Clinical COPD Questionnaire Research Articles

Predictive Value of CCQ and its Subdomains for Hospitalized Exacerbations in Chronic Obstructive Pulmonary Disease: A 3-Year Observational Prospective Study.

The prediction capacity of the Clinical COPD Questionnaire (CCQ) and its functional, symptom, and mental subdomain for COPD hospitalized exacerbation were rarely studied. To examine the prognostic capacity of the total CCQ and its three subdomains for 3-year COPD hospitalized exacerbations. We analyzed the predictive ability of total CCQ score and its subdomains for hospitalized exacerbations in an observational cohort of 987 subjects with stable COPD from the RealDTC, an ongoing multicenter prospective study. Hospitalized exacerbations were prospectively collected every 6month for a maximum of 3years. The total CCQ and its functional and symptom domain, but not the mental domain, were significantly associated with 3-year hospitalized exacerbations by multivariate Cox regression analysis. The predictive capacity of functional domain was similar to that of the total CCQ, but significantly stronger than the symptom and mental domain by ROC analysis (P < 0.05). ROC curves also showed that the AUC of exacerbation history combined with CCQ functional domain was larger than that of exacerbation history alone (P < 0.0001). Additionally, the predictive value of multivariable models that contains CCQ functional domain was significantly better than the corresponding model without CCQ functional domain (P < 0.05). The total CCQ and its functional and symptom domain were independent risk factors of 3-year hospitalized exacerbations. The prognostic capacity of the functional domain was similar to that of total CCQ, and was significantly stronger than the symptom and mental domain. The CCQ functional domain was able to increase the predictive power of exacerbation history and other multivariable prediction models, indicating it may have an important role in the multivariable prediction tool for hospitalized exacerbation, and its combination with other clinical variables might be used as a low-cost approach for assessments of the disease severity and severe exacerbation in COPD patients in the future.

Specific foreign tools for assessing the quality of life of patients with COPD

Patients with chronic obstructive pulmonary disease (COPD) usually have a decreased quality of life (QOL). Specialized questionnaires on QOL may be more sensitive when studying individual issues of COPD therapy than general (universal) questionnaires. Conducting a review of specific tools for assessing the quality of life of patients with COPD. The study was carried out based on the results of a search of scientific literature presented in the bibliographic databases PubMed (USA) and ELIBRARY.RU (Russia, Russian-language sources). Keywords were used to search for relevant sources: «quality of life», «COPD», «chronic obstructive pulmonary disease» etc. In order to search for information on individual questionnaires, queries containing the names of the questionnaires were used. Additional references were obtained using the search engines Google and Yandex. Based on the results of a study of the scientific literature and a search in the PubMed / Medline information base, 22 specific tests used to assess the quality of life of patients with COPD were considered. These tests demonstrate different relevance and scientific applicability in recent years. Five tests were most often used in foreign and domestic studies: St. George respiratory questionnaire (SGRQ), the COPD assessment test (CAT), the modified Medical Research Council dyspnea scale (mMRC), the chronic respiratory questionnaire (CRQ), the clinical COPD questionnaire (CCQ). Further study as well as local adaptation (if so required) of some questionnaires will open up new opportunities for their wider implementation into the routine daily practice of providing medical care to patients with COPD in the regions.

Correlation between Respiratory Symptoms Questionnaire and Pulmonary Function Test in Chronic Obstructive Lung Disease Patients: A Tertiary Care Hospital Study

