Influencing factors of good quality of life among chronic obstructive pulmonary disease patients living in Zhejiang Province, China.

Chronic obstructive pulmonary disease (COPD) is a chronic, progressive and debilitating disease that affects quality of life (QOL), especially among patients living in poor environments. This study aimed to determine the influencing factors of good QOL among COPD patients living in Zhejiang, China. A cross-sectional study was conducted to collect data from participants in six tertiary hospitals in Zhejiang Province by a simple random sampling method. A validated questionnaire was used to collect general information, environmental factors, and COPD stage. The standardized St. George's Respiratory Questionnaire (SGRQ) was used to assess QOL. Logistic regression was used to determine influencing factors of good QOL among COPD patients at a significance level of α = 0.05. A total of 420 participants were recruited for analysis. The overall prevalence of patients with good QOL was 25.7%. Six variables were found to be associated with good QOL in the multivariable analysis. Patients who were employed had 2.35 times (95% CI 1.03-5.34) greater odds of having good QOL than those who were unemployed. Those whose family income was higher than 100,000 CNY had 2.49 times (95% CI 1.15-5.39) greater odds of having good QOL than those whose family income was lower than 100,000 CNY. Those who had treatment expenses less than 5,000 CNY had 4.57 (95% CI 1.57-13.30) times greater odds of having good QOL than those who had treatment expenses of 5,000 CNY or higher. Those who had mild or moderate airflow limitation were 5.27 times (95% CI 1.61-17.26) more likely to have good QOL than those who were in a severe or very severe stage of COPD. Those who had a duration of illness less than 60 months had 5.57 times (95% CI 1.40-22.12) greater odds of having good QOL than those who had a duration of illness of 120 months or more. Those who were not hospitalized within the past 3 months had 9.39 times (95% CI 1.62-54.43) greater odds of having good QOL than those who were hospitalized more than twice over the past 3 months. Socioeconomic status, disease stage and accessibility were associated with good QOL among COPD patients in Zhejiang Province, China. Increasing family income and implementing measures to improve the accessibility of medical care, including developing a proper system to decrease the cost of treatment for COPD patients, can improve patients' QOL.

Comparison of Disease Severity Classifications of Chronic Obstructive Pulmonary Disease: GOLD vs. STAR in Clinical Practice.

BACKGROUND: In chronic obstructive pulmonary disease (COPD), there are two known classifications for assessing what is called disease severity. One is the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification, which is based on the post-bronchodilator value of FEV1 (% reference). The other is the STaging of Airflow obstruction by Ratio (STAR), with four grades of severity in subjects with an FEV1/FVC ratio <0.70: STAR 1 ≥0.60 to <0.70, STAR 2 ≥0.50 to <0.60, STAR 3 ≥0.40 to <0.50, and STAR 4 <0.40. PURPOSE: The aim of this study was to compare the staging of COPD using the GOLD and STAR classifications in clinical practice. METHODS: We reanalyzed data from our outpatient cohort study, which included 141 participants with COPD from 2015 to 2023. We compared mortality and COPD-specific health status between the GOLD 1 to 4 groups and the STAR 1 to 4 groups. RESULTS: By simple calculation, GOLD and STAR severity classes coincided in 75 participants (53.2%). The weighted Bangdiwala B value with linear weights was 0.775. The participants were observed for up to 95 months, with a median of 54 months. Death was confirmed in 29 participants (20.5%). In univariate Cox proportional hazards analyses, there was a significant difference in mortality between the GOLD 1 and GOLD 3 + 4 groups, with the GOLD 1 group used as the reference [hazard ratio 4.222 (95% CI 1.298-13.733), p = 0.017]. However, there was no statistically significant predictive relationship between STAR 1 and STAR 2, or between STAR 1 and STAR 3 + 4. St. George's Respiratory Questionnaire (SGRQ) Total and COPD Assessment Test (CAT) scores were significantly different between all GOLD groups, except for the CAT score between GOLD 1 and GOLD 2. The SGRQ Total and CAT scores were significantly different between STAR 1 and STAR 3 + 4, but not between STAR 1 and STAR 2. CONCLUSION: From the perspective of all-cause mortality and COPD-specific health status, the GOLD classification is more discriminative than STAR.

