Real-world performance of SARS-Cov-2 serology tests in the United States, 2020.

BACKGROUND: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. METHODS: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters. RESULTS: A total of 15,615 people were observed to have at least one serology test 14-90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (PPA range: 79-96%) compared to non-Hispanic (60-89%) patients; in those presenting with at least one COVID-19 related symptom (69-93%) as compared to no such symptoms (63-91%); and in inpatient (70-97%) and emergency department (93-99%) compared to outpatient (63-92%) settings across datasets. PPA was highest in those with diabetes (75-94%) and kidney disease (83-95%); and lowest in those with auto-immune conditions or who are immunocompromised (56-93%). The odds ratios (OR) for seropositivity were higher in Hispanics compared to non-Hispanics (OR range: 2.59-3.86), patients with diabetes (1.49-1.56), and obesity (1.63-2.23); and lower in those with immunocompromised or autoimmune conditions (0.25-0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets. CONCLUSION: Although the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests.

Real-world utilization of SARS-CoV-2 serological testing in RNA positive patients across the United States.

BACKGROUND: As diagnostic tests for COVID-19 were broadly deployed under Emergency Use Authorization, there emerged a need to understand the real-world utilization and performance of serological testing across the United States. METHODS: Six health systems contributed electronic health records and/or claims data, jointly developed a master protocol, and used it to execute the analysis in parallel. We used descriptive statistics to examine demographic, clinical, and geographic characteristics of serology testing among patients with RNA positive for SARS-CoV-2. RESULTS: Across datasets, we observed 930,669 individuals with positive RNA for SARS-CoV-2. Of these, 35,806 (4%) were serotested within 90 days; 15% of which occurred <14 days from the RNA positive test. The proportion of people with a history of cardiovascular disease, obesity, chronic lung, or kidney disease; or presenting with shortness of breath or pneumonia appeared higher among those serotested compared to those who were not. Even in a population of people with active infection, race/ethnicity data were largely missing (>30%) in some datasets-limiting our ability to examine differences in serological testing by race. In datasets where race/ethnicity information was available, we observed a greater distribution of White individuals among those serotested; however, the time between RNA and serology tests appeared shorter in Black compared to White individuals. Test manufacturer data was available in half of the datasets contributing to the analysis. CONCLUSION: Our results inform the underlying context of serotesting during the first year of the COVID-19 pandemic and differences observed between claims and EHR data sources-a critical first step to understanding the real-world accuracy of serological tests. Incomplete reporting of race/ethnicity data and a limited ability to link test manufacturer data, lab results, and clinical data challenge the ability to assess the real-world performance of SARS-CoV-2 tests in different contexts and the overall U.S. response to current and future disease pandemics.

Impact of the Affordable Care Act on Colorectal Cancer Incidence and Mortality.

INTRODUCTION: The Patient Protection and Affordable Care Act eliminated cost sharing for preventive services, including colorectal cancer screening for individuals aged 50-75 years with private health insurance. This study examines the impact of the Affordable Care Act's removal of cost sharing for colorectal cancer screening on colorectal cancer incidence and mortality. METHODS: Trends in colorectal cancer incidence and colorectal cancer‒related mortality were modeled among 2,113,283 Kaiser Permanente Northern California members aged ≥50 years between 2003 and 2016 using an interrupted time-series design. As a sensitivity analysis, a controlled analysis utilized a comparison group of members covered with pre‒Affordable Care Act zero cost sharing for colorectal cancer screening. Analyses were performed in 2019 and 2020. RESULTS: The colorectal cancer incidence dropped by 17% around the time the Affordable Care Act was enacted (change in level incidence rate ratio; 95% CI=0.77, 0.90, 2-sided p-value <0.0001), followed by a 3% further decrease per year (95% CI=0.93, 1.00, p=0.05). A similar pattern was observed for colorectal cancer‒related mortality. The controlled results indicated that the elimination of cost sharing for screening due to the Affordable Care Act was associated with greater improvements in colorectal cancer outcomes among members previously covered by health plans with out-of-pocket costs for screening than among those with health plans with zero cost sharing for screening before the Affordable Care Act. CONCLUSIONS: The elimination of cost sharing for colorectal cancer screening due to the Affordable Care Act was associated with a decrease in age-, race/ethnicity-, and sex-adjusted colorectal cancer incidence and colorectal cancer‒related mortality, implying that policies that remove barriers to screening, particularly financial burden from cost sharing, can result in improved colorectal cancer outcomes.

COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.

BACKGROUND: The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems research, regulatory science, data science, and epidemiology to participate in a large parallel analysis of different data sets to further explore the effectiveness of these treatments. METHODS: Electronic health record (EHR) and claims data were extracted from seven separate databases. Parallel analyses were undertaken on data extracted from each source. Each analysis examined time to mortality in hospitalized patients treated with hydroxychloroquine, azithromycin, and the two in combination as compared to patients not treated with either drug. Cox proportional hazards models were used, and propensity score methods were undertaken to adjust for confounding. Frequencies of adverse events in each treatment group were also examined. RESULTS: Neither hydroxychloroquine nor azithromycin, alone or in combination, were significantly associated with time to mortality among hospitalized COVID-19 patients. No treatment groups appeared to have an elevated risk of adverse events. CONCLUSION: Administration of hydroxychloroquine, azithromycin, and their combination appeared to have no effect on time to mortality in hospitalized COVID-19 patients. Continued research is needed to clarify best practices surrounding treatment of COVID-19.

