Prevalence of depression in women with low income living in developed countries.

OBJECTIVE: To conduct a systematic review of studies reporting prevalence rates of depression in women living in low-income circumstances in developed countries. METHODS: The published and unpublished literature was searched for studies reporting prevalence of depression in women with low income in developed countries. Searches, data extraction, and methodological appraisal were conducted twice independently. To perform the analysis, the meta and metafor packages in R, a random effect model to account for both between and within studies' variances, and the restricted maximum likelihood method for estimation were used. RESULTS: One-hundred sixty-four studies, involving 218,035 participants, were located through the search process. The point prevalence of depression among women in low-income circumstances using self-report instruments in 134 studies was 37.4% (95% CI, 34.0%-40.7%). Additionally, the point prevalence according to depression diagnosis in 25 studies was 22.9% (95% CI, 17.8%-28.5%). CONCLUSIONS: The high rate of depression among women living in low-income circumstances is of serious public health concern. POLICY IMPLICATIONS: Women living in low-income circumstances should receive screening and referral/treatment in not only medical service settings, but also in social service settings serving women receiving welfare benefits.

Opinion on the Use of Animal Models in Nonclinical Safety Assessment: Pros and Cons.

Nonclinical evaluation of human safety risks for new chemical entities (NCEs) is primarily conducted in conventional healthy animals (CHAs); however, in certain instances, animal models of diseases (AMDs) can play a critical role in the understanding of human health risks. Animal models of diseases may be especially important when there is a need to understand how disease conditions associated with the intended indication might impact risk assessment of NCEs or when CHAs lack the human-specific target of interest (receptor, etc). Although AMDs have potential benefits over CHAs, they also have limitations. Understanding these limitations and optimizing the AMDs of interest should be done prior to proceeding with studies that will guide development of NCE. The purpose of this manuscript is to provide an overview of the major pros and cons of utilization of AMDs in nonclinical safety assessment.

Copovidone-related Cutaneous Response in the Dog.

A cutaneous response (localized swelling and/or erythema of the skin) has been noted in dog toxicology studies in which multiple, unrelated compounds were administered orally with copovidone as a vehicle. The response has been noted in studies with 6 different test items that are structurally unrelated and span several different therapeutic indications spanning an approximate 6-year period (2009-2015). A factor common among the studies is the formulation-a copovidone amorphous solid dispersion (ASD). Cutaneous responses have not been observed in dogs administered non-ASD formulations of the same test items but have occasionally been noted in placebo (copovidone control) dogs. Polyvinylpyrrolidone (a polymer of one of the primary components of copovidone) has been reported to result in similar findings in dogs when administered by the intravenous route. Considerations for the role of copovidone and the potential role of histamine in the cutaneous changes are outlined.

Regulatory Forum Opinion Piece*: Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey.

An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies. The survey determined that the majority of companies used AMDs during drug discovery primarily as a means for proactively assessing potential nonclinical safety issues prior to the conduct of toxicology studies, followed closely by the use of AMDs to better understand toxicities associated with exaggerated pharmacology in traditional toxicology models or to derisk issues when the target is only expressed in the disease state. In contrast, the survey results indicated that the use of AMDs in development is infrequent, being used primarily to investigate nonclinical safety issues associated with targets expressed only in disease states and/or in response to requests from global regulatory authorities.

A systematic review of near real-time and point-of-care clinical decision support in anesthesia information management systems.

Anesthesia information management systems (AIMS) are sophisticated hardware and software technology solutions that can provide electronic feedback to anesthesia providers. This feedback can be tailored to provide clinical decision support (CDS) to aid clinicians with patient care processes, documentation compliance, and resource utilization. We conducted a systematic review of peer-reviewed articles on near real-time and point-of-care CDS within AIMS using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies were identified by searches of the electronic databases Medline and EMBASE. Two reviewers screened studies based on title, abstract, and full text. Studies that were similar in intervention and desired outcome were grouped into CDS categories. Three reviewers graded the evidence within each category. The final analysis included 25 articles on CDS as implemented within AIMS. CDS categories included perioperative antibiotic prophylaxis, post-operative nausea and vomiting prophylaxis, vital sign monitors and alarms, glucose management, blood pressure management, ventilator management, clinical documentation, and resource utilization. Of these categories, the reviewers graded perioperative antibiotic prophylaxis and clinical documentation as having strong evidence per the peer reviewed literature. There is strong evidence for the inclusion of near real-time and point-of-care CDS in AIMS to enhance compliance with perioperative antibiotic prophylaxis and clinical documentation. Additional research is needed in many other areas of AIMS-based CDS.

