Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Urticaria are Underused in Clinical Practice.

BACKGROUND: Patient-reported outcome measures (PROMs) are validated and standardized tools that complement physician evaluations and guide treatment decisions. PROMs are crucial for monitoring atopic dermatitis (AD) and chronic urticaria (CU) in clinical practice, but there are unmet needs and knowledge gaps regarding their use in clinical practice. OBJECTIVE: We investigated the global real-world use of AD and CU PROMs in allergology and dermatology clinics as well as their associated local and regional networks. METHODS: Across 72 specialized allergy and dermatology centers and their local and regional networks, 2,534 physicians in 73 countries completed a 53-item questionnaire on the use of PROMs for AD and CU. RESULTS: Of 2,534 physicians, 1,308 were aware of PROMs. Of these, 14% and 15% used PROMs for AD and CU, respectively. Half of physicians who use PROMs do so only "rarely" or "sometimes". AD and CU PROM usage is associated with being female, younger, and a dermatologist. POSCORAD and UAS were the most utilized PROMs for AD and CU, respectively. Monitoring disease control and activity are the main drivers of the use of PROMs. Time constraints were the primary obstacle to using PROMs, followed by the impression that patients dislike PROMs. AD and CU PROM users would like training in selecting the proper PROM. CONCLUSION: Even though PROMs offer several benefits, their use in routine practice is suboptimal, and physicians perceive barriers to their use. It is essential to attain higher levels of PROM implementation in accordance with national and international standards.

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.

A Diagnostic Challenge in an Adolescent with Collagen VI-Related Myopathy and Emotional Disorder-Case Report.

Collagen VI-related disorders constitute a spectrum of severities from the milder Bethlem myopathy (BM) to the Ullrich congenital muscular dystrophy (UCMD), which is more severe, and an intermediate form characterized by muscle weakness that begins in infancy. Affected children are able to walk, although walking becomes increasingly difficult starting in early adulthood. They develop contractures in the ankles, elbows, knees, and spine in childhood. In some affected cases, the respiratory muscles are weakened, requiring mechanical ventilation, particularly during sleep. Individuals with collagen VI-related myopathy are at risk of restrictive lung disease and sleep-disordered breathing due to the development of scoliosis associated with neuromuscular weakness. Typical signs of respiratory failure are not always present, and some patients are unaware that their respiratory muscles have become weaker. Here, we report a case of an intermediate form of collagen VI-related myopathy confirmed by next-generation sequencing. The girl presented morning headache, irritability, and aggressiveness, and because of these main symptoms, she was referred by the neurologist for respiratory evaluation. The result of spirometry was associated with hypoventilation shown during sleep studies, indicating the necessity to initiate home non-invasive ventilation (NIV) with immediate improvement in the symptoms. Neuromuscular disorders (NMDs) have a great impact on sleep, but only very few studies evaluating sleep quality in young patients with collagen VI-related myopathy have been described. Daytime symptoms of sleep-disordered breathing may include irritability, emotional lability, and poor attentiveness, but these can be overseen by the severity of other complex medical problems in patients with collagen VI-related myopathy. We underline the importance of the close monitoring of respiratory function, sleep evaluation, and decision making to support the NIV treatment of other collagen VI-related myopathy variant-specific patients. Early recognition of sleep disturbances and initiation of respiratory support can preserve or enhance the quality of life for patients and their caregivers. Routine screening for identification of emotional distress should be instituted in the clinical practice using validated psychological measures in a multidisciplinary approach with different intervention strategies for both patient and parent when necessary.

Predictive factors of adherence in Patients with Obstructive Sleep Apnea Syndrome to Continuous Positive Airway Pressure Therapy in Romania.

