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Introduction The Dyspnoea-12 (D-12) is a brief, easy to complete questionnaire for measuring breathlessness. Objectives To facilitate further efforts to measure dyspnoea in real clinical settings, the authors aimed to develop and validate a Japanese version of the D-12 and also compare the D-12 with the Baseline Dyspnea Index (BDI) and the Activity component of the St. George's Respiratory Questionnaire (SGRQ). Methods The standardized procedure in accordance with international guidelines was used to create the translation. A validation study with a cross-sectional observational design was conducted on 122 subjects with stable chronic obstructive pulmonary disease (COPD). Results The internal consistency of the D-12 was high (Cronbach's coefficient α = 0.883) and similar to that of the BDI (α = 0.824) and SGRQ Activity (α = 0.872). The relationships between tools were statistically significant (|Rs | = 0.53 to 0.66). Although the scores obtained from all three tools were skewed toward the milder end of the respective scales, this deviation was most prominent in the D-12 with a floor effect of 48.4%. Conclusion The Japanese version of the D-12 was successfully validated, but we should be careful of any floor effect and marked skew to the mild end of the scale, especially in subjects with mild COPD.

Introduction The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study. Methods Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52. Results The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (− 1.8 units, p

Objective Our objective was to determine if treatment with cyclophosphamide (CYC) and mycophenolate mofetil (MMF) improves patient-reported outcomes (PROs) among patients with systemic sclerosis-related interstitial lung disease (SSc-ILD). Methods This study examined PROs in patients with SSc-ILD (N = 142) who participated in the Scleroderma Lung Study II, a randomized controlled trial comparing MMF for 2 years with oral CYC for 1 year followed by 1 year of a placebo. Joint models were created to evaluate the course of PROs over 2 years. The difference in PRO scores from baseline to 24 months was measured, and the percentage of patients meeting the minimum clinically important difference (MCID) was calculated. Correlations between PROs and SSc-ILD disease severity measures were also examined. Results Treatment with CYC and MMF led to improvements in several PROs with no between-treatment differences. Scores for the Transitional Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) improved significantly over 2 years, and 29%/24% and 28%/25% of participants in the CYC/MMF groups met or exceeded the MCID estimates for TDI and SGRQ, respectively. At baseline, the forced vital capacity (FVC) percentage predicted (FVC%-predicted) did not correlate with the Baseline Dyspnea Index or SGRQ. However, improvements in the FVC%-predicted were weakly associated with improvements in dyspnea (assessed by the TDI) and SGRQ scores. Conclusion Treatment with CYC and MMF improved overall health-related quality of life in patients with SSc-ILD. The relationship between PRO measures and the FVC was relatively weak, suggesting that PROs provide complementary information about treatment efficacy not captured by changes in the FVC alone in this patient population.

Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV(1)) to forced vital capacity (FVC) ratio ≥ 0.70. Recruitment began in July 2017 with the goal of enrolling 580 participants. The baseline examination includes spirometry (with slow and forced maneuvers) and symptom questionnaires. A follow-up phone call at 4 weeks assesses symptoms and safety. The second and final visit at week 12 includes spirometry before and after study drug (hourly over 3 hours) and follow-up symptom questionnaires. The primary endpoint is the proportion of individuals who experience a 4-unit improvement in St George’s Respiratory Questionnaire (SGRQ) score at 12 weeks without treatment failure, defined as an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilators, corticosteroids or antibiotics. Key secondary endpoints include the proportion of individuals with a 2-unit improvement in the CAT score; 1-unit improvement in the Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI), both a 4-unit improvement in SGRQ and a 1-unit improvement in BDI/TDI; and mean change in SGRQ, CAT and BDI/TDI. Other secondary endpoints include area under the curve 0-3 hours for FEV(1) after study drug, change from baseline in trough inspiratory capacity, forced expiratory flow 25%-75% of FVC (FEF(25-75)) iso-volume FEF(25-75 )and mean change in symptoms and rescue medication use based on daily diary. We anticipate results to be available in 2021. This paper describes the RETHINC study and explains the rationale behind it.

The Borg and Modified Medical Research Council (mMRC) dyspnea scales have been used to evaluate dyspnea in sarcoidosis. The Baseline Dyspnea Index (BDI) and Transitional Dyspnea Index (TDI) are useful for the assessment of dyspnea in COPD. It is not known if the BDI-TDI accurately assesses dyspnea in sarcoidosis patients.Data was analyzed from the Registry for Advanced Sarcoidosis (ReAS), a multi-national database enrolling patients with advanced sarcoidosis and a comparison group of sarcoidosis patients with non-advanced disease. At baseline, patients completed a BDI questionnaire along with spirometry, 6-min walk distance (6MWD), mMRC, Borg score, fatigue assessment score (FAS) and HRQoL assessments using Kings Sarcoidosis Questionnaire (KSQ) and St Georges Respiratory Questionnaire (SGRQ). At 12-months, patients with advanced disease completed a TDI questionnaire along with the other measures. Correlations between BDI and baseline variables, and between TDI and changes in baseline variables were evaluated.There was significant correlation (p 0.001 for all) between BDI and baseline 6MWD (rho = 0.336), FVC% (rho = 0.387), FEV1% (rho = 0.285), DLCO% (rho = 0.355), mMRC (rho = -0.721), Borg score (rho = -0.389), FAS (rho = -0.669), SGRQ (rho = -0.785), and KSQ (rho = 0.318 to 0.724). At follow-up, TDI correlated with BDI, but not with changes in pulmonary function or other dyspnea measures.BDI scores correlated with pulmonary function, 6MWD, and other dyspnea measures. TDI scores did not correlate with changes in pulmonary function or other dyspnea measures. BDI may be a useful independent measure of dyspnea in sarcoidosis patients. The role of TDI needs further evaluation in longitudinal studies associated with changes in clinical parameters.

Pulmonary adenoid cystic carcinoma (ACC) is a rare type of non-small cell lung carcinoma that may develop life-threatening severe malignant airway obstruction (SMAO). Currently, limited therapeutic approaches exist for ACC-SMAO. We investigated the efficacy and safety of para-toluenesulfonamide (PTS) intratumoral injection for ACC-SMAO. In this phase III, multicenter, non-randomized, single-arm, open-label trial, we recruited eight hospitalized patients with ACC-SMAO between October 2009 and January 2011. Within the first year, patients received PTS injection for 2–3 sessions weekly, with 2 weeks as a single course. Pre- and post-treatment assessments, including vital sign assessment, dyspnea index, chest computed tomography (CT), were performed shortly before PTS injection and at day 30 post-treatment. We extended the observation to 5 years to determine overall survival. The primary endpoint was the CT-assessed airway objective response rate (ORR) at day 30. The key secondary endpoint was the overall survival (OS) at 5 years post-treatment. At baseline, mean airway tumor cross-sectional area was 153.3 mm2 (n=8), and the mean airway obstruction rate was 86.1%. The airway ORR reached 100% (33.3% complete remission and 66.7% partial remission). PTS treatment reduced the airway tumor size from 158.2 to 22.7 mm2 and the average airway obstruction rate decreased from 83.1% to 14.4% (n=6). The 5-year overall survival rate was 50.0%. Median survival duration was 4.98 years (range, 1.39–5.00 years). Four patients (50.0%) had stable disease. Compared with baseline dyspnea index, the transitional dyspnea index increased significantly at 30 days after treatment (mean difference: 5.40; 95% CI, 0.31–10.49; P

Objectives To compare two questionnaires that measure health-related quality of life (HRQL) in idiopathic pulmonary fibrosis (IPF) patients. Background IPF is a disease with a progressive course as it is associated with high rates of mortality and a median survival rate of 3–4 years, so it severely affects the patient’s quality of life. General and disease-specific questionnaires are available to assess HRQL. Patients and methods HRQL was measured in 30 previously diagnosed IPF patients using a general questionnaire [short form 36 and specific questionnaires − St George’s Respiratory Questionnaire (SGRQ)]. Pulmonary function tests and 6-min walking distance test (6MWDT) were used to assess the patients’ functional status. Dyspnea at rest was evaluated by baseline dyspnea index and after exercise by the modified Borg scale. Results Pulmonary function tests showed a restrictive pattern, a decline in the exercise capacity of the patient (6MWDT), and higher scores of dyspnea at rest and following exercise. Both questionnaires showed a good correlation with some of patients’ functional parameters but all of the SGRQ domains showed a strong correlation with all functional status parameters. Also, a good correlation with HRQL was presented by 6MWDT and baseline dyspnea index. Conclusion Specific SGRQ is a more suitable instrument for HRQL assessment in IPF patients than the general questionnaire (short form 36).

