Software as a Medical Device (SaMD) in Digestive Healthcare: Regulatory Challenges and Ethical Implications.

The growing integration of software in healthcare, particularly the rise of standalone software as a medical device (SaMD), is transforming digestive medicine, a field heavily reliant on medical imaging for both diagnosis and therapeutic interventions. This narrative review aims to explore the impact of SaMD on digestive healthcare, focusing on the evolution of these tools and their regulatory and ethical challenges. Our analysis highlights the exponential growth of SaMD in digestive healthcare, driven by the need for precise diagnostic tools and personalized treatment strategies. This rapid advancement, however, necessitates the parallel development of a robust regulatory framework to ensure SaMDs are transparent and deliver universal clinical benefits without the introduction of bias or harm. In addition, the discussion highlights the importance of adherence to the FAIR principles for data management-findability, accessibility, interoperability, and reusability. However, enhanced accessibility and interoperability require rigorous protocols to ensure compliance with data protection guidelines and adequate data security, both of which are crucial for effective integration of SaMDs into clinical workflows. In conclusion, while SaMDs hold significant promise for improving patients' outcomes in digestive medicine, their successful integration into clinical workflow depends on rigorous data protection protocols and clinical validation. Future directions include the need for adequate clinical and real-world studies to demonstrate that these devices are safe and well-suited to healthcare settings.

Feasibility and Acceptability of Pediatric Smartphone Lung Auscultation by Parents: Cross-Sectional Study.

Background: The use of a smartphone built-in microphone for auscultation is a feasible alternative to the use of a stethoscope, when applied by physicians. Objective: This cross-sectional study aims to assess the feasibility of this technology when used by parents-the real intended end users. Methods: Physicians recruited 46 children (male: n=33, 72%; age: mean 11.3, SD 3.1 y; children with asthma: n=24, 52%) during medical visits in a pediatric department of a tertiary hospital. Smartphone auscultation using an app was performed at 4 locations (trachea, right anterior chest, and right and left lung bases), first by a physician (recordings: n=297) and later by a parent (recordings: n=344). All recordings (N=641) were classified by 3 annotators for quality and the presence of adventitious sounds. Parents completed a questionnaire to provide feedback on the app, using a Likert scale ranging from 1 ("totally disagree") to 5 ("totally agree"). Results: Most recordings had quality (physicians' recordings: 253/297, 85.2%; parents' recordings: 266/346, 76.9%). The proportions of physicians' recordings (34/253, 13.4%) and parents' recordings (31/266, 11.7%) with adventitious sounds were similar. Parents found the app easy to use (questionnaire: median 5, IQR 5-5) and were willing to use it (questionnaire: median 5, IQR 5-5). Conclusions: Our results show that smartphone auscultation is feasible when performed by parents in the clinical context, but further investigation is needed to test its feasibility in real life.

Multidisciplinary Development and Initial Validation of a Clinical Knowledge Base on Chronic Respiratory Diseases for mHealth Decision Support Systems.

Most mobile health (mHealth) decision support systems currently available for chronic obstructive respiratory diseases (CORDs) are not supported by clinical evidence or lack clinical validation. The development of the knowledge base that will feed the clinical decision support system is a crucial step that involves the collection and systematization of clinical knowledge from relevant scientific sources and its representation in a human-understandable and computer-interpretable way. This work describes the development and initial validation of a clinical knowledge base that can be integrated into mHealth decision support systems developed for patients with CORDs. A multidisciplinary team of health care professionals with clinical experience in respiratory diseases, together with data science and IT professionals, defined a new framework that can be used in other evidence-based systems. The knowledge base development began with a thorough review of the relevant scientific sources (eg, disease guidelines) to identify the recommendations to be implemented in the decision support system based on a consensus process. Recommendations were selected according to predefined inclusion criteria: (1) applicable to individuals with CORDs or to prevent CORDs, (2) directed toward patient self-management, (3) targeting adults, and (4) within the scope of the knowledge domains and subdomains defined. Then, the selected recommendations were prioritized according to (1) a harmonized level of evidence (reconciled from different sources); (2) the scope of the source document (international was preferred); (3) the entity that issued the source document; (4) the operability of the recommendation; and (5) health care professionals' perceptions of the relevance, potential impact, and reach of the recommendation. A total of 358 recommendations were selected. Next, the variables required to trigger those recommendations were defined (n=116) and operationalized into logical rules using Boolean logical operators (n=405). Finally, the knowledge base was implemented in an intelligent individualized coaching component and pretested with an asthma use case. Initial validation of the knowledge base was conducted internally using data from a population-based observational study of individuals with or without asthma or rhinitis. External validation of the appropriateness of the recommendations with the highest priority level was conducted independently by 4 physicians. In addition, a strategy for knowledge base updates, including an easy-to-use rules editor, was defined. Using this process, based on consensus and iterative improvement, we developed and conducted preliminary validation of a clinical knowledge base for CORDs that translates disease guidelines into personalized patient recommendations. The knowledge base can be used as part of mHealth decision support systems. This process could be replicated in other clinical areas.

