Change In St George's Respiratory Questionnaire Research Articles

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

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

The value of radiomic features in chronic obstructive pulmonary disease assessment: a prospective study

To investigate whether radiomic features could supply additional information in the assessment of lung function, health status, and exacerbation of chronic obstructive pulmonary disease (COPD). This prospective study enrolled 197 patients who underwent high-resolution chest computed tomography (CT) between 2009 and 2011. A total of 17 radiomic features from chest CT images were selected to explore the applicability of radiomics in the evaluation of COPD. Spirometric lung function testing, modified Medical Research Council (mMRC), St George's respiratory questionnaire (SGRQ), 6-minute walk test (6MWT), and exacerbations were collected at baseline and 1-year follow-up. The relationships of radiomic features, lung function, health status, and exacerbation were assessed using linear and logistic multivariate analyses. At baseline visit, radiomic features were significantly associated with forced expiratory volume in 1 second percent of predicted (FEV1 % predicted), FEV1/forced vital capacity (FVC), mMRC, and SGRQ after multivariate adjustment. At 1-year follow-up, original_10thpercentile was associated with mMRC change, and original_10thpercentile, original_elongation, original_sphericity, and original_glv were associated with SGRQ change. Original_flatness was associated with exacerbation and can improve the prediction performance of other models for exacerbation. No radiomic features correlated with the 6MWT. Radiomic features were associated with airflow obstruction, health status, and exacerbation of COPD independent of other factors, showing promise in the assessment of COPD.

Phase II Investigation of the Efficacy of Antimycobacterial Therapy in Chronic Pulmonary Sarcoidosis

BackgroundA Phase I, single-center investigation found that 8 weeks of antimycobacterial therapy improved sarcoidosis FVC. Safety and efficacy assessments have not been performed in a multicenter cohort.Research QuestionThe objective of this study was to determine the safety and efficacy of antimycobacterial therapy on the physiological and immunologic end points of sarcoidosis.Study Design and MethodsIn a double-blind, placebo-controlled, multicenter investigation, patients with pulmonary sarcoidosis were randomly assigned to receive 16 weeks of concomitant levofloxacin, ethambutol, azithromycin, and rifabutin (CLEAR) or matching placebo to investigate the effect on FVC. The primary outcome was a comparison of change in percentage of predicted FVC among patients randomized to receive CLEAR or placebo in addition to their baseline immunosuppressive regimen. Secondary outcomes included 6-min walk distance (6MWD), St. George’s Respiratory Questionnaire (SGRQ) score, adverse events, and decrease in mycobacterial early secreted antigenic target of 6 kDa (ESAT-6) immune responses.ResultsThe intention-to-treat analysis revealed no significant differences in change in FVC among the 49 patients randomized to receive CLEAR (1.1% decrease) compared with the 48 randomized to receive placebo (0.02% increase) (P = .64). Physiological parameters such as the change in 6MWD were likewise similar (P = .91); change in SGRQ favored placebo (–8.0 for placebo vs –1.5 for CLEAR; P = .028). The per-protocol analysis revealed no significant change in FVC at 16 weeks between CLEAR and placebo. There was no significant change in 6MWD (36.4 m vs 6.3 m; P = .24) or SGRQ (–2.3 vs –7.0; P = .14). A decline in ESAT-6 immune responses at 16 weeks was noted among CLEAR-treated patients (P = .0003) but not patients receiving placebo (P = .24).InterpretationDespite a significant decline in ESAT-6 immune responses, a 16-week CLEAR regimen provided no physiological benefit in FVC or 6MWD among patients with sarcoidosis.

Design of the Redefining Therapy in Early COPD Study.

Redefining Therapy in Early COPD (RETHINC) is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms as defined by COPD Assessment Test (CAT) score ≥ 10 despite preserved spirometry defined by post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio ≥ 0.70. Recruitment began in July 2017 with the goal of enrolling 580 participants. The baseline examination includes spirometry (with slow and forced maneuvers) and symptom questionnaires. A follow-up phone call at 4 weeks assesses symptoms and safety. The second and final visit at week 12 includes spirometry before and after study drug (hourly over 3 hours) and follow-up symptom questionnaires. The primary endpoint is the proportion of individuals who experience a 4-unit improvement in St George's Respiratory Questionnaire (SGRQ) score at 12 weeks without treatment failure, defined as an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilators, corticosteroids or antibiotics. Key secondary endpoints include the proportion of individuals with a 2-unit improvement in the CAT score; 1-unit improvement in the Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI), both a 4-unit improvement in SGRQ and a 1-unit improvement in BDI/TDI; and mean change in SGRQ, CAT and BDI/TDI. Other secondary endpoints include area under the curve 0-3 hours for FEV1 after study drug, change from baseline in trough inspiratory capacity, forced expiratory flow 25%-75% of FVC (FEF25-75) iso-volume FEF25-75 and mean change in symptoms and rescue medication use based on daily diary. We anticipate results to be available in 2021. This paper describes the RETHINC study and explains the rationale behind it.

Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial.

We evaluated the effectiveness of an interdisciplinary, primary care-based model of care for chronic obstructive pulmonary disease (COPD).A cluster randomised controlled trial was conducted in 43 general practices in Australia. Adults with a history of smoking and/or COPD, aged ≥40 years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD. The model of care comprised smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase). Main outcomes included changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function at 6 and 12 months.We identified 272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase. Intention-to-treat analysis showed no statistically significant difference in change in SGRQ at 6 months (adjusted between-group difference 2.45 favouring intervention, 95% CI -0.89-5.79). Per protocol analyses showed clinically and statistically significant improvements in SGRQ in those receiving the full intervention compared to usual care (difference 5.22, 95% CI 0.19-10.25). No statistically significant differences were observed in change in CAT, dyspnoea, smoking abstinence or lung function.No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care. Low uptake was a limitation.

The importance of exercise self-efficacy for clinical outcomes in pulmonary rehabilitation.

Pulmonary rehabilitation (PR) improves functional exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD), although these outcomes are often not maintained following PR. Self-efficacy is a precursor to outcomes achievement, yet few studies have examined the importance of self-efficacy to outcome improvement during PR, or how it develops over time. Further, the contribution of exercise-specific self-efficacy to outcomes in PR is unknown. The aims of this study were to determine (a) whether baseline exercise self-efficacy predicts PR attendance and change in functional exercise capacity and health status over PR, and (b) if exercise self-efficacy changes with PR. Fifty-eight out of 64 patients with COPD completed PR and assessments of exercise self-efficacy (task, coping, scheduling), the 6-minute walk test (6MWT), and St. George's Respiratory Questionnaire (SGRQ) at the beginning and end of PR. Analyses were conducted to predict attendance, and change in 6MWT and SGRQ, while controlling for baseline demographic and clinical indicators. Change in 6MWT, SGRQ, and self-efficacy with PR was also examined. Clinically significant increases in the 6MWT and SGRQ were achieved with PR. Stronger task self-efficacy predicted better attendance, while stronger coping self-efficacy predicted greater 6MWT improvement. No variables predicted SGRQ change. Scheduling self-efficacy significantly improved with PR, whereas task and coping self-efficacy did not. Baseline exercise self-efficacy appears to be a determinant of rehabilitation attendance and functional exercise improvement with PR. Clinicians should evaluate and target exercise self-efficacy to maximize adherence and health outcome improvement with PR. (PsycINFO Database Record

Pneumothorax following Endobronchial Valve Therapy and Its Impact on Clinical Outcomes in Severe Emphysema

Background: Patients who achieve significant target lobe volume reduction (TLVR) following endobronchial valve (EBV) treatment may experience substantial improvements in clinical outcome measures. However, in cases of rapid TLVR, the risk of pneumothorax increases due to parenchymal rupture of the adjacent untreated lobe. Target lobe collapse may be more likely in EBV-treated patients who have low collateral ventilation. Objectives: The aim of this study was to evaluate the impact of pneumothorax on outcome following EBV treatment. Methods: Data from three prospective clinical trials (the US and European cohorts of VENT and the Multicenter Chartis study) were retrieved for the analysis. All patients had undergone chest X-ray within 24 h of EBV implantation to explore the presence of pneumothorax. TLVR was assessed at either 30 (Chartis study) or 180 days (VENT), and clinical outcome measures (forced expiratory volume in 1 s (FEV₁), St. George's Respiratory Questionnaire (SGRQ) and 6-min-walk distance (6-MWD)) were assessed 180 days after implantation. Results: The overall rate of pneumothorax following valve therapy was 5.9% (25/421). Among these patients, 68% had a prolonged air leak for >7 days. However, patients who experienced a pneumothorax benefitted from EBV therapy, with a mean TLVR of 65% (n = 20). The mean percent change in FEV₁ was 15 ± 15%, and the mean change in SGRQ was -7 ± 12 points. Conclusions: Although pneumothorax is a complication of EBV placement, it does not appear to have a negative impact on clinical outcome in terms of FEV₁ and health-related quality of life.

