Experiences with Prototyping and Making in Virtual Classes

The pandemic caused people to teach classes virtually that they never imagined could be taught virtually. Hands-on classes are among the most challenging to move from in-person to virtual. In this paper, we focus on how prototyping in engineering classes was handled when those classes were taught virtually during the COVID-19 pandemic. Four engineering educators from a diverse set of four schools were engaged on this topic through written reflections and two focus groups. Learning from this experience has implications for these classes as they remain virtual and shift to hybrid and back to in-person. The four educators each found ways to make prototyping work in virtual classes. Shifting closed-ended prototyping from in-person to virtual classes was found to require less change than shifting open-ended prototyping. Within open-ended prototyping, the instructors generally narrowed scopes and took on less ambitious projects, with students engaging in new ways that produced impressive prototypes that surprised some the educators. Access to materials and tools was handled through different approaches, with curated sets of materials that maintain design freedom being important for open-ended projects while a standard set of materials for all teams worked for closedended projects. Students expressed more interest in doing projects individually. For those that worked on teams, approaches included having the whole team produce one prototype and having each person produce a prototype. Having each person produce their own prototype opened up the possibility that students would not truly collaborate. Even though they were all virtual, teams of students who had to make a single prototype generally worked better than expected.

Plain language summary of Pfizer-BioNTech BNT162b2 vaccine protection against COVID-19 and its safety in participants 12- to 15-years-old

What is this summary about? This is a summary of an article about part of a clinical study for the BNT162b2 COVID-19 vaccine, also called the Pfizer-BioNTech vaccine. The article was published in the New England Journal of Medicine in May 2021. This summary describes how the vaccine worked in participants 12- to 15-years old. The part of the study described in the article is ongoing and expected to finish March 2023. This means that the final results may be different from the results included in this summary. What happened in this study? The part of the study described in this summary included participants 12- to 15-years old who had no serious health issues. The BNT162b2 vaccine had already been studied in participants 16 years of age or older. In this part of the study, the researchers wanted to find out: * How effective and safe the vaccine was in participants 12- to 15-years old. * What the immune response to the vaccine and the vaccine safety were like in 12- to 15-year-olds compared with 16- to 25-year-olds. * How well the vaccine prevented SARS-CoV-2 infections in participants who received the vaccine compared to those who did not. This is also called efficacy of the BNT162b2 vaccine Half of the participants in this study received 2 injections of the BNT162b2 vaccine and half received 2 injections of a placebo in a muscle of the upper arm. The placebo looked like the BNT162b2 vaccine but did not have any active vaccine in it. What were the results? * BNT162b2 had a favorable safety profile. The most common reactions were pain at the injection site, fatigue, and headache. None of the participants had serious reactions to the vaccine. * The 12- to 15-year-old participants' immune system responses to the BNT162b2 vaccine were as good as or stronger than the 16- to 25-year-old participants' immune responses. * The participants who received the BNT162b2 vaccine were less likely to get COVID-19 compared with the participants who got the placebo.Copyright © 2023 The Authors.

Did the UK's public health shielding policy protect the clinically extremely vulnerable during the COVID-19 pandemic in Wales? Results of EVITE Immunity, a linked data retrospective study.

