Psychometric Validation of the Patient-Reported Experience Measure (PREM) Questionnaire "HowRwe" in Patients With Respiratory Disease Receiving Home Respiratory Therapies.

Introduction: The patient experience is defined as all the interactions that occur between patients and the healthcare system. The experience of patients with respiratory disease with home respiratory treatments (HRT) is not captured in currently available Patient-Reported Outcome Measures (PROM). We present the psychometric validation of the Patient-Reported Experience Measure (PREM) 'HowRwe' in Spanish and for respiratory patients with HRT. Methods: After translation following ISPOR guidelines (International Society for Pharmacoeconomics and Outcomes Research), the questionnaire was administered to adult respiratory patients who were receiving treatment at Hospital Universitario de La Princesa. The administration was done in two stages with 6 months of difference between the pre- and post-test. Results: We studied 228 respiratory patients, with a mean (SD) age of 64.1 (13.2) years, 52.2% were men, 68.0% were married or coupled, and 56.6% were retired. Reliability coefficients of the scale were adequate, with α = .921 and Ω = .929 for pre-test, and α = .940 and Ω = .958 for post. The confirmatory factor analysis tested for pre- and post-intervention, showed an excellent overall fit: χ2(2) = 49.380 (p < .001), CFI = .941 and SRMR = .072; and χ2(2) = 37.579 (p < .001), CFI = .982 and SRMR = .046, respectively. No statistically significant associations were observed for neither age, adherence nor quality of life, except between HowRwe post-test and quality of life pre-test (r = .14 [.01,.26]; p = .035). No significant differences were found in sociodemographic variables. No differences in pre-test or post-test were found in effect of HRT. 85.6% of patients found the content of HowRwe "Useful", and the preferred channel to respond it were paper, app and email. Conclusions: The Spanish version of the 'HowRwe' questionnaire to measure the experience in respiratory patients with home respiratory treatments (HRT), has adequate psychometric properties and conceptual and semantic equivalence with the original English version.

Introducción: La experiencia del paciente se define como todas las interacciones que ocurren entre los pacientes y el sistema de salud. La experiencia de los pacientes con enfermedades respiratorias con terapias respiratorias domiciliarios (TRD) no se refleja en las Medidas de resultados informados por el paciente (PROM) disponibles actualmente. Presentamos la validación psicométrica de la Medida de Experiencia Reportada por el Paciente (PREM por sus siglas en inglés) 'HowRwe' en español y para pacientes respiratorios con TRD. Métodos: Después de la traducción siguiendo las pautas de ISPOR (Sociedad Internacional de Farmacoeconomía e Investigación de Resultados), el cuestionario se administró a pacientes respiratorios adultos que estaban recibiendo tratamiento en el Hospital Universitario de La Princesa. La administración se realizó en dos etapas con 6 meses de diferencia entre el pre y post test. Resultados: Se estudiaron 228 pacientes respiratorios, con una edad media (DE) de 64,1 ± 13,2 años, el 52,2% eran hombres, el 68,0% estaban casados o en pareja y el 56,6% eran jubilados. Los coeficientes de confiabilidad de la escala fueron adecuados, con α = .921 y Ω = .929 para el pretest, y α = .940 y Ω = .958 para el post. El análisis factorial confirmatorio testado para pre y postintervención, mostró un ajuste global excelente: χ2(2) = 49.380 (p < .001), CFI = .941 y SRMR = .072; y χ2(2) = 37,579 (p < .001), CFI = .982 y SRMR = .046, respectivamente. No se observaron asociaciones estadísticamente significativas ni para la edad, la adherencia ni para la calidad de vida, excepto entre HowRwe postest y calidad de vida pretest (r = .14 [.01,.26];p = .035). No se encontraron diferencias significativas en las variables sociodemográficas. No se encontraron diferencias en el efecto de la TRH en el pretest o postest. El 85,6% de los pacientes encontró "útil" el contenido de HowRwe y el canal preferido para responder fue el papel, la aplicación y el correo electrónico. Conclusiones: La versión española del cuestionario 'HowRwe' para medir la experiencia en pacientes respiratorios con tratamientos respiratorios domiciliarios (TRH), tiene adecuadas propiedades psicométricas y equivalencia conceptual y semántica con la versión original en inglés.

Clinical characteristics and outcomes among hospitalised COVID-19 patients across epidemic waves in Spain: An unCoVer analysis.

