St. George's Respiratory Questionnaire Scores Research Articles

Efficacy of Digital Therapeutics for Pulmonary Rehabilitation: A Multi-Center, Randomized Controlled Trial.

This study aimed to investigate the efficacy and safety of digital therapeutics (DTx), EASYBREATH, for pulmonary rehabilitation (PR) in patients with chronic respiratory diseases (CRDs). This prospective randomized controlled trial was conducted at multiple centers. Participants were randomly allocated 1:1 to the DTx group (DTxG), provided with DTx using EASYBREATH. The DTxG underwent an 8-week PR program with evaluations conducted at baseline, four weeks, and eight weeks. The control group (CG) underwent one PR session and was advised to exercise and undergo the same evaluation. The primary outcome was the change in six-minute walking distance (6MWD) over eight weeks, and secondary outcomes included changes in scores of Modified Medical Research Council (mMRC), chronic obstructive pulmonary disease assessment test (CAT), and St. George's respiratory questionnaire (SGRQ). The change in 6MWD after eight weeks demonstrated a significant difference between the DTxG and CG (57.68 m vs. 21.71 m, p = 0.0008). The change in mMRC scores (p = 0.0008), CAT scores (p < 0.0001), and total SGRQ scores (p = 0.0003) also showed a significant difference between the groups after eight weeks. EASYBREATH significantly improved exercise capacity, alleviated dyspnea, and enhanced the overall quality of life at eight weeks. EASYBREATH is a highly accessible, time-efficient, and effective treatment option for CRD with high compliance.

Long-Term SGRQ Stability in a Cohort of Individuals with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease.

Health-related quality of life (HRQoL) assessments such as St. George's Respiratory Questionnaire (SGRQ) are often used as outcome measures to evaluate patient-perceived changes in health status among individuals with lung disease. Several factors have been linked to deterioration in SGRQ, including symptoms (dyspnea, wheezing) and exercise intolerance. Whether these findings apply to individuals with alpha-1 antitrypsin deficiency (AATD) remains incompletely studied. This longitudinal study examines the trajectory of SGRQ scores in a cohort of United States individuals with AATD-associated lung disease and defines factors associated with longitudinal change. Individuals with AATD-associated lung disease enrolled in AlphaNet, a disease management program, who had ≥3 SGRQ measurements collected between 2009 and 2019, and baseline data for clinically important variables were included in these analyses. Data collected after lung transplants were excluded. Mixed-effects model analyses were used to evaluate the changes in SGRQ total and subscale scores over time and by modified Medical Research Council (mMRC) Scale, use of oxygen, age, sex, productive cough, and exacerbation frequency at baseline. Sensitivity analyses were conducted to examine the potential effect of survivor bias. Participants (n=2456, mean age 57.1±9.9 years, 47% female) had a mean SGRQ total score of 44.7±18.9 at baseline, 48% used oxygen regularly, and 55% had ≥2 exacerbations per year. The median length of follow-up was 6 (IQR 3-9) years. The SGRQ total score and subscales remained stable throughout the observation period. Age, mMRC categories, presence or absence of productive cough, frequency of exacerbations, and use of oxygen at baseline were significantly associated with the rate of change of SGRQ total (p<0.0001). We observed long-term stability in HRQoL and an association between the rate of change in SGRQ and baseline mMRC, exacerbation frequency, productive cough, and use of oxygen in this cohort of individuals with AATD-associated lung disease.

Effects of Home-Based Pulmonary Training Program on Functional Exercise Capacity and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease

Background: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, characterized by persistent respiratory symptoms and airflow limitation. Despite the availability of various treatments, there is a growing interest in exploring more effective strategies to manage symptoms, enhance exercise capacity, and improve the quality of life for COPD patients. Pulmonary rehabilitation, including both supervised and home-based exercises, has emerged as a promising approach. Objective: The aim of this study was to evaluate the effectiveness of a combined approach of Active Cycle of Breathing Technique (ACBT) with a home-based exercise regimen in improving functional exercise capacity and quality of life in patients with COPD, compared to ACBT alone. Methods: This was a randomized controlled trial involving 44 COPD patients, divided into two groups: Group A received ACBT alone, while Group B participated in ACBT plus a home-based exercise program. The intervention lasted for four weeks. Outcome measures included the St. George’s Respiratory Questionnaire (SGRQ) for quality of life, the 30-second arm curl test for upper extremity function, and the 6-minute walk test (6MWT) for lower extremity function. Data were analyzed using SPSS version 25, with the Mann-Whitney and Wilcoxon tests for between-group and pre-post intervention comparisons, respectively. Results: Group B showed more significant improvements in exercise capacity and respiratory symptoms compared to Group A. Specifically, the 6MWT distances increased from an average of 365.60±57.81 meters to 370.40±54.29 meters in Group B, indicating enhanced lower extremity function. Similarly, the SGRQ scores, reflecting quality of life, demonstrated more substantial improvement in Group B, though specific numerical results for this and the 30-second arm curl test were not significantly different between groups. Conclusion: The study concludes that combining ACBT with a home-based exercise regimen significantly benefits COPD patients by improving functional exercise capacity and potentially enhancing the quality of life. This combined approach could serve as a viable addition to the COPD management strategy, emphasizing the importance of comprehensive, patient-centered care.

