PMID- 21131468 OWN - NLM STAT- MEDLINE DCOM- 20110711 LR - 20220409 IS - 1535-4970 (Electronic) IS - 1073-449X (Linking) VI - 183 IP - 9 DP - 2011 May 1 TI - Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. PG - 1231-7 LID - 10.1164/rccm.201007-1179OC [doi] AB - RATIONALE: The 6-minute-walk test (6MWT) is a practical and clinically meaningful measure of exercise tolerance with favorable performance characteristics in various cardiac and pulmonary diseases. Performance characteristics in patients with idiopathic pulmonary fibrosis (IPF) have not been systematically evaluated. OBJECTIVES: To assess the reliability, validity, and responsiveness of the 6MWT and estimate the minimal clinically important difference (MCID) in patients with IPF. METHODS: The study population included all subjects completing a 6MWT in a clinical trial evaluating interferon gamma-1b (n = 822). Six-minute walk distance (6MWD) and other parameters were measured at baseline and at 24-week intervals using a standardized protocol. Parametric and distribution-independent correlation coefficients were used to assess the strength of the relationships between 6MWD and measures of pulmonary function, dyspnea, and health-related quality of life. Both distribution-based and anchor-based methods were used to estimate the MCID. MEASUREMENTS AND MAIN RESULTS: Comparison of two proximal measures of 6MWD (mean interval, 24 d) demonstrated good reliability (coefficient = 0.83; P < 0.001). 6MWD was weakly correlated with measures of physiologic function and health-related quality of life; however, values were consistently and significantly lower for patients with the poorest functional status, suggesting good construct validity. Importantly, change in 6MWD was highly predictive of mortality; a 24-week decline of greater than 50 m was associated with a fourfold increase in risk of death at 1 year (hazard ratio, 4.27; 95% confidence interval, 2.57- 7.10; P < 0.001). The estimated MCID was 24-45 m. CONCLUSIONS: The 6MWT is a reliable, valid, and responsive measure of disease status and a valid endpoint for clinical trials in IPF. FAU - du Bois, Roland M AU - du Bois RM AD - National Heart & Lung Institute, Imperial College, London, United Kingdom. r.dubois@imperial.ac.uk FAU - Weycker, Derek AU - Weycker D FAU - Albera, Carlo AU - Albera C FAU - Bradford, Williamson Z AU - Bradford WZ FAU - Costabel, Ulrich AU - Costabel U FAU - Kartashov, Alex AU - Kartashov A FAU - Lancaster, Lisa AU - Lancaster L FAU - Noble, Paul W AU - Noble PW FAU - Sahn, Steven A AU - Sahn SA FAU - Szwarcberg, Javier AU - Szwarcberg J FAU - Thomeer, Michiel AU - Thomeer M FAU - Valeyre, Dominique AU - Valeyre D FAU - King, Talmadge E Jr AU - King TE Jr LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PT - Validation Study DEP - 20101203 PL - United States TA - Am J Respir Crit Care Med JT - American journal of respiratory and critical care medicine JID - 9421642 SB - IM CIN - Am J Respir Crit Care Med. 2011 May 1;183(9):1122-4. PMID: 21531951 MH - Aged MH - Dyspnea/etiology/physiopathology MH - Exercise Test/*methods MH - Female MH - Humans MH - Idiopathic Pulmonary Fibrosis/complications/*diagnosis/physiopathology MH - Lung/physiopathology MH - Male MH - Middle Aged MH - Predictive Value of Tests MH - Quality of Life MH - Reproducibility of Results MH - *Walking EDAT- 2010/12/07 06:00 MHDA- 2011/07/12 06:00 CRDT- 2010/12/07 06:00 PHST- 2010/12/07 06:00 [entrez] PHST- 2010/12/07 06:00 [pubmed] PHST- 2011/07/12 06:00 [medline] AID - 201007-1179OC [pii] AID - 10.1164/rccm.201007-1179OC [doi] PST - ppublish SO - Am J Respir Crit Care Med. 2011 May 1;183(9):1231-7. doi: 10.1164/rccm.201007-1179OC. Epub 2010 Dec 3.