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Importance: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. Methods: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged [≥]18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. Discussion: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.
Subject(s)
COVID-19 , Severe Acute Respiratory SyndromeABSTRACT
COVID-19, the novel coronavirus that has disrupted lives around the world, continues to challenge how humans interact in public and shared environments. Repopulating the micro-spatial setting of an office building, with virus spread and transmission mitigation measures, is critical for a return to normalcy. Advice from public health experts, such as maintaining physical distancing from others and well-ventilated spaces, are essential, yet there is a lack of sound guidance on configuring office usage that allows for a safe return of workers. This paper highlights the potential for decision-making and planning insights through location analytics, particularly within an office setting. Proposed is a spatial analytic framework addressing the need for physical distancing and limiting worker interaction, supported by geographic information systems, network science, and spatial optimization. The developed modeling approach addresses dispersion of assigned office spaces as well as associated movement within the office environment. This can be used to support the design and utilization of offices in a manner that minimizes the risk of COVID-19 transmission. Our proposed model produces two main findings: (1) that the consideration of minimizing potential interaction as an objective has implications for the safety of work environments, and (2) that current social distancing measures may be inadequate within office settings. Our results show that leveraging exploratory spatial data analyses through the integration of geographic information systems, network science, and spatial optimization, enables the identification of workspace allocation alternatives in support of office repopulation efforts. © 2022 held by the owner/author(s).
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Objective/Background: Healthcare workers have experienced high rates of psychiatric symptom burden and occupational attrition during the COVID-19 pandemic. Identifying contributory factors can inform prevention and mitigation measures. Here, we explore the potential contributions of occupational stressors vs COVID-19 infection to insomnia symptoms in US healthcare workers.Patients/Methods: An online self-report survey was collected between September 2020 and July 2022 from N = 594 US healthcare workers, with longitudinal follow-up up to 9 months. Assessments included the Insomnia Severity Index (ISI), the PTSD Checklist for DSM-5 (PCL-5), and a 13-item scale assessing COVID-19 related occupational stressors. Results: Insomnia was common (45% of participants reported at least moderate and 9.2% reported severe symptoms at one or more timepoint) and significantly associated with difficulty completing work-related tasks, increased likelihood of occupational attrition, and thoughts of suicide or self-harm (all p<.0001). In multivariable regression with age, gender, and family COVID-19 history as covariates, past two-week COVID-related occupational stressors, peak COVID-related occupational stressors, and personal history of COVID-19 infection were all significantly related to past two-week ISI scores (ß = 1.7 ± 0.14SE, ß = 0.08 ± 0.03, and ß = 0.69 ± 0.22 respectively). Although similar results were found for the PCL-5, when ISI and PCL-5 items were separated by factor, COVID-19 infection was significantly related only to the factor consisting of sleep-related items. Conclusions: Both recent occupational stress and personal history of COVID-19 infection were significantly associated with insomnia in healthcare workers. These results suggest that both addressing occupational stressors and reducing rate of COVID-19 infection are important to protect healthcare workers and the healthcare workforce.
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We investigated the impact of the transition to online architectural design studios in response to the COVID-19 pandemic at the University of New South Wales in Sydney, Australia. The study focussed specifically on student and tutor perceptions of online design studio before the sudden transition to online delivery, and how those perceptions shifted through the initial months of online delivery. We consider the pedagogical context in which the shift to online teaching took place and the evident successes and failures in the early iterations of online studio. We discuss similar and contrasting perceptions in student and tutor groups and observe the changes in these perceptions prior to and after teaching and learning in online studios. The paper concludes with a series of questions directed to the architectural design studio teaching community regarding the apparent inevitability of a future in which both FTF and online-only studios are surpassed with hybrid design studios. © 2023 The Authors. International Journal of Art & Design Education published by National Society for Education in Art and Design and John Wiley & Sons Ltd.
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COVID-19, the novel coronavirus that has disrupted lives around the world, continues to challenge how humans interact in public and shared environments. Repopulating the micro-spatial setting of an office building, with virus spread and transmission mitigation measures, is critical for a return to normalcy. Advice from public health experts, such as maintaining physical distancing from others and well-ventilated spaces, are essential, yet there is a lack of sound guidance on configuring office usage that allows for a safe return of workers. This paper highlights the potential for decision-making and planning insights through location analytics, particularly within an office setting. Proposed is a spatial analytic framework addressing the need for physical distancing and limiting worker interaction, supported by geographic information systems, network science, and spatial optimization. The developed modeling approach addresses dispersion of assigned office spaces as well as associated movement within the office environment. This can be used to support the design and utilization of offices in a manner that minimizes the risk of COVID-19 transmission. Our proposed model produces two main findings: (1) that the consideration of minimizing potential interaction as an objective has implications for the safety of work environments, and (2) that current social distancing measures may be inadequate within office settings. Our results show that leveraging exploratory spatial data analyses through the integration of geographic information systems, network science, and spatial optimization, enables the identification of workspace allocation alternatives in support of office repopulation efforts.
