New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science.

The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary teams, DARS conducts mission-critical research to provide answers to scientific questions and solutions to regulatory challenges. Staffed by experts across the translational research spectrum, DARS forms synergies by pulling together scientists and experts from diverse backgrounds to collaborate in tackling some of the most complex challenges facing FDA. This includes (but is not limited to) assessing the systemic absorption of sunscreens, evaluating whether certain drugs can convert to carcinogens in people, studying drug interactions with opioids, optimizing opioid antagonist dosing in community settings, removing barriers to biosimilar and generic drug development, and advancing therapeutic development for rare diseases. FDA tasks DARS with wide ranging issues that encompass regulatory science; DARS, in turn, helps the Agency solve these challenges. The impact of DARS research is felt by patients, the pharmaceutical industry, and fellow regulators. This article reviews applied research projects and initiatives led by DARS and conducts a deeper dive into select examples illustrating the impactful work of the Division.

LIME Explainability on Flower Classification

Artificial Intelligence is becoming more advanced with increasing complexity in generating the predictions and as a result it is becoming more challenging for the users to understand and retrace how the algorithm is predicting the outcomes. Artificial intelligence has also been contributing in making decisions. There are many flowers in the world so the botanist scientists need help in identifying or recognizing which type of flower. The paper presents an x-ray diagnostic model and the explained with Local interpretable model-agnostic explanations LIME method. The model is trained with various COVID as well as non-COVID images. Whereas chest X-rays are segmented to extract the lungs and the model predictions are tested with perturbated images that are generated using LIME. This paper opens a wide area of research in the field of XAI. © 2022 IEEE.

Acute SARS-CoV-2-induced Psychosis in an Adolescent.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease 2019 illness is less common in children than in adults. Here, we report an unvaccinated 16-year-old male, normally fit and well with no previous personal or family history of mental illness, who developed moderate respiratory illness related to SARS-CoV-2 infection that was followed by acute psychosis. Neuropsychiatric manifestations are well documented in adults with SARS-CoV-2 infections; however, there are few reports in the pediatric population. This case illustrates that acute psychosis is a possible complication in children with mild SARS-CoV-2 illness and highlights the need for vigilance.

The impact of COVID-19 on oncology professionals-one year on: lessons learned from the ESMO Resilience Task Force survey series.

BACKGROUND: COVID-19 has had a significant impact on the well-being and job performance of oncology professionals globally. The European Society for Medical Oncology (ESMO) Resilience Task Force collaboration set out to investigate and monitor well-being since COVID-19 in relation to work, lifestyle and support factors in oncology professionals 1 year on since the start of the pandemic. METHODS: An online, anonymous survey was conducted in February/March 2021 (Survey III). Key outcome variables included risk of poor well-being or distress (expanded Well-Being Index), feeling burnout (single item from expanded Well-Being Index), and job performance since COVID-19. Longitudinal analysis of responses to the series of three surveys since COVID-19 was carried out, and responses to job demands and resources questions were interrogated. SPSS V.26.0/V.27.0 and GraphPad Prism V9.0 were used for statistical analyses. RESULTS: Responses from 1269 participants from 104 countries were analysed in Survey III: 55% (n = 699/1269) female, 54% (n = 686/1269) >40 years, and 69% (n = 852/1230) of white ethnicity. There continues to be an increased risk of poor well-being or distress (n = 464/1169, 40%) and feeling burnout (n = 660/1169, 57%) compared with Survey I (25% and 38% respectively, P < 0.0001), despite improved job performance. Compared with the initial period of the pandemic, more participants report feeling overwhelmed with workload (45% versus 29%, P < 0.0001). There remain concerns about the negative impact of the pandemic on career development/training (43%), job security (37%). and international fellowship opportunities (76%). Alarmingly, 25% (n = 266/1086) are considering changing their future career with 38% (n = 100/266) contemplating leaving the profession. CONCLUSION: Oncology professionals continue to face increased job demands. There is now significant concern regarding potential attrition in the oncology workforce. National and international stakeholders must act immediately and work closely with oncology professionals to draw up future-proof recovery plans.

