Patient safety and quality of care: EURHOBOP and EUROTRACS

Patient safety and quality of care has become a major political issue in the European policy makers’ agenda. The EURHOBOP and EUROTRACS projects are actions implemented by the EC to achieve the objective of the Health Programme 2008–2013

Pascal Garel 

Chief Executive

Isabella Notarangelo

Health Economist

HOPE, the European Hospital and Healthcare Federation

Patient safety and quality of care has become a major political issue on the European policy makers’ agenda since the early 2000s. It represents one of the most important factors of how individuals perceive their overall quality of life. Patients want to exercise their right to choose how and with whom they engage for their healthcare. Furthermore, they are increasingly becoming stakeholders in their own care journey and they want to know more about the access to care as well as about the quality of services. Governments, health authorities and institutions are challenged to provide additional information on these issues and to encourage providers to publish data and indicators. The trend contributed to make patients more conscious and to raise their expectations on the level of care. Consequently, policy makers and healthcare professionals are more aware of the fact that quality and patient safety are top priorities both at the national and hospital level.

Actions on patient safety and quality of care are part of a broader strategy implemented by the European Commission to achieve the objectives of the Health Programme 2008–2013. Relevant initiatives were put in place by Member States, institutions, stakeholders and organisations to improve European healthcare systems and to develop recommendations to European and national policy makers. The EURHOBOP and EUROTRACS projects, of which HOPE is a partner, fall into this category. 

EURHOBOP

The project

EURHOBOP (EURopean HOspital Benchmarking by Outcomes in acute coronary syndrome Processes) is a project co-funded by the European Commission’s Executive Agency for Health and Consumers in the frame of the Health Programme 2008–2013. Completed in summer 2012, it was based on the results obtained in the EUPHORIC (www.euphoric-project.eu) pilot study, which defined a set of in-hospital indicators determining the quality of care in acute coronary syndrome patients. The general objective of EURHOBOP is to promote the reduction of health inequalities as well as the dissemination of information related to cardiovascular and coronary artery disorders. The Municipal Institute of Health Assistance – Municipal Institute of Medical Research (IMAS-IMIM) in Spain led the project and involved eight institutions from seven European countries (Belgium, Finland, France, Germany, Greece, Italy and Portugal).

The information used to produce the mathematical models was gathered from 70 hospitals, from the organisations participating to the project and from the French database “Programme de médicalisation des systems d’information”. Data provided by each partner involved 200 consecutive individual patients with a discharge diagnosis of myocardial infarction or unstable angina  (retrospectively recruited) and contributed to the validation process of the functions developed by the EUPHORIC project. The standardisation of in-hospital case fatality measurement offered European hospitals the opportunity to self-benchmark and to obtain objective information on their performances in terms of quality of care provided in coronary angiography and percutaneous interventions as well as myocardial infarction general management.

The benchmarking functions are available on the project website (www.eurhobop.eu) in total confidentiality: the analysis entering summarised patient characteristics and some features of the hospital interested and the country where the hospital is, is necessary. Besides the benchmarking, EURHOBOP has also investigated the costs associated with the management of acute coronary syndrome patients and the role of gender in the access to optimal care. One of the major results of the project was its ability in enrolling new partners: these organisations contributed to the project development on a voluntary basis.

The scientific contribution

EURHOBOP partners contributed to the publication of studies in relevant European journals of cardiology, with the aim of analysing in-depth scientific issues linked with arguments debated in the project as well as producing and sharing knowledge. The evidence that emerged in the following articles helped to reach the expected results of the project, such as the benchmarking of hospital performance and of the management of specific cardiovascular diseases.  

In one of the first articles,1  the Faculty of Medicine of the University of Porto, led by Anna Azavedo, published the context of EURHOBOP in June 2013 in the European Journal of Preventive Cardiology. Its aim consisted of analysing age and sex inequalities in the prescription of evidence-based pharmacological therapy following an acute coronary syndrome (ACS) event in Portugal. Authors studied 747 episodes of ST-segment elevation myocardial infarction (STEMI) and 1364 of non-ST-segment elevation acute coronary syndrome (NSTE-ACS), within a sample of acute coronary syndrome cases consecutively discharged from 10 Portuguese hospitals in 2008–2009. Results showed that sex had no significant effect on treatment prescription. Regarding the age, the recommended therapies were substantially under-prescribed in older patients. Overall, the vast majority of patients were discharged on evidence-based secondary preventive medications, but only half received a five-drug combination.

In May 2014, the Research and Prevention on Cardiovascular Diseases group of Toulouse, led by Jean Ferrières in cooperation with EURHOBOP working group, published the results of a specific study conducted on the EURHOBOP population-based longitudinal cohort in the journal Heart.2  The objective was to describe the current characteristics of patients admitted to hospital for acute coronary syndrome (ACS) in Western Europe and to analyse whether international in-hospital mortality variations are explained by differences in patient baseline characteristics and in clinical management. 

