31 results on '"CLINICAL COPD QUESTIONNAIRE"'
Search Results
2. The Effectiveness and Tolerability of Glycopyrronium for Patients with Chronic Obstructive Pulmonary Disease in a Clinical Setting: GLARE-Taiwan.
- Author
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Huang, Wei-Chang, Lin, Sheng-Hao, Hang, Liang-Wen, Lin, Ching-Hsiung, and Hsu, Jeng-Yuan
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CHRONIC obstructive pulmonary disease , *CEREBRAL infarction - Abstract
Glycopyrronium (GLY) is a pharmacological maintenance treatment for chronic obstructive pulmonary disease (COPD). However, its effectiveness and tolerability for COPD patients in routine clinical practice have not been well-investigated. This study aimed to assess the effectiveness of GLY on health-related quality of life and its safety in patients with COPD in a routine clinical care setting. This multi-center, prospective, six-month observational study recruited patients diagnosed with COPD and treated with GLY at three medical centers in central Taiwan. The full analysis set (n = 102) had a significant improvement in the Clinical COPD Questionnaire total (mean ± SD = −0.39 ± 0.90, p = 0.002), symptoms (mean ± SD = −0.61 ± 0.90, p < 0.001) and mental state scores (mean ± SD = −0.54 ± 1.72, p = 0.021) but not the functional state score (mean ± SD = −0.10 ± 1.15, p = 0.529). During the observational period, 58 patients (52.73%) experienced adverse events; only one adverse event (dizziness) was suspected to be related to the study drug. Three patients (2.73%) discontinued the study and GLY treatment because of an adverse event. One patient (0.91%) died during the study period because of a cerebral infarction, which was judged to be not associated with GLY treatment. In conclusion, GLY could be effective in improving the health status and is safe for patients with COPD in a real-life setting. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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- View/download PDF
3. Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study
- Author
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Valipour A, Avdeev S, Barczyk A, Bayer V, Fridlender Z, Georgieva M, Kudela O, Medvedchikov A, Miron R, Sanzharovskaya M, Šileikienė V, Šorli J, Spielmanns M, and Szalai Z
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tiotropium ,olodaterol ,copd ,ccq ,clinical copd questionnaire ,non-interventional study ,Diseases of the respiratory system ,RC705-779 - Abstract
Arschang Valipour,1 Sergey Avdeev,2 Adam Barczyk,3 Valentina Bayer,4 Zvi Fridlender,5 Mariela Georgieva,6 Ondřej Kudela,7 Alexey Medvedchikov,8 Ramona Miron,9 Maria Sanzharovskaya,8 Virginija Šileikienė,10 Jurij Šorli,11 Marc Spielmanns,12 Zsuzsanna Szalai13 1Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Vienna Health Care Group, Klinik Floridsdorf, Vienna, Austria; 2I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; 3Wydział Nauk Medycznych Śląskiego Uniwersytetu Medycznego, Katowice, Poland; 4Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 5Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 6Medical Center “Sv.ivan Rilski” OOD, Vidin, Bulgaria; 7Department of Pneumology, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Charles University in Prague, Hradec Kralove, Czech Republic; 8Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria; 9Clinical Pneumophtysiology Hospital Iasi, Iasi, Romania; 10Faculty of Medicine, Clinic of Chest Diseases, Immunology and Allergology, Institute of Clinical Medicine, Vilnius University, Vilnius, Lithuania; 11Bolnišnica Topolšica, Topolšica, Slovenia; 12Zürcher RehaZentrum Wald, Wald, Switzerland; 13Petz Aladar County Teaching Hospital, Gyor, HungaryCorrespondence: Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Vienna Health Care Group, Klinik Floridsdorf, Brünner Straße 68, 1210 Vienna, AustriaTel +43 1 277 00-72201Fax +43 1 277 00 99 2208Email arschang.valipour@gesundheitsverbund.atBackground: The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD).Objective: This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice.Methods: Data were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks.Results: Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks’ treatment, 81.4% (95% confidence interval [95% CI] 80.24– 82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00– 1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43– 92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) and 74.2% of those pretreated with LABA or long-acting muscarinic antagonist (LAMA) monotherapy. Overall, rescue medication decreased by 1.25 puffs/day (95% CI 1.19– 1.31) versus baseline. In total, 29 patients (0.6%) reported drug-related adverse events and 7 patients reported serious adverse events (0.15%).Conclusion: In 4700 COPD patients, 6 weeks’ treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol.Keywords: tiotropium, olodaterol, COPD, CCQ, Clinical COPD Questionnaire, non-interventional study
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- 2021
4. Correlation of CAT, CCQ and mMRC Scores in Patients of COPD with Exacerbation and after Treatment
- Author
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Mradul Kumar Daga, Govind Mawari, Shashank Singh, Shrusthi Walad, Suraj Khubiyal, Deepu Bharali, Naresh Kumar, and HS Hira
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copd assessment test ,clinical copd questionnaire ,forced expiratory volume ,global initiative for chronic obstructive lung disease ,modified medical research council scale ,st. george’s respiratory questionnaire ,Medicine - Abstract
Introduction: Chronic Obstructive Pulmonary Disease (COPD), a globally prevalent disease holds a huge stake among all pulmonary patients being admitted throughout the year. Various disease specific and health related quality of life questionnaires such as the Constructed Response Question (CRQ) and St. George’s Respiratory Questionnaire (SGRQ) are readily available, although, attributing to their complex structure, they can’t be used in a widespread manner. Some new scores like COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) were developed to ease-off this dilemma. However, there is a need to justify usage of these patient-friendly simplified scores by objectifying their inter-score reliability and correlation with disease severity and progression using statistical analysis. Aim: To analyse efficacious use of CAT, CCQ score and modified Medical Research Council (mMRC) scale in assessing health status of COPD with exacerbation. Additionally, it was also targeted to assess the inter-score correlation and reliability. Materials and Methods: A total of 180 confirmed cases of COPD with exacerbation were included in this study and subjected to requisite biochemical parameters, assessment scores at their admission, after 1 week and then after 4-6 week (at stabilisation) and spirometry. 136 patients were followed-up to 4-6 weeks and studied. Quantitative and qualitative variables thus obtained were compared statistically to find out correlation, if any. A p-value of
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- 2020
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5. Correlation of CAT, CCQ and mMRC Scores in Patients of COPD with Exacerbation and after Treatment.
- Author
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DAGA, MRADUL KUMAR, MAWARI, GOVIND, SINGH, SHASHANK, WALAD, SHRUSTHI, KHUBIYAL, SURAJ, BHARALI, DEEPU, KUMAR, NARESH, and HIRA, H. S.
