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The preclinical time course of SARS-CoV-2 shedding is not well-described. Understanding this time course will help to inform risk of SARS-CoV-2 transmission. During an outbreak in a congregate setting, we collected paired mid-turbinate nasal swabs for antigen testing and reverse-transcription polymerase chain reaction (RT-PCR) every other day from all consenting infected and exposed persons. Among 12 persons tested prospectively before and during SARS-CoV-2 infection, ten of 12 participants (83%) had completed a primary COVID-19 vaccination series prior to the outbreak. We recovered SARS-CoV-2 in viral culture from 9/12 (75%) of participants. All three persons from whom we did not recover SARS-CoV-2 in viral culture had completed their primary vaccination series. We recovered SARS-CoV-2 from viral culture in 6/9 vaccinated persons and before symptom onset in 3/6 symptomatic persons. These findings underscore the need for both non-pharmaceutical interventions and vaccination to mitigate transmission.

Early response after 2 to 4 weeks of antidepressant therapy has been shown to predict remission by 8 to 12 weeks. Most of the work to date on early response has been done using data from randomized controlled trials.This naturalistic study uses archival data from a national tele-mental health company. The positive and negative predictive values as well as sensitivity and specificity were calculated using different drops in baseline Patient Health Questionnaire 9 scores at various periods. Demographic and clinical characteristics were compared between early responders versus those lacking early response. Binary logistic regression analyses determined if early response was predictive of remission, response, and greater than minimal improvement at 14 weeks. For those who do not show early improvement, treatments were investigated using binary logistic regression to see if changes predicted later outcomes.Positive predictive values for all endpoints improved with the strength of early response but did not improve much with the time allowed for that response to occur. In contrast, negative predictive values increased substantially with time. Using a definition of 30% drop in Patient Health Questionnaire 9 score at week 4, 56.5% of patients were early responders. Early responders were ~3.2 times more likely to achieve remission than those lacking early response. Of nonresponders by week 4, those prescribed atypical antipsychotics (+SSRI) had significantly reduced odds of response at week 14, whereas those prescribed a norepinephrine and dopamine reuptake inhibitor had increased odds.Early response may be associated with better outcomes at 14 weeks. In those with lack of response by week 4, patients prescribed a norepinephrine and dopamine reuptake inhibitor may achieve superior outcomes.

This study seeks to identify and characterize key barriers associated with PrEP therapy as self-reported by users on social media platforms. We used data mining and unsupervised machine learning approaches to collect and analyze COVID-19 and PrEP-related posts from three social media platforms including Twitter, Reddit, and Instagram. Predominant themes detected by unsupervised machine learning and manual annotation included users expressing uncertainty about PrEP treatment adherence due to COVID-19, challenges related to accessibility of clinics, concerns about PrEP costs and insurance coverage, perceived lower HIV risk leading to lack of adherence, and misinformation about PrEP use for COVID-19 prevention.

The aim of this study was to measure the association of working from home (WFH) with work productivity loss due to caregiving responsibilities or health problems during the COVID-19 pandemic.We conducted an online survey of family/friend caregivers (n = 150 WFH/75 non-WFH) and patients (n = 95/91) who worked during the past 7 days in May and July 2020, respectively. Absenteeism and presenteeism were measured using the Valuation of Lost Productivity questionnaire.Working from home was associated with higher odds of absenteeism (odds ratio, 2.53; 95% confidence interval, 1.11 to 5.77) and presenteeism (2.79; 1.26 to 6.18) among caregivers and higher odds of presenteeism among patients (2.78; 1.13 to 6.84). However, among caregivers with absenteeism more than 0 days, WFH was significantly associated with fewer absent workdays.Working from home was not associated with overall absenteeism and presenteeism in caregivers or patients. Working from home allows a more flexible and inclusive workplace without impacting productivity, although further research is needed.