The Clinical COPD Questionnaire: response to pulmonary rehabilitation and minimal clinically important difference

BackgroundThe Clinical COPD Questionnaire (CCQ) is a simple 10-item, health-related quality of life questionnaire (HRQoL) with good psychometric properties. However, little data exists regarding the responsiveness of the CCQ to...

St. George's Respiratory Questionnaire Has Longitudinal Construct Validity in Lymphangioleiomyomatosis

BackgroundLymphangioleiomyomatosis (LAM) is an uncommon, progressive, cystic lung disease that causes shortness of breath, hypoxemia, and impaired health-related quality of life (HRQL). Whether St. George's Respiratory Questionnaire (SGRQ), a respiratory-specific HRQL instrument, captures longitudinal changes in HRQL in patients with LAM is unknown. MethodsUsing data from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus trial, we performed analyses to examine associations between SGRQ scores and values for four external measures (anchors). Anchors included (1) FEV1, (2) diffusing capacity of the lung for carbon monoxide, (3) distance walked during the 6-min walk test, and (4) serum vascular endothelial growth factor-D. ResultsSGRQ scores correlated with the majority of anchor values at baseline, 6 months, and 12 months. Results from longitudinal analyses demonstrated that SGRQ change scores tracked changes over time in values for each of the four anchors. At 12 months, subjects with the greatest improvement from baseline in FEV1 experienced the greatest improvement in SGRQ scores (Symptoms domain, −13.4 ± 14.6 points; Activity domain, −6.46 ± 8.20 points; Impacts domain, −6.25 ± 12.8 points; SGRQ total, −7.53 ± 10.0 points). Plots of cumulative distribution functions further supported the longitudinal validity of the SGRQ in LAM. ConclusionsIn LAM, SGRQ scores are associated with variables used to assess LAM severity. The SGRQ is sensitive to change in LAM severity, particularly when change is defined by FEV1, perhaps the most clinically relevant and prognostically important variable in LAM. The constellation of results here supports the validity of the SGRQ as capable of assessing longitudinal change in HRQL in LAM.

Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review.

BackgroundInteractions between spirometry and patient-reported outcomes in COPD are not well understood. This systematic review and study-level analysis investigated the relationship between changes in FEV1 and changes in health status with bronchodilator therapy.MethodsSix databases (to October 2009) were searched to identify studies with long-acting bronchodilator therapy reporting FEV1 and health status, dyspnoea or exacerbations. Mean and standard deviations of treatment effects were extracted for each arm of each study. Relationships between changes in trough FEV1 and outcomes were assessed using correlations and random-effects regression modelling. The primary outcome was St George's Respiratory Questionnaire (SGRQ) total score.ResultsThirty-six studies (≥3 months) were included. Twenty-two studies (23,654 patients) with 49 treatment arms each contributing one data point provided SGRQ data. Change in trough FEV1 and change in SGRQ total score were negatively correlated (r = -0.46, p < 0.001); greater increases in FEV1 were associated with greater reductions (improvements) in SGRQ. The correlation strengthened with increasing study duration from 3 to 12 months. Regression modelling indicated that 100 mL increase in FEV1 (change at which patients are more likely to report improvement) was associated with a statistically significant reduction in SGRQ of 2.5 (95% CI 1.9, 3.1), while a clinically relevant SGRQ change (4.0) was associated with 160.6 (95% CI 129.0, 211.6) mL increase in FEV1. The association between change in FEV1 and other patient-reported outcomes was generally weak.ConclusionsOur analyses indicate, at a study level, that improvement in mean trough FEV1 is associated with proportional improvements in health status.

Relapse of health related quality of life and psychological health in patients with chronic obstructive pulmonary disease 6 months after rehabilitation

