Chronic Respiratory Questionnaire Dyspnea Domain Research Articles

A randomised controlled trial to investigate the use of high-frequency airway oscillations as training to improve dyspnoea in COPD.

IntroductionChronic obstructive pulmonary disease (COPD) is characterised by expiratory flow limitation resulting in symptomatic dyspnoea, sputum retention and ventilation heterogeneity. Changes in breathing mechanics affect the ability of respiratory muscles to respond to the ventilatory demands, increasing the sensation of dyspnoea. A high-frequency airway oscillating device has been developed to combine respiratory muscle training and oscillations to improve dyspnoea and sputum retention within COPD.Methods and analysisPatients with symptomatic COPD (Medical Research Council Breathlessness scale grade ≥2) will be recruited to a double-blind, randomised, sham-controlled trial. Both groups will follow an 8-week intervention phase using the device three times per day for 5 min at a time. This will be recorded in a self-reported diary. The device applies a flow resistive load and oscillations for combined training. Those receiving the sham device will follow the same protocol; however, the mechanism of action will be removed from the device. Improvements in the Chronic Respiratory Questionnaire-Dyspnoea domain will be the primary outcome measure. Secondary outcomes will explore respiratory muscle function, health-related quality of life, exercise capacity and physical activity. The Lung Clearance Index will be an exploratory outcome. Outcomes will be explored using the most appropriate statistical test, dependent on the sample distribution. Focus groups will be an exploratory outcome and analysed by thematic analysis.Ethics and disseminationEthical approval has been obtained from the East Midlands-Leicester South Research Ethics Committee and the trial has been registered through the ISRCTN Registry. The study results will be disseminated to the appropriate stakeholders through presentations, conferences and peer-reviewed journals.

Telerehabilitation versus traditional centre-based pulmonary rehabilitation for people with chronic respiratory disease: protocol for a randomised controlled trial

BackgroundPulmonary rehabilitation is an effective therapeutic intervention for people with chronic respiratory disease. However, fewer than 5% of eligible individuals receive pulmonary rehabilitation on an annual basis, largely due to limited availability of services and difficulties associated with travel and transport. The Rehabilitation Exercise At Home (REAcH) study is an assessor-blinded, multi-centre, randomised controlled equivalence trial designed to compare the efficacy of home-based telerehabilitation and traditional centre-based pulmonary rehabilitation in people with chronic respiratory disease.MethodsParticipants will undertake an 8-week group-based pulmonary rehabilitation program of twice-weekly supervised exercise training, either in-person at a centre-based pulmonary rehabilitation program or remotely from their home via the Internet. Supervised exercise training sessions will include 30 min of aerobic exercise (cycle and/or walking training). Individualised education and self-management training will be delivered. All participants will be prescribed a home exercise program of walking and strengthening activities.Outcomes will be assessed by a blinded assessor at baseline, after completion of the intervention, and 12-months post intervention. The primary outcome is change in dyspnea score as measured by the Chronic Respiratory Questionnaire – dyspnea domain (CRQ-D). Secondary outcomes will evaluate the efficacy of telerehabilitation on 6-min walk distance, endurance cycle time during a constant work rate test, physical activity and quality of life. Adherence to pulmonary rehabilitation between the two models will be compared. A full economic analysis from a societal perspective will be undertaken to determine the cost-effectiveness of telerehabilitation compared to centre-based pulmonary rehabilitation.DiscussionAlternative models of pulmonary rehabilitation are required to improve both equity of access and patient-related outcomes. This trial will establish whether telerehabilitation can achieve equivalent improvement in outcomes compared to traditional centre-based pulmonary rehabilitation. If efficacious and cost-effective, the proposed telerehabilitation model is designed to be rapidly deployed into clinical practice.Trial registrationClinical trial registered with the Australian and New Zealand Clinical Trials Register at (ACTRN12616000360415). Registered 21 March 2016.

A Lifestyle Physical Activity Intervention for Patients with Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.

