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12th May 2025
Some patients with carotid stenosis can be treated with medical therapy alone for stroke prevention and will gain no additional benefit from revascularisation. This is according to two-year interim results of multi-centre randomised trial.
Carotid endarterectomy or stenting was usually offered to patients with carotid stenosis to prevent stroke, but the guidance was based on randomised trials conducted more than 30 years ago, an international research team wrote in The Lancet Neurology.
Given improvements in medical therapy, the researchers wanted to assess whether patients with asymptomatic or symptomatic carotid stenosis with a predicted low to intermediate predicted stroke risk gained any additional benefit from revascularisation if they were receiving optimal medical therapy (OMT).
Patients were eligible for inclusion in the European Carotid Surgery Trial (ECST-2) if they were aged 18 years and older and had atherosclerotic carotid stenosis of 50% or greater with or without symptoms.
Symptomatic patients were required to have a predicted five-year risk of stroke of less than 20% based on the Carotid Artery Risk (CAR) score – a risk model which accounts for factors such as percentage of narrowing in the carotid artery and medical history, including diabetes.
The CAR score was recalibrated from an earlier carotid surgery trial and tested for the first time in this study, researchers explained.
A total of 429 patients with a median age of 72 years were enrolled across 30 centres in the UK, Europe and Canada and randomly assigned 1:1 to either OMT alone or OMT plus revascularisation.
OMT included a low cholesterol diet, target-adjusted cholesterol-lowering medication, antihypertensive therapy, antithrombotic therapy and regular checks to adjust the medication as necessary.
The primary outcome for this two-year interim analysis of the five-year trial was a hierarchical outcome composite of:
However, researchers found no evidence for benefit of revascularisation in addition to OMT in the first two years following the procedure.
The findings provided an important step towards more individualised treatment in patients with carotid stenosis enabled by the CAR score, they said.
‘Our results indicate that this CAR score reliably predicted patients at low risk of stroke, with a two-year risk of ipsilateral stroke in the OMT alone group of only 2.9% compared with 6.2% in the OMT plus revascularisation group,’ they added.
They stressed, however, that the findings only applied to the group of patients with low or intermediate risk symptomatic stenosis selected using the CAR score, and to asymptomatic patients.
‘Identifying patients with carotid stenosis who are at high risk of future stroke, who might benefit from revascularisation, should also be a goal of future research,’ they concluded.
Senior author Professor Martin Brown, emeritus professor of stroke medicine at UCL Queen Square Institute of Neurology in London, said that while further follow-up is needed, his research team recommend using the CAR score to identify patients who could be managed with OMT alone.
‘This approach emphasises personal assessment and intensive treatment of vascular risk factors, potentially sparing many patients from the discomfort and risks of carotid surgery or stenting,’ he said.
‘Additionally, this method could lead to substantial cost savings for health services.’
The National Institute for Health and Care Research (NIHR), the Stroke Association and the Leeds Neurology Foundation funded the research in the UK, and the Swiss National Science Foundation and the Dutch Organisation for Knowledge and Innovation in Health, Healthcare and Well-Being funded the study in Europe.
Dr Louise Flanagan, head of research at the Stroke Association, said surgery or stenting could lead to complications including an increased risk of stroke, and other unpleasant side effects.
‘The CAR risk score offers the opportunity to take away the downsides of surgery and stenting by using medical therapy alone, as well as combining medical therapy with surgery,’ she said.
‘The medical therapies used to reduce the risk of stroke from atherosclerosis work by treating risk factors for stroke, including high cholesterol and raised blood pressure, which we are putting at the heart of our recommendations for the Government’s 10 Year Health Plan.’
Last year, research suggested that paediatric cholesterol tests and the adoption of an ‘adolescent cholesterol passport’ could help prevent up to one-fifth of premature heart disease. It found that elevated levels of cholesterol and dyslipidaemia in children and adolescents increased the risk of heart issues such as subclinical atherosclerosis in their mid-20s and premature death by their mid-40s.
Women who have never smoked are around 50% more likely than their male counterparts to develop chronic obstructive pulmonary disease (COPD), new research reveals.
Published in the journal BMJ Open Respiratory Research, the study challenges the belief that women are at higher risk of COPD than men because they are more vulnerable to the effects of cigarette smoke, which was previously thought to explain the disparity in COPD rates between sexes.
The research suggests that the extra burden of COPD in women should be considered when assessing respiratory illness in female patients, particularly in those patients who have never smoked.
Despite significant reductions in the number of people who smoke in the last 50 years, COPD remains a leading cause of death in both the UK and US.
Women tend to develop COPD at a younger age than men, and often experience more severe symptoms, prompting the suggestion that increased COPD rates in women are due to a heightened susceptibility to the effects of cigarette smoke.
To explore this further, the researchers analysed data from the 2020 US National Health Interview Survey (NHIS), both to try to understand potential links between the development of COPD and gender and to produce an updated estimate of the prevalence and impact of COPD.
Over 32,000 people responded to the survey, including 12,638 women and 10,390 men. All participants were aged 40 or over and provided information on their smoking history, what tobacco products they used, and whether they vaped. The analyses were adjusted for sociodemographic covariates.
