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Research digest: Identifying medication adherence challenges to support best practice across Europe

3rd January 2025

A recent study identifying critical indicators related to medication adherence emphasises the complexity of the issue and the difficulty in predicting adherence to medications. The findings suggest a need for tailored, country-specific interventions and health policies to increase adherence, improve health outcomes and reduce economic burdens.

Researchers identified and prioritised indicators related to medication adherence (IRMAs) across 39 European countries and Israel through an online expert survey. Follow-up work involved collecting country-specific data on IRMAs in two countries through a targeted literature review and subsequent data validation with a second online expert survey.

Survey participants were medication adherence experts from various clinical fields, including physicians, pharmacists, psychologists and nurses who were all part of the European Network to Advance Best Practices and Technology on Medication Adherence (ENABLE).

A total of 17 out of 34 invited ENABLE members responded to the initial survey, resulting in 205 indicators of IRMA. The second survey saw 21 participants rank the 205 indicators, and 25 indicators emerged with a relevance score above 3.5.

The researchers were able to group the IRMAs into six main categories:

  1. Country characteristics such as healthcare provider, demographics or method of payment
  2. Social and economic factors including how medication was paid for and socioeconomic status
  3. Therapy-related factors such as the number of medications taken
  4. Patient-related factors linked to behaviours and attitudes
  5. Condition-related factors around the nature of the illness
  6. Healthcare system-related factors such as availability of services.

In addition, the researchers included ‘country population’ as an additional indicator because of its essential role in facilitating comparative analyses across countries in the future.

The findings offered a comprehensive understanding of the factors influencing medication adherence and successfully highlighted the priority areas as perceived by healthcare professionals engaged in this field. They will have significant implications for policymakers, healthcare providers and researchers, according to the researchers.

‘These results suggest that effective adherence-enhancing interventions must extend beyond addressing patient and therapy-related factors to include broader socio-economic and healthcare system-related determinants,’ the researchers said.

The researchers said the findings will enable fair comparisons across countries and provide a basis for the prediction of medication adherence rates in further studies.

Further research is also needed to rank these indicators accordingly and better comprehend their impact, and this could benefit from incorporating patient viewpoints to enhance the comprehensiveness and applicability of the findings, the researchers added.

Reference
Ágh T et al. and European Network to Advance Best Practices and Technology on Medication Adherence (ENABLE) Collaborators (2024). Identifying and presenting key country-specific indicators related to medication adherence: a comprehensive study across European countries. Front. Pharmacol. 15:1390629. doi: 10.3389/fphar.2024.1390629.

Remanufacturing single-use medical devices: views from England, France and beyond

13th November 2024

The remanufacturing of single-use medical devices has the potential to significantly reduce greenhouse gas emissions from health systems, and while there are impressive examples of best practice, there is still a long way to go across much of Europe. Here, Bob Unwin and Josselin Duchateau share an overview of remanufacturing and describe how the practice works at Stepping Hill Hospital, part of Stockport NHS Foundation Trust, UK, and efforts to get programmes started in France.

A growing body of evidence finds that when it comes to harmful greenhouse gas emissions, hospitals are part of the problem.

Health systems generate nearly 5% of all global greenhouse gas emissions and a staggering 71% of these emissions come from the supply chain. In a study looking at emissions from the UK’s NHS, single-use medical devices were found to have an outsized impact on the NHS carbon footprint.

A regulatory framework for commercial remanufacturing of medical devices labelled for ‘single use’, also known as SUDS, began in the United States in 1998, and Germany followed in 2002. Commercial remanufacturers – meaning the work is done by private industry outside of the clinical setting – are regulated under the EU Medical Device Regulation (MDR) 2017/245 in force since May 2021. Today, over 11,900 hospitals and surgical centres use reprocessed devices globally. 

Remanufactured SUDs must be compliant with the MDR under Article 17. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) guideline regulated the remanufacturing of SUDs from 2016. CE marked remanufactured devices must obtain the same levels of cleanliness, sterility and functionality as required of a virgin device.

Remanufactured SUDs cost at least 30-50% less than the virgin devices, according to the Association of Medical Device Reprocessors (AMDR). They also reduce waste, greenhouse gas emissions, and reliance on the international supply chain that hospitals found to be vulnerable during the Covid-19 pandemic.

Commercial remanufacturers collect devices, decontaminate, function test, clean, repackage, sterilise and return the SUDs for reuse by hospitals and clinics. Thus, remanufacturing creates a circular economy.

Peer-reviewed life cycle assessments are a well-established resource for comparing environmental impact across numerous categories to examine the cradle-to-grave impact on air, water and land for choices between two or more products.

A research team from Fraunhofer – the prestigious German research society – confirmed through a well-designed life cycle assessment that a remanufactured electrophysiology catheter resulted in a 50% reduction in greenhouse gas emissions compared to its virgin alternative when shipped from the UK to Germany where the devices were remanufactured and returned to the UK. Numerous additional peer reviewed life cycle assessments confirm substantial CO2 reductions at an average of 41% from the use of remanufactured SUDs.

