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Objective: This is the first prospective cohort study in Singapore to investigate the COVID-19 vaccine-associated myocarditis to understand its pathophysiology. Introduction: Acute myocarditis and other cardiovascular symptoms have been observed to be associated with the two mRNA-based coronavirus disease 2019 (COVID-19) vaccines-namely Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273)-currently in-use in Singapore. The mechanisms through which myocarditis occurs are unknown, hence our study aims to understand the pathophysiology of myocarditis associated with COVID-19 vaccines. Method(s): Patients with onset of cardiac manifestations were recruited from multiple hospital outpatient clinics between November 2021 and September 2022. Clinical history and physical examination data was collected with blood sample collection, echocardiography, 12-lead electrocardiogram (ECG), coronary angiography and magnetic resonance imaging (MRI) at recruitment and 6-month follow-up. Analysis of biomarkers, genetic, serological and MRI data was conducted. Result(s): As of 6 September 2022, a total of 5 patients have been enrolled (4 males, 1 female). The most commonly reported symptoms across all patients were chest pain/discomfort (80%), followed by palpitations (40%). MRI evidence of myocarditis has been detected in 2 (50%) of the male patients, of which both reported two or more symptoms occurring 1-2 days post-vaccination. Both patients have each received at least two doses of either the Pfizer-BioNTech BNT162b2 vaccine or Moderna mRNA-1273 vaccine. Their MRI findings were consistent with myocarditis. On late gadolinium enhancement (LGE) imaging, epicardial enhancement at the basal inferolateral segment and mid-wall enhancement at the apical anterior, lateral and inferior walls were observed in one patient. Patchy, mid-wall LGE in the basal inferior/inferolateral wall was observed in the other patient. No MRI evidence of myocarditis was available for the sole female patient. Conclusion(s): While more data is needed to definitively prove the association of the two mRNA-based Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 COVID-19 vaccines with post-vaccination myocarditis, we believe our findings may support further investigations to enable risk stratification for vaccine-associated myocarditis and identify potential preventative strategies accordingly.
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Aims: The COVID-19 pandemic caused significant disruption to clinical research, reducing the ability of patients to visit clinical sites for face-to-face visits. This has accelerated the trend of initiating decentralised research, where patients complete some, or all, of the study procedures at home. These studies have potential upsides of greater convenience for the patient and possibly lower costs for sponsors. Conversely de-centralised trials bring the challenge of ensuring rigour and high levels of completion when administering PROs via an electronic PRO (ePRO) solution. The methodology and compliance levels of an de-centralised observational validation study are presented. Method(s): A 10-week de-centralised, observation study was completed in US, UK and Germany to assess the psychometric properties of the Asthma Daytime and Night-time Symptoms Diaries (ADSD/ANSD). Following IRB review and approval, multiple PROs were administered via a Bring your Own Device ePRO solution, including the ADSD/ANSD, SGRQ, EQ-5D, PROMIS Sleep Disturbance 8a. Fair-market value honoraria were phased over the period of the study. PRO compliance was monitored throughout the study, with pre-programmed scheduled reminders and escalating triggered alerts implemented to facilitate compliance. Result(s): 235 moderateto-severe asthma patients have been recruited. An interim assessment of the compliance indicates that over 90% of patients completed at least 4 days of daily data each week. The end of study overall compliance will be analysed and stratified by days completed per week. The frequency and distribution pattern of reminders will be assessed. Compliance patterns by country, demographics and baseline characteristics will be reported. Lessons learned will be discussed in detail to inform best practice. Conclusion(s): Decentralised trials are increasing in popularity. PROs are progressively being viewed as fundamental to Patient Focused Drug Development. The interim results from this ongoing study demonstrate that high levels of PRO completion are possible in a decentralised, BYOD study, with numerous and variable PRO administration frequency. This highlights the importance of well designed, patient friendly research protocols, in ensuring high levels of patient compliance in remote settings. On completion of study, compliance and compliance reminder metrics will be presented, stratified by baseline and demographic characteristics.
