Clinical COPD Questionnaire Research Articles

The effect of an outpatient care on-demand-system on health status and costs in patients with COPD. A randomized trial

Traditionally, outpatient visits for COPD are fixed, pre-planned by the pulmonologist. This is not a patient centered method, nor, in times of increasing COPD prevalence and resource constraints, perhaps the optimal method. This pilot study, determined the effect of an on-demand-system, patient initiated outpatient visits, on health status, COPD-related healthcare resource-use and costs. Patients were randomized between on-demand-system (n = 49) and usual care (n = 51), with a 2-year follow-up. Primary, health status was assessed with Clinical COPD Questionnaire (CCQ). Secondary endpoints were: St. George's Respiratory Questionnaire (SGRQ), Short Form-36 (SF-36) scores, visits to general practitioners (GP), pulmonologists, and pulmonary nurse practitioners (PNP), exacerbations and total treatment costs from healthcare providers and healthcare insurance perspectives. Participants had a mean FEV(1) 1.3 ± 0.4 liters and were 69 ± 9 years. CCQ total scores deteriorated in both groups, with no significant difference between them. CCQ symptom domain did show a significant and clinically relevant difference in favor of the on-demand-group, -0.4 ± 0.21, CI95% -0.87; -0.02, p = 0.04. Similar tendency was found for the SGRQ whereas results for SF-36 were inconsistent. Patients in the on-demand-group visited GP significantly less (p = 0.01), but PNP significantly more, p = 0.003. Visits to pulmonologists and exacerbations were equally frequent in both groups. Mean total costs per patient were lower in the on-demand-group in comparison with usual care, difference of €-518 (-1993; 788) from healthcare provider and €-458 (-2700; 1652) insurance perspective. The on-demand-system was comparable with usual care, had a cost-saving tendency, and can be instituted with confidence in the COPD outpatient care setting.

Health status measured by the Clinical COPD Questionnaire (CCQ) improves following post-acute pulmonary rehabilitation in patients with advanced COPD: a prospective observational study.

Aims:To evaluate outcomes of the Clinical Chronic obstructive pulmonary disease (COPD) Questionnaire (CCQ) in patients with advanced COPD admitted for a post-acute pulmonary rehabilitation (PR) programme and to relate (change in) health status to lung function, degree of dyspnoea and (change in) functional capacity.Methods:This is a prospective observational study in patients with advanced COPD admitted for a post-acute PR programme in a skilled nursing facility. Health status (CCQ) and functional capacity were measured before and after rehabilitation.Results:Health status measured by the CCQ was severely impaired and showed significant and clinically relevant improvement during the post-acute PR programme. Moderate to strong correlations were found between CCQ scores and functional capacity on admission and at discharge. Moderate correlations were found between improvement in CCQ scores and improvement in functional capacity. No correlation was found between CCQ scores and lung function (forced expiratory volume in 1 s % predicted).Conclusions:Health status measured by the CCQ improves following a post-acute PR programme in patients with advanced COPD and correlates with improvement in functional capacity. These results suggest that the CCQ is sensitive to change in response to PR in this specific group of patients.

Questionnaires in Multidimensional Assessment of Chronic Obstructive Pulmonary Disease: Two Sides of the Same Coin

In recent decades, the diagnosis of chronic obstructive ulmonary disease (COPD) has been veering from simple oneimensional schemes to more complex strategies based on ultidimensional approaches or on phenotypes. The latest update f the GOLD1 strategy recommends the use of three questionnaires or the assessment of the patient’s situation: the COPD Assessment est (CAT),2 the modified Medical Research Council (MRC) dyspnea cale,3 and the Clinical COPD Questionnaire (CCQ).4 The inclusion of hese three different questionnaires in the GOLD strategy to assess he impact of the disease in patients has provoked an interesting ebate on the multidimensional assessment of the disease. In order to verify the equivalence of these questionnaires, sevral authors have conducted observational studies, describing a eality that was intuitively perceived by the clinician: the results f these questionnaires, while individually valid in assessing the mpact of the disease, are not superimposable. In this respect, some tudies have highlighted a lack of agreement between CAT and RC,5 while others report the discrepancies between the MRC nd the St. George’s respiratory questionnaire.6 The differences are educed by changing the cutoff for the MRC questionnaire in the OLD classification. Thus, Jones et al.7 suggest that if patients with nd without dyspnea (MRC grade 0) are separated, the distribuion of patients over the various GOLD types is very similar to that btained using CAT with the current cutoff values. The idea behind these studies is that if the classification perentages with both scales in a given patient cohort agree, then they ould all be used interchangeably for categorizing COPD patients. owever, as Jones et al.7 point out, concordance in the distribuion of GOLD types does not necessarily mean that patients who btain the same scores on the different questionnaires using these ew cutoff values will be exactly the same. In this respect, it should