Abstract Objective: This study aimed to investigate the correlation between respiratory symptoms assessed by the Respiratory Symptoms Questionnaire (RSQ) and pulmonary function test (PFT) results in patients diagnosed with chronic obstructive pulmonary disease (COPD) at a tertiary care hospital. Methods: This analytical, cross-sectional study was conducted at Sree Balaji Medical College and Hospital, Chennai, involving 130 COPD patients presenting with symptoms of breathlessness, chronic cough, and wheeze. Data collection instruments used were: (1) RSQ: The RSQ was utilized to assess respiratory symptoms, including breathlessness, cough, and wheeze, (2) PFT: PFT assessments, including spirometry, were performed to measure lung function impairment objectively. Participants completed the RSQ under supervision, followed by PFT assessments conducted by trained respiratory technologists using standardized procedures. Results: Descriptive statistics were computed for demographic variables and questionnaire scores. Pearson correlation analysis was employed to assess the association between respiratory symptoms measured by RSQ and PFT parameters. The Chi-square analysis determined the overall association between symptom scores and PFT results across the COPD severity groups. Significant correlations were observed between severe COPD and St. George’s Respiratory Questionnaire, moderate COPD and Clinical COPD Questionnaire, and moderate-to-severe COPD and COPD Assessment Test (P &lt; 0.05). Nonsignificant correlations were found between mild COPD and symptom scores (P &gt; 0.05). The Chi-square analysis confirmed a strong association between respiratory symptoms and PFT results (P = 0.04). Conclusion: This study highlights the importance of comprehensive symptom assessment alongside the objective measures of lung function in COPD management. Integrating tools such as RSQ with PFTs enables clinicians to obtain a holistic understanding of patients’ disease status and tailor treatment strategies accordingly.

Treatment Adherence and Health Status of Patients With COPD Under Treatment With Salmeterol/Fluticasone via the Elpenhaler® Device: The AHEAD Study.

Chronic obstructive pulmonary disease (COPD) is a heterogeneous progressive lung condition characterized by long-term respiratory symptoms and airflow limitation. Appropriate bronchodilation is the cornerstone of COPD treatment, leading to better health status as well as benefits in prognosis and mortality. In the current open, noninterventional, observational study, 716 patients diagnosed with COPD of variable severity were administered a fixed-dose combination (FDC) of fluticasone propionate and salmeterol (500 + 50 mcg) through the Elpenhaler® device. The patients' adherence to treatment (based on the MMAS-8 [8-item Morisky Medication Adherence Scale]) and health status (based on the CCQ [Clinical COPD Questionnaire]) were assessed at the beginning of the study and at the end of the 3-month follow-up period. The mean ± SD MMAS-8 score at 1 and 3 months was 6.12 ± 1.89 and 6.45 ± 1.80, respectively, indicating medium adherence overall; however, there was a statistically significant increase of 0.33 units in the MMAS-8 score at the end of the follow-up (paired t-test p < 0.0001), suggestive of an improvement in adherence throughout the study. Higher adherence was associated with better health status at baseline, which further improved by the end of the follow-up. Moreover, we observed a statistically significant decrease of 1.07 points (p < 0.0001) in the mean CCQ total score from the baseline (CCQ score = 2.2 ± 1.00) until the end of the study follow-up (CCQ score = 1.13 ± 0.67). Similar conclusions were also drawn in the mean domain scores regarding symptoms (score equal to 1.36 ± 0.72, decrease by 1.18) as well as functional and mental state (scores equal to 0.86 ± 0.73 and 1.20 ± 0.88, decrease by 1.04 and 1.00, respectively, p < 0.0001). Similarly, when patients were stratified into subgroups with and without comorbidities, the former group showed an increase of 7% in the patients with medium to high adherence during the course of the study. In the same patient subgroup, there was a notable decrease in CCQ score by 1.18 points (p < 0.0001) during the study. The administration of FDC of fluticasone propionate and salmeterol, (500 + 50 mcg) via the Elpenhaler® device for COPD, resulted in a well-maintained or slight increase in treatment adherence and a subsequent benefit in health status, which further persisted after 3 months of treatment.

The role of serum chloride ion in the prognosis of COPD

BackgroundAs exacerbations of chronic obstructive pulmonary disease (COPD) are one of the leading causes of hospitalization and are associated with significant mortality, it is particularly important to accurately assess the risk of exacerbations in COPD. Most of the current clinical biomarkers are related to inflammation and few consider how ion levels affect COPD. Chloride ion, the second most abundant serum electrolyte, has been shown to be associated with poor prognoses in several diseases, but their relationship with COPD remains unclear. MethodsIn total, 105 patients with acute exacerbations of COPD were recruited. Data on clinical characteristics, lung function, blood count, blood biochemistry, relevant scales including the Clinical COPD Questionnaire (CCQ), BODE (BMI, airflow obstruction, dyspnea, exercise capacity) index and the St. George's Respiratory Questionnaire (SGRQ) were collected from all patients for statistical analysis. ResultThere were significant differences in lung function indicators and disease severity in the low chloride ion subgroup compared with the high chloride ion subgroup. On multiple logistic regression analysis, chloride ion was an independent factor affecting lung function in COPD patients (OR=0.808, 95% CI: 0.708 - 0.922, p=0.002). The sensitivity of chloride ion in predicting COPD severity was 78%, the specificity was 63%, and the area under the curve was 0.734 (p<0.001). Subgroup analysis showed that chloride ion was a stronger predictor in male and smoking patients. ConclusionsChloride ion was a novel prognostic biomarker for COPD, and low levels of chloride ion were independently associated with exacerbations in COPD patients.

