State-level economic uncertainty and cardiovascular disease deaths: evidence from the United States.

The relationship between economic recessions and cardiovascular mortality has been widely explored. However, there is limited evidence on whether economic uncertainty alone is linked to cardiovascular disease deaths. This study examines the association between economic uncertainty and mortality from diseases of the circulatory system in the United States. We obtained monthly state-level mortality data from 2008 to 2017 and used indices capturing economic uncertainty from national/international sources and local sources. Panel data modelling was used to account for unobserved time-invariant differences between the states. Our findings suggest that economic uncertainty is independently linked to cardiovascular mortality. Uncertainty arising from national/international sources is associated with cardiovascular deaths, whereas the respective index capturing uncertainty from state/local sources is not. Deaths respond asymmetrically with respect to uncertainty fluctuations - with high levels of uncertainty driving the association. One- and two-month lagged uncertainty levels are also associated with mortality. Several robustness checks further validate the baseline findings. Overall, economic uncertainty is an independent predictor of cardiovascular mortality which appears to act as a psychosocial stressor and a short-term trigger. Public health strategies for cardiovascular disease need to consider factors driving economic uncertainty. Preventive measures and raising awareness can intensify in periods of economic uncertainty.

Economic uncertainty and cardiovascular disease mortality.

Previous studies have found a link between economic conditions, such as recessions and unemployment, and cardiovascular disease as well as other health outcomes. More recent research argues that economic uncertainty-independently of unemployment-can affect health outcomes. Using data from England and Wales, we study the association between fluctuations in economic uncertainty and cardiovascular disease mortality in the short term for the period 2001-2019. Controlling for several economic indicators (including unemployment), we find that economic uncertainty alone is strongly associated with deaths attributed to diseases of the circulatory system, ischemic heart disease and cerebrovascular disease. Our findings highlight the short-term link between economic conditions and cardiovascular health and reveal yet another health outcome that is associated with uncertainty.

The Effect of the COVID-19 Pandemic on Digital Health-Seeking Behavior: Big Data Interrupted Time-Series Analysis of Google Trends.

BACKGROUND: Due to the emergency responses early in the COVID-19 pandemic, the use of digital health in health care increased abruptly. However, it remains unclear whether this introduction was sustained in the long term, especially with patients being able to decide between digital and traditional health services once the latter regained their functionality throughout the COVID-19 pandemic. OBJECTIVE: We aim to understand how the public interest in digital health changed as proxy for digital health-seeking behavior and to what extent this change was sustainable over time. METHODS: We used an interrupted time-series analysis of Google Trends data with break points on March 11, 2020 (declaration of COVID-19 as a pandemic by the World Health Organization), and December 20, 2020 (the announcement of the first COVID-19 vaccines). Nationally representative time-series data from February 2019 to August 2021 were extracted from Google Trends for 6 countries with English as their dominant language: Canada, the United States, the United Kingdom, New Zealand, Australia, and Ireland. We measured the changes in relative search volumes of the keywords online doctor, telehealth, online health, telemedicine, and health app. In doing so, we capture the prepandemic trend, the immediate change due to the announcement of COVID-19 being a pandemic, and the gradual change after the announcement. RESULTS: Digital health search volumes immediately increased in all countries under study after the announcement of COVID-19 being a pandemic. There was some variation in what keywords were used per country. However, searches declined after this immediate spike, sometimes reverting to prepandemic levels. The announcement of COVID-19 vaccines did not consistently impact digital health search volumes in the countries under study. The exception is the search volume of health app, which was observed as either being stable or gradually increasing during the pandemic. CONCLUSIONS: Our findings suggest that the increased public interest in digital health associated with the pandemic did not sustain, alluding to remaining structural barriers. Further building of digital health capacity and developing robust digital health governance frameworks remain crucial to facilitating sustainable digital health transformation.

Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review.