Health-related quality of life in chronic obstructive pulmonary disease patients in Korea.

BackgroundThere are few publications on quality measurement of COPD health state according to the severity level using EQ-5D in Korea. The present study aimed to evaluate the health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD) in terms of disease severity in Korea.MethodsTotally two hundred patients with COPD were consecutively recruited in one tertiary hospital of Korea. Each respondent was asked to fill out the questionnaire through a face-to-face interview after providing informed consent. The questionnaire included general and clinical characteristics as well as the EQ-5D and Clinical COPD Questionnaire (CCQ). HRQoL was evaluated according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and severity of breathlessness.ResultsThe adjusted mean EQ-5D index scores were 0.83, 0.88, 0.81 and 0.60 in stage I, II, III and IV, respectively. The EQ-5D index tended to decrease with GOLD criteria. The adjusted mean EQ-Visual Analog Scale (VAS) scores ranged from 65.1 in stage IV to 73.9 in stage I. The CCQ total scores deteriorated with an increasing GOLD stage and severity of breathlessness (all P < 0.001). The correlation between CCQ total score and EQ-5D index was −0.69.ConclusionsOur study shows that HRQoL in COPD measured by EQ-5D and CCQ worsens with the GOLD stage and severity of breathlessness. EQ-5D and CCQ could be useful instruments for an evaluation of HRQoL in COPD patients in Korea.

Differences in patient outcomes between a 6, 7 and 8 week pulmonary rehabilitation programme: A service evaluation

ObjectiveTo investigate changes and differences in patient outcomes over time for 6, 7 and 8 week pulmonary rehabilitation programmes in order to identify optimal duration. SettingCommunity based pulmonary rehabilitation programmes in the East of England. ParticipantsIn total 363 participants completed one of the three pulmonary rehabilitation programmes. Patients with a chronic respiratory condition showing a commitment to the pulmonary rehabilitation programme and no contraindications to exercise were included. InterventionPulmonary rehabilitation twice a week for 6, 7 or 8 weeks. Main outcome measuresSt Georges Respiratory Questionnaire (SGRQ), Clinical COPD Questionnaire (CCQ), Hospital Anxiety and Depression Scale (HADS) and Incremental Shuttle Walk Test (ISWT). ResultsAll programmes showed improvements in ISWT post rehabilitation, with the 8 week programme showing the greatest improvement. ConclusionFindings show that greatest improvements in terms of exercise capacity may be seen from 8 week pulmonary rehabilitation programmes, but that improvement for the ISWT can be obtained from 6, 7 or 8 week programmes.

Effect of treatment with Roflumilast on quality of life in COPD patients: results from the DINO study (Daxas in COPD therapy)

Improvement of quality of life (QoL) is an important goal of COPD management. This single-arm, non-interventional study investigated the effects of add-on roflumilast (Rof) on QoL in routine medical practice by means of the Clinical COPD Questionnaire (CCQ). Also, data on tolerability of treatment with Rof and patients' mental state were collected.

Health status during hospitalisations for chronic obstructive pulmonary disease exacerbations: the validity of the Clinical COPD Questionnaire

Hospitalisations for chronic obstructive pulmonary disease (COPD) exacerbations are characterised by a significant worsening of the respiratory symptoms which can impair the health status (HS). However little is known on the HS behaviour during such events. Prospective study evaluating the validity of the Clinical COPD Questionnaire (CCQ) as a HS measure in hospitalisations for COPD exacerbations. The CCQ total score (CCQ-T) correlated with EQ-VAS (-0.51, p < 0.0001), was able to discriminate between longer and shorter duration hospitalisation (CCQ-T 3.83 vs 3.03, respectively p = 0.001), had a Cronbach-α of 0.86, and improved significantly over the hospitalisation period (CCQ-T on day 7 of hospitalisation 2.55 vs 3.77 at baseline, p < 0.0001). CCQ is an excellent tool for the assessment of the HS dynamics in hospitalisations for COPD exacerbations.

