Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial.

INTRODUCTION: Treatment with LABA/LAMA is recommended in GOLD B patients. We hypothesized that triple therapy (LABA/LAMA/ICS) will be superior to LABA/LAMA in achieving and maintaining clinical control (CC), a composite outcome that considers both impact and disease stability in a subgroup of GOLD B patients (here termed GOLD B+ patients) characterized by: (1) remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/µL. METHODS: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92µg/umeclidinium (UMEC) 55µg/vilanterol (VI) 22µg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia. RESULTS: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026. CONCLUSIONS: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.

[Home Respiratory Therapies: SEPAR Technical Document for Institutional Decision Support]. / Terapias respiratorias domiciliarias: documento técnico de la Sociedad Española de Neumología y Cirugía Torácica (SEPAR) de apoyo institucional a la toma de decisiones.

Home Respiratory Therapies (HRT) encompass a variety of treatments for patients with chronic respiratory diseases, administered at home over extended periods. The Service Providers of HRT (SPHRT) collaborate with hospital resources to address chronic respiratory diseases, acting as strategic partners. The contracting of HRT in the public health system involves contests where the SPHRT present technical and economic offers. The purpose of this document is to provide a technical basis that can assist professionals, SPHRT, and the administration in making decisions when calling for, evaluating, and deciding on such contests.

Proposal and Definition of an Intelligent Clinical Decision Support System Applied to the Prediction of Dyspnea after 12 Months of an Acute Episode of COVID-19.

Long COVID is a condition that affects a significant proportion of patients who have had COVID-19. It is characterised by the persistence of associated symptoms after the acute phase of the illness has subsided. Although several studies have investigated the risk factors associated with long COVID, identifying which patients will experience long-term symptoms remains a complex task. Among the various symptoms, dyspnea is one of the most prominent due to its close association with the respiratory nature of COVID-19 and its disabling consequences. This work proposes a new intelligent clinical decision support system to predict dyspnea 12 months after a severe episode of COVID-19 based on the SeguiCovid database from the Álvaro Cunqueiro Hospital in Vigo (Galicia, Spain). The database is initially processed using a CART-type decision tree to identify the variables with the highest predictive power. Based on these variables, a cascade of expert systems has been defined with Mamdani-type fuzzy-inference engines. The rules for each system were generated using the Wang-Mendel automatic rule generation algorithm. At the output of the cascade, a risk indicator is obtained, which allows for the categorisation of patients into two groups: those with dyspnea and those without dyspnea at 12 months. This simplifies follow-up and the performance of studies aimed at those patients at risk. The system has produced satisfactory results in initial tests, supported by an AUC of 0.75, demonstrating the potential and usefulness of this tool in clinical practice.

Chronic Obstructive Lung Disease: Treatment Guidelines and Recommendations for Referral and Multidisciplinary Continuity of Care.

Chronic Obstructive Pulmonary Disease (COPD) constitutes a major public health problem, and it is anticipated that its prevalence will continue to increase in the future. Its progressive nature requires a continuous and well-coordinated care approach. The follow-up for COPD should primarily focus on disease screening and control, which includes monitoring of pulmonary function, prevention of exacerbations, identification of aggravating factors and comorbidities, as well as ensuring treatment adequacy and adherence. However, existing clinical practice guidelines and consensus documents offer limited recommendations for the follow-up. In this context, we undertake a review of COPD treatment and the continuity of care recommendations endorsed by several scientific societies. Moreover, we underscore the importance of the involvement of nursing and community pharmacy in this process, as well as the utilization of quality indicators in the provision of care for the disease.