BACKGROUND: Digital therapeutics are patient-facing digital health interventions that can significantly alter the health care landscape. Despite digital therapeutics being used to successfully treat a range of conditions, their uptake in health systems remains limited. Understanding the full spectrum of uptake factors is essential to identify ways in which policy makers and providers can facilitate the adoption of effective digital therapeutics within a health system, as well as the steps developers can take to assist in the deployment of products. OBJECTIVE: In this review, we aimed to map the most frequently discussed factors that determine the integration of digital therapeutics into health systems and practical use of digital therapeutics by patients and professionals. METHODS: A scoping review was conducted in MEDLINE, Web of Science, Cochrane Database of Systematic Reviews, and Google Scholar. Relevant data were extracted and synthesized using a thematic analysis. RESULTS: We identified 35,541 academic and 221 gray literature reports, with 244 (0.69%) included in the review, covering 35 countries. Overall, 85 factors that can impact the uptake of digital therapeutics were extracted and pooled into 5 categories: policy and system, patient characteristics, properties of digital therapeutics, characteristics of health professionals, and outcomes. The need for a regulatory framework for digital therapeutics was the most stated factor at the policy level. Demographic characteristics formed the most iterated patient-related factor, whereas digital literacy was considered the most important factor for health professionals. Among the properties of digital therapeutics, their interoperability across the broader health system was most emphasized. Finally, the ability to expand access to health care was the most frequently stated outcome measure. CONCLUSIONS: The map of factors developed in this review offers a multistakeholder approach to recognizing the uptake factors of digital therapeutics in the health care pathway and provides an analytical tool for policy makers to assess their health system's readiness for digital therapeutics.

Coverage of New Drugs in Medicare Part D.

Policy Points Only a small minority of new drugs in "nonprotected" classes are widely covered by Part D plans nationwide in the year after US Food and Drug Administration (FDA) approval. Part D plans frequently apply utilization management restrictions such as prior authorizations to newly approved drugs in both protected and nonprotected classes. Drug price influences both formulary inclusion (in nonprotected classes) and coverage restrictions (in both protected and nonprotected classes), while other drug characteristics such as therapeutic benefits are not consistently associated with formulary design. Plans do not seem to favor the minority of drugs that are determined to offer added therapeutic benefit over existing alternatives. CONTEXT: Medicare Part D is an outpatient prescription drug benefit for older Americans covering more than 46 million beneficiaries. Except for mandatory coverage for essentially all drugs in six protected classes, plans have substantial flexibility in how they design their formularies: which drugs are covered, which drugs are subject to restrictions, and what factors determine formulary placement. Our objective in this paper was to document the extent to which Part D plans limit coverage of newly approved drugs. METHODS: We examined the formulary design of 4,582 Part D plans from 2014 through 2018 and measured (1) the decision to cover newly approved drugs in nonprotected classes, (2) use of utilization management tools in protected and nonprotected classes, and (3) the association between plan design and drug-level characteristics such as 30-day cost, therapeutic benefit, and the US Food and Drug Administration (FDA) expedited regulatory pathway. FINDINGS: The FDA approved 109 new drugs predominantly used in outpatient settings between 2013 and 2017. Of these, 75 fell outside of the six protected drug classes. One-fifth of drugs in nonprotected classes (15 out of 75) were covered by more than half of plans during the first year after approval. Coverage was often conditional on utilization management strategies in both protected and nonprotected classes: only seven drugs (6%) were covered without prior authorization requirements in more than half of plans. Higher 30-day drug costs were associated with more widespread coverage in nonprotected classes: drugs that cost less than $150 for a 30-day course were covered by fewer than 20% of plans while those that cost more than $30,000 per 30 days were covered by more than 50% of plans. Plans were also more likely to implement utilization management tools on high-cost drugs in both protected and nonprotected classes. A higher proportion of plans implemented utilization management strategies on covered drugs with first-in-class status than drugs that were not first in class. Other drug characteristics, including availability of added therapeutic benefit and inclusion in FDA expedited regulatory approval, were not consistently associated with plan coverage or formulary restrictions. CONCLUSIONS: Newly approved drugs are frequently subject to formulary exclusions and restrictions in Medicare Part D. Ensuring that formulary design in Part D is linked closely to the therapeutic value of newly approved drugs would improve patients' welfare.

