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Background Poor medication adherence is a major challenge in asthma, and objective assessment of inhaler adherence is needed. The InspirerMundi app aims to monitor adherence while providing a positive experience through gamification and social support. Objective This study aimed to evaluate the feasibility and acceptability of the InspirerMundi app to monitor medication adherence in adolescents and adults with persistent asthma (treated with daily inhaled medication). Methods A 1-month mixed method multicenter observational study was conducted in 26 secondary care centers from Portugal and Spain. During an initial face-to-face visit, physicians reported patients’ asthma therapeutic plan in a structured questionnaire. During the visits, patients were invited to use the app daily to register their asthma medication intakes. A scheduled intake was considered taken when patients registered the intake (inhaler, blister, or other drug formulation) by using the image-based medication detection tool. At 1 month, patients were interviewed by phone, and app satisfaction was assessed on a 1 (low) to 5 (high) scale. Patients were also asked to point out the most and least preferred app features and make suggestions for future app improvements. Results A total of 107 patients (median 27 [P25-P75 14-40] years) were invited, 92.5% (99/107) installed the app, and 73.8% (79/107) completed the 1-month interview. Patients interacted with the app a median of 9 (P25-P75 1-24) days. At least one medication was registered in the app by 78% (77/99) of patients. A total of 53% (52/99) of participants registered all prescribed inhalers, and 34% (34/99) registered the complete asthma therapeutic plan. Median medication adherence was 75% (P25-P75 25%-90%) for inhalers and 82% (P25-P75 50%-94%) for other drug formulations. Patients were globally satisfied with the app, with 75% (59/79) scoring ≥4,; adherence monitoring, symptom monitoring, and gamification features being the most highly scored components; and the medication detection tool among the lowest scored. A total of 53% (42/79) of the patients stated that the app had motivated them to improve adherence to inhaled medication and 77% (61/79) would recommend the app to other patients. Patient feedback was reflected in 4 major themes: medication-related features (67/79, 85%), gamification and social network (33/79, 42%), symptom monitoring and physician communication (21/79, 27%), and other aspects (16/79, 20%). Conclusions The InspirerMundi app was feasible and acceptable to monitor medication adherence in patients with asthma. Based on patient feedback and to increase the registering of medications, the therapeutic plan registration and medication detection tool were redesigned. Our results highlight the importance of patient participation to produce a patient-centered and engaging mHealth asthma app.

We aimed to identify persistent asthma phenotypes among adolescents and to evaluate longitudinally asthma-related outcomes across phenotypes. Adolescents (13&ndash, 17 years) from the prospective, observational, and multicenter INSPIRERS studies, conducted in Portugal and Spain, were included (n = 162). Latent class analysis was applied to demographic, environmental, and clinical variables, collected at a baseline medical visit. Longitudinal differences in clinical variables were assessed at a 4-month follow-up telephone contact (n = 128). Three classes/phenotypes of persistent asthma were identified. Adolescents in class 1 (n = 87) were highly symptomatic at baseline and presented the highest number of unscheduled healthcare visits per month and exacerbations per month, both at baseline and follow-up. Class 2 (n = 32) was characterized by female predominance, more frequent obesity, and uncontrolled upper/lower airways symptoms at baseline. At follow-up, there was a significant increase in the proportion of controlled lower airway symptoms (p &lt, 0.001). Class 3 (n = 43) included mostly males with controlled lower airways symptoms, at follow-up, while keeping symptom control, there was a significant increase in exacerbations/month (p = 0.015). We have identified distinct phenotypes of persistent asthma in adolescents with different patterns in longitudinal asthma-related outcomes, supporting the importance of profiling asthma phenotypes in predicting disease outcomes that might inform targeted interventions and reduce future risk.