Introduction: Obstructive sleep apnea syndrome (OSAS) is a very frequent and underdiagnosed pathology with important social and economic implications. Continuous positive airway pressure (CPAP) is the gold standard for the treatment of OSAS, but adherence is low, with multiple factors being involved in this phenomenon. The purpose of the current study is to evaluate the causes of low adherence to CPAP among adults with OSAS and patients' symptoms. Materials and methods: We performed a prospective cohort study which included 95 patients admitted to Rosiori de Vede Pneumology Hospital, who were diagnosed with OSAS between January 2021-January 2023 and had indication to receive CPAP. Patients were divided into two groups (adherents and non-adherents) and were evaluated for one year based on completing a questionnaire and downloading data from the compliance card of CPAP on their regular visits at one month, six months and 12 months after diagnosis. Results:The predictive factors identified for non-adherence included oro-nasal mask use, low OSAS severity, low level of education, type D personality, high level of daytime sleepiness, and the first period of time with CPAP. Conclusion:Obstructive sleep apnea syndrome is a frequent and underdiagnosed pathology which benefits from CPAP as the gold standard treatment option. Although therapeutic results are favourable and effects are rapidly observed in symptomatic moderate-severe OSA, adherence to therapy remains low.

Characteristics of severe asthma patients on biologics: a real-life European registry study.

Background: The use of anti-interleukin-5 (IL5) for severe asthma is based on criteria from randomised controlled trials (RCTs), but in real-life patients might not fulfil the eligibility criteria but may benefit from biologics. We aimed to characterise patients starting anti-IL5(R) in Europe and evaluate the discrepancies between initiation of anti-IL5(R) in real life and in RCTs. Materials and methods: We performed a cross-sectional analysis with data from the severe asthma patients at the start of anti-IL5(R) in the Severe Heterogeneous Asthma Research collaboration Patient-centred (SHARP Central) registry. We compared the baseline characteristics of the patients starting anti-IL5(R) from 11 European countries within SHARP with the baseline characteristics of the severe asthma patients from 10 RCTs (four for mepolizumab, three for benralizumab and three for reslizumab). Patients were evaluated following eligibility criteria from the RCTs of anti-IL5 therapies. Results: Patients starting anti-IL5(R) in Europe (n=1231) differed in terms of smoking history, clinical characteristics and medication use. The characteristics of severe asthma patients in the SHARP registry differed from the characteristics of patients in RCTs. Only 327 (26.56%) patients fulfilled eligibility criteria of all the RCTs; 24 patients were eligible for mepolizumab, 100 for benralizumab and 52 reslizumab. The main characteristics of ineligibility were: ≥10 pack-years, respiratory diseases other than asthma, Asthma Control Questionnaire score ≤1.5 and low-dose inhaled corticosteroids. Conclusion: A large proportion of patients in the SHARP registry would not have been eligible for anti-IL5(R) treatment in RCTs, demonstrating the importance of real-life cohorts in describing the efficacy of biologics in a broader population of patients with severe asthma.

Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study.

Introduction: Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown. Materials and methods: The European Respiratory Society (ERS) SHARP Clinical Research Collaboration conducted a three-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on seven end-points: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies. Results: Availability of biologics varied between countries, with 17 out of 28 countries having all five existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, forced expiratory volume in 1 s was used in 46%. Blood eosinophils were an inclusion criterion in all countries for interleukin-5 (IL-5)-targeted and IL-4/IL-13-targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73% (191 out of 263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity. Conclusion: Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation.

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.

Romanian Guidelines for the Diagnosis and Treatment of GERD-induced Respiratory Manifestations.

BACKGROUND AND AIMS: Gastroesophageal reflux disease (GERD) is a common condition present in daily practice with a wide range of clinical phenotypes. In this line, respiratory conditions may be associated with GERD. The Romanian Societies of Gastroenterology and Neurogastroenterology, in association with the Romanian Society of Pneumology, aimed to create a guideline regarding the epidemiology, diagnosis and treatment of respiratory conditions associated with GERD. METHODS: Delphi methodology was used and eleven common working groups of experts were created. The experts reviewed the literature according to GRADE criteria and formulated 34 statements and recommendations. Consensus (>80% agreement) was reached for some of the statements after all participants voted. RESULTS: All the statements and the literature review are presented in the paper, together with their correspondent grade of evidence and the voting results. Based on >80% voting agreement, a number of 22 recommendations were postulated regarding the diagnosis and treatment of GERD-induced respiratory symptoms. The experts considered that GERD may cause bronchial asthma and chronic cough in an important number of patients through micro-aspiration and vagal-mediated tracheobronchial reflex. GERD should be suspected in patients with asthma with suboptimal controlled or after exclusion of other causes, also in nocturnal refractory cough which needs gastroenterological investigations to confirm the diagnosis. Therapeutic test with double dose proton pump inhibitors (PPI) for 3 months is also useful. GERD induced respiratory conditions are difficult to treat; however,proton pump inhibitors and laparoscopic Nissen fundoplication are endorsed for therapy. CONCLUSIONS: This guideline could be useful for the multidisciplinary management of GERD with respiratory symptoms in current practice.

