Vaccination Intention Following Receipt of Vaccine Information Through Interactive Simulation vs Text Among COVID-19 Vaccine-Hesitant Adults During the Omicron Wave in Germany.

Conclusions and Relevance: In this cross-sectional study, vaccine-hesitant adults presented with an interactive risk ratio simulation were more likely to show positive change in COVID-19 vaccination intention and benefit-to-harm assessment than those presented with a conventional text-based information format. These findings suggest that the interactive risk communication format can be an important tool in addressing vaccination hesitancy and fostering public trust. Design, Setting, and Participants: Cross-sectional study conducted online with 1255 COVID-19 vaccine-hesitant adult residents of Germany in April and May 2022, surveyed using a probability-based internet panel maintained by respondi, a research and analytics firm. Participants were randomized to 1 of 2 presentations on the benefits and adverse events associated with vaccination. Exposure: Participants were randomized to a text-based description vs an interactive simulation presenting age-adjusted absolute risks of infection, hospitalization, ICU admission, and death after exposure to coronavirus in vaccinated vs unvaccinated individuals relative to the possible adverse effects as well as additional (population-level) benefits of COVID-19 vaccination. Importance: Hesitancy toward COVID-19 vaccination is a major factor in stagnating uptake rates and in the risk of health care systems becoming overwhelmed. Main Outcomes and Measures: Absolute change in respondents' COVID-19 vaccination intention category and benefit-to-harm assessment category. Objective: To compare an interactive risk ratio simulation (intervention) with a conventional text-based risk information format (control) and analyze change in participants' COVID-19 vaccination intention and benefit-to-harm assessment. Results: Participants were 1255 COVID-19 vaccine-hesitant residents of Germany (660 women [52.6%]; mean [SD] age, 43.6 [13.5] years). A total of 651 participants received a text-based description, and 604 participants received an interactive simulation. Relative to the text-based format, the simulation was associated with greater likelihood of positive change in vaccination intentions (19.5% vs 15.3%, respectively; absolute difference, 4.2%; adjusted odds ratio [aOR], 1.45; 95% CI, 1.07-1.96; P = .01) and benefit-to-harm assessments (32.6% vs 18.0%; absolute difference, 14.6%; aOR, 2.14; 95% CI, 1.64-2.80; P < .001). Both formats were also associated with some negative change. However, the net advantage (positive - negative change) of the interactive simulation over the text-based format was 5.3 percentage points for vaccination intention (9.8% vs 4.5%) and 18.3 percentage points for benefit-to-harm assessment (25.3% vs 7.0%). Positive change in vaccination intention (but not in benefit-to-harm assessment) was associated with some demographic characteristics and attitudes to COVID-19 vaccination; negative changes were not.

[Mapping Regional Differences in Infection Rates for the Coronavirus (COVID-19): Results of a Bayesian Approach to Administrative Districts of Bavaria]. / Kartografische Darstellung regionaler Unterschiede der Infektionsraten beim Coronavirus (COVID-19): Ergebnisse einer bayesianischen Glättung über Landkreise Bayerns.

BACKGROUND: Since the beginning of the COVID-19 pandemic, thematic maps showing the spread of the disease have been of great public interest. From the perspective of risk communication, those maps can be problematic, since random variation or extreme values may occur and cover up the actual regional patterns. One potential solution is applying spatial smoothing methods. The aim of this study was to show changes in incidence ratios over time in Bavarian districts using spatially smoothed maps. METHODS: Data on SARS-CoV-2 were provided by the Bavarian Health and Food Safety Authority on 29.10.2021 and 17.02.2022. The demographic data per district are derived from the Statistical Report of the Bavarian State Office for Statistics for 2019. Four age groups per sex (<18, 18-29, 30-64,>64 years) divided into 16 time periods (01/28/2020 to 12/31/2021) were included. Maps show standardized incidence ratios (SIR) spatially smoothed by Bayesian hierarchical modelling. RESULTS: The SIR varied remarkably between districts. Variations occurred for each time period, showing changing regional patterns over time. CONCLUSION: Smoothed health maps are suitable for showing trends in incidence ratios over time for COVID-19 in Bavaria and offer the advantage over traditional maps in giving more realistic estimates by including neighborhood relationships. The methodological approach can be seen as a first step to explain the regional heterogeneity in the pandemic, and to support improved risk communication.

Area Deprivation and COVID-19 Incidence and Mortality in Bavaria, Germany: A Bayesian Geographical Analysis.