Reprocessing of SUDs fact file

Stepping Hill Hospital’s Green Plan

In 2022, Stockport NHS Foundation Trust staff initiated a Green Plan, which included targets such as reducing greenhouse emissions by 85% by 2032, a 75% cut in business travel emissions by 2030, and achieving a ‘net zero’ carbon footprint by 2040 in line with wider NHS ambitions.

Supply chain leadership had become aware that an inordinate amount of greenhouse gas emissions from hospitals resulted from the supply chain. They sought to implement initiatives proven to reduce greenhouse gas emissions.

The leadership team’s research included review of NHS support for SUD remanufacturing including NHS-funded research and the NHS ‘Device Remanufacture “How to” Guide’ for the use of commercially remanufactured devices that documented substantial savings and emissions benefits at other hospitals.

The remanufacturing programme launched at Stockport NHS Foundation Trust in July 2022 significantly reduced Stepping Hill Hospital’s waste stream and greenhouse gas emissions. The Trust generated savings of approximately £33,000 during the fiscal year 2022/23 and received an additional £350 through a collections agreement with their remanufacturing partner.

While switching products can be difficult, as surgeons always have preferred medical devices, they had no difficulties using the remanufactured products because they were using the same product make and model. In the fiscal year 2023/24, the programme saved £40,763.52. By replacing 183 virgin surgical Harmonic Scissors (devices) with their reprocessed counterparts, Stepping Hill eliminated the use of the equivalent of 209 kg of CO2.

A remanufacturing example for other nations

The Stockport programme underscores the UK’s leadership in circular innovation in healthcare, standing out as a key example.

Taking this further, in October 2024, the UK’s Department of Health announced ‘a major crackdown on waste’ in an effort to save millions of pounds a year, helping to divert more resources to frontline NHS care. The ‘Design for Life roadmap’ strategy is a full-throttle approach to driving a circular economy. A commitment to use remanufactured SUDs plays a leading role, with plans to radically cut the number of SUDs in the health service and reduce its reliance on foreign imports.

Many European nations, such as Belgium, Germany, and Spain, have also embraced remanufactured devices. However, in the EU, the MDR only allows remanufacturing when permitted by national law within individual Member States, with the requirement to notify the European Commission of their regulations.

This ‘opt-in’ model does not incentivise countries to adopt the practice and adds extra regulatory hurdles before they may do so. As a result, in some European countries, concerned healthcare providers and other industry stakeholders must often raise their voices to advocate change in linear, outdated, or stagnant national policies. An illustrative example of this is France.

Outside of the hospital, France has long been a leader in the promotion of a circular economy – a 2023 policy saw the French Government pay people to repair old clothes rather than throw them away, for example. But French hospitals are given no such treatment, and the use of remanufactured devices has been banned in France.

This ban has been a thorn in the side of environmentally minded French clinicians and healthcare staff. In December 2022, a position paper published in Le Monde signed by representatives of different medical and pharmaceutical scientific societies called for a lift of this ban.

At the April 2023 European Heart Rhythm Association Congress in Barcelona, Spain, numerous French clinicians and researchers spoke forcefully in favour of the use of remanufactured devices. Then, in March 2024, a group of more than 20 doctors from the French Society of Cardiology published a position paper that similarly endorsed remanufacturing and advocated wider regulatory and professional acceptance of remanufactured devices across the continent.

Thankfully, French authorities appear to have seen the writing on the wall: in the Social Security Financing Bill for 2024, the Government included an article finally authorising the use of remanufactured devices as part of a two-year experiment.

Remanufacturing momentum in France

In a recent report detailing how the experiment could work, the General Inspectorate of Social Affairs (IGAS) and the General Inspectorate of the Environment and Sustainable Development (IGEDD) situated the potential adoption of device remanufacturing as part of France’s broader efforts to reduce its healthcare sector’s environmental footprint.

According to the report, the experiment will examine commercial remanufacturing of SUDs for four French healthcare establishments. As France lacks any existing infrastructure for a medical device remanufacturing industry, the report further encourages working with an experienced commercial remanufacturing partner.

In its own report commenting on the experiment, the French National Academies of Medicine, Pharmacy and Surgery highlighted that stakeholders across the board support the idea, provided that safety, technical and regulatory standards are maintained.

It would seem, at last, that the regulatory and medical communities in France are on the same page about this critical issue. The success of this experiment could pave the way for more sustainable practices, aligning with France’s aspirations to be a leader in the sustainable transition of healthcare. All eyes will be on this two-year trial as it explores the safety, cost-effectiveness and sustainability of remanufacturing medical devices in one of Europe’s largest healthcare sectors.

While a firm date for the commencement of the programme has not been set, the Directorate General of Health has stated that the decrees implementing the experiment should be finalised by the end of 2024. The current working draft proposes to evaluate both CE and CS remanufacturing routes, therefore allowing the experiment to cover a wide number of devices.

The experimentation phase should last two years, and the evaluation of the experiment will result in either a prolongation of the ban, or a modification of the law legalising remanufacturing of SUDs in France.

In addition to the UK successes and the French experiment, remanufacturing of SUDs is currently permitted in Belgium, Croatia, Germany, Ireland, the Netherlands, Spain, Portugal, Sweden and Israel. Globally, commercial, regulated remanufacturing of SUDs also takes place in the US, Canada, Japan, Israel and Australia.