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OBSTRUCTIVE lung diseases ,DISEASE exacerbation - Abstract
Introduction: Chronic Obstructive Pulmonary Disease (COPD), a globally prevalent disease holds a huge stake among all pulmonary patients being admitted throughout the year. Various disease specific and health related quality of life questionnaires such as the Constructed Response Question (CRQ) and St. George’s Respiratory Questionnaire (SGRQ) are readily available, although, attributing to their complex structure, they can’t be used in a widespread manner. Some new scores like COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) were developed to ease-off this dilemma. However, there is a need to justify usage of these patient-friendly simplified scores by objectifying their inter-score reliability and correlation with disease severity and progression using statistical analysis. Aim: To analyse efficacious use of CAT, CCQ score and modified Medical Research Council (mMRC) scale in assessing health status of COPD with exacerbation. Additionally, it was also targeted to assess the inter-score correlation and reliability. Materials and Methods: A total of 180 confirmed cases of COPD with exacerbation were included in this study and subjected to requisite biochemical parameters, assessment scores at their admission, after 1 week and then after 4-6 week (at stabilisation) and spirometry. 136 patients were followed-up to 4-6 weeks and studied. Quantitative and qualitative variables thus obtained were compared statistically to find out correlation, if any. A p-value of <0.05 was considered significant. Results: Mean difference between CAT score at exacerbation and at 1 week and CAT score at exacerbation and at 4-6 weeks were statistically significant. The changes in CCQ scores from exacerbation to 1 week and 6 weeks were also found to be statistically significant. Similar pattern was also observed in assessing timescale variability of mMRC score. There was good correlation between CAT, CCQ and mMRC scores at exacerbation, 1 week and it continually intensified as patients progressed towards a more stable state (4-6 weeks). Similar pattern was also observed with significant progressive positive correlation between change in CAT, CCQ and mMRC scores from exacerbation to 1 week and from exacerbation to 4-6 weeks. Conclusion: These score have a high correlative reliability when used to assess health status among various stages of disease from exacerbation towards a stable state. Similarly, correlation between change of individual score from exacerbation towards recovery state was also high. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
6. Occurrence of Anxiety and Depression among Stable COPD Patients and its Impact on Functional Capability
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Debabani Biswas, Subhasis Mukherjee, Rajarshi Chakroborty, Somsubhra Chatterjee, Subrata Rath, Runa Das, and Shabana Begum
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clinical copd questionnaire ,hamilton depression rating scale ,six-minute walk test ,state trait anxiety inventory ,Medicine - Abstract
Introduction: Anxiety and depression are important but often under-diagnosed co-morbid conditions in patients with Chronic Obstructive Pulmonary Disease (COPD) which may affect the functional capacity of the patients. Aim: To find out the proportion of depression and anxiety among stable COPD patients using a validated questionnaire suitable for use in clinic and the factors affecting their reduced functional capability as assessed by six-minute walk test. Materials and Methods: This was a descriptive cross-sectional study. Seventy five patients diagnosed with stable COPD in outpatient Department of Pulmonary Medicine in a tertiary care hospital, satisfying all inclusion criteria, were included in the study. They were examined clinically, categorized as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity assessment guideline and interviewed by designated interviewer using validated questionnaire for depression (Hamilton depression rating scale, HAM-D) and anxiety (State Trait Anxiety Inventory, STAI). The functional exercise capacity of the patient was assessed by six-minute walk test. Statistical analysis was performed using Minitab software (version16.1). Results: Among 75 stable COPD patients (68 male, 7 female), majority (32 out of 75) had both depression and anxiety, while only anxiety or depression was present in 9 each. The patients with depression had no significant difference in six-minute walk distance, change in heart rate and respiratory rate (p = 0.4186, 0.219 and 0.41 respectively) as compared to those without depression, but were found to be more dyspnoeic at the end of the test (p= 0.003). There was also no significant difference in walk distance in patients with high STAI score as compared to those with low STAI score (p= 0.276). Conclusion: Both anxiety and depression were present in majority of the stable COPD patients. The presence of these co-morbid conditions had no significant effect on the functional status of the patients in the form of reduced six-minute walk distance, though they were more symptomatic than those without these co-morbidities.
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- 2017
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7. Cross-Cultural Adaptation, Reliability and Validity Study of the Persian Version of the Clinical COPD Questionnaire
- Author
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Neda Hasanpour, Behrouz Attarbashi Moghadam, Ramin Sami, and Kamran Tavakol
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Chronic obstructive pulmonary disease ,Health-related quality of life ,Clinical COPD questionnaire ,Reliability ,Validity ,Medicine (General) ,R5-920 - Abstract
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.
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- 2016
8. Occurrence of Anxiety and Depression among Stable COPD Patients and its Impact on Functional Capability.
- Author
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BISWAS, DEBABANI, MUKHERJEE, SUBHASIS, CHAKROBORTY, RAJARSHI, CHATTERJEE, SOMSUBHRA, RATH, SUBRATA, DAS, RUNA, and BEGUM, SHABANA
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OBSTRUCTIVE lung diseases ,ANXIETY risk factors ,MENTAL depression risk factors - Abstract
Introduction: Anxiety and depression are important but often under-diagnosed co-morbid conditions in patients with Chronic Obstructive Pulmonary Disease (COPD) which may affect the functional capacity of the patients. Aim: To find out the proportion of depression and anxiety among stable COPD patients using a validated questionnaire suitable for use in clinic and the factors affecting their reduced functional capability as assessed by six-minute walk test. Materials and Methods: This was a descriptive cross-sectional study. Seventy five patients diagnosed with stable COPD in outpatient Department of Pulmonary Medicine in a tertiary care hospital, satisfying all inclusion criteria, were included in the study. They were examined clinically, categorized as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity assessment guideline and interviewed by designated interviewer using validated questionnaire for depression (Hamilton depression rating scale, HAM-D) and anxiety (State Trait Anxiety Inventory, STAI). The functional exercise capacity of the patient was assessed by six-minute walk test. Statistical analysis was performed using Minitab software (version16.1). Results: Among 75 stable COPD patients (68 male, 7 female), majority (32 out of 75) had both depression and anxiety, while only anxiety or depression was present in 9 each. The patients with depression had no significant difference in six-minute walk distance, change in heart rate and respiratory rate (p = 0.4186, 0.219 and 0.41 respectively) as compared to those without depression, but were found to be more dyspnoeic at the end of the test (p= 0.003). There was also no significant difference in walk distance in patients with high STAI score as compared to those with low STAI score (p= 0.276). Conclusion: Both anxiety and depression were present in majority of the stable COPD patients. The presence of these co-morbid conditions had no significant effect on the functional status of the patients in the form of reduced six-minute walk distance, though they were more symptomatic than those without these co-morbidities. [ABSTRACT FROM AUTHOR]
