The 6-Minute-Walk Distance Test as a Chronic Obstructive Pulmonary Disease Stratification Tool: Insights from the COPD Biomarker Qualification Consortium
Year: 2016
Type: article
Abstract: 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: , 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.
Institutions: Brigham and Women's Hospital, Harvard University, Boehringer Ingelheim (Germany), University of Tübingen, Temple University, National Health Service, National Institute for Health and Care Research, Imperial College London, University of Pittsburgh Medical Center, University of California, Los Angeles, The Lundquist Institute, Harbor–UCLA Medical Center, COPD Foundation, University of Nebraska Medical Center
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2464969376