BACKGROUND Poor medication adherence is a major challenge in asthma, and objective assessment of inhaler adherence is needed. The InspirerMundi app aims to monitor adherence while providing a positive experience through gamification and social support. OBJECTIVE This study aimed to evaluate the feasibility and acceptability of the InspirerMundi app to monitor medication adherence in adolescents and adults with persistent asthma (treated with daily inhaled medication). METHODS A 1-month mixed method multicenter observational study was conducted in 26 secondary care centers from Portugal and Spain. During an initial face-to-face visit, physicians reported patients’ asthma therapeutic plan in a structured questionnaire. During the visits, patients were invited to use the app daily to register their asthma medication intakes. A scheduled intake was considered taken when patients registered the intake (inhaler, blister, or other drug formulation) by using the image-based medication detection tool. At 1 month, patients were interviewed by phone, and app satisfaction was assessed on a 1 (low) to 5 (high) scale. Patients were also asked to point out the most and least preferred app features and make suggestions for future app improvements. RESULTS A total of 107 patients (median 27 [P25-P75 14-40] years) were invited, 92.5% (99/107) installed the app, and 73.8% (79/107) completed the 1-month interview. Patients interacted with the app a median of 9 (P25-P75 1-24) days. At least one medication was registered in the app by 78% (77/99) of patients. A total of 53% (52/99) of participants registered all prescribed inhalers, and 34% (34/99) registered the complete asthma therapeutic plan. Median medication adherence was 75% (P25-P75 25%-90%) for inhalers and 82% (P25-P75 50%-94%) for other drug formulations. Patients were globally satisfied with the app, with 75% (59/79) scoring ≥4,; adherence monitoring, symptom monitoring, and gamification features being the most highly scored components; and the medication detection tool among the lowest scored. A total of 53% (42/79) of the patients stated that the app had motivated them to improve adherence to inhaled medication and 77% (61/79) would recommend the app to other patients. Patient feedback was reflected in 4 major themes: medication-related features (67/79, 85%), gamification and social network (33/79, 42%), symptom monitoring and physician communication (21/79, 27%), and other aspects (16/79, 20%). CONCLUSIONS The InspirerMundi app was feasible and acceptable to monitor medication adherence in patients with asthma. Based on patient feedback and to increase the registering of medications, the therapeutic plan registration and medication detection tool were redesigned. Our results highlight the importance of patient participation to produce a patient-centered and engaging mHealth asthma app.

This work was funded by ERDF (European Regional Development Fund) through the operations: POCI- -01-0145-FEDER-029130 (“mINSPIRERS—mHealth to measure and improve adherence to medication in chronic obstructive respiratory diseases - generalisation and evaluation of gamification, peer support and advanced image processing technologies”) co-funded by the COMPETE2020 (Programa Operacional Competitividade e Internacionalização), Portugal 2020 and by Portuguese Funds through FCT (Fundação para a Ciência e a Tecnologia). © 2020, Sociedade Portuguesa de Alergologia e Imunologia Clinica. All rights reserved. Aims: To identify distinct asthma control clusters based on Control of Allergic Rhinitis and Asthma Test (CARAT) and to compare patients’ characteristics among these clusters. Methods: Adults and adolescents (≥13 years) with persistent asthma were recruited at 29 Portuguese hospital outpatient clinics, in the context of two observational studies of the INSPIRERS project. Demographic and clinical characteristics, adherence to inhaled medication, beliefs about inhaled medication, anxiety and depression, quality of life, and asthma control (CARAT, >24 good control) were collected. Hierarchical cluster analysis was performed using CARAT total score (CARAT-T). Results: 410 patients (68% adults), with a median (percentile 25–percentile 75) age of 28 (16-46) years, were analysed. Three clusters were identified [mean CARAT-T (min-max)]: cluster 1 [27(24-30)], cluster 2 [19(14-23)] and cluster 3 [10(2-13)]. Patients in cluster 1 (34%) were characterised by better asthma control, better quality of life, higher inhaler adherence and use of a single inhaler. Patients in clusters 2 (50%) and 3 (16%) had uncontrolled asthma, lower inhaler adherence, more symptoms of anxiety and depression and more than half had at least one exacerbation in the previous year. Further-more, patients in cluster 3 were predominantly female, had more unscheduled medical visits and more anxiety symp-toms, perceived a higher necessity of their prescribed inhalers but also higher levels of concern about taking these inhalers. There were no differences in age, body mass index, lung function, smoking status, hospital admissions or specialist physician follow-up time among the three clusters. Conclusion: An unsupervised method based on CARAT--T, identified 3 clusters of patients with distinct, clinically meaningful characteristics. The cluster with better asthma control had a cut-off similar to the established in the validation study of CARAT and an additional cut-off seems to distinguish more severe disease. Further research is necessary to validate the asthma control clusters identified. publishersversion published

