Publications by authors named "S L Schmikli"
Background And Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.
Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022.
Introduction: COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees.
Methods: A prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries.
Background: In the past, several studies investigated factors that are prognostic or associated with outcome after anterior cruciate ligament (ACL) reconstruction. A recent review showed that only limited evidence is available for most studied factors, and that insufficient analysis methods were used commonly. Therefore, the aim of this study was to add more weight to the existing evidence, about factors that are associated with a more rapid outcome after ACL reconstruction.
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- This study compared the effectiveness of soft bracing versus taping for treating acute lateral ankle ligamentous sprains (ALALS) over four weeks in 157 adults.
- After a year, the rates of re-injury were similar between the two treatment groups, with slightly more re-injuries reported in the brace group.
- However, participants in the brace group had worse scores on a specific ankle test one year later, suggesting bracing may not be as effective for long-term outcomes.
Objectives: To compare the incidence and characteristics of injuries between Dutch amateur and professional male soccer players during one entire competition season.
Design: A prospective two-cohort design.
Methods: During the 2009-2010 season, 456 Dutch male amateur soccer players and 217 professional players were prospectively followed.