Anxiety Management among Non-Clinical Society towards COVID-19 Pandemic in the Iranian Context

The COVID-19 pandemic has had a major effect on our lives. Many of us are facing challenges that can be stressful and overwhelming and cause strong emotions in adults and children. The purpose of this study was to measure the level of anxiety of non-clinical individuals in the Iranian community towards COVID-19 in Tehran. The present study is a descriptive correlational method with 308 individuals participating in the study through an online recall. A researcher-made coronary anxiety questionnaire with 18 questions was used to collect data. The data were analyzed by using Cronbach's alpha internal consistency and Guttman's λ2 method. Confirmatory factor analysis (CFA) using Lisrel-8.8 software was used to evaluate the tool construct validity. To standardize the raw scores, they were converted to standard T scores and percentile rank using Jmetrik-4.1.1 software and were prepared as normative tables. The Guttman's λ2 value for the whole questionnaire was obtained as (λ = 0.922), Cronbach's alpha coefficient for psychological symptoms as (α = 0.879), physical symptoms as (α = 0.861), and for the whole questionnaire as (α = 0.919). The range of scores of the questionnaire factors and total score of COVID-related anxiety severity based on standard T scores was divided into three domains: mild, moderate, and severe. The increase in psychological and physical symptom scores of coronavirus anxiety was significantly associated with physical symptoms, anxiety, depression, and social dysfunction. The fact that anxiety acts as a predisposing and health-threatening variable has confirmed that other researchers should examine its psychometric properties in other populations (especially compared to the clinical population to increase the diagnostic value of this questionnaire) as well as in relation to other psychological, social and medical concepts and variables. © 2022 Copyright 2022 by Koninklijke Brill NV, Leiden, The Netherlands.

Clinical Application of Detecting COVID-19 Risks: A Natural Language Processing Approach.

The clinical application of detecting COVID-19 factors is a challenging task. The existing named entity recognition models are usually trained on a limited set of named entities. Besides clinical, the non-clinical factors, such as social determinant of health (SDoH), are also important to study the infectious disease. In this paper, we propose a generalizable machine learning approach that improves on previous efforts by recognizing a large number of clinical risk factors and SDoH. The novelty of the proposed method lies in the subtle combination of a number of deep neural networks, including the BiLSTM-CNN-CRF method and a transformer-based embedding layer. Experimental results on a cohort of COVID-19 data prepared from PubMed articles show the superiority of the proposed approach. When compared to other methods, the proposed approach achieves a performance gain of about 1-5% in terms of macro- and micro-average F1 scores. Clinical practitioners and researchers can use this approach to obtain accurate information regarding clinical risks and SDoH factors, and use this pipeline as a tool to end the pandemic or to prepare for future pandemics.

Open science and conflict of interest policies of medical and health sciences journals before and during the COVID-19 pandemic: A repeat cross-sectional study: Open science policies of medical journals.

Objectives: To audit the transparent and open science standards of health and medical sciences journal policies and explore the impact of the COVID-19 pandemic. Design: Repeat cross-sectional study. Setting: 19 journals listed in Google Scholar's Top Publications for health and medical sciences. Participants: Blood, Cell, Circulation, European Heart Journal, Gastroenterology, Journal of Clinical Oncology, Journal of the American College of Cardiology, Nature Genetics, Nature Medicine, Nature Neuroscience, Neuron, PLoS ONE, Proceedings of the National Academy of Sciences, Science Translational Medicine, The British Medical Journal, The Journal of the American Medical Association, The Lancet, The Lancet Oncology, and The New England Journal of Medicine. Main outcome measures: We used the Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts of interest (COIs) to evaluate journals standards. Results: TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 2-12.5) out of a possible 24 points in February 2020 to 7 (IQR: 4-12) in May 2021, but overall, scores were very low at both time points. Journal policies scored highest for their adherence to data transparency and scored lowest for preregistration of study protocols and analysis plans and the submission of replication studies. Most journals fulfilled all ICMJE provisions for reporting COIs before (84%; n = 16) and during (95%; n = 18) the COVID-19 pandemic. Conclusions: The COVID-19 pandemic has highlighted the importance of practising open science. However, requirements for open science practices in audited policies were overall low, which may impede progress in health and medical research. As key stakeholders in disseminating research, journals should promote a research culture of greater transparency and more robust open science practices.

