Effects of working from home on lifestyle behaviors and mental health during the COVID-19 pandemic: A survey study.

The COVID-19 outbreak has led to relevant changes in everyday life worldwide. One of these changes has been a rapid transition to and an increasing implementation of working from home (WH) modality. This study aimed to evaluate the impact of mandatory WH during the COVID-19 pandemic on lifestyle behaviors, Mediterranean diet adherence, body weight, and depression. An online cross-sectional survey was conducted in the early 2022 at the National Research Council of Italy using ad hoc questions and validated scales collecting information on physical activity, sedentary behavior, hobbies/pastimes, dietary habits including adherence to the Mediterranean diet, body weight, and depression during WH compared with before WH. 748 respondents were included in the study. An increased sedentary lifetime was reported by 48% of respondents; however, the subsample of workers who previously performed moderate physical activity intensified this activity. Body weight gain during WH was self-reported in 39.9% of respondents. Mediterranean diet adherence increased (p≪0.001) during WH compared with before WH. The average level of mental health did not record an overall variation; however, the proportion of subjects with mild and moderate depression increased (p = 0.006), while workers who reported values indicative of depression before the transition declared an improvement. These findings highlight health-related impact of WH during the COVID-19 pandemic that may inform future strategies and policies to improve employees' health and well-being.

Lifestyle Medicine: An Antidote to Cardiovascular Diseases.

Despite numerous advances in basic understanding of cardiovascular disease pathophysiology, pharmacology, therapeutic procedures, and systems improvement, there hasn't been much decline in heart disease related mortality in the US since 2010. Hypertension and diet induced risk continue to be the leading causes of cardiovascular morbidity. Even with the excessive mortality associated with the COVID-19 pandemic, in 2020, heart disease remained the leading cause of death. Given the degree of disease burden, morbidity, and mortality, there is an urgent need to redirect medical professionals' focus towards prevention through simple and cost effective lifestyle strategies. However, current practice paradigm and financial compensation systems are mainly centered disease management and not health promotion. For example, the financial value placed on 3-10 min smoking cessation counseling (.24RVUs) is 47-fold lower than an elective PCI (11.21 RVUs). The medical community seems to be enamored with the latest and greatest technology, new devices, and surgical procedures. What if the greatest technology of all was simply the way we live every day? Perhaps when this notion is known by enough, we will switch to this lifestyle medicine technology to prevent disease in the first place.

EIDD-1931 Treatment Tweaks CYP3A4 and CYP2C8 in Arthritic Rats to Expedite Drug Interaction: Implication in Oral Therapy of Molnupiravir.

EIDD-1931 is the active form of molnupiravir, an orally effective drug approved by the United States Food and Drug Administration (USFDA) against COVID-19. Pharmacokinetic alteration can cause untoward drug interaction (drug-drug/disease-drug), but hardly any information is known about this recently approved drug. Therefore, we first investigated the impact of the arthritis state on the oral pharmacokinetics of EIDD-1931 using a widely accepted complete Freund's adjuvant (CFA)-induced rat model of rheumatoid arthritis (RA) after ascertaining the disease occurrence by paw swelling measurement and X-ray examination. Comparative oral pharmacokinetic assessment of EIDD-1931 (normal state vs arthritis state) showed that overall plasma exposure was augmented (1.7-fold) with reduced clearance (0.54-fold), suggesting its likelihood of dose adjustment in arthritis conditions. In order to elucidate the effect of EIDD-1931 treatment at a therapeutic regime (normal state vs arthritis state) on USFDA-recommended panel of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) for drug interaction using the same disease model, we monitored protein and mRNA expressions (rat homologs) in liver tissue by western blotting (WB) and real time-polymerase chain reaction (RT-PCR), respectively. Results reveal that EIDD-1931 treatment could strongly influence CYP3A4 and CYP2C8 among experimental proteins/mRNAs. Although CYP2C8 regulation upon EIDD-1931 treatment resembles similar behavior under the arthritis state, results dictate a potentially reverse phenomenon for CYP3A4. Moreover, the lack of any CYP inhibitory effect by EIDD-1931 in human/rat liver microsomes (HLM/RLM) helps to ascertain EIDD-1931 treatment-mediated disease-drug interaction and the possibility of drug-drug interaction with disease-modifying antirheumatic drugs (DMARDs) upon coadministration. As elevated proinflammatory cytokine levels are prevalent in RA and nuclear factor-kappa B (NF-kB) and nuclear receptors control CYP expressions, further studies should focus on understanding the regulation of affected CYPs to subside unexpected drug interaction.