Purpose This paper aims to disseminate results from research into three forms of online abuse: text messages, picture messages and online stalking. Design/methodology/approach Using a mixed methods design, qualitative and quantitative datasets were derived from an online anonymous questionnaire to identify themes associated with incidents of online abuse. Findings Women of all ages have experienced online abuse from men and other women. Men have also been targets of online abuse from other men and women. Research limitations/implications Researchers should strive to include mature-aged cohorts. Practical implications Researchers should not limit themselves to education settings for their sampling. Online abuse may meet the legal definition of “psychic assault”. The recent legislation against online abuse needs to extend beyond protecting young people and children. Social media owners must take more responsibility for the content on their platforms. Social implications The results from this research strongly suggest that gender alone is no longer pivotal to ones’ vulnerability to online abusers. Originality/value This research uses a more age-inclusive sample to include the experiences of people aged 25–75, who have largely been excluded from previous studies that have concentrated on the 18–25 age group.

Health disparities are closely linked with economic, social, or environmental disadvantage and are the differences observed between groups as related to disease morbidity and mortality, injury, or violence. U.S. Food and Drug Administration Office of Minority Health and Health Equity and the American Pharmacists Association are both committed to the advancement of health equity and to increasing education and awareness of diabetes-related health disparity issues. Pharmacists are strategically located within the health care system and have the knowledge and skills to support the reduction of health disparities in patients with diabetes. This article highlights some of the many approaches and resources pharmacists can use in addressing health disparities and describes culturally competent, health literate, and numerate techniques for providing education and communicating with patients who have diabetes.

Christian, especially Protestant, identity is often framed through the lens of belief, particularly belief understood as an interior orientation. Through an examination of the non-denominational Protestant group, the ‘Little Flock’, founded by Watchman Nee in the early 20th century, we trace enduring aspects of Little Flock theology in contemporary Chinese Protestant practice. In particular, we attend to conceptions of and debates surrounding belief and how to determine the quality of one’s faith—whether or not one might be considered not just a Christian, but a ‘good’ one.

Joint Institutions are created from two different universities joining together to create a collaborative research and education effort. Compared to traditional universities, several unique challenges present themselves from this arrangement. We are especially interested in the student experience at UK-China Joint Institutes. We therefore organized a conference with the UK-China Joint Institute Alliance to aggregate knowledge on this issue. This paper summarizes the topics presented and discussed at the conference including: student learning and methods with which to measure and improve it, monitoring and incentivizing student engagement, the transition period from high school to university, teaching evaluations of staff, and lastly, learning and teaching during the COVID-19 pandemic.

This paper explores the relationship between labour market dualization, insecurity and low fertility, through a case study of South Korea, an extreme case of ultra-low fertility where the total fertility rate fell to 0.84 in 2020. It is argued that the long-term nature of the insecurity associated with dualization, as well as its impact on people’s perceptions of present and future insecurity, mark dualization out as a particular phenomenon whose impact on fertility current demographic approaches struggle to fully understand. Rather than restricting the focus to the education-employment transition, we show how permanent insecurity in highly dualized labour markets depresses fertility.

SDHD encodes subunit D of the succinate dehydrogenase complex, an integral membrane protein. Across cancer types, recurrent SDHD promoter mutations were reported to occur exclusively in melanomas, at a frequency of 4% to 5%. These mutations are predicted to disrupt consensus ETS transcription factor–binding sites and are correlated with both reduced SDHD gene expression and poor prognosis. However, the consequence of these mutations on SDHD expression in melanoma is still unclear. Here, we found that expression of SDHD in melanoma correlated with the expression of multiple ETS transcription factors, particularly in SDHD promoter wild-type samples. Consistent with the predicted loss of ETS transcription factor binding, we observed that recurrent hotspot mutations resulted in decreased luciferase activity in reporter assays. Furthermore, we demonstrated specific GABPA and GABPB1 binding to probes containing the wild-type promoter sequences, with binding disrupted by the SDHD hotspot promoter mutations in both quantitative mass spectrometry and band-shift experiments. Finally, using siRNA-mediated knockdown across multiple melanoma cell lines, we determined that loss of GABPA resulted in reduced SDHD expression at both RNA and protein levels. These data are consistent with a key role for GABPA/B1 as the critical ETS transcription factors deregulating SDHD expression in the context of highly recurrent promoter mutations in melanoma and warrant a detailed search for other recurrent promoter mutations that create or disrupt GABPA consensus sequences. Cancer Res; 77(7); 1649–61. ©2017 AACR.