The study included 12,231 consecutive acute coronary syndrome patients admitted between 2008 and 2010 in 53 hospitals from Finland, France, Germany, Greece, Portugal and Spain. It showed that in-hospital mortality rates of ST-segment elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) patients were two to three times higher in Finland, Germany and Portugal than in Greece and Spain, with intermediate values for France. Differences in baseline characteristics and in clinical management partly explain the differences in outcome. In-hospital acute coronary syndrome mortality is highly impacted by differences in pre-hospital patient management that is directly related to healthcare system organisation. Several key messages emerged from the article. Despite improvements, there are still differences between countries in ACS patient presentations and in their clinical management.

These led to significant variations in ACS in-hospital mortality, which was paradoxically higher in Northern European countries. Thus, these results highlighted the heterogeneity in ACS management that persists between countries and the consequent necessity of taking pre-hospital mortality into account in further studies on the efficiency of healthcare systems. 

Finally, REGICOR Study Group, Cardiovascular Epidemiology and Genetics Group and IMIM – Hospital del Mar Medical Research Institute (Barcelona, Spain), coordinator of the EURHOBOP project, published an article  at the beginning of 2015 in the International Journal of Cardiology.3 The study is aimed to explain the benchmarking system developed in the EURHOBOP project with the purpose of assessing patient management in acute myocardial infarction (AMI) and percutaneous coronary intervention (PCI). The method used consisted of comparing in-hospital mortality rate among hospitals with similar characteristics and similar patient profiles. For the first time in Europe it was possible to assess hospital performances in this sense. 

Previously, such a system was only available in the US or in single European countries. Professionals can easily proceed with the comparison when data on patients affected by acute coronary syndrome is available. It is also necessary to take into account further variables such as indicators related to the country as well as figures on the hospital and patients. The model was conceived and developed in its first version as a result of the pilot phase of the EUPHORIC project (www.euphoric-project.eu) and further finalised in the EURHOBOP project, with a cohort of 15,170 acute coronary syndrome patients. Then, information was externally validated with a cohort of 55,955 European acute coronary syndrome patients, showing good discrimination at patient level and acceptable accuracy at hospital level. 

Dissemination 

EURHOBOP partners disseminated results that emerged from the project to their own networks. One of the most valuable pieces of evidence was the fact that many healthcare organisations and hospitals decided to contribute to the project voluntarily. This trend underlines the will to know more about the benchmarking of results and hospital performance management related to cardiovascular diseases at the European level. Furthermore, EURHOBOP highlighted that the comparison of hospital performances is a tool to enhance patient safety and quality of care. For this reason, it was one of the eleven European projects selected by the European Commission to be presented during the Promoting Patient Safety and Quality of Care: The EU contribution to national action meeting organised by Consumers, Health and Food Executive Agency (CHAFEA) in Rome on 2–3 December 2014. The event fell under the auspices of the Italian Presidency of the Council of the European Union with the support of Università Cattolica del Sacro Cuore – Facoltà di Medicina e Chirurgia as part of a broader strategy of the European Commission to support the dissemination of results of the EU Health Programme 2008–2013. The first day was divided into two sessions, chaired respectively by Directorate General for Health and Food Safety (DG SANTE) and Haute Autorité de Santé (HAS), focusing on improving patient safety in hospital settings and promoting quality of care across the health system.

EURHOBOP results in terms of quality of care in coronary heart disease management were presented in this context by Jaume Marrugat De La Iglesia, the coordinator of the project, on behalf of IMIM – Hospital del Mar Medical Research Institute (Spain). The day after, the debate was mainly based on the current policy agenda and on the challenges and opportunities for future collaboration at the European level. Sessions were chaired by the European Observatory on Health Systems and Policies and by the Directorate General for Health and Food Safety (DG SANTE) and hosted speakers of European and national organisations or institutions from Belgium, Croatia, Denmark, France, Italy, Sweden and the Netherlands. The event brought together stakeholders, institutional actors and media interested to the topic at all levels. Within the guests, several journalists were invited in order to raise awareness of results and impact of EU actions to a wider audience.

EUROTRACS – European Treatment and reduction of acute cornary syndrome

The project

EUROTRACS is a project funded by the European Commission Directorate-General Health and Food Safety (DG SANTE) aimed at contributing to the main objective of the EU Health Programme 2008–2013: to promote health, including the reduction of health inequalities. EUROTRACS, started in June 2013 and due to end in May 2015, is coordinated by IMIM, Hospital del Mar Medical Research Institute (Spain), with partners coming from Belgium, France, Germany, Greece, Italy, Portugal and Israel. The team uses the same database as the one for collecting information in the EURHOBOP project. The goal consists of examining the cost effectiveness of integrated approaches to chronic disease prevention with a particular focus on diabetes, cardiovascular and respiratory diseases. Although the project is still running, important outcomes were already reached by February 2015. Partners worked together on estimates of the coronary artery disease (CAD) and in-hospital mortality in acute coronary syndrome (ACS) patients for each participating country. The results of these studies helped to finalise two deliverables of the project (D03-00 and D04-00), which are explained in more detail in the following paragraphs.

