Prospective, multi-site evaluation of the Cepheid Xpert Xpress CoV-2 plus test on nasal and nasopharyngeal swabs.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues its largely aseasonal spread with millions of cases per year. Highly sensitive, point-of-care testing is critical for rapid detection of coronavirus disease 2019 (COVID-19) cases and initiation of antiviral therapy to avert adverse health outcomes and reduce onward transmission of the virus. While hundreds of COVID-19 diagnostics received emergency use authorization from the FDA during the pandemic, significantly fewer have navigated the course to FDA clearance or approval. Here, we determined the clinical performance of the Cepheid Xpert Xpress CoV-2 plus for detection of SARS-CoV-2 in 3,750 anterior nasal swab (NS) specimens and nasopharyngeal swab (NPS) from 32 sites in comparison to the FDA-authorized BioFire Respiratory Panel 2.1. Three-quarters of specimens collected were tested on the Xpert Xpress CoV-2 plus in the point-of-care setting. Overall positive percent agreement (PPA) was 98.1% (95% CI: 96.7%-98.9%) and negative percent agreement (NPA) was 98.3% (97.7%-98.7%). Performance of the Xpert Xpress CoV-2 plus was slightly improved in NS compared to NPS specimens, with PPA of 99.3% versus 97.0% (Fisher's exact test, P = 0.06) and NPA of 98.3% versus 98.2% (P = 0.89), respectively. Assay PPA was similar between untrained and trained users (98.7% vs 97.3%, P = 0.75), while NPA was slightly improved for untrained users (99.0% vs 97.6%, P = 0.0003). This study showed that Cepheid Xpert Xpress COV-2 plus is highly sensitive and specific/has high PPA and NPA for detection of SARS-CoV-2 from both NS and NPS specimens. IMPORTANCE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to cause millions of infections and tens of thousands of deaths per year in the United States. While the FDA authorized hundreds of SARS-CoV-2 tests during the public health emergency, significantly fewer have made the transition to being cleared or approved. There continues to be a need for FDA-authorized point-of-care SARS-CoV-2 testing that can be performed by untrained users. We conducted a large prospective study of the Cepheid Xpert Xpress CoV-2 plus test for detection of SARS-CoV-2 in both nasal and nasopharyngeal swabs by trained and untrained users. The assay demonstrated excellent clinical performance characteristics and, as a result of this study, was cleared by the FDA.

Suicidal Ideation Disparities Among Transgender and Gender Diverse Compared to Cisgender Community Health Patients.

BACKGROUND: Transgender and gender diverse (TGD) individuals experience more severe psychological distress and may be at higher risk for suicide compared to cisgender individuals. The existing literature largely consists of small-sample studies that do not assess subgroup differences. OBJECTIVE: To examine rates of self-reported suicidal ideation among four TGD groups compared to cisgender individuals. DESIGN: Data were extracted from the electronic health records of patients receiving primary care at a community health center specializing in sexual and gender minority health. A logistic regression was used to examine the relationship between sociodemographic variables and the presence of current suicidal ideation. PARTICIPANTS: 29,988 patients receiving care at a community health center in Northeastern US between 2015 and 2018. MAIN MEASURES: Demographic questionnaire, 9-item Patient Health Questionnaire KEY RESULTS: Younger age, sexual and gender minority identity, and public/grants-based insurance were associated with significantly higher odds of suicidal ideation. Relative to cisgender men, transgender men (OR=2.08; 95% CI=1.29-3.36; p=.003), transgender women (OR=3.08; 95% CI=2.05-4.63; p<.001), nonbinary (NB) individuals assigned male at birth (AMAB; OR=3.55; 95% CI=1.86-6.77; p<001), and NB individuals assigned female at birth (AFAB; OR=2.49; 95% CI=1.52-4.07; p<001) all endorsed significantly higher odds of current suicidal ideation, controlling for age, race, ethnicity, sexual orientation, and insurance status. Larger proportions of transgender women (23.6%) and NB AMAB individuals (26.7%) reported suicidal ideation not only compared to cisgender men (6.1%) and women (6.6%), but also compared to transgender men (17.4%; χ2[5, n=25,959]=906.454, p<0.001). CONCLUSIONS: TGD patients were at significantly increased risk of suicidal ideation, even after accounting for age, race, ethnicity, sexual orientation, and insurance status. Findings suggest distinct risk profiles by assigned sex at birth. Consistent assessment of and intervention for suicidal ideation should be prioritized in settings that serve TGD patients.

