Minimal Clinically Important Differences in COPD Lung Function

The FEV1 is widely used by physicians in the diagnosis, staging, treatment, monitoring and establishing prognosis for patients with COPD. The MCID is the smallest difference which patients perceive as beneficial and which would mandate a change in patient management. A precise MCID for FEV1 has not been established. In attempt to establish a MCID for predose or trough FEV1, several limitations need to be addressed. There are issues such as reproducibility, repeatability, acceptability, variability, placebo effect, and equipment effects. Patient factors, such as baseline level of FEV1, albuterol reversibility, diurnal variation, influence the results. Nonetheless, using anchoring techniques, a change in pre dose FEV1 of about 100 mL can be perceived by patients, correlates with fewer relapses following exacerbations and is in the range usually achieved with bronchodilators approved for COPD. In the future, consistent reporting of spirometric variables, such as a predose FEV1 and other outcomes, can be incorporated into a more quantitative effort to establish the MCID. Also distributional/statistical methods may be useful in determining the MCID FEV1.

[1]  V. Brusasco,et al.  Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. , 2003, Thorax.

[2]  C. Jenkins,et al.  The TORCH (TOwards a Revolution in COPD Health) survival study protocol , 2004, European Respiratory Journal.

[3]  Richard Doll,et al.  Mortality in relation to smoking: 22 years' observations on female British doctors. , 1980, British medical journal.

[4]  B. Make,et al.  Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD , 2004, European Respiratory Journal.

[5]  W. MacNee,et al.  Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper , 2004, European Respiratory Journal.

[6]  J. Hankinson,et al.  Is my lung function really that good? Flow-type spirometer problems that elevate test results. , 2004, Chest.

[7]  A. Sharafkhaneh,et al.  Novel method for measuring effects of gas compression on expiratory flow. , 2004, American journal of physiology. Regulatory, integrative and comparative physiology.

[8]  Ciro Casanova,et al.  The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. , 2004, The New England journal of medicine.

[9]  P. Enright,et al.  Repeatability of spirometry in 18,000 adult patients. , 2004, American journal of respiratory and critical care medicine.

[10]  M. Decramer,et al.  Clinical Trial Design Considerations in Assessing Long‐Term Functional Impacts of Tiotropium in COPD: The Uplift Trial , 2004, COPD.

[11]  R. Pauwels,et al.  Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease: GOLD Executive Summary Updated 2003 , 2004, COPD.

[12]  J. Donohue,et al.  A Short-Term Comparison of Fluticasone Propionate/Salmeterol with Ipratropium Bromide/Albuterol for the Treatment of COPD , 2004, Treatments in respiratory medicine.

[13]  N. Anthonisen,et al.  Contemporary management of chronic obstructive pulmonary disease: scientific review. , 2003, JAMA.

[14]  J. Hankinson,et al.  Spirometric reference values for the 6-s FVC maneuver. , 2003, Chest.

[15]  E. R. Sutherland,et al.  Inhaled corticosteroids reduce the progression of airflow limitation in chronic obstructive pulmonary disease: a meta-analysis , 2003, Thorax.

[16]  N. Chavannes,et al.  Validity of spirometric testing in a general practice population of patients with chronic obstructive pulmonary disease (COPD) , 2003, Thorax.

[17]  N. Hanania,et al.  The Efficacy and Safety of Fluticasone Propionate (250 μg)/Salmeterol (50 μg) Combined in the Diskus Inhaler for the Treatment of COPD , 2003 .

[18]  J. Donohue,et al.  Tolerance to bronchodilating effects of salmeterol in COPD. , 2003, Respiratory medicine.

[19]  I. Stiell,et al.  Outpatient oral prednisone after emergency treatment of chronic obstructive pulmonary disease. , 2003, The New England journal of medicine.

[20]  C. Strange,et al.  Long-Term Effects of Inhaled Corticosteroids on FEV1 in Patients with Chronic Obstructive Pulmonary Disease , 2003, Annals of Internal Medicine.

[21]  R. Pauwels,et al.  Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial , 2003, The Lancet.

