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OBJECTIVE: To estimate youth exposure to smoking in movies in the UK and compare the likely effect with the USA. METHODS: We collected tobacco occurrences data for 572 top-grossing films in the UK screened from 2001 to 2006 and estimated the number of on-screen tobacco impressions delivered to British youths in this time period. RESULTS: 91% of films in our sample that contained smoking were youth-rated films (British Board of Film Classification rating ‘15’ and lower), delivering at least 1.10 billion tobacco impressions to British youths during theatrical release. British youths were exposed to 28% more smoking impressions in UK youth-rated movies than American youth-rated movies, because 79% of movies rated for adults in the USA (‘R’) are classified as suitable for youths in the UK (‘15’ or ‘12A’). CONCLUSION: Because there is a dose-response relation between the amount of on-screen exposure to smoking and the likelihood that adolescents will begin smoking, the fact that there is substantially higher exposure to smoking in youth-rated films in the UK than in the USA suggests that the fraction of all youth smoking because of films in the UK is probably larger than in the USA. Other countries with ratings systems that are less conservative (in terms of language and sexuality) than the USA will also be likely to deliver more on-screen tobacco impressions to youths. Assigning an ‘18’ classification to movies that contain smoking would substantially reduce youth exposure to on-screen smoking and, hence, smoking initiation among British youths. [ABSTRACT FROM AUTHOR]

SummationCopper-64 (T1/2= 12.7 hours; β+, 0.653 MeV [17.8 %]; β−, 0.579 MeV [38.4 %]) has decay characteristics that allow for positron emission tomography (PET) imaging and targeted radiotherapy of cancer. The well-established coordination chemistry of copper allows for its reaction with a wide variety of chelator systems that can potentially be linked to peptides and other biologically relevant small molecules, antibodies, proteins, and nanoparticles. The 12.7-hours half-life of 64Cu provides the flexibility to image both smaller molecules and larger, slower clearing proteins and nanoparticles. In a practical sense, the radionuclide or the 64Cu-radiopharmaceuticals can be easily shipped for PET imaging studies at sites remote to the production facility. Due to the versatility of 64Cu, there has been an abundance of novel research in this area over the past 20 years, primarily in the area of PET imaging, but also for the targeted radiotherapy of cancer. The biologic activity of the hypoxia imaging agent, 60/64Cu-ATSM, has been described in great detail in animal models and in clinical PET studies. An investigational new drug application for 64Cu-ATSM was recently approved by the U.S. Food and Drug Administration (FDA) in the United States, paving the way for a multicenter trial to validate the utility of this agent, with the hopeful result being FDA approval for routine clinical use. This article discusses state-of-the-art cancer imaging with 64Cu radiopharmaceuticals, including 64Cu-ATSM for imaging hypoxia, 64Cu-labeled peptides for tumor-receptor targeting, 64Cu-labeled monoclonal antibodies for targeting tumor antigens, and 64Cu-labeled nanoparticles for cancer targeting. The emphasis of this article will be on the new scientific discoveries involving 64Cu radiopharmaceuticals, as well as the translation of these into human studies. [ABSTRACT FROM AUTHOR]

Recent national focus on the value of increasing US supplies of indigenous renewable energy underscores the need for re-evaluating all alternatives, particularly those that are large and well distributed nationally. A panel was assembled in September 2005 to evaluate the technical and economic feasibility of geothermal becoming a major supplier of primary energy for US base-load generation capacity by 2050. Primary energy produced from both conventional hydrothermal and enhanced (or engineered) geothermal systems (EGS) was considered on a national scale. This paper summarizes the work of the panel which appears in complete form in a 2006 MIT report, ‘The future of geothermal energy’ parts 1 and 2.In the analysis, a comprehensive national assessment of US geothermal resources, evaluation of drilling and reservoir technologies and economic modelling was carried out. The methodologies employed to estimate geologic heat flow for a range of geothermal resources were utilized to provide detailed quantitative projections of the EGS resource base for the USA. Thirty years of field testing worldwide was evaluated to identify the remaining technology needs with respect to drilling and completing wells, stimulating EGS reservoirs and converting geothermal heat to electricity in surface power and energy recovery systems. Economic modelling was used to develop long-term projections of EGS in the USA for supplying electricity and thermal energy. Sensitivities to capital costs for drilling, stimulation and power plant construction, and financial factors, learning curve estimates, and uncertainties and risks were considered. [ABSTRACT FROM AUTHOR]

This article notes some modifications in the Texas standard fire insurance contract as of March 1926. A fire insurance policy consists of the main contract of a general nature used to cover all fire risks, and one or more amending clauses to make the contract fit the conditions of the specific risk. In so far as the terms of the contract are concerned, the buyer of fire insurance in any of the U.S. obtains a standard article, prescribed and controlled by the Legislature or by officers in charge of the regulation of insurance. State governments have control over insurance because the Supreme Court of the U.S. has ruled that insurance is not to be regarded as an article of commerce. The Legislature of Texas has given to the State Insurance Commission the power to make, promulgate, and establish uniform policies of insurance and to prescribe all standard forms, clauses, and indorsements used on or in connection with insurance policies. In Texas the State Insurance Commission prescribes a policy patterned after the former New York policy but altered to harmonize with laws which have been passed by the Legislature. It is the purpose of this article to indicate briefly the nature of these changes and their significance.

Discusses the operation and methods of a reciprocal fire insurance in the U.S. Illustration of reciprocal insurance; Subscriber's agreement and power of attorney; Commission on premiums.

AbstractVesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 109plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 1010PFU/ml (total yield, 1 × 1013PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC. [ABSTRACT FROM AUTHOR]

Background: Hereditary angioedema (HAE) is a rare genetic disorder characterized by painful, debilitating, and potentially fatal swelling attacks. Lanadelumab is approved as long-term prophylaxis (LTP) in patients with HAE. However, real-world data on LTP use in patients with HAE are limited. Objective: To describe clinical characteristics, attack history, and quality of life (QoL) of patients with HAE type I/II who were receiving lanadelumab or other LTPs. Methods: Data were drawn from the Adelphi HAE Disease Specific Program, a cross-sectional survey of HAE physicians conducted in the United States from July to November 2021. Physician-reported disease characteristics, HAE attack frequency, and QoL were compared among patients receiving lanadelumab or other LTPs for at least 12 months. Results: Physicians reported data for 144 patients, of whom 29 had received lanadelumab and 115 had received another prophylaxis for at least 12 months. The mean ± standard deviation number of attacks in the previous 12 months was lower among patients receiving lanadelumab than other LTPs (2.3 ± 3.1 versus 3.4 ± 2.8, respectively; p = 0.075). Although both groups had similar current disease activity and severity, more patients receiving lanadelumab versus other LTPs had high disease activity (51.7% versus 12.5%, respectively; p < 0.0001) and disease severity rated as severe (51.7% versus 16.1%, respectively; p = 0.0001) at diagnosis. Physicians reported that more patients who received lanadelumab had good or very good QoL (72.4%) than those receiving other LTPs (36.5%) (p = 0.003). Conclusion: Analysis of these findings suggests lower attack frequency, lower symptomatic impact, and better QoL in patients treated with lanadelumab than another prophylaxis in a real-world setting.