Tobacco Patterns and Risk of Chronic Obstructive Pulmonary Disease: Results From a Cross-Sectional Study

Introduction: There is still uncertainty about which aspects of cigarette smoking influence the risk of Chronic Obstructive Pulmonary Disease (COPD). The aim of this study was to estimate the COPD risk as related to duration of use, intensity of use, lifetime tobacco consumption, age of smoking initiation and years of abstinence. Methods: We conducted an analytical cross-sectional study based on data from the EPISCAN-II study (n=9092). All participants underwent a face-to-face interview and post-bronchodilator spirometry was performed. COPD was defined as post-bronchodilator FEV1/FVC<70%. Parametric and nonparametric logistic regression models with generalized additive models were used. Results: 8819 persons were included; 858 with COPD and 7961 without COPD. The COPD risk increased with smoking duration up to ≥50 years [OR 3.5 (95% CI: 2.3–5.4)], with smoking intensity up to ≥39cig/day [OR 10.1 (95% CI: 5.3–18.4)] and with lifetime tobacco consumption up to >29 pack-years [OR 3.8 (95% CI: 3.1–4.8)]. The COPD risk for those who started smoking at 22 or later was 0.9 (95% CI: 0.6–1.4). The risk of COPD decreased with increasing years of cessation. In comparison with both never smokers and current smokers, the lowest risk of COPD was found after 15–25 years of abstinence. Conclusion: COPD risk increases with duration, intensity, and lifetime tobacco consumption and decreases importantly with years of abstinence. Age at smoking initiation shows no effect. After 15–25 years of cessation, COPD risk could be equal to that of a never smoker. This work suggests that the time it takes to develop COPD in a smoker is about 30 years. (AU)

The impact of the SARS-CoV-2 pandemic on the demographic, clinical and social profiles of patients admitted to the Pneumology Department for a COPD exacerbation.

INTRODUCTION: Although a reduction in admissions for pathologies other than SARS-CoV-2 has been reported during the pandemic, there are hardly any specific studies in relation to COPD. The objective of this study was to analyse differences in the profile of those admitted for AEPOC and their prognosis during this period. METHODS: Prospective study (SocioEPOC validation cohort) conducted in two hospitals. Demographic, clinical and social characteristics were compared among patients admitted for an AECOPD before and after the declaration of the COVID-19 healthcare emergency. Mortality and the need for hospital care in the following 3 months were analysed. RESULTS: 340 patients (76.6% male, 72 years, FEV1 43.5%) were included, 174 in the post-pandemic phase. During pandemic, especially before population-level vaccination, admissions for AECOPD were in patients with more severe disease and with a higher level of eosinophils. No differences were found in social profile, except they had more informal caregivers. The mortality rate at 90 days was the same (9%), although those admitted during the pandemic came for more hospital visits in the following 3 months (53.8% vs. 42%; p = 0.003), with the pandemic phase being an independent predictor of this possibility (OR = 1.6.; 95% IC = 1.1-2.6). CONCLUSIONS: In the first few months of the pandemic, the clinical profile of patients hospitalised for an AECOPD differed from that both prior to this period and during the latter months of the pandemic, with minimal changes at the social level. Although the mortality rate were similar, unscheduled hospital visits increased during the COVID-19 pandemic.

Is the diagnostic yield of mediastinal lymph node cryobiopsy (cryoEBUS) better for diagnosing mediastinal node involvement compared to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)? A systematic review.

