Factors that affect blood eosinophil counts in a non-asthmatic population: Post hoc analysis of data from Brazil.

BACKGROUND: Improved understanding of the normal range of blood eosinophil counts (BEC) and conditions that influence them in non-asthmatic individuals should allow more accurate estimation of the threshold at which eosinophilic disease should be considered, diagnosed, and treated. This analysis investigated the impact of atopy, smoking, and parasitic infection on BEC. METHODS: This was a post hoc analysis of non-asthmatic subjects from a case-control study (CONEP 450/10) conducted at the Program for Control of Asthma in Bahia (ProAR). Participant BECs were measured at baseline; correlations between predefined risk factors and BEC were assessed via univariate and stratified analysis. RESULTS: Of the 454 participants included, 3% were helminth parasite-positive, 18% were non-helminth parasite-positive; and 450 had BEC data. The median (interquartile range [IQR]) BEC was 152 (96, 252) cells/µL. Any positive skin prick test, elevated total immunoglobulin E, allergic rhinitis, and being a current smoker were all individually associated with higher BEC (p < 0.05) compared with BEC in participants without these factors, but having a non-helminthic parasitic infection was not. Participants with all 4 risk factors that were associated with higher BEC had a median (IQR) BEC of 192 cells/µL (94, 416) versus 106 cells/µL (70, 164) for those with no risk factors. CONCLUSIONS: In non-asthmatic subjects, atopy, allergic rhinitis, and current smoking status were associated with higher BEC compared with subjects without these factors, but BEC values were well below the threshold commonly accepted as normal. Therefore, BEC should be interpreted in the context of an individual's medical conditions and other BEC-influencing factors.

Body mass index, asthma, and respiratory symptoms: a population-based study.

OBJECTIVE: To estimate the prevalence of respiratory symptoms and asthma, according to body mass index (BMI), as well as to evaluate factors associated with physician-diagnosed asthma, in individuals ≥ 40 years of age. METHODS: This was a population-based cross-sectional study conducted in Florianópolis, Brazil, with probability sampling. Data were collected during home visits. Demographic data were collected, as were reports of physician-diagnosed asthma, respiratory symptoms, medications in use, and comorbidities. Anthropometric measurements were taken. Individuals also underwent spirometry before and after bronchodilator administration. Individuals were categorized as being of normal weight (BMI < 25 kg/m2), overweight (25 kg/m2 ≥ BMI < 30 kg/m2), or obese (BMI ≥ 30 kg/m2). RESULTS: A total of 1,026 individuals were evaluated, 274 (26.7%) were of normal weight, 436 (42.5%) were overweight, and 316 (30.8%) were obese. The prevalence of physician-diagnosed asthma was 11.0%. The prevalence of obesity was higher in women (p = 0.03), as it was in respondents with ≤ 4 years of schooling (p < 0.001) or a family income of 3-10 times the national minimum wage. Physician-diagnosed asthma was more common among obese individuals than among those who were overweight and those of normal weight (16.1%, 9.9%, and 8.0%, respectively; p = 0.04), as were dyspnea (35.5%, 22.5%, and 17.9%, respectively; p < 0.001) and wheezing in the last year (25.6%, 11.9%, and 14.6%, respectively; p < 0.001). These results were independent of patient smoking status. In addition, obese individuals were three times more likely to report physician-diagnosed asthma than were those of normal weight (p = 0.005). CONCLUSIONS: A report of physician-diagnosed asthma showed a significant association with being ≥ 40 years of age and with having a BMI ≥ 30 kg/m2. Being obese tripled the chance of physician-diagnosed asthma.

Body mass index, asthma, and respiratory symptoms: a population-based study / Índice de massa corpórea, asma e sintomas respiratórios: um estudo de base populacional

ABSTRACT Objective: To estimate the prevalence of respiratory symptoms and asthma, according to body mass index (BMI), as well as to evaluate factors associated with physician-diagnosed asthma, in individuals ≥ 40 years of age. Methods: This was a population-based cross-sectional study conducted in Florianópolis, Brazil, with probability sampling. Data were collected during home visits. Demographic data were collected, as were reports of physician-diagnosed asthma, respiratory symptoms, medications in use, and comorbidities. Anthropometric measurements were taken. Individuals also underwent spirometry before and after bronchodilator administration. Individuals were categorized as being of normal weight (BMI < 25 kg/m2), overweight (25 kg/m2 ≥ BMI < 30 kg/m2), or obese (BMI ≥ 30 kg/m2). Results: A total of 1,026 individuals were evaluated, 274 (26.7%) were of normal weight, 436 (42.5%) were overweight, and 316 (30.8%) were obese. The prevalence of physician-diagnosed asthma was 11.0%. The prevalence of obesity was higher in women (p = 0.03), as it was in respondents with ≤ 4 years of schooling (p < 0.001) or a family income of 3-10 times the national minimum wage. Physician-diagnosed asthma was more common among obese individuals than among those who were overweight and those of normal weight (16.1%, 9.9%, and 8.0%, respectively; p = 0.04), as were dyspnea (35.5%, 22.5%, and 17.9%, respectively; p < 0.001) and wheezing in the last year (25.6%, 11.9%, and 14.6%, respectively; p < 0.001). These results were independent of patient smoking status. In addition, obese individuals were three times more likely to report physician-diagnosed asthma than were those of normal weight (p = 0.005). Conclusions: A report of physician-diagnosed asthma showed a significant association with being ≥ 40 years of age and with having a BMI ≥ 30 kg/m2. Being obese tripled the chance of physician-diagnosed asthma.

