Objective: The assessment of the quality of life in patients with lung cancer has become one of the main goals in current clinical trials. To assess the quality of life of these patients, the most widely used instrument is the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) in conjunction with its supplemental 13-item lung cancer-specific module (QLQ-LC13). The objective of this study was to assess the reproducibility of the Brazilian Portuguese version of these questionnaires. Methods: A prospective study involving 30 stable outpatients with lung cancer who completed the instruments on the first day of the study and two weeks later. Results: The test-retest reproducibility using the intraclass correlation coefficient for the EORTC QLQ-C30 and the QLQ-LC13 ranged from 0.64 to 1.00 and from 0.64 to 0.95, respectively. No correlations were found between the domains of the instruments and clinical parameters. Conclusions: Our findings show that these instruments were reproducible in this sample of patients with lung cancer in Brazil.

Keywords: Lung neoplasms; Reproducibility of results; Quality of life.

Introduction: The use of inhaled drugs through metered-dose inhaler has been advocated for years. Nonetheless, a small number of patients are routinely treated by this technique. Prescriptions of inhaled drugs by healthcare providers are not frequent, usually because they anticipate patients will not be able to perform the technique correctly. In addition, healthcare providers do not usually take their time to appropriately teach patients how to use metered-dose inhalers correctly. Objective: To evaluate the percentage of uninstructed patients that learn how to use a metered-dose inhaler correctly after being taught by a pneumologist. Patients and methods: One hundred and nineteen patients from a private clinic were prospectively studied in São Paulo, southeastern Brazil. Patients were exhaustively taught how to use the metered-dose inhaler at the first consultation and were told to return after 10 days, when they were asked to perform the technique exactly the way they were doing it at home. Their performance was classified as correct, slightly incorrect, intermediately incorrect, and totally incorrect. Results: Twenty-six patients were excluded for not coming to the second appointment. The final sample comprised 93 patients. Age ranged from 9 to 81 years (mean age 42.6 ± 21); 59.2% of the patients were male and 40.8% female. Considering all patients, only 16.25 of them used the metered-dose inhaler totally incorrectly and 19.3% performed the technique intermediately incorrectly. The most frequent mistakes were: metered-dose inhaler device was placed inside the mouth; inspiration before jet was activated; fast aspiration; inspiration through the nose. Thirty-three percent of patients who were under 15 and over 75 years performed the technique correctly. Conclusion: This study has demonstrated that the majority of the patients learned how to use the metered-dose inhaler correctly after being properly and extensively taught.

Keywords: Nebulizers and vaporizers. Inhalation administration. Learning.

Background: Asthma education programs induce better asthma control and are one of main recommendations in guidelines. The programs recommendations should include a nurse in the educational team applying the structured program. The purpose of the intervention is to bring a change in the daily life of the patient and the family in order to improve disease control and quality of life. Aim: To standardize and apply a structured post-consultation model as part of multidisciplinary care in an educational program for asthmatic patients seen at the outpatient clinic of a public hospital, and to monitor the changes in asthma knowledge and quality of life. Methods: A longitudinal prospective study over six months with regular visits at four week intervals (total = 6 visits), conducted at the outpatient department of Unifesp/EPM/HSP, and the patients were included after signing a consent form. The asthma structured educational plan was conducted by a multidisciplinary team and addressed the following issues: what is asthma, relief and prevention medicines, daily report of symptoms and dyspnea score, training of the correct use of inhaled medication, discussion and actions regarding triggering factors and how to avoid them, and tips to recognize the signals of uncontrolled asthma. A standard questionnaire about general knowledge on asthma and a quality of life questionnaire were applied at the beginning, during the course, and at the end of the program. Results: 26 asthmatics were followed over six months and showed a statistically significant improvement in their identification and management of asthma skills as well as better quality of life indices. Conclusion: The model of care and the approach and training techniques were adequate and useful in the development of a structured educational program for socially deprived patients.