Sexual Orientation and Gender Identity Data Completeness at US Federally Qualified Health Centers, 2020 and 2021.

Objectives. To assess the performance of US federally qualified health centers (FQHCs) after 6 years of required sexual orientation and gender identity (SOGI) data reporting and update estimated proportions of sexual and gender minorities cared for at FQHCs. Methods. We conducted secondary analyses of data reported to the 2020 and 2021 Uniform Data System from 1297 FQHCs caring for nearly 30 000 000 patients annually. We used multivariable logistic regression to explore FQHC-level and patient-level factors associated with SOGI data completeness. Results. SOGI data were missing for 29.1% and 24.0% of patients, respectively. Among patients with reported SOGI data, 3.5% identified as sexual minorities and 1.5% identified as gender minorities. Southern FQHCs and those caring for more low-income and Black patients were more likely to have above-average SOGI data completeness. Larger FQHCs were more likely to have below-average SOGI data completeness. Conclusions. Substantial increases in SOGI data completeness at FQHCs over 6 years reflect the success of reporting mandates. Future research is needed to identify other patient-level and FQHC-level factors contributing to residual levels of SOGI data missingness. (Am J Public Health. 2023;113(8):883-892. https://doi.org/10.2105/AJPH.2023.307323).

Androgenetic alopecia incidence in transgender and gender diverse populations: A retrospective comparative cohort study.

BACKGROUND: Androgenetic alopecia (AGA) is a significant challenge for many transgender and gender diverse (TGD) patients, but the rate of AGA among TGD patients receiving gender-affirming hormone therapy (GAHT) compared to cisgender patients has not yet been studied on a large scale. OBJECTIVE: We examined the incidence of AGA among TGD patients receiving GAHT compared to cisgender patients. METHODS: Retrospective cohort study using electronic health records from 37,826 patients seen at Fenway Health between August 1, 2014, and August 1, 2020. Crude and adjusted incidence rate ratios (aIRR) for AGA were calculated using Poisson regression. RESULTS: TGD patients receiving masculinizing GAHT had aIRR 2.50, 95% CI 1.71-3.65 and 1.30, 95% CI 0.91-1.86 compared to cisgender women and cisgender men, respectively. The rate of AGA for TGD patients receiving feminizing GAHT was not significantly different compared to cisgender men but was significantly increased compared to cisgender women (aIRR 1.91, 95% CI 1.25-2.92). LIMITATIONS: Inability to determine causation and limited generalizability. CONCLUSION: TGD patients receiving masculinizing GAHT have 2.5 times the rate of AGA compared to cisgender women, whereas TGD patients on feminizing GAHT did not have a significantly increased rate of AGA compared to cisgender men.

Differential Virulence Contributions of the Efflux Transporter MexAB-OprM in Pseudomonas syringae Infecting a Variety of Host Plants.

Efflux transporters such as MexAB-OprM contribute to bacterial resistance to diverse antimicrobial compounds. Here, we show that MexB contributes to epiphytic and late-stage apoplastic growth of Pseudomonas syringae strain B728a, as well as lesion formation in common bean (Phaseolus vulgaris). Although a ∆mexB mutant formed fewer lesions after topical application to common bean, these lesions contain the same number of cells (105 to 107 cells) as those caused by the wild-type strain. The internalized population size of both the wild-type and the ∆mexB mutant within small samples of surface-sterilized asymptomatic portions of leaves varied from undetectably low to as high as 105 cells/cm2. Localized bacterial populations within individual lesions consistently exceeded 105 cells/cm2. Strain B728a was capable of moderate to extensive apoplastic growth in diverse host plants, including lima bean (P. lunatus), fava bean (Vicia faba), pepper (Capsicum annuum), Nicotiana benthamiana, sunflower (Helianthus annuus), and tomato (Solanum lycopersicum), but MexB was not required for growth in a subset of these plant species. A model is proposed that MexB provides resistance to as-yet-unidentified antimicrobials that differ between plant species. [Formula: see text] Copyright © 2022 The Author(s). This is an open access article distributed under the CC BY 4.0 International license.

