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Paul Enright, MD; Vito Brusasco, MD
Author and Funding Information

From the University of Arizona (Dr Enright); and the Department of Internal Medicine (Dr Brusasco), University of Genoa.

Correspondence to: Paul Enright, MD, 4460 Ina Rd, Tucson, AZ 85718; e-mail: lungguy@gmail.com


Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Enright has been paid in the past year by the American Thoracic Society, the COPD Foundation, and CME companies to prepare CME media on the topic of spirometry for COPD case finding by primary care providers. He was also paid by InterMune and Gilead to review and report the quality of pulmonary function tests for clinical trials of patients with idiopathic pulmonary fibrosis. He was trained in developing persuasive presentations and effective public speaking as a member of the Boehringer Ingelheim speakers’ bureau of key opinion leaders. He has received six-figure consulting fees from Schering and from Pfizer Inc for reviewing the quality of spirometry tests done for a study of mometasone for COPD and varenicline for smoking cessation in patients with COPD. During the past 3 years, he has been invited to give talks at the international meetings of professional organizations in which he presented evidence againsts the continued use of the faulty fixed ratio for the detection of COPD. In exchange for these talks, his registration fees were waived and sometimes his travel costs were reimbursed. During the past month, he was invited to do this again during the CHEST meeting in Honolulu. Dr Brusasco reported that he received funds from Lofarma for consultancies in 2008, speaking fees at conferences sponsored by Boehringer Ingelheim in 2008, fees from GlaxoSmithKline for speaking at a conference in 2010, fees from Beohringer Ingelheim for consultancy in 2009 and 2010, fees from Deep Breeze for consultancy in 2009 and 2010, fees from Dompé for consultancy in 2009 and 2010, fees in 2008 from GlaxoSmithKline for participating in advisory boards, fees in 2010 from Nycomed for consultancy, fees from Menarini for consultancy in 2008, and fees from Novartis for participating in an Advisory Board in 2010. Dr Brusasco’s institution participated in several multicenter clinical trials financed by pharmaceutical companies (Chiesi; Merck, Sharpe & Dohme; Boehringer Ingelheim; GlaxoSmithKline; Novartis).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2011 American College of Chest Physicians


Chest. 2011;139(5):1254-1255. doi:10.1378/chest.11-0359
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To the Editor:

We thank Dr Fabbri for his letter, which gives us the opportunity to further clarify our view1 on this issue without fear of self-plagiarism, a term that includes “text recycling” but not opinions consistently repeated on different occasions.2,3 We acknowledge the merit of the GOLD (Global Initiative for Chronic Obstructive Lung Disease) initiative for COPD, in providing a “living document” that is updated every year in response to newly published evidence. Certainly, the majority of the GOLD guideline is based on good evidence, but its current recommendation to use the faulty FEV1/FVC fixed ratio to define airway obstruction is not and, thus, should be changed soon.4

During the past 3 decades, several clinical trials have used the fixed FEV1/FVC ratio as an inclusion criterion, and we participated in some of them. This criterion allowed inclusion of a broad range of smokers, with lung function ranging from normal (FEV1 above the fifth percentile) to severely compromised, which increased the statistical power to demonstrate differences in outcome between severity categories (including those with borderline or no airway obstruction). But it is a mistake to consider the inclusion criteria of these studies as providing evidence for a definition of clinically important COPD, especially when diagnosing and treating individual patients. Note that the number of subjects in some of these studies with the ratio <0.70 but above the fifth percentile lower limit of normal was negligible—for example, 13 out of 718, or 1.8%.5

In the past, the investigators in large, multicenter, randomized, clinical trials considered change in FEV1, an index of the natural history of COPD, as the primary outcome measure. Only after these randomized clinical trials proved that available inhaled drugs were not effective in slowing the loss of FEV1 were alternate COPD outcome measures, such as improved quality of life or reductions in outpatient exacerbations, proposed.6

