Search

Luca Stingeni,1 Anna Belloni Fortina,2 Ilaria Baiardini,3,4 Katharina Hansel,1 Devis Moretti,5 Filippo Cipriani5 1Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy; 2Unit of Dermatology, Department of Medicine - DIMED, University of Padua, Padua, Italy; 3Respiratory Unit for Continuity of Care, IRCCS, Ospedale Policlinico San Martino, Genova, Italy; 4Personalized Medicine Asthma, & Allergy Clinic, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; 5Sanofi Genzyme, Sanofi S.r.l., Milan, ItalyCorrespondence: Anna Belloni FortinaUnit of Dermatology, Department of Medicine – DIMED, University of Padua, Via Gallucci, 4, Padova, 35128, ItalyEmail anna.bellonifortina@unipd.itBackground: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent eczematous lesions and intense pruritus. AD patients are known to face a considerable disease burden, including physical and emotional limitations. There is still limited knowledge about daily implications in education and occupation. We describe disease social stigmatization by measuring bullying and self-isolation in students and professional discrimination in workers. Overall loss of productivity, either at school and at the workplace, was quantified as the sum of absenteeism (number of days AD sick leave) and presenteeism (number of days with decreased focus and functionality).Methods: An on-line web survey was sent to 3235 random recipients and 401 met the inclusion criteria (self-reporting AD and ≥ 12 yo). The survey domains included daily limitations, QoL, feelings and relationships, together with specific questions about bullying, discrimination and loss of productivity.Results: AD negatively affected QoL in 51.6% of respondents, whereas 68.8% considered AD as a real limit to daily routine. More in detail, 39.3% of students were victims of bullying and 33.9% of workers felt discriminated because of AD. On average, absenteeism in students was for 17.1 days/year (presenteeism: 19.5 days/year), whereas in workers, the estimate was 10.9 days/year (presenteeism: 13.1 days/year). Absenteeism and presenteeism were more pronounced in bullied/discriminated subjects.Conclusion: AD multidimensional implications deeply affect and undermine personal and professional fulfillments. Our results contribute to a better understanding of what living with AD means.Keywords: atopic dermatitis, discrimination, absenteeism, presenteeism

The large amount of evidence and the renewed interest in upper and lower airways involvement in infectious and inflammatory diseases has led Interasma (Global Asthma Association) to take a position on United Airways Diseases (UAD).Starting from an extensive literature review, Interasma executive committee discussed and approved this Manifesto developed by Interasma scientific network (INES) members.The manifesto describes the evidence gathered to date and defines, states, advocates, and proposes issues on UAD (rhinitis, rhinosinusitis and nasal polyposis), and concomitant/comorbid lower airways disorders (asthma, chronic obstructive pulmonary disease, bronchiectasis, cystic fibrosis, obstructive sleep apnoea) with the aim of challenging assumptions, fostering commitment, and bringing about change. UAD refers to clinical pictures characterized by the coexistence of upper and lower airways involvement, driven by a common pathophysiological mechanism, leading to a greater burden on patient's health status and requiring an integrated diagnostic and therapeutic plan. The high prevalence of UAD must be taken into account. Upper and lower airways diseases influence disease control and patient's quality of life.Patients with UAD need to have a timely and adequate diagnosis, treatment, and, when recommended, referral for management in a specialized center. Diagnostic testing including skin prick or serum specific IgE, lung function, fractional exhaled nitric oxide (FeNO), polysomnography, allergen-specific immunotherapies, biological therapies and home based continuous positive airway pressure (CPAP) whenever these are recommended, should be part of the management plan for UAD. Education of medical students, physicians, health professionals, patients and caregivers on the UAD is needed.

PURPOSE OF REVIEW Gastro-esophageal reflux is a possible cause of uncontrolled symptoms of asthma and should be actively investigated and treated before severe asthma is diagnosed and biological therapy started. RECENT FINDINGS Recent investigations on esophageal function and tissue biomarkers in patients with asthma and associated GERD have established a relevant role for esophageal motility and neuronal sensory abnormalities in linking the two diseases. Characterization of the underpinning inflammatory substrate has showed mixed results as both neutrophilic and eosinophilic type 2 inflammatory changes have been described. SUMMARY New findings regarding inflammatory mechanisms in GERD-associated asthma as well as new diagnostic tools to investigate functional esophageal abnormalities and characterize asthma endotype have identified potential treatable traits that may improve the clinical management and outcome of asthmatic patients with GERD.

Background The international guideline for urticaria recommends the use of the Urticaria Activity Score 7 (UAS7) and the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) to assess patients with chronic spontaneous urticaria (CSU) for their disease activity and impact on quality of life, respectively. Over the last decade, both tools have been validated in many different languages but not in Arabic. Objective To validate the Arabic UAS7 and CU-Q2oL in patients with CSU in Lebanon. Methods After a structured translation process of both instruments into Arabic, their construct and known-groups validity as well as internal consistency reliability were tested in a longitudinal prospective study using a cluster sample of 152 Lebanese CSU patients. The study also included a repetitive administration of both instruments in 2-week intervals in 44 patients in order to assess their test-retest reliability. Results Both the Arabic UAS7 and CU-Q2oL demonstrated high internal consistency (Cronbach alpha of 0.95 and 0.82, respectively) and moderate-to-high test-retest reliability (intraclass coefficient of 0.61 and 0.91, respectively). Exploratory factor analysis of the Arabic CU-Q2oL revealed five components that explained 81.8% of the total variance. Significant correlations were found between the Arabic CU-Q2oL and the Dermatology Life Quality Index (DLQI) (r = 0.86) and mild-to-moderate correlations between the Arabic UAS7 and CU-Q2oL (r = 0.52) as well as the DLQI (r = 0.51). Conclusions Our findings demonstrate that the Arabic versions of the UAS7 and the CU-Q2oL are valid and reliable patient-reported outcome measures in patients with CSU in Lebanon.

Background Allergic rhinitis (AR) and asthma are two common chronic diseases that often coexist. There is a need for a validated tool to evaluate HRQoL of Portuguese speakers with asthma and/or rhinitis patients in clinical practice. Objectives To adapt and validate RhinAsthma Patient Perspective (RAPP) in Portuguese. Methods The RAPP questionnaire was translated into Portuguese. Asthmatics with comorbidities and rhinitis attending the allergy department of Coimbra University Hospital were asked to complete the Portuguese translation of RAPP, in addition to the SF-12, ACT, and a Symptomatologic VAS twice, with a 4-week interval between visits. During Visit 2, a Global Rating Scale (GRS) was completed to assess any change in health status. Scale dimensions, internal consistency and convergent validity, reliability, discriminant ability and responsiveness to change, as well as Minimal Clinical Difference were assessed. Results Factor and confirmatory analysis confirm the unidimensional structure of the questionnaire. Internal consistency has been shown to be satisfactory (0.82 visit 1 and 0.86 at visit 2). The tool is able to discriminate between patients on the basis of asthma severity, asthma control level, and rhinitis severity; convergent validity showed a significant correlation with SF-2 Physical component (r = −0.46 and 0.42, p at Visits 1 and 2). An ICC of 0.97 and a CCC = 0.94 indicate that the tool is highly reliable. Responsiveness was shown in detecting a significant association with GRS changes (r = 0.41, p Conclusions The Portuguese version of RAPP has been demonstrated to have good measurement properties and sensitivity to health changes, which will provide a valid, reliable and standardized HRQoL measurement in patients with asthma and comorbid allergic rhinitis in clinical practice.