The AMDR – the nonprofit trade association representing the remanufacturers – hopes to remove the ‘opt-in’ language in the EU MDR in a move that will make it easier for more countries in Europe to benefit from this sustainable option and reduce greenhouse gas emissions within their health systems.

Authors

Bob Unwin, registered nurse, directorate manager, theatre and critical care at Stepping Hill Hospital, Stockport NHS Foundation Trust, UK

Josselin Duchateau, clinical electrophysiologist, University Hospital of Bordeaux, France

Closing the gap: standardising organ donation and transplantation success in Europe

3rd October 2024

European Donation Day, taking place on 5 October 2024, is an opportune time to acknowledge the remarkable progress being made in organ donation and transplantation in Europe and to discuss how to accelerate further achievements. Here, Dr Chloë Ballesté Delpierre, elected member of the European Society for Organ Transplantation Council (ESOT), shares her thoughts.

Organ transplantation is one of modern medicine’s most significant milestones, providing life-saving treatments to countless individuals. However, significant disparities persist in access to these procedures, leaving many without the care they need.

The number of patients receiving transplants in Europe varies widely, from 114.8 per million in Spain to just 7.6 in Bulgaria in 2019 – a stark disparity.1 As technological advancements and innovations like bio-artificial organs continue to transform patient care, they also underscore the challenge of preventing these inequities from widening.2

The 2023 Global Convergence in Transplantation Summit marked a significant step toward addressing such disparities, highlighting the critical need to standardise practices and ensure equitable access for all.3

Leveraging successes to overcome challenges

Successful programmes in Spain, Portugal, Italy, Croatia and the UK provide valuable lessons for developing a blueprint for best practice throughout Europe. The deceased organ donor rate can also be used to evaluate successful practice, measured per million of population (pmp) in 2023.4

Spain’s programme with 49.38 deceased donors pmp, is regarded as a global benchmark.4 The country excels due to its robust three-tiered governance structure: specialised doctors in organ donation, a comprehensive reimbursement strategy and strong media collaboration.5

This structure, covering national strategy, regional coordination and hospital-level donor management, is key to its success and Spain’s commitment to innovation, including donation after circulatory death and expanded donor criteria, further strengthens its leadership in this space.5

Portugal with 37.13 deceased donors pmp is catching up with Spain and emerging as a global leader in organ donation.4 Of note is how Portugal capitalised on its close geographical, governmental and cultural ties with Spain to foster collaboration and knowledge exchange, which significantly strengthened its own organ donation and transplantation system.6 Other key strategies include a focus on tertiary prevention, reforms in dialysis governance and sustained financial commitment.6

Italy, with 29.39 deceased donors pmp,4 has developed a robust organ donation system coordinated by the National Transplant Network, with legal frameworks, cultural integration of altruistic donation and a national training strategy that has increased donation rates.7

Similarly, Croatia has built an efficient national transplantation network, with strong central governance, collaboration and resource-efficient management that ensures sustained excellence in organ donation practices.8 In Croatia, Spain, Portugal and Italy, intensive care doctors are also actively involved in organ donation.5-8

In the UK, organ donation and transplantation have seen significant progress, with 1,510 deceased donors (22.35 pmp) and 938 living donors in 2023/24, enabling 4,651 transplants – a 6% increase in deceased donors and a 3% rise in transplants from the previous year.9

The UK’s success stems from its integration of research with clinical practice, donor coordinators and impactful public awareness campaigns. These efforts are supported by robust funding structures and significant investments in infrastructure and technology.9

On the other end of the spectrum, Greece lags behind its European counterparts with 8.45 deceased donors pmp4 and an urgent need for systemic reform. The Onassis Foundation recommends establishing an independent national transplant organisation with strong governmental backing, implementing a ‘soft opt-out’ consent policy, integrating donor specialists in hospitals and focusing on public trust and education.10

Based on the success of Spain, Portugal and the UK, key priorities for Greece include expanding infrastructure, standardising the organ donation process, improving reimbursement systems and emphasising patient-centred care.10 A dedicated task force is advised to oversee these complex reforms.

Collective efforts for organ donation

To effectively build on the successful programmes described in this article, other countries must adapt these best practices to their unique cultural, legal and healthcare contexts.11

A flexible and aligned approach that balances local needs with European standards is required, along with collective efforts to close the gaps in organ donation and transplantation.

A recently developed 16-domain conceptual framework offers a comprehensive guide for developing and evaluating national programmes, focusing on responsiveness, efficiency and equity.12

This framework promotes a standardised approach that considers the diverse realities across jurisdictions, ensuring that all patients, regardless of their location or socio-economic status, benefit from the latest advancements in transplantation technology. This serves as a strong example, but additional initiatives across Europe are required to standardise clinical practices and ensure equitable access to transplantation.

ESOT is actively collaborating with the World Health Organization, among other stakeholders, on this matter, with a strong dedication to continuing the efforts to bridge the gap in Europe.

By working together, we can create a more equitable system, extending the benefits of organ transplantation to every corner of Europe and addressing disparities that hinder progress.