RESUMO Objetivo: Estimar a prevalência de sintomas respiratórios e asma de acordo com o índice de massa corpórea (IMC) em indivíduos com idade ≥ 40 anos e avaliar os fatores associados ao relato de diagnóstico médico de asma. Métodos: Estudo transversal de base populacional realizado no município de Florianópolis (SC), com coleta domiciliar de dados e processo de amostragem probabilístico. Foram coletadas informações demográficas, assim como sobre relato de diagnóstico médico de asma, sintomas respiratórios, medicações em uso e comorbidades. Também foram realizadas medidas antropométricas e espirometria pré- e pós-broncodilatador. O IMC foi categorizado em normal (IMC < 25 kg/m2), sobrepeso (25 kg/m2 ≥ IMC < 30 kg/m2) e obesidade (IMC ≥ 30 kg/m2). Resultados: Foram avaliados 1.026 indivíduos, 274 (26,7%) com IMC normal, 436 (42,5%) com sobrepeso e 316 (30,8%) obesos. A prevalência de diagnóstico médico de asma foi de 11,0%. A prevalência de obesidade foi maior em mulheres (p = 0,03) e em entrevistados com escolaridade < 4 anos (p < 0,001) ou com renda familiar entre 3-10 salários mínimos. Obesos, quando comparados com aqueles com sobrepeso e peso normal, relataram mais frequentemente diagnóstico médico de asma (16,1%, 9,9% e 8,0%, respectivamente; p = 0,04), dispneia (35,5%, 22,5% e 17,9%, respectivamente; p < 0,001) e sibilos no último ano (25,6%, 11,9% e 14,6%, respectivamente; p < 0,001). Esses resultados foram independentes do status tabágico. Além disso, obesos tinham uma chance três vezes maior de relato de diagnóstico médico de asma do que não obesos (p = 0,005). Conclusões: Houve associação significativa entre o relato de diagnóstico médico de asma em indivíduos com idade ≥ 40 anos e IMC ≥ 30 kg/m2. Ser obeso triplicou a chance de diagnóstico médico de asma.

Prevalence and Characteristics of Asthma-Chronic Obstructive Pulmonary Disease Overlap in Routine Primary Care Practices.

Rationale: Adults may exhibit characteristics of both asthma and chronic obstructive pulmonary disease (COPD), a situation recently described as asthma-COPD overlap (ACO). There is a paucity of information about ACO in primary care.Objectives: To estimate the prevalence and describe characteristics of individuals with ACO in primary care practices among patients currently diagnosed with asthma, COPD, or both; and to compare the prevalence and characteristics of ACO among the three source populations.Methods: The Respiratory Effectiveness Group conducted a cross-sectional study of individuals ≥40 years old and with ≥2 outpatient primary care visits over a 2-year period in the UK Optimum Patient Care Research Database. Patients were classified into one of three source populations based on diagnostic codes: 1) COPD only, 2) both asthma and COPD, or 3) asthma only. ACO was defined as the presence of all of the following 1) age ≥40 years, 2) current or former smoking, 3) post-bronchodilator airflow limitation (forced expiratory volume in 1 second/forced vital capacity <0.7), and 4) ≥12% and ≥200 ml reversibility in post-bronchodilator forced expiratory volume in 1 second.Results: Among 2,165 individuals (1,015 COPD only, 395 with both asthma and COPD, and 755 asthma only), the overall prevalence of ACO was 20% (95% confidence interval, 18-23%). Patients with ACO had a mean age of 70 years (standard deviation, 11 yr), 60% were men, 73% were former smokers (the rest were current smokers), and 66% were overweight or obese. Comorbid conditions were common in patients with ACO, including diabetes (53%), cardiovascular disease (36%), hypertension (30%), eczema (23%), and rhinitis (21%). The prevalence of ACO was higher in patients with a diagnosis of both asthma and COPD (32%) compared with a diagnosis of COPD only (20%; P < 0.001) or asthma only (14%; P < 0.001). Demographic and clinical characteristics of ACO varied across these three source populations.Conclusions: One in five individuals with a diagnosis of COPD, asthma, or both asthma and COPD in primary care settings have ACO based on the Respiratory Effectiveness Group ACO Working group criteria. The prevalence and characteristics of patients with ACO varies across the three source populations.

Prevalence of smoking and reasons for continuing to smoke: a population-based study.

OBJECTIVE: To investigate the prevalence of smoking and the reasons for continuing to smoke among adults in Brazil. METHODS: This was a cross-sectional, population-based study including 1,054 individuals ≥ 40 years of age, residents of the city of Florianopolis, Brazil, of whom 183 were smokers. All of the smokers completed the University of São Paulo Reasons for Smoking Scale (USP-RSS). Depressive symptoms were evaluated with the Hospital Anxiety and Depression Scale, and spirometry was performed to screen for COPD. RESULTS: Of the 183 smokers, 105 (57.4%) were female, 138 (75.4%) were White, and 125 (63.8%) were in a low economic class. The mean level of education among the smokers was 9.6 ± 6.1 years. The mean smoking history was 29 ± 15 pack-years, 59% of the men having a ≥ 30 pack-year smoking history. Approximately 20% of the smokers had COPD, and 29% had depressive symptoms, which were more common in the women. The USP-RSS scores were highest for the pleasure of smoking (PS), tension reduction (TR), and physical dependence (PD) domains (3.9 ± 1.1, 3.6 ± 1.2, and 3.5 ± 1.3, respectively). Scores for the PS, TR, and weight control (WC) domains were significantly higher in women. Smokers with a > 20 pack-year smoking history scored significantly higher on the PD, PS, automatism, and close association (CA) domains. Smoking history was associated with the PD, PS, TR, and CA domains. Depressive symptoms were associated with the PD, social smoking, and CA domains (p = 0.001; p = 0.01; p = 0.09, respectively). Female gender and a low level of education were associated with the PS domain (p = 0.04) and TR domain (p < 0.001). CONCLUSIONS: The prevalence of smoking in our sample was relatively high (17.4%). The USP-RSS domains PS, TR, and WC explain why individuals continue smoking, as do depressive symptoms.