Efficacy and Safety of Medical Thoracoscopic Bulla Volume Reduction in the Treatment of Chronic Obstructive Pulmonary Disease Combined With Giant Emphysematous Bullae

To explore the efficacy and safety of medical thoracoscopic bulla volume reduction for the treatment of chronic obstructive pulmonary disease (COPD) combined with giant emphysematous bullae (GEB). A total of 66 patients with COPD combined with GEB were enrolled in the study. All the subjects received treatment at Zhengzhou Central Hospital affiliated with Zhengzhou University between March 2021 and December 2022. The subjects were divided into two groups, a medical thoracoscope group consisting of 30 cases treated with medical thoracoscopic bulla volume reduction and a surgical thoracoscope group consisting of 36 cases treated by video-assisted thoracoscopic surgery. All patients were followed up before discharge and 3 months and 6 months after discharge. The preoperative and postoperative levels of the pulmonary function, 6-minute walk distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ) scores and differences in postoperative complications were compared between the two groups. The operative duration, postoperative length-of-stay, and surgical costs and hospitalization bills, and the maximum visual analog scale (VAS) pain scores at 24 h after the procedure were assessed. The baseline data of the two groups were comparable, showing no statistically significant difference. The forced expiratory volume in 1 second (FEV1) 6 months after the procedures improved in both the medical thoracoscopy group ([0.78±0.29] L vs. [1.02±0.31] L, P<0.001) and the surgical thoracoscopy group ([0.80±0.21] L vs. [1.03±0.23] L, P<0.001) compared to that before the procedures. Improvements to a certain degree in 6MWT and SGRQ scores were also observed in the two groups at 3 months and 6 months after the procedures (P<0.05). In addition, no statistically significant difference in these indexes was observed during the follow-up period of the patients in the two groups. There was no significant difference in operating time between the two groups. The medical thoracoscopy group had shorter postoperative length-of-stay ([7.3±2.6] d) and 24-hour postoperative VAS pain scores (3.0 [2.0, 3.3]) than the surgical thoracoscopic group did ([10.4±4.3] d and 4.5 [3.0, 5.0], respectively), with the differences being statistically significant (P<0.05). Surgical cost and total hospitalization bills were lower in the medical thoracoscopy group than those in the surgical thoracoscopy group (P<0.05). The complication rate in the medical thoracoscopy group was lower than that in the surgical thoracoscopy group (46.7% vs. 52.8%), but the difference was not statistically significant. Medical thoracoscopic reduction of bulla volume can significantly improve the pulmonary function, quality of life, and exercise tolerance of patients with COPD combined with GEB, and it can reduce postoperative short-term pain and shorten postoperative length-of-stay. The procedure has the advantages of minimal invasiveness, quick recovery, and low costs. Hence extensive clinical application is warranted.

Role of detailed psychological evaluation and treatment in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease.

Psychological co-morbidities are common in chronic obstructive pulmonary disease (COPD) but remain overlooked. Psychosocial interventions are deemed to promote mental health and optimize management. This study aimed to determine the role of detailed psychological evaluation and treatment in the comprehensive management of COPD. COPD patients after screening with the general health questionnaire-12 (GHQ-12) for psychological co-morbidity were divided into three groups (26 patients each): i) group A [GHQ-12 score<3, received pulmonary rehabilitation (PR) and standard medical management]; ii and iii) group B and C (GHQ-12 score>3, in addition, received management by a psychiatrist and counseling by a pulmonologist, respectively). At baseline and 8 weeks of follow-up, all participants were evaluated for respiratory [forced expiratory volume in the first second (FEV1), six-minute walk distance (6-MWD), St. George's respiratory questionnaire (SGRQ), modified medical research council (mMRC) dyspnea scale], and psychological [GHQ-12, patient distress thermometer (PDT), coping strategy checklist (CSCL), World Health Organization-quality of life-brief (WHOQOL-Bref-26), and depression anxiety stress scales (DASS)] parameters. Psychological distress (GHQ-12>3) decreased significantly at follow-up, with 11.5% and 53.8% of patients having psychological distress in groups B and C, respectively, versus baseline (p<0.001). mMRC score, SGRQ score, FEV1 and 6-MWD significantly improved in all three groups. Improvement in mMRC and SGRQ was maximal in group B when compared with the other groups. PDT, CSCL, and WHO-QOL-Bref-26 scores improved significantly at follow-up in all three groups, with maximum improvement in group B, followed by group C, and then group A. The DASS score also improved maximally in group B. Patients should be screened for psychological co-morbidities using simple screening tools. PR plays an important role in improving the psychology of COPD patients. However, results are better with directed psycho-educative sessions by non-experts and best with definitive treatment by psychiatrists.