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Building a shared understanding of non-functional requirements (NFRs) is a known but understudied challenge in requirements engineering, especially in organizations that adopt continuous software engineering (CSE) practices. During the peak of the COVID-19 pandemic, many CSE organizations complied with working remotely due to the imposed health restrictions;some continued to work remotely while implementing business processes to facilitate team communication and productivity. In remote CSE organizations, managing NFRs becomes more challenging due to the limitations to team communication. While previous research has identified the factors that lead to a lack of shared understanding of NFRs in CSE, we still have a significant gap in understanding how CSE organizations, particularly in remote work, build a shared understanding of NFRs. We conduct a three-month ethnography-informed case study of a remote CSE organization. Through thematic analysis of our qualitative data from interviews and observations, we identify a number of practices for building a shared understanding of NFRs, such as validating NFRs through feedback. The collaborative workspace the organization uses for remote interaction is Gather, which simulates physical workspaces, and which our findings suggest allows for informal communications instrumental for building shared understanding. In addition, we describe the limitations to building a shared understanding of NFRs in the organization, such as gaps in communication and the limited understanding of customer context. As actionable insights, we discuss our findings in light of proactive practices that represent opportunities for software organizations to invest in building a shared understanding of NFRs in their development. © 2022 IEEE.
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Abstract Objective/Background: Healthcare workers have experienced high rates of psychiatric symptom burden and occupational attrition during the COVID-19 pandemic. Identifying contributory factors can inform prevention and mitigation measures. Here, we explore the potential contributions of occupational stressors vs COVID-19 infection to insomnia symptoms in US healthcare workers. Patients/Methods: An online self-report survey was collected between September 2020 and July 2022 from N=594 US healthcare workers, with longitudinal follow-up up to 9 months. Assessments included the Insomnia Severity Index (ISI), the PTSD Checklist for DSM-5 (PCL-5), and a 13-item scale assessing COVID-19 related occupational stressors. Results: Insomnia was common (45% of participants reported at least moderate and 9.2% reported severe symptoms at one or more timepoint) and significantly associated with difficulty completing work-related tasks, increased likelihood of occupational attrition, and thoughts of suicide or self-harm (all p<.0001). In multivariable regression with age, gender, and family COVID-19 history as covariates, past two-week COVID-related occupational stressors, peak COVID-related occupational stressors, and personal history of COVID-19 infection were all significantly related to past two-week ISI scores (Beta=1.7+/-0.14SE, Beta=0.08+/-0.03, and Beta=0.69+/-0.22 respectively). Although similar results were found for the PCL-5, when ISI and PCL-5 items were separated by factor, COVID-19 infection was significantly related only to the factor consisting of sleep-related items. Conclusions: Both recent occupational stress and personal history of COVID-19 infection were significantly associated with insomnia in healthcare workers. These results suggest that both addressing occupational stressors and reducing rate of COVID-19 infection are important to protect healthcare workers and the healthcare workforce.
Subject(s)
Occupational Diseases , Tooth Attrition , Sleep Initiation and Maintenance Disorders , Mental Disorders , Stress Disorders, Post-Traumatic , COVID-19ABSTRACT
Background/Aims Nailfold capillaroscopy has a key role in the assessment of patients with Raynaud's phenomenon (RP) providing a window of opportunity for the early diagnosis of systemic sclerosis (SSc). Anecdotal evidence indicates that this opportunity is not being fully realised across UK rheumatology centres. Reasons for apparent discrepancies in use of capillaroscopy may relate to a lack of expertise, confidence or equipment. Exploratory work has demonstrated the potential for an internet-based standardised system for clinical reporting of nailfold capillaroscopy images to mitigate current inequities in care provision. The overall aim of this study was to understand current practices in the diagnosis of SSc in UK rheumatology centres with specific reference to identifying barriers to the use of nailfold capillaroscopy. A secondary aim was to understand rheumatologists' views on a standardised system to facilitate the timely diagnosis of SSc. Methods An online survey comprising closed and free-text questions was developed using expert (n=7) opinion from clinicians, scientists and health service researchers. The survey was piloted (n=5) and sent to UK-based rheumatologists using established electronic mailing lists between 2nd October 2020 and 8th March 2021. Respondents were asked to describe workloads and practices typically seen before the COVID-19 pandemic. Data were analysed using descriptive statistics and thematic analysis. Results Survey responses were received from 104 rheumatologists representing centres across the UK. Wide variation in terms of workloads and practices were described (See Table 1). Only 41% (n=43) of respondents reported using nailfold capillaroscopy provided at their centres. Key barriers were access to equipment and a lack of expertise in terms of acquiring and analysing images. Respondents indicated that a centralised internet-based system for storing images and sharing diagnoses would provide access to expertise and the possibility of timely diagnoses Conclusion Substantial variation in approaches to the diagnosis of SSc across the UK was identified. Potential benefits of a standardised system were described by respondents including the improved diagnosis and management of SSc, realising potential patient benefits and reducing current health inequalities. Survey findings provide evidence to help develop future studies to develop and evaluate the proposed new system.