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- 2017
- Full Text
- View/download PDF
9. Cross-Cultural Adaptation, Reliability and Validity Study of the Persian Version of the Clinical COPD Questionnaire.
- Author
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Hasanpour, Neda, Moghadam, Behrouz Attarbashi, Sami, Ramin, and Tavakol, Kamran
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OBSTRUCTIVE lung diseases , *PERSIAN language , *CROSS-cultural studies , *QUESTIONNAIRES , *INTRACLASS correlation , *CRONBACH'S alpha - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2016
10. Targeting exertional breathlessness to improve physical activity
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IMPACT ,TIOTROPIUM PLUS OLODATEROL ,MORTALITY ,MANAGEMENT ,CLINICAL COPD QUESTIONNAIRE ,FIXED-DOSE COMBINATION ,OBSTRUCTIVE PULMONARY-DISEASE ,EXERCISE CAPACITY ,SCALE ,TIOTROPIUM/OLODATEROL - Abstract
Primary care physicians (PCPs) play a crucial role in the diagnosis and management of chronic obstructive pulmonary disease (COPD). By working together with patients to target exertional breathlessness and increase physical activity, PCPs have an important role to play, early in the disease course, in improving patient outcomes in both the short and long term. In this article, we consider how physical activity affects disease progression from the PCP perspective. We discuss the role of pharmacological therapy, the importance of an holistic approach and the role of PCPs in assessing and promoting physical activity. The complexity and heterogeneity of COPD make it a challenging disease to treat. Patients' avoidance of activity, and subsequent decline in capacity to perform it, further impacts the management of the disease. Improving patient tolerance of physical activity, increasing participation in daily activities and helping patients to remain active are clear goals of COPD management. These may require an holistic approach to management, including pulmonary rehabilitation and psychological programmes in parallel with bronchodilation therapy, in order to address both physiological and behavioural factors. PCPs have an important role to optimise therapy, set goals and communicate the importance of maintaining physical activity to their patients. In addition, optimal treatment that addresses activity-related breathlessness can help prevent the downward spiral of inactivity and get patients moving again, to improve their overall health and long-term prognosis.
- Published
- 2021
11. Targeting exertional breathlessness to improve physical activity
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Janwillem W. H. Kocks and Miguel Román-Rodríguez
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Activities of daily living ,IMPACT ,medicine.medical_treatment ,Disease ,OBSTRUCTIVE PULMONARY-DISEASE ,Physicians, Primary Care ,EXERCISE CAPACITY ,Pulmonary Disease, Chronic Obstructive ,Diseases of the respiratory system ,Quality of life (healthcare) ,medicine ,MANAGEMENT ,Humans ,Pulmonary rehabilitation ,Set (psychology) ,Intensive care medicine ,Exercise ,SCALE ,COPD ,Rehabilitation ,Primary Health Care ,RC705-779 ,business.industry ,MORTALITY ,Public Health, Environmental and Occupational Health ,medicine.disease ,TIOTROPIUM/OLODATEROL ,Dyspnea ,TIOTROPIUM PLUS OLODATEROL ,CLINICAL COPD QUESTIONNAIRE ,FIXED-DOSE COMBINATION ,business ,Patient education - Abstract
Primary care physicians (PCPs) play a crucial role in the diagnosis and management of chronic obstructive pulmonary disease (COPD). By working together with patients to target exertional breathlessness and increase physical activity, PCPs have an important role to play, early in the disease course, in improving patient outcomes in both the short and long term. In this article, we consider how physical activity affects disease progression from the PCP perspective. We discuss the role of pharmacological therapy, the importance of an holistic approach and the role of PCPs in assessing and promoting physical activity. The complexity and heterogeneity of COPD make it a challenging disease to treat. Patients’ avoidance of activity, and subsequent decline in capacity to perform it, further impacts the management of the disease. Improving patient tolerance of physical activity, increasing participation in daily activities and helping patients to remain active are clear goals of COPD management. These may require an holistic approach to management, including pulmonary rehabilitation and psychological programmes in parallel with bronchodilation therapy, in order to address both physiological and behavioural factors. PCPs have an important role to optimise therapy, set goals and communicate the importance of maintaining physical activity to their patients. In addition, optimal treatment that addresses activity-related breathlessness can help prevent the downward spiral of inactivity and get patients moving again, to improve their overall health and long-term prognosis.