A Narrative Review of Meaningful Use and Anesthesia Information Management Systems.

The US federal government has enacted legislation for a federal incentive program for health care providers and hospitals to implement electronic health records. The primary goal of the Meaningful Use (MU) program is to drive adoption of electronic health records nationwide and set the stage to monitor and guide efforts to improve population health and outcomes. The MU program provides incentives for the adoption and use of electronic health record technology and, in some cases, penalties for hospitals or providers not using the technology. The MU program is administrated by the Department of Health and Human Services and is divided into 3 stages that include specific reporting and compliance metrics. The rationale is that increased use of electronic health records will improve the process of delivering care at the individual level by improving the communication and allow for tracking population health and quality improvement metrics at a national level in the long run. The goal of this narrative review is to describe the MU program as it applies to anesthesiologists in the United States. This narrative review will discuss how anesthesiologists can meet the eligible provider reporting criteria of MU by applying anesthesia information management systems (AIMS) in various contexts in the United States. Subsequently, AIMS will be described in the context of MU criteria. This narrative literature review also will evaluate the evidence supporting the electronic health record technology in the operating room, including AIMS, independent of certification requirements for the electronic health record technology under MU in the United States.

Low-Income Cancer Survivors' Use of Health-Promoting Behaviors.

This cross-sectional correlation study examined use of health-promoting (HP) behaviors and self-efficacy for engaging in HP behaviors. Participants reported higher HP behavior scores for health responsibility, interpersonal relationships, and spiritual growth, and lower scores for physical activity/exercise, nutrition, and stress management. Low physical activity, stress management, and nutrition scores suggest nurses can implement strategies that encourage use of these HP behaviors and enhance self-efficacy.

A Narrative Review of Cervical Cancer Screening Utilization Among Haitian Immigrant Women in the U.S.: Health Beliefs, Perceptions, and Societal Barriers and Facilitators.

Haitian immigrant women living in the U.S. have a higher rate of cervical cancer mortality than any other ethnic group, primarily due to lower rates of screening test utilization. Therefore, it is important to understand the issues affecting their pap smear screening behaviors. We conducted a narrative review of articles from PubMed, SCOPUS, Embase, CINAHL/Nursing, and Psych Info. Inclusion criteria: U.S. Haitian immigrant, screening, cervical cancer, health beliefs/perceptions. Exclusion criteria: HPV-vaccine. Primary barriers: (1) lack of knowledge of cervical cancer, HPV, and pap smears; (2) lack of culturally appropriate dissemination of information; and (3) difficulty obtaining the test. Primary facilitators: (1) provider recommendations, (2) Haitian media to disseminate health information, and (3) having health insurance. This review highlights the points for intervention by health professionals and policy makers to address this group's low pap smear utilization.

Feasibility, Acceptability, and Health Outcomes Associated With Telehealth for Children in Families With Limited English Proficiency.