Symptoms of anxiety and depression in patients with persistent asthma: a cross-sectional analysis of the INSPIRERS studies.

OBJECTIVES: Anxiety and depression are relevant comorbidities in asthma, but, in Portugal and Spain, data on this topic are scarce. We assessed, in patients with asthma, the frequency of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) and the European Quality of Life Five Dimension Questionnaire (EQ-5D); the level of agreement between these questionnaires, and the factors associated with these symptoms. METHODS: This is a secondary analysis of the INSPIRERS studies. A total of 614 adolescents and adults with persistent asthma (32.6±16.9 years, 64.7% female) were recruited from 30 primary care centres and 32 allergy, pulmonology and paediatric clinics. Demographic and clinical characteristics, HADS and EQ-5D were collected. A score ≥8 on Hospital Anxiety and Depression Scale-Anxiety/Hospital Anxiety and Depression Scale-Depression or a positive answer to EQ-5D item 5 indicated the presence of these symptoms. Agreement was determined by Cohen's kappa. Two multivariable logistic regressions were built. RESULTS: According to HADS, 36% of the participants had symptoms of anxiety and 12% of depression. According to EQ-5D, 36% of the participants had anxiety/depression. The agreement between questionnaires in identifying anxiety/depression was moderate (k=0.55, 95% CI 0.48 to 0.62). Late asthma diagnosis, comorbidities and female gender were predictors of anxiety/depression, while better asthma control, health-related quality of life and perception of health were associated with lower odds for anxiety/depression. CONCLUSION: At least 1/3 of the patients with persistent asthma experience symptoms of anxiety/depression, showing the relevance of screening these disorders in patients with asthma. EQ-5D and HADS questionnaires showed a moderate agreement in the identification of anxiety/depression symptoms. The identified associated factors need to be further investigated in long-term studies.

Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study.

BACKGROUND: Validated questionnaires are used to assess asthma control over the past 1-4 weeks from reporting. However, they do not adequately capture asthma control in patients with fluctuating symptoms. Using the Mobile Airways Sentinel Network for airway diseases (MASK-air) app, we developed and validated an electronic daily asthma control score (e-DASTHMA). METHODS: We used MASK-air data (freely available to users in 27 countries) to develop and assess different daily control scores for asthma. Data-driven control scores were developed based on asthma symptoms reported by a visual analogue scale (VAS) and self-reported asthma medication use. We included the daily monitoring data from all MASK-air users aged 16-90 years (or older than 13 years to 90 years in countries with a lower age of digital consent) who had used the app in at least 3 different calendar months and had reported at least 1 day of asthma medication use. For each score, we assessed construct validity, test-retest reliability, responsiveness, and accuracy. We used VASs on dyspnoea and work disturbance, EQ-5D-VAS, Control of Allergic Rhinitis and Asthma Test (CARAT), CARAT asthma, and Work Productivity and Activity Impairment: Allergy Specific (WPAI:AS) questionnaires as comparators. We performed an internal validation using MASK-air data from Jan 1 to Oct 12, 2022, and an external validation using a cohort of patients with physician-diagnosed asthma (the INSPIRERS cohort) who had had their diagnosis and control (Global Initiative for Asthma [GINA] classification) of asthma ascertained by a physician. FINDINGS: We studied 135 635 days of MASK-air data from 1662 users from May 21, 2015, to Dec 31, 2021. The scores were strongly correlated with VAS dyspnoea (Spearman correlation coefficient range 0·68-0·82) and moderately correlated with work comparators and quality-of-life-related comparators (for WPAI:AS work, we observed Spearman correlation coefficients of 0·59-0·68). They also displayed high test-retest reliability (intraclass correlation coefficients range 0·79-0·95) and moderate-to-high responsiveness (correlation coefficient range 0·69-0·79; effect size measures range 0·57-0·99 in the comparison with VAS dyspnoea). The best-performing score displayed a strong correlation with the effect of asthma on work and school activities in the INSPIRERS cohort (Spearman correlation coefficients 0·70; 95% CI 0·61-0·78) and good accuracy for the identification of patients with uncontrolled or partly controlled asthma according to GINA (area under the receiver operating curve 0·73; 95% CI 0·68-0·78). INTERPRETATION: e-DASTHMA is a good tool for the daily assessment of asthma control. This tool can be used as an endpoint in clinical trials as well as in clinical practice to assess fluctuations in asthma control and guide treatment optimisation. FUNDING: None.