Purpose: Human trafficking (HT) is the fastest growing crime in the world and a major health concern for healthcare. There is a critical lack of healthcare provider targeted HT education, resulting in the failure to identify, rescue, and provide proper care for victims of HT in the United States. All healthcare professionals must be vigilant and proactive in identifying and assisting victims of HT. Recognizing this need, the aim of this paper is to improve case managers' awareness and knowledge of their role in HT., Primary Practice Settings: The primary setting for purposes of this paper is the hospital as this is the most likely setting where a case manager would encounter a victim of HT. It has been reported that 87.8% of victims report they have been in contact with a healthcare professional at some point during their trafficking with 63.3% occurring in a hospital/emergency room., Conclusion and Implications for Case Management Practice: Given the prevalence of HT and the likelihood of numbers growing, case managers should proactively learn to identify, rescue, and provide patient-centered care for victims of HT. This can be achieved through the knowledge of tools that exist to assist case managers in the identification of victims, including the AMP and SOAR models. Additionally, it is important to know one's role, debunk the myths, and recognize the signs associated with trafficking. Providing a collaborative, patient-centered care approach that supports and empowers the victim will lead to improved victim outcomes and may aid the successful prosecution of the trafficker., Competing Interests: The author reports no actual or potential conflict of interest including financial, personal, or other relationships with organizations and companies that could inappropriately influence this article., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Heterogeneity of outcomes across different clinical trial study sites is often inevitable. Understanding how outcomes differ by site is important for planning future programs and studies. We examined the extent of heterogeneity of hepatitis C virus (HCV) treatment cascade outcomes among persons who inject drugs (PWIDs) across sixteen clinical sites utilized in the HERO Study-a pragmatic randomized trial of HCV treatment support. Treatment cascade outcomes included averages of overall treatment adherence and proportions of treatment initiation, treatment completion, sustained virologic response (SVR) test completion, and SVR achievement. The HERO study utilized 16 clinical sites across the United States (US): eight opioid treatment programs (OTPs) and eight community health centers (CHCs). Variability of the outcomes across the 16 clinical sites was assessed using ranges and intraclass correlation coefficients (ICC) estimated from mixed-effects linear or logistic regression models. Treatment initiation was analyzed in the intention-to-treat (ITT) sample (N = 755); treatment completion, adherence, and SVR test completion in the modified ITT (mITT) sample, which is the sample that initiated treatment (N = 623); and SVR achievement in the mITT and per-protocol (PP, N = 501) samples. Across the 16 clinical sites, the range observed in the averages of overall treatment adherence was from 68% to 81% [ICC = 0.026 (0.005, 0.054)], and the ranges of proportions observed were from 68% to 96% for treatment initiation [ICC (95% CI) = 0.086 (0.051, 0.155)], 60% to 100% for treatment completion [ICC = 0.049 (0.008, 0.215)], 54% to 95% for SVR test completion [ICC = 0.096 (0.006, 0.177)], 46% to 90% for SVR achievement in the mITT sample [ICC = 0.070 (0.014, 0.122)], and 76% to 100% for SVR achievement in the PP sample [ICC = 0.143 (0.021, 0.422)]. The variability of the outcomes across 16 US sites treating HCV among PWIDs appears to be substantial in view of the ranges and ICC values of the outcomes. It is imperative to develop tailored interventions to target the sources of variability and reduce barriers at the patient, provider, clinic, and state policy levels to facilitate more equitable access to HCV treatment and reduce heterogeneity in treatment outcomes.

As part of the response to the highly pathogenic avian influenza A(H5N1) virus outbreak in U.S. cattle and poultry and the associated human cases, CDC and partners are monitoring influenza A virus levels and detection of the H5 subtype in wastewater. Among 48 states and the District of Columbia that performed influenza A testing of wastewater during May 12-July 13, 2024, a weekly average of 309 sites in 38 states had sufficient data for analysis, and 11 sites in four states reported high levels of influenza A virus. H5 subtype testing was conducted at 203 sites in 41 states, with H5 detections at 24 sites in nine states. For each detection or high level, CDC and state and local health departments evaluated data from other influenza surveillance systems and partnered with wastewater utilities and agriculture departments to investigate potential sources. Among the four states with high influenza A virus levels detected in wastewater, three states had corresponding evidence of human influenza activity from other influenza surveillance systems. Among the 24 sites with H5 detections, 15 identified animal sources within the sewershed or adjacent county, including eight milk-processing inputs. Data from these early investigations can help health officials optimize the use of wastewater surveillance during the upcoming respiratory illness season., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. John Anderson reports support from the Council of State and Territorial Epidemiologists (CSTE) for travel to the 2023 Advanced Molecular Detection Days and the 2024 Advanced Molecular Detection Academy. Alexandria B. Boehm reports institutional support from the Sergey Brin Family Foundation and grant support from the U.S. National Science Foundation for research coordination network for wastewater-based epidemiology and from the Sloan Foundation for public health partnerships and wastewater-based epidemiology, and membership on the state of California wastewater-based epidemiology committee of the State Water Board. Ruth Lynfield reports support from the Infectious Diseases Society of America, CSTE, the National Foundation for Infectious Diseases, and the American Academy of Pediatrics to attend state epidemiology meetings, ID Week, CSTE Board meetings and CSTE annual conference, National Foundation for Infectious Diseases meeting, and the Committee on Infectious Diseases meeting. Marlene K. Wolfe reports a subaward gift to Stanford University, a grant from the Rockefeller Foundation for implementation of wastewater-based epidemiology in Bangladesh and Ghana and a subaward from Ceres Nanosciences (subaward from National Institutes of Health funding) for wastewater monitoring research, and support from the American Society of Microbiology for an invited talk at a conference. No other potential conflicts of interest were disclosed.

Background: Transcatheter tricuspid valve-in-valve (ViV) replacement has yielded good hemodynamic outcomes in the treatment of dysfunctional bioprosthetic valves (BPVs). Intentional fracture of certain rigid BPV frames, if feasible, allows a larger implanted valve when compared with implant into an unfractured BPV. There remains limited data on the feasibility of tricuspid valve frame fracture., Aims: Evaluate the feasibility of transcatheter tricuspid ViV replacement with fracture of the underlying BPV ring., Methods: An international multicenter registry of tricuspid ViV replacement with intentional tricuspid valve frame fracture was created. Demographic data along with procedural characteristics, outcomes, and follow-up data were collected. Comparison was made to the pre- and post-ViV replacement with fracture of the tricuspid valve frame conditions., Results: Ten patients from six centers were included with a median age and weight of 29 years and 67.3 kg respectively. Tricuspid valve frame fracture was performed using a median balloon diameter 3 mm (IQR 3-5) larger than the true inner diameter (ID). The final ID was a mean of 1.5 mm (95% CI: 0.35, 2.64: p < 0.05), and median 1.1 mm (0.5, 2.1) larger than the reported true ID of the surgical BPV after ViV replacement. The mean tricuspid inflow gradient by echocardiogram decreased by 6.65 mmHg (95% CI: 4.14, 9.15: p < 0.001). All procedures were without complication, specifically there was no heart block, pericardial effusion, or right coronary disruption., Conclusion: Intentional tricuspid valve frame fracture with tricuspid ViV replacement is feasible and can increase the valve orifice potentially reducing the risk of ViV patient prosthesis mismatch and is not associated with significant complications., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Importance: Hepatitis C virus (HCV) reinfection after curative treatment remains a concern for people who inject drugs., Objective: To assess the incidence of HCV reinfection and associated risk factors., Design, Setting, and Participants: This cohort study is a secondary analysis of a randomized clinical trial that was conducted across opioid treatment programs and community health centers in the US between September 2016 and August 2018. The current analyses were performed in March 2022. People who inject drugs who achieved sustained virologic response (SVR) were followed for up to 42 months., Exposure: Patients were randomly assigned to receive modified directly observed therapy or patient navigation., Main Outcomes and Measures: The primary outcome was rate of HCV reinfection. Change in reinfection rates over time was assessed using a Poisson regression model., Results: A total of 415 participants (mean [SD] age, 44.7 [11.5] years; 302 male [72.8%]) achieved a SVR and had 1 or more post-SVR assessments for HCV RNA. Overall, 302 (72.8%) reported recent injection drug use, 192 (46.3%) were living in unstable housing, and 313 (75.4%) had received recent methadone or buprenorphine for opioid use disorder. The overall reinfection rate was 11.4 per 100 person-years at risk (95% CI, 8.7-14.7 per 100 person-years at risk) over 518 person-years of follow-up. Reinfection rates varied significantly across sites, ranging from 2.9 per 100 person-years at risk (95% CI, 0.1-16.3 per 100 person-years) to 25.2 per 100 person-years at risk (95% CI, 15.6-38.5 per 100 person-years at risk) (P = .006). There was a significant decrease in incident reinfection with increasing post-SVR follow-up (weeks 0-24, 15.5 per 100 person-years; 95% CI, 10.3-22.3 per 100 person-years; weeks 73-144, 4.3 per 100 person-years; 95% CI, 0.9-12.5 per 100 person-years; P = .008). Reinfection rates were lower for participants aged 40 years or older than for younger participants (adjusted incidence rate ratio, 0.32; 95% CI, 0.18-0.57) and for participants for whom methamphetamine was not detected in urinary drug screening compared with participants for whom methamphetamine was detected (adjusted incidence rate ratio, 0.41; 95% CI, 0.21-0.82). Participants who reported injection drug use within the preceding 3 months had higher risk of reinfection than those who did not have recent injection drug use (adjusted incidence rate ratio, 3.33; 95% CI, 1.86-5.97)., Conclusions and Relevance: In this cohort study of people who injected drugs and were treated for HCV infection in community settings, reinfection was high in the period immediately after SVR but decreased significantly over time. These findings highlight the importance of early intervention to prevent reinfection., Trial Registration: ClinicalTrials.gov Identifier: NCT02824640.

