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Introduction: Clinical trials and real-life studies have been published showing effectiveness of benralizumab in severe eosinophilic asthmatic patients. The aim of the present study is to describe super-responders to benralizumab in a series of 79 patients who completed at least 1 year of treatment, and to compare super-responders with non super-responders. Methods: This is a multicenter study of the Register of Severe Asthma of the Region of Murcia (RE-ASGRAMUR) Group performed in eight hospitals under the conditions of routine clinical practice. Patients with zero exacerbations and no oral corticosteroid therapy for asthma were considered super-responders. We analyzed clinical, functional, and inflammatory parameters of selected patients.Results: In all, 50 of the 79 patients (63%) met the super-responder criteria. In addition, 36% of the patients (26/71) were considered as complete responders to treatment (superresponder + Asthma Control Test [ACT] ≥ 20 + forced expiratory volume in 1 s [FEV1] ≥ 80%). The super-responders were significantly older in age (P = 0.0029), had higher eosinophils count (P = 0.0423), higher proportion of nasal polyps (P = 0.036), and they had less severe disease at baseline. After 1 year of treatment, the super-responders had higher levels of ACT questionnaire (23 vs 19, P = 0.0007) and better percentage of FEV1 (83 vs 75, P = 0.0359). Conclusion: Almost two of the three patients treated with benralizumab were super-responders after 1 year of treatment and 36% had a complete response. Super-responders were associated with older age, higher eosinophils count, had nasal polyposis as comorbidity, and had less severe disease at baseline. This data illustrated the good real-life response of patients with severe eosinophilic asthma to the treatment with benralizumab.

Published data on vitamin D and the quality of life of asthma patients are scarce and disparate. The ACVID clinical trial, published in 2020, showed the efficacy of calcifediol in improving asthma control in asthma patients with vitamin D deficiency. Data on vitamin D and quality of life measured by the Mini-AQLQ questionnaire were analysed: supplemented patients showed improved quality of life compared with a placebo group, and the initial mini-AQLQ scores were improved for both groups.

BackgroundThe relationship between asthma and vitamin D deficiency has been known for some time. However, interventional studies conducted in this regard have shown conflicting results.ObjectiveTo evaluate the efficacy of vitamin D supplementation in asthmatic patients in improving the degree of control of asthma.MethodsRandomised, triple-blind, placebo-controlled, parallel-group study in adult asthmatic patients with serum 25-hydroxyvitamin-D3 ResultsOne hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women). Of the 112 patients, 106 (95%) completed the trial. Half the patients (56) were assigned to the intervention group and the other half to the control group. A statistically significant clinical improvement was observed in the intervention group (+3.09) compared with the control group (−0.57) (difference 3.66 (95% CI 0.89 to 5.43); pConclusionAmong adults with asthma and vitamin D deficiency, supplementation with weekly oral calcifediol compared with placebo improved asthma control over 6 months. Further research is needed to assess long-term efficacy and safety.Trial registration numberNCT02805907.

Juan Miguel Sánchez-Nieto,1,2 Rubén Andújar-Espinosa,3 Roberto Bernabeu-Mora,1,2 Chunshao Hu,1 Beatriz Gálvez-Martínez,1 Andrés Carrillo-Alcaraz,1 Carlos Federico Álvarez-Miranda,3 Olga Meca-Birlanga,1 Eva Abad-Corpa4 1Division of Pneumology, Hospital Morales Meseguer, 2University of Murcia, 3Division of Pneumology, Hospital Arrixaca, Murcia, 4Department of Professional Development Unit, Murcia, Spain Background: Self-management interventions improve different outcome variables in various chronic diseases. Their role in COPD has not been clearly established. We assessed the efficacy of an intervention called the self-management program on the need for hospital care due to disease exacerbation in patients with advanced COPD.Methods: Multicenter, randomized study in two hospitals with follow-up of 1 year. All the patients had severe or very severe COPD, and had gone to either an accident and emergency (A&E) department or had been admitted to a hospital at least once in the previous year due to exacerbation of COPD. The intervention consisted of a group education session on the main characteristics of the disease, an individual training session on inhalation techniques, at the start and during the 3rd month, and a written action plan containing instructions for physical activity and treatment for stable phases and exacerbations. We determined the combined number of COPD-related hospitalizations and emergency visits per patient per year. Secondary endpoints were number of patients with visits to A&E and the number of patients hospitalized because of exacerbations, use of antibiotics and corticosteroids, length of hospital stay, and all-cause mortality.Results: After 1 year, the rate of COPD exacerbations with visits to A&E or hospitalization had decreased from 1.37 to 0.89 (P=0.04) and the number of exacerbations dropped from 52 to 42 in the group of patients who received the intervention. The numbers of patients hospitalized, at 19 (40.4%) versus 20 (52.6%) (P=0.26), and those who went to A&E, at 9 (19.1%) versus 14 (36.8%) (P=0.06), due to exacerbation of COPD were also lower in this group. Intake of antibiotics was higher in the intervention group, whereas use of glucocorticoids was slightly lower, though there were no significant differences (P=0.30). There were also no differences between groups in the length of hospital stay (P=0.154) or overall mortality (P=0.191).Conclusion: The implementation of a self-management program for patients with advanced COPD reduced exacerbations that required hospital care. Keywords: self-management, COPD, severe exacerbations