Measuring adherence to inhaled control medication in patients with asthma: Comparison among an asthma app, patient self-report and physician assessment.

BACKGROUND: Previous studies have demonstrated the feasibility of using an asthma app to support medication management and adherence but failed to compare with other measures currently used in clinical practice. However, in a clinical setting, any additional adherence measurement must be evaluated in the context of both the patient and physician perspectives so that it can also help improve the process of shared decision making. Thus, we aimed to compare different measures of adherence to asthma control inhalers in clinical practice, namely through an app, patient self-report and physician assessment. METHODS: This study is a secondary analysis of three prospective multicentre observational studies with patients (≥13 years old) with persistent asthma recruited from 61 primary and secondary care centres in Portugal. Patients were invited to use the InspirerMundi app and register their inhaled medication. Adherence was measured by the app as the number of doses taken divided by the number of doses scheduled each day and two time points were considered for analysis: 1-week and 1-month. At baseline, patients and physicians independently assessed adherence to asthma control inhalers during the previous week using a Visual Analogue Scale (VAS 0-100). RESULTS: A total of 193 patients (72% female; median [P25-P75] age 28 [19-41] years old) were included in the analysis. Adherence measured by the app was lower (1 week: 31 [0-71]%; 1 month: 18 [0-48]%) than patient self-report (80 [60-95]) and physician assessment (82 [51-94]) (p < 0.001). A negligible non-significant correlation was found between the app and subjective measurements (ρ 0.118-0.156, p > 0.05). There was a moderate correlation between patient self-report and physician assessment (ρ = 0.596, p < 0.001). CONCLUSIONS: Adherence measured by the app was lower than that reported by the patient or the physician. This was expected as objective measurements are commonly lower than subjective evaluations, which tend to overestimate adherence. Nevertheless, the low adherence measured by the app may also be influenced by the use of the app itself and this needs to be considered in future studies.

Patients' Satisfaction with Remote Asthma Medical Follow-Up Before and During the COVID-19 Pandemic.

Background: The COVID-19 pandemic forced the change of health care services, favoring the use of remote consultations. Objective: To assess the differences in asthma medical follow-up before and during the COVID-19 pandemic and to evaluate patients' satisfaction regarding remote consultations. Methods: A cross-sectional, observational, web-based study, including 335 Portuguese patients with self-reported physician-diagnosed asthma, was conducted. The survey was available between February and May 2021 and included questions about patients' sociodemographic and clinical characteristics and follow-up (consultations' type and satisfaction in 2019 and 2020). Satisfaction was assessed using 10 statements on different aspects of patient experience (Likert scale 1-5), with a total score between 10 and 50. Results: The 335 patients included had a median [P25-P75] age of 27 [21-43] years and 75% had uncontrolled asthma. Overall, fewer participants had consultations during the pandemic compared to 2019 (161 vs. 185; p < 0.001). Most patients had ≥1 face-to-face consultation both in 2020 and 2019 (131 vs. 184; p < 0.001). In 2020, there was an increase in the proportion of participants reporting ≥1 remote (telephonic plus video) consultation (40% vs. 3%; p < 0.001). This increase was mainly attributed to the use of telephonic consultation (38% vs. video 3%, p < 0.001). Patients' satisfaction was similar in 2020 and 2019 for face-to-face consultations (44 [38-47] and 44 [39-48], p = 0.136). In 2020, satisfaction with remote consultations was slightly lower than with face-to-face (43 [37-46] vs. 44 [38-47], p < 0.001). Conclusions: Even though patients were slightly more satisfied with face-to-face consultations, remote consultations can be an alternative in follow-up services for patients with asthma in the near future.

