Objective: To test the reliability, validity, and interpretability of the Brazilian version of the Clinical COPD Questionnaire (CCQ) in patients with COPD. Methods: Fifty patients with COPD completed the CCQ by interview on two occasions. At the first visit, the CCQ was administered twice, by two different raters, approximately 10 min apart; the patients also underwent spirometry and were administered the COPD Assessment Test, the modified Medical Research Council scale, and Saint George's Respiratory Questionnaire (SGRQ). At the second visit (1-2 weeks later), the CCQ was readministered. We tested the hypothesis that the CCQ total score would correlate positively with the total and domain SGRQ scores (r = 0.5). Results: Of the 50 patients, 30 (60%) were male. The mean age was 66 ± 8 years, and the mean FEV1 was 44.7 ± 17.9% of the predicted value. For all CCQ items, Cronbach's alpha coefficient (95% CI) was 0.93 (0.91-0.96). To analyze the interrater reliability and test-retest reliability of the CCQ, we calculated the two-way mixed effects model/single measure type intraclass correlation coefficient (0.97 [95% CI: 0.95-0.98] and 0.92 [95% CI: 0.86-0.95], respectively); the agreement standard error of measurement (0.65 for both); the smallest detectable change at the individual level (1.81 and 1.80, respectively) and group level (0.26 and 0.25, respectively); and the limits of agreement (-0.58 to 0.82 and -1.14 to 1.33, respectively). The CCQ total score correlated positively with all SGRQ scores (r = 0.70 for all). Conclusions: The Brazilian version of the CCQ showed an indeterminate measurement error, as well as satisfactory interrater/test-retest reliability and construct validity.

Keywords: Pulmonary disease, chronic obstructive; Health status; Patient reported outcome measures; Validation study.

Objective: To translate the Understanding COPD (UCOPD) questionnaire into Portuguese, adapt it for use in Brazil, and assess its reliability. Methods: The UCOPD questionnaire consists of two sections, designated section A and section B. Section A comprises 18 items divided into three domains: "About COPD", "Managing Symptoms of COPD", and "Accessing Help and Support". Section B includes five questions regarding patient satisfaction with the educational component of pulmonary rehabilitation programs. The UCOPD questionnaire was applied twice on the same day by two different raters (with a 10-min interval between applications) and once again 15-20 days later. The Wilcoxon test was used in order to compare the scores among applications. Reliability was assessed by the intraclass correlation coefficient and Bland-Altman plots. Results: The study sample consisted of 50 COPD patients (35 men; mean age, 65.3 ± 7.91 years; mean FEV1, 36.4 ± 16.2% of the predicted value). Inter-rater intraclass correlation coefficients for section A total scores and domain scores ranged from moderate to high. Section A scores and domain scores had no significant differences regarding test-retest reliability (p < 0.05). The test-retest and inter-rater Cronbach's alpha coefficients for section A total scores were 0.93 and 0.86, respectively (p < 0.001). There were no floor or ceiling effects. Conclusions: The Brazilian Portuguese version of the UCOPD questionnaire is reliable.

Keywords: Pulmonary disease, chronic obstructive; reproducibility of results; Health knowledge, attitudes, practice.

Objective: Simple diagnostic methods can facilitate the diagnosis of COPD, which is a major public health problem. The objective of this study was to investigate the accuracy of clinical variables in the diagnosis of COPD. Methods: Patients with COPD and control subjects were prospectively evaluated by two investigators regarding nine clinical variables. The likelihood ratio for the diagnosis of COPD was determined using a logistic regression model. Results: The study comprised 98 patients with COPD (mean age, 62.3 ± 12.3 years; mean FEV1, 48.3 ± 21.6%) and 102 controls. The likelihood ratios (95% CIs) for the diagnosis of COPD were as follows: 4.75 (2.29-9.82; p < 0.0001) for accessory muscle recruitment; 5.05 (2.72-9.39; p < 0.0001) for pursed-lip breathing; 2.58 (1.45‑4.57; p < 0.001) for barrel chest; 3.65 (2.01-6.62; p < 0.0001) for decreased chest expansion; 7.17 (3.75-13.73; p < 0.0001) for reduced breath sounds; 2.17 (1.01-4.67; p < 0.05) for a thoracic index ≥ 0.9; 2.36 (1.22-4.58; p < 0.05) for laryngeal height ≤ 5.5 cm; 3.44 (1.92-6.16; p < 0.0001) for forced expiratory time ≥ 4 s; and 4.78 (2.13-10.70; p < 0.0001) for lower liver edge ≥ 4 cm from lower costal edge. Inter-rater reliability for those same variables was, respectively, 0.57, 0.45, 0.62, 0.32, 0.53, 0.32, 0.59, 0.52 and 0.44 (p < 0.0001 for all). Conclusions: Various clinical examination findings could be used as diagnostic tests for COPD.

