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Objectives: To quantify the longitudinal change in stair climb performance (a measure indicative of both physical function and muscle power), determine whether physical activity is related to slower decline in performance, and to identify factors that modify the longitudinal change in performance among women from midlife to late life. Design: Longitudinal cohort study with up to 15 study visits. Setting: Two sites of the Study of Women's Health Across the Nation. Participants: Black (n=411) and white (N=419) women followed from median age 47.0 (44.6–49.6) to 62.0 (55.8–65.3) years. Interventions: N/A. Measurements: Performance on a stair climb test (ascend/descend 4 steps, 3 cycles) was timed. Physical activity (PA) was assessed using the Kaiser Physical Activity Survey (KPAS; possible range 0–15 points). Sociodemographic and health factors were assessed via self-report. BMI was calculated with measured height and weight. Mixed-effects regression modeled longitudinal change in stair climb performance. Results: Average baseline stair climb time was 18.12 seconds (95% CI: 17.83–18.41), with 0.98% (95% CI: 0.84%–1.11%) annual slowing. In fully adjusted models, higher levels of PA were associated with faster stair climb times (2.09% faster per point higher, 95% CI: −2.87%–1.30%), and black women had 5.22% (95% CI: 2.43%–8.01%) slower performance compared to white women. Smoking, financial strain, diabetes, osteoarthritis, fair/poor health, and stroke were associated with 3.36% (95% CI: 0.07%–6.65%), 7.56% (95% CI: 4.75%–10.37%), 8.40% (95% CI: 2.89%–13.92%), 8.46% (95% CI: 5.12%–11.79%), 9.16% (95% CI: 4.72%–13.60%), and 16.94% (95% CI: 5.37%–28.51%) slower performance, respectively. In separate models, higher BMI (per 1-unit), osteoarthritis, fair/poor health, and diabetes, were each associated with 0.06% (95% CI:0.04%–0.08%), 0.48% (95% CI:0.12%–0.84%), 0.81% (95% CI:0.35%–1.28%), and 0.84% (95% CI:0.22%–1.46%), additional slowing per year over time. Conclusion: Significant declines in function were evident as women transitioned from midlife to early late life. Declines were amplified by indicators of poor health, emphasizing the importance of health in midlife for promoting healthy aging. [ABSTRACT FROM AUTHOR]

Emerging approaches show promise for regulatory use.

Background: The Centers for Medicare and Medicaid Services consider the 30-day hospital readmission rate an outcome of care measure; a high rate is associated with high-cost and bed utilization., Purpose: The Division of Vascular Surgery at a large academic medical center implemented a 15-week quality improvement project in the fall of 2022 to reduce readmissions among patients deemed high-risk for readmission and discharged to home., Methods: The discharging provider utilized the "HOSPITAL Score for Readmission" tool to identify patients at high-risk for unplanned 30-day readmission to receive the intervention, which included follow-up with a primary care provider (PCP) within two weeks of hospital discharge to address non-surgical medical conditions that may have been exacerbated during the hospital stay. A hospital based transitional care clinic bridged medical care for identified patients without an established PCP or whose PCP could not accommodate an appointment until PCP assumption of care. Discharging providers included 11 nurse practitioners and 2 surgery residents; each received a one-on-one educational teaching session and a weekly reminder e-mail through week 9., Results: A total of 158 vascular surgery patients (low and high-risk) were discharged home over 15 weeks with 30 patients (19%) having an unplanned readmission within 30-days from discharge. Adherence issues with the intervention among staff allowed for the high-risk group to be divided into those who did not receive the intervention versus those who did. The high-risk patients who did not receive the intervention had a higher readmission rate (30.4%) than the high-risk patients who did receive the intervention (21.4%)., Conclusions: Numerous acute and chronic medical problems were treated at the PCP/transitional care clinic visits, which may have contributed to the reduction in rate of readmissions occurring within 30-days for those patients. Increased usage of the transitional care clinic identified a gap that patients continue to require assistance with establishing care with a PCP and further process change in the future is needed to ensure successful transition for all patients., Competing Interests: Declarations of competing interest None., (Copyright © 2024 Society for Vascular Nursing, Inc. Published by Elsevier Inc. All rights reserved.)

