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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).
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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).
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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).
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Introduction: The impact of treatment experience with ECMO prior to the COVID-19 pandemic era on the outcomes of ECMO during the COVID-19 pandemic has not been well investigated. The aim of this study was to investigate the differences in the outcomes of ECMO between highvolume hospitals in Japan before the COVID-19 pandemic and low-volume hospitals. Method(s): This is a prospective observational cohort study of patients with fatal COVID-19 pneumonia in Japan receiving ECMO. The association between patient background, high/low-volume hospitals, and survival from February 2020 to November 2021 were evaluated. Prognostic factors were assessed by Kaplan-Meier and Cox proportional hazards analyses. High-volume hospitals were defined as those with a total of at least 20 cases prior to the COVID-19 pandemic era. Result(s): Ten hospitals (1.1% of a total of 900 ICUs in Japan) were classified as high-volume hospitals, with a median number of ECMO cases of 35.5 (IQR, 25.5-40.5). There were a total of 1,214 ECMO cases during the COVID-19 pandemic, of which 1030 (85%) were treated in low-volume hospitals and 184 (15%) were treated in high-volume hospitals. Kaplan-Meier analysis demonstrated slightly better survival in high-volume hospitals in 30-day (p=0.062) and 60-day (p=0.11) survivals, whereas, in 90-day survival, the two groups were almost identical (p=0.87). Cox proportional hazards analysis also failed to demonstrate that high-volume hospital before the COVID-19 pandemic era was independent prognostic factor (HR, 0.97;95%CI, 0.74-1.28). Conclusion(s): In Japan, high-volume hospital prior to the COVID-19 pandemic era was not independent prognostic factor.
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RATIONALE4,4-44,4% of children suffer from post-COVID syndrome, commonly known as long- COVID, after an acute SARS-CoV-2 infection. However, an uniform clinical definition, and guidelines to diagnose or treat children suspected of long-COVID are lacking. Multiple careprograms have been initiated worldwide. In this study, we aimed to assess the currently available pediatric international long-COVID care programs and explore the characteristics of their patient cohorts.METHODSWe established an international network (IP4C) and performed a crosssectional analysis from aggregated data collected by its members using a survey. Topics included: the used definition for long-covid in children, the organization of pediatric long-COVID clinics and long-COVID patients characteristics. Descriptive analysis of the aggregated data was used to summarize and compare each of these categories across countries. RESULTSWe included data concerning organization of care from 17 cohorts based in 13 different countries. A wide range of definitions for long COVID was used, which differed mostly in duration of symptoms and the necessity of microbiologically proven SARS-COV-2 infection. 66,6-100% of patients in the long- COVID cohorts suffered from complaints for more than twelve weeks, and 49,5-97,3% of patients had a positive RT-PCR or serology for SARS-CoV-2. Most long-COVID care programs consisted of real-life visits with multidisciplinary teams, consisting of general pediatricians, pediatric lung specialists, cardiologists and infectiologist, a physiotherapist and psychologist. The type of investigations performed at the long-COVID clinics ranged from assessment of medical history (100%) and standardized questionnaires (91%) to in depth evaluation of organ functioning (e.g. spirometry performed in 0-100% of patients). Aggregated data of 431 long-COVID patients from 11 dedicated long-COVID care programs were analyzed. Mean age of patients ranged from 6,5-16,4 years old. Girls were overrepresented in most cohorts (20-65%). 28-81,8% of patient had a positive medical history, most commonly atopic syndrome, asthma and prematurity. Most patients (90- 100%) suffered from asymptomatic or mild acute COVID-19. Frequent long-COVID symptoms were fatigue, headaches, concentration difficulties, dyspnea and sleep disturbances. 5-37% of patients had severe limitations in daily life. CONCLUSIONSThis is the first study to describe the organization of pediatric long-COVID care. It demonstrates that pediatric long-COVID is recognized worldwide as a multisystemic disease, but its definition and care programs for pediatric long- COVID patients differ between cohorts. A clear definition of pediatric long-COVID is needed to improve international scientific collaboration and patient care. Our international network will facilitate further collaboration in investigation pathophysiology and therapeutic interventions in order to provide evidence based medical care for these patients.
