Leading by example: Leveraging academic innovation centers in times of crisis

Universities worldwide are increasingly investing in academic innovation centers that are designed to encourage their students to pursue careers focused on innovation and technology. This chapter explores the educational opportunities of these academic innovation centers during crisis situations by documenting how an academic innovation center at Florida State University - the Innovation Hub - was able to encourage university students to engage in creative problem solving through design thinking, emerging technologies, and experiential learning during the COVID-19 pandemic. The results of these efforts demonstrate that academic innovation centers, during times of global crisis, have a unique opportunity to lead by example, enhancing their educational impact by connecting students directly with real-world challenges as creative problem solvers with the power to improve their communities. © Springer Nature Switzerland AG 2021. All rights reserved.

Feasibility and preliminary efficacy of structured programming and a parent intervention to mitigate accelerated summer BMI gain: a pilot study.

BACKGROUND: This study assessed the initial feasibility and preliminary efficacy of providing children a free summer day camp and a parent intervention to improve self-regulation and mitigate accelerated summer BMI gain. METHODS: This pilot 2x2 factorial randomized control trial used a mixed-methods design to evaluate providing children a free summer day camp (SCV), a parent intervention (PI), and the combination of these two strategies (SCV+PI) to mitigate accelerated summer body mass index (BMI) gain. Progression criteria for feasibility and efficacy were assessed to determine if a full-scale trial was warranted. Feasibility criteria included recruitment capability (≥80 participants recruited) retention (≥70% participants retained), compliance (≥80% of participants attending the summer program with children attending ≥60% of program days, and ≥80% of participants completing goal setting calls with ≥60% of weeks syncing their child's Fitbit), and treatment fidelity (≥80% of summer program days delivered for ≥9 h/day, and ≥80% of participant texts delivered). Efficacy criteria were assessed via achieving a clinically meaningful impact on zBMI (i.e., ≥0.15). Changes in BMI were estimated using intent-to-treat and post hoc dose-response analyses via multilevel mixed-effects regressions. RESULTS: For recruitment, capability and retention progression criteria were met with a total of 89 families participating and 24 participants randomized to the PI group, 21 randomized to the SCV group, 23 randomized to the SCV+PI group, and 21 randomized to the control. However, fidelity and compliance progression criteria were not achieved due to COVID-19 and lack of transportation. Progression criteria for efficacy was also not achieved as intent-to-treat analyses did not show changes in BMI gain that were clinically meaningful. Post hoc dose-response analyses showed that for each day (0 to 29) of summer programming children attended they gained -0.009 (95CI= -0.018, -0.001) less in BMI z score. CONCLUSIONS: Engagement in both the SCV and PI was not ideal due to COVID-19 and lack of transportation. Providing children with structured summer programming to mitigate accelerated summer BMI gain may be an effective strategy. However, because feasibility and efficacy progression criteria were not met, a larger trial is not warranted until further pilot work is completed to ensure children attend the programming. TRIAL REGISTRATION: The trial reported herein was prospectively registered at ClinicalTrials.gov. Trial #: NCT04608188.

At-risk patient and healthcare provider perspectives on clinical trial participation for ductal carcinoma in situ

Background: Significant challenges exist in recruiting newly diagnosed ductal carcinoma in situ (DCIS) patients to participate in presurgical intervention trials. Perceived motivators and barriers to participation have not been formally studied from the patient or healthcare provider (HCP) perspective. Based on our experience in the Promise Study (NCT02694809), we hypothesized that delaying surgery and concern for side effects are barriers to trial participation and that access to new treatments and financial benefits are motivators. To improve recruitment, we conducted focus groups to better understand barriers and motivators for trial participation in our patient population. Methods: Three focus groups with post-menopausal women (PMW) without history of DCIS, one focus group with patients previously treated for DCIS, and two HCP focus groups were conducted. Due to COVID-19, the focus groups took place online via videoconferencing and included participants from across the United States. A thirdparty facilitator generated discussion on predetermined topics including knowledge of DCIS, clinical trial recruitment materials, hormone replacement therapy, healthcare delivery and clinical trials during COVID-19, and perceived motivators and barriers to trial participation in general and specifically for women with DCIS. Here, we focus on comparing perceived influential factors for patient participation in DCIS clinical trials in PMW and HCP focus groups. Qualitative thematic analysis was completed on focus group transcripts in NVivo. Results: PMW had no knowledge of DCIS prior to the focus groups and believed DCIS should be removed promptly. PMW believed barriers to DCIS clinical trial participation included the potential for the study drug to cause harm, distrust of medicine, and the fact that DCIS is not life-threatening. PMW identified helping future DCIS patients, accessing better treatment, and easing anxiety as motivators for DCIS trial participation. HCPs believed patients were motivated by increased monitoring by the medical team, financial incentive, and access to newer treatment. HCPs believed that delays in DCIS surgery, the potential for the intervention to be harmful or ineffective, and the trial causing patient anxiety were barriers. Neither group emphasized time commitment as a barrier to DCIS trial participation. PMW were not motivated by financial incentives. Conclusions: Knowledge about DCIS is lacking in PMW. PMW and HCPs agreed that the risk of harm caused by study interventions is a deterrent to trial participation and that access to superior treatment is a motivator. However, PMW and HCPs did not agree on other motivators and barriers which could lead to missed recruitment opportunities. Providing educational materials on DCIS and addressing motivators and barriers to clinical trial participation may increase recruitment to presurgical DCIS trials.

