Introduction: the promises of digital healthcare

It is no secret that the healthcare systems across Europe are currently facing a series of crises and challenges^[1]. While it has been established that every single EU country currently faces a shortage of health workers^[2], the demand of care is growing and is expected to grow even further due to the ageing population^[3] and the increasing burden of chronic illnesses. As our rapidly changing societies test the limits of individual resilience, the nature of care is set to evolve, to become more holistic, integrated, person-centred^[4]and more humane. Strengthening defenses and preparedness against pandemics and other major cross-border threats such as those brought by climate change remains also an area where progress is urgently needed^[5]. And to make it more difficult still, all this must be achieved with shrinking budgets.

In this difficult context, digital innovation is often presented as a solution, or even THE solution, that will make it possible to meet all the challenges at once.

Over the last years, technology’s potential to transform the healthcare system has become increasingly undeniable, especially from the patient perspective. Among others, telemedicine and remote monitoring can help manage chronic or post-operative conditions, artificial intelligence (AI) and big data can help predict risks and personalise treatments, virtual reality devices can improve the training of healthcare professionals in surgical and emergency procedures, medication management systems have the ability to ensure the safe use of medication at every stage from prescription to administration. 

While it is ethically sound and wise not to give in to the siren call of innovation and to remain vigilant about the evaluation and validation of technologies with a view to improving patient safety and outcomes ^[6],[7], progress is such that one might legitimately wonder whether it is not unsafe or unethical not to adopt some of well evidence-based technological solutions.

If digital health and available solutions hold so many promises, why are tangible results still a long way off? Again, from the patient perspective, why over 1 in 10 patients continue to be harmed during care, with approximately 50% of the safety lapses considered preventable^[8]? 

What are the missing links between technology potential and tangible results?

The specific context and needs of the different stakeholders in care delivery

The authors of this article, being actively involved in organisations dedicated to improving the safety and the quality of care, believe that achieving the potential of digital innovation requires careful consideration for the growing complexity of the healthcare systems and for the specific context and needs of the different stakeholders involved in the care delivery. Leading change in such an environment is a sensitive matter and has to be handled accordingly, listening to and understanding each other’s needs, finding common ground to build on. 

The day-to-day reality and the priorities of healthcare professionals 

Careful consideration of their context and needs implies the absence of prejudice and the deconstruction of stereotypes, such as a so-called medical culture of resistance to change and digital innovation. Would this rather simplistic belief really fit with the reality of men and women who use technological tools in their daily lives? Why would they not in their professional lives? 

The working conditions in which healthcare professionals seem to be a more consistent barrier: how could teams suffering from staff shortages, undermined by chronic fatigue^[9] and overwhelmed by the growing demand for care, be engaged to uptake new digital tools and dedicate time to implement changes that will completely redesign their working habits? 

Another obvious obstacle is the lack of information technology (IT) support and expertise to use the technologies^[10], a barrier difficult to overcome given the current high rate of innovation. Let’s not forget either that healthcare professionals may have experienced in the past a disastrous implementation of a technology or IT system, leading to more administrative work or rework. Launch any of them on the subject and you’ll quickly understand that it’s a very sensitive matter.  

Another way of reading this reality is to look less at the obstacles and more at the motivations of healthcare professionals in relation to technology, and to note that they appear to devote the time potentially freed up by a digital solution to improving the quality of care, to caring for their patients, to training and education and, finally, to a better work-life balance^[11].  These seem to us to be enlightening priorities for mobilising healthcare professionals around the uptake and implementation of technologies. They should above all encourage debate on the use of possible efficiency gains associated with technology. 

The delicate situation of healthcare managers regarding technology

Another simplistic assumption would be to think that healthcare managers’ lack of enthusiasm for investing in new technologies is the main barrier to digital transformation and that it would mainly be due to shrinking budgets. In this view, public policies providing larger budgets or incentives to investing into digital innovation should quickly resolve the matter. 

The shrinking budget part is not entirely wrong, especially given the current global economic context. However, this overlooks the fact that their primary mission is, while keeping the ship financially afloat, to respond to a growing demand for quality care with shrinking teams^[12], a situation largely due to challenging working conditions for the mental and physical health of the medical workforce^[13],[14].

While the prospect of efficiency gains to compensate for staff shortages may seem tempting, the life sciences and medication markets are overwhelmed by technological innovation. In these conditions, which investment should be prioritised? How to find the time to carry out in-depth analyses to distinguish the qualities of one digital solution from another and assess its integral cost, maintenance included? How to confirm that a specific technology is really adaptable to the context of the organisation?  

This last question is to be linked to another underestimated limiting factor, being the weight of technological history. Past investments have shaped digital and sometimes physical environments, in such a way that it can limit the ability to incorporate a new technology. Integration and Interoperability are key aspects which, if not managed, can lead to malfunctions, extra work, frustrations and additional departures.

Finally, the transformation of the digital environment brings new challenges to the management of medical data, as data breaches can have serious legal and patient trust impacts. Beyond security and privacy, data quality requires special attention as it can also compromise patient safety.

The changing role of the patient driven by technology

Even if patients can be presumed to have a positive a priori attitude towards technologies likely to improve their health and safety, many cutting-edge technologies require patients to be kept informed and even more involved. Telemedicine and remote monitoring, for example, require patients or informal caregivers (family, neighbours, friends) to participate in measuring parameters and reporting unusual symptoms. Digital medication support programmes to increase patient medication adherence require computer literacy.

The evolution is such that some see it as a veritable cultural transformation, supported by digital and objective data accessible to both caregivers and patients, leading to an equal level doctor-patient relationship, with shared decision-making^[15]. 

It is therefore of utmost importance to gauge patients’ appetence for the digital devices put in place, and their ability to use them in a relevant and autonomous way or with the help of informal caregivers. Otherwise, all the efforts put into a digital solution will be in vain. There is even a risk of a rebound effect. For example, if remote monitoring coupled with artificial intelligence to detect anomalies in the monitoring of parameters is not properly explained, it could generate mistrust and provoke inappropriate reactions on the part of the patient. 

The reflexes and limitations of the companies developing digital solutions

Reducing life sciences and pharmaceutical companies to purely profit-driven bodies is a caricature. As any organisation, they are made up of individuals with a wide range of motivations. These motivations generally include the desire to respond to the need to improve patient safety and the quality of care. And this is where health and economic interests meet, since there is no viable business project without meeting a genuine need. 