Methacholine challenge test as indicator for add on inhaled corticosteroids in COPD patients

BackgroundBronchial hyperreactivity (BHR) has been described in COPD. Inhaled corticosteroids (ICS) are used in the treatment of asthma, but the beneficial effects of steroid treatment in COPD are debatable. It has been suggested that inhaled corticosteroids are more likely to have beneficial effects in patients with COPD with more severe bronchial hyperresponsiveness. Aim of the workTo investigate whether airway responsiveness to methacholine predicts response to add-on ICS treatment. Subjects and methodsThe study included 50 COPD patients stage I and stage II according to GOLD classification based on lung function and reversibility test. All cases were subjected to written informed consent, through history talking and clinical examination, chest X-ray, ECG and laboratory tests and methacholine challenge test. Then all patients were assessed by pulmonary function test, Clinical COPD Questionnaire (CCQ) and modified medical research council (MMRC) dyspnea scale. We added budesonide 800mg daily with the previous medication for 6months then patients were reevaluated again by the same tools used in the last visit. ResultsOur study showed that among 50 COPD patients with GOLD I or GOLD II classification 24 (48%) patients were positive for methacholine challenge test. Cases with positive methacholine test showed significant improvement regarding both CCQ and MMRC dyspnea scale with ICS treatment with no significant difference between both groups regarding pulmonary function tests. ConclusionThe present study concluded that the presence of BHR to methacholine identifies patients with mild to moderate COPD who are likely to respond to ICS treatment.

Are GOLD ABCD groups better associated with health status and costs than GOLD 1234 grades? A cross-sectional study

Aims:To investigate the association of the GOLD ABCD groups classification with costs and health-related quality of life (HR-QoL) and to compare this with the GOLD 1234 grades classification that was primarily based on lung function only.Methods:In a cross-sectional study, we selected patients diagnosed with chronic obstructive pulmonary disease (COPD) from electronic medical records of general practices. Multi-level analysis was used with costs (medication, primary care, healthcare, societal), disease-specific and generic HR-QoL as independent variables. Either the new or the old GOLD stages were included in the analysis together with several covariates (age, gender, living situation, co-morbidity, self-efficacy, smoking, education, employment).Results:611 patients from 28 general practices were categorised as GOLD-A (n=333), GOLD-B (n=110), GOLD-C (n=80) and GOLD-D (n=88). Patients in the GOLD-B and GOLD-D groups had the highest prevalence of co-morbidities and the lowest level of physical activity, self-efficacy, and employment. The models with GOLD ABCD groups were more strongly related to and explained more variance in costs and in disease-specific and generic HR-QoL than the models with GOLD 1234 grades. The mean Clinical COPD Questionnaire score worsened significantly, with scores 1.04 (GOLD-B), 0.4 (GOLD-C) and 1.21 (GOLD-D) worse than for patients in GOLD-A. Healthcare costs per patient were significantly higher in GOLD-B (72%), GOLD-C (74%) and GOLD-D (131%) patients than in GOLD-A patients.Conclusions:The GOLD ABCD groups classification is more closely associated with costs and HR-QoL than the GOLD 1234 grades classification. Furthermore, patients with GOLD-C had a better HR-QoL than those with GOLD-B but the costs of the two groups did not differ.

