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Background Sexual assault prevention is a priority for the military and is likely to be most effective when tailored to specific needs and individual experiences. Technology advances make it possible to integrate individualized programming into group education settings common to military training, but this approach is not without potential challenges. Prior to implementing and evaluating a novel prevention program, it is critical to conduct a feasibility study to assess the extent to which the program can be successfully implemented, is acceptable to participants, and can be rigorously evaluated. This paper presents the results of a large feasibility study of the Sexual Communication and Consent (SCC) program in Air Force Basic Military Training. The objectives were to understand (1) the suitability and acceptability of SCC and study procedures, (2) the research team’s resources and ability to manage and implement the study and SCC, and (3) the appropriateness of the data collection procedures and outcome measures. Methods The 26-week feasibility study involved more than 9000 trainees. At pretest, the sample was 73% male and 90% straight. Half of trainees (51%) reported not being in a romantic relationship, and 46% reported being in an exclusive romantic relationship. SCC involved 6 h of training over two sessions delivered 2 weeks apart. Sessions combined tablet-based training that was tailored to individual sexual assault risk (for revictimization, first-time victimization, or perpetration based on a screening instrument) with instructor-led classroom activities and discussion. Results Trainee, instructor, and observer data indicated that the program was feasible, implemented with high fidelity, and acceptable to trainees. Technology and data collection procedures worked well, but time constraints led to program changes, missed content, and missing survey data. Staff time and skill requirements for SCC implementation exceeded those of standard training. Conclusions Our results suggest that high-quality implementation of tailored sexual assault prevention training is feasible in a military environment, and they inform recommendations for program revisions, future evaluation, and sustainability.

Background Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility. Methods This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states—Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars. Results State-level average and median start-up cost (representing 8–10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost. Conclusion We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments.

Background. In September 2008, an outbreak of pneumonia associated with an emerging human adenovirus (human adenovirus serotype 14 [HAdV-14]) occurred on a rural Southeast Alaska island. Nine patients required hospitalization, and 1 patient died. Methods. To investigate the outbreak, pneumonia case patients were matched to control participants on the basis of age, sex, and community of residence. Participants in the investigation and their household contacts were interviewed, and serum samples and respiratory tract specimens were collected. Risk factors were evaluated by means of conditional logistic regression. Results. Among 32 pneumonia case patients, 21 (65%) had confirmed or probable HAdV-14 infection. None of 32 matched control participants had evidence of HAdV-14 infection (P < .001 for the difference). Factors independently associated with pneumonia included contact with a known HAdV-14–infected case patient (odds ratio [OR], 18.3 [95% confidence interval {CI}, ≥2.0]), current smoking (OR, 6.7 [95% CI, ≥0.9]), and having neither traveled off the island nor attended a large public gathering (OR, 14.7 [95% CI, ≥2.0]). Fourteen (67%) of 21 HAdV-14–positive case patients belonged to a single network of people who socialized and often smoked together and infrequently traveled off the island. HAdV-14 infection occurred in 43% of case-patient household contacts, compared with 5% of control-participant household contacts (P = .005) Conclusions. During a community outbreak in Alaska, HAdV-14 appeared to have spread mostly among close contacts and not widely in the community. Demographic characteristics and illness patterns among the case patients were similar to those observed in other recent outbreaks of HAdV-14 infection in the United States.

The practical applications of software have exploded in the past twenty years to the point that software as a medical device (SaMD) is now embedded as standard technology in the medical health care system. The opportunity to enter the device market has attracted a new population of companies with less experience in medical product regulation than traditional medical device companies. Many of these companies have become accustomed to software development methods, such as the popular Agile methods, whose approaches do not fit comfortably in FDA’s conception of design controls for medical devices. The structured nature of current design control methods for regulated medical devices has raised questions about whether the current regulatory requirements impede rapid device development and innovation without justifiably improving product safety. The Health Policy Triangle (HPT) framework was applied to data received from an online survey soliciting the views and experience of 83 industry professionals involved in medical device software development regarding opportunities and challenges related to the implementation of design controls. Results suggested that the industry is broadly satisfied with the current state of design control for digital health technology (DHT) and is actively involved in continuing to shape the regulations that oversee the development. The views on the process, content, and context of developing software as a medical device (SaMD) and software in a medical device (SiMD) were similar across regulatory and engineering experts. Most felt that Agile software development lifecycles (SDLC) can be used compliantly within the existing design control framework but may be best suited to specific situations rather than the sole SDLC methodology. Many, though, want more specific technical guidance to operate effectively within the existing framework.Differences in opinions were expressed with respect to specific guidance and policy documents. Better promotion of new guidance documents, such as those for low-risk software, may need to be directed to newer entrants to the field, where many identify deficiencies. Further, the industry respondents indicated the need for more specific and practical examples related to best practices and technical solutions, especially in clinical decision-support and cybersecurity guidance on cybersecurity documents.