InspirerMundi app aims to transform adherence into a positive experience through gamification and social support, while allowing objective monitoring of inhaler adherence. We explored patients’ engagement with this app. Adolescents and adults with persistent asthma, followed in 24 Portuguese hospital outpatient clinics, were invited by their physicians to use the InspirerMundi app daily for 4 months and register medication and symptoms. To stimulate engagement, the app includes a gamification component (point and badge system with a storyline of a warrior evolving to an Inspirer-advanced player that can motivate warriors to improve adherence). During the study period, patients received 3 phone interviews for additional data collection and 6 text messages to promote app engagement. Usage rate (days with app uses/total days) during weeks that followed a contact (phone/message) were compared to weeks with no contacts. A total of 77 patients (27±13y) were recruited and 72 used the app a median[P25-P75] of 48[24-114] days (usage rate 60[32-83]%).Total use period was >30 days for 2/3 of patients and >90 days for 1/3. Sixty-four patients registered ≥1 medication; 66 patients answered a median of 14[4-35] symptom questionnaires; 63 received ≥1 badge; and 9 achieved Inspirers level. Text messages did not seem to influence usage rate (p=.386), while phone calls seemed to have a negative effect (p=.003). 16 (22%) users continued to use the app after the end of the study. The usage rate of InspirerMundi app was higher than usage reported for other health apps. These results might be related to the app engagement features and to the recommendation of use by a physician. Additional contacts do not seem to improve app usage rate.

The Portuguese Severe Asthma Registry (RAG) is a national web-based disease registry of adult and pediatric patients with severe asthma. Since its launch, plans for collaborative research were established. This study aims to describe the baseline characteristics of the patients included in RAG and the planned research activities. RAG collects real-life data patients with severe asthma followed at specialized care centres (Global Initiative for Asthma step 4/5). RAG’s data are collected at the time of routine medical appointments. A total of 68 patients were included by 22 physicians. The median age was 55 yrs (P25-P75, 48-63), two patients were The management of severe asthma is still an unmet need. Further characterization of patients, treatments and asthma phenotypes may improve disease-related knowledge and ultimately optimize care pathways.

Unsupervised methods may unveil the potential of the INSPIRERS studies to comprehend the heterogeneous characteristics of asthma. Therefore, we aimed to identify distinct classes of asthma among the participants, using latent class analysis (LCA), and to compare their characteristics across classes. We applied LCA to 308 adults (≥18 years) with persistent asthma (treated with daily inhaled medication) participants in the observational and prospective INSPIRERS studies, conducted in 26 secondary care outpatient clinics from Portugal and Spain. The classifying variables included asthma-related demographics, unscheduled healthcare use, Control of Allergic Rhinitis and Asthma Test (CARAT), and EuroQol 5 dimensions (EQ-5D) questionnaires. A three-class model was identified. Class 1 (21%) and Class 2 (26%) were characterized by highly symptomatic and uncontrolled asthma, with concomitant upper airways symptoms and reporting problems across all EQ-5D dimensions; they differed on high unscheduled healthcare use (Class 1) and early asthma onset (Class 2). Class 3 (53%): early asthma onset, controlled asthma with upper airways symptoms and without problems in EQ-5D dimensions. Compared to other classes, Class 1 had a higher proportion of subjects with FEV1 Three distinct and clinically meaningful unsupervised classes of asthma were identified among participants of the INSPIRERS studies, revealing the studies’ potential to support and enable patient-centered care and further research.

