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.

Association of anti-diabetic drugs and covid-19 outcomes in patients with diabetes mellitus type 2 and chronic kidney disease: Nationwide registry analysis.

INTRODUCTION: Patients with diabetes mellitus type 2 and chronic kidney disease (T2DM-CKD) have a 5 times higher risk of developing severe SARS-CoV-2 infection than those without these 2 diseases. The goal of this study is to provide information on T2DM-CKD and COVID-19 outcomes, with an emphasis on the association with anti-diabetic medications. METHODOLOGY: Study is designed as a retrospective cohort analysis covering the years 2020 and 2021. Data from the National Diabetes Registry (CroDiab) were linked to hospital data, primary healthcare data, Causes of Death Registry 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. RESULTS: Of 231 796 patients with diabetes mellitus type 2 in the database, 7 539 were T2DM-CKD (3.25%). The 2-year cumulative incidences of all three studies' outcomes were higher in T2DM-CKD than in diabetes patients without CKD (positivity 18.1% vs. 14.4%; hospitalization 9.7% vs. 4.2%; death 3.3% vs. 1.1%, all p<0.001). For COVID-19 hospitalization, protective factors were SGLT-2 inhibitors use (OR 0.430; 95%CI 0.257-0.719) and metformin use (OR 0.769; 95% CI 0.643-0.920), risk factors were insulin use (1.411; 95%CI 1.167-1.706) and sulfonylureas use (OR 1.226; 95% CI 1.027-1.464). For SARS-CoV-2 positivity protective factors were SGLT-2 inhibitors (0.607; 95% CI 0.448-0.823), repaglinide use (OR 0.765; 95% CI 0.593-0.986) and metformin use (OR 0.857; 95% CI 0.770-0.994). DPP-4 inhibitors showed a non-significant decrease in risk for COVID-19 death (OR 0.761; 95% CI 0.568-1.019). CONCLUSION: T2DM-CKD are heavily burdened by COVID-19 disease. Our results suggest no association between antidiabetic drugs and COVID-19 death outcome while SGLT-2 and metformin show to be protective against COVID-19 hospitalization and infection, repaglinide against infection, and insulin and sulfonylureas show to be risk factors for COVID-19 hospitalization and infection. Further research in T2DM-CKD is needed.

Developing and testing a protocol using a common data model for federated collection and analysis of national perinatal health indicators in Europe.

Context: International comparisons of the health of mothers and babies provide essential benchmarks for guiding health practice and policy, but statistics are not routinely compiled in a comparable way. These data are especially critical during health emergencies, such as the coronavirus disease (COVID-19) pandemic. The Population Health Information Research Infrastructure (PHIRI) project aimed to promote the exchange of population data in Europe and included a Use Case on perinatal health. Objective: To develop and test a protocol for federated analysis of population birth data in Europe. Methods: The Euro-Peristat network with participants from 31 countries developed a Common Data Model (CDM) and R scripts to exchange and analyse aggregated data on perinatal indicators. Building on recommended Euro-Peristat indicators, complemented by a three-round consensus process, the network specified variables for a CDM and common outputs. The protocol was tested using routine birth data for 2015 to 2020; a survey was conducted assessing data provider experiences and opinions. Results: The CDM included 17 core data items for the testing phase and 18 for a future expanded phase. 28 countries and the four UK nations created individual person-level databases and ran R scripts to produce anonymous aggregate tables. Seven had all core items, 17 had 13-16, while eight had ≤12. Limitations were not having all items in the same database, required for this protocol. Infant death and mode of birth were most frequently missing. Countries took from under a day to several weeks to set up the CDM, after which the protocol was easy and quick to use. Conclusion: This open-source protocol enables rapid production and analysis of perinatal indicators and constitutes a roadmap for a sustainable European information system. It also provides minimum standards for improving national data systems and can be used in other countries to facilitate comparison of perinatal indicators.

Enablers and barriers to the secondary use of health data in Europe: general data protection regulation perspective.