COVID-19 Legacy.

Coronavirus disease 2019 (COVID-19) is an infection caused by the severe acute respiratory syndrome-coronavirus-2 virus that led to a pandemic. Acute manifestations of COVID-19 include fever, cough, dyspnea, respiratory failure, pneumonitis, anosmia, thromboembolic events, cardiogenic shock, renal injury, ischemic strokes, encephalitis, and cutaneous eruptions, especially of hands or feet. Prolonged symptoms, unpredictable recoveries, and chronic sequelae (long COVID) sometimes emerge even for some people who survive the initial illness. Sequelae such as fatigue occasionally persist even for those with only mild to moderate cases. There is much to learn about postacute COVID-19 dyspnea, anosmia, psychosis, thyroiditis, cardiac arrhythmia, and/or multisystem inflammatory response syndrome in children. Determining prognoses is imprecise. Examining patient databases about those who have survived COVID-19 is warranted. Multidisciplinary teams are assessing such disease databases to better understand longer-term complications and guide treatment.

Virtual Rounding in Stroke Care and Neurology Education During the COVID-19 Pandemic - A Residency Program Survey.

BACKGROUND AND PURPOSE: During the coronavirus disease 2019 (COVID-19) pandemic, we instituted virtual inpatient stroke rounds and acute stroke evaluations via telemedicine in the emergency department. We sought to explore trainees' and experienced providers' views on stroke care and education. METHODS: The implementation and the survey took place at a single academic comprehensive stroke center in northeast Ohio in the United States. "Virtual rounding" consisted of patient presentation and discussion in the morning in on-line virtual team format followed by in-person patient rounds in small groups. Acute stroke evaluations in the emergency department included direct in-person evaluation by neurology residents with supervision over telemedicine.The neurology residents, stroke fellows, stroke nurse practitioners, and stroke staff physicians were surveyed 2 months after implementation. Quantitative data was analyzed using descriptive statistical analysis, written responses in comment sections were analyzed using content analysis. RESULTS: Thirty-two of 42 (73%) surveys were completed. Nine (45%) residents and 5 (42%) experienced providers responded that virtual rounds did not compromise learning and education on stroke service. Fifteen (75%) residents and all experienced providers agreed that virtual rounds protected caregivers from exposure to the virus. While more than a third of residents (37%) did not feel comfortable utilizing telemedicine in ED, the majority of experienced providers (89%) were at ease with it. A total of 58% of residents and 67% of experienced providers felt that they were spending less time at the bedside, and 42% of residents and 58% of experienced providers felt less connected to patients during the pandemic. CONCLUSION: Majority of neurology residents' experience was not positive utilising telemedicine as compared to other staff providers. This is likely attributed to lack of prior exposure and unpreparedness. Incorporation of telemedicine curricula in medical school and residency training could prepare the next generation physicians to effectively use these technologies and meet the growing need for telehealth services for current and future pandemics.

Tele-Neurorehabilitation During the COVID-19 Pandemic: Implications for Practice in Low- and Middle-Income Countries.

The importance of neurorehabilitation services for people with disabilities is getting well-recognized in low- and middle-income countries (LMICs) recently. However, accessibility to the same has remained the most significant challenge, in these contexts. This is especially because of the non-availability of trained specialists and the availability of neurorehabilitation centers only in urban cities owned predominantly by private healthcare organizations. In the current COVID-19 pandemic, the members of the Task Force for research at the Indian Federation of Neurorehabilitation (IFNR) reviewed the context for tele-neurorehabilitation (TNR) and have provided the contemporary implications for practicing TNR during COVID-19 for people with neurological disabilities (PWNDs) in LMICs. Neurorehabilitation is a science that is driven by rigorous research-based evidence. The current pandemic implies the need for systematically developed TNR interventions that is evaluated for its feasibility and acceptability and that is informed by available evidence from LMICs. Given the lack of organized systems in place for the provision of neurorehabilitation services in general, there needs to be sufficient budgetary allocations and a sector-wide approach to developing policies and systems for the provision of TNR services for PWNDs. The pandemic situation provides an opportunity to optimize the technological innovations in health and scale up these innovations to meet the growing burden of neurological disability in LMICs. Thus, this immense opportunity must be tapped to build capacity for safe and effective TNR services provision for PWNDs in these settings.