INTRODUCTION: New tools such as cryobiopsy of mediastinal lymph nodes (cryoEBUS) have been described to improve the diagnostic usefulness of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The literature suggests that this novel procedure could be associated with greater diagnostic usefulness than conventional EBUS-TBNA. METHODS: To develop a systematic analysis and meta-analysis on the diagnostic diagnostic yield and safety of cryobiopsy of hilar and mediastinal adenopathies compared to EBUS-TBNA. RESULTS: Seven studies that had included a total of 555 patients were considered in this review, with 365 (65.7%) of these patients having an etiology of malignant lymph node involvement. The overall diagnostic usefulness of cryoEBUS was higher compared to EBUS-TBNA (92% vs. 80%). However, when the results were analysed according to the specific aetiologies of the adenopathies, cryoEBUS was especially useful in cases of lymphomas or non-pulmonary carcinomas (83% vs. 42%) and in cases that were benign (87% vs. 60.1%), with no significant differences being found in specific cases of lung cancer. For lymphoma, cryoEBUS was diagnostic in 87% of cases compared to 12% for EBUS-TBNA and in addition, also allowed the characterisation of every lymphoma subtype. Genetic studies and immunohistochemical determination of PD-L1 was possible in almost all (97%) of the samples obtained by cryoEBUS, while this was only possible in 79% of those obtained by EBUS-TBNA. The most frequent complication was light bleeding, which was described in up to 85% of cases in some series. CONCLUSION: CryoEBUS could represent a promising technique in the diagnostic algorithm used for mediastinal and hilar involvement. Although cryoEBUS did not significantly improve the diagnosis of lung cancer compared to EBUS-TBNA, the results were significantly better in patients with benign pathologies and other tumour types, including lymphomas. In addition, it seems that the samples obtained by cryoEBUS better defined the histological subtypes of lymphoma and allowed complete molecular characterisation in cases of lung cancer. The technique has proven to be safe and no serious complications were described after the procedure.

Tobacco Patterns and Risk of Chronic Obstructive Pulmonary Disease: Results From a Cross-Sectional Study.

INTRODUCTION: There is still uncertainty about which aspects of cigarette smoking influence the risk of Chronic Obstructive Pulmonary Disease (COPD). The aim of this study was to estimate the COPD risk as related to duration of use, intensity of use, lifetime tobacco consumption, age of smoking initiation and years of abstinence. METHODS: We conducted an analytical cross-sectional study based on data from the EPISCAN-II study (n=9092). All participants underwent a face-to-face interview and post-bronchodilator spirometry was performed. COPD was defined as post-bronchodilator FEV1/FVC<70%. Parametric and nonparametric logistic regression models with generalized additive models were used. RESULTS: 8819 persons were included; 858 with COPD and 7961 without COPD. The COPD risk increased with smoking duration up to ≥50 years [OR 3.5 (95% CI: 2.3-5.4)], with smoking intensity up to ≥39cig/day [OR 10.1 (95% CI: 5.3-18.4)] and with lifetime tobacco consumption up to >29 pack-years [OR 3.8 (95% CI: 3.1-4.8)]. The COPD risk for those who started smoking at 22 or later was 0.9 (95% CI: 0.6-1.4). The risk of COPD decreased with increasing years of cessation. In comparison with both never smokers and current smokers, the lowest risk of COPD was found after 15-25 years of abstinence. CONCLUSION: COPD risk increases with duration, intensity, and lifetime tobacco consumption and decreases importantly with years of abstinence. Age at smoking initiation shows no effect. After 15-25 years of cessation, COPD risk could be equal to that of a never smoker. This work suggests that the time it takes to develop COPD in a smoker is about 30 years.

Design of an Intelligent Decision Support System Applied to the Diagnosis of Obstructive Sleep Apnea.

Obstructive sleep apnea (OSA), characterized by recurrent episodes of partial or total obstruction of the upper airway during sleep, is currently one of the respiratory pathologies with the highest incidence worldwide. This situation has led to an increase in the demand for medical appointments and specific diagnostic studies, resulting in long waiting lists, with all the health consequences that this entails for the affected patients. In this context, this paper proposes the design and development of a novel intelligent decision support system applied to the diagnosis of OSA, aiming to identify patients suspected of suffering from the pathology. For this purpose, two sets of heterogeneous information are considered. The first one includes objective data related to the patient's health profile, with information usually available in electronic health records (anthropometric information, habits, diagnosed conditions and prescribed treatments). The second type includes subjective data related to the specific OSA symptomatology reported by the patient in a specific interview. For the processing of this information, a machine-learning classification algorithm and a set of fuzzy expert systems arranged in cascade are used, obtaining, as a result, two indicators related to the risk of suffering from the disease. Subsequently, by interpreting both risk indicators, it will be possible to determine the severity of the patients' condition and to generate alerts. For the initial tests, a software artifact was built using a dataset with 4400 patients from the Álvaro Cunqueiro Hospital (Vigo, Galicia, Spain). The preliminary results obtained are promising and demonstrate the potential usefulness of this type of tool in the diagnosis of OSA.

