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Key Points: Question: How many excess deaths and years of potential life lost for the Black population, compared with the White population, occurred in the United States from 1999 through 2020? Findings: Based on Centers for Disease Control and Prevention data, excess deaths and years of potential life lost persisted throughout the period, with initial progress followed by stagnation of improvement and substantial worsening in 2020. The Black population had 1.63 million excess deaths, representing more than 80 million years of potential life lost over the study period. Meaning: After initial progress, excess mortality and years of potential life lost among the US Black population stagnated and then worsened, indicating a need for new approaches. Importance: Amid efforts in the US to promote health equity, there is a need to assess recent progress in reducing excess deaths and years of potential life lost among the Black population compared with the White population. Objective: To evaluate trends in excess mortality and years of potential life lost among the Black population compared with the White population. Design, setting, and participants: Serial cross-sectional study using US national data from the Centers for Disease Control and Prevention from 1999 through 2020. We included data from non-Hispanic White and non-Hispanic Black populations across all age groups. Exposures: Race as documented in the death certificates. Main outcomes and measures: Excess age-adjusted all-cause mortality, cause-specific mortality, age-specific mortality, and years of potential life lost rates (per 100 000 individuals) among the Black population compared with the White population. Results: From 1999 to 2011, the age-adjusted excess mortality rate declined from 404 to 211 excess deaths per 100 000 individuals among Black males (P for trend <.001). However, the rate plateaued from 2011 through 2019 (P for trend =.98) and increased in 2020 to 395—rates not seen since 2000. Among Black females, the rate declined from 224 excess deaths per 100 000 individuals in 1999 to 87 in 2015 (P for trend <.001). There was no significant change between 2016 and 2019 (P for trend =.71) and in 2020 rates increased to 192—levels not seen since 2005. The trends in rates of excess years of potential life lost followed a similar pattern. From 1999 to 2020, the disproportionately higher mortality rates in Black males and females resulted in 997 623 and 628 464 excess deaths, respectively, representing a loss of more than 80 million years of life. Heart disease had the highest excess mortality rates, and the excess years of potential life lost rates were largest among infants and middle-aged adults. Conclusions and relevance: Over a recent 22-year period, the Black population in the US experienced more than 1.63 million excess deaths and more than 80 million excess years of life lost when compared with the White population. After a period of progress in reducing disparities, improvements stalled, and differences between the Black population and the White population worsened in 2020. This study focuses on differences in mortality and years of potential life lost between Black and White populations to understand recent trends. [ABSTRACT FROM AUTHOR]

Background: Whether there are sex differences in hemodynamic profiles among people with elevated blood pressure is not well understood and could guide personalization of treatment. Methods and results: We described the clinical and hemodynamic characteristics of adults with elevated blood pressure in China using impedance cardiography. We included 45,082 individuals with elevated blood pressure (defined as systolic blood pressure of ≥130 mmHg or a diastolic blood pressure of ≥80 mmHg), of which 35.2% were women. Overall, women had a higher mean systolic blood pressure than men (139.0 [±15.7] mmHg vs 136.8 [±13.8] mmHg, P<0.001), but a lower mean diastolic blood pressure (82.6 [±9.0] mmHg vs 85.6 [±8.9] mmHg, P<0.001). After adjusting for age, region, and body mass index, women <50 years old had lower systemic vascular resistance index (beta-coefficient [β] -31.7; 95% CI: -51.2, -12.2) and higher cardiac index (β 0.07; 95% CI: 0.04, 0.09) than men of their same age group, whereas among those ≥50 years old women had higher systemic vascular resistance index (β 120.4; 95% CI: 102.4, 138.5) but lower cardiac index (β -0.15; 95% CI: -0.16, -0.13). Results were consistent with a propensity score matching sensitivity analysis, although the magnitude of the SVRI difference was lower and non-significant. However, there was substantial overlap between women and men in the distribution plots of these variables, with overlapping areas ranging from 78% to 88%. Conclusions: Our findings indicate that there are sex differences in hypertension phenotype, but that sex alone is insufficient to infer an individual's profile. [ABSTRACT FROM AUTHOR]