The prevalence of asthma in Italy is estimated to be around 4%; it affects approximately 2,000,000 citizens, and up to 80-90% of patients have mild-to-moderate asthma. Despite the clinical relevance of mild-to-moderate asthma, longitudinal observational data are very limited, including data on disease progression (worsening vs. improvement), the response to treatment, and prognosis. Studies are needed to develop long-term, observational, real-life research in large cohorts. The primary outcomes of this study will be based on prospective observation and the epidemiological evolution of mild and moderate asthma. Secondary outcomes will include patient-reported outcomes, treatments over time, disease-related functional and inflammatory patterns, and environmental and life-style influences.This study, called the Mild/Moderate Asthma Network of Italy (MANI), is a research initiative launched by the Italian Respiratory Society and the Italian Society of Allergology, Asthma and Clinical Immunology. MANI is a cluster-based, real world, cross-sectional, prospective, observational cohort study that includes 20,000 patients with mild-to-moderate asthma. (ClinicalTrials.gov Identifier: NCT04796844).Despite advances in asthma care, several research gaps remain to be addressed through clinical research. This study will add important new knowledge about long-term disease history, the transferability of clinical research results to daily practice, the efficacy of currently recommended strategies, and their impact on the burden and evolution of the disease.MANI:Mild/Moderate Asthma Network of ItalySANI:Severe Asthma Network ItalyGINA:Global Initiative for AsthmaSABA:short acting β2-agonistsICS:inhaled corticosteroidsCRF:Case Report Form.

Background: RhinAsthma Patient Perspective (RAPP) is a short, validated questionnaire for assessing health-related quality of life (HRQoL) in adult patients with comorbid asthma and rhinitis, while a paediatric version is still not available. Objective: The current study aimed to develop and validate the RAPP-children questionnaire. Methods: RAPP-children was derived by combining RhinAsthma-children subscales into five unique items. At baseline (T0) and after 30 days (T1), 150 children (6-11 years) with comorbid asthma (predominantly intermittent or mild persistent) and rhinitis were given the following: RAPP-children, RhinAsthma-children, Paediatric Asthma Quality of Life Questionnaire (PAQLQ, age >6 years), Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Childhood Asthma Control Test (CACT), KiddyKindl® (age 6 years) or KidKindl® (age >6 years), and a Visual Analogue Scale for nasal symptoms (VAS). At the final visit, a Global Rating of Change (GRC) scale was administered. The approved study was registered on the central registration system ClinicalTrials.gov (ID: NCT03276416). Results: RAPP-children fairly reproduced RhinAsthma-children scores (concordance correlation coefficients between 0.91 and 0.95). RAPP-children showed adequate convergent validity (absolute Spearman's rho larger than 0.5 with PAQLQ, PRQLQ, CACT, KiddyKindl/KidKindl, and VAS), internal consistency (Cronbach's alpha > 0.70), repeatability (intra-cluster correlation coefficient between 0.61 and 0.8) in the presence of clinical stability (GRC = 0), discriminant validity (sensitivity to asthma control status and rhinitis severity), and sensitivity to symptom improvements (GRC > 1). The minimal important difference (MID) was -20. Floor and ceiling effects were minimal. RAPP-children showed fair usability also in younger children (6-8 years). Conclusion & clinical relevance: RAPP-children is a valid, five-item questionnaire for assessing HRQoL in children aged 6 to 11 years with concomitant asthma and rhinitis. Although further investigation is required in moderate and severe asthmatics, this tool can be useful in clinical trials and in routine medical practice for improving the management of respiratory allergy in children.

This is Part 2 of an updated follow-up review of the World Allergy Organization (WAO) position paper on the diagnosis and treatment of urticaria and angioedema. Since that document was published, new advances in the understanding of the pathogenesis of chronic urticaria, and greater experience with the use of biologics in patients with severe refractory disease, mainly omalizumab, have been gained. For these reasons, WAO decided to initiate an update targeted to general practitioners around the world, incorporating the most recent information on epidemiology, immunopathogenesis, comorbidities, quality of life, clinical case presentations, and the management of chronic spontaneous and chronic inducible urticaria, and urticaria in special situations such as childhood and pregnancy. A special task force of WAO experts was invited to write the different sections of the manuscript, and the final document was approved by the WAO Board of Directors. This paper is not intended to be a substitute for current national and international guidelines on the management of urticaria and angioedema, but to provide an updated simplified guidance for physicians around the world who have to manage patients with this common ailment.

Background: Allergic asthma is the predominant phenotype in clinical practice. Allergen immunotherapy is the only curative and specific approach for the treatment of allergies with clinical benefits for several years after its discontinuation. Despite advances, the use of allergen immunotherapy in allergic asthma is still suboptimal and controversial.Objective: The purpose of this article is to review the published data about the impact of allergen immunotherapy with the most commonly used allergen extracts on allergic asthma outcomes, including both clinical parameters and patients' subjective experience (quality of life).Methods: As data sources several databases were used, including PubMed, Scopus, Web of Science (2002-2019) and search in English and Spanish languages was performed using the following terms: "allergen immunotherapy" and "asthma" in combination with "house dust mite", "birch pollen", "grass pollen", "olive tree pollen", "molds", "pets" and "asthma quality of life". Randomised control trials and meta-analysis from reviewed publications were selected.Results: Emerging data relating to the positive impact on asthma outcomes of allergen immunotherapy allows the addition of this treatment as a therapeutic option in mild to moderate asthmatics sensitized to house dust mite and pollens. Limited data are available for patients sensitized to molds and pets, as well in severe allergic asthma population.Conclusion: Allergen immunotherapy remains a potential therapeutic option for some patients with allergic asthma. Further research is needed to define the optimal period of treatment, the possible therapeutic role in the treatment of severe allergic asthma, and the cost-effectiveness of allergen immunotherapy in asthmatic patients.

Objective: No validated instrument is currently available in English for use in daily practice to assess Health Related Quality of Life (HRQoL) in asthma and comorbid allergic rhinitis (AR). The ai...

Background Hypersensitivity reactions to drugs are unpredictable and can be very complex and severe, even life threatening. Assess its impact on patient’s health related quality of life (HRQoL) is crucial. The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the only validated disease-specific HRQoL questionnaire. We aimed to translate and cross-cultural validate the DrHy-Q to the Portuguese population. It was also our purpose to determine the impact of drug hypersensitivity on patients’ HRQoL. Methods The translation and cross-cultural adaptation of the DrHy-Q to Portuguese was performed according to standards. Reliability of the DrHy-Q Portuguese version was assessed in terms of internal consistency and test–retest reliability. Structural validity, divergent validity (with a generic health related QoLQ-PGWBI) and discriminant validity were also evaluated. Forty patients accepted to participate in the validation phase. The Portuguese version of the DrHy-Q was applied to 260 consecutively adult patients, studied in our Department for suspected drug hypersensitivity. Results The Portuguese DrHy-Q showed adequate internal consistency (Cronbach’s ɑ = 0.938), good test–retest reliability [ICC = 0.713 (95% CI 0.488–0.850] and one-dimensional structure. No significant correlation was found between the DrHy-Q and the PGWBI total scores (r = − 0.010, p = 0.957). Two hundred of patients completed the study: 78.5% female; mean age = 44 ± 15 years. Mean DrHy-Q score was 36.8 ± 12.6. Two clinical factors significantly predict DrHy-Q total score: clinical manifestations and number of suspected drugs. Patients with anaphylaxis (β = 11.005; 95% CI 5.523; 16.487), urticaria/angioedema (β = 7.770; 95% CI 2.600; 12.940) and other manifestations (β = 7.948; 95% CI 1.933; 13.962) are more likely to have higher DrHy-Q total score than patients with maculopapular exanthema. Patients with ≥ 2 suspected drugs are also more likely to have worse QoL (β = 7.927; 95% CI 3.687; 12.166). Conclusion The Portuguese version of DrHy-Q revealed adequate validity and reliability, indicating that it is appropriate to assess the impact of drug hypersensitivity on patients’ HRQoL, providing data for a better comprehension and management of our patients. Moreover, our results highlight that the severity of the drug hypersensitivity reaction and the number of suspected drugs have impact on patient’s DrHy-QoL.