However, the technologies developed by these industries may not find their market, or they may be under-exploited, generating frustrations. There may be many reasons for this, but those on which the industries can act are -in their views- limited, given that interactions with the health professionals or with the patient are regulated and that what happens in the healthcare setting is beyond their reach and responsibility. 

As a result, the companies behave most of the time like any economic player and act on the only levers that enable them to meet their need to differentiate themselves from their competitors: pushing the innovation cursor ever further, developing new functionalities and add-ons to their products, at the risk of promoting innovation for innovation’s sake, pushing the human factor and ergonomics to the sideline, and blurring the clarity of the available offer. 

Seeking convergence and recreating links

From theory to action: patient safety as guiding principle

Rather than setting the respective expectations against each other, blaming a specific stakeholder for missed opportunities and slow digital transformation of the healthcare, seeking convergences and find a way to move forward based on common interests seems a more fruitful approach.

From the review of the various health stakeholders’ priorities, a common interest which could act as a driver to align everyone’s action is clearly emerging: the improvement of patient safety and outcomes. However, this common interest should be seen as tightly linked with the wellbeing and safety of healthcare professionals as, at the end of the day, the patient’s fate relies in their hands and the implementation of any improvement requires their participation^[16]. It therefore needs to be prioritised by all healthcare stakeholders, and particularly the managers of health settings, as a way of addressing issues of retention, burnout and fatigue of healthcare professionals^[17].

Fostering constructive collaboration between healthcare stakeholders around the improvement of patient safety and outcomes through digital transformation is a fine idea on paper but needs to be turned into reality. And the only way to do that is to look at the specific context of each care environment to assess priorities and, more specifically, its challenges in terms of patient safety. 

A good place to start is with an internal process for reporting and analysing near-misses and adverse events, together with other sources or methodologies such as a patient reports of patient safety^[18] or the use of “triggers” or clues to identify adverse events^[19]. Such a rational approach will make it possible to avoid, or at least limit, the risk of bias represented by games of influence within healthcare institutions, based on the prestige or volume of activity of an individual or a department.

If these figures are not tracked or are unreliable (in many countries it is still a legal or cultural issue to talk openly about incidents), national or global scientific studies could still provide details about the significance and the causes of a particular adverse event. However, they have the disadvantage of being disconnected from the reality of practice in the care environment concerned especially as, in recent years, the technologisation of care has led to more complex errors^[20]. As a result, priority must be given to strengthening internal tracking and analysis of near-misses and adverse events.

Assessment of needs: the necessary involvement of the healthcare staff 

The involvement of healthcare staff is essential to put the figures into context, detect patient safety risks and analyses their causes, propose improvements and most importantly implement them.

And that is where management must be open and agile; it may well be that the right solution to prevent a patient safety problem is not always technological. Revising a pathway or introducing a checklist-type routine may sometimes be more than enough. In some cases, technology can even bring additional problems instead of solving them. It may also be that a suitable solution lies with another kind of innovation, such as integrating a network or entering into a partnership to share knowledge, data, equipment and practices. 

When it comes to defining a solution, the involvement of the staff produces another benefit, that of integrating both the needs of the patients and the vision the staff has of its own work. They will be the first to point out the risk represented by a technological solution that would have the effect of adding to their mental or physical workload, or of degrading the meaning of the care they provide, by reducing the quality of time they can make available to their patients, if only to express their attention and compassion. 

These benefits will be particularly evident when it comes to drawing up the list of technical specifications for the proposed solution. Whether it’s a question of essential functionalities, levels of interoperability, adaptability, alarm, navigability or ergonomics, the involvement of medical teams in the definition of the envisaged solution will offer the best guarantee of its use. 

The implementation of digital solutions, a collaborative challenge

It would be easy to think of implementing a technology as simply grafting a new tool onto an existing process. However, most of today’s technologies are disruptive in nature, requiring at the very least an adaptation of processes, or even a complete re-engineering. And it is only at this price that the benefits associated with the technology, both in terms of patient outcomes and efficiency, can be realised.

To achieve this, the medical teams will need to be given time to plan and carry out all the necessary stages: development of an alternative process, implementation of the solution in test mode, upskilling and training, gradual transition to the new process, evaluation and corrective adjustments. And it is unrealistic to imagine that they will be able to do this in addition to their usual work, when they are already struggling to provide a high-quality care to all their patients. Or to achieve that without any support in terms of project management. 

It is also at this stage that increased collaboration with an industrial supplier can make sense. For instance, what would prevent an industrial company from venturing further into the field of assistance with the implementation of their technologies, to ensure that they are used to their best? Some leading companies have already demonstrated that it was possible to develop a recommended implementation plan, a target pathway and specific hands-on training, to provide experts throughout the implementation process and after, underlying the importance of communication around problems and incidents. The industrial company acting in this way facilitates the implementation of its solution, ensures that it is used appropriately to achieve its potential, and gains a competitive advantage. 

It is also at this stage that patient involvement proves crucial, to configure the solution in the best possible way, adapting it to different patient profiles and addressing issues such as data privacy and quality, digital literacy, security and lack of trust. 

Conclusions

The operational approach developed in this article aims to encourage discussion and collaboration between health stakeholders around the possibility and conditions to enhance patient safety and outcomes through innovation in all healthcare settings across Europe. 

In this article we have suggested the following ways forward:

1. Rather than blaming any specific stakeholder (healthcare professionals, healthcare managers, patients, industry) for the missed opportunities and slow digital transformation of healthcare, convergences should be sought around an obvious common interest: improving patient safety and outcomes.
   
2. At the level of each care setting, the assessment of patient safety priorities is a key point that should not be overlooked. Healthcare professionals should be closely involved in putting the figures into context, identifying patient safety risks, analysing their causes and proposing improvements that meet patients’ needs, the vision of their own work and their wellbeing and safety.
   
3. When an improvement under consideration involves investment in a digital solution, the close involvement of medical teams could be the best guarantee of its use, providing valuable input on essential functionalities, levels of interoperability, adaptability, alarms, navigability or ergonomics.
   