BACKGROUND AND OBJECTIVES: The COVID-19 pandemic had a significant impact in population health worldwide, and particularly in people with pre-existing chronic diseases. Early risk identification and stratification is essential to reduce the impact of future outbreaks of pandemic potential. This study aimed to comprehensively examine factors associated with COVID-19 mortality across the pandemic waves in Spain. METHODS: A retrospective study analyzed the characteristics of 13,974 patients admitted to Spanish hospitals due to SARS-CoV-2 infection from 2020-01-28 to 2022-12-31. The demographic and clinical features of patients during hospitalization on each pandemic waves were analyzed. MAIN FINDINGS: The findings highlight the heterogeneity of patient characteristics, comorbidities and outcomes, across the waves. The high prevalence of cardiometabolic diseases (53.9%) among COVID-19 patients emphasizes the importance of controlling these risk factors to prevent severe COVID-19 outcomes. CONCLUSIONS: In summary, the study associate hospital mortality with factors such as advanced age and comorbidities. The decline in mortality after the 4th wave indicates potential influences like vaccination, viral adaptation, or improved treatments. Notably, dementia and cancer metastases emerge as critical factors linked to higher mortality, highlighting the importance of addressing these conditions in COVID-19 management and preparing for future challenges.

NFκB and NLRP3/NLRC4 inflammasomes regulate differentiation, activation and functional properties of monocytes in response to distinct SARS-CoV-2 proteins.

Increased recruitment of transitional and non-classical monocytes in the lung during SARS-CoV-2 infection is associated with COVID-19 severity. However, whether specific innate sensors mediate the activation or differentiation of monocytes in response to different SARS-CoV-2 proteins remain poorly characterized. Here, we show that SARS-CoV-2 Spike 1 but not nucleoprotein induce differentiation of monocytes into transitional or non-classical subsets from both peripheral blood and COVID-19 bronchoalveolar lavage samples in a NFκB-dependent manner, but this process does not require inflammasome activation. However, NLRP3 and NLRC4 differentially regulated CD86 expression in monocytes in response to Spike 1 and Nucleoprotein, respectively. Moreover, monocytes exposed to Spike 1 induce significantly higher proportions of Th1 and Th17 CD4 + T cells. In contrast, monocytes exposed to Nucleoprotein reduce the degranulation of CD8 + T cells from severe COVID-19 patients. Our study provides insights in the differential impact of innate sensors in regulating monocytes in response to different SARS-CoV-2 proteins, which might be useful to better understand COVID-19 immunopathology and identify therapeutic targets.

Association between occupational exposure and chronic obstructive pulmonary disease and respiratory symptoms in the Spanish population

Introduction: The aim of this study was to analyze the impact of occupational exposure on chronic obstructive pulmonary disease (COPD) and respiratory symptoms in the general Spanish population.MethodsThis was a study nested in the Spanish EPISCAN II cross-sectional epidemiological study that included participants who had completed a structured questionnaire on their occupational history, a questionnaire on respiratory symptoms, and forced spirometry. The data were analyzed using Chi-square and Student's t tests and adjusted models of multiple linear regression and logistic regression.ResultsWe studied 7502 subjects, 51.1% women, with a mean age of 60±11 years. Overall, 53.2% reported some respiratory symptoms, 7.9% had respiratory symptoms during their work activity, 54.2% were or had been smokers, and 11.3% (851 subjects) met COPD criteria on spirometry. A total of 3056 subjects (40.7%) reported exposure to vapors, gases, dust or fumes (VGDF); occupational exposure to VGDF was independently associated with the presence of COPD (OR 1.22, 95% CI: 1.03–1.44), respiratory symptoms (OR 1.45, 95%: CI 1.30–1.61), and respiratory symptoms at work (OR 4.69, 95% CI: 3.82–5.77), with a population attributable fraction for COPD of 8.2%.ConclusionsOccupational exposure is associated with a higher risk of COPD and respiratory symptoms in the Spanish population. These results highlight the need to follow strict prevention measures to protect the respiratory health of workers. (AU)

Association between occupational exposure and chronic obstructive pulmonary disease and respiratory symptoms in the Spanish population.