Background: Area deprivation has been shown to be associated with various adverse health outcomes including communicable as well as non-communicable diseases. Our objective was to assess potential associations between area deprivation and COVID-19 standardized incidence and mortality ratios in Bavaria over a period of nearly 2 years. Bavaria is the federal state with the highest infection dynamics in Germany and demographically comparable to several other European countries. Methods: In this retrospective, observational ecological study, we estimated the strength of associations between area deprivation and standardized COVID-19 incidence and mortality ratios (SIR and SMR) in Bavaria, Germany. We used official SARS-CoV-2 reporting data aggregated in monthly periods between March 1, 2020 and December 31, 2021. Area deprivation was assessed using the quintiles of the 2015 version of the Bavarian Index of Multiple Deprivation (BIMD 2015) at district level, analyzing the overall index as well as its single domains. Results: Deprived districts showed higher SIR and SMR than less deprived districts. Aggregated over the whole period, the SIR increased by 1.04 (95% confidence interval (95% CI): 1.01 to 1.07, p = 0.002), and the SMR by 1.11 (95% CI: 1.07 to 1.16, p < 0.001) per BIMD quintile. This represents a maximum difference of 41% between districts in the most and least deprived quintiles in the SIR and 110% in the SMR. Looking at individual months revealed clear linear association between the BIMD quintiles and the SIR and SMR in the first, second and last quarter of 2021. In the summers of 2020 and 2021, infection activity was low. Conclusions: In more deprived areas in Bavaria, Germany, higher incidence and mortality ratios were observed during the COVID-19 pandemic with particularly strong associations during infection waves 3 and 4 in 2020/2021. Only high infection levels reveal the effect of risk factors and socioeconomic inequalities. There may be confounding between the highly deprived areas and border regions in the north and east of Bavaria, making the relationship between area deprivation and infection burden more complex. Vaccination appeared to balance incidence and mortality rates between the most and least deprived districts. Vaccination makes an important contribution to health equality.

[Regional and Temporal Trends in SARS-CoV-2-Associated Mortality in Bavaria: An Age-Stratified Analysis Over 5 Quarters for Persons Aged 50 and Older]. / Regionale und zeitliche Trends der SARS-CoV-2 assoziierten Sterblichkeit in Bayern: Eine altersstratifizierte Analyse über 5 Quartale für Personen ab 50 Jahren.

OBJECTIVE: The aim of this study was to investigate the influence of regional factors such as incidence rate, hospitalizations, socio-economic status and nursing homes on the regional and temporal heterogeneity of SARS-CoV-2-associated mortality in Bavaria. METHODOLOGY: Official Bavarian SARS-CoV-2 reporting data were considered for three age groups (50-64, 65-74,>74 years) between March 2020 and April 2021. Maps of regional standardized mortality rates were spatially smoothed using a Bayesian hierarchical model. RESULTS: The picture of regional mortality was heterogeneous with an increasing gradient toward the northeast. Adjustment for standardized incidence rates, hospitalizations of infected persons, and availability of care homes for the elderly levelled the heterogeneity. CONCLUSION: The north-east gradient in Bavarian SARS-CoV-2-specific mortality rates is clearly explained by the comparable gradient in regional incidence rates. Other regional factors show a less clear influence.

Medical journal requirements for clinical trial data sharing: Ripe for improvement.

Florian Naudet and co-authors discuss strengthening requirements for sharing clinical trial data.

[Regional monitoring of infections by means of standardized case fatality rates using the example of SARS-CoV-2 in Bavaria]. / Regionales Monitoring von Infektionen mittels standardisierter Fallfatalitätsraten am Beispiel von SARS-CoV-2 in Bayern.

BACKGROUND: Maps of the temporal evolution of the regional distribution of a health-related measure enable public health-relevant assessments of health outcomes. OBJECTIVES: The paper introduces the concept of standardized case fatality rate (sCFR). It describes the ratio of the regional variation in mortality to the regional variation in the documented infection process. The regional sCFR values are presented in maps and the time-varying regional heterogeneity observed in them is interpreted. MATERIALS AND METHODS: The regional sCFR is the quotient of the regional standardized mortality and case rate. It is estimated using a bivariate model. The sCFR values presented in maps are based on SARS-CoV­2 reporting data from Bavaria since the beginning of April 2020 until the end of March 2021. Four quarters (Q2/20, Q3/20, Q4/20, and Q1/21) are considered. RESULTS: In the quarters considered, the naïve CFR values in Bavaria are 5.0%, 0.5%, 2.5%, and 2.8%. In Q2/20, regional sCFR values are irregularly distributed across the state. This heterogeneity weakens in the second wave of the epidemic. In Q1/21, only isolated regions with elevated sCFR (> 1.25) appear in southern Bavaria. Clusters of regions with sCFR > 1.25 form in northern Bavaria, with Oberallgäu being the region with the lowest sCFR (0.39, 95% credibility interval: 0.25-0.55). CONCLUSIONS: In Bavaria, heterogeneous regional SARS-CoV-2-specific sCFR values are shown to change over time. They estimate the relative risk of dying from or with COVID-19 as a documented case. Strong small-scale variability in sCFR suggests a preference for regional over higher-level measures to manage the incidence of infection.

