COVID-19 vaccination acceptance, safety and side-effects in European patients with severe asthma.

Background: Vaccination is vital for achieving population immunity to severe acute respiratory syndrome coronavirus 2, but vaccination hesitancy presents a threat to achieving widespread immunity. Vaccine acceptance in chronic potentially immunosuppressed patients is largely unclear, especially in patients with asthma. The aim of this study was to investigate the vaccination experience in people with severe asthma. Methods: Questionnaires about vaccination beliefs (including the Vaccination Attitudes Examination (VAX) scale, a measure of vaccination hesitancy-related beliefs), vaccination side-effects, asthma control and overall safety perceptions following coronavirus disease 2019 (COVID-19) vaccination were sent to patients with severe asthma in 12 European countries between May and June 2021. Results: 660 participants returned completed questionnaires (87.4% response rate). Of these, 88% stated that they had been, or intended to be, vaccinated, 9.5% were undecided/hesitant and 3% had refused vaccination. Patients who hesitated or refused vaccination had more negative beliefs towards vaccination. Most patients reported mild (48.2%) or no side-effects (43.8%). Patients reporting severe side-effects (5.7%) had more negative beliefs. Most patients (88.8%) reported no change in asthma symptoms after vaccination, while 2.4% reported an improvement, 5.3% a slight deterioration and 1.2% a considerable deterioration. Almost all vaccinated (98%) patients would recommend vaccination to other severe asthma patients. Conclusions: Uptake of vaccination in patients with severe asthma in Europe was high, with a small minority refusing vaccination. Beliefs predicted vaccination behaviour and side-effects. Vaccination had little impact on asthma control. Our findings in people with severe asthma support the broad message that COVID-19 vaccination is safe and well tolerated.

Diagnosis and treatment of adult asthma patients in Serbia: a 2022 experts group position statement.

INTRODUCTION: Asthma is the most common non-communicable chronic lung condition across all ages. Epidemiological data indicate that many asthma patients in Serbia remain undiagnosed and untreated. The implementation of recent global advances in asthma management is limited due to the lack of a systematic approach, drug availability and regulatory affairs. In addition, the global coronavirus disease pandemic has posed a significant challenge, particularly in resource-limited settings. AREAS COVERED: In this paper, we propose an algorithm for treating adult asthma patients in Serbia. We performed PubMed database search on published asthma clinical trials and guidelines from 1 January 2015 to 10 March 2020. The consensus process incorporated a modified Delphi method that included two rounds of e-mail questionnaires and three rounds of national asthma expert meetings. We focus on 1) objective diagnosis of asthma, 2) the implementation of up-to-date therapeutic options, and 3) the identification and referral of severe asthma patients to newly established severe asthma centers. EXPERT OPINION: Regional specificities and variations in healthcare systems require the adaptation of evidence-based knowledge. Practical, clinically oriented algorithms designed to overcome local barriers in healthcare delivery may facilitate timely and adequate asthma diagnosis and the local implementation of current advances in asthma management.

Predicting 30-Day Readmission Risk for Patients With Chronic Obstructive Pulmonary Disease Through a Federated Machine Learning Architecture on Findable, Accessible, Interoperable, and Reusable (FAIR) Data: Development and Validation Study.

BACKGROUND: Owing to the nature of health data, their sharing and reuse for research are limited by legal, technical, and ethical implications. In this sense, to address that challenge and facilitate and promote the discovery of scientific knowledge, the Findable, Accessible, Interoperable, and Reusable (FAIR) principles help organizations to share research data in a secure, appropriate, and useful way for other researchers. OBJECTIVE: The objective of this study was the FAIRification of existing health research data sets and applying a federated machine learning architecture on top of the FAIRified data sets of different health research performing organizations. The entire FAIR4Health solution was validated through the assessment of a federated model for real-time prediction of 30-day readmission risk in patients with chronic obstructive pulmonary disease (COPD). METHODS: The application of the FAIR principles on health research data sets in 3 different health care settings enabled a retrospective multicenter study for the development of specific federated machine learning models for the early prediction of 30-day readmission risk in patients with COPD. This predictive model was generated upon the FAIR4Health platform. Finally, an observational prospective study with 30 days follow-up was conducted in 2 health care centers from different countries. The same inclusion and exclusion criteria were used in both retrospective and prospective studies. RESULTS: Clinical validation was demonstrated through the implementation of federated machine learning models on top of the FAIRified data sets from different health research performing organizations. The federated model for predicting the 30-day hospital readmission risk was trained using retrospective data from 4.944 patients with COPD. The assessment of the predictive model was performed using the data of 100 recruited (22 from Spain and 78 from Serbia) out of 2070 observed (records viewed) patients during the observational prospective study, which was executed from April 2021 to September 2021. Significant accuracy (0.98) and precision (0.25) of the predictive model generated upon the FAIR4Health platform were observed. Therefore, the generated prediction of 30-day readmission risk was confirmed in 87% (87/100) of cases. CONCLUSIONS: Implementing a FAIR data policy in health research performing organizations to facilitate data sharing and reuse is relevant and needed, following the discovery, access, integration, and analysis of health research data. The FAIR4Health project proposes a technological solution in the health domain to facilitate alignment with the FAIR principles.