INTRODUCTION: The UK shielding policy intended to protect people at the highest risk of harm from COVID-19 infection. We aimed to describe intervention effects in Wales at 1 year. METHODS: Retrospective comparison of linked demographic and clinical data for cohorts comprising people identified for shielding from 23 March to 21 May 2020; and the rest of the population. Health records were extracted with event dates between 23 March 2020 and 22 March 2021 for the comparator cohort and from the date of inclusion until 1 year later for the shielded cohort. RESULTS: The shielded cohort included 117,415 people, with 3,086,385 in the comparator cohort. The largest clinical categories in the shielded cohort were severe respiratory condition (35.5%), immunosuppressive therapy (25.9%) and cancer (18.6%). People in the shielded cohort were more likely to be female, aged ≥50 years, living in relatively deprived areas, care home residents and frail. The proportion of people tested for COVID-19 was higher in the shielded cohort (odds ratio [OR] 1.616; 95% confidence interval [CI] 1.597-1.637), with lower positivity rate incident rate ratios 0.716 (95% CI 0.697-0.736). The known infection rate was higher in the shielded cohort (5.9% vs 5.7%). People in the shielded cohort were more likely to die (OR 3.683; 95% CI: 3.583-3.786), have a critical care admission (OR 3.339; 95% CI: 3.111-3.583), hospital emergency admission (OR 2.883; 95% CI: 2.837-2.930), emergency department attendance (OR 1.893; 95% CI: 1.867-1.919) and common mental disorder (OR 1.762; 95% CI: 1.735-1.789). CONCLUSION: Deaths and healthcare utilisation were higher amongst shielded people than the general population, as would be expected in the sicker population. Differences in testing rates, deprivation and pre-existing health are potential confounders; however, lack of clear impact on infection rates raises questions about the success of shielding and indicates that further research is required to fully evaluate this national policy intervention.

Plain language summary of Pfizer-BioNTech BNT162b2 COVID-19 vaccine safety in participants 16 years or older and protection against COVID-19 in participants 12 years or older

What is this summary about?This is a summary of an article about part of a clinical study for the BNT162b2 COVID-19 vaccine, also called the Pfizer-BioNTech vaccine. The article was published in the New England Journal of Medicine in September 2021. The part of the study described in the article began in July 2020 and is ongoing. This means that the final results may be different from the results included in this summary.What happened in this study?The participants in this study received 2 injections of either the BNT162b2 vaccine or a placebo, 21 days apart. The placebo looked like the BNT162b2 vaccine but had no active vaccine in it. None of the trial participants or study teams knew who received vaccine or placebo.What were the results?Most of the reactions to the injections were mild or moderate and lasted for a short period of time. The most common reactions were pain at the injection site, extreme tiredness (fatigue), and headache. These reactions usually happened in the first 7 days after receiving a vaccine dose. A small number of participants had severe reactions to the vaccine.Compared to participants who received the placebo, participants who received the BNT162b2 vaccine were much less likely to become ill if they were infected with the virus that causes COVID-19. The vaccine also had very good efficacy at preventing severe COVID-19.Participants in South Africa who received the BNT162b2 vaccine were less likely to become ill after infection with the beta variant of the virus compared to participants who received the placebo. The beta variant was very common in South Africa when the study was taking place.

THE CHAIR STAND TEST IS A RELIABLE FRAILTY METRIC FOR PREDICTING WAITLIST MORBIDITY AND MORTALITY IN PATIENTS WITH CIRRHOSIS

Background Frailty is defined as a clinical state of increased vulnerability to health and age associated stressors. The liver frailty index (LFI), composed of grip strength, chair stand and balance testing, is an accepted predictor of morbidity and mortality in cirrhosis. With the need for COVID-19 related social distancing, many appointments are being carried out virtually. The chair stand subcomponent of the LFI has the potential to be evaluated virtually, with a high reliability as compared to in-person testing noted in other disease populations. Objective To determine if the chair stand test is an independent predictor of morbidity and mortality in patients with cirrhosis. Methods 822 adult patients with cirrhosis were prospectively enrolled from five centers (3 in Canada, 1 in the United States, and 1 in India). Inclusion criteria included adult patients with cirrhosis. 787 of these patients completed a chair stand test at baseline, measured as the time (seconds) a patient takes to rise from sitting with their arms folded across their chest five times (measured in-person). The times were divided into 3 categories: >15 seconds, between 10 and 15 seconds, and <10 seconds. Patients who could not complete 5 chair stands were classified in the >15 seconds category. Primary outcome was all-cause mortality. Secondary outcome was unplanned all-cause hospital admission. Fine-Gray proportional hazard regression models were used to evaluate the association between the chair stand time and the outcomes. We adjusted for baseline age, sex, and MELD score and accounted for liver transplantation as a competing risk. Cumulative incidence functions were used to create a graphical representation of the survival analysis. Results Patients were divided into three groups: group 1, <10 seconds (n = 276);group 2, 10-15 seconds (n = 290);and group 3, >15 seconds (n = 221). Mortality was increased in group 3 in comparison to group 1 (HR 3.21, 95% CI: 2.16-4.78, p<0.001). Similarly, the hazard of non-elective hospitalizations was higher in group 3 in comparison to group 1 (HR 2.24, 95% CI: 1.73-2.91, p<0.001). Overall, patients with chair stand times greater than 15 seconds had increased all-cause mortality (HR 2.78, 95% CI 2.01-3.83, p<0.001) and non-elective hospitalizations (HR 1.84, 95% CI 1.48-2.29, p<0.001) when compared to patients with times less than 15 seconds. Conclusion A time to complete 5 chair stands of >15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform. (Figure Presented)