Long-acting B-2 agonists (LABA) or long-acting muscarinic antagonists (LAMA): which one may be the first option in group A COPD patients?

Long-acting muscarinic antagonists (LAMA) or beta-2 agonists (LABA) have been recommended for symptom control in group A COPD patients as a first-line bronchodilator treatment in GOLD guidelines. However, there is no mention of priority/superiority between the two treatment options. We aimed to compare the effectiveness of these treatments in this group. The study cohort was formed of all subjects from six pulmonology clinics with an initial diagnosis of COPD who were new users of a LAMA or LABA from January 2020 to December 2021. Seventy-six group A COPD patients, in whom LABA or LAMA therapy had been started in the last 1month as a first-line treatment, were included in our study. Participants were evaluated with spirometry, COPD Assessment Test (CAT), mMRC scale, and St. George Respiratory Questionnaire (SGRQ) for three times (baseline, 6-12th months). There were 76 group A COPD patients with LAMA (67.1%) and LABA (32.9%). The number of patients who improved in CAT score at the end of the first year was significantly higher in patients using LAMA than those using LABA (p = 0.022); the improvement at minimum clinically important difference (MCID) in CAT score of LAMA group at 1st year was also significant (p = 0.044). SGRQ total and impact scores were found to be statistically lower at 1st year compared to baseline in patients using LAMA (p = 0.010 and 0.006, respectively). Significant improvement was detected in CAT and SGRQ scores at the 6th month visit in the LAMA group having emphysema (p = 0.032 and 0.002, respectively). According to significant improvements in CAT and SGRQ score, LAMA may be preferred over LABA as a bronchodilator agent in group A COPD patients, especially in emphysema-dominant phenotype.

Association of musculoskeletal involvement with lung function and mortality in patients with idiopathic pulmonary fibrosis

Idiopathic pulmonary fibrosis (IPF) is a progressive disease associated with high mortality. Low muscle mass, frailty and sarcopenia lead to functional impairment that negatively impact quality of life and survival but are not used in clinical practice. We aimed to determine the association of Fat-free mass index (FFMI) and frailty with lung function, exercise tolerance and survival in patients with IPF. In this study, 70 patients with IPF underwent assessment of body composition, lung function, 6-min walk distance (6MWD) testing, hand grip strength, quality of life (QoL) assessment by St. George’s Respiratory questionnaire (SGRQ) and frailty assessment using the SHARE-FI tool. FFMI was calculated using pectoralis muscle cross-sectional area (PM-CSA) on CT chest images and the lowest quartile defined reduced muscle mass. Sarcopenia was defined as low FFMI and handgrip strength. Regression analyses were conducted to determine predictive value of frailty, low FFMI and sarcopenia on clinical outcomes. The Cox proportional hazards model was used to analyze the impact of FFMI and frailty score on survival. The mean age was 70 years with moderate impairment in lung function (mean ppFVC 68.5%, ppDLCO 45.6%). Baseline forced vital capacity (p < 0.001), diffusion capacity of lung for carbon monoxide (p = < 0.01), 6WMD (p < 0.05) were significantly lower in frail patients compared to non-frail patients. BMI was found to closely correlate with FFMI (r = 0.79, p < 0.001), but not with frailty score (r = − 0.2, p = 0.07). Frailty was a significant predictor of FVC, DLCO, 6MWD, SGRQ scores when adjusted for age and gender. Muscle mass and sarcopenia were significant predictors of FVC, DLCO, but not 6MWD or QoL scores. Multivariate cox-proportional hazards ratio model adjusting for age and gender showed that frailty was significantly associated with increased mortality (HR = 2.6, 95% CI 1.1–6.1). Low FFMI (HR = 1.3, 95% CI 0.6–2.8), and sarcopenia (HR = 2.1, 95% CI 0.8–5.3), though associated with a trend to increased mortality, were not statistically significant. Frailty is associated with lower lung function and higher mortality in patients with IPF. Longitudinal evaluations are necessary to further determine the associations between low FFMI, sarcopenia and frailty with outcomes in IPF.

Efficacy and safety of mepolizumab in a Chinese population with severe asthma: a phase III, randomised, double-blind, placebo-controlled trial.