Introduction Chronic obstructive pulmonary disease (COPD) is an increasingly common cause of death worldwide. Its cardinal symptoms include breathlessness and severely reduced exercise capacity. Several patient-reported outcome (PRO) measures are used to assess health-related quality of life (HRQoL), functional performance, and breathlessness in patients with COPD. Exercise testing is employed to measure functional performance objectively, which is generally believed to impact on overall HRQoL. However, the extent to which commonly used laboratory- and field-based exercise test results correlate with PROs has not been systematically assessed. Materials and methods A search of Embase, MedLine, and the Cochrane Library identified primary publications in English that reported data on the correlations (Pearson's r or Spearman's ρ) between the outcomes of exercise tests and HRQoL and breathlessness PROs. Studies reporting on the following tests were included: 6-minute walk test (6MWT), 12MWT, incremental and endurance shuttle walk tests, incremental and endurance cycle ergometer tests, and treadmill tests. Results Of 3,205 articles screened, 28 were deemed eligible for inclusion. The most commonly reported HRQoL PRO measure was the St George's Respiratory Questionnaire (13 studies), and the most commonly reported breathlessness PRO measure was the Baseline Dyspnea Index (six studies). The St George's Respiratory Questionnaire appears to correlate very weakly to moderately with the 6MWT, and breathlessness PROs appear to be moderately to strongly associated with 6MWT outcomes. Across all studies, the 6MWT was the most commonly reported exercise test. Very few publications reporting associations between other exercise tests and PRO measures were found. Conclusion This review found evidence to support the association of 6MWT outcomes with HRQoL and breathlessness PROs. There were limited data showing correlations with the outcomes of other exercise tests. Further work is required to examine the associations between these PROs and exercise test outcomes.

Objective Surgeons have hesitated to adopt minimally invasive diaphragm plication techniques because of technical limitations rendering the procedure cumbersome or leading to early failure or reduced efficacy. We sought to demonstrate efficacy and durability of our thoracoscopic plication technique using a single running suture. Methods We retrospectively reviewed patients who underwent our technique for diaphragm plication since 2008. We used a single, buttressed, double-layered, to-and-fro running suture with additional plicating horizontal mattress sutures as needed. Results Eighteen patients underwent thoracoscopic plication from 2008 to 2015. There were no operative mortalities and 2 unrelated late deaths. Median hospital stay was 3 days (range, 1-12). Atrial fibrillation occurred in 1 patient (5.5%), pneumonia occurred in 2 patients (11%), reintubation occurred in 1 patient (5.5%), and ileus occurred in 1 patient (5.5%). Of 14 patients with complete follow-up, median follow-up was 29.4 months (range, 3.4-84.7). Significant increases between preoperative and postoperative pulmonary function tests (% predicted values) were found for mean forced expiratory volume in 1 second (73.5% ± 3.5% to 88.8% ± 4.5%, P = .002) and mean forced vital capacity (70.6% ± 3.5% to 82.3% ± 3.5%, P = .002). Preoperative mean Baseline Dyspnea Index was 8.1 ± 0.7. Mean Transitional Dyspnea Index 6 months postoperatively was 7.1 ± 0.6 (moderate to major improvement). Transitional Dyspnea Index at last contact (median 29.4 months postoperatively) was 7.2 ± 0.6 ( P = .38). Compared with previously published results, this is at least equivalent. Conclusions Thoracoscopic diaphragm plication with a running suture is safe and achieves excellent early and long-term improvements. This addresses technical challenges of tying multiple interrupted sutures by video-assisted thoracoscopic surgery without any apparent compromise to efficacy or durability.

Background Cough is a common symptom of scleroderma-related interstitial lung disease (SSc-ILD), but its relationship to other characteristics of SSc-ILD, impact on cough-specific quality of life (QoL), and response to therapy for SSc-ILD have not been well studied. Methods We investigated frequent cough (FC) in patients with SSc-ILD (N = 142) enrolled in the Scleroderma Lung Study II, a randomized controlled trial comparing mycophenolate mofetil (MMF) and oral cyclophosphamide (CYC) as treatments for interstitial lung disease (ILD). We determined the impact of FC on QoL (Leicester Cough Questionnaire [LCQ]), evaluated the change in FC in response to treatment for SSc-ILD, and examined the relationship between gastroesophageal reflux disease (GERD) and cough during the trial. Results Study participants who reported FC at baseline (61.3%) reported significantly more dyspnea, exhibited more extensive ILD on high-resolution CT, had a lower diffusing capacity for carbon monoxide, and reported more GERD symptoms than did those without FC. Cough-specific QoL was modestly impaired in patients with FC (total LCQ score, 15.4 ± 3.7; normal range, 3-21 [higher scores indicate worse QoL]). The proportion of patients with FC at baseline declined by 44% and 41% over 2 years in the CYC and MMF treatment arms, respectively, and this decline was significantly related to changes in GERD and ILD severity. Conclusions FC occurs commonly in SSc-ILD, correlates with both the presence and severity of GERD and ILD at baseline, and declines in parallel with improvements in both ILD and GERD over a 2-year course of therapy. Frequent cough might serve as a useful surrogate marker of treatment response in SSc-ILD trials. Trial Registry ClinicalTrials.gov; No.: NCT00883129; URL: www.clinicaltrials.gov.

Introduction: Dyspnoea is one of the most common symptoms in chronic obstructive pulmonary disease (COPD) and has been associated with poor clinical outcomes. Aims and objectives: To investigate relationships between dyspnoea severity, baseline characteristics and outcomes in patients with COPD. Methods: Data from two 1-year, randomized trials (NCT00168844; NCT00168831) of tiotropium Respimat® 5 µg and placebo were pooled. This retrospective analysis assessed characteristics and outcomes of patients by Baseline Dyspnea Index score. Results: Of 1317 patients, 337 (26%) had mild or no dyspnoea at baseline, 743 (56%) moderate dyspnoea and 237 (18%) severe dyspnoea (Table). Baseline demographic characteristics were similar across dyspnoea categories. However, higher levels of dyspnoea correlated with more advanced COPD (GOLD Stage), and greater use of short-acting bronchodilators and inhaled corticosteroids. Patients with severe dyspnoea reported more exacerbations within the past year. Increasing dyspnoea at baseline correlated with greater risk of moderate–severe (P=0.0005) and severe (P=0.0198) exacerbations during the study. Tiotropium reduced moderate–severe exacerbation risk and significantly improved FEV1 and FVC across all dyspnoea categories. Conclusions: Patients with more severe dyspnoea had more advanced COPD, and a higher risk of exacerbation. Tiotropium improved outcomes regardless of baseline dyspnoea severity.

Background: Limited options exist for alleviation of exertional dyspnea in interstitial lung disease (ILD). Exertional dyspnea in ILD is associated with increased inspiratory neural drive (IND) to the diaphragm (Faisal et al, AJRCCM 2016;193(3):299-309). We assessed the impact of nebulized fentanyl on dyspnea intensity, IND and its physiological underpinnings in ILD during constant work rate (CWR) cycle exercise. Methods: This randomized double-blind cross-over study examined the effect of 100mcg nebulized fentanyl vs. placebo on dyspnea (Borg scale), IND using diaphragmatic electromyography (EMGdi/EMGdi, max), pulmonary gas exchange and dynamic respiratory mechanics during 4-min CWR exercise (performed at 75% peak work rate) in ILD subjects. Results: Subjects (n=21) had Baseline Dyspnea Index of 7.8±1.7; TLC 70±12%predicted, FVC 79±17%predicted and DLCO 50±15%predicted (mean±SD). With placebo from rest to end-exercise dyspnea increased to 4.1±1.2 Borg units, IND increased from 17±7% to 61±13%, minute ventilation (VE) increased from 15.5±3.3L/min to 58.7±11.6L/min and inspiratory reserve volume (IRV) dropped from 1.6±0.5L to 0.6±0.2L (mean±SD). Significant inter-relationships were found between increased dyspnea, increased IND and decreased IRV (all p Conclusions: In ILD exertional dyspnea increases in tandem with IND as IRV decreases. Nebulized fentanyl had no effect on dyspnea, IND, dynamic respiratory mechanics or their inter-relationships during exercise.

