A national evaluation analysis and expert interview study of real-world data sources for research and healthcare decision-making.

Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting where major attempts are made to enable secondary use of RWD (e.g. law on the organisation of research, "Forschungsorganisationsgesetz"). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and data governance framework, which should inform researchers, as well as policy- and decision-makers, to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies.

Costs attributable to hypercholesterolemia in a single period and over the life cycle.

Hypercholesterolemia is a major risk factor for atherosclerotic cardiovascular disease leading to reduced (healthy) life years. The aim of this study is to quantify the societal costs associated with hypercholesterolemia. We use epidemiologic data on the distribution of cholesterol levels as well as data on relative risks regarding ischemic heart disease, stroke, and other cardiovascular diseases. The analytical approach is based on the use of population-attributable fractions applied to direct medical, direct non-medical and indirect costs using data of Austria. Within a life-cycle analysis we sum up the costs of hypercholesterolemia for the population of 2019 and, thus, consider future morbidity and mortality effects on this population. Epidemiologic data suggest that approximately half of Austria's population have low-density lipoprotein cholesterol (LDL-C) levels above the target levels (i.e., are exposed to increased risk). We estimate that 8.2% of deaths are attributable to hypercholesterolemia. Total costs amount to about 0.33% of GDP in the single-period view. In the life-cycle perspective, total costs amount to €806.06 million, €312.1 million of which are medical costs, and about €494 million arise due to production loss associated with hypercholesterolemia. The study points out that significant shares of deaths, entries into disability pension and care allowance, full-time equivalents lost to the labor market as well as monetary costs for the health system and the society could be avoided if LDL-C-levels of the population were reduced.

Policy implications of heterogeneous demand reactions to changes in cost-sharing: Patient-level evidence from Austria.

Cost-sharing is a prominent tool in many healthcare systems, both for raising revenue and steering patient behaviour. Although the effect of cost-sharing on demand for healthcare services has been heavily studied in the literature, researchers often apply a macro-perspective to these issues, opening the door for policy makers to the fallacy of assuming uniform demand reactions across a spectrum of different forms of treatments and diagnostic procedures. We use a simple classification system to categorize 11 such healthcare services along the dimensions of urgency and price to estimate patients' (anticipatory) demand reactions to a reduction in the co-insurance rate by a sickness fund in the Austrian social health insurance system. We use a two-stage study design combining matching and two-way fixed effects difference-in-differences estimation. Our results highlight how an overall joint estimate of an average increase in healthcare service utilization (0.8%) across all healthcare services can be driven by healthcare services that are deferrable (+1%), comparatively costly (+1.4%) or both (+1.6%) and for which patients also postponed their consumption until after the cost-sharing reduction. In contrast, we do not find a clear demand reaction for inexpensive or urgent services. The detailed analysis of the demand reaction for each individual healthcare service further illustrates their heterogeneity. We show that even comparatively minor changes to the costs borne by patients may already evoke tangible (anticipatory) demand reactions. Our findings help policy makers better understand the implications of heterogeneous demand reactions across healthcare services for using cost-sharing as a policy tool.

The role of primary care during the pandemic: shared experiences from providers in five European countries.