- Published
- 2021
- Full Text
- View/download PDF
12. Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study
- Author
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Marc Spielmanns, Maria Sanzharovskaya, Ramona Miron, Mariela Georgieva, Jurij Sorli, Valentina Bayer, Adam Barczyk, Ondřej Kudela, Zvi G Fridlender, Zsuzsanna Szalai, Alexey Medvedchikov, Virginija Šileikienė, Arschang Valipour, and Sergey Avdeev
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medicine.medical_specialty ,International Journal of Chronic Obstructive Pulmonary Disease ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,tiotropium ,Internal medicine ,medicine ,Clinical endpoint ,COPD ,030212 general & internal medicine ,Medical prescription ,Adverse effect ,biology ,business.industry ,olodaterol ,Olodaterol ,General Medicine ,Lama ,biology.organism_classification ,medicine.disease ,CCQ ,Confidence interval ,Obstructive lung disease ,Clinical COPD Questionnaire ,non interventional study ,030228 respiratory system ,chemistry ,Clinical Trial Report ,business ,non-interventional study - Abstract
Arschang Valipour,1 Sergey Avdeev,2 Adam Barczyk,3 Valentina Bayer,4 Zvi Fridlender,5 Mariela Georgieva,6 OndÅej Kudela,7 Alexey Medvedchikov,8 Ramona Miron,9 Maria Sanzharovskaya,8 Virginija ŠileikienÄ,10 Jurij Šorli,11 Marc Spielmanns,12 Zsuzsanna Szalai13 1Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Vienna Health Care Group, Klinik Floridsdorf, Vienna, Austria; 2I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; 3WydziaÅ Nauk Medycznych ÅlÄ skiego Uniwersytetu Medycznego, Katowice, Poland; 4Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 5Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 6Medical Center “Sv.ivan Rilski” OOD, Vidin, Bulgaria; 7Department of Pneumology, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Charles University in Prague, Hradec Kralove, Czech Republic; 8Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria; 9Clinical Pneumophtysiology Hospital Iasi, Iasi, Romania; 10Faculty of Medicine, Clinic of Chest Diseases, Immunology and Allergology, Institute of Clinical Medicine, Vilnius University, Vilnius, Lithuania; 11Bolnišnica Topolšica, Topolšica, Slovenia; 12Zürcher RehaZentrum Wald, Wald, Switzerland; 13Petz Aladar County Teaching Hospital, Gyor, HungaryCorrespondence: Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Vienna Health Care Group, Klinik Floridsdorf, Brünner Straße 68, 1210 Vienna, AustriaTel +43 1 277 00-72201Fax +43 1 277 00 99 2208Email arschang.valipour@gesundheitsverbund.atBackground: The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD).Objective: This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice.Methods: Data were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks.Results: Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks’ treatment, 81.4% (95% confidence interval [95% CI] 80.24– 82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00– 1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43– 92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) and 74.2% of those pretreated with LABA or long-acting muscarinic antagonist (LAMA) monotherapy. Overall, rescue medication decreased by 1.25 puffs/day (95% CI 1.19– 1.31) versus baseline. In total, 29 patients (0.6%) reported drug-related adverse events and 7 patients reported serious adverse events (0.15%).Conclusion: In 4700 COPD patients, 6 weeks’ treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol.Keywords: tiotropium, olodaterol, COPD, CCQ, Clinical COPD Questionnaire, non-interventional study
- Published
- 2021
13. Health status deterioration in subjects with mild to moderate airflow obstruction, a six years observational study
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Thierry Troosters, Miek Hornikx, Heleen Demeyer, Wim Janssens, Fernanda M.M. Rodrigues, Hans Van Remoortel, and Matthias Loeckx
- Subjects
Male ,Aging ,Time Factors ,Exacerbation ,IMPACT ,Health Status ,Physical fitness ,Disease ,Pulmonary Disease, Chronic Obstructive ,Quality of life ,QUALITY-OF-LIFE ,Medicine and Health Sciences ,PULMONARY-DISEASE ,Prospective Studies ,Depression (differential diagnoses) ,COPD ,LIMITATION ,Chronic obstructive pulmonary disease ,Longitudinal studies ,Middle Aged ,Cohort ,Female ,REHABILITATION ,medicine.medical_specialty ,HOSPITAL ANXIETY ,Chronic obstructive pulmonary ,VALIDATION ,Health status ,Internal medicine ,medicine ,Humans ,Airflow obstruction ,Exercise ,Aged ,lcsh:RC705-779 ,disease ,business.industry ,Research ,lcsh:Diseases of the respiratory system ,medicine.disease ,Health Surveys ,EXACERBATIONS ,Physical Fitness ,Case-Control Studies ,RISK-FACTORS ,Quality of Life ,Observational study ,CLINICAL COPD QUESTIONNAIRE ,business ,Follow-Up Studies - Abstract
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
- Published
- 2019
14. Baseline health status and setting impacted minimal clinically important differences in COPD: an exploratory study
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Danijel Jelusic, Michael Schuler, Harma Alma, Corina de Jong, Thys van der Molen, Boudewijn J. Kollen, Michael Wittmann, Robbert Sanderman, Janwillem W. H. Kocks, Konrad Schultz, Life Course Epidemiology (LCE), Clinical Psychology and Experimental Psychopathology, Health Psychology Research (HPR), Groningen Research Institute for Asthma and COPD (GRIAC), and Psychology, Health & Technology
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Receiver Operating Characteristics ,Male ,3 weeks follow-up ,Epidemiology ,muscle ,medicine.medical_treatment ,retrospective study ,UT-Hybrid-D ,COPD Assessment Test (CAT) ,Minimal Clinically Important Difference ,3 months follow-up ,MCID ,PR ,medical research ,0302 clinical medicine ,Germany ,ROC ,12 months follow-up ,False Discovery Rate ,COPD ,IMT ,Minimal clinically important difference ,CAT ,GRC ,forced expiratory volume ,Obstructive lung disease ,clinical practice ,Spirometry ,medicine.medical_specialty ,modified Medical Research Council dyspnea scale ,Proportion of the variance of the dependent factor explained by independent factors ,QoL ,university hospital ,9 months follow-up ,Global initiative for Obstructive Lung Disease ,03 medical and health sciences ,Inter-Quartile Range ,Humans ,Pulmonary rehabilitation ,GOLD ,human ,SD ,Aged ,Retrospective Studies ,SGRQ ,Clinical COPD Questionnaire (CCQ) ,dyspnea ,medicine.disease ,CCQ ,major clinical study ,University Medical Center Groningen ,Clinical trial ,quality of life ,Standard Deviation ,Confidence Interval ,COPD Assessment Test ,Inspiratory Muscle Training ,030217 neurology & neurosurgery ,Health Status ,Global Rating of Change scale ,Forced Expiratory Volume in one second % Predicted ,St. George Respiratory Questionnaire ,Pulmonary Disease, Chronic Obstructive ,Quality of life ,gender ,Pulmonary Rehabilitation ,030212 general & internal medicine ,RIMTCORE ,FEV1%Pred ,6 months follow-up ,Netherlands ,Randomized Controlled Trials as Topic ,T0 ,R(2) ,receiver operating characteristic ,T2 ,medicine.diagnostic_test ,T1 ,Half Standard Deviation: AUC ,IQR ,article ,CI ,Minimal Clinically Important Difference (MCID) ,Middle Aged ,T4 ,T3 ,humanities ,T5 ,Area Under the Curve ,comorbidity ,Observational Studies as Topic ,RCP ,Treatment Outcome ,0.5SD ,St. George’s Respiratory Questionnaire (SGRQ) ,Female ,mMRC ,Chronic Obstructive Pulmonary Disease ,St. George's Respiratory Questionnaire (SGRQ) ,FDR ,Baseline ,medicine ,follow up ,controlled study ,deterioration ,correlation coefficient ,Number of Patients ,Intraclass Correlation Coefficient ,business.industry ,ICC ,Routine Clinical Practice ,questionnaire ,Comorbidity ,Clinical COPD Questionnaire ,Physical therapy ,Routine Inspiratory Muscle Training within COPD Rehabilitation ,business ,UMCG ,chronic obstructive lung disease ,Chronic Obstructive Pulmonary Disease (COPD) - Abstract
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.