Introduction The goals of chronic obstructive pulmonary disease (COPD) treatment are to relieve dyspnea, increase exercise capacity, and improve quality of life. The relation of exercise capacity, dyspnea level, and quality of life with long-term mortality is unclear. Aim of the study was to assess the effect of exercise capacity, dyspnea level and quality of life on long-term mortality risk in patients with COPD. Materials and Methods Dyspnea level was assessed using the modified Medical Research Council (mMRC), Borg and Baseline Dyspnea Index (BDI) and Body Obstruction Dyspnea Exercise (BODE), health-related quality of life with St. George's Respiratory Questionnaire, and exercise capacity with the 6-minute walking test (6MWT) and cardiopulmonary exercise test. At the end of 8-year follow-up period, the relation between these tests and mortality was examined. Result A total of 42 patients with stable COPD were included in the study. Sixteen patients died during the approximately 8-year follow-up period. Univariate analysis revealed that VO2 peak [HR: 1.845; CI: (1.336-2.55); p

Background Severe malignant airway obstruction (SMAO) is a life-threatening form of non-small cell lung carcinoma (NSCLC). Objectives To determine the efficacy and safety of para -toluenesulfonamide (PTS) intratumoral injection in NSCLC-SMAO. Methods Ninety patients with NSCLC-SAO received repeated courses of PTS intratumoral injection until tumor sizes had reduced by 50% or greater. Primary endpoint was objective alleviation rate, assessed by chest computed tomography (CT) and bronchoscopy, at day 7 and 30 following final dosing. Secondary endpoints included airway obstruction, spirometry, quality-of-life and survival time. Results In full-analysis set ( N =88), using RECIST criteria, PTS treatment resulted in a significant objective alleviation rate [chest CT: 59.1% (95%CI: 48.1%–69.5%), bronchoscopy: 48.9% (95%CI: 38.1%–59.8%) at day 7; chest CT: 43.2% (95%CI: 32.7%–54.2%), bronchoscopy: 29.6% (95%CI: 20.3%–40.2%) at day 30]. There was a remarkable increase in FVC (mean difference: 0.35 liters, 95%CI: 0.16–0.53 liters), FEV 1 (mean difference: 0.27 liters, 95%CI: 0.07–0.48 liters), Baseline Dyspnea Index (mean difference: 64.8%, 95%CI: 53.9–74.7%) and Functional Assessment of Cancer Therapy-Lung Cancer Subscale (mean difference: 6·9, 95%CI: 3.8-9.9) at day 7 post-treatment. We noted significantly reduced prevalence of atelectasis (by 42.9%) and Eastern Cooperative Oncology Group physical performance scale (mean difference: 7.2, 95%CI: 3.9–10.5). Median survival time was 394 days in full-analysis set and 460 days in per-protocol set. Adverse events were reported in 64.0% of subjects. Seven severe adverse events (7.9%) were reported, of which three led to death (drug-related in one case). Conclusion PTS intratumoral injection is effective and well tolerated for palliative therapy of NSCLC-SMAO.

Objectives In chronic obstructive pulmonary disease (COPD), quality of life and exercise capacity are altered in relationship to dyspnea. Benefits of inspiratory muscle training (IMT) on quality of life, dyspnea, and exercise capacity were demonstrated, but when it is associated to pulmonary rehabilitation (PR), its efficacy on dyspnea is not demonstrated. The aim of this systematic review with meta-analysis was to verify the effect of IMT using threshold devices in COPD patients on dyspnea, quality of life, exercise capacity, and inspiratory muscles strength, and the added effect on dyspnea of IMT associated with PR (vs. PR alone). Study selection This systematic review and meta-analysis was conducted on the databases from PubMed, Science direct, Cochrane library, Web of science, and Pascal. Following key words were used: inspiratory, respiratory, ventilatory, muscle, and training. The searching period extended to December 2017. Two reviewers independently assessed studies quality. Results Forty-three studies were included in the systematic review and thirty-seven studies in the meta-analysis. Overall treatment group consisted of six hundred forty two patients. Dyspnea (Baseline Dyspnea Index) is decreased after IMT. Quality of life (Saint George's Respiratory Questionnaire), exercise capacity (6 min walk test) and Maximal inspiratory pressure were increased after IMT. During PR, no added effect of IMT on dyspnea was found. Conclusion IMT using threshold devices improves inspiratory muscle strength, exercise capacity and quality of life, decreases dyspnea. However, there is no added effect of IMT on dyspnea during PR (compared with PR alone).

The chronic obstructive pulmonary disease (COPD) and asthma are chronic airway diseases that cause considerable physical, emotional and social restrictions. The life quality of patients who suffer from these diseases, is more affected by dyspnea then by other symptoms. That way is possible to correlate the impact of dyspnea on their life quality. The Pulmonary Rehabilitation Program (PRP) helps to improve the physical fitness and quality of life. This paper presents a study of the life quality and the dyspnea intensity in chronic lung disease patients. The research has participation of fourteen patients, distributed as seven suffering from COPD and the other seven suffering from asthma, for both gender and with an age average of 74.2 ± 8.9. The patients answer the following questionnaires: Baseline Dyspnea Index (BDI), Medical Research Council (MRC) Dyspnea Scale, Airways Questionnaire 20 (AQ20) and the Brazilian version of the Short-Form (SF-36) life quality questionnaire. From the present study, it was concluded that asthma patients have a less impaired life quality, since the dyspnea intensity is lesser, compared to the one with COPD.

Introduction: The Global initiative for chronic Obstructive Lung Disease (GOLD) recommends treating patients with chronic obstructive pulmonary disease (COPD) based on a combined assessment of symptom severity and airflow limitation and/or exacerbation risk. According to GOLD, patients with mild-to-moderate airflow limitation and distressing symptoms such as dyspnea should be treated with a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA). If symptoms persist on monotherapy, GOLD recommends a combination of bronchodilators (LABA/LAMA). Methods: We performed a post-hoc analysis of data from two 26-week, prospective clinical trials to investigate the effect of treating patients with moderate-to-severe dyspnea with the once-daily LABA/LAMA combination indacaterol/glycopyrronium (IND/GLY) 110/50 µg compared with placebo, once-daily tiotropium 18 µg, and twice-daily salmeterol/fluticasone propionate (SFC) 50/500 µg. In this analysis, a Baseline Dyspnea Index (BDI) score ≤7 was used to identify dyspneic patients. Results: In dyspneic patients, IND/GLY significantly improved Transition Dyspnea Index (TDI) total scores compared with tiotropium (0.59 units; p

We investigated use of the tunnelled catheter in a large palliative population with malignancy-associated ascites employing retrospective analysis of a prospectively maintained patient database of tunnelled peritoneal catheter insertions for refractory malignancy-associated ascites or new rapidly accumulating ascites. We found that a 100 percent procedural success rate was achieved with 395 tunnelled catheters inserted in 386 patients. Catheters remained In situ for 66 days, on average. In a total of 22 cases (5.57 percent), complications developed. Nonfatal Infections occurred most commonly — in 15 cases (3.80 percent). Ascites stopped reaccumulating in 16 cases (4.05 percent), leading to catheter removal. The mean Baseline Dyspnea Index was 3.79 (95 percent confidence interval [CI], 3.64-3.94); the mean Transitional Dyspnea Index postinsertion was 5.14 (95 percent CI, 4.94–5.34). In all, 13 patients completed serial European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires. Postinsertion, overall quality of life improved significantly (p

Background and Aims: Dyspnoea-12 assesses dyspnea based on the physical and affective components of the symptom. The aim of this study was to translate the Dyspnoea-12 into Portuguese, and to obtain validation data regarding the use of this tool in patients with chronic obstructive lung disease (COPD). Methods: The English version of the scale Dyspnoea-12 underwent a formal translation process into Portuguese as spoken in Brazil with the final version being called Dyspnoea-12-Pt. The latter was applied to 51 Portuguese-speaking patients with COPD (33 men; age: 66.4±8.1 years; FEV1: 48.7±17.2 % pred). Participants also completed the Medical Research Council dyspnea scale (MRC), the Baseline Dyspnea Index (BDI), the Hospital Anxiety and Depression scale, the Saint George’s Respiratory Questionnaire (SGRQ), and performed spirometry and the Six Minute Walk Test (6 MWT). Forty five volunteers in stable clinical conditions also completed the Dyspnoea-12-Pt scale approximately two weeks after the first evaluation.Results: Dyspnoea-12-Pt showed significant correlations with the scales MRC (r=0.494), BDI (r= -0.511), SGRQ (r=0.806), Anxiety (r=0.471), Depression (0.414) and walked distance in the 6 MWT (r=0.329). Cronbach´s alpha of Dyspnoea-12-Pt total was 0.921 and the intraclass correlation coefficient between sequential measures was 0.829. Conclusion: The scale Dyspnoea-12-Pt exhibits acceptable psychometric properties and may be used as an evaluation tool of dyspnea in Portuguese speaking COPD patients.