In China, the prevalence of severe asthma with eosinophilic phenotype is rising, yet treatment options are limited. Mepolizumab is the first targeted biologic therapy for eosinophilic-driven disease in China. This study (clinicaltrials.gov identifier NCT03562195) evaluated efficacy and safety of mepolizumab in Chinese patients with severe asthma. The phase III, multicentre, randomised, placebo-controlled, double-blind, parallel-group study enrolled patients aged ≥12 years with severe asthma, with two or more exacerbations in the previous year, and on inhaled corticosteroids plus at least one controller medication. Following a 1-4-week run-in, patients were randomised 1:1 to mepolizumab 100 mg or placebo subcutaneously every 4 weeks for 52 weeks. The primary end-point was annualised rate of clinically significant exacerbations (CSEs) through week 52. Secondary end-points were time to first CSE, frequency of CSEs requiring hospitalisation/emergency department visits or hospitalisation over 52 weeks, mean change in St George's Respiratory Questionnaire (SGRQ) total score and pre-bronchodilator forced expiratory volume in 1 s (FEV1) at week 52; safety was evaluated. The modified intention-to-treat population included 300 patients. At week 52 with mepolizumab versus placebo, annualised rate of CSEs was 65% lower (0.45 versus 1.31 events per year; rate ratio 0.35, 95% CI 0.24-0.50; p<0.001); time to first CSE longer (hazard ratio 0.38, 95% CI 0.26-0.56; p<0.001) and number of CSEs requiring hospitalisation/emergency department visit lower (rate ratio 0.30, 95% CI 0.12-0.77; p=0.012). From baseline to week 52, SGRQ score improved (p=0.001) and pre-bronchodilator FEV1 increased (p=0.006). Incidence of adverse events was similar between treatment groups. Mepolizumab provided clinical benefits to patients with severe asthma in China and showed a favourable benefit-risk profile.

Impact of post-COVID-19 lung damage on pulmonary function, exercise tolerance and quality of life in Indian subjects.

After recovery from COVID-19, there is data to suggest potential long-term pulmonary sequelae and associated impairment of functional capacity. This cross-sectional study was designed to assess the impact on respiratory function in a cohort of Indian subjects. Subjects who had recovered from COVID-19 were recruited. Clinical symptoms, pulmonary function test results, 6-minute walk test (6MWT) results, St George's Respiratory questionnaire (SGRQ) and chest radiographs were obtained. Information on the COVID-19 illness during hospitalization, baseline laboratory biomarkers and the disease severity categories as outlined by WHO (asymptomatic, mild, moderate, severe and critical), were retrieved from the hospital records. The 'COVID pneumonia'(WHO category moderate, severe & critical) group was compared with the 'Mild COVID' (WHO category mild) group and likewise, the WHO category moderate and the WHO category severe/critical groups were compared. In 207 subjects, whose mean age was 48.7 years were assessed after an average of 63 days from onset of symptom, 35% had TLC< 80% (restrictive defect), 8.3% had FEV1/FVC<70% (obstructive defect) and 44.4% had diminished DLCO<80% (diffusing capacity). The 'COVID-19 pneumonia' group when compared to the 'mild COVID-19' group, had lower FVC% (77.85 VS 88.18; P = 0.001), TLC% (79.48 VS 87.91; P = 0.0002), DLCO% (75.30 VS 89.20; P<0.0001) and DLCO/VA% (105.6 VS 111.8; P = 0.032), decreased minimum oxygen saturation (94.89 VS 97.73; P<0.0001) and more subjects had a drop in saturation of ≥ 4% (21.69% VS 4.84%; P = 0.001) during the 6MWT, and a greater mean total SGRQ score (29.2 VS 11.0; P<0.0001). To our knowledge, this is the first such report on Indian subjects. We have shown that post-COVID-19 lung damage leads to significant impairment of lung function, quality of life and effort tolerance.

Comparative Effects of Buteyko Breathing Technique and Active Cycle of Breathing Technique on Dyspnea and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease

Background: Chronic Obstructive Pulmonary Disease (COPD) significantly impacts the quality of life due to symptoms like dyspnea. Non-pharmacological interventions, particularly breathing techniques, have gained attention for their potential to improve patient outcomes. Objective: This study aimed to compare the effectiveness of the Buteyko Breathing Technique (BBT) and the Active Cycle of Breathing Technique (ACBT) in reducing dyspnea and enhancing the quality of life in COPD patients. Methods: In a randomized clinical trial conducted at Jinnah Hospital, Lahore, 40 COPD patients (mean age 59.70 ± 5.89 years; 70% male) were assigned to either BBT or ACBT groups. Both groups received standard treatments of bronchodilators and inhaled corticosteroids. The intervention involved three sessions per week for six weeks. Dyspnea was measured using the Modified Borg Scale (MBS), and quality of life was assessed through the St. George’s Respiratory Questionnaire (SGRQ). Normality of data was confirmed via the Shapiro-Wilk test, and parametric tests (paired and independent T-tests) were used for statistical analysis. Results: Pre-treatment MBS in the BBT group was 6.7 ± 1.56, reducing to 2.9 ± 1.21 post-treatment. The SGRQ scores also showed improvement from 71.5 ± 8.44 to 36.8 ± 6.6. In the ACBT group, the MBS score decreased from 7.3 ± 1.56 to 3.95 ± 1.36, and SGRQ scores from 71.6 ± 8.46 to 42.55 ± 6.61. The between-group comparison indicated a more significant improvement in the BBT group, with post-treatment p-values of 0.01 for MBS and 0.009 for SGRQ. Conclusion: Both BBT and ACBT effectively improved dyspnea and quality of life in COPD patients, with BBT showing a greater impact. These findings suggest that BBT could be a preferable non-pharmacological intervention in COPD management. However, individual patient factors should be considered when choosing the appropriate technique.