Supplementary Figure 1. Confirmation of the recurrent C524, C541 and C544 SDHD promoter mutations in melanoma cell lines via Sanger sequencing. Supplementary Figure 2. Expression of SDHD in melanomas harboring promoter mutations compared to SDHD wild-type samples across TCGA samples. Supplementary Figure 3. Luciferase reporter assays for the C541T and C544T SDHD hotspot promoter mutations in multiple melanoma cell lines. Supplementary Figure 4. Prediction of the consequences of the C541T and C544T SDHD promoter mutations on transcription factor binding. Supplementary Figure 5. mRNA expression correlation between SDHD and multiple ETS transcription factors in TCGA SKCM samples harboring the SDHD C523T promoter mutation. Supplementary Figure 6. Band-shift analysis of recombinant human ELF1 binding to wild-type and C523T, C524T, C541T, and C544T SDHD promoter sequences. Supplementary Figure 7. Effect of siRNA-mediated knockdown of ELF1 on SDHD expression in melanoma cells. Supplementary Figure 8. Effect of siRNA-mediated knockdown of PRDM1 or IRF4 on SDHD expression and SDHD promoter activity in melanoma cells. Supplementary Table 1. SDHD promoter mutations identified in melanoma tumors datasets (TCGA, Broad and Yale) and melanoma cell lines. Supplementary Table 2. MotifBreakR results predicting the effects of recurrent SDHD promoter mutations (C523T, C524T, C541T, C544T, and C548T) on transcription factor binding sites. Supplementary Table 3. Oligonucleotide design for quantitative mass spectrometry.

In post-war Germany and South Korea, not only was vocational education and training key to the two countries' export-oriented growth models, it also promoted social inclusion. More recently, the knowledge economy has put this skills-based, inclusive growth model under pressure, and we see labour market dualisation calling into question the social contracts in the two countries. Studying education reform in Germany and Korea, we analyse government capacity to reconcile efficiency and inclusion in the knowledge economy, in the context of twin pressures from firms (with changing skills needs) and parents (with high aspirations for their children). We show that the German government, drawing on its corporatist past, has been more successful in mediating these pressures than Korea, where hierarchical business relations undermined employer engagement and more inclusive policies.

Self-efficacy is an essential component of students’ motivation and success in writing. There have been great advancements in our theoretical understanding of writing self-efficacy over the past 40 years; however, there is a gap in how we empirically model the multidimensionality of writing self-efficacy. The purpose of the present study was to examine the multidimensionality of writing self-efficacy, and present validity evidence for the adapted Self-Efficacy for Writing Scale (SEWS) through a series of measurement model comparisons and person-centered approaches. Using a sample of 1,466 8th–10th graders, results showed that a bifactor exploratory structural equation model best represented the data, demonstrating that the SEWS exhibits both construct-relevant multidimensionality and the presence of a global theme. Using factor scores derived from this model, we conducted latent profile analysis to further establish validity of the measurement model and examine how students disaggregate into groups based on their response trends of the SEWS. Three profiles emerged, differentiated by global writing self-efficacy, with substantively varying factor differences among the profiles. Concurrent, divergent, and discriminant validity evidence was established through a series of analyses that assessed predictors and outcomes of the profiles (e.g., demographics, standardized writing assessments, and grades). Theoretical and practical implications and avenues for future research are discussed.

From an economic model in which education and growth reinforced each other, South Korea has developed a pathological equilibrium holding back economic and social progress. Low labour productivity and skills mismatch undermine the economic prospects of the country, and sharp rises in inequality in an ever more dualised labour market erode social cohesion. Governments of different political persuasion have recognised these challenges, and they have thought to reinvigorate vocational education and training (VET). However, this article shows that large employers – which were at the heart of a segmentalist coalition between business and government when collective skills formation of the Developmental State was dismantled – continue to undermine any efforts of meaningful vocational skills formation. It is argued that the country’s hierarchical production regime and, related to this, labour market dualisation provide the micro-foundations for successive failure in VET reform; and without challenging large employers’ dominant position in the Korean political economy and without addressing labour market dualism, the reform of VET policy can be expected to remain a futile endeavour.