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- 2018
15. Influence of comorbid heart disease on dyspnea and health status in patients with COPD – a cohort study
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Scott Montgomery, Josefin Sundh, Karin Lisspers, Maaike Giezeman, Björn Ställberg, Christer Janson, and Mikael Hasselgren
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Male ,Time Factors ,Heart disease ,Respiratory Medicine and Allergy ,Health Status ,heart failure ,Comorbidity ,Logistic regression ,Pulmonary Disease, Chronic Obstructive ,0302 clinical medicine ,Risk Factors ,Surveys and Questionnaires ,030212 general & internal medicine ,Longitudinal Studies ,Prospective Studies ,Prospective cohort study ,Lung ,Lungmedicin och allergi ,Original Research ,COPD ,Confounding ,CAT ,General Medicine ,Middle Aged ,Prognosis ,Disease Progression ,Population study ,Female ,mMRC ,Cohort study ,Adult ,medicine.medical_specialty ,Heart Diseases ,International Journal of Chronic Obstructive Pulmonary Disease ,Risk Assessment ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Aged ,Sweden ,business.industry ,medicine.disease ,CCQ ,ischemic heart disease ,Clinical COPD Questionnaire ,Dyspnea ,030228 respiratory system ,Heart failure ,modified Medical Research Council dyspnea score ,business ,COPD Assessment Test - Abstract
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
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- 2018
16. Health status in patients with COPD treated with roflumilast: two large noninterventional real-life studies: DINO and DACOTA
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Claus Vogelmeier, Rüdiger Sauer, Peter Kardos, Ingo Mokros, and Russell, Richard
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Cyclopropanes ,Male ,Time Factors ,Health Status ,Aminopyridines ,Severity of Illness Index ,Pulmonary Disease, Chronic Obstructive ,0302 clinical medicine ,Quality of life ,Forced Expiratory Volume ,Germany ,Surveys and Questionnaires ,Prospective Studies ,030212 general & internal medicine ,Lung ,Original Research ,Aged, 80 and over ,COPD ,General Medicine ,Middle Aged ,clinical COPD questionnaire ,Bronchodilator Agents ,Treatment Outcome ,Benzamides ,Drug Therapy, Combination ,Female ,medicine.symptom ,medicine.drug ,medicine.medical_specialty ,Nausea ,roflumilast ,International Journal of Chronic Obstructive Pulmonary Disease ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,phosphodiesterase-4 inhibitor ,In patient ,ddc:610 ,Roflumilast ,Aged ,business.industry ,lung function ,Airway obstruction ,medicine.disease ,quality of life ,030228 respiratory system ,Spirometry ,Copd assessment test ,observational study ,COPD assessment test ,Observational study ,Phosphodiesterase 4 Inhibitors ,business - Abstract
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
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- 2018
17. Influence of comorbid heart disease on dyspnea and health status in patients with COPD - a cohort study
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Giezeman, Maaike, Hasselgren, Mikael, Lisspers, Karin, Ställberg, Björn, Montgomery, Scott, Janson, Christer, Sundh, Josefin, Giezeman, Maaike, Hasselgren, Mikael, Lisspers, Karin, Ställberg, Björn, Montgomery, Scott, Janson, Christer, and Sundh, Josefin
- Abstract
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
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- 2018
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18. Health status in patients with coexistent COPD and heart failure
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EXACERBATIONS ,OUTCOMES ,Minnesota Living with Heart Failure Questionnaire ,QUALITY-OF-LIFE ,SURVEY SF-36 ,heart failure ,CAT ,CCQ ,OBSTRUCTIVE PULMONARY-DISEASE ,Clinical COPD Questionnaire ,chronic obstructive pulmonary disease - Abstract
Background: 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.
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- 2014
19. Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease
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Thys van der Molen, Jan W.K. van den Berg, Steven M. Uil, Ynze P. de Jong, Ioanna Tsiligianni, Huib A. M. Kerstjens, Judith M. Vonk, Janwillem W. H. Kocks, and Groningen Research Institute for Asthma and COPD (GRIAC)
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Male ,Chronic bronchitis ,Exacerbation ,health status ,law.invention ,Pulmonary Disease, Chronic Obstructive ,Randomized controlled trial ,Quality of life ,law ,Adrenal Cortex Hormones ,QUALITY-OF-LIFE ,Outcome Assessment, Health Care ,hospital ,PREDICTORS ,media_common ,Original Research ,Netherlands ,COPD ,HEALTH-STATUS ,Convalescence ,PRIMARY-CARE ,General Medicine ,Middle Aged ,RANDOMIZED CONTROLLED-TRIAL ,Prognosis ,Hospitalization ,LUNG-FUNCTION ,CHRONIC-BRONCHITIS ,admission ,Disease Progression ,Female ,medicine.medical_specialty ,media_common.quotation_subject ,International Journal of Chronic Obstructive Pulmonary Disease ,Placebo ,Internal medicine ,COPD EXACERBATIONS ,medicine ,Humans ,Intensive care medicine ,Aged ,Maximal Expiratory Flow Rate ,Proportional Hazards Models ,Proportional hazards model ,business.industry ,MORTALITY ,Health Status Disparities ,prediction ,medicine.disease ,Survival Analysis ,Clinical COPD Questionnaire ,Dyspnea ,TIME-COURSE ,Self Report ,Patient Participation ,business - Abstract
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
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- 2013
20. Occurrence of Anxiety and Depression among Stable COPD Patients and its Impact on Functional Capability
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Runa Das, Somsubhra Chatterjee, Rajarshi Chakroborty, Subhasis Mukherjee, Subrata Rath, Debabani Biswas, and Shabana Begum
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medicine.medical_specialty ,Clinical Biochemistry ,lcsh:Medicine ,clinical copd questionnaire ,03 medical and health sciences ,0302 clinical medicine ,Rating scale ,Heart rate ,medicine ,Outpatient clinic ,030212 general & internal medicine ,Depression (differential diagnoses) ,state trait anxiety inventory ,COPD ,six-minute walk test ,Internal Medicine Section ,business.industry ,lcsh:R ,General Medicine ,medicine.disease ,Obstructive lung disease ,030228 respiratory system ,Physical therapy ,Anxiety ,hamilton depression rating scale ,medicine.symptom ,business ,State-Trait Anxiety Inventory - Abstract
Introduction Anxiety and depression are important but often under-diagnosed co-morbid conditions in patients with Chronic Obstructive Pulmonary Disease (COPD) which may affect the functional capacity of the patients. Aim To find out the proportion of depression and anxiety among stable COPD patients using a validated questionnaire suitable for use in clinic and the factors affecting their reduced functional capability as assessed by six-minute walk test. Materials and methods This was a descriptive cross-sectional study. Seventy five patients diagnosed with stable COPD in outpatient Department of Pulmonary Medicine in a tertiary care hospital, satisfying all inclusion criteria, were included in the study. They were examined clinically, categorized as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity assessment guideline and interviewed by designated interviewer using validated questionnaire for depression (Hamilton depression rating scale, HAM-D) and anxiety (State Trait Anxiety Inventory, STAI). The functional exercise capacity of the patient was assessed by six-minute walk test. Statistical analysis was performed using Minitab software (version16.1). Results Among 75 stable COPD patients (68 male, 7 female), majority (32 out of 75) had both depression and anxiety, while only anxiety or depression was present in 9 each. The patients with depression had no significant difference in six-minute walk distance, change in heart rate and respiratory rate (p = 0.4186, 0.219 and 0.41 respectively) as compared to those without depression, but were found to be more dyspnoeic at the end of the test (p= 0.003). There was also no significant difference in walk distance in patients with high STAI score as compared to those with low STAI score (p= 0.276). Conclusion Both anxiety and depression were present in majority of the stable COPD patients. The presence of these co-morbid conditions had no significant effect on the functional status of the patients in the form of reduced six-minute walk distance, though they were more symptomatic than those without these co-morbidities.