The Clinical Chronic Obstructive Pulmonary Disease Questionnaire: Cut Point for GOLD 2013 Classification

The Clinical Chronic Obstructive Pulmonary Disease Questionnaire: Cut Point for GOLD 2013 Classification

New GOLD classification: longitudinal data on group assignment

RationaleLittle is known about the longitudinal changes associated with using the 2013 update of the multidimensional GOLD strategy for chronic obstructive pulmonary disease (COPD).ObjectiveTo determine the COPD patient distribution of the new GOLD proposal and evaluate how this classification changes over one year compared with the previous GOLD staging based on spirometry only.MethodsWe analyzed data from the CHAIN study, a multicenter observational Spanish cohort of COPD patients who are monitored annually. Categories were defined according to the proposed GOLD: FEV1%, mMRC dyspnea, COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and exacerbations-hospitalizations. One-year follow-up information was available for all variables except CCQ data.ResultsAt baseline, 828 stable COPD patients were evaluated. On the basis of mMRC dyspnea versus CAT, the patients were distributed as follows: 38.2% vs. 27.2% in group A, 17.6% vs. 28.3% in group B, 15.8% vs. 12.9% in group C, and 28.4% vs. 31.6% in group D. Information was available for 526 patients at one year: 64.2% of patients remained in the same group but groups C and D show different degrees of variability. The annual progression by group was mainly associated with one-year changes in CAT scores (RR, 1.138; 95%CI: 1.074-1.206) and BODE index values (RR, 2.012; 95%CI: 1.487-2.722).ConclusionsIn the new GOLD grading classification, the type of tool used to determine the level of symptoms can substantially alter the group assignment. A change in category after one year was associated with longitudinal changes in the CAT and BODE index.

A telerehabilitation intervention for patients with Chronic Obstructive Pulmonary Disease: a randomized controlled pilot trial

Objective: First, to investigate the effects of a telerehabilitation intervention on health status and activity level of patients with Chronic Obstructive Pulmonary Disease (COPD), compared to usual care. Second, to investigate how patients comply with the intervention and whether compliance is related to treatment outcomes. Design: a randomized controlled pilot trial Subjects: Thirty-four patients diagnosed with COPD. Intervention: The telerehabilitation application consists of an activity coach (3D-accelerometer with smartphone) for ambulant activity registration and real-time feedback, complemented by a web portal with a symptom diary for self-treatment of exacerbations. The intervention group used the application for 4 weeks. The control group received usual care. Main measures: Activity level measured by a pedometer (in steps/day), health status by the Clinical COPD Questionnaire at baseline and after intervention. Compliance was expressed as the time the activity coach was worn. Results: Fourteen intervention and 16 control patients completed the study. Activity level (steps/day) was not significantly affected by the intervention over time. There was a non-significant difference in improvement in health status between the intervention (−0.34±0.55) and control group (0.02±0.57, p=0.10). Health status significantly improved within the intervention group (p=0.05). The activity coach was used more than prescribed (108%) and compliance was related to the increase in activity level for the first two feedback weeks (r=0.62, p=0.03). Conclusions: This pilot study shows the potential of the telerehabilitation intervention: compliance with the activity coach was high, which directly related to an improvement in activity levels.

P34 The minimal clinically important difference of the COPD assessment test

BackgroundThe COPD (chronic obstructive pulmonary disease) assessment test (CAT) is a simple 8-item, health status instrument (Jones PW et al 2009). It has good psychometric properties and has been shown...

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...

Effects of long-acting bronchodilators and prednisolone on inspiratory lung function parameters in stable COPD