Measuring burden of disease in both asthma and COPD by merging the ACQ and CCQ: less is more?

Symptoms of asthma and COPD often overlap, and both diseases can co-exist in one patient. The asthma control questionnaire (ACQ) and clinical COPD questionnaire (CCQ) were developed to assess disease burden in respectively asthma or COPD. This study explores the possibility of creating a new questionnaire to assess disease burden in all obstructive lung diseases by integrating and reducing questions of the ACQ and CCQ. Data of patients with asthma, COPD and asthma-COPD overlap (ACO) were collected from a primary and secondary care center. Patients completed ACQ and CCQ on the same day. Linear regression tested correlations. Principal Component Analysis (PCA) was used for item reduction. The secondary cohort with asthma and COPD patients was used for initial question selection (development cohort). These results were reproduced in the primary care cohort and secondary cohort of patients with ACO. The development cohort comprised 252 patients with asthma and 96 with COPD. Correlation between ACQ and CCQ in asthma was R = 0.82, and in COPD R = 0.83. PCA determined a selection of 9 questions. Reproduction in primary care data (asthma n = 1110, COPD n = 1041, ACO = 355) and secondary care data of ACO patients (n = 53) resulted in similar correlations and PCA-derived selection of questions. In conclusion, PCA determined a selection of nine questions of the ACQ and CCQ: working title ‘the Obstructive Lung Disease Questionnaire’. These results suggest that this pragmatic set of questions might be sufficient to assess disease burden in obstructive lung disease in both primary as secondary care.

Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease

Many patients with chronic obstructive pulmonary disease (COPD), heart failure (HF), and interstitial lung disease (ILD) endure poor quality of life despite conventional therapy. Palliative care approaches may benefit this population prior to end of life. Determine the effect of a nurse and social worker palliative telecare team on quality of life in outpatients with COPD, HF, or ILD compared with usual care. Single-blind, 2-group, multisite randomized clinical trial with accrual between October 27, 2016, and April 2, 2020, in 2 Veterans Administration health care systems (Colorado and Washington), and including community-based outpatient clinics. Outpatients with COPD, HF, or ILD at high risk of hospitalization or death who reported poor quality of life participated. The intervention involved 6 phone calls with a nurse to help with symptom management and 6 phone calls with a social worker to provide psychosocial care. The nurse and social worker met weekly with a study primary care and palliative care physician and as needed, a pulmonologist, and cardiologist. Usual care included an educational handout developed for the study that outlined self-care for COPD, ILD, or HF. Patients in both groups received care at the discretion of their clinicians, which could include care from nurses and social workers, and specialists in cardiology, pulmonology, palliative care, and mental health. The primary outcome was difference in change in quality of life from baseline to 6 months between the intervention and usual care groups (FACT-G score range, 0-100, with higher scores indicating better quality of life, clinically meaningful change ≥4 points). Secondary quality-of-life outcomes at 6 months included disease-specific health status (Clinical COPD Questionnaire; Kansas City Cardiomyopathy Questionnaire-12), depression (Patient Health Questionnaire-8) and anxiety (Generalized Anxiety Disorder-7) symptoms. Among 306 randomized patients (mean [SD] age, 68.9 [7.7] years; 276 male [90.2%], 30 female [9.8%]; 245 White [80.1%]), 177 (57.8%) had COPD, 67 (21.9%) HF, 49 (16%) both COPD and HF, and 13 (4.2%) ILD. Baseline FACT-G scores were similar (intervention, 52.9; usual care, 52.7). FACT-G completion was 76% (intervention, 117 of 154; usual care, 116 of 152) at 6 months for both groups. Mean (SD) length of intervention was 115.1 (33.4) days and included a mean of 10.4 (3.3) intervention calls per patient. In the intervention group, 112 of 154 (73%) patients received the intervention as randomized. At 6 months, mean FACT-G score improved 6.0 points in the intervention group and 1.4 points in the usual care group (difference, 4.6 points [95% CI, 1.8-7.4]; P = .001; standardized mean difference, 0.41). The intervention also improved COPD health status (standardized mean difference, 0.44; P = .04), HF health status (standardized mean difference, 0.41; P = .01), depression (standardized mean difference, -0.50; P < .001), and anxiety (standardized mean difference, -0.51; P < .001) at 6 months. For adults with COPD, HF, or ILD who were at high risk of death and had poor quality of life, a nurse and social worker palliative telecare team produced clinically meaningful improvements in quality of life at 6 months compared with usual care. ClinicalTrials.gov Identifier: NCT02713347.