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Introduction: People with multiple sclerosis (PwMS) treated with anti-CD20 therapies and fingolimod are less likely to successfully produce a humoral response to COVID-19 vaccines 1 and 2. Objective(s): To measure the humoral and/or cellular response to COVID-19 booster vaccinations in a cohort of PwMS who were previously seronegative after their initial COVID vaccine course. Aim(s): To determine whether there is a benefit of COVID-19 booster vaccinations for people with MS who are known to have had an attenuated response to initial vaccines. Method(s): We studied a cohort of PwMS all of whom were seronegative for anti-SARS-CoV-2 spike protein IgG after the 1st and 2nd COVID-19 vaccines, including PwMS treated with ocrelizumab (n=53), fingolimod (n=15), other DMTs (n=9) and no DMT (n=2). Dried blood spot +/- whole blood samples were obtained from participants at 2-8 weeks after their 3rd (n=79) and 4th (n=40) COVID-19 vaccines. Samples were used to measure anti-SARS-CoV-2 spike protein IgG (ELISA) and T-cell response (IFN-g release assay measured on whole blood). Result(s): Overall 27/79 (34%) who were seronegative after COVID vaccine 2 seroconverted after vaccine 3. Seroconversion rates were 17% for PwMS treated with ocrelizumab, 47% for fingolimod and 100% for other DMTs. A further 2/30 (7%) of those who remained seronegative after vaccine 3 seroconverted after vaccine 4. Anti-SARS-CoV-2 T-cell responses were measurable in 26/40 (65%) after vaccine 3 and 13/19 (68%) after vaccine 4 but were conspicuously absent in people treated with fingolimod. Overall, 75% of participants showed either humoral or cellular response after receiving 4 COVID vaccinations. PwMS with laboratory evidence of prior COVID-19 infection had higher measurable T-cell responses. Conclusion(s): Booster vaccinations for COVID-19 are associated with incremental benefits in measurable immunity in those with attenuated responses to the initial vaccine course. Overall, three quarters of those who were seronegative after COVID vaccines 1 & 2 had a measurable immune response after COVID vaccine 4. This data supports the use of booster vaccinations in pwMS at risk of attenuated vaccine response.
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This paper engages with current debate on the role of the university following COVID-19, exposing the ongoing corruption of traditional values of the tertiary sector, and the shift in teaching and learning expectations across the academy. It highlights the negative impact of the huge decline in government funding since the 1990s, salary inequity, ongoing job loss and decline in teaching and learning conditions within universities, alongside proven wage theft and exploitation of sessional and casual staff. Government neglect of the higher education sector is obvious in its refusal to support any university staff through JobKeeper funding. These issues, together with an ongoing public apathy towards the education sector, have demoralised, disenfranchised and fragmented this vital knowledge-rich professional cohort. The critique argues that government funding to the tertiary sector must be increased to positively incentivise and restore the role of the public university in a democratic society. There should be a clear recalibration of higher education within the public sector. Staff need to work together across disciplines and hierarchies to address proven dysfunctional practices within the academy with a strong, united voice. It advances some recommendations to recapture the spirit of the once idealistic university mission, while also addressing the many-stranded, utilitarian functions that are demanded in a complex, changing landscape.
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While numerous studies on the impacts of COVID-19 on university learning and teaching are now emerging, there has been less critical attention focused on the impact of the shift to online engagement on student-staff partnership (SSP) practices. This article analyses the experiences and perceptions of students and staff from an Australian university as they shifted their partnership practices online during the pandemic. It provides valuable insights into the specific positive and negative impacts of online SSP for students and staff, foregrounding both groups' perceptions of the accessibility and communication aspects of online SSP. The study's findings lead to the recommendation of a blended approach and will be of use as SSP programs recalibrate for a post-COVID context.