Hospital-based telework: The pandemic pilot

This narrative inquiry dissertation study explored the experiences of nonclinical hospital staff placed on pandemic-imposed telework status from the spring of 2020, spring 2022 due to COVID-19. The purpose of this study is to address gaps in the existing literature regarding the feasibility of hospital staff to telework and identify ways to strengthen manager trust in the context of remote work. The study provides an in-depth narrative on the impact of telework on nonclinical care hospital departments and to addresses lessons learned in making remote work more feasible.This study utilized qualitative narrative inquiry approach to address the central research question and two sub-questions. A convenience sample of 11 hospital staff who experienced pandemic imposed telework participated in open ended Microsoft Teams interviews and gave in depth feedback on their lived experience with telework. Verbatim transcripts were used to code and analyze emerging themes. ATLAS.ti Cloud software was used to code and develop thematic analysis of the interviews. A total of 72 unique codes and eight themes resulted from the analysis of the interviews. The result is six recommendations that support the roll out of telework within hospitals. These findings support current research regarding strengths and weaknesses of telework and identify ways to support managers and staff moving forward. Additionally, the research fills the gap in literature regarding the feasibility and experience of telework by nonclinical hospital staff. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

In Vitro and In Vivo Characterization of a Broadly Neutralizing Anti-SARS-CoV-2 Antibody Isolated from a Semi-Immune Phage Display Library.

Neutralizing antibodies targeting the receptor-binding domain (RBD) of SARS-CoV-2 are among the most promising strategies to prevent and/or treat COVID-19. However, as SARS-CoV-2 has evolved into new variants, most of the neutralizing antibodies authorized by the US FDA and/or EMA to treat COVID-19 have shown reduced efficacy or have failed to neutralize the variants of concern (VOCs), particularly B.1.1.529 (Omicron). Previously, we reported the discovery and characterization of antibodies with high affinity for SARS-CoV-2 RBD Wuhan (WT), B.1.617.2 (Delta), and B.1.1.529 (Omicron) strains. One of the antibodies, called IgG-A7, also blocked the interaction of human angiotensin-converting enzyme 2 (hACE2) with the RBDs of the three strains, suggesting it may be a broadly SARS-CoV-2 neutralizing antibody. Herein, we show that IgG-A7 efficiently neutralizes all the three SARS-CoV-2 strains in plaque reduction neutralization tests (PRNTs). In addition, we demonstrate that IgG-A7 fully protects K18-hACE2 transgenic mice infected with SARS-CoV-2 WT. Taken together, our findings indicate that IgG-A7 could be a suitable candidate for development of antibody-based drugs to treat and/or prevent SARS-CoV-2 VOCs infection.

Accuracy of telephone screening tools to identify dementia patients remotely: systematic review.

The COVID19 pandemic highlighted the need for remote diagnosis of cognitive impairment and dementia. Telephone screening for dementia may facilitate prompt diagnosis and optimisation of care. However, it is not clear how accurate telephone screening tools are compared with face-to-face screening. We searched Cochrane, MEDLINE, Embase, Web of Science, PubMed and Scopus for all English language papers published between January 1975 and February 2021 which compared telephone screening for dementia/ mild cognitive impairment and an in-person reference standard, performed within six-weeks. We subsequently searched paper reference lists and contacted authors if data were missing. Three reviewers independently screened studies for inclusion, extracted data, and assessed study quality using an adapted version of the Joanna Briggs Institute's critical appraisal tool. Twenty-one studies including 944 participants were found. No one test appears more accurate, with similar validities as in-person testing. Cut-offs for screening differed between studies based on demographics and acceptability thresholds and meta-analysis was not appropriate. Overall the results suggest telephone screening is acceptably sensitive and specific however, given the limited data, this finding must be treated with some caution. It may not be suitable for those with hearing impairments and anxiety around technology. Few studies were carried out in general practice where most screening occurs and further research is recommended in such lower prevalence environments.

Exploring the Status of Life Expectancy at Birth in Indian States and the Evolving Health Perspectives for well-being

The present study aims to assess the life expectancy at birth (LEB) of the fifteen major states in India and verify for the regional disparity in LEB over the study period. An analysis of secondary data on LEB is performed. The coefficient of variation (CV) of LEB across states is estimated to examine sigma-convergence and absolute convergence is assessed by means of ordinary least square (OLS) technique. Gini Coefficient is also used to measure the change in regional inequality in LEB over the time period. A technique of estimating divergence reduction is employed to assess the accomplishment of states on the LEB indicator. The sigma and absolute convergence estimation reveals that India is experiencing continuous gains in life expectancy and regional divide in LEB has reduced over the years. But a regional gap still remains. A variation in life expectancy is mostly caused by differences in the social determinants of health viz. potable water, medical care, sanitation, hygiene. The states which are aiming at improving LEB should focus on non-clinical measures as well to enhance the life span of individuals and also to reduce the burden on health infrastructure. The health policy design and implementation should also be designed in creating health rather than purely focused on curing illness. A pandemic like the coronavirus disease (COVID -19) has urged a new way of looking at health;beyond pharmaceutical measures. Social, meditative and technology based intervention can help in improving the life expectancy and other health indicators.

