Q&A

In this interview, Sujay Jadhav, global vice president, study start-up, Oracle Health Sciences, touches on how COVID has affected study start-up and what new perspectives it has forced the industry to have on its own challenges. [...]assessing site ability to leverage telehealth will be a factor in site selection. Andy Studna is an Assistant Editor for Applied Clinical Trials Sujay Jadhav Global Vice President, Study Start-Up, Oracle Health Sciences Problems with startup, more than any other phase of a clinical trial, have the greatest potential to increase timelines and budgets.

The Benefits and Limitations of Teaching English for Specific Purposes Online and Face-to-Face: Sport and Health Sciences Students' Perspectives

The restrictions imposed to limit the spread of COVID-19 resulted in the switch from in-person to online teaching, including the teaching of foreign languages in 2020-2022. This study uses the feedback of students who have studied English for Specific Purposes (ESP) in virtual and classroom settings. The aim is to investigate the benefits and limitations of each approach for language acquisition in ESP for sport and health sciences. A questionnaire to ascertain students' experiences was distributed to 60 students in sport and health sciences who studied ESP at the Latvian Academy of Sport Education. It was found that online and face-to-face studies of ESP in sport and health sciences tended to facilitate the acquisition of different language skills. In the questionnaire, students reported consistent progress in the study of vocabulary and reading the texts related to their area of study during both online and face-to-face studies, but less improvement was reported in the areas of grammar and speaking skills. Overall, synchronous online live classes would facilitate the steady and continuous development of all language skills if supplemented by continuous support from the teaching personnel, regular offline meetings or classes, and access to specially designed online resources.

Non-steroidal anti-inflammatory drugs amid COVID-19 pandemic: An ally or an enemy?

As the current global pandemic of the novel coronavirus diseases 2019 (COVID-19) continues to rage, the scientific and medical worlds are working to establish an effective therapy against the illness. Recently questions regarding non-steroidal anti-inflammatory drugs (NSAIDs) as a potential therapeutic option for COVID-19 have surfaced. While some studies hint towards the possible benefit of NSAIDs against SARS-CoV-2 infection, the current body of evidence also sheds light on the potential risk of using NSAIDs in COVID-19 patients. Thus, the available literature does not provide conclusive evidence for or against the use of NSAIDs for treating COVID-19 patients. Given the limited data available, we suggest cautionary approaches for the public to avoid possible harm until further evidence emerges. NSAIDs should not be used as the first-line agents for COVID-19 unlessunder medical supervision. Moreover, patients with chronic inflammatory conditions should continue the NSAIDs as per their regular prescriptions.

Comparison of Knowledge and Practices among University Students of Allied Health Sciences and Engineering Departments in University of Lahore, Pakistan about Corona Virus Disease

Background: Corona Viruses is a group of viruses that cause diseases in both humans and mammals and are known to cause chronic respiratory diseases. The viruses among them include SARS, MERS and COVID-19. The most recent pandemic was a result of COVID-19. Older people and those with underlying medical problems are more likely to develop serious illness. Objective(s): To compare the knowledge and practices of Allied Health and Engineering students of the University of Lahore about Corona Virus Disease. Methodology: A cross-sectional questionnaire based survey was conducted on 326 students studying in Allied health Sciences and Engineering departments of UOL. The data was compiled in SPSS, version 24 for analysis. Result(s): The students of Allied Health Sciences had a better understanding and were more aware of COVID-19, its percussions and the methods to prevent its spread than of the Engineering Students. More than half of the Engineering students have found to have less understanding about the causative agent of the COVID-19 and similar trend was found in other categories. Health sciences students showed higher tendency towards hands hygiene practices than engineering students. Practical implication: Lessons learned from different outbreaks of infectious diseases suggested that knowledge and practices towards infectious diseases are associated with level of panic emotion among the population, which can further complicate attempts to prevent the spread of the disease. To facilitate outbreak management of COVID-19 in Lahore, Pakistan, there is an urgent need to understand the public's awareness of COVID-19. Keeping these considerations in mind this research was kicked-off to gauge the knowledge and practices of these medical and engineering students about Corona virus disease. Conclusion(s): The study shows that educational background plays a vital role in disease control and it will help in successful uptake of control interventions for prevention of COVID-19.Copyright © 2023 Lahore Medical And Dental College. All rights reserved.

