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Background Patients with COPD need to cope with a disabling disease, which leads to health status impairment. Aim To investigate the long term change of health status in subjects with mild to moderate airflow obstruction and to compare this to subjects without airflow obstruction, with and without a smoking history. Second, to investigate the factors potentially associated to rapid health status decline in our total cohort. Methods Two hundred and one subjects were included. Generic [Short form 36 health survey (SF36) and EuroQol - 5 dimensions (EQ-5D)] and disease specific [Clinical COPD questionnaire (CCQ) and COPD Assessment Test (CAT)] health status questionnaires were regularly repeated over a six years period. Other functional outcomes comprised measures of lung function, physical fitness, physical activity and emotional state. Results On average, health status decline did not differ between groups with the exception of the EQ-5D index, which deteriorated faster in subjects with airflow obstruction compared to the never smoking control group [− 0.018(0.008) versus 0.00006(0.003), p = 0.03]. Subjects presenting at least one exacerbation had faster rate of deterioration measured with CAT [0.91(0.21) versus − 0.26(0.25), p

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.

Maaike Giezeman,1,2 Mikael Hasselgren,1 Karin Lisspers,3 Björn Ställberg,3 Scott Montgomery,4–6 Christer Janson,7 Josefin Sundh8 1School of Medical Sciences, Örebro University, Örebro, Sweden; 2Centre for Clinical Research, County Council of Värmland, Karlstad, Sweden; 3Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden; 4Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden; 5Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; 6Department of Epidemiology and Public Health, University College, London, UK; 7Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden; 8Department of Respiratory Medicine, School of Medical Sciences, Örebro University, Örebro, Sweden Purpose: The aim of this study was to examine the changing influence over time of comorbid heart disease on symptoms and health status in patients with COPD. Patients and methods: This is a prospective cohort study of 495 COPD patients with a baseline in 2005 and follow-up in 2012. The study population was divided into three groups: patients without heart disease (no-HD), those diagnosed with heart disease during the study period (new-HD) and those with heart disease at baseline (HD). Symptoms were measured using the mMRC. Health status was measured using the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT; only available in 2012). Logistic regression with mMRC ≥2 and linear regression with CCQ and CAT scores in 2012 as dependent variables were performed unadjusted, adjusted for potential confounders, and additionally adjusted for baseline mMRC, respectively, CCQ scores. Results: Mean mMRC worsened from 2005 to 2012 as follows: for the no-HD group from 1.8 (±1.3) to 2.0 (±1.4), (P=0.003), for new-HD from 2.2 (±1.3) to 2.4 (±1.4), (P=0.16), and for HD from 2.2 (±1.3) to 2.5 (±1.4), (P=0.03). In logistic regression adjusted for potential confounding factors, HD (OR 1.71; 95% CI: 1.03–2.86) was associated with mMRC ≥2. Health status worsened from mean CCQ as follows: for no-HD from 1.9 (±1.2) to 2.1 (±1.3) with (P=0.01), for new-HD from 2.3 (±1.5) to 2.6 (±1.6) with (P=0.07), and for HD from 2.4 (±1.1) to 2.5 (±1.2) with (P=0.57). In linear regression adjusted for potential confounders, HD (regression coefficient 0.12; 95% CI: 0.04–5.91) and new-HD (0.15; 0.89–5.92) were associated with higher CAT scores. In CCQ functional state domain, new-HD (0.14; 0.18–1.16) and HD (0.12; 0.04–0.92) were associated with higher scores. After additional correction for baseline mMRC and CCQ, no statistically significant associations were found. Conclusion: Heart disease contributes to lower health status and higher symptom burden in COPD but does not accelerate the worsening over time. Keywords: COPD Assessment Test, CAT, Clinical COPD Questionnaire, CCQ, modified Medical Research Council dyspnea score, mMRC, ischemic heart disease, heart failure