References

  1. Dominguez-Gil, B. (2020). International figures on donation and transplantation 2019. Newsletter Transplant, 25, 51–53.
  2. Ambagtsheer, F., Annema, C., Forsythe, J., Jansen, N., & Paredes-Zapata, D. (2024). Ethical and legal aspects of organ donation and transplantation. Transplant International, 37. https://doi.org/10.3389/ti.2024.13011.
  3. Pullen, L. C. (2024). Creating an international standard: Global convergence in transplantation. American Journal of Transplantation, 24(2), 151–153.
  4. IRODaT (2023). International Registry in Organ Donation and Transplantation [accessed September 2024].
  5. Streit, S., Johnston-Webber, C., Mah, J., Prionas, A., Wharton, G., Casanova, D., Mossialos, E., & Papalois, V. (2023). Ten Lessons From the Spanish Model of Organ Donation and Transplantation. Transplant International, 36. https://doi.org/10.3389/ti.2023.11009.
  6. Streit, S., Johnston-Webber, C., Mah, J., Prionas, A., Wharton, G., Paulino, J., Franca, A., Mossialos, E., & Papalois, V. (2023). Lessons from the Portuguese solid organ donation and transplantation system: Achieving success despite challenging conditions. Transplant International, 36. https://doi.org/10.3389/ti.2023.11008.
  7. Mah, J., Johnston-Webber, C., Prionas, A., Romagnoli, J., Streit, S., Wharton, G., Mossialos, E., & Papalois, V. (2023). How to Structure a Successful Organ Donation and Transplantation System in Eight (Not So Easy) Steps: An Italian Case StudyTransplant international : official journal of the European Society for Organ Transplantation36, 11010. https://doi.org/10.3389/ti.2023.11010.
  8. Mah, J., Johnston-Webber, C., Prionas, A., Bušić, M., Streit, S., Wharton, G., Mossialos, E., & Papalois, V. (2023). Organ Donation in Croatia: The Importance of a National Champion, a Comprehensive Plan, and International CollaborationsTransplant International: Official journal of the European Society for Organ Transplantation36, 11011. https://doi.org/10.3389/ti.2023.11011.
  9. NHS Blood and Transplant. (2024). Organ donation and transplantation activity report 2023/24 [accessed September 2024].
  10. Johnston-Webber, C., Prionas, A., Wharton, G., Streit, S., Mah, J., Boletis, I., Mossialos, E., & Papalois, V. (2023). The national organ donation and transplantation program in Greece: Gap analysis and recommendations for change. Transplant International, 36. https://doi.org/10.3389/ti.2023.11013.
  11. Berney, T., Ulasi, I. I., Balleste, C., Martins, P. N., Bellini, M. I., Valantine, H. A., & Potena, L. (2022). Editorial: Equity in Transplantation: A Commitment for Progress in Troubled TimesTransplant International35, 10781. https://doi.org/10.3389/ti.2022.10781.
  12. Johnston-Webber, C., Mah, J., Streit, S., Prionas, A., Wharton, G., Mossialos, E., & Papalois, V. (2023). A conceptual framework for evaluating national organ donation and transplantation programs. Transplant International, 36, 11006. https://doi.org/10.3389/ti.2023.11006.

Interventions to retain healthcare professionals revealed in latest METEOR study

24th July 2024

Improving working conditions and introducing incentives in four key areas have been suggested as ways to retain healthcare professionals in hospitals, according to the EU-funded METEOR Project.

Published in the journal Qualitative Health Research, the findings highlight professional and personal support, education, financial incentives and regulatory measures as the main factors that healthcare organisations should focus on to retain their staff, in addition to improving working conditions.

The study involved a series of eight online co-creation workshops and four Delphi sessions surveying nurses and clinicians at eight European hospitals in four countries: Belgium, the Netherlands, Italy and Poland.

A thematic analysis was conducted, resulting in multiple interventions that were clustered into the four pre-defined themes.

Interviewees in all four countries emphasised the importance of leadership training, interdisciplinary teamwork and support for the non-clinical workload as key factors that could improve their working conditions.

Anke Boone, a researcher at the Centre for Environment and Health at KU Leuven and a co-author of the METEOR study, said: ‘In our workshops, healthcare professionals told us that personal support is key to enhancing job satisfaction. It also creates resilience against workplace stressors, mainly by knitting teams together more strongly.’

Incentives for staff retention

The professional and personal support interventions highlighted in the study to retain staff included regular interprofessional team meetings, leadership training programs, self-scheduling and sabbaticals, support for administrative and non-clinical work, and the provision of psychological counselling.

When it came to education, interviewees from all countries stressed the need for continuous professional development opportunities, including onboarding and mentorship programmes. They also advocated for a hospital-based development budget, allocated to each employee, as part of a comprehensive personal development plan.

Financial incentives included the provision of competitive salaries, adequate spending on infrastructure, extra benefits such as secure, permanent employment contracts.

However, as Olivia Lavreysen, a researcher at the Centre for Environment and Health at KU Leuven and a co-author of the METEOR study, pointed out, ‘many healthcare professionals say they’re willing to take a pay cut if it would mean an improvement in their current working conditions. That clearly shows that job quality and the level of support from healthcare organisations is more important than money.’

Desired regulatory measures addressed the need for harmonised legislation spanning local, national and international levels, fixed healthcare worker-to-patient ratios, and effective workload monitoring tools.

