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Rationale: A positive bronchodilator response (BDR) according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines require both 200 ml and 12% increase in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) after bronchodilator inhalation. This dual criterion is insensitive in those with high or low FEV1. Objectives: To establish BDR criteria with volume or percentage FEV1 change. Methods: The largest FEV1 and FVC were identified fromthree pre- and three post-bronchodilator maneuvers in COPDGene (Genetic Epidemiology of COPD) participants. A total of 7,741 individuals with coefficient of variation less than 15% for both FEV1 and FVC formed bronchodilator categories of FEV1 response: negative (0.00% to 0.00 L to 9.00% to 16.00% to 0.16 L to 26.00% or >0.26 L). These response size categories are based on empirical limits considering average FEV1 increase of approximately 160 ml and the clinically important difference for FEV1. To compare flow and volume response characteristics, BDR-FEV1 category assignments were applied for the BDR-FVC response. Results: Twenty percent met mild and 31% met moderate or marked BDR-FEV1 criteria, whereas 12% met mild and 33% met moderate or marked BDR-FVC criteria. In contrast, only 20.6% met ATS/ERS positive criteria. Compared with the negative BDR-FEV1 category, the minimal, mild, moderate, and marked BDR-FEV1 categories were associated with greater 6-minute-walk distance and lower St. George's Respiratory Questionnaire and modified Medical Research Council dyspnea scale scores. Compared with negative BDR, moderate and marked BDR-FEV1 categories were associated with fewer exacerbations, and minimal BDR was associated with lower computed tomography airway wall thickness. Compared with the negative category, all BDR-FVC categories were associated with increasing emphysema percentage and gas trapping percentage. Moderate and marked BDR-FVC categories were associated with higher St. George's Respiratory Questionnaire scores but fewer exacerbations and lower dyspnea scores. Conclusions: BDR grading by FEV1 volume or percentage response identified subjects otherwise missed by ATS/ERS criteria. BDR grades were associated with functional exercise performance, quality of life, exacerbation frequency, dyspnea, and radiological airway measures. BDR grades in FEV1 and FVC indicate different clinical and radiological characteristics. United States Department of Health & Human Services National Institutes of Health (NIH) - USA NIH National Heart Lung & Blood Institute (NHLBI) National Center for Advancing Translational Sciences through UCLA CTSI Grant

Objectives Minimal clinically important differences (MCIDs) are used as fixed numbers in the interpretation of clinical trials. Little is known about its dynamics. This study aims to explore the impact of baseline score, study setting, and patient characteristics on health status MCIDs in chronic obstructive pulmonary disease (COPD). Study Design and Setting Baseline and follow-up data on the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and St. George's Respiratory Questionnaire (SGRQ) were retrospectively analyzed from pulmonary rehabilitation (PR) and routine clinical practice (RCP). Anchor- and distribution-based MCID estimates were calculated and tested between settings, gender, age, Global initiative for Obstructive Lung Disease (GOLD) classification, comorbidities, and baseline health status. Results In total, 658 patients were included with 2,299 change score measurements. MCID estimates for improvement and deterioration ranged for all subgroups 0.50–6.30 (CAT), 0.10–0.84 (CCQ), and 0.33–12.86 (SGRQ). Larger MCID estimates for improvement and smaller ones for deterioration were noted in patients with worse baseline health status, females, elderly, GOLD I/II patients, and patients with less comorbidities. Estimates from PR were larger. Conclusion Baseline health status and setting affected MCID estimates of COPD health status questionnaires. Patterns were observed for gender, age, spirometry classification, and comorbidity levels. These outcomes would advocate the need for tailored MCIDs.

