COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects.

BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.

Impact of the first COVID-19 lockdown on study satisfaction and burnout in medical students in Split, Croatia: a cross-sectional presurvey and postsurvey.

OBJECTIVES: To evaluate the impact of the first COVID-19 lockdown in 2020 on the burnout and study satisfaction of medical students. DESIGN: A cross-sectional study with a presurvey and postsurvey. SETTING: University of Split School of Medicine (USSM), Split, Croatia. The lockdown in the COVID-19 pandemic lasted from late March to mid-May 2020. There was a full switch to e-learning at the USSM during this period, and all clinical teaching was stopped. PARTICIPANTS: Students enrolled in the 2019/2020 academic year. Data were collected before lockdown in December 2019 and January 2020 and again after the end of lockdown in June 2020. PRIMARY AND SECONDARY OUTCOME MEASURES: Study satisfaction was assessed using the study satisfaction survey. Burnout was assessed using two instruments: Oldenburg Burnout Inventory and Copenhagen Burnout Inventory. We used Bayesian statistics to compare before-and-after differences. RESULTS: 437 independent responses (77.2% response rate) were collected before and 235 after lockdown (41.5% response rate). 160 participant responses were eligible for pairing. There was no significant difference for both paired and unpaired participants in study satisfaction before (3.38 on a 1-5 scale; 95% credible interval (95% CrI) 3.32 to 3.44) and after (3.49, 95% CrI 3.41 to 3.57) lockdown. We found no evidence (Bayes factor (BF10) >3.00 as a cut-off value) for an increase in the level of burnout before and after lockdown, both in independent and paired samples. CONCLUSIONS: It seems that the first pandemic-related lockdown and a switch to e-learning did not affect burnout levels among medical students or their perception of their study programme. More insight is needed on the short-term and long-term effects of the COVID-19 pandemic on medical students and their education. Well-structured longitudinal studies on medical student burnout during the COVID-19 pandemic are needed.