[22]  M Cazzola,et al.  Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD , 2003, European Respiratory Journal.

[23]  M. Pecchiari,et al.  Bronchodilation test in COPD: effect of inspiratory manoeuvre preceding forced expiration , 2003, European Respiratory Journal.

[24]  V. Brusasco,et al.  Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. , 2003, Thorax.

[25]  M. Stanbrook,et al.  Corticosteroid therapy for patients with acute exacerbations of chronic obstructive pulmonary disease: a systematic review. , 2002, Archives of internal medicine.

[26]  J. Yates,et al.  Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. , 2002, American journal of respiratory and critical care medicine.

[27]  E. Bateman,et al.  A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. , 2002, Chest.

[28]  W. Bailey,et al.  The FEV1/FEV6 predicts lung function decline in adult smokers. , 2002, Respiratory medicine.

[29]  Toru Oga,et al.  Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. , 2002, Chest.

[30]  S. K. Chhabra,et al.  Comparison of bronchodilator responsiveness in asthma and chronic obstructive pulmonary disease. , 2002, The Indian journal of chest diseases & allied sciences.

[31]  J. V. van Noord,et al.  Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease , 2002, European Respiratory Journal.

[32]  G. Della Cioppa,et al.  Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. , 2002, Chest.

[33]  L. Forkert,et al.  Response of lung volumes to inhaled salbutamol in a large population of patients with severe hyperinflation. , 2002, Chest.

[34]  D. Beaton,et al.  Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. , 2002, Current opinion in rheumatology.

[35]  J. V. van Noord,et al.  Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium , 2002, European Respiratory Journal.

[36]  B. Smith,et al.  Long-acting beta2-agonists for chronic obstructive pulmonary disease patients with poorly reversible airflow limitation. , 2001 .

[37]  C. Brambilla,et al.  Cilomilast, a selective phosphodiesterase-4 inhibitor for treatment of patients with chronic obstructive pulmonary disease: a randomised, dose-ranging study , 2001, The Lancet.

[38]  R. Zuwallack,et al.  Salmeterol plus theophylline combination therapy in the treatment of COPD. , 2001, Chest.

[39]  M. Decramer,et al.  The Bronchitis Randomized On NAC Cost-Utility Study (BRONCUS): hypothesis and design. BRONCUS-trial Committee. , 2001, The European respiratory journal.

[40]  D. D. Briggs,et al.  The spirometric efficacy of once-daily dosing with tiotropium in stable COPD: a 13-week multicenter trial. The US Tiotropium Study Group. , 2000, Chest.

[41]  R. Crapo,et al.  FEV(6) is an acceptable surrogate for FVC in the spirometric diagnosis of airway obstruction and restriction. , 2000, American journal of respiratory and critical care medicine.

[42]  S. Spencer,et al.  Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial , 2000, BMJ : British Medical Journal.

[43]  W. Hop,et al.  Long-term treatment of chronic obstructive pulmonary disease with salmeterol and the additive effect of ipratropium. , 2000, The European respiratory journal.

[44]  R. A. McIvor,et al.  The Placebo Effect in Asthma Drug Therapy Trials: A Meta-Analysis , 2000, The Journal of asthma : official journal of the Association for the Care of Asthma.

[45]  D. Niewoehner,et al.  Relation of FEV1 to Clinical Outcomes during Exacerbations of Chronic Obstructive Pulmonary Disease , 2000 .

[46]  W. Bailey,et al.  Smoking cessation and lung function in mild-to-moderate chronic obstructive pulmonary disease. The Lung Health Study. , 2000, American journal of respiratory and critical care medicine.

[47]  W. Tierney,et al.  Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. , 1999, Journal of clinical epidemiology.

[48]  L. Davies,et al.  Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial , 1999, The Lancet.

[49]  J Zhang,et al.  What are minimal important changes for asthma measures in a clinical trial? , 1999, The European respiratory journal.

[50]  A. Dirksen,et al.  Reversible and irreversible airflow obstruction as predictor of overall mortality in asthma and chronic obstructive pulmonary disease. , 1999, American journal of respiratory and critical care medicine.

