WASHINGTON REPORT

FNIH will manage an ACTIV steering committee to develop an inventory of potential candidates, launch master protocols with a single control arm, and set criteria for ranking potential candidates for first-wave and subsequent evaluation. [...]a third group will tap NIH's extensive clinical trial network infrastructure to build capacity for expediting trials and to study different populations and disease stages. ?o advance vaccine development, another ACTIV group will form a collaborative framework to map epitopes and develop assays, establish protocols for sampling and immunological analyses, collect clinical data on immunological responses and endpoints, and engage with regulators on surrogate endpoints for clinical evaluation. Jill Wechsler MULTIPLE WEBSITES IDENTIFY AND TRACK RESEARCH ON COVID Widespread research activity is available from these and other organizations: * The University of Oxford Center for Evidence-Based Medicines lists more than 1000 clinical trials at http:// covid19.trialstracker.net/index.html * Bill & Melinda Gates Foundation with Cytel identifies more than 600 trials in the US and other regions at https://covid19-trialscom * TranspariMed offers a guide to multiple trials at https://www.transparimed.org/ * Bi°Century tracks vaccines and therapeutics in its COVID-19 Resource Center, https://www.biocentury.com/ clinical-vaccines-and-therapies * World Health Organization: https://www. who.int/emergencies/diseases/novelcoronavirus-2019/global-researchon-novel-coronavirus-2019-ncov/ * Regulatory Affairs Professionals Society: https://www.raps.org/newsand-articles/news-articles/2020/3/ covid-19-therapeutics-tracker

Accelerating Innovation Adoption to Support Drug Development Operations

The industry has responded by incorporating remote monitoring techniques and fast-tracking the use of hybrid and decentralized clinical trial (DCT) models, at a pace never seen before. Interactive voice response systems (IVRS) and electronic data capture (EDC) solutions were introduced in the late 1980s and early '90s but these are only now reaching wide adoption by sponsors and contract research organizations (CROs).1 Electronic patient-reported outcomes (ePRO), electronic clinical outcomes assessment (eCOA), and eSource technologies, while introduced in the mid to late '90s, have yet to achieve wide adoption.2 This pattern holds true for risk-based monitoring (RBM), digital health outcomes, and other innovative approaches and solutions. [...]the survey focused on opportunities for accelerating the innovation adoption process. A variety of roles were also represented, including professionals from clinical operations (46%);clinical development (9%);innovation management (17%);data science & data management (10%);information technology (3%);and 15% from other roles. [...]14.5% of respondents were part of a centralized or dedicated innovation group, whereas the majority (85.5%) worked outside of such an innovation group. [...]responses reflect a broad cross-section of views and perspectives from which to learn more about how the biopharmaceutical industry approaches the innovation adoption process, what gets in the way, and how organizations and the industry more broadly can accelerate new technologies and innovations.

Consolidating Ireland's Indigenous Social Enterprise Sector - A Policy Perspective

The National Social Enterprise Policy for Ireland (2019 - 2022) was a watershed moment for social enterprise in Ireland. Ireland has a rich, proud and diverse experience of social economy and social enterprise, yet the policy framework developed comparatively later than in some other EU member states. Since its launch in 2019, the Policy has helped to significantly shape the social enterprise sector in Ireland including through targeted measures and improved coherence across government policy. At the same time, the sector is still in a nascent phase and faces dramatic new challenges associated with the realities of focussing on social impact whilst trading in a competitive market economy traditionally focussed on export-potential, which have been exacerbated by the economic effects of the COVID-19 pandemic. As this foundational Policy comes to the end of its term, the Government, in partnership with the sector, now faces another significant juncture which will determine how successful social enterprise can be in moving from the margins to the mainstream and contributing to Ireland's economic, social and environmental progress. The current article seeks to clarify the features of Ireland's indigenous social enterprise sector, and offers perspectives on some of the prerequisites for an ambitious and impactful successor policy in 2023 to unlock the potential of the sector to grow in scale and impact.

Comment on: 'Should We Interfere with the Interleukin-6 Receptor During COVID-19: What Do We Know?'/Authors' Reply to Chia Siang Kow et al.: Comment on: 'Should We Interfere with the Interleukin-6 Receptor During COVID-19: What Do We Know So Far?'