THE CHAIR STAND TEST IS A RELIABLE FRAILTY METRIC FOR PREDICTING WAITLIST MORBIDITY AND MORTALITY IN PATIENTS WITH CIRRHOSIS

Background Frailty is defined as a clinical state of increased vulnerability to health and age associated stressors. The liver frailty index (LFI), composed of grip strength, chair stand and balance testing, is an accepted predictor of morbidity and mortality in cirrhosis. With the need for COVID-19 related social distancing, many appointments are being carried out virtually. The chair stand subcomponent of the LFI has the potential to be evaluated virtually, with a high reliability as compared to in-person testing noted in other disease populations. Aims To determine if the chair stand test is an independent predictor of morbidity and mortality in patients with cirrhosis. Methods 822 adult patients with cirrhosis were prospectively enrolled from five centers (3 in Canada, 1 in the United States, and 1 in India). Inclusion criteria included adult patients with cirrhosis. 787 of these patients completed a chair stand test at baseline, measured as the time (seconds) a patient takes to rise from sitting with their arms folded across their chest five times (measured in-person). The times were divided into 3 categories: >15 seconds, between 10 and 15 seconds, and <10 seconds. Patients who could not complete 5 chair stands were classified in the >15 seconds category. Primary outcome was all-cause mortality. Secondary outcome was unplanned all-cause hospital admission. Fine-Gray proportional hazard regression models were used to evaluate the association between the chair stand time and the outcomes. We adjusted for baseline age, sex, and MELD score and accounted for liver transplantation as a competing risk. Cumulative incidence functions were used to create a graphical representation of the survival analysis. Results Patients were divided into three groups: group 1, <10 seconds (n = 276);group 2, 10–15 seconds (n = 290);and group 3, >15 seconds (n = 221). Mortality was increased in group 3 in comparison to group 1 (HR 3.21, 95% CI: 2.16–4.78, p<0.001). Similarly, the hazard of non-elective hospitalizations was higher in group 3 in comparison to group 1 (HR 2.24, 95% CI: 1.73–2.91, p<0.001). Overall, patients with chair stand times greater than 15 seconds had increased all-cause mortality (HR 2.78, 95% CI 2.01–3.83, p<0.001) and non-elective hospitalizations (HR 1.84, 95% CI 1.48–2.29, p<0.001) when compared to patients with times less than 15 seconds. Conclusions A time to complete 5 chair stands of >15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform. Funding Agencies None

Critical values of learning to speak English for Japanese clinicians.

We suggest three reasons why Japanese clinicians should learn to speak English: international academic interaction, gaining experience abroad, and having another skill in the rapidly changing world during the COVID-19 pandemic. Not only reading and writing English but also speaking the language is inevitable for Japanese clinicians. Although speaking English is not easy owing to the disparity between English and Japanese, verbal English fluency adds tremendous value to academic development.

