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1.
Arch Bronconeumol ; 2021 Mar 17.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-33840553

RESUMO

The Spanish COPD Guidelines (GesEPOC) were first published in 2012, and since then have undergone a series of updates incorporating new evidence on the diagnosis and treatment of COPD. GesEPOC was drawn up in partnership with scientific societies involved in the treatment of COPD and the Spanish Patients' Forum. Their recommendations are based on an evaluation of the evidence using GRADE methodology, and a narrative description of the evidence in areas in which GRADE cannot be applied. In this article, we summarize the recommendations on the pharmacological treatment of stable COPD based on 9 PICO questions. COPD treatment is a 4-step process: 1) diagnosis, 2) determination of the risk level, 3) initial and subsequent inhaled therapy, and 4) identification and management of treatable traits. For the selection of inhaled therapy, high-risk patients are divided into 3 phenotypes: non-exacerbator, eosinophilic exacerbator, and non-eosinophilic exacerbator. Some treatable traits are general and should be investigated in all patients, such as smoking or inhalation technique, while others affect severe patients in particular, such as chronic hypoxemia and chronic bronchial infection. COPD treatment is based on long-acting bronchodilators with single agents or in combination, depending on the patient's risk level. Eosinophilic exacerbators must receive inhaled corticosteroids, while non-eosinophilic exacerbators require a more detailed evaluation to choose the best therapeutic option. The new GesEPOC also includes recommendations on the withdrawal of inhaled corticosteroids and on indications for alpha-1 antitrypsin treatment. GesEPOC offers a more individualized approach to COPD treatment tailored according to the clinical characteristics of patients and their level of complexity.

2.
Chest ; 2021 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-33878339

RESUMO

BACKGROUND: The value of the single breath diffusion capacity for carbon monoxide (DLco) relates to outcomes in COPD patients. However, little is known about the natural course of DLco over time, the intersubject variability and the factors that may influence DLco progression. RESEARCH QUESTION: What is the natural course of DLco in COPD patients over time, and which other factors, including sex differences could influence this progression? STUDY DESIGN AND METHODS: We phenotyped 602 smokers (33% women) of which 506 (84%) had COPD and 96 (16%) had no airflow limitation. Lung function including DLco was monitored annually over five years. A random-coefficient model was used to evaluate DLco changes over time. RESULTS: The mean (±SE) yearly decline in DLco% in COPD patients was 1.34 ± 0.015%/year. This was steeper compared with non-COPD controls (0.04 ± 0.032%/year, p=0.004). Sixteen percent of the COPD patients vs 4.3% of the controls, had a statistically significant DLco% slope annual decline (4.14%/year). At baseline, women with COPD had lower DLco values (11.37 ± 2.27%, p <0.001) in spite of a higher FEV1% than men. Compared to men, women with COPD had a steeper DLco annual decline of 0.89 ± 0.42 %/year, (p= 0.039). INTERPRETATION: Patients with COPD have an accelerated decline in DLco compared to smokers without the disease. However, the decline is slow and a testing interval of 3 to 4 years may be clinically informative. The lower and more rapid decline of DLco values in women compared to men, suggests a differential impact of sex in gas exchange function.