Background: Pulmonary Langerhans Cell Histiocytosis (PLCH) is a diffuse cystic disease associated with reduced exercise capacity. However, the mechanisms involved in exercise limitation in PLCH are not completely understood. Objectives: To evaluate exercise performance and the main mechanisms of exercise limitation in PLCH. Methods: A cross-sectional study that evaluated 25 patients with PLCH (32% men, age 44 ± 9 years, 72% former or current smokers, with baseline dyspnea index 7 ± 3) underwent echocardiogram, six minute walk test (6MWT), pulmonary functions tests and incremental cardiopulmonary exercise test (CPET) on treadmill, with evaluation of dynamic hyperinflation. Results: Echocardiography suggested pulmonary hypertension in 67% of patients (tricuspid regurgitant jet velocity was 3.08 ± 0.78 m/s). The distance walked was 449 ± 93 m. FEV1 was 62 ± 21%, RV/TLC was 43 ± 11 and DLCO was 55 ± 23%. An obstructive pattern, air trapping and reduced DLCO were found in 76%, 36% and 76%, respectively. Maximal oxygen consumption was 88 ± 24% of predicted, and was reduced in half of patients. Ventilatory limitation, pulmonary hypertension (PH), dynamic hyperinflation and oxygen desaturation were identified in 36%, 23%, 66% and 73% of patients, respectively, during exercise, and most patients had more than one mechanism involved. Conclusions: Reduced exercise capacity is common among PLCH patients and is mainly associated with gas exchange impairment, ventilatory limitation, dynamic hyperinflation and PH, frequently with multifactorial involvement. Financial support: FAPESP (Sao Paulo Research Foundation), grant 2015/06604-0

Aim: Smoking and nicotine exposure increase insulin resistance and the risk of type 2 diabetes. Despite the pulmoner rehabilitation has many benefits, only a number of patients participate in programs. Telerehabilitation (TR) allows to the use of communication tehcnology to provide rehabilitation services in their home. Our study was conducted to evaluate the effect of TR on dyspnea and exercise capacity in patients with type 2 diabetes mellitus who smoked. Methods: Twenty smoker patients with type 2 diabetes mellitus randomized to either TR group (n:12, mean age 55.3±11.2 years, BMI:33.6±5.2 kg/m2 ) or a control group (n:8, mean age 50.2±13.8 years, BMI:26.0±2.3 kg/m2). Exercise capacity was assessed by Six Minute Walk Test (6MWT). Baseline dyspnea index (BDI) was used to determine dyspnea level. TR program include callisthenic and respiratory exercise at home by internet based video conferences, 3 days a week, for 6 weeks. Control group was just performed assessments before and after 6 weeks. Result: 6MWT distance (p:0.00), BDI functional impairment (p:0.00), magnitude of task (p:0.03) subparameters scores were improved in TR group. There were no significant differences in control group. Change in BDI functional impairment (p:0.02), magnitude of effort (p:0.02) and task (p:0.00) subparameters significantly differed between two groups. Conclusions: Our study shows that TR program may be effective on dyspnea and exercise capacity in type 2 diabetes mellitus patients who smoked. In addition to these health benefits, rehabilitation team may save time, labor and treatment costs by using TR.

Rationale: Nintedanib treatment in patients with IPF was evaluated in RCTs. However, little is known about the effect of nintedanib on multidimensional evaluation. Aim: To evaluate the efficacy of nintedanib on multidimensional aspects in real-world conditions. Methods: This is a single center retrospective observational study. We reviewed the data for 37 patients, who commenced treatment with nintedanib. In this study, patients who had baseline FVC less than 50 % predicted were excluded. Data was collected regarding demographics, pulmonary function tests, six-minute walk tests (6MWT), St. George9s Respiratory Questionnaire (SGRQ), and Baseline dyspnea index (BDI), at 6 months prior to nintedanib (pre 6M), at baseline, and at 6 months after starting of nintedanib (post 6M). Sequential changes of variables were analyzed using linear mixed models with Bonferroni’s correction. Results: Our cohort had an average age of 70.4±6.5 years, and the majority of patients were male (84%). The average length of nintedanib treatment was 276±175 days and the median duration of follow up after nintedanib administration was 401 days. In the mixed models, the mean (±SE) of FVC at pre 6M, at baseline, and at post 6M were 77.7±3.3, 71.2±3.2 and 68.0±3.3, respectively. In contrast with a significant decline in 6 months prior to nintedanib (p=0.006), there was stabilization in 6 months following nintedanib (p=0.315). This tendency is the same for DLco, SGRQ and BDI. Conclusions: It is reassuring to find that real world patients have favorable and similar outcomes to those in the clinical trials. Further study is needed to reveal the effect of nintedanib on multidimensional evaluation.

Context: Chronic obstructive pulmonary disease (COPD) is defined as a disease characterized by the presence of airflow obstruction that is attributed to either chronic bronchitis or emphysema. Dyspnea is one of the common symptoms of COPD where it is associated with limited physical activity and increased anxiety and depression. Anxiety and depression are frequent in patients with COPD and it increases as the severity of disease progresses. This article will serve us to know about the correlation between anxiety and depression with the Baseline Dyspnea Index in COPD Patients. Aims: The aim of this study was to study the correlation of Baseline Dyspnea Index and Hospital-associated anxiety and depression in COPD patients. Settings and Design: Settings-Bahusaheb Talegaon Rural Hospital, Pune Maharashtra, India. Design-Correlation study, Validated Hospital anxiety and depression scale was used along with Baseline Dyspnea Index to check correlation in COPD Patients. Subjects and Methods: This correlation study received institutional ethical approval. All participants according to inclusion criteria coming to the rural hospital were selected. Informed consent was obtained from each participant. Baseline Dyspnea Index and Hospital Anxiety-Depression scale. Statistical Analysis Used: Statistical analysis of data was reported, using instant application in that nonparametric test (Spearman's correlation coefficient) was used. Results: The result shows that there was a positive correlation between anxiety and the Baseline Dyspnea Index (functional impairment) in COPD Patients. Whereas there was a negative correlation of depression and the Baseline Dyspnea Index. Conclusions: The present study included COPD patients which state that the Baseline Dyspnea Index has a significant relation with anxiety in which functional impairment has greater significance. Depression does not have a significant relationship with the Baseline Dyspnea Index.

Background Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in COPD. Our objectives were to compare the efficacy and safety of once-daily umeclidinium bromide (UMEC)/vilanterol (VI) 125/25 μg with placebo and UMEC or VI monotherapy in COPD. Methods This was a double-blind, placebo-controlled, parallel-group study. A total of 1,493 patients were randomized (3:3:3:2) to 24 weeks of treatment with UMEC/VI 125/25 μg, UMEC 125 μg, VI 25 μg, or placebo once daily via dry powder inhaler. Results Primary efficacy end point was trough FEV 1 on day 169 (23-24 h postdose). Additional lung-function, symptomatic, and health-related quality-of-life end points were also assessed. Safety evaluations included adverse events, vital signs, ECG, and clinical laboratory measurements. All active treatments significantly improved trough FEV 1 vs placebo (0.124-0.238 L, all P P ≤ .001). Improvements for UMEC/VI 125/25 μg vs placebo were observed for the Transition Dyspnea Index (1.0 unit, P P Conclusions Once-daily UMEC/VI 125/25 μg was well tolerated and provided greater improvements in lung function, health status, and dyspnea scores compared with monotherapy components and placebo over 24 weeks. This study supports the use of UMEC/VI 125/25 μg for the maintenance treatment of COPD. Trial registry ClinicalTrials.gov ; No.: NCT01313637; URL: www.clinicaltrials.gov .