BackgroundIn chronic obstructive pulmonary disease (COPD), there is a poor correlation between forced expiratory volume in 1 s (FEV1) and dyspnea following bronchodilator use. Better correlations have been observed between inspiratory lung function parameters (ILPs) and dyspnea, which drives our interest in ILPs. However, the acute and prolonged effects of long-acting bronchodilators and oral corticosteroids on ILPs have not been well investigated. Therefore, the aim of this study was to investigate the effects of these treatments on the ILPs, FEV1, dyspnea (visual analog scale (VAS)) and clinical COPD questionnaire (CCQ). MethodsTwenty-eight stable COPD patients had their ILPs and FEV1 measured both before and 2 h after the use of a single dose of 18 mcg bronchodilator tiotropium and 50 mcg salmeterol. Thereafter, the patients were randomized to 2 weeks of treatment with 30 mg oral prednisolone once daily or oral placebo in combination with daily treatment with these two bronchodilators. Four weeks after the cessation of the randomized treatment, the ILPs and FEV1 were again measured. After each intervention, any change in the VAS score was assessed. ResultsWith both bronchodilators, significant improvements in ILPs were demonstrated (p < 0.005), with the exception of changes in ILPs inspiratory capacity (IC) and forced inspiratory flow at 50% of the vital capacity (FIF50) after tiotropium inhalation. After 2 weeks of treatment with prednisolone, significant differences were found for ILP forced inspiratory volume in 1 s (FIV1) and FEV1 compared with placebo. These differences were no longer present 4 weeks after the cessation of prednisolone. Significant relationships between ILPs and VAS scores were only found after 2 weeks of treatment with prednisolone or placebo. ConclusionsAfter a single dose of long-acting bronchodilator salmeterol, significant improvements are observed in all ILPs and in FIV1 and PIF after tiotropium. Two weeks of oral corticosteroid treatment improved the FIV1 and FEV1. The dyspnea VAS score was only significantly correlated with the ILPs after 2 weeks of oral corticosteroid treatment.

The Severe Respiratory Insufficiency Questionnaire scored best in the assessment of health-related quality of life in chronic obstructive pulmonary disease

ObjectiveThere are limited data on health-related quality of life (HRQL) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure during an admission requiring ventilatory support. The aim was to assess and compare the reliability and validity of the Clinical COPD Questionnaire (CCQ), Chronic Respiratory Questionnaire (CRQ), Maugeri Respiratory Failure-28 (MRF-28) Questionnaire, and Severe Respiratory Insufficiency (SRI) Questionnaire in patients with very severe COPD. Study Design and SettingOne hundred eighty hospitalized patients filled out the CCQ, CRQ, MRF-28, SRI, Groningen Activity Restriction Scale (GARS), Hospital Anxiety and Depression Scale (HADS), and the Medical Research Council Dyspnea Scale (MRC). Reliability was examined by assessing distribution of total scores, floor and ceiling effects, and internal consistency (using Cronbach α coefficient). Construct validity between questionnaires and also the other measurements were tested with Spearman ρ. ResultsAll four questionnaires were feasible in this setting and had reasonable characteristics for distribution of total scores, floor and ceiling effects, internal consistency, and construct validity. On balance, the SRI scored best. Additionally, the SRI had a remarkable high explained variance by HADS, GARS, and MRC (73%). ConclusionThe SRI performed slightly better than the CCQ, CRQ, and MRF-28, which renders it the preferred questionnaire for scoring HRQL in patients with very severe COPD.

Putting health status guided COPD management to the test: protocol of the MARCH study.

BackgroundChronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible and usually progressive. Current guidelines, among which the Dutch, have so far based their management strategy mainly on lung function impairment as measured by FEV1, while it is well known that FEV1 has a poor correlation with almost all features of COPD that matter to patients. Based on this discrepancy the GOLD 2011 update included symptoms and impact in their treatment algorithm proposal. Health status measures capture both symptoms and impact and could therefore be used as a standardized way to capture the information a doctor could otherwise only collect by careful history taking and recording. We hypothesize that a treatment algorithm that is based on a simple validated 10 item health status questionnaire, the Clinical COPD Questionnaire (CCQ), improves health status (as measured by SGRQ) and classical COPD outcomes like exacerbation frequency, patient satisfaction and health care utilization compared to usual care based on guidelines.Methods/DesignThis hypothesis will be tested in a randomized controlled trial (RCT) following 330 patients for two years. During this period general practitioners will receive treatment advices every four months that are based on the patient’s health status (in half of the patients, intervention group) or on lung function (the remaining half of the patients, usual care group).DiscussionDuring the design process, the selection of outcomes and the development of the treatment algorithm were challenging. This is discussed in detail in the manuscript to facilitate researchers in designing future studies in this changing field of implementation research.Trial registrationNetherlands Trial Register, NTR2643

Efficacy and safety of AZD1981, a CRTH2 receptor antagonist, in patients with moderate to severe COPD

