Remdesivir Use in the Real-World Setting: An Overview of Available Evidence.

In the years of Coronavirus Disease 2019 (COVID-19), various treatment options have been utilized. COVID-19 continues to circulate in the global population, and the evolution of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus has posed significant challenges to the treatment and prevention of infection. Remdesivir (RDV), an anti-viral agent with in vitro efficacy against coronaviruses, is a potent and safe treatment as suggested by a plethora of in vitro and in vivo studies and clinical trials. Emerging real-world data have confirmed its effectiveness, and there are currently datasets evaluating its efficacy and safety against SARS-CoV-2 infections in various clinical scenarios, including some that are not in the SmPC recommendations according for COVID-19 pharmacotherapy. Remdesivir increases the chance of recovery, reduces progression to severe disease, lowers mortality rates, and exhibits beneficial post-hospitalization outcomes, especially when used early in the course of the disease. Strong evidence suggests the expansion of remdesivir use in special populations (e.g., pregnancy, immunosuppression, renal impairment, transplantation, elderly and co-medicated patients) where the benefits of treatment outweigh the risk of adverse effects. In this article, we attempt to overview the available real-world data of remdesivir pharmacotherapy. With the unpredictable course of COVID-19, we need to utilize all available knowledge to bridge the gap between clinical research and clinical practice and be sufficiently prepared for the future.

Handbook of Outpatient Medicine: Second Edition

The practice of outpatient medicine in the 21st century has become fast-paced and challenging. The busy practitioner learns to make accurate decisions regarding diagnoses and treatments, individualizing them based on the patients' particular characteristics and desires. Patients typically present with more than one issue, spanning from wanting information about a vaccine to having symptoms of an acute and serious infectious disease, while also needing care of their chronic conditions. In order to function in a timely manner, the provider needs a reliable resource to aid in making efficient decisions. This text is designed to fulfill this purpose. Now fully revised and expanded, Handbook of Outpatient Medicine, 2e provides a quick, portable, algorithm-based guide to diagnosis and management of common problems seen in adult patients. Written by experienced primary care practitioners, this text emphasizes efficient decision-making necessary in the fast-paced realm of the medical office. It covers general considerations such as the physical examination, care of special populations, and pain management and palliative care. It also focuses on common symptoms and disorders by system, including endocrine, respiratory, cardiac, orthopedic, neurologic, genitourinary, and gynecologic. For each disorder, symptoms, red flags, algorithms for differential diagnosis, related symptoms and findings, laboratory workup, treatment guidelines, and clinical pearls are discussed. One of the major updates in this edition is a chapter dedicated to COVID-19. This chapter focuses on COVID-19 diagnosis, care and sequelae, including what to do after discharge from the hospital. Since the global pandemic has affected medicine as a whole, many of the chapters also discuss COVID-19 as a differential diagnosis. Newer and higher quality photos have also been added in several chapters to help illustrate techniques more efficiently, including new imaging modalities for chest pain. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2018, 2022.

News Focus

This section offers medical-related news briefs for the year 2023 in the United Kingdom (UK) which includes funding allocated by the Department for Health and Social Care for women's health hubs in England, plan for the spring Covid-19 booster campaign, and areas with highest emergency admissions and death rates for lung conditions.

Journaling among home care workers during the COVID-19 pandemic: A promising method for qualitative data collection

Qualitative methods that capture individual lived experiences throughout rapidly changing circumstances are particularly important during public health emergencies. The COVID-19 pandemic has put home care workers at risk as they provide vital services in homes to individuals with chronic conditions or disabilities. Using a 6-week journaling process in which we enrolled participants at different points, we sought to examine experiences of home care workers (n = 47) in the United States in New York and Michigan during April–July 2020 of the COVID-19 pandemic. Our methods for data collection and analysis were guided by a general qualitative approach as we aimed to examine the weekly perspectives and lived experiences of home care workers. We asked individuals to respond to our journaling prompts weekly to capture their reflections in "real time." To better understand home care workers' perspectives on journaling and the broader external context in which they provided care, we triangulated our data with interviews with home care workers (n = 19) and home health agency representatives (n = 9). We explored the feasibility of a rolling journaling process during an unprecedented public health emergency, characterized by rapid changes and uncertainty in day-to-day life, and reflect on lessons learned to guide future research on journaling for data collection, particularly for marginalized workers during public health crises, when events are evolving rapidly.

