Assessing barriers to access and equity for COVID-19 vaccination in the US.

BACKGROUND: Historical vaccination coverage in economically disadvantaged, ethnic minority, non-affluent white and agricultural populations in the US has lagged coverage in more affluent urban and suburban white populations due to a variety of social and economic factors. In the current COVID-19 pandemic, sociocultural and economic challenges continue to present significant obstacles to achieving equitable uptake of COVID-19 vaccines. The goal of this study was to qualitatively assess perceptions of key US healthcare stakeholders of the most significant barriers to COVID-19 vaccine access and equity to better characterize their expected impact on US communities. METHODS: After conducting a targeted literature review (TLR), we hypothesized 20 high-impact barriers which included structural and logistical barriers, capturing systemic challenges to vaccine accessibility, and attitudinal and informational barriers, affecting patient willingness to pursue vaccination. We developed a qualitative discussion guide, which included both open-ended and closed-ended questions, and interview stimulus material to conduct one-on-one in-depth interviews to assess the expected prevalence, severity, and persistence of these 20 high-impact barriers, which were hypothesized based on TLR. As a part of this qualitative study, we conducted one-on-one in-depth interviews with a diverse set of 15 US healthcare stakeholders who were involved in the COVID-19 vaccine rollout in states with relatively disparate vaccination rates by ethnicity. These stakeholders were selected to reflect an array of roles in the COVID-19 vaccine rollout, including infectious disease specialists, pharmacists, community advocacy representatives, and partners of local governments involved in the COVID-19 vaccine rollout and community education. RESULTS: Respondents identified limited vaccination sites in rural settings and technology-related barriers as the most prevalent and severe structural and logistical barriers in US communities. Respondents assessed COVID-19 vaccine safety concerns and politically motivated skepticism to be the most prevalent and severe attitudinal and informational barriers. Respondents cited proliferation of mobile vaccination clinics and local community messaging to endorse vaccines as the most effective solutions to these top structural and attitudinal barriers. Respondents expected politically motivated skepticism to be the most significant and persistent barrier to broader vaccine uptake in the US. CONCLUSIONS: Our study suggests that attitudinal barriers, particularly politically motivated skepticism, are likely to remain the most persistent challenges to widespread vaccination against COVID-19 in the US.

Incidence and economic burden of respiratory syncytial virus among adults in the United States: A retrospective analysis using 2 insurance claims databases.

