Exploring Culinary Heritage: Insights from Local Gatekeepers in the Province of Antique Philippines (preprint)

This study explores the Province of Antique's culinary heritage through the perspectives of local gatekeepers, aiming to provide insights into the historical, cultural, and social significance of their practices. Through interviews and literature analysis, the research investigates the culinary practices, opportunities, and challenges faced by local gatekeepers. Major themes include the use of indigenous ingredients, traditional healing practices, and the impact of modernization on culinary traditions. Recipes such as Sinanlag nga Manok highlight the incorporation of local ingredients and sustainable practices. Challenges such as the loss of traditional knowledge and the effects of the COVID-19 pandemic are also discussed. By shedding light on Antique's culinary heritage, the study aims to contribute to the promotion of cultural understanding, preservation of traditional practices, and support for local economies.

Long COVID is associated with severe cognitive slowing (preprint)

Background COVID-19 survivors may suffer from a wide range of chronic cognitive symptoms for months or years as part of post-COVID-19 conditions (PCC). To date, there is no definitive objective cognitive marker for PCC. We hypothesised that a key common deficit in people with PCC might be generalised cognitive slowing. Methods To examine cognitive slowing, PCC patients completed two short web-based cognitive tasks, Simple Reaction Time (SRT) and Number Vigilance Test (NVT). 270 patients diagnosed with PCC at two different clinics in UK and Germany were compared to two control groups: individuals who contracted COVID-19 before but did not experience PCC after recovery (No-PCC group) and uninfected individuals (No-COVID group). Findings We identified pronounced cognitive slowing in PCC patients, which distinguished them from age-matched healthy individuals who previously had symptomatic COVID-19 but did not manifest PCC. Cognitive slowing was evident even on a 30-second task measuring simple reaction time (SRT), with PCC patients responding to stimuli ~3 standard deviations slower than healthy controls. This finding was replicated across two clinic samples in Germany and the UK. Comorbidities such as fatigue, depression, anxiety, sleep disturbance, and post-traumatic stress disorder did not account for the extent of cognitive slowing in PCC patients. Furthermore, cognitive slowing on the SRT was highly correlated with the poor performance of PCC patients on the NVT measure of sustained attention. Interpretation Together, these results robustly demonstrate pronounced cognitive slowing in people with PCC, which distinguishes them from age-matched healthy individuals who previously had symptomatic COVID-19 but did not manifest PCC. This might be an important factor contributing to some of the cognitive impairments reported in PCC patients. Funding Wellcome Trust (206330/Z/17/Z), NIHR Oxford Health Biomedical Research Centre, the Thuringer Aufbaubank (2021 FGI 0060), German Forschungsgemeinschaft (DFG, FI 1424/2-1) and the Horizon 2020 Framework Programme of the European Union (ITN SmartAge, H2020-MSCA-ITN-2019-859890).

COVID-19 Post-Vaccination Observation

Peripheral Transcriptomics in Acute and Long-Term Kidney Dysfunction in SARS-CoV2 Infection (preprint)

Background. Acute kidney injury (AKI) is common in hospitalized patients with SARS-CoV2 infection despite vaccination and leads to long-term kidney dysfunction. However, peripheral blood molecular signatures in AKI from COVID-19 and their association with long-term kidney dysfunction are yet unexplored. Methods. In patients hospitalized with SARS-CoV2, we performed bulk RNA sequencing using peripheral blood mononuclear cells (PBMCs). We applied linear models accounting for technical and biological variability on RNA-Seq data accounting for false discovery rate (FDR) and compared the functional enrichment and pathway results to a historical sepsis-AKI cohort. Finally, we evaluated the association of these signatures with long-term trends in kidney function. Results. Of 283 patients, 106 had AKI. After adjustment for sex, age, mechanical ventilation, and chronic kidney disease (CKD), we identified 2635 significant differential gene expressions at FDR<0.05. Top canonical pathways were EIF2 signaling, oxidative phosphorylation, mTOR signaling, and Th17 signaling, indicating mitochondrial dysfunction and endoplasmic reticulum (ER) stress. Comparison with sepsis associated AKI showed considerable overlap of key pathways (48.14%). Using follow-up estimated glomerular filtration rate (eGFR) measurements from 115 patients, we found that 164/2635 (6.2%) of the significantly differentiated genes were associated with overall decrease in long-term kidney function. The strongest associations were autophagy, renal impairment via fibrosis and cardiac structure/function. Conclusions. We show that AKI in SARS-CoV2 is a multifactorial process with mitochondrial dysfunction driven by ER stress whereas long-term kidney function decline is associated with cardiac structure and function, and immune dysregulation. Functional overlap with sepsis-AKI also highlights common signatures indicating generalizability in therapeutic approaches.