Funding: This research was funded by the Shanghai Social Science Innovation Research Base, for “Research on Transitional Sociology with Chinese Characteristics”. This paper foregrounds the Turnerian experiences of pilgrims themselves, for whom pilgrimage is perhaps first and foremost the process of experiencing faith with their whole body and mind. At the Chinese Catholic pilgrimage site of Sheshan, located in western Shanghai, multiple meanings and possibilities are written onto the body of the pilgrim as it interacts with sacred materialities. In the process, the pilgrim materially orients themselves towards the transcendent other and to people and events throughout time. The boundary between subject and object is increasingly blurred in the pilgrim’s imagination, and pilgrimage becomes a ‘porous’ mind-body experience for them. In the process, as pilgrims repeatedly physically enact doctrine and doctrinal texts in the course of pilgrimage—while simultaneously rooting them in their own personal lives—Sheshan is, through the concrete actions of worshippers layered up over time, continually being re-made as sacred. Publisher PDF

Roman Catholicism has been a repeated subject of interest for anthropology, from Julian Pitt-Rivers’s early ethnography of an Andalusian Catholic community to Talal Asad’s historical anthropological work on medieval monastics. Furthermore, a number of prominent social anthropologists of the mid-20th century—e.g., E. E. Evans-Pritchard, Mary Douglas, Victor Turner, and Godfrey Lienhardt—were themselves Catholics, a fact which infused not just their biography but often their subsequent work. At the same time, anthropologists on the whole have rarely taken Roman Catholicism as the focus of study; instead, Roman Catholicism has often been the invisible backdrop against which the main ethnographic action takes place. In the wake of the development of the anthropology of Christianity, however, an anthropology of Catholicism has burgeoned. The modern Catholic Church, with around 1.3 billion members worldwide, is the largest institution in history. As such, scholars have often examined the way the Church maintains itself as a unified institution even while containing vast spectrums of diversity in practice, theology, and lived experience. Resulting literature has often focused on this, examining institutional continuity over both time—such as the legacy of Catholic evangelization as a key part of colonial endeavors—and space—such as the question of syncretism and the nature of Catholicism’s relationship with indigenous cultures around the world.

This report describes genome sequences for nine Listeria innocua strains that varied in hemolytic phenotypes on sheep blood agar. All strains were sequenced using Pacific Biosciences (PacBio) single-molecule real-time (SMRT) chemistry; overall, the average read length of these sequences was 2,869,880 bp, with an average GC content of 37%.

Coral reefs are highly diverse ecosystems that provide many goods and ecosystem services globally. Coral reef ecosystems are also threatened by environmental stressors from anthropogenic sources and shifting climates. The United Nations Sustainable Development Goal 14 (“Life Below Water”) addresses the need to conserve and sustainably use the ocean, seas, and marine ecosystems, including reef systems. Belize’s coral reef system is the second largest in the world, providing sources of income to Belizeans through tourism and fisheries as well as coastline protection. In order to conserve their marine ecosystems, Belize has a network of Marine Protected Areas (MPAs) throughout their coastal waters. Using Aqua MODIS satellite imagery from 2002 to 2022, Google Earth Engine, and RStudio, we present a workflow to calculate stress days on MPAs and a coral vulnerability index based on sea surface temperature (SST) and Kd (490), a proxy of water clarity. The Corozal Bay, Swallow Caye, Port Honduras, and South Water Caye MPAs had the highest percentages of stress days and coral vulnerability stress index score based on these two parameters among the 24 MPAs analyzed. Additionally, SST in the warmest month of the year in Belize were seen to increase across all MPAs from 2002 to 2022 (p < 0.01). This GEE toolkit provides a straightforward and accessible tool to help governments monitor both water quality and risks to coral reefs in accordance with SDG 14.