The effect of the COVID-19 pandemic on severe asthma care in Europe: will care change for good?

Background: The coronavirus disease 2019 (COVID-19) pandemic has put pressure on healthcare services, forcing the reorganisation of traditional care pathways. We investigated how physicians taking care of severe asthma patients in Europe reorganised care, and how these changes affected patient satisfaction, asthma control and future care. Methods: In this European-wide cross-sectional study, patient surveys were sent to patients with a physician-diagnosis of severe asthma, and physician surveys to severe asthma specialists between November 2020 and May 2021. Results: 1101 patients and 268 physicians from 16 European countries contributed to the study. Common physician-reported changes in severe asthma care included use of video/phone consultations (46%), reduced availability of physicians (43%) and change to home-administered biologics (38%). Change to phone/video consultations was reported in 45% of patients, of whom 79% were satisfied or very satisfied with this change. Of 709 patients on biologics, 24% experienced changes in biologic care, of whom 92% were changed to home-administered biologics and of these 62% were satisfied or very satisfied with this change. Only 2% reported worsening asthma symptoms associated with changes in biologic care. 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.

FAIR4Health: Findable, Accessible, Interoperable and Reusable data to foster Health Research.

Due to the nature of health data, its sharing and reuse for research are limited by ethical, legal and technical barriers. The FAIR4Health project facilitated and promoted the application of FAIR principles in health research data, derived from the publicly funded health research initiatives to make them Findable, Accessible, Interoperable, and Reusable (FAIR). To confirm the feasibility of the FAIR4Health solution, we performed two pathfinder case studies to carry out federated machine learning algorithms on FAIRified datasets from five health research organizations. The case studies demonstrated the potential impact of the developed FAIR4Health solution on health outcomes and social care research. Finally, we promoted the FAIRified data to share and reuse in the European Union Health Research community, defining an effective EU-wide strategy for the use of FAIR principles in health research and preparing the ground for a roadmap for health research institutions. This scientific report presents a general overview of the FAIR4Health solution: from the FAIRification workflow design to translate raw data/metadata to FAIR data/metadata in the health research domain to the FAIR4Health demonstrators' performance.

Characteristics of COPD Phenotypes in Serbia.

BACKGROUND: Establishing a regional/national/international registry of patients suffering from chronic obstructive pulmonary disease (COPD) is essential for both research and healthcare, because it enables collection of comprehensive real-life data from a large number of individuals. OBJECTIVE: The aim of this study was to describe characteristics of COPD patients from the Serbian patient registry, and to investigate actual differences of those characteristics among the COPD phenotypes. METHODS: The Serbian registry of patients with COPD was established in 2018 at University of Kragujevac, Faculty of Medical Sciences, based on an online platform. Entry in the Registry was allowed for patients who were diagnosed with COPD according to the following criteria: symptoms of dyspnea, chronic cough or sputum production, history of risk factors for COPD and any degree of persistent airflow limitation diagnosed at spirometry. RESULTS: In the Serbian COPD registry B and D GOLD group were dominant, while among the COPD phenotypes, the most prevalent were non-exacerbators (49.4%) and then frequent exacerbators without chronic bronchitis (29.6%). The frequent exacerbator with chronic bronchitis phenotype was associated with low levels of bronchopulmonary function and absolute predominance of GOLD D group. Anxiety, depression, insomnia, hypertension and chronic heart failure were the most prevalent in the frequent exacerbator with chronic bronchitis phenotype; patients with this phenotype were also treated more frequently than other patients with a triple combination of the most effective inhaled anti-obstructive drugs: long-acting muscarinic antagonists, long-acting beta 2 agonists and corticosteroids. CONCLUSION: In conclusion, the data from the Serbian registry are in line with those from other national registries, showing that frequent exacerbators with chronic bronchitis have worse bronchopulmonary function, more severe signs and symptoms, and more comorbidities (especially anxiety and depression) than other phenotypes. Other studies also confirmed worse quality of life and worse prognosis of the AE-CB phenotype, stressing importance of both preventive and appropriate therapeutic measures against chronic bronchitis.