Overall, women were found to have a higher COPD prevalence (7.8%) than men (6.5%). This was despite their lower cigarette smoke exposure – women reported smoking fewer daily cigarettes than men, averaging around 18 compared with around 22, and to have done so for fewer years. And they were less likely than men to have started smoking before the age of 15, at around 19% compared with 28%.
The prevalence of COPD was higher among women who had ever smoked than it was among men – at 16% compared with 11.5%. But it was also much higher among women than men who had never smoked – the prevalence of COPD was almost twice as high in women who had never smoked as it was in male never-smokers, at just over 3% compared with just over 1.5%.
In further analysis, women were found to have a 47% higher relative risk of being diagnosed with COPD, after accounting for other variables that could influence their risk.
And, crucially, the gender disparity persisted irrespective of smoking history: among those who had never smoked, women were 62% more likely to be diagnosed with COPD than men, while among those who had ever smoked they were 43% more likely to have COPD.
The researchers concluded: ‘Our findings refine prior estimates of COPD among those without a smoking history and re-emphasise the high burden of COPD in women, underscoring the need for thoughtful efforts to prevent, diagnose, and treat their disease.’
A version of this article was originally published by our sister publication Nursing in Practice.
Nearly half of Trust leaders (47%) are scaling back services to deliver on financial plans, with a further 43% considering this option, a survey by NHS Providers has found.
The survey, which received responses from 114 different trusts, accounting for 56% of the provider sector, found that virtual wards, rehabilitation centres, talking therapies and diabetes services for young people were the services identified as at risk.
A further 26% said they will need to close some services to deliver their financial plans, with a further 55% saying this was currently under consideration.
The NHS Providers survey also found that a third (37%) of Trust leaders said their organisation was cutting clinical posts amid financial pressures, with a further 40% considering this.
Around 86% of Trust leaders said their job cuts would also include non-clinical teams, including HR, finance, estates, digital and communications staff. There was also a reduction in temporary staffing costs reported among 91% of respondents, as well as a recruitment freeze among 85% of leaders.
Nearly nine in 10 (88%) of respondents said they do not have enough funding to invest in prevention – a key Government priority and a leading ambition in its upcoming 10 Year Health Plan.
When it comes to the knock-on impact on patients, 45% of Trust leaders reported being moderately or extremely concerned their actions will compromise patient experience, while 94% said the steps needed to deliver financial plans would have a negative impact on staff wellbeing and culture at a time of existing low morale, burnout and vacancies.
Commenting that ‘Trust leaders will always put patient safety and quality of care first’, interim chief executive of NHS Providers Saffron Cordery said: ‘NHS Trusts face competing priorities of improving services for patients and boosting performance while trying to balance the books with ever-tighter budgets. National leaders must appreciate that makes a hard job even harder.
‘It’s really worrying to hear Trust leaders tell us highly valued staff and services including vital work to address health inequalities and prevention could be among the early casualties of budget cuts. These decisions are never taken lightly and will always be a last resort.
‘They’re committed to working with the Government to build a better health service but fear immediate financial pressures could undermine plans to transform the NHS.’
The BMA said it was ‘deeply concerning’ that so many Trusts were thinking of cutting services.
Professor Phil Banfield, chair of BMA council, said: ‘Patients up and down the country will be wondering how this can be possible when they see hospitals already buckling under the pressure of understaffing, A&E patients lining corridors, waiting lists that seem endless and clinical staff eternally on the verge of burnout.
‘To be in that situation and then to cut the number of doctors will seem absurd to most people. We are already hugely under-doctored amongst comparable countries.
‘What we need is for Government to get a grip of a currently fragmented health system. There needs to be an honesty with the public about the scale of the financial challenge of restoring our NHS and the costs of reorganising services, which must be driven by the clinical need of patients, not managerial expediency.’
A version of this article was originally published by our sister publication Healthcare Leader.
A consensus statement outlining strategies for the identification and management of cardiopulmonary risk in chronic obstructive pulmonary disease has been developed by a global expert working group. Co-chair Professor Chris Gale discusses the findings and highlights the importance of a shared understanding and multidisciplinary teamwork in addressing the challenges.
There is good evidence from historical and recent multinational observational studies for the association of acute exacerbations of chronic obstructive pulmonary disease (COPD) and a range of cardiovascular events. The cardiovascular events that occur with a greater magnitude of risk in individuals with COPD following an exacerbation compared with individuals with COPD who have not had an exacerbation include myocardial infarction, decompensated heart failure, arrhythmias and stroke.
It is not fully understood why acute exacerbations of COPD are associated with higher risk of cardiovascular events. Presently, there are three proposed mechanisms: systemic inflammation triggered by lung inflammation that triggers atherothrombosis; hyperinflation that reduces cardiac output; and hypoxaemia, which causes pulmonary hypertension and right heart failure.
Of note is that many individuals with COPD have underlying cardiovascular disease or are at higher risk of cardiovascular disease. As such, they have an underlying substrate that is catalysed into an acute event by way of an exacerbation.