Health Needs and Experiences of a LGBT Population in Georgia and South Carolina.

The 2016 Municipal Equality Index rated Augusta, the largest city in the Central Savannah River Area (CSRA), as one of the least lesbian, gay, bisexual, and transgender (LGBT) friendly cities in America. To understand the context of our region in relation to LGBT wellness, we conducted the first LGBT health needs assessment of the CSRA, assessing physical and mental health status and health care needs and experiences in the community. Participants (N = 436) were recruited using venue and snowball sampling and completed an anonymous online survey. Overall, the health problems experienced (i.e., obesity, depression) were not uniformly experienced across sexual orientation and gender identity; some groups experienced significantly higher rates of these conditions than others. Similarly, transgender individuals in particular reported higher rates of negative experiences with health care providers. Regional and national dissemination of these findings is critical to reducing health disparities and improving wellness of our local LGBT community.

Predictors of anxiety among sexual minority individuals in the Southern US.

Sexual minority individuals experience a disproportionate burden of mental health issues, particularly in less populous cities of the southern United States. Unique identity-related stressors may explain these disparities. The current study examines relationships between sexual minority stress, identity, and anxiety in sexual minority individuals from a small metropolitan area of the South. Sexual minority individuals (N = 249) from the Central Savannah River Area completed a survey assessing minority stress (i.e., identity-based discrimination, internalized homophobia), identity (i.e., outness comfort, community connectedness) and history of anxiety as part of a larger lesbian, gay, bisexual, transsexual, queer community health needs assessment. All minority stress variables were significantly, positively associated with an anxiety history whereas community connectedness was significantly, negatively associated with anxiety history at the bivariate level. A multiple logistic regression model revealed that assault history was significantly associated with increased odds of anxiety history, whereas community connectedness was associated with decreased odds of anxiety history. These results demonstrate an influence of discriminatory experiences on anxiety in sexual minority individuals of the South and the protective value of community connectedness. Providers and advocates should work at the individual, community, and systemic levels to eliminate lesbian, gay, bisexual discrimination and facilitate community involvement, thereby reducing mental health disparities. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system.

PURPOSE: We evaluated associations between personal and clinical social support and non-adherence to adjuvant endocrine therapy (AET) in a large, Northern California breast cancer (BC) cohort from an integrated healthcare network. METHODS: This study included 3382 women from the Pathways Study diagnosed from 2005 to 2013 with stages I-III hormone receptor-positive BC and who responded to the Medical Outcomes Study Social Support and Interpersonal Processes of Care surveys, approximately 2 months post-diagnosis. We used logistic regression to evaluate associations between tertiles of social support and non-initiation (< 2 consecutive prescription fills within a year after diagnosis). Among those who initiated treatment, we used proportional hazards regression to evaluate associations with discontinuation (≥ 90 day gap) and non-adherence (< 80% medical possession ratio). RESULTS: Of those who initiated AET (79%), approximately one-fourth either discontinued AET or were non-adherent. AET non-initiation was more likely in women with moderate (adjusted OR 1.18, 95% CI 0.96-1.46) or low (OR 1.30, 95% CI 1.05-1.62) versus high personal social support (P trend = 0.02). Women with moderate (HR 1.20, 95% CI 0.99-1.45) or low (HR 1.32, 95% CI 1.09-1.60) personal social support were also more likely to discontinue treatment (P trend = 0.01). Furthermore, women with moderate (HR 1.25, 95% CI 1.02-1.53) or low (HR 1.38, 95% CI 1.12-1.70) personal social support had higher non-adherence (P trend = 0.007). Associations with clinical social support and outcomes were similar. Notably, high clinical social support mitigated the risk of discontinuation when patients' personal support was moderate or low (P value = 0.04). CONCLUSIONS: Women with low personal or clinical social support had higher AET non-adherence. Clinician teams may need to fill support gaps that compromise treatment adherence.

Mental Health Correlates of Cigarette Use in LGBT Individuals in the Southeastern United States.

BACKGROUND: Smoking prevalence for lesbian, gay, bisexual, and transgender (LGBT) individuals is higher than for heterosexual, cisgender individuals. Elevated smoking rates have been linked to psychiatric comorbidities, substance use, poverty, low education levels, and stress. OBJECTIVES: This study examined mental health (MH) correlates of cigarette use in LGBT individuals residing in a metropolitan area in the southeastern United States. METHODS: Participants were 335 individuals from an LGBT health needs assessment (mean age 34.7; SD = 13.5; 63% gay/lesbian; 66% Caucasian; 81% cisgender). Demographics, current/past psychiatric diagnoses, number of poor MH days in the last 30, the Patient Health Questionnaire (PHQ) 2 depression screener, the Three-Item Loneliness Scale, and frequency of cigarette use were included. Analyses included bivariate correlations, analysis of variance (ANOVA), and regression. RESULTS: Multiple demographic and MH factors were associated with smoker status and frequency of smoking. A logistic regression indicated that lower education and bipolar disorder were most strongly associated with being a smoker. For smokers, a hierarchical regression model including demographic and MH variables accounted for 17.6% of the variance in frequency of cigarette use. Only education, bipolar disorder, and the number of poor MH days were significant contributors in the overall model. Conclusions/Importance: Less education, bipolar disorder, and recurrent poor MH increase LGBT vulnerability to cigarette use. Access to LGBT-competent MH providers who can address culturally specific factors in tobacco cessation is crucial to reducing this health disparities.