Identifying critical inhalation technique errors in Dry Powder Inhaler use in patients with COPD based on the association with health status and exacerbations: findings from the multi-country cross-sectional observational PIFotal study

BackgroundCorrect inhaler use depends on a complex interplay of factors, including device preparation and generating sufficient inspiratory flow. It is currently unknown which inhalation technique errors can be considered critical in Chronic Obstructive Pulmonary Disease (COPD) patients on Dry Powder Inhaler (DPI) maintenance therapy.ObjectiveTo investigate the association between inhalation technique errors and health status or exacerbations in patients with COPD. Additionally, the association between the number of errors and COPD outcomes was determined.MethodsThe PIFotal study is a cross-sectional multi-country observational study in a primary care setting, including 1434 COPD patients aged ≥ 40 years (50.1% female; mean age 69.2 yrs) using a DPI for their maintenance therapy. Inhalation technique was video recorded and scored by two independent researchers using inhaler-specific checklists. Health status was assessed with two questionnaires; the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The number of moderate and severe exacerbations in the past 12 months was recorded. Critical errors were identified based on their association with health status or exacerbations through multi-level prediction models adjusted for identified confounding.ResultsErrors in inhalation technique steps ‘Breathe in’, ‘Hold breath’, and ‘Breathe out calmly after inhalation’ were significantly associated with poorer CCQ and CAT outcomes and thus deemed critical. None of the errors were significantly associated with moderate exacerbations. Patients with errors ‘Preparation’, ‘Hold inhaler in correct position during inhalation’, and ‘Breathe in’ had significantly more severe exacerbations, and therefore these errors were also deemed critical. 81.3% of patients with COPD made at least one critical error. Specific combinations of errors were associated with worse outcomes. The more inhalation technique errors identified, the poorer the health status and the higher the exacerbation rate.ConclusionIn this study, we identified multiple critical inhalation technique errors in COPD patients using DPIs each associated with poorer outcomes. Explorative analysis revealed that specific combinations of errors may be of clinical relevance, especially those related to the inhalation manoeuvre. COPD outcomes worsened with increasing error count. These results warrant further prospective longitudinal studies to establish the effect of correcting these errors on COPD control.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04532853 (31/08/2020)

The effectiveness of an unsupervised home-based pulmonary rehabilitation with self-management program in patients with chronic obstructive pulmonary disease.

To assess the effectiveness of an unsupervised home-based pulmonary rehabilitation with self-management program in patients with chronic obstructive pulmonary disease (COPD). A few recent studies have shown that unsupervised home-based pulmonary rehabilitation can improve the clinical outcome of patients with COPD. More studies are needed to prove its benefits. This study used a quasi-experimental design. Seventy-two admitted COPD patients were assigned to experimental group or control group through purposeful sampling. Data were collected from March 2016 to November 2017 in the Thoracic Intensive Care Unit of a Medical Center in Taiwan. The Medical Research Council dyspnea scale, the COPD Self-Efficacy Scale and the Clinical COPD Questionnaire were measured before education and at the first, second and third months after discharge. The Medical Research Council dyspnea scale and COPD Self-Efficacy Scale results in the experimental group were significantly improved compared with the control group in the third month after discharge. The Clinical COPD Questionnaire score continued to improve in both groups in the third month after discharge, and there was no difference between the two groups. A short-term unsupervised home-based pulmonary rehabilitation with self- management program had significant benefits for patients with COPD. The long-term effects need to be confirmed.