Conjoint interventions for posttraumatic stress disorder (PTSD) offer an opportunity to target symptoms' broader social impact, including couples' relationship satisfaction. Technology-assisted interventions may help overcome access to care barriers for couples. Couple Helping Overcome PTSD and Enhance Satisfaction (HOPES) is a coached internet-based couples' intervention for PTSD adapted from cognitive behavioral conjoint therapy, an evidence-based dyadic therapy for PTSD. This pilot study examined the implementation feasibility, acceptability, and preliminary efficacy of Couple HOPES in a sample of 15 United States veterans with PTSD and their romantic partners within a Veterans Affairs (VA) Medical Center setting. There were significant improvements in veterans' PTSD symptoms (self- and partner-reported) and both veterans' and partners' relationship satisfaction, though the effect sizes were small (all g 's < .40). Importantly, the 73% retention rate and participant feedback at postassessment suggest this online adaptation may help couples overcome barriers to accessing care. More broadly, this pilot study helps answer questions regarding where digital health interventions fit into the continuum of PTSD care within the VA system. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Nonclinical testing has served as a foundation for evaluating potential risks and effectiveness of investigational new drugs in humans. However, the current two-dimensional (2D) in vitro cell culture systems cannot accurately depict and simulate the rich environment and complex processes observed in vivo, whereas animal studies present significant drawbacks with inherited species-specific differences and low throughput for increased demands. To improve the nonclinical prediction of drug safety and efficacy, researchers continue to develop novel models to evaluate and promote the use of improved cell- and organ-based assays for more accurate representation of human susceptibility to drug response. Among others, the three-dimensional (3D) cell culture models present physiologically relevant cellular microenvironment and offer great promise for assessing drug disposition and pharmacokinetics (PKs) that influence drug safety and efficacy from an early stage of drug development. Currently, there are numerous different types of 3D culture systems, from simple spheroids to more complicated organoids and organs-on-chips, and from single-cell type static 3D models to cell co-culture 3D models equipped with microfluidic flow control as well as hybrid 3D systems that combine 2D culture with biomedical microelectromechanical systems. This article reviews the current application and challenges of 3D culture systems in drug PKs, safety, and efficacy assessment, and provides a focused discussion and regulatory perspectives on the liver-, intestine-, kidney-, and neuron-based 3D cellular models., (© 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics. This article has been contributed to by US Government employees and their work is in the public domain in the USA.)

This article provides an overview of selected ongoing international efforts that have been inspired by Edward Zigler's vision to improve programs and policies for young children and families in the United States. The efforts presented are in close alignment with three strategies articulated by Edward Zigler: (a) conduct research that will inform policy advocacy; (b) design, implement, and revise quality early childhood development (ECD) programs; and (c) invest in building the next generation of scholars and advocates in child development. The intergenerational legacy left by Edward Zigler has had an impact on young children not only in the United States, but also across the globe. More needs to be done. We need to work together with a full commitment to ensure the optimal development of each child.

Guinea pigs (Cavia spp.) have a long association with humans. From as early as 10,000 years ago they were a wild food source. Later, domesticated Cavia porcellus were dispersed well beyond their native range through pre-Columbian exchange networks and, more recently, widely across the globe. Here we present 46 complete mitogenomes of archaeological guinea pigs from sites in Peru, Bolivia, Colombia, the Caribbean, Belgium and the United States to elucidate their evolutionary history, origins and paths of dispersal. Our results indicate an independent centre of domestication of Cavia in the eastern Colombian Highlands. We identify a Peruvian origin for the initial introduction of domesticated guinea pigs (Cavia porcellus) beyond South America into the Caribbean. We also demonstrate that Peru was the probable source of the earliest known guinea pigs transported, as part of the exotic pet trade, to both Europe and the southeastern United States. Finally, we identify a modern reintroduction of guinea pigs to Puerto Rico, where local inhabitants use them for food. This research demonstrates that the natural and cultural history of guinea pigs is more complex than previously known and has implications for other studies regarding regional to global-scale studies of mammal domestication, translocation, and distribution.