Peter Kardos,1 Ingo Mokros,2 Rüdiger Sauer,3,4 Claus F Vogelmeier5,6 1Group Practice and Centre for Allergy, Respiratory, and Sleep Medicine, at Maingau Red Cross Hospital, Frankfurt am Main, Germany; 2AstraZeneca GmbH, Unternehmensbereich Medizin, Wedel, Germany; 3Group Practice with Respiratory, Allergy and Sleep Unite, Lung Center, Ulm, Germany; 4Health Center Clinic Blaubeuren, Blaubeuren, Germany; 5Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Marburg, Germany; 6German Center for Lung Research (DZL), Giessen, Germany Purpose: DINO and DACOTA were prospective, noninterventional studies assessing the health status and quality of life of patients with COPD newly treated with roflumilast 500 µg once-daily add-on therapy.Patients and methods: Patients were evaluated over 6 months. Clinical COPD questionnaire (CCQ) and COPD assessment test (CAT) scores were recorded at baseline and after 3 and 6 months. In DACOTA, post-bronchodilator FEV1 was recorded at each time point.Results: Of 5,462 and 3,645 patients recruited into DINO and DACOTA, respectively, 3,274 patients in DINO and 916 patients in DACOTA completed the 6-month visit. Almost all patients had severe or very severe airway obstruction; mean baseline CCQ total score was 3.9 in DINO and 3.7 in DACOTA. Overall, 33.8% of patients in DACOTA and 30.6% in DINO discontinued treatment prematurely. Significant and clinically relevant improvements in CCQ total scores were observed in both studies (mean change from baseline of 1.36 in DINO and 0.91 in DACOTA at Month 6 [all P

Jan Willem H Kocks,1,2 Jan Willem K van den Berg,3 Huib AM Kerstjens,2,4 Steven M Uil,3 Judith M Vonk,2,5 Ynze P de Jong,3 Ioanna G Tsiligianni,1,2 Thys van der Molen1,2 1Department of General Practice, 2Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, 3Department of Pulmonary Diseases, Isala Klinieken, Zwolle, 4Department of Pulmonary Diseases and Tuberculosis, 5Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands Background: Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods: Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George's Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results: All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar. Conclusion: Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD. Keywords: health status, Clinical COPD Questionnaire, hospital, admission, prediction

Farida F Berkhof,1 Leola Metzemaekers,1 Steven M Uil,1 Huib AM Kerstjens,2 Jan WK van den Berg11Department of Pulmonary Diseases, Isala Hospital, Zwolle, 2Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the NetherlandsBackground: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are both common diseases that coexist frequently. Patients with both diseases have worse stable state health status when compared with patients with one of these diseases. In many outpatient clinics, health status is monitored routinely in COPD patients using the Clinical COPD Questionnaire (CCQ) and in HF patients with the Minnesota Living with Heart Failure Questionnaire (MLHF-Q). This study validated and compared which questionnaire, ie, the CCQ or the MLHF-Q, is suited best for patients with coexistent COPD and HF.Methods: Patients with both COPD and HF and aged ≥40 years were included. Construct validity, internal consistency, test–retest reliability, and agreement were determined. The Short-Form 36 was used as the external criterion. All questionnaires were completed at baseline. The CCQ and MLHF-Q were repeated after 2 weeks, together with a global rating of change.Results: Fifty-eight patients were included, of whom 50 completed the study. Construct validity was acceptable. Internal consistency was adequate for CCQ and MLHF-Q total and domain scores, with a Cronbach's alpha ≥0.70. Reliability was adequate for MLHF-Q and CCQ total and domain scores, and intraclass correlation coefficients were 0.70–0.90, except for the CCQ symptom score (intraclass correlation coefficient 0.42). The standard error of measurement on the group level was smaller than the minimal clinical important difference for both questionnaires. However, the standard error of measurement on the individual level was larger than the minimal clinical important difference. Agreement was acceptable on the group level and limited on the individual level.Conclusion: CCQ and MLHF-Q were both valid and reliable questionnaires for assessment of health status in patients with coexistent COPD and HF on the group level, and hence for research. However, in clinical practice, on the individual level, the characteristics of both questionnaires were not as good. There is room for a questionnaire with good evaluative properties on the individual level, preferably tested in a setting of patients with COPD or HF, or both.Keywords: Clinical COPD Questionnaire, Minnesota Living with Heart Failure Questionnaire, chronic obstructive pulmonary disease, heart failure