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- 2016
21. Een astma/COPD-dienst voor de huisartsenpraktijk
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respiratory tract disease assessment ,interdisciplinary communication ,Asthma/COPD service ,clinical effectiveness ,disease exacerbation ,Asthma Control Questionnaire ,asthma ,Clinical COPD Questionnaire ,chronic obstructive lung disease ,smoking - Abstract
DoelHet beschrijven van de effectiviteit en het functioneren van een astma/COPD-dienst (AC-dienst).OpzetObservationeel onderzoek.MethodeIn Noord-Nederland kunnen huisartsen patiënten met luchtwegklachten voor onderzoek verwijzen naar de AC-dienst, die in 2007 werd opgericht door lokale longartsen, huisartsen en het huisartsenlaboratorium Certe. De patiënt vult voor het onderzoek thuis 3 vragenlijsten in, de Clinical COPD Questionnaire(CCQ), de Asthma Control Questionnaire(ACQ) en een anamnesevragenlijst. In het laboratorium wordt de longfunctie bepaald en lichamelijk onderzoek uitgevoerd. Alle gegevens worden via internet naar een longarts gestuurd, die de huisarts via diens informatiesysteem adviseert over diagnose en behandeling. Zo nodig kan de longarts een vervolgconsult aanbieden. Voor deze publicatie beschikten wij over de gegevens van 14.748 aangemelde patiënten en 3721 vervolgconsulten.ResultatenDe longartsen diagnosticeerden 6201 patiënten (42%) met astma, 2728 (19%) met COPD en 1039 (7%) met de dubbeldiagnose ‘astma/COPD’. De longarts adviseerde voor 940 patiënten (6%) een medicatieverandering en een vervolgconsult na 3 maanden. In deze groep daalde het aantal instabiele COPD patiënten (CCQ ≥ 1) van 134 (67%) naar 99 (50%). Het aantal patiënten met instabiel astma (ACQ ≥ 1,5) daalde van 245 (43%) naar 137 (24%). Bij 1642 (11%) patiënten adviseerde de longarts geen medicatieverandering en verzocht de huisarts om een vervolgconsult na 12 maanden. Deze patiënten waren in het algemeen stabiel, met lichte verbeteringen in rookstatus, exacerbaties en inhalatietechniek.ConclusieOngeveer 60% van de patiënten in de regio is in de periode 2007-2014 ten minste eenmaal door de AC-dienst beoordeeld. De adviezen aan de huisartsen over diagnose en behandeling resulteerden in betere patiëntgerelateerde uitkomsten, zowel bij astma- als bij COPD-patiënten., OBJECTIVE: A study of the effectiveness and functioning of an asthma/COPD service (AC service).DESIGN: Observational study.METHOD: General practitioners (GPs) in the northern part of the Netherlands can refer patients with airway symptoms to the AC service, which was set up in 2007 by local pulmonologists, GPs and the primary care laboratory CERTE. Before the assessment, patients fill in three questionnaires at home: the Clinical COPD Questionnaire (CCQ), the Asthma Control Questionnaire (ACQ) and a medical history list. The laboratory assesses lung function and a physical examination is carried out. All data is sent via the Internet to a pulmonologist, who advises the GP on diagnosis and treatment via an information system. The pulmonologist can offer a follow-up service if required. For this publication we had access to data from 14,748 registered patients and 3721 follow-up consultations.RESULTS: The pulmonologist diagnosed 6201 (42%) patients with asthma, 2728 (19%) with COPD and 1039 (7%) with 'asthma/COPD overlap syndrome'. The pulmonologist advised that 940 patients (6%) should have a change in medication and reassessment after 3 months. In this group, the number of unstable COPD patients (CCQ ≥ 1) dropped from 134 (67%) to 99 (50%). The number of patients with unstable asthma (ACQ ≥ 1.5) dropped from 245 (3%) to 137 (24%). For 1642 (11%) patients the pulmonologist advised no change in medication and the GP referred the patient for reassessment after 12 months. These patients were generally stable, with a slight improvement in smoking status, exacerbations and inhalation technique.CONCLUSION: Approximately 60% of all patients with asthma or COPD in this region were assessed by the AC service at least once in the period 2007-2014. Advice on diagnosis and treatment given to the GP resulted in better patient-related outcomes in both asthma and COPD patients.