Anvil - System Architecture and Experiences from Deployment and Early User Operations

Anvil is a new XSEDE advanced capacity computational resource funded by NSF. Designed with a systematic strategy to meet the ever increasing and diversifying research needs for advanced computational capacity, Anvil integrates a large capacity high-performance computing (HPC) system with a comprehensive ecosystem of software, access interfaces, programming environments, and composable services in a seamless environment to support a broad range of current and future science and engineering applications of the nation's research community. Anchored by a 1000-node CPU cluster featuring the latest AMD EPYC 3rd generation (Milan) processors, along with a set of 1TB large memory and NVIDIA A100 GPU nodes, Anvil integrates a multi-tier storage system, a Kubernetes composable subsystem, and a pathway to Azure commercial cloud to support a variety of workflows and storage needs. Anvil was successfully deployed and integrated with XSEDE during the world-wide COVID-19 pandemic. Entering production operation in February 2022, Anvil will serve the nation's science and engineering research community for five years. This paper describes the Anvil system and services, including its various components and subsystems, user facing features, and shares the Anvil team's experience through its early user access program from November 2021 through January 2022. © 2022 Owner/Author.

Extended cohort for e-health, environment and DNA (exceed) COVID-19 focus

Background: New data collection in established longitudinal population studies provides an opportunity for studying the risk factors and sequelae of the novel coronavirus disease 2019 (COVID-19), plus the indirect impacts of the COVID-19 pandemic on wellbeing. The Extended Cohort for E-health, Environment and DNA (EXCEED) cohort is a population-based cohort (N>11,000), recruited from 2013 in Leicester, Leicestershire and Rutland. EXCEED includes consent for electronic healthcare record (EHR) linkage, spirometry, genomic data, and questionnaire data.

End-to-end SARS-CoV-2 transmission risks in sport: current evidence and practical recommendations

The coronavirus disease 2019 (COVID-19) pandemic has caused disruption to professional and recreational sports across the world. The SARS-CoV-2 virus can be transmitted by relatively large respiratory droplets that behave ballistically, and exhaled aerosol droplets, which potentially pose a greater risk. This review provides a summary of end-to-end SARS-CoV-2 transmission risk factors for sport and an overview of transmission mechanisms to be considered by all stakeholders. The risk of SARS-CoV-2 transmission is greatest indoors, and primarily influenced by the ventilation of the environment and the close proximity of individuals. The SARS-CoV-2 transmission risks outdoors, e.g. via water, and from fomites, appear less than initially thought. Mitigation strategies include good end-to-end scenario planning of activities to optimise physical distancing, face mask wearing and hygiene practice of individuals, the environment and equipment. The identification and removal of infectious individuals should be undertaken by means of the taking of temperature and COVID-19 symptom screening, and the use of diagnostic monitoring tests to identify asymptomatic individuals. Using adequate video footage, data from proximity technology and subject interviews, the identification and isolation of 'close contacts' should also be undertaken to limit SARS-CoV-2 transmission within sporting environments and into the wider community. Sports should aim to undertake activities outdoors where possible, given the lower SARS-CoV-2 transmission risk, in comparison to indoor environments.