Reducing lead exposure is a public health priority for the US Food and Drug Administration as well as other federal agencies. The goals of this research were to 1) update the maximum daily dietary intake of lead from food, termed an interim reference level (IRL), for children and for women of childbearing age (WOCBA) and 2) to confirm through a literature review that with the exception of neurodevelopment, which was not evaluated here, no adverse effects of lead consistently occur at the blood lead level (BLL) associated with the IRL. Because no safe level of lead exposure has yet been identified for children's health, the IRLs of 3 μg/day for children and 12.5 μg/day for WOCBA were derived from the Centers for Disease Control and Prevention reference value of 5 μg/dL BLL, the level at which public health actions should be initiated. The literature review showed that no adverse effects of lead consistently occurred at the BLL associated with the IRLs (0.5 μg/dL). The IRLs of 3 μg/day for children and 12.5 μg/day for WOCBA should serve as useful benchmarks in evaluating the potential for adverse effects of dietary lead., (Published by Elsevier Inc.)

Dietary exposures to lead were estimated for older children, females of childbearing age and adults based on lead concentration data from the FDA's Total Diet Study and on food consumption data from What We Eat In America (WWEIA), the food survey portion of the National Health and Nutrition Examination Survey (NHANES). Estimated mean exposures varied based on the population and on the three different substitution scenarios for lead values below the limit of detection (non-detects = 0; non-detects = limit of detection; hybrid approach). Estimated mean lead exposures range from 1.4 to 4.0 µg/day for older children (males and females 7-17 years), 1.6 to 4.6 µg/day for women of childbearing age (females 16-49 years) and 1.7 to 5.3 µg/day for adults (males and females 18 years and older). Estimated 90th percentile lead exposures range from 2.3 to 5.8 µg/day for older children, 2.8 to 6.7 µg/day for women of childbearing age and 3.2 to 7.8 µg/day for adults. Exposure estimates suggest some older children may be exposed to dietary lead above the FDA interim reference level for lead in children of 3 µg/day. The results of this study can be used by the FDA to prioritise research and regulatory efforts in the area of dietary lead exposure.

Background : Cannabis and tobacco use are significant public health concerns among young adults, with concurrent (in the same time period) and simultaneous (at the same time so the effects overlap) use of both substances on the rise. Few studies have examined these behaviors among college students. Objective : We examined the prevalence of concurrent and simultaneous cannabis and cigarette (combustible or electronic) use among a sample of college students and characterized the psychosocial predictors of concurrent and simultaneous use compared to using cannabis alone. Methods : Data on past-3 months cannabis and cigarette use were collected on 1352 college students who were past-year cannabis and alcohol users yielding four groups: cannabis-only users ( n =  686), concurrent cannabis and cigarette users (CCAC ; n  = 235), simultaneous cannabis and cigarette users (SCAC; n  = 293), and non-recent users of either substance ( n  = 138). Multinomial logistic regression analyses were utilized to predict group membership. Results : Relative to the cannabis-only group, White, compared to Non-White students, males, compared to females, frequent, compared to infrequent, alcohol users, including those who used alcohol simultaneously with cigarettes, and illicit drug users were more likely to belong to the CCAC or SCAC group. Conclusions : Findings suggest the need for unique intervention efforts to prevent onset or reduce co-use among male and White students as well as illicit drug users and frequent alcohol users.