3.
Arch Bronconeumol ; 2021 Feb 13.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-33771388

RESUMO

INTRODUCTION: Frequent-exacerbator COPD (fe-COPD) associated with frequent hospital admissions have high morbidity, mortality and use of health resources. These patients should be managed in personalized integrated care models (ICM). Accordingly, we aimed to evaluate the long-term effectiveness of a fe-COPD ICM on emergency room (ER) visits, hospital admissions, days of hospitalization, mortality and improvement of health status. METHODS: Prospective-controlled study with analysis of a cohort of fe-COPD patients assigned to ICM and followed-up for maximally 7 years that were compared to a parallel cohort who received standard care. All patients had a confirmed diagnosis of COPD with a history of ≥2 hospital admissions due to exacerbations in the year before enrollment. The change in CAT score and mMRC dyspnea scale, hospital admissions, ER visits, days of hospitalization, and mortality were analyzed. RESULTS: 141 patients included in the ICM were compared to 132 patients who received standard care. The ICM reduced hospitalizations by 38.2% and ER visits by 69.7%, with reduction of hospitalizations for COPD exacerbation, ER visits and days of hospitalization (p<0.05) compared to standard care. Further, health status improved among the ICM group after 1 year of follow-up (p=0.001), effect sustained over 3 years. However, mortality was not different between groups (p=0.117). Last follow-up CAT score>17 was the strongest independent risk factor for mortality and hospitalization among ICM patients. CONCLUSIONS: An ICM for fe-COPD patients effectively decreases ER and hospital admissions and improves health status, but not mortality.

4.
NPJ Prim Care Respir Med ; 31(1): 9, 2021 02 16.
Artigo em Inglês | MEDLINE | ID: mdl-33594082

RESUMO

Chronic obstructive pulmonary disease (COPD) and asthma impact on work productivity, but their population-based burden and clinical predictors are understudied. In this observational, real-life study, work absence of 14,383 asthma and/or COPD patients present in the MAJORICA cohort (Spain) was compared with the general population. Using multivariable regression, we studied the association of work absence with demographic and clinical characteristics. Patients with asthma and/or COPD had more work absence than the general population (15.2% vs 8.9%, p < 0.0001). Patients with asthma had more often periods of work absence compared to patients with COPD (16.0% vs 12.8%, p < 0.0001). The number of days absent were, however, less in asthma than in COPD (median: 15 days [IQR: 5-51] vs 39 days [IQR: 13-134], p < 0.001). Patients with asthma-COPD overlap were in between (14.5% with absence; median: 27 days [IQR: 10-82]). Comorbid anxiety, allergic rhinitis, and sleep apnoea were independently associated with more work absence.

5.
Artigo em Inglês | MEDLINE | ID: mdl-33549843

RESUMO

BACKGROUND: There is a lack of tools to quantify the response to monoclonal antibodies (mAbs) holistically in severe uncontrolled asthma patients. OBJECTIVE: To develop a valid score to assist specialists in this clinical context. METHODS: The score was developed in four subsequent phases: (1) elaboration of the theoretical model of the construct intended to be measured (response to mAbs); (2) definition and selection of items and measurement instruments by Delphi survey; (3) weight assignment of the selected items by multicriteria decision analysis using the Potentially All Pairwise RanKings of All Possible Alternatives methodology using the 1000minds software; and (4) face validity assessment of the obtained score. RESULTS: Four core items, with different levels of response for each, were selected: severe exacerbations, oral corticosteroid use, symptoms (evaluated by Asthma Control Test), and bronchial obstruction (assessed by FEV1 percent predicted). Severe exacerbations and oral corticosteroid maintenance dose were weighted most heavily (38% each), followed by symptoms (13%) and FEV1 (11%). Higher scores in the weighted system indicate a better response and the range of responses runs from 0 (worsening) to 100 (best possible response). Face validity was high (intraclass correlation coefficient of 0.86). CONCLUSIONS: The FEV1, exacerbations, oral corticosteroids, symptoms score allows clinicians to quantify response in severe uncontrolled asthma patients who are being treated with mAbs.

