PMID- 21940789 OWN - NLM STAT- MEDLINE DCOM- 20120207 LR - 20220409 IS - 1535-4970 (Electronic) IS - 1073-449X (Linking) VI - 184 IP - 12 DP - 2011 Dec 15 TI - Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference. PG - 1382-9 LID - 10.1164/rccm.201105-0840OC [doi] AB - RATIONALE: Forced vital capacity (FVC) is an established measure of pulmonary function in idiopathic pulmonary fibrosis (IPF). Evidence regarding its measurement properties and minimal clinically important difference (MCID) in this population is limited. OBJECTIVES: To assess the reliability, validity, and responsiveness of FVC and estimate the MCID in patients with IPF. METHODS: The study population included all 1,156 randomized patients in two clinical trials of IFN-gamma1b. FVC and other measures of functional status were measured at screening or baseline and 24-week intervals thereafter. Reliability was assessed based on two proximal measures of FVC, validity was assessed based on correlations between FVC and other measures of functional status, and responsiveness was assessed based on the relationship between 24-week changes in FVC and other measures of functional status. Distribution-based and anchor-based methods were used to estimate the MCID. MEASUREMENTS AND MAIN RESULTS: Correlation of percent-predicted FVC between measurements (mean interval, 18 d) was high (r = 0.93; P < 0.001). Correlations between FVC and other parameters were generally weak, with the strongest observed correlation between FVC and carbon monoxide diffusing capacity (r = 0.38; P < 0.001). Correlations between change in FVC and changes in other parameters were slightly stronger (range, r = 0.16-0.37; P < 0.001). Importantly, 1-year risk of death was more than twofold higher (P < 0.001) in patients with a 24-week decline in FVC between 5% and 10%. The estimated MCID was 2-6%. CONCLUSIONS: FVC is a reliable, valid, and responsive measure of clinical status in patients with IPF, and a decline of 2-6%, although small, represents a clinically important difference. FAU - du Bois, Roland M AU - du Bois RM AD - Imperial College, London, UK. ron@du-bois.co.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 - King, Talmadge E Jr AU - King TE Jr FAU - Lancaster, Lisa AU - Lancaster L FAU - Noble, Paul W AU - Noble PW FAU - Sahn, Steven A AU - Sahn SA FAU - Thomeer, Michiel AU - Thomeer M FAU - Valeyre, Dominique AU - Valeyre D FAU - Wells, Athol U AU - Wells AU LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Validation Study DEP - 20110922 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 Dec 15;184(12):1329-30. PMID: 22174111 MH - Aged MH - Female MH - Humans MH - Idiopathic Pulmonary Fibrosis/*diagnosis MH - Male MH - Middle Aged MH - Predictive Value of Tests MH - Prognosis MH - Reproducibility of Results MH - *Vital Capacity EDAT- 2011/09/24 06:00 MHDA- 2012/02/09 06:00 CRDT- 2011/09/24 06:00 PHST- 2011/09/24 06:00 [entrez] PHST- 2011/09/24 06:00 [pubmed] PHST- 2012/02/09 06:00 [medline] AID - 201105-0840OC [pii] AID - 10.1164/rccm.201105-0840OC [doi] PST - ppublish SO - Am J Respir Crit Care Med. 2011 Dec 15;184(12):1382-9. doi: 10.1164/rccm.201105-0840OC. Epub 2011 Sep 22.