Cannabis - a Rewritten History and Its Pulmonary Consequences.

Cannabis presents itself as another challenge of the last decade. Better and better deciphered through in-depth studies, this drug remains a source of scientific debates. Legalized in some states, it competes with tobacco regarding the effects generating respiratory symptoms, chronic bronchitis, bronchial cancer, respiratory infections, etc. In this article we will review the pharmacology, epidemiology, clinical and prevention aspects and try to demonstrate which of these are the most effective means of prevention. This review proves once again that this drug has many hidden dangers.

High 24-Hour Respiratory Symptoms and Low Physical Activity in the Stable COPD Romanian Cohort of SPACE Study.

OBJECTIVE: This study assessed the characteristics and the relationship between symptoms in any part of the 24-hour (24-h) day, physical activity level (PAL), and other clinical and functional outcomes in stable COPD patients. PATIENTS AND METHODS: Out of the 2162 patients enrolled in the SPACE study (The Symptoms and Physical Activity in COPD patients in Europe, clinicaltrials.gov NCT03031769), 406 (18.8%) were recruited from Romania. Here, we present the Romanian cohort results. Eligible patients were adults with age at least 40 years, confirmed diagnosis of stable COPD, current or former smokers with a smoking history of minimum 10 pack-years. The 24-h respiratory symptoms were assessed using Early Morning Symptoms of COPD Instrument (EMSCI), Evaluating Respiratory Symptoms in COPD (E-RS™: COPD) and Nighttime Symptoms of COPD Instrument (NiSCI). During clinical interview, patients self-evaluated PAL through Exercise as Vital Sign (EVS) and Yale Physical Activity Survey (YPAS). Physicians assessed PAL through their clinical judgment. RESULTS: For each combination of 2 between the early morning (EM), daytime (DT) and night-time (NT) symptoms of the 24-h day, there was a significant association (p < 0.001 for each). All symptoms significantly correlated with exacerbation history (p < 0.001 for EM and NT, p=0.002 for DT), and number of severe exacerbations (p < 0.001 for DT, p=0.001 for EM and p=0.026 for NT, respectively). The 24-h symptoms correlated negatively and significantly with PAL (p < 0.001), irrespective of the assessment used. Self-reported PAL negatively correlated with dyspnea, symptom burden, severity of disease and number of exacerbations (p < 0.001). Patients spent an average (standard deviation) of 25.8 (21.0) hours/week performing physical activity. Physicians overestimated their patients' daily PAL. CONCLUSION: A negative and significant correlation between the 24-h day symptoms and PAL was identified in stable COPD patients. Physicians need to routinely assess PAL using adequate tools and start educating inactive COPD patients to optimize their disease outcomes.

Impact of Smoking on Women During the Covid-19 Pandemic.

The coronavirus disease 2019 (COVID-19) brought in 2020 an important challenge for health-care systems and authorities. Smoking and its influence on this disease remain, after months of the pandemic, one of the debatable risk factors. From the literature point of view, the focus of most articles is on smoking as a possible general risk factor for all analyzed populations. Women tend to represent a more significant population in exposed occupations. In our mini-review, we try to dig deeper, looking for gender-related health effects of smoking in this pandemic context, its effects on the infection with this novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), on illness severity, and on the rate of hospitalization and mortality. Despite the fact that the male gender is reported in many articles as a predictor of a poor outcome, we suggest that further research is needed to confirm or deny these relationships. Moreover, studies focusing specifically on women in these study populations are required.