Purpose The pulmonary rehabilitation program has become a cornerstone in the management of patients with chronic obstructive pulmonary disease (COPD). Programs based in hospital and treatment facilities, however, are inconvenient and underutilized. A home-based program is a promising alternative, but studies of its effectiveness have yielded inconsistent results. The purpose of this study is to evaluate the impact of home-based pulmonary rehabilitation programs on health-related quality of life (HRQoL) and other health outcomes in patients with COPD. Methods Randomized controlled trials (RCTs) of home-based pulmonary rehabilitation programs published between February 1991 and February 2012 were retrieved from electronic databases (PubMed, Cochrane Library, Science Direct, China National Knowledge Infrastructure [CNKI], and Wanfang Database). Two reviewers independently assessed topical relevance and trial quality, extracted data for meta-analysis using the Review Manager v5.1 software, and contacted the original studies' authors for additional information. Findings Eighteen trials, comprising 733 randomized patients, were included in the meta-analysis. COPD patients experienced significant relief in dyspnea status, measured by the Borg score (Fixed effects model, WMD = −0.92, 95% CI: −1.61~−0.23, p = .009) and baseline dyspnea index (BDI) (Fixed effects model, WMD = −1.77, 95% CI: −2.65~−0.89, p

Background: Activity-related dyspnea is the main contributor to the altered quality of life in diffuse parenchymal lung diseases (DPLD). Instruments pertaining to dyspnea are classified as pertaining to domains of sensory-perceptual experience, affective distress or symptom/disease impact; whether these domains are equally related to lung function impairments remains to be established. Objectives: They were to assess the relationships between two domains of dyspnea (sensory-perceptual experience and symptom impact) and pulmonary function tests according to their evaluation of ventilatory demand, capacity and drive in patients suffering from DPLD. Methods: Fifty patients were prospectively enrolled (median age, 58 years; 25 women) and underwent spirometry, body plethysmography, measurements of lung diffusion for carbon monoxide (DLCO) and nitric oxide, maximal airway pressures (capacity and demand assessments), mouth occlusion pressure at 0.1 s (P0.1: respiratory drive assessment) and a 6-min walk test with Borg score assessment (dyspnea: sensory domain). The impact domain of dyspnea was evaluated using the baseline dyspnea index. Results: The sensory domain of dyspnea was linked to demand (CO transfer coefficient, kCO) only, while the impact domain was independently linked to demand and capacity (kCO and forced vital capacity, respectively). Among resting pulmonary function tests, both P0.1 and DLCO allowed the assessment of these two domains of dyspnea. Conclusions: In DPLD, the sensory-perceptual domain of dyspnea is mainly linked to alterations in ventilatory demand while the impact domain is related to both demand and capacity. DLCO that assesses both demand and capacity and P0.1 were the strongest correlates of dyspnea.

International audience; BACKGROUND:Some studies suggest that asthma-COPD overlap syndrome (ACOS) is associated with worse outcomes than chronic obstructive pulmonary disease (COPD). The goal of this study was to further explore the clinical characteristics and survival of patients with ACOS identified in a real-life cohort of patients with COPD.METHODS:Data from the French COPD cohort 'INITIATIVES BronchoPneumopathie Chronique Obstructive' (n = 998 patients) were analyzed to assess the frequency of ACOS defined as a physician diagnosis of asthma before the age of 40 years and to analyze its impact. Univariate analyses were performed to assess the relationship between ACOS and sociodemographic characteristics, risk factors (smoking, occupational exposure, atopic diseases), symptoms (chronic bronchitis, dyspnea-modified Medical Research Council scale and baseline dyspnea index), quality of life (QoL), mood disorders, exacerbations, comorbidities, lung function, prescribed treatment, and survival.RESULTS:ACOS was diagnosed in 129 patients (13%). In multivariate analyses, ACOS was associated negatively with cumulative smoking (odds ratio [OR]: 0.992; 95% CI 0.984-1.000 per pack-year) and positively with obesity: OR: 1.97 [1.22-3.16], history of atopic disease (hay fever: OR: 5.50 [3.42-9.00] and atopic dermatitis: OR 3.76 [2.14-6.61]), and drug use (LABA + ICS: 1.86 [1.27-2.74], antileukotrienes 4.83 [1.63-14.34], theophylline: 2.46 [1.23-4.91], and oral corticosteroids: [2.99;.1.26-7.08]). No independent association was found with dyspnea, QoL, exacerbations, and mortality.CONCLUSIONS:Compared to 'pure' COPD patients, patients with ACOS exhibit lower cumulative smoking, suffer more from obesity and atopic diseases, and use more asthma treatments. Disease severity (dyspnea, QoL, exacerbations, comorbidities) and prognosis (mortality) are not different from 'pure' COPD patients.

Background Idiopathic pulmonary fibrosis (IPF) is characterized by progressive impairment of lung function and degradation of daily activity; however, this degradation has not been adequately elucidated. The objective of this study was to measure the physical activity of patients with IPF to determine its relationships with physiological parameters and survival rate. Methods In total, 31 patients with IPF and 20 age-matched healthy participants were enrolled in this study. Physical activity was assessed using a physical activity monitor. The relationships among physical activity, physiological data, questionnaire-based patient-centered data, and survival were examined. Results Physical activity, expressed as daily activity energy expenditure (AEE), was significantly lower, and the percentage of sedentary time was significantly longer in patients with IPF than in healthy participants. Moreover, AEE was moderately correlated with body-mass index, forced vital capacity, diffusing capacity of carbon monoxide, and partial arterial pressure of oxygen. Relatively strong correlation was also observed between AEE and the 6-min walk distance, but not with daily dyspnea, depression, and health-related quality of life scores. Prognostic analysis indicated that daily AEE was a significant predictor of survival. Conclusions Patients with IPF were significantly inactive compared with age-matched healthy participants. In patients with more impaired physiological functions, the lower the physical activity was, the more was the sedentary time increased. Furthermore, lower daily physical activity resulted in significantly worse survival.

Exertional dyspnea scales (EDS) and health-related quality-of-life questionnaires (HRQoLQs) are used to assess chronic obstructive pulmonary disease (COPD). The GOLD guidelines categorize patients according to either 1 of these 2 domains, the lung function and the frequency of acute exacerbations in the preceding year, however with inconsistent results. Combining EDS and HRQoLQs may yield better results; however, the best combination is unclear. Whether the EDS quantifies the exercise capacity or the dyspnea perception is also unclear. The study was designed to correlate the EDS with exercise capacity and dyspnea perception and to evaluate the best combination of the EDS and HRQoLQ. Three EDS were compared by exercise capacity and Borg scores at rest and during exercise in 57 patients with COPD. Three HRQoLQs were compared by 4 domains of clinical assessments, and 2 types of exercise. The strength of correlation |r| was categorized by quartiles from

Background : Some studies suggest that ACOS is associated with worse outcomes than COPD. The goal of this study was to further explore the clinical characteristics and survival of patients with ACOS identified in a real-life cohort of COPD patients. Methods : Data from the French COPD cohort “Initiatives BPCO” (n=998 patients) were analyzed to assess the frequency of ACOS defined as a physician diagnosis of asthma before the age of 40 years and to analyze its impact. Univariate analyses were performed to assess the relationship between ACOS and risk factors (smoking, occupational exposure, atopic diseases), symptoms (chronic bronchitis , dyspnea -modified Medical Research Council scale and baseline dyspnea index-), quality of life, mood disorders, exacerbations, comorbidities, lung function, prescribed treatment, and survival. Results : ACOS was diagnosed in 129 patients (13%). In multivariate analyses, ACOS was associated negatively with cumulative smoking (Odds Ratio –OR-: 0.992; 95%CI 0.984-1.000 per pack-year) and positively with obesity: OR: 1.97 [1.22-3.16], history of atopic disease (hay fever: OR: 5.50 [3.42-9.00] and atopic dermatitis: OR 3.76 [2.14-6.61]), and drug use (LABA+ ICS: 1.86 [1.27-2.74], anti-leukotrienes 4.83 [1.63-14.34], theophylline: 2.46; [1.23-4.91] and oral corticosteroids: [2.99;.1.26-7.08]). No independent association was found with dyspnea, QoL, exacerbations and mortality. Conclusions : Compared to “pure”COPD patients, patients with ACOS exhibit lower cumulative smoking, suffer more from obesity and atopic diseases and use more asthma treatments. Disease severity (dyspnea, QoL, exacerbations, comorbidities) and prognosis (mortality) are not different from “pure” COPD patients.

Background: Physical activity plays a cardinal role in health status and mortality in patients with chronic respiratory disease. Although recent study has shown that there is a significant reduction in physical activity in patients with idiopathic pulmonary fibrosis (IPF), the relationships between physical activity and clinical parameters have not been clarified. The purpose of this study was to investigate the predictors of physical activity in patients with IPF. Methods: Physical activity (steps per day) was monitored in 74 stable IPF patients (mean age: 68.5±7.7 years, mean %FVC: 80.1±21.8 %) using accelerometer for 1 week. The following clinical parameters were measured: age, body mass index (BMI), lung function, arterial blood gases, baseline dyspnea index (BDI), hospital anxiety and depression scale (HADS), cardiopulmonary exercise test (peak VO 2 , minimum SpO 2 ), peripheral muscle strength and respiratory muscle strength. Correlation analysis and subsequent stepwise multiple regression analysis were carried out to assess the associations between these parameters and physical activity. Results: Physical activity (steps per day) was 5192±3717 steps. Age, FVC, DLCO, PaO 2 , BDI, and peak VO 2 were significantly correlated with physical activity. Multiple regression analysis showed that peak VO 2 , PaO 2 and age were independent predictors of physical activity in IPF patients (standardized β: 0.31, 0.29, -0.23, respectively, r 2 :0.369). Conclusions: PaO 2 , age and exercise capacity were predictors of physical activity in IPF patients.