Physical inactivity is associated with poor outcomes among patients with chronic obstructive pulmonary disease (COPD). To determine effectiveness of a behavioral intervention intended to increase daily physical activity with the goal of improving health-related quality of life and functional performance. We conducted a randomized trial among patients with COPD cared for in primary care and pulmonary clinics. The patients were at least 45 years of age and eligible for pulmonary rehabilitation. All patients received self-management education during a 6-week run-in period. Subsequently, patients were randomized to usual care or the intervention delivered over 20 weeks. Co-primary outcomes were change from baseline in Chronic Respiratory Questionnaire dyspnea domain score and 6-minute-walk distance measured at 6, 12, and 18 months after randomization. A total of 325 patients were enrolled, with 156 randomized to receive usual care and 149 to receive the intervention. At 18 months, there was no overall statistical or clinically significant change in the dyspnea domain in either group. However, for 6-minute-walk distance, there were statistically significant declines in both groups. In contrast, 6-minute-walk distance remained stable (5.3 m; P = 0.54) among patients in the intervention group with moderate spirometric impairment, but it was associated with clinically and statistically significant declines (-28.7 m; P = 0.0001) among usual care patients with moderate spirometric impairment. Overall, there was no increase in adverse events associated with the intervention, which was associated with a lower prevalence of hospitalization for COPD exacerbations (28.3%) compared with usual care (49.5%). During this 18-month trial among outpatients with COPD, a health coach-based behavioral intervention did not improve scores in the dyspnea domain of the Chronic Respiratory Questionnaire or 6-minute-walk test distance. However, subgroup analyses suggested that there may be differential effects for specific outcomes that vary with severity of COPD. Specifically, benefits of this low-intensity intervention may be limited to 6-minute walk distance among patients with moderate spirometric impairment. Clinical trial registered with www.clinicaltrials.gov (NCT1108991).

Domain-Specific Self-Efficacy Is Associated with Measures of Functional Capacity and Quality of Life among Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease

The relationship between self-efficacy and health behaviors is well established. However, little is known about the relationship between self-efficacy and health-related indicators among patients with chronic obstructive pulmonary disease (COPD). The purpose of this cross-sectional cohort study was to test the hypothesis that the total score and specific subdomain scores of the COPD Self-Efficacy Scale (CSES) are associated with functional capacity and quality of life in a group of patients with moderate to severe COPD. Relationships were examined in a cross-sectional study of baseline data collected as part of a randomized trial. Self-efficacy was measured using the five domains of the CSES: negative affect, emotional arousal, physical exertion, weather/environment, and behavioral. Measures of quality of life and functional capacity included SF-12: physical and mental composite scores, Chronic Respiratory Questionnaire dyspnea domain, and the 6-minute-walk test. Statistical analyses included Spearman correlation and categorical analyses of self-efficacy ("confident" vs. "not confident") using general linear models adjusting for potential confounders. There were 325 patients enrolled with a mean age (standard deviation) of 68.5 (9.48) years, 49.5% male, and 91.69% non-Hispanic white. The negative affect, emotional arousal, and physical exertion domains were moderately correlated (range, 0.3-0.7) with the SF-12 mental composite score and Chronic Respiratory Questionnaire dyspnea domain. In models exploring each CSES domain as "confident" versus "not confident" and adjusting for age, sex, race, pack-years, and airflow obstruction severity, there were multiple clinically and statistically significant associations between the negative affect, emotional arousal, and physical exertion domains with functional capacity and quality of life. The aggregated total CSES score was associated with better quality of life and functional capacity. Our analysis of subdomains revealed that the physical exertion, negative affect, and emotional arousal subdomains had the largest associations with functional capacity and quality of life indicators. These findings suggest that interventions to enhance self-efficacy may improve the functional capacity and quality of life of patients with moderate to severe COPD.

Opioid therapy for refractory dyspnea in patients with advanced chronic obstructive pulmonary disease: patients' experiences andoutcomes.