Keywords: Physical examination; Diagnosis; Pulmonary disease, chronic obstructive.

Introduction: A great emphasis has been placed on health-related quality of life of COPD patients and specific questionnaires have been developed in order to measure it. Interventions directed to improve symptoms and decrease morbi-mortality may be evaluated by such questionnaires. Objective: This study describes the language and cultural adaptation of a new (and short) disease-specific health status questionnaire developed for chronic obstructive pulmonary diseases: the Airways Questionnaire 20 (AQ20). This questionnaire has only 20 simple items, and is one of the shortest ones ever described in the literature. Methods: In order to validate this questionnaire in Brazil, an initial translation from English to Portuguese has been made. The cultural adaptation was taken into consideration and then a back translation to English was undertaken, in order to obtain a final Portuguese version. Correlations were made with FEV1, SpO2, BMI and another disease specific health status questionnaire, the Saint George Respiratory Questionnaire (SGRQ), previously validated in Brazil. To test the reproducibility of AQ20, the interclass correlation ratio was done. Results: The interclass correlation ratio for the total score was a = 0.90 (intraobserver variability) and a = 0.93 (interobserver variability). The correlation with total SGRQ score was 0.76, with p < 0.001. Conclusion: It can be concluded that the Brazilian Portuguese version of AQ20 is reproducible, with good correlation with SGRQ total score, which makes it a valid questionnaire to measure health status in obstructive patients in Brazil.

Objective: To translate the Breathing Problems Questionnaire (BPQ) into Portuguese and adapt it to the Brazilian culture, as well as to evaluate its reproducibility in patients with COPD. Methods: After the BPQ had been translated and adapted to the Brazilian culture, it was administered to a subgroup of 8 patients in order to identify their uncertainties and difficulties. The questionnaire was reviewed by an expert committee, and its final version was arrived at. A second translator back-translated the final version into English, which was sent to the original author in order to verify that the original meaning of the questionnaire had been maintained. After the approval of the original author, the final Portuguese-language version of the questionnaire was administered to 50 patients with COPD, in order to evaluate its reproducibility. Results: The mean response time was 9.5 min. Of the 50 patients, 21 were female and 29 were male. The mean age was 65.8 ± 7.5 years. Most of the patients were classified as having moderate COPD (29.16%) or severe COPD (52%). The intraclass correlation coefficient (ICC) for the total score was 0.94. The ICCs for the eleven BPQ domains and its two subscales were also above 0.70. Moderate correlations were found between the BPQ domains and subscales. Conclusions: The translation and cultural adaptation of the BPQ for use in Brazil was deemed appropriate, because the patients could easily understand and answer the questions. In addition, the Brazilian version of the BPQ questionnaire was found to be reliable, showing good reproducibility.

Keywords: Pulmonary disease; chronic obstructive; Quality of life; Reproducibility of results.

Objective: To translate The Manchester Respiratory Activities of Daily Living (MRADL) questionnaire into Portuguese and to create a version of the MRADL that is cross-culturally adapted for use in Brazil. Methods: The English-language version of the MRADL was translated into Portuguese by two health care researchers who were fluent in English. A consensus version was obtained by other two researchers and a pulmonologist. That version was back-translated into English by another translator who was a native speaker of English and fluent in Portuguese. The cognitive debriefing process consisted in having 10 COPD patients complete the translated questionnaire in order to test its understandability, clarity, and acceptability in the target population. On the basis of the results, the final Portuguese-language version of the MRADL was produced and approved by the committee and one of the authors of the original questionnaire. Results: The author of the MRADL questioned only a few items in the translated version, and some changes were made to the mobility and personal hygiene domains. Cultural differences regarding the domestic activities domain were found, in particular regarding the item "Do you have the ability to do a full clothes wash and hang them out to dry?", due to socioeconomic and climatic issues. The item "Do you take care of your garden?" was questioned by the participants who lived in apartments, being modified to "Do you take care of your garden or plants in your apartment?" Conclusions: The final Portuguese-language version of the MRADL adapted for use in Brazil was found to be easy to understand and easily applied.

Keywords: Activities of daily living; Questionnaires; Translations; Pulmonary disease, chronic obstructive.