Solutions From Mexican-Descent Perinatal Women To Pandemic-Related Food, Mental Health, And Health And Safety Stressors.

Latina women in the US were disproportionately affected by the COVID-19 pandemic because of structural racism, including discrimination, reduced care access, and elevated risk for illness and death. Although several US policies were implemented to offset the economic toll of the pandemic, few addressed complex stressors, particularly those among Mexican-descent mothers. This qualitative study with thirty-eight perinatal women and mothers of young children who were of Mexican descent sought to identify pandemic-related stressors and solicit recommendations for addressing them during future large-scale crises. Identified stressors included food access issues, mental health needs, and health and safety concerns. The women's recommendations revealed feasible and actionable strategies, including increased access to behavioral and health care services and accessible information about food-related resources. The findings highlight the critical need for responsive policies and programs to ensure the well-being of Mexican-descent perinatal women and mothers of young children during large-scale crises.

Dysphagia in COVID-19 Patients on Extracorporeal Membrane Oxygenation.

Patients on extracorporeal membrane oxygenation (ECMO) are infrequently nourished via oral feeding due to aspiration risks. Patients with COVID-19 and on ECMO represent a subpopulation that has additional factors that may affect their swallow function. This study aimed to describe the swallow function and ability to maintain oral feeding in patients with COVID-19 while on ECMO. A retrospective study of patients with COVID-19 who started veno-venous ECMO at the beginning of the COVID-19 pandemic (March 2020 and August 2020) was conducted at a tertiary care hospital. Clinical swallow evaluations and videofluoroscopic swallow studies (VFSS) were analyzed using standardized measurement scales. Pearson's correlation coefficient (r) identified relationships between ECMO and swallowing function at different time points. 19 patients were included; all underwent clinical swallow evaluation and 4 underwent VFSS while on ECMO. Mean age was 43.2 years (standard deviation: 9.2), mean duration of ECMO was 65.7 days (58.7), and mean duration of intubation was 14.4 days (8.6). All patients were able to undergo swallow function evaluation, regain swallow function, and resume oral feeding while cannulated. Duration of ECMO and time to feeding tube removal was positively correlated (r = 0.747, p < 0.001) with patients demonstrating less functional swallowing independence and requiring a more modified diet upon oral diet initiation. Clinical swallow evaluation and videofluoroscopic swallowing evaluation are possible for COVID-19 patients actively on ECMO. Patient swallow function can improve, and oral diet can be achieved while on ECMO, demonstrating benefit of SLP surveillance and swallowing assessment prior to ECMO decannulation.

Sex Differences in Clustering Unhealthy Lifestyles Among Survivors of COVID-19: Latent Class Analysis.

BACKGROUND: The COVID-19 pandemic has underscored the significance of adopting healthy lifestyles to mitigate the risk of severe outcomes and long-term consequences. OBJECTIVE: This study focuses on assessing the prevalence and clustering of 5 unhealthy lifestyle behaviors among Vietnamese adults after recovering from COVID-19, with a specific emphasis on sex differences. METHODS: The cross-sectional data of 5890 survivors of COVID-19 in Vietnam were analyzed from December 2021 to October 2022. To examine the sex differences in 5 unhealthy lifestyle behaviors (smoking, drinking, unhealthy diet, physical inactivity, and sedentary behavior), the percentages were plotted along with their corresponding 95% CI for each behavior. Latent class analysis was used to identify 2 distinct classes of individuals based on the clustering of these behaviors: the "less unhealthy" group and the "more unhealthy" group. We examined the sociodemographic characteristics associated with each identified class and used logistic regression to investigate the factors related to the "more unhealthy" group. RESULTS: The majority of individuals (male participants: 2432/2447, 99.4% and female participants: 3411/3443, 99.1%) exhibited at least 1 unhealthy behavior, with male participants being more susceptible to multiple unhealthy behaviors. The male-to-female ratio for having a single behavior was 1.003, but it escalated to 25 for individuals displaying all 5 behaviors. Male participants demonstrated a higher prevalence of combining alcohol intake with sedentary behavior (949/2447, 38.8%) or an unhealthy diet (861/2447, 35.2%), whereas female participants tended to exhibit physical inactivity combined with sedentary behavior (1305/3443, 37.9%) or an unhealthy diet (1260/3443, 36.6%). Married male participants had increased odds of falling into the "more unhealthy" group compared to their single counterparts (odds ratio [OR] 1.45, 95% CI 1.14-1.85), while female participants exhibited lower odds (OR 0.65, 95% CI 0.51-0.83). Female participants who are underweight showed a higher likelihood of belonging to the "more unhealthy" group (OR 1.11, 95% CI 0.89-1.39), but this was not observed among male participants (OR 0.6, 95% CI 0.41-0.89). In both sexes, older age, dependent employment, high education, and obesity were associated with higher odds of being in the "more unhealthy" group. CONCLUSIONS: The study identified notable sex differences in unhealthy lifestyle behaviors among survivors of COVID-19. Male survivors are more likely to engage in unhealthy behaviors compared to female survivors. These findings emphasize the importance of tailored public health interventions targeting sex-specific unhealthy behaviors. Specifically, addressing unhealthy habits is crucial for promoting post-COVID-19 health and well-being.