4. The successful implementation of any digital solution is a challenge whose complexity should not be underestimated and which will benefit from increased collaboration between management, healthcare professionals, development companies and patients. Time, proactivity and good project management are the key resources.   

This issue is so important it was made the main theme of the annual European Patient Safety Foundation conference in Madrid in November 2024 with the aim of raising awareness and promoting convergence at a more institutional level. Healthcare professionals and providers, patient representatives, academics, insurance companies, the life sciences industry and policy-makers will be invited to reflect on what each of them do or could do within the increasingly complex healthcare systems, in Spain and across Europe, to accelerate towards a reality where the improvement of patient safety and outcome drive all actions. 

Authors: Stéphane Boulanger (EUPSF), Mirka Cikkelova (EUPSF), Marta Macias Maroto (SECA), María Cruz Martín Delgado (FIDISP), José Joaquín Mira (FISABIO), Inmaculada Mediavilla Herrera (SECA), Santiago Tomas Vecina (FIDISP).

REFERENCES:

^[1] Cikkelova M, Gunther P, Boulanger S. Times of multiple crises: Reasons and ways to keep patient safety on the agenda. Journal of Patient Safety and Risk Management. 2023;28(5):197-200. doi:10.1177/25160435231207191

^[2] State of Health in the EU, Synthesis Report 2023, European Commission (https://health.ec.europa.eu/system/files/2023-12/state_2023_synthesis-report_en.pdf)

^[3] Belmonte, M., Grubanov-Boskovic, S., Natale, F., Conte, A., Belanger, A. and Sabourin, P., Demographic microsimulation of long-term care needs in the European Union, Publications Office of the European Union, Luxembourg, 2023, doi:10.2760/373981, JRC135303.

^[4] 2023 Flagship Technical Support Project, Towards integrated person-centred care (https://reform-support.ec.europa.eu/document/download/1701aafc-f6f8-44f7-8d0d-60eddd7e554b_en?filename=2023%20Flagships%20Techical%20Support%20projects%20-%20integrated%20care.pdf)

^[5] State of Health Preparedness Report 2023, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions (https://health.ec.europa.eu/document/download/804ecd54-5aa1-4644-9d63-60b65b814151_en?filename=security_state-preparedness_report-2023_en.pdf)

^[6] Sujan M, Scott P, Cresswell K. Digital health and patient safety: Technology is not a magic wand. Health Informatics Journal. 2020;26(4):2295-2299. doi:10.1177/1460458219876183

^[7] Gomis-Pastor M, Berdún J, Borrás-Santos A, De Dios López A, Fernández-Montells Rama B, García-Esquirol Ó, Gratacòs M, Ontiveros Rodríguez GD, Pelegrín Cruz R, Real J, Bachs I Ferrer J, Comella A. Clinical Validation of Digital Healthcare Solutions: State of the Art, Challenges and Opportunities. Healthcare (Basel). 2024 May 22;12(11):1057. doi: 10.3390/healthcare12111057. PMID: 38891132; PMCID: PMC11171879.

^[8]   Slawomirski L., Klazinga N. The economics of patient safety: from analysis to action. OECD Health Working Papers No. 145. Paris: Organisation for Economic Co-operation and Development; 2022 (https://one.oecd.org/document/DELSA/HEA/WD/HWP(2022)13/en/pdf)

^[9] Camilleri Podesta, Anne Marie; Redfern, Nancy; Abramovich, Igor; Mellin-Olsen, Jannicke; Oremuš, Krešimir; Kouki, Pinelopi; Guasch, Emilia; Novak-Jankovic, Vesna; Sabelnikovs, Olegs; Bilotta, Federico; Grigoras, Ioana. Fatigue among anaesthesiologists in Europe: Findings from a joint EBA/NASC survey. European Journal of Anaesthesiology 41(1):p 24-33, January 2024. | DOI: 10.1097/EJA.0000000000001923

^[10] Which technologies offer the biggest opportunities to save time in NHS? Alison Moulds, Tim Horton, the Health Foundation (https://www.health.org.uk/publications/long-reads/which-technologies-offer-the-biggest-opportunities-to-save-time-in-the-nhs#:~:text=Our%20survey%20found%20that%20electronic,saving%20staff%20time%20right%20now)

^[11] How would clinicians use time freed up by technology? Alison Moulds, Tim Horton, the Health Foundation (https://www.health.org.uk/publications/long-reads/how-would-clinicians-use-time-freed-up-by-technology)

^[12] State of Health in the EU, Synthesis Report 2023, European Commission (https://health.ec.europa.eu/system/files/2023-12/state_2023_synthesis-report_en.pdf)

^[13] European Biosafety Network (2021) “Mental and Psychosocial Health in Healthcare; Preventing Medication Errors and Adverse Events and Disorders in Healthcare Workers.”

^[14] ASSOCIATIONS OF PHYSICIAN BURNOUT WITH CAREER ENGAGEMENT AND QUALITY OF PATIENT CARE: SYSTEMATIC REVIEW AND META-ANALYSIS, Alexander Hodkinson, et. all, BMJ 2022;378:e070442 | doi: 10.1136/bmj-2022-070442

^[15] Meskó B, Drobni Z, Bényei É, Gergely B, Győrffy Z. Digital health is a cultural transformation of traditional healthcare. Mhealth. 2017;3:38. Published 2017 Sep 14. doi:10.21037/mhealth.2017.08.07

^[16] Pakulska T, Religioni U. Implementation of technology in healthcare entities – barriers and success factors. J Med Econ. 2023;26(1):821-823. doi:10.1080/13696998.2023.2226537

^[17] Smallwood N, Bismark M, Willis K, Burn-out in the health workforce during the COVID-19 pandemic: opportunities for workplace and leadership approaches to improve well-being, BMJ Leader 2023;7:178-181.

^[18] Wu AW. Patient reports of patient safety: An underused technology. Journal of Patient Safety and Risk Management. 2024;29(2):72-73. doi:10.1177/25160435241248869

^[19] Classen, David C. MD, MS*; Lloyd, Robert C. PhD†; Provost, Lloyd PhD†; Griffin, Frances A. RRT, MPA†; Resar, Roger MD†. Development and Evaluation of the Institute for Healthcare Improvement Global Trigger Tool. Journal of Patient Safety 4(3):p 169-177, September 2008. | DOI: 10.1097/PTS.0b013e318183a475

^[20] Borycki EM, Farghali A, Kushniruk AW. Complexity and Health Technology Safety. Stud Health Technol Inform. 2022;295:551-554. doi:10.3233/SHTI220787

The post Enhancing Patient Safety through Digital Innovation: The Missing Links appeared first on EUPSF.