The concerns of oncology professionals during the COVID-19 pandemic: results from the ESMO Resilience Task Force survey II.

BACKGROUND: The COVID-19 pandemic has resulted in significant changes to professional and personal lives of oncology professionals globally. The European Society for Medical Oncology (ESMO) Resilience Task Force collaboration aimed to provide contemporaneous reports on the impact of COVID-19 on the lived experiences and well-being in oncology. METHODS: This online anonymous survey (July-August 2020) is the second of a series of global surveys launched during the course of the pandemic. Longitudinal key outcome measures including well-being/distress (expanded Well-being Index-9 items), burnout (1 item from expanded Well-being Index), and job performance since COVID-19 were tracked. RESULTS: A total of 942 participants from 99 countries were included for final analysis: 58% (n = 544) from Europe, 52% (n = 485) female, 43% (n = 409) ≤40 years old, and 36% (n = 343) of non-white ethnicity. In July/August 2020, 60% (n = 525) continued to report a change in professional duties compared with the pre-COVID-19 era. The proportion of participants at risk of poor well-being (33%, n = 310) and who reported feeling burnout (49%, n = 460) had increased significantly compared with April/May 2020 (25% and 38%, respectively; P < 0.001), despite improved job performance since COVID-19 (34% versus 51%; P < 0.001). Of those who had been tested for COVID-19, 8% (n = 39/484) tested positive; 18% (n = 7/39) felt they had not been given adequate time to recover before return to work. Since the pandemic, 39% (n = 353/908) had expressed concerns that COVID-19 would have a negative impact on their career development or training and 40% (n = 366/917) felt that their job security had been compromised. More than two-thirds (n = 608/879) revealed that COVID-19 has changed their outlook on their work-personal life balance. CONCLUSION: The COVID-19 pandemic continues to impact the well-being of oncology professionals globally, with significantly more in distress and feeling burnout compared with the first wave. Collective efforts from both national and international communities addressing support and coping strategies will be crucial as we recover from the COVID-19 crisis. In particular, an action plan should also be devised to tackle concerns raised regarding the negative impact of COVID-19 on career development, training, and job security.

The future of the oncology workforce since COVID-19: Results of the ESMO Resilience Task Force survey series

