Assessing antibiotic prescribing in nurse practitioners: Applied cognitive task analysis.

Background: Prescribing antibiotics is a demanding and complex task where decision-making skills are of critical importance to minimize the risk of antimicrobial resistance. Despite its importance, little is known about the decision-making skills and cognitive strategies new Nurse Practitioners (NPs) use when prescribing antibiotics. Objective: To identify the cognitive demands of antibiotic prescribing complexity and to explore the cognitive strategies that new NPs in New Zealand use when prescribing antibiotics. Design: A qualitative approach using Applied Cognitive Task Analysis (ACTA) methodology. Participants: A purposive sample was recruited consisting of five NPs who had been registered within the last five years and were prescribing antibiotics as part of their scope of practice. Methods: In-depth face-to-face interviews consisting of a task diagram interview and a knowledge audit were conducted and analyzed following the ACTA protocol. Results: Four cognitive elements were identified from the data which showed the cognitive demands of prescribing antibiotics, and the cues and strategies NPs use for safe practice. These were: 1 prescribing in the face of uncertainty (complex patients and diagnostic uncertainty); 2 making clinical decisions with insufficient/poor guidance (lack of guidelines, conflicting information); 3 producing an individualized treatment plan in view of clinical and non-clinical patient factors (patient demand/expectation, inadequate patient education, risks versus benefits of antibiotic treatment); 4 ensuring treatment efficacy and continuity of care (ineffective treatment, patient care follow up). Conclusion: The ACTA framework has given insight into the current antibiotic prescribing practice of new NPs, identifying areas where professional development courses and treatment resources can be targeted to support antibiotic prescribing. NPs are likely to benefit from resources that are freely available and reflect national or local antimicrobial data. Further work is also warranted to determine whether targeted education resources and clinical pathways will help with diagnostic uncertainty, and how this could be embedded into existing curricula.

Supporting "Bleeders" and "Billers": How Safety-Net Administrators Mitigate Provider Burnout During the COVID-19 Pandemic and Beyond.

Organizational factors impacting burnout have been underexplored among providers in low-income, minority-serving, safety-net settings. Our team interviewed 14 health care administrators, serving as key decision makers in Federally Qualified Health Center primary care clinics. Using a semistructured interview guide, we explored burnout mitigation strategies and elements of organizational culture and practice. Transcribed interviews were coded and analyzed using the Braun and Clark (2006) Thematic Analysis method. Mission-Driven Ethos to Mitigate Provider Burnout emerged as the primary theme with 2 categories: (1) Promoting the Mission: "Bleeders" and (2) Competing Priorities: "Billers." These categories represent various properties and reflect administrators' use of organizational mission statement as a driver of staff recruitment, training, retention, and stratification. Data collection occurred before and during the COVID-19 global pandemic, as such additional themes associated with administrative behaviors during a prolonged, clinical crisis provide insight into possible strategies that may mitigate burnout in this setting.

Design control considerations for biologic-device combination products.

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting development of innovative, safe and effective combination products. It remains the manufacturer's responsibility to comply with the relevant requirements and regulations, and develop good business practices that clearly describe how these practices comply with FDA's final rule (21 CFR Part 4) and aligns with the company's already established quality system.

Intermolecular interactions and morphology of aqueous polymer/surfactant mixtures containing cationic chitosan and nonionic sorbitan esters.

In this study, the impact of surfactant molecular composition (saturated sorbitan monolaurate or unsaturated sorbitan monooleate) on polymer/surfactant assemblies was examined. Specifically, the associations between the cationic chitosan and the uncharged surfactants were monitored by surface tension, turbidity, and conductivity measurements. Bright field, confocal laser scanning, and transmission electron microscopy revealed that nanometer-sized chitosan/surfactant aggregates comprised of a chitosan-rich shell and a chitosan-poor core agglomerate at high surfactant concentrations to yield micrometer-scaled supramolecular structures with highly ordered internal structure. The size and architecture of these chitosan/surfactant assemblies were dependent on the structure and concentration of the surfactant employed. The association mechanism among chitosan, surfactant, and the chitosan/surfactant aggregates was discussed in terms of the semirigid polyelectrolyte character of chitosan and the hydrophobic character of sorbitan esters. This study provides important insight into the structural and physical parameters of surfactant that govern the formation of multicompartment polymer/surfactant assemblies.

Characterization of atrazine-induced gonadal malformations in African clawed frogs (Xenopus laevis) and comparisons with effects of an androgen antagonist (cyproterone acetate) and exogenous estrogen (17beta-estradiol): Support for the demasculinization/feminization hypothesis.