Development and Validation of a Digital Image Processing-Based Pill Detection Tool for an Oral Medication Self-Monitoring System.

Long-term adherence to medication is of critical importance for the successful management of chronic diseases. Objective tools to track oral medication adherence are either lacking, expensive, difficult to access, or require additional equipment. To improve medication adherence, cheap and easily accessible objective tools able to track compliance levels are necessary. A tool to monitor pill intake that can be implemented in mobile health solutions without the need for additional devices was developed. We propose a pill intake detection tool that uses digital image processing to analyze images of a blister to detect the presence of pills. The tool uses the Circular Hough Transform as a feature extraction technique and is therefore primarily useful for the detection of pills with a round shape. This pill detection tool is composed of two steps. First, the registration of a full blister and storing of reference values in a local database. Second, the detection and classification of taken and remaining pills in similar blisters, to determine the actual number of untaken pills. In the registration of round pills in full blisters, 100% of pills in gray blisters or blisters with a transparent cover were successfully detected. In the counting of untaken pills in partially opened blisters, 95.2% of remaining and 95.1% of taken pills were detected in gray blisters, while 88.2% of remaining and 80.8% of taken pills were detected in blisters with a transparent cover. The proposed tool provides promising results for the detection of round pills. However, the classification of taken and remaining pills needs to be further improved, in particular for the detection of pills with non-oval shapes.

What Do Physicians Think About the Use of Telemedicine to Recruit and Assess Participants in mHealth-Related Clinical Studies as a Consequence of the COVID-19 Pandemic?

Objectives: To evaluate physician's opinion and availability to participate in mHealth-related clinical studies with patient recruitment and assessment via telemedicine and to identify characteristics associated with the willingness to participate. Methods: Cross-sectional, observational study, based on an anonymous web survey conducted in May-Jun of 2020 to 237 physicians, from Portugal and Spain that collaborated with an asthma mHealth project (INSPIRERS). Results: Response rate was 51% (n = 120). Most (74%, n = 89) physicians were available to participate in such studies, but 62% anticipated lower recruiting capacity and 40% increased difficulty in obtaining quality data. Physicians aged ≤40 years, from secondary care (vs. general practitioners) and that used apps in personal life or clinical practice were more likely to be available. Conclusions: Three-quarters of the physicians were available to participate in mHealth-related clinical studies with patient recruitment and assessment through telemedicine. Age group, medical specialty, and app use were associated with the willingness to participate.

Development and validation of combined symptom-medication scores for allergic rhinitis.

BACKGROUND: Validated combined symptom-medication scores (CSMSs) are needed to investigate the effects of allergic rhinitis treatments. This study aimed to use real-life data from the MASK-air® app to generate and validate hypothesis- and data-driven CSMSs. METHODS: We used MASK-air® data to assess the concurrent validity, test-retest reliability and responsiveness of one hypothesis-driven CSMS (modified CSMS: mCSMS), one mixed hypothesis- and data-driven score (mixed score), and several data-driven CSMSs. The latter were generated with MASK-air® data following cluster analysis and regression models or factor analysis. These CSMSs were compared with scales measuring (i) the impact of rhinitis on work productivity (visual analogue scale [VAS] of work of MASK-air® , and Work Productivity and Activity Impairment: Allergy Specific [WPAI-AS]), (ii) quality-of-life (EQ-5D VAS) and (iii) control of allergic diseases (Control of Allergic Rhinitis and Asthma Test [CARAT]). RESULTS: We assessed 317,176 days of MASK-air® use from 17,780 users aged 16-90 years, in 25 countries. The mCSMS and the factor analyses-based CSMSs displayed poorer validity and responsiveness compared to the remaining CSMSs. The latter displayed moderate-to-strong correlations with the tested comparators, high test-retest reliability and moderate-to-large responsiveness. Among data-driven CSMSs, a better performance was observed for cluster analyses-based CSMSs. High accuracy (capacity of discriminating different levels of rhinitis control) was observed for the latter (AUC-ROC = 0.904) and for the mixed CSMS (AUC-ROC = 0.820). CONCLUSION: The mixed CSMS and the cluster-based CSMSs presented medium-high validity, reliability and accuracy, rendering them as candidates for primary endpoints in future rhinitis trials.