Background: The ESMO Resilience Task Force has investigated wellbeing since COVID-19 in relation to work, lifestyle and support factors in oncology professionals globally. We reported on the significant impact of the initial surge of the pandemic on wellbeing and job performance (Banerjee et al. 2021). As the pandemic continues, it is imperative to understand experiences and concerns to better inform support measures for the oncology workforce. Methods: Three anonymous online surveys were conducted during the COVID-19 pandemic (S1, Apr/May 2020;S2, Jul/Aug 2020;S3, Feb/Mar 2021). Longitudinal analysis of responses at these timepoints were conducted. Here, we present responses to questions on job demands and resources, and perceived job performance since COVID-19 (JP-CV). Results: We analysed 3894 individual responses (S1, n=1520;S2, n=942;S3, n=1432): 53% (n=1961/3731) female, 45% (n=1679/3731) =/<40 years, 31% (n=1132/3692) non-white ethnicity, >100 countries. There has been significant increases from S1 to S3 (p<0.001) in feeling overwhelmed with workload (29% vs 45%);COVID-19-related clinical (14% vs 58%) and research (16% vs 64%) work;out-of-hours work (16% vs 41%), shift work (12% vs 26%) and overall working hours (17% vs 47%);and inadequate time for personal/family life (35% vs 45%). 59% (n=1156/1946) were unable to take allocated annual leave. While JP-CV has improved (34% vs 49%, p<0.001), there remained concerns about the negative impact of the pandemic on career development/training (43%), job security (37%) and international fellowship opportunities (76%). Overall, less than half had felt supported by their work management, professional societies or government, and/or had access to wellbeing support services. 25% (n=266/1086) were considering changing their future career with 38% (n=100/266) contemplating leaving the profession. Conclusions: Since COVID-19, oncology professionals have reported increased job demands, concerns over career development/training and job security, and inadequate time for personal life. There is a real threat of potential attrition in the current workforce. National and international stakeholders must act together to ensure robust recovery plans as we emerge from the COVID-19 crisis. Legal entity responsible for the study: The authors. Funding: ESMO. Disclosure: K.H.J. Lim: Financial Interests, Personal, Invited Speaker, Speaker honorarium: Janssen;Non-Financial Interests, Officer, Trainees committee representative for the North West deanery: Royal College of Physicians (UK);Non-Financial Interests, Officer, Trainees representative at the RCP Patient Safety Committee: Royal College of Physicians (UK);Non-Financial Interests, Officer, ACP representative at the RCP Student and Foundation Doctor Network (SFDN): Royal College of Physicians (UK);Non-Financial Interests, Officer, Trainees committee member: Association of Cancer Physicians (ACP) UK;Non-Financial Interests, Officer, Young Oncologists Committee (YOC): ESMO;Non-Financial Interests, Officer, Resilience Task Force (RTF): ESMO;Other, Currently funded by Wellcome-Imperial 4i Clinical Research Fellowship: Wellcome Trust. K. Punie: Other, Institutional, Other, institution received speaker fees or honoraria for consultancy/advisory roles: AstraZeneca, Eli Lilly, Gilead Sciences, Medscape, MSD, Novartis, Pfizer, Pierre Fabre, Hoffmann La Roche, Mundi Pharma, PharmaMar, Teva, Vifor Pharma;Other, Institutional, Research Grant: Sanofi;Other, Personal, Other, Travel support: AstraZeneca, Novartis, Pfizer, PharmaMar and Roche. C. Oing: Other, Personal, Other, research funding and honoraria: Roche;Other, Personal, Other, travel grant and honoraria: Medac Pharma and Ipsen Pharma;Other, Personal, Other, travel grant: PharmaMar. E. Elez: Other, Personal, Other, personal fees: Hoffman La - Roche, Bristol Myers Squibb, Servier, Amgen, Merck Serono, ArrayBiopharma, Sanof. T.M.S. Amaral: Other, Personal, Other, personal fees: Pierre Fabre and CeCaVa;Other, Personal, Other, personal fees and travel grants: BMS;Other, Perso al, Other, grants, personal fees and travel grants: Novartis;Other, Personal, Other, grants: Neracare, Sanofi and SkylineDx. P. Garrido Lopez: Other, Personal, Other, personal fees: Roche, MSD, BMS, Boerhinger-Ingelheim, Pfizer, AbbVie, Novartis, Lilly, AstraZeneca, Janssen, Blueprint Medicines, Takeda, Gilead, and ROVI. M. Lambertini: Other, Personal, Other, Consultant: Roche, AstraZeneca, Lilly and Novartis;Other, Personal, Other, Honoraria: Theramex, Roche, Novartis, Takeda, Pfizer, Sandoz, and Lilly. C.B. Westphalen: Other, Personal, Other, honoraria, travel support and advisory board: Bayer, BMS, Celgene, Roche, Servier, Shire/Baxalta, RedHil, and Taiho;Other, Personal, Other, speaker honoraria: Ipsen;Other, Personal, Advisory Board: GSK, Sirtex, and Rafael. J.B.A.G. Haanen: Other, Personal, Advisory Role, personal fees for advisory role: Neogene Tx;Other, Institutional, Other, grants and fees paid to institution: BMS, MSD, Novartis, BioNTech, Amgen;Other, Institutional, Other, fees paid to institution: Achilles Tx, GSK, Immunocore, Ipsen, Merck Serono, Molecular Partners, Pfizer, Roche/Genentech, Sanofi, Seattle Genetics, Third Rock Ventures, Vaximm. C. Hardy: Other, Personal, Other, Director of a private company Hardy People Ltd.: Hardy People Ltd. S. Banerjee: Other, Institutional, Research Grant: AstraZeneca, Tesaro and GSK;Other, Personal, Other, Honoraria: Amgen, AstraZeneca, MSD, GSK, Clovis, Genmab, Merck Serono, Mersana, Pfizer, Seattle Genetics, and Tesaro. All other authors have declared no conflicts of interest.