Assessment of health status and its correlation with lung function in patients with chronic obstructive pulmonary disease: a study from a tertiary care center in north India.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 recommends a comprehensive multidimensional assessment for patients with chronic obstructive pulmonary disease (COPD) and stresses the need for evaluation of their health status and quality of life (QOL). The COPD assessment test (CAT), clinical COPD questionnaire (CCQ), and St. George respiratory questionnaire (SGRQ) are recommended by GOLD for such assessments. However, their correlation with spirometry in the Indian population is not known. Other similar questionnaires like the COPD and sleep impact scale (CASIS), functional performance inventory-short form (FPI-SF), and COPD and asthma fatigue scale (CAFS), though used internationally as a research tool, are still in the offspring stage and have never been used in India. A cross-sectional study was hence conducted in the Department of Pulmonary Medicine, Government Medical College, Patiala, Punjab, India, on 100 COPD patients. Patients were assessed for health status and QOL by CAT, CCQ, SGRQ, CASIS, FPI-SF, and CAFS. The relationship between these questionnaires and airflow limitations was investigated. The majority of the patients were males (n=97), >50 years of age (n=83), illiterate (n=72), had moderate/severe COPD, and belonged to group B (n=66). The mean value of forced expiratory volume in one second (FeV1) decreased with a deterioration in CAT and CCQ score grouping (p<0.001). Patients with poorer CAT and CCQ scores belonged to higher GOLD grades (k=0.33, p<0.001). The correlation of health-related quality of life (HRQL) questionnaires among each other, with FEV1 predicted and with GOLD grade, was strong to very strong in most of the comparisons (p<0.01 in the majority). On comparison of GOLD grade with mean scores of HRQL questionnaires, it was seen that with the increase in GOLD grading from 1 to 4, the mean values of CAT, CCQ, SGRQ, CASIS, FPI-SF, and CAFS also deteriorated (p<0.001, p<0.001, p<0.001, p<0.005, p<0.001 and p<0.001, respectively). Various easy-to-use HRQL scores should be routinely used in outpatient departments for a comprehensive assessment of COPD patients. These questionnaires, in combination with clinical features, can help in providing a rough estimate of the severity of the disease in places where lung function assessments are not readily available.

A cross sectional pilot study to assess the role of phthalates on respiratory morbidity among patients with chronic obstructive pulmonary disease

BackgroundChronic Obstructive Pulmonary Disease (COPD) affects ∼16 million U.S. adults. Phthalates, synthetic chemicals in consumer products, may adversely impact pulmonary function and airway inflammation; however, their role on COPD morbidity remains unknown. ObjectiveWe examined associations between phthalate exposures and respiratory morbidity among 40 COPD patients who were former smokers. MethodsWe quantified 11 phthalate biomarkers in urine samples collected at baseline in a 9-month prospective cohort study in Baltimore, Maryland. COPD baseline morbidity measures included: health status and quality of life measures (CAT: COPD Assessment Test, CCQ: Clinical COPD Questionnaire, SGRQ: St. George's Respiratory Questionnaire; mMRC: Modified Medical Research Council Dyspnea Scale), and lung function. Information on prospective exacerbation data was monitored monthly during the 9-month longitudinal follow-up period. To examine associations between morbidity measures and phthalate exposures, we used multivariable linear and Poisson regression models for continuous and count outcomes, respectively, adjusting for age, sex, race/ethnicity, education, and smoking pack-years. ResultsHigher mono-n-butyl phthalate (MBP) concentrations were associated with increased CAT(β, 2.41; 95%CI, 0.31–4.51), mMRC (β, 0.33; 95%CI 0.11–0.55), and SGRQ (β, 7.43; 95%CI 2.70–12.2) scores at baseline. Monobenzyl phthalate (MBzP) was also positively associated with CCQ and SGRQ scores at baseline. Higher concentrations of the molar sum of Di (2-ethylhexyl) phthalate (DEHP) were associated with increased incidence of exacerbations during the follow-up period (incidence rate ratio, IRR = 1.73; 95%CI 1.11, 2.70 and IRR = 1.94; 95%CI 1.22, 3.07, for moderate and severe exacerbations, respectively). MEP concentrations were inversely associated with incidence of exacerbations during the follow-up period. ConclusionsWe found that exposure to select phthalates was associated with respiratory morbidity among COPD patients. Findings warrant further examination in larger studies given widespread phthalate exposures and potential implications for COPD patients should relationships observed be causal.