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

Background: 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. Objective: 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. Methods: 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. Results: 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). Conclusions: 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.

Effect of YuPingFeng granules on clinical symptoms of stable COPD: study protocol for a multicenter, double-blind, and randomized controlled trial.

BACKGROUND: Reducing current clinical symptoms and the risks of future exacerbations is the main goal of stable COPD management. Traditional Chinese medicine has unique advantages in chronic disease management. YuPingFeng (YPF), as a classical prescription, has been proven to reduce the risk of exacerbations, but there is a lack of high-quality evidence for the assessment of clinical symptoms and quality of life, particularly for the assessment of treatment response of microecology and immunity. METHODS/DESIGN: This is a prospective, multicentre, randomized, double-blind, placebo-controlled clinical trial. A total of 316 eligible subjects with moderate to severe COPD will be randomized 1:1 to receive YPF or placebo. Participants will receive either YPF or a placebo at 5 g three times daily for 52 weeks. The primary outcome will be the change in the COPD Assessment Test (CAT) score after 52 weeks of treatment. Secondary outcomes will include changes in the St George's Respiratory Questionnaire (SGRQ) score and clinical symptom score, among others. Outcomes will be measured at each visit. The study will continue for 52 weeks and will include six visits to each subject (at day 0 and weeks 4,12,24,36 and 52). In the event of exacerbations, subjects will be required to go back to the hospital once on the first day of exacerbation or when their condition permits. DISCUSSION: This trial will provide research methods to evaluate the clinical efficacy, safety, and the possible mechanism of YPF in the treatment of stable moderate-to-severe COPD patients. In addition, we hope to provide more possibilities for TCM to participate in the management of stable COPD. TRIAL REGISTRATION: The trial was registered at the Chinese Clinical Trials Registry on 3 June 2022 (ChiCTR2200060476; date recorded: 3/6/2022, https://www.chictr.org.cn/ ).

Clinical phenotypes of COPD and their impact on quality of life: A cross-sectional study.

BACKGROUND: A Chronic Obstructive Pulmonary Disease (COPD) phenotype is a single or group of disease characteristics that describe differences between individuals based on clinically important factors such as symptoms, exacerbations, morbidity, and treatment responses. Many studies estimated the prevalence of various phenotypes, but very few studies looked into their quality of life. We aimed to estimate the prevalence of different COPD phenotypes and their disease-specific Health-Related Quality of Life (HRQoL). MATERIALS AND METHODS: The prospective study, with a sample size of 136, was conducted between May 2021 and December 2022 in a tertiary teaching institute. Based on their clinical features, COPD patients were classified into 4 different clinical phenotypes, and their disease-specific quality of life was assessed using St. George Respiratory Questionnaire-COPD(SGRQ-c) and COPD Assessment Test (CAT) questionnaires. RESULTS: Among 136 COPD patients, the frequency of Non-Exacerbator (NE), Exacerbator Emphysema (EEM), Exacerbator Chronic Bronchitis (ECB), and Asthma COPD overlap (ACO) phenotypes was 79(58.1 %), 16(11.8 %), 31(22.8 %), and 10(7.4 %) respectively. Based on the SGRQ-c score, the ECB and EEM phenotypes had a significantly poorer Quality of life (QoL) when compared with NE(P<0.0001), ACO(P=0.011), phenotypes. Similarly, ECB and EEM phenotypes had significantly poorer QoL when compared to NE(P<0.0001), and ACO(P=0.015), based on the CAT score. ECB and EEM patients also had the worst scores in all individual CAT items and SGRQ-c components. CONCLUSION: NE was the most common followed by ECB phenotype. ECB and EEM phenotypes recorded the poorest quality of life without any significant differences among them. Further research is needed in the future to determine whether phenotype-specific therapies can produce better clinical outcomes.