COVID-19 Communication Ecology: Visualizing Communication Resource Connections During a Public Health Emergency Using Network Analysis

The COVID-19 outbreak began in December 2019 and soon became a global pandemic, resulting in major public health consequences for countries across the world. As the COVID-19 outbreak evolved, individuals were challenged to understand the risk of COVID-19 and to identify ways to stay safe. This understanding was accomplished through COVID-19 communication ecologies that consist of interpersonal, organizational, and mediated communication resources. In the current study, we examine the U.S. COVID-19 communication ecology in September 2021. We introduce the communication ecology network (CEN) model, which posits that similar useful communication resources will cluster in a communication ecology, and we use network analysis for visualization of the ecology. Our results indicate a robust COVID-19 communication ecology. The most important communication resources in the ecology were partisan and organizational communication resources. We identify and discuss five clusters within the COVID-19 communication ecology and examine how use of each of these clusters is associated with belief in COVID-19 misinformation. Our use of network analysis illustrates benefits of this analytical approach to studying communication ecologies.

The impact of COVID-19 on oncology professionals: results of the ESMO Resilience Task Force survey collaboration.

BACKGROUND: The impact of the coronavirus disease 2019 (COVID-19) pandemic on well-being has the potential for serious negative consequences on work, home life, and patient care. The European Society for Medical Oncology (ESMO) Resilience Task Force collaboration set out to investigate well-being in oncology over time since COVID-19. METHODS: Two online anonymous surveys were conducted (survey I: April/May 2020; survey II: July/August 2020). Statistical analyses were performed to examine group differences, associations, and predictors of key outcomes: (i) well-being/distress [expanded Well-being Index (eWBI; 9 items)]; (ii) burnout (1 item from eWBI); (iii) job performance since COVID-19 (JP-CV; 2 items). RESULTS: Responses from survey I (1520 participants from 101 countries) indicate that COVID-19 is impacting oncology professionals; in particular, 25% of participants indicated being at risk of distress (poor well-being, eWBI ≥ 4), 38% reported feeling burnout, and 66% reported not being able to perform their job compared with the pre-COVID-19 period. Higher JP-CV was associated with better well-being and not feeling burnout (P < 0.01). Differences were seen in well-being and JP-CV between countries (P < 0.001) and were related to country COVID-19 crude mortality rate (P < 0.05). Consistent predictors of well-being, burnout, and JP-CV were psychological resilience and changes to work hours. In survey II, among 272 participants who completed both surveys, while JP-CV improved (38% versus 54%, P < 0.001), eWBI scores ≥4 and burnout rates were significantly higher compared with survey I (22% versus 31%, P = 0.01; and 35% versus 49%, P = 0.001, respectively), suggesting well-being and burnout have worsened over a 3-month period during the COVID-19 pandemic. CONCLUSION: In the first and largest global survey series, COVID-19 is impacting well-being and job performance of oncology professionals. JP-CV has improved but risk of distress and burnout has increased over time. Urgent measures to address well-being and improve resilience are essential.

The impact of COVID-19 on oncology professionals: Initial results of the ESMO resilience task force survey collaboration