Background: In the 2014 GOLD update high symptom groups are defined based either on the CCQ or the CAT. The current standard of health status measurement in clinical trials is the SGRQ, this is however due to its length difficult to use in daily practice. As alternative CCQ and CAT have been proposed. So far no data has been published demonstrating the correlation between the German versions of the CCQ and CAT and the SGRQ Methods 346 COPD patients underwent a 3-week intensive rehabilitation programme. At baseline the patients completed the CAT, CCQ and SGRQ. Pearson correlations between the questionnaires were calculated. Results Data from N=307 patients could be included. 64.5% were male, mean age of 57.3 (6.9) years, mean FEV1 50.2%pred, 38.2% GOLD II, 37.9% GOLDIII, 23.9% GOLDIV. All correlations were significant (p0,8. Discussion There is a high correlation between the German versions of the CCQ and CAT and with SGRQ as standard. Both CCQ and CAT are quick and valid alternatives for the longer SGRQ in evaluating health status using the German language. (Table Presented).

Background & objectives: Suppressed adrenal responses associated with inhaled steroid use have been reported in patients with bronchiectasis and have been shown to be associated with poor quality of life. This study was undertaken to examine the prevalence of suppressed cortisol responses in stable bronchiectasis and determine their correlation with the use of inhaled corticosteroids, radiologic severity of bronchiectasis and quality of life (QOL) scores. Methods: In this case-control study, cases were patients with bronchiectasis and suppressed cortisol responses and controls were healthy volunteers, and patients with bronchiectasis without suppressed cortisol responses. Symptoms, lung function test values, exercise capacity, HRCT severity scores for bronchiectasis, exacerbations, inhaled corticosteroid use and quality of life scores were compared between patients with and without suppressed cortisol values. Results: Forty consecutive patients with bronchiectasis and 40 matched controls underwent 1-μg cosyntropin testing. Baseline cortisol (mean difference -2.0 μg/dl, P=0.04) and 30-minute stimulated cortisol (mean difference -3.73 μg/dl, P=0.001) were significantly lower in patients with bronchiectasis. One patient had absolute adrenal insufficiency and 39.5 per cent (15/38) patients with bronchiectasis had impaired stimulated responses. Baseline and stimulated cortisol responses were unaffected by inhaled steroids (O.R 1.03, P=0.96). SGRQ scores were negatively correlated with body mass (r= -0.51, P=0.001) and bronchiectasis severity (r=0.37, P=0.019), but not related to baseline or stimulated cortisol responses. Interpretation & conclusions: Our results showed that the impaired adrenal responses to 1-μg cosyntropin were common in patients with bronchiectasis. This was not associated with the use of inhaled steroids or severity of bronchiectasis. Poor health status was associated with advanced disease and not with cortisol responses to the 1-μg cosyntropin test.

Rationale In the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013 strategy document, assessment of symptoms is advised to be performed by the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), or modified Medical Research Council (mMRC). Cut points of resp. CCQ≥1, CAT≥10 and mMRC≥2 indicate highly symptomatic patients (groups B and D). Recently a cut point of ≥25 of the St. George Respiratory Questionnaire (SGRQ) has been suggested as gold standard.1 The current study investigates the criterion validity of CCQ, CAT and mMRC using the advised cut point of SGRQ based on sensitivity and specificity analysis. Methods Two datasets were used: A) 238 patients participated in a 3-week Pulmonary Rehabilitation (PR) program (63% male, 51%FEV1pred., 40 mean packyears, 57 mean age, 40/39/21% GOLD stage II/III/IV) and B) 90 patients from primary care2, 90% male, 56%FEV pred., 1 16/47/30/6% GOLD I/II/III/IV. Primary outcome is the correspondence between recommended cut point of the SGRQ, CCQ, CAT and mMRC expressed in sensitivity and specificity using receiver operating characteristic (ROC) curves. Taking into account the possibility of unsatisfactory sensitivity and specificity, scatterplots with regression lines were used to visually explore alternative cut points, which were consecutively evaluated using ROC curves. Results Mean total CCQ, CAT, SGRQ scores and median mMRC: dataset A: resp. 2.9, 20.2, 50.1, and 2, and dataset B: 1.6, 14.1, 36.3, and 2. The table shows ROC analysis results using the suggested SGRQ cut point of 25. Visual inspection of the scatterplots revealed that SGRQ=20 might serve as more corresponding cut point, with ROC results in the table. This was confirmed by regression analysis. Conclusions In these two samples the suggested cut point for the SGRQ (≥25) does not seem to correspond well to the established cut points of both the CCQ and CAT, resulting in low specificity levels, the correspondence with mMRC seems satisfactory for the rehabilitation sample. A SGRQ threshold of ≥20 shows good sensitivity and specificity for CCQ and CAT, as well as improved specificity for the mMRC. This value corresponds better to established cut points for CCQ, CAT and mMRC in both patient groups. (Table Presented).