Moving from traditional to more advanced treatments in stroke care is cost-effective: A case study from Greece.

OBJECTIVES: Stroke is the most common cause of disability in high-income countries. Several countries offer a limited range of advanced treatments with implications for outcomes, disability and costs. This study estimates the burden of disability that could have been avoided through the transition from traditional (no intravenous thrombolytic therapy (IVT), or endovascular thrombectomy (EVT)) to modern stroke treatments (treatment in stroke units, IVT and EVT). We perform a cost-effectiveness analysis comparing best practice with traditional stroke care, using Greece as a case study. MATERIALS AND METHODS: A Markov model was used to calculate costs and Quality Adjusted Life Years (QALYs) for each treatment strategy, using a lifetime horizon. Data for model inputs were derived from meta-analyses of trials, and national and international cost databases. Sensitivity analyses were also performed to address potential uncertainty and test the robustness of the findings. RESULTS: Incremental effectiveness comprised 0.22 QALYs per patient and year. Best practice was cost-effective for more than 90% of all iterations (ICER for the baseline scenario: €2,109.25/QALY). Sensitivity analysis demonstrated that the findings remain robust. Considering the stroke incidence in Greece, the annual additional cost to implement best practice was calculated to be between 0.07%-0.15% of the total health expenditure. CONCLUSION: Best practice stroke treatment was cost-effective and affordable in a case study based on Greece. The results could be leveraged by including effects of preventive policies and rehabilitation. They also highlight the importance of adopting modern treatment strategies from a cost-effectiveness perspective, apart from the improved clinical outcomes.

Community acquired pneumonia: a cost-of-illness analysis in Greece.

INTRODUCTION: Community acquired pneumonia (CAP) is an acute respiratory infection with high clinical and economic burden, especially when hospitalisation is required. The present study aimed to assess the mean direct cost per CAP outpatient and inpatient care in Greece, in the absence of previous estimates. METHODS: A retrospective analysis of patients at a tertiary hospital, treated between October 2015 and March 2016, was conducted. Resource use data for inpatients and outpatients were collected (diagnostic tests, medication, physician visits and length of hospitalisation, where applicable). Cost calculations followed a third party payer perspective. Additionally, two regression models were employed to identify the determinants of hospitalisation and the main drivers of inpatient and outpatient cost. RESULTS: Overall, 149 inpatients and 100 outpatients were included in the analysis. Mean hospitalisation duration was 11.35 days (standard deviation (SD)=9.71 days). Mean direct cost per patient was €110.64 (SD=€58.23) and €7406.56 (SD=€12,124.93) for outpatient and inpatient cases respectively. (At the time period for the study, €1.00 was approximately A$1.50.) The main inpatient cost driver was hospitalisation (94.97%), followed by medication (3.30%) and diagnostic tests (0.87%). For outpatients, key cost drivers, in order of magnitude, were prescribed medication (38.84%), diagnostic tests (33.51%) and physician visits (17.54%). The regression analyses showed that the probability of hospitalisation increases with age and number of symptoms, whereas average cost is mainly influenced by gender, duration and number of symptoms, and the presence of comorbidities. CONCLUSION: The results indicate that, in Greece, CAP is accompanied by a significant economic burden, mainly attributable to hospitalisation. Interventions toward reducing the influence of contributors to the incidence and probability of hospitalisation are essential from a clinical and policy perspective. Also, the association of symptoms - in terms of number and duration - and age with hospitalisation probability and costs highlights that special attention should be given to the high risk groups of the population, such as the elderly and the rural residents, both in terms of preventive and therapeutic services.