Introduction: Sleep disturbances and night time symptoms are associated with the level of control of ashtma symptoms and quality of life Aims and objectives: Main aim: validate the Sleep Jenkins Questionnaire (SJQ) into Spanish. Secondary aim: assess quality of sleep in asthmatic patients using the SJQ and the Medical Outcome Study (MOS) sleep scale and analyse the metric properties of the SJQ Method: A multicentric prospective study with an intervention group of asthmatic patients and a control group. A total of 90 cases and 90 controls were included. The questionnaires were administered during 3 successive visits at a 3 weeks and 3 months interval Results: The test re-test of SJQ between V1 and V2 in the 90 cases showed temporary stability. Patients who had exacerbation of asthma between V2 and V3 had higher scores in SJQ (worse quality of sleep) at V3 than V2, which shows the sensivity to change of the test. A good correlation between the two measurament scales was observed at V1. The SJQ score between cases and controls during V1 showed significant differences in quality of sleep in both grooups. No statistically significant differences were found in quality of sleep depending on the severity of asthma but statistically significant differences were observed according to the control of asthma. The overall quality of sleep of our patients was good Conclusions: The SJQ showed temporary stability in the test-retest, sensitivity to change and validity criteria

Background Clinical audits have reported considerable variability in COPD medical care and frequent inconsistencies with recommendations. The objectives of this study were to identify factors associated with a better adherence to clinical practice guidelines and to explore determinants of this variability at the the hospital level. Methods EPOCONSUL is a Spanish nationwide clinical audit that evaluates the outpatient management of COPD. Multilevel logistic regression with two levels was performed to assess the relationships between individual and disease-related factors, as well as hospital characteristics. Results A total of 4508 clinical records of COPD patients from 59 Spanish hospitals were evaluated. High variability was observed among hospitals in terms of medical care. Some of the patient’s characteristics (airflow obstruction, degree of dyspnea, exacerbation risk, presence of comorbidities), the hospital factors (size and respiratory nurses available) and treatment at a specialized COPD outpatient clinic were identified as factors associated with a better adherence to recommendations, although this only explains a small proportion of the total variance. Conclusion To be treated at a specialized COPD outpatient clinic and some intrinsic patient characteristics were factors associated with a better adherence to guideline recommendations, although these variables were only explaining part of the high variability observed among hospitals in terms of COPD medical care.