Translation and cultural adaptation of the King's Brief Interstitial Lung Disease health status questionnaire for use in Brazil / Tradução e adaptação cultural do King's Brief Interstitial Lung Disease health status questionnaire

ABSTRACT Objective: To translate the King's Brief Interstitial Lung Disease (K-BILD) questionnaire to Portuguese and culturally adapt it for use in Brazil. The K-BILD quantifies the health status of patients with ILD. Methods: The process involved the following steps: authorization from the author of the original (English-language) questionnaire; translation of the questionnaire to Portuguese by three translators, working independently; merging of the translations by a committee of specialists; back-translation of the questionnaire to English; revision and readjustment of the back-translation by the committee of specialists; evaluation by the original author; revision of the back-translation; cognitive debriefing (verification of the clarity and acceptability of the Portuguese-language version in the target population-i.e., patients with ILD); and finalization of the Portuguese-language version. Results: In the cognitive debriefing step, 20 patients with ILD were interviewed. After the interviews, the clarity and acceptability index of each question was ≥ 0.8, which is considered acceptable. Conclusions: The Portuguese-language version of K-BILD appears to be easily administered to and understood by patients with ILD in Brazil. To our knowledge, this is the only instrument in Brazilian Portuguese that is designed to evaluate the impact that ILD has on the various aspects of the lives of those it affects.

RESUMO Objetivo: Traduzir e adaptar culturalmente o King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire, utilizado para mensurar o estado de saúde em pacientes com doença pulmonar intersticial (DPI), para a língua portuguesa falada no Brasil. Métodos: As seguintes etapas foram realizadas: autorização do autor do instrumento original; preparação; tradução do K-BILD da língua inglesa para a língua portuguesa falada no Brasil por três tradutores independentes; unificação das traduções por um comitê de especialistas; retradução do português para o inglês; revisão e readequação da retradução pelo comitê de especialistas; avaliação do autor do original; revisão da versão em inglês; desdobramento cognitivo (observação da clareza e aceitabilidade do questionário traduzido na população-alvo); e elaboração da versão final em português. Resultados: Na etapa de desdobramento cognitivo foram entrevistados 20 pacientes com DPI. Após todas as entrevistas, o índice de clareza e aceitabilidade das questões foi igual ou maior que 0,8, indicando um índice de clareza aceitável para todas as questões. Conclusões: A versão do K-BILD mostrou ser compreensível e de fácil aplicação. Até onde sabemos, esse é atualmente o único instrumento disponível em português falado no Brasil dirigido à avaliação do impacto da DPI em vários aspectos da vida desses pacientes.

Prevalence of smoking and reasons for continuing to smoke: a population-based study / Prevalência de tabagismo e motivos para continuar a fumar: estudo de base populacional

ABSTRACT Objective: To investigate the prevalence of smoking and the reasons for continuing to smoke among adults in Brazil. Methods: This was a cross-sectional, population-based study including 1,054 individuals ≥ 40 years of age, residents of the city of Florianopolis, Brazil, of whom 183 were smokers. All of the smokers completed the University of São Paulo Reasons for Smoking Scale (USP-RSS). Depressive symptoms were evaluated with the Hospital Anxiety and Depression Scale, and spirometry was performed to screen for COPD. Results: Of the 183 smokers, 105 (57.4%) were female, 138 (75.4%) were White, and 125 (63.8%) were in a low economic class. The mean level of education among the smokers was 9.6 ± 6.1 years. The mean smoking history was 29 ± 15 pack-years, 59% of the men having a ≥ 30 pack-year smoking history. Approximately 20% of the smokers had COPD, and 29% had depressive symptoms, which were more common in the women. The USP-RSS scores were highest for the pleasure of smoking (PS), tension reduction (TR), and physical dependence (PD) domains (3.9 ± 1.1, 3.6 ± 1.2, and 3.5 ± 1.3, respectively). Scores for the PS, TR, and weight control (WC) domains were significantly higher in women. Smokers with a > 20 pack-year smoking history scored significantly higher on the PD, PS, automatism, and close association (CA) domains. Smoking history was associated with the PD, PS, TR, and CA domains. Depressive symptoms were associated with the PD, social smoking, and CA domains (p = 0.001; p = 0.01; p = 0.09, respectively). Female gender and a low level of education were associated with the PS domain (p = 0.04) and TR domain (p < 0.001). Conclusions: The prevalence of smoking in our sample was relatively high (17.4%). The USP-RSS domains PS, TR, and WC explain why individuals continue smoking, as do depressive symptoms.