BACKGROUND: Respiratory syncytial virus (RSV) is a common, contagious, and seasonal pathogen causing 64 million acute respiratory infections annually in adults and children worldwide. High-risk adults, including older adults and those with cardiopulmonary conditions or weakened immune systems, are more likely to be infected. However, limited information exists on RSV incidence and associated costs among adults, including high-risk patients. OBJECTIVE: To evaluate the annual incidence of medically attended, International Classification of Diseases (ICD)-coded RSV among commercially insured adults and assess health care costs among adults with ICD-coded RSV in the United States. METHODS: Optum's deidentified Clinformatics Data Mart Database (January 01, 2007, to June 30, 2020) and IBM's MarketScan Databases (January 01, 2000, to July 31, 2020) were used. Medically attended, ICD-coded RSV incidence among adults was assessed from July 1 of a given year to June 30 of the next year and reported per 100,000 population. Trends in all-cause mean weekly costs pre-RSV and post-RSV diagnosis were reported. Results were reported overall and among patients aged 60-64 years, 65 years or older, 85 years or older, and 18-59 years at high risk of severe RSV (defined as having cardiopulmonary conditions or a weakened immune system). RESULTS: Annual incidence of medically attended, ICD-coded RSV in adults overall was 22.0-52.9 in Optum and 23.4-63.6 in MarketScan. Incidence rates were higher among patients aged 60-64 years (Optum: 25.2-66.1; MarketScan: 31.9-82.1), 65 years or older (Optum: 37.3-75.5; MarketScan: 54.1-97.3), 85 years or older (Optum: 92.4-140.6; MarketScan: 79.4-234.7), and 18-59 years at high risk of severe RSV (Optum: 41.3-135.9; MarketScan: 46.3-112.4). Mean weekly costs increased during the week before (Optum: $2,325; MarketScan: $2,080) and post-RSV diagnosis (Optum: $9,523; MarketScan: $3,551), compared with those in weeks 2-8 pre-RSV diagnosis (Optum: $1,350; MarketScan: $872). The increases in mean weekly costs during the week before and the week following RSV diagnosis were higher among patients aged 60-64 years (mean weekly costs in weeks 2-8 pre-RSV, week 1 pre-RSV, week 1 post-RSV; Optum: $1,623, $2,690, $10,823; MarketScan: $1,259, $2,992, $5,069), 65 years or older (Optum: $1,731, $3,067, $12,866; MarketScan: $1,517, $3,571, $5,268), 85 years or older (Optum: $1,563, $2,430, $18,134; MarketScan: $1,613, $4,113, $6,231), and 18-59 years at high risk of severe RSV (only for MarketScan: $1,237, $3,294, $5,531; costs were similar for Optum). CONCLUSIONS: Incidence of medically attended, ICD-coded RSV in adults was 22.0-63.6 per 100,000 population, a likely underestimation since RSV was not systematically tested and only RSV-coded cases were observed. Incremental costs associated with RSV were substantial. Incidence rates and costs were higher among patients aged 60 years or older and patients at high risk of severe RSV. DISCLOSURES: This study was sponsored by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design, interpretation of results, manuscript preparation, and publication decisions. B. Brookhart and D. Anderson are employees of Janssen Scientific Affairs, LLC, and are stockholders of Johnson & Johnson. C. Rossi, B. Emond, J. Wang, P. Lefebvre, and M.-H. Lafeuille are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript. M. Mesa-Frias. and S. Drummond are former employees of Janssen Scientific Affairs, LLC. L. Lamerato is an employee of Henry Ford Health System and received research funding from Janssen Scientific Affairs, LLC.

Economic Burden of COVID-19: A Systematic Review.

Objective: To review and qualitatively synthesize the evidence related to the economic burden of COVID-19, including healthcare resource utilization and costs. Methods: A systematic review of studies that assessed the economic burden [eg, direct costs, productivity, macroeconomic impact due to non-pharmaceutical interventions (NPIs) and equity] of COVID-19 was conducted by searches in EMBASE, MEDLINE, MEDLINE-IN-PROCESS, and The Cochrane Library, as well as manual searches of unpublished research for the period between January 2020 to February 2021. Single reviewer data extraction was confirmed independently by a second reviewer. Results: The screening process resulted in a total of 27 studies: 25 individual publications, and 2 systematic literature reviews, of narrower scopes, that fulfilled the inclusion criteria. The patients diagnosed with more severe COVID-19 were associated with higher costs. The main drivers for higher costs were consistent across countries and included ICU admission, in-hospital resource use such as mechanical ventilation, which lead to increase costs of $2082.65 ± 345.04 to $2990.76 ± 545.98. The most frequently reported indirect costs were due to productivity losses. On average, older COVID-19 patients incurred higher costs when compared to younger age groups. An estimation of a 20% COVID-19 infection rate based on a Monte Carlo simulation in the United States led to a total direct medical cost of $163.4 billion over the course of the pandemic. Conclusion: The COVID-19 pandemic has generated a considerable economic burden on patients and the general population. Preventative measures such as NPIs only have partial success in lowering the economic costs of the pandemic. Implementing additional preventative measures such as large-scale vaccination is vital in reducing direct and indirect medical costs, decreased productivity, and GDP losses.

Real-world evidence on adherence and completion of the two-dose recombinant zoster vaccine and associated factors in U.S. adults, 2017-2021.