6.
Artigo em Inglês | MEDLINE | ID: mdl-33531800

RESUMO

Background: Clinical control in chronic obstructive pulmonary disease (COPD) has not been completely characterized. A proposal of clinical control criteria (CCC) has been recently defined and validated as a tool for determining control, but there is scarce information on patients with severe COPD. Objective: To evaluate clinical control in severe COPD using the CCC. Patients and Methods: The study design was observational, multicenter, cross-sectional study involving 4801 patients with severe COPD in Spain. Clinical control was defined according to clinical impact (dyspnea grade, use of rescue treatment in last week, sputum color, and daily physical activity) and stability (exacerbations in last 3 months and patient's perception about health status). Clinical control of COPD was alternatively evaluated with the COPD assessment test (CAT) and the presence of exacerbations in the last 3 months. Results: According to CCC, 61.0% of patients had low clinical impact, and 41.4% showed clinical stability. Overall, 29.9% of patients had both low clinical impact and stability (controlled), whereas 70.1% showed high clinical impact and/or no clinical stability (non-controlled). COPD control was also assessed by using only the definition of CAT≤16 and no exacerbations in the last 3 months. Results obtained with this definition were similar to those obtained by CCC, and the concordance between both definitions was high (Kappa index = 0.698). Conclusion: By using the CCC, approximately only one third of patients with severe COPD were considered as controlled. Physical activity, adherence to inhalers, age, post-bronchodilator FEV1, age-adjusted Charlson comorbidity index, and healthcare level were independent factors associated with COPD control.

7.
Respir Res ; 22(1): 36, 2021 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-33541356

RESUMO

BACKGROUND: Control in COPD is a dynamic concept that can reflect changes in patients' clinical status that may have prognostic implications, but there is no information about changes in control status and its long-term consequences. METHODS: We classified 798 patients with COPD from the CHAIN cohort as controlled/uncontrolled at baseline and over 5 years. We describe the changes in control status in patients over long-term follow-up and analyze the factors that were associated with longitudinal control patterns and related survival using the Cox hazard analysis. RESULTS: 134 patients (16.8%) were considered persistently controlled, 248 (31.1%) persistently uncontrolled and 416 (52.1%) changed control status during follow-up. The variables significantly associated with persistent control were not requiring triple therapy at baseline and having a better quality of life. Annual changes in outcomes (health status, psychological status, airflow limitation) did not differ in patients, regardless of clinical control status. All-cause mortality was lower in persistently controlled patients (5.5% versus 19.1%, p = 0.001). The hazard ratio for all-cause mortality was 2.274 (95% CI 1.394-3.708; p = 0.001). Regarding pharmacological treatment, triple inhaled therapy was the most common option in persistently uncontrolled patients (72.2%). Patients with persistent disease control more frequently used bronchodilators for monotherapy (53%) at recruitment, although by the end of the follow-up period, 20% had scaled up their treatment, with triple therapy being the most frequent therapeutic pattern. CONCLUSIONS: The evaluation of COPD control status provides relevant prognostic information on survival. There is important variability in clinical control status and only a small proportion of the patients had persistently good control. Changes in the treatment pattern may be relevant in the longitudinal pattern of COPD clinical control. Further studies in other populations should validate our results. TRIAL REGISTRATION: Clinical Trials.gov: identifier NCT01122758.

8.
Arch. bronconeumol. (Ed. impr.) ; 57(1): 61-69, ene. 2021. tab, graf, mapas
Artigo em Inglês | IBECS-Express | IBECS | ID: ibc-ET5-2496

RESUMO

BACKGROUND: Two previous national epidemiological studies, IBERPOC in 1997 and EPISCAN in 2007, determined the COPD burden in Spain. Changes in demographics and exposure to risk factors demand the periodic update of COPD prevalence and its determinants. METHODS: EPISCAN II aimed to estimate the prevalence of COPD in the general population aged 40 years or older in all 17 regions of Spain. A random population screening sample, requiring 600 participants per region performed a questionnaire plus post-bronchodilator (post-BD) spirometry. RESULTS: A total of 12,825 subjects were initially contacted, and 9433 (73.6%) agreed to participate, of whom 9092 performed a valid spirometry. Baseline characteristics were: 52.6% women, mean ± SD age 60 ± 11 years, 19.8% current- and 34.2% former-smokers. The prevalence of COPD measured by post-BD fixed ratio FEV1/FVC < 0.7 was 11.8% (95% C.I. 11.2-12.5) with a high variability by region (2.4-fold). Prevalence was 14.6% (95% C.I. 13.5-15.7) in males and 9.4% (95% C.I. 8.6-10.2) in females; according to the lower limit of normal (LLN) was 6.0% (95% C.I. 5.5-6.5) overall, by sex being 7.1% (95% C.I. 6.4-8.0) in males and 4.9% (95% C.I. 4.3-5.6) in females. Underdiagnosis of COPD was 74.7%. Cases with COPD were a mean of seven years older, more frequently male, of lower attained education, and with more smokers than the non-COPD population (p < 0.001). However, the number of cigarettes and pack-years in non-COPD participants was substantial, as it was the reported use of e-cigarettes (7.0% vs. 5.5%) (p = 0.045). There were also significant social and clinical differences including living alone, previous respiratory diagnoses, more comorbidities measured with the Charlson index, greater BODE and COTE scores, cognitive impairment, and depression (all p < 0.001). CONCLUSIONS: COPD remains prevalent in Spain and frequently underdiagnosed


