Evolving Science on Cardiovascular Disease Among Hispanic/Latino Adults: JACC International.

The landmark, multicenter HCHS/SOL (Hispanic Community Health Study/Study of Latinos) is the largest, most comprehensive, longitudinal community-based cohort study to date of diverse Hispanic/Latino persons in the United States. The HCHS/SOL aimed to address the dearth of comprehensive data on risk factors for cardiovascular disease (CVD) and other chronic diseases in this population and has expanded considerably in scope since its inception. This paper describes the aims/objectives and data collection of the HCHS/SOL and its ancillary studies to date and highlights the critical and sizable contributions made by the study to understanding the prevalence of and changes in CVD risk/protective factors and the burden of CVD and related chronic conditions among adults of diverse Hispanic/Latino backgrounds. The continued follow-up of this cohort will allow in-depth investigations on cardiovascular and pulmonary outcomes in this population, and data from the ongoing ancillary studies will facilitate generation of new hypotheses and study questions.

Economic and Psychosocial Impact of COVID-19 in the Hispanic Community Health Study/Study of Latinos.

Objectives: To examine the prevalence and correlates of economic hardship and psychosocial distress experienced during the initial phase of the coronavirus disease 2019 (COVID-19) pandemic in a large cohort of Hispanic/Latino adults. Methods: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), an ongoing multicenter study of Hispanic/Latino adults, collected information about COVID-19 illness and psychosocial and economic distress that occurred during the pandemic (N=11,283). We estimated the prevalence of these experiences during the initial phase of the pandemic (May 2020 to May 2021) and examined the prepandemic factors associated with pandemic-related economic hardship and emotional distress using multivariable log linear models with binomial distributions to estimate prevalence ratios. Results: Almost half of the households reported job losses and a third reported economic hardship during the first year of the pandemic. Pandemic-related household job losses and economic hardship were more pronounced among noncitizens who are likely to be undocumented. Pandemic-related economic hardship and psychosocial distress varied by age group and sex. Contrary to the economic hardship findings, noncitizens were less likely to report pandemic-related psychosocial distress. Prepandemic social resources were inversely related to psychosocial distress. Conclusions: The study findings underscore the economic vulnerability that the pandemic has brought to ethnic minoritized and immigrant populations in the United States, in particular noncitizens. The study also highlights the need to incorporate documentation status as a social determinant of health. Characterizing the initial economic and mental health impact of the pandemic is important for understanding the pandemic consequences on future health. Clinical Trial Registration Number: NCT02060344.

Comparison of COVID-19 hospitalization costs across care pathways: a patient-level time-driven activity-based costing analysis in a Brazilian hospital.

BACKGROUND: The COVID-19 pandemic raised awareness of the need to better understand where and how patient-level costs are incurred in health care organizations, as health managers and other decision-makers need to plan and quickly adapt to the increasing demand for health care services to meet patients' care needs. Time-driven activity-based costing offers a better understanding of the drivers of cost throughout the care pathway, providing information that can guide decisions on process improvement and resource optimization. This study aims to estimate COVID-19 patient-level hospital costs and to evaluate cost variability considering the in-hospital care pathways of COVID-19 management and the patient clinical classification. METHODS: This is a prospective cohort study that applied time-driven activity-based costing (TDABC) in a Brazilian reference center for COVID-19. Patients hospitalized during the first wave of the disease were selected for their data to be analyzed to estimate in-hospital costs. The cost information was calculated at the patient level and stratified by hospital care pathway and Ordinal Scale for Clinical Improvement (OSCI) category. Multivariable analyses were applied to identify predictors of cost variability in the care pathways that were evaluated. RESULTS: A total of 208 patients were included in the study. Patients followed five different care pathways, of which Emergency + Ward was the most followed (n = 118, 57%). Pathways which included the intensive care unit presented a statistically significant influence on costs per patient (p <  0.001) when compared to Emergency + Ward. The median cost per patient was I$2879 (IQR 1215; 8140) and mean cost per patient was I$6818 (SD 9043). The most expensive care pathway was the ICU only, registering a median cost per patient of I$13,519 (IQR 5637; 23,373) and mean cost per patient of I$17,709 (SD 16,020). All care pathways that included the ICU unit registered a higher cost per patient. CONCLUSIONS: This is one of the first microcosting study for COVID-19 that applied the TDABC methodology and demonstrated how patient-level costs vary as a function of the care pathways followed by patients. These findings can be used to develop value reimbursement strategies that will inform sustainable health policies in middle-income countries such as Brazil.

