Impact of obesity on the clinical profile of a population-based sample with chronic obstructive pulmonary disease.

AIMS: To characterize the distribution of BMI in a population-based sample of COPD patients and to evaluate the impact of obesity on their health status, exercise tolerance, systemic inflammation and comorbidity. METHODS: A population-based sample of 3,797 subjects aged 40-80 years from the EPI-SCAN study was selected. Subjects were categorized according their body mass index (BMI) as underweight (<18.5 kg/m2), normal weight (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (BMI≥30.0 kg/m2). Subjects were evaluated with post-bronchodilator spirometry and 6-minute walk tests. Smoking habits, respiratory symptoms, generic and specific quality of life, daily physical activities, comorbidities and systemic inflammatory biomarkers were recorded. RESULTS: The prevalence of obesity or being overweight was higher in the 382 COPD patients than in the subjects without airflow limitation (29.4%, 95%CI 24.8-33.9% vs. 24.3, 95%CI 22.9-25.8; and 44.7%, 95%CI 39.7-49.6% vs. 43.0%, 95%CI 41.3-44.6, respectively; p = 0.020). In the COPD subgroup, obese subjects presented more dyspnea and less chronic cough, chronic bronchitis or chronic phlegm than normal-weight patients, as well as a worse health status. Moreover, reduced exercise tolerance and higher plasmatic C-reactive protein levels were found in the obese patients, who also presented a greater prevalence of cardiovascular disease (adjusted odds ratio 4.796, 95%CI 1.806-12.736, p = 0.002). CONCLUSIONS: In a population-based sample, obesity is more prevalent in COPD patients than in subjects without airflow limitation. Furthermore, obesity affects the clinical manifestations, quality of life and exercise tolerance of COPD patients, and it may contribute to a phenotype characterized by increased systemic inflammation and greater frequency of cardiovascular comorbidity.

Infradiagnóstico de la enfermedad pulmonar obstructiva crónica en mujeres: cuantificación del problema, determinantes y propuestas de acción / Underdiagnosis of Chronic Obstructive Pulmonary Disease in Women: Quantification of the Problem, Determinants and Proposed Actions

Introducción: La distribución de la enfermedad pulmonar obstructiva crónica (EPOC) en mujeres y su infradiagnóstico y determinantes en la población no están bien descritos. El estudio EPI-SCAN es un estudio epidemiológico, observacional, realizado en 11 centros españoles en la población general de edades entre 40 y 80 años. Pacientes y método: En este trabajo se describen las tasas y se extrapola la carga poblacional a partir de los 3.802 participantes del estudio EPI-SCAN. Resultados: Con 2.005 mujeres y 1.797 hombres participantes, se obtuvo una prevalencia de EPOC inferior en mujeres (5,7%; IC95%, 4,7-6,7) que en hombres (15,1%; IC95%, 13,5-16,8; p<0,05). Entre los 386 participantes con EPOC, las 114 (29,5%) mujeres eran más jóvenes, menos fumadoras actualmente y tenían menor exposición tabáquica, y referían menos nivel de estudios (p<0,05). Respecto a los síntomas respiratorios, no existían diferencias por sexo en tos, disnea o sibilantes, pero las mujeres con EPOC referían esputo menos frecuentemente (p<0,05). No existían diferencias en la gravedad espirométrica de la EPOC entre mujeres y hombres. El 73% de los pacientes con criterios de EPOC fueron infradiagnosticados, y este porcentaje se distribuye desigualmente por sexo, siendo 1,27 veces más frecuente en mujeres (86,0%) que en hombres (67,6%) (p<0,05). Extrapolando las tasas de prevalencia e infradiagnóstico de EPOC a la población, se estima que en España entre las mujeres con edades comprendidas entre 40 y 80 años existirían 628.102 mujeres con EPOC, de las cuales 540.168 aún estarían sin diagnosticar. Conclusiones: La EPOC está más infradiagnosticada en mujeres que en hombres en España (AU)