Patterns of E-Cigarette Use Among Primary Care Patients at an Urban Community Center.

Tobacco use remains the leading cause of preventable disease and death in the US. The number of tobacco products has grown over the past decade. E-cigarette use has increased rapidly in recent years, but patterns and correlates of use have not been thoroughly assessed. We examined relationships among demographic factors, e-cigarette and conventional cigarette use in a large sample (N = 12,409) of adult patients at a community health center in the Northeastern US. Overall, 13% (N = 1675) of the sample reported ever using e-cigarettes. In logistic regression models, ever having used e-cigarettes was associated with younger age (ages 18-25; OR = 3.5, p < 0.001). Being transgender (OR = 1.8, p < 0.001), bisexual (OR = 1.5, p < 0.001), un-partnered (OR = 1.5, p < 0.001), having a lower income (OR = 1.6, p < 0.001) or a high BMI (OR = 1.4, p = 0.009) were associated with increased odds of use, whereas being a woman (OR = 0.7, p < 0.001) or Black/African American (OR = 0.7, p = 0.007) were associated with lower odds of use. Of the participants who reported e-cigarette use, a majority also endorsed current or former use of conventional cigarettes. Individuals who formerly used conventional cigarettes were nearly three times more likely to report daily e-cigarette use than current users. Among primary care patients at a community health center, e-cigarette use was reported by a sizeable portion of the sample. Overall, odds of use were higher in certain patient populations, and individuals who formally used cigarettes were more likely to report e-cigarette use than individuals who currently smoke, suggesting that e-cigarettes may be functioning as a cessation aid or a strategy to reduce conventional cigarette use.

Sexual Orientation and Gender Identity Data Collection at US Health Centers: Impact of City-Level Structural Stigma in 2018.

Objectives. To examine the relationship between city-level structural stigma pertaining to sexual orientation and gender identity (SOGI) and completeness of patient SOGI data collection at US federally qualified health centers (FQHCs). Methods. We used the Human Rights Campaign's Municipal Equality Index to quantify city-level structural stigma against sexual and gender minority people in 506 US cities across 49 states. We ascertained the completeness of SOGI data collection at FQHCs from the 2018 Uniform Data System, which describes FQHC patient demographics and service utilization. We included FQHCs in cities captured by the structural stigma index in multinomial generalized linear mixed models to examine the relationship between city-level structural stigma and SOGI data completeness. Results. FQHCs in cities with more protective sexual orientation nondiscrimination policies reported more complete patient sexual orientation data (adjusted odds ratio [AOR] = 1.6; 95% confidence interval [CI] = 1.2, 2.1). This association was also found for gender identity nondiscrimination policies and gender identity data collection (AOR = 1.7; 95% CI = 1.3, 2.2). Conclusions. Municipal sexual and gender minority nondiscrimination laws are associated with social and municipal environments that facilitate patient SOGI data collection.(Am J Public Health. 2021;111(11):2059-2063. https://doi.org/10.2105/AJPH.2021.306414).

Psychological Attempts to Change a Person's Gender Identity From Transgender to Cisgender: Estimated Prevalence Across US States, 2015.

Objectives. To examine exposure to psychological attempts to change a person's gender identity from transgender to cisgender (PACGI) among transgender people in the United States, lifetime and between the years 2010 and 2015, by US state.Methods. We obtained data from the 2015 US Transgender Survey, a cross-sectional nonprobability sample of 27 716 transgender people in the United States, to estimate the percentage exposed to PACGI in each US state.Results. Overall, 13.5% of the sample indicated lifetime exposure to PACGI, ranging across all US states from 9.4% (South Carolina) to 25.0% (Wyoming). The percentage of transgender adults in the United States reporting exposure to PACGI between 2010 and 2015 was 5% overall, and across all states ranged from 1.2% (Alaska) to 16.3% (South Dakota).Conclusions. Despite major medical organizations identifying PACGI as ineffective and unethical, 13.5% of transgender people in the United States reported lifetime exposure to this practice. Findings suggest that this practice has continued in every US state as recently as the period 2010 to 2015.

Required Sexual Orientation and Gender Identity Reporting by US Health Centers: First-Year Data.