This study aimed to evaluate the short- and long-term effects of 4-week inpatient rehabilitation on health-related quality of life (HRQL), anxiety and depression in patients with chronic obstructive pulmonary disease (COPD) and investigate the influence of clinical and socio-demographical factors on unaltered or improved HRQL after discharge. A total of 111 consecutive cases with mild-to-very severe COPD were recruited from three rehabilitation centres and measured at baseline (t1), 4 weeks (t2) and 6-month follow-up (t3). Disease severity was assessed by spirometric tests, HRQL by The St. George's Respiratory Questionnaire (SGRQ) and anxiety and depression by The Hospital Anxiety and Depression Scale (HADS). Socio-demography and co-morbidity was also reported. Changes in SGRQ and HADS scores from baseline to follow-up were analysed by paired-sample t-test, and logistic regression was used to investigate the influence of different factors on HRQL after discharge. Health-related quality of life and depression improved between t1 and t2: a change of -3.6 for the SGRQ impact score (p = 0.009), -2.8 for the SGRQ total score (p = 0.012), a clinical relevant change of -4.0 for the SGRQ symptom score (p = 0.012) and a reduction of -0.7 for the HADS depression score (p = 0.011). Between t2 and t3, all SGRQ and HADS scores deteriorated with enhancement of SGRQ impact score (+3.5, p = 0.016), SGRQ total score (+2.5, p = 0.029), HADS anxiety score (+1.1, p = 0.000), HADS depression score (+0.6, p = 0.022) and HADS total score (+1.7, p = 0.000). No significant differences between t1 and t3 were found, except for HADS anxiety score (+0.9, p = 0.003). Patients living alone were 2.9 times more likely to maintain or improve HRQL 6 months after rehabilitation than patients living with someone (95% CI 1.1-7.8, p = 0.039). Short-term benefits on HRQL and depression after rehabilitation relapsed at 6-month follow-up, but without any further deterioration from baseline. Living alone may be beneficial to maintain or improve HRQL after discharge.

Health-related quality of life and functional status in end-stage COPD: a longitudinal study

Since there is still a dearth of information about the end stage of chronic obstructive pulmonary disease (COPD), the main aim of this study was to examine the development of health-related quality of life (HRQoL) and functional status over time in COPD patients in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage IV. 82 Dutch COPD patients completed the St George's Respiratory Questionnaire (SGRQ) for HRQoL and the Groningen Activities for Daily Living Restriction Scale (GARS) for functional status every 3 months during the year following enrolment. Survival was followed up to 5 yrs after enrolment. Data were analysed by stratifying the study population into severity subgroups according to the lowest, intermediate and highest tertile of SGRQ and GARS at baseline. Outcome measures were change in SGRQ and GARS scores over time and survival time. In the majority of patients, scores on the SGRQ and GARS declined gradually over time. In the subgroup of 32 patients that died within 2 yrs of enrolment, these scores also declined gradually, without steep deteriorations. In patients with end-stage COPD, HRQoL and functional status deteriorated gradually over time, indicating that clinicians did not gain much additional support for differentiating the end stage of COPD by considering HRQoL and functional status using the SGRQ and GARS.

Predicting Corticosteroid Response in Chronic Obstructive Pulmonary Disease Using Exhaled Nitric Oxide

Predicting corticosteroid response in COPD is important but difficult. Response is more likely to occur in association with eosinophilic airway inflammation, for which the fraction of exhaled nitric oxide (Fe(NO)) is a good surrogate marker. We aimed to establish whether Fe(NO) levels would predict the clinical response to oral corticosteroid in COPD. We performed a double-blind, crossover trial of steroid in patients with COPD. After a 4-week washout of inhaled steroids, patients received prednisone 30 mg/d or matching placebo, in random order, with an intervening 4-week washout. The predictive values of Fe(NO) for clinically significant changes in 6-minute-walk distance (6MWD), spirometry (FEV(1)), and St. George's Respiratory Questionnaire (SGRQ) were calculated. A total of 65 patients (mean FEV(1) = 57% predicted) were randomized. With prednisone, there was a net increase of 13 m in 6MWD (P = 0.02) and 0.06 L in postbronchodilator FEV(1) (P = 0.02) compared with placebo. The change in SGRQ was not significant. Using receiver operator characteristic analysis, the area under the curve for an increase of 0.2 L in FEV(1) was 0.69 (P = 0.04) with an optimum Fe(NO) cut-point of 50 ppb. The positive and negative predictive values were 67 and 82%, respectively. FE(NO) was not a significant predictor for changes in 6MWD or SGRQ. Fe(NO) is a weak predictor of short-term response to oral corticosteroid in COPD, its usefulness being limited to predicting increase in FEV(1). Clinical trial registered with www.anzctr.org.au (ACTRN12605000683639).