The main results

The main objective of EUROTRACS is to define a utility analysis (cost effectiveness analysis) in terms of cost per quality-adjusted life year (QALY) in two scenarios:

• Reducing smoking, dyslipidaemia and hypertension population prevalence by means of population interventions designed to prevent coronary artery disease incidence;
• Optimising the use of coronary angiography and percutaneous intervention procedures in the management of patients affected by acute coronary syndrome with special emphasis on people older than 64 years. The ratio is to minimise the inequalities in this patient subgroup characterised by higher mortality rates compared to patients younger than 65 years.

To perform the cost effectiveness analysis described in the first scenario, a mathematical model was set up to estimate the number of coronary events that will occur in a given population within 10 years, using incidence projection methods. To build the mathematical model, each participating country was requested to provide data regarding their coronary artery disease (CAD) incidence rates for the population aged 35–74 years; projections of population in 2015 and 2025 and cardiovascular risk factors prevalence (diabetes, smoking, blood pressure and total cholesterol distributions) in 2000–2010. Information was made available by gender. The output of the model covers the period 2005–2025 and foresees for each participating country, different paths considering three kinds of situation:

• 10% total cholesterol reduction both in men and in women
• 10% reduction in hypertension in both men and women
• 10% reduction in smoking in both men and women

Furthermore, the model works on the trend that the number of cases and the prevented cases would have if a 10% reduction is applied to one of the considered variables: total cholesterol, hypertension or smoking. In all the countries, the most effective intervention for men is the reduction of smoking followed by the reduction of total cholesterol and then hypertension. For women, reduction of hypertension represents the most effective intervention, followed by smoking and total cholesterol. It is possible to use the model when the three factors are combined. The table above shows the comparison of the figures resulting from the application of this model.

To implement the cost–utility analyses described in the second scenario, in-hospital mortality for acute coronary syndrome (ACS) in each participating country was estimated for people included in different age groups (35–64, 65–74, 75–84 and ≥85 years). Information was collected in a database accounting for 85,308 patients. A further element considered in the research was the distinction between STEACS and NSTEACS acute coronary syndrome. The first acronym refers to an acute coronary syndrome heart attack that can occur with electrographic signs called ST elevation. The second one corresponds to an acute coronary syndrome heart attack occurring with non-ST elevation electrographic signs. 

Results showed that 36% of people whose data is listed in the database had a STEACS event, 48% had a NSTEACS event, 7% had a non-classifiable acute coronary syndrome and for the remaining 9% the information for acute coronary syndrome was not available. 

In all the countries considered, the analyses showed a significant decrease in in-hospital mortality when patients had undergone percutaneous coronary intervention. When patients were stratified by age, sex and diagnosis, the decrease was statistically significant in:

• Men, if aged 35–64 years, in the following countries: Germany, Italy and Spain. If aged 65 and older, in Germany, Greece, Italy, Portugal and Spain;
• Women, if aged 35–64 years in Germany only and if aged 65 and older in Germany, Greece, Italy, Portugal and Spain. 

Partners are working together to develop a predictive internet-based model aimed to interactively analyse the 10-year coronary artery disease (CAD) event incidence, obtained by modifying the population prevalence of the targeted risk factors (smoking, cholesterol, hypertension). Decreasing coronary artery disease (CAD) morbidity and mortality in the most cost efficient manner is a public health priority at European and national levels. Moreover, identification of acute coronary syndrome (ACS) procedures associated with the minimum in-hospital mortality, represents an urgent requirement in order to update current guidelines, especially regarding the elderly.

Finally, evidence from the EUROTRACS project will try to influence EU policy makers to design national and international public health actions with the scope of increasing quality of life and longevity. The idea is that obtaining 10-year estimates of coronary artery disease (CAD) mortality and associated costs will allow a more rational allocation of health resources in the European countries. EUROTRACS will produce useful results for the society by contributing to reduce coronary artery disease (CAD) and acute coronary syndrome (ACS) morbidity, mortality and cost and age-dependent inequalities in acute coronary syndrome (ACS) in-hospital treatment.