First recognized in China, in December 2019, COVID-19 spread worldwide from the beginning of 2020. Italy was one of the first countries to be threatened by COVID-19, and a general lockdown was declared the 9 march 2020. This was the first global lockdown in the modern era and its effect on population was unknown. To date, poor data investigated the effects of the pandemic and the lockdown on sleep quality (SQ). We produced an anonymous and spontaneous online survey to investigate sleep impairment during COVID-19 pandemic in Italy. We asked to assess general health status, including COVID-19 disease, and working status. We used Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS) and Insomnia Severity Index (ISI). 1178 participants joined the survey, mean age 36 (67% F). 31% were unemployed, 20.5% employed, 21% health workers (HW) and 27.5% smart-workers (SW). 11% had diagnosis or symptoms of COVID-19. 57% referred that SQ was impaired compared to the pre-lockdown period. Median PSQI was 7 [4-10] and ISI 8 [4-2] suggesting poor SQ and mild insomnia. HW had poorer SQ compared to SW and general population (p=0.03), and higher ISI value compared to employed, SW and general population (p=0.04). There were no differences between groups in ESS. Participant that reported COVID-19 disease had more SQ impairment and insomnia compared to healthy participant, with PSQI 8.6 vs 7.1 (pl0.001); ESS 7.3 vs 6.4 (p=0.012) and ISI 10.4 vs 8.1 (pl0.001). In conclusion, during the lockdown, Italian population had insomnia and poor SQ, with COVID-19 as an independent risk factor for sleep impairment. Moreover, health-workers had higher risk to develop sleep impairment presumably due to the work and emotional loads.

Background: Disease awareness is a challenge in the management of chronic obstructive pulmonary disease (COPD). Objectives: The aim of this analysis was to explore the association between COPD optimal and suboptimal awareness, clinical parameters, and the following patient-reported outcomes: modified Medical Research Council (mMRC), Treatment Satisfaction Questionnaire (TSQM-9), COPD Assessment Test (CAT), Morisky Medication-Taking Adherence Scale (MMAS-4), and Brief Illness Perception Questionnaire (B-IPQ). Methods: This post hoc analysis of the SAT study included all enrolled patients for whom awareness (Disease Awareness in COPD Questionnaire – DACQ) was assessed at baseline and 12 months. DACQ scores ≥80 were considered an indicator of an optimal awareness. Results: 367 patients (25.8% women, median age 72 years) were included in the analysis. At enrollment, 74 patients (20.2%) had a DACQ score ≥80. Patients with suboptimal awareness, compared to those in which awareness was optimal, had higher median scores for CAT (p = 0.0001) and mMRC (p = 0.0031), a lower median TSQM-9 global score (p < 0.0001), and higher median B-IPQ score (p < 0.0001). The proportion of patients who had exacerbations during the previous year was higher in patients with suboptimal COPD awareness than in those with DACQ score ≥80 (42.8 vs. 21.4%, p = 0.0009). During the 12-month observation period, illness perception, adherence, and treatment satisfaction were found to be independent factors significantly associated with level of disease awareness. Conclusion: The results of our post hoc analysis suggest that patients’ awareness of their COPD disease is related to both clinical outcomes and how they perceive and manage their condition.

There are large between- and within-country variations in COVID-19 death rates. Some very low death rate settings such as Eastern Asia, Central Europe, the Balkans and Africa have a common feature of eating large quantities of fermented foods whose intake is associated with the activation of the Nrf2 (Nuclear factor (erythroid-derived 2)-like 2) anti-oxidant transcription factor. There are many Nrf2-interacting nutrients (berberine, curcumin, epigallocatechin gallate, genistein, quercetin, resveratrol, sulforaphane) that all act similarly to reduce insulin resistance, endothelial damage, lung injury and cytokine storm. They also act on the same mechanisms (mTOR: Mammalian target of rapamycin, PPARγ:Peroxisome proliferator-activated receptor, NFκB: Nuclear factor kappa B, ERK: Extracellular signal-regulated kinases and eIF2α:Elongation initiation factor 2α). They may as a result be important in mitigating the severity of COVID-19, acting through the endoplasmic reticulum stress or ACE-Angiotensin-II-AT1R axis (AT1R) pathway. Many Nrf2-interacting nutrients are also interacting with TRPA1 and/or TRPV1. Interestingly, geographical areas with very low COVID-19 mortality are those with the lowest prevalence of obesity (Sub-Saharan Africa and Asia). It is tempting to propose that Nrf2-interacting foods and nutrients can re-balance insulin resistance and have a significant effect on COVID-19 severity. It is therefore possible that the intake of these foods may restore an optimal natural balance for the Nrf2 pathway and may be of interest in the mitigation of COVID-19 severity.

BACKGROUND RhinAsthma Patient Perspective (RAPP) is the only validated tool for assessing of health-related quality of life (HRQoL) related to asthma and rhinitis in individual patients. OBJECTIVE To compare the HRQoL burden among countries and explore the usefulness of RAPP as a complementary measure in disease management. METHODS In this post hoc analysis of the RAPP International Study, the enrolled population was clustered into patients with controlled rhinitis and controlled asthma (CA/CR), uncontrolled rhinitis and controlled asthma (CA/UR), controlled rhinitis and uncontrolled asthma (UA/CR), and uncontrolled rhinitis and uncontrolled asthma (UA/UR). RESULTS We recruited 575 adult patients. Significant differences among countries were observed in the mean RAPP score (from 15.7 in Spain to 18.7 in the Philippines) although the percentage of subjects with an optimal HRQoL (RAPP

BACKGROUND High atopy prevalence has been reported in athletes. Having an age-specific questionnaire for predicting atopy is important for an optimal management of young athletes. The study objectives were as follows: (i) developing a scoring system for the Pediatric Allergy Questionnaire for Athletes (AQUAped); (ii) identifying the optimal age target within the range 7-14 years; (iii) assessing AQUAped validity and repeatability in the identified target population. METHODS A total of 133 young athletes (age 7-14 years) were recruited. Following a screening visit, the participants filled AQUAped at baseline (T0) and after 7 days (T1), concomitantly undergoing skin prick testing. Using atopy as the gold standard (positivity to ≥1 aeroallergen), the 12 core items were scored based on their likelihood ratios, and a total score was calculated. The optimal cut-off was identified based on the Youden's criterion. The repeatability of AQUAped was assessed through the intra-cluster correlation coefficient (ICC). The optimal age target was identified as the largest age range associated with an acceptable cross-validated area under the receiver operating characteristic curve (AUC ≥ 0.70) and an excellent ICC (≥0.75). RESULTS Forty (30%) children were atopic; the optimal age target was 10-14 years (cross-validated AUC = 0.70, ICC = 0.81). AQUAped total score ranged from -26 to 75, and only 5% of non-atopic children had AQUAped ≥ 24. AQUAped ≥ 2 had 82% specificity, 60% sensitivity, and 74% overall accuracy. CONCLUSION Developing and testing a scoring system for AQUAped showed that it is a valid and reliable tool for the screening of atopy in young athletes aged 10-14 years.