Background: The impact of the COVID-19 (CV-19) pandemic on wellbeing has the potential for serious negative consequences on work, home life and patient care. The ESMO Resilience Task Force collaboration set out to investigate wellbeing in oncology over time since CV-19. Methods: 2 online surveys were conducted (survey I April/May;survey II July/August 2020). Statistical analyses were used to examine group differences, associations and to explore predictors of key outcomes: 1) wellbeing/distress (Wellbeing Index (WBI-9)), 2) burnout (1 item);and 3) CV-19 job performance (2 item CJP;standard of care and job delivery compared to pre-CV 19). Results: Survey I had 1520 participants from 101 countries. Responses indicate that CV-19 is impacting the oncology workforce resulting in a number of changes to work and personal lives. 25% were at risk of distress (poor wellbeing, WBI ≥4);38% reported feeling burnout and 66% were not able to perform their job compared to pre-CV-19. Higher CJP was significantly associated with better wellbeing and not feeling burnout (p<0.01). Differences were seen in wellbeing and CJP between countries (p<0.001) and related to CV-19 country mortality rate (p<0.05). The main predictors of wellbeing, burnout and CJP were resilience and changes to work hours. Others frequently identified were coping strategies, ethnicity, concern about training/career, worried about current wellbeing, and working conditions. In Survey II, results from 942 participants are undergoing analysis. Overall, comparisons between surveys show overall wellbeing and burnout rates have worsened overtime but CJP has improved. Among 272 participants who completed both surveys, WBI scores ≥4 (indicating higher risk of distress) and burnout rates were higher in survey II compared to survey I (22% vs 31% p=0.01;35% vs 49% p=0.001 respectively) suggesting wellbeing and burnout may be worsening overtime. CJP improved (38% vs 54% p<0.001). Conclusions: In the largest global survey series, COVID-19 is impacting on the wellbeing and job performance of oncology professionals. Risk of distress and burnout has increased over time. Urgent measures to address wellbeing and improve resilience are essential. Legal entity responsible for the study: ESMO. Funding: ESMO. Disclosure: S. Banerjee: Research grant/Funding (institution): AstraZeneca;Research grant/Funding (self): GSK;Honoraria (self): Amgen;Honoraria (self): AstraZeneca;Honoraria (self): MSD;Honoraria (self): GSK;Honoraria (self): Clovis;Honoraria (self): Genmab;Honoraria (self): Merck Serono;Honoraria (self): Mersana;Honoraria (self): Pfizer;Honoraria (self): Seattle Genetics;Honoraria (self): Tesaro. C. Oing: Research grant/Funding (institution): PharmaMar;Travel/Accommodation/Expenses: Ipsen;Travel/Accommodation/Expenses: PharmaMar;Travel/Accommodation/Expenses: Medac. K. Punie: Honoraria (self): AstraZeneca;Honoraria (self): Eli Lilly;Honoraria (self): Novartis;Honoraria (self): Pfizer;Honoraria (self): Pierre Fabre;Honoraria (self): Hoffmann La Roche;Honoraria (self): Vifor Pharma;Speaker Bureau/Expert testimony: Eli Lilly;Speaker Bureau/Expert testimony: Mundi Pharma;Speaker Bureau/Expert testimony: Novartis;Speaker Bureau/Expert testimony: Pfizer;Speaker Bureau/Expert testimony: Hoffmann La Roche;Honoraria (self): Teva;Research grant/Funding (institution): Sanofi;Travel/Accommodation/Expenses: AstraZeneca;Travel/Accommodation/Expenses: Novartis;Travel/Accommodation/Expenses: Pfizer;Travel/Accommodation/Expenses: PharmaMar;Travel/Accommodation/Expenses: Hoffmann La Roche. M. Lambertini: Advisory/Consultancy: Roche;Advisory/Consultancy: Novartis;Honoraria (institution): Theramex;Honoraria (institution): Takeda;Honoraria (institution): Roche;Honoraria (institution): Lilly;Honoraria (institution): Pfizer;Honoraria (institution): Novartis. C. Benedikt Westphalen: Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bayer;Honoraria (self), Honoraria (institution), Travel/Accommodation/Expenses: Celge e;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MedScape;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Rafael Pharmaceuticals;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: RedHIll;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Servier;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Shire;Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Taiho;Research grant/Funding (institution): Roche. P. Garrido Lopez: Advisory/Consultancy: AbbVie;Speaker Bureau/Expert testimony: AstraZeneca;Advisory/Consultancy: BluePrint Medicine;Advisory/Consultancy, Speaker Bureau/Expert testimony: Boerhinger Ingelheim;Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS;Advisory/Consultancy: Gilead;Advisory/Consultancy: Guardant Health;Advisory/Consultancy: Janssen;Advisory/Consultancy: Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD;Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda;Speaker Bureau/Expert testimony: Rovi;Speaker Bureau/Expert testimony: Sysmex. T.M.S. Amaral: Honoraria (self), Travel/Accommodation/Expenses: BMS;Honoraria (self), Travel/Accommodation/Expenses: Novartis;Honoraria (self): PIerre Fabre;Honoraria (institution): Neracare;Honoraria (institution): Sanofi. J.B.A.G. Haanen: Advisory/Consultancy: AIMM THerapeutics;Advisory/Consultancy: Amgen;Advisory/Consultancy: AZ;Advisory/Consultancy: Bayer;Advisory/Consultancy: BioNtech;Advisory/Consultancy: BMS;Advisory/Consultancy: GSK;Advisory/Consultancy: Gateta;Advisory/Consultancy: Immunocore;Advisory/Consultancy: Ipsen;Advisory/Consultancy: Merck Serono;Advisory/Consultancy: MSD;Advisory/Consultancy: Molecular Partners;Advisory/Consultancy: Roche;Advisory/Consultancy: Sanofi;Advisory/Consultancy: Seattle Genetics;Advisory/Consultancy: Third Rock Venture;Advisory/Consultancy: Vaximm;Research grant/Funding (institution): Neogene;Research grant/Funding (institution): Amgen;Research grant/Funding (institution): BMS;Research grant/Funding (institution): BIoNthech;Research grant/Funding (institution): MSD;Research grant/Funding (institution): Novartis;Advisory/Consultancy: Genentech. All other authors have declared no conflicts of interest.