Recurrent Clostridioides difficile infection, associated with dysbiosis of gut microbiota, has substantial disease burden in the USA. RBX2660 is a live biotherapeutic product consisting of a broad consortium of microbes prepared from human stool that is under investigation for the reduction of recurrent C. difficile infection.A randomized, double-blind, placebo-controlled, phase III study, with a Bayesian primary analysis integrating data from a previous phase IIb study, was conducted. Adults who had one or more C. difficile infection recurrences with a positive stool assay for C. difficile and who were previously treated with standard-of-care antibiotics were randomly assigned 2:1 to receive a subsequent blinded, single-dose enema of RBX2660 or placebo. The primary endpoint was treatment success, defined as the absence of C. difficile infection diarrhea within 8 weeks of study treatment.Of the 320 patients screened, 289 were randomly assigned and 267 received blinded treatment (n = 180, RBX2660; n = 87, placebo). Original model estimates of treatment success were 70.4% versus 58.1% with RBX2660 and placebo, respectively. However, after aligning the data to improve the exchangeability and interpretability of the Bayesian analysis, the model-estimated treatment success rate was 70.6% with RBX2660 versus 57.5% with placebo, with an estimated treatment effect of 13.1% and a posterior probability of superiority of 0.991. More than 90% of the participants who achieved treatment success at 8 weeks had sustained response through 6 months in both the RBX2660 and the placebo groups. Overall, RBX2660 was well tolerated, with manageable adverse events. The incidence of treatment-emergent adverse events was higher in RBX2660 recipients compared with placebo and was mostly driven by a higher incidence of mild gastrointestinal events.RBX2660 is a safe and effective treatment to reduce recurrent C. difficile infection following standard-of-care antibiotics with a sustained response through 6 months.NCT03244644; 9 August, 2017.Clostridioides difficile is a diarrhea-causing bacterium that is associated with potentially serious and fatal consequences. Antibiotics used to treat or prevent infections have a side effect of damaging the healthy protective gut bacteria (microbiota). Damage to the gut microbiota can allow C. difficile to over-grow and produce toxins that injure the colon. Paradoxically, the standard of care treatment of C. difficile infection (CDI) is antibiotics. Although initially effective for the control of diarrhea, antibiotics can leave a patient at risk for CDI recurrence after antibiotic treatment is stopped. Live biotherapeutic products are microbiota-based treatments used to repair the gut microbiota. These products have been shown to reduce the recurrence of CDI. RBX2660 is an investigational microbiota-based live biotherapeutic. RBX2660 contains a diverse set of microorganisms. RBX2660 has been developed to reduce CDI recurrence in adults following antibiotic treatment for recurrent CDI. This study was conducted to demonstrate that RBX2660 is effective and safe in treating patients with recurrent CDI. Treatment was considered successful in participants who did not experience CDI recurrence within 8 weeks after administration. Overall, statistical modeling demonstrated that 70.6% of participants treated with RBX2660 and 57.5% of participants treated with placebo remained free of CDI recurrence through 8 weeks. A 13.1 percentage point increase in treatment success was observed with RBX2660 treatment compared with placebo. In participants who achieved treatment success at 8 weeks, more than 90% remained free of CDI recurrence through 6 months. The most common side effects with RBX2660 treatment were abdominal pain and diarrhea. No serious treatment-related side effects were reported. The current data from the comprehensive clinical development program support a positive benefit-risk profile for RBX2660 in the reduction of CDI recurrence in adults following antibiotic therapy for recurrent CDI.

With the tremendous volume of data captured during surgeries and procedures, critical care, and pain management, the field of anesthesiology is uniquely suited for the application of machine learning, neural networks, and closed loop technologies. In the past several years, this area has expanded immensely in both interest and clinical applications. This article provides an overview of the basic tenets of machine learning, neural networks, and closed loop devices, with emphasis on the clinical applications of these technologies.

Funding: This research was funded by a grant from the Leverhulme Trust and a John Simon Guggenheim Memorial Foundation fellowship. How did khipus-knotted cords that encode information-function within the economic systems of the postcolonial Andes? Best known as the method by which the Incas recorded administrative data, khipu use continued into the nineteenth and twentieth centuries. Few studies of modern khipus, however, have analyzed how khipu cords were integrated with the institutions of the modern state, such as the hacienda. This article examines a set of modern khipus from the Island of the Sun in Bolivia. These khipus, which contain dried potatoes and beans, are the first ever known to include agricultural produce. Our analysis demonstrates how the circulation of khipu styles within the Island of the Sun was linked to hacienda production, underscoring the intimate relationship between khipus and hacienda culture. Modern herding and crop khipus did not arise out of a generalized Andean consciousness but were products of specific historical and economic circumstances. Postprint

Dental fluorosis is a common disorder caused by excessive fluoride intake during tooth development. The esthetic consequences of dental fluorosis can negatively affect oral health-related quality of life and have lasting psychosocial effects. In severe cases, where the fluorosed enamel is prone to chipping, flaking, and developing caries, minimally invasive procedures are ineffectual and a more substantial restorative approach is required to restore optimal function and esthetics. However, no definitive guidelines exist for the management and treatment of severe dental fluorosis due to the limited evidence available in the literature. This case report describes the full-mouth rehabilitation of a patient with severe dental fluorosis utilizing adhesively bonded all-ceramic crowns, veneers, and overlays. The successful follow-up on this case indicates that adhesively bonded restorations may provide a viable option in the functional and esthetic management of severely fluorosed dentition.