Resumen: Introducción. El uso de la gamificación en salud es una herramienta útil para incrementar la motivación cuan­do se aplica a salud. Los objetivos fueron realizar una revisión sobre evidencias científicas de aplicaciones con elementos de gamificación en salud, identificar características de calidad, elaborar un check-list y aplicarlo a apli­caciones para la deshabituación tabáquica con elementos de gamificación. Métodos. Se realizó una búsqueda bibliográfica en Pubmed sobre gamificación en salud y una búsqueda de apps de cese tabáquico con elementos de gamificación. Se elaboró un check-list para evaluar la calidad, elementos de gamificación y técnicas de cambio de comportamiento utilizados, posteriormente se aplicó a las apps seleccionadas. Resultados. Se incluyeron 14 apps sobre gamificación en deshabituación tabáquica. Solo 4 (28,6%) identificaron fuentes de información fiables y solo 2 (14,3%) informaron sobre políticas de acceso y tratamiento de datos. Las técnicas de cambio de comportamiento identificadas fueron retroalimentación en todas las apps, automonitorización en 12 (85,7%) y cambios basados en los éxitos pasados en 13 (92,9%). Conclusiones. Existen pocos estudios sobre aplica­ciones para la deshabituación tabáquica con elementos de gamificación, con gran variabilidad en metodología, variables medidas y escasas evidencias. La creación de un check-list sobre calidad de las aplicaciones podría disminuir esta variabilidad y mejorar la calidad de los estudios futuros. Son necesarios nuevos estudios.Palabras clave: Deshabituación tabáquica; Aplicaciones móviles; Terapia de comportamiento; Cese tabáquico.Abstract: Introduction. The use of health gamification has proven to be a useful tool to increase motivation and com­mitment when applied to health. The objectives were to review the scientific evidences of health gamification applications, to identify the quality characteristics, to develop a check list to evaluate it and to apply it to the appli­cations in smoking cessation. Methodology. PubMed search on health gamification and a search for smoking cessation apps with gamification elements in the most important application stores. A checklist was developed to evaluate the quality, gamification elements and behavior change techniques used, and was applied to the selected apps. Results. We included 14 apps on gamification in smoking cessation. Only 4 (28.6%) identified reliable sou­rces of information and only 2 (14.3%) reported on access policies and data processing. Behavior change techni­ques identified were feedback in all apps, self-monitoring in 12 (85.7%) and changes based on past successes 13 (92.9%). Conclusions. There are few studies on gamification applications in smoking cessation, with a high variabi­lity in the methodology, measured variables and with little evidence. Creating a checklist on the quality of smoking cessation apps could decrease this variability and improve the quality of future studies. Further studies are needed.Keywords: Tobacco Use Cessation; Mobile Applications; Behavior Therapy; Smoking Cessation.

Background: To validate the Test of Adherence to Inhalers' (TAI), a 12-item questionnaire designed to assess the adherence to inhalers in patients with COPD or asthma. Methods: A total of 1009 patients with asthma or COPD participated in a cross-sectional multicenter study. Patients with electronic adherence 80% were defined as adherents. Construct validity, internal validity, and criterion validity were evaluated. Self-reported adherence was compared with the Morisky-Green questionnaire. Results: Factor analysis study demonstrated two factors, factor 1 was coincident with TAI patient domain (items 1 to 10) and factor 2 with TAI health-care professional domain (items 11 and 12). The Cronbach's alpha was 0.860 and the test-retest reliability 0.883. TAI scores correlated with electronic adherence (=0.293, p=0.01). According to the best cut-off for 10 items (score 50, area under the ROC curve 0.7), 569 (62.5%) patients were classified as non-adherents. The non-adherence behavior pattern was: erratic 527 (57.9%), deliberate 375 (41.2%), and unwitting 242 (26.6%) patients. As compared to Morisky-Green test, TAI showed better psychometric properties. Conclusions: The TAI is a reliable and homogeneous questionnaire to identify easily non-adherence and to classify from a clinical perspective the barriers related to the use of inhalers in asthma and COPD., This study was funded by the Integrated Research Asthma Program (PII Asthma) together with the Integrated Research COPD Program (PII COPD) of the Spanish Respiratory Society (SEPAR). Unconditional funding was provided by Chiesi, who did not participate in data collection, interpretation of the results, or writing of the manuscript.