Incident allergic diseases in post-COVID-19 condition: multinational cohort studies from South Korea, Japan and the UK.

As mounting evidence suggests a higher incidence of adverse consequences, such as disruption of the immune system, among patients with a history of COVID-19, we aimed to investigate post-COVID-19 conditions on a comprehensive set of allergic diseases including asthma, allergic rhinitis, atopic dermatitis, and food allergy. We used nationwide claims-based cohorts in South Korea (K-CoV-N; n = 836,164; main cohort) and Japan (JMDC; n = 2,541,021; replication cohort A) and the UK Biobank cohort (UKB; n = 325,843; replication cohort B) after 1:5 propensity score matching. Among the 836,164 individuals in the main cohort (mean age, 50.25 years [SD, 13.86]; 372,914 [44.6%] women), 147,824 were infected with SARS-CoV-2 during the follow-up period (2020-2021). The risk of developing allergic diseases, beyond the first 30 days of diagnosis of COVID-19, significantly increased (HR, 1.20; 95% CI, 1.13-1.27), notably in asthma (HR, 2.25; 95% CI, 1.80-2.83) and allergic rhinitis (HR, 1.23; 95% CI, 1.15-1.32). This risk gradually decreased over time, but it persisted throughout the follow-up period (≥6 months). In addition, the risk increased with increasing severity of COVID-19. Notably, COVID-19 vaccination of at least two doses had a protective effect against subsequent allergic diseases (HR, 0.81; 95% CI, 0.68-0.96). Similar findings were reported in the replication cohorts A and B. Although the potential for misclassification of pre-existing allergic conditions as incident diseases remains a limitation, ethnic diversity for evidence of incident allergic diseases in post-COVID-19 condition has been validated by utilizing multinational and independent population-based cohorts.

Navigating sarcopenia in COVID-19 patients and survivors: Understanding the long-term consequences, transitioning from hospital to community with mechanisms and interventions for future preparedness.

The coronavirus disease 2019 (COVID-19) pandemic has caused widespread devastation, with millions of confirmed cases and deaths worldwide. Although there were efforts made to develop treatments and vaccines for COVID-19, the coexistence of sarcopenia, a muscle disorder, has been largely overlooked. It is while new variants of this disease (eg, BA.2.86) are challenging the current protocols. Sarcopenia is associated with increased mortality and disability, and shares common mechanisms with COVID-19, such as inflammation, hormonal changes, and malnutrition. This can worsen the effects of both conditions. Furthermore, survived patients with COVID-19 who have elevated risk, as well as aging, which increases the process of sarcopenia. Therefore, addressing sarcopenia in patients with COVID-19 and surviving individuals can be crucial for improving outcomes and preventing long-term disability. During hospital stays, assessing sarcopenia through indicators like muscle wasting and malnutrition is important. Nutritional interventions, such as malnutrition screening and enteral feeding, play a critical role in preventing sarcopenia in hospitals. Mental health and physical activity evaluations and interventions are also necessary. Even after recovering from COVID-19, there is a risk of developing sarcopenia, requiring continued monitoring. Nutrition and physical activity considerations are vital for prevention and management, necessitating tailored training programs and diet therapy. Mental health should not be overlooked, with regular screening, and community-based interventions. Infrastructure should support physical activity, and mental health services must become more accessible. Community engagement through support groups and peer networks can foster resilience and social connection. Efforts are needed to promote healthy diets and ensure access to nutritious foods.