We assessed the feasibility of the InspirerMundi app to monitor medication adherence in adolescents and adults with persistent asthma (treated with daily inhaled medication). A 1-month multicentre observational study was conducted in 26 hospital outpatient clinics from Portugal and Spain. During medical visits (T0), 107 patients were invited to use the app daily to register their asthma medication intakes. A scheduled intake was considered taken when patients presented the medication (inhaler, blister or other recipients) to an app image detection tool. Physicians reported patients’ asthma therapeutic plan at T0. At 1-month, patients were interviewed by phone and app satisfaction was assessed on a 1(low)-5(high) scale. A total of 99 patients (29±13 years) installed the app (93%) and 79 (74%) completed the 1-month interview. At least one medication was registered in the app by 77 patients (72%): 73 ≥1 inhaler and 42 at least another medication, e.g., pills, nasal spray. Almost 90% of patients registered in the app at least 50% of medications of the therapeutic plan, with 71% registering all prescribed inhalers and 52% all other prescribed medication. Median medication adherence was 75[25-90]% for inhalers and 82[50-94]% for other types. Most patients were satisfied with the features of medication adherence monitoring (70% scored ≥4), but less with the inhaler detection tool (53% ≥4). Half of the patients (53%) stated that the app had motivated them to better adhere to inhaled medication. InspirerMundi app was feasible to monitor medication adherence in patients with asthma. These results led to the redesign of the therapeutic plan registration and of the inhaler detection tool.

Copyright © 2018 Ana Sá-Sousa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited., The Portuguese Severe Asthma Registry (Registo de Asma Grave Portugal, RAG) was developed by an open collaborative network of asthma specialists. RAG collects data from adults and pediatric severe asthma patients that despite treatment optimization and adequate management of comorbidities require step 4/5 treatment according to GINA recommendations. In this paper, we describe the development and implementation of RAG, its features, and data sharing policies. The contents and structure of RAG were defined in a multistep consensus process. A pilot version was pretested and iteratively improved. The selection of data elements for RAG considered other severe asthma registries, aiming at characterizing the patient's clinical status whilst avoiding overloading the standard workflow of the clinical appointment. Features of RAG include automatic assessment of eligibility, easy data input, and exportable data in natural language that can be pasted directly in patients' electronic health record and security features to enable data sharing (among researchers and with other international databases) without compromising patients' confidentiality. RAG is a national web-based disease registry of severe asthma patients, available at asmagrave.pt. It allows prospective clinical data collection, promotes standardized care and collaborative clinical research, and may contribute to inform evidence-based healthcare policies for severe asthma., RAG was financed by an unrestricted grant from Novartis Farma-Produtos Farmacêuticos, S.A., which had no participation in any part of the development and implementation of the registry and has no access to the stored data for any purpose. The first author is financed by a PhD Grant (PD/BD/113665/2015) and financed by the European Social Fund and national funds of MCTES (Ministério da Ciência, Tecnologia e Ensino Superior) through FCT (Fundação para a Ciência e Tecnologia, I.P) PhD Programme Ref. PD/0003/2013-Doctoral Programme in Clinical and Health Services Research (PDICSS). Te publication of this article was supported by ERDF (European Regional Development Fund) through the operation POCI-01-0145- FEDER-007746 funded by the Programa Operacional Competitividade e Internacionalização – COMPETE2020 and by National Funds through FCT - Fundação para a Ciência e a Tecnologia within CINTESIS, R&D Unit (reference UID/IC/4255/2013).