We agree with Drs Robberts and Schermer that the important “million-dollar question” is how to confidently detect the susceptible smokers who will subsequently develop clinically important COPD if they continue smoking. As shown by results from the Lung Health Study7 in middle-aged smokers with FEV1/FVC <0.70 (see Figure 2 in our counterpoint editorial1), those with an FEV1 >70%, a threshold close to the lower limit of normal for FEV1, had a mean subsequent loss of FEV1 near normal (−1.2% per year). Only below the middle of GOLD stage 2 was the mean annual loss of FEV1 relatively rapid. However, there was a very wide variation, so the predictive power was very low even when all baseline characteristics of the smokers were considered in a multivariate model (R2 =0.10). Other cohort studies have collected longitudinal data from large numbers of smoking adults, including those >65 years of age, and we encourage them to similarly analyze these data. We eagerly await new genetic and biochemical markers, which will begin to clear the smoke in our prophetic crystal ball. It is actually more like a $5 billion (or Euro) question, since that is the current worldwide COPD inhaler market, which would greatly expand if we could confidently predict who is developing COPD and had a drug to substantially dampen the progression of COPD in these susceptible smokers. Don’t hold your breath.

Enright P, Brusasco V. Counterpoint: should we abandon FEV1/FVC <0.70 to detect airway obstruction? Yes. Chest. 2010;1385:1040-1042. [CrossRef] [PubMed]
 
Chalmers I. Intentional self-plagiarism. Lancet. 2009;3749699:1422. [CrossRef] [PubMed]
 
DHHS Office of Research IntegrityDHHS Office of Research Integrity Avoiding plagiarism, self-plagiarism, and other questionable writing practices: a guide to ethical writing. Office of Research Integrity Web site.http://ori.dhhs.gov/education/products/plagiarism/. Accessed February 9, 2011.
 
Quanjer PH, Enright PL, Miller MR. Pulmonaria Group Pulmonaria Group Open letter: the need to change the method for defining mild airway obstruction. Prim Care Respir J. 2010;193:288-291. [CrossRef] [PubMed]
 
Calverley PM, Kuna P, Monsó E. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010;10412:1858-1868. [CrossRef] [PubMed]
 
Cazzola M, MacNee W, Martinez FJ, et al; American Thoracic Society American Thoracic Society European Respiratory Society Task Force on outcomes of COPD European Respiratory Society Task Force on outcomes of COPD Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;312:416-469. [CrossRef] [PubMed]
 
Miller MR, Quanjer PH, Swanney MP, Ruppel G, Enright PL. Interpreting lung function data using 80% predicted and fixed thresholds misclassifies more than 20% of patients. Chest. 2011;1391:52-59. [CrossRef] [PubMed]
 

Figures

Tables

References

Enright P, Brusasco V. Counterpoint: should we abandon FEV1/FVC <0.70 to detect airway obstruction? Yes. Chest. 2010;1385:1040-1042. [CrossRef] [PubMed]
 
Chalmers I. Intentional self-plagiarism. Lancet. 2009;3749699:1422. [CrossRef] [PubMed]
 
DHHS Office of Research IntegrityDHHS Office of Research Integrity Avoiding plagiarism, self-plagiarism, and other questionable writing practices: a guide to ethical writing. Office of Research Integrity Web site.http://ori.dhhs.gov/education/products/plagiarism/. Accessed February 9, 2011.
 
Quanjer PH, Enright PL, Miller MR. Pulmonaria Group Pulmonaria Group Open letter: the need to change the method for defining mild airway obstruction. Prim Care Respir J. 2010;193:288-291. [CrossRef] [PubMed]
 
Calverley PM, Kuna P, Monsó E. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010;10412:1858-1868. [CrossRef] [PubMed]
 
Cazzola M, MacNee W, Martinez FJ, et al; American Thoracic Society American Thoracic Society European Respiratory Society Task Force on outcomes of COPD European Respiratory Society Task Force on outcomes of COPD Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;312:416-469. [CrossRef] [PubMed]
 
Miller MR, Quanjer PH, Swanney MP, Ruppel G, Enright PL. Interpreting lung function data using 80% predicted and fixed thresholds misclassifies more than 20% of patients. Chest. 2011;1391:52-59. [CrossRef] [PubMed]
 
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