“Europe’s Health workforce crisis is associated with unprecedented levels of fatigue among healthcare professionals, which threatens patient safety and care quality. Yet, the adoption of technologies that could potentially improve this situation has been frustratingly slow,” according to Mirka Cikkelova, General Secretary of the European Patient Safety Foundation EUPSF. What goes wrong in fixing the health system through digitalisation?

What was your path to becoming a patient safety advocate?

It led through various experiences in EuroChild, the European Parliament, and ultimately, the European Society of Anesthesiology and Intensive Care (ESAIC), where I was responsible for coordinating the organization of conferences and managing the scientific programs. This is how I became aware of patient safety and met many different, engaged healthcare professionals striving to bring about change. However, I also witnessed the impact on their own well-being and safety. 

Coming from Slovakia and still having many contacts there, I am aware of many cases of delayed treatments, incorrect diagnoses, and, unfortunately, preventable deaths. Living in Belgium for many years, a country where patient and family involvement and safety measures are more robust, I feel that my family and I are safer as patients. Although there is always room for improvement, numerous necessary patient safety measures are generally better implemented, such as proper patient identification, follow-up after discharge, screenings, and prevention programs. 

My passion for patient safety comes from this contrast and my desire to embrace complexity, understand people’s motivations and behaviors, think differently, and drive high-quality work. Growing up as a scout leader, I still strive to live by a simple principle: “Try and leave this world a little better than you found it.”

Delayed treatments, incorrect diagnoses, preventable deaths – is patient safety at risk in today’s medicine?

It’s no secret that healthcare systems across Europe face multiple crises and challenges. Patient harm is an urgent public health issue, and patient safety is a shared challenge across Europe. Alarmingly, 1 in every 10 patients experiences harm while receiving services in a hospital. As many as 4 in 10 patients are estimated to be harmed while receiving care in primary and ambulatory settings across OECD countries. More than half of these cases of patient harm are preventable.

These numbers have been concerning for a while. Still, two new factors increase patient risks: a shortage of healthcare workers, especially nurses, which the COVID-19 pandemic has exacerbated, and the growing demand for care due to an aging population and the increasing burden of chronic illnesses.

Let’s talk about the shortage of healthcare workers. Due to demographics and the rising prevalence of non-communicable diseases, the demand for healthcare services is rising while the number of healthcare professionals is limited. How can we, in this situation, secure safe, affordable, and accessible healthcare services?

First of all, we must acknowledge that this is no simple task. The complexity of care delivery is increasing due to several factors, including a large number of stakeholders, the use of technology, and the fragmentation of care. Therefore, we need to match this complexity with a nuanced approach, taking into account and understanding the specific contexts and needs of different stakeholders in care delivery—such as healthcare professionals, hospital managers, patients, the life sciences industry, and insurance companies. After carefully considering their contexts and needs, we should seek convergence and rebuild links by identifying shared interests.

This is how we approach the work at the European Patient Safety Foundation—by bringing representatives from all types of stakeholders to the table, discussing and understanding their contexts, problems, and motivations. From our review of various health stakeholders’ priorities, one common driver aligns the actions of all our Affiliates: the improvement of patient safety and outcomes. Therefore, we are convinced that safe, affordable, and accessible healthcare services are possible if we accept patient safety and healthcare professionals’ well-being and safety as guiding principles.

The EUPSF claims that approaches to improving patient safety must embrace the complexity of healthcare systems and the interdependencies between processes, technologies, and the human factor, seeking to produce a sustained positive impact. What role do new technologies play in this regard?

Over the last few years, the potential of technology to transform healthcare systems has become increasingly undeniable, especially from the patient’s perspective. For example, telemedicine and remote monitoring can help manage chronic or post-operative conditions, while artificial intelligence (AI) and big data can help predict risks and personalize treatments. Virtual reality devices can improve the training of healthcare professionals in surgical and emergency procedures, and medication management systems can ensure the safe use of medication at every stage, from prescription to administration.

While it is crucial to stay vigilant about evaluating and validating these technologies to improve patient safety and outcomes, the progress and potential are so significant that one might legitimately wonder whether it is unsafe or unethical not to adopt some of these technological solutions. However, despite many promises, we still see few tangible results: Why do over 1 in 10 patients continue to be harmed during care, with approximately 50% of safety lapses being preventable?

Leading change in such an environment is sensitive and must be handled accordingly. At the same time, it is also an excellent opportunity to redesign tasks, processes, and the roles of individual stakeholders.

Technologies like electronic health records, which give access to patient data, have contributed to better patient outcomes and, paradoxically, to healthcare professionals’ burnout. Doctors are overburdened with administrative work. How can we fix this?

There are many existing technologies with the potential to save time and reduce the burden of administrative work for healthcare workers. However, the uptake and implementation of these technologies have been very slow. 

Among the reasons is the outdated IT infrastructure in hospitals, which is often incompatible with these technologies. The time lost using inefficient technologies, like faxes, also limits the availability of healthcare professionals to implement new technologies that could improve the situation. With many healthcare settings facing staff shortages, there is no time left to invest in such tasks. It’s a vicious cycle, especially since implementing new technologies requires rebuilding entire IT systems and processes in hospitals, which necessitates significant investments of time and resources.

We can only address this issue through collaboration, sharing knowledge and resources, and avoiding repeatedly solving the same problems from scratch in each hospital or country.

Which technology are you most excited about?

It’s not about my perspective—I believe that healthcare professionals are best positioned to identify which technologies align with patient safety priorities in their specific settings. They should be involved in discussions about the potential efficiency gains associated with new technologies and how the time that technology frees up will be used. We must listen to them, especially since their well-being is crucial to ensuring patient safety.

Recent surveys – like the one from The Health Foundation – highlight how freed-up time from technology could be used in various ways beyond increasing care volumes. This could include enhancing the quality of patient consultations, allowing more time for critical thinking, or engaging in broader professional activities like training, research, and quality improvement. 