[...]the mortality reduction has previously been reported in the prospective meta-analysis [2] conducted by The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group. Nonetheless, owing to relatively scarce evidence, it is still unclear whether monoclonal IL-6 antibodies reduce mortality in patients with COVID-19, similar to the IL-6 receptor inhibitors. [...]large-scale randomised trials should also be conducted to establish the role of monoclonal IL-6 antibodies in the treatment of COVID-19. [...]among hypothetical long-term complications, peripheral neuropathy would also be noticeable [10] and may contribute to the broad long COVID pattern. [...]there is a theoretical risk of altering the efficacy of immune checkpoint inhibitors during tumour disease management [11].

Forms of participation and learning of mathematics in virtual workgroups in engineering students

The objective of the research was to determine the relationship between the type of participation, collaborative organizational structure of the groups and the learning of mathematics, in a group task carried out in virtual form by the context of health emergency by COVID19. During four weeks, eight working groups composed of three environmental engineering students worked four activities on the analysis of the variation of functions. The working meetings were developed by ZOOM and WhatsApp. It was found that reasoning and argumentation as well as problem solving is favored when students express new ideas or explanations about any doubt or when they address the content of the task, especially in groups with an integrative organizational structure. © 2023 IEEE.

Best practices for pediatricians in diagnosing and treating asthma

Additionally, they can treat atopic comorbidities such as atopic dermatitis, chronic urticaria, nasal polyps, eosinophilic esophagitis, and hypereosinophilic syndrome, resulting in improved quality of life for our patients. Parents should be made aware of its updated black box warning for possible effects on mental health and behavior changes,3 including but not limited to suicidal ideation. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair);advises restricting use for allergic rhinitis.

A Review of An Open World: How America Can Win the Contest for Twenty-First-Century Order by Rebecca Lissner and Mira Rapp-Hooper

The authors stress that both economic and military investments will be required to counter China's integration of statecraft and industry.1 It is further suggested that a selective procurement of allies within the Asian-Pacific region is necessary to counter Chinese economic dominance, military aggression, and coercive practices.2 An Open World suggests that the United States should look to build on existing relationships within trade and security cooperatives in the Indo-Pacific region and bolster the Quadrilateral Security Dialogue, known as the Quad, to become a formal alliance that projects a robust military presence to counter Chinese aggression and encroachment within the South China Sea. [...]the authors point out the current dearth of expertise, talent, and diplomatic finesse that exists within the United States Department of State. In November 2020, the four members participated in a joint naval exercise meant to improve sea readiness for their fleets.6 This exercise was followed by a virtual meeting the following March and the establishment of working groups to tackle challenges such as supply-chain resilience and COVID-19 vaccine production and distribution.7 If these working groups are the extent of the Quad's influence, then the United States needs to seek other alliances to combat China's aggressive economic and military tactics. Coupling public and private sector goals While this type of partnership with private firms is promising, the authors admit to the widening gap between the national security interests of the public sector and the industrial mission of private corporations, which seems to weaken their argument.

LEARNING THROUGH A PANDEMIC: INNOVATIONS IN LABORATORY MEDICINE

Pooling Through the Waves JARED BULLARD MD, FRCPC Jared Bullard is an Associate Professor in the Departments of Pediatrics & Child Health and Medical Microbiology & Infectious Diseases at the Max Rady College of Medicine, Rady Faculty of Health Sciences and Associate Medical Director, Cadham Provincial Laboratory Investigator, Children's Hospital Research Institute of Manitoba, in Winnipeg. [...]NH has recently developed a pathway for internationally educated MLTs (IEMLTs), who may start as laboratory clerks or MLAs and be able to secure MLT positions once they gain CSMLS certification. Rethinking Safety DAVID GOLDFARB MD, FRCPC David Goldfarb, MD, FRCPC, is a Clinical Associate Professor in the Department of Pathology and Laboratory Medicine at the University of British Columbia, Associate Head of the Department of Pathology and Laboratory Medicine at BC Children's Hospital and BC Womens Hospital and Health Centre, and Medical Microbiologist and Pediatric Infectious Disease Physician at BC Children's Hospital in Vancouver.