This study describes the degree to which blood draws occurred among hospitalized patients during traditional sleep hours and investigates trends over time. [ABSTRACT FROM AUTHOR]

Importance: The elimination of racial and ethnic differences in health status and health care access is a US goal, but it is unclear whether the country has made progress over the last 2 decades.Objective: To determine 20-year trends in the racial and ethnic differences in self-reported measures of health status and health care access and affordability among adults in the US.Design, Setting, and Participants: Serial cross-sectional study of National Health Interview Survey data, 1999-2018, that included 596 355 adults.Exposures: Self-reported race, ethnicity, and income level.Main Outcomes and Measures: Rates and racial and ethnic differences in self-reported health status and health care access and affordability.Results: The study included 596 355 adults (mean [SE] age, 46.2 [0.07] years, 51.8% [SE, 0.10] women), of whom 4.7% were Asian, 11.8% were Black, 13.8% were Latino/Hispanic, and 69.7% were White. The estimated percentages of people with low income were 28.2%, 46.1%, 51.5%, and 23.9% among Asian, Black, Latino/Hispanic, and White individuals, respectively. Black individuals with low income had the highest estimated prevalence of poor or fair health status (29.1% [95% CI, 26.5%-31.7%] in 1999 and 24.9% [95% CI, 21.8%-28.3%] in 2018), while White individuals with middle and high income had the lowest (6.4% [95% CI, 5.9%-6.8%] in 1999 and 6.3% [95% CI, 5.8%-6.7%] in 2018). Black individuals had a significantly higher estimated prevalence of poor or fair health status than White individuals in 1999, regardless of income strata (P < .001 for the overall and low-income groups; P = .03 for middle and high-income group). From 1999 to 2018, racial and ethnic gaps in poor or fair health status did not change significantly, with or without income stratification, except for a significant decrease in the difference between White and Black individuals with low income (-6.7 percentage points [95% CI, -11.3 to -2.0]; P = .005); the difference in 2018 was no longer statistically significant (P = .13). Black and White individuals had the highest levels of self-reported functional limitations, which increased significantly among all groups over time. There were significant reductions in the racial and ethnic differences in some self-reported measures of health care access, but not affordability, with and without income stratification.Conclusions and Relevance: In a serial cross-sectional survey study of US adults from 1999 to 2018, racial and ethnic differences in self-reported health status, access, and affordability improved in some subgroups, but largely persisted. [ABSTRACT FROM AUTHOR]

Background: Patients with comorbid conditions have a higher risk of mortality with SARS-CoV-2 (COVID-19) infection, but the impact on heart failure patients living near a disease hotspot is unknown. Therefore, we sought to characterize the prevalence and outcomes of COVID-19 in a live registry of heart failure patients across an integrated health care system in Connecticut. Methods: In this retrospective analysis, the Yale Heart Failure Registry (NCT04237701) that includes 26,703 patients with heart failure across a 6-hospital integrated health care system in Connecticut was queried on April 16th, 2020 for all patients tested for COVID-19. Sociodemographic and geospatial data as well as, clinical management, respiratory failure, and patient mortality were obtained via the real-time registry. Data on COVID-19 specific care was extracted by retrospective chart review. Results: COVID-19 testing was performed on 900 symptomatic patients, comprising 3.4% of the Yale Heart Failure Registry (N = 26,703). Overall, 206 (23%) were COVID- 19+. As compared to COVID-19-, these patients were more likely to be older, black, have hypertension, coronary artery disease, and were less likely to be on renin angiotensin blockers (P<0.05, all). COVID-19- patients tended to be more diffusely spread across the state whereas COVID-19+ were largely clustered around urban centers. 20% of COVID-19+ patients died, and age was associated with increased risk of death [OR 1.92 95% CI (1.33–2.78); P<0.001]. Among COVID-19+ patients who were ≥85 years of age rates of hospitalization were 87%, rates of death 36%, and continuing hospitalization 62% at time of manuscript preparation. Conclusions: In this real-world snapshot of COVID-19 infection among a large cohort of heart failure patients, we found that a small proportion had undergone testing. Patients found to be COVID-19+ tended to be black with multiple comorbidities and clustered around lower socioeconomic status communities. Elderly COVID-19+ patients were very likely to be admitted to the hospital and experience high rates of mortality. [ABSTRACT FROM AUTHOR]

