Association of anti-diabetic drugs and COVID-19 outcomes in patients with diabetes mellitus type 2 and cardiomyopathy.

There is a scarcity of information on the population with diabetes mellitus type 2 and cardiomyopathy (PDMC) in COVID-19, especially on the association between anti-diabetic medications and COVID-19 outcomes. Study is designed as a retrospective cohort analysis covering 2020 and 2021. Data from National Diabetes Registry (CroDiab) were linked to hospital data, primary healthcare data, the SARS-CoV-2 vaccination database, and the SARS-CoV-2 test results database. Study outcomes were cumulative incidence of SARS-CoV-2 positivity, COVID-19 hospitalizations, and COVID-19 deaths. For outcome predictors, logistic regression models were developed. Of 231 796 patients with diabetes mellitus type 2 in the database, 14 485 patients had cardiomyopathy. The two2-year cumulative incidence of all three studies' COVID-19 outcomes was higher in PDMC than in the general diabetes population (positivity 15.3% vs. 14.6%, p = 0.01; hospitalization 7.8% vs. 4.4%, p < 0.001; death 2.6% vs. 1.2%, p < 0.001). Sodium-Glucose Transporter 2 (SGLT-2) inhibitors therapy was found to be protective of SARS-CoV-2 infections [OR 0.722 (95% CI 0.610-0.856)] and COVID-19 hospitalizations [OR 0.555 (95% CI 0.418-0.737)], sulfonylureas to be risk factors for hospitalization [OR 1.184 (95% CI 1.029-1.362)] and insulin to be a risk factor for hospitalization [OR 1.261 (95% CI 1.046-1.520)] and death [OR 1.431 (95% CI 1.080-1.897)]. PDMC are at greater risk of acquiring SARS-CoV-2 infection and having worse outcomes than the general diabetic population. SGLT-2 inhibitors therapy was a protective factor against SARS-CoV-2 infection and against COVID-19 hospitalization, sulfonylurea was the COVID-19 hospitalization risk factor, while insulin was a risk factor for all outcomes. Further research is needed in this diabetes sub-population.

Methodological guidelines to estimate population-based health indicators using linked data and/or machine learning techniques.

BACKGROUND: The capacity to use data linkage and artificial intelligence to estimate and predict health indicators varies across European countries. However, the estimation of health indicators from linked administrative data is challenging due to several reasons such as variability in data sources and data collection methods resulting in reduced interoperability at various levels and timeliness, availability of a large number of variables, lack of skills and capacity to link and analyze big data. The main objective of this study is to develop the methodological guidelines calculating population-based health indicators to guide European countries using linked data and/or machine learning (ML) techniques with new methods. METHOD: We have performed the following step-wise approach systematically to develop the methodological guidelines: i. Scientific literature review, ii. Identification of inspiring examples from European countries, and iii. Developing the checklist of guidelines contents. RESULTS: We have developed the methodological guidelines, which provide a systematic approach for studies using linked data and/or ML-techniques to produce population-based health indicators. These guidelines include a detailed checklist of the following items: rationale and objective of the study (i.e., research question), study design, linked data sources, study population/sample size, study outcomes, data preparation, data analysis (i.e., statistical techniques, sensitivity analysis and potential issues during data analysis) and study limitations. CONCLUSIONS: This is the first study to develop the methodological guidelines for studies focused on population health using linked data and/or machine learning techniques. These guidelines would support researchers to adopt and develop a systematic approach for high-quality research methods. There is a need for high-quality research methodologies using more linked data and ML-techniques to develop a structured cross-disciplinary approach for improving the population health information and thereby the population health.

Coping with interoperability in the development of a federated research infrastructure: achievements, challenges and recommendations from the JA-InfAct.