Managing Risks in Clinical Trials During a Pandemic with ICH E6 (R2)

Consisting of a variety of required components-including but not limited to quality risk assessments, a written Quality Risk Management Plan, and strategic, centralized data reviews-the revision underscores the importance of a robust RBQM framework to ensure clinical trial execution in compliance with GCP. In this article, we will examine the overall value of ICH E6 (R2) to sponsors, as well as how COVID-19 has and will continue to influence sponsors' consideration of risk-based monitoring as a key component of clinical trial operations. [...]if they have not proactively identified key data and processes that could bring potential risk, they run the danger of getting "lost in the weeds" and overlooking risk factors that later breached tolerance limits and resulted in issues that had some level of impact on the study and its results. At Rho, we consider a robust RBQM framework to include dedicated quality risk managers, RBQM templates to assist with creating the plans required by ICH E6 (R2), a strategic approach to data review, among other components.

An Exploration of Journals Requested by Health Sciences Libraries through DOCLINE Interlibrary Loan During the Early COVID-19 Pandemic

COVID-19 challenged information exchange globally, including interlibrary loan (ILL). This project explored DOCLINE ILL borrowing data from 15 academic, hospital, and association health sciences libraries before and during the pandemic to understand gaps in ILL coverage. We reviewed aggregate filled and unfilled borrowing data from March to August in 2019 and 2020. We compared these time periods to each other and to system-wide fill rates. We normalized journal titles, added journal price and language, calculated descriptive statistics and odds ratios, and conducted 2-proportion z-tests of differences. In our sample of 14,891 requests, the odds of requests being unfilled were 2.7 times higher in 2020 than in 2019. While the proportion of non-English language content requested did not change, a significantly higher proportion went unfilled in 2020. The rate of unfilled requests for older items also rose significantly between 2019 and 2020. Our findings support the conclusion that the COVID-19 pandemic significantly influenced ILL article request fulfillment in health sciences libraries. Libraries should consider collection development strategies to increase the accessibility of articles held only in print, and those with specialized print collections may want to prioritize digitization of older materials. Future research on the availability, utility, and expense of the materials more likely to remain unfilled should inform publisher backfile prioritization as well as consortial and individual library collection development practices. © 2023, Association of College and Research Libraries. All rights reserved.

The Post-Pandemic CRO Landscape

None is inconsequential: advancing digital technology, globalization of clinical trials, changes in clinical trial design, the inflow of private equity dollars, fewer sponsors lost to mergers and acquisitions, more CROs, the costs of clinical trials, precision medicine, lack of available talent, and-an under the radar trend-the continuing challenges of chronic disease. A 2020 report called them a "primary factor" in the growth of global CRO services market.2 Casey McTigue, an executive director at SRS Acquiom, an M&A services firm, put it this way: "We have seen record setting volumes for M&A." Market attention In 2019, the life sciences recruiter Pr°Clinical considered the following CROs worthy of close attention from investors and pharma alike: PPD, Medpace, PRA Health Sciences, KCR, ICON, IQVIA, PSI, Parexel.3 Of the eight, three still stand alone;the rest have merged or been acquired. Combined, their network covers 2,800 hospitals, clinics and long-term care facilities, and 200 research and pharmaceutical companies, a press release says. Since the combined R&D outlay of the top pharma houses now hovers at the $100 billion-and that majority of trials have CRO involvement-even the math challenged can appreciate the CRO industry's losses, or gains, depending on the road chosen.6 But the CRO industry has already proved its resiliency. Despite changes in market conditions between 2008 and 2019, SRS Acquiom found that of the 227 private life sciences deals in which it was the shareholder representative, 163 had earnouts, the potential dollar figure more than $37 billion.

Vaccination prevents severe COVID-19 outcome in patients with neutralizing type 1 interferon autoantibodies.