Predictors of Quality-of-Life Improvement at Different Minimum Clinically Important Difference Values in Patients with Chronic Obstructive Pulmonary Disease after Climatic Rehabilitation Treatment.

BACKGROUND: The minimum clinically important difference (MCID) for the St George's Respiratory Questionnaire (SGRQ) is debated in chronic obstructive pulmonary disease (COPD) quality-of-life (QoL) assessments. This study aimed to determine whether there is a difference in predictors of clinically significant improvement between the traditional (value of 4) and newly proposed MCID SGRQ (value of 7) after climatic rehabilitation treatment. Climatic rehabilitation treatment consists of two main parts: climatotherapy, which typically involves the controlled exposure of individuals to natural environmental elements, and climatic rehabilitation, which includes other therapeutic factors such as physical activities as well as educating the patient to change their lifestyle. METHODS: This study included 90 consecutive patients diagnosed with COPD who underwent structured complex pulmonary rehabilitation in High Tatras, part of the Carpathian Mountains. The examination before and after treatment included spirometry, QoL assessment using the SGRQ, 6 min walk test (6-MWT), and the Borg, Beck and Zung scale. RESULTS: Patients showed statistically significant improvement after the intervention in FEV1, FEV1/FVC, 6-MWT, (p < 0.001), anxiety scores, depression, and improvement in dyspnoea both before and after the 6-MWT (p < 0.001). For both MCID for SGRQ levels 4 and 7, we confirmed the same predictors of clinical improvement for bronchial obstruction grade (spirometry) and exercise capacity (6-MWT), for quality of life in activity score and total score. CONCLUSION: The results suggest that both the proposed MCID for SGRQ values could be sufficient to assess the clinical significance of the achieved change in health status when assessing the need for pulmonary rehabilitation comprising climatotherapy in patients with COPD.

COPD exacerbations and patient-reported outcomes according to post-bronchodilator FEV1 - a post-hoc analysis of pooled data.

BACKGROUND: Management strategies of chronic obstructive pulmonary disease (COPD) need to be tailored to the forced expiratory volume in one second (FEV1), exacerbations, and patient-reported outcomes (PROs) of individual patients. In this study, we analyzed the association and correlation between the FEV1, exacerbations, and PROs of patients with stable COPD. METHODS: This was a post-hoc analysis of pooled data from two cross-sectional studies that were previously conducted in Malaysia from 2017 to 2019, the results of which had been published separately. The parameters measured included post-bronchodilator FEV1 (PB-FEV1), exacerbations, and scores of modified Medical Research Council (mMRC), COPD Assessment Test (CAT), and St George's Respiratory Questionnaire for COPD (SGRQ-c). Descriptive, association, and correlation statistics were used. RESULTS: Three hundred seventy-four patients were included in the analysis. The PB-FEV1 predicted was < 30% in 85 (22.7%), 30-49% in 142 (38.0%), 50-79% in 111 (29.7%), and ≥ 80% in 36 (9.6%) patients. Patients with PB-FEV1 < 30% predicted had significantly more COPD exacerbations than those with PB-FEV1 30-49% predicted (p < 0.001), 50-79% predicted (p < 0.001), and ≥ 80% predicted (p = 0.002). The scores of mMRC, CAT, and SGRQ-c were not significantly higher in patients with more severe airflow limitation based on PB-FEV1 (p = 0.121-0.271). The PB-FEV1 predicted had significant weak negative correlations with exacerbations (r = - 0.182, p < 0.001), mMRC (r = - 0.121, p = 0.020), and SGRQ-c scores (r = - 0.114, p = 0.028). There was a moderate positive correlation between COPD exacerbations and scores of mMRC, CAT, and SGRQ-c (r = 0.407-0.482, all p < 0.001). There were significant strong positive correlations between mMRC score with CAT (r = 0.727) and SGRQ-c scores (r = 0.847), and CAT score with SGRQ-c score (r = 0.851) (all p < 0.001). CONCLUSIONS: In COPD patients, different severity of airflow limitation was not associated with significant differences in the mMRC, CAT, and SGRQ-c scores. Exacerbations were significantly more frequent in patients with very severe airflow limitation only. The correlation between airflow limitation with exacerbations, mMRC, and SGRQ-c was weak.