The scientific contribution

EUROTRACS consortium committed itself to produce scientific results that contributed to reach the final goal of the project, described more in detail in the paragraph above. The first article  was published by the Cardiovascular Research Group of IMIM in the Journal of Epidemiology and Community Health in March 2014.4 The content describes a mathematical system, as known as CASSANDRA, implemented to predict the 10-year number of coronary artery population in Girona, Catalonia and Spain. The subjects treated in this context represent the basis of the EUROTRACS project. Furthermore, the system permits to analyse the impact that some interventions aimed at reducing or spontaneous changes in cardiovascular risk factor prevalence would have at 10 years in terms of the expected number of coronary artery disease (CAD) events and incidence. The CASSANDRA model provides support to health planning considering the expected demographic evolution of the population as well as user-proposed changes in the prevalence of cardiovascular risk factors occurring in the next 10 years. 

Dissemination

CHAFEA (Consumer, Health, Agriculture and Food Executive Agency) and DG SANTE (Directorate General for Health and Food Safety) collaborated together to organise a workshop on Chronic Diseases and Healthy Ageing (CD-HA), which was hosted by the Ministry of Health, Welfare and Sport of The Netherlands on 12–13 February 2015.5  The event aimed to “share the knowledge acquired through the CD-HA actions funded under the second Health Programme 2008–2013”, and at same time to demonstrate how their results can be used to improve EU countries capacities to respond to the challenges of chronic diseases and healthy ageing. The participation of policy makers active at EU, national and regional levels and their interactions with authorities, patient organisations and representatives of industries and international organisations facilitated the discussion on how to address specific major chronic diseases and healthy ageing across the lifecycle.

The event was focused on disseminating results on actions on the topic at EU, national and regional, as well as local levels and it involved speakers and experts from Belgium, France, Germany, Ireland, Luxembourg, Spain, The Netherlands, United Kingdom and other EU countries. The target audience was composed of experts on chronic diseases and healthy ageing, policy makers, and health professionals.

One of the 10 actions needed to present its preliminary results was the EUROTRACS project. The intervention of the coordinator of the project, Dr Jaume Marrugat from IMIM – Hospital del Mar Medical Research Institute (Spain), was focused on the concept of cost effectiveness of health interventions and in particular on the connection between efficient healthcare and better quality of care. Moreover, the speaker explained how the preliminary results of EUROTRACS project could contribute at the EU level.

In general, the workshop sought to show how the outcomes of the projects selected can be used to build the evidence base on improving quality of life, efficiencies and resources management in European health systems. Furthermore, it explored where specific actions in relevant areas helped to respond to the burden of chronic diseases and healthy ageing. Finally, it was showed how the EU Health Programme tackled chronic diseases and healthy ageing and it encouraged participants to develop future recommendations within the following issues: 

• How did the projects of the second Health Programme provide add value in economic, social and political terms in the field of chronic diseases and healthy ageing?
• How can the results and outcomes of the projects be used and re-invested in the most efficient way at national and regional levels?
• On the basis of the projects, which prevention measures are the most cost effective in the short- and in the long-term, and how could they be implemented EU-wide? How could the EU and its Member States promote their implementation? Which risk factors need to be addressed more efficiently?
• How do the public health projects funded by the EU help tackle the burden of chronic diseases?
• How can health and care systems take up the results of the public health projects to the ageing challenge and growing phenomena of frailty and multi-morbidity and chronic diseases in general?
• How could the European Union support Member States’ attempts towards ensuring the sustainability of achievements and implementation of good practice in the management of chronic diseases, prevention and healthy ageing? How can the actions knowledge, deliverables (tools, training programmes) become permanent and available to support the Member States’ policies and improve their capacities on chronic diseases and healthy ageing? 
• What are the main messages of public health projects that can be taken up further onto health policy levels? 

Within the individual sessions and panels, the objectives were to extract key points in terms of future challenges and recommendations for EU-wide debate and policy development and to suggest a set of key conclusions on if and how the EU could further bring added value towards a more effective response to the chronic disease burden and improved healthy ageing.

References

1. Pereira M et al. Age and sex inequalities in the prescription of evidence-based pharmacological therapy following an acute coronary syndrome in Portugal: the EURHOBOP study. Eur J Prev Cardiol 2014;21(11):1401–8.
2. André R et al. International differences in acute coronary syndrome patients’ baseline characteristics, clinical management and outcomes in Western Europe: the EURHOBOP study. Heart 2014;100(15):1201–7. 
3. Degano IR et al. A European benchmarking system to evaluate in-hospital mortality rates in acute coronary syndrome: The EURHOBOP project. Int J Cardiol 2015. DOI: http://dx.doi.org/10.1016/j.ijcard.2015.01.019.
4. Grau M et al. Validation of a population coronary disease predictive system: the CASSANDRA model. J Epidemiol Community Health 2014;68:1009.
5. http://ec.europa.eu/chafea/documents/health/cd-ha-agenda-background_en.pdf