Do We Know the Minimal Clinically Important Difference (MCID) for COPD Exacerbations?

References

• Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma 
Quality of Life Questionnaire. Eur Respir J 1999; 14:32–
38.
   PubMed Web of Science ®Google Scholar
• Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J 1999; 14:902–907.
   PubMed Web of Science ®Google Scholar
• Pizzichini E, Pizzichini MMM, Efthimiadis A, Indices of airway inflammation in induced sputum: Reproducibility and validity of cell and fluid-phase measurements. Amer J Respir Crit Care Med 1996; 154:308–317.
   PubMed Web of Science ®Google Scholar
• Horvath I, Donnelly LE, Kiss A, Combined use of exhaled hydrogen peroxide and nitric oxide in monitoring asthma. Amer J Respir Crit Care Med 1998; 158:1042–1046.
   PubMed Web of Science ®Google Scholar
• Chapman KR, Verbeek PR, White JG, Rebuck AS. Effect of a short course of prednisone in the prevention of early relapse after the emergency room treatment of acute asthma. New Engl J Med 1991; 324:788–794.
   PubMed Web of Science ®Google Scholar
• Chapman KR, Boulet LP, Rea RM, Franssen E. Suboptimal asthma control: prevalence, detection and consequences in general practice. Eur Respir J 2008; 31:320–325.
   PubMed Web of Science ®Google Scholar
• Laitinen LA, Laitinen A, Haahtela T. A comparative study of the effects of an inhaled corticosteroid, budesonide, and a â2-agonist, terbutaline, on airway inflammation in newly diagnosed asthma: A randomized, double- blind, parallel-group controlled trial. J Allergy Clin Immunol 1992; 90:32–42.
   PubMed Web of Science ®Google Scholar
• Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation: The St. George's Respiratory Questionnaire. Am Rev Respir Dis 1992; 145:1321–1327.
   PubMed Web of Science ®Google Scholar
• O'Donnell DE, Fluge T, Gerken F, Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 2004; 23:832–840.
   PubMed Web of Science ®Google Scholar
• Sin DD, Lacy P, York E, Man SF. Effects of fluticasone on systemic markers of inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 170:760–765.
   PubMed Web of Science ®Google Scholar
• Health Indicators 2008. Canadian Institutes for Health Research, 2008. (Accessed 25 March 2012).
   Google Scholar
• Spencer S, Jones PW, Globe SG. Time course of recovery of health status following an infective exacerbation of chronic bronchitis. Thorax 2003; 58:589–593.
   PubMed Web of Science ®Google Scholar
• Chang CL, Sullivan GD, Karalus NC, Hancox RJ, McLachlan JD, Mills GD. Audit of acute admissions of chronic obstructive pulmonary disease: inpatient management and outcome. Intern Med J 2007; 37:236–241.
   PubMed Web of Science ®Google Scholar
• Gunen H, Hacievliyagil SS, Kosar F, Factors affecting survival of hospitalised patients with COPD. Eur Respir J 2005; 26:234–241.
   PubMed Web of Science ®Google Scholar
• Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005; 60:925–931.
   PubMed Web of Science ®Google Scholar
• Donaldson GC, Seemungal TAR, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002; 57:847–852.
   PubMed Web of Science ®Google Scholar
• Calverley PM. Minimal clinically important difference–exacerbations of COPD. COPD 2005; 2:143–148.
   PubMedGoogle Scholar
• Cazzola M, MacNee W, Martinez FJ, Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J 2008; 31:416–469.
   PubMed Web of Science ®Google Scholar
• Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis 1987; 40:171–178.
   PubMedGoogle Scholar
• Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10:407–415.
   PubMedGoogle Scholar
• Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002; 77:371–383.
   PubMed Web of Science ®Google Scholar
• Schunemann HJ, Akl EA, Guyatt GH. Interpreting the results of patient reported outcome measures in clinical trials: the clinician's perspective. Health Qual Life Outcomes 2006; 4:62.
   PubMed Web of Science ®Google Scholar
• Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting 
the significance of changes in health-related quality-of-life scores. J Clin Oncol: 1998; 16:139–44.
   PubMed Web of Science ®Google Scholar
• Norman GR. The relation between the minimally important difference and patient benefit. COPD 2005; 2:69–73.
   PubMedGoogle Scholar
• de Vet HC, Terwee CB, Ostelo RW, Beckerman H, Knol DL, Bouter LM. Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change. Health Qual Life Outcomes 2006; 4:54–58.
   PubMed Web of Science ®Google Scholar
• Gatchel RJ, Mayer TG. Testing minimal clinically important difference: additional comments and scientific reality testing. Spine J 2010; 10:330–332.