ANTECEDENTES: Dos estudios epidemiológicos nacionales anteriores, IBERPOC en 1997 y EPISCAN en 2007, determinaron la carga de EPOC en España. Los cambios en la demografía y la exposición a factores de riesgo exigen una actualización periódica de la prevalencia de EPOC y sus determinantes. MÉTODOS: EPISCAN II tuvo como objetivo estimar la prevalencia de EPOC en la población general de 40 años o más en las 17 Comunidades Autónomas de España. Una muestra aleatoria de población para cribado, que requirió 600 participantes por región, realizó un cuestionario y una espirometría tras la administración de un broncodilatador (post-BD). RESULTADOS: Un total de 12.825 sujetos fueron contactados inicialmente, y 9.433 (73,6%) aceptaron participar, de los cuales 9.092 realizaron una espirometría válida. Las características sociodemográficas basales fueron: un 52,6% eran mujeres, la edad media ± DE era de 60 ± 11 años, un 19,8% eran fumadores activos y un 34,2% eran exfumadores. La prevalencia de EPOC medida por el criterio de cociente fijo post-BD FEV1/FVC < 0,7 fue del 11,8% (IC 95%: 11,2-12,5) con una alta variabilidad por región (2,4 veces). La prevalencia fue del 14,6% (IC 95%: 13,5-15,7) en varones y del 9,4% (IC 95%: 8,6-10,2) en mujeres; considerando el límite inferior de la normalidad (LIN), fue del 6,0% (IC 95%: 5,5-6,5) en la muestra global y, por sexos, del 7,1% (IC 95%: 6,4-8,0) en varones y del 4,9% (IC 95%: 4,3-5,6) en mujeres. El infradiagnóstico de la EPOC fue del 74,7%. Los casos con EPOC tenían de media 7 años más, eran con mayor frecuencia varones, tenían menor nivel educativo y había más fumadores que en la población sin EPOC (p < 0,001). Sin embargo, el número de cigarrillos y paquetes/año en los participantes que no tenían EPOC fue sustancial, como también fue elevado el uso de cigarrillos electrónicos (7,0 vs. 5,5%) (p = 0,045). También hubo diferencias sociales y clínicas significativas que incluyeron: vivir solo, diagnósticos previos de enfermedad respiratoria, más comorbilidades medidas con el índice de Charlson, puntuaciones más altas en el índice BODE y la escala COTE, deterioro cognitivo y depresión (todos p < 0,001). CONCLUSIONES: La EPOC sigue siendo prevalente en España y con frecuencia está infradiagnosticada