Objective: We aimed to compare patient's and physician's ratings of inhaled medication adherence and to identify predictors of patient-physician discordance. Design: Baseline data from two prospective multicentre observational studies. Setting: 29 allergy, pulmonology and paediatric secondary care outpatient clinics in Portugal. Participants: 395 patients (≥13 years old) with persistent asthma. Measures: Data on demographics, patient-physician relationship, upper airway control, asthma control, asthma treatment, forced expiratory volume in one second (FEV1) and healthcare use were collected. Patients and physicians independently assessed adherence to inhaled controller medication during the previous week using a 100 mm Visual Analogue Scale (VAS). Discordance was defined as classification in distinct VAS categories (low 0-50; medium 51-80; high 81-100) or as an absolute difference in VAS scores ≥10 mm. Correlation between patients' and physicians' VAS scores/categories was explored. A multinomial logistic regression identified the predictors of physician overestimation and underestimation. Results: High inhaler adherence was reported both by patients (median (percentile 25 to percentile 75) 85 (65-95) mm; 53% VAS>80) and by physicians (84 (68-95) mm; 53% VAS>80). Correlation between patient and physician VAS scores was moderate (rs=0.580; p

The paper version of CARAT (pCARAT) is valid to assess asthma control over a 4-week period. For follow-up purposes, assessment through mobile apps (aCARAT) or telephone (tCARAT) may be useful alternatives. We explored the psychometric properties of the aCARAT and tCARAT. Patients with asthma were recruited at secondary care outpatient clinics. During medical visits, patients filled in the pCARAT and were invited to complete the aCARAT in the following days using the app of project Inspirers (InspirerMundi). After 1 week, tCARAT was collected. Patients completing the 3 CARAT versions within 28 days were analysed. CARAT scores (0-worst, 30-best) were calculated. The internal consistency (Cronbach’s α), convergent validity (Spearman correlation-rs) and reliability (intraclass correlation coefficient-ICC, Bland-Altman analysis) were determined. 55 patients (21 male; median 19 [interquartile range 17-37]y) were included. The aCARAT was completed by 82% of patients within 1 week of pCARAT; and by 78% within 1 week of tCARAT. The median pCARAT score was 21[17-24], the aCARAT 21[18-26], and the tCARAT 23[21-26]. Internal consistency was good for all versions (α=.73-.77). pCARAT was more strongly correlated with aCARAT than with tCARAT. Reliability was better for aCARAT than for tCARAT (table 1). App and telephonic CARAT versions are valid and reliable, exhibiting comparable psychometric properties to the paper version. These new CARAT versions are promising alternatives for assessing control in patients with asthma.

EvASTHMApt aimed to assess the relation between clinical practice and outcomes of patients’ attending hospital emergency rooms (ER) due to asthma exacerbations (AE) in Portugal. AE management was evaluated in a prospective, multicentric, observational study in 13 ERs with a structured phone interview follow-up (FU) at 30 and 60 days. Results: 237 patients (pts) (65% adults) were included (Oct/16 - Mar/17). Main trigger factor was infection (78%). Previous control medication with steroids (ICS) was used by 57% of pts and 4% were under systemic steroids (SCS). In previous year 52% of adults and 68% of children had AE (47%>2 AE) and 10% and 5% hospitalizations, respectively. Only 18% adults and 22% children has spirometry in previous year. At ER, 74% of pts received SCS and oxygen (O2) rates varied between hospitals (adults:15-75%; children:0-53%). 22% (44 adults; 9 children) were hospitalized, 7% in ICUs, 96% requiring SCS, 90% O2 and 31% had comorbidities, mostly respiratory infection, tracheo-bronchitis and pneumonia. At discharge (ER and hospitalization), 77% pts changed medication, 62% were prescribed with ICS and 46% SCS; 2.5% received no asthma treatment. Around 72% pts completed FU at 30 and 60-days: medical appointment was scheduled in 59%, ⅓ of which within 60 days after discharge. At 30 and 60-days FU, 22% and 26% had AE leading to ER visit in 9% and 8% respectively. Conclusion: Most pts attending ER due to asthma AE had AE in the previous year. Almost ½ were not taking ICS and ¼ had another AE in the 60 days after ER. Improvement areas in asthma care at ER were identified: increase monitoring such spirometry and medication use, as well as point of care increase in ICS treatment (⅓ pts left ER without ICS) and timely medical appointment (59% pts had one in the 60 days FU).

