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      Scores of Health-Related Quality of Life Questionnaire Worsen Consistently in Patients of COPD: Estimating Disease Progression over 30 Years by SReFT with Individual Data Collected in SUMMIT Trial

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          Abstract

          The aim of this study was to elucidate the lifelong disease progression of chronic obstructive pulmonary disease (COPD) with biomarker changes and identify their influencing factors, by utilizing a new analysis method, Statistical Restoration of Fragmented Time-course (SReFT). Individual patient data ( n = 1025) participating in the Study to Understand Mortality and MorbidITy (SUMMIT, NCT01313676), which was collected within the observational period of 4 years, were analyzed. The SReFT analysis suggested that scores of St. George’s Respiratory Questionnaire and COPD assessment test, representative scores of the health-related quality of life (HRQOL) questionnaire, increased consistently for 30 years of disease progression, which was not detected by conventional analysis with a linear mixed effect model. It was estimated by the SReFT analysis that normalized forced expiratory volume in one second for age, sex, and body size (%FEV1) reduced for the initial 10 years from the onset of the disease but thereafter remained constant. The analysis of HRQOL scores and lung functions suggested that smoking cessation slowed COPD progression by approximately half and that exacerbation accelerated it considerably. In conclusion, this retrospective study utilizing SReFT elucidated the progression of COPD over 30 years and associated quantitative changes in the HRQOL scores and lung functions.

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          Chronic obstructive pulmonary disease.

          Peter Barnes, Peter Burney, Edwin K Silverman … (2015)
          Chronic obstructive pulmonary disease (COPD) is a common disease with high global morbidity and mortality. COPD is characterized by poorly reversible airway obstruction, which is confirmed by spirometry, and includes obstruction of the small airways (chronic obstructive bronchiolitis) and emphysema, which lead to air trapping and shortness of breath in response to physical exertion. The most common risk factor for the development of COPD is cigarette smoking, but other environmental factors, such as exposure to indoor air pollutants - especially in developing countries - might influence COPD risk. Not all smokers develop COPD and the reasons for disease susceptibility in these individuals have not been fully elucidated. Although the mechanisms underlying COPD remain poorly understood, the disease is associated with chronic inflammation that is usually corticosteroid resistant. In addition, COPD involves accelerated ageing of the lungs and an abnormal repair mechanism that might be driven by oxidative stress. Acute exacerbations, which are mainly triggered by viral or bacterial infections, are important as they are linked to a poor prognosis. The mainstay of the management of stable disease is the use of inhaled long-acting bronchodilators, whereas corticosteroids are beneficial primarily in patients who have coexisting features of asthma, such as eosinophilic inflammation and more reversibility of airway obstruction. Apart from smoking cessation, no treatments reduce disease progression. More research is needed to better understand disease mechanisms and to develop new treatments that reduce disease activity and progression.
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            Depressive symptoms and chronic obstructive pulmonary disease: effect on mortality, hospital readmission, symptom burden, functional status, and quality of life.

            Mathew Niti, Philip Eng, H-Z Cao … (2007)
            Depressive symptoms are common among patients with chronic obstructive pulmonary disease (COPD), but depression's impact on COPD outcomes has not been fully investigated. We evaluated the impact of comorbid depression on mortality, hospital readmission, smoking behavior, respiratory symptom burden, and physical and social functioning in patients with COPD. In this prospective cohort study, 376 consecutive patients with COPD hospitalized for acute exacerbation were followed up for 1 year. The independent associations of baseline comorbid depression (designated as a Hospital Anxiety and Depression Scale score of > or =8) with mortality, hospital readmission, length of stay, persistent smoking, and quality of life (determined by responses to the St George Respiratory Questionnaire) were evaluated after adjusting for potential confounders. The prevalence of depression at admission was 44.4%. The median follow-up duration was 369 days, during which 57 patients (15.2%) died, and 202 (53.7%) were readmitted at least once. Multivariate analyses showed that depression was significantly associated with mortality (hazard ratio, 1.93; 95% confidence interval, 1.04-3.58), longer index stay (mean, 1.1 more days; P = .02) and total stay (mean, 3.0 more days; P = .047), persistent smoking at 6 months (odds ratio, 2.30; 95% confidence interval, 1.17-4.52), and 12% to 37% worse symptoms, activities, and impact subscale scores and total score on the St George Respiratory Questionnaire at the index hospitalization and 1 year later, even after controlling for chronicity and severity of COPD, comorbidities, and behavioral, psychosocial, and socioeconomic variables. Comorbid depressive symptoms in patients with COPD are associated with poorer survival, longer hospitalization stay, persistent smoking, increased symptom burden, and poorer physical and social functioning. Interventions that reduce depressive symptoms may potentially affect COPD outcomes.
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              The COPD assessment test: a systematic review.