The Effects of an Eight-Week Swimming Program on Body Composition and Assessment of Dietary Intake in Post-COVID-19 Patients.

COVID-19 infection and its consequences (long-term COVID-19 syndrome) have implications for weight loss, body composition, and diet quality. In the context of the "PostCovSwim" project, which is part of a broader international study, the impact of an eight-week swimming program on post-COVID-19 patients' nutritional status (i.e., body composition and dietary intake) was evaluated. Body composition and dietary intake were assessed by medically approved and calibrated bioelectrical impedance (Tanita 780 S MA) and food frequency questionnaires. At the baseline, most participants were classified as overweight based on their body mass index (BMI). However, their body fat percentage (BF%) classification indicated normal weight, although females were near obesity thresholds. Furthermore, at the baseline, according to the BMI classification, 62% of females and 61% of males were female, whereas according to the BF% for obesity classification, 44% of females and 43% of males were considered overweight or obese. Surprisingly, despite the eight-week program, there were no significant changes in body composition. Additionally, the assessment of dietary intake, which remained consistent throughout the study, revealed dietary imbalances characterized by an unhealthy low-carbohydrate, high-fat dietary pattern. This dietary pattern entailed excessive consumption of ultraprocessed foods; reduced carbohydrate intake (39% E vs. 37% E); increased total fat intake (46% E vs. 47% E); increased saturated fatty acids (14% E vs. 13% E); increased cholesterol (412 mg/d vs. 425 mg/d); increased free sugars (7% E vs. 7% E); and inadequate intake of fibre (24 g/d vs. 20 g/d), polyunsaturated fatty acids (6.6% E vs. 7.7% E), vitamin B12 (in females: 3.1 µg/d), vitamin C (86 mg/d vs. 66 mg/d), vitamin D (2 µg/d vs. 3.2 µg/d), folate (in males: 258 µg/d), calcium (777 mg/d vs. 743 mg/d), and selenium (in males: 66 µg/d). After an eight-week swimming program following COVID-19, no significant changes were observed in the subjects' body composition. Their dietary intake was found to not align with the dietary recommendations. These findings underscore the urgency of implementing comprehensive dietary and lifestyle interventions for post-COVID-19 patients to optimize their recovery and overall well-being. Physical activity, like a swimming program, may positively affect various aspects of human well-being.

Changing sustainable diet behaviours during the COVID-19 Pandemic: inequitable outcomes across a sociodemographically diverse sample of adults.

The objective of this study was to describe changes in sustainable dietary behaviours (those that support environmental, economic, and physical health) among a sample of US adults during the COVID-19 pandemic and to examine differences in changes by individuals' race/ethnicity and socioeconomic status. Therefore, a cross-sectional online survey study was conducted in April 2021 (N = 1,488, mean age = 42.7 (SD = 12.6)) receiving outpatient care from Michigan Medicine, the University of Michigan health system. Enrolment quotas were established to ensure a diverse sample-one-third of participants identified as African American/Black, one-third Hispanic/Latino, one-third White, and one-third low-income. Participants reported engaging in more behaviours that are supportive of a sustainable diet one year into the COVID-19 pandemic compared to before. This is particularly true regarding ecologically and economically sustaining behaviours such as taking fewer trips to the grocery store, increased use of home grocery delivery, increased cooking at home, and greater consumption of healthy foods. Not all behaviour changes promoted sustainable food systems; namely, the use of farmer's markets and Community Supported Agriculture (CSAs) declined. White and high-income participants were more likely than African American/Black, Hispanic/Latino, and low-income individuals to engage in ecologically and economically sustainable dietary behaviours during the pandemic. Meanwhile, African American/Black participants reported large increases in physical health sustainable dietary behaviours. To support the continuation of greater engagement with sustainable diets, policies that increase access to public transportation, limit the frequency with which consumers have groceries delivered, increase work-from-home options, and improve access for low-income populations should be prioritised.

COVID-19 and climate change concerns: Matters arising.

