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 The COVID-19 pandemic has put pressure on health-care services forcing the reorganization of traditional care pathways. Aim To investigate;(1) how physicians taking care of severe asthma patients in Europe reorganized care during the COVID-19 pandemic;(2) patient satisfaction with these changes;and (3) impact on future care. Methods In this European-wide cross-sectional study, patient surveys were sent to patients with a physiciandiagnosis of severe asthma, and physician surveys to severe asthma specialists (November 2020 - May 2021). Results 1101 patients and 268 physicians from 16 European countries contributed to the study. Common physicianreported changes in severe asthma care included use of video/phone consultations (46%) and change to home administered biologics (38%), which resulted in high satisfaction levels in most patients (Figure 1). Many physicians expect continued implementation of video/phone consultations (41%) and home administration of biologics (52%). Conclusions Change to video/phone consultations and home administration of biologics was common in severe asthma care during the COVID-19 pandemic, and was associated with high satisfaction levels in most but not all cases. Many physicians expect these changes to continue in future severe asthma care, though satisfaction levels may change after the pandemic. (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).