INTRODUCTION: The aim of this study was to analyze the impact of occupational exposure on chronic obstructive pulmonary disease (COPD) and respiratory symptoms in the general Spanish population. METHODS: This was a study nested in the Spanish EPISCAN II cross-sectional epidemiological study that included participants who had completed a structured questionnaire on their occupational history, a questionnaire on respiratory symptoms, and forced spirometry. The data were analyzed using Chi-square and Student's t tests and adjusted models of multiple linear regression and logistic regression. RESULTS: We studied 7502 subjects, 51.1% women, with a mean age of 60±11 years. Overall, 53.2% reported some respiratory symptoms, 7.9% had respiratory symptoms during their work activity, 54.2% were or had been smokers, and 11.3% (851 subjects) met COPD criteria on spirometry. A total of 3056 subjects (40.7%) reported exposure to vapors, gases, dust or fumes (VGDF); occupational exposure to VGDF was independently associated with the presence of COPD (OR 1.22, 95% CI: 1.03-1.44), respiratory symptoms (OR 1.45, 95%: CI 1.30-1.61), and respiratory symptoms at work (OR 4.69, 95% CI: 3.82-5.77), with a population attributable fraction for COPD of 8.2%. CONCLUSIONS: Occupational exposure is associated with a higher risk of COPD and respiratory symptoms in the Spanish population. These results highlight the need to follow strict prevention measures to protect the respiratory health of workers.

Beneficial effect of temporary methotrexate interruption on B and T cell responses upon SARS-CoV-2 vaccination in patients with rheumatoid arthritis or psoriatic arthritis.

B and T cell responses were evaluated in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) after 1 or 2 weeks of methotrexate (MTX) withdrawal following each COVID-19 vaccine dose and compared with those who maintained MTX. Adult RA and PsA patients treated with MTX were recruited and randomly assigned to 3 groups: MTX-maintenance (n = 72), MTX-withdrawal for 1 week (n = 71) or MTX-withdrawal for 2 weeks (n = 73). Specific antibodies to several SARS-CoV-2 antigens and interferon (IFN)-γ and interleukin (IL)-21 responses were assessed. MTX withdrawal in patients without previous COVID-19 was associated with higher levels of anti-RBD IgG and neutralising antibodies, especially in the 2-week withdrawal group and with higher IFN-γ secretion upon stimulation with pools of SARS-CoV-2 S peptides. No increment of RA/PsA relapses was detected across groups. Our data indicate that two-week MTX interruption following COVID-19 vaccination in patients with RA or PsA improves humoral and cellular immune responses.

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)

Impact of the COVID-19 pandemic in mortality due to respiratory diseases: A comparative analysis of 2021 and 2020 vs 2019 in Spain / Impacto de la pandemia de COVID-19 en la mortalidad por enfermedades respiratorias: análisis comparativo de 2021 y 2020 frente a 2019 en España

Introduction We previously reported an increase in respiratory mortality in 2020 in Spain after COVID-19. It is unclear if this rise is sustained in the longer-term. We aimed to determine whether respiratory mortality in 2021 in Spain returned to pre-pandemic levels. Material and methods In an observational, large study using official National Institute of Statistics data, we explored deaths due to respiratory diseases, that is, all causes of death by the standard WHO list of diseases of the respiratory system plus COVID-19, tuberculosis and lung cancer. Using the latest available official data of Spain, we analyzed changes in the mortality pattern in Spain from January 2019 to December 2021. We endorsed STROBE guidance for observational research. Results There were 98,714 deaths due to respiratory diseases in 2021 in Spain, corresponding to 21.9% of all deaths, becoming second in the ranking of causes of death. Respiratory diseases mortality in Spain has not returned to pre-pandemic levels in 2021, still with an increase of 30.3% (95% CI 30.2–30.4) compared to rates in 2019. All respiratory-specific causes of death decreased in 2021, except for lung cancer, that increased in women and decreased in men compared to 2019 (both p<0.05). In a multivariate analysis some established risk factors for respiratory diseases mortality were confirmed, such as male gender and older age; further, an association with reduced mortality in rural Spain was observed, still with a large geographical variability. Conclusions The COVID-19 pandemic has had a lasting impact on deaths due to respiratory diseases and certain specific causes of death in 2021, and it has disproportionately affected certain regions (AU)