We should not either forget about the patient’s involvement in this process, as the expected outcome will highly depend on their ability to actively participate in their own care. Their involvement is also crucial to configuring the solution in the best possible way, adapting it to different patient profiles, and addressing issues such as data privacy and quality, digital literacy, security, and lack of trust. 

One of the EUPSF’s campaigns focuses on fighting fatigue. How big is the problem of fatigue among healthcare professionals?

Fatigue affects the well-being and safety of health professionals with greater intensity and on a greater scale than ever before. This is leading to unseen levels of burnout, mental health problems, and people leaving the profession, endangering the continuity and quality of care in Europe. Let’s face it: fatigue is only one of the symptoms of a deep crisis. The working conditions have become increasingly difficult. The limits of what is humanely reasonable to expect from health workers have been crossed. And the COVID-19 pandemic has just made things worse! We are all concerned.

Fatigue is not just a physical burden; it impacts healthcare professionals’ daily professional and personal lives, affects their morale, and endangers their and their patients’ lives. In the long term, fatigue can lead to burnout and mental health problems, which have reached unprecedented levels in European healthcare. 

Physicians experiencing burnout are twice as likely to be involved in patient safety incidents, show low professionalism, and are over twice as likely to receive low satisfaction ratings from patients. The most obvious danger is to their patients, but fatigue can also lead to accidents on the way home when they risk falling asleep at the wheel. 

As Dr. Hans Henri P. Kluge, WHO Regional Director for Europe, stated: “The health workforce crisis in Europe is no longer a looming threat—it is here and now. Health providers and workers across our region are clamoring for help and support.” 

Together with all supporters of our collaborative campaign, we are convinced that no improvement and resilience can be achieved for healthcare in Europe if we don’t start by addressing the basic physical and psychological needs of healthcare professionals and improving their well-being and safety.

The so-called “iron triangle” of healthcare consists of cost, access, and quality. Trade-offs are necessary, which means that when we improve one or two elements, the third one will be affected. If we want to maximize quality and access, costs will also rise. Is there an out-of-the-box solution for this problem?

The solution is simple but not attractive in our current society: we must stop bingeing on short-termism and believing there is a quick fix for complex problems. Many existing studies suggest that consistent investment in quality, patient safety, and prevention could lead to significant cost savings, especially by eliminating many preventable errors, rehospitalizations, infections, etc. 

We know exactly what needs to be done. It just goes against the grain of our society of immediacy and the market that meets all our needs in real time.

Most healthcare systems are built around paying for the quantity of health services provided, not the outcomes and quality. Is it possible to maximize patient safety in such an environment, or should we strive to change how our health systems work?

In these times of multiple crises, any project or work that does not question the existing way of working or strive for a change in processes is just delaying the problem or, potentially, even making it worse. We should use the opportunities that new technologies and innovations offer to reinvent healthcare systems. In the meantime, the lack of quality affects the health of society as a whole and comes at a huge cost.

How do you envision the future of healthcare?

I don’t have a crystal ball, and I do not think that the future of healthcare is written yet. It will be shaped by us as a society. I hope we will collectively have the wisdom to remember that health is intrinsically linked to the quality of our environment and living conditions. And that we will let our actions be guided not by personal interests but by the goal of improving our shared well-being. The focus should always be on the common good: health.

Regarding digital innovation, we must remain vigilant about evaluating and validating new technologies with a view to improving patient safety and outcomes. We should never forget that technologies are just tools that must be designed, implemented, and used in a way that genuinely supports healthcare professionals in providing better and safer care to their patients.

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Gunther P (2023) Prioritising Patient Safety and Combatting Fatigue in Healthcare. HealthManagement.org The Journal. 23(6):414-417.

We are thankful to the Editorial Board of the HealthManagement.org for an excellent collaboration and support with promotion of our conference.

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Prof. Reinhard Strametz holds the chair for patient safety at RheinMain University in Wiesbaden/Germany. Before that, he worked as an anesthesiologist at Frankfurt University Hospital and was Chief Quality Officer of this hospital. For over than twenty years, as both a doctor and an economist, he has been interested in aspects of quality and clinical risk management and today has the honor of heading the Wiesbaden Institute for Healthcare Economics and Patient Safety (WiHelP).

Why does Patient Safety and, more specifically, the topic “Leadership, team and organisational performance” personally matter to you?

Over the last two decades, we have learned a lot about tools for mitigating clinical risks, especially in hospital care. But sometimes these tools work well in one place and fail miserably in many others. The main reason for this is not the way in which they have been used, but because some medical facilities do not have a sufficient safety culture. In addition, secure communication and sufficient team performance will play a key role in the successful implementation of patient safety measures. But what is the basis for this to happen?

Initially, we talked about the “error culture” that needed to be improved, but today we focus more on concepts of High-Reliability Organisations and Safety Culture. The latter can be seen as the goal of our efforts, but to some extent it is also a prerequisite for the success of our efforts, the fertilizer, so to speak, for the still tender seedling of patient safety in many organisations.

And who will create the culture? Whose responsibility is it to ensure that an appropriate safety culture takes root in facilities? That’s right, it’s the job of the leaders. It’s one of the most important and noblest duties of healthcare leaders. 

What exactly is “second victim support”? Do you know of any examples of such support systems in the field? What is your experience in this area?

A Second Victim can be defined as any health care worker who is directly or indirectly involved in an unanticipated adverse patient event, an unintentional healthcare error, or a patient injury and who becomes a victim in the sense that he or she also suffers negative consequences.

This is a genuine human reaction and evidence shows that the majority of health care workers are already second victims. The problem with this human reaction is that, without proper support, it will lead to dysfunctional coping strategies like self-stigmatisation, loss of self-confidence, substance abuse or the practice of defensive medicine. Worse still, those affected might develop serious mental health conditions such as post-traumatic stress disorder (PTSD) or depression. This is a serious hazard to health worker safety but also to patient safety as the likelihood of making (additional) mistakes increases dramatically. Without sufficient and timely support, this can become a vicious circle.

On the other hand, we know that particularly early support during the experience of the second victim phenomenon is very likely to lead to complete recovery or even fulfilment. We have to acknowledge that the treatment of PTSD is very effective, but only at an early stage of this condition. As the second victim phenomenon is clearly linked to occupational circumstances and therefore consitutes an occupational hazard, programs to support second victims should be implemented as part of health promotion and prevention programs in. the workplace in any healthcare institution.