Our earlier work had identified gaps in the knowledge base about cardiopulmonary risk in COPD, and we were aware that the literature did not provide detailed guidance on this topic. In particular, we noted an absence of dedicated clinical practice guidelines about cardiovascular disease and risk in individuals with COPD from national and international respiratory and cardiovascular organisations.
Our aim was to write a paper that would help pulmonologists, cardiologists, primary care physicians and other healthcare professionals understand, identify and manage cardiopulmonary risk in patients with COPD.
We invited 100 clinical and academic experts in cardiovascular disease and COPD from around the world from the Global Working Group in Cardiopulmonary Risk in COPD to contribute to the consensus statement.
The final consensus statement is: ‘Given the high burden of fatal and non-fatal major cardiovascular and respiratory events in patients with COPD, it is important that cardiopulmonary risk is assessed and managed’.
The statement should be viewed as a pragmatic guide for clinicians and a call to action to better understand and treat COPD-associated cardiopulmonary risk rather than a definitive set of evidence-based guidelines.
In addition to the consensus statement and clinical guide, we developed internationally agreed definitions of cardiopulmonary events and cardiopulmonary risk in COPD.
We propose that people with COPD be thoroughly evaluated for cardiovascular disease. At a minimum, a cardiovascular disease history and, as necessary, additional investigations should be performed annually as dictated.
Evaluation should include any history of chest pain/tightness, orthopnoea, paroxysmal nocturnal dyspnoea, palpitations, syncope and disproportionate dyspnoea. In addition, a full lipid profile, haemoglobin a1c, complete blood count, urea and electrolytes, estimated glomerular filtration rate, thyroid function, liver function (collectively representing a basic metabolic panel), N-terminal pro-B-type natriuretic peptide, blood pressure and a 12-lead electrocardiogram should be taken.
Individuals with cardiovascular risk factors or disease who have a regular cough or expectoration, recurrent ‘chest infections’, a significant smoking history, or breathlessness should complete spirometry to confirm the presence of COPD.
We have provided a blueprint for the identification and management of cardiopulmonary risk in people with COPD. Implementation of the consensus recommendations will be achieved through education and awareness campaigns, shared understanding and improved interdisciplinary working, outputs from research about cardiopulmonary risk in COPD, and adoption into national guidelines.
It is important to be aware that individuals with COPD have, or are at risk of, cardiovascular disease and adverse cardiovascular events. When COPD co-exists with cardiovascular disease, it carries a worse prognosis – about one in five of these individuals will die from cardiovascular disease.
There are evidence-based treatments for cardiovascular disease, and these should not be withheld in individuals with COPD. Equally, optimising lung health with inhaled therapies to reduce acute exacerbations offers the potential to reduce the burden of cardiovascular events.
Interdisciplinary working across pulmonology and cardiovascular medicine is required to better identify disease – be it incident cases of COPD or cardiovascular disease within prevalent COPD – estimate risk and deliver optimal care.
Discrete models of parallel referrals from primary care to separate cardiology and pulmonology specialists may impede optimal care. Alternative care models could comprise multidisciplinary team discussions and virtual review, multispeciality clinics for people presenting with undifferentiated breathlessness, inclusion (and contracting) of cardiopulmonary risk assessment in the annual COPD review, early cardiopulmonary review following a moderate or severe COPD exacerbation and dedicated cardiopulmonary risk clinics.
Allied health professionals, including pharmacists, specialist nurses and certified respiratory educators could be upskilled to enable the identification and initial management of cardiopulmonary risk in the community as well as at cardiology and respiratory clinics. Indeed, it has been shown that a COPD care pathway can successfully be embedded in an existing cardiology outpatient clinic infrastructure.
The consensus paper provides a comprehensive yet pragmatic approach to tackling cardiopulmonary events in individuals with COPD. It is written by clinical experts, with input from 100 contributors from around the world, for healthcare professionals. The paper also highlights areas where there remain knowledge gaps and scientific uncertainty.
Adopting the consensus recommendations, novel research into the interplay between cardiovascular disease and COPD and its treatment and integrating these findings into clinical guidelines will improve cardiopulmonary outcomes in COPD.
Chris P Gale MBBS PhD Med MSc FESC FRCP
Professor of cardiovascular medicine and honorary consultant cardiologist, Leeds Teaching Hospitals NHS Trust and the Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, UK
8th May 2025
The risk of giving birth to a child with congenital heart disease is approximately 50% higher for mothers with anaemia compared to those without, research has found.
Published in BJOG: An International Journal of Obstetrics & Gynaecology, the researchers said the findings have the potential to substantially reduce the number of children born with congenital heart disease – currently estimated as approximately 2.5 million globally each year.
Using data from the UK Clinical Practice Research Datalink GOLD database of electronic health records, the researchers analysed electronic health records from 2,776 women who had a child diagnosed with congenital heart disease. These cases were matched to 13,880 women whose children did not have a congenital heart disease diagnosis.
The researchers used the World Health Organization definition of anaemia (< 110 g/L haemoglobin) and analysed women with a haemoglobin measurement in the first 100 days of pregnancy and a child diagnosed with congenital heart disease within the first five years of life.