RESUMO Objetivo: Investigar a prevalência de tabagismo e as razões para continuar a fumar em adultos no Brasil. Métodos: Estudo transversal de base populacional com 1.054 indivíduos com idade ≥ 40 anos residentes em Florianópolis (SC), dos quais 183 eram tabagistas. Todos os fumantes preencheram a Escala Razões para Fumar da Universidade de São Paulo (ERF-USP). Os sintomas de depressão foram avaliados por meio da Hospital Anxiety and Depression Scale, e a presença ou ausência de DPOC foi determinada por meio de espirometria. Resultados: Dos 183 fumantes, 105 (57,4%) eram do sexo feminino, 138 (75,4%) eram brancos e 125 (63,8%) pertenciam a uma classe econômica baixa. A média de escolaridade entre os fumantes foi de 9,6 ± 6,1 anos. A média de carga tabágica foi de 29 ± 15 anos-maço, e 59% dos homens apresentavam carga tabágica ≥ 30 anos-maço. Aproximadamente 20% dos fumantes apresentavam DPOC, e 29% apresentavam sintomas de depressão, mais comuns entre as mulheres. A pontuação obtida na ERF-USP foi maior nos domínios prazer de fumar (PF), redução da tensão (RT) e dependência física (DF): 3,9 ± 1,1; 3,6 ± 1,2 e 3,5 ± 1,3, respectivamente. A pontuação obtida nos domínios PF, RT e controle de peso (CP) foi significativamente maior entre as mulheres. Fumantes com carga tabágica > 20 anos-maço obtiveram pontuação significativamente maior nos domínios DF, PF, automatismo e associação estreita (AE). A carga tabágica relacionou-se com os domínios DF, PF, RT e AE. Sintomas de depressão relacionaram-se com os domínios DF, tabagismo social e AE (p = 0,001; p = 0,01; p = 0,09, respectivamente). Sexo feminino e baixa escolaridade relacionaram-se com os domínios PF (p = 0,04) e RT (p < 0,001). Conclusões: A prevalência de tabagismo em nossa amostra foi relativamente alta (17,4%). Os domínios PF, RT e CP da ERF-USP, bem como os sintomas de depressão, explicam por que os indivíduos continuam a fumar.

The patient profile of individuals with Alpha-1 antitrypsine gene mutations at a referral center in Brazil.

OBJECTIVE: The clinical, functional, radiological and genotypic descriptions of patients with an alpha-1 antitrypsin (A1AT) gene mutation in a referral center for COPD in Brazil. METHODS: A cross-sectional study of patients with an A1AT gene mutation compatible with deficiency. We evaluated the A1AT dosage and genotypic, demographic, clinical, tomographic, and functional characteristics of these patients. RESULTS: Among the 43 patients suspected of A1AT deficiency (A1ATD), the disease was confirmed by genotyping in 27 of them. The A1AT median dosage was 45 mg/dL, and 4 patients (15%) had a normal dosage. Median age was 54, 63% of the patients were male, and the respiratory symptoms started at the age of 40. The median FEV1 was 1.37L (43% predicted). Tomographic emphysema was found in 77.8% of the individuals. The emphysema was panlobular in 76% of them and 48% had lower lobe predominance. The frequency of bronchiectasis was 52% and the frequency of bronchial thickening was 81.5%. The most common genotype was Pi*ZZ in 40.7% of participants. The other genotypes found were: Pi*SZ (18.5%), PiM1Z (14.8%), Pi*M1S (7.4%), Pi*M2Z (3.7%), Pi*M1I (3.7%), Pi*ZMnichinan (3.7%), Pi*M3Plowell (3.7%), and Pi*SF (3.7%). We did not find any significant difference in age, smoking load, FEV1, or the presence of bronchiectasis between the groups with a normal and a reduced A1AT dosage, neither for 1 nor 2-allele mutation for A1ATD. CONCLUSIONS: Our patients presented a high frequency of emphysema, bronchiectasis and bronchial thickening, and early-beginning respiratory symptoms. The most frequent genotype was Pi*ZZ. Heterozygous genotypes and normal levels of A1AT also manifested significant lung disease.

Evaluation of the preference, satisfaction and correct use of Breezhaler® and Respimat® inhalers in patients with chronic obstructive pulmonary disease - INHALATOR study.

The INHALATOR study was a randomized, multicentre, open label, two-period of 7 days each, crossover study, with 7 days of washout in-between, aiming to evaluate the correct use, satisfaction and preference between Breezhaler® and Respimat® devices in patients under daily use of open Spiriva® or open Onbrize®, as monotherapy for treatment of mild or moderate COPD. Patients aged ≥40 years with a smoking history of at least 10 pack-year were included in the study. Primary endpoint was the rate of correct use of each device at the first day of treatment after reading the drug leaflet information and was evaluated under the supervision of a trained evaluator. At the end of each treatment phase, the inhaler use was re-evaluated and a satisfaction questionnaire was completed. The patients' preference for the inhaler devices was assessed at the end of the study. After exclusions due to screening failures, 140 patients were randomized: 136 received at least one dose of Breezhaler® and 135 of Respimat®. At treatment start, the rate of correct inhaler use was 40.4% (95%CI: 32.2%-48.7%) for Breezhaler® and 36.3% (95%CI: 28.2%-44.4%) for Respimat® (p = 0.451). After 7 days, the rates were 68.9% (95%CI: 61.1%-76.7%) and 60.4% (95%CI: 52.2%-68.7%), respectively (p = 0.077). According to the Feeling of Satisfaction with Inhaler Questionnaire - FSI 10 patients were more satisfied using Breezhaler® than Respimat® and 57.1% preferred using Breezhaler® (p = 0.001) while 30.1% preferred Respimat® (p < 0.001).

