Abstract
BackgroundChronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. The aim of this study was to investigate the relationships between 1-year CID and the following long-term clinical outcomes in Japanese patients with COPD who have been reported to have different characteristics compared to the Westerners.MethodsAmong Japanese patients with COPD enrolled in the Hokkaido COPD cohort study, 259 patients who did not drop out within the first year were analyzed in this study. Two definitions of CID were used. Definition 1 comprised ≥ 100 mL decrease in forced expiratory volume in 1 s (FEV1), ≥ 4-unit increase in St George’s Respiratory Questionnaire (SGRQ) score from baseline, or moderate or severe exacerbation. For Definition 2, the thresholds for the FEV1 and SGRQ score components were doubled. The presence of CID was evaluated within the first year from enrollment, and analyzed the association of the presence of CID with following 4-year risk of exacerbations and 9-year mortality.ResultsPatients with CID using Definition 1, but not any single CID component, during the first year had a significantly worse mortality compared with those without CID. Patients with CID using Definition 2 showed a similar trend on mortality, and had a shorter exacerbation-free survival compared with those without CID.ConclusionsAdoption of CID is a beneficial and useful way for the assessment of long-term disease progression and clinical outcomes even in Japanese population with COPD. The definition of CID might be optimized according to the characteristics of COPD population and the observation period for CID.
Highlights
Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression
A composite clinically important deterioration (CID) endpoint was developed to measure short-term worsening of disease status, comprising the following: lung function (≥ 100 mL decline in forced expiratory volume in 1 s [Forced expiratory volume in 1 s (FEV1)]), health status (≥ 4-unit increase in St George’s Respiratory Questionnaire [SGRQ]), and the incidence of moderate or severe exacerbation [3]
In this study, we evaluated whether CID status assessed during the first year of observation could be used to predict long-term clinical outcomes of Japanese patients with COPD using data from the Hokkaido COPD cohort study
Summary
Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition with a complex progression of many clinical presentations, which vary in both their presence and severity [1]. A composite clinically important deterioration (CID) endpoint was developed to measure short-term worsening of disease status, comprising the following: lung function (≥ 100 mL decline in forced expiratory volume in 1 s [FEV1]), health status (≥ 4-unit increase in St George’s Respiratory Questionnaire [SGRQ]), and the incidence of moderate or severe exacerbation [3]. Most of the participants in those studies were from Western countries, and it is still unclear whether this definition of CID is useful in diverse COPD populations
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