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Introduction: During the COVID-19 pandemic there has been a reduction in trainee hands-on learning opportunities due to curtailment of elective workload. Our study aims to assess the impact of non-consultant led operating on theatre list efficiency. Methods: Prospective data collection over an eight week period of consecutive elective day case hernia lists at a newly established regional centre of excellence for day surgery. Specifically recording of key time points in surgical cases including time ready, knife to skin, last suture and exit theatre. This was achieved using the Theatre Management System (TMS). Results: 46 patients underwent open unilateral elective inguinal hernia repair. 54% (N=25) of cases were trainee led. Median trainee time was 53 minutes, vs 51 minutes for consultant led procedures;no significant difference (p>0.05). Conclusion: Day case elective hernia lists can be efficient training opportunities for general surgical trainees. Our results demonstrate that trainee-led operating in this setting have not resulted in significantly increased surgical time or operative theatre inefficiency. It is widely acknowledged there is benefit to training in performing the same technical skill within a short time frame.
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BACKGROUND: CoV2 preS dTM is a stabilised pre-fusion spike protein vaccine produced in a baculovirus expression system being developed against SARS-CoV-2. We present interim safety and immunogenicity results of the first-in-human study of the CoV2 preS dTM vaccine with two different adjuvant formulations. METHODS: This phase 1-2, randomised, double-blind study is being done in healthy, SARS-CoV-2-seronegative adults in ten clinical research centres in the USA. Participants were stratified by age (18-49 years and ≥50 years) and randomly assigned using an interactive response technology system with block randomisation (blocks of varying size) to receive one dose (on day 1) or two doses (on days 1 and 22) of placebo or candidate vaccine, containing low-dose (effective dose 1·3 µg) or high-dose (2·6 µg) antigen with adjuvant AF03 (Sanofi Pasteur) or AS03 (GlaxoSmithKline) or unadjuvanted high-dose antigen (18-49 years only). Primary endpoints were safety, assessed up to day 43, and immunogenicity, measured as SARS-C0V-2 neutralising antibodies (geometric mean titres), assessed on days 1, 22, and 36 serum samples. Safety was assessed according to treatment received in the safety analysis set, which included all randomly assigned participants who received at least one dose. Neutralising antibody titres were assessed in the per-protocol analysis set for immunogenicity, which included participants who received at least one dose, met all inclusion and exclusion criteria, had no protocol deviation, had negative results in the neutralisation test at baseline, and had at least one valid post-dose serology sample. This planned interim analysis reports data up to 43 days after the first vaccination; participants in the trial will be followed up for 12 months after the last study injection. This trial is registered with ClinicalTrials.gov, NCT04537208, and is ongoing. FINDINGS: Between Sept 3 and Sept 29, 2020, 441 individuals (299 aged 18-49 years and 142 aged ≥50 years) were randomly assigned to one of the 11 treatment groups. The interim safety analyses included 439 (>99%) of 441 randomly assigned participants (299 aged 18-49 years and 140 aged ≥50 years). Neutralising antibody titres were analysed in 326 (74%) of 441 participants (235 [79%] of 299 aged 18-49 years and 91 [64%] of 142 aged ≥50 years). There were no vaccine-related unsolicited immediate adverse events, serious adverse events, medically attended adverse events classified as severe, or adverse events of special interest. Among all study participants, solicited local and systemic reactions of any grade after two vaccine doses were reported in 81% (95% CI 61-93; 21 of 26) of participants in the low-dose plus AF03 group, 93% (84-97; 74 of 80) in the low-dose plus AS03 group, 89% (70-98; 23 of 26) in the high-dose plus AF03 group, 95% (88-99; 81 of 85) in the high-dose plus AS03 group, 29% (10-56; five of 17) in the unadjuvanted high-dose group, and 21% (8-40; six of 29) in the placebo group. A single vaccine dose did not generate neutralising antibody titres above placebo levels in any group at days 22 or 36. Among participants aged 18-49 years, neutralising antibody titres after two vaccine doses were 13·1 (95% CI 6·40-26·9) in the low-dose plus AF03 group, 20·5 (13·1-32·1) in the low-dose plus AS03 group, 43·2 (20·6-90·4) in the high-dose plus AF03 group, 75·1 (50·5-112·0) in the high-dose plus AS03 group, 5·00 (not calculated) in the unadjuvanted high-dose group, and 5·00 (not calculated) in the placebo group. Among participants aged 50 years or older, neutralising antibody titres after two vaccine doses were 8·62 (1·90-39·0) in the low-dose plus AF03 group, 12·9 (7·09-23·4) in the low-dose plus AS03 group, 12·3 (4·35-35·0) in the high-dose plus AF03 group, 52·3 (25·3-108·0) in the high-dose plus AS03 group, and 5·00 (not calculated) in the placebo group. INTERPRETATION: The lower than expected immune responses, especially in the older age groups, and the high reactogenicity after dose two were probably due to higher than anticipated host-cell protein content and lower than planned antigen doses in the formulations tested, which was discovered during characterisation studies on the final bulk drug substance. Further development of the AS03-adjuvanted candidate vaccine will focus on identifying the optimal antigen formulation and dose. FUNDING: Sanofi Pasteur and Biomedical Advanced Research and Development Authority.