INTRODUCTION: Poor compliance with adult vaccination recommendations contributes to substantial disease burden. Evidence on adherence, completion, and completion timeliness for the 2-dose recombinant herpes zoster vaccine (RZV) and factors associated with these outcomes is limited and not readily generalizable for the entire U.S. METHODS: This retrospective, observational study examined adherence, completion, and the impact of sociodemographic, clinical and geographical factors among U.S. adults ≥ 50 years receiving RZV (4/20/2017 to 3/31/2021), using a large, geographically representative administrative claims database. Continuous enrollment in a medical benefit plan for six months prior to and following the index date (first observed vaccine dose) was required. Adherence was defined as receipt of the 2nd dose within 2-6 months, per label recommendation. Completion (receipt of all doses) was assessed at 6, 12, 18, and 24 months. RESULTS: Among 726,352 adults included, the adherence rate was 71.8%. Among 208,311 adults with 24-month follow-up, the completion rate was 72.3% after 6 months and 86.2% after 24 months. Logistic regression showed low adherence/completion was associated with younger age, Black or Hispanic race/ethnicity, lower income, lower educational attainment, and possessing commercial rather than Medicare healthcare insurance. Recipients identified using pharmacy claims had much higher adherence (74.0%) than those identified using medical claims (48.0%). CONCLUSIONS: Adherence and completion rates for RZV are suboptimal, especially for adults aged 50-64, racial/ethnic minorities, individuals with lower socio-economic status and those without Medicare insurance. More research and public health efforts are needed to understand and address potential barriers to RZV uptake, adherence and completion.

Hepatitis vaccination adherence and completion rates and factors associated with low compliance: A claims-based analysis of U.S. adults.

Poor compliance with multi-dose vaccine schedules by adults for whom hepatitis (Hep) A and B vaccines are recommended contributes to major Hep A and B disease burdens among high-risk U.S. adults. Evidence on hepatitis vaccine series adherence, completion, timeliness of completion, and factors associated with these outcomes, is limited and not readily generalizable for U.S. adults. This retrospective, observational study examined adherence, completion, its timeliness, and the impact of sociodemographic and clinical factors on these outcomes among a large, geographically representative sample of U.S. adults. We analyzed the Optum Clinformatics SES administrative claims database (1/1/2010-6/30/2020) for recipients of 2-dose (HepA, HepB2) or 3-dose (HepB3, HepAB) hepatitis vaccines. Adherence was defined as receipt of booster doses within specified assessment periods, per label-recommended schedules. Completion (receipt of all doses) was assessed at 6, 12, 18, and 24 months.The study included 356,828 adults ≥19 years old who were continuously enrolled in a medical benefit plan for one (HepB2), six (HepB3; HepAB), or 18 months (HepA) prior to and following the index date (first observed vaccine dose). Adherence and 24-month completion rates were: HepA (27.0%, 28.4%), HepB2 (32.2%, 44.8%), HepB3 (14.3%, 37.3%), HepAB, (15.3%, 33.8%). Kaplan-Meier completion curves plateaued after about 6 months for HepB2 and about 12 months for HepA, HepB3, and HepAB vaccines. Logistic regression analyses showed risk for low adherence/completion was generally associated with male gender, younger age, Black or Hispanic race/ethnicity, lower educational or household income attainment, and more comorbidities. Adherence and completion rates for all hepatitis vaccine series are low, especially for males, younger adults, those with lower socio-economic status and more comorbidities. To our knowledge, this is the largest claims-based analysis of adherence and completion rates for U.S. adults initiating all currently available HepA and HepB vaccines. Findings may inform hepatitis vaccination programming.

The societal economic value of COVID-19 vaccines in the United States.

AIMS: The COVID-19 pandemic has claimed the lives of more than 800,000 people in the United States (US) and has been estimated to carry a societal cost of $16 trillion over the next decade. The availability of COVID-19 vaccines has had a profound effect on the trajectory of the pandemic, with wide-ranging benefits. We aimed to estimate the total societal economic value generated in the US from COVID-19 vaccines. METHODS: We developed a population-based economic model informed by existing data and literature to estimate the total societal value generated from COVID-19 vaccines by avoiding COVID-19 infections as well as resuming social and economic activity more quickly. To do this, we separately estimated the value generated from life years saved, healthcare costs avoided, quality of life gained, and US gross domestic product (GDP) gained under a range of plausible assumptions. RESULTS: Findings from our base case analysis suggest that from their launch in December 2020, COVID-19 vaccines were projected to generate $5.0 trillion in societal economic value for the US from avoided COVID-19 infections and resuming unrestricted social and economic activity more quickly. Our scenario analyses suggest that the value could range between $1.8 and $9.9 trillion. Our model indicates that the most substantial sources of value are derived from reduction in prevalence of depression ($1.9 trillion), gains to US GDP ($1.4 trillion), and lives saved from fewer COVID-19 infections ($1.0 trillion). LIMITATIONS: Constructed as a projection from December 2020, our model does not account for the Delta or future variants, nor does it account for improvements in COVID-19 treatment. CONCLUSIONS: The magnitude of economic benefit from vaccination highlights the need for coordinated policy decisions to support continued widespread vaccine uptake in the US.