Subjective social status, social network and health disparities: empirical evidence from Greece.

BACKGROUND: Several studies suggest that socioeconomic status affects (SES) affects self-rated health (SRH), both in Greece and internationally. However, prior research mainly uses objective measures of SES, instead of subjective evaluations of individuals' social status. Based on this, this paper aims to examine (a) the impact of the economic dowturn on SRH in Greece and (b) the relationship between subjective social status (SSS), social network and SRH. METHODS: The descriptive analysis is based on four cross-sectional surveys conducted by the National School of Public Health, Athens, Greece (2002, 2006, 2011, 2015), while the data for the empirical investigation were derived from the 2015 survey (Health + Welfare Survey GR). The empirical strategy is based on an ordinal logistic regression model, aiming to examine how several variables affect SRH. Size of social network and SSS are among the independent variables employed for the empirical analysis RESULTS: According to our findings, average SRH has deteriorated, and the percentage of the population that reports very good/good SRH has also decreased. Moreover, our empirical analysis suggests that age, existence of a chronic disease, size of social network and SSS affect SRH in Greece. CONCLUSION: Our findings are consistent with the existing literature and confirm a social gradient in health. According to our analysis, health disparities can be largely attributed to socioeconomic inequalities. The adverse economic climate has impact on socioeconomic differences which in turn affect health disparities. Based on these, policy initiatives are necessasy in order to mitigate the negative impact on health and the disparities caused by economic dowturn and the occuring socioeconomic inequalities.

Economic crisis, austerity and unmet healthcare needs: the case of Greece.

BACKGROUND: The programme for fiscal consolidation in Greece has led to income decrease and several changes in health policy. In this context, this study aims to assess how economic crisis affected unmet healthcare needs in Greece. METHODS: Time series analysis was performed for the years 2004 through 2011 using the EU-SILC database. The dependent variable was the percentage of people who had medical needs but did not use healthcare services. Median income, unemployment and time period were used as independent variables. We also compared self-reported unmet healthcare needs drawn from a national survey conducted in pre-crisis 2006 with a similar survey from 2011 (after the onset of the crisis). A common questionnaire was used in both years to assess unmet healthcare needs, including year of survey, gender, age, health status, chronic disease, educational level, income, employment, health insurance status, and prefecture. The outcome of interest was unmet healthcare needs due to financial reasons. Ordinary least squares, as well as logistic regression analysis were conducted to analyze the results. RESULTS: Unmet healthcare needs increased after the enactment of austerity measures, while the year of participation in the survey was significantly associated with unmet healthcare needs. Income, educational level, employment status, and having insurance, private or public, were also significant determinants of unmet healthcare needs due to financial reasons. CONCLUSIONS: The adverse economic environment has significantly affected unmet health needs. Therefore health policy actions and social policy measures are essential in order to mitigate the negative impact on access to healthcare services and health status.

Quantifying the economic benefits of prevention in a healthcare setting with severe financial constraints: the case of hypertension control.

Hypertension significantly contributes to the increased cardiovascular morbidity and mortality, thus leading to rising healthcare costs. The objective of this study was to quantify the clinical and economic benefits of optimal systolic blood pressure (SBP), in a setting under severe financial constraints, as in the case of Greece. Hence, a Markov model projecting 10-year outcomes and costs was adopted, in order to compare two scenarios. The first one depicted the "current setting", where all hypertensives in Greece presented an average SBP of 164 mmHg, while the second scenario namely "optimal SBP control" represented a hypothesis in which the whole population of hypertensives would achieve optimal SBP (i.e. <140 mmHg). Cardiovascular events' occurrence was estimated for four sub-models (according to gender and smoking status). Costs were calculated from the Greek healthcare system's perspective (discounted at a 3% annual rate). Findings showed that compared to the "current setting", universal "optimal SBP control" could, within a 10-year period, reduce the occurrence of non-fatal events and deaths, by 80 and 61 cases/1000 male smokers; 59 and 37 cases/1000 men non-smokers; whereas the respective figures for women were 69 and 57 cases/1000 women smokers; and accordingly, 52 and 28 cases/1000 women non-smokers. Considering health expenditures, they could be reduced by approximately €83 million per year. Therefore, prevention of cardiovascular events through BP control could result in reduced morbidity, thereby in substantial cost savings. Based on clinical and economic outcomes, interventions that promote BP control should be a health policy priority.