The purpose of this study was to determine the effect of reflexology on reducing dyspnea and fatigue in patients with chronic obstructive pulmonary disease (COPD).The study was conducted as a pretest-posttest experimental design. The population of the study consisted of 60 patients (30 in experimental group and 30 in control group). Patient Description Form, Baseline Dyspnea Index (BDI) and Visual Analogue Scale-Fatigue (VAS-F) were used to collect the data.The difference between pretest-posttest dyspnea and fatigue mean scores of patients in the experimental group was statistically significant (p.01). The difference between pretest-posttest dyspnea and fatigue mean scores of patients in the control group was statistically insignificant (p.05).It was determined that the reflexology reduced dyspnea and fatigue in patients with COPD.Complementary methods such as reflexology should be used with pharmacological methods to reduce dyspnea and fatigue of COPD patients.

Objective To identify baseline characteristics of patients with scleroderma-related interstitial lung disease (SSc-ILD) that could serve as predictors of the most favorable response to 12-month treatment with oral cyclophosphamide (CYC). Methods Regression analyses were retrospectively applied to the Scleroderma Lung Study data in order to identify baseline characteristics that correlated with the absolute change in forced vital capacity (FVC) (% predicted values) and the placebo-adjusted change in % predicted FVC over time (the CYC treatment effect). Results Completion of the CYC arm of the Scleroderma Lung Study was associated with a placebo-adjusted improvement in the % predicted FVC of 2.11% at 12 months, which increased to 4.16% when patients were followed up for another 6 months (P = 0.014). Multivariate regression analyses identified the maximal severity of reticular infiltrates (assessed as maximum fibrosis scores) on high-resolution computed tomography (HRCT) at baseline, the modified Rodnan skin thickness score (MRSS) at baseline, and the Mahler baseline dyspnea index as independent correlates of treatment response. When patients were stratified on the basis of whether 50% or more of any lung zone was involved by reticular infiltrates on HRCT and/or whether patients exhibited an MRSS of at least 23, a subgroup of patients emerged in whom there was an average CYC treatment effect of 9.81% at 18 months (P < 0.001). Conversely, there was no treatment effect (a −0.58% difference) in patients with less severe HRCT findings and a lower MRSS at baseline. Conclusion A retrospective analysis of the Scleroderma Lung Study data identified the severity of reticular infiltrates on baseline HRCT and the baseline MRSS as patient features that might be predictive of responsiveness to CYC therapy.

SummaryBackgroundsFibrotic nonspecific interstitial pneumonia (f-NSIP) has been recognized as a distinct disease entity. KL-6 has been reported to be a useful serum marker in interstitial lung diseases. However, few previous reports evaluated the value of serum KL-6 exclusively in f-NSIP, as distinct from other subtypes of idiopathic interstitial pneumonia, therefore the associations of serum KL-6 with clinical and radiologic findings in this population remain unclear.MethodsSerum KL-6 levels were measured in twenty-six consecutive patients with f-NSIP diagnosed by surgical lung biopsy. Pulmonary function testing, bronchoalveolar lavage, subjective measurement of dyspnea using baseline dyspnea index (BDI), and HRCT were performed in parallel. Two radiologists conducted independent visual examinations of the pattern and extent of abnormalities on HRCT.ResultsSerum KL-6 levels were elevated above the cut-off level in all patients. In univariate analysis serum KL-6 levels showed negative correlations with BDI (rho=−0.52; p

We examined the contribution of alterations in central ventilatory control, static and dynamic respiratory mechanics and their interaction to exertional breathlessness in healthy human pregnancy. Detailed ventilatory, respiratory mechanical/muscular and perceptual responses to incremental cycle exercise were compared in the third trimester (TM(3)) and again approximately 5 months post-partum (PP) in women with (B, n = 12) and without (NB, n = 15) clinically significant activity-related breathlessness (measured by the baseline dyspnea index). In contrast to NB, breathlessness intensity ratings were significantly higher at any given work rate during exercise in TM(3) versus PP within B. This difference could not be explained by differences in central ventilatory control or respiratory mechanical/muscular factors. When compared with NB, the B group had an exaggerated ventilatory response to exercise in PP and TM(3), and appeared to lack central desensitization to the perceptual effects of maternal hyperventilation that was manifest within the NB group. In conclusion, gestational breathlessness could not be explained by alterations in central ventilatory control or respiratory mechanical/muscular factors, but reflected the normal awareness of increased ventilation.

SummaryBackgroundAlthough sarcoidosis most commonly affects the lungs, it is a multisystemic disease that often involves other organs. In this study, we compared fatigue, dyspnea, and the impact upon the activities of daily living and health status scores between patients with isolated pulmonary and pulmonary plus extrapulmonary sarcoidosis.MethodsIn this cross-sectional study, we investigated 81 biopsy proven sarcoidosis patients. Fatigue was assessed by the standardized Fatigue Scale (FS). Dyspnea was determined by the Baseline Dyspnea Index (BDI) and the Modified Medical Research Council (MRC) Dyspnea Scale. Activities of daily living were assessed with the List of Daily Activities (DAL). Health status was measured by two standardized questionnaires: a generic measure – fifteen-dimensional measure of health-related quality of life (15D), and a respiratory-specific measure – St George's Respiratory Questionnaire (SGRQ). Patients were excluded if they had an associated illness that could influence their health status.ResultsStatistically significant differences were demonstrated between the isolated pulmonary group and the pulmonary plus extrapulmonary group for fatigue (FS–total score: 2.4±0.64 vs. 2.8±0.62, p=0.007), dyspnea (BDI: 8.45±2.44 vs. 5.92±1.84, p

Made available in DSpace on 2013-09-27T14:54:10Z (GMT). No. of bitstreams: 1 WOS000254302300005.pdf: 232506 bytes, checksum: 2a88f2cff18e16e1cda2a08739984c24 (MD5) Previous issue date: 2008-04-01 Made available in DSpace on 2013-09-30T18:20:02Z (GMT). No. of bitstreams: 1 WOS000254302300005.pdf: 232506 bytes, checksum: 2a88f2cff18e16e1cda2a08739984c24 (MD5) Previous issue date: 2008-04-01 Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-20T13:35:03Z No. of bitstreams: 1 WOS000254302300005.pdf: 232506 bytes, checksum: 2a88f2cff18e16e1cda2a08739984c24 (MD5) Made available in DSpace on 2014-05-20T13:35:03Z (GMT). No. of bitstreams: 1 WOS000254302300005.pdf: 232506 bytes, checksum: 2a88f2cff18e16e1cda2a08739984c24 (MD5) Previous issue date: 2008-04-01 Little evidence-based guidance is available to aid clinicians in determining short-term prognoses in very severe COPD patients. Therefore, the present study was designed to provide a prospective assessment (1) of the mortality rates and (2) whether the baseline measurements may be determinants of 1-year mortality in hypoxemic COPD patients receiving long-term oxygen therapy (LTOT).Seventy-eight clinically stable patients with advanced COPD treated using LTOT were enrolled in a prospective cohort study. Outcome variable: first-year mortality. Baseline measurements: categorical variables: age (= 60 years); gender; body mass index (= 20 kg/m(2)); fat-free mass (FFM) index (3); and corticosteroid use. Continuous variables: smoking history; lung function; FFM; fat mass; hemoglobin; hematocrit; arterial blood gases; forearm muscle strength; St. George's Respiratory Questionnaire (SGRQ); and comorbidity score. By the end of 1-year of follow-up, 12 patients (15.4%) had died. Kaplan-Meier curves showed that BDI

