health and wellbeing schemes’.
However, the decision was strongly criticised by doctors, including the BMA and the Doctors’ Association UK, who said it was ‘short-sighted’ and ‘cruel’.
Now, NHS England has agreed to ‘extend the service’ for secondary care health professionals by 12 months while a review is carried out.
It confirmed that the service will remain in place for GPs and other primary care staff for another 12 months until the end of March next year.
NHS England chief workforce officer Dr Navina Evans said: ‘Following discussions with Practitioner Health on their current service for secondary care doctors, dentists and senior staff, we have jointly agreed to extend the service by 12 months, for both existing and new service users, while we carry out a wider review to ensure that all NHS staff groups have the mental health support they need.’
Professor Dame Clare Gerada, an ambassador for NHS Practitioner Health who is also a GP, said she was ‘delighted’ that the extension was agreed and that the service will ‘work closely’ with NHS England on the review.
The Royal College of Physicians (RCP) has welcomed the announcement and said it will ‘take an active interest in [the new review] process, recommending that any new solution must be either equal to or better than the current situation‘.
The RCP added: ‘All NHS staff groups must have the mental health support they need.‘
NHS Practitioner Health provides mental health and addiction support for healthcare professionals so that they are able to remain in, or return safely to, work.
According to figures for 2022/23, 6,741 new patients registered with the service, with average registrations per month at 562, up from 225 before the pandemic.
Prior to the reversal of the decision, in a post on X (formerly Twitter), Professor Dame Gerada said: ‘To remind, [NHS Practitioner Health] was established following suicide of a psychiatrist who also killed her baby and highlighted the barriers doctors have in accessing mental health care.’
She added: ‘I am so proud of the 32,000 doctors/dentists/nurses/paramedics/and others who have sought our help.‘
BMA workforce lead Dr Latifa Patel said doctors are ‘more burnt-out’ than ever‘, and described NHS England’s withdrawal of funding as a ‘short-sighted financial decision with potentially harmful consequences for both doctors and patients’.
She added: ‘We need to have assurances that its review of services will lead to equal or better provision of mental health support in the future.’
In December 2023, a report from the British Psychological Society called for priority long-term investment in NHS staff mental health and wellbeing.
An earlier survey showed that health professionals ranked work-related stress, workload intensity and staffing levels as the primary ‘push factors’ underpinning decisions to leave the NHS.
A version of this story was originally published by our sister publication Pulse.
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