There are a few flagship projects in Europe, such as KoHi in Vienna/Austria, MISE in Spain or PSU-Helpline in Germany, but we are still miles away from a comprehensive solution in all healthcare institutions in Europe, such as the one already implemented for needle-stick injuries, for example.

Is this an easy subject to tackle in the field? Doesn’t it run against the culture of the super-carer, who deals with every situation?

That is a very valid point. During our research, we identified three major barriers to overcome, which lie within ourselves. 

Firstly, we are trained to be the healthiest, to be heroic and to cope with every situation. But sooner or later we will find out that beyond sleep deprivation, loss of social contacts outside our healthcare institution and, of course a considerable amount of resilience, we  remain human beings with natural limits. 

To overcome these inhibitions, the peer support by colleagues has proved very effective. It would be more difficult to admit, as a “bulletproof” doctor, that I need the help from a psychologist. Another advantage is that my colleague also knows my situation very well and probably may have experienced a similar one him- or herself.

The second barrier is related to our training to be confident and to show confidence to our patients. The risk of being overconfident is inherent. We hypothesised that a significant proportion of medical doctors and nurses who are overconfident in their ability to adapt would underestimate the risk of becoming second victims and, unfortunately, we were able to confirm this.A third barrier is also related to our socialisation. When asked about their knowledge on the Second Victim Phenomenon before assessing their own symptom load, only a minority of doctors and nurses had ever heard of it, which may explain the self-stigma, which can also be seen as a potential barrier to accepting help, as they might feel they do not deserve support. This phenomenon and evidence-based ways to prevent or mitigate its potential effects should therefore be taught as part of our basic medical education.

What are the advantages of such support systems?

Besides acute care provided to second victims, implementing such programs will also increase the psychological safety of staff, which is a cornerstone of effective teamwork and mitigation of clinical risks.

Implementing such programs is therefore a triple win: Firstly, healthcare workers will benefit from increased psychological safety as well as sufficient primary and secondary prevention. Secondly, our patients will benefit from a reduced risk of errors leading to harmful preventable adverse events, which, according to numerous OECD reports, will also save huge amounts of money. Thirdly, the healthcare organisation will benefit from reduced staff turnover, which in our economic simulations also pays off very well.

Implementing such programs should therefore be considered as a no-brainer as they can improve the  quality of care while reducing costs, with a high return on investment. 

What are the key points to bear in mind when implementing them?

Support programs, like any implementation in healthcare, need to be evidence-based, contextualised and facilitated, for example by honest communication about the issue and explicit leadership. If our role-models admit that this is a serious problem that sooner or later will affect everyone in the business, they will be able to overcome the taboo, that still exists in many institutions. 

Successful programs will include both peer support of trained and sensitized colleagues and professional support that will be available in a timely manner. But apart from treatment of second victims, those programs should start before in creating psychological safety by creating a safety culture in which self-care is not regarded as selfishness but as an expression of professionalism.

We should always remember what is said in the World Medical Association Declaration of Geneva: “I WILL ATTEND TO my own health, well-being, and abilities in order to provide care of the highest standard… I MAKE THESE PROMISES solemnly, freely, and upon my honour”

Do you see a link between the widespread implementation of support programs and any general issues or crises that could affect healthcare systems and patient safety?

The greatest challenge facing healthcare systems around the world is maintaining their capacity in terms of staff. We are in the midst of a huge staffing crisis, seeing many trained healthcare workers to either leave their countries to make up for shortages elsewhere or to even drop out of the healthcare system.

By creating a culture of safety and support, we can fight this crisis, which will otherwise lead to the collapse of healthcare systems in the near future. It is not about bringing more and more people into our healthcare systems and burning them out, but about keeping those who are already in the system healthy and safe. Because if we don´t care for them now, they won´t care for us in the future. 

Prof. Dr. Reinhard Strametz
Wiesbaden Institute for Healthcare Economics and Patient Safety (Germany)
LEADERSHIP, TEAM AND ORGANIZATIONAL PERFORMANCE  
Why and how to design a safety-oriented organization?  

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Andrea Rappagliosi is currently Senior Vice-President Public Affairs EMEA, Canada and LATAM at Edwards Lifesciences, after holding various international positions in the healthcare industry. In 2022, Andrea joined the European Patient Safety Foundation as a Board Member. 

Edwards Lifesciences has supported the Fighting Fatigue Together campaign since the very beginning. Why is this campaign important to you?

Patient safety is our foremost priority, driven by our mission  of transforming patients life by  enhancing patient outcomes. Health worker safety and patient safety are intrinsically interconnected. Human factors, such as fatigue, poor working conditions and staff shortages, can culminate in diminished patient satisfaction, compromised care quality, medical errors, and substantial costs for both caregivers and healthcare systems. Hence, ensuring the well-being of healthcare workers is imperative to achieving safe and favourable patient outcomes. This can be only achieved by combining the fast adoption of technological innovation with the setting of innovative integrated process from diagnosis to treatment and cure, able to transform and elevate the standard of care by reducing the burden on healthcare workers and healthcare system at large.

The increasing workload and the shortage of staff that hit Europe over the past few years have led to an extremely high and worrying level of fatigue among healthcare workers in Europe. The largest German health insurance association AOK, has found among its insured members that, sickness related to burnout among carers caused an average of 28.2 days of incapacity for work per 100 AOK members – almost twice more than in other professions with 14.2 days^[1]! In the Netherlands a recent study shows that with the ageing of the population and the rise in chronic disease, the demand in healthcare will keep growing and by 2040, 1 out of 4 workers will have to be a healthcare worker in order to meet the demand^[2]. This is concerning when we know that 40% of medical doctors are close to retirement age in one third of countries in Europe^[3]. As indicated by WHO Europe we are facing a ticking bomb: the healthcare workforce crisis.

The Fighting Fatigue Together campaign is critical to raise awareness of the state of fatigue among healthcare workers and its impact on patient safety and outcomes. This campaign is the first of its kind in Europe. 

