Construction and use of a risk stratification instrument for vaccination of elderly against Covid-19 / Construção e utilização de instrumento de estratificação de risco para vacinação de idosos contra a Covid-19 / Construcción y uso de un instrumento de estratificación de riesgo para la vacunación del anciano contra el Covid- 19

Objetivo: Relatar a experiência da construção e utilização de um instrumento de estratificação de risco para vacinação de idosos contra a COVID-19. Métodos: Relato da experiência desenvolvida no município de Massapê ­ Ceará, durante o ano de 2021, a partir do início da campanha de vacinação de idosos contra a COVID-19. Descrição da Experiência: Por conta da escassez de imunobiológicos, na fase inicial da vacinação contra a COVID-19, a Secretaria da Saúde do município de Massapê, estado do Ceará, criou um instrumento para estratificação de riscos sanitários, epidemiológicos e sociais dos idosos, contendo seus dados sociodemográficos e as comorbidades. Após o estabelecimento das variáveis, foram estabelecidos escores para os estratos de risco, que foram classificados em baixo (um a três pontos), médio (quatro a seis pontos), alto (sete a nove pontos) e muito alto (dez pontos e mais). Considerações Finais: O estudo mostra que, apesar da pandemia de COVID-19, uma crise sanitária global sem precedentes como já dito, ações pontuais, mesmo que localizadas, podem ter efeito em cadeia e ser replicadas em outros cenários e momentos.

Objective: To report the experience of building and using a risk stratification instrument for vaccinating the elderly against COVID-19. Methods: Report of the experience developed in the municipality of Massapê - Ceará, during the year 2021, from the beginning of the vaccination campaign for the elderly against COVID-19. Experience Description: Due to the scarcity of immunobiologicals, in the initial phase of vaccination against COVID-19, the Department of Health of the municipality of Massapê, state of Ceará, created an instrument to stratify the health, epidemiological and social risks of the elderly, containing sociodemographic data and comorbidities of the elderly. After establishing the variables, scores were established for the risk strata, which were classified as low (one to three points), medium (four to six points), high (seven to nine points) and very high (ten points and more). Final Considerations: The study shows that, despite the COVID-19 pandemic, an unprecedented global health crisis as already mentioned, specific actions, even if localized, can have a chain effect and be replicated in other scenarios and times.

Objetivo: Relatar la experiencia de construcción y uso de un instrumento de estratificación de riesgo para la vacunación de ancianos contra la COVID-19. Métodos: Informe de la experiencia desarrollada en el municipio de Massapê - Ceará, durante el año 2021, desde el inicio de la campaña de vacunación de ancianos contra la COVID-19. Descripción de la Experiencia: Debido a la escasez de inmunobiológicos, en la fase inicial de la vacunación contra la COVID-19, la Secretaría de Salud del municipio de Massapê, estado de Ceará, creó un instrumento para estratificar los riesgos sanitarios, epidemiológicos y sociales de los ancianos, que contiene datos sociodemográficos y comorbilidades de los ancianos. Luego de establecer las variables, se establecieron puntajes para los estratos de riesgo, los cuales se clasificaron en bajo (uno a tres puntos), medio (cuatro a seis puntos), alto (siete a nueve puntos) y muy alto (diez puntos y más). Consideraciones finales: El estudio muestra que, a pesar de la pandemia de COVID-19, una crisis sanitaria mundial sin precedentes como ya se mencionó, las acciones específicas, aunque sean localizadas, pueden tener un efecto en cadena y replicarse en otros escenarios y tiempos.

Implications of COVID-19 for the busy gastroenterologist.