Effects of the Menstrual Cycle on Triceps Surae Properties in Women

Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation

Addressing the Human Rights Challenges of Older Persons with Disabilities (preprint)

The World Health Organization has reported that approximately 16% of the global population, over 1.3 billion people worldwide, had some form of disability, and that an additional 190 million people (3.8% of people over 15 years of age) experience serious difficulties in functioning normally on a daily basis. In the US, 61 million, or 26% of, adult Americans have some form of disability, and 2 in 5 adults over the age of 65 have a disability. It has been reported that close to half of all people over the age of 65 in the European Union have some form of disability, putting them at increased risk of neglect, loss of support, abuse and poverty. While the number of persons with disabilities is large, their experiences are diverse and not all people with disabilities are equally disadvantaged. For example, disability does not necessarily imply limited well-being and poverty; however, growing evidence confirms that disability and poverty are highly correlated, and that disability is both a cause and consequence of poverty and disability and poverty reinforce each other in ways that contribute to increased vulnerability and exclusion. While the Convention on the Rights of Persons with Disabilities was adopted in 2006 and went into force in 2008, making it the first binding international instrument addressing the needs of persons with disabilities worldwide, disabled persons of all ages, and particular those who are older, face a number of barriers to inclusion including attitudinal barriers (e.g., stereotypes, prejudices, other forms of paternalistic and patronizing treatment, discrimination, fear, bullying and low expectations of people with disabilities); institutional barriers (i.e., laws, policies, strategies or practices that discriminate against people with disabilities including lack of enforcement and political support for policies); “internalized” barriers (i.e., due to stigma and stereotyping, disabled persons refrain from pro-active behavior in expressing their opinions and claiming their rights); lack of participation including lack of consultation and involvement of people with disabilities in decision making; inadequate data, statistics and evidence on what works; and inaccurate concerns over the costs and difficulties of disability inclusion (e.g., concerns that disability inclusion is too difficult and requires specialist knowledge or require special programs that would unduly burden existing resources). In addition, older people with disabilities face special issues. In her July 2019 report to the UN General Assembly, the UN Special Rapporteur on the Rights of Persons with Disabilities identified several human rights challenges affecting older persons with disabilities, including stigma and stereotypes; direct and indirect discrimination; denial of autonomy and legal capacity; institutionalization and lack of community support; violence and abuse; lack of adequate social protection; and lack of access to palliative care. She argued that “[t]he intersection between older age and disability results in both aggravated forms of discrimination and specific human rights violations against older persons with disabilities” and that older persons with disabilities were subject to a greater extent to loss of power, denial of autonomy, marginalization and cultural devaluation; more prone to social isolation, exclusion, poverty and abuse; and vulnerable to gaps in human rights protection and age-biased interpretations of human rights standards. The Special Rapporteur also pointed to fragmentation of policies for older persons and persons with disabilities as leading to “the invisibility in law and in practice of experiences of disability in later life” which, when combined with a general perception that older persons with disabilities are a “burden” or “less deserving”, leads to members of these groups given lower priority in policies and receiving services that are of a lower quality, especially in situations where there is a scarcity of resources.This work discusses the wide range of topics that should be covered in any comprehensive campaign to address the human rights challenges of persons with disabilities including the intersection of ableism and ageism driven by ignorance and stigmatization, discrimination in the workplace against older persons with disabilities and the lack of employment opportunities for members of that group, access to adequate physical and mental health services, autonomy and legal capacity, abuse, inclusion of older persons with disabilities in the community (i.e., independent living, accessibility, adequate housing, inclusive and sustainable communities and participation), social protection, access to education and justice and protection of older persons with disabilities during emergencies such as the Covid-19 pandemic.