Clinical Profile and Quality of Life of Patients With Post-pulmonary Tuberculosis Sequelae Presenting to a Tertiary Care Hospital.

Background and objective There is a dearth of studies on the clinical presentation of patients with post-pulmonary tuberculosis (PTB) sequelae and its impact on their quality of life (QoL). In light of this, we conducted this study to analyze the clinical profile and QoL in patients with post-PTB sequelae. Methods Patients with a history of treated PTB and evidence of radiological damage were enrolled prospectively from November 2018 till June 2020 to study their clinical profile and QoL as per the eligibility criteria. A detailed clinical history was taken along with posteroanterior-view chest X-rays and CT scans of the thorax with bronchial angiography in patients with hemoptysis. QoL was assessed using the Hindi version of St. George's Respiratory Questionnaire (SGRQ) for which permission was obtained from the St. George's University of London. SGRQ scores were calculated using score calculation algorithms (Microsoft Excel-based) and missing data imputation as recommended by its developer. Results A total of 174 patients were included in the analysis. The analyzed population was relatively younger (mean age: 44.27 years) with BMIs leaning toward the lower side of normal (median: 19.6 kg/m²); the majority of the patients were males (59%) and non-smokers (77%). PTB had been diagnosed clinico-radiologically in the majority (68%) of patients with non-compliance to antitubercular treatment (ATT) being reported by only 9% of patients. Multiple courses of ATT were received by about one-third of patients, mainly on a clinico-radiologic basis. Systemic hypertension (HTN) (11%) and diabetes mellitus (DM) (9%) were the most common comorbidities. The most common symptom complex found was cough, expectoration, and dyspnea (n=102, 59%). At least one incidence of massive hemoptysis was reported by 20% of patients. Bronchial artery embolization (BAE) was performed for moderate to massive hemoptysis in 26% of patients with a success rate of >90%. One-fifth of the study participants required hospitalization for exacerbation of respiratory symptoms with more than half of these (59%) requiring ventilatory support. Health-related QoL was significantly impaired as reflected by a median SGRQ total score of 45.53. The most affected domain of QoL was the activity domain (mean score: 45.47). Females had worse QoL as compared to males (p=0.0062), and so did underweight patients (p=0.048). The prolonged duration of the illness also significantly impaired the QoL (p<0.001, r=0.313). Conclusion The sequelae of PTB are under-recognized even among physicians and are frequently misdiagnosed as active PTB. The QoL is more severely affected due to residual damage. This study highlights the clinical profile of this patient population and underscores the need to recognize post-PTB sequelae as a separate entity. An important remedy to mitigate its long-term consequences is its inclusion and recognition in national and international TB guidelines to facilitate its early identification and promote further research to address its evidence-based management.

Pulmonary-specific quality of life and dyspnea among patients hospitalized for coronavirus disease 2019: Evaluation of patient groups 1, 3 and 6 months after discharge.

BACKGROUND: Shortand long-term lung damage after coronavirus disease 2019 (COVID-19) has been emphasized in many studies, but pulmonary-specific health-related quality of life (HRQOL) has been examined only in a limited capacity. OBJECTIVES: In this study, we aimed to assess pulmonary-specific HRQOL and dyspnea among patients hospitalized for COVID-19 by applying the St George's Respiratory Questionnaire (SGRQ) to patient groups 1, 3 and 6 months following discharge (groups T1, T3 and T6). MATERIAL AND METHODS: This cross-sectional study was conducted between April 2020 and December 2020 at a tertiary hospital in Turkey. A total of 345 patients with a definite diagnosis of COVID-19 were included in our research. RESULTS: Total SGRQ score was significantly lower in the T6 group than in the T1 group (p < 0.001). The SGRQ-Symptom score was similar in the T3 and T6 groups, while the T1 group had significantly higher values (p < 0.001). The SGRQ-Activity score was significantly lower in the T6 group than in the T1 and T3 groups (p = 0.001), while the SGRQ-Impact score was significantly higher in the T6 group compared to the other 2 groups (p < 0.001). When the patients were analyzed statistically in terms of dyspnea, the difference between the baseline and 6-month results was found to be statistically significant (p < 0.001). CONCLUSIONS: Although long-term consequences are still not fully known, the SGRQ scores and dyspnea outcomes of our patients show that pulmonary-specific HRQOL and dyspnea remain at a similar level from discharge until the 6th month after discharge. Studies with extended and longitudinal follow-up are required.