Results from The Quiet Project- UK Acoustic Community's response to COVID19

The COVID-19 Lockdown created a new kind of environment both in the UK and globally, never experienced before or likely to occur again. A vital and time-critical working group was formed with the aim of gathering crowd-source high quality baseline noise levels and other supporting information. The acoustic community were mobilised through existing networks engaging private companies, public organisations, and academics to gather data in accessible places. A website was designed to advertise the project, provide instructions and to formalise the uploading of noise data, observations, and Soundscape feedback. The data was collected at 99 locations by 80 acousticians (64 male, 16 female) using professional grade calibrated instrumentation with 83% of measurements including spectral data. The locations covered 19 urban, 61 suburban, and 19 rural sites. The Lockdown 1 dataset consisted of a total of 1.6 GB of measurements and material (video, photos) covering 834 days between 1st April and 14th July 2020. This makes the award winning Quiet Project the largest ever noise and soundscape database ever recorded. The paper presents the quietest places in the UK and Ireland. As a government funded research project the databank will be made publicly available to assist future research. © 2022 Internoise 2022 - 51st International Congress and Exposition on Noise Control Engineering. All rights reserved.

International Medical Corps' Approach to Solving COVID-19 Vaccine Hesitancy

During the COVID-19 pandemic, we supported vaccination efforts across 17 countries through logistic and technical support, through managing or supporting vaccine campaigns and the vaccination process, and through water, sanitation and hygiene (WASH) programs and biomedical waste management. In the past, the lack of equitable access to vaccines has been a problem in humanitarian and resource-poor settings;however, with such a high global demand for COVID-19 vaccines, delay in access could lead to a vicious cycle of hesitancy, low uptake and emergence of new strains.2 UNDERSTANDING VACCINE HESITANCY Vaccine hesitancy is defined as "a delay in acceptance or refusal of vaccines despite the availability of vaccination services"3 The WHO has recognized it as one of the biggest threats to global health.4 Vaccine hesitancy is contextdependent and can change over time. The first consensus definition of vaccine hesitancy was reached in 2014, when the WHO's SAGE working group on vaccine hesitancy defined it.3 Since then, there has been progress in understanding the drivers of vaccine hesitancy and in addressing them, but operational guidance on mitigating hesitancy at the community level was limited when we started working on COVID-19 vaccination. A LOCALLY RESPONSIVE FRAMEWORK FOR A GLOBAL PROBLEM Keeping in mind the urgency of the issue, the contextual differences inherent to vaccine hesitancy, and the lack of global guidance on the topic, International Medical Corps decided to create a process by which we would have some guiding values and a flexible operational process that adjusts to local conditions.

TMS Asian/Pacific Islander (API) Working Group Seeks to Raise Awareness

While API has a sizeable presence in the TMS community, they are underrepresented in leadership roles. This is similar to what is seen throughout the US. Asian Americans comprise 13% of the American workforce, but only hold 6% of leadership positions. The discrepancy is even greater in the technology sector at 27% and 14%, respectively. This disproportionate representation has often sidelined the voice of the API community--a situation that is particularly dangerous in our current times. Although anti-Asian hate is not a new phenomenon, crimes against Asian/Pacific Islander (API) communities rose considerably during the COVID-19 pandemic.

Sosiaali- ja terveysalan ammattilaisten kasautuva koronakuorma: kyselytutkimus Suomen tilanteesta syksyllä 2020