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Multifaceted thinking is essential to address global proposal. Learning experience in multidisciplinary fields is useful. Following steps are important: multifaceted understanding the purpose of instructions to society, considering advantages and disadvantages, considering options, and considering relationship between individual behavior and society. As a multidisciplinary field, Biomedical Engineering has been applied to the present study. As a topic of case study, COVID-19 has been selected. While answering the questions, the students (in Japan, and in Thailand) noticed the multifaceted problem and the diversity of related disciplines. The education system provided the experience of linking biomedical engineering learning (statistics, biomeasurement, cellular mechanics, micromachining, designing, immunology, artificial organs) to the proposal of the solution to the global problem. © 2022 IMCIC 2022 - 13th International Multi-Conference on Complexity, Informatics and Cybernetics, Proceedings. All rights reserved.
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Objectives: The COVID-19 pandemic has spread across the world, leading to government measures such as national lockdowns and social distancing, which are associated with a negative impact on mental health. This study evaluated the impact of COVID-19 on anxiety, depression and resilience in Dutch children and adults with cystic fibrosis (CF) or primary ciliary dyskinesia (PCD) and their caregivers during the second wave of the pandemic. Methods: Adolescents (12–18 years), adults and caregivers of children (0–18 years) with CF or PCD completed screening questionnaires from Sept-Dec 2020 on anxiety (GAD-7), depression (PHQ-9), and resilience (BRS). The psychosocial impact of COVID-19 was measured by the Exposure and Family Impact Survey (CEFIS) part 2, which was translated into Dutch using EMA guidelines. Results from the GAD-7 and PHQ-9 were compared to participants’ pre-pandemic scores. Results: 65 individuals participated (CF: 6 adolescents, 32 caregivers. PCD: 17 patients, 10 caregivers). Prevalence of symptoms of anxiety and depression (score of ≥5 on the GAD-7 and/or PHQ-9) during the pandemic was high (34% and 37% respectively for CF, 48% and 37% PCD), but median GAD-7 and PHQ-9 scores during the pandemic (CF: GAD-7 = 3.0 and PHQ-9 = 2.5;PCD: GAD-7 = 3.0 and PHQ-9 = 4.0) did not differ from the pre-pandemic outcomes for both groups (CF: GAD-7 = 2.0 and PHQ-9 = 2.0;PCD: GAD-7 = 5.0, PHQ-9 = 5.0). Resilience was within the normal range (mean for CF: 3.33;PCD: 3.29). The mean CEFIS scores for both CF and PCD corresponded to a low (PCD: 11.3) to normal (CF: 21.7) impact. Conclusion: Despite the high prevalence of symptoms of anxiety and depression in this selected population, there was no detected change in these symptoms during the pandemic. Therefore, the current study could not demonstrate a significant impact of COVID-19 on mental health, but does still emphasise the need for psychological care in individuals with CF or PCD and their caregivers.
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The global community has accelerated the spread of the virus. Medicine alone cannot solve the pandemic. The change of the lifestyle by new technology helps to coexist with viruses. The academic field has been divided into each specialized field. The modern communication tools (internet, and database), on the other hand, promote multidisciplinary academic fields. The multidisciplinary field is not just a collection of fields, but a fusion among fields. Many problems in global society cannot be solved by a single disciplinarian. The global society is waiting for a multi-disciplinarian. For students, it is not easy to find the way to learn a multidisciplinary field: the curriculum, the textbook, the learning team, and the teacher (the adviser). "Biomedical Engineering"is one of the multidisciplinary fields. It has many related fields: biology, medicine, informatics, and engineering. The topic includes case studies related to COVID-19 (education for the undergraduate and the graduate courses) based on the author's experiences: from cross cultural to symbiosys. Copyright © 2021 by the International Institute of Informatics and Systemics.