Coronavirus disease 2019 (COVID-19) is an infection caused by a novel coronavirus (SARS-CoV-2) originated in China in December 2020 and declared pandemic by WHO. This coronavirus mainly spreads through the respiratory tract and enters cells through angiotensin-converting enzyme 2 (ACE2). The clinical symptoms of COVID-19 patients include fever, cough, and fatigue. Gastrointestinal symptoms (diarrhea, anorexia, and vomiting) may be present in 50% of patients and may be associated with worst prognosis. Other risk factors are older age, male gender, and underlying chronic diseases. Mitigation measures are essential to reduce the number of people infected. Hospitals are a place of increased SARS-CoV-2 exposure. This has implications in the organization of healthcare services and specifically endoscopy departments. Patients and healthcare workers safety must be optimized in this new reality. Comprehension of COVID-19 gastrointestinal manifestations and implications of SARS-CoV-2 in the management of patients with gastrointestinal diseases, under or not immunosuppressant therapies, is essential. In this review, we summarized the latest research progress and major societies recommendations regarding the implications of COVID-19 in gastroenterology, namely the adaptations that gastroenterology/endoscopy departments and professionals must do in order to optimize the provided assistance, as well as the implications that this infection will have, in particularly vulnerable patients such as those with chronic liver disease and inflammatory bowel disease under or not immunosuppressant therapies.

COVID-19 and the liver: overview.

On 12 March 2020, the WHO declared that the coronavirus disease 2019 (COVID-19) constitutes a pandemic. Cases of liver damage or dysfunction (mainly characterized by moderately elevated serum aspartate aminotransferase levels) have been reported among patients with COVID-19. However, it is currently uncertain whether the COVID-19 related liver damage/dysfunction is due mainly to the viral infection by itself or other coexisting conditions, such as the use of potentially hepatotoxic medications and the coexistence of systemic inflammatory response, respiratory distress syndrome-induced hypoxia, and multiple organ dysfunction. Individuals at high risk for severe COVID-19 are typical of older age and/or present with comorbid conditions such as diabetes, cardiovascular disease, and hypertension. This is also the same profile for those at increased risk for unrecognized underlying liver disease, especially nonalcoholic fatty liver disease. This could make them more susceptible to liver injury from the virus, medications used in supportive management, or hypoxia. So the aim of this review was to illustrate the clinical implications of COVID-19 on the liver in healthy and diseased states as well as the implications of common liver disorders on the outcome of COVID-19.

Understanding preclinical and clinical immunogenicity risks in novel biotherapeutics development.

Immunogenicity continues to pose a challenge in the development of biotherapeutics like conventional therapeutic-proteins and monoclonal antibodies as well as emerging modalities such as gene-therapy components, gene editing, and CAR T cells. The approval of any therapeutic is based on a benefit-risk evaluation. Most biotherapeutics address serious medical conditions where the standard of care has a poor outcome. Consequently, even if immunogenicity limits the utility of the therapeutic in a sub-set of patients, the benefit-risk assessment skews in favor of approval. Some cases resulted in the discontinuation of biotherapeutics due to immunogenicity during drug development processes, This special issue presents a platform for review articles offering a critical assessment of accumulated knowledge as well as novel findings related to nonclinical risks that extend our understanding of the immunogenicity of biotherapeutics. Some of the studies in this collection leveraged assays and methodologies refined over decades to support more clinically relevant biological samples. Others have applied rapidly advancing methodologies in pathway-specific analyses to immunogenicity. Similarly, the reviews address urgent issues such as the rapidly emerging cell and gene therapies which hold immense promise but could have limited reach as a significant number of the patient population could potentially not benefit due to immunogenicity. In addition to summarizing the work presented in this special issue we have endeavored to identify areas where additional studies are required to understand the risks of immunogenicity and develop appropriate mitigation strategies.

Current topic of vascular function in hypertension.

Vascular function assessment is useful for the evaluation of atherosclerosis severity, which may provide additional information for cardiovascular risk stratification. In addition, vascular function assessment is helpful for a better understanding of pathophysiological associations between vascular dysfunction and cardiometabolic disorders. In 2020 and 2021, although coronavirus disease 2019 (COVID-19) was still a worldwide challenge for health care systems, many excellent articles regarding vascular function were published in Hypertension Research and other major cardiovascular and hypertension journals. In this review, we summarize new findings on vascular function and discuss the association between vascular function and COVID-19, the importance of lifestyle modifications for the maintenance of vascular function, and the usefulness of vascular function tests for cardiovascular risk assessment. We hope this review will be helpful for the management of cardiovascular risk factors, including hypertension and cardiovascular diseases, in clinical practice.

Coverage, completion and outcomes of COVID-19 risk assessments in a multi-ethnic nationwide cohort of UK healthcare workers: a cross-sectional analysis from the UK-REACH Study.