The Evidence-based Toxicology Collaboration (EBTC) was established recently to translate evidence-based approaches from medicine and health care to toxicology in an organized and sustained effort. The EBTC held a workshop on "Evidence-based Toxicology for the 21st Century: Opportunities and Challenges" in Research Triangle Park, North Carolina, USA on January 24-25, 2012. The presentations largely reflected two EBTC priorities: to apply evidence-based methods to assessing the performance of emerging pathway-based testing methods consistent with the 2007 National Research Council report on "Toxicity Testing in the 21st Century" as well as to adopt a governance structure and work processes to move that effort forward. The workshop served to clarify evidence-based approaches and to provide food for thought on substantive and administrative activities for the EBTC. Priority activities include conducting pilot studies to demonstrate the value of evidence-based approaches to toxicology, as well as conducting educational outreach on these approaches.

The American Heart Association has recently released a new set of guidelines for prevention of infective endocarditis with major changes and clarifications regarding who should receive antibiotic prophylaxis and who does not require it. The new guidelines are based on the current available evidence and deviate greatly from the previous ones. A summary of the changes and the evidence and philosophy behind this statement is presented in this article. Along with it is the current status of often-conflicting topics on other uses of antibiotic prophylaxis in dentistry. Special notes on heart murmur, patient information sheets, and continuing education questions are also included.

Three open-label extension trials evaluated the safety of budesonide inhalation suspension (BIS; Pulmicort Respules) in 670 children (8 months-9 years of age) with mild-to-severe persistent asthma. Patients were randomized to receive either BIS or conventional asthma therapy (CAT) for 52 weeks. The percentage of patients who discontinued because of clinical adverse events was low and similar among the CAT (0.4%) and BIS (0.7%) groups. After adjusting for length of time in the studies, there were no clinically relevant differences between the BIS and CAT groups in the type, incidence, or intensity of adverse events; vital signs or physical examination outcomes; or changes in clinical laboratory evaluations or oral fungal cultures.

The Free Trade Agreement between the United States and Canada (FTA) went into effect January 1, 1989. To implement certain provisions of the agreement on technical regulations and standards, the United States Food and Drug Administration's Center for Veterinary Medicine, Health and Welfare Canada's Bureau of Veterinary Drugs, and Agriculture Canada established the Working Group on Veterinary Drug Tolerances. The progress of the working group and its continuing efforts to harmonize tolerances for approximately 15 veterinary drugs are discussed. This paper proposes use of the toxicologically determined acceptable daily intake (ADI) for the drug as the safety standard for reaching conclusions on the acceptability of residues in meat for human consumption. Specifically, the "equivalence" of different MRLs for the same veterinary drug would be determined by considering whether they are likely to result in dietary residues that exceed the other country's ADI for the drug. Estimates are made for the veterinary drugs lasalocid, fenbendazole, morantel tartrate, halofuginone, and tilmicosin. Based on these estimates, the U.S. and Canadian MRLs for each drug would be considered equivalent for trade purposes.

Concern over the presence of veterinary drug residues in food has been increasing world wide. Because of this concern the Food and Drug Administration's Center for Veterinary Medicine (CVM) has been involved on an international basis in efforts to develop food safety standards for veterinary drugs. The major thrust of the Codex Committee on Residues of Veterinary Drugs in Foods (CC/RVDF) has been to achieve international agreement on veterinary drugs issues. CVM is an active participant on this committee. The CC/RVDF has established a list of priority veterinary drugs that are, or that have the potential to cause trade problems as the result of public health concerns. Included in this list are anabolic hormones, chloramphenicol, sulfonamides, nitrofurans, nitroimidazoles, somatotropins, benzimidazoles and trypanocides. In the upcoming years, the CC/RVDF will work toward developing international maximum residue levels for these compounds. The evaluation of the toxicity of veterinary drug-bound residues is another area of international concern. In conjunction with the Bureau of Veterinary Medicine, Health and Welfare Canada, CVM is developing guidelines on biological models to demonstrate the safety of veterinary drug-bound residues. In working with veterinary drug regulators from other countries, CVM has new solutions to human food safety problems.