Depressive states among adults with diabetes: Findings from the National Health and Nutrition Examination Survey, 2007-2012.

AIMS: To determine (1) the prevalence of SubD states among adults with diabetes, and (2) whether evidence exists of an independent association between diabetes status and SubD, controlling for selected confounders. METHODS: Data from the 2007-2012 National Health and Nutrition Examination Surveys were combined to estimates of depressive states by diabetes status among the noninstitutionalized U.S. adult population, and to assess the association of diabetes status and depressive states using a polytomous logistic regression model. RESULTS: An estimated 17%, or 3.7 million, of U.S. adults with diabetes (diagnosed and undiagnosed) met criteria for either mD or ssD. The majority of SubD cases with diabetes were found to be ssD (10.1%) compared with mD (6.9%). After controlling for the effects of age, sex, race and ethnicity, education, body mass index, and poverty as covariates, an independent association persists between diagnosed diabetes and each SubD grouping (ssD: OR=1.82, CIs 1.33, 2.47; mD: OR=1.95, CIs 1.39, 2.74) compared with respondents having no diabetes. No association was found between depression and undiagnosed diabetes or prediabetes compared with those having no diabetes. CONCLUSION: Milder forms of depression such as ssD and mD are more extant than major depressive episodes among adults with diabetes. The odds that an adult with diagnosed diabetes meets the criteria for ssD or mD are higher by 80% and 95%, respectively, after controlling for age, sex, race and ethnicity, education, body mass index, and poverty factors when compared against adults with no diabetes.

Social capital, mortality, cardiovascular events and cancer: a systematic review of prospective studies.

BACKGROUND: Social capital is considered to be an important determinant of life expectancy and cardiovascular health. Evidence on the association between social capital and all-cause mortality, cardiovascular disease (CVD) and cancer was systematically reviewed. METHODS: Prospective studies examining the association of social capital with these outcomes were systematically sought in Medline, Embase and PsycInfo, all from inception to 8 October 2012. We categorized the findings from studies according to seven dimensions of social capital, including social participation, social network, civic participation,social support, trust, norm of reciprocity and sense of community, and pooled the estimates across studies to obtain summary relative risks of the health outcomes for each social capital dimension. We excluded studies focusing on children, refugees or immigrants and studies conducted in the former Soviet Union. RESULTS: Fourteen prospective studies were identified. The pooled estimates showed no association between most social capital dimensions and all-cause mortality, CVD or cancer. Limited evidence was found for association of increased mortality with social participation and civic participation when comparing the most extreme risk comparisons. CONCLUSIONS: Evidence to support an association between social capital and health outcomes is limited. Lack of consensus on measurements for social capital hinders the comparability of studies and weakens the evidence base.

International scientific collaboration in HIV and HPV: a network analysis.

Research endeavours require the collaborative effort of an increasing number of individuals. International scientific collaborations are particularly important for HIV and HPV co-infection studies, since the burden of disease is rising in developing countries, but most experts and research funds are found in developed countries, where the prevalence of HIV is low. The objective of our study was to investigate patterns of international scientific collaboration in HIV and HPV research using social network analysis. Through a systematic review of the literature, we obtained epidemiological data, as well as data on countries and authors involved in co-infection studies. The collaboration network was analysed in respect to the following: centrality, density, modularity, connected components, distance, clustering and spectral clustering. We observed that for many low- and middle-income countries there were no epidemiological estimates of HPV infection of the cervix among HIV-infected individuals. Most studies found only involved researchers from the same country (64%). Studies derived from international collaborations including high-income countries and either low- or middle-income countries had on average three times larger sample sizes than those including only high-income countries or low-income countries. The high global clustering coefficient (0.9) coupled with a short average distance between researchers (4.34) suggests a "small-world phenomenon." Researchers from high-income countries seem to have higher degree centrality and tend to cluster together in densely connected communities. We found a large well-connected community, which encompasses 70% of researchers, and 49 other small isolated communities. Our findings suggest that in the field of HIV and HPV, there seems to be both room and incentives for researchers to engage in collaborations between countries of different income-level. Through international collaboration resources available to researchers in high-income countries can be efficiently used to enroll more participants in low- and middle-income countries.