COVID-19 vaccine in participants (ptcpts) with cancer: Subgroup analysis of efficacy/safety from a global phase III randomized trial of the BNT162b2 (tozinameran) mRNA vaccine

Background: Patients with cancer are at higher risk of developing COVID-19 disease, adverse outcomes, and increased mortality. Phase III COVID-19 vaccine trials have demonstrated safety/efficacy against COVID-19 and prevented hospitalizations and deaths;however, most excluded ptcpts with cancer. We present phase 3 tozinameran mRNA COVID-19 vaccine trial results from ptcpts with a cancer history at baseline, either ongoing or not, per the Charlson Comorbidity Index and up to 6 months of follow-up. Methods: Between Jul 2020-Jan 2021, 46429 ptcpts ≥12 y at 152 sites in 6 countries were randomized in a placebo-controlled, observer-blinded trial of 2-dose tozinameran, showing 95% protection against COVID-19 and favorable safety (Polack et al NEJM, Dec 2020). After emergency use authorization, ptcpts were allowed to unblind and placebo recipients received vaccine. Data prior to unblinding for crossover up to 13 Mar 2021 are presented for ptcpts ≥16 y for safety and ≥12 y for efficacy. Adverse event (AE) data are controlled for follow-up time before unblinding and reported as incidence rate (IR) per 100-person-y of follow-up. Results: Of ptcpts ≥16 y, 1647 had a prior diagnosis of cancer and were not on active immunosuppressive treatment (755 M;892 F;median age 66 y [range 22-91]). Most common solid cancers included breast (n=458), prostate (n=360), and melanoma (n=210). AEs were reported at IRs of 94.0 (vaccine) and 49.3 (placebo) per 100-person-y;most common AEs were reactogenicity events (injection-site pain [IR: 40.2 vaccine;4.2 placebo];fatigue [IR: 21.4 vaccine;7.6 placebo];pyrexia [IR: 19.8 vaccine;0.7 placebo]). 1 vaccine ptcpt withdrew due to a vaccine-related AE. No vaccine-related deaths were reported. Among ptcpts ≥12 y with cancer, 3 vaccine and 27 placebo recipients developed COVID-19 from 7 days post-Dose 2;vaccine efficacy (VE) was 89.7% (95% CI 66.5-98.0%). This compares favorably with overall VE of 91.1%. Updated results will be presented. Conclusions: Tozinameran has similar efficacy/safety in ptcpts with cancer as in the overall population. These results inform tozinameran use in COVID-19 and in future trials in patients with cancer. Clinical trial identification: NCT04368728. Editorial acknowledgement: Editorial assistance was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, and was funded by Pfizer. Legal entity responsible for the study: Study sponsored by BioNTech, managed by Pfizer. Funding: Pfizer and BioNTech. Disclosure: S.J. Thomas: Financial Interests, Personal and Institutional, Research Grant, Advisory role: Pfizer. J.L. Perez: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S.P. Lockhart: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S. Hariharan: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. N. Kitchin: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. R. Bailey: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. K. Liau: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. E. Lagkadinou: Financial Interests, Personal, Full or part-time Employment: BioNTech. Ö. Türeci: Financial Interests, Personal, Research Grant: BioNTech. U. Şahin: Financial Interests, Personal, Research Grant: BioNTech. X. Xu: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S.S. Dychter: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. C. Lu: Financial Interests, Personal, Full or part-time Employment: Pfizer. W. Gruber: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. All other authors have declared no conflicts of interest.

Incorporating a wellness initiative into a general medicine advanced pharmacy practice experience