Interviewees hoped that such measures would alleviate workload pressures, support retention and ensure sustainable staffing levels, which are crucial for mitigating burnout and fostering professional satisfaction.

No one-sized-fits-all approach

The authors concluded that while there is no one-size-fits-all approach to workforce retention, tailoring these interventions to address pressures within an organisation is encouraged.

Co-author Lode Godderis, professor at the Centre for Environment and Health at KU Leuven, added: ‘Healthcare providers need to look closely into their organisations and listen to employees to address their needs.’

Earlier METEOR findings revealed that 9% of doctors and nearly 14% of nurses intend to leave their professions, citing low job satisfaction, growing depersonalisation and emotional exhaustion as primary factors.

Lessons from auditing cardiovascular care to improve patient outcomes in Italy

4th July 2024

The results of a national audit and quality improvement project looking to optimise cardiovascular care across Italy has recently been presented at the Italian National Association of Hospital Cardiologists conference. Here, Professor Furio Colivicchi speaks to Helen Quinn about the rationale for the audit study, the key findings and next steps, plus the team’s ambitions to widen the scope of the project to support more patients nationally and across Europe.

Cardiovascular diseases (CVDs) are the leading cause of death globally. Figures produced by the World Health Organization (WHO) estimate 17.9 million lives are lost each year as a result of CVDs, with four out of five of these deaths being a result of heart attacks and strokes.

Finding ways to reduce death and ill health related to CVD is a primary goal of many researchers around the globe, including Professor Furio Colivicchi.

After training in internal medicine, Professor Colivicchi moved to clinical cardiology and developed a particular interest in secondary cardiovascular prevention. He joined the San Filippo Neri Hospital in Rome in 1991, becoming its director of cardiology in 2013, and he’s also a professor of cardiovascular medicine at Tor Vergata University of Rome’s School of Medicine.

In Italy, the prevalence of CVD is nearly two-fold higher than the global rate, and Professor Colivicchi is working hard to improve best practice and patient outcomes. He is currently undertaking an audit of cardiovascular care across the country with the Italian National Association of Hospital Cardiologists (ANMCO) for which he is also immediate past president.

The audit analyses admissions and treatment pathways for CVD patients throughout the country and examines whether the guidelines for treatments are being adhered to and how to improve this likelihood.

Guidelines for clinical practice

Current guidelines from the European Society of Cardiology (ESC), published in 2019, advise the use of high-intensity statins and subsequently, ezetimibe and PCSK9 inhibitors to reduce low-density lipoprotein cholesterol (LDL-C) levels below 55 mg/dL within four weeks.

However, such combination therapy is not used as much as it should be in clinical practice, and Professor Colivicchi and his team suggest this is due to therapeutic inertia, where clinicians do not always consider the information contained in such guidelines.

‘There is a gap between what should be done according to the guidelines, what the scientific evidence is about the management of certain cardiovascular conditions and what is actually performed in clinical practice,’ Professor Colivicchi says.

According to the guidelines patients with recurrent cardiac events should be reaching lower LDL-C levels of 40mg/dL – a target Professor Colivicchi describes as ‘rather ambitious’.

‘We have evidence from several observational studies in Europe, the United States and Italy that these levels were not reached in clinical practice. Patients were not following a proper path to the reduction of cardiovascular risk, which is the reduction of ischemic recurrences in particular,’ he explains. ‘Our idea was to have a photo of what was going on and then give feedback to the institutions involved in the project.’

Auditing cardiovascular care

To begin the study, entitled ‘Optimisation of the pathways from hospital discharge to follow up: the APPRO-EVO AUDIT ACS Project’, Professor Colivicchi organised observations in over 50 hospitals throughout Italy, which involved around 500 cardiologists and more than 1,100 patients.

The clinicians involved in the study collected data over four weeks, describing the general management of their patients, the epidemiological features of this population, the kind of lipid-lowering treatment implemented and whether these patients could or could not reach the recommended targets as outlined in the ESC guidelines. The audit and feedback methodology aimed to improve the quality of healthcare given to high-risk patients.

Professor Colivicchi says: ‘This is the general idea about audit; it is a circle in which you have to check what you do, try to improve your practice, and then check again to see what has actually happened. If you close the gap, then there is always an improvement.’

After collecting and analysing the initial data, the researchers undertook a second audit involving more than 1,000 additional patients to see if anything had changed following the feedback from the first audit.

Professor Colivicchi found a ‘striking increase’ in the use of new drugs in the second audit, particularly PCSK9 inhibitors and monoclonal antibodies, to treat the most severe forms of hypercholesterolemia.

Optimising cardiovascular therapies and meeting targets

The results, which Professor Colivicchi presented at the recent ANMCO conference, show that in the first phase, just 60% of the patients were discharged from hospital with a combination therapy, including a statin plus ezetimibe. The remaining patients were discharged usually with only a statin.

Following the feedback from the first audit, the number of patients receiving combination therapy rose to 75%, and the use of PCSK9 inhibitors rose from 10% to 17% in the second audit. In addition, more than 80% of patients reached the recommended targets in the guidelines.