Staying Connected During a Global Pandemic: Telephone Support for Vulnerable Populations

This qualitative organisational ethnography explores and analyses the ways in which a local government-provided volunteer telephone support program for vulnerable and older members of the community quickly adapted to continue working during the pandemic. Thematic analysis of data collected through researcher participation in 26 weekly zoom debrief sessions with local government staff and volunteers captures the experience of providing telephone support during a pandemic. Three key themes emerged as integral to the shaping and reshaping of the service: (1) the importance of care and relationships in service provision;(2) the need for flexibility to make service change;and (3) like a beating heart, the regular calls became part of the rhythm of life, providing certainty for staff, volunteers, and those they called. This program offers a model for best practice in low cost, low risk, place-based interventions that can increase social connection for vulnerable community members. IMPLICATIONS Organisational flexibility and a focus on care and relationships underpin best-practice human service delivery—this is emphasised in times of crisis. Volunteer engagement, commitment, and performance are enhanced by positive and caring relationships with paid staff. Befriending schemes can provide a vital means of social support that contributes to maintaining the health and wellbeing of the ageing population.

Barriers to and solutions for representative inclusion across the lifespan and in life course research: The need for structural competency highlighted by the COVID-19 pandemic.

Exclusion of special populations (older adults; pregnant women, children, and adolescents; individuals of lower socioeconomic status and/or who live in rural communities; people from racial and ethnic minority groups; individuals from sexual or gender minority groups; and individuals with disabilities) in research is a pervasive problem, despite efforts and policy changes by the National Institutes of Health and other organizations. These populations are adversely impacted by social determinants of health (SDOH) that reduce access and ability to participate in biomedical research. In March 2020, the Northwestern University Clinical and Translational Sciences Institute hosted the "Lifespan and Life Course Research: integrating strategies" "Un-Meeting" to discuss barriers and solutions to underrepresentation of special populations in biomedical research. The COVID-19 pandemic highlighted how exclusion of representative populations in research can increase health inequities. We applied findings of this meeting to perform a literature review of barriers and solutions to recruitment and retention of representative populations in research and to discuss how findings are important to research conducted during the ongoing COVID-19 pandemic. We highlight the role of SDOH, review barriers and solutions to underrepresentation, and discuss the importance of a structural competency framework to improve research participation and retention among special populations.

The Impact of COVID-19 on Anxiety Disorders in Youth: Coping with Stress, Worry, and Recovering from a Pandemic.

The primary objective of this article is to consider the impact of the coronavirus disease-19 pandemic on pediatric anxiety from both a clinical and system-of-care lens. This includes illustrating the impact of the pandemic on pediatric anxiety disorders and consideration of factors important for special populations, including children with disabilities and learning differences. We consider the clinical, educational, and public health implications for addressing mental health needs like anxiety disorders and how we might promote better outcomes, particularly for vulnerable children and youth.

Staying Connected During a Global Pandemic: Telephone Support for Vulnerable Populations

This qualitative organisational ethnography explores and analyses the ways in which a local government-provided volunteer telephone support program for vulnerable and older members of the community quickly adapted to continue working during the pandemic. Thematic analysis of data collected through researcher participation in 26 weekly zoom debrief sessions with local government staff and volunteers captures the experience of providing telephone support during a pandemic. Three key themes emerged as integral to the shaping and reshaping of the service: (1) the importance of care and relationships in service provision;(2) the need for flexibility to make service change;and (3) like a beating heart, the regular calls became part of the rhythm of life, providing certainty for staff, volunteers, and those they called. This program offers a model for best practice in low cost, low risk, place-based interventions that can increase social connection for vulnerable community members. IMPLICATIONS Organisational flexibility and a focus on care and relationships underpin best-practice human service delivery—this is emphasised in times of crisis. Volunteer engagement, commitment, and performance are enhanced by positive and caring relationships with paid staff. Befriending schemes can provide a vital means of social support that contributes to maintaining the health and wellbeing of the ageing population.

The prevalence of adverse reactions among individuals with three-dose COVID-19 vaccination.