Objectives. To assess the performance of US health centers during the first year of required sexual orientation and gender identity (SOGI) data reporting and to estimate the baseline proportion of lesbian, gay, bisexual, and transgender patients accessing health centers. Methods. We conducted a secondary analysis of SOGI data from 2016. These data were reported by 1367 US health centers caring for 25 860 296 patients in the United States and territories. Results. SOGI data were missing for 77.1% and 62.8% of patients, respectively. Among patients with data, 3.7% identified as lesbian, gay, bisexual, or something else; 0.4% identified as transgender male or female; 27.5% did not disclose their sexual orientation; and 9.3% did not disclose their gender identity. Conclusions. Although health centers had a high percentage of missing SOGI data in the first year of reporting, among those with data, the percentages of lesbian, gay, bisexual, and transgender people were similar to national estimates, and disclosure was more than 70%. Future data collection efforts would benefit from increased training for health centers and improved messaging on the clinical benefits of SOGI data collection and reporting.

Outcomes in an Interdisciplinary Diabetes Clinic in Rural Primary Care.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of an interdisciplinary diabetes team model of care in assisting patients to achieve improved glucose control in a primary care rural setting. METHODS: A family medicine clinic at a rural university medical center developed an interdisciplinary diabetes team clinic composed of a certified diabetes educator/dietitian, a case manager, a pharmacist, nursing staff, a family medicine resident, a psychologist, and a board-certified family medicine attending physician. Patients were referred if their hemoglobin A1c (HbA1c) was ≥9% (75 mmol/mol); patients were seen for an initial consultation and for additional visits as needed. RESULTS: A total of 94 patients attended an initial visit and at least 1 follow-up within 6 months. Mean age was 57 ± 13 years, and 54% were female. Median time from the initial intensive diabetes clinic visit to a follow-up visit was 2.8 months. There was a significant reduction in median HbA1c percentage from 10.25% (88.5 mmol/mol) ± 1.4% (range 73-104 mmol/mol) at the initial intensive diabetes clinic visit to 8.7% (72 mmol/mol) ± 1.8% (range 52-92 mmol/mol) at a 1- to 6-month follow-up (z = -7.161, P < 0.001) and a significant difference between baseline HbA1c (10.25% [88.5 mmol/mol] ± 1.4% [range 73-104 mmol/mol]) and latest HBA1c (1-18 months later) 8.4% (68 mmol/mol) ± 2.2% (range 44-92 mmol/mol; z = -7.022, P < 0.001). Overall, 86% of patients had a lower HbA1c at follow-up, and 33% had an HbA1c <8% (64 mmol/mol). There were no differences in patients' blood pressure, immunization rates, or lipid values between baseline and follow-up visits (P > 0.05). CONCLUSIONS: An interdisciplinary team approach to glycemic control can achieve significant reductions in HbA1c in the rural primary care setting.

Treatment Outcomes Associated with Quitting Cigarettes Among Sexual Minority Men Living with HIV: Antiretroviral Adherence, Engagement in Care, and Sustained HIV RNA Suppression.

Cigarette smoking is particularly harmful for sexual minority men living with HIV. This study aimed to find benefits of quitting by examining relationships between smoking and sustained HIV RNA suppression, recent CD4 count, ART medication adherence, and engagement in HIV medical care. Sexual minority men (n = 346), former or current smokers, received HIV care at a community health center. Survey responses were combined with electronic health record data in adjusted regression models. Most patients were Caucasian (87%) and 148 (46%) had incomes below the poverty level and 80% had sustained HIV RNA suppression. Compared to current smokers, former smokers had increased odds of sustaining HIV RNA suppression (OR 1.89; 95% CI 1.02-3.48) of reporting > 90% adherence (OR 2.25; 95% CI 1.21-4.17), and were less likely to miss appointments (OR 0.37; 95% CI 0.17-0.82). Heavier smokers (OR 0.36; 95% CI 0.17-0.77) and patients who smoked the longest (OR 0.31; 95% CI 0.14-0.68) had reduced odds of sustaining HIV RNA suppression. Smoking assessment, treatment, and referral could augment HIV outcomes for sexual minority men with HIV.

An examination of the perceived impact of a continuing interprofessional education experience on opiate prescribing practices.