BACKGROUND: Telehealth use in pediatrics increased during the COVID-19 pandemic and may improve health care access. It may also exacerbate health care disparities among families with limited English proficiency (LEP). OBJECTIVE: To systematically review the feasibility, acceptability, and/or associations between telehealth delivery and health outcomes for interventions delivered synchronously in the United States. DATA SOURCES: PubMed, Embase, and Scopus. STUDY ELIGIBILITY CRITERIA: Original research exploring pediatric health outcomes after telehealth delivery and studies that explored the feasibility and acceptability including surveys and qualitative studies. PARTICIPANTS: Patients 0 to 18 years with LEP and/or pediatric caregivers with LEP. STUDY APPRAISAL AND SYNTHESIS METHODS: Two authors independently screened abstracts, conducted full-text review, extracted information using a standardized form, and assessed study quality. A third author resolved disagreements. RESULTS: Of 1831 articles identified, 9 were included in the review. Half of the studies explored videoconferencing and the other half studied health care delivered by telephone. Feasibility studies explored telehealth for children with anxiety disorders and mobile phone support for substance abuse treatment among adolescents. Acceptability studies assessed parental medical advice-seeking behaviors and caregivers' general interest in telehealth. Health outcomes studied included follow-up of home parenteral nutrition, developmental screening, and cognitive behavioral therapy. LIMITATIONS: The articles were heterogeneous in approach and quality. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Telehealth appears acceptable and feasible among children in families with LEP, with a limited evidence base for specific health outcomes. We provide recommendations both for the implementation of pediatric telehealth and future research. PROSPERO REGISTRATION: CRD42020204541.

Use of animal models of human disease for nonclinical safety assessment of novel pharmaceuticals.

Animal models of human disease are commonly utilized to gain insight into the potential efficacy and mode of action of novel pharmaceuticals. However, conventional (healthy) rodent and nonrodent models are generally utilized in nonclinical safety testing. Animal models of human disease may be helpful in understanding safety risks of compounds in nonclinical or clinical development, with their greatest value being in targeted or hypothesis-driven studies to help understand the mechanism of a particular toxicity. Limitations of animal models of disease in nonclinical safety testing include a lack of historical control, heterogeneity in disease expression, a limited life span, and confounding effects of the disease. In most instances, animal models of human disease should not be utilized to supplant testing in conventional animal models. While of potential benefit, testing in an animal model of human disease should only be taken after adequate consideration of relevance along with benefits and limitations of the proposed model.

Health promotion for cancer survivors: adaptation and implementation of an intervention.

Randomized control trial of a health promotion intervention was implemented for low-income cancer survivors. The majority of participants were female, older, divorced, educated, and unemployed or on disability leave. Findings indicate the health promotion intervention improved cancer survivors' self-efficacy and increased their use of health-promoting behaviors.

Front-of-Package Nutrition Labeling and Its Impact on Food Industry Practices: A Systematic Review of the Evidence.

The obesity epidemic has become a major public health concern globally, and the food supply is a significant driver of this trend. Front-of-package (FOP) labels have been implemented in many countries to encourage healthier food choices. This systematic review aimed to examine the effect of FOP label implementation on food manufacturers' practices. A comprehensive search of multiple databases was conducted following PRISMA guidelines, identifying 39 relevant articles from 1990 to 2021. The studies indicated that FOP labels conveying intuitive information influenced product reformulation, whereas those with numerical information without specific guidance had no impact on reducing unhealthy nutrients. The most common outcomes were sodium, sugar, and calorie reduction. Mandatory policies reported higher and more consistent effects on product reformulation compared to voluntary approaches. Voluntary FOP labeling resulted in low uptake and tended to be applied to healthier products. Food manufacturers responded to FOP labeling heterogeneously, depending on the label design and type of enforcement. FOP label implementation can reduce nutrients of concern but food manufacturers behave strategically by labeling healthier choices. This review provides recommendations for maximizing the benefits of using FOP labels to prevent obesity, and findings can inform future public health research and policymaking.

Nutrition association with skin integrity and pressure injury in critically ill pediatric patients.