BACKGROUND: Information for Action! is a Joint Action (JA-InfAct) on Health Information promoted by the EU Member States and funded by the European Commission within the Third EU Health Programme (2014-2020) to create and develop solid sustainable infrastructure on EU health information. The main objective of this the JA-InfAct is to build an EU health information system infrastructure and strengthen its core elements by a) establishing a sustainable research infrastructure to support population health and health system performance assessment, b) enhancing the European health information and knowledge bases, as well as health information research capacities to reduce health information inequalities, and c) supporting health information interoperability and innovative health information tools and data sources. METHODS: Following a federated analysis approach, JA-InfAct developed an ad hoc federated infrastructure based on distributing a well-defined process-mining analysis methodology to be deployed at each participating partners' systems to reproduce the analysis and pool the aggregated results from the analyses. To overcome the legal interoperability issues on international data sharing, data linkage and management, partners (EU regions) participating in the case studies worked coordinately to query their real-world healthcare data sources complying with a common data model, executed the process-mining analysis pipeline on their premises, and shared the results enabling international comparison and the identification of best practices on stroke care. RESULTS: The ad hoc federated infrastructure was designed and built upon open source technologies, providing partners with the capacity to exploit their data and generate dashboards exploring the stroke care pathways. These dashboards can be shared among the participating partners or to a coordination hub without legal issues, enabling the comparative evaluation of the caregiving activities for acute stroke across regions. Nonetheless, the approach is not free of a number of challenges that have been solved, and new challenges that should be addressed in the eventual case of scaling up. For that eventual case, 12 recommendations considering the different layers of interoperability have been provided. CONCLUSION: The proposed approach, when successfully deployed as a federated analysis infrastructure, such as the one developed within the JA-InfAct, can concisely tackle all levels of the interoperability requirements from organisational to technical interoperability, supported by the close collaboration of the partners participating in the study. Any proposal for extension, should require further thinking on how to deal with new challenges on interoperability.

Making Use of Comparable Health Data to Improve Quality of Care and Outcomes in Diabetes: The EUBIROD Review of Diabetes Registries and Data Sources in Europe.

Background: Registries and data sources contain information that can be used on an ongoing basis to improve quality of care and outcomes of people with diabetes. As a specific task of the EU Bridge Health project, we carried out a survey of diabetes-related data sources in Europe. Objectives: We aimed to report on the organization of different sources of diabetes information, including their governance, information infrastructure and dissemination strategies for quality control, service planning, public health, policy and research. Methods: Survey using a structured questionnaire to collect targeted data from a network of collaborating institutions managing registries and data sources in 17 countries in the year 2017. Results: The 18 data sources participating in the study were most frequently academic centres (44.4%), national (72.2%), targeting all types of diabetes (61.1%) covering no more than 10% of the target population (44.4%). Although population-based in over a quarter of cases (27.8%), sources relied predominantly on provider-based datasets (38.5%), fewer using administrative data (16.6%). Data collection was continuous in the majority of cases (61.1%), but 50% could not perform data linkage. Public reports were more frequent (72.2%) as well as quality reports (77.8%), but one third did not provide feedback to policy and only half published ten or more peer reviewed papers during the last 5 years. Conclusions: The heterogeneous implementation of diabetes registries and data sources hampers the comparability of quality and outcomes across Europe. Best practices exist but need to be shared more effectively to accelerate progress and deliver equitable results for people with diabetes.

QUALITY ASSURANCE OF REGISTRIES FOR HEALTH TECHNOLOGY ASSESSMENT.

OBJECTIVES: The aim of this study was to identify guidelines and assessment tools used by health technology agencies for quality assurance of registries and investigate the current use of registry data by HTA organizations worldwide. METHODS: As part of a European Network for Health Technology Assessment Joint Action work package, we undertook a literature search and sent a questionnaire to all partner organizations on the work package and all organizations listed in the International Society for Pharmaco-economics and Outcomes Research directory. RESULTS: We identified thirteen relevant documents relating to quality assurance of registries. We received fifty-five responses from organizations representing twenty-one different countries, a response rate of 40.5 percent (43/110). Many agencies, particularly in Europe, are already drawing on a range of registries to provide data for their HTA. Less than half, however, use criteria or standards to assess the quality of registry data. Nearly all criteria or standards in use have been internally defined by organizations rather than referring to those produced by an external body. A comparison of internal and external standards identified consistency in several quality dimensions, which can be used as a starting point for the development of a standardized tool. CONCLUSION: The use of registry data is more prevalent than expected, strengthening the need for a standardized registry quality assessment tool. A user-friendly tool developed in conjunction with stakeholders will support the consistent application of approved quality standards, and reassure critics who have traditionally considered registry data to be unreliable.

Quantification of coronary atherosclerotic burden with coronary computed tomography angiography: adapted Leaman score in Croatian patients.