How Important is Spirometry for Identifying Patients with COPD Appropriate for Palliative Care?

Providing palliative care to patients with chronic obstructive pulmonary disease (COPD) is a priority. Spirometry demonstrating airflow limitation is a diagnostic test for COPD and a common inclusion criterion for palliative care research. However, requiring spirometry with airflow limitation may exclude appropriate patients unable to complete spirometry, or patients with preserved-ratio impaired spirometry and symptoms or imaging consistent with COPD. To determine differences in quality of life (QOL) and symptoms between patients with COPD identified based on International Classification of Diseases (ICD) codes and spirometry with airflow limitation compared to ICD codes only. Patients with COPD enrolled in a palliative care trial were included. Patients were at high risk of hospitalization and death and reported poor QOL. Baseline measures of QOL (Functional Assessment of Cancer Therapy-General (FACT-G), the Clinical COPD Questionnaire, and Quality of Life at the End of Life), and symptoms (Patient Health Questionnaire-8, Generalized Anxiety Disorder-7, fatigue, Insomnia Severity Index) were compared. Two hundred eight patients with COPD were predominantly male, White, and average age was 68.4. Between patients with ICD codes and spirometry with airflow limitation compared to patients with ICD codes only, there were no significant differences in FACT-G (59.0 vs. 55.0, P=0.33), other measures of QOL, or symptoms between groups. These results imply that spirometry may not need to be a requirement for inclusion into palliative care research or clinical care for patients with poor quality of life and at high risk for adverse outcomes.

A Preliminary Investigation of Mobile Respiratory Function Testing in Western Australian Communities

Although underutilized, spirometry is essential in the diagnosis and management of chronic obstructive pulmonary disease (COPD) and asthma. This study aimed to investigate a mobile (i.e., transportable) lung function testing (LFT) services in two metropolitan and two rural clinics in Western Australia. Individuals attending a mobile LFT clinic in 2021 were invited to complete questionnaires at baseline and after 6–8 weeks. Questionnaires were completed by 59/74 (79.7%) respondents (mean age 62.5 ± 14.2 years); most were female (35/59; 59.3%). A history of asthma was reported in 50.9% (30/59) and COPD in 18.6% (11/59) of respondents [13.6% (8/59) reported both]. At baseline, most (22/30; 73.3%) had asthma control test scores ≤19 (mean 16.6; range 8.0–25.0); at follow-up, 16/31 (51.6%) had scores ≤19 (mean score 18.0; range 6.0–25.0). Of the 11 diagnosed with COPD at baseline, the mean Clinical COPD Questionnaire and COPD assessment test scores were greater at follow-up (1.9 vs. 2.3; and: 10.3 vs. 14.7 respectively), reflecting worsening disease. Most participants (57/59; 96.6%) were satisfied with the LFT experience. The role of mobile LFT services to optimize the diagnosis and management of chronic lung disease and to minimize patient burden requires further investigation to improve short term patient outcomes.

Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease

BackgroundReplicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men. MethodsParticipants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women. ResultsRevefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1–2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women. ConclusionsMaintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men. Clinicaltrials.govNCT02459080; NCT02512510.

The Impact of Coronavirus Infection on Health-Related Quality of Life in Amateur CrossFit Athletes.