Discontinuation versus continuation of renin-angiotensin-system inhibitors in COVID-19 (ACEI-COVID): a prospective, parallel group, randomised, controlled, open-label trial.

BACKGROUND: SARS-CoV-2 entry in human cells depends on angiotensin-converting enzyme 2, which can be upregulated by inhibitors of the renin-angiotensin system (RAS). We aimed to test our hypothesis that discontinuation of chronic treatment with ACE-inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) mitigates the course o\f recent-onset COVID-19. METHODS: ACEI-COVID was a parallel group, randomised, controlled, open-label trial done at 35 centres in Austria and Germany. Patients aged 18 years and older were enrolled if they presented with recent symptomatic SARS-CoV-2 infection and were chronically treated with ACEIs or ARBs. Patients were randomly assigned 1:1 to discontinuation or continuation of RAS inhibition for 30 days. Primary outcome was the maximum sequential organ failure assessment (SOFA) score within 30 days, where death was scored with the maximum achievable SOFA score. Secondary endpoints were area under the death-adjusted SOFA score (AUCSOFA), mean SOFA score, admission to the intensive care unit, mechanical ventilation, and death. Analyses were done on a modified intention-to-treat basis. This trial is registered with ClinicalTrials.gov, NCT04353596. FINDINGS: Between April 20, 2020, and Jan 20, 2021, 204 patients (median age 75 years [IQR 66-80], 37% females) were randomly assigned to discontinue (n=104) or continue (n=100) RAS inhibition. Within 30 days, eight (8%) of 104 died in the discontinuation group and 12 (12%) of 100 patients died in the continuation group (p=0·42). There was no significant difference in the primary endpoint between the discontinuation and continuation group (median [IQR] maximum SOFA score 0·00 (0·00-2·00) vs 1·00 (0·00-3·00); p=0·12). Discontinuation was associated with a significantly lower AUCSOFA (0·00 [0·00-9·25] vs 3·50 [0·00-23·50]; p=0·040), mean SOFA score (0·00 [0·00-0·31] vs 0·12 [0·00-0·78]; p=0·040), and 30-day SOFA score (0·00 [10-90th percentile, 0·00-1·20] vs 0·00 [0·00-24·00]; p=0·023). At 30 days, 11 (11%) in the discontinuation group and 23 (23%) in the continuation group had signs of organ dysfunction (SOFA score ≥1) or were dead (p=0·017). There were no significant differences for mechanical ventilation (10 (10%) vs 8 (8%), p=0·87) and admission to intensive care unit (20 [19%] vs 18 [18%], p=0·96) between the discontinuation and continuation group. INTERPRETATION: Discontinuation of RAS-inhibition in COVID-19 had no significant effect on the maximum severity of COVID-19 but may lead to a faster and better recovery. The decision to continue or discontinue should be made on an individual basis, considering the risk profile, the indication for RAS inhibition, and the availability of alternative therapies and outpatient monitoring options. FUNDING: Austrian Science Fund and German Center for Cardiovascular Research.

Inequality indices to monitor geographic differences in incidence, mortality and fatality rates over time during the COVID-19 pandemic.

BACKGROUND: It is of interest to explore the variability in how the COVID-19 pandemic evolved geographically during the first twelve months. To this end, we apply inequality indices over regions to incidences, infection related mortality, and infection fatality rates. If avoiding of inequality in health is an important political goal, a metric must be implemented to track geographical inequality over time. METHODS: The relative and absolute Gini index as well as the Theil index are used to quantify inequality. Data are taken from international data bases. Absolute counts are transformed to rates adjusted for population size. RESULTS: Comparing continents, the absolute Gini index shows an unfavorable development in four continents since February 2020. In contrast, the relative Gini as well as the Theil index support the interpretation of less inequality between European countries compared to other continents. Infection fatality rates within the EU as well as within the U.S. express comparable improvement towards more equality (as measured by both Gini indices). CONCLUSIONS: The use of inequality indices to monitor changes in geographic inequality over time for key health indicators is a valuable tool to inform public health policies. The absolute and relative Gini index behave complementary and should be reported simultaneously in order to gain a meta-perspective on very complex dynamics.