I strongly believe EUPSF can play a pivotal role in coordinating this pan-European effort to enhance patient safety and outcomes in Europe. It is crucial to have more industry members, hospital providers, patient safety stakeholders and policy makers joining forces and supporting the campaign. Only by working together can we tackle healthcare workers fatigue, improve patient safety and outcomes, and build the resilience of healthcare systems in Europe.

New technologies open new prospects for improving patient outcomes and safety. But, on the other hand, they require healthcare workers to adapt their knowledge and practices up to date and to be ever more responsive. What could be done to ensure that medical innovation actually achieves its objective and doesn’t become just another source of fatigue?

In this current environment, all stakeholders have a role to play in improving patient safety and outcomes. 

First, the industry has the responsibility to develop innovations at the service of patients, health professionals, but also supporting the efficiency and sustainability of our healthcare system. Innovation is no longer an option, but a necessity to meet the challenges of our health system and initiate a real transformation under the 4 Ps framework: for a more preventive, predictive, personalised, participatory and evidence-based medicine. 

Second, healthcare systems are not currently designed to embrace these innovations and exploit their full potential. They need to urgently prioritise and accelerate the adoption of these innovative technologies or processes which increase hospital efficiencies, optimise hospitals capacity and improve quality of care, therefore reducing the burden on healthcare workers. 

Third, patients should be better informed and empowered in their treatment journey. They should have the right to be consulted and participate in the decision making in all aspects of their treatment to ensure the best outcomes. Well informed and motivated patients can have a significant impact on their own safety.

But couldn’t the industries, which are less caught up in the continuous flow of care to be provided, step in and make things easier for the hospitals?

The industry certainly has a role to play in developing innovations and designing processes leading to hospital efficiencies and resources optimisation. Innovations, such as digital technologies for predictive medicines based on AI-derived algorithms or technologies and devices which make minimally invasive procedures feasible, have showcased their potential to yield significant advantages for patients in terms of clinical outcomes and resource efficiency. Additionally, they can allow automating tasks, offer decision support, reduce hospital length of stay, ultimately reducing the pressure on healthcare systems.

Mr. Andrea Rappagliosi
Edwards Lifesciences (Switzerland)
WELLBEING AND SAFETY OF THE HEALTHCARE WORKERS
Panel discussion, “Fighting Fatigue Together – Collaborating across Europe”

^[1] AOK-Studie: Erhöhtes Risiko für Burn-out bei Pflegekräften (aerztezeitung.de), 2022

^[2] Gupta – Prevent the next wave – Why labour-saving innovations are needed in healthcare and how an innovative ecosystem enables progression

^[3] Ticking timebomb: Without immediate action, health and care workforce gaps in the European Region could spell disaster (who.int)

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As representatives of the European Patient Safety Foundation, the authors wish to share with the wider patient safety community some current perspectives from across Europe. As the title suggests, in their view, the healthcare systems are dominated by the reality of having to deal with what are seen as multiple crises at the same time, and somehow keep patient safety on the agenda and come up with strategies and initiatives to make improvements. The situation is made even more complex by the fact that these crises take an additional toll on those responsible for delivering safe care, healthcare staff themselves, who already have to cope with difficult working conditions in normal times.

We are thankful to the Editorial Board of the Journal of Patient Safety and Risk Management for an excellent collaboration and support with promotion of our conference.

Visit Journal’s homepage

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Dr. Irene Grossmann works at the Delft University of Technology (Netherlands), as assistant professor at the  Centre for Safety in Healthcare at the Delft University of Technology. She is co-founder and co-lead of the Institute for Health Systems Science at the same university. Besides her academic work she holds a clinical position as a surgeon, previously working as a surgical oncologist and on the intensive care, currently working part-time at the Emergency Care Department.

Why does patient safety matter to you? 

For me, patient safety is an integral part of my professional responsibility. During my career, both in research and in clinical practice, I have encountered several situations that have left me wondering whether we do the right things and do things right. These situations made me raise questions. For example, I designed and collected data in a prospective database of colorectal cancer patients. As we needed an unselected cohort, we included all patients within a specific time frame (2007-2011). My data turned out to be rather different from those in the literature, in terms of patient characteristics and outcomes. One of our observations was an unexpectedly high mortality of patients undergoing right hemicolectomy. When I raised this issue, I was met, next to recognition, also with resistance and denial. I was repeatedly told: “That doesn’t happen in our hospital”. Our local results were later found to be the same as the national results. So, why the resistance? For us it was just a sign that we needed to look at the causes, but that feeling was clearly not always shared.

Why are you focusing, in your work, on the question of the implementation?

Because there is a huge gap between the knowledge and know-how already available, and what is known and applied in the medical domain. When I started in my position at the TU Delft two years ago, I obviously had some ideas, since I had applied for the position, but honestly, I had no clue yet how extensive the knowledge in safety sciences was. It just does not reach healthcare somehow. After a year or so, I also realised that there is no need to develop anything new in the areas of change management, quality improvement strategies or the creation of learning organisations, as it is already all there. Instead, we need an idea how to propel this knowledge into the health and care sector. I chose to focus on what medical professionals need to embrace knowledge that they are mostly unfamiliar with, such as engineering – and systems science.

How can we achieve results in terms of patient safety, especially in times of crisis?

Well, our vision is that especially in times of crisis safety should be addressed. Safety is an outcome of well-functioning systems; the better the systems function, the lower the waste and the higher the quality and safety. This is not just a theory; it has been proven in other domains and it is a key statement from both the OECD and the WHO. It requires leadership and, in my professional opinion, a systems perspective to understand the mechanisms of failure and the changes that are needed to address these. Quality improvement also is a continuous and never-ending process. Projects on safety in healthcare are often not imbedded in the organisation but merely temporary add-ons. To achieve sustained safety improvements, safety must be part of the daily routine, infrastructure and, ultimately, workplace culture. This can be done, but it must be a priority. Safety is not just a task for individual healthcare professionals to signal and resolve; for a large part, safety can be organised. This means that the leadership must take responsibility for doing precisely that.

Dr. Irene Grossmann
TU Delft Centre for Safety in Healthcare (The Netherlands)
CHALLENGES OF IMPLEMENTATION
Tools and recommendations for implementing patient safety practices

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Why does the wellbeing and safety of the healthcare workers personally matter to you?