Tutkimuksen tarkoitus: Tutkimuksen tarkoituksena oli kuvata, minkälaisia työhön liittyviä muutoksia sosiaali- ja terveysalan henkilöstölle on koronapandemian myötä tullut ja missä määrin ne ovat kasautuneet samoille työntekijäryhmille. Aineisto ja menetelmät: Aineistona on syksyllä 2020 Suomesta kerätty sosiaali- ja terveysalan työntekijöistä koostuva kyselyaineisto (N=22 528, vastausprosentti 67). Analysoinnissa käytettiin kuvailevia analyysimenetelmiä (prosenttijakaumia ja ristiintaulukointia). Tulokset: Noin kolmannes sosiaali- ja terveysalan henkilöstöstä kokee työmääränsä kasvaneen ja pelänneensä terveytensä puolesta. Lisäksi noin puolet on joutunut käyttämään suojavarusteita ja joutuneensa opettelemaan uusia tietoja ja taitoja. Monet näistä vaikutuksista kasautuvat nuorille, työntekijäasemassa toimiville ja tietyille ammattiryhmille: röntgenhoitajille, sairaanhoitajille, laboratoriohoitajille ja laboranteille, lähi-ja perushoitajille. Päätelmät: Koronakuorma kasautuu tietyille työntekijäryhmille. Jatkossa näiden ryhmien työssäjaksamista ja työhyvinvointia tulee tukea ja toimenpiteitä kohdentaa kyseisille ryhmille. Erityisesti työntekijöiden palautumiseen tulee kiinnittää huomiota sekä tarjota sosiaalista tukea.Alternate :The purpose of the study: The purpose of the study was to describe what kind of work-related changes have occurred among social and health care personnel during the corona pandemic and to what extent these have accumulated to same working groups. Data and methods: We use survey data of Finnish social and health care employees collected in autumn 2020 (N=22 528, response rate 67%). Descriptive statistics (percent distributions and crosstabulations) were used to analyze data. Results: Approximately one third of social and health care employees feel that their workload has increased because of Covid-19 pandemic, and they have feared for the sake of their own health. Furthermore, half of them has had to use protective equipment and to acquire new knowledge and skills. Many of these effects accumulate to young workers, those in employee position and to certain occupational groups: radiologists, nurses, laboratory nurses and laboratory assistants and primary care nurses. Conclusions: Corona burden accumulates to certain working groups. In the future there is need to pay attention to the resilience and well-being of these groups and target actions for them. Especially recovery of these employees needs attention and they should be offered social support.

How Las Vegas Upped Its Transportation Game with the Arrival of Pro Sports

It's no secret that Las Vegas NV is well equipped to handle large-scale events, hosting an average of 300 major events each year--including National Football League (NFL) and National Hockey League (NHL) games, NASCAR races, Ultimate Fighting Championship (UFC) events, World Boxing Council-sanctioned matches, and high-profile college football games like the PAC-12 championship and ESPN-owned Las Vegas Bowl. Added to the mix are all-star celebrity residencies that helped to fuel the city's steady drumbeat of more than 42 million annual visitors in 2019. Powerhouse headliners like Katy Perry, Carrie Underwood, Adele, and Usher, in addition to major music festivals like Electric Daisy Carnival and Life is Beautiful, ensure that Las Vegas keeps its moniker as the "Entertainment Capital of the World." Added to that are more than 20,000 conventions of all sizes, including 60 of the world's largest, that easily make Las Vegas one of the country's top convention destinations.

How a Community Approach Can Drive Pharmacovigilance Activities in Low-Resource Settings during a Public Health Emergency: Lessons from COVID-19: An International Journal of Medical Toxicology and Drug Experience