INTRODUCTION: There are limited data on the outcomes of COVID-19 risk assessment in healthcare workers (HCWs) or the association of ethnicity, other sociodemographic and occupational factors with risk assessment outcomes. METHODS: We used questionnaire data from UK-REACH (UK Research study into Ethnicity And COVID-19 outcomes in Healthcare workers), an ethnically diverse, nationwide cohort of UK HCWs. We derived four binary outcomes: (1) offered a risk assessment; (2) completed a risk assessment; (3) working practices changed as a result of the risk assessment; (4) wanted changes to working practices after risk assessment but working practices did not change.We examined the association of ethnicity, other sociodemographic/occupational factors and actual/perceived COVID-19 risk variables on our outcomes using multivariable logistic regression. RESULTS: 8649 HCWs were included in total. HCWs from ethnic minority groups were more likely to report being offered a risk assessment than white HCWs, and those from Asian and black ethnic groups were more likely to report having completed an assessment if offered. Ethnic minority HCWs had lower odds of reporting having their work change as a result of risk assessment. Those from Asian and black ethnic groups were more likely to report no changes to their working practices despite wanting them.Previous SARS-CoV-2 infection was associated with lower odds of being offered a risk assessment and having adjustments made to working practices. DISCUSSION: We found differences in risk assessment outcomes by ethnicity, other sociodemographic/occupational factors and actual/perceived COVID-19 risk factors. These findings are concerning and warrant further research using actual (rather than reported) risk assessment outcomes in an unselected cohort.

Development and validation of a biological risk assessment tool among hospital personnel under COVID-19 pandemic conditions.

The need for a biological disease risk assessment method to prevent the contagion of these diseases, particularly among healthcare personnel, is crucial. Therefore, this study aimed to develop and validate a biological risk assessment tool for biological agents among hospital personnel under COVID-19 conditions. This cross-sectional study was performed on 301 employees in two hospitals. Firstly, we identified the items affecting the contagion of biological agents. Then, we computed the weight of the items using the Fuzzy Analytical Hierarchy Process (FAHP) method. We used the identified items and the estimated weights in the next step to develop a predictive equation. The outcome of this tool was the risk score of biological disease contagion. After that, we used the developed method to evaluate the biological risk of the participants. The ROC curve was also used to reveal accuracy of developed method. In this study, 29 items were identified and categorized into five dimensions, including environmental items, ventilation items, job items, equipment-related items, and organizational items. The weights of these dimensions were estimated at 0.172, 0.196, 0.255, 0.233, and 0.144, respectively. The final weight of items was used to develop a predictive equation. The area under ROC curves (AUC) was also calculated as 0.762 (95% CI: 0.704, 0.820) (p<0.001). The tools developed using these items had acceptable diagnostic accuracy for predicting the risk of biological diseases in health care. Therefore, one can apply it in identifying persons exposed to dangerous conditions.

Risk-Based Monitoring in Clinical Trials: 2021 Update.

Clinical trial quality depends on ensuring participant safety and data integrity, which require careful management throughout the trial lifecycle, from protocol development to final data analysis and submission. Recent developments-including new regulatory requirements, emerging technologies, and trial decentralization-have increased adoption of risk-based monitoring (RBM) and its parent framework, risk-based quality management (RBQM) in clinical trials. The Association of Clinical Research Organizations (ACRO), recognizing the growing importance of these approaches, initiated an ongoing RBM/RBQM landscape survey project in 2019 to track adoption of the eight functional components of RBQM. Here we present results from the third annual survey, which included data from 4889 clinical trials ongoing in 2021. At least one RBQM component was implemented in 88% of trials in the 2021 survey, compared with 77% in 2020 and 53% in 2019. The most frequently implemented components in 2021 were initial and ongoing risk assessments (80 and 78% of trials, respectively). Only 7% of RBQM trials were Phase IV, while the proportions of Phase I-III trials ranged 27-36%. Small trials (< 300 participants) accounted for 60% of those implementing RBQM. The therapeutic areas with the largest number of RBQM trials were oncology (38%), neurology (10%), and infectious diseases (9%). The 2021 survey confirmed a pattern of increasing RBM/RBQM adoption seen in earlier surveys, with risk assessments, which have broad regulatory support, driving RBQM growth; however, one area requiring further development is implementation of centralized monitoring combined with reductions in source data verification (SDV) and source data review (SDR).