Background The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process. Four expert committees (General and Plastic Surgery and Dentistry; Orthopaedics, Traumatology, Rehabilitation, Rheumatology; Circulatory System; and Neurology) have published at least one Scientific Opinion (SO) under the Clinical Evaluation Consultation Procedure (CECP) in 2021–2022. Methods The four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0–2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0–2 scale. Results All committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0–0.15 and 0.15–0.69, respectively, in the biological domain, and 0.12–0.55 and 0.23–0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues. Conclusion Expert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques.

Infection by larval trematodes often causes a cessation of egg production in its molluscan intermediate host and is referred to as parasitic castration. Because phenoloxidase (PO) has been shown to be involved in egg formation in other invertebrate species, we investigated the role of PO in normal egg production in the snail, Biomphalaria glabrata, and the effects of Schistosoma mansoni infection on the PO pathway in this snail. Our data showed that PO activity in the albumen gland (AG) is initially expressed when snails reach a size of approximately 8 mm in shell diameter and continues to increase as snails grow, indicating a developmental link between snail size and AG PO expression. Egglaying was also shown to be coincidental with the onset of PO expression in the AG, thereby supporting a direct association between PO activity and egg production. In addition, exposure of snails to diethyldithiocarbamate (DDC), a PO inhibitor, affected normal in vivo egg production, as evidenced by a significant decrease in the numbers of eggs laid in DDC-treated groups compared to nontreated groups. Normal resumption of egg-laying activity in treated snails following withdrawal of the drug indicated that inhibition was reversible. Taken together, the results of our developmental and DDC-exposure studies provide strong support for a crucial role of PO in normal egg production in this animal. Finally, AG PO activities of infected and uninfected control snails were measured over the course of S. mansoni infection. Our results showed that both total and specific enzyme activities in the AG of infected snails were significantly decreased at 28 and 33 days postinfection (PI) when compared to those of control snails. Results of subsequent experiments assessing the effects of larval infection on L-tyrosine (PO substrate) levels in AG and ovotestis revealed a significant increase in the levels of this compound in both organs over the course of infection. It is concluded that AG PO activity is functionally linked to egg formation in normal snails and that a strong association exists between parasite-mediated decrease in AG PO activity and parasitic castration. However, from the data presented, a direct causal relationship linking infection, decreased PO, and castration has yet to be established.

The article by [Tim Philp] on Dark matter in astronomy was particularly excellent. This subject can be mind numbing at the best of times. Yet, he has effectively described this phenomenon in a way that makes it easy to understand.

I might very well be a traitor to the cause for my views, but I believe them and so do many of my other friends (some of whom are disabled). I believe the Supreme Court's decision to give the school board's final say in the placement of disabled students was outstanding and about time. [See the box at right on the court ruling.] This rule seems to be thrown out the window when dealing with mentally disabled children. I have seen high school students who are disabled who do not know how to read, write, do the barest math or even communicate past a pre-school level with the other students. The Supreme Court was giving reasons for its decision in the case of Emily Eaton of Burford, near Brantford, a 12-year-old girl with cerebral palsy. Emily, who cannot speak or use sign language effectively, became the focus of a five-year court battle after her parents demanded she be allowed to attend regular classes at her local school. The Brant County school board wanted Emily, then a grade 2 pupil, to attend a special class for disabled students at a different school.

Historical information about cheese and a recipe for cottage cheese dip are presented for children.