BACKGROUND: The COVID-19 pandemic necessitated wide-ranging adaptations to the organisation of health systems, and primary care is no exception. This article aims to collate insights on the role of primary care during the pandemic. The gained knowledge helps to increase pandemic preparedness and resilience. METHODS: The role of primary care during the pandemic in five European countries (Austria, Denmark, France, Hungary, Italy) was investigated using a qualitative approach, namely case study, based on document analysis and semi-structured interviews. In total, 31 interviews were conducted with primary care providers between June and August 2022. The five country case studies were subjected to an overarching analysis focusing on successful strategies as well as gaps and failures regarding pandemic management in primary care. RESULTS: Primary care providers identified disruptions to service delivery as a major challenge emerging from the pandemic which led to a widespread adoption of telehealth. Despite the rapid increase in telehealth usage and efforts of primary care providers to organise face-to-face care delivery in a safe way, some patient groups were particularly affected by disruptions in service delivery. Moreover, primary care providers perceived a substantial propagation of misinformation about COVID-19 and vaccines among the population, which also threatened patient-physician relationships. At the same time, primary care providers faced an increased workload, had to work with insufficient personal protective equipment and were provided incongruous guidelines from public authorities. There was a consensus among primary care providers that they were mostly sidelined by public health policy in the context of pandemic management. Primary care providers tackled these problems through a diverse set of measures including home visits, implementing infection control measures, refurbishing used masks, holding internal meetings and relying on their own experiences as well as information shared by colleagues. CONCLUSION: Primary care providers were neither well prepared nor the focus of initial policy making. However, they implemented creative solutions to the problems they faced and applying the learnings from the pandemic could help in increasing the resilience of primary care. Attributes of an integrated health system with a strong primary care component proved beneficial in addressing immediate effects of the pandemic.

Divergent COVID-19 vaccine policies: Policy mapping of ten European countries.

BACKGROUND: The COVID-19 pandemic highlighted the fragmented nature of governmental policy decisions in Europe. However, the extent to which COVID-19 vaccination policies differed between European countries remains unclear. Here, we mapped the COVID-19 vaccination policies that were in effect in January 2022 as well as booster regulations in April 2022 in Austria, Denmark, England, France, Germany, Ireland, Italy, the Netherlands, Poland, and Spain. METHODS: National public health and health policy experts from these ten European nations developed and completed an electronic questionnaire. The questionnaire included a series of questions that addressed six critical components of vaccine implementation, including (1) authorization, (2) prioritization, (3) procurement and distribution, (4) data collection, (5) administration, and (6) mandate requirements. RESULTS: Our findings revealed significant variations in COVID-19 vaccination policies across Europe. We observed critical differences in COVID-19 vaccine formulations authorized for use, as well as the specific groups that were provided with priority access. We also identified discrepancies in how vaccination-related data were recorded in each country and what vaccination requirements were implemented. CONCLUSION: Each of the ten European nations surveyed in this study reported different COVID-19 vaccination policies. These differences complicated efforts to provide a coordinated pandemic response. These findings might alert policymakers in Europe of the need to coordinate their efforts to avoid fostering divergent and socially disruptive policies.

Impact of national-scale targeted point-of-care symptomatic lateral flow testing on trends in COVID-19 infections, hospitalisations and deaths during the second epidemic wave in Austria (REAP3).

BACKGROUND: In October 2020, amidst the second COVID-19 epidemic wave and before the second-national lockdown, Austria introduced a policy of population-wide point-of-care lateral flow antigen testing (POC-LFT). This study explores the impact of this policy by quantifying the association between trends in POC-LFT-activity with trends in PCR-positivity (as a proxy for symptomatic infection), hospitalisations and deaths related to COVID-19 between October 22 and December 06, 2020. METHODS: We stratified 94 Austrian districts according to POC-LFT-activity (number of POC-LFTs performed per 100,000 inhabitants over the study period), into three population cohorts: (i) high(N = 24), (ii) medium(N = 45) and (iii) low(N = 25). Across the cohorts we a) compared trends in POC-LFT-activity with PCR-positivity, hospital admissions and deaths related to COVD-19; b) compared the epidemic growth rate before and after the epidemic peak; and c) calculated the Pearson correlation coefficients between PCR-positivity with COVID-19 hospitalisations and with COVID -19 related deaths. RESULTS: The trend in POC-LFT activity was similar to PCR-positivity and hospitalisations trends across high, medium and low POC-LFT activity cohorts, with association with deaths only present in cohorts with high POC-LFT activity. Compared to the low POC-LFT-activity cohort, the high-activity cohort had steeper pre-peak daily increase in PCR-positivity (2.24 more cases per day, per district and per 100,000 inhabitants; 95% CI: 2.0-2.7; p < 0.001) and hospitalisations (0.10; 95% CI: 0.02, 0.18; p = 0.014), and 6 days earlier peak of PCR-positivity. The high-activity cohort also had steeper daily reduction in the post-peak trend in PCR-positivity (-3.6; 95% CI: -4.8, -2.3; p < 0.001) and hospitalisations (-0.2; 95% CI: -0.32, -0.08; p = 0.001). PCR-positivity was positively correlated to both hospitalisations and deaths, but with lags of 6 and 14 days respectively. CONCLUSIONS: High POC-LFT-use was associated with increased and earlier case finding during the second Austrian COVID-19 epidemic wave, and early and significant reduction in cases and hospitalisations during the second national lockdown. A national policy promoting symptomatic POC-LFT in primary care, can capture trends in PCR-positivity and hospitalisations. Symptomatic POC-LFT delivered at scale and combined with immediate self-quarantining and contact tracing can thus be a proxy for epidemic status, and hence a useful tool that can replace large-scale PCR testing.