The findings showed that of 123 mothers whose babies had congenital heart disease, 4.4% of the women had anaemia. Of the 390 mothers whose babies had normal heart function, 2.8% of the mothers had anaemia. After adjusting for potential influencing factors, the odds of giving birth to a child with congenital heart disease were 47% higher among anaemic mothers.
Dr Duncan Sparrow PhD, associate professor and British Heart Foundation senior basic science research fellow at the University of Oxford, and the corresponding author on the study, said: ‘We already know that the risk of congenital heart disease can be raised by a variety of factors, but these results develop our understanding of anaemia specifically and take it from lab studies to the clinic. Knowing that early maternal anaemia is so damaging could be a game-changer worldwide.’
The Population Attributable Fraction (PAF) was calculated to be 1.4% from the 2.8% prevalence in the population measured. However, previous estimates suggest levels of anaemia may be as high as 7% in the first trimester and up to 13% in some areas. In these cases, maternal anaemia may account for up to 6.2% of UK congenital heart disease cases.
Dr Sparrow added: ‘Because iron deficiency is the root cause of many cases of anaemia, widespread iron supplementation for women – both when trying for a baby and when pregnant – could help prevent congenital heart disease in many newborns before it has developed.’
The researchers suggested a clinical trial of periconceptional iron supplementation would be beneficial in light of their results, stating it would be a minimally invasive and low-cost intervention which could prevent some congenital heart disease if iron deficiency anaemia is proven to be a cause.
Last year, research found that diet and exercise interventions before and during pregnancy could lower cardiovascular risk in children of obese mothers.
A version of this article was originally published by our sister publication Nursing in Practice.
Some bacteria have already become resistant to ceftazidime/avibactam – one of the new antibiotics introduced to the NHS in 2017.
A new study published by the UK Health Security Agency (UKHSA) highlights the risk, and although the levels of resistance are currently low, it provides a stark reminder that appropriate antibiotic use is essential to slowing the development of resistance.
Antibiotic resistance occurs naturally, but it can be accelerated by increased use, whether the use is appropriate or not. Ceftazidime/avibactam treats some of the most serious hospital infections, such as bloodstream infections. The drug is a ‘reserve’ classified antibiotic and clinicians only prescribe it in exceptional circumstances, typically when patients have hard-to-treat infections caused by known multi-drug resistant bacteria, often when other antibiotics have failed.
The UKHSA researchers analysed data from routine surveillance samples between 2016 and 2020 to assess the levels of ceftazidime/avibactam testing, resistance and usage in England, providing baselines for future monitoring. Routine surveillance samples provided reported ceftazidime/avibactam resistance categorisation and reference laboratory samples, allowing the assessment of minimum inhibitory concentration (MICs) and molecular data.
The analysis shows that 6.3% of bacteria tested in routine surveillance already showed resistance to the drug. Resistance levels varied across bacterial species and fluctuated slightly over time, stabilising as routine surveillance testing was established. Nearly 70% of NHS Trusts used the antibiotic during the study period.
Dr Colin Brown, UKHSA deputy director responsible for antimicrobial resistance (AMR), said: ‘This study reminds us how important resistance surveillance is. Research like this means clinicians and prescribers can access the most relevant information available to prescribe the best antibiotics for their patients, while protecting the long-term effectiveness of antibiotics for future use.’
The researchers said that to treat infections effectively, carbapenemase gene detection and variant identification in ceftazidime/avibactam surveillance are important and suggest that healthcare professionals must monitor and identify resistant bacteria targeted by this antibiotic.
To support the initiatives to keep antibiotics working, the UKHSA has launched a new digital campaign to tackle the threat of antibiotic resistance and help keep antibiotics working. The campaign is aimed at younger generations and is named after a new mascot, ‘Andi Biotic’. Over the six-week digital campaign, Andi will answer uncertainties people have about antibiotics, ensuring they understand when these medicines are appropriate, the importance of taking them only when prescribed, and why they should never be saved for future use.
Dr Brown added: ‘We aren’t going to be able to tackle antibiotic resistance solely by finding new drugs. While we continue to support innovation in developing new treatments, resistance will emerge, and so it’s important that we all work together to keep antibiotics working.’
In February, the UKHSA widened the list of first-option antibiotics in an effort to tackle AMR.
Later that month, the National Audit Office warned that the Government has made ‘limited progress’ in achieving its vision of containing AMR and questioned the UK’s resilience to this public health threat. The public spending watchdog was joined by organisations such as the British Society for Antimicrobial Chemotherapy in urging the Government to invest in the NHS to ensure the healthcare workforce is fully equipped to tackle AMR.
Last year, research aimed at quantifying excess antibiotic use in an acute UK hospital found that nearly a quarter of antibiotic days of therapy were unnecessary.
A version of this article was originally published by our sister publication Nursing in Practice.
Women with endometriosis have a significantly higher risk of developing autoimmune and autoinflammatory diseases, a study shows.
Conditions such as osteoarthritis, rheumatoid arthritis, multiple sclerosis, coeliac disease and psoriasis are among the comorbid conditions significantly linked to endometriosis.
For the first time, researchers at the University of Oxford identified a genetic correlation between endometriosis and many of these diseases, suggesting a shared genetic basis may explain the increased risk.