The patient profile of individuals with Alpha-1 antitrypsine gene mutations at a referral center in Brazil / Perfil dos pacientes com mutação no gene da alfa-1 antitripsina em um centro de referência no Brasil

ABSTRACT Objective: The clinical, functional, radiological and genotypic descriptions of patients with an alpha-1 antitrypsin (A1AT) gene mutation in a referral center for COPD in Brazil. Methods: A cross-sectional study of patients with an A1AT gene mutation compatible with deficiency. We evaluated the A1AT dosage and genotypic, demographic, clinical, tomographic, and functional characteristics of these patients. Results: Among the 43 patients suspected of A1AT deficiency (A1ATD), the disease was confirmed by genotyping in 27 of them. The A1AT median dosage was 45 mg/dL, and 4 patients (15%) had a normal dosage. Median age was 54, 63% of the patients were male, and the respiratory symptoms started at the age of 40. The median FEV1 was 1.37L (43% predicted). Tomographic emphysema was found in 77.8% of the individuals. The emphysema was panlobular in 76% of them and 48% had lower lobe predominance. The frequency of bronchiectasis was 52% and the frequency of bronchial thickening was 81.5%. The most common genotype was Pi*ZZ in 40.7% of participants. The other genotypes found were: Pi*SZ (18.5%), PiM1Z (14.8%), Pi*M1S (7.4%), Pi*M2Z (3.7%), Pi*M1I (3.7%), Pi*ZMnichinan (3.7%), Pi*M3Plowell (3.7%), and Pi*SF (3.7%). We did not find any significant difference in age, smoking load, FEV1, or the presence of bronchiectasis between the groups with a normal and a reduced A1AT dosage, neither for 1 nor 2-allele mutation for A1ATD. Conclusions: Our patients presented a high frequency of emphysema, bronchiectasis and bronchial thickening, and early-beginning respiratory symptoms. The most frequent genotype was Pi*ZZ. Heterozygous genotypes and normal levels of A1AT also manifested significant lung disease.

RESUMO Objetivo: Caracterização clínica, funcional, radiológica e genotípica dos pacientes portadores de mutações do gene da alfa-1 antitripsina (A1AT) em um centro de referência em doença pulmonar obstrutiva crônica (DPOC) no Brasil. Métodos: Estudo transversal de pacientes com mutação no gene da A1AT compatível com deficiência. Foram avaliadas características genotípicas, demográficas, clínicas, tomográficas, de função pulmonar, e dosagem de A1AT. Resultados: De 43 pacientes suspeitos para deficiência de alfa-1 antitripsina (DA1AT), a doença foi confirmada por genotipagem em 27. A mediana da dosagem de A1AT foi de 45 mg/dL, e 4 pacientes (15%) apresentavam dosagens normais. A idade mediana foi de 54 anos, 63% dos participantes eram do sexo masculino e a idade do início dos sintomas prevalente foi aos 40 anos. A mediana do volume expiratório forçado no primeiro segundo (VEF1) foi de 1,37 L (43% do previsto). Enfisema tomográfico foi encontrado em 77,8% dos indivíduos, sendo panlobular em 76% e de predomínio em lobos inferiores em 48%. A frequência de bronquiectasias foi de 52%, e a de espessamento brônquico, de 81,5%. O genótipo mais encontrado foi Pi*ZZ (40,7%). Os demais genótipos foram: Pi*SZ (18,5%), Pi*M1Z (14,8%), Pi*M1S (7,4%), Pi*M2Z (3,7%), Pi*M1I (3,7%), Pi*ZMnichinan (3,7%), Pi*M3Plowell (3,7%) e Pi*SF (3,7%). Não encontramos diferença significativa para idade, carga tabágica, VEF1 e presença de bronquiectasias entre os grupos com dosagem de A1AT normal versus alterada, nem entre 1 alelo versus 2 alelos com mutação para DA1AT. Conclusões: Nossos pacientes apresentaram alta frequência de enfisema, bronquiectasias e espessamento brônquico, com início precoce dos sintomas respiratórios. O genótipo mais frequente foi Pi*ZZ, embora genótipos heterozigotos e níveis normais de A1AT também tenham se manifestado com doença pulmonar significativa.

Rhinosinusitis symptoms, smoking and COPD: Prevalence and associations.

OBJECTIVE (S): To estimate the prevalence and associations among rhinosinusitis symptoms, smoking and chronic obstructive pulmonary disease (COPD). DESIGN: Cross-sectional study. SETTING: Population-based. PARTICIPANTS: All adults aged 40 years or more living in the selected households in the city of Florianópolis (Florianópolis, Santa Catarina, Brazil). MAIN OUTCOME MEASURES: Assessment instruments comprised household interviews, anthropometric measurements and spirometry. Rhinosinusitis symptoms were based on the responses to the 22-item Sinonasal Outcome Test (SNOT-22) questionnaire; smoking status was defined by the criteria of the CDC, and the functional diagnosis of COPD was done by spirometry. RESULTS: The prevalence (n = 1056) of rhinosinusitis symptoms, smoking and COPD was 14.7%, 17.9% and 8.7%, respectively. Multivariate analysis showed that, with the exception of COPD, all other clinical variables (smoking, previous diagnosis of rhinitis, previous diagnosis of gastritis/ulcer/gastroesophageal reflux, and symptoms of depression) remained associated with higher prevalence of rhinosinusitis symptoms. CONCLUSIONS: Rhinosinusitis symptoms were common both in smokers and in patients with COPD. However, only tobacco was significantly associated with rhinosinusitis symptoms and can act as a cofounder in the association between COPD and rhinosinusitis symptoms.

Is the COPD Assessment Test sensitive for differentiating COPD patients from active smokers and nonsmokers without lung function impairment? A population-based study.