Collaborative Cohort of Cohorts for COVID-19 Research (C4R) Study: Study Design.

The Collaborative Cohort of Cohorts for COVID-19 Research (C4R) is a national prospective study of adults comprising 14 established US prospective cohort studies. Starting as early as 1971, investigators in the C4R cohort studies have collected data on clinical and subclinical diseases and their risk factors, including behavior, cognition, biomarkers, and social determinants of health. C4R links this pre-coronavirus disease 2019 (COVID-19) phenotyping to information on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute and postacute COVID-related illness. C4R is largely population-based, has an age range of 18-108 years, and reflects the racial, ethnic, socioeconomic, and geographic diversity of the United States. C4R ascertains SARS-CoV-2 infection and COVID-19 illness using standardized questionnaires, ascertainment of COVID-related hospitalizations and deaths, and a SARS-CoV-2 serosurvey conducted via dried blood spots. Master protocols leverage existing robust retention rates for telephone and in-person examinations and high-quality event surveillance. Extensive prepandemic data minimize referral, survival, and recall bias. Data are harmonized with research-quality phenotyping unmatched by clinical and survey-based studies; these data will be pooled and shared widely to expedite collaboration and scientific findings. This resource will allow evaluation of risk and resilience factors for COVID-19 severity and outcomes, including postacute sequelae, and assessment of the social and behavioral impact of the pandemic on long-term health trajectories.

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults.

INTRODUCTION: In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials. METHODS: Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest. RESULTS: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39). DISCUSSION: The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

Billing And Insurance-Related Administrative Costs: A Cross-National Analysis.

Billing and insurance-related costs are a significant source of wasteful health care spending in Organization for Economic Cooperation and Development nations, but these administrative burdens vary across national systems. We executed a microlevel accounting of these costs in different national settings at six provider locations in five nations (Australia, Canada, Germany, the Netherlands, and Singapore) that supplements our prior study measuring the costs in the US. We found that billing and insurance-related costs for inpatient bills range from a low of $6 in Canada to a high of $215 in the US for an inpatient surgical bill (purchasing power parity adjusted). We created a taxonomy of billing and insurance-related activities (eligibility, coding, submission, and rework) that was applied to data from the six sites and allows cross-national comparisons. Higher costs in the US and Australia are attributed to high coding costs. Much of the savings achieved in some nations is attributable to assigning tasks to people in lower-skill job categories, although most of the savings are due to more efficient billing and insurance-related processes. Some nations also reduce these costs by offering financial counseling to patients before treatment. Our microlevel approach can identify specific cost drivers and reveal national billing features that reduce coding costs. It illustrates a valuable pathway for future research in understanding and mitigating administrative costs in health care.

Collection of free-living accelerometry data in large clinical studies before and during the COVID-19 pandemic

The recent COVID-19 pandemic had a substantial impact on clinical research, including recruitment and follow-up visits in new and ongoing studies, especially affecting ones focused on older, at-risk adults. As the objective assessment of physical activity with wearables is usually initiated during in-person visits, the collection of these data experienced substantial, unplanned gaps. We report the frequency of data collection (visits-per-month) in studies collaborating with the Accelerometry Resource Core (ARC) at Johns Hopkins Center on Aging and Health. We focus on two, NIH-funded, studies that implemented the ARC accelerometry protocol. The Atherosclerosis Risk in Communities that stopped visit 8 enrollment in early 2020 and reinstated in 2021 for visit 9, and the Peripheral Artery Disease Study of SOL that started the data collection in early 2021, first via the mail-in protocol, then shifting towards in-clinic visits. Through March 2020, ARC processed an average of 125 new accelerometry per month (SD = 54). There was no new data collected for the remainder of 2020. The collection restarted in January 2021 with an average of 55 (SD = 43) files a month in the first and 112 (SD = 53) in the second quarter of 2021. A total of 573 new accelerometry observations were collected across both studies since the first wave of COVID-19 in March 2020 including 282 observations collected exclusively using a mail-in protocol. This recovery of data collection demonstrates that wearable devices allow for safer, remote assessment of physical activity, function, and sleep eliminating the need for in-person visits.