9.
Lancet Respir Med ; 9(3): 260-274, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33357499

RESUMO

BACKGROUND: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. METHODS: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18-75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per µL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (2:1; stratified by previous exacerbation count [two, or three or more], maintenance oral corticosteroid use, and region), using an integrated web-based response system, to receive benralizumab at 30 mg every 8 weeks (first three doses given 4 weeks apart) or matched placebo for 24 weeks. Primary efficacy measure was annualised asthma exacerbation rate, with rate ratio (RR) calculated over the approximate 24-week follow-up. Secondary efficacy measures included change from baseline to end of treatment (week 24) in St George's Respiratory Questionnaire (SGRQ) total score (key secondary endpoint), FEV1, peak expiratory flow (PEF), ACQ-6, Predominant Symptom and Impairment Assessment (PSIA), Clinician Global Impression of Change (CGI-C), Patient Global Impression of Change (PGI-C), and Sino-Nasal Outcome Test-22 (SNOT-22). All efficacy analyses, except for SNOT-22, were summarised and analysed using the full analysis set on an intention-to-treat population (all randomly assigned patients receiving investigational product, regardless of protocol adherence or continued participation in the study). SNOT-22 was summarised for the subgroup of patients with physician-diagnosed nasal polyposis with informed consent. This study is registered with ClinicalTrials.gov, NCT03170271. FINDINGS: Between July 7, 2017, and Sept 25, 2019, 656 patients received benralizumab (n=427) or placebo (n=229). Baseline characteristics were consistent with severe eosinophilic asthma. Benralizumab significantly reduced exacerbation risk by 49% compared with placebo (RR estimate 0·51, 95% CI 0·39-0·65; p<0·0001) over the 24-week treatment period and provided clinically meaningful and statistically significant improvement from baseline to week 24 in SGRQ total score versus placebo (least squares mean change from baseline -8·11 (95% CI -11·41 to -4·82; p<0·0001), with similar differences at earlier timepoints. Benralizumab improved FEV1, PEF, ACQ-6, CGI-C, PGI-C, PSIA, and SNOT-22 at week 24 versus placebo, with differences observed early (within weeks 1 to 4). Adverse events were reported for 271 (63%) of 427 patients on benralizumab versus 143 (62%) of 229 patients on placebo. The most commonly reported adverse events for the 427 patients receiving benralizumab (frequency >5%) were nasopharyngitis (30 [7%]), headache (37 [9%]), sinusitis (28 [7%]), bronchitis (22 [5%]), and pyrexia (26 [6%]). Fewer serious adverse events were reported for benralizumab (23 [5%]) versus placebo (25 [11%]), and the only common serious adverse event (experienced by >1% of patients) was worsening of asthma, which was reported for nine (2%) patients in the benralizumab group and nine (4%) patients in the placebo group. INTERPRETATION: Our results extend the efficacy profile of benralizumab for patients with severe eosinophilic asthma, showing early clinical benefits in patient-reported outcomes, HRQOL, lung function, and nasal polyposis symptoms. FUNDING: AstraZeneca.


Assuntos
Antiasmáticos/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Asma/tratamento farmacológico , Adulto , Antiasmáticos/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Progressão da Doença , Método Duplo-Cego , Eosinófilos/efeitos dos fármacos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Espirometria
10.
ERJ Open Res ; 6(4)2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33263033

RESUMO

In 2019, The Global Initiative for Chronic Obstructive Lung Disease (GOLD) modified the grading system for patients with COPD, creating 16 subgroups (1A-4D). As part of the COPD Cohorts Collaborative International Assessment (3CIA) initiative, we aim to compare the mortality prediction of the 2015 and 2019 COPD GOLD staging systems. We studied 17 139 COPD patients from the 3CIA study, selecting those with complete data. Patients were classified by the 2015 and 2019 GOLD ABCD systems, and we compared the predictive ability for 5-year mortality of both classifications. In total, 17 139 patients with COPD were enrolled in 22 cohorts from 11 countries between 2003 and 2017; 8823 of them had complete data and were analysed. Mean±sd age was 63.9±9.8 years and 62.9% were male. GOLD 2019 classified the patients in milder degrees of COPD. For both classifications, group D had higher mortality. 5-year mortality did not differ between groups B and C in GOLD 2015; in GOLD 2019, mortality was greater for group B than C. Patients classified as group A and B had better sensitivity and positive predictive value with the GOLD 2019 classification than GOLD 2015. GOLD 2015 had better sensitivity for group C and D than GOLD 2019. The area under the curve values for 5-year mortality were only 0.67 (95% CI 0.66-0.68) for GOLD 2015 and 0.65 (95% CI 0.63-0.66) for GOLD 2019. The new GOLD 2019 classification does not predict mortality better than the previous GOLD 2015 system.