Raman spectroscopy-based detection of RNA viruses in saliva: A preliminary report.

Several non-invasive Raman spectroscopy-based assays have been reported for rapid and sensitive detection of pathogens. We developed a novel statistical model for the detection of RNA viruses in saliva, based on an unbiased selection of a set of 65 Raman spectral features that mostly attribute to the RNA moieties, with a prediction accuracy of 91.6% (92.5% sensitivity and 88.8% specificity). Furthermore, to minimize variability and automate the downstream analysis of the Raman spectra, we developed a GUI-based analytical tool "RNA Virus Detector (RVD)." This conceptual framework to detect RNA viruses in saliva could form the basis for field application of Raman Spectroscopy in managing viral outbreaks, such as the ongoing COVID-19 pandemic. (http://www.actrec.gov.in/pi-webpages/AmitDutt/RVD/RVD.html).

Decline in Stroke Presentations During COVID-19 Surge.

BACKGROUND AND PURPOSE: We aimed to investigate the acute stroke presentations during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: The data were obtained from a health system with 19 emergency departments in northeast Ohio in the United States. Baseline period from January 1 to March 8, 2020, was compared with the COVID period from March 9, to April 2, 2020. The variables included were total daily stroke alerts across the hospital emergency departments, thrombolysis, time to presentation, stroke severity, time from door-to-imaging, time from door-to-needle in thrombolysis, and time from door-to-puncture in thrombectomy. The 2 time periods were compared using nonparametric statistics and Poisson regression. RESULTS: Nine hundred two stroke alerts during the period across the emergency departments were analyzed. Total daily stroke alerts decreased from median, 10 (interquartile range, 8-13) during baseline period to median, 8 (interquartile range, 4-10, P=0.001) during COVID period. Time to presentation, stroke severity, and time to treatment were unchanged. COVID period was associated with decrease in stroke alerts with rate ratio of 0.70 (95% CI, 0.60-0.28). Thrombolysis also decreased with rate ratio, 0.52 (95% CI, 0.28-0.97) but thrombectomy remained unchanged rate ratio, 0.93 (95% CI, 0.52-1.62) Conclusions: We observed a significant decrease in acute stroke presentations by ≈30% across emergency departments at the time of surge of COVID-19 cases. This observation could be attributed to true decline in stroke incidence or patients not seeking medical attention for emergencies during the pandemic.