Model-informed Dose Selection of Dual Toll-like Receptor 7/8 Inhibitor Enpatoran (M5049) for the Treatment of COVID-19 Pneumonia

Background. Enpatoran, formerly known as M5049, is a potential first-in-class small molecule antagonist of toll-like receptors (TLR) 7 and 8, which may prevent viral-associated hyperinflammatory response and progression to 'cytokine storm' in coronavirus disease 2019 (COVID-19) patients. The objective of this study was to leverage existing population pharmacokinetic/pharmacodynamic (popPK/PD) models for enpatoran to inform dose selection for an accelerated Phase II study in COVID-19 patients with pneumonia. Methods. The popPK/PD models were based on plasma PK and PD biomarker (ex vivo-stimulated interleukin [IL]6 and interferon α [IFNα] secretion) data from the enpatoran first-in-human Phase I study in healthy participants (Port A, et al. Lupus Sci Med 2020;7(Suppl. 1): P135). A two-compartment model describing PK used a sigmoidal Emax model with proportional decrease from baseline characterizing the PD response across the investigated single and multiple daily dose range of 1-200 mg (N=72). Concentrations that inhibited 50% and 90% (IC50/IC90) of cytokine secretion were estimated and stochastic simulations were performed to assess target coverage under different dosing regimens. Results. Simulations suggested that, to achieve maximal inhibition of IL-6 over time, enpatoran PK concentrations would be maintained above the IC90 throughout the dosing interval with doses of 100 mg and 50 mg twice daily in 90% and 30% of participants, respectively. In comparison, IFNα inhibition was predicted to be lower, with IC90 coverage in 60% and 8% of participants with twice daily doses of 100 mg and 50 mg enpatoran, respectively. Conclusion. Utilization of existing popPK/PD models allowed for the accelerated development of enpatoran in COVID-19 to address an unprecedented global pandemic. Rational model-informed dose selection was supported by data from a Phase I study in which there were no safety concerns.

Perspectives on Collector Collaboration

In 2019, we launched the Northern Arizona Paleoindian Project to expand on findings from the Rock Art Ranch (RAR) Research Experiences for Undergraduates (REU;NSF#1262184). The REU recovered 24 Paleoindian artifacts in association with drainages. Expansion of the research required mitigation of the patchwork landownership in the area, which encouraged a collector-collaboration model following Pitblado (2014) and Douglass et alia (2017). We held public events in collaboration with a network of agencies, avocational groups, collectors, and landowners to assess potential for Paleoindian archaeology in the area. In March 2020, however, the COVID-19 pandemic halted our efforts, allowing us to evaluate our project and practice. We find that tapping into existing local networks of responsible resource stewards (RRS) can greatly accelerate project development. We also find that private collections are endangered, and preserving this portion of the archaeological record requires documentation and long-term curation. Most importantly, we find that archaeologists working with collectors are uniquely positioned to build bridges between Indigenous communities, RRS, and professional archaeologists to help stabilize legacy collections and that this focus should drive collector-collaboration research design. Ultimately, the project must move toward a community-based participatory research design to seek equitable and culturally appropriate curation plans for local legacy collections. Copyright © The Author(s), 2022. Published by Cambridge University Press on behalf of Society for American Archaeology.

High SARS-CoV-2 seroprevalence in health care workers but relatively low numbers of deaths in urban Malawi

Background: In low-income countries, like Malawi, important public health measures including social distancing or a lockdown have been challenging to implement owing to socioeconomic constraints, leading to predictions that the COVID-19 pandemic would progress rapidly. However, due to limited capacity to test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, there are no reliable estimates of the true burden of infection and death. We, therefore, conducted a SARS-CoV-2 serosurvey amongst health care workers (HCWs) in Blantyre city to estimate the cumulative incidence of SARS-CoV-2 infection in urban Malawi.

Water, sanitation, and hygiene (WASH) insecurity will exacerbate the toll of COVID-19 on women and girls in low-income countries

The novel coronavirus disease (COVID-19) pandemic is having a significant global impact on livelihoods, health, and general well-being. This policy brief argues that in low-income countries (LICs) where water, sanitation, and hygiene (WASH) insecurity is widespread and closely entangled with poverty and other vulnerabilities, COVID-19 will have a particularly devastating impact on women and girls because they bear the disproportionate burden of water collection, sanitation, hygiene, and family welfare ‒ responsibilities embedded in longstanding sociocultural norms. WASH insecurity refers to the physical and relational inequities in WASH access. Using three pathways ‒ reproductive and perinatal health, cultural norms and the risk of COVID-19 infections, and physical and mental health ‒ we discuss how WASH insecurity will worsen the impact of COVID-19 on women and girls in LICs. © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.