Barriers in access to healthcare services for chronic patients in times of austerity: an empirical approach in Greece.

OBJECTIVES: To investigate the magnitude of barriers in access to health services for chronic patients and the socioeconomic and demographic characteristics that affect them. METHODS: A cross-sectional study was conducted in 1,594 chronic patients suffering from diabetes, hypertension, COPD and Alzheimer. Logistic regression analyses were carried out in order to explore the factors related to economic and geographical barriers in access, as well as the determinants of barriers due to waiting lists. RESULTS: A total of 25% of chronic patients face geographical barriers while 63.5% and 58.5% of them are in front of economic and waiting list barriers, respectively. Unemployed, low-income and low-educated are more likely to face economic barriers in access. Moreover, women, low-income patients, and patients with lower health status are more likely to be in front of geographical barriers. In addition, the probability of waiting lists occurrence is greater for unemployed, employees and low income patients. CONCLUSIONS: Barriers in access can be mainly attributed to income decrease and unemployment. In this context, health policy measures are essential for removing barriers in access. Otherwise, inequalities may increase and chronic patients' health status will be deteriorated. These consequences imply adverse effects on health expenditure.

Patient outcomes, efficiency, and adverse events for elective hip and knee replacement in private and NHS hospitals: a population-based cohort study in England.

Background: Since the early 2000s, the National Health Service (NHS) in England has expanded provision of publicly funded care in private hospitals as a strategy to meet growing demand for elective care. This study aims to compare patient outcomes, efficiency and adverse events in private and NHS hospitals when providing elective hip and knee replacement. Methods: We conducted a population-based cohort study including patients ≥18 years, undergoing a publicly funded elective hip or knee replacement in private and NHS hospitals in England between January 1st 2016 and March 31st 2019. Comparative probability was estimated for three patient outcome measures (in-hospital mortality, emergency readmissions with 28 days, hospital transfers), two efficiency measures (pre-operative length of stay (LOS) >0 day and post-operative LOS >2 days), and four adverse events (hospital-associated infection, adverse drug reactions, pressure ulcers, venous thromboembolism). Probit regression was used to adjust for observable confounding followed by instrumental variable (IV) analyses to also account for unobserved confounding at the patient-level. Propensity score matching was then used as a robustness check. Findings: Our study sample included 169,232 patients in private hospitals, and 262,659 patients in NHS hospitals. Estimates from probit regression indicated that treatment in private hospital was associated with reduced probability of in-hospital mortality (-0.0009, 95% CI -0.0010, -0.0007), emergency readmissions (-0.0181, 95% CI -0.0191, -0.0172), hospital transfers (-0.0076, 95% CI -0.0084, -0.0068), prolonged post-operative LOS (-0.1174, 95% CI -0.1547, -0.0801), hospital-associated infection (-0.0115, 95% CI -0.0123, -0.0107), adverse drug reactions (-0.0051, 95% CI -0.0056, -0.0046), pressure ulcers (-0.0017, 95% CI -0.0019, -0.0014), and venous thromboembolism (-0.0027, 95% CI -0.0031, -0.0022). IV analyses produced no significant differences between private and NHS hospitals, except for lower probability in private hospitals of hospital-associated infection (-0.0057, 95% CI -0.0081, -0.0032), and greater probability in private hospitals of prolonged post-operative LOS (0.2653, 95% CI 0.1833, 0.3472). Propensity score matching produced similar results to probit regression. Interpretation: Our findings indicate there is potentially important unobservable confounding at the patient-level between private and NHS hospitals not adjusted for when using probit regression or propensity score matching. Funding: This research did not receive any dedicated funding.