Human Rights of Persons with Disabilities (preprint)

The World Health Organization has reported that approximately 16% of the global population, over 1.3 billion people worldwide, had some form of disability, and that an additional 190 million people (3.8% of people over 15 years of age) experience serious difficulties in functioning normally on a daily basis. In the US, 61 million, or 26% of, adult Americans have some form of disability, and 2 in 5 adults over the age of 65 have a disability. While the Convention on the Rights of Persons with Disabilities was adopted in 2006 and went into force in 2008, making it the first binding international instrument addressing the needs of persons with disabilities worldwide, disabled persons of all ages, and particular those who are older, face a number of barriers to inclusion including attitudinal barriers (e.g., stereotypes, prejudices, other forms of paternalistic and patronizing treatment, discrimination, fear, bullying and low expectations of people with disabilities); institutional barriers (i.e., laws, policies, strategies or practices that discriminate against people with disabilities including lack of enforcement and political support for policies); “internalized” barriers (i.e., due to stigma and stereotyping, disabled persons refrain from pro-active behavior in expressing their opinions and claiming their rights); lack of participation including lack of consultation and involvement of people with disabilities in decision making; inadequate data, statistics and evidence on what works; and inaccurate concerns over the costs and difficulties of disability inclusion (e.g., concerns that disability inclusion is too difficult and requires specialist knowledge or require special programs that would unduly burden existing resources). A comprehensive campaign to address the human rights challenges of persons with disabilities must address a wide range of topics including ableism driven by ignorance and stigmatization, discrimination in the workplace and lack of employment opportunities, access to adequate physical and mental health services, autonomy and legal capacity, abuse, inclusion in the community (i.e., independent living, accessibility, adequate housing, inclusive and sustainable communities and participation), social protection, access to education and justice and protection during emergencies such as the Covid-19 pandemic. Particular attention should be paid to the needs of women, children, people of color and older persons with disabilities. While governments have the primary responsibility for protecting the human rights of persons with disabilities, non-governmental entities, such as businesses, can also play a part in improving the lives of this growing segment of the population.

Tobacco consumption behavior change during the COVID-19 pandemic is associated with perceived COVID threat (preprint)

Rationale: Tobacco use is a risk factor for COVID-19 adverse outcomes. Despite health implications, data conflict regarding COVID-19 and tobacco consumption. We present results from a survey of health behaviors during the pandemic to identify how COVID-19 influenced tobacco use. Methods: A national internet-based survey was deployed between May-September 2020. We analyzed participants who reported current or former smoking. We tabulated change in tobacco use, whether changes related to COVID-19, and measures of anxiety, depression, and novel perceived COVID-19 threat scale. We employed multinomial logistic regression to determine associations between these items and tobacco consumption. Results: We identified 500 respondents who reported ever smoking previously, 150 of which were currently smoking. Of 220 participants who reported any use of vapes, 110 were currently vaping. Increased perceived threat of COVID-19 was associated with both increased (aRRincrease 1.75, 95% CI [1.07–2.86], P = 0.03) and decreased (aRRdecrease 1.72 [1.04–2.85], P = 0.03) tobacco consumption relative to no change. There were no significant relationships found between perceived threat of COVID-19 and vaping behavior. Conclusions: As perceived COVID-19 threat increased, people were more likely to increase or decrease their smoking than stay the same, even after controlling for anxiety and depression, both of which can affect smoking in either direction. Further study into motivators of increasing or decreasing affected tobacco consumption, and how barriers to care from safer-at-home policies and changes in care delivery moderate change in tobacco use will aid planning tobacco reduction interventions during the ongoing and future respiratory viral pandemics.

Telehealth and Remote Patient Monitoring Innovations in Nursing Practice: State of the Science

[...]findings of this rapid review suggest that the state of the telehealth and RPM scientific literature is in its infancy. Health Information Management Systems Society (HIMSS);the American Nurses Association (ANA);Johnson & Johnson;Society of Nurse Scientists, Innovators, Entrepreneurs and Leaders (SONSIEL);and the American Organization of Nurse Leaders (AONL). [...]the Joanna Briggs Institute (JBI) Critical Appraisal Tools (2017) were used to appraise the quality (i.e., low, moderate, high) of each article from the traditional literature. [View full size] Data extraction, reported in Table 2. lists these descriptors for each study: a description of the Innovation, study design, conceptual model, sample, sampling strategy, setting, data analysis or analytics techniques, concept deployed, quality of the research and the role of the nurse-author(s).

Graduate Nurse Education Programs: Transition Pathway for Registered Nurse Employment

(20171 purported that "increased nursing education enrolments to cater for possible future nursing shortages, (ii) decreased state expenditure on health services and, (iii) graduate employment dictated by staff vacancies rather than ensuring sustainability of the future workforce" (p. 251) are contributing factors. Sample and Data Collection Convenience sampling technique was used, and to ensure sufficient data sampling, two cohorts of graduating students were Invited to participate. The online survey data collection Incorporated closed and opened ended questions about participant engagement with the profession of nursing. All study participants, including the graduates with a previous Diploma of Nursing, provided a 100% response rate to their intention to register with the Nursing and Midwifery Board as a registered nurse (RN).