Introducción Previamente informamos de un aumento de la mortalidad respiratoria en 2020 en España tras la COVID-19. No está claro si este aumento se mantiene a largo plazo. Nuestro objetivo fue determinar si la mortalidad respiratoria en 2021 en España volvió a los niveles previos a la pandemia. Métodos En un gran estudio observacional con datos oficiales del Instituto Nacional de Estadística exploramos las muertes por enfermedades respiratorias, es decir, todas las causas de muerte según la lista estándar de enfermedades del sistema respiratorio de la Organización Mundial de la Salud más COVID-19, tuberculosis y cáncer de pulmón. Utilizando los últimos datos oficiales disponibles de España analizamos los cambios en el patrón de mortalidad en España desde enero de 2019 hasta diciembre de 2021. Seguimos la guía STROBE para investigación observacional. Resultados Se produjeron 98.714 muertes por enfermedades respiratorias en 2021 en España, lo que corresponde a 21,9% del total de muertes, situándose en el segundo lugar del ranking de causas de muerte. La mortalidad por enfermedades respiratorias en España no ha vuelto a los niveles previos a la pandemia en 2021, aun con un aumento de 30,3% (IC 95% 30,2-30,4) respecto a las tasas de 2019. Todas las causas de muerte específicas de las vías respiratorias disminuyeron en 2021, excepto el cáncer de pulmón, que aumentó en mujeres y disminuyó en hombres en comparación con 2019 (ambos p < 0,05). En un análisis multivariado se confirmaron algunos factores de riesgo establecidos para la mortalidad por enfermedades respiratorias, como el género masculino y la edad avanzada; además, se observó una asociación con la reducción de la mortalidad en la España rural, aun con una gran variabilidad geográfica. Conclusiones La pandemia de COVID-19 ha tenido un impacto duradero en las muertes por enfermedades respiratorias y ciertas causas específicas de muerte en 2021, y ha afectado de manera desproporcionada a ciertas regiones (AU)

Impact of the COVID-19 pandemic in mortality due to respiratory diseases: A comparative analysis of 2021 and 2020 vs 2019 in Spain.

INTRODUCTION: We previously reported an increase in respiratory mortality in 2020 in Spain after COVID-19. It is unclear if this rise is sustained in the longer-term. We aimed to determine whether respiratory mortality in 2021 in Spain returned to pre-pandemic levels. MATERIAL AND METHODS: In an observational, large study using official National Institute of Statistics data, we explored deaths due to respiratory diseases, that is, all causes of death by the standard WHO list of diseases of the respiratory system plus COVID-19, tuberculosis and lung cancer. Using the latest available official data of Spain, we analyzed changes in the mortality pattern in Spain from January 2019 to December 2021. We endorsed STROBE guidance for observational research. RESULTS: There were 98,714 deaths due to respiratory diseases in 2021 in Spain, corresponding to 21.9% of all deaths, becoming second in the ranking of causes of death. Respiratory diseases mortality in Spain has not returned to pre-pandemic levels in 2021, still with an increase of 30.3% (95% CI 30.2-30.4) compared to rates in 2019. All respiratory-specific causes of death decreased in 2021, except for lung cancer, that increased in women and decreased in men compared to 2019 (both p<0.05). In a multivariate analysis some established risk factors for respiratory diseases mortality were confirmed, such as male gender and older age; further, an association with reduced mortality in rural Spain was observed, still with a large geographical variability. CONCLUSIONS: The COVID-19 pandemic has had a lasting impact on deaths due to respiratory diseases and certain specific causes of death in 2021, and it has disproportionately affected certain regions.

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.

ABO blood group as a determinant of COVID-19 and Long COVID: An observational, longitudinal, large study.

BACKGROUND: An association of ABO blood group and COVID-19 remains controversial. METHODS: Following STROBE guidance for observational research, we explored the distribution of ABO blood group in patients hospitalized for acute COVID-19 and in those with Long COVID. Contingency tables were made and risk factors were explored using crude and adjusted Mantle-Haentzel odds ratios (OR and 95% CI). RESULTS: Up to September 2022, there were a total of 5,832 acute COVID-19 hospitalizations in our hospital, corresponding to 5,503 individual patients, of whom blood group determination was available for 1,513 (27.5%). Their distribution by ABO was: 653 (43.2%) group 0, 690 (45.6%) A, 113 (7.5%) B, and 57 (3.8%) AB, which corresponds to the expected frequencies in the general population. In parallel, of 676 patients with Long COVID, blood group determination was available for 135 (20.0%). Their distribution was: 60 (44.4%) from group 0, 61 (45.2%) A, 9 (6.7%) B, and 5 (3.7%) AB. The distribution of the ABO system of Long COVID patients did not show significant differences with respect to that of the total group (p ≥ 0.843). In a multivariate analysis adjusting for age, sex, ethnicity, and severity of acute COVID-19 infection, subgroups A, AB, and B were not significantly associated with developing Long COVID with an OR of 1.015 [0.669-1.541], 1.327 [0.490-3.594] and 0.965 [0.453-2.058], respectively. The effect of the Rh+ factor was also not significant 1,423 [0.772-2,622] regarding Long COVID. CONCLUSIONS: No association of any ABO blood subgroup with COVID-19 or developing Long COVID was identified.