Diagnosis and management of chronic obstructive pulmonary disease in Serbia: an expert group position statement.

In recent years, several national chronic obstructive pulmonary disease (COPD) guidelines have been issued. In Serbia, the burden of COPD is high and most of the patients are diagnosed at late stages. Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy is poorly implemented in real-life practice, as many patients are still prescribed inhaled corticosteroids (ICS)-containing regimens and slow-release theophylline. In this document, we propose an algorithm for treating COPD patients in Serbia based on national experts' opinion, taking into account global recommendations and recent findings from clinical trials that are tailored according to local needs. We identified four major components of COPD treatment based on country specifics: active case finding and early diagnosis in high-risk population, therapeutic algorithm for initiation and escalation of therapy that is simple and easy to use in real-life practice, de-escalation of ICS in low-risk non-exacerbators, and individual choice of inhaler device based on patients' ability and preferences. With this approach we aim to facilitate implementation of the recommendation, initiate the treatment in early stages, improve cost-effectiveness, reduce possible side effects, and ensure efficient treatment.

Pattern of Response to Bronchial Challenge with Histamine in Patients with Non-Atopic Cough-Variant and Classic Asthma.

BACKGROUND: The aim of this study was to establish whether non-atopic patients with cough variant asthma (CVA) have different pattern of response to direct bronchoconstrictors than non-atopic patients with classic asthma (CA). METHOD: A total of 170 patients of both sexes with stable CVA and CA were screened for the study and 153 were included. Patients with proven atopy were not included and 17 patients with worsening of their condition or with verified bronchial obstruction during screening were excluded. All included patients performed spirometry and underwent a bronchial challenge with histamine according to long-standing protocol in our laboratory. RESULTS: Significantly higher frequency of bronchial hyper-responsiveness (BHR) was found in patients with CA than in patients with CVA (63.9% vs. 44.9%, respectively; p < 0.05). Sensitivity was significantly lower in patients with CVA (p < 0.05), while no significant difference was found in maximal response and responsiveness. Only patients with positive challenge tests were included in the analysis. CONCLUSION: Adult non-atopic patients with CVA and CA have a pattern of response to non-specific bronchial stimuli similar to atopic patients with same conditions, with the exception of similar maximal response, which may reflect the efficacy of previous treatment. We believe that further studies are needed to clarify the mechanisms involved in airway response to non-specific stimuli in CVA and CA, especially in non-atopic patients. Further studies should also clarify whether this response pattern has any implications on clinical presentation or on treatment options.

Chilaiditi's sign and syndrome: theoretical facts and a case report.

INTRODUCTION: Chilaiditi's syndrome is a rare condition manifested by gastrointestinal symptoms, and radiologically verified by transposition of the large intestine loop. This radiological finding with no manifested symptoms is termed the Chilaiditi's sign. The aim of this case report was to remind the clinicians of the possibility of this rare syndrome, whose symptoms and signs may be misinterpreted and inadequately treated, with consequent diverse complications. CASE REPORT: W We presented the theoretical facts and a patient in whom the diagnosis of Chilaiditi's syndrome was established incidentally, when hospitalized for an exacerbation of his chronic obstructive pulmonary disease. The Chilaiditi's sign was verified as an incidental finding on chest X-ray performed to evaluate the primary disease. CONCLUSION: Chilaiditi's syndrome is a benign condition which rarely requires surgery. Its clinical importance lies in adequate differential diagnostic approach and timely management of potentially serious complications.

Early detection of asthma and chronic obstructive pulmonary disease in primary care patients.

INTRODUCTION: Asthma and chronic obstructive pulmonary disease are often unrecognized and undertreated. The aim of this study was to describe the frequency of chronic obstructive pulmonary disease and asthma in primary care patients in Serbia, and to examine the agreement between general practitioners and pulmonologists on the diagnosis of chronic obstructive pulmonary disease and asthma. MATERIAL AND METHODS: In this multicenter observational study, the general practitioners identified eligible patients from October 2009 to June 2010. The study included all adult patients with respiratory symptoms and/or smoking history based on structured interview. The patients were referred to a pulmonologist and underwent a diagnostic work-up, including spirometry. RESULTS: There were 2074 patients, 38.4% men, their mean age being 54 +/- 15.5 years. The patients were mostly current (40.3%) or ex-smokers (27.4%). The common symptoms included shortness of breath (84.9%), cough (79.1%) and wheezing (64.3%). The diagnosis of chronic obstructive pulmonary disease was confirmed by pulmonologists in 454 (21.9%) and asthma in 455 (21.9%) patients. The chronic obstructive pulmonary disease was newly diagnosed in 226 (10.9%) and asthma in 269 (13%) of the cases. There was a moderate agreement between the pulmonologists and general practitioners on the diagnosis of chronic obstructive pulmonary disease (kappa 0.41, 95% CI 0.36-0.46) and asthma (kappa 0.42, 95% CI 0.37-0.465). CONCLUSION: A significant number of patients seen in the general practitioner's office were diagnosed with chronic obstructive pulmonary disease or asthma and half of them represent new cases. A substantial proportion of patients referred to a pulmonologist by primary care physicians have been misdiagnosed.