Introduction: Undertaking effective drug safety monitoring can be particularly challenging in low-resource settings due to a lack of infrastructure, weak regulatory systems and poor access to training and education [1]. Given the continued impact the COVID-19 pandemic is having upon health systems globally, it is essential to ensure that pharmacovigilance systems in these vulnerable settings have the capacity to address both the exacerbated pre-existing and novel challenges that they now face [2]. This project seeks to harness the membership of an online pharmacovigilance platform, globalpharmacovigilance.org (GPV) to work together in a 'community of practice' (CoP) on specific challenges facing pharmacovigilance during the pandemic [3, 4]. Objective: To gather consensus on pharmacovigilance priorities in low-resource settings during the COVID-19 pandemic and provide resources to address them using a CoP model. Methods: This project has built on a consensus-gathering methodology developed by The Global Health Network that has been implemented successfully during the pandemic to address wider COVID-19 research priorities. An online survey of GPV members was used to identify highly-ranked areas for pharmacovigilance improvement in low-resource settings during the pandemic. A virtual workshop was then hosted to invite further discussion on the survey results and reach consensus on the highest priorities. Members of the CoP were next invited to form virtual working groups, each focussing on one of the top 3 priorities identified. These groups are being supported by GPV to work together and facilitate the development (or provision, if pre-existing) of pharmacovigilance resources to address the priorities identified. Results: Of the 43 pharmacovigilance 'themes' that were presented to the CoP membership in the initial survey, 3 topics were identified as the highest priorities at that point in the COVID-19 pandemic, where support, training and guidance are needed;'The safety of COVID-19 vaccination in pregnancy', 'The safety of COVID-19 vaccination in children/adolescents' and 'Analysis of COVID-19 vaccine safety data'. As of May 2022, the number of GPV members interested in involvement in working groups addressing these themes are 207, 206, and 284 respectively. Initial group meetings took place in April 2022 and discussions are ongoing as to how to take group activities forward and address the priorities identified. Conclusion: A CoP model represents an effective method of consensus gathering amongst pharmacovigilance stakeholders at a global level, and allows rapid identification of healthcare priorities during public health emergencies. It is anticipated that working groups outputs will include the provision of resources designed to address the priorities identified.

Digital Media and Pharmacovigilance: The SIMeF Pharmacovigilance Working Group Perspective: An International Journal of Medical Toxicology and Drug Experience

Introduction: Digital media are integrated in our daily routine, play a critical role in the dissemination of health information and disease prevention guidelines and are becoming more impacting in pharma-companies activities, with an increasing trend after the pandemic period. They pose pharmacovigilance challenges for application of PV rules. a structured approach is needed for pharmacovigilance departments in the new digital scenario. Objective: The SIMeF pharmacovigilance working group worked on digital topic since two years, addressing it in a structured way: from a a specific survey (1), to proposals for addressing the needs underlined, to seminars and events for capability building and discussions among experts. SIMEF group also worked on a proposal guideline for sup-porting PV departments (6), suggesting a framework for managing sponsored digital activities with potential collection of adverse events, to provide useful operative suggestions on PV requirements management. Methods: A research on the regulation in force and the current status of digital media was conducted, with a focus on pharmacovigilance, privacy and quality aspects. The guideline was written considering the expertise of the authors in the management of pharmacovigilance activities. Seminars were done to favour discussions among experts. Results: All healthcare sectors are impacted by digital media: scientific societies, academic institutions, patients' associations, hospitals and healthcare institutions are increasing their online presence 2,3. Social media are used by patients to compare health data, collect treatment information and discuss with physicians, with an increasing active role. Digital media should be considered as a potential source of AEs by pharmacompanies, when managing sponsored activities. PV aspects of digital activities are currently described, although not in details, in different regulations by EMA, FDA and MHRA. Management digital projects by pharmacompanies is complex and require a structured multifunctional process, to guarantee a holistic approach to regulatory and legal requirements. Many aspects should be considered for compliance and efficiency. SIMeF work pose considerations on the importance of crossfunctional work, early pharmacovigilance advice, tracking system, execution of risk-based assessment, escalation to quality, SOPs presence, personnel trainings (including vendors) and a Quality System covering PV. New skills and capability will be crucial for PV departments in future. Conclusion: Digital media are powerful instrument to increase patients and physicians involvement and to support disease knowledge. The rising amount of safety data generated through digital opens a challenge for pharmacompanies. This work is a starting point to trigger broader discussions around PV quality system for digital activities.