BACKGROUND: To date, no disease-specific tool is available to assess the impact of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) on Health Related Quality of Life (HRQoL). Therefore, the purpose of this study was to develop and validate a questionnaire specifically designed to this aim: the Nasal Polyposis Quality of Life questionnaire –NPQ.METHODS: According to the current guidelines, the development and validation of the NPQ occurred in two separate steps involving different groups of patients.RESULTS: In the development process of NPQ an initial list of items of 40 items was given to 60 patients with CRSwNP; the 27 most significant items were selected and converted into questions. The validation procedure involved 107 patients (mean age 52.9±12.4). NPQ revealed a five-dimensional structure and high levels of internal consistency (Cronbach's alpha 0.95). Convergent validity (Spearman’ coefficient r=0.75; p< 0.01), discriminant validity (sensitivity to VAS score), reliability in a sample of patients with a stable health status (Interclass Coefficient 0.882) were satisfactory. Responsiveness to clinical changes was accomplished. The minimal important difference was 7. CONCLUSIONS: NPQ is the first questionnaire for the assessment of HRQoL in CRSwNP. Our results provide that the new tool is valid, reliable, and sensitive to individual changes.

In the last 20 years, growing interest towards rhinosinusitis became evident in medical literature; yet, it is still difficult to identify the real prevalence of chronic rhinosinusitis (CRS). Epidemiological studies are few and they are built on heterogeneous populations and diagnostic methods. The major step forward has been an increasing awareness of CRS as a disease characterized by heterogeneous clinical scenarios, high impact on quality of life and elevated social costs. Patient stratification in phenotypes, identification of the pathobiological mechanism at the origin of the disease (endotype) and its comorbidities, are pivotal in the diagnostic process and they should be addressed to tailor the treatment. A multidisciplinary approach and shared diagnostic-therapeutic processes are therefore mandatory. Oncological multidisciplinary boards are models to imitate. The role of a multidisciplinary board is inspired to precision medicine principles: tracing a diagnostic pathway with the purpose of identifying the patient’s immunological profile, monitoring therapeutical processes, abstaining from the selfish experience of a single specialist, and placing the patient at the center of the therapeutic plan. Patient participation is a fundamental step to optimize the disease clinical course, improving patient’s quality of life and reducing the socioeconomical burden.MAIN TEXT

Background Urticaria is a disorder affecting skin and mucosal tissues characterized by the occurrence of wheals, angioedema or both, the latter defining the urticaria-angioedema syndrome. It is estimated that 12–22% of the general population has suffered at least one subtype of urticaria during life, but only a small percentage (estimated at 7.6–16%) has acute urticaria, because it is usually self-limited and resolves spontaneously without requiring medical attention. This makes likely that its incidence is underestimated. The epidemiological data currently available on chronic urticaria in many cases are deeply discordant and not univocal, but a recent Italian study, based on the consultation of a national registry, reports a prevalence of chronic spontaneous urticaria of 0.02% to 0.4% and an incidence of 0.1–1.5 cases/1000 inhabitants/year. Methods We reviewed the recent international guidelines about urticaria and we described a methodologic approach based on classification, pathophysiology, impact on quality of life, diagnosis and prognosis, differential diagnosis and management of all the types of urticaria. Conclusions The aim of the present document from the Italian Society of Allergology, Asthma and Clinical Immunology (SIAAIC) and the Italian Society of Allergological, Occupational and Environmental Dermatology (SIDAPA) is to provide updated information to all physicians involved in diagnosis and management of urticaria and angioedema.

Background Respiratory disorders are a major cause of morbidity and mortality in amyotrophic lateral sclerosis (ALS). Current guidelines suggest the provision of noninvasive ventilation (NIV) for symptomatic hypoventilation in patients with ALS. Inspite of these results the proportion of ALS patients on tracheostomy invasive ventilation (TIV) is relatively high. Methods Thirty-two patients were included in the study: 16 patients were treated with nocturnal NIV associated with diurnal mouthpiece ventilation (MPV) and 16 with TIV .The primary endpoint of the study was to evaluate survival in the two groups. Secondary endpoints were to evaluate differences in the two populations in terms of clinical outcomes and quality of life (HRQoL). Results Cox analysis survival data shows no statically difference in the hazard function of the two groups. The comparison between the two groups showed a significant improvement in the average value of gas indices (paO2, paCO2) in the group treated with TIV in comparison to the group treated with MPV/NIV. Conversely, the evaluation of the questionnaires on HRQoL showed a higher score in patients treated with MPV/NIV compared to those treated with TIV. Conclusions Ventilatory treatment with MPV and TIV did not demonstrate significant differences in survival. Patients treated with MPV reported a better HRQoL, although TIV group showed higher ventilatory parameters improvement than MPV group.

PURPOSE OF REVIEW: The aim of this review is to highlight the conceptual and practical knowledge for interpreting score changes in patient-reported outcomes (PROs) that have been validated for chronic spontaneous urticaria (CSU). RECENT FINDINGS: The urticaria guidelines recommends to assess PROs as Health-Related Quality of Life, disease activity and disease control, to detect the CSU impact and the overall treatment effect. To this aim it is crucial to determine the minimal important difference (MID) to assess if changes in questionnaire scores represent either perceived improvement or deterioration for patients. Methods for establishing the MID are well defined and are clustered into two broad categories: distribution-based and anchor-based. SUMMARY: For the majority of the available questionnaires for CSU, an MID has been defined, according to the results of various approaches. In most of the studies in our review, anchor-based methods, either alone or in combination with distribution ones, were used. The available information regarding MIDs across validated tools for CSU patients helps to interpret measurement scores and allows the implementation of PROs in routine practices.

Background: Severe asthma is a serious condition with a significant burden on patients' morbidity, mortality, and quality of life. Some biological therapies targeting the IgE and interleukin-5 (IL5) mediated pathways are now available. Due to the lack of direct comparison studies, the choice of which medication to use varies. We aimed to explore the beliefs and practices in the use of biological therapies in severe asthma, hypothesizing that differences will occur depending on the prescribers’ specialty and experience. Methods: We conducted an online survey composed of 35 questions in English. The survey was circulated via the INterasma Scientific Network (INESNET) platform as well as through social media. Responses from allergists and pulmonologists, both those with experience of prescribing omalizumab with (OMA/IL5) and without (OMA) experience with anti-IL5 drugs, were compared. Results: Two hundred eighty-five (285) valid questionnaires from 37 countries were analyzed. Seventy-on percent (71%) of respondents prescribed biologics instead of oral glucocorticoids and believed that their side effects are inferior to those of Prednisone 5 mg daily. Agreement with ATS/ERS guidelines for identifying severe asthma patients was less than 50%. Specifically, significant differences were found comparing responses between allergists and pulmonologists (Chi-square test, p < 0.05) and between OMA/IL5 and OMA groups (p < 0.05). Conclusions: Uncertainties and inconsistencies regarding the use of biological medications have been shown. The accuracy of prescribers to correctly identify asthma severity, according to guidelines criteria, is quite poor. Although a substantial majority of prescribers believe that biological drugs are safer than low dose long-term treatment with oral steroids, and that they must be used instead of oral steroids, every effort should be made to further increase awareness. Efficacy as disease modifiers, biomarkers for selecting responsive patients, timing for outcomes evaluation, and checks need to be addressed by further research. Practices and beliefs regarding the use of asthma biologics differ between the prescriber's specialty and experience; however, the latter seems more significant in determining beliefs and behavior. Tailored educational measures are needed to ensure research results are better integrated in daily practice.