‘We were able to demonstrate that when there is a particular attention to clinical practice, the healthcare providers tend to improve their performance. Patients were followed more carefully because when you know that someone is observing you and assessing what you’re doing, there is specific care in what is actually done,’ says Professor Colivicchi.

The next stage is to expand the project from 50 to 200 and then 300 hospitals, including minor and community hospitals throughout Italy. Professor Colivicchi hopes that clinicians will perform the assessments every six months.

He adds: ‘When you implement a quality improvement procedure within every single hospital, you can improve the practice and reach the goals recommended by the guidelines. If you reach the target, you can expect to improve clinical outcomes over the medium to long term. So, this is the underlying logic: you need that feedback.’

Prevention through clinical improvement

Through the study, Professor Colivicchi notes that the CVD patients arriving at the hospital often showed many modifiable risk factors that had not been addressed. These included smoking, being diabetic with suboptimal control of glucose metabolism, hypertension without proper treatment, as well as high cholesterol. The findings from the study show that if antiplatelet therapy is appropriately managed to reduce LDL-C, cardiovascular recurrence events will also be reduced – even in high-risk populations.

‘Prevention is relevant. Secondary prevention is extremely relevant because the effectiveness of preventive procedures is more prevalent in those patients at high cardiac risk. So, you can reduce the number of the events that are recurrent in more than 50% of patients,’ Professor Colivicchi explains.

The team is sharing the data with the Italian Ministry of Health and the local health authorities to provide them with evidence that certain interventions are effective in improving clinical practice. The evidence from the audit allows clinicians to optimise the choice of treatments, ultimately promoting a higher quality of care in a safer and more efficient way.

Professor Colivicchi’s evidence showed that, overall, there was a better use of therapeutic resources in the at-risk population and thus an increased likelihood of achieving the therapeutic targets recommended by the current ESC guidelines.

‘This experience is just one step in the direction of quality improvement. We think we are always doing the best for our patients, but this is not necessarily true. We have to measure what we do every day, and then we must be accountable for what we do. This is an approach we can implement to have some objective evidence of our clinical practice and to improve it properly,’ Professor Colivicchi concludes.

Only time will tell just how extensive the improvements are to patient care throughout Italy as a result of the audit study, but the researchers hope the impact is even more widespread than that. Their process is likely to be applicable to other health services and can help to support the implementation of best practice around the world.

Experts champion risk-stratified approach to breast cancer screening

23rd May 2024

Adopting a risk-stratified approach to breast cancer screening could help improve the benefit-to-harm ratio and the cost-effectiveness of screening programmes, European experts say.

In an invited review published in the journal European Radiology outlining the European Society of Breast Imaging’s general recommendations on breast cancer screening, the authors said that programmes usually included all women irrespective of their breast cancer risk, with age being the only determining factor.

Senior author Dr Ritse Mann, breast and interventional radiologist at the Radboud University Medical Center in Nijmegen, The Netherlands, and colleagues said breast cancer was the most frequently occurring cancer in Europe, accounting for about 15% of all new cancer cases and for about 30% of all new cancer cases in women.

Mammographic screening allowed for early cancer diagnosis, thereby reducing cancer mortality and the need for aggressive treatments.

‘Nevertheless, breast cancer remains the leading cause of cancer death among women worldwide, and although the benefits of mammographic screening outweigh the harms in the general population and the “one-size-fits-all” approach remains easier to implement, further improvements are sought,’ Dr Mann and colleagues wrote.

‘Moving to screening programmes adjusted to personal risk level instead of age-based population screening could improve the performance of a screening programme by reducing underdiagnosis, false positives, and over-diagnosis as well as improving cost-effectiveness.’

Several risk prediction models were available to estimate an individual’s risk of developing breast cancer, they said.

If possible, risk assessment should be performed at a young age (approximately 25 years) to effectively tailor screening recommendations.

Women found to be at a high risk of developing breast cancer should start screening as early as 25 years of age with annual breast MRI (evidence level 1), the recommendations stated, supplemented with annual or biennial mammography from age 35-40 years.

Evidence also supported the use of breast MRI screening in women with extremely dense breast tissue, preferably every two to three years.

‘If MRI is not available, supplemental ultrasound can be performed as an alternative, although the added value of supplemental ultrasound regarding cancer detection remains more limited,’ the experts wrote.

Breast density category should always be reported after mammography screening, they noted, as this had important implications for the performance of supplemental and alternative imaging methods.

Overall, regular mammography should be considered the mainstay of breast cancer screening (evidence level 1), but digital breast tomosynthesis could be performed as an alternative.

For women at intermediate risk of breast cancer, supplemental imaging modalities, including digital breast tomosynthesis, ultrasound, breast MRI, and, more recently, contrast-enhanced mammography, were available and had already shown potential to further increase diagnostic performance.

Artificial intelligence had also shown promising results in supporting risk categorisation and interval cancer reduction, Dr Mann and colleagues noted.

Women should be properly informed about the advantages as well as disadvantages of a breast cancer screening test to be able to make informed choices. Indeed, the experts said: ‘Individual screening recommendations should be made through a shared decision-making process between women and physicians.’

If there was a move to risk-based cancer screening rather than relying on age-based population screening, informed decision-making would become even more important to increase acceptability among those lower risk women who were candidates for reduced screening intensity, Dr Mann and colleagues suggested.