Covid-19 pandemic lessons: uncritical communication of test results can induce more harm than benefit and raises questions on standardized quality criteria for communication and liability.

BACKGROUND: The COVID-19 pandemic is characterized by both health and economic risks. A 'safety loop' model postulates risk-related decisions are not based on objective and measurable risks but on the subjective perception of those risks. We here illustrate a quantification of the difference between objective and subjective risks. METHOD: The objective risks (or chances) can be obtained from traditional 2 × 2 tables by calculating the positive (+LR) and negative (-LR) likelihood ratios. The subjective perception of objective risks is calculated from the same 2 × 2 tables by exchanging the X- and Y-axes. The traditional 2 × 2 table starts with the hypothesis, uses a test and a gold standard to confirm or exclude the investigated condition. The 2 × 2 table with inverted axes starts with the communication of a test result and presumes that the communication of bad news (whether right or false) will induce 'Perceived Anxiety' while good news will induce 'Perceived Safety'. Two different functions (confirmation and exclusion) of both perceptions (Perceived Anxiety and Safety) can be quantified with those calculations. RESULTS: The analysis of six published tests and of one incompletely reported test on COVID-19 polymerase chain reactions (completed by four assumptions on high and low sensitivities and specificities) demonstrated that none of these tests induces 'Perceived Safety'. Eight of the ten tests confirmed the induction of 'Perceived Anxiety' with + LRs (range 3.1-5900). In two of these eight tests, a -LR (0.25 and 0.004) excluded the induction of 'Perceived Safety'. CONCLUSIONS: Communication of test results caused perceived anxiety but not perceived safety in 80% of the investigated tests. Medical tests - whether true or false - generate strong psychological messages. In the case of COVID-19 tests may induce more perceived anxiety than safety. Risk communication has to balance objective and subjective risks.

A Case of COVID-19 Induced Thrombotic Thrombocytopenic Purpura.

Thrombotic Thrombocytopenic Purpura (TTP) is a challenging thrombotic diathesis which requires prompt diagnosis and therapeutic intervention in order to avoid life-threatening consequences. There are two forms of TTP, congenital and acquired, with the acquired form constituting about 90% of cases. Both forms are associated with a deficiency of ADAMTS-13, a metalloproteinase enzyme responsible for cleaving ultra-large von Willebrand factor (uLvWF), preventing its pathologic accumulation. Within the last year, many of the diverse and serious effects of the COVID-19 virus have come to recognition, with some of the most dire consequences involving devastating vascular and hematologic complications. As with many viruses, it seems that the endothelium and the vasculature are often prime targets. Here, we report a case of a 30 year old male who was diagnosed with TTP approximately one week after a positive COVID-19 test result. He responded appropriately to plasma exchange (PLEX), caplacizumab, and steroids. We believe it is important to investigate a potential link between these two conditions, as TTP has significant morbidity and mortality risk if left unattended. We hope that our report will contribute to a better understanding of this potential link.

Influence of a COVID-19 vaccine's effectiveness and safety profile on vaccination acceptance.

Although a safe and effective vaccine holds the greatest promise for resolving the COVID-19 pandemic, hesitancy to accept vaccines remains common. To explore vaccine acceptance decisions, we conducted a national survey of 1,000 people from all US states in August of 2020 and a replication in December of 2020. Using a 3 × 3 × 3 factorial experimental design, we estimated the impact of three factors: probability of 1) protection against COVID-19, 2) minor side effects, and 3) a serious adverse reactions. The outcome was respondents' reported likelihood of receiving a vaccine for the coronavirus. Probability of vaccine efficacy (50%, 70%, or 90%) had the largest effect among the three factors. The probability of minor side effects (50%, 75%, 90%) including fever and sore arm, did not significantly influence likelihood of receiving the vaccine. The chances of a serious adverse reaction, such as temporary or permanent paralysis, had a small but significant effect. A serious adverse reaction rate of 1/100,000 was more likely to discourage vaccine use in comparison to rates of 1/million or 1/100 million. All interactions between the factors were nonsignificant. A replication following the announcement that vaccines were 95% effective showed small, but significant increases in the likelihood of taking a vaccine. The main effects and interactions in the model remained unchanged. Expected benefit was more influential in respondents' decision making than expected side effects. The absence of interaction effects suggests that respondents consider the side effects and benefits independently.