A hallmark of patients with autoimmune polyendocrine syndrome type 1 (APS-1) is serological neutralizing autoantibodies against type 1 interferons (IFN-I). The presence of these antibodies has been associated with severe course of COVID-19. The aims of this study were to investigate SARS-CoV-2 vaccine tolerability and immune responses in a large cohort of patients with APS-1 (N = 33) and how these vaccinated patients coped with subsequent infections. We report that adult patients with APS-1 were able to mount adequate SARS-CoV-2 spike-specific antibody responses after vaccination and observed no signs of decreased tolerability. Compared with age- and gender-matched healthy controls, patients with APS-1 had considerably lower peak antibody responses resembling elderly persons, but antibody decline was more rapid in the elderly. We demonstrate that vaccination protected patients with APS-1 from severe illness when infected with SARS-CoV-2 virus, overriding the systemic danger of IFN-I autoantibodies observed in previous studies.

Exploratory Factorial Model of Hydric Conservation in the COVID-19 era

Scenarios of scarcity, shortages, healthiness and scarcity are proposed to which HEIs would react, but with nuances according to the capacities of the areas of knowledge such as the case of health sciences and administrative economic sciences. [...]a Modeling is a mapping of the variables indicative of a behavior based on inclusion criteria such as the consensus of the literature regarding the SDG-6 and its observation in HEIs. [...]verifiability frameworks prevail in the biological and health sciences. [...]a comparison between different sources observing the same phenomenon generates the veracity of a data [9]. The IES only covers a few disciplines that respond to the development needs of the region, as well as the projected labor demand [10]. [...]the objective of this work is to contribute with empirical evidence to the SDG indicators: scarcity, drought, depletion, sanitation, purification, quality and floods [11].

Biological mechanisms underpinning the development of long COVID.

As COVID-19 evolves from a pandemic to an endemic disease, the already staggering number of people that have been or will be infected with SARS-CoV-2 is only destined to increase, and the majority of humanity will be infected. It is well understood that COVID-19, like many other viral infections, leaves a significant fraction of the infected with prolonged consequences. Continued high number of SARS-CoV-2 infections, viral evolution with escape from post-infection and vaccinal immunity, and reinfections heighten the potential impact of Long COVID. Hence, the impact of COVID-19 on human health will be seen for years to come until more effective vaccines and pharmaceutical treatments become available. To that effect, it is imperative that the mechanisms underlying the clinical manifestations of Long COVID be elucidated. In this article, we provide an in-depth analysis of the evidence on several potential mechanisms of Long COVID and discuss their relevance to its pathogenesis.

122nd Annual Meeting Medical Library Association, Inc. New Orleans, LA May 3–6, 2022

The Medical Library Association (MLA) held its 122nd annual meeting May 3-6, 2022, in New Orleans LA. The meeting was entitled "MLA '22: Reconnect. Renew. Reflect" and utilized a hybrid model with some events in person, and some virtually. The virtual meeting was again broken into segments, all available using a variety of online platforms. Total attendance for the meeting was 1,250 with 575 attending in-person, and 675 virtually. Additional meeting content--including the meeting program and various electronic presentations from the business meetings, plenary sessions, poster sessions, and program sessions can be accessed by all meeting registrants via the MLA '22 website.

Virtual Services in the Health Sciences Library: A Handbook

Pope reviews Virtual Services in the Health Sciences Library: A Handbook edited by Amanda R. Scull.

International Classification of Diseases (ICD)

This article presents the history, contents, structures, functions, and applications of the International Classification of Diseases (ICD), which is a global standard maintained by the World Health Organization (WHO). The article aims to present ICD from the knowledge organization perspective and focuses on the current versions, ICD-10 and ICD-11. It also introduces the relationship between ICD and other health knowledge organization systems (KOSs), plus efforts in research and development reported in health informat-ics. The article concludes that the high-level effort of promoting a unified classification system such as ICD is critical in providing a common language for systematic recording, reporting, analysis, interpretation, and comparison of mortality and morbidity data. It greatly enhances the constancy of coding across languages, cultures, and healthcare systems around the world.

Assessment of SARS-CoV-2 neutralizing antibody titers in breastmilk from convalescent and vaccinated mothers.