Background: Hereditary angioedema (HAE) is a rare genetic condition characterized by painful and often debilitating swelling attacks. Little is known about the differences in outcomes between patients with HAE types I or II (type I: HAE caused by C1 esterase inhibitor deficiency; type II: HAE caused by C1 esterase inhibitor dysfunction), with decreased or dysfunctional C1 esterase inhibitor (C1-INH), and those with normal C1-INH (nC1-INH-HAE). Objective: To compare physician- and patient-reported real-world outcomes in patients with HAE types I/II versus patients with nC1-INH-HAE. Methods: Data were drawn from the Adelphi HAE Disease Specific Programme TM a real-world, cross-sectional survey of HAE-treating physicians and their patients in the United States conducted between July and November 2021. Physicians reported patient disease activity and severity, and recent attack history. Patient-reported outcomes were collected. Bivariate tests used were either the Student's t -test, the Fisher exact test, or Mann-Whitney U test. Results: Physicians (N = 67) provided data on 368 patients (92.4% HAE types I/II and 7.6% nC1-INH-HAE). Physicians reported that a higher proportion of patients with nC1-INH-HAE had moderate or high disease activity and moderate or severe disease severity both at diagnosis and at data collection versus those with HAE types I/II. Patients with nC1-INH-HAE versus patients with HAE types I/II experienced increased attack severity (34.6% versus 4.4%) and hospitalization rate during the most recent attack (39.3% versus 6.6%), and reported lower health status and quality of life, via the European Quality of Life 5 Dimension 5 Level (US tariff) and Angioedema Quality of Life, respectively. On average, 25% of the patients with nC1-INH-HAE reported absenteeism and work or activity impairment due to HAE compared with 2.7% of patients with HAE types I/II. Both patient groups reported improvements in disease activity and severity from diagnosis to the time of data collection. Conclusion: These real-world findings suggest that patients with nC1-INH-HAE have increased disease activity and severity, and experience greater impairment to their quality of life, work, and daily functioning than patients with HAE types I/II. Powered statistical analyses are required to confirm these findings.

Competency-based education is increasingly being adopted across the health professions. A model for competency-based education in veterinary medicine was recently developed by a working group of the American Association of Veterinary Medical Colleges (AAVMC) and is being used in institutions worldwide. The purpose of this study was to gather information on progress in and barriers to implementing competency-based education (including use of the AAVMC competency-based veterinary education [CBVE] Model) by AAVMC member schools to inform the development of strategies to support institutions in successful implementation of the CBVE Model. A cross-sectional survey was developed and distributed to AAVMC member institutions via an AAVMC web-based communication platform. Thirty-four of 55 AAVMC member institutions responded to the survey (62% response rate). Twenty schools reported using a competency-based education framework. Eleven of these institutions had implemented the AAVMC CBVE Framework, with an additional 12 institutions anticipating implementing it over the next 3 years. Timing, resources, and change management were the most commonly reported challenges to implementation. Suggestions for development of training resources included translation of milestones to pre-clinical courses, development of assessments, guidance on making progress decisions, illustrative overviews of specific components of the CBVE Model (e.g., the AAVMC CBVE Framework, EPAs, entrustment scales, milestones), and curriculum mapping. This study assesses progress in implementing the CBVE Model in AAVMC member schools and aids in identifying key challenges and resources to support faculty and institutions in the successful adoption and implementation of this educational model.

Menu labeling regulations in the United States mandate chain restaurants to display calorie information for standard menu items, intending to facilitate healthy dietary choices and address obesity concerns. For this study, we utilized machine learning techniques to conduct a novel sentiment analysis of public opinions regarding menu labeling regulations, drawing on Twitter data from 2008 to 2022. Tweets were collected through a systematic search strategy and annotated as positive, negative, neutral, or news. Our temporal analysis revealed that tweeting peaked around major policy announcements, with a majority categorized as neutral or news-related. The prevalence of news tweets declined after 2017, as neutral views became more common over time. Deep neural network models like RoBERTa achieved strong performance (92% accuracy) in classifying sentiments. Key predictors of tweet sentiments identified by the random forest model included the author's followers and tweeting activity. Despite limitations such as Twitter's demographic biases, our analysis provides unique insights into the evolution of perceptions on the regulations since their inception, including the recent rise in negative sentiment. It underscores social media's utility for continuously monitoring public attitudes to inform health policy development, execution, and refinement.

Objective: To determine factors associated with a positive male patient experience (PMPE) at fertility clinics among male patients., Design: Cross-sectional study Setting: Not applicable Patients: Male respondents to the FertilityIQ questionnaire ( www.fertilityiq.com ) reviewing the first or only US clinic visited between June 2015 and August 2020., Interventions: None Main outcome measures: PMPE was defined as a score of 9 or 10 out of 10 to the question, "Would you recommend this fertility clinic to a best friend?". Examined predictors included demographics, payment details, infertility diagnoses, treatment, and outcomes, physician traits, and clinic operations and resources. Multiple imputation was used for missing variables and logistic regression was used to calculate adjusted odds ratios (aORs) for factors associated with PMPE., Results: Of the 657 men included, 60.9% reported a PMPE. Men who felt their doctor was trustworthy (aOR 5.01, 95% CI 0.97-25.93), set realistic expectations (aOR 2.73, 95% CI 1.10-6.80), and was responsive to setbacks (aOR 2.43, 95% CI 1.14-5.18) were more likely to report PMPE. Those who achieved pregnancy after treatment were more likely to report PMPE; however, this was no longer significant on multivariate analysis (aOR 1.30, 95% CI 0.68-2.47). Clinic-related factors, including ease of scheduling appointments (aOR 4.03, 95% CI 1.63-9.97) and availability of same-day appointments (aOR 4.93, 95% CI 1.75-13.86), were associated with PMPE on both univariate and multivariate analysis. LGBTQ respondents were more likely to report PMPE, whereas men with a college degree or higher were less likely to report PMPE; however, sexual orientation (aOR 3.09, 95% CI 0.86-11.06) and higher educational level (aOR 0.54, 95% CI 0.30-1.10) were not associated with PMPE on multivariate analysis., Conclusion: Physician characteristics and clinic characteristics indicative of well-run administration were the most highly predictive of PMPE. By identifying factors that are associated with a PMPE, clinics may be able to optimize the patient experience and improve the quality of infertility care that they provide for both men and women., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Caring for patients with hereditary angioedema (HAE), especially rural patients, has challenges., Objective: To confirm experiences of allergy and immunology health professionals in diagnosing and treating patients with HAE, including those living in rural settings., Methods: An online survey of 2996 members of the American College of Allergy, Asthma, and Immunology was conducted in April 13 to May 3, 2022. Eligible participants were association members (physician, fellow, or allied health professional members) currently practicing allergy or immunology, in the United States, seeing or treating at least 1 patient with HAE yearly., Results: A total of 138 responders saw an average of 9 patients with HAE yearly; 12% of the patients resided in a rural area. They reported that 66% of their patients with HAE had type I, 15% type II, and 19% HAE C1nl-INH. Misdiagnosis was the top diagnostic challenge reported (82%). Inability to afford treatment was the top treatment challenge (76%). Other observations include the sentiment that patients with HAE with government insurance are at a disadvantage because it is not accepted by many specialists who treat HAE (64%) and that better payments for drugs from Medicaid and Medicare (57%) and better payments to providers from Medicaid and Medicare (49%) could better support the treatment of patients in rural settings. Responders expressed a preference for therapies administered at home (72%). Since the coronavirus disease 2019 pandemic, 86% of the respondents used telehealth for appointments occasionally., Conclusion: Our findings illustrate the challenge of diagnosing HAE, especially HAE C1nl-INH, and the economic challenges of treatment, which can be compounded for those living in rural areas. We provide a call to action for addressing several of these real challenges., (Copyright © 2023 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Monitoring aeroallergens has a long history within the American Academy of Allergy, Asthma & Immunology. The Aeroallergen Network of the National Allergy Bureau is composed mainly of members of the American Academy of Allergy, Asthma & Immunology, whose objectives are to enhance the knowledge of aerobiology and its relationship to allergy, increase the number of certified stations, maintain the standardization and quality of aerobiology data, improve the alert and forecast reporting system, and increase ties with other scientific entities inside and outside the United States. The public has a keen interest in pollen counts and pollen forecasts, as do many health professionals in the allergy community. In this review, we explore the past, present, and future of allergen monitoring with a focus on methods used for sampling, the training of those performing the analysis, and emerging technologies in the field. Although the development of automated samplers with machine intelligence offers great promise for meeting the goal of a fully automated system, there is still progress to be made regarding reliability and affordability., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Importance: Long-term sequelae after symptomatic SARS-CoV-2 infection may impact well-being, yet existing data primarily focus on discrete symptoms and/or health care use., Objective: To compare patient-reported outcomes of physical, mental, and social well-being among adults with symptomatic illness who received a positive vs negative test result for SARS-CoV-2 infection., Design, Setting, and Participants: This cohort study was a planned interim analysis of an ongoing multicenter prospective longitudinal registry study (the Innovative Support for Patients With SARS-CoV-2 Infections Registry [INSPIRE]). Participants were enrolled from December 11, 2020, to September 10, 2021, and comprised adults (aged ≥18 years) with acute symptoms suggestive of SARS-CoV-2 infection at the time of receipt of a SARS-CoV-2 test approved by the US Food and Drug Administration. The analysis included the first 1000 participants who completed baseline and 3-month follow-up surveys consisting of questions from the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29; 7 subscales, including physical function, anxiety, depression, fatigue, social participation, sleep disturbance, and pain interference) and the PROMIS Short Form-Cognitive Function 8a scale, for which population-normed T scores were reported., Exposures: SARS-CoV-2 status (positive or negative test result) at enrollment., Main Outcomes and Measures: Mean PROMIS scores for participants with positive COVID-19 tests vs negative COVID-19 tests were compared descriptively and using multivariable regression analysis., Results: Among 1000 participants, 722 (72.2%) received a positive COVID-19 result and 278 (27.8%) received a negative result; 406 of 998 participants (40.7%) were aged 18 to 34 years, 644 of 972 (66.3%) were female, 833 of 984 (84.7%) were non-Hispanic, and 685 of 974 (70.3%) were White. A total of 282 of 712 participants (39.6%) in the COVID-19-positive group and 147 of 275 participants (53.5%) in the COVID-19-negative group reported persistently poor physical, mental, or social well-being at 3-month follow-up. After adjustment, improvements in well-being were statistically and clinically greater for participants in the COVID-19-positive group vs the COVID-19-negative group only for social participation (β = 3.32; 95% CI, 1.84-4.80; P < .001); changes in other well-being domains were not clinically different between groups. Improvements in well-being in the COVID-19-positive group were concentrated among participants aged 18 to 34 years (eg, social participation: β = 3.90; 95% CI, 1.75-6.05; P < .001) and those who presented for COVID-19 testing in an ambulatory setting (eg, social participation: β = 4.16; 95% CI, 2.12-6.20; P < .001)., Conclusions and Relevance: In this study, participants in both the COVID-19-positive and COVID-19-negative groups reported persistently poor physical, mental, or social well-being at 3-month follow-up. Although some individuals had clinically meaningful improvements over time, many reported moderate to severe impairments in well-being 3 months later. These results highlight the importance of including a control group of participants with negative COVID-19 results for comparison when examining the sequelae of COVID-19.