Dyspnea that is refractory to conventional treatments affects up to 50% of patients with advanced chronic obstructive pulmonary disease (COPD). Although professional societies recommend opioids in this setting, evidence supporting their use over months is limited. We conducted a multicentre mixed-methods study to understand patients' experiences when opioids are added to optimized conventional treatments for advanced COPD. A total of 44 patients (median age 74, range 51-89 years) agreed to participate in this 6-month study. After baseline assessments, immediate-release morphine sulfate syrup (initially 0.5 mg twice daily) was slowly titrated upward based on weekly assessments of symptoms. We conducted semistructured interviews and collected contemporaneous measures of health-related quality of life, severity of dyspnea, anxiety, depression, global ratings of opioid "helpfulness" and adverse effects before, at 2 months and at 4-6 months after opioids were started. Of the 44 patients, 32 (73%) completed the trial; 27 (90%) of 30 patients reported the opioid treatment as very (43%) or somewhat (47%) helpful. Three main themes emerged from the patients' overall positive experiences: small gains have big impact; realign hopes with reality; and "try it." Significant improvements were observed in median (interquartile range) scores between baseline and 4-6 months' assessment for health-related quality of life (Chronic Respiratory Questionnaire: 3.5 [2.8-4.0] v. 4.2 [3.6-4.8]; and Chronic Respiratory Questionnaire-Dyspnea domain: 2.8 [2.3-3.6] v. 3.9 [2.8-4.5]) and decreases in severity of dyspnea (numerical rating scale: 7.0 [5.0-8.0] v. 5.0 [4.0-6.0]). Adverse effects were minimal for most patients. Opioids were a helpful and acceptable intervention for refractory dyspnea in patients with advanced COPD. Many of the patients experienced sustained benefits over months, which supports recent recommendations to consider opioids in this setting. ClinicalTrial.gov, no. NCT00982891.

Early versus Late Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients with Acute Exacerbations: A Randomized Trial

Background: Around the world, the timing of referral of chronic obstructive pulmonary disease (COPD) patients for pulmonary rehabilitation differs from immediately after exacerbation (early) to later on when patients are in a stable state (late). There are no trials comparing the different time points of referral for pulmonary rehabilitation. Objectives: Our aim was to compare the effects of early and late pulmonary rehabilitation on exacerbation rates and health-related quality of life (HRQOL) in COPD patients with exacerbations. Methods: We randomized COPD patients (Global Initiative for Chronic Obstructive Lung Disease stages II–IV) with a recent exacerbation to early (within 2 weeks) or late pulmonary rehabilitation (starting 6 months after randomization and in a stable state). The primary outcome was the exacerbation rate over 18 months, and secondary outcomes included HRQOL and mortality. We used multivariate analyses and an intention-to-treat analysis approach. Results: We randomized 36 patients to pulmonary rehabilitation. On average, patients with early rehabilitation (n = 19) had 2.61 (SD 2.96) exacerbations requiring systemic corticosteroids and/or antibiotics, compared to 2.77 (SD 3.41) in patients with late rehabilitation (adjusted incidence rate ratio 0.83, 95% confidence interval 0.43–1.63; p = 0.60). Over the 18-month period, patients with late rehabilitation experienced more dyspnea (difference on Chronic Respiratory Questionnaire dyspnea domain 0.74 and on the Medical Research Council dyspnea scale 0.37), but neither these differences nor any difference in HRQOL domains reached statistical significance. Conclusions: We did not find any statistically significant differences between early and late pulmonary rehabilitation. However, our trial indicates that early rehabilitation may lead to faster recovery of HRQOL after exacerbations compared to rehabilitation later on when patients are in a stable state.

Patterns of Domestic Activity and Ambulatory Oxygen Usage in COPD

The aim of this study was to examine patterns of domestic activity and ambulatory oxygen usage in patients with COPD in their domestic environment. Twenty patients (14 men; mean age, 73.4 years [SD, 6.8 years]; FEV1, 1.0 L [SD, 0.5 L]) with stable COPD were recruited after completing a 7-week pulmonary rehabilitation program. Patients were either hypoxic at rest or had desaturation during exercise. Patients were randomized to an 8-week, double-blind, placebo-controlled trial of cylinder oxygen vs cylinder air. Total domestic physical activity and health-related quality of life (HRQL) measures were recorded before and after intervention. There were no significant changes in domestic activity or HRQL measures after the intervention for either cylinder oxygen or cylinder air, except for a worsening of the Chronic Respiratory Questionnaire dyspnea domain on cylinder air. There was a significant increase in mean duration (minutes per day) of cylinder use (p < 0.05) between weeks 1 vs 7 and weeks 1 vs 8 for the oxygen group. However, when comparing the two groups together, there were no between-group differences in cylinder use or time spent outside the home. Over the 8 weeks the majority of patients were using the cylinders in the home rather than outside, however, the number of times patients reported using the cylinders outside the home increased over the 8 weeks for the oxygen group. In the short term, ambulatory oxygen therapy is not associated with improvements in physical activity, HRQL, or time spent away from home. However, the use of cylinder oxygen increased over the 8 weeks compared to cylinder air. Patients need time to learn how to use oxygen, and ambulatory oxygen appears to enhance activities rather than increase them.