BACKGROUND: The General Data Protection Regulation is a regulation in EU law on data protection and privacy in the European Union. We aimed to provide an overview of the General Data Protection Regulation (GDPR) enablers and barriers to the secondary use of health data in Europe from the research we conducted in the Joint Action InfAct (Information for Action!) WP10 Assessing and piloting interoperability for public health policy, as well as to provide an example of a national-level case study on experiences with secondary use of health data and GDPR on an example of the Austrian COVID-19 data platform. METHODS: We have identified a number of European initiatives, projects and organizations that have dealt with cross-border health data sharing, linkage and management by desk research and we conducted 17 semi-structured in-depth interviews and analyzed the interview transcripts by framework analysis. RESULTS: GDPR was seen as an enabler to the secondary use of health data in Europe when it comes to user rights over their data, pre-existing laws regarding data privacy and data sharing, sharing anonymized statistics, developing new data analysis approaches, patients` trust towards dealing with their health data and transparency. GDPR was seen as a barrier to the secondary use of health data in Europe when it comes to identifiable and individual-level data, data sharing, time needed to complete the process, workload increase, differences with local legal legislations, different (and stricter) interpretations and access to data. CONCLUSION: The results of our analysis show that GDPR acts as both an enabler and a barrier for the secondary use of health data in Europe. More research is needed to better understand the effects of GDPR on the secondary use of health data which can serve as a basis for future changes in the regulation.

Breastfeeding: A standard or an intervention? Review of systematic reviews.

Clinical trials designed to answer treatment-related questions typically compare an intervention group that receives a drug or other intervention to a control group that serves as a standard against which results of the intervention are evaluated. An observed divergence from this trend in research papers on breastfeeding led us to hypothesize that the majority of breastfeeding research designs assign breastfed children to an intervention group rather than the control group, although breastfeeding is a physiological way of feeding infants that may be considered as a general standard. Headlines and abstracts of 760 publications identified in 2 databases were checked, and a total of 68 systematic reviews were included in our review with the goal to see if breastfed children were mostly considered as the intervention or control group. Our review showed that in 79,41% of papers breastfed children were regarded as the intervention group. The results of these papers were usually presented in a manner to show breastfeeding was beneficial in comparison to formula-feeding - as if breastfeeding was a health intervention. This way of data presentation probably helps to form attitude that formula-feeding is the norm and breastfeeding an optional choice, a "superstandard" with certain health benefits. Therefore, all available studies that regard breastfeeding should be interpreted with caution. We suggest that authors, while conducting and reporting clinical trials, regard breastfed children as the control group, and non-breastfed children as the intervention group.

Prevalence of somatic comorbidities among coronavirus disease 2019 patients in Croatia in the first pandemic wave: data from national public health databases.

AIM: To determine the prevalence of common somatic comorbidities among coronavirus disease 2019 (COVID-19) positive patients in Croatia in the first pandemic wave, and assess the differences in clinical outcomes depending on the presence of comorbidities. METHODS: We analyzed data from patients confirmed to be SARS-CoV-2-positive from February through May 2020. The data were obtained from clinical laboratories, primary health care providers, and hospitals. Previously recorded comorbidities, including diabetes, cancer, circulatory diseases, chronic pulmonary, and kidney disease, were analyzed. RESULTS: Among 2249 patients, 46.0% were men (median age 51 years; median disease duration 27 days). Hospitalization was required for 41.8% patients, mechanical ventilation for 2.5%, while 4.7% of all patients died. Patients who died were significantly older (median 82 vs 50 years, P<0.001) with a higher prevalence of all investigated comorbidities (all p's <0.001), more frequently required mechanical ventilation (34% vs 1%, P<0.001), and had shorter length of hospital stay (median 13 vs 27 days, P<0.001) with no sex preponderance. Patients requiring mechanical ventilation were significantly older (median age 70 vs 51 years, P<0.001), more frequently men (59.6% vs 45.7%, P=0.037), showed a higher prevalence of all comorbidities except ischemic heart and chronic kidney disease (all p's <0.001), and demonstrated a higher case-fatality rate (63.2% vs 3.2%, P<0.001). CONCLUSION: COVID-19 patients who died in the first pandemic wave in Croatia were more likely to suffer previous somatic comorbidities. This corroborates the findings of similar studies and calls for further research into the underlying disease mechanisms, hence providing ground for more efficient preventive measures.