Subject(s)
Adjuvants, Immunologic/administration & dosage , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Immunogenicity, Vaccine , Recombinant Proteins/administration & dosage , SARS-CoV-2/immunology , Adult , Antibodies, Neutralizing/drug effects , Antibodies, Viral/drug effects , COVID-19 Vaccines/immunology , Double-Blind Method , Female , Humans , Male , Middle Aged , Recombinant Proteins/immunology , Spike Glycoprotein, Coronavirus , United States/epidemiologyABSTRACT
Andrew Murray argues that you can use your forced exile from the lab to produce better future experiments by dissecting your past failures and successes and collaboratively critiquing the experiments you're planning for your return to the lab.
Subject(s)
COVID-19 , Heparin , Anticoagulants/therapeutic use , Humans , Intensive Care Units , Propensity Score , Retrospective Studies , SARS-CoV-2ABSTRACT
BackgroundEffective vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are urgently needed. CoV2 preS dTM is a stabilised pre-fusion S protein vaccine produced in a baculovirus expression system. We present interim safety and immunogenicity results of the first-in-human study of the CoV2 preS dTM vaccine with two different adjuvant formulations. MethodsThis Phase I/II, randomised, double-blind study (NCT04537208) is being conducted in healthy, SARS-CoV-2-seronegative adults in the USA. Participants were stratified by age (18-49 and [≥]50 years) and randomised to receive one (on Day[D]1) or two doses (D1, D22) of placebo or candidate vaccine, containing: low-dose (LD, effective dose 1.3 {micro}g) or high-dose (HD, 2.6 {micro}g) antigen with adjuvant AF03 (Sanofi Pasteur) or AS03 (GlaxoSmithKline); or unadjuvanted HD (18-49 years only). Safety was assessed up to D43. SARS-CoV-2 neutralising and binding antibody profiles were assessed in D1, D22 and D36 serum samples. FindingsThe interim safety analyses included 439/441 randomised participants. There were no related unsolicited immediate AEs, serious AEs, medically attended AEs classified as severe, or AE of special interest. More grade 3 solicited reactions were reported than expected after the second dose in the adjuvanted vaccine groups. Neutralising and binding antibody responses after two vaccine doses were higher in adjuvanted versus unadjuvanted groups, in AS03-versus AF03-adjuvanted groups, in HD versus LD groups, and in younger versus older age strata. InterpretationThe lower than expected immune responses, especially in the older age stratum, and the higher than anticipated reactogenicity post dose 2 were likely due to a higher than anticipated host cell protein content and lower than planned antigen dose in the clinical material. Further development of the AS03-adjuvanted candidate vaccine will focus on identifying the optimal antigen formulation and dose.
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Background: The COVID-19 pandemic has greatly affected front line health care workers (HCW) and first responders (FR). The infection risk from SARS CoV-2, the high mortality of hospitalized COVID-19 patients and the duration of the pandemic have created sustained and often traumatic stressors affecting HCW and FR. Objectives: To assess the relationship of COVID-19 stressor frequency scores to psychiatric rating scale scores amongst HCW and FR. To determine if psychiatric rating scale scores mediate stressor effects on perceived work function and likelihood of remaining in current occupation. Design: Observational, self-report in a convenience sample Participants: 118 HCW and FR caring for COVID-19 patients in the United States. Main Measure: COVID-19 related stressor frequencies were assessed using a 17-item questionnaire. Psychiatric symptoms were assessed with the PTSD Checklist 5 (PCL5), the Patient Health Questionnaire 9 (for depression) (PHQ9), the Insomnia Severity Index (ISI), and the General Anxiety Disorder 7 (GAD7). Key Results: Stressor frequency scores correlated significantly with PCL5 scores (R=.57, p<1e-8), PHQ scores (R=.35, P