Objective: To determine the association between the primary site of infection and in-hospital mortality as the main outcome, or the need for admission to the intensive care unit as a secondary outcome, in patients with sepsis admitted to the emergency department. Methods: This was a secondary analysis of a multicenter prospective cohort. Patients included in the study were older than 18 years with a diagnosis of severe sepsis or septic shock who were admitted to the emergency departments of three tertiary care hospitals. Of the 5022 eligible participants, 2510 were included. Multiple logistic regression analysis was performed for mortality. Results: The most common site of infection was the urinary tract, present in 27.8% of the cases, followed by pneumonia (27.5%) and intra-abdominal focus (10.8%). In 5.4% of the cases, no definite site of infection was identified on admission. Logistic regression revealed a significant association between the following sites of infection and in-hospital mortality when using the urinary infection group as a reference: pneumonia (OR 3.4; 95%CI, 2.2 - 5.2; p < 0.001), skin and soft tissues (OR 2.6; 95%CI, 1.4 - 5.0; p = 0.003), bloodstream (OR 2.0; 95%CI, 1.1 - 3.6; p = 0.018), without specific focus (OR 2.0; 95%CI, 1.1 - 3.8; p = 0.028), and intra-abdominal focus (OR 1.9; 95%CI, 1.1 - 3.3; p = 0.024). Conclusions: There is a significant association between the different sites of infection and in-hospital mortality or the need for admission to an intensive care unit in patients with sepsis or septic shock. Urinary tract infection shows the lowest risk, which should be considered in prognostic models of these conditions. [ABSTRACT FROM AUTHOR]

Background: Disparities in multimorbidity prevalence indicate health inequalities, as the risk of morbidity does not intrinsically differ by race/ethnicity. This study aimed to determine if multimorbidity differences by race/ethnicity are decreasing over time.Methods: Serial cross-sectional analysis of the National Health Interview Survey, 1999-2018. Included individuals were ≥18 years old and categorized by self-reported race, ethnicity, age, and income. The main outcomes were temporal trends in multimorbidity prevalence based on the self-reported presence of ≥2 of 9 common chronic conditions.Findings: The study sample included 596,355 individuals (4.7% Asian, 11.8% Black, 13.8% Latino/Hispanic, and 69.7% White). In 1999, the estimated prevalence of multimorbidity was 5.9% among Asian, 17.4% among Black, 10.7% among Latino/Hispanic, and 13.5% among White individuals. Prevalence increased for all racial/ethnic groups during the study period (P ≤ .001 for each), with no significant change in the differences between them. In 2018, compared with White individuals, multimorbidity was more prevalent among Black individuals (+2.5 percentage points) and less prevalent among Asian and Latino/Hispanic individuals (-6.6 and -2.1 percentage points, respectively). Among those aged ≥30 years, Black individuals had multimorbidity prevalence equivalent to that of Latino/Hispanic and White individuals aged 5 years older, and Asian individuals aged 10 years older.Conclusions: From 1999 to 2018, a period of increasing multimorbidity prevalence for all the groups studied, there was no significant progress in eliminating disparities between Black individuals and White individuals. Public health interventions that prevent the onset of chronic conditions in early life may be needed to eliminate these disparities. [ABSTRACT FROM AUTHOR]