Multicentre study on the accuracy of lung ultrasound in the diagnosis and monitoring of respiratory sequelae in the medium and long term in patients with COVID-19.

Introduction: Lung ultrasound (LUS) has proven to be a more sensitive tool than radiography (X-ray) to detect alveolar-interstitial involvement in COVID-19 pneumonia. However, its usefulness in the detection of possible pulmonary alterations after overcoming the acute phase of COVID-19 is unknown. In this study we proposed studying the utility of LUS in the medium- and long-term follow-up of a cohort of patients hospitalized with COVID-19 pneumonia. Materials and methods: This was a prospective, multicentre study that included patients, aged over 18 years, at 3 ± 1 and 12 ± 1 months after discharge after treatment for COVID-19 pneumonia. Demographic variables, the disease severity, and analytical, radiographic, and functional clinical details were collected. LUS was performed at each visit and 14 areas were evaluated and classified with a scoring system whose global sum was referred to as the "lung score." Two-dimensional shear wave elastography (2D-SWE) was performed in 2 anterior areas and in 2 posterior areas in a subgroup of patients. The results were compared with high-resolution computed tomography (CT) images reported by an expert radiologist. Results: A total of 233 patients were included, of whom 76 (32.6%) required Intensive Care Unit (ICU) admission; 58 (24.9%) of them were intubated and non-invasive respiratory support was also necessary in 58 cases (24.9%). Compared with the results from CT images, when performed in the medium term, LUS showed a sensitivity (S) of 89.7%, specificity (E) 50%, and an area under the curve (AUC) of 78.8%, while the diagnostic usefulness of X-ray showed an S of 78% and E of 47%. Most of the patients improved in the long-term evaluation, with LUS showing an efficacy with an S of 76% and E of 74%, while the X-ray presented an S of 71% and E of 50%. 2D-SWE data were available in 108 (61.7%) patients, in whom we found a non-significant tendency toward the presentation of a higher shear wave velocity among those who developed interstitial alterations, with a median kPa of 22.76 ± 15.49) versus 19.45 ± 11.39; p = 0.1). Conclusion: Lung ultrasound could be implemented as a first-line procedure in the evaluation of interstitial lung sequelae after COVID-19 pneumonia.

Occupation as a risk factor of small cell lung cancer.

Small cell lung cancer (SCLC) comprises approximately 10% of all lung cancer cases. Tobacco is its main risk factor; however, occupation might play a role in this specific lung cancer subtype. The effect of occupation on SCLC risk has been hardly studied and therefore we aim to assess the role of occupation on the risk of SCLC. To do this, we designed a multicentric, hospital-based, case-control study. Cases consisted exclusively in SCLC patients and controls were recruited from patients having minor surgery at the participating hospitals. Face to face interviews emphasizing occupation and tobacco consumption were held and residential radon was also measured. Logistic regression models were adjusted with odds ratios with 95%CI as estimations of the effect. 423 cases and 905 controls were included. Smoking prevalence was higher in cases compared to controls. Those who worked in known-risk occupations for lung cancer showed an OR of 2.17 (95%CI 1.33; 3.52), with a similar risk when men were analysed separately. The results were adjusted by age, sex, smoking and indoor radon exposure. Those who worked in known-risk occupations and were moderate or heavy smokers had a SCLC risk of 12.19 (95%CI 5.68-26.38) compared with never or moderate smokers who had not worked in such occupations. Occupation is a relevant risk factor of SCLC, and it seems that its effect is boosted when tobacco smoking is present.

Evolution and long­term respiratory sequelae after severe COVID-19 pneumonia: nitric oxide diffusion measurement value.