11.
ERJ Open Res ; 6(4)2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33043045

RESUMO

The phenotypic characteristics of chronic obstructive pulmonary disease (COPD) in individuals younger than 50 years of age (early COPD) are not well defined. This prospective, multicentre, case-control study sought to describe these characteristics and compare them with those of smokers (≥10 pack-years) of similar age with normal spirometry (controls). We studied 92 cases (post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <0.7) and 197 controls. Results were contrasted with participants with similar inclusion criteria recruited into the ECLIPSE and COPDGene cohorts. Cases had moderate airflow limitation (FEV1 71.3±20.8%) but were often symptomatic, used healthcare resources frequently, had air trapping (residual volume 150.6±55.5% ref.), had reduced diffusing capacity (84.2±20.7% ref.) and had frequent evidence of computed tomography (CT) emphysema (61%). Of note, less than half of cases (46%) had been previously diagnosed with COPD. Interestingly, they also often reported a family history of respiratory diseases and had been hospitalised because of respiratory problems before the age of 5 years more frequently than controls (12% versus 3%, p=0.009). By and large, these observations were reproduced when available in the ECLIPSE and COPDGene cohorts. These results show that early COPD is associated with substantial health impact and significant structural and functional abnormalities, albeit it is often not diagnosed (hence, treated). The fact that a sizeable proportion of patients with early COPD report a family history of respiratory diseases and/or early-life events (including hospitalisations before the age of 5 years) renders further support to the possibility of early-life origin of COPD.

13.
Arch Bronconeumol ; 2020 Sep 16.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-32950310

RESUMO

BACKGROUND: Two previous national epidemiological studies, IBERPOC in 1997 and EPISCAN in 2007, determined the COPD burden in Spain. Changes in demographics and exposure to risk factors demand the periodic update of COPD prevalence and its determinants. METHODS: EPISCAN II aimed to estimate the prevalence of COPD in the general population aged 40 years or older in all 17 regions of Spain. A random population screening sample, requiring 600 participants per region performed a questionnaire plus post-bronchodilator (post-BD) spirometry. RESULTS: A total of 12,825 subjects were initially contacted, and 9433 (73.6%) agreed to participate, of whom 9092 performed a valid spirometry. Baseline characteristics were: 52.6% women, mean±SD age 60±11 years, 19.8% current- and 34.2% former-smokers. The prevalence of COPD measured by post-BD fixed ratio FEV1/FVC<0.7 was 11.8% (95% C.I. 11.2-12.5) with a high variability by region (2.4-fold). Prevalence was 14.6% (95% C.I. 13.5-15.7) in males and 9.4% (95% C.I. 8.6-10.2) in females; according to the lower limit of normal (LLN) was 6.0% (95% C.I. 5.5-6.5) overall, by sex being 7.1% (95% C.I. 6.4-8.0) in males and 4.9% (95% C.I. 4.3-5.6) in females. Underdiagnosis of COPD was 74.7%. Cases with COPD were a mean of seven years older, more frequently male, of lower attained education, and with more smokers than the non-COPD population (p<0.001). However, the number of cigarettes and pack-years in non-COPD participants was substantial, as it was the reported use of e-cigarettes (7.0% vs. 5.5%) (p=0.045). There were also significant social and clinical differences including living alone, previous respiratory diagnoses, more comorbidities measured with the Charlson index, greater BODE and COTE scores, cognitive impairment, and depression (all p<0.001). CONCLUSIONS: COPD remains prevalent in Spain and frequently underdiagnosed.