Younger women experience worse health status than men after their index episode of acute myocardial infarction (AMI). However, whether women have a higher risk for cardiovascular and noncardiovascular hospitalizations in the year after discharge is unknown. The aim of this study was to determine sex differences in causes and timing of 1-year outcomes after AMI in people aged 18 to 55 years. Data from the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study, which enrolled young patients with AMI across 103 U.S. hospitals, were used. Sex differences in all-cause and cause-specific hospitalizations were compared by calculating incidence rates ([IRs] per 1,000 person-years) and IR ratios with 95% CIs. We then performed sequential modeling to evaluate the sex difference by calculating subdistribution HRs (SHRs) accounting for deaths. Among 2,979 patients, at least 1 hospitalization occurred among 905 patients (30.4%) in the year after discharge. The leading causes of hospitalization were coronary related (IR: 171.8 [95% CI: 153.6-192.2] among women vs 117.8 [95% CI: 97.3-142.6] among men), followed by noncardiac hospitalization (IR: 145.8 [95% CI: 129.2-164.5] among women vs 69.6 [95% CI: 54.5-88.9] among men). Furthermore, a sex difference was present for coronary-related hospitalizations (SHR: 1.33; 95% CI: 1.04-1.70; P = 0.02) and noncardiac hospitalizations (SHR: 1.51; 95% CI: 1.13-2.07; P = 0.01). Young women with AMI experience more adverse outcomes than men in the year after discharge. Coronary-related hospitalizations were most common, but noncardiac hospitalizations showed the most significant sex disparity. [Display omitted] [ABSTRACT FROM AUTHOR]

Key Points: Question: When medical devices that had been cleared under the FDA's 510(k) pathway are subject to Class I recalls, how often did the predicates for these devices also have a history of recalls? Findings: In this cross-sectional analysis of 156 cases of 510(k)–authorized devices with Class I recalls from 2017 through 2021, 44.1% used predicates with Class I recalls. In addition, 48.1% of these devices were subsequently used as predicates to authorize descendant devices later subject to Class I recalls. The risk of a Class I recall was 6.40 times higher for descendants that used predicates with Class I recalls than for devices using Class I recall–free predicates. Meaning: Stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety. Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall—the FDA's most serious designation indicating a high probability of adverse health consequences or death—as predicates for new devices. The consequences for patient safety are not known. Objective: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. Design and Setting: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. Main Outcomes and Measures: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. Results: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40]; P<.001). Conclusions and Relevance: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety. This cross-sectional study evaluates the frequency of new devices receiving US Food and Drug Administration approval through its 510(k) pathway based on predicate devices that had been subject to a Class 1 recall. [ABSTRACT FROM AUTHOR]

Background: Infection fatality rate and infection hospitalization rate, defined as the proportion of deaths and hospitalizations, respectively, of the total infected individuals, can estimate the actual toll of coronavirus disease 2019 (COVID-19) on a community, as the denominator is ideally based on a representative sample of a population, which captures the full spectrum of illness, including asymptomatic and untested individuals.Objective: To determine the COVID-19 infection hospitalization rate and infection fatality rate among the non-congregate population in Connecticut between March 1 and June 1, 2020.Methods: The infection hospitalization rate and infection fatality rate were calculated for adults residing in non-congregate settings in Connecticut prior to June 2020. Individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies were estimated using the seroprevalence estimates from the recently conducted Post-Infection Prevalence study. Information on total hospitalizations and deaths was obtained from the Connecticut Hospital Association and the Connecticut Department of Public Health, respectively.Results: Prior to June 1, 2020, nearly 113,515 (90% confidence interval [CI] 56,758-170,273) individuals were estimated to have SARS-CoV-2 antibodies, and there were 7792 hospitalizations and 1079 deaths among the non-congregate population. The overall COVID-19 infection hospitalization rate and infection fatality rate were estimated to be 6.86% (90% CI, 4.58%-13.72%) and 0.95% (90% CI, 0.63%-1.90%), respectively, and there was variation in these rate estimates across subgroups; older people, men, non-Hispanic Black people, and those belonging to 2 of the counties had a higher burden of adverse outcomes, although the differences between most subgroups were not statistically significant.Conclusions: Using representative seroprevalence estimates, the overall COVID-19 infection hospitalization rate and infection fatality rate were estimated to be 6.86% and 0.95%, respectively, among community residents in Connecticut. [ABSTRACT FROM AUTHOR]