Rehabilitation in COPD: the long-term effect of a supervised 7-week program succeeded by a self-monitored walking program

Pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) improves exercise tolerance and health status, however, these effects have been shown to decline after termination of the rehabilitation program. This study has examined the long-term effect of a 7-week supervised rehabilitation program combined with daily self-monitored training at home on exercise tolerance and health status. Two hundred and nine consecutive COPD patients who had completed a 7-week pulmonary rehabilitation program were assessed with endurance shuttle walk test (ESWT) and the St George's Respiratory Questionnaire (SGRQ) at baseline, 0, 3, and 12 months after the program. Sixty-eight (32.5%) patients did not attend the 1-year follow-up. Among the 141 patients who competed the 1-year evaluation, the initial improvement after the 7-week program in the ESWT time was 180 s or 101% (p = 0.001) and in SGRQ 3.4 units (p = 0.001). These effects were maintained at the 1-year evaluation (ESWT 59% above baseline; p < 0.001 and improved SGRQ 3.0 units compared with baseline; p = 0.011). The 31 patients who attended the 6-month, but not the 12-month evaluation, improved ESWT time by 96 s (p = 0.02) without any change in SGRQ +2.0 (p = 0.40). A relative simple and inexpensive 7-week supervised rehabilitation program combined with daily self-monitored training at home was able to maintain significant improvement in exercise tolerance and health status throughout 1 year. Death and hospital admissions due to acute exacerbations were the main reasons for non-attendance in the follow-up period.

Combining scores from different patient reported outcome measures in meta-analyses: when is it justified?

BackgroundCombining outcomes and the use of standardized effect measures such as effect size and standardized response mean across instruments allows more comprehensive meta-analyses and should avoid selection bias. However, such analysis ideally requires that the instruments correlate strongly and that the underlying assumption of similar responsiveness is fulfilled. The aim of the study was to assess the correlation between two widely used health-related quality of life instruments for patients with chronic obstructive pulmonary disease and to compare the instruments' responsiveness on a study level.MethodsWe systematically identified all longitudinal studies that used both the Chronic Respiratory Questionnaire (CRQ) and the St. George's Respiratory Questionnaire (SGRQ) through electronic searches of MEDLINE, EMBASE, CENTRAL and PubMed. We assessed the correlation between CRQ (scale 1 – 7) and SGRQ (scale 1 – 100) change scores and compared responsiveness of the two instruments by comparing standardized response means (change scores divided by their standard deviation).ResultsWe identified 15 studies with 23 patient groups. CRQ change scores ranged from -0.19 to 1.87 (median 0.35, IQR 0.14–0.68) and from -16.00 to 3.00 (median -3.00, IQR -4.73–0.25) for SGRQ change scores. The correlation between CRQ and SGRQ change scores was 0.88. Standardized response means of the CRQ (median 0.51, IQR 0.19–0.98) were significantly higher (p < 0.001) than for the SGRQ (median 0.26, IQR -0.03–0.40).ConclusionInvestigators should be cautious about pooling the results from different instruments in meta-analysis even if they appear to measure similar constructs. Despite high correlation in changes scores, responsiveness of instruments may differ substantially and could lead to important between-study heterogeneity and biased meta-analyses.

Predictors of success and failure in pulmonary rehabilitation

The purpose of the present study was to identify prognostic features of chronic obstructive pulmonary disease (COPD) associated with success or failure in pulmonary rehabilitation. Patients were stratified according to the Medical Research Council (MRC) dyspnoea score. A total of 74 stable COPD patients (mean+/-sd age 68+/-10 yrs), 21 MRC dyspnoea score grade 1/2, 29 grade 3/4 and 24 grade 5, with a mean forced expiratory volume in one second of 1.1+/-0.6 L, attended for rehabilitation. Assessments consisted of the following: quadriceps torque, 6-minute walking distance (6MWD), Brief Assessment Depression Cards and St George's Respiratory Questionnaire (SGRQ). Predictors of drop-out and of response (a change in SGRQ of four points or 6MWD of 54 m) were tested using binary logistic regression. In total, 51 patients completed the study. Of these, 39 (77%) showed a clinically significant benefit in either 6MWD or SGRQ. Baseline variables were poor predictors of response in each case. Significant differences were seen between MRC dyspnoea score groups for change in 6MWD and SGRQ Score. Only grade 1/2 and 3/4 patients improved. Depression was a risk factor for subject drop-out compared with nondepressed patients. Baseline state is a poor predictor of response to rehabilitation, although Medical Research Council dyspnoea score grade 5 patients showed smaller magnitudes of improvement than patients with less severe Medical Research Council dyspnoea score grades. Risk of drop-out is significantly greater in depressed compared with nondepressed patients.