OBJECTIVE: To assess COPD Assessment Test (CAT) scores in adults with and without COPD, as well as to compare the CAT scores for nonsmokers, former smokers, and smokers without COPD with those for patients with COPD. METHODS: This was a cross-sectional population-based study (the Respira Floripa study). The study included adults ≥ 40 years of age residing in the city of Florianópolis, Brazil. A total of 846 households were surveyed. In addition to completing the Respira Floripa questionnaire and the CAT, participants underwent pulmonary function testing. RESULTS: We analyzed data on 1,057 participants (88.1% of the predicted sample size). A functional diagnosis of COPD was made in 92 participants (8.7%). Of those, 72% were unaware that they had COPD. The mean CAT score was higher in the group of COPD patients than in that of individuals without COPD (10.6 [95% CI: 8.8-12.4] vs. 6.6 [95% CI: 6.1-7.0]; p < 0.01). Individual item scores were significantly higher in the patients with COPD than in the individuals without COPD (p < 0.001), the exception being the scores for the items related to sleep (p = 0.13) and energy (p = 0.08). The mean CAT score was higher in the group of COPD patients than in nonsmokers (5.8 [95% CI: 5.3-6.4]) and former smokers (6.4 [95% CI: 5.6-7.2]; p < 0.05). However, there were no significant differences in the mean CAT score between the group of COPD patients and smokers without COPD (9.5 [95% CI: 8.2-10.8]; p > 0.05), the exception being the mean scores for confidence leaving home (p = 0.02). CONCLUSIONS: CAT scores were higher in the group of patients with COPD than in nonsmokers and former smokers without COPD. However, there were no significant differences in CAT scores between COPD patients and smokers without COPD. Smokers with an FEV1/FVC ratio > 0.70 have impaired health status and respiratory symptoms similar to those observed in COPD patients.

Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials.

RATIONALE: Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease associated with chronic bronchitis and a history of exacerbations. Further characterization of patients most likely to benefit is warranted. OBJECTIVES: Define characteristics that most robustly identify patients who derive greatest exacerbation risk reduction with roflumilast. METHODS: Predefined, pooled analyses of REACT (Roflumilast in the Prevention of COPD Exacerbations While Taking Appropriate Combination Treatment; NCT01329029) and RE2SPOND (Roflumilast Effect on Exacerbations in Patients on Dual [LABA/ICS] Therapy; NCT01443845) multicenter, randomized, double-blind, placebo-controlled studies. The primary endpoint was rate of moderate or severe exacerbations per patient per year. MEASUREMENTS AND MAIN RESULTS: In the overall intention-to-treat population (n = 4,287), roflumilast reduced moderate or severe exacerbations by 12.3% (rate ratio, 0.88, 95% confidence interval, 0.80-0.97; P = 0.0086) and severe exacerbations by 16.1% (0.84; 0.71-0.99; P = 0.0409) versus placebo. The reduction in moderate or severe exacerbations with roflumilast was most pronounced in patients who had been hospitalized for an exacerbation in the prior year (0.74; 0.63-0.88; P = 0.0005); had more than two exacerbations in the prior year (0.79; 0.65-0.96; P = 0.0160); or had baseline eosinophils ≥150 cells/µl (0.81; 0.71-0.93; P = 0.0020), ≥150 to <300 cells/µl (0.84; 0.71-0.98; P = 0.0282), or ≥300 cells/µl (0.77; 0.61-0.97; P = 0.0264). Similar subgroup results were noted for severe exacerbations. In patients with prior hospitalization and higher baseline blood eosinophil concentrations, roflumilast reduced moderate or severe exacerbations by 34.5% at ≥150 cells/µl (0.65; 0.52-0.82; P = 0.0003) and 42.7% at ≥300 cells/µl (0.57; 0.37-0.88; P = 0.0111) versus placebo. CONCLUSIONS: This prespecified, pooled analysis confirms the benefit of roflumilast in decreasing exacerbations in patients with prior hospitalization for exacerbation, greater exacerbation frequency, and higher (≥150 cells/µl, ≥150 to <300 cells/µl, or ≥300 cells/µl) baseline blood eosinophil count.

Is the COPD Assessment Test sensitive for differentiating COPD patients from active smokers and nonsmokers without lung function impairment? A population-based study / O COPD Assessment Test é sensível para diferenciar pacientes com DPOC de indivíduos tabagistas e não tabagistas sem a doença? Um estudo de base populacional

ABSTRACT Objective: To assess COPD Assessment Test (CAT) scores in adults with and without COPD, as well as to compare the CAT scores for nonsmokers, former smokers, and smokers without COPD with those for patients with COPD. Methods: This was a cross-sectional population-based study (the Respira Floripa study). The study included adults ≥ 40 years of age residing in the city of Florianópolis, Brazil. A total of 846 households were surveyed. In addition to completing the Respira Floripa questionnaire and the CAT, participants underwent pulmonary function testing. Results: We analyzed data on 1,057 participants (88.1% of the predicted sample size). A functional diagnosis of COPD was made in 92 participants (8.7%). Of those, 72% were unaware that they had COPD. The mean CAT score was higher in the group of COPD patients than in that of individuals without COPD (10.6 [95% CI: 8.8-12.4] vs. 6.6 [95% CI: 6.1-7.0]; p < 0.01). Individual item scores were significantly higher in the patients with COPD than in the individuals without COPD (p < 0.001), the exception being the scores for the items related to sleep (p = 0.13) and energy (p = 0.08). The mean CAT score was higher in the group of COPD patients than in nonsmokers (5.8 [95% CI: 5.3-6.4]) and former smokers (6.4 [95% CI: 5.6-7.2]; p < 0.05). However, there were no significant differences in the mean CAT score between the group of COPD patients and smokers without COPD (9.5 [95% CI: 8.2-10.8]; p > 0.05), the exception being the mean scores for confidence leaving home (p = 0.02). Conclusions: CAT scores were higher in the group of patients with COPD than in nonsmokers and former smokers without COPD. However, there were no significant differences in CAT scores between COPD patients and smokers without COPD. Smokers with an FEV1/FVC ratio > 0.70 have impaired health status and respiratory symptoms similar to those observed in COPD patients.

