Notes

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There have been a few case reports and one small series of low grade papillary sinonasal (Schneiderian) carcinomas (LGPSC) which mimic papillomas but have overtly invasive growth and which occasionally metastasize. We describe the morphologic, clinical, immunohistochemical, and molecular features of five patients with LGPSC compared with eight cases each of inverted papilloma (IP) and conventional nonkeratinizing squamous cell carcinoma (SCC) with papillary growth. All LGPSC were nested with predominantly pushing invasion, no stromal reaction, and frequent surface papillary growth. All consisted of one cell type only, with polygonal cells with round nuclei, no (or limited) cytologic atypia, low mitotic activity, and prominent neutrophilic infiltrate. One patient had slightly more infiltrative bone invasion, another lymphovascular, perineural, and skeletal muscle invasion, and a third nodal metastasis after 17 years. By comparison, IPs had bland cytology, neutrophilic microabscesses, mixed immature squamous, goblet cell, and respiratory epithelium, and extremely low mitotic activity. Nonkeratinizing SCCs had basaloid-appearing cells with nuclear pleomorphism, brisk mitotic activity, and apoptosis. All LGPSC were p63 positive. Mitotic activity and Ki67 indices were significantly higher for LGPSCs than IPs and significantly lower than NKSCCs, while p53 immunohistochemistry in LGPSC was identical to nonkeratinizing SCC and higher than for IP. Sequencing showed all five tumors to harbor a MUC6 mutation, one tumor to harbor CDKN2A and PIK3R1 mutations, and one tumor to harbor a NOTCH1 mutation. All LGPSC lacked EGFR and KRAS mutations and lacked copy number variations of any main cancer genes. At a median follow up of 12 months, two LGPSC recurred locally, and one patient died after massive local recurrences and nodal metastases. LGPSC is a distinct, de novo sinonasal carcinoma that can be differentiated from papillomas by morphology and selected immunohistochemistry.
This study evaluated student satisfaction with an educational exercise using feature films to learn about performing a psychiatric mental status examination.

Following the completion of an educational exercise designed by the first author, students in a behavioral medicine course completed surveys regarding their satisfaction with the exercise as a tool for learning how to perform a mental status examination. The educational exercise involved an initial didactic lecture followed by group exercises and individual presentations, utilizing feature films as tools for understanding the mental status examination. Each student selected a movie depicting a character with a psychiatric or substance-use disorder and performed a hypothetical mental status examination for the character, which they presented to their classmates.

One hundred nine (109) students (97.3%) in the course completed evaluations of the educational exercise, and the majority found the exercise valuable; 93.6% of respondents felt that their ability to conceptualize a case had improved because of the exercise. In general evaluations of the course, this particular educational exercise was frequently mentioned in response to a free-form question about "the best part of the course."

Movies depicting psychiatric illness and substance use disorders can be a fun and highly effective tool for helping students to learn and develop competency in the performance of mental status examinations.
Movies depicting psychiatric illness and substance use disorders can be a fun and highly effective tool for helping students to learn and develop competency in the performance of mental status examinations.Follicular lymphoma (FL) is one of the most common subtypes of non-Hodgkin lymphoma worldwide. Improved survival outcomes with rituximab-based therapy in clinical trials led to the establishment of rituximab-based immunochemotherapy as standard of care for first-line (1L) treatment of FL. In the GALLIUM trial, obinutuzumab-based immunochemotherapy demonstrated improved progression-free survival (PFS), prolonged time-to-next antilymphoma treatment (TTNT) and comparable overall survival (OS) compared with rituximab-based immunochemotherapy as 1L treatment for FL. Using GALLIUM as an example, this article aims to explain how improved outcomes in 1L treatment of FL have changed the landscape for the design and interpretation of future trials. As approved therapies for 1L FL already achieve good responses, it is becoming more difficult to design trials that demonstrate further treatment benefits with the currently accepted primary endpoints. New endpoints are needed to reflect the long remission times, low relapse rates, and impact of subsequent therapies in FL. PFS is used as a primary efficacy endpoint in registrational clinical trials for indolent malignancies like FL, where improvement in OS is not always observed due to the large number of patients and long study duration required to demonstrate a clear survival benefit. However, there are limitations to using PFS as the primary endpoint. Other potential endpoints, including TTNT, progression of disease within 2 years, response rate, and minimal residual disease status are explored.
The oral explanation (OE) is a critical event during new marketing authorisation procedures in the European Union (EU). The primary objective of the present study was to investigate how many procedures, having an OE in front of the Committee for Medicinal Products for Human Use (CHMP), resulted in a regulatory approval for oncology products.