The aim of this study was to assess how the disease, developing over the course of coronavirus infection, affects the quality of life of athletes practicing amateur sports who are not burdened with comorbidities. The study included 102 amateur CrossFit athletes (54 (53%) women and 48 (47%) men) who had been infected with SARS-CoV-2, but were not hospitalized. The training experience of the respondents ranged from 1.5 to 15 years (average: 6.7 ± 3.8 years). The quality of life was assessed with EQ-5D-5L and Clinical COPD Questionnaire (CCQ), which was used to assess the quality of life specific to the respiratory system, and the severity of dyspnea was assessed using the MRC questionnaire. The training experience did not differ statistically significantly between men and women (p = 0.595). The quality of life in men according EQ-5D-5L was statistically significantly higher than in the case of women (0.979 ± 0.028 vs. 0.942 ± 0.073 (p < 0.001), respectively), and in EQ-VAS it was significantly higher in men than in women (85.64 ± 10.4 vs. 72.5 ± 19.36 points (p < 0.001)). The assessment of dyspnea by means of mMRC showed its higher intensity in women than in men. The differences were not statistically significant (p = 0.195). In men, a significantly lower result of the quality of life was noted in the CCQ questionnaire: 0.71 ± 0.57 vs. 1.14 ± 0.84 points (p = 0.009). The HRQOL, which surveyed amateur CrossFit after COVID-19, was higher in men than in women. People practicing strength- and strength-endurance-based sports rated their quality of life as the highest. Most of the subjects observed a slight intensification of dyspnea. The findings can be used for future healthcare measures to be applied in the population of CrossFit athletes.

Reliability and Validity of Clinical COPD Questionnaire and Chronic Respiratory Questionnaire in Patients with COPD using Tiotropium Over a Period of 26 Weeks

Reliability and Validity of Clinical COPD Questionnaire and Chronic Respiratory Questionnaire in Patients with COPD using Tiotropium Over a Period of 26 Weeks

The Effectiveness and Tolerability of Glycopyrronium for Patients with Chronic Obstructive Pulmonary Disease in a Clinical Setting: GLARE-Taiwan.

Glycopyrronium (GLY) is a pharmacological maintenance treatment for chronic obstructive pulmonary disease (COPD). However, its effectiveness and tolerability for COPD patients in routine clinical practice have not been well-investigated. This study aimed to assess the effectiveness of GLY on health-related quality of life and its safety in patients with COPD in a routine clinical care setting. This multi-center, prospective, six-month observational study recruited patients diagnosed with COPD and treated with GLY at three medical centers in central Taiwan. The full analysis set (n = 102) had a significant improvement in the Clinical COPD Questionnaire total (mean ± SD = −0.39 ± 0.90, p = 0.002), symptoms (mean ± SD = −0.61 ± 0.90, p < 0.001) and mental state scores (mean ± SD = −0.54 ± 1.72, p = 0.021) but not the functional state score (mean ± SD = −0.10 ± 1.15, p = 0.529). During the observational period, 58 patients (52.73%) experienced adverse events; only one adverse event (dizziness) was suspected to be related to the study drug. Three patients (2.73%) discontinued the study and GLY treatment because of an adverse event. One patient (0.91%) died during the study period because of a cerebral infarction, which was judged to be not associated with GLY treatment. In conclusion, GLY could be effective in improving the health status and is safe for patients with COPD in a real-life setting.

Patient activation is a treatable trait in patients with chronic airway diseases: An observational study.

BackgroundSelf-management is key for reducing the burden of disease in chronical illness. However, applying self-management presupposes behavioral change. Sufficient knowledge, skills, confidence and motivation to make the needed behavior changes are important prerequisites. During the past years the Integral Diagnostic Trajectory was developed for patients with asthma or COPD which aims to identify treatable traits and activating patients for self-management.ObjectiveIn the present study the effects of the Integral Diagnostic Trajectory on the Patient Activation Measure (PAM®) were examined. In addition, predictive variables for PAM baseline scores and change scores were sought.Materials and methodsA total of 241 patients with asthma or COPD referred to the pulmonologist at the Radboud university medical center, location Dekkerswald, Nijmegen were included. Patient activation was measured before the first visit and after the intervention with the 13-item PAM®. Additional, patient characteristics and health status were measured with the Nijmegen Clinical Screening Instrument (NCSI), modified Medical Research Council (mMRC), Asthma Control Questionnaire (ACQ), and COPD Clinical Questionnaire (CCQ).ResultsFifty percent of the patients with asthma and seventy percent of the patients with COPD had low levels of activation at baseline (PAM level 1–2). Baseline PAM scores could be explained in patients with asthma for 7% by number of severe problems in health status. And for 18% in patients with COPD by number of severe problems, age and employment status. After the intervention both groups significantly improved on the PAM (T0: 56.0 ± 13.1 vs. T1:63.3 ± 14.0 in asthma, and T0: 50.0 ± 8.8 vs. 58.4 ± 11.1 in COPD). Multivariate stepwise regression analysis showed that only 24% of the change in score could be explained by baseline PAM score and being employed in patients with asthma, and 18% of the variance in change score could be predicted by baseline PAM score in COPD.ConclusionThe present study showed that low level of activation is a common feature in patients with asthma and COPD. With a relatively short and seemingly simple intervention patients can reach higher levels of patient activation, which is a prerequisite for adopting self-management techniques in daily life.