Introduction: The distribution of chronic obstructive pulmonary disease (COPD) in women, and its underdiagnosis and determinants in the general population, have not been well described. The EPI-SCAN study is an epidemiologic, observational study conducted at 11 Spanish centers on the general population aged 40–80. Patients and method: This paper describes the rates and extrapolates the population burden from the 3802 participants of the EPI-SCAN study. Results: With 2005 female and 1797 male participants, there was a lower prevalence of COPD in women (5.7%; 95% CI, 4.7–6.7) than in men (15.1%; 95% CI, 13.5–16.8; P<0.05). Among the 386 participants with COPD, 114 (29.5%) were women, who were younger, currently smoked less and had lower tobacco smoke exposure, while reporting a lower level of education (P<0.05). As for the respiratory symptoms, there were no differences between sexes for cough, dyspnea or wheezing, but the women with COPD reported sputum less frequently (P<0.05). There were no differences in the spirometric severity of COPD between women and men. Overall, 73% of the patients with spirometric COPD criteria were underdiagnosed, and this percentage is unevenly distributed by sex, being 1.27 times more frequent in women (86.0%) than in men (67.6%) (P<.05). By extrapolating the rates of prevalence and underdiagnosis of COPD to the general population, we estimate that there are 628102 Spanish women between the ages of 40 and 80 with COPD, 540168 of whom still have not been diagnosed. Conclusions: There is a greater underdiagnosis of COPD in women than in men in Spain (AU)

Characterisation of the overlap COPD-asthma phenotype. Focus on physical activity and health status.

BACKGROUND: Patients with COPD may share some clinical characteristics with asthma sufferers. This phenotypic overlap between COPD and asthma is not yet well characterised. METHOD: We have analysed data from the EPI-SCAN study, an epidemiological, population-based study in Spain that included 3885 (40 to 80-year-old) subjects in order to investigate the clinical and systemic inflammatory characteristics of COPD patients previously diagnosed with asthma. Generic and COPD-specific quality of life, as well as physical activity, were also assessed through standardised and validated questionnaires. RESULTS: A total of 385 (10.1%) subjects were diagnosed with COPD, 67 (17.4%) being classified with the COPD-asthma overlap phenotype. Such patients were more likely to have dyspnea and wheezing (p<0.001 in both comparisons) and more frequent exacerbations (p<0.001). No differences in systemic inflammatory markers were observed except for lower NOx concentrations in overlap patients (p=0.013). This overlap phenotype significantly worsened specific quality of life (11.1 units on the St. George's Respiratory Questionnaire (SGRQ), 95%CI: 4.88-17.36) and reduced physical activity (3.49 units on the London Chest Activities of Daily Living (LCADL) scale, 95%CI: 1.06-5.94). CONCLUSIONS: In this population-based study, 17.4% of the individuals identified with COPD had an overlap COPD-asthma phenotype. This patient subgroup had more dyspnea, wheezing, exacerbations, worse respiratory-specific quality of life, and reduced levels of physical activity. Specific interventions may be required to adequately care for this subgroup of patients.

Frequency of multi-dimensional COPD indices and relation with disease activity markers.

Our aim was to describe the population-based distribution of several COPD multi-dimensional indices and to evaluate their relationship with daily physical activity, co-morbidity, health status and systemic inflammatory biomarkers. From a population-based sample of 3,802 subjects aged 40-80 from the EPI-SCAN study, 382 subjects (10.2%) with a post-bronchodilator FEV1/FVC<0.7 were identified as COPD. Smoking habits, respiratory symptoms, quality of life, co-morbidities, lung function and inflammatory biomarkers were recorded. Health status and daily physical activity were assessed using the EQ-5D and LCADL questionnaires, respectively. The new GOLD grading and the BODE, ADO, DOSE, modified DOSE, e-BODE, BODEx, CPI, SAFE and HRS indices were determined. A notable dispersion in the total scores was observed, although 83-88% of the COPD patients were classified into the mildest level and 1-3% in the most severe. The SAFE index was the best independent determinant of daily physical activity; the SAFE and ADO indices were associated with presence of co-morbidity; and the SAFE and modified DOSE indices were independently related to health status. The systemic biomarkers showed a less consistent relation with several indices. In a population-based sample of COPD patients, the SAFE index reaches the highest relation with physical activity, co-morbidity and health status.