Pharmacological strategies for smoking cessation in patients with chronic obstructive pulmonary disease: a pragmatic review.

Introduction: Chronic obstructive pulmonary disease (COPD) is progressive inflammatory disease of the lungs in which smoking plays a significant pathogenic role. Smoking cessation is the only therapeutic intervention which was demonstrated to interfere with disease progression. Smoking cessation intervention can benefit from pharmacological therapies such as nicotine replacement therapies, bupropion, or varenicline which can be given individually or in combination, their effectiveness being demonstrated in various clinical trials enrolling COPD patients.Areas covered: The authors provide a pragmatic discussion of the clinical data of the main studies evaluating therapies for smoking cessation within COPD starting with the seminal Lung Health Study and continuing with more recent ones.Expert opinion: Smoking cessation is one of the most difficult therapeutic interventions in COPD, despite having the highest impact on disease progression and despite the demonstrated benefit of the discussed pharmacological therapies. Potential approaches to maximize its chance of success might be represented by prolonging the time of administration, combinational options, or sequential pharmacotherapy.

Possible Nutritional Interventions in COVID 19.

At the end of 2019, a new viral pandemic evolution totaly surprised all services worldwide. This pandemic hit has a huge interference with three global crises: governance, economics, and migration (1). It is a new coronavirus infection, "COVID-19" (which is the acronym of "coronavirus disease 2019"), first reported to the WHO Country Office in China on the 31st of December 2019 and detected in Wuhan, the largest metropolitan area in China's Hubei province (2), COVID-19 outbreak situation on 6 April 2020 was with more than 1 175 000 confirmed cases, more than 65 000 deaths and already reported in 209 countries (3). This new coronavirus belongs to the Orthocoronavirinae subfamily of the Coronaviridae family (order Nidovirales) and it is a positive-stranded RNA virus with a crown-like appearance under an electron microscope, SARS-CoV-2 belonging to the beta CoVs human category. It is sensitive to ultraviolet rays and heat and is inactivated by lipid solvents including ether (75%), ethanol, chlorine-containing disinfectant, peroxyacetic acid and chloroform (except for chlorhexidine) (4) Genomic analyses suggest that SARS-CoV-2 probably evolved from a strain found in bats. The mammalian host between bats and humans is not well known; also, it is not certain whether this intermediary really exists (5). The pathogenic mechanism inducing pneumonia is complex. The virus is capable of producing an excessive immune reaction in the host; for some patients, the disaster starts from a 'cytokine storm' with tissue damage (one of the protagonists is IL6) (6).

Awareness and use of heated tobacco products among adult smokers in six European countries: findings from the EUREST-PLUS ITC Europe Surveys.

BACKGROUND: The study assessed awareness and use of heated tobacco products (HTPs) and factors that influenced these issues among cigarette smokers from six European countries in 2016 (Wave 1) and 2018 (Wave 2). METHODS: A survey was conducted among a nationally representative sample of cigarette smokers aged 18 years or older from Germany, Greece, Hungary, Poland, Romania and Spain in 2016 (N = 6011) and 2018 (N = 6027; 53% of smokers from the previous wave were retained, regardless of smoking status and dropouts were replaced by a replenishment sample of smokers). Data were collected through face-to-face interviews. Estimates were produced using weighted data. The study presents the cross-sectional results. RESULTS: Awareness of HTPs increased from 8% to 17% between the two waves. At Wave 1, 1.1% of the smokers declared having used HTPs at least once during their lifetime; and at Wave 2, this increased to 1.9% (around 1% or less in four countries, except for Greece and Romania where it was around 4%). Factors associated with HTPs use among those who had ever heard about these products at Wave 1 were country of residence, being a daily cigarette smoker and ever use of electronic cigarettes. At Wave 2, ever use of HTPs was significantly higher among those who had tried to quit smoking combustible cigarettes in the last 12 months, had tried electronic cigarettes during lifetime and perceived HTPs as less dangerous than combustible cigarettes; the country of residence was also associated with HTPs use. CONCLUSION: This study offers insights into the behaviours and perceptions of European adult smokers regarding HTPs, an important emerging issue in the field of tobacco control.