The findings are published in the journal Human Reproduction and examine both the clinical associations and the biological mechanisms that can drive these comorbidities.
The study, funded by the charity Wellbeing of Women UK, analyses data from 8,223 women with endometriosis and over 64,000 with immune-related disease from the UK Biobank. This data enabled the researchers to examine the link between endometriosis and 31 different autoimmune diseases and investigate a possible biological basis for the increased comorbidity across immunological conditions. The autoimmune diseases analysed included 17 classical autoimmune, 10 autoinflammatory and four mixed-pattern diseases.
The researchers analysed retrospective data to determine whether endometriosis was more commonly experienced before or after a coexisting autoimmune disease. They conducted a cross-sectional analysis to uncover common associations between conditions and also conducted genome-wide association studies (GWAS) and used Mendelian randomisation methods to explore shared genetic factors and potential causal links.
The results showed women with endometriosis had a 30-80% higher risk of developing immune-related conditions, particularly autoimmune diseases like rheumatoid arthritis, multiple sclerosis, and coeliac disease, and autoinflammatory conditions such as osteoarthritis and psoriasis.
The researchers discovered a strong genetic correlation between endometriosis and both osteoarthritis and rheumatoid arthritis, and to a lesser extent, with multiple sclerosis.
The study is the first to provide genetic evidence suggesting a potential causal relationship between endometriosis and rheumatoid arthritis, indicating that the existence of one condition may contribute to the development of the other.
Professor Krina Zondervan, head of the Nuffield Department of Women’s and Reproductive Health at John Radcliffe Hospital, University of Oxford, and joint senior author, said: ‘Very large studies integrating clinical and genetic information, such as conducted here, are able to provide valuable new insights into disease biology. In this case, we have provided solid evidence of a link between endometriosis and subsequent risk of diseases such as osteoarthritis and rheumatoid arthritis, and we have shown this has a biological basis.’
It is hoped that this new information can be leveraged to look for new treatment avenues that may work across all of these conditions. The findings highlight the importance of long-term monitoring of immunological comorbidities, including conditions such as fatigue, joint pain, psoriasis and gastrointestinal issues, as well as understanding the links between such conditions and endometriosis.
Janet Lindsay, CEO of Wellbeing of Women, added: ‘This research is an important step towards building a more accurate understanding of endometriosis, a condition that affects one in 10 women globally. For too long, there has been too little investment in research into women’s health issues like endometriosis. The findings show a link between endometriosis and autoimmune diseases that could pave the way towards faster diagnosis and more personalised treatments.’
The research team said further studies focusing on biomarker identification, clinical trials and targeted treatment options will be critical in moving from understanding the genetic and phenotypic associations to actionable healthcare solutions.
A version of this article was originally published by our sister publication Nursing in Practice.
6th May 2025
The Pre-DX trial is investigating pre-operative Oncotype DX testing on core biopsy for breast cancer instead of the traditional post-operative approach. Here, with an introduction from Hospital Healthcare Europe editor Helena Beer, the lead investigator of the trial, Mr Henry Cain, discusses this ‘natural next step’ in the evolution of novel approaches to breast cancer diagnostics, what the trial found and how it’s set to transform clinical practice.
When considering post-surgery adjuvant therapy for patients with oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer, genetic testing has been shown to effectively guide recommendations.
Standard practice is to order the test in the post-operative setting on a specimen from the excised invasive carcinoma, but recent efforts have focused on determining whether earlier testing is possible.
Mr Henry Cain, consultant oncoplastic breast surgeon at the Royal Victoria Infirmary, part of Newcastle upon Tyne Hospitals NHS Foundation Trust, has observed meaningful improvements in the patient pathway by shifting the ordering of the test from oncologists post-surgery to surgeons immediately following the procedure. This has the benefit of shorter waiting times for adjuvant treatment.
But a group of UK researchers, led by Mr Cain, set about pushing the boundaries even further by performing the test on the diagnostic core biopsy in the pre-operative setting – the technical possibility of which had been intimated.
‘Coupled with increasing confidence in the reliability of core biopsy testing, it made sense to take this a step further and explore testing even earlier at the point of diagnostic biopsy,’ he says. ‘This shift offered the opportunity to further streamline care and potentially alleviate patient anxiety by providing crucial treatment information much earlier in the journey.’
The result was the Pre-DX trial, and its findings were recently presented at the 19th St. Gallen International Breast Cancer Conference 2025, which Mr Cain delves into here.
The primary aim was not to alter treatment sequencing, since patients in this cohort are not candidates for neoadjuvant treatment, as they typically have small cancers suitable for breast-conserving surgery. Instead, the trial sought to understand whether testing earlier in the pathway could improve efficiency within the standard treatment process and enhance the patient experience.
We aimed to reduce unnecessary appointments and deliver care more efficiently. From a patient perspective, we wanted to see whether addressing key treatment questions earlier, such as the need for chemotherapy, could reduce stress and uncertainty at a difficult time. Our hypothesis was that having this clarity earlier would positively impact patients’ emotional wellbeing.