              Nisha Gupta, Lancelot M. Pinto, Andreea Morogan … (2014)
              The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. We aimed to systematically evaluate the literature for reliability, validity, responsiveness and minimum clinically important difference (MCID) of the CAT. Multiple databases were searched for studies analysing the psychometric properties of the CAT in adults with chronic obstructive pulmonary disease. Two reviewers independently screened, selected and extracted data, and assessed methodological quality of relevant studies using the COSMIN checklist. From 792 records identified, 36 studies were included. The number of participants ranged from 45 to 6469, mean age from 56 to 73 years, and mean forced expiratory volume in 1 s from 39% to 98% predicted. Internal consistency (reliability) was 0.85-0.98, and test-retest reliability was 0.80-0.96. Convergent and longitudinal validity using Pearson's correlation coefficient were: SGRQ-C 0.69-0.82 and 0.63, CCQ 0.68-0.78 and 0.60, and mMRC 0.29-0.61 and 0.20, respectively. Scores differed with GOLD stages, exacerbation and mMRC grades. Mean scores decreased with pulmonary rehabilitation (2.2-3 units) and increased at exacerbation onset (4.7 units). Only one study with adequate methodology reported an MCID of 2 units and 3.3-3.8 units using the anchor-based approach and distribution-based approach, respectively. Most studies had fair methodological quality. We conclude that the studies support the reliability and validity of the CAT and that the tool is responsive to interventions, although the MCID remains debatable.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Clin Med
                Journal ID (iso-abbrev): J Clin Med
                Journal ID (publisher-id): jcm
                Title: Journal of Clinical Medicine
                Publisher: MDPI
                ISSN (Electronic): 2077-0383
                Publication date (Electronic): 18 August 2020
                Publication date Collection: August 2020
                Volume: 9
                Issue: 8
                Electronic Location Identifier: 2676
                Affiliations
                [1 ]Clinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba 260-8675, Japan; s.kawamatsu.gifu@ 123456gmail.com (S.K.); ryota-j@ 123456chiba-u.jp (R.J.); shogo.1202.tandf@ 123456gmail.com (S.A.); ysokhdk@ 123456gmail.com (H.Y.); hiromi-s@ 123456chiba-u.jp (H.S.)
                [2 ]Clinical Operations, Japan Development, GlaxoSmithKline, Tokyo 107-0052, Japan
                [3 ]Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo 160-8582, Japan; yasunori.sato@ 123456keio.jp
                Author notes
                [* ]Correspondence: hisaka@ 123456chiba-u.jp ; Tel.: +81-43-226-2880
                Author information
                https://orcid.org/0000-0001-8815-4829
                Article
                Publisher ID: jcm-09-02676
                DOI: 10.3390/jcm9082676
                PMC ID: 7464378
                PubMed ID: 32824840
                SO-VID: 965f61f2-d445-49f7-a1c7-d2f896ff0fa2
                Copyright © © 2020 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 30 July 2020
                Date accepted : 14 August 2020
                Categories
                Subject: Article

                Keywords: chronic obstructive pulmonary disease,disease progression,health-related quality of life,smoking,statistical restoration of fragmented time-course
                Data availability:
                Keywords: chronic obstructive pulmonary disease, disease progression, health-related quality of life, smoking, statistical restoration of fragmented time-course

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