Careful hand feeding in a geriatric step-down hospital: a retrospective study

Objective. To evaluate the safety and effectiveness of the careful hand feeding (CHF) programme in a geriatric step-down hospital. Methods. Medical records of patients aged >65 years who received CHF in FungYiu King Hospital between February 2017 and November 2021 were retrospectively reviewed. Results. 446 patients (178 men and 268 women) aged 66 to 109 (mean, 91) years were included for analysis. 88% of patients were severely frail or very severely frail. 70% of patients had advanced dementia. 81.3% of patients had dysphagia. 44% of patients were in imminent death status (who were highly likely to die within a week) before starting CHF. Food intake during CHF was poor or very poor in 51 % of patients and satisfactory or good in 49% of patients. 90% of patients required clinically assisted hydration. The mean length of hospital stay was 19.3?16 days, and the mean duration of CHF was 14?13.5 days. 39% of patients died during the index admission;most of the remaining 61% of patients were discharged to their original placement. 27 (6%) patients had pneumonia. Independent predictors for pneumonia were the length of hospital stay (odds ratio=1.024, p=0.014) and poor/very poor intake (odds ratio=1.82, p=0.017). Conclusion. CHF is safe in a geriatric step-down hospital and avoids use of a nasogastric feeding tube in patients in their last phase of life. It fosters comfort and dignity for dying patients. Most patients can return to their original placement for CHF after discharge.

Making a paediatric intensive care unit sustainable – where to start?

Aims‘There is so much waste on our unit’, an echo heard throughout departments in the National Health Service (NHS). With increasing waste noted on our paediatric intensive care unit (PICU), exacerbated by the COVID-19 pandemic, and the COP26 momentum, there was a strong desire from PICU staff members, and even parents, to start turning this particular PICU into a sustainable one.A PICU Sustainability working group was set up with 3 core members and over 10 collaborators, known as the ‘sustainability friends’. The group aims to add direction and focus to making this PICU sustainable and a player in the NHS’ commitment to becoming ‘carbon net zero’.As a working group, the ideas were endless and almost impossible to decide where to start. There had been previous sustainability attempts but these quickly tapered out due to lack of interest and eventually ceased with the COVID-19 pandemic. It is well described in literature that interventions are more successful if there is a desire for that specific intervention.1 Knowing this, we sent out questionnaires to find out the top 3 things staff and parents found wasteful on the unit and suggestions on how to tackle these.MethodsAn online questionnaire was designed with three blank space questions and was sent to all staff members on the PICU via electronic mail and posters were put on the unit with a QR code for easy access. Humorous cartoons were used in the questionnaire to encourage responses. These were placed in staff areas as well as the parents’ room to encourage parent involvement. An electronic sustainability diary was uploaded online to document past projects, current projects, future plans and contact details.ResultsThe questionnaire generated 89 suggestions from 35 respondents. The majority of these were from nursing staff (68.5%), as well as doctors (14.3%), domestic services (8.6%), pharmacy team (5.7%) and dietitians (2.9%).Suggestions were categorised into 6 sub-categories: Equipment, PPE, Waste, Drugs, Environment and Patient Bedside. The top 6 desired changes were 1) Re-introduce recycling bins (51%) 2) Reduce unnecessary glove use (22%) 3) Reduce unnecessary apron use (22%), 4) Minimise drug wastage (13%) 5) Reduce unnecessary lights being left on (13%) 6) Reduce the amount of bedside trolley equipment thrown out between new patients (13%).ConclusionThe sustainability working group created a sustainability calendar with monthly themes starting with the most popular suggestion from the survey. This calendar will be displayed in staffing areas and every month an audit will be conducted to assess the intervention. Audit results will be added to this calendar and a monthly Sustainability newsletter. The sustainability diary will facilitate handover for incoming working group members and as a way of reporting to senior managers. In future, we hope we can expand this approach to a trust-wide level to increase the impact on climate change. Listening to staff and acting on what they feel needs to be changed is crucial to make everyday practice sustainable.ReferenceMichie, S. Behaviour change wheel: a new method for characterising and designing behaviour change interventions.

Former chief nurse Broodkoorn among nurses honoured

During the pandemic, Broodkoorn established and led the Ministry of Health's infection prevention and control team for the COVID-19 response, providing clinical guidance on the use of personal protective equipment across the health and disability system. Through the clinic, she supplies items to Pacific families in need, including bedding, furniture, food parcels and home-cooked meals. * Husband and wife MATAIO BROWN and SARAH BROWN were both made MNZM for services to mental health and prevention of family violence. Funds were raised to gift 9350 copies of the book to all prisoners in the country through the Department of Corrections. Since 2019, they have partnered with the Ministry of Social Development and Aviva as ambassadors for the antiviolence "It's Not OK" campaign.