Introduction: Despite evidence supporting the benefits of marriage on cardiovascular health, the impact of marital/partner status on the long-term readmission of young acute myocardial infarction (AMI) survivors is less clear. We examined the association between marital/partner status and 1-year all-cause readmission and explored sex differences among young AMI survivors. Methods: Data were from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled young adults aged 18–55 years with AMI (2008–2012). The primary end point was all-cause readmission within 1 year of hospital discharge, obtained from medical records and patient interviews and adjudicated by a physician panel. We performed Cox proportional hazards models with sequential adjustment for demographic, socioeconomic, clinical, and psychosocial factors. Sex-marital/partner status interaction was also tested. Results: Of the 2,979 adults with AMI (2002 women [67.2%]; mean age 48 [interquartile range, 44–52] years), unpartnered individuals were more likely to experience all-cause readmissions compared with married/partnered individuals within the first year after hospital discharge (34.6% versus 27.2%, hazard ratio [HR] = 1.31; 95% confidence interval [CI], 1.15–1.49). The association attenuated but remained significant after adjustment for demographic and socioeconomic factors (adjusted HR, 1.16; 95% CI, 1.01–1.34), and it was not significant after further adjusting for clinical factors and psychosocial factors (adjusted HR, 1.10; 95%CI, 0.94–1.28). A sex-marital/partner status interaction was not significant (p = 0.69). Sensitivity analysis using data with multiple imputation and restricting outcomes to cardiac readmission yielded comparable results. Conclusions: In a cohort of young adults aged 18–55 years, unpartnered status was associated with 1.3-fold increased risk of all-cause readmission within 1 year of AMI discharge. Further adjustment for demographic, socioeconomic, clinical, and psychosocial factors attenuated the association, suggesting that these factors may explain disparities in readmission between married/partnered versus unpartnered young adults. Whereas young women experienced more readmission compared to similar-aged men, the association between marital/partner status and 1-year readmission did not vary by sex. [ABSTRACT FROM AUTHOR]

Objective: Health-related expenditures resulting from diabetes are rising in the U.S. Medication nonadherence is associated with worse health outcomes among adults with diabetes. We sought to examine the extent of reported cost-related medication nonadherence (CRN) in individuals with diabetes in the U.S.Research Design and Methods: We studied adults age ≥18 years with self-reported diabetes from the National Health Interview Survey (NHIS) (2013-2018), a U.S. nationally representative survey. Adults reporting skipping doses, taking less medication, or delaying filling a prescription to save money in the past year were considered to have experienced CRN. The weighted prevalence of CRN was estimated overall and by age subgroups (<65 and ≥65 years). Logistic regression was used to identify sociodemographic characteristics independently associated with CRN.Results: Of the 20,326 NHIS participants with diabetes, 17.6% (weighted 2.3 million) of those age <65 years reported CRN, compared with 6.9% (weighted 0.7 million) among those age ≥65 years. Financial hardship from medical bills, lack of insurance, low income, high comorbidity burden, and female sex were independently associated with CRN across age groups. Lack of insurance, duration of diabetes, current smoking, hypertension, and hypercholesterolemia were associated with higher odds of reporting CRN among the nonelderly but not among the elderly. Among the elderly, insulin use significantly increased the odds of reporting CRN (odds ratio 1.51; 95% CI 1.18, 1.92).Conclusions: In the U.S., one in six nonelderly and one in 14 elderly adults with diabetes reported CRN. Removing financial barriers to accessing medications may improve medication adherence among these patients, with the potential to improve their outcomes. [ABSTRACT FROM AUTHOR]