METEOR project shows EU hospital clinicians ready to quit as retention issues continue

13th March 2024

Almost one in 10 doctors across the European Union (EU) intend to leave their profession, according to a new cross-sectional study from the EU-funded METEOR Project, highlighting widespread retention issues.

Researchers from the METEOR Project – which collects scientific knowledge on job retention of healthcare workers in Europe to develop policy recommendations to increase job retention – asked 381 physicians and 1,351 nurses at hospitals in Belgium, the Netherlands, Italy and Poland about their intention to exit the profession or leave their current hospital, and the factors influencing their decisions to quit.

The results showed 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.

The survey also revealed 16.3% of doctors and 8.4% of nurses are considering leaving their current jobs. Factors impacting nurse and physician retention in hospitals highlighted job dissatisfaction, lack of career development and poor work-life balance as the main determinants of intention to leave,, which the researchers suggested can ‘help governments and hospital administrators combat the trend’.

Laura Maniscalco, co-author of the study and research fellow at the University of Palermo (UNIPA), said: ‘Many doctors want to leave their current workplaces because of the management and personal issues. In the high-stress environment of a hospital, they can face challenges in terms of work-life balance or conflicts that can result in bullying.

‘Additionally, the ineffectiveness of the management system and understaffing can force them to work in areas outside of their expertise, leading to role conflicts and reducing opportunities for career advancement.”

Domenica Matranga, a professor at the UNIPA and co-author of the study, added: ‘Our research suggests that nurses may [also] no longer find their job rewarding or valued. This issue is connected with relatively low salaries, tough working conditions and, of course, the physical and emotional pressure caused by the pandemic.‘

This latest study adds to ongoing research highlighting and addressing the pressures on clinical workforces across the EU and UK.

Recommendations to enhance the wellbeing of doctors in Europe were published in November 2023 as part of a new policy from the Standing Committee of European Doctors. These aimed to improve patient care, professional excellence and overall job satisfaction and included focusing on adequate staffing and workload management, embracing a people-focused working culture, championing mentoring and peer support networks and supporting doctors as parents and carers.

Staff retention and mental health issues have also been noted amongst UK clinicians in recent months. A survey of 1,958 NHS health professionals from across the UK in September highlighted understaffing as a main factor pushing healthcare workers to leave the NHS.

A UK surgical workforce census report published in January 2024 found that 61% of respondents cited burnout and stress as the main challenge in surgery due to excessive workloads, and 50% of respondents across all career grades indicated that they considered leaving the workforce in the past year. 

And last summer NHS chief executive Amanda Pritchard acknowledged that the NHS was seeing higher levels of sickness among staff compared to pre-pandemic, particularly due to poor mental health and anxiety, some of which she said was ‘directly related to what people have been through over what was an extraordinarily difficult few years’.

The turnover crisis comes as the healthcare sector struggles with an existing shortage of medical personnel. Projections from the World Health Organization indicate that in six years Europe will need 18.2 million healthcare workers to meet the growing demand for healthcare services driven by an ageing population and increased prevalence of chronic diseases.

As a result, the authors of this latest METEOR Project study are urging healthcare managers across the EU to ‘devise effective retention strategies, taking into account job satisfaction, work engagement, and a positive working climate’, adding that ‘such internal policies are crucial, given the difficulty of finding replacements for departing professionals’.

Remote cardiac e-health tool drives efficiencies and improves patient care in Amsterdam

26th February 2024

An e-health programme developed by the Cardiology Centres Netherlands (CCN) has been rolled out to patients at Amsterdam UMC’s Heart Centre to supplement their care and support cardiologists.

The HartWacht mobile app (HeartGuard, in English) is suitable for patients with high blood pressure, cardiac arrhythmias or heart failure and uses a small measurement instrument, around the size of a cereal bar, to monitor their blood pressure and arrythmias at home.

Making it possible to take an ECG remotely, the app means patients need to visit their cardiologist less frequently. It also gives clinicians more precise measurements and enables them to act faster where necessary.

Amsterdam UMC is the first academic hospital to use this e-health programme, which was developed in 2016 by CCN where it is already being used to track data from more than 3,000 patients.

Michiel Winter, cardiologist at Amsterdam UMC, leader of the HartWacht project, and chairman of CCN’s Board of Directors, said: ‘Since we started the e-health programme we have seen a decrease in the number of ambulance-calls for these patients, and, because we can see what is going on with the patient from a distance, we can immediately reassure and advise or intervene where necessary.’

In addition, CCN analyses show the system results in fewer visits to the emergency department, and that patients who use HartWacht come to the outpatient clinic less often and need fewer nursing days.

Dr Winter said home monitoring with the e-health tool offers peace of mind for patients who often have to deal with lifelong heart disease. ‘It is very reassuring for patients [as] they immediately receive feedback in the app after a measurement,’ he added.

Clinicians can also help patients in a timelier manner with less unnecessary care, as all patient data collected by the app is analysed by a central team before any abnormal readings are shared with the patient’s cardiologist.

Jasper Selder, cardiologist and biomedical engineer at Amsterdam UMC and co-leader of the e-health project, said: ‘It relieves us of our worries because all non-abnormal health measurements are filtered out – often the bulk of all measurements – so that we can focus on patients with abnormal measurements.