Procedures for new marketing authorisation applications (MAAs) and Type II variations (new indication) for oncology products with at least one OE (with or without a Scientific Advisory Group (SAG) meeting) and for which the outcome took place between 31 January 2016 to 31 January 2020 were included in the analysis. Publicly available agendas/meeting minutes and assessment reports were used to obtain information on the products.

An OE occurred in about 20% of procedures (n = 28/150) for oncology products during the review period. read more The majority of procedures having an OE (61%), with or without any SAG meeting, led to MAA/Type II variation approval in the Centralised Procedure. It was also observed that in 41% of the cases a successful outcome was contingent upon willingness of the applicant to restrict the indication.

A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure.
A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure.
Additional antibiotic options are needed to treat bone and joint infections caused by penicillin-resistant Gram-positive pathogens.

This subanalysis of the Telavancin Observational Use Registry (TOUR™) aimed to record real-world telavancin usage patterns in patients with bone and joint infections treated with telavancin.

TOUR was a multicenter observational-use registry study conducted at 45 US sites between January 2015 and March 2017. Patient characteristics, infection type, infecting pathogen(s), previous treatment, telavancin dosing and duration, clinical response, and adverse event data were collected by retrospective medical chart reviews. As such, inclusion/exclusion criteria were limited, and any patient receiving at least one dose of telavancin at the discretion of the treating physician was eligible. Patients were assessed as either positive clinical response, failed treatment, or indeterminate outcome.

Of the 1063 patients enrolled in TOUR, 27.4% (291/1063) were patients with bone and jointered with ClinicalTrials.gov (NCT02288234) on 11 November, 2014.
This trial was registered with ClinicalTrials.gov (NCT02288234) on 11 November, 2014.The purpose of this study was to examine relationships among caregiver social support, caregiver depressive symptoms, medication adherence, and asthma control in a sample of low-income, urban, Black children aged 3-12 years with uncontrolled asthma and their caregivers. Using longitudinal data from a randomized controlled trial (RCT) assessing the efficacy of an environmental control educational intervention, we used generalized estimating equations and ordered logistic regression models to evaluate the relationship between caregiver social support (Medical Outcomes Study Social Support Survey), depressive symptoms (Center for Epidemiologic Studies Depression scale), and two child asthma outcomes (a) medication adherence (Asthma Medication Ratio) and (b) asthma control. At baseline, 45.7% of the 208 children had very poorly controlled asthma. Nearly a third of caregivers (97% female) had clinically significant depressive symptoms at each data collection point. Social support was not associated with either asthma outcome nor did it moderate the relationship between depressive symptoms and child asthma outcomes. Higher caregiver depressive symptoms predicted decreased medication adherence (b=-0.003, SE 0.002). Moderate asthma at baseline (OR 0.305, SE 0.251), severe asthma at baseline (OR 0.142, SE 0.299), household income less then $20,000 per year (OR 0.505, SE 0.333), and fall season (OR 0.643, SE 0.215) were associated with poorer asthma control. Attending to the social context of low-income, urban, Black children with asthma is critical to reduce asthma morbidity. Maternal depressive symptoms are modifiable and should be targeted in interventions to improve child asthma outcomes in this vulnerable population. The RCT was registered with ClinicalTrials.gov (NCT01981564) in October 2013.Racial-ethnic minority youth between the ages of 13 and 24 in the USA are disproportionately impacted by HIV. Low HIV knowledge and psychological antecedents such as low perception of risk and low sexual negotiation skills have all been associated with HIV risk behaviors; however, the role of ethnic identity on these factors is unclear in the literature. Ethnic identity, which is a critical part of identity development among racial-ethnic minority youth, has been found to be a protective factor in risk-taking behaviors. However, limited research is available on the role of ethnic identity in HIV prevention research among youth. For this study, data were collected as part of a larger HIV prevention education program using a sample of 564 students of color (Meanage = 16.30, standard deviation [SD] = 1.26; 67.4% Hispanic, 29.5% Black) from an underserved northeastern US urban community. We examined whether ethnic identity moderated the relationship between psychological antecedents (e.g., perception of risk and sexual negotiation skills), gender, and viral hepatitis knowledge on HIV knowledge. Findings revealed that ethnic identity significantly moderated the relationship between psychological antecedent variables and HIV knowledge by strengthening these associations as ethnic identity increased. Female adolescents were also more likely to have higher levels of HIV knowledge than males. Findings provide support for cultural and gender-specific prevention programs for racial-ethnic minority youth that seek to reduce HIV risk behaviors by increasing ethnic identity, particularly in under-resourced communities.
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