Objective To adapted the Drug Hypersensitivity Quality of Life (DrHy-Q) Questionnaire from Italian into Thai and assessed its validity and reliability. Design Prospectively recruited during January 2012–May 2017. Setting Multicenter; six Thai tertiary university hospitals. Study Participants Total of 306 patients with physician-diagnosed drug hypersensitivity. Interventions Internal consistency and test–retest reliability were evaluated among 68 participants using Cronbach’s ɑ and intra-class correlation coefficient (ICC). The validity of Thai DrHy-Q was assessed among 306 participants who completed World Health Organization Quality of Life-BREF (WHOQOL-BREF-THAI). Construct and divergent validities were assessed for Thai DrHy-Q. Known-groups validity assessing discriminating ability was conducted in Thai DrHy-Q and WHOQOL-BREF-THAI. Main outcome measures Validity; reliability; single vs. multiple drug allergy; non-severe cutaneous adverse reactions (SCAR) vs. SCAR. Results Thai DrHy-Q showed good reliability (Cronbach’s ɑ = 0.94 and ICC = 0.8). Unidimensional factor structure was established by confirmatory factor analysis (CFI&TLI = 0.999, RMSEA = 0.02). Divergent validity was confirmed by weak correlation between Thai DrHy-Q and WHOQOL-BREF-THAI domains (Pearson’s r = −0.41 to −0.19). Known-groups validity of Thai DrHy-Q was confirmed with significant difference between patients with and without life-threatening SCAR (P = 0.02) and patients with multiple implicated drug classes vs. those with one class (P < 0.01); while WHOQOL-BREF-THAI could differentiate presence of life-threatening SCAR (P < 0.01) but not multiple-drug allergy. Conclusions Thai DrHy-Q was reliable and valid in evaluating quality of life among patients with drug hypersensitivity. Thai DrHy-Q was able to discriminate serious drug allergy phenotypes from non-serious manifestations in clinical practice and capture more specific drug-hypersensitivity aspects than WHOQOL-BREF-THAI.

Background Chronic urticaria is defined as the appearance of urticarial lesions and/or angioedema during a period of more than six weeks. We aimed at developing the Portuguese version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and at testing its reliability and the content, construct and criterion validity. Methods The forward-backward approach to a linguistic equivalence was followed, after which a clinical review and a cognitive debriefing with patients were performed. The intraclass correlation coefficient checked test-retest reliability with patients filling the same questionnaire with one week apart and the Cronbach’s alpha indicator assessed the internal consistency. Construct validity was tested by an exploratory factor analysis and by hypothesis tests involving sociodemographic and clinical patient characteristics, including the urticaria control test (UCT). On the other hand, criterion validity was tested through correlations with the Short-Form Health Survey SF-36, EQ-5D-5 L, and the Dermatology Quality of Life Index (DLQI). Results A total of 162 patients from seven hospital units were included. The mean (standard deviation) age was 42.6 (13.3) and 81.6% were female. CU-Q2oL was entirely filled by all respondents. Internal consistency was 0.947 for the overall score, ranging from 0.661 (limits) to 0.899 (sleep problems) and the corresponding reproducibility indicator was 0.910, based on 23 patients and ranging from 0.711 (swelling) and 0.957 (looks). Exploratory factor analysis in general confirmed the original structure originally obtained by the authors. All CU-Q2oL dimensions were highly correlated with DLQI Index and differentiated well between males and females, and between different levels of wheals and pruritus. In addition, moderate negative correlations were found between Cu-Q2oL scores and the dimensions from SF-36 and EQ-5D-5 L. Conclusions The satisfactory metric properties confirmed the cultural adaptation and validity of CU-Q2oL into Portuguese population, providing the clinicians with a valid tool to evaluate the impact of chronic urticaria on patient’s QoL and therefore adjust their treatment. Trial registration number Not applicable.

This is Part 1 of an updated follow-up review of a World Allergy Organization (WAO) position paper published in 2012 on the diagnosis and treatment of urticaria and angioedema. Since 2012, there have been advances in the understanding of the pathogenesis of chronic urticaria, and greater experience with the use of biologics, such as omalizumab, in patients with severe refractory disease. For these reasons, the WAO decided to initiate an update targeted to general practitioners around the world, incorporating the most recent information on epidemiology, immunopathogenesis, comorbidities, quality of life, clinical case presentations, and the management of chronic spontaneous and chronic inducible urticaria, including urticaria in special situations such as childhood and pregnancy. A special task force of WAO experts was invited to write the different sections of the manuscript, and the final document was approved by the WAO Board of Directors. This paper is not intended to be a substitute for current national and international guidelines on the management of urticaria and angioedema but to provide an updated, simplified guidance for physicians around the world who manage patients with this common ailment.

BACKGROUND: Chronic urticaria is a debilitating disease that considerably affects health-related quality of life, and the Chronic Urticaria Quality of Life Questionnaire is the only questionnaire specifically designed for its evaluation. OBJECTIVE: To evaluate the quality of life of patients with chronic urticaria, using the Brazilian Portuguese version of the Chronic Urticaria Quality of Life Questionnaire. METHODS: The Chronic Urticaria Quality of Life Questionnaire was self-administered in 112 chronic urticaria patients and disease activity was assessed through the Urticaria Activity Score. Clinical and socio-demographic characteristics of patients were studied, such as: age, sex, etiologic diagnosis of chronic urticaria, duration of disease and Urticaria Activity Score. RESULTS: The population studied was composed 85.72% of women with a mean age of 46 years (18-90), while the median disease duration period was 10 years (3 months-60 years). Regarding the etiologic diagnosis, 48.22% had chronic spontaneous urticaria; 22.32% associated with inducible urticaria, 28.57% with chronic autoimmune urticaria, and 23.21% had physical urticaria alone. Disease activity evaluated using the Urticaria Activity Score was 1.04 ± 1.61 (0-6). The total score for the Chronic Urticaria Quality of Life Questionnaire was 36 (0-100) and dimension I (sleep/mental status/eating) had a greater impact on quality of life. The items with the highest mean scores were nervousness and shame over lesions, while the items with the lowest scores were lip swelling and limitations on sporting activities. CONCLUSIONS: Chronic urticaria compromises patients' quality of life, mainly those with more severe disease or who are diagnosed with chronic autoimmune urticaria.

the RhinAsthma Patient Perspective (RAPP) is the only available tool to assess HRQoL in daily practice. The aim of this study is to cross-culturally validate the RAPP in Spanish.The RAPP was translated into Spanish. Adult patients receiving usual care for asthma and allergic rhinitis (AR) were recruited consecutively and assessed twice with a four-week interval between visits to test the psychometric properties of the questionnaire.149 patients (62.8% female) with a mean age of 37.7 years completed the study. Exploratory and confirmatory factor analysis confirmed the uni-dimensional structure of the questionnaire. Internal consistency (0.73 at visit 1; 0.87 at visit 2), convergent and discriminant validity (p.05 at both visits) were satisfactory. Reliability was confirmed by an ICC of 0.69 and a CCC of 0.74. Responsiveness was supported by a significant association with VAS (r=0.28, p0.003) and ACT (r=-0.35, p0.01). The minimal clinical difference (MID) value in the analyzed population was 2.The Spanish version of RAPP was demonstrated to have satisfactory psychometric properties and is a valid, reliable and responsive tool for the assessment of asthma and AR HRQoL in clinical practice.