Breastmilk contains antibodies that could protect breastfed infants from infections. In this work, we examined if antibodies in breastmilk could neutralize SARS-CoV-2 in 84 breastmilk samples from women that were either vaccinated (Comirnaty, mRNA-1273, or ChAdOx1), infected with SARS-CoV-2, or both infected and vaccinated. The neutralization capacity of these sera was tested using pseudotyped vesicular stomatitis virus carrying either the Wuhan-Hu-1, Delta, or BA.1 Omicron spike proteins. We found that natural infection resulted in higher neutralizing titers and that neutralization correlated positively with levels of immunoglobulin A in breastmilk. In addition, significant differences in the capacity to produce neutralizing antibodies were observed between both mRNA-based vaccines and the adenovirus-vectored ChAdOx1 COVID-19 vaccine. Overall, our results indicate that breastmilk from naturally infected women or those vaccinated with mRNA-based vaccines contains SARS-CoV-2 neutralizing antibodies that could potentially provide protection to breastfed infants from infection.

Perceptions of Health Sciences Faculty Students about Covid-19 and their Attitudes towards Covid-19 Vaccination

Objective: It is thought that the COVID-19 pandemic can be controlled with an effective and safe vaccination. The thoughts and attitudes of individuals towards the disease and the vaccine are important for the success of vaccination. This study was conducted to determine the perceptions of health sciences faculty students about COVID-19 and their attitudes towards COVID-19 vaccination. Method: A cross-sectional descriptive research design was used. The study consisted of students studying at the Faculty of Health Sciences between June and September 2021. A total of 674 students participated in the study. Findings: The mean age of participants was 20.62±1.88 years, and 85.3% of them were female. Of the participants, 76.1% stated that they had been vaccinated against COVID-19. It was found that positive attitudes towards the COVID-19 vaccine were high among students who were male, were studying nutrition and dietetics, and were 3rd and 4th-year students. Conclusions: In this study determined that most of the students had received the COVID-19 vaccine. Students obtained the lowest score on the belief sub-dimension of the perception of causes of COVID-19 scale and the highest on the environment sub-dimension. It was found that students' scores on the attitudes towards the COVID-19 vaccine scale were moderate.

Terveystieteiden opettajaopiskelijoiden pedagogiset ratkaisut ja digitaaliset resurssit opetusharjoittelussa COVID-19-pandemian aikana

The purpose of the study was to describe the pedagogical solutions and the use of digital resources during the teaching practice of health sciences teacher students in distance and contact teaching during the COVID-19 pandemic. Distance teaching consisted of starting of a teaching event, lecture with activating methods, utilization of participatory and in-depth learning methods and concluding a teaching event. Contact teaching consisted of starting of a teaching event, lecture with activating methods, utilization of participatory and indepth learning methods, instruction, practice and concluding a teaching event. Teacher students had the opportunity to practice and apply their theoretical skills studied in health sciences teacher education courses in practical environments corresponding to social, healthcare and rehabilitation learning environments.

Health Sciences students' experience of COVID-19 case management and contact tracing in Cape Town, South Africa.

BACKGROUND: COVID-19 has challenged health and higher education systems globally. Managing the epidemic in Cape Town, South Africa (SA), required partnerships with universities and setting up of de novo systems for mass case and contact tracing (C&CT). Health sciences, predominantly medical students, as well as social work and psychology students formed the core of this telephone-based work over the 18 months when SARS-CoV-2 caused severe disease. METHODS: This qualitative study aimed to elicit students' motivations for becoming involved in C&CT, their experiences, and recommendations for C&CT and curricula. After Cape Town's first COVID-19 wave, six on-line focus groups comprising 23 students were conducted, and a further four were conducted with 13 students after the second wave. As the researchers were predominantly educators previously involved in undergraduate health sciences education, the study's purpose was to reflect on students' experiences to make educational and health system recommendations. RESULTS: Students were largely motivated to mitigate the impact of the epidemic on society and support people affected by COVID-19, as well as hone their professional skills. While these motivations were realised, students also needed to learn new skills - to autonomously work remotely, using novel communication strategies to engage those affected and use virtual groups to connect with colleagues. They managed responsibilities within the healthcare systems that did not always work smoothly, distressed cases who were financially insecure, difficult employers, and language barriers. They were prepared through training, and supported by virtual, yet effective teamwork and debriefing opportunities. Although the work was sometimes physically and emotionally exhausting, students found the work personally meaningful. They embraced public health's role to protect population and individuals' health. CONCLUSION: New teaching and learning practices adopted due to Covid-19 lockdowns enabled this digital C&CT project. It facilitated students to become confident, work autonomously and navigate challenges they will encounter as young professionals. The programme demonstrated that novel opportunities for rich student learning, such as in telehealth, can be embedded into public health and clinical functions of health services in contexts such as in SA, deepening partnerships between the health services and universities, to mutual benefit.

mHealth and e-Learning in health sciences curricula: a South African study of health sciences staff perspectives on utilisation, constraints and future possibilities.

