JCV seroconversion rate during the SARS COVID-19 pandemic.

The transmission route of the John Cunningham virus (JCV) is not clearly understood. The high prevalence of JCV in urine and sewage and the stability of the viral particles observed suggest that contaminated water, food, and fomites could be the vehicles of JCV transmission through the oral route. Multiple Sclerosis (MS) patients treated with Natalizumab are at risk of developing progressive multifocal leukoencephalopathy (PML), and hence, JCV serology is monitored for risk stratification. Social restrictions introduced in 2020 which intended to limit the transmission of SARS-CoV-2 are associated with decreased rates of other communicable diseases, as has been shown in recent observational studies. We evaluated the prevalence of seroconversion prior to and during the coronavirus disease (COVID -19) pandemic based on clinical records of JCV serology status in a single-center cohort of Natalizumab-treated Multiple Sclerosis patients. We hypothesized that seroconversion rates would decrease due to behavioral changes. However, seroconversion rates were stable during the COVID-19 pandemic compared to the pre-pandemic. These findings support the notion that JCV is transmitted via the GI tract rather than the respiratory system.

BNT162b2 mRNA COVID-19 Vaccine Three-Dose Safety and Risk of COVID-19 in Patients With Myasthenia Gravis

Objective To study the COVID-19 vaccine three-dose safety and risk of COVID- 19 in patients with myasthenia gravis Background Various vaccines, including those against SARS-CoV-2, were reported to trigger or exacerbate myasthenia gravis (MG). As COVID-19 may potentially contribute to the tendency of MG patients to develop respiratory failure, it is important to study the safety of vaccines against SARS-CoV-2 and assess the risk of COVID-19 in MG patients. Design/Methods Among 215 MG patients treated in Tel Aviv Medical Center, 160 were interviewed about their response to the three-dose BNT162b2 mRNA vaccine. We assessed exacerbation rate and safety in a period of up to 6 weeks from each vaccine dose, as well as patient morbidity and mortality during COVID-19 compared to the general population. Results 430 vaccine doses were administered across 150 patients. Thirteen patients (8.7%) complained of exacerbation within 6 weeks (risk period) of each vaccine dose, 8 (5.3%) confirmed by physician report. The exacerbation rates were similar during the risk period (5.6%) compared to corresponding period the previous year (4.8%). MG onset rates during the vaccination period were unaffected compared to previous years. Exacerbation rate among 15 patients who had COVID-19 was significantly higher (40%) compared to rate in the risk period following vaccination, with higher severe or lethal COVID-19 (26.7%) compared to the general population (0.96%), occurring in unvaccinated, steroidtreated, generalized MG patients. Conclusions Three-dose BNT162b2 vaccination is neither associated with exacerbation nor the new onset of MG, whereas COVID-19 is associated with severe disease and death in unvaccinated, steroid-treated generalized MG patients. Hence, it is strongly recommended for generalized MG patients to get vaccinated.

Academic medical center clinical research professional workforce: Part 2 - Issues in staff onboarding and professional development.

Background: Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway. Materials/Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers. Results: Results suggest there are several barriers to training the CRP workforce, including balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, identifying/enlisting institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. Two universal threads present throughout all themes are the need for effective communication and the need to improve professionalization of the CRP career pathway. Conclusion: Few institutions have solved all the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. We applied a socio-technical lens to illustrate our findings and the need for NCATS-funded academic medical centers to work collaboratively within and across institutions to overcome training barriers and support a vital, well-qualified workforce and present several exemplars from the field to help attain this goal.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.