Underdiagnosis of chronic obstructive pulmonary disease in women: quantification of the problem, determinants and proposed actions.

INTRODUCTION: The distribution of chronic obstructive pulmonary disease (COPD) in women, and its underdiagnosis and determinants in the general population, have not been well described. The EPI-SCAN study is an epidemiologic, observational study conducted at 11 Spanish centers on the general population aged 40 to 80. PATIENTS AND METHOD: This paper describes the rates and extrapolates the population burden from the 3,802 participants of the EPI-SCAN study. RESULTS: With 2,005 female and 1,797 male participants, there was a lower prevalence of COPD in women (5.7%; 95%CI, 4.7-6.7) than in men (15.1%; 95%CI, 13.5-16.8; P<.05). Among the 386 participants with COPD, 114 (29.5%) were women, who were younger, currently smoked less and had lower tobacco smoke exposure, while reporting a lower level of education (P<.05). As for the respiratory symptoms, there were no differences between sexes for cough, dyspnea or wheezing, but the women with COPD reported sputum less frequently (P<.05). There were no differences in the spirometric severity of COPD between women and men. Overall, 73% of the patients with a spirometric COPD criteria were underdiagnosed, and this percentage is unevenly distributed by sex, being 1.27 times more frequent in women (86.0%) than in men (67.6%) (P<.05). By extrapolating the rates of prevalence and underdiagnosis of COPD to the general population, we estimate that there are 628,102 Spanish women between the ages of 40 and 80 with COPD, 540,168 of whom still have not been diagnosed. CONCLUSIONS: There is a greater underdiagnosis of COPD in women than in men in Spain.

Spirometrically-defined restrictive ventilatory defect: population variability and individual determinants.

BACKGROUND: A spirometrically-defined restrictive ventilatory defect is a common finding when performing spirometry. AIMS: We aimed to determine the frequency, geographical variation, individual consequences, and 'severity' of the restrictive ventilatory defect. METHODS: A population-based study was conducted in Spain. The response rate from 11 participating centres was 88.9%, totalling 3,802 participants. A restrictive ventilatory defect was defined according to pre-bronchodilator spirometry as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC) >0.70 and a predicted FVC <80%, in accordance with current American Thoracic Society/European Respiratory Society guidelines. RESULTS: The prevalence of a restrictive ventilatory defect was 12.7% (95% CI 9.7% to 15.7%), with the highest in Seville (19.4%) and Burgos (18.5%) and the lowest in Oviedo (5.2%) and Madrid-La Princesa (5.7%) (p<0.000). Although most of the participants (97.1%) with a restrictive ventilatory defect were objectively considered 'mild' by spirometry (%predicted FVC 50-80%), they reported more phlegm, dyspnoea, and wheezing than healthy control participants (p<0.000), and scored worse in all St George's Respiratory Questionnaire domains of quality of life and activities of daily living (p<0.000). Interestingly, they scored similarly to participants with chronic obstructive pulmonary disease (COPD) in both (p=0.102 and p=0.217). In a multivariate analysis, older age, male gender, heavy smoking, low education, and high body mass index were independently associated with having a restrictive ventilatory defect. CONCLUSIONS: A restrictive ventilatory defect in spirometry is a common finding (12.7%) with a highly variable geographical distribution (range 3.7) whose population burden is important in terms of quality of life and activities of daily living and similar to that of an obstructive pattern compatible with COPD.

Overdiagnosing subjects with COPD using the 0.7 fixed ratio: correlation with a poor health-related quality of life.