Systemic and Airway Epigenetic Disruptions Are Associated with Health Status in COPD.

Epigenetic modifications are common in chronic obstructive pulmonary disease (COPD); however, their clinical relevance is largely unknown. We hypothesized that epigenetic disruptions are associated with symptoms and health status in COPD. We profiled the blood (n = 57) and airways (n = 62) of COPD patients for DNA methylation (n = 55 paired). The patients' health status was assessed using the St. George's Respiratory Questionnaire (SGRQ). We conducted differential methylation analyses and identified pathways characterized by epigenetic disruptions associated with SGRQ scores and its individual domains. 29,211 and 5044 differentially methylated positions (DMPs) were associated with total SGRQ scores in blood and airway samples, respectively. The activity, impact, and symptom domains were associated with 9161, 25,689 and 17,293 DMPs in blood, respectively; and 4674, 3730 and 5063 DMPs in airways, respectively. There was a substantial overlap of DMPs between airway and blood. DMPs were enriched for pathways related to common co-morbidities of COPD (e.g., ageing, cancer and neurological) in both tissues. Health status in COPD is associated with airway and systemic epigenetic changes especially in pathways related to co-morbidities of COPD. There are more blood DMPs than in the airways suggesting that blood epigenome is a promising source to discover biomarkers for clinical outcomes in COPD.

Impact of dietary counselling on the nutritional status and quality of life among pulmonary tuberculosis patients - A randomized control trial.

BACKGROUND & AIM: Undernutrition and TB have a bidirectional relationship, which is especially relevant in the Indian context. Undernutrition is an established risk factor for the progression of latent TB infection to active TB. Undernutrition at the population level contributes to an estimated 55% of annual TB incidence in India. TB leads to weight loss, wasting, and worsening of nutritional status. Hence, the present study aimed to determine the impact of dietary counselling on the nutritional status and the health-related quality of life of PTB patients. MATERIALS & METHOD: This was an interventional study (randomized controlled trial) that involved patients with PTB. 46 patients (23 patients as experimental and 23 patients as a control group) were enrolled in the study from June 2019 to February 2020 and they were divided into 2 categories based on BMI (underweight and normal weight). The special dietary counselling was given to the experimental group patients and the normal protocol was followed with the control group. The patients were followed up, till completion of treatment i.e., 6 months from enrolment. RESULTS: In our study, nearly half of the patients were underweight and DM was the predominant comorbidity. The BMI increased after dietary counselling in the experimental group than the control group (P = 0.0053) in underweight individuals. Total protein (P = 0.0025), and serum albumin (P = 0.0048) levels were found to be significantly improved in the experimental group. SGRQ symptom score (P = 0.0036) has significantly reduced in the experimental group in underweight individuals than the control group. CONCLUSION: Personalized dietary counselling was found to have a positive impact on BMI, total protein, and albumin levels in the experimental group, especially in underweight individuals. Besides, the quality of life measured using SGRQ showed that symptom score were also significantly reduced in the experimental group than the control group.

The Quality of Life of Coronavirus Disease Survivors Living in Rural and Urban Area of Riau Province, Indonesia.