Anxiety Management among Non-Clinical Society towards C OVI D-19 Pandemic in the Iranian Context

The COVID-19 pandemic has had a major effect on our lives. Many of us are facing challenges that can be stressful and overwhelming and cause strong emotions in adults and children. The purpose of this study was to measure the level of anxiety of nonclinical individuals in the Iranian community towards COVID-19 in Tehran. The present study is a descriptive correlational method with 308 individuals participating in the study through an online recall. A researcher-made coronary anxiety questionnaire with 18 questions was used to collect data. The data were analyzed by using Cronbach's alpha internal consistency and Guttman's lambda 2 method. Confirmatory factor analysis (CFA) using Lisrel-8.8 software was used to evaluate the tool construct validity. To standardize the raw scores, they were converted to standard T scores and percentile rank using Jmetrik-4.1.1 software and were prepared as normative tables. The Guttman's lambda 2 value for the whole questionnaire was obtained as (lambda = 0.922), Cronbach's alpha coefficient for psychological symptoms as (alpha = 0.879), physical symptoms as (alpha = 0.861), and for the whole questionnaire as (alpha = 0.919). The range of scores of the questionnaire factors and total score of COVID-related anxiety severity based on standard T scores was divided into three domains: mild, moderate, and severe. The increase in psychological and physical symptom scores of coronavirus anxiety was significantly associated with physical symptoms, anxiety, depression, and social dysfunction. The fact that anxiety acts as a predisposing and health-threatening variable has confirmed that other researchers should examine its psychometric properties in other populations (especially compared to the clinical population to increase the diagnostic value of this questionnaire) as well as in relation to other psychological, social and medical concepts and variables.

Laboratory information management system for COVID-19 non-clinical efficacy trial data.

BACKGROUND: As the number of large-scale studies involving multiple organizations producing data has steadily increased, an integrated system for a common interoperable format is needed. In response to the coronavirus disease 2019 (COVID-19) pandemic, a number of global efforts are underway to develop vaccines and therapeutics. We are therefore observing an explosion in the proliferation of COVID-19 data, and interoperability is highly requested in multiple institutions participating simultaneously in COVID-19 pandemic research. RESULTS: In this study, a laboratory information management system (LIMS) approach has been adopted to systemically manage various COVID-19 non-clinical trial data, including mortality, clinical signs, body weight, body temperature, organ weights, viral titer (viral replication and viral RNA), and multiorgan histopathology, from multiple institutions based on a web interface. The main aim of the implemented system is to integrate, standardize, and organize data collected from laboratories in multiple institutes for COVID-19 non-clinical efficacy testings. Six animal biosafety level 3 institutions proved the feasibility of our system. Substantial benefits were shown by maximizing collaborative high-quality non-clinical research. CONCLUSIONS: This LIMS platform can be used for future outbreaks, leading to accelerated medical product development through the systematic management of extensive data from non-clinical animal studies.

Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan.

The efficacy and safety of vaccines for the prevention of infectious diseases are mostly evaluated based on the induction of an immune response against antigens, and do not necessarily depend on the dose administered. Therefore, there are some specific aspects that need to be considered in the development of vaccines and have been described in "The Guidelines for the non-clinical studies of vaccines for the prevention of infectious disease" in Japan. Recent changes in the vaccine development field, such as the introduction of vaccines developed overseas in Japan and vaccine development on a global scale have increased the need for revision of these guidelines. In this study, we identified the current challenges in the development of vaccines through comparison of Japanese and international guidelines. We conducted a questionnaire-based survey of pharmaceutical industries in Japan, and found issues related to non-clinical studies, such as the necessity of safety pharmacology studies and repeated-dose toxicity studies for each route of administration. We examined international guidelines on these issues as well as review reports by regulatory authorities, and determined that the results of repeated-dose toxicity studies can be used to decide whether safety pharmacology studies are required, and that studies to evaluate toxicity due to systemic effects may not be necessary for both intramuscular and subcutaneous administration. We propose revision of the guidelines for the non-clinical studies of vaccines in Japan taking international harmonizaion into account. We expected that the revised guidelines will promote smooth and rational vaccine development.