14.
Int J Chron Obstruct Pulmon Dis ; 15: 2091-2100, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32943862

RESUMO

Chronic airflow obstruction affects a wide range of airway diseases, the most frequent of which are asthma, COPD, and bronchiectasis; they are clearly identifiable in their extremes, but quite frequently overlap in some of their pathophysiological and clinical characteristics. This has generated the description of new mixed or overlapping disease phenotypes with no clear biological grounds. In this special article, a group of experts provides their perspective and proposes approaching the treatment of chronic airway disease (CAD) through the identification of a series of therapeutic goals (TG) linked to treatable traits (TT) - understood as clinical, physiological, or biological characteristics that are quantifiable using biomarkers. This therapeutic approach needs validating in a clinical trial with the strategy of identification of TG and treatment according to TT for each patient independently of their prior diagnosis.

15.
Int J Chron Obstruct Pulmon Dis ; 15: 1801-1811, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32884252

RESUMO

Introduction: Despite the evidence provided by clinical trials, there are some uncertainties and controversies regarding the use of triple inhaled therapy. With the aim of evaluating clinical practice in specialized respiratory units, a Delphi consensus document was implemented on the use of single-inhaler fixed-dose triple therapies after 1 year of use in Spain. Methods: A scientific committee of COPD experts defined a thematic index, guided a systematic literature review and helped design the Delphi questionnaire. This was sent to the other 45 COPD experts between April and June 2019. Agreement/disagreement on 58 statements was tested in two rounds using a Likert scale. Replies were classified as a consensus when ≥80% of the panelists agreed; a majority when a degree of agreement of ≥66% was reached; and divergence if agreement was <66%. Results: After two rounds, 44.44% of the statements reached consensus, 14.81% reached majority and 40.74% were divergent. Panelists agreed that escalating from double bronchodilation should be phenotype-based and aim to prevent exacerbations but not for improving symptoms. The addition of an antimuscarinic to inhaled corticosteroids combinations achieves improvement in lung function, symptoms and exacerbation prevention. Main safety concerns included the increased risk of pneumonia as compared to bronchodilator therapies, with similar cardiovascular effects. There was no consensus agreement on patient type response based on blood eosinophil counts or obstruction severity. Conclusion: The low degree of consensus among panelists may reflect the complexity of severe COPD management. The information provided here may be useful to clinicians implementing personalized medicine for COPD patients.

16.
PLoS One ; 15(8): e0238216, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32841275

RESUMO

INTRODUCTION: Coronavirus disease 2019 (COVID-19) pneumonia is associated to systemic hyper-inflammation and abnormal coagulation profile. D-dimer elevation is particularly frequent, and values higher than 1µg/mL have been associated with disease severity and in-hospital mortality. Previous retrospective studies found a high pulmonary embolism (PE) prevalence, however, it should be highlighted that diagnoses were only completed when PE was clinically suspected. MATERIAL AND METHODS: Single-center prospective cohort study. Between April 6th and April 17th 2020, consecutive confirmed cases of COVID-19 pneumonia with D-dimer >1 µg/mL underwent computed tomography pulmonary angiography (CTPA) to investigate the presence and magnitude of PE. Demographic and laboratory data, comorbidities, CTPA scores, administered treatments, and, clinical outcomes were analysed and compared between patients with and without PE. RESULTS: Thirty consecutive patients (11 women) were included. PE was diagnosed in 15 patients (50%). In patients with PE, emboli were located mainly in segmental arteries (86%) and bilaterally (60%). Patients with PE were significantly older (median age 67.0 (IQR 63.0-73.0) vs. 57.0 (IQR 48.0-69.0) years, p = .048) and did not differ in sex or risk factors for thromboembolic disease from the non-PE group. D-dimer, platelet count, and, C reactive protein values were significantly higher among PE patients. D-dimer values correlated with the radiologic magnitude of PE (p<0.001). CONCLUSIONS: Patients with COVID-19 pneumonia and D-dimer values higher than 1 µg/mL presented a high prevalence of PE, regardless of clinical suspicion. We consider that these findings could contribute to improve the prognosis of patients with COVID-19 pneumonia, by initiating anticoagulant therapy when a PE is found.