Background: COPD is a major public health problem. Health status has become an important tool in its diagnostics and management with CCQ, CAT and SGRQ as the main instruments. Important is to what extent a change in its score is clinically relevant. The Minimal Clinically Important Difference (MCID) defines this. Current MCIDs are 0.4 (CCQ), 2.0 (CAT) and 4.0 (SGRQ). This study investigated the MCID of these tools using multiple approaches, since existing evidence is limited. Methods: In total 316 patients participated in a 3-week Pulmonary Rehabilitation programme (63% male, 51%FEV1pred., 41 mean packyears, 58 years mean age, 2/50/38/10% GOLD stage I/II/III/IV). Anchor-based approaches, including patient-referencing, criterion-referencing and questionnaire-referencing, and the distribution-based methods SEM and 0.5SD were used to determine the MCID. Results: Discussion: This study showed that the MCID of a tool might differ depending on which method is used. Estimates ranged from 0.30 to 0.51 for CCQ, from 2.17 to 3.50 for CAT and from 6.17 to 7.92 for SGRQ. The current published MCID of the CCQ fits well in this range, however the MCID of the CAT and SGRQ in the literature is below the range found. (Table Presented).

The clinical COPD questionnaire (CCQ) has been developed to measure the health status of COPD patients. The aim of this study was to translate CCQ into the Persian language and assess the validity and reliability of the translated version. We used a forward-backward procedure to translate the questionnaire. In a cross-sectional study 100 COPD patients and 50 healthy subjects over 40 years old were selected to assess the reliability and construct validity of the instrument. The face and content validity were used for the questionnaire validity. Validity was examined in a population of patients with COPD, using the Persian validated version of the St George's Respiratory Questionnaire (PSGRQ). In order to assess the questionnaire’s reliability, the Intraclass correlation coefficient (ICC) and Cronbach’s alpha were calculated. Test-retest reliability was tested by re-administering the Persian version of the CCQ (PCCQ) after 1 week. Test-retest carry out of data demonstrates that the PCCQ has excellent reliability (ICC for all 3 domains were higher than 0.9). Internal consistency was found by Cronbach’s alpha to be 0.96, 0.94, 0.97, and 0.98 for the symptom, mental state, functional state and total scores respectively. In addition, the correlation between the components of PCCQ and PSGRQ showed satisfactory construct validity. Analyzing the data from healthy subjects and patients divulged that the PCCQ has acceptable discriminant validity. In general, the PCCQ had satisfactory reliability and validity for assessing health-related quality of life status of Iranian COPD patients.

Background: COPD is a major public health problem. Health status has become an important tool in its diagnostics and management with CCQ, CAT and SGRQ as the main instruments. Important is to what extent a change in its score is clinically relevant. The Minimal Clinically Important Difference (MCID) defines this. Current MCIDs are 0.4 (CCQ), 2.0 (CAT) and 4.0 (SGRQ). This study investigated the MCID of these tools using multiple approaches, since existing evidence is limited. Methods: In total 316 patients participated in a 3-week Pulmonary Rehabilitation programme (63% male, 51%FEV1pred., 41 mean packyears, 58 years mean age, 2/50/38/10% GOLD stage I/II/III/IV). Anchor-based approaches, including patient-referencing, criterion-referencing and questionnaire-referencing, and the distribution-based methods SEM and 0.5SD were used to determine the MCID. Results: Discussion: This study showed that the MCID of a tool might differ depending on which method is used. Estimates ranged from 0.30 to 0.51 for CCQ, from 2.17 to 3.50 for CAT and from 6.17 to 7.92 for SGRQ. The current published MCID of the CCQ fits well in this range, however the MCID of the CAT and SGRQ in the literature is below the range found. (Table Presented).