BACKGROUND: Current research highlights the positive impact of nutrition therapy, particularly enteral nutrition, in critical illness. However, little attention is given to the impact of nutrition on skin integrity during critical illness. Skin integrity is at risk in critically ill children owing to necessary clinical therapies and challenges of providing nutrition therapy. METHODS: We conducted a narrative literature review with three main thematic concepts to drive our literature search: the association of nutrition therapy with (1) skin integrity; (2) injury, wounds, and wound healing; and (3) differences of skin color. Using pertinent search and subject terms, PubMed, CINAHL, EMBASE, and SCOPUS databases were searched, yielding 316 articles. After removal of duplicates, articles were reviewed based on inclusion and exclusion criteria defined by the authors; only eight articles met the defined criteria to inform this review. RESULTS: Large and important gaps exist in the current literature regarding an association between nutrition therapy, skin injury, and wound healing. Little to no attention was found for associations with skin color. The resulting narrative review addresses these topics and subtopics with additional references included that are independent of the original search strategy. CONCLUSIONS: A dearth of evidence exists describing associations between nutrition and disruption of skin integrity in pediatric critical illness. Children with dark skin are at increased risk, as manifestation and identification of disruption to skin integrity may not be recognized. Research is needed to describe these associations and the impact of nutrition on skin integrity, including differences of skin color.

A short guide to peer-reviewed, MEDLINE-indexed complementary and alternative medicine journals.

Complementary and alternative medicine (CAM) comprises a multitude of disciplines, for example, acupuncture, ayurvedic medicine, biofeedback, herbal medicine, and homeopathic medicine. While research on CAM interventions has increased and the CAM literature has proliferated since the mid-1990s, a number of our colleagues have expressed difficulties in deciding where to publish CAM articles. In response, we created a short guide to peer-reviewed MEDLINE-indexed journals that publish CAM articles. We examined numerous English-language sources to identify titles that met our criteria, whether specific to or overlapping CAM. A few of the resources in which we found the journal titles that we included are Alternative Medicine Foundation, American Holistic Nurses Association, CINAHL/Nursing Database, Journal Citation Reports database, MEDLINE, PubMed, and Research Council for Complementary Medicine. We organized the 69 selected titles for easy use by creating 2 user-friendly tables, one listing titles in alphabetical order and one listing them in topical categories. A few examples of the topical categories are Acupuncture, CAM (general), Chinese Medicine, Herbal/Plant/Phytotherapy, Neuroscience/Psychology, Nursing/Clinical Care. Our study is the first to list general CAM journals, specialty CAM journals, and overlapping mainstream journals that are peer reviewed, in English, and indexed in MEDLINE. Our goal was to assist both authors seeking publication and mainstream journal editors who receive an overabundance of publishable articles but must recommend that authors seek publication elsewhere due to space and priority issues. Publishing in journals indexed by and included in MEDLINE (or PubMed) ensures that citations to articles will be found easily.

Preclinical development of a molecular clamp-stabilised subunit vaccine for severe acute respiratory syndrome coronavirus 2.

OBJECTIVES: Efforts to develop and deploy effective vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue at pace. Here, we describe rational antigen design through to manufacturability and vaccine efficacy of a prefusion-stabilised spike (S) protein, Sclamp, in combination with the licensed adjuvant MF59 'MF59C.1' (Seqirus, Parkville, Australia). METHODS: A panel recombinant Sclamp proteins were produced in Chinese hamster ovary and screened in vitro to select a lead vaccine candidate. The structure of this antigen was determined by cryo-electron microscopy and assessed in mouse immunogenicity studies, hamster challenge studies and safety and toxicology studies in rat. RESULTS: In mice, the Sclamp vaccine elicits high levels of neutralising antibodies, as well as broadly reactive and polyfunctional S-specific CD4+ and cytotoxic CD8+ T cells in vivo. In the Syrian hamster challenge model (n = 70), vaccination results in reduced viral load within the lung, protection from pulmonary disease and decreased viral shedding in daily throat swabs which correlated strongly with the neutralising antibody level. CONCLUSION: The SARS-CoV-2 Sclamp vaccine candidate is compatible with large-scale commercial manufacture, stable at 2-8°C. When formulated with MF59 adjuvant, it elicits neutralising antibodies and T-cell responses and provides protection in animal challenge models.

ABT-751, a novel tubulin-binding agent, decreases tumor perfusion and disrupts tumor vasculature.