Background The validity of pulmonary thromboendarterectomy for treatment of relatively peripheral type of chronic thromboembolic pulmonary hypertension (CTEPH) remains uncertain. The survival and quality of life (QOL) of patients with relatively peripheral type of CTEPH was investigated at follow up. Methods and Results Between April 1999 and March 2006, 83 consecutive patients with CTEPH were evaluated for surgical indication and underwent computed tomography angiography. The extent of central disease was scored (ie, CD score), and a CD score of ≤1 was judged as relatively peripheral disease. Forty-three patients were excluded from surgery, and 40 patients, including 14 cases of relatively peripheral disease, underwent surgery. Long-term survival and QOL scores at follow up (1-3 years) were compared between the surgically and medically treated groups of relatively peripheral disease. Survival curves between the 2 treatment groups were not significantly different (p=0.78) because of high operative mortality (21.4%). However, improvement in physical functioning, role function (physically related), general health perception (as assessed by the Medical Outcome Study Short Form 36), and baseline dyspnea index were significantly higher in the group treated surgically compared with the medically treated group. Conclusions Pulmonary thromboendarterectomy offers better QOL even in those patients with relatively peripheral type of CTEPH, although operative mortality must be reduced. (Circ J 2008; 72: 958 - 965)

BACKGROUND: Few data are available for the efficacy of "triple therapy" with two long-acting bronchodilators and an inhaled corticosteroid in chronic obstructive pulmonary disease (COPD). We designed this study to assess efficacy of single-inhaler combination of an extra fine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) in COPD compared with beclometasone dipropionate and formoterol fumarate (BDP/FF) treatment.METHODS: TRILOGY was a randomised, parallel group, double-blind, active-controlled study done in 159 sites across 14 countries. The sites were a mixture of primary, secondary, and tertiary care providers, and specialist investigation units. Eligible patients with COPD had post-bronchodilator forced expiratory volume in 1 s (FEV1) of lower than 50%, one or more moderate-to-severe COPD exacerbation in the previous 12 months, COPD Assessment Test total score of 10 or more, and a Baseline Dyspnea Index focal score of 10 or less. Patients who met the inclusion and exclusion criteria at screening entered a 2-week open-label run-in period where they received beclometasone dipropionate (100 μg) and formoterol fumarate (6 μg) in two actuations twice daily. Patients were then randomly assigned (1:1) with an interactive response technology system to either continue BDP (100 μg) and FF (6 μg) or step-up to BDP (100 μg), FF (6 μg), and GB (12·5 μg) in two actuations twice daily for 52 weeks via pressurised metered-dose inhaler. The three co-primary endpoints were pre-dose FEV1, 2-h post-dose FEV1, and Transition Dyspnea Index (TDI) focal score, all measured at week 26 in the intention-to-treat population (all patients who were randomly assigned and received at least one dose of study drug and had at least one post-baseline efficacy assessment). Safety outcomes were measured in the safety population (all patients who were randomly assigned and received at least one dose of study drug). Secondary endpoints included moderate-to-severe COPD exacerbation rate over 52 weeks. This study is registered with ClinicalTrials.gov number NCT01917331.FINDINGS: Between March 21, 2014, and Jan 14, 2016, 1368 patients received either BDP/FF/GB (n=687) or BDP/FF (n=681). At week 26, BDP/FF/GB improved pre-dose FEV1 by 0·081 L (95% CI 0·052-0·109; pINTERPRETATION: We provide evidence for the clinical benefits of stepping up patients with COPD from an inhaled corticosteroid/long-acting β2-agonist combination treatment to triple therapy using a single inhaler.FUNDING: Chiesi Farmaceutici SpA.

Pneumonectomy is associated with high morbidity and mortality. After pneumonectomy, data on health-related quality of life (HRQoL) or its correlation with dyspnea and lung function are scarce. Our main aim was to evaluate long-term HRQoL after pneumonectomy.In a retrospective one-center cross-sectional study, we investigated 31 of 98 patients who underwent pneumonectomy between January 1997 and October 2003 due to primary lung cancer. Pre- or postoperative chemotherapy or radiotherapy was applied according to hospital protocol. In June 2004, all patients alive received the generic HRQoL instrument (15D), as well as the Baseline Dyspnea Index (BDI). Results of the 15D were compared with those for an age- and gender-standardized general population. In April 2005, 20 patients participated in follow-up spirometric pulmonary function tests.The 15D total score and its various dimensions were significantly lower after pneumonectomy than in the general population. Females both in 15D score and in the BDI had more dyspnea (p0.05). No difference appeared between right and left pneumonectomy patients, except for more prominent dyspnea in women with right-sided pneumonectomy.Pneumonectomy had a negative impact on patients' HRQoL. The use of a broad HRQoL instrument like the 15D, which covers multiple dimensions of HRQoL, yields a more accurate evaluation than did a single-dimension HRQoL instrument. Possibilities for sleeve-resection should be considered thoroughly before any pneumonectomy.Quality of life (QoL) after pneumonectomy, as measured with a generic QoL instrument, the 15D, was compared in an age- and gender-standardized population. QoL after pneumonectomy was significantly lower, especially in women after right-sided pneumonectomy.

Objective: There is still controversy about the feasibility and long-term outcome of surgical treatment of acquired diaphragm paralysis. We analyzed the long-term effects on pulmonary function and level of dyspnea after unilateral or bilateral diaphragm plication. Methods: Between December 1996 and January 2006, 22 consecutive patients underwent diaphragm plication. Before surgery, spirometry in both seated and supine positions and a Baseline Dyspnea Index were assessed. The uncut diaphragm was plicated as tight as possible through a limited lateral thoracotomy. Patients with a follow-up exceeding 1 year (n = 17) were invited for repeat spirometry and assessment of changes in dyspnea level using the Transition Dyspnea Index (TDI). Results: Mean follow-up was 4.9 years (range 1.2—8.7). All spirometry variables showed significant improvement. Mean vital capacity (VC) in seated position improved from 70% (of predicted value) to 79% (p < 00.03), and in supine position from 54% to 73% (p = 0.03). Forced expiratory volume in 1 s (FEV1) in supine position improved from 45% to 63% (p = 0.02). Before surgery the mean decline in VC changing from seated to supine position was 32%. At follow-up this had improved to 9% (p = 0.004). For FEV1 these values were 35% and 17%, respectively (p < 0.02). TDI showed remarkable improvement of dyspnea (mean + 5.69 points on a scale of 9 to +9). Conclusion: Diaphragm plication for single- or double-sided diaphragm paralysis provides excellent long-term results. Most patients were severely disabled before surgery but could return to a more or less normal way of life afterwards. # 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Rationale It is postulated that in patients with severe tracheobronchomalacia (TBM), airway stabilization with stents may relieve symptoms. Objectives To evaluate the effect of silicone stents (tracheal, mainstem bronchus, or both) on symptoms, quality of life, lung function, and exercise capacity in these patients. Methods A prospective observational study in which baseline measurements were compared to those obtained 10 to 14 days after stent placement. Measurements and main results Of 75 referred patients, 58 had severe disease and underwent therapeutic rigid bronchoscopy with stent placement. Mean age was 69 years (range, 39 to 91 years), 34 were men, 33 had COPD, and 13 had asthma. Almost all patients (n = 57) had dyspnea as a sole symptom or in combination with cough and recurrent infections; four patients required mechanical ventilation for respiratory failure. In 45 of 58 patients, there was reported symptomatic improvement; quality of life scores improved in 19 of 27 patients (p = 0.002); dyspnea scores improved in 22 of 24 patients (p = 0.001); functional status scores improved in 18 of 26 patients (p = 0.002); and mean exercise capacity improved from baseline, although not significantly. The 49 complications included mainly 21 partial stent obstructions, 14 infections, and 10 stent migrations. Most patients with concomitant COPD also improved on most measures. Conclusions In the short term, airway stabilization with silicone stents in patients with severe TBM can improve respiratory symptoms, quality of life, and functional status. Coexisting COPD is not an absolute contraindication to a stenting trial in this population. Stenting is associated with a high number of short-term and long-term but generally reversible complications.

Respiratory symptoms are not well characterized in amyotrophic lateral sclerosis (ALS). The baseline dyspnea index (BDI) and transition dyspnea index (TDI) are indices designed to measure change in dyspnea over time. They are easy to administer and do not inquire about specific physical tasks. The latter makes these scales particularly well suited for use in ALS. This study evaluated the ability of the BDI and TDI to measure dyspnea in 46 subjects with ALS. The BDI/TDI had excellent reproducibility. The TDI detected worsening dyspnea by 4 weeks and declined significantly more over the subsequent 8 weeks. The TDI was significantly associated with changes in forced vital capacity and appeared more sensitive to changes in dyspnea than the ALS functional rating scale-respiratory subscale (ALS-FRS R) and a visual analog scale of breathlessness. The BDI and TDI thus appear to be useful measures in ALS and may have both clinical and research applications.