The aim of the study was to quantify the total coronary atherosclerotic burden in patients with suspected coronary artery disease (CAD) defined by coronary computed tomography adapted Leaman score (CT-LeSc) and to estimate its cut-off level for high coronary atherosclerotic burden. We enrolled 434 consecutive patients referred to coronary computed tomography angiography, of which 261 patients fulfilled the study inclusion criteria. Demographic and clinical characteristics, as well as CAD risk factors were obtained. CAD pre-test probabilities were estimated by the Diamond-Forrester model and Morise score. The coronary atherosclerotic burden was estimated using CT-LeSc. As a cut-off for a high coronary atherosclerotic burden, we used 3rd tercile (Tc3) (CT-LeSc ≥ 5.52). We evaluated the association of clinical characteristics and risk factors with Tc3 in univariate and multivariate analysis. There were 60.9% males and 39.1% females, 81% of patients had above-normal weight, 68.2% hypertension, 54.0% dyslipidemia, 15.3% diabetes mellitus, 12.3% positive smoking history and 11.9% had a family history of CAD. According to the Diamond-Forrester model and Morise score the majority of patients had intermediate risk, 59.7 and 52.8%, followed by the high-risk group, 36.0 and 34.4%, respectively. Age, dyslipidemia, hypertension and pre-test risk scores in the univariate analysis significantly predicted Tc3. In the multivariate analysis, male sex (p = 0.004), dyslipidemia (p = 0.002) and coronary calcium score (< 0.001) were identified as predictors of Tc3. CT-LeSc quantified the total coronary atherosclerotic burden and showed an association of risk factors and pre-test probabilities with Tc3.

Addressing the Data Linking Challenges.

BACKGROUND: PARENT JA (cross-border Patient Registries iNiTiative Joint Action), a joint EU and Member States project, has conducted a research among EU patient registries aimed at gathering information on the registries' interoperability readiness. Leaning on the information and data collected through the previous PARENT JA research, this study aims to provide more detailed view into the registry holders' practical challenges with data linking. Since the studies which dealt with patient data exchange have often neglected the registry holders' performance of data exchange, we wanted to put a spotlight on various EU registry holders' practices and operations, aiming to detect their needs and concerns in the process of running an interoperable registry. The focus of this study was identifying the main practices and challenges in patient registries interoperability improvement. METHODS: The basis for this analysis were the data collected in the series of structured interviews. The size of the interview sample was 13 patient registries, each from a different EU country. The structured interview consisted of nine questions and was conducted in two parts: oral and written. The answers were analysed using open coding. RESULTS: Results are interpreted in the context of the six main themes that emerged through a comprehensive analysis. (1) Examples of data exchange: The most common reported data exchange practices were seen only as a way to achieve the most immediate needs and interests of the individual registries. (2) Awareness and use of international standards: International data and clinical standards were not widely used by the interviewed registries. (3) Use of data models and formats: In the area of data models and formats there is no universally used practice. (4) Data request protocols and procedures: Procedures and protocols varied, mostly depending on the national legal systems in which the patient registries operated. (5) Data security and integrity: Security of personal data was a universal concern for all registry holders that were interviewed; identifiable individual data was shared only in one case. (6) Opportunities and challenges of registry interoperability: most registry holders responded that their registries were well prepared for interoperability practices and that data exchange has never been their primary operative concern. CONCLUSIONS: Most of the difficulties regarding data linking were not necessarily associated with technical issues, which registry holders listed outright. Our analysis showed that the lack of interoperability came as a result of organizational or legal constraints that made the registries unable to process and conduct data linking quickly and effectively with other sources.

The Child Health Care System of Croatia.

The Republic of Croatia is a Parliamentary Republic with a population of 4.2 million people that sits on the Adriatic coast within Central Europe. Gross domestic product is approximately 60% of the European Union average, which in turn, limits health service spending. The health system is funded through universal health insurance administered by the Croatian Health Insurance Fund based on the principles of social solidarity and reciprocity. The children of Croatia are guaranteed access to universal primary, hospital, and specialist care provided by a network of health institutions. Pediatricians and school medicine specialists provide comprehensive preventive health care for both preschool and school-aged children. Despite the Croatian War of Independence in the late 20th century, indicators of child health and measures of health service delivery to children and families are steadily improving. However, similar to many European countries, Croatia is experiencing a rise in the "new morbidities" and is responding to these new challenges through a whole society approach to promote healthy lifestyles and insure good quality of life for children.

PARENT joint action: increasing the added value of patient registries in a cross-border setting.