Changes in digital healthcare search behavior during the early months of the COVID-19 pandemic: A study of six English-speaking countries.

Public interest is an important component influencing the likelihood of successfully implementing digital healthcare. The onset of the COVID-19 pandemic allowed us to assess how public interest in digital health changed in response to disruptions in traditional health services. In this study, we used a difference-in-differences approach to determine how digital healthcare search behavior shifted during the early months of the COVID-19 pandemic compared to the same period in 2019 across six English-speaking countries: the United States, Canada, the United Kingdom, New Zealand, Australia, and Ireland. In most cases, we observed that the official declaration of the COVID-19 pandemic on 11 March 2020 was associated with a significant overall increase in the volume of digital healthcare searches. We also found notable heterogeneity between countries in terms of the keywords that were used to search for digital healthcare, which could be explained by linguistic differences across countries or the different national digital health landscapes. Since online searches could be an initial step in the pathway to accessing health services, future studies should investigate under what circumstances increased public interest translates into demand for and utilization of digital healthcare.

Evaluation of the NHS England evidence-based interventions programme: a difference-in-difference analysis.

BACKGROUND: The NHS England evidence-based interventions programme (EBI), launched in April 2019, is a novel nationally led initiative to encourage disinvestment in low value care. METHOD: We sought to evaluate the effectiveness of this policy by using a difference-in-difference approach to compare changes in volume between January 2016 and February 2020 in a treatment group of low value procedures against a control group unaffected by the EBI programme during our period of analysis but subsequently identified as candidates for disinvestment. RESULTS: We found only small differences between the treatment and control group after implementation, with reductions in volumes in the treatment group 0.10% (95% CI 0.09% to 0.11%) smaller than in the control group (equivalent to 16 low value procedures per month). During the month of implementation, reductions in volumes in the treatment group were 0.05% (95% CI 0.03% to 0.06%) smaller than in the control group (equivalent to 7 low value procedures). Using triple difference estimators, we found that reductions in volumes were 0.35% (95% CI 0.26% to 0.44%) larger in NHS hospitals than independent sector providers (equivalent to 47 low value procedures per month). We found no significant differences between clinical commissioning groups that did or did not volunteer to be part of a demonstrator community to trial EBI guidance, but found reductions in volume were 0.06% (95% CI 0.04% to 0.08%) larger in clinical commissioning groups that posted a deficit in the financial year 2018/19 before implementation (equivalent to 4 low value procedures per month). CONCLUSIONS: Our analysis shows that the EBI programme did not accelerate disinvestment for procedures under its remit during our period of analysis. However, we find that financial and organisational factors may have had some influence on the degree of responsiveness to the EBI programme.

Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping.

BACKGROUND: The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care (eg, digital apps), research so far has primarily focused on the policy innovations that facilitated this outside of Europe. OBJECTIVE: This study examines the digital health reimbursement strategies in 8 European countries (Belgium, France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) and Israel. METHODS: We mapped available digital health reimbursement strategies using a scoping review and policy mapping framework. We reviewed the literature on the MEDLINE, Embase, Global Health, and Web of Science databases. Supplementary records were identified through Google Scholar and country experts. RESULTS: Our search strategy yielded a total of 1559 records, of which 40 (2.57%) were ultimately included in this study. As of August 2023, digital health solutions are reimbursable to some extent in all studied countries except Poland, although the mechanism of reimbursement differs significantly across countries. At the time of writing, the pricing of digital health solutions was mostly determined through discussions between national or regional committees and the manufacturers of digital health solutions in the absence of value-based assessment mechanisms. Financing digital health solutions outside traditional reimbursement schemes was possible in all studied countries except Poland and typically occurs via health innovation or digital health-specific funding schemes. European countries have value-based pricing frameworks that range from nonexistent to embryonic. CONCLUSIONS: Studied countries show divergent approaches to the reimbursement of digital health solutions. These differences may complicate the ability of patients to seek cross-country health care in another country, even if a digital health app is available in both countries. Furthermore, the fragmented environment will present challenges for developers of such solutions, as they look to expand their impact across countries and health systems. An increased emphasis on developing a clear conceptualization of digital health, as well as value-based pricing and reimbursement mechanisms, is needed for the sustainable integration of digital health. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.