Exploring the effectiveness of demand-side retail pharmaceutical expenditure reforms : Cross-country evidence from weighted-average least squares estimation.

Increasing expenditures on retail pharmaceuticals bring a critical challenge to the financial stability of healthcare systems worldwide. Policy makers have reacted by introducing a range of measures to control the growth of public pharmaceutical expenditure (PPE). Using panel data on European and non-European OECD member countries from 1990 to 2015, we evaluate the effectiveness of six types of demand-side expenditure control measures including physician-level behaviour measures, system-level price-control measures and substitution measures, alongside a proxy for cost-sharing and add a new dimension to the existing empirical evidence hitherto based on national-level and meta-studies. We use the weighted-average least squares regression framework adapted for estimation with panel-corrected standard errors. Our empirical analysis suggests that direct patient cost-sharing and some-but not all-demand-side measures successfully dampened PPE growth in the past. Cost-sharing schemes stand out as a powerful mechanism to curb PPE growth, but bear a high risk of adverse effects. Other demand-side measures are more limited in effect, though may be more equitable. Due to limitations inherent in the study approach and the data, the results are only explorative.

Risk assessment of COVID-19 epidemic resurgence in relation to SARS-CoV-2 variants and vaccination passes.

The introduction of COVID-19 vaccination passes (VPs) by many countries coincided with the Delta variant fast becoming dominant across Europe. A thorough assessment of their impact on epidemic dynamics is still lacking. Here, we propose the VAP-SIRS model that considers possibly lower restrictions for the VP holders than for the rest of the population, imperfect vaccination effectiveness against infection, rates of (re-)vaccination and waning immunity, fraction of never-vaccinated, and the increased transmissibility of the Delta variant. Some predicted epidemic scenarios for realistic parameter values yield new COVID-19 infection waves within two years, and high daily case numbers in the endemic state, even without introducing VPs and granting more freedom to their holders. Still, suitable adaptive policies can avoid unfavorable outcomes. While VP holders could initially be allowed more freedom, the lack of full vaccine effectiveness and increased transmissibility will require accelerated (re-)vaccination, wide-spread immunity surveillance, and/or minimal long-term common restrictions.

When to end a lock down? How fast must vaccination campaigns proceed in order to keep health costs in check?

We propose a simple rule of thumb for countries which have embarked on a vaccination campaign while still facing the need to keep non-pharmaceutical interventions (NPI) in place because of the ongoing spread of SARS-CoV-2. If the aim is to keep the death rate from increasing, NPIs can be loosened when it is possible to vaccinate more than twice the growth rate of new cases. If the aim is to keep the pressure on hospitals under control, the vaccination rate has to be about four times higher. These simple rules can be derived from the observation that the risk of death or a severe course requiring hospitalization from a COVID-19 infection increases exponentially with age and that the sizes of age cohorts decrease linearly at the top of the population pyramid. Protecting the over 60-year-olds, which constitute approximately one-quarter of the population in Europe (and most OECD countries), reduces the potential loss of life by 95 percent.

The benefits, costs and feasibility of a low incidence COVID-19 strategy.