BACKGROUND: Considering the adverse reactions to vaccination against coronavirus disease 2019 (COVID-19), some people, particularly the elderly and those with underlying medical conditions, are hesitant to be vaccinated. This study aimed to explore the prevalence of adverse reactions and provide direct evidence of vaccine safety, mainly for the elderly and people with underlying medical conditions, to receive COVID-19 vaccination. METHODS: From 1st March to 30th April 2022, we conducted an online survey of people who had completed three doses of COVID-19 vaccination by convenience sampling. Adverse reaction rates and 95% confidence intervals were calculated. In addition, conditional logistic regression was used to compare the differences in adverse reactions among the elderly and those with underlying medical conditions with the general population. RESULTS: A total of 3339 individuals were included in this study, of which 2335 (69.9%) were female, with an average age of 32.1 ± 11.4 years. The prevalence of adverse reactions after the first dose of inactivated vaccine was 24.6% (23.1-26.2%), 19.2% (17.8-20.7%) for the second dose, and 19.1% (17.7-20.6%) for the booster dose; among individuals using messenger RNA vaccines, the prevalence was 42.7% (32.3-53.6%) for the first dose, 47.2% (36.5-58.1%) for the second dose, and 46.1% (35.4-57.0%) for the booster dose. Compared with the general population, the prevalence of adverse events did not differ in individuals with underlying medical conditions and those aged 60 and above. CONCLUSIONS: For individuals with underlying medical conditions and those aged 60 and above, the prevalence of adverse reactions is similar to that of the general population, which provides a scientific basis regarding vaccination safety for these populations.

COVID-19 associated liver injury: A general review with special consideration of pregnancy and obstetric outcomes.

Liver injury is an increasingly recognized extra-pulmonary manifestation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Coronavirus disease 2019 (COVID-19) associated liver injury (COVALI) is a clinical syndrome encompassing all patients with biochemical liver injury identified in the setting of SARS-CoV-2 infection. Despite profound clinical implications, its pathophysiology is poorly understood. Unfortunately, most information on COVALI is derived from the general population and may not be applicable to individuals under-represented in research, including pregnant individuals. This manuscript reviews: Clinical features of COVALI, leading theories of COVALI, and existing literature on COVALI during pregnancy, a topic not widely explored in the literature. Ultimately, we synthesized data from the general and perinatal populations that demonstrates COVALI to be a hepatocellular transaminitis that is likely induced by systemic inflammation and that is strongly associated with disease severity and poorer clinical outcome, and offered perspective on approaching transaminitis in the potentially COVID-19 positive patient in the obstetric setting.

Protecting vulnerable patients this winter

With Covid-19 an ongoing concern, the current pressures on the NHS and the added stresses of a cost-of-living crisis mean this winter will present a challenge greater than most of us have encountered in our careers to date.

THE IMPACT OF COVID-19 ON PERINATAL MENTAL HEALTH - PART 1

The perinatal period is a high risk for onset and relapse of mental health problems. The COVID-19 pandemic is a particularly stressful occurrence with reported negative impacts on perinatal mental health, hence the need to understand these impacts on pregnant and post-partum childbearing women and people, and prioritise interventions to alleviate them. This is the first of two articles.

Benefit-risk evaluation of COVID-19 vaccination in special population groups of interest.

Several population groups display an increased risk of severe disease and mortality following SARS-CoV-2 infection. These include those who are immunocompromised (IC), have a cancer diagnosis, human immunodeficiency virus (HIV) infection or chronic inflammatory disease including autoimmune disease, primary immunodeficiencies, and those with kidney or liver disease. As such, improved understanding of the course of COVID-19 disease, as well as the efficacy, safety, and benefit-risk profiles of COVID-19 vaccines in these vulnerable groups is paramount in order to inform health policy makers and identify evidence-based vaccination strategies. In this review, we seek to summarize current data, including recommendations by national health authorities, on the impact and benefit-risk profiles of COVID-19 vaccination in these populations. Moving forward, although significant efforts have been made to elucidate and characterize COVID-19 disease course and vaccine responses in these groups, further larger-scale and longer-term evaluation will be instrumental to help further guide management and vaccination strategies, particularly given concerns about waning of vaccine-induced immunity and the recent surge of transmission with SARS-CoV-2 variants of concern.

Prevention is better …

The article presents the discussion on service tackling tuberculosis in London's homeless. Topics include obesity levels among nurses and supporting workers remaining high showing the consequences;increasing the risks of musculoskeletal conditions and mental health conditions being the the main causes of sickness absence in health services.

Reflections of methodological and ethical challenges in conducting research during COVID-19 involving resettled refugee youth in Canada.