Objective: To evaluate the frequency of asthma-COPD overlap (ACO) in patients with COPD and to compare, from a clinical, laboratory, and functional point of view, patients with and without ACO, according to different diagnostic criteria. Methods: The participants underwent evaluation by a pulmonologist, together with spirometry and blood tests. All of the patients were instructed to record their PEF twice a day. The diagnosis of ACO was based on the Proyecto Latinoamericano de Investigación en Obstrucción Pulmonar (PLATINO, Latin American Project for the Investigation of Obstructive Lung Disease) criteria, the American Thoracic Society (ATS) Roundtable criteria, and the Spanish criteria. We investigated patient histories of exacerbations and hospitalizations, after which we applied the COPD Assessment Test and the modified Medical Research Council scale, to classify risk and symptoms in accordance with the GOLD criteria. Results: Of the 51 COPD patients, 14 (27.5%), 8 (12.2%), and 18 (40.0) were diagnosed with ACO on the basis of the PLATINO, ATS Roundtable, and Spanish criteria, respectively. The values for pre-bronchodilator FVC, post-bronchodilator FVC, and pre-bronchodilator FEV1 were significantly lower among the patients with ACO than among those with COPD only (1.9 ± 0.4 L vs. 2.4 ± 0.7 L, 2.1 ± 0.5 L vs. 2.5 ± 0.8 L, and 1.0 ± 0.3 L vs. 1.3 ± 0.5 L, respectively). When the Spanish criteria were applied, IgE levels were significantly higher among the patients with ACO than among those with COPD only (363.7 ± 525.9 kU/L vs. 58.2 ± 81.6 kU/L). A history of asthma was more common among the patients with ACO (p < 0.001 for all criteria). Conclusions: In our sample, patients with ACO were more likely to report previous episodes of asthma and had worse lung function than did those with COPD only. The ATS Roundtable criteria appear to be the most judicious, although concordance was greatest between the PLATINO and the Spanish criteria.

Keywords: Asthma/diagnosis; Pulmonary disease, chronic obstructive/diagnosis; Asthma-chronic obstructive pulmonary disease overlap syndrome/diagnosis.

Objective: To correlate health-related quality of life (HRQL) of women with COPD with clinical parameters and with the six-minute walk distance (6MWD; six-minute walk test). Methods: Cross-sectional study involving 30 female patients diagnosed with mild or moderate COPD treated at the Respiratory Outpatient Clinic of the Presidente Dutra University Hospital. Patients completed the Saint George's Respiratory Questionnaire (SGRQ) and were evaluated in terms of respiratory pressures, spirometry parameters and 6MWD. Descriptive statistical analysis was carried out, as were Student's t-tests for dependent variables, together with Pearson's and Spearman's correlation coefficients for numerical and ordinal variables, respectively. Results: According to the SGRQ total scores, HRQL was impaired, to some extent, in most of the participants. Most SGRQ total scores were between the second and the third quartiles, reflecting poor HRQL. The participants also presented poor functional capacity. Mean 6MWD (317.7 m), inspiratory muscle strength (−53.48 cmH2O) and expiratory muscle strength (69.5 cmH2O) were all below reference values. We found that HRQL was not correlated with body mass index or pulmonary function. However, HRQL presented a negative linear correlation with age, MIP and 6MWD, as well as a positive correlation with the sensation of dyspnea and fatigue. Conclusions: In this study, HRQL, determined using the SGRQ, was severely impaired in COPD patients, who presented severe limitations in functional capacity, breath control and personal life.

Keywords: Quality of life; Pulmonary disease, chronic obstructive; Women.

Objective: To adapt the PROactive Physical Activity in COPD-clinical visit (C-PPAC) instrument to the cultural setting in Brazil and to determine the criterion validity, test-retest reliability agreement, and internal consistency of this version. Methods: A protocol for cultural adaptation and validation was provided by the authors of the original instrument and, together with another guideline, was applied in a Portuguese-language version developed by a partner research group from Portugal. The adapted Brazilian Portuguese version was then cross-sectionally administered twice within a seven-day interval to 30 individuals with COPD (57% were men; mean age was 69 ± 6 years; and mean FEV1 was 53 ± 18% of predicted) to evaluate internal consistency and test-retest reliability. Participants also completed the International Physical Activity Questionnaire (IPAQ), the modified Medical Research Council scale, the COPD Assessment Test, and Saint George's Respiratory Questionnaire to evaluate criterion validity. Results: The C-PPAC instrument showed good internal consistency and excellent test-retest reliability: "amount" domain = 0.87 (95% CI, 0.73-0.94) and "difficulty" domain = 0.90 (95% CI, 0.76-0.96). Bland & Altman plots, together with high Lin's concordance correlation coefficients, reinforced that agreement. Criterion validity showed moderate-to-strong correlations of the C-PPAC with all of the other instruments evaluated, especially with the IPAQ (rho = -0.63). Conclusions: The Brazilian Portuguese version of the C-PPAC is a reliable and valid instrument for evaluating the experience of Brazilian individuals with COPD with their physical activity in daily life.