Objective: There is evidence that asthma is associated with an increase in psychiatric symptoms and mental disorders. This association can make it difficult to achieve asthma control. The purpose of this study was to determine whether the level of asthma control is associated with anxiety and depression. Methods: A cross-sectional study involving 78 patients with confirmed moderate or severe asthma and under regular treatment at the Asthma Outpatient Clinic of the Federal University of São Paulo Hospital São Paulo, in the city of São Paulo, Brazil. The patients were divided into two groups by asthma control status, as assessed by the asthma control test, and were subsequently compared in terms of demographic, clinical, and spirometric data, as well as scores for asthma quality of life and hospital anxiety/depression. Results: The sample was predominantly female. Of the 78 patients, 49 (63%) were classified as having uncontrolled asthma. The prevalence of anxiety and of anxiety+depression was significantly higher among patients with uncontrolled asthma than among those with controlled asthma (78% and 100%; p = 0.04 and p = 0.02, respectively), whereas there were no differences between the two groups in terms of the prevalence of depression, spirometry results, or quality of life score. Conclusions: In this sample, the prevalence of anxiety symptoms was higher in the patients with uncontrolled asthma than in those with controlled asthma.In the evaluation of asthma patients, the negative impact of mood states ought to be taken into consideration when asthma control strategies are being outlined.

Keywords: Asthma; Anxiety; Depression; Cross-sectional studies.

Objective: To evaluate the pharmaceutical equivalence of a test formulation (fixed-dose combination of budesonide and formoterol fumarate in a single capsule dispensed in an Aerocaps® inhaler) in relation to a reference formulation (budesonide and formoterol fumarate in two separate capsules dispensed in an Aerolizer® inhaler). Methods: This was an in vitro study in which we performed the identification/quantification of the active ingredients by HPLC and determined dose uniformity and aerodynamic particle size distribution in the test and reference formulations. Results: In the test formulation, the content of budesonide and formoterol was 111.0% and 103.8%, respectively, compared with 110.5% and 104.5%, respectively, in the reference formulation. In the test formulation, dose uniformity regarding budesonide and formoterol was 293.2 µg and 10.2 µg, respectively, whereas it was 353.0 µg and 11.1 µg in the reference formulation. These values are within the recommended range for this type of formulation (75-125% of the labeled dose). The fine particle fraction (< 5 µm) for budesonide and formoterol was 45% and 56%, respectively, in the test formulation and 54% and 52%, respectively, in the reference formulation. Conclusions: For both of the formulations tested, the levels of active ingredients, dose uniformity, and aerodynamic diameters were suitable for use with the respective dry powder inhalers.

Keywords: : Asthma; Budesonide; Bronchodilator agents; Drug therapy, combination.

Objective: Lung cancer patients often experience profound physical and psychosocial changes as a result of disease progression or treatment side effects. Fatigue, pain, dyspnea, depression, and sleep disturbances appear to be the most common symptoms in such patients. The objective of the present study was to examine the prevalence of symptoms in lung cancer patients in order to identify subgroups (clusters) of patients, grouped according to the magnitude of the symptoms, as well as to compare the quality of life among the identified subgroups. Methods: A cross-sectional study involving agglomerative hierarchical clustering. A total of 50 lung cancer patients were evaluated in terms of their demographic characteristics and their scores on three quality of life questionnaires, namely the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), the Functional Assessment of Cancer Therapy-Lung, and the Medical Outcomes Study 36-item Short-form Survey. The cluster analysis took into account the magnitude of the most prevalent symptoms as assessed by the EORTC QLQ-C30 symptom scale scores; those symptoms were fatigue, pain, dyspnea, and insomnia. Results: Three clusters (subgroups)_of patients were identified on the basis of the magnitude of the four most prevalent symptoms. The three subgroups of patients were as follows: patients with mild symptoms (n = 30; 60%); patients with moderate symptoms (n = 14; 28%); and patients with severe symptoms (n = 6; 12%). The subgroup of patients with severe symptoms had the worst quality of life, as assessed by the total scores and by the integrated domains of all three instruments. Conclusions: This study highlights the importance of symptom cluster assessment as an important tool to assess the quality of life of patients with chronic diseases, such as lung cancer.

The direct costs incurred in managing patients with poorly controlled asthma are high and educational programs could decrease these costs. Aim: The objectives of this study were to compare the direct cost of the implementation of an educational program for adult asthmatic patients with the cost of the usual care delivered to asthmatics by specialists. Methods: Five years ago, a six-month study demonstrated that an educational program improved clinical outcomes (22 in educational program-E and 20 patients in control group-C). Throughout the educational intervention period all cases of hospitalization, emergency and regular calls involving patients from both groups were recorded. The basis for the values utilized in the calculation of costs was the healthcare database of the Brazilian government (DATASUS). The overall medication cost/patient in both groups was based on the amount of medication taken during the month preceding the last call. The final values were converted into US dollars. Results: The mean direct cost/patient in the educational (E) and control (C) groups and the difference (Δ) between groups were: hospitalizations (C = US$ 183, E = 0, Δ = US$ 183); emergency calls (C = US$ 14, E = US$ 5, Δ = US$ 9); regular calls (C = US$ 10, E = US$ 24, Δ = -US$ 14); medication (C = US$ 124,3, E = US$ 195,6, Δ = -US$ 71,3). The total cost was US$ 33/patient in group C and US$ 224/patient in group E with an average cost saving of US$ 107/patient. Conclusion: The expenses with medication is higher in E group because the regular use of maintenance drugs, however the study suggested that the application of the asthma education program reduced the total direct costs of asthma.