Until the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, developing countries, especially countries in the African continent, battled with the impact of climate change on the food value-chain systems and general livelihood. In this study, we discuss climate change concerns post-COVID-19 and argue that the outbreak of the COVID-19 pandemic has exacerbated the vulnerabilities of most developing and emerging economies. This has heightened political tensions and unrest among such developing nations. We suggest enhancement and intensification of efficient and effective locally engineered adaptation strategies in the post-COVID-19 era for countries that have been susceptible to the impact of climate change and other recent shocks.

Coordination chemistry suggests that independently observed benefits of metformin and Zn2+ against COVID-19 are not independent.

Independent trials indicate that either oral Zn2+ or metformin can separately improve COVID-19 outcomes by approximately 40%. Coordination chemistry predicts a mechanistic relationship and therapeutic synergy. Zn2+ deficit is a known risk factor for both COVID-19 and non-infectious inflammation. Most dietary Zn2+ is not absorbed. Metformin is a naked ligand that presumably increases intestinal Zn2+ bioavailability and active absorption by cation transporters known to transport metformin. Intracellular Zn2+ provides a natural buffer of many protease reactions; the variable "set point" is determined by Zn2+ regulation or availability. A Zn2+-interactive protease network is suggested here. The two viral cysteine proteases are therapeutic targets against COVID-19. Viral and many host proteases are submaximally inhibited by exchangeable cell Zn2+. Inhibition of cysteine proteases can improve COVID-19 outcomes and non-infectious inflammation. Metformin reportedly enhances the natural moderating effect of Zn2+ on bioassayed proteome degradation. Firstly, the dissociable metformin-Zn2+ complex could be actively transported by intestinal cation transporters; thereby creating artificial pathways of absorption and increased body Zn2+ content. Secondly, metformin Zn2+ coordination can create a non-natural protease inhibitor independent of cell Zn2+ content. Moderation of peptidolytic reactions by either or both mechanisms could slow (a) viral multiplication (b) viral invasion and (c) the pathogenic host inflammatory response. These combined actions could allow development of acquired immunity to clear the infection before life-threatening inflammation. Nirmatrelvir (Paxlovid®) opposes COVID-19 by selective inhibition the viral main protease by a Zn2+-independent mechanism. Pending safety evaluation, predictable synergistic benefits of metformin and Zn2+, and perhaps metformin/Zn2+/Paxlovid® co-administration should be investigated.

Three years into the pandemic: Insights of the COVID-19 impacts on food security and nutrition in low and middle-income countries.

The COVID-19 pandemic triggered a global crisis with unanticipated and diverse consequences. Moreover, the pandemic has considerably impacted food dynamics in low- and middle-income countries (LMICs), where food systems have already been challenged. These countries also have the highest share of the world's malnourished and food insecure. Therefore, this paper aims to analyze the pandemic's impact on food security dimensions (availability, accessibility, utilization, and stability), with a special emphasis on LMICs. According to the results, the pandemic immediately impacted food security by limiting food production and availability. It also had an indirect impact when lockdowns and other confinement measures (e.g., social distancing, movement restrictions) made it more difficult for individuals to access food and maintain a healthy, balanced diet (cf. food utilization). Indeed, with rising unemployment and poverty, access to food has been the most critically undermined aspect of food security. At the utilization level, COVID-19 adversely influences the nutritional state of both individuals and countries, leading to an increase in all forms of malnutrition. Finally, the impact of COVID-19 on the stability dimension is dependent on the length of the pandemic as well as the effectiveness with which recovery plans are followed to ensure universal vaccine availability, among other factors. As a result, including agricultural and food systems in recovery strategies is crucial to mitigating the pandemic's long-term effects on food security.

Effect of Elexacaftor/Tezacaftor/Ivacaftor on Pseudomonas aeruginosa Acquisition and Chronic Infection at a Single Pediatric Cystic Fibrosis Care Center.