This study assesses the status of health-related quality of life (HRQOL) among coronavirus survivors living in rural and urban districts in Riau province, Indonesia. The cross-sectional study was conducted among 468 and 285 Coronavirus disease (COVID-19) survivors living in rural and urban areas, respectively in August 2021. The St. George Respiratory Questionnaire (SGRQ) was used to measure the HRQOL of COVID-19 survivors. A higher total score domain corresponds to worse quality of life status. Quantile regression with the respect to 50th percentile found a significant association for the factors living in rural areas, being female, having comorbidities, and being hospitalized during treatment, with total score of 4.77, 2.43, 7.22, and 21.27 higher than in their contra parts, respectively. Moreover, having received full vaccination had the score 3.96 in total score. The HRQOL of COVID-19 survivors living in rural areas was significantly lower than in urban areas. Factors such as living in rural areas, female sex, having comorbidities, and history of symptomatic COVID-19 infection were identified as significant predictors for lower quality of life. Meanwhile, having full vaccination is a significant predictor for a better quality of life. The results of this study can provide the targeted recommendations for improvement of HRQOL of COVID-19 survivors.

Impact of rapid correction of vitamin D deficiency in asthmatic patients.

BACKGROUND: Asthma is one of the most common chronic diseases, which is a growing public health concern worldwide. In recent years, there has been an increasing number of interests in the relationship between vitamin D level and asthma control. Hence, the objective of this study was to assess the effect of high doses of vitamin D3 injection on asthmatic patient's respiratory condition and quality of life. METHODS: This was a single arm, before and after interventional study involving 18 patients with moderate to severe asthma. Spirometry test, St George's respiratory questionnaire (SGRQ) and serum vitamin D assay were performed. Subjects with 25-hydroxyvitamin D3 (25-(OH) D3) < 20 ng/ml were deemed deficient (n = 18) and received 2 intramuscular injections of vitamin D3 300,000 IU at monthly intervals consecutively. RESULTS: The mean changes of forced expiratory volume in the first second (FEV1) were significantly different in subjects who received vitamin D3 injections (p = 0.008). Also, the mean changes in FEV1/forced vital capacity ratio (FEV1/FVC) were significant (p < 0.001) as well as maximum expiratory flow between 25% and 75% of FVC (MEF25-75) (p = 0.001). Interestingly, improvement in clinical parameters of SGRQ was also observed with significant differences in total score (p = 0.001). Naturally, serum vitamin D levels were increased in our patients following the injections (p < 0.001). CONCLUSIONS: Our findings suggest that screening for serum 25-(OH) D3 deficiency is important in asthmatic patients and correction of this deficiency with high doses of vitamin D3 injection may lead to improvement in pulmonary function, symptoms and quality of life (QOL).

Comparison between tools for measuring breathlessness: Cross-sectional validation of the Japanese version of the Dyspnoea-12.

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.

Health-Related Quality of Life and Productivity Among US Patients with Severe Asthma.

BACKGROUND: Health-related quality of life (HRQoL) and productivity of patients with confirmed severe asthma (SA) have not been well characterized in large, real-world populations. PURPOSE: To characterize SA impact on HRQoL, work productivity, and activity impairment in a large, real-world cohort in the United States (US). METHODS: CHRONICLE is an observational study of specialist-treated adults (≥18 years) in the US with SA receiving biologics or maintenance systemic corticosteroids (mSCS), or those persistently uncontrolled by high-dosage inhaled corticosteroids with additional controllers (HD ICS+). At enrollment, patients completed the St. George's Respiratory Questionnaire (SGRQ) and Work Productivity and Activity Impairment (WPAI) questionnaire. Results were analyzed for those enrolled between February 2018 and February 2020. RESULTS: Among patients who completed enrollment questionnaires (n = 1109), mean age was 54 years and most were women (70%). Among SGRQ respondents (n = 960), mean (SD) total score was 43 (23); 51% reported good/very good health. Among WPAI respondents (n = 1057; 566 employed), mean (SD) overall work impairment was 21% (25). Patients receiving biologics (vs mSCS, HD ICS+ only) had better SGRQ total scores (38 vs 59, 48) and lower work impairment (17% vs 34%, 27%). Patients with better SGRQ activity scores relative to symptom scores had better SGRQ impacts scores, total scores, and reported better overall health. CONCLUSION: SA significantly affects HRQoL, work productivity, and activity. The SGRQ is a valuable research instrument for evaluating HRQoL in SA. Due to its association with HRQoL and overall health, activity impairment should be a focus when monitoring patients' disease control. STUDY REGISTRATION: ClinicalTrials.gov Identifier: NCT03373045.