Introduction The RhinAsthma Patient Perspective (RAPP) was developed in Italian to assess the Health Related Quality of Life (HRQoL) impairment in patients with asthma and allergic rhinitis (AR) in daily practice. Aim To cross-culturally validate the Polish version. Material and methods The Polish version was administered to patients suffering from asthma and rhinitis in a prospective observational study. Polish RAPP, along with SF-12, ACT, and a Symptomatologic VAS was filled in twice, with a 4-week interval between visits. At visit 2, a Global Rating Scale (GRS) was completed to assess any change in health status. Internal consistency, validity, reliability, discriminant ability and responsiveness to change as well as Minimal Important Difference were determined. Results The factor and confirmatory analysis revealed a unidimensional structure of RAPP. Internal consistency was satisfactory with Cronbach's α (visit 1 = 0.85, visit 2 = 0.89). High reliability (ICC = 0.89 and a CCC = 0.94) was found. Validity analyses showed good correlations of the Polish RAPP with Physical and Mental Component Scores of SF-12. In addition, RAPP adequately discriminated patients on the basis of the asthma control level and rhinitis severity (p < 0.03 for all the analyses), and demonstrated to be sensitive to change. MID value was 1 point. Conclusions The study confirmed the reliability and validity of the Polish version of RAPP demonstrating that it is a useful tool in the assessment of HRQoL in patients with asthma and comorbid allergic rhinitis, in clinical practice.

Background: Adherence to inhaled drugs is linked to patients’ satisfaction with their device, and an incorrect use can negatively affect the outcomes of asthma treatment. We speculated that this is particularly true in elderly asthmatic subjects. Aim: We performed a national pre-post interventional multicentre study, enrolling moderate-to-severe asthmatic subjects aged ≥65 ​years treated with fixed inhaled combination drugs by dry powder inhaler (DPI) or pressurized metered dose inhaler (pMDI). Adherence and critical errors were evaluated by means of validated questionnaires at first visit (V1) and after 3–6 months (V2). At V1, subjects underwent intensive training on the correct use of their device by physical demonstration. Results: A total of 411 asthmatics (F/M: 238/173, mean age±SD: 72 ​± ​5 ​years) participated to the study. At V1, 50% of the study subjects showed an Asthma Control Test (ACT) score ≤19 despite GINA step 3 and 4 treatment, and 40% had experienced at least one severe asthma exacerbation in the previous year. Poor adherence to treatment was recorded in 43% of subjects, and at least one error in using the device was registered in 56% of subjects. At V2, available for 318 patients, both the percentage of individuals with poor adherence and with at least one critical error significantly decreased (from 46% to 25%, and from 49% to 25%, respectively; p ​

Ilaria Baiardini,1 Paola Rogliani,2 Pierachille Santus,3 Angelo G Corsico,4 Marco Contoli,5 Nicola Scichilone,6 Fabiano Di Marco,7 Patrizia Lessi,8 Carla Scognamillo,8 Giorgia Molinengo,9 Fabio Ferri,10 Vincenzo Patella,11 Giuseppe Fiorentino,12 Mauro Carone,13 Fulvio Braido14 1Department of Biomedical Sciences, Humanitas University, Milan, Italy; 2Respiratory Unit, Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, Italy; 3Department of Biomedical and Clinical Sciences (DIBIC), University of Milan, Milan, Italy; 4Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; 5Department of Medical Sciences, University of Ferrara, Ferrara, Italy; 6Department of Biomedicine and Internal and Specialistic Medicine (DIBIMIS), University of Palermo, Palermo, Italy; 7Department of Health Sciences, University of Milan, Milan, Italy; 8Boehringer Ingelheim, Milan, Italy; 9Department of Psychology, University of Turin, Turin, Italy; 10MediNeos Observational Research, Modena, Italy; 11U.O. di Allergologia e Immunologia Clinica del Dipartimento delle Discipline Mediche, Battipaglia, Italy; 12U.O.C. Malattie, Fisiopatologia e Riabilitazione Respiratoria A.O. dei Colli, Naples, Italy; 13UOC Pneumologia, ICS Maugeri, IRCCS Cassano Murge, Murge, Italy; 14Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCS San Martino, Genoa, Italy Background: Patient awareness of COPD refers to knowledge and acceptance of the disease and its treatment. Although it is relevant to management and outcomes, the disease awareness of patients is poorly investigated, and no validated questionnaires are currently available. We aimed to develop the novel Disease Awareness in COPD Questionnaire (DACQ), which was validated in relation to demographic and clinical features, in patients participating in the SATisfaction and Adherence to COPD Treatment (SAT) study.Methods: DACQ was developed according to a list of items regarding the patient’s knowledge, acceptance, and perception of COPD as well as of treatment needs. The questionnaire was validated by assessing internal structure and consistency, correlations with other patient-reported outcomes, and stability over time. Furthermore, the extent of disease awareness of patients enrolled in the SAT study was assessed by using DACQ, and correlations with demographic and clinical features were evaluated.Results: DACQ was composed of four domains. Overall reliability and stability over time were adequate; correlations between DACQ and other tools measuring different constructs (ie, treatment satisfaction, illness perception, impact of COPD symptoms on daily life, and dyspnea severity) were, as expected, more limited. In the enrolled patient sample, a suboptimal level of disease awareness (

So-called “P4 Medicine” (predictive, preventive, personalized, participative) represents the cornerstones of a model of clinical medicine, which offers concrete opportunities to modify the healthcare paradigm: the individual‘s participation becomes the key to put into practice the other three aspects of P4 with each patient. An active involvement of patients is necessary to guarantee effective self-management in asthma. It includes sharing decisions with patients for their clinical-therapeutical approach, the use of novel technologies to implement the patients participation in the disease management, to obtain significant and relevant improvement in patient reported outcomes, such as quality of life and asthma control.

A burden of respiratory and allergic symptoms up to almost 60% has been observed in young and adult athletes, influencing physical performances1 . The Allergy Questionnaire for Athletes (AQUA©) is a validated screening tool for the prediction of the atopic status in adult athletes2 ; it was recently tested in Belgian young elite athletes (12-14 years old)3 , but its actual feasibility and suitability for children and adolescent was not evaluated. Indeed, there is evidence that children are prone to employ "satisficing" response strategies, answering every question positively/negatively, or simply not answering4 . Therefore, the present cross-sectional survey was carried out to assess feasibility of a linguistically simplified version of AQUA© in children and adolescents, stratifying by sport practice and focusing on the core items (12 questions, 5 to 14 and 16 to 17) related to allergy. The study was approved by the local Institutional Ethics Committee (Palermo 1, Italy, Approval Number: 07/2017), and registered on the central registration system ClinicalTrials. gov (ID: NCT03286894). This article is protected by copyright. All rights reserved.