While clinical appointments are essential, they are also resource intensive. We often see patients returning for visits where little new information is shared – appointments that could have been avoided if results had been available earlier. Reducing these touchpoints not only makes the journey less burdensome for patients but also eases pressure on breast services.
Fewer unnecessary appointments mean shorter treatment timelines and a more efficient use of NHS resources. This translates into better throughput and a less stressful care experience.
The trial showed that patients who received their results earlier had lower anxiety and depression scores by the time they reached adjuvant treatment. We tracked these metrics at multiple points to ensure that we weren’t simply shifting anxiety to an earlier stage.
Patients consistently told us that their two biggest concerns at diagnosis were: “Will I need a mastectomy?” and “Will I need chemotherapy?” By answering one of those questions earlier, we helped reduce the emotional toll of uncertainty. The data confirmed what we had long heard anecdotally – that earlier clarity can significantly ease a patient’s mental burden.
The good news is that integrating pre-operative genetic testing into routine practice is straightforward. The criteria remain the same – the key is accurately identifying patients who meet them at an earlier stage.
Ordering and discussing the test is no different from the post-operative setting. The only additional step is communication with pathology teams to ensure that the correct biopsy specimen – one with a minimum of 2mm tumour focus – is submitted for testing. Our trial demonstrated a test success rate of 98-99% on core biopsy, in line with traditional post-operative specimens.
In summary, the process fits seamlessly into existing workflows and offers meaningful benefits for both patients and the clinical teams.
I wouldn’t say that we encountered any hurdles that were particularly difficult to overcome. In fact, the reason the trial succeeded is that it was very carefully considered and designed to fit in seamlessly with the normal clinical pathway in each unit.
The key principle we adhered to was ensuring the trial didn’t require any additional steps, biopsies or processes beyond standard practice, as we didn’t want to create any extra burdens for the units. The trial was designed with real-world application in mind from the very beginning.
Our aim was to avoid a situation where we investigated an intervention that – even if successful in the trial setting – would be incredibly difficult to implement into routine practice.
In my view, the trial exemplifies a well-considered, well-designed study, which succeeded in minimising potential logistical and technical challenges.
The small number of patients who switched to neoadjuvant treatment reflects the deliberate design of the trial. Our aim was not to explore a change in treatment sequencing but to assess how early genomic testing could improve the standard surgical pathway.
We specifically targeted ER-positive, HER2-negative patients who were already scheduled for surgery, as most in this group would not typically receive neoadjuvant therapy. The low switch rate therefore validates the inclusion criteria and confirms that the pathway studied was both appropriate and consistent with real-world practice.
The trial clearly demonstrated that pre-operative genomic testing can deliver a positive impact on the standard patient pathway and experience. The findings support data from other studies demonstrating the oncological utility of the test in patients requiring downstaging, providing valuable information at the point of diagnosis.
Yes, absolutely. Covid-19 threw a spanner in the works. When we designed trials before the pandemic, we were basing our models on patients typically having six to eight appointments as part of their standard workup.
Then everything changed. Many units in the control arm ended up having only two or three appointments, as they tried to minimise face-to-face contact. This significantly affected clinical touchpoints. It became much more difficult to demonstrate a sizeable reduction, since many of those appointments had already been removed from the system.
These reductions were a response to a crisis. We may have streamlined the process, but it impacted the quality of care. A lot of results were given over the phone, often not by the treating physician. Appointments were combined and the personal touch was often lost.
Since the end of the pandemic, we have seen a rebound, with most units returning to a more standardised, face-to-face approach. However, it’s important to remember that in the Pre-DX trial, we didn’t dictate how units should use the genetic test results, it was simply another piece of data.
The trial didn’t mandate specific changes in the intervention arm. However, when this becomes standard practice, units looking to make those efficiencies will be aiming to leverage this to their benefit.
The trial wouldn’t have been possible without strong multidisciplinary collaboration. From the start, we needed accurate radiology to stage the patient pre-operatively. Then there were the pathological inputs and surgeons. The oncologists also needed to be comfortable with the results from the core biopsies and the plan for addressing them. It was critical to achieve the buy-in of all these groups.
The design of trial and intervention meant that no additional work was required for the healthcare professionals, which was a critical factor in winning their support. It did not require additional biopsies – only that radiologists and surgeons continued to do what they do every day, providing accurate readings and advice on biopsies.
We made the process as seamless as possible, integrating smoothly into existing workflows and creating an environment open to collaboration.
The trial did exactly this. The test’s ability to identify patients who will and will not benefit from chemotherapy early in their diagnostic pathway allows for a radically more tailored treatment strategy.
Instead of a one-size-fits-all approach, clinicians can confidently de-escalate treatment for the approximately seven out of 10 of patients unlikely to require chemotherapy, sparing them from unnecessary side effects and improving their quality of life.
Conversely, the trial enables the early identification of the 30% of patients who do require chemotherapy, allowing for a timelier referral to oncology and potentially a shift in the treatment sequence. This proactive approach allows for earlier initiation of chemotherapy, potentially improving outcomes for this higher-risk group.
By integrating the Pre-DX findings into clinical practice, we can move towards a more efficient patient pathway, directing resources and expertise to those who need them most.