Determinants of the Use of Health and Fitness Mobile Apps by Patients With Asthma: Secondary Analysis of Observational Studies.

BACKGROUND: Health and fitness apps have potential benefits to improve self-management and disease control among patients with asthma. However, inconsistent use rates have been reported across studies, regions, and health systems. A better understanding of the characteristics of users and nonusers is critical to design solutions that are effectively integrated in patients' daily lives, and to ensure that these equitably reach out to different groups of patients, thus improving rather than entrenching health inequities. OBJECTIVE: This study aimed to evaluate the use of general health and fitness apps by patients with asthma and to identify determinants of usage. METHODS: A secondary analysis of the INSPIRERS observational studies was conducted using data from face-to-face visits. Patients with a diagnosis of asthma were included between November 2017 and August 2020. Individual-level data were collected, including age, gender, marital status, educational level, health status, presence of anxiety and depression, postcode, socioeconomic level, digital literacy, use of health services, and use of health and fitness apps. Multivariate logistic regression was used to model the probability of being a health and fitness app user. Statistical analysis was performed in R. RESULTS: A total of 526 patients attended a face-to-face visit in the 49 recruiting centers and 514 had complete data. Most participants were ≤40 years old (66.4%), had at least 10 years of education (57.4%), and were in the 3 higher quintiles of the socioeconomic deprivation index (70.1%). The majority reported an overall good health status (visual analogue scale [VAS] score>70 in 93.1%) and the prevalence of anxiety and depression was 34.3% and 11.9%, respectively. The proportion of participants who reported using health and fitness mobile apps was 41.1% (n=211). Multivariate models revealed that single individuals and those with more than 10 years of education are more likely to use health and fitness mobile apps (adjusted odds ratio [aOR] 2.22, 95%CI 1.05-4.75 and aOR 1.95, 95%CI 1.12-3.45, respectively). Higher digital literacy scores were also associated with higher odds of being a user of health and fitness apps, with participants in the second, third, and fourth quartiles reporting aORs of 6.74 (95%CI 2.90-17.40), 10.30 (95%CI 4.28-27.56), and 11.52 (95%CI 4.78-30.87), respectively. Participants with depression symptoms had lower odds of using health and fitness apps (aOR 0.32, 95%CI 0.12-0.83). CONCLUSIONS: A better understanding of the barriers and enhancers of app use among patients with lower education, lower digital literacy, or depressive symptoms is key to design tailored interventions to ensure a sustained and equitable use of these technologies. Future studies should also assess users' general health-seeking behavior and their interest and concerns specifically about digital tools. These factors may impact both initial engagement and sustained use.

Lung Auscultation Using the Smartphone-Feasibility Study in Real-World Clinical Practice.

Conventional lung auscultation is essential in the management of respiratory diseases. However, detecting adventitious sounds outside medical facilities remains challenging. We assessed the feasibility of lung auscultation using the smartphone built-in microphone in real-world clinical practice. We recruited 134 patients (median[interquartile range] 16[11-22.25]y; 54% male; 31% cystic fibrosis, 29% other respiratory diseases, 28% asthma; 12% no respiratory diseases) at the Pediatrics and Pulmonology departments of a tertiary hospital. First, clinicians performed conventional auscultation with analog stethoscopes at 4 locations (trachea, right anterior chest, right and left lung bases), and documented any adventitious sounds. Then, smartphone auscultation was recorded twice in the same four locations. The recordings (n = 1060) were classified by two annotators. Seventy-three percent of recordings had quality (obtained in 92% of the participants), with the quality proportion being higher at the trachea (82%) and in the children's group (75%). Adventitious sounds were present in only 35% of the participants and 14% of the recordings, which may have contributed to the fair agreement between conventional and smartphone auscultation (85%; k = 0.35(95% CI 0.26-0.44)). Our results show that smartphone auscultation was feasible, but further investigation is required to improve its agreement with conventional auscultation.