A practice test and selection of a core set of outcome-based quality indicators in Dutch primary care physical therapy for patients with COPD: a cohort study

AimTo estimate the comparability and discriminability of outcome-based quality indicators by performing a practice test in Dutch physical therapy primary care, and to select a core set of outcome-based quality indicators that are well accepted by physical therapists based on their perceived added value as a quality improvement tool.MethodsFirst, a list of potential quality indicators was defined, followed by determination of the comparability (case-mix adjusted multilevel analysis) and discriminability (intraclass correlation coefficient (ICC)). Second, focus group meetings were conducted with stakeholders (physical therapists and senior researchers) to select a core set of quality indicators.ResultsOverall, 229 physical therapists from 137 practices provided 2651 treatment episodes. Comparability: in 10 of the 11 case-mix adjusted models, the ICC increased compared with the intercept-only model. Discriminability: the ICC ranged between 0.01 and 0.34, with five of the 11 ICCs being >0.10. The majority of physical therapists in each focus group preferred the inclusion of seven quality indicators in the core set, including three process and four outcome indicators based upon the 6-min walk test (6MWT), the Clinical COPD Questionnaire (CCQ), and the determination of quadriceps strength using a hand-held dynamometer.ConclusionThis is the first study to describe the comparability and discriminability of the outcome-based quality indicators selected for patients with COPD treated in primary care physical therapy practices. Future research should focus on increasing data collection in daily practice and on the development of tangible methods to use as the core set of a quality improvement tool.

Effectiveness of chronic obstructive pulmonary disease (COPD) treatment with a combination of tiotropium / olodaterol in Polish standard clinical practice as measured by the improvement of the Clinical COPD Questionnaire score: an observational study.

Health‑related quality of life in patients with chronic obstructive pulmonary disease (COPD) can be measured by the Clinical COPD Questionnaire (CCQ). In this study, the CCQ was used to assess the therapeutic success of a fixed‑dose tiotropium / olodaterol combination treatment in Polish COPD patients. We aimed to evaluate the changes in the CCQ score in Polish patients with COPD after 6 weeks of treatment with tiotropium / olodaterol and to assess the predictors of response to this treatment. Data of the Polish subgroup of the NIS‑CCQ observational study (NCT03663569) were extracted. COPD patients who had received a new tiotropium / olodaterol prescription were included. The primary end point was therapeutic success predefined as a 0.4‑point reduction in the CCQ score after 6 weeks of tiotropium / olodaterol treatment. Post‑hoc logistic regression analysis was performed to identify the predictors of response to the treatment. After 6 weeks of treatment, 72.4% of patients achieved therapeutic success. The therapy was successful in 83.4% of treatment‑naïve patients, as compared with 62.6% and 73.3% of those previously treated with long‑acting muscarinic antagonists or long‑acting β2 agonists in monotherapy and in combination with inhaled corticosteroids, respectively. Therapeutic success was achieved by at least 50% of patients regardless of the COPD severity and exacerbation history but it was more frequent in patients with more severe disease. The airflow limitation severity grades 2 to 4, modified Medical Research Council Dyspnea Scale classes 2 to 4, exacerbations within the last year before the study, and treatment‑naïve status predicted a better response to tiotropium / olodaterol. Tiotropium / olodaterol treatment improved clinical control in Polish COPD patients. Therapeutic success was the most pronounced in individuals with more severe COPD and in the treatment‑naïve group but occurred also in those with moderate disease and in previously treated participants.