ABT-751 is an orally bioavailable tubulin-binding agent that is currently under clinical development for cancer treatment. In preclinical studies, ABT-751 showed antitumor activity against a broad spectrum of tumor lines including those resistant to conventional chemotherapies. In this study, we investigated the antivascular properties of ABT-751 in a rat subcutaneous tumor model using dynamic contrast-enhanced magnetic resonance imaging. A single dose of ABT-751 (30 mg/kg, intravenously) induced a rapid, transient reduction in tumor perfusion. After 1 h, tumor perfusion decreased by 57% before recovering to near pretreatment levels within 6 h. In contrast, ABT-751 produced little change in muscle perfusion at either time point. To further elucidate mechanisms of drug action at the cellular level, we examined the effects of ABT-751 on endothelial cells using an in-vitro assay. ABT-751, at concentrations corresponding to plasma levels achieved in vivo, caused endothelial cell retraction and significant loss of microtubules within 1 h. The severity of these morphological changes was dose-dependent but reversible within 6 h after the discontinuation of the drug. Taken together, these results show that ABT-751 is a tubulin-binding agent with antivascular properties. Microtubule disruption and morphological changes in vascular endothelial cells may be responsible, at least in part, for the dysfunction of tumor blood vessels after ABT-751 treatment.

Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017.

IMPORTANCE: The human and financial costs of treating surgical site infections (SSIs) are increasing. The number of surgical procedures performed in the United States continues to rise, and surgical patients are initially seen with increasingly complex comorbidities. It is estimated that approximately half of SSIs are deemed preventable using evidence-based strategies. OBJECTIVE: To provide new and updated evidence-based recommendations for the prevention of SSI. EVIDENCE REVIEW: A targeted systematic review of the literature was conducted in MEDLINE, EMBASE, CINAHL, and the Cochrane Library from 1998 through April 2014. A modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and the strength of the resulting recommendation and to provide explicit links between them. Of 5759 titles and abstracts screened, 896 underwent full-text review by 2 independent reviewers. After exclusions, 170 studies were extracted into evidence tables, appraised, and synthesized. FINDINGS: Before surgery, patients should shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day. Antimicrobial prophylaxis should be administered only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made. In cesarean section procedures, antimicrobial prophylaxis should be administered before skin incision. Skin preparation in the operating room should be performed using an alcohol-based agent unless contraindicated. For clean and clean-contaminated procedures, additional prophylactic antimicrobial agent doses should not be administered after the surgical incision is closed in the operating room, even in the presence of a drain. Topical antimicrobial agents should not be applied to the surgical incision. During surgery, glycemic control should be implemented using blood glucose target levels less than 200 mg/dL, and normothermia should be maintained in all patients. Increased fraction of inspired oxygen should be administered during surgery and after extubation in the immediate postoperative period for patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation. Transfusion of blood products should not be withheld from surgical patients as a means to prevent SSI. CONCLUSIONS AND RELEVANCE: This guideline is intended to provide new and updated evidence-based recommendations for the prevention of SSI and should be incorporated into comprehensive surgical quality improvement programs to improve patient safety.

Tumor suppression by a rationally designed reversible inhibitor of methionine aminopeptidase-2.

Methionine aminopeptidase (MetAP)-2 has been suggested as a novel target for cancer therapy because the anticancer agent TNP-470 irreversibly inactivates the catalytic activity of this enzyme. However, the importance of MetAP2 in cell growth and tumor progression was uncertain because previous data were based on the chemically reactive TNP-470. Here we show that a rationally designed reversible MetAP2 inhibitor, A-357300, suppresses tumor growth preclinically without the toxicities observed with TNP-470. We have synthesized this bestatin-type MetAP2 inhibitor with the aid of crystal structures of the enzyme-inhibitor complexes and parallel synthesis. A-357300 induces cytostasis by cell cycle arrest at the G(1) phase selectively in endothelial cells and in a subset of tumor cells, but not in most primary cells of nonendothelial type. A-357300 inhibits angiogenesis both in vitro and in vivo and shows potent antitumor efficacy in carcinoma, sarcoma, and neuroblastoma murine models. These data affirm that MetAP2 plays a pivotal role in cell growth and establish that reversible MetAP2 inhibitors are promising novel cancer therapeutic agents.