Research involving migrant youth involves navigating and negotiating complex challenges in order to uphold their rights and dignity, but also all while maintaining scientific rigour. COVID-19 has changed the global landscape within many domains and has increasingly highlighted inequities that exist. With restrictions focusing on maintaining physical distancing set in place to curb the spread of the virus, conducting in-person research becomes complicated. This article reflects on the ethical and methodological challenges encountered when conducting qualitative research during the pandemic with Syrian migrant youth who are resettled in Canada. The three areas discussed from the study are recruitment, informed consent and managing the interviews. Special attention to culture as being part of the study's methodology as an active reflexive process is also highlighted. The goal of this article is to contribute to the growing understanding of complexities of conducting research during COVID-19 with populations which have layered vulnerabilities, such as migrant youth. This article hopes that the reflections may help future researchers in conducting their research during this pandemic by being cognizant of both the ethical and methodological challenges discussed.

Immunotherapy use outside clinical trial populations: never say never?

BACKGROUND: Based on favourable outcomes in clinical trials, immune checkpoint inhibitors (ICIs), most notably programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitors, are now widely used across multiple cancer types. However, due to their strict inclusion and exclusion criteria, clinical studies often do not address challenges presented by non-trial populations. DESIGN: This review summarises available data on the efficacy and safety of ICIs in trial-ineligible patients, including those with autoimmune disease, chronic viral infections, organ transplants, organ dysfunction, poor performance status, and brain metastases, as well as the elderly, children, and those who are pregnant. In addition, we review data concerning other real-world challenges with ICIs, including timing of therapy switch, relationships to radiotherapy or surgery, re-treatment after an immune-related toxicity, vaccinations in patients on ICIs, and current experience around ICI and coronavirus disease-19. Where possible, we provide recommendations to aid the often-difficult decision-making process in those settings. CONCLUSIONS: Data suggest that ICIs are often active and have an acceptable safety profile in the populations described above, with the exception of PD-1 inhibitors in solid organ transplant recipients. Decisions about whether to treat with ICIs should be personalised and require multidisciplinary input and careful counselling of patients with respect to potential risks and benefits. Clinical judgements need to be carefully weighed, considering factors such as underlying cancer type, feasibility of alternative treatment options, or activity in trial-eligible patients.

Safety and efficacy of immune checkpoint inhibitors in non-small-cell lung cancer: focus on challenging populations.

In recent years, immune-checkpoint inhibitors (ICIs) have represented one of the major breakthroughs in advanced non-small cell lung cancer treatment scenario. However, enrollment in registering clinical trials is usually restricted, since frail patients (i.e., elderly, individuals with poor performance status and/or active brain metastases), as well as patients with chronic infections or who take concurrent medications, such as steroids, are routinely excluded. Thus, safety and efficacy of ICIs for these subgroups have not been adequately assessed in clinical trials, although these populations often occur in clinical practice. We reviewed the available data regarding the use of ICIs in these 'special' populations, including a focus on the issues raised by the administration of immunotherapy in lung cancer patients infected with Sars-Cov-2.

Ethical considerations of recruiting migrant workers for clinical trials.

Migrant workers in dormitories are an attractive source of clinical trial participants. However, they are a vulnerable population that has been disproportionately affected by the COVID-19 pandemic. Guidelines on recruiting vulnerable populations (such as prisoners, children or the mentally impaired) for clinical trials have long been established, but ethical considerations for migrant workers have been neglected. This article aims to highlight and explain what researchers recruiting migrant workers must be cognizant of, and offers recommendations to address potential concerns. The considerations raised in this article include: three types of illiteracy, power dynamics, the risks associated with communal living and potential benefits to the migrant workers as well as researchers.

Controlled human infection with SARS-CoV-2 to study COVID-19 vaccines and treatments: bioethics in Utopia.

A number of papers have appeared recently arguing for the conclusion that it is ethically acceptable to infect healthy volunteers with severe acute respiratory syndrome coronavirus 2 as part of research projects aimed at developing COVID-19 vaccines or treatments. This position has also been endorsed in a statement by a working group for the WHO. The papers generally argue that controlled human infection (CHI) is ethically acceptable if (1) the risks to participants are low and therefore acceptable, (2) the scientific quality of the research is high, (3) the research has high social value, (4) participants give full informed consent, and (5) there is fair selection of participants. All five conditions are necessary premises in the overall argument that such research is ethically acceptable. The arguments concerning risk and informed consent have already been critically discussed in the literature. This paper therefore looks specifically at the arguments relating to condition 3 'high social value' and condition 5 'fair selection of participants' and shows that whereas they may be valid, they are not sound. It is highly unlikely that the conditions that are necessary for ethical CHI trials to take place will be fulfilled. Most, if not all, CHI trials will thus be well intentioned but unethical.