The ATLAS ASMA Study: Assessing the Impact of Asthma on Patients' Life - The Spanish Patients' Perspective.

Purpose: ATLAS ASMA described the psychosocial impact of asthma on patients' daily life from patients' perspectives (in terms of impaired personal and intimate relationships, sleep quality, leisure time, daily activities, and others) in Spain. Secondary objective includes description of time since diagnosis, expectations, and satisfaction of patients about disease, treatment and medical assistance received, adherence to treatment, perceived control of asthma, and health-related quality of life. Patients and Methods: This was a cross-sectional, observational study, based on a self-administered online survey for adult patients (≥18 years) with asthma. Patients with asthma diagnosis of any type and severity who voluntarily participated in the survey through a web link were included consecutively. In the present manuscript, only adult patients' data are included. Results: A total of 132 adults with asthma were included. Moderate/severe asthma constituted 59.1% of the patients (females 71.2%). Overall, most relevant areas affected due to asthma were leisure activities (67.0%) and the quality/quantity of sleep (52.3%). Moderate/severe patients perceived some degree of impairment in work, school, or at home due asthma more frequently vs mild patients (55.2% vs 10.9%). Poorly controlled asthma (ACT≤19) was reported in 41 (70.7%) and 10 (21.7%) moderate/severe and mild patients (p<0.000), respectively. Mild patients obtained higher mean (SD) Mini-AQLQ score than moderate/severe asthma patients (5.6 [1.0] vs 4.3 [1.1], p<0.000), likewise higher significant results for every individual dimension. Most patients cited little limitation to intense efforts (20.5%). Half of the patients mentioned needing more information about asthma. Topics those patients like to have more information were difficulties that may can have and legal topics (78.6%), asthma evolution (78.6%), secondary effects or issues related to the treatment (61.9%) and legal topics (61.9%). Conclusion: The study reported important insights on psychosocial impact of asthma on patients' daily life from patients' perspectives along with health determinants in asthma-related health outcomes, sociodemographic and psychosocial factors.

Sleep apnea-COPD overlap syndrome is associated with larger left carotid atherosclerotic plaques.

Background: Little is known about whether the overlap syndrome (OS) combining features of chronic obstructive pulmonary disease (COPD) and sleep apnea-hypopnea syndrome increases the risk of stroke associated with COPD itself. Methods: We prospectively studied 74 COPD patients and 32 subjects without lung disease. Spirometry and cardiorespiratory polygraphy were used to assess the pulmonary function of the study population and ultrasound measurements of intima media thickness (IMT) as well as the volume of plaques in both carotid arteries were also evaluated. Results: Polygraphic criteria of OS were met in 51% of COPD patients. We found that 79% of patients with OS and 50% of COPD patients without OS had atherosclerotic plaques in the left carotid artery (p = 0.0509). Interestingly, the mean volume of atherosclerotic plaques was significantly higher in the left carotid artery of COPD patients with OS (0.07 ± 0.02 ml) than in those without OS (0.04 ± 0.02 ml, p = 0.0305). However, regardless of the presence of OS, no significant differences were observed in both presence and volume of atherosclerotic plaques in the right carotid artery of COPD patients. Adjusted-multivariate linear regression revealed age, current smoking and the apnea/hypopnea index (OR = 4.54, p = 0.012) as independent predictors of left carotid atherosclerotic plaques in COPD patients. Conclusions: This study suggests that the presence of OS in COPD patients is associated with larger left carotid atherosclerotic plaques, indicating that OS might be screened in all COPD patients to identify those with higher risk of stroke.

Plitidepsin in adult patients with COVID-19 requiring hospital admission: A long-term follow-up analysis.