OBJECTIVES: As cystic fibrosis (CF) lung disease progresses, the airways become infected with opportunistic pathogens, such as Pseudomonas aeruginosa (PA). In October 2019, the US Food and Drug Administration approved elexacaftor/tezacaftor/ivacaftor (ETI), a highly effective modulator therapy (HEMT), for individuals 12 years and older with 1 copy of the F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation. ETI increases the amount of and function of CFTR in the respiratory epithelium, improving mucociliary clearance and reducing static airway mucus, a major trigger for chronic infection and inflammation. METHODS: A retrospective analysis of inhaled tobramycin (iTOB) prescriptions between January 1, 2016, and December 31, 2021, was performed. This captured data before and after ETI approval at Children's Mercy Kansas City (CMKC). The number of individuals with new PA acquisition and individuals considered -chronically infected was analyzed. RESULTS: The number of eradication prescriptions declined in 2020 and 2021, with 15 (7%) and 12 (5%) -individuals prescribed therapy for those years, respectively. A similar pattern was observed for -prescriptions for chronic infection. A reduction was seen in 2020 and 2021, with 28 (13%) and 20 (9%) individuals -prescribed therapy for the respective years. CONCLUSIONS: The CMKC experienced a decrease in the number of courses of iTOB prescribed during the last 6 years. The reasons for this are likely multifactorial and may include the implementation of standardized PA surveillance and eradication protocols, the effect of HEMT on mucociliary clearance and airway microbiology, and the poorly understood effects of the SARS-CoV-2 pandemic on the epidemiology of respiratory infections.

COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials.

BACKGROUND: Although the SARS-CoV-2 vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions. METHODS: A post-hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, COVID-19 vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a "tempered immune system" (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS (NTIS) individuals starting at 14 days after completion of the primary series through the blinded phase for each of the four trials. An analysis of participants living with well-controlled HIV was conducted using the same methods. RESULTS: 3,852/30,351 (12.7%) Moderna participants, 3,088/29,868 (10.3%) Novavax participants, 3,549/32,380 (11.0%) AstraZeneca participants, and 5,047/43,788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (versus placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants vs NTIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with HIV. CONCLUSIONS: For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared to those with non-tempered immune systems in the four COVID-19 vaccine randomized controlled efficacy trials.

Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process. The objective of this research is to examine and document the shared encounters involving remote inspections and evaluations carried out by SFDA from 2020 to 2022. This will be achieved through the evaluation of the accuracy of document evaluation and the extent to which the objectives of smart GxP inspections were met. Data were collected from local and international smart inspections reports conducted by SFDA between 2020 and 2022, covering medical device manufacturers, pharmaceutical manufacturing sites, warehouses, accreditation offices, scientific offices, and food manufacturing facilities. The results indicate that smart GxP inspections were effective in achieving visit objectives, showing a high degree of document evaluation accuracy. The findings of this study support the use of smart GxP inspections as a valuable alternative to on-site inspections, offering a practical solution to regulatory compliance during the pandemic and beyond. Although the SFDA recognizes the usefulness of smart inspections in upholding regulatory oversight in the face of various challenges, it does not endorse the complete replacement of conventional on-site inspection methods. The SFDA acknowledges significant limitations associated with the current technological resources used in remote regulatory assessments, and these limitations will be explored in the relevant sections.

The Psychosocial, Organizational, and Environmental Stressors Experienced by Food Service Workers in a Hospital Setting during the COVID-19 Pandemic.

OBJECTIVE: To identify stressors faced by hospital food service workers amid the COVID-19 pandemic and effective interventions mitigating these stressors. METHODS: In this cross-sectional study, we conducted surveys (n = 305) and interviews (n = 9) in the summer and fall of 2022 with employees in hospital settings to determine the psychosocial, organizational, and environmental stressors they faced during the COVID-19 pandemic and interventions that improved health and well-being. FINDINGS: The main stressors reported were fear of infection, increased work demands and schedule unpredictability, and financial insecurity. Employee well-being was bolstered by regular, clear, bidirectional communication; a sense of community and purpose; benefits like paid sick leave and health insurance coverage; and organizational policies that included masking and vaccine requirements demonstrating commitment to protecting worker health. CONCLUSION: Organizations can play a critical role in guarding the health, well-being, and resilience of frontline workers.

Mental Health Concerns During COVID-19: An Observational Study Among a Predominantly Black Community in New York City.