BACKGROUND: The current debate about the lower limit of normal (LLN) vs the 0.7 fixed ratio to diagnose COPD is not completely resolved, and little information about the clinical impact of these different criteria is available. We compared differences in health-related quality of life, exacerbations, exercise tolerance, physical activity, comorbidity, and systemic biomarkers of subjects with FEV(1)/FVC < 0.7 but > LLN (ratio-only group) vs subjects without COPD and those with mild or moderate to severe COPD. METHODS: A population-based sample of 3,802 subjects aged 40 to 80 years from the Epidemiologic Study of COPD in Spain was selected. Subjects were evaluated with postbronchodilator spirometry, quality-of-life and physical activity questionnaires, and 6-min walk tests. Exacerbations within the previous year and comorbidities were recorded. Systemic biomarkers were measured after excluding subjects with conditions associated with systemic inflammatory processes. RESULTS: Fixed-ratio COPD overdiagnosis affects up to 4.6% of subjects aged 40 to 80 years, is more frequent in men, and increases with age. After adjusting for confounding factors, the ratio-only group had a worse health-related quality of life than the non-COPD group, with poorer scores in all questionnaire domains (P < .05). However, no differences between the two groups for respiratory exacerbations, 6-min walk distance, physical activity, or systemic biomarkers were observed. Ratio-only subjects did not present greater risk for cardiovascular disease (adjusted relative OR, 1.47; 95% CI, 0.81-2.64), whereas subjects with mild COPD did (adjusted relative OR, 2.32; 95% CI, 1.11-4.84). CONCLUSIONS: Subjects receiving a diagnosis of COPD by the fixed ratio present worse self-reported quality of life than subjects without COPD but had similar exercise, frequency of exacerbations, and indices of systemic effects.

Systemic inflammation in chronic obstructive pulmonary disease: a population-based study.

BACKGROUND: Elevated circulating levels of several inflammatory biomarkers have been described in selected patient populations with COPD, although less is known about their population-based distribution. The aims of this study were to compare the levels of several systemic biomarkers between stable COPD patients and healthy subjects from a population-based sample, and to assess their distribution according to clinical variables. METHODS: This is a cross-sectional study design of participants in the EPI-SCAN study (40-80 years of age). Subjects with any other condition associated with an inflammatory process were excluded. COPD was defined as a post-bronchodilator FEV1/FVC < 0.70. The reference group was made of non-COPD subjects without respiratory symptoms, associated diseases or prescription of medication. Subjects were evaluated with quality-of-life questionnaires, spirometry and 6-minute walk tests. Serum C-reactive protein (CRP), tumor necrosis factor (TNF)-alpha, interleukins (IL-6 and IL-8), alpha1-antitrypsin, fibrinogen, albumin and nitrites/nitrates (NOx) were measured. RESULTS: We compared 324 COPD patients and 110 reference subjects. After adjusting for gender, age, BMI and tobacco consumption, COPD patients showed higher levels of CRP (0.477 +/- 0.023 vs. 0.376 +/- 0.041 log mg/L, p = 0.049), TNF-alpha (13.12 +/- 0.59 vs. 10.47 +/- 1.06 pg/mL, p = 0.033), IL-8 (7.56 +/- 0.63 vs. 3.57 +/- 1.13 pg/ml; p = 0.033) and NOx (1.42 +/- 0.01 vs. 1.36 +/- 0.02 log nmol/l; p = 0.048) than controls. In COPD patients, serum concentrations of some biomarkers were related to severity and their exercise tolerance was related to serum concentrations of CRP, IL-6, IL-8, fibrinogen and albumin. CONCLUSIONS: Our results provide population-based evidence that COPD is independently associated with low-grade systemic inflammation, with a different inflammatory pattern than that observed in healthy subjects.

[Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. / Satisfacción y preferencia del paciente asmático por los dispositivos de inhalación. Aplicación del FSI-10.