Relative responsiveness of the Chronic Respiratory Questionnaire, St. Georges Respiratory Questionnaire and four other health-related quality of life instruments for patients with chronic lung disease

Selection of heath-related quality of life (HRQL) instruments that are most responsive to changes in HRQL prevents investigators from drawing false-negative conclusions about the effectiveness of an intervention. The objective of this study was to compare the responsiveness of the Chronic Respiratory Questionnaire (CRQ), the St. Georges Respiratory Questionnaire (SGRQ) and four other HRQL instruments. We enrolled 177 patients with chronic lung disease, primarily COPD (93%), who completed 8 weeks of respiratory rehabilitation. Patients completed the CRQ, the SGRQ and four generic measures (SF-36, Feeling Thermometer, Standard Gamble and Health Utilities index 3) at the beginning of the rehabilitation program and 12 weeks thereafter. We calculated standardized response means (SRMs) for each instrument, from the change score divided by the standard deviation of the change score. We observed the largest SRM for the CRQ (0.24-0.66 for the four CRQ domains on the interviewer-administered and 0.56-0.84 for the self-administered format) and the SGRQ (0.33-0.51 for the three SGRQ domains and total score). The CRQ dyspnea domain was statistically significantly more responsive than any other instrument including the SGRQ. For the SGRQ, the total and impacts domain were significantly more responsive than the generic and preference-based instruments. This study confirms that the CRQ and SGRQ are substantially more responsive than generic measures, and suggests particularly strong responsiveness for the self-administered CRQ.

Eformoterol n-of-1 trials in chronic obstructive pulmonary disease poorly reversible to salbutamol

Benefits of long acting beta 2 agonists are unclear for severe chronic obstructive pulmonary disease (COPD) patients with poor response to short acting bronchodilators. We aimed to evaluate 1) effects of eformoterol in such patients using a 'n-of-1' double crossover study design, and 2) aggregate data as a double-blind, double crossover randomized control trial. Subjects with forced expiratory volume in one second (FEV1) < 60% predicted, and poor response to short acting bronchodilators were studied six times over 18 weeks. During that time they were prescribed four weeks of either eformoterol or placebo, followed by the alternate, and then a second crossover. Four-weekly measures included six minute walk distance (6MWD), FEV1, previous two weeks of symptoms, and chronic respiratory questionnaire (CRQ) including treatment goal items. Of 27 original subjects (21 male, mean age of 70 years, five smokers, mean prebronchodilator FEV1 36% predicted), one subject had clinically significant concordant improvement in the CRQ dyspnoea domain and 6MWD (by 51 metres), but not for other outcomes. There were no concordant improvements in any other subjects. Aggregate double crossover data analysis demonstrated no improvement in any outcome measures. The 'n-of-1' study design and aggregate data analysis demonstrated lack of benefit from eformoterol in COPD patients with poor response to short acting bronchodilators.

Self-administration and standardisation of the chronic respiratory questionnaire: a randomised trial in three German-speaking countries

The chronic respiratory questionnaire (CRQ) has demonstrated excellent measurement properties in patients with chronic obstructive pulmonary disease (COPD), but in its original form it is limited by the requirement for interviewer-administration and the individualised dyspnoea questions. The objective of this randomised trial was to examine the evaluative properties of the interviewer and self-administered German CRQ as well as of a standardised CRQ dyspnoea domain. In a multinational trial we randomly allocated 71 patients with COPD to complete the interviewer administered CRQ (CRQ-IA) or the self-administered CRQ (CRQ-SA) and other validation measures at the beginning and end of a respiratory rehabilitation program. We assessed and compared responsiveness and longitudinal validity of the CRQ. The change scores of all CRQ domains were above the minimal clinically important difference of 0.5. Responsiveness of the fatigue domain was higher for the CRQ-SA compared to CRQ-IA ( P=0.02), but there was no difference in responsiveness on the other domains. Compared to the standardised dyspnoea domain the individualised dyspnoea questions tended to show greater responsiveness for both the CRQ-IA ( P=0.07) and CRQ-SA ( P=0.10). We found better longitudinal validity for the CRQ-SA represented by larger correlations between CRQ change scores and those of other validation instruments. Taken these results into consideration, researchers in COPD, in particular those in German-language countries can utilise any one of four CRQ formats that have proved both valid and responsive.