Feasibility and Acceptability of an Asthma App to Monitor Medication Adherence: Mixed Methods Study.

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.

InspirerMundi-Remote Monitoring of Inhaled Medication Adherence through Objective Verification Based on Combined Image Processing Techniques.

BACKGROUND: The adherence to inhaled controller medications is of critical importance for achieving good clinical results in patients with chronic respiratory diseases. Self-management strategies can result in improved health outcomes and reduce unscheduled care and improve disease control. However, adherence assessment suffers from difficulties on attaining a high grade of trustworthiness given that patient self-reports of high-adherence rates are known to be unreliable. OBJECTIVE: Aiming to increase patient adherence to medication and allow for remote monitoring by health professionals, a mobile gamified application was developed where a therapeutic plan provides insight for creating a patient-oriented self-management system. To allow a reliable adherence measurement, the application includes a novel approach for objective verification of inhaler usage based on real-time video capture of the inhaler's dosage counters. METHODS: This approach uses template matching image processing techniques, an off-the-shelf machine learning framework, and was developed to be reusable within other applications. The proposed approach was validated by 24 participants with a set of 12 inhalers models. RESULTS: Performed tests resulted in the correct value identification for the dosage counter in 79% of the registration events with all inhalers and over 90% for the three most widely used inhalers in Portugal. These results show the potential of exploring mobile-embedded capabilities for acquiring additional evidence regarding inhaler adherence. CONCLUSION: This system helps to bridge the gap between the patient and the health professional. By empowering the first with a tool for disease self-management and medication adherence and providing the later with additional relevant data, it paves the way to a better-informed disease management decision.

Profiling Persistent Asthma Phenotypes in Adolescents: A Longitudinal Diagnostic Evaluation from the INSPIRERS Studies.

We aimed to identify persistent asthma phenotypes among adolescents and to evaluate longitudinally asthma-related outcomes across phenotypes. Adolescents (13-17 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 < 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.

Monitoring Adherence to Asthma Inhalers Using the InspirerMundi App: Analysis of Real-World, Medium-Term Feasibility Studies.

Background: Poor medication adherence is a major challenge in asthma and objective assessment of inhaler adherence is needed. InspirerMundi app aims to monitor inhaler adherence while turning it into a positive experience through gamification and social support. Objective: We assessed the medium-term feasibility of the InspirerMundi app to monitor inhaler adherence in real-world patients with persistent asthma (treated with daily inhaled medication). In addition, we attempted to identify the characteristics of the patients related to higher app use. Methods: Two real-world multicenter observational studies, with one initial face-to-face visit and a 4-month telephone interview, were conducted in 29 secondary care centers from Portugal. During an initial face-to-face visit, patients were invited to use the app daily to register their asthma medication intakes. A scheduled intake was considered taken when patients took a photo of the medication (inhaler, blister, or others) using the image-based medication detection tool. Medication adherence was calculated as the number of doses taken as a percentage of the number scheduled. Interacting with the app ≥30 days was used as the cut-off for higher app use. Results: A total of 114 patients {median 20 [percentile 25 to percentile 75 (P25-P75) 16-36] years, 62% adults} were invited, 107 (94%) installed the app and 83 (73%) completed the 4-month interview. Patients interacted with the app for a median of 18 [3-45] days, translated on a median use rate of 15 [3-38]%. Median inhaler adherence assessed through the app was 34 [4-73]% when considering all scheduled inhalations for the study period. Inhaler adherence assessed was not significantly correlated with self-reported estimates. Median adherence for oral and other medication was 41 [6-83]% and 43 [3-73]%, respectively. Patients with higher app use were slightly older (p = 0.012), more frequently taking medication for other health conditions (p = 0.040), and more frequently prescribed long-acting muscarinic antagonists (LAMA, p = 0.024). After 4 months, Control of Allergic Rhinitis and Asthma Test (CARAT) scores improved (p < 0.001), but no differences between patients interacting with the app for 30 days or less were seen. Conclusions: The InspirerMundi app was feasible to monitor inhaler adherence in patients with persistent asthma. The persistent use of this mHealth technology varies widely. A better understanding of characteristics related to higher app use is still needed before effectiveness studies are undertaken.