Impact of COPD exacerbations leading to hospitalization on general and disease-specific quality of life.

RATIONALE: Acute exacerbations negatively impact quality of life in patients with chronic obstructive pulmonary disease (COPD), but the impact of hospitalized exacerbations on quality of life is not clear. We hypothesized that patients with hospitalized exacerbations would benefit from hospitalization and experience improvement in general and disease-specific quality of life (as measured by the St. George's respiratory questionnaire (SGRQ) and the medical outcomes study 36-item short form health survey (SF-36)) compared to those without exacerbations, or with non-hospitalized acute exacerbations. METHODS: 1219 COPD patients enrolled in either the simvastatin for the prevention of exacerbations in moderate-to severe COPD Trial (STATCOPE) or azithromycin for prevention of exacerbations of COPD trial (MACRO) were analyzed. Demographic information, spirometry, and symptom scores were noted at baseline. Exacerbation events and changes in quality of life scores were assessed over a mean of 538 days of follow-up. RESULTS: Of patients studied, 25.6% were hospitalized, 44.0% had at least one outpatient exacerbation, and 30.4% had no exacerbation. Baseline SGRQ and SF-36 scores were severely impaired in all groups studied. Over time, SF-36 scores did not change significantly between groups. SGRQ symptom domain scores improved in other groups but did not improve in those hospitalized for a COPD exacerbation. CONCLUSIONS: At baseline, patients hospitalized for acute exacerbations of COPD had more impaired quality of life scores. Over time, SGRQ symptom domain scores improved in other groups but did not in those who were hospitalized. Other measurements of quality of life were not improved by hospitalization for COPD.

Complexity of design in early phase respiratory clinical trials; evaluating impact of primary endpoints and sponsor size.

Asthma and COPD represent most of the clinical trials in the respiratory area. The Primary Endpoint (PE) defines how trials are conducted. We hypothesised that small and mid-sized pharmaceutical companies may be innovative in the selection of their trial endpoints, to be time- and cost-effective. To test this, a record of industry-sponsored phase II trials in asthma, COPD and Asthma/COPD over 11 years was obtained. The type of PE and the influence these had on length, number of subjects and investigational trial sites were evaluated for the different disease categories. Differences in the type of PE used by large versus small/mid-sized companies were found for both asthma and COPD trials (p = 0.011 and 0.025), with sponsorship influencing the conduction of these. In asthma, studies sponsored by large companies were significantly longer than those from smaller companies (p = 0.0001). Additionally, large companies intended to recruit more subjects (asthma: p = 0.0048, COPD: p ≤ 0.0001) and use more investigational sites (asthma: p = 1 × 10-7, COPD: p = 1 × 10-5) than those from small and mid-size companies. A sub-analysis of the time and subject requirements associated with each type of PE did not provide an explanation for the differences observed. In conclusion, this exploratory analysis indicates differences in study size, duration and type of PE used by small/mid-sized and large companies. For some types of endpoints, differences in length and study size were found. However, it wasn't possible to attribute these differences between sponsors solely to the choice of PE, pointing out to the complexity of running clinical trials.