Different subsets of asthma patients may be recognized according to the exposure trigger and the frequency and severity of clinical signs and symptoms. Regarding the exposure trigger, generally asthma can be classified as allergic (or atopic) and nonallergic (or nonatopic). Allergic and nonallergic asthma are distinguished by the presence or absence of clinical allergic reaction and in vitro IgE response to specific aeroallergens. The mechanisms of allergic asthma have been extensively studied with major advances in the last two decades. Nonallergic asthma is characterized by its apparent independence from allergen exposure and sensitization and a higher degree of severity, but little is known regarding the underlying mechanisms. Clinically, allergic and nonallergic asthma are virtually indistinguishable in exacerbations, although exacerbation following allergen exposure is typical of allergic asthma. Although they both show several distinct clinical phenotypes and different biomarkers, there are no ideal biomarkers to stratify asthma phenotypes and guide therapy in clinical practice. Nevertheless, some biomarkers may be helpful to select subsets of atopic patients which might benefit from biologic agents, such as omalizumab. Patients with severe asthma, uncontrolled besides optimal treatment, notwithstanding nonatopic, may also benefit from omalizumab therapy, although currently there are no randomized double-blind placebo controlled clinical trials to support this suggestion. However, omalizumab discontinuation according to each patient's response to therapy and pharmacoeconomical analysis are questions that remain to be answered. info:eu-repo/semantics/publishedVersion

The analysis of outcomes from patients with severe asthma treated with omalizumab, using real-life prospective data, should contribute to future informed decisions about this treatment in Portugal.The aim of this study was to assess the clinical effect of omalizumab in Portuguese patients with severe persistent allergic asthma, considering specifically asthma control and exacerbations.This was an observational, prospective, multicentre study. Data were collected at routine care over a 12-month period. Disease control was defined by Control of Allergic Rhinitis and Asthma Test (CARAT) global score >24.All asthma patients already under treatment with omalizumab in 7 departments from 6 Portuguese hospitals were included (n = 48). Most (77%) patients were female and the mean (SD) age was 51.9 (10.2) years old. During the study period, asthma was controlled in 34% of the visits and the 12-month exacerbation rate was 1.7 per patient (0.6 with unscheduled medical care). One-third of the patients needed unscheduled medical care because of asthma and 29% had to start or increase oral corticosteroid. There was still a 41% reduction in the total sum of oral corticosteroids usage from the first to the last trimester of the study.During routine treatment with omalizumab, Portuguese patients with severe asthma achieved asthma control in 1/3 of the visits and only 1/3 needed unscheduled or Emergency Room care because of asthma exacerbations. These outcomes support the maintenance of the clinical effect during treatment with omalizumab in routine care in Portugal. Keywords: Severe asthma, Omalizumab, Asthma control, Exacerbations, Observational study

Extrinsic allergic alveolitis and sarcoidosis are two granulomatosis of the lung characterized by non- -necrotizing granuloma. Both have typical bronchoalveolar lavage immunology, with opposite CD4/CD8 relation. However, sarcoidosis does not have such well defined etiology as extrinsic allergic alveolitis. The authors present two cases with similar clinical course, imagiology, lung function and immunology, although they both had an histology that was not concordant with the bronchoalveolar lavage, and with the peculiarity of being two elements of the same family, co -inhabitants and with a clinical presentation only a few weeks apart.

Sarcoidosis is a multisystemic granulomatous disease of unknown aetiology, characterized by the presence of non-caseating epithelioid cell granulomas on tissue biopsy of affected organs. It may involve any organ, presenting in multiple forms to clinicians of different specialties. In its extra-thoracic form it may involve the liver (50-80%), spleen (40-80%), eye (20-50%), extrathoracic lymph nodes (30%), skin (25%), nervous system (10%), heart (5%), kidney, muscle and bone, sometimes without symptoms. The presence of extrathoracic disease may affect the prognosis and treatment options for sarcoidosis. The authors present a review of the major extra-thoracic manifestations of sarcoidosis regarding its clinical presentation, diagnosis, treatment, follow-up and prognosis.