Intensive care in non-critical units: representations and practices of novice graduate nurses / El cuidado intensivo en unidades no críticas: representaciones y prácticas de enfermeros recién graduados / O cuidado intensivo em unidades não-críticas: representações e práticas de enfermeiros recém-formados

ABSTRACT Objective: to analyze the practices of novice graduated nurses in view of their social representations on intensive care to the critical patient provided in non-critical patient units. Method: a qualitative research, based on social representations, with 26 novice graduated nurses at a private university in Rio de Janeiro (Brazil). Data collection made between 2016 and 2017 by a semi-structured interview and lexical analysis by Alceste software. Results: the context of the Intensive Care Unit influences social representations, which mobilizes identity aspects of this environment that stereotype the ward as a disorganized place and that does not have material resources and trained professionals. Thus, when novice undergraduates act and despite the effort and dedication fail to transfer the patient, fear and lack of confidence are exacerbated, resulting in actions that can bring risks to the patient. Conclusion: there are stereotypes in relation to the clinic that limit the care actions of the novice undergraduates in relation to the critical patient, and should be re-signified in generalist education. It is recommended to develop follow-up programs for novice graduated nurses.

RESUMEN Objetivo: analizar las prácticas de enfermeros recién graduados sobre la base de sus representaciones sociales acerca del cuidado intensivodel paciente crítico prestado en unidades de pacientes no críticos. Método: investigación cualitativa, pautada en representaciones sociales, con 26 enfermeros recién graduados en una universidad privada de Rio de Janeiro (Brasil). La recolección de datos se realizó entre 2016 y 2017 mediante entrevistas semiestructuradas y análisis del tipo lexical por el software Alceste. Resultados: el contexto de la Unidad de Terapia Intensiva influye sobrelas representaciones sociales, y crea aspectos identitarios de este ambiente que marcan un estereotipo y estigmatizan a la enfermería como un lugar desorganizado que no dispone de recursos materiales ni de profesionales capacitados. En ese contexto, cuando actúan los recién graduados, y, a pesar de su esfuerzo y dedicación, no logran trasladar al paciente, se exacerban el miedo y la falta de confianza, que resultan en acciones que pueden implicar riesgos para el paciente. Conclusión: hay estereotipos en relación a la clínica que limitan los cuidados que el recién graduado presta al paciente crítico y que deben ser resignificados en la formación de grado. Se recomienda desarrollar programas de acompañamiento de enfermeros recién graduados.

RESUMO Objetivo: analisar as práticas de enfermeiros recém-formados em face das suas representações sociais sobre o cuidado intensivo ao paciente crítico prestado em unidades de pacientes não-críticos. Método: pesquisa qualitativa, pautada nas representações sociais, com 26 enfermeiros recém-formados em uma universidade privada do Rio de Janeiro (Brasil). Coleta de dados entre 2016 e 2017 por entrevista semiestruturada e análise do tipo lexical pelo software Alceste. Resultados: o contexto da Unidade de Terapia Intensiva influencia as representações sociais, o que mobiliza aspectos identitários deste ambiente que estereotipam a enfermaria como um local desorganizado e que não dispõe de recursos materiais e de profissionais capacitados. Com isso, quando os recém-formados agem e apesar do esforço e dedicação não conseguem transferir o paciente, exacerbam-se o medo e falta de confiança, resultando em ações que podem trazer riscos ao paciente. Conclusão: há estereótipos em relação à clínica que limitam as ações de cuidado do recém-formado frente ao paciente crítico, devendo ser resignificados na formação generalista. Recomenda-se desenvolver programas de acompanhamento dos enfermeiros recém-formados.

Patient-physician discordance in assessment of adherence to inhaled controller medication: a cross-sectional analysis of two cohorts.