Study objectives: This study was developed to investigate the influence of thoracic and upperlimb muscle function on 6-min walk distance (6MWD) in patients with COPD. Design: A prospective, cross-sectional study. Setting: The pulmonary rehabilitation center of a university hospital. Patients: Thirty-eight patients with mild to very severe COPD were evaluated. Measurements and results: Pulmonary function and baseline dyspnea index (BDI) were assessed, handgrip strength, maximal inspiratory pressure (PImax), and 6MWD were measured, and the one-repetition maximum (1RM) was determined for each of four exercises (bench press, lat pull down, leg extension, and leg press) performed on gymnasium equipment. Quality of life was assessed using the St. George Respiratory Questionnaire (SGRQ). We found statistically significant positive correlations between 6MWD and body weight (r 0.32; p < 0.05), BDI (r 0.50; p < 0.01), FEV1 (r 0.33; p < 0.05), PImax (r 0.53; p < 0.01), and all values of 1RM. A statistically significant negative correlation was observed between 6MWD and dyspnea at the end of the 6-min walk test (r 0.29; p < 0.05), as well as between 6MWD and the SGRQ activity domain (r 0.45; p < 0.01) and impact domain (r 0.34; p < 0.05) and total score (r 0.40; p < 0.01). Multiple regression analysis selected body weight, BDI, PImax, and lat pull down 1RM as predictive factors for 6MWD (R 2 0.589). Conclusions: The results of this study showed the importance of the skeletal musculature of the thorax and upper limbs in submaximal exercise tolerance and could open new perspectives for training programs designed to improve functional activity in COPD patients. (CHEST 2006; 129:551–557)

Health-related quality of life (HRQOL) is an individual's perception of physical and mental health.The objective of this study was to examine the relationships between symptoms and HRQOL in individuals with chronic obstructive pulmonary disease (COPD), using a modification of a HRQOL model in COPD.A correlational descriptive design was used to examine the relationships between symptoms and HRQOL in individuals with COPD.A convenience sample of 58 subjects with a medical diagnosis of COPD, specifically chronic bronchitis or emphysema, was evaluated.The Vertical Visual Analogue Scale, Baseline Dyspnea Index, Bronchitis-Emphysema Symptom Checklist, Positive and Negative Affect Scales, Pulmonary Functional Status and Dyspnea Questionnaire, and Medical Outcome Study Short Form-36 Health Survey were used.Variables that affected the physical health component of HRQOL included breathlessness, physical impairment, and reduced activities of daily living (adjusted R(2) = .52, P.001), and variables that affected the mental health component of HRQOL were breathlessness, hopelessness and anxiety, and negative affective trait (adjusted R(2) = .58, P.001).Breathlessness, physical impairment, reduced activities of daily living, hopelessness and anxiety, and negative affective trait seem to contribute to physical and mental components of HRQOL in individuals with COPD.

Summary Question of the study : The aim of our study was to examine the relationship between health-related quality of life (HRQL), lung function parameters and intensity of dyspnea in order to determinate what variables influence the HRQL in patients with pulmonary emphysema. Patients and methods : Forty (mean aged 66±9) consecutive male patients with pulmonary emphysema were evaluated. All patients underwent spirometry, measurement of lung volumes, inspiratory and expiratory respiratory pressure (MIP and MEP), measurement of corrected carbon monoxide diffusing capacity (KCO), and 6-min walking test (6MWT). The scale of dyspnea by the baseline dyspnea index (BDI) and British Medical Council Research (MCR), and the quality of life by Chronic Respiratory Question Disease (CRQD) were also assessed. Results : FEV 1 , FVC, 6MWT, KCO, MEP, MIP, BDI and MCR were correlated with dimensions of CRQD. Factor analysis reduced these variables to four factors, which accounted for 86.2% of the total variance: (1) airway obstruction, (2) dyspnea, (3) capacity of effort, (4) maximum static respiratory pressure. In the multiple regression model BDI and MEP explained the 64% of the total variance of CRQD. Conclusions : Quality of life measured by CRQD in patients with emphysema is predominantly determined by dyspnea, and in minor degree by expiratory muscle strength. Our results underscore the usefulness of dyspnea scales and MEP in the evaluation of HRQL in patients with emphysema.

Objective To determine whether baseline self-assessment measures of health status and physiologic indices of disease severity in alveolitis-positive patients with systemic sclerosis (SSc) correlate with the severity of their dyspnea, and to quantify functional impairment in patients with scleroderma lung disease and compare it with that in patients with chronic obstructive pulmonary disease (COPD). Methods SSc patients (n = 138) with diffuse (n = 81) or limited (n = 57) cutaneous disease and active alveolitis (determined by bronchoalveolar lavage and/or high-resolution computed tomography) who participated in the National Heart, Lung, and Blood Institute–sponsored, multicenter, parallel-group, double-blind, randomized, placebo-controlled trial of oral cyclophosphamide for treatment of SSc-associated interstitial lung disease were evaluated. Pearson's univariate correlations were determined between the Short Form 36 (SF-36) physical component summary (PCS) and mental component summary (MCS) scales, functional questionnaires, and physiologic parameters of breathing (forced vital capacity [FVC] and single-breath diffusing capacity for carbon monoxide [DLCO]). Student's t-test was used to compare subgroups. Scores from 2 instruments for self-assessment of breathlessness, Mahler's baseline dyspnea index (BDI) and a visual analog scale (VAS) for breathing, were divided at the median. Values for the DLCO and FVC (% predicted) were divided based on the American Thoracic Society guidelines for mild (>70% of predicted), moderate (50–70% of predicted), and severe (

Study objective: To investigate the efficacy and safety of a fully human monoclonal antibody recognizing the chemokine interleukin (IL)-8 in patients with COPD. Design: Randomized, double-blind, parallel-group, placebo-controlled trial. Setting: Eighteen clinics/hospitals in the United States. Patients: One hundred nine patients with stable COPD. Interventions: Three IV infusions of either monoclonal antibody recognizing IL-8 (800-mg loading dose; 400-mg subsequent doses) or active buffer solution administered monthly over a 3-month period. Measurements and results: The differences in the transition dyspnea index (TDI) total score, the primary outcome measure, between fully human monoclonal IgG 2 antibody directed against IL-8 and placebo were 0.8, 1.0, 0.8, and 0.3 at week 2 (p = 0.046) and months 1 to 3, respectively. At all time points, the proportion of patients achieving ≥ 1 point improvement in the TDI was greater for the monoclonal antibody group compared with the placebo group: 28% vs 11% at week 2 (p = 0.028). There were no significant differences observed for lung function, health status, 6-min walking distance, and adverse events between groups. Conclusions: The results of this phase 2 study suggest that neutralization of IL-8 with monoclonal antibody therapy may improve dyspnea in patients with COPD. These results support the further investigation of monoclonal antibody therapy targeting IL-8 for the treatment of this disease.

Patients hospitalised for exacerbations contribute significantly to the total chronic obstructive pulmonary disease (COPD)-related healthcare costs. This study aimed to determine the resource use and costs of exacerbations by exacerbation-severity and to identify risk factors for hospitalisation. Exacerbations and the details of all associated healthcare utilisation were recorded as part of a prospective cost-effectiveness analysis linked to two randomised controlled trials comparing tiotropium with ipratropium in 519 patients with stable COPD at study entry in the Netherlands and Belgium. Exacerbation-severity was rated by the physician. A Cox proportional hazards analysis was performed to identify independent risk factors of hospitalisation. Covariates that entered this analysis were smoking status, pack-years, body mass index, number of concomitant diseases, number of concomitant medications, use of inhaled steroids, physician visits prior to trial, FEV 1 % predicted, quality of life, baseline dyspnea index (BDI) and treatment arm. The mean number of exacerbations per patient was 0.70 (95%-CI:0.60, 0.81). About 10% of the exacerbations was severe, 47% moderate and 43% was mild. The mean costs of these exacerbations were Euro 4007 (95%-CI:2004, 6011), Euro 579 (390, 768) and Euro 86 (49, 124), respectively. In addition to treatment arm, a body mass index below 18.5 (RR:3.62), each additional concomitant diagnosis (RR:1.40) and a decrease of 1 point in the baseline dyspnea index (RR:1.18) were significant risk factors of hospitalisation. Exacerbations that were associated with a hospitalisation accounted for 90% of the total costs of exacerbations. Underweight, history of concomitant diseases and increased dyspnea (BDI score) are factors that are likely to identify patients who are at increased risk for generating high costs due to hospitalisation.