TY - JOUR
T1 - GOLD 2011 disease severity classification in COPDGene
T2 - A prospective cohort study
AU - Han, Mei Lan K.
AU - Muellerova, Hana
AU - Curran-Everett, Douglas
AU - Dransfield, Mark T.
AU - Washko, George R.
AU - Regan, Elizabeth A.
AU - Bowler, Russell P.
AU - Beaty, Terri H.
AU - Hokanson, John E.
AU - Lynch, David A.
AU - Jones, Paul W.
AU - Anzueto, Antonio
AU - Martinez, Fernando J.
AU - Crapo, James D.
AU - Silverman, Edwin K.
AU - Make, Barry J.
N1 - Funding Information:
MKH participated in advisory boards for Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Genentech, Novartis, and Medimmune; participated on speaker's bureaus for Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Grifols therapeutics, and the National Association for Continuing Education, and WebMD; has consulted for Novartis and United Biosource Corporation; and has received royalties from UpToDate and ePocrates. HM is an employee of GlaxoSmithKline R&D and own shares and stock options of GlaxoSmithKline. MTD has consulted for GlaxoSmithKline and Boehringer Ingelheim; his institution has received funds to undertake clinical research trials for NHLBI, Aeirs, GlaxoSmithKline, Boehringer Ingelheim, Pfizer, Otsuka, Boston Scientific, and Contocor. GRW has consulted for Spiration. DAL has served as consultant to several trials in idiopathic pulmonary fibrosis, sponsored by Gilead, Actelion, Johnson and Johnson, and Intermune; is a consultant for Perceptive Imaging; and receives research support from Siemens. PWJ consulted for Almirall, AstraZeneca, Bayer, Forest, GlaxoSmithKline, Novartis, Pearl, Roche, and Spiration; has received grants through his institution from GlaxoSmithKline; and has served on speakers' bureau for Almirall, GlaxoSmithKline, and Novartis; and has received no royalties. AA is a member of GOLD scientific and Executive committees; has participated in scientific meetings or courses organised and financed by various pharmaceutical companies including Boehringer Ingelheim, Bayer Healthcare, GlaxoSmithKline, and Forest Laboratories; has been a consultant for AstraZeneca, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Bayer Healthcare, Forest Laboratories, Intermune, and Amgen; has been the principal investigator for research done at his institution (University of Texas Health Science Center at San Antonio) who were paid for participating in multicentre clinical trials sponsored by GlaxoSmithKline, Bayer-Schering Pharma, Lilly, National Institutes of Health, and COPDGene. FJM has served on advisory boards relating to COPD-related topics for GlaxoSmithKline, MedImmune, AstraZeneca, Merck, Pearl Therapeutics, Novartis, United BioSource Corporation, Forest Laboratories, and Almirall; he has consulted for Actelion Pharmaceuticals, Boehringer Ingelheim, Nycomed, Forest Laboratories, F. Hoffmann-La Roche; Bayer, Merck/Schering-Plough, Health Learning Systems, Talecris Biotherapeutics, Comgenex, fb Communications, BoomComm, and Actelion; has served on speaker's bureaus for GlaxoSmithKline, National Association for Continuing Education, Med-Ed, Potomac Center for Medical Education, Pfizer, Boehringer Ingelheim, Merck/Schering-Plough, Vox Medica, American Lung Association, WebMD, ePocrates, AstraZeneca, France Foundation, CME Incite, and Altana/Nycomed; his institution has received funds from Boehringer Ingelheim for a clinical trial; has received royalties from Associates in Medical Marketing and Castle Connolly; has developed educational materials for the France Foundation, HIT Global, and ePocrates; has served on steering committees for clinical trials supported by GlaxoSmithKline, Nycomed, Forest Laboratories, and Actelion. EKS has received grant support and consulting fees from GlaxoSmithKline for studies of COPD genetics; has received honoraria and consulting fees from AstraZeneca; and has received consulting fees from Merck. BJM has participated in advisory boards, speaker's bureaus, consultations, and multicentre clinical trials with funding from the National Heart, Lung, and Blood Institute, Abbott Laboratories, Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Dey Pharma, Embryon, Forest Laboratories, GlaxoSmithKline, Ikaria, MedImmune, Merck, Nabi Biopharmaceuticals, Nycomed, Novartis, Pfizer, Respironics, Merck/Schering-Plough, SeQual Technologies, and Talecris Biotherapeutics. DC-E, EAR, RPD, THB, JEH, and JDC declare no conflicts of interest.
Funding Information:
The COPDGene project is supported by grants from the National Heart, Lung, and Blood Institute ( U01HL089897 and U01HL089856 ). The project is also supported by the COPD Foundation through contributions made to an Industry Advisory Board comprised of AstraZeneca, Boehringer Ingelheim, Novartis, and Sepracor.