In the summer of 2021, European governments removed most NPIs after experiencing prolonged second and third waves of the COVID-19 pandemic. Most countries failed to achieve immunization rates high enough to avoid resurgence of the virus. Public health strategies for autumn and winter 2021 have ranged from countries aiming at low incidence by re-introducing NPIs to accepting high incidence levels. However, such high incidence strategies almost certainly lead to the very consequences that they seek to avoid: restrictions that harm people and economies. At high incidence, the important pandemic containment measure 'test-trace-isolate-support' becomes inefficient. At that point, the spread of SARS-CoV-2 and its numerous harmful consequences can likely only be controlled through restrictions. We argue that all European countries need to pursue a low incidence strategy in a coordinated manner. Such an endeavour can only be successful if it is built on open communication and trust.

A look into the future of the COVID-19 pandemic in Europe: an expert consultation.

How will the coronavirus disease 2019 (COVID-19) pandemic develop in the coming months and years? Based on an expert survey, we examine key aspects that are likely to influence the COVID-19 pandemic in Europe. The challenges and developments will strongly depend on the progress of national and global vaccination programs, the emergence and spread of variants of concern (VOCs), and public responses to non-pharmaceutical interventions (NPIs). In the short term, many people remain unvaccinated, VOCs continue to emerge and spread, and mobility and population mixing are expected to increase. Therefore, lifting restrictions too much and too early risk another damaging wave. This challenge remains despite the reduced opportunities for transmission given vaccination progress and reduced indoor mixing in summer 2021. In autumn 2021, increased indoor activity might accelerate the spread again, whilst a necessary reintroduction of NPIs might be too slow. The incidence may strongly rise again, possibly filling intensive care units, if vaccination levels are not high enough. A moderate, adaptive level of NPIs will thus remain necessary. These epidemiological aspects combined with economic, social, and health-related consequences provide a more holistic perspective on the future of the COVID-19 pandemic.

Comparing the diagnostic accuracy of point-of-care lateral flow antigen testing for SARS-CoV-2 with RT-PCR in primary care (REAP-2).

BACKGROUND: Testing for COVID-19 with quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) may result in delayed detection of disease. Antigen detection via lateral flow testing (LFT) is faster and amenable to population-wide testing strategies. Our study assesses the diagnostic accuracy of LFT compared to RT-PCR on the same primarycare patients in Austria. METHODS: Patients with mild to moderate flu-like symptoms attending a general practice network in an Austrian district (October 22 to November 30, 2020) received clinical assessment including LFT. All suspected COVID-19 cases obtained additional RT-PCR and were divided into two groups: Group 1 (true reactive): suspected cases with reactive LFT and positive RT-PCR; and Group 2 (false non-reactive): suspected cases with a non-reactive LFT but positive RT-PCR. FINDINGS: Of the 2,562 symptomatic patients, 1,037 were suspected of COVID-19 and 826 (79.7%) patients tested RT-PCR positive. Among patients with positive RT-PCR, 788/826 tested LFT reactive (Group 1) and 38 (4.6%) non-reactive (Group 2). Overall sensitivity was 95.4% (95%CI: [94%,96.8%]), specificity 89.1% (95%CI: [86.3%, 91.9%]), positive predictive value 97.3% (95%CI:[95.9%, 98.7%]) and negative predictive value 82.5% (95%CI:[79.8%, 85.2%]). Reactive LFT and positive RT-PCR were positively correlated (r = 0.968,95CI=[0.952,0.985] and κ = 0.823 , 95%CI=[0.773,0.866]). Reactive LFT was negatively correlated with Ct-value ( r  = -0.2999, p  < 0.001) and pre-test symptom duration (r = -0.1299,p = 0.0043) while Ct-value was positively correlated with pre-test symptom duration (r = 0.3733),p < 0.001). INTERPRETATION: We show that LFT is an accurate alternative to RT-PCR testing in primary care. We note the importance of administering LFT properly, here combined with clinical assessment in symptomatic patients. FUNDING: Thomas Czypionka received funding from the European Union's Horizon 2020 Research and Innovation Programe under the grant agreement No 101016233 (PERISCOPE). No further funding was available for this study.