Introduction: Wellness is an active process of becoming aware of and making choices toward a healthy and fulfilling life. Pharmacy educators are in a unique position to bring awareness, engage in discussion, and provide initiatives to improve student wellbeing. In a recent study, postgraduate year 1 pharmacy residents most frequently reported the following coping mechanisms: 1) spending time with family and friends;2) staying optimistic;3) engaging in enjoyable activities;4) exercising/sports;5) sleep. As result, 5 wellness initiatives (faith, fitness, family/friends, fun, food) were incorporated into a 5-week advanced pharmacy practice experience (APPE). Research Question or Hypothesis: To determine the impact of a wellness initiative on fourth year pharmacy students' overall wellness during a general medicine APPE Study Design: Prospective, anonymous, electronic survey Methods: A survey was created, pilot-tested, and distributed to 15 pharmacy students completing a general medicine APPE at one community hospital from July 2019 to March 2020. Survey results were analyzed using Wilcoxon Signed Rank test (SPSS Inc., Version 26) and descriptive statistics. Results: A total of 10 surveys were completed (67% response rate). On a scale of 1 to 10, participants reported improved satisfaction with their overall wellness as a result of the rotational activities (median [IQR]: 6 [4.75-10] vs 8.5 [7-10];P = 0.027). Faith discussions were reported as having the greatest impact on student wellness while healthy eating habits had the least. Respondents reported fasting from social media had the most positive impact on their wellness, while budgeting had the least positive impact. Ninety-percent of participants strongly agreed the wellness initiatives contributed to a positive learning environment during the APPE and moreover were better prepared to cope and find balance during the COVID-19 pandemic. Conclusion: Incorporating a wellness initiative into a fourth-year pharmacy APPE had a positive impact on students' overall wellness.

"Freedom to Breathe": Youth Participatory Action Research (YPAR) to Investigate Air Pollution Inequities in Richmond, CA.

Air pollution is a major contributor to human morbidity and mortality, potentially exacerbated by COVID-19, and a threat to planetary health. Participatory research, with a structural violence framework, illuminates exposure inequities and refines mitigation strategies. Home to profitable oil and shipping industries, several census tracts in Richmond, CA are among the most heavily impacted by aggregate burdens statewide. Formally trained researchers from the Center for Environmental Research and Children's Health (CERCH) partnered with the RYSE youth justice center to conduct youth participatory action research on air quality justice. Staff engaged five youth researchers in: (1) collaborative research using a network of passive air monitors to quantify neighborhood disparities in nitrogen dioxide (NO2) and sulfur dioxide (SO2), noise pollution and community risk factors; (2) training in environmental health literacy and professional development; and (3) interpretation of findings, community outreach and advocacy. Inequities in ambient NO2, but not SO2, were observed. Census tracts with higher Black populations had the highest NO2. Proximity to railroads and major roadways were associated with higher NO2. Greenspace was associated with lower NO2, suggesting investment may be conducive to improved air quality, among many additional benefits. Youth improved in measures of empowerment, and advanced community education via workshops, Photovoice, video, and "zines".

Prisons and Immigrant Detention Centers as Structural Determinants of Coronavirus Transmission and Case Severity

We at the W. Montague Cobb/NMA Health Institute share growing concern regarding prisons and immigrant detention as structural determinants of Coronavirus disparities for our most vulnerable and underserved populations. Black or African American adults represent 12% of the U.S. adult population but 33% of the sentenced prison population, with nearly six times the imprisonment rate for whites. Interestingly, but not surprisingly, immigrants who are also Black may be at higher risk for being detained compared to their non-Black immigrant counterparts because of racial profiling. Whereas Black immigrants account for 20 percent of immigrants facing deportation on criminal grounds and three out the last thirteen deaths in detention due to COVID-19, they comprise only 7 percent of the immigrant population. Wallace et al.’s recent Morbidity and Mortality Weekly (MMWR) Report noted 4,893 cases and 88 deaths among incarcerated or detained residents, 2,778 cases and 15 deaths among staff members, and at least one confirmed case among 420 facilities and representing 86% of the 37 of 54 jurisdictions reporting. Although the epidemiologic data on Coronavirus within these settings remains incomplete, we do know that crowded conditions and other factors that propagate pathogen transmission are common. Furthermore, these transient settings likely posit risk for local social networks, and the general population. In light of the burgeoning pandemic, guided decarceration and accompanying social support programs should be public health priorities as well as the adoption of national clinical management standards with additional focus on suicide prevention and mental health. Coordinated CDC-led tracking of relevant epidemiologic data including race-ethnicity and demographics of residents and staff may also be warranted. Along with protecting incarcerated or detained persons and their basic human rights, staff, and the communities to which they return, urging control measures should be the elimination of racial and ethnic disparities in health and healthcare.