The Effectiveness and Safety of Chuna Manual Therapy Adjuvant to Western Medicine in Patients with Chronic Obstructive Pulmonary Disease: A Randomized, Single-Blind, Investigator-Initiated, Pilot Trial.

Recently, non-pharmacological treatments are gaining increasing importance for improving the quality of life in patients with chronic obstructive pulmonary disease (COPD). This pilot study aimed to evaluate the feasibility of conducting extensive research on Chuna manual therapy (CMT). This study investigated the effectiveness and safety of CMT adjuvant to Western medicine (WM) in patients with COPD. Forty patients with COPD were randomized into two groups in a 1:1 ratio: experimental (CMT plus WM) and control (WM only) groups. The CMT intervention was administered once a week for eight weeks. The primary outcome measured was the 6-min walk distance (6MWD). Secondary outcomes measured were: forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), assessments using the modified Medical Research Council (mMRC) scale and Visual Analog Scale (VAS) for dyspnea, the COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), and the EuroQoL five-dimensional questionnaire (EQ-5D). The mean differences in FEV1 (L) between Weeks 1 and 8 were statistically significant between the groups (p = 0.039). Additionally, the experimental group showed improved 6MWD, mMRC, VAS for dyspnea, CAT, SGRQ (total), and EQ-VAS scores than the control group. However, the differences between the two groups were not statistically significant. No adverse events were observed during this trial. CMT has the potential to alleviate symptoms, improve quality of life, and delay the decline in lung function in patients with COPD. The results of this pilot study could lead to large-scale clinical trials in the future.

Clinical Efficacy of Mobile App-Based, Self-Directed Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-Analysis.

Pulmonary rehabilitation is well known to improve clinical symptoms (including dyspnea), quality of life, and exercise capacity in patients with chronic obstructive pulmonary disease (COPD). However, researchers have reported difficulties in practicing center-based pulmonary rehabilitation. Recently, mobile app-based pulmonary rehabilitation has become available in clinical practice. We investigated the clinical outcomes of mobile app-based pulmonary rehabilitation in patients with COPD. The objective of our study was to evaluate the clinical efficacy of mobile app-based pulmonary rehabilitation versus conventional center-based pulmonary rehabilitation for patients with COPD, using a systematic review and meta-analysis. A systematic search of the literature published between January 2007 and June 2023 was performed, using the PubMed, Embase, Cochrane, and CINAHL databases to identify relevant randomized controlled trials involving patients with COPD. Pulmonary rehabilitation programs needed to provide an exercise program on a smartphone app. Study outcomes, including exercise capacity, symptom scores, quality of life, and hospitalization, were evaluated. The meta-analysis evaluated mean differences in 6-minute walk test distances (6MWDs), COPD Assessment Test (CAT) scores, modified Medical Research Council (mMRC) dyspnea scale scores, St. George Respiratory Questionnaire (SGRQ) scores, and risk ratios for hospitalization resulting from disease exacerbation. Of the 1173 screened studies, 10 were included in the systematic review and 9 were included in the meta-analysis. Further, 6 studies were multicenter studies. There were a total of 1050 participants, and most were aged ≥65 years. There were discrepancies in the baseline participant characteristics, smartphone apps, interventions, and study outcomes among the included studies. In the meta-analysis, 5 studies assessed 6MWDs (mean difference 9.52, 95% CI -3.05 to 22.08 m), 6 studies assessed CAT scores (mean difference -1.29, 95% CI -2.39 to -0.20), 3 studies assessed mMRC dyspnea scale scores (mean difference -0.08, 95% CI -0.29 to 0.13), 2 studies assessed SGRQ scores (mean difference -3.62, 95% CI -9.62 to 2.38), and 3 studies assessed hospitalization resulting from disease exacerbation (risk ratio 0.65, 95% CI 0.27-1.53). These clinical parameters generally favored mobile app-based pulmonary rehabilitation; however, a statistically significant difference was noted only for the CAT scores (P=.02). Despite some discrepancies in the baseline participant characteristics and interventions among studies, mobile app-based pulmonary rehabilitation resulted in favorable exercise capacity, symptom score, quality of life, and hospitalization outcomes when compared with conventional pulmonary rehabilitation. In the meta-analysis, the CAT scores of the mobile app-based pulmonary rehabilitation group were significantly lower than those of the control group (P=.02). In real-world practice, mobile app-based pulmonary rehabilitation can be a useful treatment option when conventional center-based pulmonary rehabilitation is not feasible.