Introduction: Asthma and allergic rhinitis (AR) are chronic conditions in which management needs adherence to prescribed drugs. Despite the benefits of regular maintenance of asthma and AR therapy, low adherence is a frequent issue in clinical practice. Areas covered: The aim of this review is to provide a targeted analysis of the more recent literature on adherence in asthma and AR, focused on the following areas: adherence extent, barriers and consequences, effects of educational interventions and use of new technologies to improve the level of adherence. Expert commentary: Despite the extent, reasons and effects of this problem being well known, non-adherence in asthma and allergic AR remains worryingly high. Poor adherence leads to unsatisfactory health outcomes, with a negative impact on patients and society. Recent literature suggests that successful programs to improve adherence should include a combination of strategies. The new technologies represent a promising tool to improve adherence.

Background Specific instruments for health-related quality of life (HRQoL) assessment in adolescents with rhinoconjunctivitis or asthma are available. None of them evaluates rhinitis and asthma together, although they often coexist. Our aim was to validate a HRQoL questionnaire for adolescents with rhinoconjunctivitis, asthma, or both. Methods A pool of 38 items covering the main symptoms and problems related to respiratory allergy was generated based on literature review, clinical experience, and unstructured interviews to 54 adolescents. The items were randomly listed and presented to 88 consecutive outpatients (44 M; mean age 15.2 ± 3.1). Patients had to indicate which item they had experienced and, for each selected item, its importance on a four-point scale (1 = not at all; 4 = very much). Twelve items were excluded from the list, because of low importance. In the validation phase, 102 patients (54 M; mean age 15.36 ± 1.12) completed the KINDL, a generic HRQoL tool, and the new questionnaire (RHINASTHMA-Adolescents). Results Factor analysis revealed a five-dimensional structure, which explained up to 71.23% of the total variance. Association between RHINASTHMA-Adolescents and KINDL scores was all in the expected direction. Internal consistency for the extracted factors was satisfactory: Upper Airways (0.81), Lower Airways (0.89), Emotions (0.85), Social Relationship (0.79), Daily life management (0.74). Reliability was good for all factors with a Pearson coefficient ranged from 0.91 to 0.99. Conclusions RHINASTHMA-Adolescents is the first tool for evaluating HRQoL in patients with rhinitis and/or asthma. It provides a simple assessment and met the standards of validity, internal consistency, and reliability.

Proper use of inhaler devices may be problematic in elderly patients due to age-related difficulties. A survey was administered to elderly patients to investigate the usability of the Genuair® device and patients' subjective viewpoint on the device. A representative sample of the Italian population aged ≥ 65 years was completed with a pre-defined sample of 89 patients with hand arthritis/arthrosis. Of 526 respondents, 88 were not self-sufficient. Only the replies of the 438 self-sufficient respondents were analyzed. A total of 107 participants (24%) reported having respiratory diseases, and 81 of these (76%) were users of inhaler devices. After the first test, the device was considered “practical/handy” by 90% of patients and “easy to use” by 89%. After the second test, in which patients received a demonstration of the correct inhalation maneuver, the percentage of patients scoring ≥ 7 increased to 93% for the first characteristic and was confirmed for the second, with no differences between the groups in terms of age, educational level, use of devices, and presence of arthritis/arthrosis. The mean time to explain the inhaler technique and to perform a correct inhalation was 1'38"± 1'37", and 70% of the respondents required less than 2 minutes, with no differences between the groups in terms of age, education level, use of devices, and presence of arthritis/arthrosis. In conclusion, Genuair® was well accepted and easy to use in a representative sample of the Italian population aged ≥ 65 years. These characteristics make it a valid choice in the elderly, thus enabling patients to better cope with the problems and difficulties that are common to this age group.

Inhaled therapy is key to the management of chronic obstructive pulmonary disease (COPD). New drugs and inhalers have recently been launched or will soon become available, and the expiry of patent protection covering several currently used inhaled bronchodilators and corticosteroids will be accompanied by the development of bioequivalent, generic inhaled drugs. Consequently, a broader availability of branded and generic compounds will increase prescription opportunities. Given the time course of COPD, patients are likely to switch drugs and inhalers in daily practice. Switching from one device to another, if not accompanied by appropriate training for the patient, can be associated with poor clinical outcomes and increased use of health care resources. In fact, while it seems reasonable to prescribe generic inhaled drugs to reduce costs, inadequate use of inhaler devices, which is often associated with a poor patient-physician or patient-pharmacist relationship, is one of the most common reasons for failure to achieve COPD treatment outcomes. Further research is needed to quantify, as in asthma, the impact of inappropriate switching of inhalers in patients with COPD and show the outcomes related to the effect of using the same device for delivering inhaled medications.

Lack of therapeutic adherence is a relevant problem in clinical practice and it can be assessed via validated tools such as the Test of Adherence to Inhalers (TAI). Education on the correct use of inhaler devices has been associated with improvement in adherence. Many studies highlighted the pivotal role of pharmacists in promoting therapeutic adherence in the management of respiratory diseases.To evaluate the effectiveness on adherence and clinical parameters of an educational intervention administered by clinical pharmacists (CPs) to patients with asthma on long-term inhalation therapy.A prospective comparative study involving 34 community pharmacies in Italy (23 intervention, 11 control). Enrolled subjects were evaluated for adherence to inhalation therapy by TAI, asthma control by "Asthma Control Test" (ACT), and lung function at baseline and after 2 months. The educational intervention at baseline was based on TAI results and administered by specifically trained pharmacists.A total of 242 consecutive subjects (167 intervention, 75 control) were enrolled. There was a significant improvement in TAI score, ACT and lung function parameters (p-value0.001) in the intervention group between baseline and the follow-up visit. Patients with baseline ACT≥20 maintained disease control more frequently in the intervention group compared to the control arm (95% vs 79.5%, p = 0.004). Conclusions through administration of TAI-driven educational interventions addressing both technical and psychological issues, trained CPs can help improve adherence to treatment and asthma control.

Minimal clinically important difference (MCID) can be defined as the smallest change or difference in an outcome measure that is perceived as beneficial and would lead to a change in the patient's medical management.The aim of the current expert consensus report is to provide a “state-of-the-art” review of the currently available literature evidence about MCID for end-points to monitor asthma control, in order to facilitate optimal disease management and identify unmet needs in the field to guide future research.A series of MCID cut-offs are currently available in literature and validated among populations of asthmatic patients, with most of the evidence focusing on outcomes as patient reported outcomes, lung function and exercise tolerance. On the contrary, only scant and partial data are available for inflammatory biomarkers. These clearly represent the most interesting target for future development in diagnosis and clinical management of asthma, particularly in view of the several biologic drugs in the pipeline, for which regulatory agencies will soon require personalised proof of efficacy and treatment response predictors.

