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      From COPD epidemiology to studies of pathophysiological disease mechanisms: challenges with regard to study design and recruitment process : Respiratory and Cardiovascular Effects in COPD (KOLIN)

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          ABSTRACT

          Background: Chronic obstructive pulmonary disease (COPD) is a largely underdiagnosed disease including several phenotypes. In this report, the design of a study intending to evaluate the pathophysiological mechanism in COPD in relation to the specific phenotypes non-rapid and rapid decline in lung function is described together with the recruitment process of the study population derived from a population based study.

          Method: The OLIN COPD study includes a population-based COPD cohort and referents without COPD identified in 2002–04 ( n = 1986), and thereafter followed annually since 2005. Lung function decline was estimated from baseline in 2002–2004 to 2010 (first recruitment phase) or to 2012/2013 (second recruitment phase). Individuals who met the predefined criteria for the following four groups were identified; group A) COPD grade 2–3 with rapid decline in FEV 1 and group B) COPD grade 2–3 without rapid decline in FEV 1 (≥60 and ≤30 ml/year, respectively), group C) ever-smokers, and group D) non-smokers with normal lung function. Groups A–C included ever-smokers with >10 pack years. The intention was to recruit 15 subjects in each of the groups A-D.

          Results: From the database groups A–D were identified; group A n = 37, group B n = 29, group C n = 41, and group D n = 55. Fifteen subjects were recruited from groups C and D, while this goal was not reached in the groups A ( n = 12) and B ( n = 10). The most common reasons for excluding individuals identified as A or B were comorbidities contraindicating bronchoscopy, or inflammatory diseases/immune suppressive medication expected to affect the outcome.

          Conclusion: The study is expected to generate important results regarding pathophysiological mechanisms associated with rate of decline in lung function among subjects with COPD and the in-detail described recruitment process, including reasons for non-participation, is a strength when interpreting the results in forthcoming studies.

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          Most cited references34

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          The natural history of chronic airflow obstruction.

          A prospective epidemiological study of the early stages of the development of chronic obstructive pulmonary disease was performed on London working men. The findings showed that forced expiratory volume in one second (FEV1) falls gradually over a lifetime, but in most non-smokers and many smokers clinically significant airflow obstruction never develops. In susceptible people, however, smoking causes irreversible obstructive changes. If a susceptible smoker stops smoking he will not recover his lung function, but the average further rates of loss of FEV1 will revert to normal. Therefore, severe or fatal obstructive lung disease could be prevented by screening smokers' lung function in early middle age if those with reduced function could be induced to stop smoking. Infective processes and chronic mucus hypersecretion do not cause chronic airflow obstruction to progress more rapidly. There are thus two largely unrelated disease processes, chronic airflow obstruction and the hypersecretory disorder (including infective processes).
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            Determinants of underdiagnosis of COPD in national and international surveys.

            COPD ranks within the top three causes of mortality in the global burden of disease, yet it remains largely underdiagnosed. We assessed the underdiagnosis of COPD and its determinants in national and international surveys of general populations.
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              Lung function and mortality in the United States: data from the First National Health and Nutrition Examination Survey follow up study.

              D Mannino (2003)
              A study was undertaken to define the risk of death among a national cohort of US adults both with and without lung disease. Participants in the first National Health and Nutrition Examination Survey (NHANES I) followed for up to 22 years were studied. Subjects were classified using a modification of the Global Initiative for Chronic Obstructive Lung Disease criteria for chronic obstructive pulmonary disease (COPD) into the following mutually exclusive categories using the forced expiratory volume in 1 second (FEV(1)), forced vital capacity (FVC), FEV(1)/FVC ratio, and the presence of respiratory symptoms: severe COPD, moderate COPD, mild COPD, respiratory symptoms only, restrictive lung disease, and no lung disease. Proportional hazard models were developed that controlled for age, race, sex, education, smoking status, pack years of smoking, years since quitting smoking, and body mass index. A total of 1301 deaths occurred in the 5542 adults in the cohort. In the adjusted proportional hazards model the presence of severe or moderate COPD was associated with a higher risk of death (hazard ratios (HR) 2.7 and 1.6, 95% confidence intervals (CI) 2.1 to 3.5 and 1.4 to 2.0), as was restrictive lung disease (HR 1.7, 95% CI 1.4 to 2.0). The presence of both obstructive and restrictive lung disease is a significant predictor of earlier death in long term follow up.
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                Author and article information

                Journal
                Eur Clin Respir J
                Eur Clin Respir J
                ZECR
                zecr20
                European Clinical Respiratory Journal
                Taylor & Francis
                2001-8525
                2017
                17 December 2017
                : 4
                : 1
                : 1415095
                Affiliations
                [ a ] Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University , Umeå, Sweden
                [ b ] Department of Public Health and Clinical Medicine, Division of Occupational and Environmental Medicine, Umeå University , Umeå, Sweden
                [ c ] Department of Health Science, Division of Health and Rehabilitation, Luleå University of Technology , Luleå, Sweden
                Author notes
                CONTACT Anne Lindberg anne.lindberg@ 123456algmed.se

                Working address: Department of Respiratory Medicine, Sunderby Hospital, 971 80 Luleå, Sweden

                Author information
                http://orcid.org/0000-0003-4266-1782
                http://orcid.org/0000-0002-0553-8067
                http://orcid.org/0000-0002-2574-479X
                http://orcid.org/0000-0002-5948-6880
                Article
                1415095
                10.1080/20018525.2017.1415095
                5738647
                29296255
                2c77f60f-9045-4e9c-8c93-f53c59227fa1
                © 2017 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 02 November 2017
                : 29 November 2017
                Page count
                Tables: 3, References: 44, Pages: 8
                Funding
                Funded by: Hjärt-Lungfonden 10.13039/501100003793
                Funded by: Hjärt-Lungfonden 10.13039/501100003793
                Funded by: County Council of Västerbotten (ALF)
                Funded by: King Gustaf V’s and Queen Victoria’s Freemason Foundation
                Funded by: County Council of Norrbotten
                Funded by: Northern County Councils Regional Federation
                Financial support was granted by the Swedish Heart-Lung Foundation, the Västerbotten County Council, Visare Norr Fund/Northern County Councils Regional Federation, Umeå University, and King Gustaf V’s and Queen Victoria’s Freemason Foundation.
                Categories
                Research Article
                Research Article

                chronic obstructive pulmonary disease,disease mechanisms,lung function decline,smoking habits

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