BACKGROUND AND OBJECTIVE: Lack of adherence to inhaled corticosteroid therapy is common in patients with asthma, and it has been suggested that allowing patients to choose their own inhalers would resolve this problem. The FSI-10 (Feeling of Satisfaction with Inhaler) is a self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The aim of this study was to define the measurement properties of the FSI-10 questionnaire and to use this inventory to compare satisfaction and preferences of patients with asthma regarding 3 different devices for delivery of inhaled corticosteroids: Turbuhaler, Accuhaler, and Novolizer. PATIENTS AND METHODS: We performed a multicenter, prospective, observational study in 112 stable asthmatic patients (64 women; mean [SD] age, 37 [22] years) treated on a regular basis with inhaled corticosteroids. The use of the devices was explained to the patients and the order in which they should be used in each case was randomly assigned. The devices were used for 7-day periods and at the end of each the FSI-10 questionnaire was completed for the device used. Once the protocol was completed, patients stated their preference for the different devices used. RESULTS: The FSI-10 was easily understood and rapidly completed, and it exhibited acceptable measurement properties. Factor analysis showed that the measure was unidimensional. Although acceptance of all 3 devices assessed was reasonable, the FSI-10 questionnaire detected significant differences between them: Turbuhaler and Novolizer scored higher than Accuhaler on a number of questions. This preference is partly explained by Turbuhaler having been the device that was commonly used by the patients prior to the study. However, the highest scoring and most often preferred inhaler in patients under 16 years of age was the Novolizer, even though the Turbuhaler had also usually been used by those patients prior to the study. CONCLUSIONS: The FSI-10 is a useful instrument for assessing the degree of satisfaction of asthmatic patients regarding available inhalation devices. It is easy to understand and complete, and able to identify differences in patient satisfaction with the different inhalers.

Satisfacción y preferencia del paciente asmático por los dispositivos de inhalación. Aplicación del FSI-10 / Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 questionnaire

ANTECEDENTES Y OBJETIVO: El incumplimiento terapéutico con los corticoides inhalados (CI) es frecuente en los pacientes con asma. Se ha señalado que la elección del dispensador por el paciente facilitaría la solución del problema. El FSI-10 (Evaluación de la Satisfacción con el Inhalador) es un cuestionario autorrellenable que valora las opiniones sobre comodidad, dificultad, transportabilidad y manejabilidad de los dispositivos para CI. El objetivo de este trabajo ha sido definir las propiedades métricas del FSI-10 y comparar, mediante este inventario, la satisfacción y las preferencias de los pacientes con asma respecto a 3 dispositivos para CI: Turbuhaler® (T), Accuhaler® (A) y Novolizer® (N). PACIENTES Y MÉTODOS: Hemos realizado un estudio observacional, prospectivo y multicéntrico en 112 asmáticos (64 mujeres; edad media ± desviación estándar: 37 ± 22 años) estables y tratados regularmente con CI. Se les explicó la técnica de utilización de los dispositivos a evaluar y, aleatoriamente, se asignó el orden en que debían emplearlos. Usaron los dispositivos durante períodos de 7 días, tras los cuales cumplimentaron el FSI-10. Completado el protocolo, todos ellos expresaron el grado de preferencia por los dispositivos empleados. RESULTADOS: El FSI-10 resultó fácil de comprender y rápido de cumplimentar, y mostró propiedades métricas aceptables. El análisis factorial exploratorio muestra la unidimensionalidad de la medida. La aceptación de los 3 dispositivos evaluados fue razonable, pero el FSI-10 detectó diferencias significativas entre ellos: los sistemas T y N se valoraron mejor que A en bastantes preguntas del cuestionario. Esta preferencia responde en parte al hecho de que T era el dispositivo comúnmente utilizado con anterioridad por los pacientes. Sin embargo, para los menores de 16 años el inhalador preferido y mejor puntuado fue N, a pesar de que en este subgrupo también era el T el habitualmente manejado. CONCLUSIONES: El FSI-10 es un instrumento útil para evaluar el grado de satisfacción del paciente asmático con los dispositivos de inhalación disponibles. Es comprensible, de fácil manejo y capaz de identificar diferencias de satisfacción entre distintos inhaladores