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- 2016
22. Een astma/COPD-dienst voor de huisartsenpraktijk
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Metting, E I, Riemersma, R A, Kocks, Jan-Willem H., Piersma-Wichers, Margriet G., Sanderman, R, van der Molen, T, Experimental Psychotherapy & Psychopathology, Health Psychology Research, and Groningen Research Institute for Asthma and COPD
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respiratory tract disease assessment ,interdisciplinary communication ,Asthma/COPD service ,clinical effectiveness ,disease exacerbation ,Asthma Control Questionnaire ,asthma ,Clinical COPD Questionnaire ,chronic obstructive lung disease ,smoking - Abstract
Doel Het beschrijven van de effectiviteit en het functioneren van een astma/COPD-dienst (AC-dienst). Opzet Observationeel onderzoek. Methode In Noord-Nederland kunnen huisartsen patiënten met luchtwegklachten voor onderzoek verwijzen naar de AC-dienst, die in 2007 werd opgericht door lokale longartsen, huisartsen en het huisartsenlaboratorium Certe. De patiënt vult voor het onderzoek thuis 3 vragenlijsten in, de Clinical COPD Questionnaire(CCQ), de Asthma Control Questionnaire(ACQ) en een anamnesevragenlijst. In het laboratorium wordt de longfunctie bepaald en lichamelijk onderzoek uitgevoerd. Alle gegevens worden via internet naar een longarts gestuurd, die de huisarts via diens informatiesysteem adviseert over diagnose en behandeling. Zo nodig kan de longarts een vervolgconsult aanbieden. Voor deze publicatie beschikten wij over de gegevens van 14.748 aangemelde patiënten en 3721 vervolgconsulten. Resultaten De longartsen diagnosticeerden 6201 patiënten (42%) met astma, 2728 (19%) met COPD en 1039 (7%) met de dubbeldiagnose ‘astma/COPD’. De longarts adviseerde voor 940 patiënten (6%) een medicatieverandering en een vervolgconsult na 3 maanden. In deze groep daalde het aantal instabiele COPD patiënten (CCQ ≥ 1) van 134 (67%) naar 99 (50%). Het aantal patiënten met instabiel astma (ACQ ≥ 1,5) daalde van 245 (43%) naar 137 (24%). Bij 1642 (11%) patiënten adviseerde de longarts geen medicatieverandering en verzocht de huisarts om een vervolgconsult na 12 maanden. Deze patiënten waren in het algemeen stabiel, met lichte verbeteringen in rookstatus, exacerbaties en inhalatietechniek. Conclusie Ongeveer 60% van de patiënten in de regio is in de periode 2007-2014 ten minste eenmaal door de AC-dienst beoordeeld. De adviezen aan de huisartsen over diagnose en behandeling resulteerden in betere patiëntgerelateerde uitkomsten, zowel bij astma- als bij COPD-patiënten.
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- 2016
23. Health status in patients with coexistent COPD and heart failure: a validation and comparison between the Clinical COPD Questionnaire and the Minnesota Living with Heart Failure Questionnaire
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Farida F. Berkhof, Jan W.K. van den Berg, Steven M. Uil, Huib A. M. Kerstjens, and Leola Metzemaekers
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Male ,medicine.medical_specialty ,Intraclass correlation ,Health Status ,Comorbidity ,International Journal of Chronic Obstructive Pulmonary Disease ,chronic obstructive pulmonary disease ,Pulmonary Disease, Chronic Obstructive ,Cronbach's alpha ,Quality of life ,Predictive Value of Tests ,Risk Factors ,Surveys and Questionnaires ,medicine ,Health Status Indicators ,Humans ,Outpatient clinic ,Prospective Studies ,Aged ,Netherlands ,Original Research ,Heart Failure ,COPD ,business.industry ,Reproducibility of Results ,Construct validity ,General Medicine ,medicine.disease ,Clinical COPD Questionnaire ,Minnesota Living with Heart Failure Questionnaire ,Predictive value of tests ,Physical therapy ,Female ,business - Abstract
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
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- 2014
24. Health status in patients with coexistent COPD and heart failure: a validation and comparison between the Clinical COPD Questionnaire and the Minnesota
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Berkhof, Farida F., Metzemaekers, Leola, Uil, Steven M., Kerstjens, Huib A. M., van den Berg, Jan W. K., Physics of Nanodevices, and Groningen Research Institute for Asthma and COPD (GRIAC)
- Subjects
EXACERBATIONS ,OUTCOMES ,Minnesota Living with Heart Failure Questionnaire ,QUALITY-OF-LIFE ,SURVEY SF-36 ,heart failure ,CAT ,CCQ ,OBSTRUCTIVE PULMONARY-DISEASE ,Clinical COPD Questionnaire ,chronic obstructive pulmonary disease - Abstract
Background: 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.
- Published
- 2014
25. Investigating the MCID of health status tools for patients with COPD in pulmonary rehabilitation
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St. George Respiratory Questionnaire ,questionnaire ,health status ,COPD Assessment Test ,pulmonary rehabilitation ,Clinical COPD Questionnaire - Abstract
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).
- Published
- 2014
26. Influence of comorbid heart disease on dyspnea and health status in patients with COPD - a cohort study.
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Giezeman M, Hasselgren M, Lisspers K, Ställberg B, Montgomery S, Janson C, and Sundh J
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- Adult, Aged, Comorbidity, Disease Progression, Dyspnea diagnosis, Dyspnea physiopathology, Female, Heart Diseases diagnosis, Heart Diseases physiopathology, Humans, Longitudinal Studies, Male, Middle Aged, Prognosis, Prospective Studies, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive physiopathology, Risk Assessment, Risk Factors, Surveys and Questionnaires, Sweden epidemiology, Time Factors, Dyspnea epidemiology, Health Status, Heart Diseases epidemiology, Lung physiopathology, Pulmonary Disease, Chronic Obstructive epidemiology
- Abstract
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., Competing Interests: Disclosure The authors report no conflicts of interest in this work.
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- 2018
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27. Health status in patients with COPD treated with roflumilast: two large noninterventional real-life studies: DINO and DACOTA.
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Kardos P, Mokros I, Sauer R, and Vogelmeier CF
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- Aged, Aged, 80 and over, Aminopyridines adverse effects, Benzamides adverse effects, Bronchodilator Agents adverse effects, Cyclopropanes adverse effects, Cyclopropanes therapeutic use, Drug Therapy, Combination, Female, Forced Expiratory Volume, Germany, Health Status, Humans, Lung physiopathology, Male, Middle Aged, Phosphodiesterase 4 Inhibitors adverse effects, Prospective Studies, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive physiopathology, Quality of Life, Severity of Illness Index, Spirometry, Surveys and Questionnaires, Time Factors, Treatment Outcome, Aminopyridines therapeutic use, Benzamides therapeutic use, Bronchodilator Agents therapeutic use, Lung drug effects, Phosphodiesterase 4 Inhibitors therapeutic use, Pulmonary Disease, Chronic Obstructive drug therapy
- Abstract
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 FEV
1 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 <0.001]). Changes in CAT total score from baseline to Month 6 indicated that the average clinical impact of COPD was reduced from a severe (score: 21-30) to a moderate (score: 11-20) impairment. In DACOTA, mean change in post-bronchodilator FEV1 was 202 mL ( P <0.001). Diarrhea, nausea, and weight decrease were the most frequently reported adverse drug reactions., Conclusion: In real-life clinical practice, roflumilast treatment as an add-on therapy is associated with clinically relevant improvements in health status and quality of life., Competing Interests: Disclosure IM is a former employee of Takeda and a current employee of AstraZeneca. PK reports personal fees from Takeda during the conduct of the study; personal fees from AstraZeneca, Chiesi, GSK, Novartis, Menarini, Teva, and Mundipharma outside the submitted work. CV reports no relevant conflicts of interest in the current study, and the following relevant financial activities outside of the submitted work: personal fees from Almirall, Cipla, Berlin Chemie/Menarini, CSL Behring, and Teva; grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Mundipharma, Novartis, and Takeda; grants from German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Bayer Schering Pharma AG, MSD, and Pfizer. RS reports no conflicts of interest in this work. The authors report no other conflicts of interest in this work.- Published
- 2018
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28. The 2014 Updated GOLD Strategy: A Comparison of the Various Scenarios.
