PMID- 27332504
OWN - NLM
STAT- MEDLINE
DCOM- 20170719
LR  - 20220410
IS  - 1535-4970 (Electronic)
IS  - 1073-449X (Print)
IS  - 1073-449X (Linking)
VI  - 194
IP  - 12
DP  - 2016 Dec 15
TI  - The 6-Minute-Walk Distance Test as a Chronic Obstructive Pulmonary Disease 
      Stratification Tool. Insights from the COPD Biomarker Qualification Consortium.
PG  - 1483-1493
AB  - RATIONALE: The 6-minute-walk distance (6MWD) test predicts mortality in chronic 
      obstructive pulmonary disease (COPD). Whether variability in study type 
      (observational vs. interventional) or region performed limits use of the test as 
      a stratification tool or outcome measure for therapeutic trials is unclear. 
      OBJECTIVES: To analyze the original data from several large observational studies 
      and from randomized clinical trials with bronchodilators to support the 
      qualification of the 6MWD test as a drug development tool in COPD. METHODS: 
      Original data from 14,497 patients with COPD from six observational (n = 9,641) 
      and five interventional (n = 4,856) studies larger than 100 patients and longer 
      than 6 months in duration were included. The geographical, anthropometrics, 
      FEV(1), dyspnea, comorbidities, and health status scores were measured. 
      Associations between 6MWD and mortality, hospitalizations, and exacerbations 
      adjusted by study type, age, and sex were evaluated. Thresholds for outcome 
      prediction were calculated using receiver operating curves. The change in 6MWD 
      after inhaled bronchodilator treatment and surgical lung volume reduction were 
      analyzed to evaluate the responsiveness of the test as an outcome measure. 
      MEASUREMENTS AND MAIN RESULTS: The 6MWD was significantly lower in nonsurvivors, 
      those hospitalized, or who exacerbated compared with those without events at 6, 
      12, and greater than 12 months. At these time points, the 6MWD receiver operating 
      characteristic curve-area under the curve to predict mortality was 0.71, 0.70, 
      and 0.68 and for hospitalizations was 0.61, 0.60, and 0.59, respectively. After 
      treatment, the 6MWD was not different between placebo and bronchodilators but 
      increased after surgical lung volume reduction compared with medical therapy. 
      Variation across study types (observational or therapeutic) or regions did not 
      confound the ability of 6MWD to predict outcome. CONCLUSIONS: The 6MWD test can 
      be used to stratify patients with COPD for clinical trials and interventions 
      aimed at modifying exacerbations, hospitalizations, or death.
FAU - Celli, Bartolome
AU  - Celli B
AD  - 1 Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Tetzlaff, Kay
AU  - Tetzlaff K
AD  - 2 Boehringer Ingelheim, Ingelheim, Germany.
AD  - 3 Department of Sports Medicine, University of Tuebingen, Tuebingen, Germany.
FAU - Criner, Gerard
AU  - Criner G
AD  - 4 Temple University Medical Center, Philadelphia, Pennsylvania.
FAU - Polkey, Michael I
AU  - Polkey MI
AD  - 5 National Institute for Health Research Respiratory Biomedical Research Unit at 
      the Royal Brompton and Harefield National Health Service Foundation Trust and 
      Imperial College, London, United Kingdom.
FAU - Sciurba, Frank
AU  - Sciurba F
AD  - 6 University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
FAU - Casaburi, Richard
AU  - Casaburi R
AD  - 7 Rehabilitation Clinical Trials Center, Los Angeles Biomedical Research 
      Institute at Harbor-UCLA Medical Center, Torrance, California.
FAU - Tal-Singer, Ruth
AU  - Tal-Singer R
AD  - 8 GlaxoSmithKline Research and Development, King of Prussia, Pennsylvania.
FAU - Kawata, Ariane
AU  - Kawata A
AD  - 9 Evidera, Bethesda, Maryland.
FAU - Merrill, Debora
AU  - Merrill D
AD  - 10 COPD Foundation, Washington, District of Columbia; and.
FAU - Rennard, Stephen
AU  - Rennard S
AD  - 11 Division of Pulmonary, Allergy, Sleep and Critical Care Medicine, University 
      of Nebraska Medical Center, Omaha, Nebraska.
CN  - COPD Biomarker Qualification Consortium
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
RN  - 0 (Biomarkers)
SB  - IM
MH  - Aged
MH  - Biomarkers
MH  - Consensus Development Conferences as Topic
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Predictive Value of Tests
MH  - Pulmonary Disease, Chronic Obstructive/*diagnosis/*physiopathology
MH  - Reproducibility of Results
MH  - Walk Test/*methods/*statistics & numerical data
PMC - PMC5215028
OTO - NOTNLM
OT  - 6-minute-walk distance
OT  - chronic obstructive pulmonary disease
OT  - outcomes
EDAT- 2016/06/23 06:00
MHDA- 2017/07/20 06:00
PMCR- 2017/06/15
CRDT- 2016/06/23 06:00
PHST- 2016/06/23 06:00 [pubmed]
PHST- 2017/07/20 06:00 [medline]
PHST- 2016/06/23 06:00 [entrez]
PHST- 2017/06/15 00:00 [pmc-release]
AID - 10.1164/rccm.201508-1653OC [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 2016 Dec 15;194(12):1483-1493. doi: 
      10.1164/rccm.201508-1653OC.