Further research should prioritise two key areas: the long-term oncological impact of early genomic testing and, crucially, the integration of patient-reported outcomes and quality of life measures directly into clinical trial design.
Regarding the oncological impact, I’d like to see continued investigation into trials that stratify patients based on clinical staging and genomic risk profiles, using tools such as the Oncotype DX test to guide treatment pathways. Specifically, the research should focus on long-term outcomes such as overall survival, recurrence rates and the ability to reduce mortality by tailoring treatment intensity based on these early genomic assessments. These studies should aim to definitively demonstrate whether early, genomically informed treatment decisions lead to improved survival and reduced recurrence compared to traditional approaches.
Equally important is a shift in how we approach patient experience within clinical trials. We need more research that illustrates that “bolting on” patient experience as an afterthought is simply not sufficient. Instead, it should be an integral component of trial design, influencing treatment decisions and endpoints alongside traditional oncological measures.
This would involve proactively assessing patient wellbeing, emotional state and quality of life at various points through the treatment journey. Trials could explore how different treatment pathways – guided by genomic risk and incorporating patient feedback – impact anxiety, depression, fatigue and overall satisfaction with care.
Ultimately, the goal is to develop treatment strategies that not only improve oncological outcomes but minimise the emotional and psychological burden on patients, ensuring they navigate their breast cancer journey as seamlessly as possible. This requires a fundamental shift in how we value and integrate patient experience into the research process, giving it the same weight as traditional oncological endpoints.
2nd May 2025
Acute appendicitis serves as a critical indicator of emergency healthcare performance, and the AlliGatOr study is set to examine global variations in appendectomy care. Project lead Theophilus Teddy Kojo Anyomih discusses the study’s aims, its potential to inform policy recommendations and how its findings around best practice could help strengthen emergency care systems and improve patient outcomes worldwide.
Acute appendicitis is one of the most frequent surgical emergencies worldwide. Yet, the choice between conservative (non-operative) management and appendicectomy is influenced by a complex interplay of clinical, systemic and sociocultural factors. Patient presentation, access to imaging, surgical workforce availability, and even the patient’s ability to afford care all contribute to this decision.
In high-resource settings, early diagnosis supported by imaging enables tailored care pathways, often including laparoscopic surgery. In contrast, many low- and middle-income countries (LMICs) face limited diagnostic and surgical resources, leading to delayed or even missed operative intervention. In some contexts, conservative management with antibiotics may be adopted – not because it is optimal, but because surgery is unavailable.
This global heterogeneity in resources and decision-making is a key motivator behind the Appendicitis Global Outcomes (AlliGatOr) study. By comparing systems worldwide, we aim to distinguish decisions driven by clinical best practices from those shaped by logistical constraints.
AlliGatOr leverages a common emergency condition to illuminate how surgical systems function across diverse contexts. By using appendicitis as a tracer condition, the study provides real-time insight into the performance, equity and resilience of emergency surgical care worldwide.
Coordinated by the National Institute for Health and Care Research (NIHR) Global Surgery Unit at the University of Birmingham, the study is supported by a vast network of collaborators spanning multiple countries and hospitals. Its delivery is powered by national leads, consultant hospital leads, co-leads and mini-teams comprising residents and trainees, medical students and allied professionals.
This inclusive and decentralised model builds local capacity, empowers teams on the ground and fosters peer-to-peer learning across borders.
The AlliGatOr study has two key aims:
1. To identify areas for system strengthening in emergency surgical care
2. To evaluate global variation in the presentation, diagnosis, management and outcomes of acute appendicitis.
To achieve these goals, the study collects standardised data across eight predefined 14-day windows between February and May 2025. During each period, participating teams record all consecutive appendicectomy cases, collecting detailed patient-level data on presentation, imaging, surgical approach and 30-day outcomes – including complications, length of hospital stay and readmissions.
In parallel, hospitals complete a mandatory site survey that provides contextual data on imaging availability, surgical expertise and resource access.
Additionally, two sub-studies are nested within AlliGatOr: one focusing on waste management and sustainability in operating theatres, and another exploring the financial burden of surgery in LMICs.
AlliGatOr is not just a data collection exercise: it is a mechanism for shaping policy and practice at both local and global levels. It contributes to progress in several key areas, including improving emergency surgical care, identifying disparities in access to healthcare and refining clinical guidelines.
By benchmarking metrics such as time to surgery, imaging use, access to laparoscopy and complication rates, AlliGatOr identifies modifiable bottlenecks in care delivery. Hospitals can compare their own data against global standards to drive targeted, locally led quality improvements.
Previous studies, such as Hippo, GlobalSurg 1 and 2 run by the GlobalSurg Collaborative, have revealed stark disparities in regional access to safe surgery.
AlliGatOr continues this work, mapping disparities and generating evidence for targeted investment and policy reform.
Most existing appendicitis guidelines are based on data from high-income countries. AlliGatOr provides a richer, more inclusive dataset, allowing for greater nuance in clinical recommendations. Whether adjusting imaging expectations or tailoring antibiotic use, the study redefines what ‘best practice’ means across different contexts.