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Background: People dependent on unit HD are vulnerable to COVID-19. We describe the safety and outcomes of reducing HD frequency to minimise patient exposure to the virus. Methods: HD was reduced from thrice to twice-weekly in selected patients for 9 weeks from March 2020. Urine output, heart failure, fluid-overload, hyperkalaemia, medication and patient preference were considered. Patients were asked to restrict dietary potassium, salt and fluid. Selected patients reducing HD frequency received 10g onceweekly sodium zirconium cyclosilicate (SZC). Group 1: Continue thrice-weekly HD Group 2: Twice-weekly HD +SZC Group 3: Twice-weekly HD -SZC. Pre-HD serum potassium (sK+) and bicarbonate (sHCO3 -), systolic blood pressure (SBP) and weights were monitored. COVID-19 transmission, hospitalisation and death were recorded. Results: Of 77 patients (mean age 70 years, 74% male), 17 continued thrice-weekly HD. 60 patients reduced to twice-weekly HD, of which 43 received SZC. There were 494 fewer HD treatments over 9 weeks. There was no significant difference in mean monthly sK+ in any group between March (pre-intervention), April and May;but 6 patients returned to thrice-weekly HD early due to hyperkalaemia or fluid-overload. SZC was increased to 10g twice-weekly in 15 patients. There was a reduction in mean monthly sHCO3 -during twice-weekly HD. No changes were made to oral or HD bicarbonate prescriptions. There was no significant difference in pre-HD weight or SBP from baseline in patients dialysing twice-weekly. Only 2 of the 14 admissions over 9-weeks were related to hyperkalaemia or fluid-overload. 5 patients tested positive for COVID-19. 2 of the 3 deaths during this period were due to COVID-19. Both were elderly males with CVD and chronic respiratory disease. 1 patient died of a MI after returning home from HD. No deaths were attributed to a reduction in HD frequency. There was no evidence of COVID-19 transmission on the HD unit. No patients were transferred to the regional hub for HD due to COVID-19. Conclusions: Reducing HD frequency in carefully selected patients is safe, and with strict infection control and timely COVID-19 testing, can reduce COVID-19 transmission and patient transfer to HD hubs. Dietetic review and SZC can reduce hyperkalaemia. Improved documentation of urinary output and cardiac function would optimise this approach.
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BACKGROUND: The coronavirus-2019 (COVID-19) pandemic is associated with increased potential for morally injurious events, during which individuals may experience, witness, or learn about situations that violate deeply held moral beliefs. However, it is unknown how pandemic risk and resilience factors are associated with COVID-related moral injury. METHODS: Individuals residing in the U.S. (N = 839; Mage = 37.09, SD = 11.06; 78% women; 63% White; 33% PTSD) participating in an online survey reported on COVID-19 related moral injury (modified Moral Injury Events Scale), perceived current and future threat of pandemic on life domains (social, financial, health), and COVID-19 risky and protective behaviors. Multivariate linear regressions examined associations of perceived threat and risky and protective behaviors on type of COVID-19 related moral injury (betrayal, transgression by others, self). RESULTS: Participants endorsed MI betrayal (57%, N = 482), transgression by other (59%, N = 497), and by self 17% (N = 145). Adjusting for sociodemographics, only future threat of COVID-19 to health was significantly associated with betrayal (B = 0.21, p = .001) and transgression by other (B = 0.16, p = .01), but not by self. In contrast, high frequency of risky behaviors was associated with transgressions by self (B = 0.23, p < .001). Sensitivity analyses showed PTSD did not moderate the observed effects. CONCLUSIONS: Betrayal and transgression by others was associated with greater perceived future threat of COVID-19 to health, but not financial or social domains. Stronger endorsement of transgression by self was associated with more frequently engaging in risky behaviors for contracting COVID-19. These findings may suggest the need for individual, community, and system level interventions to address COVID-19 related moral injury.
Subject(s)
COVID-19 , Stress Disorders, Post-Traumatic , Adult , Female , Humans , Male , Pandemics , SARS-CoV-2 , Surveys and QuestionnairesABSTRACT
The United States declared a national emergency on March 13, 2020, in response to the rapidly spreading COVID-19 pandemic after all 50 states reported laboratory-confirmed cases.1 The demand for ambulatory medical care in the US fell by almost 60% and immunization encounters at Walter Reed National Military Medical Center decreased by 76% as patients became concerned about the risk of coronavirus exposure within a clinic or hospital setting.2 Our vaccination initiatives aimed to increase our pediatric and adult immunization rates through offering two alternative immunization platforms aimed to reduce patient concerns about COVID exposure.
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As SARS-CoV-2 spread throughout the world military units had to develop ways of combatting risk to ensure force health protection and deployability of their soldiers. Medical functions were impacted and solutions needed to be found in order to incorporate these items as functioning medical platforms. In the following article, we address one unit's individual response to the difficulties faced as a Military Police Brigade in Europe. Lessons learned from the initial wave of COVID-19 across medical operations, medical readiness, virtual health, and behavioral health initiatives can be utilized for better planning and response in the future.