Introduction: QoL-B questionnaire is a self-reported outcome measure for bronchiectasis (bx) patients utilized in recent interventional trials and validated in several countries, except Italy. The objective of this study is to validate the Italian version of QoL-B questionnaire. Methods: A prospective observational study was conducted at the Policlinico Hospital, Milan, Italy, from 2016 to 2018. Bx adults who are native Italian speakers completed the QoL-B during a stable visit at baseline (T0) and after 15 days (T1), and during exacerbation (Tex). Internal Consistency Reliability (ICR) was evaluated using Cronbach’s alpha. Re-test reliability was conducted comparing each domain score T0 vs. T1. QoL-B results were compared across disease severity. Results: 81 patients (78% females; median age 65 years) were enrolled. The ICR was strong (Cronbach’s α coefficient >0.85). No differences in each domain score was identified between T0 and T1. QoL was lower in Tex vs. T0 for the Physical Functioning, Role Functioning, Vitality, Social Functioning, Health Perceptions and Respiratory Symptoms domains (all p Conclusion: The Italian translation of the QoL-B is a reliable and valid tool to evaluate health outcomes in Bx patients and correlates with disease severity.

Approximately 5%-10% of asthmatics suffer from severe asthma. New biological treatments represent a great opportunity to reduce asthma burden and to improve asthma patients' lives. Reslizumab will soon be available in several European countries. This anti-IL-5 IgG4/kappa monoclonal antibody, administered intravenously at a dose of 3 mg/kg over 20-50 minutes every 4 weeks, has been shown to be safe and effective in patients with 400 eosinophils/mu L or more in their peripheral blood. The clinical effects in reducing asthma exacerbations and in improving the quality of life and lung function are clear, but further research is needed to determine the best biological compound for a specific cluster of patients. Research data have shown that in patients who were expressing other clinical features of eosinophilic inflammation over asthma (rhinosinusitis and nasal polyposis), the clinical benefit of reslizumab was greater. Furthermore, it has also been observed that in patients with unsatisfactory response to mepolizumab, reslizumab is able to significantly improve the clinical and biological parameters. The aim of personalized medicine is to provide the right drug to the right patient at the right dose at the right moment. The biological treatments that were developed to modify specific pathological pathways not only provide us with the tools for the management of asthma patients but also clarify the biological mechanisms involved in its pathogenesis.

Background Omalizumab therapy is effective and safe in patients with chronic spontaneous urticaria (CSU) resistant to nonsedating histamine 1 (H 1 ) antihistamines (nsAHs). Objective To evaluate the efficacy and safety of omalizumab in elderly (aged ≥65 years) patients with nonsedating H 1 -antihistamine–refractory CSU in a real-life setting. Methods Patients with nonsedating H 1 -antihistamine–refractory CSU (n = 322) treated with omalizumab administered every 4 weeks in doses of 300 mg for 24 weeks were divided into 2 groups according to age at omalizumab treatment onset: 15 to 64 years and 65 years or older. Treatment response was assessed using a 7-day urticaria activity score (UAS7). Adverse effects of omalizumab therapy were recorded. Results Among patients, 32 (9.9%) were 65 years or older. At baseline, CSU characteristics were generally similar among the groups, although the presence of angioedema was statistically significantly lower in patients younger than 65 years. Any differences in weekly itch severity score, hive score, and UAS7 between the 2 age groups were not significant at weeks 4, 12, and 24, with the exception of the hive score at 24 weeks and the UAS7 at week 24. No significant between-group differences were seen in the proportion of patients with a UAS7 of 6 or lower and with a UAS7 score of 0 at weeks 4, 12, 24, and 40. The proportion of patients with at least one adverse event reported as suspected to be caused by study drug was 10% in the younger group vs 6.3% in the older group ( P = .53). Conclusion Our study found that omalizumab is a well-tolerated and effective therapy for elderly patients with nonsedating H 1 -antihistamine–refractory CSU.

Background: While fixed dose combinations (FDCs) of long-acting beta 2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are increasingly tested on their efficacy in improving lung function, their effectiveness on Patient Reported Outcomes (PROs) such as Health Related Quality of Life (HRQoL) and Health Status (HS) deserve more attention. Objectives: To review current available evidence about the treatment effect of fixed LABA/LAMA FDCs on HRQoL. Methods: A systematic literature search for randomized controlled trials (RCTs) about the impact of LABA/LAMA FDCs versus placebo, LABA or LAMA or LABA/ICS on HRQoL in Chronic obstructive pulmonary disease (COPD) patients has been performed. Results: Twenty-eight RCTs (n = 32, 165 COPD patients) investigating the impact of fixed LABA/LAMA combinations on HRQoL were included. Using the St George’ s Respiratory Questionnaire, 27 out of 28 trials assessed HRQoL. LABA/LAMA FDCs significantly improved HRQoL versus placebo in 9 out of 11 trials, while change when compared to other LABA or LAMA monocomponents was significantly better in 11 out 24. In 5 out of 6 RCTs having LABA/ICS as comparators, LABA/LAMA FDC had a similar effect and only 1 showed significant improvement in HRQL compared to LABA/ICS FDC. Conclusion: LABA/LAMA FDCs may be helpful in improving HRQoL, but because of the heterogeneity of performed trials, strong conclusions cannot be drawn. Moreover, due to the different molecule properties, treatment schedule, and device characteristics of each FDC, a generalized judgment seems inappropriate. Pragmatic trials powered to detect real-life differences in HRQoL and head-to-head comparison are needed to guide clinical practice in terms of PROs.

There is a need for validated tools to assess health-related quality of life (HRQoL) in routine clinical practice.The aim of this study was to validate the Chronic Urticaria Patient Perspective (CUPP) for assessment of patients with chronic urticaria (CU) in clinical practice.A provisional CUPP was developed from candidate items identified by following an iterative process in a retrospective analysis of 249 Chronic Urticaria Quality of Life Questionnaire questionnaires. The psychometric properties of the CUPP were then tested on a sample of patients enrolled in 13 Italian centers.The study population in the validation phase comprised 152 patients. The 10-item version of the CUPP showed satisfactory internal consistency (Cronbach's alpha values of 0.76 at visit 1 and 0.90 at visit 2), good criteria, and discriminative and convergent validity. Reliability was assessed in 34 patients with no changes in health (Global Rating Scale = 0 at visit 2) and was satisfactory (CCC [concordance correlation coefficient] = 0.9). Changes in CUPP scores were significantly associated with changes in Urticaria Activity Score (UAS)-Hive count (r = 0.36, P .001), UAS-Itch severity (r = 0.48, P.001), and UAS-Total score (r = 0.342, P.001), all of which indicated good responsiveness. The minimal important difference was 1.5.CUPP is a simple 10-question tool with good psychometric properties that provides a valid, reliable, and standardized measurement of HRQoL in patients with CU.

In this review, we herein describe the progress in management of severe asthma, evolving from a 'blockbuster approach' to a more personalized approach targeted to the utilization of endotype-driven therapies.Severe asthma characterization in phenotypes and endotypes, by means of specific biomarkers, have led to the dichotomization of the concepts of 'personalized medicine' and 'precision medicine', which are often used as synonyms, but actually have conceptual differences in meaning. The recent contribute of the omic sciences (i.e. proteomics, transcriptomics, metabolomics, genomics, …) has brought this initially theoretic evolution into a more concrete level.This step-by-step transition would bring to a better approach to severe asthmatic patients as the personalization of their therapeutic strategy would bring to a better patient selection, a more precise endotype-driven treatment, and hopefully to better results in terms of reduction of exacerbation rates, symptoms, pulmonary function and quality of life.