PURPOSE: This study examined the prevalence of mental health concerns and its association with COVID-19, selected social determinants of health, and psychosocial risk factors in a predominantly racial/ethnic minoritized neighborhood in New York City. METHODS: Adult Harlem residents (N = 393) completed an online cross-sectional survey from April to September 2021. The Patient Health Questionnaire (PHQ-4) and the Post-Traumatic Stress Disorder (PC-PTSD) were used to evaluate mental health concerns. Poisson regression with robust variance quantified the associations of interests via prevalence ratios (PR) and 95% confidence intervals (CI). RESULTS: Two-thirds (66.4%) of the residents reported experiencing mental health concerns, including PTSD (25.7%), depression (41.2%), and anxiety (48.1%). Residents with low-income housing status (PR = 1.16; 95% CI 1.01, 1.34), alcohol misuse (PR = 1.68; 95% CI 1.40, 2.01), food insecurity (PR = 1.23; 95% CI 1.07, 1.42), exposure to interpersonal violence (PR = 1.33; 95% CI 1.08, 2.65), and experience of discrimination (PR = 1.53, 95% CI 1.23-1.92) were more likely to report mental health concerns. Better community perception of the police (PR = 0.97, 95% CI 0.95, 0.99) was associated with fewer mental health concerns. No associations were observed for employment insecurity, housing insecurity, or household COVID-19 positivity with mental health concerns. CONCLUSIONS: This study showed a high prevalence of mental health concerns in a low-income racial/ethnic minoritized community, where COVID-19 and social risk factors compounded these concerns. Harlem residents face mental health risks including increased financial precarity, interpersonal violence, and discrimination exposure. Interventions are needed to address these concurrent mental health and psychosocial risk factors, particularly in racial/ethnic minoritized residents.

A large multicenter Ralstonia pickettii outbreak in critically ill patients during the COVID-19 pandemic: Epidemiological and clinical characteristics of 66 cases.

Objective: To describe a multicenter outbreak of R. pickettii that occurred in a large number of critically ill patients in a city in Colombia, during the COVID-19 pandemic. Methods: In April 2021, the National Institute for Food and Drug Surveillance (INVIMA) reported an outbreak of R. pickettii infection associated with contaminated intravenous medications. The Municipal Health Department began collecting data for all cases identified by the hospitals and the results of microbiological studies. Medical records and death certificates of included cases were reviewed. Results: Between March and May 2021, 66 cases of R. pickettii bloodstream infections from nine hospitals were documented. The median age of the patients was 60 years (IQR 51-72), and most of them had comorbidities (78.8%), mainly arterial hypertension and diabetes mellitus. At the time of the R. pickettii bloodstream infection, 89.4% had COVID-19, 86.4% were on mechanical ventilation, and 98.5% were receiving corticosteroids. The overall mortality was 81.8%. Nearly 60% of the deaths were related to R. pickettii bloodstream infections. R. pickettii was identified in the cultures from intravenous medications. Conclusions: This large multicenter outbreak caused by intravenous medications contaminated with R. pickettii mainly affected critically ill COVID-19 patients. Mortality was high and largely related to R. pickettii bloodstream infection.

Olfactory function in diabetes mellitus.

Diabetes mellitus (DM) is an increasingly common disease in both children and adults. In addition to neuronal and/or vascular disorders, it can cause chemosensory abnormalities including olfactory deterioration. The purpose of this article is to summarize current knowledge on olfactory function in DM, highlighting the impact of co-morbidities, especially obesity, thyroid dysfunction, chronic kidney disease and COVID-19 on olfactory outcomes. Research to date mostly shows that olfactory impairment is more common in people with diabetes than in the general population. In addition, the presence of concomitant diseases is a factor increasing olfactory impairment. Such a correlation was shown for type 1 diabetes, type 2 diabetes and gestational diabetes. At the same time, not only chronic diseases, but also DM in acute conditions such as COVID-19 leads to a higher prevalence of olfactory disorders during infection. Analyzing the existing literature, it is important to be aware of the limitations of published studies. These include the small number of patients studied, the lack of uniformity in the methods used to assess the sense of smell, frequently relying on rated olfactory function only, and the simultaneous analysis of patients with different types of diabetes, often without a clear indication of diabetes type. In addition, the number of available publications is small. Certainly, further research in this area is needed. From a practical point of view decreased olfactory performance may be an indicator for central neuropathy and an indication for assessing the patient's nutritional status, examining cognitive function, especially in older patients and performing additional diagnostic tests, such as checking thyroid function, because all those changes were correlated with smell deterioration.