RESUMO Objetivo: Avaliar a pontuação obtida no COPD Assessment Test (CAT, Teste de Avaliação da DPOC) por adultos com e sem DPOC, bem como comparar a pontuação obtida no CAT por não fumantes, ex-fumantes e fumantes sem DPOC com a obtida por pacientes com DPOC. Métodos: Estudo populacional transversal (Respira Floripa) do qual participaram adultos com idade ≥ 40 anos, residentes em Florianópolis (SC). Foram investigados 846 domicílios. Além de responderem aos questionários do Respira Floripa e CAT, os participantes realizaram prova de função pulmonar. Resultados: Foram analisados dados referentes a 1.057 participantes (88,1% da amostra prevista). Noventa e dois participantes (8,7%) receberam diagnóstico funcional de DPOC. Destes, 72% não estavam cientes de que tinham DPOC. A média da pontuação no CAT foi maior no grupo de pacientes com DPOC que no de indivíduos sem DPOC [10,6 (IC95%: 8,8-12,4) vs. 6,6 (IC95%: 6,1-7,0); p < 0,01]. A pontuação obtida em cada item do CAT foi significativamente maior nos pacientes com DPOC que nos indivíduos sem DPOC (p < 0,001), à exceção da pontuação obtida nos itens referentes a sono (p = 0,13) e energia (p = 0,08). A média da pontuação no CAT foi maior nos pacientes com DPOC que em não fumantes [5,8 (IC95%: 5,3-6,4)] e ex-fumantes [6,4 (IC95%: 5,6-7,2); p < 0,05]. Entretanto, não houve diferenças significativas entre os pacientes com DPOC e fumantes sem DPOC quanto à média da pontuação no CAT [9,5 (IC95%: 8,2-10,8); p > 0,05], à exceção da média da pontuação no item confiança ao sair de casa (p = 0,02). Conclusões: A pontuação no CAT foi maior no grupo de pacientes com DPOC que em não fumantes e ex-fumantes sem DPOC. Entretanto, não houve diferenças significativas entre pacientes com DPOC e fumantes sem DPOC quanto à pontuação no CAT. Fumantes com relação VEF1/CVF > 0,70 apresentam estado de saúde comprometido e sintomas respiratórios semelhantes aos de pacientes com DPOC.

Demographic Characteristics and Clinical Outcomes in Patients from Latin America Versus the Rest of the World: A TIOSPIR® Post-Hoc Analysis.

INTRODUCTION: Geographical variations may impact outcomes in chronic obstructive pulmonary disease (COPD). We evaluated differences in baseline characteristics and outcomes between patients enrolled in Latin America compared with the rest of the world (RoW) in the TIOtropium Safety and Performance In Respimat® (TIOSPIR®) trial. METHODS: TIOSPIR®, a 2-3-year, randomized, double-blind trial (n=17116; treated set), compared safety and efficacy of once-daily tiotropium Respimat® 5 and 2.5µg with tiotropium HandiHaler® 18µg. This post-hoc analysis pooled data from all treatment arms to assess mortality, exacerbations, cardiac events, and serious adverse events (SAEs) between both regions. RESULTS: At baseline, patients enrolled in Latin America (n=1000) versus RoW (n=16116) were older, with higher pack-years of smoking history and more exacerbations, but less cardiac history. In this analysis, patients in Latin America versus RoW had an increased risk of death (hazard ratio [HR] [95% confidence interval (CI)]: 1.52 [1.24-1.86]; P<.0001) or moderate-to-severe exacerbation (HR [95% CI]: 1.29 [1.18-1.41]; P<.0001), but a lower risk of severe exacerbation (HR [95% CI]: 0.82 [0.68-0.98]; P=.0333). SAE rates in Latin America were lower versus RoW (incidence rate ratio [IRR] [95% CI]: 0.82 [0.72-0.92]), including cardiac disorders (IRR [95% CI]: 0.68 [0.48-0.97]). Risk of major adverse cardiovascular events were similar (HR [95% CI]: 0.99 [0.71-1.40]; P=.9677). CONCLUSIONS: TIOSPIR® patients in Latin America had a higher risk of death or moderate-to-severe exacerbation, but a lower risk of severe exacerbation than those in RoW. Geographical differences may impact outcomes in COPD trials.

The Quebec Sleep Questionnaire on quality of life in patients with obstructive sleep apnea: translation into Portuguese and cross-cultural adaptation for use in Brazil / Quebec Sleep Questionnaire sobre qualidade de vida em pacientes com apneia obstrutiva do sono: tradução e adaptação cultural para uso no Brasil

ABSTRACT Objective: To translate the Quebec Sleep Questionnaire (QSQ), a specific instrument for the assessment of quality of life in patients with sleep obstructive apnea, into Portuguese and to create a version that is cross-culturally adapted for use in Brazil. Methods: The Portuguese-language version was developed according to a rigorous methodology, which included the following steps: preparation; translation from English into Portuguese in three versions; reconciliation to a single version; back-translation of that version into English; comparison and harmonization of the back-translation with the original version; review of the Portuguese-language version; cognitive debriefing; text review; and arrival at the final version. Results: The Portuguese-language version of the QSQ for use in Brazil had a clarity score, as measured by cognitive debriefing, ranging from 0.81 to 0.99, demonstrating the consistency of translation and cross-cultural adaptation processes. Conclusions: The process of translating the QSQ into Portuguese and creating a version that is cross-culturally adapted for use in Brazil produced a valid instrument to assess the quality of life in patients with obstructive sleep apnea.