Introduction: The APLICOV-PC study assessed the safety and preliminary efficacy of plitidepsin in hospitalized adult patients with COVID-19. In this follow-up study (E-APLICOV), the incidence of post-COVID-19 morbidity was evaluated and any long-term complications were characterized. Methods: Between January 18 and March 16, 2022, 34 of the 45 adult patients who received therapy with plitidepsin in the APLICOV-PC study were enrolled in E-APLICOV (median time from plitidepsin first dose to E-APLICOV enrollment, 16.8 months [range, 15.2-19.5 months]). All patients were functionally autonomous with regard to daily living (Barthel index: 100) and had normal physical examinations. Results: From the APLICOV-PC date of discharge to the date of the extension visit, neither Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5) grade 3-4 complications nor QT prolongation or significant electrocardiogram (EKG) abnormalities were reported. Five (14.7%) patients had another COVID-19 episode after initial discharge from APLICOV-PC, and in 2 patients (5.9%), previously unreported chest X-ray findings were documented. Spirometry and lung-diffusion tests were normal in 29 (85.3%) and 27 (79.4%) patients, respectively, and 3 patients needed additional oxygen supplementation after initial hospital discharge. None of these patients required subsequent hospital readmission for disease-related complications. Discussion: In conclusion, plitidepsin has demonstrated a favorable long-term safety profile in adult patients hospitalized for COVID-19. With the constraints of a low sample size and a lack of control, the rate of post-COVID-19 complications after treatment with plitidepsin is in the low range of published reports. (ClinicalTrials.gov Identifier: NCT05121740; https://clinicaltrials.gov/ct2/show/NCT05121740).

Unravelling young COPD and pre-COPD in the general population.

Background: Chronic obstructive pulmonary disease (COPD) is commonly diagnosed when the airflow limitation is well established and symptomatic. We aimed to identify individuals at risk of developing COPD according to the concept of pre-COPD and compare their clinical characteristics with 1) those who have developed the disease at a young age, and 2) the overall population with and without COPD. Methods: The EPISCAN II study is a cross-sectional, population-based study that aims to investigate the prevalence of COPD in Spain in subjects ≥40 years of age. Pre-COPD was defined as the presence of emphysema >5% and/or bronchial thickening by computed chromatography (CT) scan and/or diffusing capacity of the lung for carbon monoxide (D LCO) <80% of predicted in subjects with respiratory symptoms and post-bronchodilator forced expiratory volume in 1 s/forced vital capacity (FEV1/FVC) >0.70. Young COPD was defined as FEV1/FVC <0.70 in a subject ≤50 years of age. Demographic and clinical characteristics were compared among pre-COPD, young COPD and the overall population with and without COPD. Results: Among the 1077 individuals with FEV1/FVC <0.70, 65 (6.0%) were ≤50 years of age. Among the 8015 individuals with FEV1/FVC >0.70, 350 underwent both D LCO testing and chest CT scanning. Of those, 78 (22.3%) subjects fulfilled the definition of pre-COPD. Subjects with pre-COPD were older, predominantly women, less frequently active or ex-smokers, with less frequent previous diagnosis of asthma but with higher symptomatic burden than those with young COPD. Conclusions: 22.3% of the studied population was at risk of developing COPD, with similar symptomatic and structural changes to those with well-established disease without airflow obstruction. This COPD at-risk population is different from those that develop COPD at a young age.

Dissociation between physical capacity and daily physical activity in COPD patients. A population-based approach.

BADKGROUND: Physical capacity (PC) and daily physical activity (PA) are two crucial factors in the clinical course of COPD, although they do not always maintain a close relationship. The objectives were to evaluate the frequency of PC-PA dissociation in patients with COPD and subjects without airflow limitation (AL) and to identify its risk factors. METHODS: A sample of 319 COPD patients and 399 subjects without AL was consecutively obtained from a population-based sample of 9092 subjects evaluated in the EPISCAN II study. Baseline evaluation included clinical questionnaires, lung function testing, blood analysis and low-dose computed tomography (CT) scan with evaluation of lung density and airway wall thickness. A distance walked in 6 min > 70% predicted was considered an indicator of normal PC, while a Yale Physical Activity Survey summary index score <51 was used to identify with sedentary lifestyle. RESULTS: 166 COPD patients (52.0%) reported a sedentary lifestyle with evidence of preserved PC, while this phenomenon was present in 188 (47.1%) subjects without AL. In the COPD group, symptoms of chronic bronchitis, depression and elevated hematocrit and blood eosinophil count were identified as independent risk factors for PC-PA dissociation. In turn, in the subjects without AL, the risk factors for PC-PA dissociation were low fat-free mass, obesity and anxiety, as well as reduced levels of HDL-cholesterol and the absence of osteoporosis. CONCLUSIONS: Almost half of COPD patients and subjects without airflow limitation with preserved PC maintain a sedentary lifestyle, with different risk factors for sedentarism between both groups.