Assuntos
Infecções por Coronavirus/complicações , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Pneumonia Viral/complicações , Embolia Pulmonar/virologia , Idoso , Betacoronavirus , Angiografia por Tomografia Computadorizada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Prevalência , Estudos Prospectivos , Embolia Pulmonar/diagnóstico , Espanha
17.
JMIR Public Health Surveill ; 6(3): e21653, 2020 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-32845852

RESUMO

BACKGROUND: Hospital workers have been the most frequently and severely affected professional group during the COVID-19 pandemic, and have a big impact on transmission. In this context, innovative tools are required to measure the symptoms compatible with COVID-19, the spread of infection, and testing capabilities within hospitals in real time. OBJECTIVE: We aimed to develop and test an effective and user-friendly tool to identify and track symptoms compatible with COVID-19 in hospital workers. METHODS: We developed and pilot tested Hospital Epidemics Tracker (HEpiTracker), a newly designed app to track the spread of COVID-19 among hospital workers. Hospital staff in 9 hospital centers across 5 Spanish regions (Andalusia, Balearics, Catalonia, Galicia, and Madrid) were invited to download the app on their phones and to register their daily body temperature, COVID-19-compatible symptoms, and general health score, as well as any polymerase chain reaction and serological test results. RESULTS: A total of 477 hospital staff participated in the study between April 8 and June 2, 2020. Of note, both health-related (n=329) and non-health-related (n=148) professionals participated in the study; over two-thirds of participants (68.8%) were health workers (43.4% physicians and 25.4% nurses), while the proportion of non-health-related workers by center ranged from 40% to 85%. Most participants were female (n=323, 67.5%), with a mean age of 45.4 years (SD 10.6). Regarding smoking habits, 13.0% and 34.2% of participants were current or former smokers, respectively. The daily reporting of symptoms was highly variable across participating hospitals; although we observed a decline in adherence after an initial participation peak in some hospitals, other sites were characterized by low participation rates throughout the study period. CONCLUSIONS: HEpiTracker is an already available tool to monitor COVID-19 and other infectious diseases in hospital workers. This tool has already been tested in real conditions. HEpiTracker is available in Spanish, Portuguese, and English. It has the potential to become a customized asset to be used in future COVID-19 pandemic waves and other environments. TRIAL REGISTRATION: ClinicalTrials.gov NCT04326400; https://clinicaltrials.gov/ct2/show/NCT04326400.


Assuntos
Infecções por Coronavirus/epidemiologia , Epidemias , Hospitais , Programas de Rastreamento/métodos , Aplicativos Móveis , Recursos Humanos em Hospital , Pneumonia Viral/epidemiologia , Vigilância da População/métodos , Adulto , Betacoronavirus , Temperatura Corporal , Infecções por Coronavirus/complicações , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Revelação , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Projetos Piloto , Pneumonia Viral/complicações , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Espanha/epidemiologia , Telemedicina
18.
BMC Med Res Methodol ; 20(1): 212, 2020 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-32819285

RESUMO

BACKGROUND: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. METHODS: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. CONCLUSIONS: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

20.
Arch Bronconeumol ; 2020 May 19.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-32439253

RESUMO

BACKGROUND: There is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR). RESEARCH QUESTION: To determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR. STUDY DESIGN AND METHODS: A multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly (usual care). RESULTS: Ninety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9m (95% CI -4.1/+43.8)] and Chronic Respiratory Disease Questionnaire - Emotion score [0.4 points (0-0.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.0-15.4)] and Chronic Respiratory Disease Questionnaire - Emotion [0.5, (0.2-0.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models. CONCLUSIONS: The TelePR maintenance strategy was both feasible and safe but failed to show superiority over usual care, despite improvements in some HRQoL domains. Acute exacerbations may have an important negative influence on long-term physical function. CLINICALTRIALS. GOV IDENTIFIER: NCT03247933.

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