BACKGROUND AND OBJECTIVE: Lack of adherence to inhaled corticosteroid therapy is common in patients with asthma, and it has been suggested that allowing patients to choose their own inhalers would resolve this problem. The FSI-10 (Feeling of Satisfaction with Inhaler) is a self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The aim of this study was to define the measurement properties of the FSI-10 questionnaire and to use this inventory to compare satisfaction and preferences of patients with asthma regarding 3 different devices for delivery of inhaled corticosteroids: Turbuhaler, Accuhaler, and Novolizer. PATIENTS AND METHODS: We performed a multicenter, prospective, observational study in 112 stable asthmatic patients (64 women; mean [SD] age, 37 [22] years) treated on a regular basis with inhaled corticosteroids. The use of the devices was explained to the patients and the order in which they should be used in each case was randomly assigned. The devices were used for 7-day periods and at the end of each the FSI-10 questionnaire was completed for the device used. Once the protocol was completed, patients stated their preference for the different devices used. RESULTS: The FSI-10 was easily understood and rapidly completed, and it exhibited acceptable measurement properties. Factor analysis showed that the measure was unidimensional. Although acceptance of all 3 devices assessed was reasonable, the FSI-10 questionnaire detected significant differences between them: Turbuhaler and Novolizer scored higher than Accuhaler on a number of questions. This preference is partly explained by Turbuhaler having been the device that was commonly used by the patients prior to the study. However, the highest scoring and most often preferred inhaler in patients under 16 years of age was the Novolizer, even though the Turbuhaler had also usually been used by those patients prior to the study. CONCLUSIONS: The FSI-10 is a useful instrument for assessing the degree of satisfaction of asthmatic patients regarding available inhalation devices. It is easy to understand and complete, and able to identify differences in patient satisfaction with the different inhalers

Characteristics of a population of COPD patients identified from a population-based study. Focus on previous diagnosis and never smokers.

OBJECTIVE: To identify factors associated with diagnosis and health-related quality of life (HRQL) impairment in chronic obstructive pulmonary disease (COPD) patients from a population-based epidemiological study. DESIGN AND PARTICIPANTS: This was an epidemiologic, multicenter, population-based study. Three hundred and sixty-three individuals diagnosed with COPD from a randomly general population sample of 4035 individuals aged 40-69 were included in the analyses. INTERVENTIONS: Forced spirometry was performed on eligible subjects, and the European Commission for Steel and Coal (ECSC) and the St. George's Respiratory Questionnaires (SGRQ) were completed. Logistic regression models were constructed to identify variables associated with the previous diagnosis of COPD and with COPD in never smokers. A multiple linear regression model attempted to identify variables influencing HRQL impairment. RESULTS: Only 79 (21.7%) COPD patients had been previously diagnosed. Disease severity based on FEV(1), worse SGRQ score, previous respiratory disease, as well as the presence of wheezing were significantly associated with previous diagnosis. Being a woman, older than 55, with previous respiratory disease and without expectoration or wheezing characterized COPD in never smokers. A worse HRQL was associated with chronic symptoms, especially dyspnea; and with older age, cardiac comorbidity and impairment in lung function. CONCLUSIONS: Diagnosis of COPD in the community is more likely in patients with worse lung function and HRQL, and wheezing is the symptom most strongly associated with a diagnosis of COPD. Women older than 55, with previous respiratory diseases, without respiratory symptoms and mild airflow obstruction constitute the majority of individuals with COPD who have never smoked. Chronic respiratory symptoms are strongly associated with impairment in HRQL.

Can cumulative tobacco consumption, FTND score, and carbon monoxide concentration in expired air be predictors of chronic obstructive pulmonary disease?

Between 15% and 20% of smokers develop chronic obstructive pulmonary disease (COPD). The aim of the present study was to determine which characteristics of smoking, particularly the Fagerström Test for Nicotine Dependence (FTND) score, were associated with the risk of developing COPD. Data from the IBERPOC epidemiological study were analyzed. IBERPOC was a multicenter epidemiological study including 4035 individuals aged 40-69 years, 1023 (25%) of whom were active smokers. We analyzed the association between smoking characteristics--such as the cumulative consumption of tobacco, FTND score, and expired-air carbon monoxide levels--and the diagnosis of COPD. Among the smokers, 153 (15%) were diagnosed with COPD. A cumulative tobacco consumption of more than 30 pack-years (OR=4.24, 95% CI=2.83-6.36) and the FTND score (OR=1.11, 95% CI=1.02-1.21, for each point increase) were significantly associated with the diagnosis of COPD in the model obtained by logistic regression analysis with the full sample of smokers. Cumulative consumption of tobacco was associated with the diagnosis of COPD. For each point increase in the FTND score, the probability of a smoker developing COPD increased by 11%.