Police killings and suicide among Black Americans.

Black Americans are killed at higher rates by police than whites. Previous studies have shown that discrimination can lead to suicidal ideation, and that mental health of Black Americans deteriorates after police killings. The objective of this study is to examine whether police killings are associated with an increase in suicide rates amongst Black Americans. Controlling for a number of factors, we found that on months with at least one killing of a Black person by police, there were, on average, 0.0472 additional suicides per 100,000 Black Americans in the U.S. Census Division where the killing occurred. We did not find any spillover effects on other divisions. This association persisted when controlling for gun ownership, and did not seem to be a result of variance in deaths by assault. There was no association between killings of Black Americans and white suicides; white killings and Black suicides; or white killings and white suicides. This study highlights another reason for urgent action on reducing police killings.

Funding Sources of Therapeutic and Vaccine Clinical Trials for COVID-19 vs Non-COVID-19 Indications, 2020-2021.

Importance: Effective COVID-19 vaccines and therapeutics reached the market within the first year of the pandemic. This rate of development and availability was an unprecedented achievement that required attention to numerous research and development, regulatory, and policy challenges. However, only limited evidence is currently available on the sources of funding for COVID-19 clinical trials. Objective: To compare the number and funding sources of clinical trials aimed at investigating therapeutics and vaccines for COVID-19 vs those for all non-COVID-19 indications. Design, Setting, and Participants: In this cross-sectional study, clinical trials in phase 1 to 3 that were registered to start between January 1, 2020, and August 31, 2021, were examined. All relevant data were collected from ClinicalTrials.gov. Main Outcomes and Measures: Number of clinical trials and their funding sources. Results: A total of 1977 clinical trials that addressed COVID-19 therapeutics and vaccines were registered worldwide with starting dates from January 1, 2020, to August 31, 2021. This cohort represented 13.9% of all trials (N = 14 274) during the same period. Most of the COVID-19 therapeutic and vaccine clinical trials were funded by public sources (1144 [57.9%]), followed by industry (540 [27.3%]) and public-private partnerships (293 [14.8%]). Most of these studies focused on the development of anti-COVID-19 therapeutics (1680 [85.0%]) rather than vaccines (297 [15.0%]). Conclusions and Relevance: The findings of this study suggest that publicly funded research and medical institutions played a leading role as funding sources for generating effective COVID-19 therapeutics and vaccines during the first 1.5 years of the pandemic and were most likely instrumental in their rapid development. It may be beneficial for the public sector to maintain the affordability and global access to these therapeutics and vaccines to ensure that they remain available for use worldwide.

Financial protection in health among the middle-aged and elderly: Evidence from the Greek economic recession.

Since the late 2000s, the Greek economy has entered a long period of recession, with reforms and retrenchment in health care being among the main public policy priorities. This study investigates the extent to which financial protection in health has changed among older households during the Greek crisis. We focus on the middle-aged and elderly, the heavy users of health services, who have faced a substantial health and financial burden during the crisis. Our analysis shows that the headcount and overshoot of catastrophic health expenditure (CHE) substantially increased from 2007 to 2015, suggesting that financial protection has eroded to a great extent. Prior to the crisis, CHE was mainly due to inpatient care, followed by outpatient care and medicines. However, the contribution of spending for outpatient medicines to CHE substantially increased during the study period. The headcount of CHE rose across all socioeconomic groups we examined, with low-income households and households with chronic patients being disproportionately affected. In 2007, we do not report signs of socioeconomic inequalities in the risk of CHE. On the contrary, our results show that households of low socioeconomic status are more likely to incur CHE in 2015, revealing substantial inequalities in the risk of CHE. This finding raises significant distributional and equity concerns. Strengthening financial protection among older households is an imperative challenge for the Greek health system, and several policy responses need to be adopted towards this direction.