Patient registries are poorly interoperable and as a result data exchange or aggregation across organizations, regions and countries for secondary purposes (i.e. research and public health) is difficult to perform. PARENT Joint Action aims to provide EU Member States with a set of guidelines, recommendations and tools to support setting-up, management and governance of interoperable patient registries, thus helping EU Member States to drive down cost and interoperability risks of patient registries as well as improving secondary us-age of registry data in a cross-border setting.

[Creating a European registry of patient registries--a service oriented approach]. / Stvaranje registra Europskih registara u zdravstvu--servisno orijentirani pristup.

Healthcare registries in European countries are producing a large amount of data that are difficult to share and which, for the lack of interoperability, do not meet the real needs of data users, i.e. various groups of researchers, professionals and patients. Also, data gathered from healthcare registries are usually considered as isolated islands of information, which makes the task of approaching these data an arduous one. The suggested solution to these problems lies in the service approach to health registries and the data contained within them. Applying the service approach to registries, the healthcare data can escape the narrow confines of health registries in which they reside by transforming them into packages of predefined services in accordance with the end-user needs, which introduces the concept of metadata registries as service catalogues. Such a model of a service-oriented metadata registry as a catalog of services is discussed here as a real possibility and a dire need. The purpose of such a metadata registry is the collection of relevant data from the service provider and delivery of a predefined and reusable set of services to the service consumer. Interoperability thus achieved transcends the traditional problems of data exchange because it comes to grips with the services intended for and defined by the end-user, and not relying solely on data as a final deliverable. At the European Union level, such a metadata registry is currently under development, with the working title PARENT (Patient Registry Initiative) 'Registry of registries'. The mission of this metadata registry is to combine all the relevant European patient registries into such a service-oriented model.

The Croatian Adult Health Cohort Study (CroHort) --background, methodology & perspectives.

Health interview surveys are important source of health information. All previous adult population-based health interview surveys in Croatia until CroHort, were one-off projects with very limited possibility of data comparison. CroHort enabled repeated survey of CAHS 2003 respondents with almost identical questionnaire, thus providing comparable data on trends of different risk factors as well as their relation to the specific outcomes. Next follow-up survey of the CroHort cohort is foreseen for 2013. Health interview survey according to Eurostat methodology (EHIS) on the new representative sample of adult Croatian population is planned for 2014. As the data from health interview surveys are valuable in health policy, efforts should be made to increase their use by policymakers in Croatia.

Inequalities in Croatian pupils' unhealthy behaviours and health outcomes: role of school, peers and family affluence.

BACKGROUND: To examine the influence of family affluence (measure of socioeconomic status), school environment (liking school, school pressure, academic achievement and classmates support) and peer group (size of the peer group and frequency of peer contact) on unhealthy behaviours (smoking, drunkenness, physical inactivity, irregular breakfast and soft drink consumption) and health outcomes (self-rated health, multiple health complaints and life satisfaction) in Croatian pupils. METHODS: The Croatian data from Health Behaviour in School-aged Children 2005/06 (HBSC) were used (1666 11-year-olds, and 1630 15-year-olds). Binary logistic regression analysis was conducted (95% confidence intervals, P < 0.05 and P < 0.01). RESULTS: School environment and peer group were connected to more unhealthy behaviours along with greater differences in those behaviours than family affluence. The only exception was physical inactivity at age 11 (compared to high family affluence, low family affluence increased 80% odds for physical inactivity, whereas, compared to favourable school environment, poor school environment increased 50% odds). Compared to favourable school environment, poor school environment was the most consistent and strongest predictor of poor health outcomes (all three measures). No influence of peer group to health outcomes was found. Compared to high-affluent families, low-affluent families were associated to higher odds for poor self-rated health and life dissatisfaction, and, for 11-year-olds, medium-affluent families to lower odds for multiple health complaints. Gender differences in unhealthy behaviours and health outcomes were also found. CONCLUSIONS: Compared to socioeconomic inequalities, greater inequalities in unhealthy behaviours were connected to school environment and peer group, and in health outcomes to school environment.

Risk behavior of customers in centers for free voluntary HIV counselling and testing in two Croatian cities--Osijek and Zadar.