Effects of Dronabinol on Dyspnea and Quality of Life in Patients With COPD.

Dyspnea is frequently a debilitating symptom of chronic obstructive pulmonary disease (COPD). Cannabinoid receptor agonists have the potential to alter dyspnea in these patients. Our objective was to determine if dronabinol, a pure cannabinoid, improves dyspnea and exercise tolerance in COPD. In this double-blind randomized, crossover pilot study, COPD patients received up to 20mg of oral dronabinol or placebo daily for 6 weeks with an intervening washout period. Dyspnea and fatigue were assessed using the Borg scale at rest and after an incremental shuttle walk. Functional status, mood, and depression were measured using the St George's Respiratory Questionnaire (SGRQ), the Pulmonary Functional Status and Dyspnea Questionnaire (PFSDQ), and the Geriatric Depression Scale (GDS). A total of 11 participants (with mean forced expiratory volume in 1 second 50.8 ± 24.8%) completed the study with no improvement in dyspnea at rest or postexercise taking dronabinol versus placebo (Borg scale 0.27, 95% confidence interval [CI] -0.59 to 1.14 versus 0.23 points, 95% CI -0.71 to 1.07 at rest and 0.82, 95% CI -0.59 to 2.22 versus 0.36 points, 95% CI 0.13 to 2.78 post exercise; p=0.94 and p=0.69 respectively). Dronabinol compared with placebo showed no significant change in PFSDQ dyspnea scores (0.64, 95% CI -3.92 to 5.20 versus 5.0, 95% CI -6.29 to 16.29; p=0.43) or shuttle walk distances (20.7m, 95% CI -21.5 to 62.8 versus 13.7m, 95% CI -24.8 to 52.2; p=0.69). There were no significant differences in fatigue at rest and postexercise, SGRQ scores, or GDS scores. In this pilot study, dronabinol did not significantly improve dyspnea or exercise capacity compared with placebo.

Post Hoc Analysis of Lung Function Improvement and Patient-Reported Outcomes With Revefenacin in Adults With Moderate-to-Very Severe COPD and Comorbid Anxiety or Depression.

Revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist approved in the United States for the maintenance of chronic obstructive pulmonary disease (COPD), significantly improves lung function and quality of life versus placebo in patients with moderate-to-very severe COPD. Comorbid anxiety and/or depression may alter patients' symptom perception and response to bronchodilators. The impact of revefenacin in patients with COPD with comorbid anxiety and/or depression has not been previously investigated. This post hoc subgroup analysis examined data from two 12-week, randomized, phase 3 trials in patients with moderate-to-very severe COPD with the following self-reported subgroups: anxiety only (A), depression only (D), anxiety and depression (+A/+D), and neither anxiety nor depression (-A/-D). We assessed change from baseline in trough forced expiratory volume in 1 second (FEV1) at Day 85 and health status by the St George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT). Of 812 patients, 90 (11%), 110 (14%), 141 (17%), and 471 (58%) had A, D, +A/+D, and -A/-D respectively. In revefenacin versus placebo, trough FEV1 significantly improved from baseline at Day 85 across all subgroups as well as the SGRQ and CAT scores in patients with A, +A/+D, and -A/-D. Revefenacin was well tolerated regardless of A/D status, with a minimal incidence of treatment-emergent antimuscarinic adverse events across subgroups. In this analysis, revefenacin versus placebo significantly improved health outcomes in patients with moderate-to-very severe COPD with A, +A/+D, and -A/-D, but not in patients with D. The safety profile of revefenacin was not affected by comorbid anxiety/depression status.

Prospective proof-of-concept observational RESEarch about traditional herbal preparation Treatment for Chronic Obstructive Pulmonary Disease (RESET-COPD-1).

Despite advances in medical science, chronic obstructive pulmonary disease (COPD) continues to impact patients' lives significantly, due to symptom management limitations. Cheongsangboha-tang (CSBHT; Qing Shang Bu Xia Tang) and Hyunggaeyeongyo-tang (HGYGT; Jing Jie Lian Qiao Tang) have been used to treat respiratory diseases, including COPD. However, clinical data supporting their efficacy are lacking. We prospectively observed the response of patients with COPD to CSBHT and HGYGT as adjunctive therapies and assessed the feasibility of future research. Patients with COPD who were prescribed adjunctive HGYGT or CSBHT according to the COPD clinical practice protocol of Kyung Hee University Korean Medicine Hospital were recruited. Participants visited the hospital every month, for 6 months, to receive herbal preparations according to a Korean Medicine doctor's diagnosis and prescription and outcome evaluations. The primary outcome was the 6-min walking test (6-MWT). Secondary outcomes included the pulmonary function test (PFT), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), and modified Medical Research Council (mMRC) score. Syndrome differentiation, adverse events, and patient adherence were recorded. Thirty-seven patients were initially enrolled and followed up for a mean period of 154.1 days. CSBHT was prescribed to 36 patients, while one patient received either CSBHT or HGYGT, or both, throughout the entire period. During the herbal preparation treatment period, no statistically significant changes were observed in the 6-MWT. The CAT score (mean ± standard deviation) changed from 17.0 ± 5.0 to 12.5 ± 3.6, and the visual analogue scale score for dyspnea changed from 47.5 ± 18.9 to 28.4 ± 18.6 (both statistically significant from visit 5). The coronavirus disease 2019 pandemic precluded the PFT. SGRQ and mMRC scores did not change significantly. During the study period, seven patients dropped out, two experienced mild dyspepsia, and one experienced mild headache. No serious adverse effects were observed. We illustrated the therapeutic potential of CSBHT and provided preliminary clinical data on its efficacy and safety in patients with COPD. Our study highlights the need to derive optimal herbal formulations, which should be administered for an appropriate duration, based on the therapeutic goals for the treatment of COPD.