BACKGROUND: Over the last decade, developments in e-Learning and technologies are creating the groundwork for health sciences and medical education. Literature demonstrates that we have yet to reach any form of consensus about which indicators are needed to assess and teach quality health sciences and medical education through technology or innovation. There is, therefore, a greater need for a tool or platform that is properly constructed, validated and tested within health sciences. METHODS: This paper presents a study, which is part of a larger research project assessing staff and students' perceptions of the importance and relevance of different aspects of e-Learning and mHealth in health sciences curricula at four universities in South Africa. The specific objectives of this study were to: (i) assess health sciences staffs' perceptions and understanding of these two applications; and (ii) establish challenges and opportunities of e-Learning and mHealth applications in the health sector, as well as perceptions on the importance and relevance of these applications to their curricula and future practices. A combination of Focus Group Discussions (FGDs) and a key-informant interview was used. A total of 19 staff from four universities participated. Atlast.ti was used for the data analysis and the findings were coded using a primarily deductive thematic coding framework. RESULTS: The findings revealed that not all staff members are equipped or trained with new applications or technologies, such as mHealth. Most participants believed that diverse technologies and tools could be integrated with mHealth and e-Learning. Furthermore, participants agree that a new multi-modal platform, in the form of a learning management system (LMS) with relevant applications (and possible plugins) integrated, tailored towards health sciences will benefit all stakeholders, and be valuable to higher education and health sectors. CONCLUSIONS: Digitalisation as well as digital citizenship is gradually being integrated into teaching and learning. It is imperative to adapt the health sciences curricula through constructive alignments and promote health sciences education in the current 4IR. This would allow graduates to be better prepared for digitalised practice environments.

Positive feedback loops exacerbate the influence of superspreaders in disease transmission.

Superspreaders are recognized as being important drivers of disease spread. However, models to date have assumed random occurrence of superspreaders, irrespective of whom they were infected by. Evidence suggests though that those individuals infected by superspreaders may be more likely to become superspreaders themselves. Here, we begin to explore, theoretically, the effects of such a positive feedback loop on (1) the final epidemic size, (2) the herd immunity threshold, (3) the basic reproduction number, R0, and (4) the peak prevalence of superspreaders, using a generic model for a hypothetical acute viral infection and illustrative parameter values. We show that positive feedback loops can have a profound effect on our chosen epidemic outcomes, even when the transmission advantage of superspreaders is moderate, and despite peak prevalence of superspreaders remaining low. We argue that positive superspreader feedback loops in different infectious diseases, including SARS-CoV-2, should be investigated further, both theoretically and empirically.

COVID-19 vaccine antibody responses in community-dwelling adults to 48 weeks post primary vaccine series.

We report a decentralized prospective cohort study of self-reported adverse events and antibody responses to COVID vaccines derived from dried blood spots. Data are presented for 911 older (aged >70 years) and 375 younger (30-50 years) recruits to 48 weeks after the primary vaccine series. After a single vaccine, 83% younger and 45% older participants had overall seropositivity (p < 0.0001) increasing to 100/98% with the second dose, respectively (p = 0.084). A cancer diagnosis (p = 0.009), no mRNA-1273 vaccine doses (p <0 .0001), and older age (p <0 .0001) predicted lower responses. Antibody levels declined in both cohorts at 12 and 24 weeks increasing with booster doses. At 48 weeks, for participants with 3 vaccine doses, the median antibody levels were higher in the older cohort (p = 0.04) with any dose of mRNA-1273 (p <0 .0001) and with COVID infection (p <0 .001). The vaccines were well tolerated. Breakthrough COVID infections were uncommon (16% older cohort, 29% younger cohort; p < 0.0001) and mild.