Efficient Direct and Limited Environmental Transmission of SARS-CoV-2 Lineage B.1.22 in Domestic Cats.

The susceptibility of domestic cats to infection with SARS-CoV-2 has been demonstrated by several experimental studies and field observations. We performed an extensive study to further characterize the transmission of SARS-CoV-2 between cats, through both direct and indirect contact. To that end, we estimated the transmission rate parameter and the decay parameter for infectivity in the environment. Using four groups of pair-transmission experiment, all donor (inoculated) cats became infected, shed virus, and seroconverted, while three out of four direct contact cats got infected, shed virus, and two of those seroconverted. One out of eight cats exposed to a SARS-CoV-2-contaminated environment became infected but did not seroconvert. Statistical analysis of the transmission data gives a reproduction number R0 of 2.18 (95% CI = 0.92 to 4.08), a transmission rate parameter ß of 0.23 day-1 (95% CI = 0.06 to 0.54), and a virus decay rate parameter µ of 2.73 day-1 (95% CI = 0.77 to 15.82). These data indicate that transmission between cats is efficient and can be sustained (R0 > 1), however, the infectiousness of a contaminated environment decays rapidly (mean duration of infectiousness 1/2.73 days). Despite this, infections of cats via exposure to a SARS-CoV-2-contaminated environment cannot be discounted if cats are exposed shortly after contamination. IMPORTANCE This article provides additional insight into the risk of infection that could arise from cats infected with SARS-CoV-2 by using epidemiological models to determine transmission parameters. Considering that transmission parameters are not always provided in the literature describing transmission experiments in animals, we demonstrate that mathematical analysis of experimental data is crucial to estimate the likelihood of transmission. This article is also relevant to animal health professionals and authorities involved in risk assessments for zoonotic spill-overs of SARS-CoV-2. Last but not least, the mathematical models to calculate transmission parameters are applicable to analyze the experimental transmission of other pathogens between animals.

Clinical and epidemiological characteristics of the first 150 patients with COVID-19 in Lebanon: a prospective descriptive study

Background: Clinical features of confirmed COVID-19 cases cover a wide spectrum. Aims: To study the clinical, radiological and virological features of the first 150 patients with COVID-19 in Lebanon. Methods: Our university hospital was designated as the primary COVID-19 care centre in Lebanon. Between 21 February 2020, the date of the first confirmed case of COVID-19 in Lebanon, and 3 April 2020, our team treated 150 patients diagnosed with COVID-19. In this prospective descriptive study, we present our experience in treating these patients, specifically the diagnostic criteria, outcome, and demographic, clinical, radiological and biological characteristics. Results: Ninety-five (63.33%) of the patients were male and 55 (36.67%) were female. Most patients (58%) were aged > 50 years, and 8 (5.33%) were healthcare workers. Diagnosis was based on reverse transcription polymerase chain reaction, and patients were classified as mild, moderate or critical. Fifteen (10%) patients had a critical presentation and fever was the most prominent symptom at presentation. One hundred and thirty-eight (92%) patients underwent radiological evaluation. The most common laboratory findings were lymphocytopenia (34.38%), followed by neutropenia (28.13%), but leukocytosis was not prevalent (1.56%). Old age and comorbidity were significant indicators in patient risk stratification. Chest computed tomography was an invaluable method of diagnosis and management. Our radiological findings were consistent with the published literature. Conclusion: Our study underlines the variable presentation of COVID-19, the difference in severity, and the diverse methods of diagnosis. This suggests the need for a tailored approach, taking into consideration the wide spectrum of presentation.

Study protocol for the use of time series forecasting and risk analyses to investigate the effect of the COVID-19 pandemic on hospital admissions associated with new-onset disability and frailty in a national, linked electronic health data setting.