Quantifying uncertainty in health impact assessment: a case-study example on indoor housing ventilation.

Quantitative health impact assessment (HIA) is increasingly being used to assess the health impacts attributable to an environmental policy or intervention. As a consequence, there is a need to assess uncertainties in the assessments because of the uncertainty in the HIA models. In this paper, a framework is developed to quantify the uncertainty in the health impacts of environmental interventions and is applied to evaluate the impacts of poor housing ventilation. The paper describes the development of the framework through three steps: (i) selecting the relevant exposure metric and quantifying the evidence of potential health effects of the exposure; (ii) estimating the size of the population affected by the exposure and selecting the associated outcome measure; (iii) quantifying the health impact and its uncertainty. The framework introduces a novel application for the propagation of uncertainty in HIA, based on fuzzy set theory. Fuzzy sets are used to propagate parametric uncertainty in a non-probabilistic space and are applied to calculate the uncertainty in the morbidity burdens associated with three indoor ventilation exposure scenarios: poor, fair and adequate. The case-study example demonstrates how the framework can be used in practice, to quantify the uncertainty in health impact assessment where there is insufficient information to carry out a probabilistic uncertainty analysis.

Area-level deprivation and overall and cause-specific mortality: 12 years' observation on British women and systematic review of prospective studies.

BACKGROUND: Prospective studies have suggested a negative impact of area deprivation on overall mortality, but its effect on cause-specific mortality and the mechanisms that account for this association remain unclear. We investigate the association of area deprivation, using Index of Multiple deprivation (IMD), with overall and cause-specific mortality, contextualising findings within a systematic review. METHODS AND FINDINGS: We used data from 4,286 women from the British Women's Heart Health Study (BWHHS) recruited at 1999-2001 to examine the association of IMD with overall and cause-specific mortality using Cox regression models. One standard deviation (SD) increase in the IMD score had a hazard ratio (HR) of 1.21 (95% CI: 1.13-1.30) for overall mortality after adjustment for age and lifecourse individual deprivation, which was attenuated to 1.15 (95% CI: 1.04-1.26) after further inclusion of mediators (health behaviours, biological factors and use of statins and blood pressure-lowering medications). A more pronounced association was observed for respiratory disease and vascular deaths. The meta-analysis, based on 20 published studies plus the BWHHS (n=21), yielded a summary relative risk (RR) of 1.15 (95% CI: 1.11-1.19) for area deprivation (top [least deprived; reference] vs. bottom tertile) with overall mortality in an age and sex adjusted model, which reduced to 1.06 (95% CI: 1.04-1.08) in a fully adjusted model. CONCLUSIONS: Health behaviours mediate the association between area deprivation and cause-specific mortality. Efforts to modify health behaviours may be more successful if they are combined with measures that tackle area deprivation.

Assessing framing assumptions in quantitative health impact assessments: a housing intervention example.

Health impact assessment (HIA) is often used to determine ex ante the health impact of an environmental policy or an environmental intervention. Underpinning any HIA is the framing assumption, which defines the causal pathways mapping environmental exposures to health outcomes. The sensitivity of the HIA to the framing assumptions is often ignored. A novel method based on fuzzy cognitive map (FCM) is developed to quantify the framing assumptions in the assessment stage of a HIA, and is then applied to a housing intervention (tightening insulation) as a case-study. Framing assumptions of the case-study were identified through a literature search of Ovid Medline (1948-2011). The FCM approach was used to identify the key variables that have the most influence in a HIA. Changes in air-tightness, ventilation, indoor air quality and mould/humidity have been identified as having the most influence on health. The FCM approach is widely applicable and can be used to inform the formulation of the framing assumptions in any quantitative HIA of environmental interventions. We argue that it is necessary to explore and quantify framing assumptions prior to conducting a detailed quantitative HIA during the assessment stage.