Chronic pain is increasingly recognized as a public health problem. We assessed the effectiveness of a multi-modal, interprofessional educational approach aimed at empowering healthcare professionals to make deliberative changes, especially in opiate prescribing practices. Education activities included enduring webcasts, regional interprofessional roundtable events, and state-level conference presentations within targeted Kentucky and West Virginia regions of the United States. Over 1,000 participants accessed the various activities. For the live events, the largest groups reached included nurses (38.1%), nurse practitioners (31.2%), and physicians (22.1%). In addition to our reach, higher levels of educational effectiveness were measured, specifically, learner's intentions to change practice patterns, confidence in meeting patient's needs, and knowledge of pain management guidelines. The majority of the conference (58%) and roundtable (69%) participants stated they intend to make a practice change in one or more areas of chronic pain patient management in post-event evaluation. Differences in pre- and post-activity responses on the measures of confidence and knowledge, with additional comparison to a control population who were not in attendance, were analyzed using non-parametric tests of significance. While neither activity produced significant changes in confidence from pre-activity, participants were more confident post-activity than their control group peers. There were significant changes in knowledge for both live event and webcast participants. Impactful chronic pain continuing the education that emphasizes collaborative care is greatly needed; these results show that the approaches taken here can impact learner's knowledge and confidence, and hold potential for creating change in how opioid prescribing is managed.

Patient Attitudes and Participation in Hand Co-Washing in an Outpatient Clinic Before and After a Prompt.

Despite recent national emphasis, outpatient hand washing can be less than optimal. We tested a new approach involving both patient and physician hand washing. The study consisted of 384 questionnaires, 184 from phase 1 and 200 from phase 2. Patients stated doctors washed their hands 96.6% before examining them pre-intervention and 99.5% of the time post-intervention. Patients endorsed the importance of hand washing 98.7% of the time. "Co-washing" may offer a process to increase the practice of hand washing and decrease infection risk.

LIN-42, the Caenorhabditis elegans PERIOD homolog, negatively regulates microRNA transcription.

During C. elegans development, microRNAs (miRNAs) function as molecular switches that define temporal gene expression and cell lineage patterns in a dosage-dependent manner. It is critical, therefore, that the expression of miRNAs be tightly regulated so that target mRNA expression is properly controlled. The molecular mechanisms that function to optimize or control miRNA levels during development are unknown. Here we find that mutations in lin-42, the C. elegans homolog of the circadian-related period gene, suppress multiple dosage-dependent miRNA phenotypes including those involved in developmental timing and neuronal cell fate determination. Analysis of mature miRNA levels in lin-42 mutants indicates that lin-42 functions to attenuate miRNA expression. Through the analysis of transcriptional reporters, we show that the upstream cis-acting regulatory regions of several miRNA genes are sufficient to promote highly dynamic transcription that is coupled to the molting cycles of post-embryonic development. Immunoprecipitation of LIN-42 complexes indicates that LIN-42 binds the putative cis-regulatory regions of both non-coding and protein-coding genes and likely plays a role in regulating their transcription. Consistent with this hypothesis, analysis of miRNA transcriptional reporters in lin-42 mutants indicates that lin-42 regulates miRNA transcription. Surprisingly, strong loss-of-function mutations in lin-42 do not abolish the oscillatory expression patterns of lin-4 and let-7 transcription but lead to increased expression of these genes. We propose that lin-42 functions to negatively regulate the transcriptional output of multiple miRNAs and mRNAs and therefore coordinates the expression levels of genes that dictate temporal cell fate with other regulatory programs that promote rhythmic gene expression.

Dissemination Approaches to Participating Primary Care Providers in a Quality Improvement Program Addressing Opioid Use in Central Appalachia.