INTRODUCTION: There are no published studies assessing the evolution of combined determination of the lung diffusing capacity for both nitric oxide and carbon monoxide (DLNO and DLCO) 12 months after the discharge of patients with COVID-19 pneumonia. METHODS: Prospective cohort study which included patients who were assessed both 3 and 12 months after an episode of SARS-CoV-2 pneumonia. Their clinical status, health condition, lung function testings (LFTs) results (spirometry, DLNO-DLCO analysis, and six-minute walk test), and chest X-ray/computed tomography scan images were compared. RESULTS: 194 patients, age 62 years (P25-75, 51.5-71), 59% men, completed the study. 17% required admission to the intensive care unit. An improvement in the patients' exercise tolerance, the extent of the areas of ground-glass opacity, and the LFTs between 3 and 12 months following their hospital discharge were found, but without a decrease in their degree of dyspnea or their self-perceived health condition. DLNO was the most significantly altered parameter at 12 months (19.3%). The improvement in DLNO-DLCO mainly occurred at the expense of the recovery of alveolar units and their vascular component, with the membrane factor only improving in patients with more severe infections. CONCLUSIONS: The combined measurement of DLNO-DLCO is the most sensitive LFT for the detection of the long-term sequelae of COVID-19 pneumonia and it explain better their pathophysiology.

Design and Conceptual Proposal of an Intelligent Clinical Decision Support System for the Diagnosis of Suspicious Obstructive Sleep Apnea Patients from Health Profile.

Obstructive Sleep Apnea (OSA) is a chronic sleep-related pathology characterized by recurrent episodes of total or partial obstruction of the upper airways during sleep. It entails a high impact on the health and quality of life of patients, affecting more than one thousand million people worldwide, which has resulted in an important public health concern in recent years. The usual diagnosis involves performing a sleep test, cardiorespiratory polygraphy, or polysomnography, which allows characterizing the pathology and assessing its severity. However, this procedure cannot be used on a massive scale in general screening studies of the population because of its execution and implementation costs; therefore, causing an increase in waiting lists which would negatively affect the health of the affected patients. Additionally, the symptoms shown by these patients are often unspecific, as well as appealing to the general population (excessive somnolence, snoring, etc.), causing many potential cases to be referred for a sleep study when in reality are not suffering from OSA. This paper proposes a novel intelligent clinical decision support system to be applied to the diagnosis of OSA that can be used in early outpatient stages, quickly, easily, and safely, when a suspicious OSA patient attends the consultation. Starting from information related to the patient's health profile (anthropometric data, habits, comorbidities, or medications taken), the system is capable of determining different alert levels of suffering from sleep apnea associated with different apnea-hypopnea index (AHI) levels to be studied. To that end, a series of automatic learning algorithms are deployed that, working concurrently, together with a corrective approach based on the use of an Adaptive Neuro-Based Fuzzy Inference System (ANFIS) and a specific heuristic algorithm, allow the calculation of a series of labels associated with the different levels of AHI previously indicated. For the initial software implementation, a data set with 4600 patients from the Álvaro Cunqueiro Hospital in Vigo was used. The results obtained after performing the proof tests determined ROC curves with AUC values in the range 0.8-0.9, and Matthews correlation coefficient values close to 0.6, with high success rates. This points to its potential use as a support tool for the diagnostic process, not only from the point of view of improving the quality of the services provided, but also from the best use of hospital resources and the consequent savings in terms of costs and time.