Keywords: Asthma. Cost-benefit. Patient education.

Objective: To assess the quality of life of patients with lung cancer and to compare it with that of individuals without cancer. Methods: The Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) was administered to 57 patients diagnosed with lung cancer, treated at the Lung Cancer Outpatient Clinic of the Hospital São Paulo, and to a control group of 57 individuals recruited from the Extra Penha workout group. The Mann-Whitney test was used to compare the groups, domain by domain. The first model of logistic regression was adjusted for male gender, nonsurgical treatment, Karnofsky performance status and smoking, which were included as predictors. The second model was adjusted for each SF-36 domain in order to identify increases in the proportions of patients in stage IIIB or IV. Results: The lung cancer group and the control group presented the following mean scores, respectively, for the SF-36 domains: role limitations due to physical health problems, 29.39 ± 36.94 and 82.89 ± 28.80; role limitations due to emotional problems, 42.78 ± 44.78 and 86.55 ± 28.77; physical function, 56.49 ± 28.39 and 89.00 ± 13.80; vitality, 61.61 ± 23.82 and 79.12 ± 17.68; bodily pain, 62.72 ± 28.72 and 81.54 ± 19.07; general health, 62.51 ± 25.57 and 84.47 ± 13.47; emotional well-being, 68.28 ± 23.46 and 82.63 ± 17.44; and social functioning, 72.87 ± 29.20 and 91.67 ± 17.44. The logistic regression model showed that role limitations due to physical health problems, physical function and emotional well-being were predictors of stages IIIB and IV. Conclusions: The patients with lung cancer had a poorer quality of life, especially regarding physical aspects, than did the control subjects.

Keywords: Lung neoplasms; Quality of life; Health status.

Objective: There is an indirect relationship between airway obstruction in asthma and the intensity of breathlessness (dyspnea). A word labeled visual analog dyspnea scale with a 0-3 score has been widely used for the assessment of the degree of bronchoconstriction, although the perception of such obstruction varies considerably. The objective of this study was to determine whether children and adolescents are able to perceive acute exercise-induced bronchoconstriction (EIB), as well as to measure the discriminatory power of a word labeled visual analog dyspnea scale in relation to the intensity of the EIB. Methods: A cross-sectional study involving 134 children and adolescents with asthma and submitted to a six-minute steady-state exercise test on a cycle ergometer. The intensity of dyspnea was determined using a word labeled visual analog dyspnea scale prior to each determination of FEV1. The scale is scored from 0 to 3, with a logical sequence of pictures, ranging from "no symptoms" to "severe dyspnea". Variables were determined at baseline, as well as at 5, 10, and 20 min after the exercise test. The accuracy of the dyspnea scale in identifying the degree of EIB was determined by means of ROC curves for the post-exercise fall in FEV1, using cut-off points of 10%, 20%, 30%, and 40%. Results: Of the patients selected, 111 finished the study, and 52 (46.8%) presented with EIB. The area under the ROC curve increased in direct proportion to increases in the degree of bronchoconstriction. Conclusions: Among children and adolescents with asthma, the accuracy of this dyspnea scale improves as the post-exercise percentage fall in FEV1 increases. However, the predictive value of the scale is suboptimal when the percentage fall in FEV1 is lower.

Keywords: Asthma; Asthma, exercise-induced; Dyspnea.