OBJECTIVES: Practice-based research networks (PBRNs) have been described as new clinical laboratories for primary care research and dissemination. PBRNs, however, have struggled to disseminate research results in a meaningful way to participating providers and clinics. METHODS: The Central Appalachia Inter-Professional Pain Education Collaborative was developed to work with PBRN clinics using quality improvement methods, deliver statewide continuing education activities to address the issue of opioid use in patients with chronic pain, and develop a multimodal mechanism to disseminate project results to clinics and participating providers. RESULTS: Successful change in the delivery of chronic pain care was dependent on the clinic's commitment to a team-based, patient-centered approach. Statistically significant improvements were shown in 10 of 16 process measures, and 80% of the participants agreed that the quality improvement process activity increased their knowledge and would improve their performance in managing patients with chronic pain, as well as patient outcomes in their practice. CONCLUSIONS: The Central Appalachia Inter-Professional Pain Education Collaborative project used an extensive and innovative dissemination plan under the rubric of "continual dissemination." Unlike traditional dissemination efforts that focus on summary presentations, this initiative used a continual dissemination approach that updated participants quarterly through multiple means throughout the project, which improved engagement in the project.

Cardiovascular Health Status in Baby Boomers with Diabetes Mellitus.

OBJECTIVES: The objective of this study was to assess the cardiovascular health status of baby boomers with diabetes mellitus (DM) in comparison to the same-age population with DM 10 years previously. METHODS: The study was conducted in baby boomers with DM using data from the National Health and Nutrition Examination Survey (NHANES) 2009-2012 compared with NHANES 1999-2002. Cardiovascular health metrics were derived from the American Heart Association's Life's Simple 7. The primary outcome was the comparison of the proportion of individuals with each characteristic, including healthy diet, healthy weight, not smoking, exercising regularly, and maintaining an optimal level of glycated hemoglobin (HbA1C), cholesterol, and blood pressure. RESULTS: Current baby boomers with DM (NHANES 2009-2012) had more obesity (70.9% vs 58.8%; P = 0.009) and a lower proportion of ideal physical activity (20.9% vs 31.7%; P = 0.01) than people of the same age 10 years ago; fewer than 1% adhere to an ideal healthy diet. Current baby boomers more often had ideal cholesterol (59.4% vs 47.2; P = 0.01) and reached an ideal HbA1C (51.0% vs 43.4%; P = 0.047). Blood pressure control, adherence to ideal diet, and smoking rates were not significantly different from 10 years ago. In logistic regression analyses controlling for likely confounders, baby boomers persisted in having more obesity and exercising less often, and reaching an ideal cholesterol level more often (P < 0.01). CONCLUSIONS: Although improving in cholesterol and HbA1C, baby boomers demonstrated worsening in several key cardiovascular health indicators, particularly obesity and physical activity.

Patient Attitudes toward Weight Related Discussions in Rural Appalachian Primary Care Clinics.

PURPOSE: West Virginia (WV) consistently has one of the highest rates of obesity, nationally, yet previous studies suggest that conversations about weight with providers are infrequent. This study's aim was to determine frequency and type of weight-related discussions occurring in WV primary care clinics and whether discussions differed according to weight status. METHODS: A cross-sectional survey was completed by patients in rural primary care practices. Participants answered questions related to demographics, obesity related illnesses, experience receiving a physician mediated discussion, and attitude and beliefs related to weight. RESULTS: Among the total of 490 surveys collected, a little more than half of the participants (56.9%) have discussed weight with their physician; a majority of participants (89.5%) thought a physician should tell risks associated with an unhealthy weight; 78.3% participants felt weight loss is important to them; 86.1% participants believed weight affects their health. Participants with obesity were more likely than participants who are overweight to discuss weight with their physician (71.8 vs.44.0%, p<0.0001), and believed that their physicians helped them lose weight previously (29.4% vs 9.9%, p<0.0001) and can help them lose weight in the future (92.9% vs. 71.1, p<0.0001). CONCLUSION: Physicians are often having weight related discussions with patients with obesity however this discussion happens less with overweight patients. Practitioners may want to be more attentive to addressing weight related issues in overweight patients.

Adherence to Mammography Screening Guidelines Among Transgender Persons and Sexual Minority Women.

We used retrospective (2012-2013) chart review to examine breast cancer screening among transgender persons and sexual minority women (n = 1263) attending an urban community health center in Massachusetts. Transgender were less likely than cisgender patients and bisexuals were less likely than heterosexuals and lesbians to adhere to mammography screening guidelines (respectively, adjusted odds ratios = 0.53 and 0.56; 95% confidence intervals = 0.31, 0.91 and 0.34, 0.92) after adjustment for sociodemographics. Enhanced cancer prevention outreach is needed among gender and sexual minorities.