Atrazine is a potent endocrine disruptor that both chemically castrates and feminizes male amphibians. It depletes androgens in adult frogs and reduces androgen-dependent growth of the larynx in developing male larvae. It also disrupts normal gonadal development and feminizes the gonads of developing males. Gonadal malformations induced by atrazine include hermaphrodites and males with multiple testes [single sex polygonadism (SSP)], and effects occur at concentrations as low as 0.1 ppb (microg/L). Here, we describe the frequencies at which these malformations occur and compare them with morphologies induced by the estrogen, 17beta-estradiol (E2) , and the antiandrogen cyproterone acetate, as a first step in testing the hypothesis that the effects of atrazine are a combination of demasculinization and feminization. The various forms of hermaphroditism did not occur in controls. Nonpigmented ovaries, which occurred at relatively high frequencies in atrazine-treated larvae, were found in four individuals out of more than 400 controls examined (1%). Further, we show that several types of gonadal malformations (SSP and three forms of hermaphroditism) are produced by E2 exposure during gonadal differentiation, whereas a final morphology (nonpigmented ovaries) appears to be the result of chemical castration (disruption of androgen synthesis and/or activity) by atrazine. These experimental findings suggest that atrazine-induced gonadal malformations result from the depletion of androgens and production of estrogens, perhaps subsequent to the induction of aromatase by atrazine, a mechanism established in fish, amphibians, reptiles, and mammals (rodents and humans).

Effect of cobalt and chromium ions on MMP-1, TIMP-1, and TNF-alpha gene expression in human U937 macrophages: a role for tyrosine kinases.

Previous reports have suggested that the imbalance of matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) activity may contribute to prosthetic loosening. However, the mechanisms controlling these enzymes in the periprosthetic environment is unknown. We examined the effect of Co2+ and Cr3+ ions on the expression of genes encoding MMP-1, one of the principal proteinases capable of degrading native fibrillar collagens in the extracellular matrix (ECM), its inhibitor TIMP-1, and TNF-alpha, a cytokine that plays a central role in the induction of implant osteolysis. Human U937 macrophages were incubated in suspension or on phosphorylcholine (PC)-polymer coated surfaces for 24h with Co2+ and Cr3+ ions. The level of mRNAs was determined by reverse transcription-polymerase chain reaction (RT-PCR). Results show that both Co2+ and Cr3+ ions induce the expression of MMP-1, TIMP-1, and TNF-alpha mRNA in a dose-dependent manner in cell suspensions. Tyrosine kinase inhibitors have different effects on these stimulatory effects. Indeed, genistein has only partial inhibitory effect on MMP-1 and TIMP-1, with even less effect on TNF-alpha expression. In contrast, herbimycin A completely blocks MMP-1 and TNF-alpha while partially inhibiting TIMP-1. However, Co2+ and Cr3+ ions had no effect on the expression of MMP-1 and TIMP-1 in macrophages cultured on the PC-polymer, suggesting that the attachment of U937 macrophages to the PC-polymer surfaces may modify their gene expression. In fact, MMP-1 and TIMP-1 seems to be constitutively up-regulated in this condition. However, the effect of Co2+ and Cr3+ ions on macrophages cultured on PC-polymer coated surfaces is similar to what was observed in suspension. Together, these findings indicate that activation of MMP-1, TIMP-1, and TNF-alpha by Co2+ and Cr3+ ions is regulated by tyrosine kinases.

Evaluating a science diversity program at UC Berkeley: more questions than answers.

For the past three decades, much attention has been focused on developing diversity programs designed to improve the academic success of underrepresented minorities, primarily in mathematics, science, and engineering. However, ethnic minorities remain underrepresented in science majors and careers. Over the last 10 years, the Biology Scholars Program (BSP), a diversity program at the University of California (UC), Berkeley, has worked to increase the participation and success of students majoring in the biological sciences. A quantitative comparison of students in and out of the program indicates that students in BSP graduate with a degree in biology at significantly higher rates than students not in BSP regardless of race/ethnicity. Furthermore, students who are in BSP have statistically lower high school grade point averages (GPAs) and Scholastic Achievement Test (SAT) scores than students not in BSP. African-American and Hispanic students who join BSP graduate with significantly higher UC Berkeley biology GPAs than non-BSP African-American and Hispanic students, respectively. Majority (Asian and White) students in BSP graduate with statistically similar UC GPAs despite having lower SAT scores than non-BSP majority students. Although BSP students are more successful in completing a biology degree than non-program members, the results raise a series of questions about why the program works and for whom.