Rationale In the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013 strategy document, assessment of symptoms is advised to be performed by the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), or modified Medical Research Council (mMRC). Cut points of resp. CCQ≥1, CAT≥10 and mMRC≥2 indicate highly symptomatic patients (groups B and D). Recently a cut point of ≥25 of the St. George Respiratory Questionnaire (SGRQ) has been suggested as gold standard.1 The current study investigates the criterion validity of CCQ, CAT and mMRC using the advised cut point of SGRQ based on sensitivity and specificity analysis. Methods Two datasets were used: A) 238 patients participated in a 3-week Pulmonary Rehabilitation (PR) program (63% male, 51%FEV1pred., 40 mean packyears, 57 mean age, 40/39/21% GOLD stage II/III/IV) and B) 90 patients from primary care2, 90% male, 56%FEV pred., 1 16/47/30/6% GOLD I/II/III/IV. Primary outcome is the correspondence between recommended cut point of the SGRQ, CCQ, CAT and mMRC expressed in sensitivity and specificity using receiver operating characteristic (ROC) curves. Taking into account the possibility of unsatisfactory sensitivity and specificity, scatterplots with regression lines were used to visually explore alternative cut points, which were consecutively evaluated using ROC curves. Results Mean total CCQ, CAT, SGRQ scores and median mMRC: dataset A: resp. 2.9, 20.2, 50.1, and 2, and dataset B: 1.6, 14.1, 36.3, and 2. The table shows ROC analysis results using the suggested SGRQ cut point of 25. Visual inspection of the scatterplots revealed that SGRQ=20 might serve as more corresponding cut point, with ROC results in the table. This was confirmed by regression analysis. Conclusions In these two samples the suggested cut point for the SGRQ (≥25) does not seem to correspond well to the established cut points of both the CCQ and CAT, resulting in low specificity levels, the correspondence with mMRC seems satisfactory for the rehabilitation sample. A SGRQ threshold of ≥20 shows good sensitivity and specificity for CCQ and CAT, as well as improved specificity for the mMRC. This value corresponds better to established cut points for CCQ, CAT and mMRC in both patient groups. (Table Presented).

Background: In the 2014 GOLD update high symptom groups are defined based either on the CCQ or the CAT. The current standard of health status measurement in clinical trials is the SGRQ, this is however due to its length difficult to use in daily practice. As alternative CCQ and CAT have been proposed. So far no data has been published demonstrating the correlation between the German versions of the CCQ and CAT and the SGRQ Methods 346 COPD patients underwent a 3-week intensive rehabilitation programme. At baseline the patients completed the CAT, CCQ and SGRQ. Pearson correlations between the questionnaires were calculated. Results Data from N=307 patients could be included. 64.5% were male, mean age of 57.3 (6.9) years, mean FEV1 50.2%pred, 38.2% GOLD II, 37.9% GOLDIII, 23.9% GOLDIV. All correlations were significant (p0,8. Discussion There is a high correlation between the German versions of the CCQ and CAT and with SGRQ as standard. Both CCQ and CAT are quick and valid alternatives for the longer SGRQ in evaluating health status using the German language. (Table Presented).