This study utilizes satellite data to investigate water quality conditions in the San Francisco Estuary and its upstream delta, the Sacramento-San Joaquin River Delta. To do this, this study derives turbidity from the European Space Agency satellite Sentinel-2 acquired from September 2015 to June 2019 and conducts a rigorous validation with insitu measurements of turbidity from optical sensors at continuous monitoring stations. This validation includes 965 matchup comparisons between satellite and insitu sensor data across 22 stations, yielding R 2 = 0.63 and 0.75 for Nephelometric Turbidity Unit and Formazin Nephelometric Unit (FNU) stations, respectively. This study then applies remote sensing to evaluate patterns in turbidity during the Suisun Marsh Salinity Control Gates Action ("Gates action"), a pilot study designed to increase habitat access and quality for the endangered Delta Smelt. The basic strategy was to direct more freshwater into Suisun Marsh, creating more low salinity habitat that would then have higher (and more suitable) turbidity than upstream river channels. For all seven acquisitions considered from June 29 to September 27, 2018, turbidity conditions in Bays and Sloughs subregions were consistently higher (and more suitable) (26-47 FNU) than what was observed in the upstream River region (13-25 FNU). This overall pattern was observed when comparing images acquired during similar tidal stages and heights.

Background Real-time reverse transcription polymerase chain reaction (rRT-PCR) and antigen tests are important diagnostics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Sensitivity of antigen tests has been shown to be lower than that of rRT-PCR; however, data to evaluate epidemiologic characteristics that affect test performance are limited. Methods Paired mid-turbinate nasal swabs were collected from university students and staff and tested for SARS-CoV-2 using both Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA) and rRT-PCR assay. Specimens positive by either rRT-PCR or antigen FIA were placed in viral culture and tested for subgenomic RNA (sgRNA). Logistic regression models were used to evaluate characteristics associated with antigen results, rRT-PCR cycle threshold (Ct) values, sgRNA, and viral culture. Results Antigen FIA sensitivity was 78.9% and 43.8% among symptomatic and asymptomatic participants, respectively. Among rRT-PCR positive participants, negative antigen results were more likely among asymptomatic participants (odds ratio [OR] 4.6, 95% confidence interval [CI]: 1.3–15.4) and less likely among participants reporting nasal congestion (OR 0.1, 95% CI: .03–.8). rRT-PCR-positive specimens with higher Ct values (OR 0.5, 95% CI: .4–.8) were less likely, and specimens positive for sgRNA (OR 10.2, 95% CI: 1.6–65.0) more likely, to yield positive virus isolation. Antigen testing was >90% positive in specimens with Ct values Conclusions SARS-CoV-2 antigen test advantages include low cost, wide availability and rapid turnaround time, making them important screening tests. The performance of antigen tests may vary with patient characteristics, so performance characteristics should be accounted for when designing testing strategies and interpreting results.

Microcystins are toxic chemicals generated by certain freshwater cyanobacteria. These chemicals can accumulate to dangerous levels during harmful algal blooms. When exposed to microcystins, humans are at risk of hepatic injury, including liver failure. Here, we describe a method to detect microcystins in human plasma by using immunocapture followed by a protein phosphatase inhibition assay. At least 279 microcystins have been identified, and most of these compounds share a common amino acid, the Adda side chain. We targeted this Adda side chain using a commercial antibody and extracted microcystins from human samples for screening and analysis. To quantitate the extracted microcystins, we fortified plasma with microcystin-LR, one of the most well-studied, commonly detected, and toxic microcystin congeners. The quantitation range for the detection of microcystin in human plasma using this method is 0.030–0.50 ng/mL microcystin-LR equivalents. This method detects unconjugated and conjugated forms (cysteine and glutathione) of microcystins. Quality control sample accuracies varied between 98.9% and 114%, with a precision of 7.18–15.8%. Finally, we evaluated plasma samples from a community health surveillance project of Florida residents living or working near harmful algae blooms.