Keywords: Pulmonary disease, chronic obstructive; Validation study; Activities of daily living; Psychometrics.

Objective: To evaluate and correlate the quality of life (QoL) of COPD patients on long-term home oxygen therapy (LTOT) with their sociodemographic/clinical characteristics and level of dependence. Methods: This was a cross-sectional analytical study involving COPD patients on LTOT followed at the Oxygen Therapy Outpatient Clinic of the Federal University of São Paulo Hospital São Paulo, in the city of São Paulo, Brazil. Sociodemographic, clinical, and biochemical data were collected. We assessed QoL and level of dependence using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) and the Katz index, respectively. Multiple linear regression models were constructed in order to determine the influence of these variables on QoL. Results: We included 80 patients in the study. The mean age was 69.6 ± 9.1 years, and 51.3% were female. The lowest SF-36 scores were for the physical functioning and role-physical domains. All sociodemographic characteristics (except gender) were found to correlate significantly with the SF-36 domains mental health, vitality, role-physical, and social functioning. We also found that body mass index, PaO2, post-bronchodilator FEV1, hemoglobin, and Katz index correlated significantly with the physical functioning, mental health, role-physical, and bodily pain domains. In addition, oxygen flows were found to correlate negatively with the physical functioning, mental health, vitality, and role-emotional domains. Conclusions: Low scores for SF-36 domains, as well as the variables that negatively influence them, should be considered and analyzed during the development and implementation of strategies for improving the QoL of COPD patients on LTOT.

Keywords: Pulmonary disease, chronic obstructive; Quality of life; Oxygen inhalation therapy.

Objective: To identify reference values for handgrip strength through a literature search and compare the agreement of reference values from Brazil with others for handgrip strength in a sample of COPD patients in Brazil, as well as to determine which set of reference values is more discriminative regarding differences in clinical characteristics between individuals with low handgrip strength and normal handgrip strength. Methods: To identify reference values for handgrip strength, a literature search was performed; a retrospective cross-sectional analysis of baseline-only data from two unrelated studies was then performed. Individuals were evaluated for handgrip strength, peripheral muscle strength, respiratory muscle strength, pulmonary function, body composition, exercise capacity, dyspnea, and functional status. Results: Of the 45 studies that were initially selected, 9 met the criteria for inclusion in the analysis, which included 99 COPD patients in Brazil (52% of whom were male with GOLD stage II-IV COPD). The prevalence of low handgrip strength varied across studies (from 9% to 55%), the set of reference values for handgrip strength in a sample of individuals in Brazil having classified 9% of the study sample as having low handgrip strength. The level of agreement between the reference values for a sample of individuals in Brazil and the other sets of reference values varied from weak to excellent. The reference values for a sample of individuals in Brazil showed the highest number of significantly different characteristics between individuals with low and normal handgrip strength. Conclusions: The level of agreement between national and international sets of reference values for handgrip strength varied from weak to excellent in COPD patients in Brazil. Reference values for handgrip strength with higher discriminative capacity are not necessarily those that identify more individuals as having low handgrip strength.

Keywords: Pulmonary disease, chronic obstructive; Hand strength; Muscle weakness; Muscle strength; Reference values.

Cystic fibrosis (CF) is a genetic disease that results in dysfunction of the CF transmembrane conductance regulator (CFTR) protein, which is a chloride and bicarbonate channel expressed in the apical portion of epithelial cells of various organs. Dysfunction of that protein results in diverse clinical manifestations, primarily involving the respiratory and gastrointestinal systems, impairing quality of life and reducing life expectancy. Although CF is still an incurable pathology, the therapeutic and prognostic perspectives are now totally different and much more favorable. The purpose of these guidelines is to define evidence-based recommendations regarding the use of pharmacological agents in the treatment of the pulmonary symptoms of CF in Brazil. Questions in the Patients of interest, Intervention to be studied, Comparison of interventions, and Outcome of interest (PICO) format were employed to address aspects related to the use of modulators of this protein (ivacaftor, lumacaftor+ivacaftor, and tezacaftor+ivacaftor), use of dornase alfa, eradication therapy and chronic suppression of Pseudomonas aeruginosa, and eradication of methicillin-resistant Staphylococcus aureus and Burkholderia cepacia complex. To formulate the PICO questions, a group of Brazilian specialists was assembled and a systematic review was carried out on the themes, with meta-analysis when applicable. The results obtained were analyzed in terms of the strength of the evidence compiled, the recommendations being devised by employing the GRADE approach. We believe that these guidelines represent a major advance to be incorporated into the approach to patients with CF, mainly aiming to favor the management of the disease, and could become an auxiliary tool in the definition of public policies related to CF.