‘As a cardiologist, instead of having to look at dozens of heart rhythm and blood pressure measurements during the – often busy – outpatient check-ups, we now receive an immediate notification if one of those measurements falls outside the expected range, so there is more time for the cardiologist to focus on patient care.

‘Deviations also come to light more quickly and not only during checks. Based on the abnormality detected, we can immediately determine whether action is needed, such as adjusting medication or an extra check-up.’

According to Amsterdam UMC, further applications for diabetes and cardiovascular risk management will be added to the e-health programme this year.

AI and genetics underpin project to speed up CVD diagnosis and personalise treatment

16th February 2024

A new international project aiming to use artificial intelligence (AI) and genomics data to personalise therapies for patients with cardiovascular disease (CVD) has been announced.

The Next Generation Tools for Genome-Centric Multimodal Data Integration in Personalised Cardiovascular Medicine (NextGen) project aims to build AI-supported novel and synergistic tools to enable portable multimodal, multiomic and clinically oriented research in high-impact areas of cardiovascular medicine.

The tools will benefit researchers, innovators and healthcare professionals by identifying and overcoming health data linkage barriers in exemplar cardiovascular use cases that are complex or intractable with existing technology.

The ultimate goal is to provide faster diagnosis and better, more personalised treatments for patients while capitalising on increasing innovations and trends in AI technology.

The NextGen project will be delivered by a 21-member consortium of academic, clinical, technical and commercial partners from across Europe and the US, including the European Society for Cardiology, and led by University Medical Center (UMC) Utrecht and Queen Mary University of London.

Project coordinator Professor Pim van der Harst, interventional cardiologist and head of the department of cardiology at the UMC Utrecht, said: ‘No two people are exactly the same, and so it makes sense that each person needs a slightly different strategy to optimise their health. Personalised medicine is, therefore, the way forward for preventing heart disease, speeding up diagnosis, and monitoring and treating people with CVD.

‘To develop individualised therapies, we need to compile as much information as possible about individuals, and that’s where NextGen comes in. The unique picture we generate will then form the basis for improving cardiovascular health and wellbeing.’

Several real-world pilots will demonstrate the effectiveness of NextGen tools and will be integrated in the NextGen Pathfinder network of five collaborating clinical sites as a self-contained data ecosystem and comprehensive proof of concept.

The work will complement the ‘1+ Million Genomes’ initiative, which aims to enable secure access to genomics and clinical data across Europe, and the European Health Data Space – a European Commission governance framework for the safe and secure exchange, use and reuse of health data.

Consortium member Professor Panos Deloukas, professor of cardiovascular genomics and dean for Life Sciences at Queen Mary University of London’s William Harvey Research Institute, added: ‘This is a tremendous opportunity and a challenge we have in building the right toolbox that will allow [us] to unite CVD patient data across Europe and implement precision medicine to improve cardiovascular healthcare.’

The NextGen project has received €7.6 million from the EU’s Horizon Europe programme.

In August 2023, a genetic study revealed how the use of clopidogrel in British patients of south Asian ancestry appears to be less effective at preventing recurrent myocardial infarction than in those of European descent.

And earlier in 2023, single cell and spatial genomics combined with computational techniques were used to develop a comprehensive Heart Cell Atlas to better understand the heart and how it responds to treatments.

European doctors set out vision for EU health priorities ahead of parliament elections

23rd January 2024

European doctors’ ambitions to keep building a ‘coherent’ and ‘equitable’ European Health Union have been published by the Standing Committee of European Doctors (CPME).

It’s ‘Health Check for Europe 2024-2029’ sets out a vision for the EU’s health priorities ahead of the upcoming European Parliament election in June.

This includes five ambitions urging European policy makers to tackle the health workforce crisis, ensure a safe digital transformation of healthcare, enable healthier living, guarantee accessibility and effectiveness of medicines and take climate action for better health.

Commenting on the ambitions outlined in the Health Check vision, CPME president Dr Christiaan Keijzer said: ‘Whilst European countries have made huge advances in collaboration on health in recent years, we cannot take a step backwards.

‘The Covid-19 pandemic has shown that health is the foundation of our economy and society, and exposed that problems that have not been solved. Our health systems still suffer from deep structural flaws and our health workforce is exhausted and undervalued.

‘The European Health Union is not complete: the EU needs a coherent long-term vision for health in Europe and beyond for equitable access to healthcare for patients.

‘European doctors remain strongly committed partners in making these ambitions a reality.‘

On the subject of recruitment and retention, the Health Check highlights issues of ‘untenable working conditions, excessive hours, and insufficient resources‘, which mean ‘medicine is losing its attractiveness as a life-long profession, and if we continue in this path we will not have a functioning health workforce.’

This follows the publication of CPME‘s policy in November 2023 providing recommendations to enhance the wellbeing of doctors across Europe.

The policy aims to improve patient care, professional excellence, and overall job satisfaction by addressing challenges such as work-related stress, organisational culture, supportive working environments, burnout and work-life balance.

The CPME presented the five ambitions to the president of the European Parliament, MEP Roberta Metsola on 22 January 2024.

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