UNSTRUCTURED Patient perspectives are central to the U.S. Food and Drug Administration’s benefit-risk decision-making process in the evaluation of medical products. Traditional channels of communication may not be comfortable for all patients and consumers. Social media websites have increasingly been recognized by researchers as a means to gain insights on patients’ views about treatment and diagnostic options, the healthcare system, and their experiences living with their conditions. Utilizing multiple patient perspective data sources offers the FDA the opportunity to capture diverse patient voices and experiences with chronic pain. To explore diverse patients perspectives, a pilot study was conducted to examine posts from INSPIRE’s own patient platform and several social media platforms to gain insights into the key challenges and barriers faced by chronic pain patients (CPPs). The most common topics discussed among CPPs were disease burden, support and advocacy needs, and proper diagnosis. The two most frequently discussed treatments were opioids or narcotics, and devices such as transcutaneous electrical nerve stimulation (TENS) machines and spinal cord stimulators. Success in pain reduction was tempered by concerns of stigmatization regarding opioid addiction and dependency. The study illustrates how social listening data may provide valuable insights into diverse patient perspectives, preferences, and unmet needs, especially for conditions that may be perceived as stigmatizing.

This paper summarizes results from a research project collaboration between a Transportation Security Administration (TSA) organization responsible for aviation security at a mid-sized airport in the western United States and a local university. The purpose of this project was to explore the potential and utility of a learning tool designed to enhance critical thinking skills among Transportation Security Officers (TSO). Employees of the TSA are provided comprehensive and continuous training from point of hire throughout the duration of a TSO’s employment. However performance problems continue to be identified and while TSOs are annually rated on their ability to think critically no training is provided for this specific skill. During Phase 1 of this two-phased study, a learning tool was developed in the form of a situational judgment test based tacit knowledge inventory comprised of work scenarios that were oriented on developing critical thinking skills common to TSOs. In Phase 2, TSOs organized into an experimental group, participated in structured facilitated discussions that supplemented the traditional training protocol and were based on the critical thinking tacit knowledge inventory; a control group took part in only the traditional training. A significant difference was found between the experimental and control group annual performance ratings for the critical thinking scale.

Migraine affects over 40 million Americans and is the world’s second most disabling condition. As the majority of medical care for migraine occurs in primary care settings, not in neurology nor headache subspecialty practices, healthcare system interventions should focus on primary care. Though there is grade A evidence for behavioral treatment (e.g., biofeedback, cognitive behavioral therapy (CBT), and relaxation techniques) for migraine, these treatments are underutilized. Behavioral treatments may be a valuable alternative to opioids, which remain widely used for migraine, despite the US opioid epidemic and guidelines that recommend against them. Identifying and removing barriers to the use of headache behavioral therapy could help reduce the disability as well as the personal and social costs of migraine. These techniques will have their greatest impact if offered in primary care settings to the lower socioeconomic status groups at greatest risk for migraine. We review the societal and cultural challenges that impose barriers to optimal use of non-pharmacological treatment services. These barriers include insufficient knowledge of migraine/headache behavioral treatments and insufficient availability of clinicians trained in non-pharmacological treatment delivery; limited access in underserved communities; financial burden; and stigma associated with both headache and mental health diagnoses and treatment. For each barrier, we discuss potential approaches to minimizing its effect and thus enhancing non-pharmacological treatment utilization. Case Example A 25-year-old graduate student with a prior history of headaches in college is attending school in the evenings while working a full-time job. Now, his headaches have significant nausea and photophobia. They are twice weekly and are disabling enough that he is unable to complete homework assignments. He does not understand why the headaches occur on Saturdays when he pushes through all week to get through his examinations that take place on Friday evenings. He tried two different migraine preventive medications, but neither led to the 50% reduction in headache days his doctor had hoped for. His doctor had suggested cognitive behavioral therapy (CBT) before initiating the medications, but he had been too busy to attend the appointments, and the challenges in finding an in-network provider proved difficult. Now with the worsening headaches, he opted for the CBT and by the fifth week had already noted improvements in his headache frequency and intensity.