The Effectiveness of a Nonguided Mindfulness App on Perceived Stress in a Nonclinical Dutch Population: Randomized Controlled Trial.

BACKGROUND: Mindfulness has become increasingly popular, and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mobile health (mHealth). OBJECTIVE: The aim of this study is to investigate whether a nonguided mindfulness mobile app can decrease perceived stress in a nonclinical Dutch population over the course of 8 weeks, with follow-up at 6 months. METHODS: A randomized controlled trial was performed to compare an experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after 6 months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress Scale, secondary outcomes were symptoms of burnout (measured using the visual analog scale [VAS]) and psychological symptoms (measured using the Four-Dimensional Symptom Questionnaire [4DSQ] at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS: At baseline, 587 respondents were included. Results showed no postintervention differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed significantly lower scores for the experimental group after 8 weeks (P=.04 and P=.01, respectively), but not at follow-up. There were no differences between groups for psychological symptoms measured using the 4DSQ. CONCLUSIONS: These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, our findings related to diminished exhaustion at 8 weeks are encouraging and require further investigation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05246800; https://clinicaltrials.gov/show/NCT05246800.

Vaccinating adolescents against SARS-CoV-2 in England: a risk-benefit analysis.

OBJECTIVE: To offer a quantitative risk-benefit analysis of two doses of SARS-CoV-2 vaccination among adolescents in England. SETTING: England. DESIGN: Following the risk-benefit analysis methodology carried out by the US Centers for Disease Control, we calculated historical rates of hospital admission, Intensive Care Unit admission and death for ascertained SARS-CoV-2 cases in children aged 12-17 in England. We then used these rates alongside a range of estimates for incidence of long COVID, vaccine efficacy and vaccine-induced myocarditis, to estimate hospital and Intensive Care Unit admissions, deaths and cases of long COVID over a period of 16 weeks under assumptions of high and low case incidence. PARTICIPANTS: All 12-17 year olds with a record of confirmed SARS-CoV-2 infection in England between 1 July 2020 and 31 March 2021 using national linked electronic health records, accessed through the British Heart Foundation Data Science Centre. MAIN OUTCOME MEASURES: Hospitalisations, Intensive Care Unit admissions, deaths and cases of long COVID averted by vaccinating all 12-17 year olds in England over a 16-week period under different estimates of future case incidence. RESULTS: At high future case incidence of 1000/100,000 population/week over 16 weeks, vaccination could avert 4430 hospital admissions and 36 deaths over 16 weeks. At the low incidence of 50/100,000/week, vaccination could avert 70 hospital admissions and two deaths over 16 weeks. The benefit of vaccination in terms of hospitalisations in adolescents outweighs risks unless case rates are sustainably very low (below 30/100,000 teenagers/week). Benefit of vaccination exists at any case rate for the outcomes of death and long COVID, since neither have been associated with vaccination to date. CONCLUSIONS: Given the current (as at 15 September 2021) high case rates (680/100,000 population/week in 10-19 year olds) in England, our findings support vaccination of adolescents against SARS-CoV2.

From the Operating Room to Online: Medical Student Surgery Education in the Time of COVID-19.

BACKGROUND: On March 17, 2020 the Association of American Medical Colleges recommended dismissal of medical students from clinical settings due to the COVID-19 pandemic. Third-year (M3) and fourth-year (M4) medical students were at home, M4s were interested in teaching, and residents and faculty had fewer clinical responsibilities due to elective surgery cancellations. To continue M3 access to education, we created a virtual surgery elective (VSE) that aimed to broaden students' exposure to, and elicit interest in, general surgery (GS). METHODS: Faculty, surgical residents, and M4s collaborated to create a 2-wk VSE focusing on self-directed learning and direct interactions with surgery faculty. Each day was dedicated to a specific pathology commonly encountered in GS. A variety of teaching methods were employed including self-directed readings and videos, M4 peer lectures, case-based learning and operative video review with surgery faculty, and weekly surgical conferences. A VSE skills lab was also conducted to teach basic suturing and knot-tying. All lectures and skills labs were via Zoom videoconference (Zoom Video Communications Inc). A post-course anonymous survey sent to all participants assessed changes in their understanding of GS and their interest in GS and surgery overall. RESULTS: Fourteen M3s participated in this elective over two consecutive iterations. The survey response rate was 79%. Ninety-one percent of students believed the course met its learning objectives "well" or "very well." Prior to the course, 27% reported a "good understanding" and 0% a "very good" understanding of GS. Post-course, 100% reported a "good" or "very good" understanding of GS, a statistically significant increase (P = 0.0003). Eighty-two percent reported increased interest in GS and 64% reported an increase in pursuing GS as a career. CONCLUSIONS: As proof of concept, this online course successfully demonstrated virtual medical student education can increase student understanding of GS topics, increase interest in GS, and increase interest in careers in surgery. To broaden student exposure to GS, we plan to integrate archived portions of this course into the regular third-year surgery clerkship and these can also be used to introduce GS in the preclinical years.