Drivers of successful implementation of integrated care for multi-morbidity: Mechanisms identified in 17 case studies from 8 European countries.

This paper provides a deeper understanding of the mechanisms underlying implementation strategies for integrated care. As part of the SELFIE project, 17 integrated care programmes addressing multi-morbidity from eight European countries were selected and studied. Data was extracted from 'thick descriptions' of the 17 programmes and analysed both inductively and deductively using implementation theory. The following ten mechanisms for successful implementation of integrated care were identified. With regards to service delivery, successful implementers (1) commonly adopted an incremental growth model rather than a disruptive innovation approach, and found (2) a balance between flexibility and formal structures of integration. For leadership & governance, they (3) applied collaborative governance by engaging all stakeholders, and (4) distributed leadership throughout all levels of the system. For the workforce, these implementers (5) were able to build a multidisciplinary team culture with mutual recognition of each other's roles, and (6) stimulated the development of new roles and competencies for integrated care. With respect to financing, (7) secured long-term funding and innovative payments were applied as means to overcome fragmented financing of health and social care. Implementers emphasised (8) the implementation of ICT that was specifically developed to support collaboration and communication rather than administrative procedures (technology & medical devices), and (9) created feedback loops and a continuous monitoring system (information & research). The overarching mechanism was that implementers (10) engaged in alignment work across the different components and levels of the health and social care system. These evidence-based mechanisms for implementation are applicable in different local, regional and national contexts.

Regional medical practice variation in high-cost healthcare services : Evidence from diagnostic imaging in Austria.

Magnetic resonance imaging (MRI) is a popular yet cost-intensive diagnostic measure whose strengths compared to other medical imaging technologies have led to increased application. But the benefits of aggressive testing are doubtful. The comparatively high MRI usage in Austria in combination with substantial regional variation has hence become a concern for its policy makers. We use a set of routine healthcare data on outpatient MRI service consumption of Austrian patients between Q3-2015 and Q2-2016 on the district level to investigate the extent of medical practice variation in a two-step statistical analysis combining multivariate regression models and Blinder-Oaxaca decomposition. District-level MRI exam rates per 1.000 inhabitants range from 52.38 to 128.69. Controlling for a set of regional characteristics in a multivariate regression model, we identify payer autonomy in regulating access to MRI scans as the biggest contributor to regional variation. Nevertheless, the statistical decomposition highlights that more than 70% of the regional variation remains unexplained by differences between the observable district characteristics. In the absence of epidemiological explanations, the substantial regional medical practice variation calls the efficiency of resource deployment into question.

Masks and Face Coverings for the Lay Public : A Narrative Update.

Whether and when to mandate the wearing of facemasks in the community to prevent the spread of coronavirus disease 2019 remains controversial. Published literature across disciplines about the role of masks in mitigating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission is summarized. Growing evidence that SARS-CoV-2 is airborne indicates that infection control interventions must go beyond contact and droplet measures (such as handwashing and cleaning surfaces) and attend to masking and ventilation. Observational evidence suggests that masks work mainly by source control (preventing infected persons from transmitting the virus to others), but laboratory studies of mask filtration properties suggest that they could also provide some protection to wearers (protective effect). Even small reductions in individual transmission could lead to substantial reductions in population spread. To date, only 1 randomized controlled trial has examined a community mask recommendation. This trial did not identify a significant protective effect and was not designed to evaluate source control. Filtration properties and comfort vary widely across mask types. Masks may cause discomfort and communication difficulties. However, there is no evidence that masks result in significant physiologic decompensation or that risk compensation and fomite transmission are associated with mask wearing. The psychological effects of masks are culturally shaped; they may include threats to autonomy, social relatedness, and competence. Evidence suggests that the potential benefits of wearing masks likely outweigh the potential harms when SARS-CoV-2 is spreading in a community. However, mask mandates involve a tradeoff with personal freedom, so such policies should be pursued only if the threat is substantial and mitigation of spread cannot be achieved through other means.