PY - 2013/3
Y1 - 2013/3
N2 - Background: The 2011 GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease [COPD]) consensus report uses symptoms, exacerbation history, and forced expiratory volume (FEV1)% to categorise patients according to disease severity and guide treatment. We aimed to assess both the influence of symptom instrument choice on patient category assignment and prospective exacerbation risk by category. Methods: Patients were recruited from 21 centres in the USA, as part of the COPDGene study. Eligible patients were aged 45-80 years, had smoked for 10 pack-years or more, and had an FEV1/forced vital capacity (FVC) <0·7. Categories were defined with the modified Medical Research Council (mMRC) dyspnoea scale (score 0-1 vs ≥2) and the St George's Respiratory Questionnaire (SGRQ; ≥25 vs <25 as a surrogate for the COPD Assessment Test [CAT] ≥10 vs <10) in addition to COPD exacerbations in the previous year (<2 vs ≥ 2), and lung function (FEV1% predicted ≥50 vs <50). Statistical comparisons were done with k-sample permutation tests. This study cohort is registered with ClinicalTrials.gov, number NCT00608764. Findings: 4484 patients with COPD were included in this analysis. Category assignment using the mMRC scale versus SGRQ were similar but not identical. On the basis of the mMRC scale, 1507 (33·6%) patients were assigned to category A, 919 (20·5%) to category B, 355 (7·9%) to category C, and 1703 (38·0%) to category D; on the basis of the SGRQ, 1317 (29·4%) patients were assigned to category A, 1109 (24·7%) to category B, 221 (4·9%) to category C, and 1837 (41·0%) to category D (κ coefficient for agreement, 0·77). Significant heterogeneity in prospective exacerbation rates (exacerbations/person-years) were seen, especially in the D subcategories, depending on the risk factor that determined category assignment (lung function only [0·89, 95% CI 0·78-1·00]), previous exacerbation history only [1·34, 1·0-1·6], or both [1·86, 1·6-2·1; p<0·0001]). Interpretation: The GOLD classification emphasises the importance of symptoms and exacerbation risk when assessing COPD severity. The choice of symptom measure influences category assignment. The relative number of patients with low symptoms and high risk for exacerbations (category C) is low. Differences in exacerbation rates for patients in the highest risk category D were seen depending on whether risk was based on lung function, exacerbation history, or both.
AB - Background: The 2011 GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease [COPD]) consensus report uses symptoms, exacerbation history, and forced expiratory volume (FEV1)% to categorise patients according to disease severity and guide treatment. We aimed to assess both the influence of symptom instrument choice on patient category assignment and prospective exacerbation risk by category. Methods: Patients were recruited from 21 centres in the USA, as part of the COPDGene study. Eligible patients were aged 45-80 years, had smoked for 10 pack-years or more, and had an FEV1/forced vital capacity (FVC) <0·7. Categories were defined with the modified Medical Research Council (mMRC) dyspnoea scale (score 0-1 vs ≥2) and the St George's Respiratory Questionnaire (SGRQ; ≥25 vs <25 as a surrogate for the COPD Assessment Test [CAT] ≥10 vs <10) in addition to COPD exacerbations in the previous year (<2 vs ≥ 2), and lung function (FEV1% predicted ≥50 vs <50). Statistical comparisons were done with k-sample permutation tests. This study cohort is registered with ClinicalTrials.gov, number NCT00608764. Findings: 4484 patients with COPD were included in this analysis. Category assignment using the mMRC scale versus SGRQ were similar but not identical. On the basis of the mMRC scale, 1507 (33·6%) patients were assigned to category A, 919 (20·5%) to category B, 355 (7·9%) to category C, and 1703 (38·0%) to category D; on the basis of the SGRQ, 1317 (29·4%) patients were assigned to category A, 1109 (24·7%) to category B, 221 (4·9%) to category C, and 1837 (41·0%) to category D (κ coefficient for agreement, 0·77). Significant heterogeneity in prospective exacerbation rates (exacerbations/person-years) were seen, especially in the D subcategories, depending on the risk factor that determined category assignment (lung function only [0·89, 95% CI 0·78-1·00]), previous exacerbation history only [1·34, 1·0-1·6], or both [1·86, 1·6-2·1; p<0·0001]). Interpretation: The GOLD classification emphasises the importance of symptoms and exacerbation risk when assessing COPD severity. The choice of symptom measure influences category assignment. The relative number of patients with low symptoms and high risk for exacerbations (category C) is low. Differences in exacerbation rates for patients in the highest risk category D were seen depending on whether risk was based on lung function, exacerbation history, or both.
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U2 - 10.1016/S2213-2600(12)70044-9
DO - 10.1016/S2213-2600(12)70044-9
M3 - Article
C2 - 24321803
AN - SCOPUS:84877102716
VL - 1
SP - 43
EP - 50
JO - The Lancet Respiratory Medicine
JF - The Lancet Respiratory Medicine
SN - 2213-2600
IS - 1
ER -