A Study of Psychiatric Co-morbidities, Anxiety, Depression and Quality of Life in Patients of Chronic Obstructive Pulmonary Disease

ABSTRACT Aim: To study psychiatric co-morbidities, anxiety, depression, and quality of life in patients of chronic obstructive pulmonary disease (COPD). Materials and Methods: A cross-sectional, case-control study was conducted on 122 cases of COPD and equal number of age- and sex-matched controls in a tertiary care hospital. They were assessed with the Mini-International Neuropsychiatric Interview (MINI), depression, anxiety stress scale-42 (DASS-42), St. George Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Results: COPD patients and control subjects were matched with respect to age, sex, education, employment, domicile, and socioeconomic status. Psychiatric disorders were diagnosed in 56% of cases and 14% of controls. Major depressive disorder, alcohol dependence, and anxiety disorders were the most common psychiatric diagnoses. There was significantly higher prevalence of smoking in cases with COPD compared to control subjects suicidality was present in two patients. The mean scores on depression, anxiety, and stress on DASS-42 of COPD patients were significantly higher than normal controls. On the CAT majority of the COPD patients belonged to the high-impact group followed by the very high-impact group. Mean scores on the SGRQ were in the range expected in COPD patients. A multiple regression analysis revealed that significant predictors of SGRQ scores were age, gender, economic status, domicile, alcohol habits, depression, anxiety, and stress. Conclusion: COPD patients have a significantly higher prevalence of psychiatric co-morbidities compared to healthy controls. Common psychiatric disorders were major depression, alcohol dependence, and anxiety disorders along with smoking.

Nebulised granulocyte-macrophage colony-stimulating factor (GM-CSF) in autoimmune pulmonary alveolar proteinosis: a systematic review and meta-analysis.

Autoimmune pulmonary alveolar proteinosis (aPAP) results from impaired macrophage-mediated clearance of alveolar surfactant lipoproteins. Whole lung lavage has been the first-line treatment but recent reports suggest the efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF). We aimed to review the efficacy and safety of nebulised GM-CSF in aPAP. We conducted a systematic review and meta-analysis searching Embase, CINAHL, MEDLINE and Cochrane Collaborative databases (1946-1 April 2022). Studies included patients aged >18 years with aPAP receiving nebulised GM-CSF treatment and a comparator cohort. Exclusion criteria included secondary or congenital pulmonary alveolar proteinosis, GM-CSF allergy, active infection or other serious medical conditions. The protocol was prospectively registered with PROSPERO (CRD42021231328). Outcomes assessed were St George's Respiratory Questionnaire (SGRQ), 6-min walk test (6MWT), gas exchange (diffusing capacity of the lung for carbon monoxide (D LCO) % predicted) and arterial-alveolar oxygen gradient. Six studies were identified for review and three for meta-analysis, revealing that SGRQ score (mean difference -8.09, 95% CI -11.88- -4.3, p<0.0001), functional capacity (6MWT) (mean difference 21.72 m, 95% CI -2.76-46.19 m, p=0.08), gas diffusion (D LCO % predicted) (mean difference 5.09%, 95% CI 2.05-8.13%, p=0.001) and arterial-alveolar oxygen gradient (mean difference -4.36 mmHg, 95% CI -7.19- -1.52 mmHg, p=0.003) all significantly improved in GM-CSF-treated patients with minor statistical heterogeneity (I2=0%). No serious trial-related adverse events were reported. Patients with aPAP treated with inhaled GM-CSF demonstrated significant improvements in symptoms, dyspnoea scores, lung function, gas exchange and radiology indices after treatment with nebulised GM-CSF of varying duration. There is an important need to review comparative effectiveness and patient choice in key clinical outcomes between the current standard of care, whole lung lavage, with the noninvasive treatment of nebulised GM-CSF in aPAP.

Comparison of health-related quality of life measures in asthma-COPD overlap.