Abstract Objective: To evaluate whether respiratory therapy techniques influence the number of cells within and quantity of induced sputum in patients with asthma or chronic obstructive pulmonary disease (COPD). Methods: Randomized clinical trial, in which patients with asthma or COPD under intervention (n = 16 and 10, respectively) were compared with control groups (n = 16 and 10). Patients in the asthma/intervention (A/I) and COPD/intervention (C/I) groups were submitted to oscillating positive expiratory pressure maneuvers for 5 min, followed by 10 forced expiratory technique sequences. These patients were also submitted to an induced sputum protocol with inhaled hypertonic saline (3%, 4% or 5%; A/I group) or inhaled isotonic saline (C/I group). The asthma/control (A/C) and COPD/control (C/C) groups were submitted only to the standard induced sputum protocol. Results: The final mean weight of the sputum samples was significantly greater in the A/I group than in the A/C group (2,767.25 ± 998.08 mg vs. 1,689.17 ± 1,189.96 mg; p = 0.03). The mean/median total cell counts (×106/mL) were higher in the A/I and C/I groups than in the A/C and C/C groups (4.06/0.95 and 0.63/0.39, p = 0.05, vs. 5.08/1.77 and 0.64/0.40, p = 0.02). There were no statistically significant differences among the groups in terms of cell viability. Conclusions: The use of respiratory therapy techniques can increase sputum sample weight in asthma patients, as well as increasing total cell counts in patients with asthma or COPD.

Keywords: Asthma; Pulmonary disease, obstructive chronic; Sputum; Physical therapy modalities.

Objective: To evaluate the impact of a 5-day educational camp program for children with asthma in terms of improving their knowledge of asthma and enhancing their performance in the use of inhaled medication and in physical activities. Methods: Every day, the children received 20-min interactive educational sessions, the technique for using the metered-dose inhaler was reviewed, two peak flow readings were recorded, and the children performed physical activities that included breathing and relaxation exercises. A questionnaire regarding knowledge of asthma, as well as asthma triggers, asthma medications, misconceptions regarding asthma, and the use of spacers, was administered before and after the intervention. Correct use of inhaled medication and exercise-related symptoms were also evaluated before and after the intervention. Results: A total of 37 children with asthma, aged 8-10 years (15 females and 22 males), were included in this study. Of those, 25% showed an improvement in the level of knowledge of asthma after the educational camp program, as evidenced by the greater number of correct answers on three of the twelve questions analyzed (p < 0.05). The exercise-related dyspnea scores decreased significantly (p < 0.05). The ability to use inhaled medication correctly was significantly improved after the intervention (p < 0.05). Conclusions: The asthma educational camp program can improve knowledge about specific questions, encourage participation in physical activities, and improve the asthma management skills of children.

Keywords: Asthma; Asthma/prevention & control; Models, educational; Child.

Objective: To evaluate paranasal sinuses in patients with stable or acute asthma in order to determine the prevalence of acute bacterial rhinosinusitis. Methods: A cross-sectional study including 30 patients with acute asthma (73% females) treated in the emergency room and 30 patients with stable asthma (80% females) regularly monitored as outpatients. All patients completed a questionnaire on respiratory signs and symptoms and were submitted to ear, nose and throat (ENT) examination, as well as to X-ray and computed tomography (CT) imaging of the sinuses. Results: Based on the clinical diagnosis, the prevalence of acute bacterial rhinosinusitis was 40% in the patients with acute asthma and 3% in those with stable asthma. The ENT examination findings and the imaging findings in isolation were not useful to confirm the diagnosis. Conclusions: In themselves, ENT examination findings, X-ray findings and CT findings were not useful for the diagnosis of acute bacterial rhinosinusitis. Our results provide further evidence that a clinical diagnosis of bacterial rhinosinusitis should be made with caution.

Keywords: Asthma; Sinusitis; Radiography; Tomography, X-ray computed; Endoscopy.

Objective: To evaluate the capacity of the criteria described in Complementary Directive SAS/MS 12, issued on November 12, 2002, to identify patients with severe asthma, describing and comparing clinical, functional and treatment data of such patients. Methods: This was a nested case-control study using a structured database for adult asthma outpatients. We defined cases as asthma patients who met the inclusion criteria described in the directive, defining controls as those who did not. We collected and compared data related to the following: demographic characteristics; history of asthma; medications in use; comorbidities; history of tobacco use; number of exacerbations within the last 12 months, asthma-related hospitalizations and intensive care unit admissions within the last 12 months; spirometry; and sputum cytology. Results: The case and control groups consisted of 29 and 31 patients, respectively. The number of asthma exacerbations and emergency room visits within the last 12 months, as well as the number of patients that received at least one pulse of oral corticosteroids, was significantly higher in the case group than in the control group. In addition, prebronchodilator FVC was lower among the cases than among the controls. Furthermore, cytology revealed that eosinophil counts were significantly higher in the induced sputum of cases than in that of controls. Conclusions: The criteria described in the directive are suited to stratifying patients with severe asthma.

Keywords: Asthma; Budesonide; Combined modality therapy.