   PubMed Web of Science ®Google Scholar
• Jones PW. St. George's Respiratory Questionnaire: MCID. COPD 2005; 2:75–79.
   PubMedGoogle Scholar
• Schunemann HJ, Griffith L, Jaeschke R, Goldstein R, Stubbing D, Guyatt GH. Evaluation of the minimal important difference for the feeling thermometer and the St. George's Respiratory Questionnaire in patients with chronic airflow obstruction. J Clin Epidemiol 2003; 56:1170–1176.
   PubMed Web of Science ®Google Scholar
• Langsetmo L, Platt RW, Ernst P, Bourbeau J. Underreporting exacerbation of chronic obstructive pulmonary disease in a longitudinal cohort. AmJ Respir Crit Care Med 2008; 177:396–401.
   PubMed Web of Science ®Google Scholar
• Suissa S. Statistical treatment of exacerbations in therapeutic trials of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2006; 173:842–846.
   PubMed Web of Science ®Google Scholar
• Vogelmeier C, Hederer B, Glaab T, Tiotropium versus salmeterol for the prevention of exacerbations of COPD. New Engl J Med 2011; 364:1093–1103.
   PubMed Web of Science ®Google Scholar
• Petty TL. The combination of ipratropium and albuterol is more effective than either agent alone. Chest 1995; 107 Suppl.: 183S–186S.
   PubMedGoogle Scholar
• Aaron SD, Vandemheen KL, Fergusson D, Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Inter Med 2007; 146:545–555.
   PubMed Web of Science ®Google Scholar
• Suissa S, Ernst P, Vandemheen KL, Aaron SD. Methodological issues in therapeutic trials of COPD. Eur Respir J: 2008; 31:927–933.
   PubMed Web of Science ®Google Scholar
• Aaron SD, Fergusson D, Marks GB, Counting, analysing and reporting exacerbations of COPD in randomised controlled trials. Thorax 2008; 63:122–128.
   PubMed Web of Science ®Google Scholar
• Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet 2009; 374:685–694.
   PubMed Web of Science ®Google Scholar
• Anzueto A, Leimer I, Kesten S. Impact of frequency of COPD exacerbations on pulmonary function, health status and clinical outcomes. Int J Chron Obstruct Pulmon Dis 2009; 4:245–251.
   PubMedGoogle Scholar
• Zhou Y, Wang X, Zeng X, Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebo-controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology 2006; 11:603–610.
   PubMed Web of Science ®Google Scholar
• Calverley PM, Anderson JA, Celli B, Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356:775–789.
   PubMed Web of Science ®Google Scholar
• Boyd G, Morice AH, Pounsford JC, Siebert M, Peslis N, Crawford C. An evaluation of salmeterol in the treatment of chronic obstructive pulmonary disease (COPD). Eur Respir J 1997; 10:815–821.
   PubMed Web of Science ®Google Scholar
• Rossi A, Kristufek P, Levine BE, Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest 2002; 121:1058–1069.
   PubMed Web of Science ®Google Scholar
• Donohue JF, Fogarty C, Lotvall J, Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010; 182:155–162.
   PubMed Web of Science ®Google Scholar
• van Noord JA, Bantje TA, Eland ME, Korducki L, Cornelissen PJG, Dutch Tiotropium SG. A randomised controlled comparison of tiotropium and ipratropium in the treatment of chronic obstructive pulmonary disease. Thorax 2000; 55:289–294.
   PubMed Web of Science ®Google Scholar
• Vincken W, van Noord JA, Greefhorst AP, Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J 2002;19:209–16.
   PubMed Web of Science ®Google Scholar
• Casaburi R, Mahler DA, Jones PW, A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002; 19:217–224.
   PubMed Web of Science ®Google Scholar
• Tashkin DP, Celli B, Senn S, A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359:1543–1554.
   PubMed Web of Science ®Google Scholar
• Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. Br Med J 2000; 320:1297–1303.
   PubMed Web of Science ®Google Scholar
• Calverley PM, Boonsawat W, Cseke Z, Zhong N, Peterson S, Olsson H. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003; 22:912–919.
   PubMed Web of Science ®Google Scholar
• Calverley PMA, Spencer S, Willits L, Burge PS, Jones PW, Isolde SG. Withdrawal from treatment as an outcome in the ISOLDE study of COPD. Chest 2003; 124:1350–1356.
   PubMed Web of Science ®Google Scholar
• Szafranski W, Cukier A, Ramirez A, Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003; 21:74–81.
   PubMed Web of Science ®Google Scholar