RESUMO Objetivo: Traduzir para a língua portuguesa e adaptar culturalmente para uso no Brasil o Quebec Sleep Questionnaire (QSQ), um instrumento específico para a avaliação da qualidade de vida em pacientes com apneia obstrutiva do sono Métodos: A versão em português foi desenvolvida obedecendo a uma criteriosa metodologia, que incluiu as seguintes fases: preparação; tradução do inglês para o português em três versões; conciliação para uma versão única em português; retradução da versão única para o inglês; comparação e harmonização da retradução com a versão original; revisão da versão em português; desdobramento cognitivo; revisão textual; e definição da versão final. Resultados: A versão em português falado no Brasil do QSQ apresentou um índice de clareza, aferida pelo desdobramento cognitivo, que variou de 0,81 a 0,99, demonstrando a consistência dos processos de tradução e de adaptação cultural. Conclusões: O processo de tradução e adaptação cultural do QSQ para a língua portuguesa falada no Brasil produziu um instrumento válido para avaliar a qualidade de vida em pacientes com apneia obstrutiva do sono.

Translation and cultural adaptation of a specific instrument for measuring asthma control and asthma status: the Asthma Control and Communication Instrument / Tradução e adaptação cultural de um instrumento específico para medir o controle e estado da asma: Asthma Control and Communication Instrument

ABSTRACT Objective: To translate the Asthma Control and Communication Instrument (ACCI) to Portuguese and adapt it for use in Brazil. Methods: The ACCI was translated to Portuguese and adapted for use in Brazil in accordance with internationally accepted guidelines. The protocol included the following steps: permission and rights of use granted by the original author; translation of the ACCI from English to Portuguese; reconciliation; back-translation; review and harmonization of the back-translation; approval from the original author; review of the Portuguese version of the ACCI by an expert panel; cognitive debriefing (the clarity, understandability, and acceptability of the translated version being tested in a sample of the target population); and reconciliation and preparation of the final version. Results: During the cognitive debriefing process, 41 asthma patients meeting the inclusion criteria completed the ACCI and evaluated the clarity of the questions/statements. The clarity index for all ACCI items was > 0.9, meaning that all items were considered to be clear. Conclusions: The ACCI was successfully translated to Portuguese and culturally adapted for use in Brazil, the translated version maintaining the psychometric properties of the original version. The ACCI can be used in clinical practice because it is easy to understand and easily applied.

RESUMO Objetivo: Traduzir e adaptar culturalmente para a língua portuguesa falada no Brasil um instrumento que avalia a comunicação e o controle da asma, denominado Asthma Control and Communication Instrument (ACCI). Métodos: O ACCI foi traduzido e adaptado culturalmente com um protocolo que incluiu etapas internacionalmente aceitas: autorização e cessão de direitos de uso do ACCI de seu idealizador; tradução do ACCI da língua inglesa para a língua portuguesa; reconciliação; retradução; revisão e harmonização da retradução; aprovação do idealizador do ACCI; revisão da versão em português do ACCI por especialistas; desdobramento cognitivo (teste da clareza, compreensibilidade e aceitabilidade da versão traduzida em uma amostra da população-alvo) e reconciliação para a elaboração da versão final. Resultados: Na etapa do desdobramento cognitivo, foram entrevistados 41 indivíduos com asma que preencheram os critérios de inclusão. Todos responderam ao ACCI e avaliaram a clareza dos enunciados/questões e, para todos os itens, obteve-se um índice de clareza superior a 0,9, ou seja, todas as questões foram consideradas claras. Conclusões: A tradução e a adaptação cultural do ACCI para a língua portuguesa falada no Brasil foram bem-sucedidas e mantiveram as propriedades psicométricas do instrumento original. O ACCI pode ser utilizado na prática clínica por ser simples e de fácil compreensão e aplicação.

Cardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study.

BACKGROUND: Previous research suggests exposure to nicotine replacement therapy (NRT) may be associated with an increased risk of cardiovascular disease (CVD). METHODS: Using data from the United Kingdom's Clinical Practice Research Datalink, this study aimed to evaluate CVD events and survival among individuals who attempted smoking cessation with the support of NRT compared with those aided by smoking cessation advice only. We studied CVD outcomes over 4 and 52 weeks in 50,214 smokers attempting to quit - 33,476 supported by smoking cessation advice and 16,738 with the support of NRT prescribed by their primary care physician. Patients were matched (2 smoking cessation advice patients:1 NRT patient) on demographic and clinical characteristics during a baseline year preceding their quit attempt. Cox proportional hazard regression, conditional negative binomial regression model, and conditional logistic regression were used to analyze data. RESULTS: Mean (standard deviation) population age was 47 (11.2) years; 51% were females. Time to first diagnosis of ischemic heart disease (IHD) among NRT and smoking cessation advice patients was similar within the first 4 weeks, but shorter for NRT patients over 52 weeks (hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.03-1.77). A similar trend was observed for cerebrovascular disease (HR: 1.54, 95% CI: 1.08-2.19). NRT patients with a prior diagnosis of IHD or cerebrovascular disease had a higher rate of primary or secondary care consultations for IHD or cerebrovascular disease by 52 weeks (rate ratio: 1.50, 95% CI: 1.14-1.99). Patients prescribed NRT had a shorter survival time over 52 weeks, compared with those receiving advice only (HR: 1.39, 95% CI: 1.09-1.76). CONCLUSION: Our findings suggest that treatment with NRT over 4 weeks does not appear to have an impact on cardiovascular risks. However, a longer follow-up period of 52 weeks resulted in an increase in cardiovascular events for patients prescribed NRT, compared with those receiving smoking cessation advice only.