Background Recent deadly outbreaks of Marburg virus underscore the need for an effective vaccine. A summary of the latest research is needed for this WHO priority pathogen. This systematic review aimed to determine progress towards a vaccine for Marburg virus. Methods Article search criteria were developed to query PubMed for peer-reviewed articles from 1990 through 2019 on Marburg virus vaccine clinical trials in humans and pre-clinical studies in non-human primates (NHP). Abstracts were reviewed by two authors. Relevant articles were reviewed in full. Discrepancies were resolved by a third author. Data abstracted included year, author, title, vaccine construct, number of subjects, efficacy, and demographics. Assessment for risk of bias was performed using the Syrcle tool for animal studies, and the Cochrane Collaboration risk of bias tool for human studies. Results 101 articles were identified; 27 were related to Marburg vaccines. After full text review, 21 articles were selected. 215 human subjects were in three phase 1 clinical trials, and 203 NHP in 18 studies. Vaccine constructs were DNA plasmids, recombinant vesicular stomatitis virus (VSV) vectors, adenovirus vectors, virus-like particles (VLP), among others. Two human phase 1 studies of DNA vaccines had 4 adverse effects requiring vaccine discontinuation among 128 participants and 31–80% immunogenicity. In NHP challenge studies, 100% survival was seen in 6 VSV vectored vaccines, 2 DNA vaccines, 2 VLP vaccines, and in 1 adenoviral vectored vaccine. Conclusion In human trials, two Marburg DNA vaccines provided either low immunogenicity or a failure to elicit durable immunity. A variety of NHP candidate Marburg vaccines demonstrated favorable survival and immunogenicity parameters, to include VSV, VLP, and adenoviral vectored vaccines. Elevated binding antibodies appeared to be consistently associated with protection across the NHP challenge studies. Further human trials are needed to advance vaccines to limit the spread of this highly lethal virus.

While deep neural networks (DNNs) and other machine learning models often have higher accuracy than simpler models like logistic regression (LR), they are often considered to be “black box” models and this lack of interpretability and transparency is considered a challenge for clinical adoption. In healthcare, intelligible models not only help clinicians to understand the problem and create more targeted action plans, but also help to gain the clinicians’ trust. One method of overcoming the limited interpretability of more complex models is to use Generalized Additive Models (GAMs). Standard GAMs simply model the target response as a sum of univariate models. Inspired by GAMs, the same idea can be applied to neural networks through an architecture referred to as Generalized Additive Models with Neural Networks (GAM-NNs). In this manuscript, we present the development and validation of a model applying the concept of GAM-NNs to allow for interpretability by visualizing the learned feature patterns related to risk of in-hospital mortality for patients undergoing surgery under general anesthesia. The data consists of 59,985 patients with a feature set of 46 features extracted at the end of surgery to which we added previously not included features: total anesthesia case time (1 feature); the time in minutes spent with mean arterial pressure (MAP) below 40, 45, 50, 55, 60, and 65 mmHg during surgery (6 features); and Healthcare Cost and Utilization Project (HCUP) Code Descriptions of the Primary current procedure terminology (CPT) codes (33 features) for a total of 86 features. All data were randomly split into 80% for training (n = 47,988) and 20% for testing (n = 11,997) prior to model development. Model performance was compared to a standard LR model using the same features as the GAM-NN. The data consisted of 59,985 surgical records, and the occurrence of in-hospital mortality was 0.81% in the training set and 0.72% in the testing set. The GAM-NN model with HCUP features had the highest area under the curve (AUC) 0.921 (0.895–0.95). Overall, both GAM-NN models had higher AUCs than LR models, however, had lower average precisions. The LR model without HCUP features had the highest average precision 0.217 (0.136–0.31). To assess the interpretability of the GAM-NNs, we then visualized the learned contributions of the GAM-NNs and compared against the learned contributions of the LRs for the models with HCUP features. Overall, we were able to demonstrate that our proposed generalized additive neural network (GAM-NN) architecture is able to (1) leverage a neural network’s ability to learn nonlinear patterns in the data, which is more clinically intuitive, (2) be interpreted easily, making it more clinically useful, and (3) maintain model performance as compared to previously published DNNs.