The more I worked with trainees and in different multi-professional clinical teams, the more I realised that we deliver better care to patients when our workload is realistic, and people feel respected and valued as individuals. If the staff are looked after, they deliver safer and kinder service to patients.  

In recent years, as the complexity of patient care has increased, and patients have rightly expected higher standards of care, more interest has been paid to the importance of the wellbeing of healthcare staff.  We all want to be cared for by people who enjoy their jobs, who work in good teams and who have the resources to deliver the best care.

At a certain point in your career, you decided to take up the fight against healthcare professional fatigue. Why?

Over time, I began to see more and more signs that the level of fatigue among the medical staff was increasing in a worrying way. And in 2017, the untimely death of a trainee in a car accident driving home tired after a night shift convinced me we needed to take action to address staff fatigue. 

Together with a group of trainees and consultants and with the support of the Association of Anaesthetists, Royal College of Anaesthetists and Faculty of Intensive Care Medicine in the UK, we established a joint working group on fatigue.  We organised a survey and found that 57% of trainees and 45% of consultants had had an accident or a near miss driving home tired, and many had no rest facilities at work. We clearly had a problem.

As a medical professional, how would you describe your experience with fatigue?

When I was a trainee, fatigue was regarded as an occupational hazard; we were expected to cope and working long hours was regarded as a badge of honour.  We had almost no understanding of why we need to sleep and the impacts of sleep deprivation on us and on our clinical performance.  However, we did have on call rooms and rest facilities.  

Over the last 30 years, working hours have been cut by half as doctors expected a better work-life balance.  But work has become more complex, more stressful and patients rightly expect more involvement in their treatment.  Many trainee doctors work 12-hour night shifts and no longer have an on call room to sleep in.

From a professional point of view, this is obviously problematic, as fatigue affects how we think and behave in ways we may not notice; how we assess risk, make decisions, perform complex tasks, interact with colleagues, and manage our emotions. Attention, memory, response times, vigilance, hand-eye coordination, arithmetic ability and impulsivity are all affected.  

In a few words, what will you be focusing on at the conference?

I would like to explain what we’ve been able to do in the UK to try and change the approach to fatigue – both culturally and practically – in hospitals and at a political level, with the aim of making it easier for people who are interested in the problem to take action elsewhere in Europe.

Because I believe that the fatigue of healthcare professionals knows no borders. In many European countries, there are shortages of many healthcare professionals: nurses, doctors, radiographers, pharmacists, etc. Patient demand is increasing with an older, less healthy population, so healthcare professionals do their best to keep the service going, working harder to cover gaps. Naturally this takes its toll and people end up getting used to chronically shorter sleep and don’t recognise its impact on their wellbeing. Where people work in challenging and unsupportive environments, this can even lead to burnout. Much needs to be done, and I think that a European network such as the Fighting Fatigue Together, which I have joined, can help to tackle this issue more effectively across Europe. 

Finally, I’d like to open the discussion to what I consider to be an essential topic: the management of fatigue as a risk in the medical sector. All other safety-critical sectors are required by law to manage staff fatigue effectively as part of their overall safety structures. Healthcare workers have the same physiology as airline pilots and nuclear workers, so the medical sector should have the same regulatory framework. Good fatigue risk management could improve staff and patient safety, staff morale and staff retention.

Dr Nancy Redfern
EUPSF Advisory Board Member
Co-chair of the Joint Fatigue Group (UK)
WELL-BEING AND SAFETY OF THE HEALTHCARE WORKERS
Fighting Fatigue Together – Collaborating across Europe

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She holds a Diploma in Critical Care Nursing from Queensland University of Technology, Brisbane, Australia, and a PhD in Patient Safety from the University of Bergen, Norway.

Why does Patient Safety and, more specifically, the topic “Patient involvement” personally matter to you? 

Involving patients in their own safety is essential to better prevent harm to patients in healthcare, and I think we need to go further today, with more innovative and targeted patient involvement initiatives. Sometimes we don’t realise how powerful this involvement can be, in terms of changing working practices and improving the quality of care.

As an example, I’ll take the tool I’m currently working on, which are safety checklists specific to surgical patients. In fact, the idea came from a patient representative. After listening to a presentation by Professor Arvid Steinar Haugen on surgical safety checklists in 2012, he asked the following question: “What about us, the patients? Don’t we need a surgical safety checklist too»? So in 2016, the work on such a checklist began in our hospital and, right now, we are conducting a clinical trial on the effect and implementation of such a checklist.

What are exactly patient-owned checklists? What can be said about their impact?

The Surgical Patients own Safety Checklist (PASC) is designed to systemize the most crucial patient information before surgery and at discharge from hospital. It helps patients to be more aware of what actions they can take to prepare for surgery and which information they need throughout the surgical pathway. 

Preliminary results from our ongoing clinical trial on the impact and implementation of the PASC are positive from the perspective of both patients and healthcare professionals. Patients indicate that the PASC helps them better control important information and encourages them to ask questions when information is unclear or missing. For their part, healthcare professionals indicate that surgical patients who use the checklist are better informed and more involved in their safety throughout the surgical process.

Don’t you think this kind of tool can lead to tensions, with healthcare professionals feeling under the surveillance of patients? Or to a shift in responsibility for the quality of care from the healthcare professional to the patient?

It is important to specify that the PASC is developed with patients, patient representatives and an interdisciplinary healthcare team, with the aim of meeting the needs of each party.

So far, we have not experienced any negativity from healthcare professionals regarding the use of PASC. And after talking to the patients regarding the issue of the responsibility, they say that they rather receive the checklist than not, and that it makes them feel more in control of their own situation. 

What else are you going to tell at the conference?

I’d like to detail the key elements in the implementation of the PASC, so that it can be reused in other countries and healthcare settings because the benefits with the PASC are many.

For example, we all know that there is a constant shortage of healthcare professionals, which has a major impact on patient safety. Healthcare professionals are overworked, fatigued and under constant pressure to perform ever more tasks or procedures. The use of patient-specific checklists cannot solve this problem, but it can act as a systemic barrier that allows patients to prepare for surgery and request clarification or missing information.

Dr Kristin Harris
University Hospital, Bergen, Norway
PATIENT INVOLVEMENT SESSION
Surgical Patients’ owned Safety Checklist (PASC), best practice example from Norway

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