INTRODUCTION: Older people were at particular risk of morbidity and mortality during COVID-19. Consequently, they experienced formal (externally imposed) and informal (self-imposed) periods of social isolation and quarantine. This is hypothesised to have led to physical deconditioning, new-onset disability and frailty. Disability and frailty are not routinely collated at population level but are associated with increased risk of falls and fractures, which result in hospital admissions. First, we will examine incidence of falls and fractures during COVID-19 (January 2020-March 2022), focusing on differences between incidence over time against expected rates based on historical data, to determine whether there is evidence of new-onset disability and frailty. Second, we will examine whether those with reported SARS-CoV-2 were at higher risk of falls and fractures. METHODS AND ANALYSIS: This study uses the Office for National Statistics (ONS) Public Health Data Asset, a linked population-level dataset combining administrative health records with sociodemographic data of the 2011 Census and National Immunisation Management System COVID-19 vaccination data for England. Administrative hospital records will be extracted based on specific fracture-centric International Classification of Diseases-10 codes in years preceding COVID-19 (2011-2020). Historical episode frequency will be used to predict expected admissions during pandemic years using time series modelling, if COVID-19 had not occurred. Those predicted admission figures will be compared with actual admissions to assess changes in hospital admissions due to public health measures comprising the pandemic response. Hospital admissions in prepandemic years will be stratified by age and geographical characteristics and averaged, then compared with pandemic year admissions to assess more granular changes. Risk modelling will assess risk of experiencing a fall, fracture or frail fall and fracture, if they have reported a positive case of COVID-19. The combination of these techniques will provide insight into changes in hospital admissions from the COVID-19 pandemic. ETHICS AND DISSEMINATION: This study has approval from the National Statistician's Data Ethics Advisory Committee (NSDEC(20)12). Results will be made available to other researchers via academic publication and shared via the ONS website.

Cardiovascular Risk Assessment after COVID-19 Infection before Resuming Sports Activities - Practical Flowchart and Meta-Analysis

Abstract Background: The risk of sports-related sudden cardiac arrest after COVID-19 infection can be a serious problem. There is an urgent need for evidence-based criteria to ensure patient safety before resuming exercise. Objective: To estimate the pooled prevalence of acute myocardial injury caused by COVID-19 and to provide an easy-to-use cardiovascular risk assessment toolkit prior to resuming sports activities after COVID-19 infection. Methods: We searched the Medline and Cochrane databases for articles on the prevalence of acute myocardial injury associated with COVID-19 infection. The pooled prevalence of acute myocardial injury was calculated for hospitalized patients treated in different settings (non-intensive care unit [ICU], ICU, overall hospitalization, and non-survivors). Statistical significance was accepted for p values <0.05. We propose a practical flowchart to assess the cardiovascular risk of individuals who recovered from COVID-19 before resuming sports activities. Results: A total of 20 studies (6,573 patients) were included. The overall pooled prevalence of acute myocardial injury in hospitalized patients was 21.7% (95% CI 17.3-26.5%). The non-ICU setting had the lowest prevalence (9.5%, 95% CI 1.5-23.4%), followed by the ICU setting (44.9%, 95% CI 27.7-62.8%), and the cohort of non-survivors (57.7% with 95% CI 38.5-75.7%). We provide an approach to assess cardiovascular risk based on the prevalence of acute myocardial injury in each setting. Conclusions: Acute myocardial injury is frequent and associated with more severe disease and hospital admissions. Cardiac involvement could be a potential trigger for exercise-induced clinical complications after COVID-19 infection. We created a toolkit to assist with clinical decision-making prior to resuming sports activities after COVID-19 infection.

Years of life lost due to the psychosocial consequences of COVID-19 mitigation strategies based on Swiss data.

BACKGROUND: The pandemic caused by coronavirus disease 2019 (COVID-19) has forced governments to implement strict social mitigation strategies to reduce the morbidity and mortality from acute infections. These strategies, however, carry a significant risk for mental health, which can lead to increased short-term and long-term mortality and is currently not included in modeling the impact of the pandemic. METHODS: We used years of life lost (YLL) as the main outcome measure, applied to Switzerland as an example. We focused on suicide, depression, alcohol use disorder, childhood trauma due to domestic violence, changes in marital status, and social isolation, as these are known to increase YLL in the context of imposed restriction in social contact and freedom of movement. We stipulated a minimum duration of mitigation of 3 months based on current public health plans. RESULTS: The study projects that the average person would suffer 0.205 YLL due to psychosocial consequence of COVID-19 mitigation measures. However, this loss would be entirely borne by 2.1% of the population, who will suffer an average of 9.79 YLL. CONCLUSIONS: The results presented here are likely to underestimate the true impact of the mitigation strategies on YLL. However, they highlight the need for public health models to expand their scope in order to provide better estimates of the risks and benefits of mitigation.