Getting the Most From FSP Model

Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions:

CROs RISE TO COVID PANDEMIC CHALLENGES

Clearly, RBQM and DCTs are hot topics for everyone in the industry-and, importantly, the ACRO landscape surveys go beyond stakeholder opinions or perceptions to gather data on actual adoption at the individual trial level. Beyond gathering data to characterize the current landscape, CROs and technology companies invest heavily in innovation and thought leadership, and ACRO harnesses collaboration across member companies to produce knowledge and tools that can benefit all stakeholders. The COVID-19 pandemic very much highlighted the need for our entire industry to improve diversity and inclusion (D&I) in clinical research, and ACRO member companies are addressing D&I issues on every level, from patient and workforce recruitment to engaging with regulators and legislators on the development of policies that will support and incentivize a fairer and more equitable research environment.

Pandemic Highlights Urgency for New Methodologies for Evidence Generation

Randomized controlled trials, which many consider to be the gold standard of clinical research, were developed in the 1940s. [...]individual patients in the real world react often very differently to a specific drug than what has been predicted by the "mean" of a clinical trial. Many biopharmaceutical companies and AI startups are betting that with enough data, these methods will work so well that they will help to accelerate the discovery of new therapies for the novel corona virus, 2019-nCoV (see go.nature.com/3aLd0ll). * Causal AI methods might be uniquely positioned to discover underlying causes of disease and clinical response to treatment on an individual level, making personalized medicine real.

Unfolding Outbreak Scenarios Can Be a Bite-Size Treat and Other Lessons From New Zealand's First Online Environmental Health Conference

The New Zealand Institute of Environmental Health (NZIEH) is a nongovernmental institute for all environmental health professionals in New Zealand. In 2021, NZIEH held its annual conference as an online virtual event for the first time. One inclusion to the program was an evolving outbreak scenario delivered in installments including "injects" of information (i.e., inserts of information relevant to the scenario) that mimic the evolution of a real-life epidemiological outbreak investigation. Questions were posed to attendees related to each added information inject. The scenario also included discussion in virtual breakout rooms that allowed attendees to network and reach consensus before responding to questions;discussions were also initiated by the scenario facilitators. Details of the scenario, its aims, evaluation of success, and limitations of this approach are discussed.

WHAT IS A CRO?

The industry has one of the smartest workforce and most come to work with passion in their bones, whether it be in their first job or those positions that followed. [...]when all players cooperatively work together as a team with common goals, it is a winwin for society at large. According to its website, "In 1947, a young veterinarian purchased one thousand rat cages from a Virginia farm and set up a one-man laboratory in Boston, overlooking the Charles River. In other words, it is not uncommon for a CRO to provide scientific, clinical, and business continuity for pharmaceutical company sponsors. [...]to maximize the CRO's contribution to the overall development programs, the CRO should become an active member of the team.

Analysis: FDA's COVID-19 Accelerated Pathways

Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.

Topic Introduction: A Look Back to Envision the Future: Nursing Now USA as a Vehicle for Advocacy and Change, Part I

Led by the University of North Carolina Chapel Hill School of Nursing (UNC-CH SON), the American Nurses Association (ANA), and the United States Public Health Service (USPHS) Chief Nurse, the Nursing Now USA™ (NNUSA) leadership team was Identified in late 2018. At the close of the NNUSA initiative, although these statistics were tracked by Nursing Now global, numerous local and regional groups had engaged In NNUSA, including Nurses Everywhere - Grassroots to Local, Nurses International, the National Association of Indian Nurses of America, Stony Brook University School of Nursing, the Nell Hodgson Woodruff School of Nursing at Emory, and Global Health Access (GHA) Institute In Boston. Toward this end, NNUSA announced a national "Call for Proposals" to support three commissioned papers spotlighting nursing innovations;addressing diversity, equity, inclusion, or social justice Issues;and recognizing the role of nurses during an unprecedented time;and In support of 2020 The Year of the Nurse. The following questions were offered to stimulate Ideas: What evidence-based nursing practice innovations have had a major influence on the health and well-being of society or a specific population? * What educational innovations have fostered nursing practice, leadership, and research development? * What nurse-driven models of care best reflect nurse leadership in activating system change? * What leadership innovations have been implemented to ease the Impact of COVID-19 on frontline nurses and other health care workers?