To evaluate the efficacy and tolerability of the selective CRTh2 (DP2) receptor antagonist AZD1981 compared with placebo in patients with moderate to severe COPD. In this multicentre, randomised, double-blind, parallel-group, phase IIa study (ClinicalTrials.gov identifier: NCT00690482) patients with moderate to severe COPD received either AZD1981 1000mg twice daily or matching placebo for 4 weeks. Inhaled terbutaline was used as-needed as reliever medication throughout. The co-primary endpoints were change from baseline to end of treatment in pre-bronchodilator forced expiratory volume in 1s[FEV1] and the Clinical COPD Questionnaire (CCQ). Additional endpoints included other lung function measures, 6-minwalk test (6-MWT), COPD symptom score, reliever medication use and tolerability. 118 patients were randomised to treatment (AZD1981 n=61; placebo n=57); 83% of patients were male and the mean age was 63 years (range 43-83). There were no significant differences in the mean difference in change from baseline to end of treatment between AZD1981 and placebo for the co-primary endpoints of pre-bronchodilator FEV1 (AZD1981-placebo: -0.015, 95% CI: -0.10 to 0.070; p=0.72) and CCQ total score (difference: 0.042, 95% CI: -0.21 to 0.30; p=0.75). Similarly, no differences were observed between treatments for the other outcomes of lung function, COPD symptom score, 6-MWT, BODE index, and use of reliever medication. AZD1981 was well tolerated. There was no beneficial clinical effect of AZD1981, at a dose of 1000mg twice daily for 4 weeks, in patients with moderate to severe COPD. AZD1981 was well tolerated and no safety concerns were identified.

Using the DOSE index to predict changes in health status of patients with COPD: a prospective cohort study

Background:The severity of chronic obstructive pulmonary disease (COPD) should not be based on the level of airflow limitation alone. A multicomponent index such as the DOSE index (dyspnoea score (D), level of airflow obstruction (O), current smoking status (S), and exacerbations (E)) has the potential to predict important future outcomes in patients with COPD more effectively than the forced expiratory volume in one second. Health status deterioration should be prevented in COPD patients.Aims:To investigate whether the DOSE index can predict which patients are at risk of a clinically relevant change in health status.Methods:A prospective cohort study was performed using data from primary and secondary care. The DOSE score was determined at baseline and the 2-year change in the Clinical COPD Questionnaire (CCQ) score was calculated. Linear regression analysis was performed for the effect of a high DOSE score (≥4) on the change in CCQ score.Results:The study population consisted of 209 patients (112 patients from primary care). Overall, a high DOSE score was a significant predictor of a change in CCQ score after 2 years (0.41, 95% CI 0.13 to 0.70), particularly in primary care patients.Conclusions:A DOSE score of ≥4 has the ability to identify COPD patients with a greater risk of future worsening in health status.

Chronic Obstructive Pulmonary Disease (COPD) Patients’ Disease-Related Preferences

In the management of chronic obstructive pulmonary disease (COPD), knowledge of disease attributes and preferences that are important to patients is crucial. This knowledge may support drug development and optimization of COPD management strategies. To assess patient preferences in COPD and to use the conjoint methodology in order to propose a self-assessment tool based on patients' preferences gained from this conjoint analysis. This tool might then be used in future observational study settings. A two-step procedure was applied: an initial qualitative research module consisting of interviews with eight COPD patients served to assess COPD patients' health state in-depth, their attitudes towards COPD and their information sources regarding the disease, symptomatology, unmet needs, and their preferences for future COPD medications. In the main quantitative research part of the study, 300 patients (with an average age of 55years) from across Germany suffering from COPD (n=225 with stage II and n=75 with stage III COPD) participated. Each participant was presented with 15 different scenarios during the conjoint exercise. Additionally, the Clinical COPD Questionnaire (CCQ) had to be completed and attitudes towards COPD were assessed. According to the participants, the three COPD attributes of the highest relative importance were dyspnea, performance capability, and sleep quality. Frequency of administration of the medication, onset of medication, and emotional state due to COPD base medication played only a minor role. COPD symptoms were reported to have the highest impact on quality of life, according to the CCQ. Our study proposes an alternative utility-based approach of a self-reported health state concept, utilizing the fact that patients with moderate to severe COPD would trade, e.g., ease of administration and onset of medication for relief from dyspnea.