Health-related quality of life of COPD patients aged over 40 years.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the fourth most frequent disease globally, and its worldwide prevalence is projected to increase in the following decades. Health-related quality of life (HRQOL) of COPD patients depends on multiple factors. OBJECTIVE: The aim of this study was to identify the most important risk factors affecting HRQOL of COPD patients and to measure how specific clinical parameters can predict HRQOL. METHODS: A questionnaire-based cross-sectional study combined with clinical data was conducted among patients diagnosed with COPD (n = 321, 52.6% females, mean age 66.4 ± 9.5) at the National Koranyi Institute for Pulmonology, Budapest in 2019-2020. The inclusion criteria were age ≥40 years and existing COPD. Multivariate linear regression analyses were conducted on three components of the COPD-specific Saint George's Respiratory Questionnaire (SGRQ-C) and on the physical (PCS) and mental component scales (MCS) of the 36-Item Short Form Health Survey (SF-36). Multiple linear regression analysis was performed to evaluate the effects of patient and disease characteristics on COPD Assessment Test (CAT) scores. RESULTS: We found that frequent exacerbations, multiple comorbidities and tobacco smoking were associated with worse HRQOL. Engaging in more frequent physical activity and better 6-minute walking distance results were associated with better HRQOL. CONCLUSIONS: Our results indicate that the complex therapy of COPD should focus not only on improving lung functions and preventing exacerbation, but also on treating comorbidities, encouraging increased physical activity, and supporting smoking cessation to assure better HRQOL for patients.

Sleep quality and its association with health-related quality of life of patients on lung transplantation waitlist in Japan.

PURPOSE: Poor quality of sleep is a common feature in patients with various lung diseases and affects their health-related quality of life (HRQL). We evaluated sleep quality and HRQL in patients on the waitlist for lung transplantation in Japan. METHODS: In this prospective study, patient-reported and physiological data were collected from patients newly registered on the waitlist for lung transplantation in Japan. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI) and HRQL using the St. George's Respiratory Questionnaire (SGRQ). The frequency of poor sleep quality, correlations between sleep quality and various clinical parameters, and predictive factors of sleep quality were examined. RESULTS: Of 193 patients, the three most-frequent indications for lung transplantation were interstitial pneumonia (n = 96), pulmonary complications of hematopoietic stem cell transplantation (n = 25), and pulmonary hypertension (n = 17). Poor sleep quality (PSQI > 5) was observed in 102 patients (53%) and was significantly associated with worse Hospital Anxiety and Depression Score (HADS), worse SGRQ score, worse modified Medical Research Council Dyspnea score, and shorter 6-min walk distance. However, it was not associated with sex, pulmonary function, interstitial pneumonia, or arterial blood gas. Stepwise multiple regression analysis indicated that poor sleep quality was explained significantly by HADS anxiety (23%) and SGRQ Symptoms (10%). CONCLUSION: Poor sleep quality was found to be common among patients on the lung transplantation waitlist in Japan. The two most significant factors responsible for impaired sleep quality were anxiety and respiratory symptoms. Additional care should be taken to ensuring a better quality of sleep for such patients.

Daily Activities: The Impact of COPD and Cognitive Dysfunction.

OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation; however, pulmonary function does not fully account for patients' functional difficulties. The primary aim of the study was to determine the association between several domains of cognition and daily activity among those with COPD. METHOD: Eighty-nine former smokers completed a neuropsychological battery including measures across multiple domains of cognition, pulmonary function measures, and daily activity questionnaires. Using a cross-sectional design, we compared daily activity between former smokers with and without COPD using two measures (St. George's Respiratory Questionnaire [SGRQ] Activity Subscale and Lawton Instrumental Activities of Daily Living [IADL] Scale) and examined the association between cognition and daily activity among those with COPD. RESULTS: As expected, former smokers with COPD reported more difficulty than those without COPD on both activity measures (SGRQ Activity Subscale p < .001; Lawton IADL Scale p = .040). Among former smokers with COPD, poorer delayed recall was associated with more difficulty with daily activities (SGRQ Activity Subscale) (p = .038) while adjusting for severity of airflow limitation, exercise tolerance, oxygen use, dyspnea, and symptoms of anxiety and depression. CONCLUSION: The findings suggest that cognition is associated with daily activity in patients with COPD. Future research should examine whether cognitive interventions may help to maximize patients' engagement in daily activities.