The Asthma Quality of Life Questionnaire (AQLQ) and COPD assessment test (CAT) are used to assess the health status of asthma and chronic obstructive pulmonary disease (COPD), respectively. However, whether these questionnaires are appropriate in patients with asthma-COPD overlap (ACO) has not been reported. This study aimed to evaluate the performance of the AQLQ and CAT in subjects with ACO. Subjects were enrolled from two previously described observational studies in Beijing, China. ACO was defined by a consensus definition from a roundtable discussion. All subjects completed the AQLQ, CAT, St George's Respiratory Questionnaire (SGRQ), pulmonary function tests, and the Asthma Control Questionnaire (ACQ)-5. Cross-sectional construct validity was evaluated by correlating the AQLQ and CAT with SGRQ score and other measures of asthma and COPD severity. 147 subjects with ACO were recruited. There were floor effects on non-respiratory components of the CAT, and ceiling effects on emotion domains of the AQLQ. Both questionnaires were significantly correlated with ACQ-5 score but were not correlated with FEV1% predicted or FVC% predicted. The AQLQ and CAT were strongly correlated with SGRQ score (r = -0.657 and r = 0.623, respectively). Multivariable linear regression analysis showed that the AQLQ (standardized β-coefficient = -0.449, p < .001) had a stronger association with SGRQ score compared with CAT (standardized β-coefficient = 0.211, p = .023). The AQLQ and CAT were both valid for assessing the health-related quality of life in subjects with ACO, but the AQLQ performed better than CAT.

Effectiveness of a telenursing intervention program in reducing exacerbations in patients with chronic respiratory failure receiving noninvasive positive pressure ventilation: A randomized controlled trial.

Telenursing for patients with chronic respiratory failure receiving noninvasive positive pressure ventilation (NPPV) is an important aid in reducing exacerbations; however, there is insufficient evidence. This randomized controlled trial investigated the effectiveness of a telenursing intervention program in reducing exacerbations in patients with chronic respiratory failure receiving NPPV at home. We included patients receiving NPPV at home who could handle a tablet device. The intervention group (n = 15) underwent an information and communications technology-based telenursing intervention program in addition to usual care; the control group (n = 16) received the usual care only. The telenursing intervention program comprised telemonitoring and health counseling sessions via videophone. The intervention was evaluated once at enrollment and after 3 months. The primary endpoints were the number of unscheduled outpatient visits, hospitalizations, and hospital days. The secondary endpoints included the St. George's Respiratory Questionnaire (SGRQ) score, Euro QOL 5 Dimension score, Self-Care Agency Questionnaire (SCAQ) score, pulmonary function tests, and 6-min walking distance. We used the Mann-Whitney U test for our analysis. We found no significant differences between the intervention and control groups at enrollment. Then, the differences between the endpoints at baseline and 3 months after enrollment were calculated and used to compare both groups. At follow-up, the number of routine outpatient visits for acute exacerbations (p = .045), the number of hospitalizations (p = .037), the number of hospital days (p = .031), SGRQ (p = .039) score, and SCAQ (p = .034) score were significantly different. The increase in the number of unscheduled outpatient visits in the intervention group during follow-up was attributed to acute exacerbations and a significant decrease in the number of hospitalizations and hospital days. Hence, the telenursing intervention program may be effective in reducing exacerbations in patients with chronic respiratory failure receiving NPPV at home. Trial registration: UMIN Clinical Trials Registry (UMIN-CTR) UMIN000027657.

Clinical and socio-economic characteristics of a cohort of MDR/XDR TB patients in Bucharest, Romania

Abstract Background Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) patients are likely to suffer from TB-related morbidity, social and economic consequences during and beyond anti-TB treatment. The aim of this study is to describe clinical and socio-economic outcomes of TB patients in Bucharest, Romania. Methods We have established a prospective cohort of patients with MDR/XDR TB followed for more than 2 years from TB diagnosis. We have collected TB-related, laboratory and clinical data, including chest X-ray, lung function measured by spirometry, St. George's Respiratory Questionnaire (SGRQ), and socio-economic information. Results From 50 enrolled participants, 31 remained in the study till month 6. 71% were male with mean age 46.7 (SD 15.4). 41.9% had a previous TB infection and median BMI of 20.3 kg/m2. Baseline CXR showed that on average 47.3% of the lung was affected, with 32.7% at month 6. The majority (71%) of participants had lung impairment at baseline, which remained stable till month 6. The total SGRQ score improved between baseline and month 6 (30 vs 22.8), but remained significantly worse compared to healthy individuals. 52% of participants stated that TB affected their social or private life as well as their household financially at treatment start. Conclusions From the start of anti-TB treatment patients are suffering from lung impairment and experiencing socio-economic impact of TB. This cohort demonstrates a slow and slight longitudinal improvement of these outcomes and brings awareness to the need of employing social and rehabilitation programs to target TB impact. Key messages • MDR/XDR TB patients suffer from a significant morbidity and socio-economic burden in Romania. • Targeted measures are needed to address this burden during and after TB treatment.