Evaluation of the minimal important difference for the feeling thermometer and the St. George's Respiratory Questionnaire in patients with chronic airflow obstruction

Background and objective The chronic respiratory questionnaire (CRQ), the St. Georges Respiratory Questionnaire (SGRQ), and the feeling thermometer (FT) evaluate change in health-related quality of life (HRQL) in patients with chronic airflow limitation (CAL). Although the interpretability, and in particular the minimal important difference (MID) in score changes, is well established for the CRQ, this is not the case for the SGRQ and FT. The objective of our study is to explore the interpretation of the SGRQ and FT. Methods We analyzed data from 84 patients who completed the CRQ, SGRQ, and FT before beginning pulmonary rehabilitation and 3 months later. We calculated correlations between the four CRQ domains (dyspnea, fatigue, emotional function, and mastery) and the three SGRQ domains (symptoms, activities, and impact), the SGRQ total score, and the FT. When Pearson's correlations were ⩾0.5, we constructed regression equations and used the slope to calculate the change in SGRQ and FT score that corresponded to a change in CRQ score of 0.5 (the MID). Having established MID for SGRQ we than used a similar approach to examine the relation between the SGRQ and FT results. Results Comparison with the CRQ dyspnea domain suggested the MID in SGRQ total score is approximately 3.05 with a 95% confidence interval (95% CI) ranging from 0.39 to 5.71 and a change of 5.67 (95% CI 3.43–7.92) represents a moderate change (1.0 on the CRQ dyspnea domain). The MID for the FT based on the CRQ fatigue domain was 6.1 (95% CI 1.87–10.28). The FT MID based on the SGRQ activities domain, impacts domain, and total score were, respectively, 7.4 (95% CI 3.44–11.35), 5.6 (95% CI 1.6–9.64), and 5.9 (95% CI 1.97–9.78). Conclusion An MID for the SGRQ approximates the previously suggested estimate of 4 on a scale of 0 to 100. The MID for the FT in patients with CAL is approximately 5 to 8 units on the 0 to 100 scale. These MID estimates should facilitate interpretation of clinical trials in which outcome measures include the SGRQ or FT.

A Comparison of the Original Chronic Respiratory Questionnaire With a Standardized Version

The chronic respiratory questionnaire (CRQ), a widely used measure of health-related quality of life (HRQL) in patients with chronic airflow limitation, includes an individualized dyspnea domain (patients identify five important activities, and report the degree of dyspnea on a 7-point scale). Because the individualized domain is unwieldy in multicenter clinical trials, we developed a standardized version and tested its discriminative and evaluative properties. We enrolled 51 patients who completed the standardized and individualized CRQ before starting a respiratory rehabilitation program, and again 3 months later. We calculated both cross-sectional and longitudinal correlations between the two versions and a number of other HRQL instruments, and tested the relative ability of the individualized and standardized versions of the CRQ to detect improvement with rehabilitation. The results of the individualized questions suggested greater dysfunction (lower scores) than did the standardized questions both at baseline (3.18 vs 3.92, p < 0.001) and follow-up (4.62 vs 4.84, p = 0.051). The standardized dyspnea domain showed superior discriminative validity. While both techniques detected important, statistically significant improvement with rehabilitation (individualized domain mean change, 1.44; 95% confidence interval [CI], 1.11 to 1.77 [p < 0.001]; standardized domain mean change, 0.92; 95% CI, 0.61 to 1.24 [p < 0.01]), the difference in effect was substantial and statistically significant (mean difference, 0.52; 95% CI, 0.22 to 0.82; p = 0.001). The two versions showed comparable longitudinal validity. A standardized version of the CRQ dyspnea domain improves the cross-sectional validity, maintains longitudinal validity, but reduces the responsiveness. By increasing sample size, investigators can use the more efficient standardized version of the CRQ without compromising validity.