Efectividad del suero salino hipertónico nebulizado en pacientes con hipersecreción bronquial / Effectiveness of nebulized hypertonic saline in patients with bronchial hypersecretion

Introducción: El suero salino hipertónico (SSH) nebulizado mejora la calidad de vida y reduce las exacerbaciones en pacientes con fibrosis quística. Se desconoce si ofrecería los mismos beneficios en otras patologías hipersecretoras.MétodosEstudio observacional retrospectivo. Se incluyeron pacientes que superaron la prueba de tolerancia e iniciaron SSH al 5,8% con un año de seguimiento. Se cuantificaron parámetros clínicos y asistenciales en los años previo y posterior al inicio del tratamiento.ResultadosUn total de 101 pacientes, 60,4% mujeres, media de edad 65años (IC95%: 62,4-67,9): 82 (81,2%) bronquiectasias, 6 (5,9%) EPOC, 2 (2%) asma, 1 (1%) EPID y 10 (9,9%) otros. Se evidenció una reducción de la broncorrea (91,1% vs 75,2%), de las infecciones de repetición (57,4% vs 22,8%) y de los ciclos de antibioterapia (1,54 vs 0,55), así como un aumento del FEV1 (1.881ml vs 1.942ml) y una disminución de las asistencias a atención primaria (2,94 vs 1,1), de urgencias (0,36 vs 0,17) y de hospitalizaciones (0,17 vs 0,06). Setenta y tres pacientes (72,3%) presentaron una adecuada tolerancia.ConclusiónLa nebulización de SSH al 5,8% en pacientes con hipersecreción bronquial es segura y tiene un destacable impacto clínico y asistencial. (AU)

Introduction: Nebulized hypertonic saline (HS) improves quality of life and reduces exacerbations in patients with cystic fibrosis. It is unknown if it would offer the same benefits in other hypersecretory pathologies.MethodsRetrospective observational study. Patients who passed the tolerance test and started HS 5.8% with one year of follow-up were included. Clinical and healthcare parameters were quantified in the year before and after the start of treatment.Results101 patients, 60.4% women, 65years (95%CI: 62.4-67.9): 82 (81.2%) bronchiectasis, 6 (5.9%) COPD, 2 (2%) asthma, 1 (1%) ILD, and 10 (9.9%) other causes. There was a reduction in bronchorrhea (91.1% vs 75.2%), recurrent infections (57.4% vs 22.8%) and cycles of antibiotic therapy (1.54 vs 0.55), as well as an increase in FEV1 (1881ml vs. 1942ml) and a decrease in visits to primary care (2.94 vs. 1.1), emergencies (0.36 vs. 0.17) and hospitalizations (0.17 vs. 0.17). 06). 73 patients (72.3%) presented an adequate tolerance.ConclusionNebulization of HS 5.8% in patients with bronchial hypersecretion is safe and has a remarkable clinical and healthcare impact. (AU)

[Effectiveness of nebulized hypertonic saline in patients with bronchial hypersecretion]. / Efectividad del suero salino hipertónico nebulizado en pacientes con hipersecreción bronquial.

INTRODUCTION: Nebulized hypertonic saline (HS) improves quality of life and reduces exacerbations in patients with cystic fibrosis. It is unknown if it would offer the same benefits in other hypersecretory pathologies. METHODS: Retrospective observational study. Patients who passed the tolerance test and started HS 5.8% with one year of follow-up were included. Clinical and healthcare parameters were quantified in the year before and after the start of treatment. RESULTS: 101 patients, 60.4% women, 65years (95%CI: 62.4-67.9): 82 (81.2%) bronchiectasis, 6 (5.9%) COPD, 2 (2%) asthma, 1 (1%) ILD, and 10 (9.9%) other causes. There was a reduction in bronchorrhea (91.1% vs 75.2%), recurrent infections (57.4% vs 22.8%) and cycles of antibiotic therapy (1.54 vs 0.55), as well as an increase in FEV1 (1881ml vs. 1942ml) and a decrease in visits to primary care (2.94 vs. 1.1), emergencies (0.36 vs. 0.17) and hospitalizations (0.17 vs. 0.17). 06). 73 patients (72.3%) presented an adequate tolerance. CONCLUSION: Nebulization of HS 5.8% in patients with bronchial hypersecretion is safe and has a remarkable clinical and healthcare impact.