The COVID-19 pandemic has significantly affected flight attendants' health, safety, and security. Members of this group work in a densely occupied and enclosed space where social distancing is virtually impossible, compliance with mask rules is uneven, aggressive passenger incidents are at an all-time high, and the vaccination status of passengers on domestic flights is unknown. Here is a description of the response by the federal government and the United States (U.S.) airline industry from the perspective of a flight attendant union between the early days of the COVID-19 pandemic and this writing. Specifically, the issues of ventilation, face masks, aggressive passengers, quarantine and isolation, and vaccinations are reviewed, including actions taken by the executive branch of the U.S. government, regulators, airlines, manufacturers, and our crew member union. Although there will be regional differences around the globe, many of these issues are universal.

Background: Assessment of psychological reactions to delays in fertility treatment have often utilized single clinic samples during the time that fertility treatments were paused. We, therefore, assessed emotional reactions to treatment cancelations due to COVID-19 in infertility patients across the United States after treatments had begun to resume., Study Design: Cross-sectional survey emailed on 27 May 2020 and closed on 30 June 2020, to 53,600 FertilityIQ.com website users inquiring about their experience since the COVID-19 pandemic. A subset of FertilityIQ users ( n  = 13,490) opened the survey invitation and 1806 respondents participated in the survey (13.4% response rate)., Results: The majority of respondents (female, 67.4%; male, 61.7%) were 31-40 years old; most were planning to start treatment immediately (women, 42.6%; men, 44.7%) or were undergoing treatment (women, 34.9%; men, 29.8%) at the time of treatment cancelation. Patients (women, 21.1%; men 19.1%) or clinics (women, 57.7%; men, 40.4%) canceled treatment. Most clinics had resumed treatment at the time of the study (women, 90.0%; men, 73.7%). Cancelation resulted in sadness (women, 83.9%; men 86.7%) and anger (women, 45.4%; men, 36.7%); greater than half of the participants whose treatment was canceled (women: 66.8%, n  = 630; men: 73.7%, n  = 14) agreed with cancelations. Greater than 70% of respondents were at least somewhat concerned about reproductive chances (women, 84.7%; men, 72.4%) and exclusion of partners (women, 73.3%; men, 72.4%). Distress/concern was associated with clinic cancelation, disagreement with delays, age, diagnosis, and concern about delays and pregnancy chances ( p <.05)., Conclusions: Respondents were distressed/concerned about the effect of the pandemic on their fertility. Distress was highest in women with a poorer fertility prognosis, no control over treatment cancelation, and high concern about the effect of treatment delay on pregnancy chances. Emotional support, education regarding treatment delay and fertility, and efforts where possible, to include patients in decisions to delay treatment are warranted in future treatment delays.

Background: People living in rural areas of the United States experience greater health inequality than individuals residing in urban or suburban locations and encounter several barriers to obtaining optimal health care. Health disparities are compounded for patients with rare diseases such as hereditary angioedema (HAE), an autosomal dominant genetic disorder characterized by recurrent, severe abdominal pain and life-threatening oropharyngeal or laryngeal swelling., Objective: To explore the challenges of managing patients with HAE in rural areas and suggest possible improvements for optimizing care., Data Sources: PubMed was searched for articles on patient care management, treatment challenges, rural health, and HAE., Study Selections: Relevant articles were selected and reviewed., Results: Challenges in managing HAE in the rural setting were identified, including obtaining a diagnosis of HAE, easy access to a physician with expertise in HAE, continuity of care, availability of telemedicine services, access to approved HAE therapies, patient education, and economic barriers to treatment. Ways to improve HAE patient care in rural areas include health care provider recognition of the patient with undiagnosed HAE, development of individualized management plans, expansion of telemedicine, effective care at the local level, appropriate access to HAE medication, and increased awareness of patient support and advocacy groups., Conclusion: For patients with HAE living in rural areas, optimal care is complicated by health disparities. Given the scarcity with which these topics have been covered in the literature to date, it is intended that this article will serve as the impetus for a range of further initiatives focused on improving access to care., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