[51]  J. Wilson,et al.  Pharmacoeconomic evaluation of a combination of ipratropium plus albuterol compared with ipratropium alone and albuterol alone in COPD. , 1999, Chest.

[52]  D. O’Donnell,et al.  Measurement of symptoms, lung hyperinflation, and endurance during exercise in chronic obstructive pulmonary disease. , 1998, American journal of respiratory and critical care medicine.

[53]  J. FitzGerald,et al.  The effect of adding ipratropium bromide to salbutamol in the treatment of acute asthma: a pooled analysis of three trials. , 1998, Chest.

[54]  R. S. Sen,et al.  Survival and FEV1 decline in individuals with severe deficiency of α1-antitrypsin , 1998 .

[55]  P. Jones,et al.  Quality of life changes in COPD patients treated with salmeterol. , 1997, American journal of respiratory and critical care medicine.

[56]  A. Buist,et al.  Routine nebulized ipratropium and albuterol together are better than either alone in COPD. The COMBIVENT Inhalation Solution Study Group. , 1997, Chest.

[57]  D. Redelmeier,et al.  Spirometry and dyspnea in patients with COPD. When small differences mean little. , 1996, Chest.

[58]  John L. Hankinson,et al.  Standardization of Spirometry, 1994 Update. American Thoracic Society. , 1995, American journal of respiratory and critical care medicine.

[59]  P Enright,et al.  Selection of spirometric measurements in a clinical trial, the Lung Health Study. , 1995, American journal of respiratory and critical care medicine.

[60]  W. Bailey,et al.  Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study. , 1995, JAMA.

[61]  W. Bailey,et al.  Effects of Smoking Intervention and the Use of an Inhaled Anticholinergic Bronchodilator on the Rate of Decline of FEV1 , 1994 .

[62]  A. Buist,et al.  In chronic obstructive pulmonary disease, a combination of ipratropium and albuterol is more effective than either agent alone: An 85-day multicenter trial , 1994 .

[63]  J. Karpel,et al.  A comparison of inhaled ipratropium, oral theophylline plus inhaled beta-agonist, and the combination of all three in patients with COPD. , 1994, Chest.

[64]  A. Rebuck,et al.  Is the short-term response to inhaled beta-adrenergic agonist sensitive or specific for distinguishing between asthma and COPD? , 1994, Chest.

[65]  J E Cotes,et al.  Lung volumes and forced ventilatory flows , 1993, European Respiratory Journal.

[66]  J E Cotes,et al.  Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. , 1993, The European respiratory journal. Supplement.

[67]  D. Postma,et al.  Interpretation of bronchodilator response in patients with obstructive airways disease. The Dutch Chronic Non-Specific Lung Disease (CNSLD) Study Group. , 1992, Thorax.

[68]  J. Hankinson,et al.  Acceptability and reproducibility criteria of the American Thoracic Society as observed in a sample of the general population. , 1991, The American review of respiratory disease.

[69]  G. Guyatt,et al.  Measurement of health status. Ascertaining the minimal clinically important difference. , 1989, Controlled clinical trials.

[70]  T. Petty,et al.  Dose Response to Ipratropium as a Nebulized Solution in Patients with Chronic Obstructive Pulmonary Disease: Reply , 1989 .

[71]  M. Dunst Dose response to ipratropium as a nebulized solution in patients with chronic obstructive pulmonary disease. , 1989, The American review of respiratory disease.

[72]  T. Petty,et al.  Dose response to ipratropium as a nebulized solution in patients with chronic obstructive pulmonary disease. A three-center study. , 1989, The American review of respiratory disease.

[73]  Buist As Standardization of spirometry. , 1987 .

[74]  G. Mchardy,et al.  Short term variability in FEV1 and bronchodilator responsiveness in patients with obstructive ventilatory defects. , 1987, Thorax.

[75]  G. Little,et al.  The natural history of chronic bronchitis and emphysema , 1979 .

[76]  P. Wright,et al.  The Natural History of Chronic Bronchitis and Emphysema , 1977 .

[77]  K. Prowse,et al.  How many blows make an F.E.V.1.0? , 1966, Lancet.