Romanian clinical guideline for diagnosis and treatment of COPD.

Chronic obstructive pulmonary disease (COPD) is a disease with increasing prevalence and burden for health systems worldwide. Every country collects its own epidemiological data regarding COPD prevalence, morbidity and mortality while taking steps to educate the population and medical community to improve early detection and treatment. The rising COPD prevalence creates a need for comprehensive guidelines. In 2012 and 2017-2018, the Romanian Society of Pneumology (SRP) organised national inquiries for COPD, while lung physicians in Romania began receiving education regarding the correct algorithms for COPD diagnosis and therapy. During 2019, a Romanian clinical guideline for diagnosis and treatment of COPD was published, and a condensed version of key points from this guideline are presented herein. COPD is diagnosed based on the presence of three major components: relevant exposure history, respiratory symptoms, and airway limitation that is not fully reversible. Clinical evaluation of patients diagnosed with COPD should include the level of symptoms, exacerbation rate, the presence of comorbidities and determination of phenotypes. The present abridged guideline is designed to be accessible and practical for assessing and managing patients with COPD. The application of up-to-date COPD guidelines may enhance the optimism of physicians and patients in managing this disease.

Evaluating revefenacin as a therapeutic option for chronic obstructive pulmonary disease.

INTRODUCTION: In chronic obstructive pulmonary disease (COPD), inhaled long-acting antimuscarinic agents (LAMA) are effective maintenance therapies used across all severity stages of the disease. Most of them are administered via dry powder inhalers, but these devices require a potent inspiratory flow which cannot be effectively achieved by patients with advanced disease. In such patients, inhaled therapy via nebulization might be an option. AREAS COVERED: Revefenacin is a LAMA that was specifically formulated for once daily nebulization and which was authorized by the FDA as a maintenance therapy for COPD. In phase II and III clinical studies discussed in this review, revefenacin demonstrated its rapid onset of action and sustained effect on lung function on both a short- and long-term basis. EXPERT OPINION: Nebulized revefenacin with once daily use does not require any particular effort of administration and hence can be used by patients with severe airways obstruction or by those having milder cognitive deficits. Further studies are needed, however, to better document the long-term cardiovascular safety and its ability to reduce the exacerbation rate.

Helsinki by nature: The Nature Step to Respiratory Health.

BACKGROUND: The Nature Step to Respiratory Health was the overarching theme of the 12th General Meeting of the Global Alliance against Chronic Respiratory Diseases (GARD) in Helsinki, August 2018. New approaches are needed to improve respiratory health and reduce premature mortality of chronic diseases by 30% till 2030 (UN Sustainable Development Goals, SDGs). Planetary health is defined as the health of human civilization and the state of the natural systems on which it depends. Planetary health and human health are interconnected, and both need to be considered by individuals and governments while addressing several SDGs. RESULTS: The concept of the Nature Step has evolved from innovative research indicating, how changed lifestyle in urban surroundings reduces contact with biodiverse environments, impoverishes microbiota, affects immune regulation and increases risk of NCDs. The Nature Step calls for strengthening connections to nature. Physical activity in natural environments should be promoted, use of fresh vegetables, fruits and water increased, and consumption of sugary drinks, tobacco and alcohol restricted. Nature relatedness should be part of everyday life and especially emphasized in the care of children and the elderly. Taking "nature" to modern cities in a controlled way is possible but a challenge for urban planning, nature conservation, housing, traffic arrangements, energy production, and importantly for supplying and distributing food. Actions against the well-known respiratory risk factors, air pollution and smoking, should be taken simultaneously. CONCLUSIONS: In Finland and elsewhere in Europe, successful programmes have been implemented to reduce the burden of respiratory disorders and other NCDs. Unhealthy behaviour can be changed by well-coordinated actions involving all stakeholders. The growing public health concern caused by NCDs in urban surroundings cannot be solved by health care alone; a multidisciplinary approach is mandatory.