We assessed breastfeeding outcomes for a cohort of infants born to women living with HIV (WLHIV) at an urban health care center in the United States. Ten infants were exclusively breastfed for a mean duration of 4.4 (1.0-8.6) months. All had negative HIV RNA PCRs at a median age of 16 months., (© The Author(s) 2021. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: To determine the frequency of and factors associated with a patient being declined from pursuing a cycle of in vitro fertilization with autologous oocytes (IVF-AO)., Methods: A cross-sectional study using a nationwide cohort of female respondents aged 35 or over, who visited a US fertility clinic from 1/2015 to 3/2020, responded to the online FertilityIQ questionnaire ( http://www.fertilityiq.com ). All respondents were asked if they were previously declined from pursuing a cycle of IVF-AO. Examined demographic and clinical predictors included age, race/ethnicity, education, income, clinic type, care received in a mandated state, insurance coverage for fertility treatment, and self-reported infertility diagnosis. Logistic regression was used to calculate the adjusted odds ratios for factors associated with being declined from pursuing IVF-AO., Results: Of 8660 women who met inclusion criteria, 418 (4.8%) reported previously being declined a cycle of IVF-AO. In the multivariate analysis, predictors of being declined from pursuing IVF-AO included increasing age, income of less than $50,000, and diagnoses of poor oocyte quality and diminished ovarian reserve. Predictors of being less likely to report decline included some college or college degree and diagnoses of male factor, unexplained or tubal infertility. Notably, diagnosis of PCOS or residence in a state with mandated fertility coverage was not predictive of patients being declined from pursuing IVF-AO., Conclusion: Nearly 5% of patients who pursued IVF reported being declined from pursuing IVF-AO. Further studies are needed to confirm our findings and explore whether patients being declined treatment meet the criteria for futile or very poor prognosis., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: The purpose of this study was to delineate a scoring system to maximize the ethical allocation of proton beam therapy (PBT) and determine what factors are associated with receipt of PBT, including the role of specific insurance providers., Methods and Materials: Our scoring system was developed in collaboration with a multidisciplinary panel of experts. Patients submitted for PBT consideration were assigned a score by committee at a weekly peer-reviewed session at a time when our center was operating at capacity. Univariate analysis and multivariable analysis of initial and final insurance response were performed., Results: One hundred ninety-seven patients were prospectively reviewed. Ninety-three percent of patients with Medicaid coverage, 88% of patients with Medicare, and 78% of patients with private insurance were ultimately approved for PBT. Median time to final insurance response was 12 days (interquartile range, 9-18 days) for patients who were ultimately denied PBT coverage. Having primary provider C (odds ratio [OR], 14; 95% confidence interval [CI], 1.20-1.96; P = .033) or third party providers A (OR, 4.22; 95% CI, 1.71-10.9; P = .002) or B (OR, 5.28; 95% CI, 1.56-17.2; P = .006) was significantly associated with final insurance denial for PBT on univariate analysis. Total score (OR, 0.79; 95% CI, 0.67-0.90; P = .002) and having coverage through third party provider A (OR, 24.2; 95% CI, 9.51-68.9; P < .001) were associated with final insurance response on multivariable analysis., Conclusions: Our scoring system was significantly associated with receipt of proton beam therapy. Certain insurance providers are less likely to approve PBT for patients, all else being equal. Such a scoring system could be implemented effectively at other PBT facilities, and additional work is needed in ensuring patients with the most to gain from PBT will be approved by their insurance providers., (Copyright © 2021 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Overweight/obesity, prevalent cardiovascular risk factors in children, can be associated with increased risk of adverse outcomes in children with heart disease. The American College of Cardiology (ACC) developed quality metrics including a BMI metric related to identifying and counseling overweight and obese children presenting to cardiology clinics. This metric was used for a multicenter collaborative learning Quality improvement (QI) Project through the ACC Quality Network (QNet). Our aim was to increase the percentage of children between ages 3 and 18 years presenting to cardiology clinics at participating centers with BMI > 85th percentile who received appropriate counseling. Participating centers submitted data quarterly to QNet for a sample of patients who received counseling. A Key Driver Diagram was created to help teams drive improvement. Individual centers customized interventions and participated in network-wide educational learning sessions about QI and shared experience. Statistical process control charts were used. From 04/01/2017 to 09/30/2019, 27,511 patient visits were included. Among 32 participating centers, overall counseling rate was 54%. The BMI counseling rate increased from 25% in 2017Q2 to 54% in 2019Q3. There was a wide variation from 10 to 100% in the performance of individual centers. The overall rate of identification and counseling of overweight and obese children presenting to ambulatory cardiology clinics in participating centers is low. There is wide variation in the performance of centers, providing an opportunity for improvement. Using this multicenter learning approach, individual centers have demonstrated improvement. This demonstrates that collaborative learning approaches in QI can increase implementation of the metric.

Porcine reproductive and respiratory syndrome (PRRS) remains one of the most economically devastating diseases in swine population in the United States of America. Due to high mutation rate of the PRRS virus (PRRSV) genome, it is difficult to develop an accurate diagnostic assay with high strain coverage. Differentiation of field strains from the four vaccines that have been used in the USA, namely Ingelvac PRRS MLV, Ingelvac ATP, Fostera PRRS and Prime Pac PRRS, adds an additional challenge. It is difficult to use current real-time PCR systems to detect and differentiate the field strains from the vaccine strains. Luminex xTAG technology allows us to detect more molecular targets in a single reaction with a cost similar to a single real-time PCR reaction. By analysing all available 678 type 2 PRRSV (PRRSV-2) complete genome sequences, including the 4 vaccine strains, two pairs of detection primers were designed targeting the conserved regions of ORF4-ORF7, with strain coverage of 98.8% (670/678) based on in silico analysis. The virus strains sharing ≥98% identity of the complete genomes with the vaccine strains were considered vaccine or vaccine-like strains. One pair of primers for each vaccine strain were designed targeting the nsp2 region. In silico analysis showed the assay matched 94.7% (54/57) of Ingelvac PRRS ® MLV (MLV) strain and the MLV-like strains, and 100% of the other three vaccine strains. Analytical sensitivity of the Luminex assay was one to two logs lower than that of the reverse transcription real-time PCR assay. Evaluated with 417 PRRSV-2 positive clinical samples, 95% were detected by the Luminex assay. Compared to ORF5 sequencing results, the Luminex assay detected 92.4% (73/79) of MLV strains, 78.3% (18/23) of Fostera strains and 50% (2/4) of ATP strains. None of the 472 samples were the Prime Pac strain tested by either ORF5 sequencing or the Luminex assay., (© 2020 Wiley-VCH GmbH.)

Adolescents (13-24 years of age) account for more than one-fifth of new HIV diagnoses yearly, and the United States has one of the highest rates of adolescent pregnancy among high resource countries. However, there is limited information on the characteristics and outcomes of adolescents living with HIV (ALWHIV) during pregnancy and differences with pregnancy in adults living with HIV. We performed a retrospective cohort study to compare demographic characteristics, HIV viral suppression, and pregnancy outcomes in adolescents ( n  = 90) as compared with adults ( n  = 250) in an urban HIV pregnancy clinic from 2003 to 2015. Seventy-one women overall were diagnosed with HIV during pregnancy (adolescents, 25/90; adults, 46/250). One-fifth of adolescents acquired HIV perinatally. Adolescents were more likely than adults to have unintended pregnancy (83.6% vs. 68.7%, p  = 0.016) and were less likely to be virally suppressed at delivery (50.0% vs. 69.7% overall, p  = 0.001; 48.0% vs. 78.2% in postuniversal antiretroviral therapy era, p  = 0.007%). Over one-third of adolescents reported a history of any illicit substance use, and adolescents were more likely than adults to use marijuana during pregnancy (29.2% vs. 16.9%, p  = 0.013). Adolescents were less likely to experience preterm labor (11.0% vs. 24.1%, p  = 0.012) or preterm premature rupture of membranes (3.7% vs. 16.7%, p  = 0.003). There was one case of maternal-fetal transmission, which occurred in an adult pregnancy. Despite the high rate of unintended pregnancy, one-third of adolescents were discharged without an identified contraception plan. We identify several opportunities for intervention to improve reproductive health outcomes in ALWHIV.

Force health protection (FHP) is defined as "the prevention of disease and injury in order to protect the strength and capabilities" of any service population. FHP was the foundational principal of the US Public Health Service (USPHS). President John Adams' signing of An Act for Sick and Disabled Seamen on July 16, 1798, marked the first dedication of US federal resources to ensuring the well-being of US civilian sailors and Naval service members. On January 4, 1889, President Cleveland enacted the USPHS Commissioned Corps, creating the world's first (and still only) uniformed service dedicated to promoting, protecting, and advancing the health and safety of the United States and the world. Building on the lessons of the 2014-2015 response to the Ebola virus pandemic, the Corps Care program was formalized in 2017 to establish and implement a uniform and comprehensive strategy to meet the behavioral health, medical, and spiritual needs of all Commissioned Corps officers. Its role was expanded in response to the coronavirus disease 2019 (COVID-19) pandemic, which has placed unprecedented demands on health care workers and spotlighted the need for FHP strategies. We describe the FHP roles of the Corps Care program for the resiliency of Commission Corps officers in general and the Corps' impact during the response to the COVID-19 pandemic. Qualitative analysis of FHP discussions with deployed officers highlights the unique challenges to FHP presented by the pandemic response.