Can We Incorporate Societal Values in Resource Allocation Decisions Among Disease Categories? An Empirical Approach.

OBJECTIVES: Historically, resource allocation decisions in healthcare are based on univariate approaches, inevitably overlooking value dimensions that are essential from a societal welfare maximization perspective. This article aims to present a wider perspective on decision making that incorporates societal values when prioritizing future resource allocation among disease areas. METHODS: Sociotechnical application of multiple-criteria decision analysis with a set of criteria (value judgments) that are based on positive as well as normative dimensions of resource allocation. We use Greece as a case study. Societal value judgments were sourced via a multidisciplinary panel of experts who collectively provided criteria weights and scores for each alternative (16 disease categories, classified according to the Global Burden of Disease study) against each criterion. An additive value function provided the total value in priority preference for each alternative. RESULTS: The criteria that were deemed relevant to the decision-making process and their respective relative weights were burden of disease (0.245), capacity to benefit (0.190), direct cost and projected changes in the next 5 years (0.160), indirect cost (0.132), intensity of unmet needs (0.109), incidence of catastrophic expenditure (0.091), and caring externalities (0.073). The additive value function revealed that the top 5 priorities in highest total value scores were neoplasms, circulatory diseases, injuries, neurologic diseases, and musculoskeletal diseases. CONCLUSIONS: Incorporation of societal value criteria in resource allocation decisions can highlight priorities and lead to different sets of planning decisions than solely demand-driven allocation.

The Mutational Landscape of Early-Onset Breast Cancer: A Next-Generation Sequencing Analysis.

BACKGROUND: Around 5%-7% of breast cancer cases are diagnosed in women younger than 40, making it the leading cause of female cancer in the 25- to 39-year-old age group. Unfortunately, young age at diagnosis is linked to a more aggressive tumor biology and a worse clinical outcome. The identification of the mutational landscape of breast cancer in this age group could optimize the management. METHODS: We performed NGS analysis in paraffin blocks and blood samples of 32 young patients with breast cancer [<40 years] and 90 older patients during the period 2019 through 2021. All patients were treated in a single institution at the Oncology Department of "Alexandra" Hospital, Medical School, University of Athens, Greece. RESULTS: Breast tumors were characterized more frequently by HER2 overexpression [25% vs 18.9%], higher ki67 levels [75% vs 61%] and lower differentiation [71.9% vs 60%] in the younger group. PIK3CA [6/20; 30%] and TP53 [6/20; 30%] were the most frequent pathogenic somatic mutations identified in young patients, while one case of BRCA2 somatic mutation [1/20; 5%] and one case of PTEN somatic mutation [1/20; 5%] were also identified. PIK3CA mutations [16/50; 32%] and TP53 mutations [20/50; 40%] were the most common somatic mutations identified in older patients, however other somatic mutations were also reported (ATM, AKT, CHEK2, NRAS, CDKN2A, PTEN, NF1, RB1, FGFR1, ERBB2). As for germline mutations, CHEK2 [3/25; 12%] was the most common pathogenic germline mutation in younger patients followed by BRCA1 [2/25; 8%]. Of note, CHEK2 germline mutations were identified less frequently in older patients [2/61; 3%] among others [BRCA1 (2/61; 3%), ATM (2/61; 3%), APC (1/61; 1,6%) and BRCA2 (1/61; 1,6%)]. CONCLUSION: We here report the mutational profile identified via NGS in patients with early-onset breast cancer compared to their older counterparts. Although the sample size is small and no statistically significant differences were detected, we highlight the need of genetic testing to most patients in this subgroup.