Introduction: Non-pharmacological interventions in COPD can save care resources. Material and Methods: A multicentre, randomized, single-blind, parallel-group clinical trial with a one-year follow-up of a self-treatment programme (STP) versus conventional management. The STP intervention group included a group education centre, training in inhaler technique and a written treatment plan. The control group received standard care. The main variable was the severe exacerbations rate. Secondary variables were number of admissions and mortality. Results: Of the 250 patients recruited, 101 (40.4%) were included in the trial; 38 (37.62%) patients in the control group (CG) completed the trial and 47 (46.53%) in the intervention group (IG). There were no significant differences in the baseline characteristics of the patients. Twenty (52.6%) patients in the CG presented severe exacerbations vs 19 (40.4%) in the IG (P=0.262). Sixteen patients (42.1%) in the CG were hospitalised vs 12 (25.5%) in the IG (P=0.106). Two patients (5.26%) in the control group died vs none in the intervention group (P=0.383). The severe exacerbations rate was 1.37 (1.02–1.79) in the CG vs 0.89 (0.64-1.21) in the IG (P=0.049) (rate ratio, 1.53 [1.01-2.29]). The NNT (STP vs conventional treatment) to prevent one severe exacerbation per year was 6.25 (5.0-8.0). Conclusions: 1. In the first year, the STP reduced the severe exacerbations rate in patients with COPD. 2. The STP reduced the number of hospitalizations and of severe exacerbations. 3. The STP could be used in less than half of the selected population.

Introduction Differences between the opinions of patients and physicians on the impact of asthma are common. We hypothesised that patient–physician discordance may negatively affect asthma outcome. Methods A total of 2902 patients (61% women, mean age 47 years) with moderate–severe asthma and 231 physicians participated in a prospective study. At the baseline visit, data on demographics, clinical variables, degree of asthma control according to the Asthma Control Test (ACT), basic spirometry and the Hospital Anxiety and Depression Scale (HADS) were collected and an ad hoc questionnaire was completed that allowed the degree of concordance between doctors and patients to be assessed. A scheduled telephone call after 3 months was used to elicit the ACT score and the future risk of asthma. At the final visit at 6 months, the following data were recorded: ACT score, spirometry, HADS score and an ad hoc questionnaire to assess the agreement between the doctor and the patient. Changes in study variables according to patient–physician concordance or discordance were analysed. Results The rate of patient–physician discordance was 27.2%, with overestimation of disease impact by the physician in 12.3% and underestimation in 14.9%. Patient–physician opinion discordance, particularly in the case of physicians underestimating the impact of asthma, showed worse results with statistically significant differences in ACT score, a higher percentage of patients with poor asthma control and lower HADS scores. The need for hospital and emergency department admissions was also higher. Conclusion Patient–physician opinion discordance may be contributing to lower symptomatic control and increased future risk, with a higher impact when physicians underestimate the impact of asthma on their patients.

Backgrounds: AUDIPOC is a nationwide clinical audit that describes the characteristics, interventions and outcomes of patients admitted to Spanish hospitals because of an exacerbation of chronic obstructive pulmonary disease (ECOPD), assessing the compliance of these parameters with current international guidelines. The present study describes hospital resources, hospital factors related to case recruitment variability, patients' characteristics, and adherence to guidelines. Methodology/Principal Findings: An organisational database was completed by all participant hospitals recording resources and organisation. Over an 8-week period 11,564 consecutive ECOPD admissions to 129 Spanish hospitals covering 70% of the Spanish population were prospectively identified. At hospital discharge, 5,178 patients (45% of eligible) were finally included, and thus constituted the audited population. Audited patients were reassessed 90 days after admission for survival and readmission rates. A wide variability was observed in relation to most variables, hospital adherence to guidelines, and readmissions and death. Median inpatient mortality was 5% (across-hospital range 0-35%). Among discharged patients, 37% required readmission (0-62%) and 6.5% died (0-35%). The overall mortality rate was 11.6% (0-50%). Hospital size and complexity and aspects related to hospital COPD awareness were significantly associated with case recruitment. Clinical management most often complied with diagnosis and treatment recommendations but rarely (, This work was supported by Fondo de Investigacion Sanitaria (FIS), Instituto de Salud Carlos III, Ministerio de Ciencia e Innovacion (PI 08/90129, PI 90486, PI08/90578, PI 07/90503, PI 08/90251, PI 07/90516, PI 08/90529, PI 07/90309, PI 08/90457, PI 08/90129, PI 07/90721, PI 08/90550, PI08/90447, PI07/90403, PI 08/90486), Spanish Respiratory Society (SEPAR) and CIBER de Enfermedades Respiratorias (CIBERES). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.