Uncertainty in environmental health impact assessment: quantitative methods and perspectives.

Environmental health impact assessment models are subjected to great uncertainty due to the complex associations between environmental exposures and health. Quantifying the impact of uncertainty is important if the models are used to support health policy decisions. We conducted a systematic review to identify and appraise current methods used to quantify the uncertainty in environmental health impact assessment. In the 19 studies meeting the inclusion criteria, several methods were identified. These were grouped into random sampling methods, second-order probability methods, Bayesian methods, fuzzy sets, and deterministic sensitivity analysis methods. All 19 studies addressed the uncertainty in the parameter values but only 5 of the studies also addressed the uncertainty in the structure of the models. None of the articles reviewed considered conceptual sources of uncertainty associated with the framing assumptions or the conceptualisation of the model. Future research should attempt to broaden the way uncertainty is taken into account in environmental health impact assessments.

Economic modelling assessment of the HPV quadrivalent vaccine in Brazil: a dynamic individual-based approach.

We examined the cost-effectiveness of the quadrivalent HPV vaccine for the pre-adolescent female population of Brazil. Using demographic, epidemiological and cancer data, we developed a dynamic individual-based model representing the natural history of HPV/cervical cancer as well as the impact of screening and vaccination programmes. Assuming the current screening strategies, we calculated the incremental cost-effectiveness ratio (ICER) for cohorts with and without vaccination taking into account different combinations of vaccination coverage (50%, 70%, 90%) and cost per vaccinated woman (US$25, US$55, US$125, US$556). The results varied from cost-saving (coverage 50% or 70% and cost per vaccinated woman US$25) to 5950 US$/QALY (coverage 90% and cost per vaccinated 556 US$). In a scenario in which a booster shot was needed after 10 years in order to secure lifelong protection, the ICER resulted in 13,576 US$/QALY. Considering the very cost-effective and cost-effective thresholds based on Brazil's GDP per capita, apart from the booster scenario which would be deemed cost-effective, all the other scenarios would be deemed very cost-effective. Both the cost per dose of vaccine and discount rate (5%) had an important impact on the results. Vaccination in addition to the current screening programme is likely to save years of life and, depending on the cost of vaccination, may even save resources. Price negotiations between governments and manufacturers will be paramount in determining that the vaccine not only represents good value for money, but is also affordable in middle-income countries like Brazil.

Cervical cancer screening among HIV-infected women: an economic evaluation in a middle-income country.

Due to the recent widespread availability of highly active antiretroviral therapy (HAART) in middle-income countries, there has been an increase in life expectancy for women on HAART, but no corresponding decrease in cervical cancer incidence. This study evaluates the optimal cervical cancer screening strategy for HIV-infected women in a middle-income country. We developed a mathematical model, which simulates the natural history of the HPV infection, as well as the HIV-mediated immunosupression among women in Brazil. Our model was calibrated using data from the IPEC/FIOCRUZ Women's HIV-infected cohort. The model compares the lifetime effects, costs and cost-effectiveness of strategies combining cytology, HPV DNA test and colposcopy at different screening intervals for different CD4 count strata (27 strategies in total). We found that the strategy with the best cost-effectiveness profile (cost-effectiveness ratio-U$4,911/year of life saved [YLS] and probability of being cost-effective-86%) was HPV testing followed by cytology triage every year for all HIV infected women, considering a very cost-effective threshold given by Brazil's GDP per capita (US$8,625/YLS). The results were robust to changes in the input parameters as demonstrated in one-way, scenario, threshold and probabilistic sensitivity analysis. Our study indicates that annual HPV testing followed by cytology triage for all HIV-infected women is likely to be very cost-effective in a middle-income country like Brazil. The results reflect the synergic effect of using a highly sensitive screening test (HPV DNA test) in sequence with a highly specific test (cytology).