Paediatric decision-making is the art of respecting the interests of child and family with due regard for evidence, values and beliefs, reconciled using two important but potentially conflicting concepts: best interest standard (BIS) and shared decision-making (SD-M). We combine qualitative research, our own data and the normative framework of the United Nations Convention on the Rights of Children (UNCRC) to revisit current theoretical debate on the interrelationship of BIS and SD-M. Three cohorts of child, parent and health care professional interviewees (N total  = 47) from Switzerland and the United States considered SD-M an essential part of the BIS. Their responses combined with the UNCRC text to generate a coherent framework which we term the shared optimum approach (SOA) combining BIS and SD-M. The SOA separates different tasks (limiting harm, showing respect, defining choices and implementing plans) into distinct dimensions and steps, based on the principles of participation, provision and protection. The results of our empirical study call into question reductive approaches to the BIS, as well as other stand-alone decision-making concepts such as the harm principle or zone of parental discretion.Conclusion: Our empirical study shows that the BIS includes a well-founded harm threshold combined with contextual information based on SD-M. We propose reconciling BIS and SD-M within the SOA as we believe this will improve paediatric decision-making. What is Known: • Parents have wide discretion in deciding for their child in everyday life, while far-reaching treatment decisions should align with the child's best interest. • Shared decision-making harbours potential conflict between parental authority and a child's best interest. What is New: • The best interest standard should not be used narrowly as a way of saying "Yes" or "No" to a specific action, but rather in a coherent framework and process which we term the shared optimum approach. • By supporting this child-centred and family-oriented process, shared decision-making becomes crucial in implementing the best interest standard.

Implementation of the Clinical Data Interchange Standards Consortium (CDISC)'s Standard for Exchange of Nonclinical Data (SEND) by the United States Food and Drug Administration Center for Drug Evaluation and Research (US FDA CDER) has created large quantities of SEND data sets and a tremendous opportunity to apply large-scale data analytic approaches. To fully realize this opportunity, differences in SEND implementation that impair the ability to conduct cross-study analysis must be addressed. In this manuscript, a prototypical question regarding historical control data (see Table of Contents graphic) was used to identify areas for SEND harmonization and to develop algorithmic strategies for nonclinical cross-study analysis within a variety of databases. FDA CDER's repository of >1800 sponsor-submitted studies in SEND format was queried using the statistical programming language R to gain insight into how the CDISC SEND Implementation Guides are being applied across the industry. For each component needed to answer the question (defined as "query block"), the frequency of data population was determined and ranged from 6 to 99%. For fields populated <90% and/or that did not have Controlled Terminology, data extraction methods such as data transformation and script development were evaluated. Data extraction was successful for fields such as phase of study, negative controls, and histopathology using scripts. Calculations to assess accuracy of data extraction indicated a high confidence in most query block searches. Some fields such as vehicle name, animal supplier name, and test facility name are not amenable to accurate data extraction through script development alone and require additional harmonization to confidently extract data. Harmonization proposals are discussed in this manuscript. Implementation of these proposals will allow stakeholders to capitalize on the opportunity presented by SEND data sets to increase the efficiency and productivity of nonclinical drug development, allowing the most promising drug candidates to proceed through development.

Objective: To implement an organization-wide evidence-based practice change to parent-performed, delayed immersion newborn bathing across nine facilities at a military health care system., Design: Organization-wide evidence-based practice initiative using preimplementation and postimplementation data., Setting: A military health system consisting of four medical centers and five community hospitals that averages 4,000 births each year., Participants: Term newborns (≥37 weeks gestation) born within the nine facilities., Intervention/measurements: Champions were identified at each facility to change bathing practice. Baths for newborns were delayed until 24 hours of age, unless otherwise requested. Parents were instructed how to tub bathe their newborn and encouraged to complete the bath in less than 5 minutes. The team reviewed 100 records from each hospital and compared pre- and postimplementation temperature data., Results: The organization-wide practice change showed a statistically significant association between time point (i.e., before vs. after implementation) and postbathing hypothermia (χ 2  = 30.91, p < .001). In addition, data also showed fewer hypothermic temperature readings (i.e., <97.7 °F [<36.5 °C]) from the onset of birth until 8 hours of life with the new bathing process. Although this difference was not statistically significant (p = .11), it holds clinical significance if it can be replicated; newborn hypothermia requires provider notification and can lead to additional testing to rule out infection and other concerns., Conclusion: Delaying newborns' first bath was associated with a significant decrease in the number of newborns who had hypothermic temperature readings immediately after the bath. The intervention involved minimal cost with multiple benefits. Delayed immersion bathing is a family-friendly process that can be implemented across an organization., (Copyright © 2020 AWHONN. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Telestroke has been demonstrated to be a cost-effective means to expand access to care and improve outcomes in stroke; however, information on patient perceptions of this system of care delivery are limited. This study seeks to examine patient feedback of a national telestroke system within the Veterans Health Administration., Methods: Patients who received a telestroke consultation were eligible for a phone interview 2 weeks later, including questions about technology quality, telepresence, and telestroke provider communication. Satisfaction scores ranged from 1 to 7 (higher=more satisfied) and for analyses were dichotomized as 6 to 7 indicating high satisfaction versus <6. Patient variables including stroke severity (measured by the National Institutes of Health Stroke Scale) were obtained from study records. Generalized estimating equation models were used to determine what factors were associated with patient satisfaction., Results: Over 18 months, 186 interviews were completed, and 142 (76%) reported high satisfaction with telestroke. Patients with more severe stroke were less likely to recall the consultation. Factors significantly associated with patient satisfaction were higher ratings of the technology ( P <0.0001), telepresence ( P <0.0001), provider communication ratings ( P <0.0001), and overall Veterans Affairs satisfaction ( P =0.02). In the multivariate model, telepresence (odds ratio, 3.10 [95% CI, 1.81-5.31]) and provider ratings (odds ratio, 2.37 [95% CI, 1.20-4.68]) were independently associated with satisfaction. Veterans who were satisfied were more likely to recommend the technology ( P <0.0001)., Conclusions: Provider qualities, including telepresence and provider ratings, were associated with overall Veteran satisfaction with the telestroke consultation. Technology quality may be necessary but not sufficient to impact patient experience. Training providers to improve telepresence could improve patient experience with telestroke consultation.

Background: Although Screening, Brief Intervention and Referral to Treatment (SBIRT) has now been disseminated in many areas of the United States (US), much remains to be discovered about the training outcomes of non-physician professional trainees such as nurses, physician assistants, physical therapists, occupational therapists, and psychologists following SBIRT training. Methods : Training in SBIRT, an evidence-based approach to screening substance use, was embedded into five health science graduate curricula: Physician Assistant Studies, Nursing, Occupational Therapy, Physical Therapy, and Psychology. The SBIRT curriculum was adapted for each profession to include a brief introductory module addressing SBIRT's relevance for each profession, as well as profession-specific case examples and terminology. Using a nonequivalent group design, participants completed pre-and post-training assessments of substance use related attitudes, perceived competency and knowledge. Data were analyzed using a parametric test to compare pre- and post-differences. Results : Findings suggest improved attitudes as well as increased perceived competencies and core knowledge following the graduate-curriculum embedded SBIRT training, as well as between group differences on the same variables. Conclusions : SBIRT training of non-physician healthcare graduate student-trainees is a feasible training activity and results in improved trainee attitudes, perceived competency, and knowledge. SBIRT training embedded into graduate health science curricula offers an early foundation to this well-established, universal screening approach.

