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The minimal clinically important difference (MCID) for the six minute walk (6MW) test in COPD in relation to death

Michael Polkey, Martijn Spruit, Lisa Edwards, Michael Watkins, Vincent Pinto-Plata, Jørgen Vestbo, Peter Calverley, Ruth Tal-Singer, Alvar Agusti, Per Bakke, Harvey Coxson, David Lomas, William MacNee, Stephen Rennard, Edwin Silverman, Bruce Miller, Courtney Crim, Julie Yates, Emiel Wouters, Bartholeme Celli
European Respiratory Journal 2012 40: P601; DOI:
Michael Polkey
1Consultant Physician, Royal Brompton Hospital, London, United Kingdom
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Martijn Spruit
2Program Development Centre, CIRO+, a Centre of Expertise for Chronic Organ Failure, Horn, Netherlands
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Lisa Edwards
3GSK, GlaxoSmithKline, Research Triangle Park,, NC, United States
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Michael Watkins
3GSK, GlaxoSmithKline, Research Triangle Park,, NC, United States
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Vincent Pinto-Plata
4Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States
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Jørgen Vestbo
5Respiratory Medicine, University of Manchester, United Kingdom
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Peter Calverley
6Department of Respiratory Medicine, School of Clinical Science, University of Liverpool, United Kingdom
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Ruth Tal-Singer
7Galaxy Initiative, GlaxoSmithKline, King of Prussia, PA, United States
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Alvar Agusti
8Institut del Tòrax, Hospital Clínic, IDIBAPS, CIBER Enfermedades Respiratorias and Fundación Caubet-Cimera, Barcelona, Spain
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Per Bakke
9Institute of Medicine, University of Bergen, Norway
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Harvey Coxson
10Department of Radiology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada
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David Lomas
11Department of Medicine, Cambridge Institute for Medical Research, University of Cambridge, United Kingdom
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William MacNee
12ELEGI Colt Research Labs, University of Edinburgh/MRC Centre for Inflammation Research, The Queen's Medical Research Institute, Edinburgh, United Kingdom
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Stephen Rennard
13Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of Nebraska Medical Center, Omaha, NE, United States
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Edwin Silverman
14Channing Laboratory, Brigham & Women's Hospital, Boston, MA, United States
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Bruce Miller
7Galaxy Initiative, GlaxoSmithKline, King of Prussia, PA, United States
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Courtney Crim
3GSK, GlaxoSmithKline, Research Triangle Park,, NC, United States
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Julie Yates
3GSK, GlaxoSmithKline, Research Triangle Park,, NC, United States
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Emiel Wouters
2Program Development Centre, CIRO+, a Centre of Expertise for Chronic Organ Failure, Horn, Netherlands
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Bartholeme Celli
4Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States
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Abstract

Introduction: The 6MW is used to assess interventions in COPD but existing estimates of the MCID for have been derived from narrow cohorts where a non-blinded intervention, for example pulmonary rehabilitation, have been applied.

Objective: To define the MCID for 6MW distance in an unselected population.

Methods: Data from the ECLIPSE cohort were used. Briefly 2112 patients were prospectively followed for 3 years in a multicentre study. We defined an index event as death or first hospitalisation and calculated the change in 6MW (Δ6MW) in the last 12 month period before the event occurred. If a patient did not have an event the last 12 month change was used. We also related Δ6MW to commonly used outcome measures in COPD; FEV1 and St Georges Respiratory Questionnaire (SGRQ-C).

Results: Of the subjects with Δ6MW, 94 patients died and 323 were hospitalised. 6MW fell by mean (SD) 29.7 (82.9)m more in those who died than survivors (p<0.001). No significant difference in Δ6MW was observed in those who had a first hospitalisation than those who did not. Cox proportional hazard modelling showed that a Δ6MW of more than –30m conferred a hazard ratio of 1.93 (95% CI: 1.29, 2.90; p=0.001) for death. Weak relationships only were observed between Δ6MW and ΔFEV1 or Δ SGRQ.

Conclusions: A fall in 6MW of 30m or more is associated with increased risk of death in patients with COPD and therefore represents a clinically significant MCID for this test. The modest relationships between Δ6MW and ΔFEV1 or Δ SGRQ suggest that anchor based methods for determining MCID are context dependent.

Funded by GSK (SCO104960; NCT00292552).

  • COPD - management
  • Exercise
  • Skeletal muscle
  • © 2012 ERS
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The minimal clinically important difference (MCID) for the six minute walk (6MW) test in COPD in relation to death
Michael Polkey, Martijn Spruit, Lisa Edwards, Michael Watkins, Vincent Pinto-Plata, Jørgen Vestbo, Peter Calverley, Ruth Tal-Singer, Alvar Agusti, Per Bakke, Harvey Coxson, David Lomas, William MacNee, Stephen Rennard, Edwin Silverman, Bruce Miller, Courtney Crim, Julie Yates, Emiel Wouters, Bartholeme Celli
European Respiratory Journal Sep 2012, 40 (Suppl 56) P601;

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The minimal clinically important difference (MCID) for the six minute walk (6MW) test in COPD in relation to death
Michael Polkey, Martijn Spruit, Lisa Edwards, Michael Watkins, Vincent Pinto-Plata, Jørgen Vestbo, Peter Calverley, Ruth Tal-Singer, Alvar Agusti, Per Bakke, Harvey Coxson, David Lomas, William MacNee, Stephen Rennard, Edwin Silverman, Bruce Miller, Courtney Crim, Julie Yates, Emiel Wouters, Bartholeme Celli
European Respiratory Journal Sep 2012, 40 (Suppl 56) P601;
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