ABSTRACT
Introduction: Coronavirus disease 2019 COVID-19 is clearly the pandemic of the new millennium. COVID-19 determines multi organ dysfunction including the inflammatory immune responses of thyroid gland. Objective(s): To determine whether the involvement of the thyroid gland by COVID-19 manifests as thyroid hormonal changes and development of thyroid disorders. Method(s): We studied prospectively 60 patients with COVID-19 pneumonia,without previous known history of thyroid disease nor pre-existing endocrine disorders, hospitalized between May and July 2021, and we performed serum thyroid hormonal analysis within the first 24 hours after admission, including TSH, Free T3, Free T4 and their antithyroglobulin antibodies (Anti-TG and Anti-TPO), and correlate them with clinical and laboratory data. Result(s): Samples were collected from 60 patients (31 males, 51.7%). 32 out of 60 (53.3%) showed significantly lower values of TSH (0,29 +- 0,07 mIU/mL) with decreased Free T3 serum levels (2,07 +- 0,131 pmol/L) and the thyroid autoantibodies (both Anti-TG and Anti-TPO) were positive. These 32 patients (27 males) demonstrated moderate to critical illness and they needed high oxygen flow. The other 28 patients with no evidence of thyroid abnormalities showed mild to moderate COVID-19 pneumonia and none needed high oxygen flows. Conclusion(s): In our study, 32/60 (53.3%) patients with moderate to severe COPVID-19 pneumonia were diagnosed with thyroid abnormalities. Thus, the development and the progression of respiratory failure due to SARS-COV-2 may affect the thyroid function.
ABSTRACT
Background: Innovative information techniques are increasingly used to perform federated analyses in real-world studies. Whether these techniques are suitable for harmonizing patient data from non-standardized registries and evaluating treatment outcomes needs further evidence. Aim(s): To standardize patient-level registry data from SHARP (Severe Heterogeneous Asthma Registry Patientcentred) and evaluate the effectiveness of mepolizumab on frequent (>=2/yr) exacerbations in patients with severe asthma. Method(s): We standardized data from 5,871 adults with severe asthma in 10 European countries using the OMOP Common Data Model (www.ohdsi.org). Patients who had taken mepolizumab >=1 yr (2016-2021) and had exacerbation data available were included. Changes in odds of >=2 exacerbations/yr were evaluated. Result(s): Of 2,109 patients who initiated mepolizumab 563 met inclusion criteria. Analysis showed a reduction of having >=2 (vs 0-1) annual exacerbations after 1 yr mepolizumab therapy: OR (95%CI) 0.18 (0.13-0.25)[N=369] pre and 0.08 (0.05-0.13)[N=194] during the COVID-19 pandemic (Fig). Conclusion(s): By harmonizing non-standardized, patient-level registry data and applying federated analysis we demonstrated that mepolizumab reduced asthma exacerbations, consistent with current knowledge. This paves the way for future pan-European real-world severe asthma studies using patient-level data in a privacy-proof way. (Figure Presented).
ABSTRACT
Background: Clinical trials of COVID-19 vaccination provide evidence of side effects in the placebo group, consistent with some side effects reporting being a nocebo effect (Amanzio M, et al. Lancet Reg Health Eur 2022;12:100253) Aim: To investigate whether side effects of COVID-19 vaccination are associated with negative beliefs about vaccination. Method(s): European patients with severe asthma (SHARP network) completed a questionnaire (May-June 2021) about their vaccination status, the Vaccination Attitudes EXamination (VAX) Scale, a measure of vaccination hesitancy related to four different types of belief, and if vaccinated whether they experienced side effects (none, mild, severe). Result(s): 660 patients from 12 European countries participated, of whom 497 had at least a first vaccination and also completed the VAX questions and side effects. Of these patients, those reporting severe side effects (5.7%) compared to those with mild (48.2%) or no side effects (43.8%) had significantly (p = 0.001, ANOVA) more mistrust of vaccine efficacy, more concerns about future effects and more concerns about profiteering but not significantly more preference for natural immunity (Fig 1). Conclusion(s): People with severe asthma who have negative beliefs about vaccination are more likely to report severe side effects to COVID-19 vaccination. Consistent with the nocebo effect, negative beliefs create negative expectations and side effects. (Figure Presented).