The primary goal of this research is to compare risks and occurrence of HIV infection in Osijek-Baranja and Zadar County. Several chosen socioeconomic factors controlled by sex and age were investigated including level of education, employment and marital status of the free-of charge voluntary counseling and testing center (VCT) customers in the towns of Osijek and Zadar and their risk behaviors for acquiring HIV. Bivariate analysis of the differences between the customers from Osijek and Zadar showed statistically significant differences in the following variables: gender, education, number of VCT clients who use intravenous drugs (IDU), promiscuous behavior, number of homosexual clients, mode of receiving information on the VCT services, marital and partnership status, having children, inclination towards homosexual and bisexual relations, the main reasons for not using condoms, injecting drugs (IDU) needle sharing and the occurrence of hepatitis C. The analysis showed that significantly more males were counseled and tested in the city of Osijek, significantly less hepatitis C positive persons and promiscuity among all behavioral risk factors more often. A higher number of the customers of the VCT in the city of Osjek were "in permanent" relationship. Strategic management of health and health care, methods of comparing regional and national standardized indicators can provide valuable information about setting the focus, choosing priorities and establishing a good economic policy at the micro level. This study clearly established the dimensions of problems in HIV/AIDS prevention onto which it should be influenced through regional and local measures and actions. The indexes measured indicate which special initiatives and programs should be focused and set up as priorities in particular regions. The determined differences point to the need for a regional approach to HIV/AIDS prevention in purpose of improving preventive activities according to most common risk behaviors. Even though Croatia is a relatively small country, it has many regional and local features which need to be taken into consideration when developing prevention programs and activities.

[The role of county health center in the management of patients with acute coronary syndrome]. / Uloga zupanijskog doma zdravlja u zbrinjavanju bolesnika s akutnim koronarnim sindromom.

Health emergency service teams play an important role in the management of patients with acute coronary syndrome. They have to be educated, equipped, skilful and supported by the entire health care system. The role of county health center in the management of patients with acute coronary syndrome is illustrated in the article, based on the experience acquired at Medimurje County Health Center from Cakovec. The reformed Health Center activities including organization, coordination and linking of teams, population health monitoring at the local level, epidemiologic surveillance, education (active and passive, on both sides of college chair), joint diagnostic and other services, and quality control are discussed in detail. In contrast to a bureaucratic and formal one, a real and innovative reform should take account of necessary changes in the management and organization, not just in standards, rights and obligations. The management protocol for acute coronary syndrome patients is described: setting the main objective (acute coronary disease morbidity and mortality reduction), setting short-term and long-term specific goals, adoption of strategy based on the main objective (education, completion and particular programs pursuit, connecting, collaboration, quality assurance through clinical guidelines and protocols) and other elements, including dignity, leadership, teamwork, adoption and implementation of patient management protocols.

Characteristics of heavy smokers in Croatia.

The aim of this paper was to investigate the socio-demographic characteristics of heavy smokers in comparison to group the characteristics of light smokers and non-smokers. Data used for this study was collected within the Croatian Adult Health Survey (CAHS). The results show a significant gender differences in the prevalence of heavy smoking, with higher prevalence among men in all age groups. Highest prevalence of heavy smoking was found in people 35 to 64 years of age, irrespective to gender. According to analyzed socio-demographic characteristics men with low education and income who changed place of living have higher prevalence of heavy smoking. Pattern was different in women smokers. Majority of women smokers were light smokers. In women with better than average household economic status there were more smokers than non-smokers, with notable high proportion of heavy smokers in age 18 to 34 years and light smokers in age group 35 to 64. While planning future interventions at the population level, we must consider all of these characteristics and links between them, and engage all segments of society.

Health care needs, utilization and barriers in croatia--regional and urban-rural differences.

Even the most socially aware countries in the World have noticed the gap increase between the poorest and the richest population groups. The purpose of this study was to investigate the presence of inequity and to identify main barriers for equitable health care utilization by economic status, region and area of living, controlled for health needs in the Croatian adult population. The data from the Croatian Adult Health Survey 2003 were used in this study. The results show that among the respondents with higher health needs, those with economic status above average had higher proportion of regular annual general practitioner and medical specialist visits. In contrast, highly frequent visits to physician were more common in respondents who were below average economic status. Economically worse-off women, regardless on their health care needs reported gynecologist visits less regularly than the better-off women. Long waiting and the large distance from the health care facilities were the most commonly reported barriers in health care utilization. High expenses were present as the main barrier at dentist and inpatient health services utilization. Suburban and rural settlements were more burdened with long distance from the health care facilities and high expenses for all health services, aggravated by the long waiting time for visits to GP. Respondents from the urban settings reported long waiting time and unkindness of the health personnel as the main barriers. The results of this study clearly show the main barriers in the equitable health care delivery to Croatia population from the health care users perspective.