The frequency of sensitization to inhalatory allergens and concomitant rhinitis in asthmatic patients.

BACKGROUND/AIM: Asthma is one of the most common chronic pulmonary diseases. The number of asthmatics has been continuously increasing all over the world. Depending on its causing agent, asthma is classified as allergic and nonallergic. Asthma is often associated with other allergic diseases, and it is most commonly preceded by the symptoms of rhinitis. The aim of this study was to establish the type and frequency of allergic sensitization to inhalatory allergens, frequency of concomitant rhinitis, gender and age-related distribution of asthma, and the presence of some risk factors in patients with diagnosed asthma. METHODS: This retrospective and partially prospective analysis included 733 patients with asthma diagnosed in the Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica over the period January, 2004-December, 2008. The obtained date were statistically processed. RESULTS: Females were significantly more often affected by asthma (p < 0.05), most frequently at 20-29 years of age. A hereditary predisposition to the diseases in terms of atopy was registered in 34.9% of the examined subjects. Most patients had allergic asthma (79.5%). Sensitization to internal and external inhalatory allergens was verified in 77.5% and 67.6% of the patients respectively, and combined hypersensitivity to both allergen types in 48.8% of the patients. Rhinitis was registered in 63.9% and 28% of the patients with allergic and nonallergic asthma, respectively. Rhinitis symptoms preceded the occurrence of asthma in 60% of the patients, with the precedence of rhinitis ranging from 1 to 27 years. A high correlation between rhinitis and asthma was established for the disease of both allergic (r = 0.92) and nonallergic (r = 0.88) etiology. CONCLUSION: The majority of the patients have allergic asthma, and they are females at 20-29 years of age. Senstization to internal allergens is most common, and then to external ones. Rhinitis is the most common concomitant disease, usually preceding the occurrence of asthmatic symptoms.

Intrathoracic malignant peripheral nerve sheath tumor with poor outcome: a case report.

We report a case of intrathoracic malignant peripheral nerve sheath tumor in a 65-year old woman revealed after a few-month history of progressive dyspnea, appetite and body mass loss. The chest magnetic resonance (MR) examination revealed the presence of a large tumor occupying the mediastinum and a major portion of the right hemithorax. The diagnostic tumor sample was obtained by parasternal biopsy in local anesthesia. The surgical resection of the tumor could not be performed due to its excessive size, intrathoracic involvement and bad respiratory reserves of a patient. The chemotherapy and irradiation were performed as palliative measures. The lethal outcome appeared 10 months after the diagnosis was established.

A postmortem analysis of major causes of early death in patients hospitalized with COPD exacerbation.

BACKGROUND: Mortality from COPD is increasing worldwide, but detailed causes of death are rarely assessed, particularly in low-income countries. METHODS: In a retrospective study, we reviewed the autopsy reports and medical records of deceased patients admitted to the hospital for severe exacerbation of COPD, from January 2005 to December 2007, at the Institute for Pulmonary Diseases of Vojvodina, Serbia. RESULTS: Forty-three patients with a hospital admission diagnosis of COPD exacerbation underwent autopsy; all had died within 24 h of admission to the hospital. Twenty-three patients (54%) had a long COPD history (> 10 years), and 19 patients (44%) had more than one hospitalization in the last year of life. The median age at death was 70 years (interquartile range, 65 to 75 years), and male sex was predominant (n = 31; 72%). The main (primary) causes of death were reported as cardiac failure (n = 16; 37.2%), pneumonia (n = 12; 27.9%), and pulmonary thromboembolism (PTE) (n = 9; 20.9%). Respiratory failure due to a progression of COPD was the primary cause of death in six patients (14%). Most patients had more then one comorbid disease (n = 33; 77%), and the most frequent comorbid disease was chronic heart failure (n = 25; 58%). CONCLUSIONS: Autopsy results suggest that common contributing causes of early death in patients hospitalized with severe COPD exacerbation are concomitant complications, as follows: cardiac failure, pneumonia, and PTE. Quality improvement interventions should focus on recognizing and treating these conditions at the time of hospital admission.