Background: Penetration and participation of real life implementation of lifestyle change programs to prevent type 2 diabetes has been challenging. This is particularly so among low income individuals in the United States. The purpose of this study is to examine the effectiveness of financial incentives on attendance and weight loss among Medicaid beneficiaries participating in the 12-month Diabetes Prevention Program (DPP)., Methods: This is a cluster-randomized controlled trial with two financial incentive study arms and an attention control study arm. Medicaid beneficiaries with prediabetes from 13 primary care clinics were randomly assigned to individually earned incentives (IND; 33 groups; n = 309), a hybrid of individual- and group-earned incentives (GRP; 30 groups; n = 259), and an attention control (AC; 30 groups; n = 279). Up to $520 in incentives could be earned for attaining attendance and weight loss goals over 12 months. Outcomes are percent weight loss from baseline, achieving 5% weight loss from baseline, and attending 75% of core and 75% of maintenance DPP sessions. Linear mixed models were used to examine weight change and attendance rates over the 16 weeks and 12 months., Results: The percent weight change at 16 weeks for the IND, GRP, and AC participants were similar, at - 2.6, - 3.1%, and - 3.4%, respectively. However, participants achieving 5% weight loss in the IND, GRP, and AC groups was 21.5, 24.0% (GRP vs AC, P < 0.05), and 15.2%. Attendance at 75% of the DPP core sessions was significantly higher among IND (60.8%, P < 0.001) and GRP (64.0%, P < 0.001) participants than among AC (38.6%) participants. Despite substantial attrition over time, attendance at 75% of the DPP maintenance sessions was also significantly higher among IND (23.0%, P < 0.001) and GRP (26.1%, P < 0.001) participants than among AC (11.0%) participants., Conclusions: Financial incentives can improve the proportion of Medicaid beneficiaries attending the 12-month DPP and achieving at least 5% weight loss., Trial Registration: ClinicalTrials.gov NCT02422420 ; retrospectively registered April 21, 2015.

Background: In 2017, a team of forensic nurses in Maryland launched the first known nurse-led and managed service delivery program designed to meet the unique medicoforensic needs of immigrant survivors, including asylum seekers, in their community. The expanded suite of services involved conducting forensic physical evaluations, which included medicolegal history-taking, head-to-toe forensic physical assessment, photodocumentation, and presentation of related findings in the form of written affidavits for use in applications for legal reliefs in immigration court (e.g., asylum, T or U visas, Convention Against Torture)., Methods: Case-based data for patients served as part of the program (n = 8), and semistructured interview data were collected from key service delivery stakeholders (n = 5) to assess the feasibility and acceptability of this pilot program., Results: Eight asylum-seeking patients received medicoforensic nursing services between May 2017 and December 2018. Key benefits of services to clients included accessibility to timely, trauma-informed care by a professional nurse at no cost and with flexible scheduling. Furthermore, the skill sets required to conduct forensic physical evaluations were found to align with sexual assault and forensic nursing scope of practice., Conclusion: Forensic nurses are well positioned to fill current service delivery gaps to meet the medicolegal needs of this vulnerable population in civil court proceedings. Recommendations of this study may be used by other forensic nurse teams to inform the design and implementation of initiatives to expand the core services of a forensic nursing program to include asylum and immigration-specific medicolegal care.

Objective: To characterize the evaluation, treatment, and insurance coverage among couples with male factor infertility in the United States., Materials and Methods: A cohort of 969 couples undergoing fertility treatment with a diagnosis of male factor infertility were identified from an online survey. The proportion of men that were seen/not seen by a male were compared. Insurance coverage related to male factor was also assessed., Results: Overall, 98.0% of the men reported at least one abnormal semen parameter. Of these, 72.0% were referred to a male fertility specialist with the majority being referred by the gynecologist of their female partner. As part of the male evaluation, 72.2% had blood hormone testing. Of the 248 men who were not recommended to see a male fertility specialist, 96.0% had an abnormal semen analysis including 7.6% who had azoospermia. Referral to a male fertility specialist was largely driven by severity of male factor infertility rather than socioeconomic status. Insurance coverage related to male factor infertility was poor with low coverage for sperm extractions (72.9% reported 0-25% coverage) and sperm freezing (83.7% reported 0-25% coverage)., Conclusion: Although this cohort includes couples with abnormal semen parameters, 28% of the men were not evaluated by a male fertility specialist. In addition, insurance coverage for services related to male factor was low. These findings may be of concern as insufficient evaluation and coverage of the infertile man could lead to missed opportunities for identifying reversible causes of infertility/medical comorbidities and places an unfair burden on the female partner., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To determine factors associated with a positive patient experience (PPE) at fertility clinics., Design: Cross-sectional study., Setting: Not applicable., Patient(s): Female respondents to the FertilityIQ questionnaire (www.fertilityiq.com) reviewing the first or only U.S. clinic visited from July 2015 to July 2018., Intervention(s): None., Main Outcome Measure(s): PPE was defined as a score of 9 or 10 out of 10 on the question, "Would you recommend this fertility clinic to a best friend?" Examined predictors included demographics, payment details, infertility diagnoses and treatment, physician traits, and clinic operations and resources. Multiple imputation was used for missing variables. Logistic regression was used to calculate adjusted odds ratios for factors associated with PPE., Result(s): Of the 7,456 women included, 63.1% reported PPE. Pregnancy resulting from treatment was a predictor of PPE. In multivariable analysis, the strongest predictors of PPE were related to the patient-physician relationship ("feeling treated like a human rather than a number" and having a doctor with good communication skills and who set reasonable expectations). Multiple clinic-related factors were also independently associated with PPE, including satisfaction with billing, shorter wait times, and easy appointment scheduling., Conclusion(s): While pregnancy influences patients' views of their fertility clinic experience, there are other modifiable patient, physician, and clinic factors associated with PPE. Clinics may be able to optimize patient experience and improve the quality of care that they provide by being cognizant of such factors., (Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Women with disabilities experience higher rates of intimate partner violence (IPV) than the general population. Reproductive coercion, a type of intimate partner violence, is associated with an increased risk of unintended pregnancy (UIP), yet little is known about this relationship among women with disabilities., Objective: This qualitative descriptive study explored perspectives of women with disabilities who had experienced an UIP as a result of reproductive coercion., Method: In-depth, semi-structured telephone interviews were conducted with nine women living with diverse disabilities across the United States as part of a larger study examining facilitators and barriers to UIP among women with disabilities., Results: Analysis revealed three broad themes related to the ways in which physical violence and reproductive coercion elevated women's risk of UIP. They included (1) inadequate health care provider or system response, (2) disability-related risks for IPV, and (3) resource needs to optimize safety., Conclusions: This is the first in-depth exploration of ways in which reproductive coercion may lead to an increased risk of UIP among women with disabilities. Health care providers must screen for IPV and reproductive coercion and provide the necessary supports and resources for women with disabilities experiencing unintended pregnancy as a result of violence., Competing Interests: Declaration of competing interest The authors report no conflict of interest., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The Standard for Exchange of Nonclinical Data (SEND) identifies an approach for representing nonclinical data in a structured format which has been widely adopted by the pharmaceutical industry as it is required for data submission to the United States Food & Drug Administration (US FDA). The SEND Implementation Guide (SENDIG) allows for considerable flexibility in how data is represented; interpretation of these guidelines has led to significant variability in the approach to SEND dataset creation. The purposes of this manuscript are to identify common variability in certain SEND domains and to describe how variability can be managed to enable valuable cross-study analysis use cases. The example of extracting a commonly used data point, animal age, is used to illustrate the complexity and variability of SEND datasets. Developing a solution framework to the variability problem that includes all stakeholders involved in the creation and use of SEND datasets may enable future, routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2019 BioCelerate, LLC. Published by Elsevier Inc. All rights reserved.)

Resolving the origin of endangered taxa is an essential component of conservation. This information can be used to guide efforts of bolstering genetic diversity, and also enables species recovery and future evolutionary studies. Here, we used low-coverage whole genome sequencing to clarify the origin of Helianthus schweinitzii , an endangered tetraploid sunflower that is endemic to the Piedmont Plateau in the eastern United States. We surveyed four accessions representing four populations of H. schweinitzii and 38 accessions of six purported parental species. Using de novo approaches, we assembled 87,004 bp of the chloroplast genome and 6770 bp of the nuclear 35S rDNA. Phylogenetic reconstructions based on the chloroplast genome revealed no reciprocal monophyly of taxa. In contrast, nuclear rDNA data strongly supported the currently accepted sections of the genus Helianthus . Information from combined cpDNA and rDNA provided evidence that H. schweinitzii is likely an allo-tetraploid that formed as a result of hybridization between the diploids Helianthus giganteus and Helianthus microcephalus .

The practice of trauma-informed care (TIC) allows nurses in any setting to identify and intervene with traumatized individuals and to create a continuum of care when forensic nursing services are needed. The purpose of this article is to suggest ways to incorporate TIC content into baccalaureate nursing programs. We begin with an overview of baccalaureate nursing curricula and common types of traumatic experience important for students to understand. We then propose specific strategies for inclusion of TIC content in baccalaureate nursing education, using the American Association of Colleges of Nursing Essentials of Baccalaureate Education for Professional Nursing Practice. With a solid foundation in TIC, baccalaureate-prepared nursing students can provide effective patient care and better support forensic nursing practice. This will increase the capacity of the nursing profession in general to meet the needs of those affected by trauma, violence, and abuse.