Considerations in the Design of Non-Clinical Development Programmes to Support Non-Viral Genetically Modified Mesenchymal Stromal Cell Therapies.

Due to their immune suppressive pharmacology, regenerative capacity, and immune privileged status, mesenchymal stromal cells (MSCs) are an attractive cell type to treat a variety of diseases. Genetically engineered MSCs are currently in non-clinical and clinical development for a wide range of applications including the delivery of pro-drugs and therapeutic proteins or modified to enhance their regenerative potential. Unmodified MSCs have been shown to have good safety profiles in clinical development. The introduction of exogenous transgenes introduces possible additional risks that need to be assessed in non-clinical studies prior to initiating clinical studies. The use of ex vivo non-viral genetic modification approaches potentially reduces the risks associated with viral vector transfection approaches, including the potential for cell transformation. This review provides an overview of the regulatory-compliant non-clinical proof-of-concept and safety studies required to take MSC-based gene therapy products from the bench to the clinic.

Creation of a medical ward from non-clinical space amidst the Covid-19 pandemic.

INTRODUCTION: Hospitals were mandated to dramatically increase capacity during the Covid-19 crisis in New York City. Conversion of non-clinical space into medical units designated for Covid-19 patients became necessary to accommodate this mandate. METHODS: Non-clinical space was converted into medical units at multiple campuses of a large academic hospital system over 1 week. The conversion required construction to deliver basic care including oxygen supplementation. Creation of provider workspaces, handwashing areas, and colour-coded infection control zones was prioritized. Selection criteria were created with a workflow to determine appropriate patients for transfer into converted space. Staffing of converted space shifted as hospitalizations surged. RESULTS: The unit was open for 18 days and accommodated 170 unique patients. Five patients (2.9%) required transfer to a higher level of care. There were no respiratory arrests, cardiac arrests, or deaths in the new unit. CONCLUSION: Converting non-clinical space to a medical unit was accomplished quickly with staffing, workflow for appropriate patients, few patients who returned to a higher level of care, and no respiratory or cardiac arrests or deaths on the unit.

The potential effectiveness of the WHO International Health Regulations capacity requirements on control of the COVID-19 pandemic: a cross-sectional study of 114 countries.

OBJECTIVES: We examined if the WHO International Health Regulations (IHR) capacities were associated with better COVID-19 pandemic control. DESIGN: Observational study. SETTING: Population-based study of 114 countries. PARTICIPANTS: General population. MAIN OUTCOME MEASURES: For each country, we extracted: (1) the maximum rate of COVID-19 incidence increase per 100,000 population over any 5-day moving average period since the first 100 confirmed cases; (2) the maximum 14-day cumulative incidence rate since the first case; (3) the incidence and mortality within 30 days since the first case and first COVID-19-related death, respectively. We retrieved the 13 country-specific International Health Regulations capacities and constructed linear regression models to examine whether these capacities were associated with COVID-19 incidence and mortality, controlling for the Human Development Index, Gross Domestic Product, the population density, the Global Health Security index, prior exposure to SARS/MERS and Stringency Index. RESULTS: Countries with higher International Health Regulations score were significantly more likely to have lower incidence (ß coefficient -24, 95% CI -35 to -13) and mortality (ß coefficient -1.7, 95% CI -2.5 to -1.0) per 100,000 population within 30 days since the first COVID-19 diagnosis. A similar association was found for the other incidence outcomes. Analysis using different regression models controlling for various confounders showed a similarly significant association. CONCLUSIONS: The International Health Regulations score was significantly associated with reduction in rate of incidence and mortality of COVID-19. These findings inform design of pandemic control strategies, and validated the International Health Regulations capacities as important metrics for countries that warrant evaluation and improvement of their health security capabilities.