Coronavirus disease 2019 risk assessment of adults and geospatial mapping in selected communities of Southwest Nigeria.

Background: Coronavirus disease 2019 (COVID-19) remained a worldwide public health problem. Risk assessment and mapping can be deployed to assist in the control and management of disease outbreaks. Aim: The aim of this study was to conduct COVID-19 risk assessment and mapping in selected communities of Southwest Nigeria. Methods: This was a cross-sectional study of adults, 18 years and above, involving the use of multi-stage sampling. Data collection was done with a pre-tested, structured, interviewer-administered questionnaire. The Statistical Package for the Social Sciences version 23 and Environmental Systems Research Institute ArcGIS desktop version 10.5 were used for data analysis and spatial mapping, respectively. The threshold for statistical significance was set at P < 0.05. Results: The respondents' mean age was 40.6 ± 14.5 years. Self-reported vulnerability factors identified included hypertension, diabetes mellitus, working in hospital facility, cigarette smoking and age ≥60 years amongst others. About a quarter (20.2%) had a high risk of COVID-19 following risk quantification. The risk cuts across geographical locations and socio-economic status. Education was significantly associated with COVID-19 risk. The spatial interpolation map revealed that the farther a community was from the high-burden area, the lower the risk of COVID-19. Conclusion: There was a high prevalence of self-reported COVID-19 risk. Identified communities with COVID-19 high-risk burden in the risk mapping and those with stratified proximity to these areas need to be targeted by the government for a public health awareness campaign.

Race and Ethnicity-Adjusted Age Recommendation for Initiating Breast Cancer Screening.

Importance: Breast cancer (BC) is the second leading cause of cancer death in women, and there is a substantial disparity in BC mortality by race, especially for early-onset BC in Black women. Many guidelines recommend starting BC screening from age 50 years; however, the current one-size-fits-all policy to start screening all women from a certain age may not be fair, equitable, or optimal. Objective: To provide race and ethnicity-adapted starting ages of BC screening based on data on current racial and ethnic disparities in BC mortality. Design, Setting, and Participants: This nationwide population-based cross-sectional study was conducted using data on BC mortality in female patients in the US who died of BC in 2011 to 2020. Exposures: Proxy-reported race and ethnicity information was used. The risk-adapted starting age of BC screening by race and ethnicity was measured based on 10-year cumulative risk of BC-specific death. Age-specific 10-year cumulative risk was calculated based on age group-specific mortality data without modeling or adjustment. Main Outcomes and Measures: Disease-specific mortality due to invasive BC in female patients. Results: There were BC-specific deaths among 415 277 female patients (1880 American Indian or Alaska Native [0.5%], 12 086 Asian or Pacific Islander [2.9%], 62 695 Black [15.1%], 28 747 Hispanic [6.9%], and 309 869 White [74.6%]; 115 214 patients died before age 60 years [27.7%]) of any age in the US in 2011 to 2020. BC mortality per 100 000 person-years for ages 40 to 49 years was 27 deaths in Black females, 15 deaths in White females, and 11 deaths in American Indian or Alaska Native, Hispanic, and Asian or Pacific Islander females. When BC screening was recommended to start at age 50 years for all females with a 10-year cumulative risk of BC death of 0.329%, Black females reached this risk threshold level 8 years earlier, at age 42 years, whereas White females reached it at age 51 years, American Indian or Alaska Native and Hispanic females at age 57 years, and Asian or Pacific Islander females 11 years later, at age 61 years. Race and ethnicity-adapted starting ages for Black females were 6 years earlier for mass screening at age 40 years and 7 years earlier for mass screening at age 45 years. Conclusions and Relevance: This study provides evidence-based race-adapted starting ages for BC screening. These findings suggest that health policy makers may consider a risk-adapted approach to BC screening in which individuals who are at high risk are screened earlier to address mortality due to early-onset BC before the recommended age of mass screening.