Background: Patient health outcomes improve when learning health care systems use evidence to implement promising services and allocate resources effectively. Here, we examine the unique environment in which Veterans Health Administration (VHA) leadership use evidence and the facilitators and barriers to using evidence synthesis products in decision-making. We end by describing the steps researchers can take to better support the needs of health system leadership., Methods: We conducted 20 semistructured phone interviews with individuals in VHA leadership positions. We used an inductive approach to identify themes observed across key informant interviews., Results: Key informants identified several factors that fostered the use of evidence including, timeliness, lack of bias, flexible approaches, and concise reports with a clear bottom line. Barriers included lack of relevant evidence and lack of information on how to translate evidence into practice, resistance to change among providers and within the larger health system, and political pressures to implement therapies or technologies with little evidence or uncertainty. Researchers can foster evidence uptake by developing a review scope and key questions that are important to multiple stakeholders, including frontline clinicians and health system leadership., Conclusions: The VHA's evidence needs resemble other health systems, but evidence synthesis products should include a translational component to enhance implementation. Resistance to change and political pressures can further hinder the uptake of evidence within VHA.

Background: Evidence use within learning health care systems can improve patient health outcomes. Embedded in the Veterans Health Administration (VHA) since 2007, the Veterans Affairs Evidence Synthesis Program (ESP) provides tailored evidence synthesis services to support VHA's learning health care system goals. As part of the ESP's ongoing quality improvement efforts, we have been surveying our users since 2016., Methods: We reviewed data from a survey of end-users received between September 5, 2016, and June 10, 2019. The survey assessed: (1) nature of decision-making needs; (2) actions resulting from the report's findings; (3) implementation timeframe; and (4) overall perception of report content., Results: Feedback was received from 66 of the 138 operational partners requesting ESP products during the fiscal year 2015 through 2018. Requests commonly informed clinical guidance (58%), identified future research needs (58%), and determined VHA-specific implementation strategy (47%). A total of 91% of responders used reports, typically within 3 months after completion (82%). Use was typically for VHA publications and/or presentations to inform VHA policy or guidance (26%), to inform intervention/strategy adoption decisions (23%) and for medical device and therapy procurement decisions (21%). Over half (53%) of respondents indicated that it would be useful for ESP reports to include more guidance on implementing findings., Conclusion: Our survey of learning health system decision-makers' actual patterns and timing of evidence use provides valuable new information that can further support development of other health system and evidence producer partnerships and identifies key needs for better supporting health systems' uptake of evidence.

Background: Joint arthrodesis often employs autograft to promote union; graft harvesting can lead to perioperative morbidity. A Canadian randomized controlled trial (RCT) demonstrated that recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) combined with beta-tricalcium phosphate (β-TCP)-collagen was a safe, effective alternative to autograft. This multicenter North American RCT compared the safety and efficacy of rhPDGF-BB/β-TCP-collagen with autograft for ankle and hindfoot fusion. Subclassification using propensity scores (PS) incorporated patients from previous trials for enhanced statistical power for noninferiority testing and broader review of treatments., Methods: Patients requiring ankle or hindfoot arthrodesis and supplemental bone graft were treated with rhPDGF-BB/β-TCP-collagen ( n = 69) or autograft ( n = 35). Outcomes included joint fusion on computed tomography (24 weeks), clinical healing status, visual analog scale (VAS) pain, Short-Form 12 (SF-12), American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale, and Foot Function Index (FFI) scores over 52 weeks. PS methodology addressed potential selection bias arising from pooling data among these patients and 2 previous RCTs with similar inclusion criteria, surgical techniques, graft harvest techniques, and outcomes. All 132 rhPDGF-BB/β-TCP-collagen-treated patients and 167 of 189 candidate autograft-treated controls were selected for comparison by an independent statistician blinded to outcomes., Results: In the PS subclassification, 68.1% treatment patients and 68.4% controls achieved >50% osseous bridging at fusion sites. Clinical healing status was achieved in 84.8% of treated patients and 90.7% of controls at 52 weeks. Clinical, functional, and quality of life results demonstrated noninferiority of rhPDGF-BB/β-TCP-collagen to autograft. Safety-related outcomes were equivalent., Conclusion: PS subclassification analysis of 3 RCTs demonstrated that rhPDGF-BB/β-TCP-collagen was as effective as autograft for ankle and hindfoot fusions, with less pain and morbidity than treatment with autograft., Level of Evidence: Level I, prospective randomized study.

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies-often irrespective of risks and benefits or a woman's actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women's reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement-in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them., Competing Interests: The authors have declared that no competing interests exist.

Background: Care coordination is crucial to avoid potential risks of care fragmentation in people with complex care needs. While there are many empirical and conceptual approaches to measuring and improving care coordination, use of theory is limited by its complexity and the wide variability of available frameworks. We systematically identified and categorized existing care coordination theoretical frameworks in new ways to make the theory-to-practice link more accessible., Methods: To identify relevant frameworks, we searched MEDLINE®, Cochrane, CINAHL, PsycINFO, and SocINDEX from 2010 to May 2018, and various other nonbibliographic sources. We summarized framework characteristics and organized them using categories from the Sustainable intEgrated chronic care modeLs for multi-morbidity: delivery, FInancing, and performancE (SELFIE) framework. Based on expert input, we then categorized available frameworks on consideration of whether they addressed contextual factors, what locus they addressed, and their design elements. We used predefined criteria for study selection and data abstraction., Results: Among 4389 citations, we identified 37 widely diverse frameworks, including 16 recent frameworks unidentified by previous reviews. Few led to development of measures (39%) or initiatives (6%). We identified 5 that are most relevant to primary care. The 2018 framework by Weaver et al., describing relationships between a wide range of primary care-specific domains, may be the most useful to those investigating the effectiveness of primary care coordination approaches. We also identified 3 frameworks focused on locus and design features of implementation that could prove especially useful to those responsible for implementing care coordination., Discussion: This review identified the most comprehensive frameworks and their main emphases for several general practice-relevant applications. Greater application of these frameworks in the design and evaluation of coordination approaches may increase their consistent implementation and measurement. Future research should emphasize implementation-focused frameworks that better identify factors and mechanisms through which an initiative achieves impact.

Bovine viral diarrhea virus (BVDV), a ubiquitous pathogen of cattle, causes subclinical to severe acute disease. Two species of BVDV are recognized, BVDV1 and BVDV2 with BVDV1 divided into at least 21 subgenotypes and BVDV2 into 3-4 subgenotypes, most commonly using sequences from the 5' untranslated region (5' UTR). We report genomic sequencing of 8 BVDV2 isolates that did not segregate into the 2a subgenotype; but represented two additional BVDV2 subgenotypes. One BVDV2 subgenotype was previously recognized only in Asia. The other seven viruses fell into a second subgenotype that was first reported in Brazil and the U.S. in 2002. Neutralization assays using antiserum raised against vaccine strain BVDV2a 296c revealed varying degrees of neutralization of genetically diverse BVDV2 isolates. Neutralization titers decreased from 1.8 to more than a four log(2) decrease. This study illustrated the considerable genetic and antigenic diversity in BVDV2 circulating in the U.S., (Published by Elsevier Inc.)

Background: An opportunity was identified to compare perceptions of the occurrence and types of missed care at a comprehensive cancer center., Purpose: The purpose was to evaluate the difference in perceived occurrence and types of missed care between medical, surgical, and hematologic oncology units in the context of a newly implemented patient care delivery system, Primary Team Nursing (PTN)., Methods: A descriptive, repeated-measures design was used. The MISSCARE survey was distributed electronically to 580 staff members across 6 inpatient units., Results: Frequently perceived elements of missed nursing care were ambulation, turning every 2 hours, and care conference attendance. At the time of study implementation, surgical units reported 0.24 higher scores than medical units (P = .017); hematology units reported 0.26 lower scores than surgical units (P = .005). PTN status did not affect MISSCARE scores (P = .525)., Conclusions: Study findings suggest that perceived missed care in a comprehensive cancer center is similar to that in other hospital settings.