Keywords: Cystic fibrosis; GRADE approach; Cystic fibrosis/drug treatment; Clinical practice guide.

Background: Hyperhidrosis or excessive sudoresis is a chronic disease associated with important subjective distress. Objective: To propose a specific questionnaire to evaluate the quality of life of patients with hyperhidrosis. Methods: From October 1995 to March 2002, 378 patients (234 females), with a mean age of 26.8 years, were evaluated before and after video-assisted thoracic sympathectomy. Results: Therapeutic success was obtained in 90% of the procedures. The recurrence rate was 10% for palmar and 11% for axillary hyperhidrosis; 27% of the patients who had recurrence were re-operated successfully. No serious complications were reported. Of the total number of patients, 91% answered to the quality of life questionnaire, and 86% of them reported improvement after the procedure. Conclusions: Thoracic sympathectomy is a therapeutic method capable of changing the quality of life of patients with hyperhidrosis. The questionnaire applied has shown these changes.

Keywords: Thoracic sympathectomy. Quality of life.

Objective: The aim of this study was to use a Serbian-language version of the disease-specific, self-report Sarcoidosis Health Questionnaire (SHQ), which was designed and originally validated in the United States, to assess health status in sarcoidosis patients in Serbia, as well as validating the instrument for use in the country. Methods: This was a cross-sectional study of 346 patients with biopsy-confirmed sarcoidosis. To evaluate the health status of the patients, we used the SHQ, which was translated into Serbian for the purposes of this study. We compared SHQ scores by patient gender and age, as well as by disease duration and treatment. Lower SHQ scores indicate poorer health status. Results: The SHQ scores demonstrated differences in health status among subgroups of the sarcoidosis patients evaluated. Health status was found to be significantly poorer among female patients and older patients, as well as among those with chronic sarcoidosis or extrapulmonary manifestations of the disease. Monotherapy with methotrexate was found to be associated with better health status than was monotherapy with prednisone or combination therapy with prednisone and methotrexate. Conclusions: The SHQ is a reliable, disease-specific, self-report instrument. Although originally designed for use in the United States, the SHQ could be a useful tool for the assessment of health status in various non-English-speaking populations of sarcoidosis patients.

Keywords: Sarcoidosis; Health status; Validation studies; Questionnaires; Self report; Serbia.

Approximately seven million Brazilians over 40 years of age have COPD. In recent years, major advances have been made in the pharmacological treatment of this condition. We performed a systematic review including original articles on pharmacological treatments for COPD. We reviewed articles written in English, Spanish, or Portuguese; published between 2005 and 2009; and indexed in national and international databases. Articles with a sample size < 100 individuals were excluded. The outcome measures were symptoms, pulmonary function, quality of life, exacerbations, mortality, and adverse drug effects. Articles were classified in accordance with the Global Initiative for Chronic Obstructive Lung Disease criteria for the determination of the level of scientific evidence (grade of recommendation A, B, or C). Of the 84 articles selected, 40 (47.6%), 18 (21.4%), and 26 (31.0%) were classified as grades A, B, and C, respectively. Of the 420 analyses made in these articles, 236 were regarding the comparison between medications and placebos. Among these 236 analyses, the most commonly studied medications (in 66, 48, and 42 analyses, respectively) were long-acting anticholinergics; the combination of long-acting 2 agonists and inhaled corticosteroids; and inhaled corticosteroids in isolation. Pulmonary function, adverse effects, and symptoms as outcomes generated 58, 54, and 35 analyses, respectively. The majority of the studies showed that the medications evaluated provided symptom relief; improved the quality of life and pulmonary function of patients; and prevented exacerbations. Few studies analyzed mortality as an outcome, and the role that pharmacological treatment plays in this outcome has yet to be fully defined. The medications studied are safe to use in the management of COPD and have few adverse effects.

Keywords: Pulmonary disease, chronic obstructive/therapy; Pulmonary disease, chronic obstructive/mortality; Review.