As of April 2025, we are in period six of eight in our data collection timeline. The response has been phenomenal. Of over 2,000 hospitals registered globally, more than 1,100 across 108 countries have already contributed data. We have captured high-quality information from over 22,000 patients, making this the largest international cohort on appendicitis ever assembled.
This remarkable momentum reflects the strength of our collaborative network and the global commitment to improving emergency surgical care. Each data point brings us closer to uncovering the trends and insights that could reshape clinical practice.
One of the greatest values of global collaborative studies like AlliGatOr is the ability to surface low-cost, high-impact strategies that are adaptable across systems.
The study may also validate innovations such as outpatient appendicectomy protocols or task-shifting models, offering alternative pathways to effective care. By capturing and sharing these success stories, AlliGatOr builds a global repository of practical solutions.
Turning global data into national and local policy is challenging. Barriers include political inertia, limited funding and systemic resistance to change. While data is essential, it is rarely sufficient on its own.
The strength of AlliGatOr lies in its embedded model in that research is conducted within the hospitals themselves, fostering ownership and accountability. National leads can use their own country’s data to advocate for change, whether it is improved access to imaging, surgical workforce expansion or updated training curricula.
At the international level, partnerships with the World Health Organization, Ministries of Health and academic societies will be key to translating evidence into policy. Previous NIHR Global Surgery initiatives, such as COVIDSurg and Hippo, have already influenced real-world guidelines. AlliGatOr is expected to do the same.
The multidisciplinary team (MDT) extends beyond surgeons to include emergency physicians, radiologists, anaesthetists, operating theatre staff, nurses and, increasingly, allied health professionals. Their coordinated input influences diagnostic clarity, time to theatre, surgical approach and postoperative recovery.
Well-functioning MDTs are pivotal to improving patient outcomes, ensuring timely diagnosis, safer surgery and smoother recovery. Streamlined radiology support can reduce negative appendicectomy rates, while timely anaesthesia facilitates early intervention in complicated cases. In many systems, effective MDT collaboration is underpinned by clear protocols, rapid communication and a culture of shared decision-making.
However, in resource-constrained settings, MDTs often operate under strain, affecting both the reliability and timeliness of care. AlliGatOr captures this variability, offering an opportunity to benchmark how team structures influence outcomes and where improved MDT integration could offer the greatest benefit.
Our vision is for AlliGatOr to transform how appendicitis, and by extension, emergency surgery, is delivered worldwide. Specifically, we hope to see:
Ultimately, the quality of appendicitis care should not depend on where a patient lives. AlliGatOr brings us one step closer to achieving true global equity in emergency surgical care.
In a world where disparities in healthcare access persist, and emergency systems are under immense pressure, global collaborative research is not a luxury – it is a necessity. The AlliGatOr study is a powerful example of what can be achieved when clinicians worldwide unite around shared challenges.
Its legacy will extend beyond publications or conference presentations. It will live on in better-informed policies, stronger systems and, ultimately, in lives saved through safer, more equitable and more efficient surgical care.
Theophilus Teddy Kojo Anyomih MBChB
National Institute for Health and Care Research Global Surgery Unit, University of Birmingham, UK
Hospital Healthcare Europe is delighted to announce respiratory consultant and cystic fibrosis expert Dr Uta Hill as a speaker at the upcoming Clinical Excellence in Respiratory Care event on 7 May 2025.
Dr Hill is the cystic fibrosis clinical lead and bronchiectasis co-clinical lead at the Cambridge Centre for Lung Infection at Royal Papworth Hospital NHS Foundation Trust. She will share her expert insights on redefining the clinical landscape of cystic fibrosis.
Her session will cover recent advances in cystic fibrosis care, including the development of cystic fibrosis transmembrane conductance regulator modulator therapy and its impact for patients, as well as the changing pathways for adult cystic fibrosis care and the transition from paediatrics.
This session follows on from her contribution to the previous Clinical Excellence in Respiratory Care event in May 2024 in which she joined a panel discussion on the evolution of imaging techniques to support the diagnosis and staging of respiratory diseases.
Find out more about the upcoming Clinical Excellence in Respiratory Care event and register for free to hear the latest from Dr Hill on cystic fibrosis and a jam-packed agenda of other respiratory topics.
This latest event in HHE’s Clinical Excellence series brings together renowned experts from recognised Centres of Excellence and other key institutions to share best practice and explore the latest advances in respiratory care.
From modern smoking cessation and the when, why and how of lung transplantation, to wearables and artificial intelligence in sleep medicine and the management of pathogens in asthma, plus Dr Hill’s cystic fibrosis session and a range of sponsored sessions, it’s not to be missed.
The event is free to attend and will be delivered virtually live and on-demand, all tailored to provide maximum convenience and work around your busy schedule.
Select sessions most relevant to your clinical practice, specifically tailoring the day to your needs, and gain CPD hours from the comfort of your computer.
The event is fast approaching so register now to join us for Clinical Excellence in Respiratory Care on 7 May.
You can watch a selection of previous Clinical Excellence event sessions in the Catch-up zone now, as well as being able to access a whole host of additional long-reads and interviews with prominent clinicians from Centres of Excellence and beyond in the Respiratory zone – look out for the orange Clinical Excellence tag.
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