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Wilke S, Smid DE, Spruit MA, Janssen DJA, Muris JWM, van der Molen T, van den Akker M, Jones PW, Wouters EFM, and Franssen FME
- Abstract
Background : The 2014 updated Global initiative for chronic Obstructive Lung Disease (GOLD) strategy added the St. George's Respiratory Questionnaire (SGRQ) as the fourth possible symptoms measure. The impact of the suggested tools for symptoms of COPD and the different definitions of future risk on the frequency distribution and clinical characteristics of the GOLD groups remain unknown. Methods : Demographic and clinical characteristics were assessed in 542 patients with COPD (57.7% male, age 64.6 [9.0] years, FEV
1 54.7 [22.3]% predicted). Health status was assessed by the COPD-specific SGRQ and symptoms of anxiety and depression by the Hospital Anxiety and Depression Scale, anxiety (HADS-A) and depression (HADS-D) subscale. Cohen's Kappa was used to assess agreement between groups. Results : Level of agreement in frequency distribution using the modified Medical Research Council dyspnea (mMRC) scale ≥2, COPD Assessment Test (CAT) ≥10, Clinical COPD Questionnaire (CCQ) ≥1 and SGRQ ≥25 was moderate to very good. Best agreement was reached between CCQ and SGRQ (К = 0.838 or 0.851, p<0.001). Patients classified in mMRC GOLD A reported higher SGRQ scores, higher HADS-A and HADS-D scores compared to patients classified in CAT GOLD A or SGRQ GOLD A. Outcomes were comparable between the risk assessment groups. Conclusions : Choice of the symptom measure impacts GOLD groups more than choice of the exacerbation risk assessment. Health care professionals should be aware that patients are heterogeneous in terms of health status and symptoms of anxiety and depression based on the symptom measure used., Competing Interests: SW, DES, MAS, DJAJ, JWMM, MvdA and FMEF have nothing to disclose. TvdM developed the CCQ and holds the copyrights. PWJ did not receive any payment or services from a third party for any aspect of the submitted work, but reports grants and personal fees from GSK, personal fees from Novartis, Almirall, Pearl and Jannsen and his university received consulting fees for work that he performed for Novartis (outside the submitted work). EFMW did not receive any payment or services from a third party for any aspect of the submitted work, but reports grants and/or personal fees from Nycomed, AstraZeneca, GSK and Novartis (outside the submitted work).- Published
- 2014
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29. Functional and psychological variables both affect daily physical activity in COPD: a structural equations model.
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Altenburg WA, Bossenbroek L, de Greef MH, Kerstjens HA, ten Hacken NH, and Wempe JB
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- Adult, Aged, Anxiety etiology, Anxiety physiopathology, Anxiety psychology, Counseling, Depression etiology, Depression physiopathology, Depression psychology, Female, Forced Expiratory Volume physiology, Humans, Male, Middle Aged, Models, Statistical, Motivation, Psychometrics, Pulmonary Disease, Chronic Obstructive rehabilitation, Self Efficacy, Motor Activity physiology, Pulmonary Disease, Chronic Obstructive physiopathology, Pulmonary Disease, Chronic Obstructive psychology
- Abstract
Background: Daily physical activity (DPA) level is reduced in patients with COPD. The aim of this study was to investigate the association of DPA with functional and psychological variables in these patients., Methods: 155 COPD patients (102 males, median (IQR) age 62 years (54-69 years), predicted FEV1 60% (40-75%) were included. We assessed DPA (DigiWalker SW-200), functional capacity and psychological factors., Results: DPA level was significantly associated with all functional capacity variables and two psychological variables (Perceived Physical Ability Subscale, depression subscale of the Hospital Anxiety and Depression Scale). The six-minute walking distance and St. George Respiratory Questionnaire activity score explained 37% of the variance of DPA in a regression analysis. A structural equations model revealed that psychological variables indirectly explained DPA through functional capacity variables. DPA was stronger associated with functional capacity variables and weaker with psychological variables in patients with lower functional status than in patients with higher functional status., Conclusions: Higher levels of DPA are associated with better functional capacity, but interestingly, DPA is also affected by psychological factors, though only indirectly, via functional capacity. The effect of specific treatment addressing psychological factors on DPA level and exercise tolerance needs further investigation., Clinical Trial Registration: ClinicalTrials.gov, NCT00614796., (Copyright © 2013 Elsevier Ltd. All rights reserved.)
- Published
- 2013
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30. Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease.
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Kocks JW, van den Berg JW, Kerstjens HA, Uil SM, Vonk JM, de Jong YP, Tsiligianni IG, and van der Molen T
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- Adrenal Cortex Hormones therapeutic use, Aged, Disease Progression, Dyspnea physiopathology, Female, Health Status Disparities, Hospitalization statistics & numerical data, Humans, Male, Maximal Expiratory Flow Rate, Middle Aged, Netherlands epidemiology, Prognosis, Proportional Hazards Models, Self Report, Survival Analysis, Outcome Assessment, Health Care methods, Patient Participation methods, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive mortality, Pulmonary Disease, Chronic Obstructive physiopathology, Pulmonary Disease, Chronic Obstructive therapy
- Abstract
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.
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- 2013
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31. Cross-cultural adaptation, reliability and validity study of the persian version of the clinical COPD questionnaire
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Hasanpour, N., Moghadam Behrouz, B., Ramin Sami, and Tavakol, K.
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Adult ,Aged, 80 and over ,Cross-Cultural Comparison ,Male ,lcsh:R5-920 ,Chronic obstructive pulmonary disease ,Health-related quality of life ,Health Status ,Reproducibility of Results ,Iran ,Middle Aged ,Translating ,Reliability ,Clinical COPD questionnaire ,humanities ,Validity ,Pulmonary Disease, Chronic Obstructive ,Cross-Sectional Studies ,Surveys and Questionnaires ,Quality of Life ,Humans ,Female ,lcsh:Medicine (General) ,Aged ,Language - Abstract
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.
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