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<0.001). Discordance occurred in 56% of cases: in 28% physicians overestimated adherence and in 27% underestimated. Low adherence as assessed by the physician (OR=27.35 (9.85 to 75.95)), FEV1 ≥80% (OR=2.59 (1.08 to 6.20)) and a first appointment (OR=5.63 (1.24 to 25.56)) were predictors of underestimation. An uncontrolled asthma (OR=2.33 (1.25 to 4.34)), uncontrolled upper airway disease (OR=2.86 (1.35 to 6.04)) and prescription of short-acting beta-agonists alone (OR=3.05 (1.15 to 8.08)) were associated with overestimation. Medium adherence as assessed by the physician was significantly associated with higher risk of discordance, both for overestimation and underestimation of adherence (OR=14.50 (6.04 to 34.81); OR=2.21 (1.07 to 4.58)), while having a written action plan decreased the likelihood of discordance (OR=0.25 (0.12 to 0.52); OR=0.41 (0.22 to 0.78)) (R2=44%). CONCLUSION: Although both patients and physicians report high inhaler adherence, discordance occurred in half of cases. Implementation of objective adherence measures and effective communication are needed to improve patient-physician agreement.

High oral corticosteroid exposure and overuse of short-acting beta-2-agonists were associated with insufficient prescribing of controller medication: a nationwide electronic prescribing and dispensing database analysis.

BACKGROUND: Recurrent use of oral corticosteroids (OCS) and over-use of short-acting beta-2-agonists (SABA) are factors associated with adverse side effects and asthma-related death. We aim to quantify high OCS exposure, SABA over-use and its association with prescription and adherence to maintenance treatment for respiratory disease, among patients with prescriptions for respiratory disease, from the Portuguese electronic prescription and dispensing database (BDNP). METHODS: This was a 1-year (2016) retrospective population-based analysis of a random sample of adult patients from the BDNP, the nationwide compulsory medication prescription system. We assessed high OCS exposure (dispensing ≥ 4 packages containing 20 doses of 20 mg each of prednisolone-equivalent, ≥ 1600 mg/year) on patients on persistent respiratory treatment (PRT-prescription for > 2 packages of any respiratory maintenance medications). Excessive use of SABA was defined as having a ratio of SABA-to-maintenance treatment > 1 or having SABA over-use (dispensing of > 1 × 200 dose canister/month, of 100 µg of salbutamol-equivalent). Factors associated with high OCS exposure were assessed by multinomial logistic regression. RESULTS: The estimated number of patients on PRT was 4786/100,000 patients. OCS was prescribed to more than 1/5 of the patients on PRT and 101/100,000 were exposed to a high-dose (≥ 1600 mg/year). SABA excessive use was found in 144/100,000 patients and SABA over-use in 24/100,000. About 1/6 of SABA over-users were not prescribed any controller medication and 7% of them had a ratio maintenance-to-total ≥ 70% (high prescription of maintenance treatment). Primary adherence (median%) to controller medication was 66.7% for PRT patients, 59.6% for patients exposed to high OCS dose and 75.0% for SABA over-users. High OCS exposure or SABA over-use were not associated with primary adherence. High OCS exposure was associated with a maintenance-to-total medication ratio < 70% (insufficient prescription of maintenance treatment), age > 45 years old and male sex. CONCLUSIONS: Exposure to high-dose of OCS (101 per 100,000 patients) and SABA over-use (24 per 100,000) were frequent, and were associated with a low maintenance-to-total prescription ratio but not with primary non-adherence. These results suggest there is a need for initiatives to reduce OCS and SABA inappropriate prescribing.

Newly undergraduate nurses and intensive care in units of non-critical patients.

OBJECTIVE: To identify the social representations of newly undergraduate nurses on the intensive care of Nursing to critical patients hospitalized in non-critical patient units. METHOD: Qualitative and descriptive research. Twenty-six newly undergraduate nurses from a private university participated. An in-depth interview was conducted with semi-structured script. The analysis was of lexical type with the help of Alceste 2012 software. RESULTS: The social representations were built according to the image of the intensive care unit, although patients were out of this environment. Care is understood as complex and specialized, requiring graduate training. Therefore, undergraduation training was considered insufficient to provide this type of care, creating fear and insecurity in the newly undergraduate nurses. FINAL CONSIDERATIONS: Intensive care confronts newly undergraduate nurses with feelings of unpreparedness to care for, but it mobilizes to broaden the knowledge to provide care. There is evidence of a theory-practice dichotomy and weaknesses in teaching-learning experiences in undergraduate education.