PMID- 29099620 OWN - NLM STAT- MEDLINE DCOM- 20190709 LR - 20240207 IS - 1535-4970 (Electronic) IS - 1073-449X (Print) IS - 1073-449X (Linking) VI - 197 IP - 5 DP - 2018 Mar 1 TI - Reliability and minimal clinically important differences of forced vital capacity: Results from the Scleroderma Lung Studies (SLS-I and SLS-II). PG - 644-652 LID - 10.1164/rccm.201709-1845OC [doi] AB - OBJECTIVES: To assess the reliability and the minimal clinically important differences (MCID) for FVC% predicted in the Scleroderma Lung Study I and II. METHODS: Using data from SLS I and II (N=300), we evaluated the test-retest reliability for FVC% predicted (FVC%; screening vs. baseline) using intra-class correlation (ICC). MCID estimates at 12 months were calculated in the pooled cohort (SLS-I and II) using 2 anchors: Transition Dyspnea Index (>/=change of 1.5 units for improvement and worsening, respectively) and the SF-36 Health Transition question: "Compared to one year ago, how would you rate your health in general now?", where "somewhat better" or "somewhat worse" were defined as the MCID estimates. We next assessed the association of MCID estimates for improvement and worsening of FVC% with patient reported outcomes (PROs) and computer-assisted quantitation of extent of fibrosis (QLF) and of total ILD (QILD) on HRCT. RESULTS: Reliability of FVC%, assessed at a mean of 34 days, was 0.93 for the pooled cohort. The MCID estimates for the pooled cohort at 12 months for FVC% improvement ranged from 3.0 % to 5.3% and for worsening from -3.0% to -3.3%. FVC% improvement by >/=MCID was associated with either statistically significant or numerical improvements in some PROs, QILD, and QLF, while FVC% worsening >/=MCID was associated with statistically significant or numerical worsening of PROs, QILD, and QLF. CONCLUSION: FVC% has acceptable test-retest reliability, and we have provided the MCID estimates for FVC% in SSc-ILD based changes at 12 months from baseline in two clinical trials. Clinical trial registration available at www.clinicaltrials.gov, IDs NCT00004563 and NCT00883129. FAU - Kafaja, Suzanne AU - Kafaja S AD - UCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; skafaja@mednet.ucla.edu. FAU - Clements, Philip J AU - Clements PJ AD - UCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; pclements@mednet.ucla.edu. FAU - Wilhalme, Holly AU - Wilhalme H AD - UCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; hwilhalme@mednet.ucla.edu. FAU - Tseng, Chi-Hong AU - Tseng CH AD - UCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; tseng.ch@gmail.com. FAU - Furst, Daniel E AU - Furst DE AD - UCLA Medical Center, David Geffen School of Medicine at UCLA, Medicine, Los Angeles, California, United States ; DEFurst@mednet.ucla.edu. FAU - Kim, Grace Hyun AU - Kim GH AD - UCLA, Radiological Science, Los Angeles, California, United States ; gracekim@mednet.ucla.edu. FAU - Goldin, Jonathan AU - Goldin J AD - UCLA School Of Medicine, Los Angeles, California, United States ; jgoldin@mednet.ucla.edu. FAU - Volkmann, Elizabeth R AU - Volkmann ER AD - University of California Los Angeles David Geffen School of Medicine, 12222, Department of Medicine, Los Angeles, California, United States ; evolkmann@mednet.ucla.edu. FAU - Roth, Michael D AU - Roth MD AD - UCLA School of Medicine, Department of Medicine, Los Angeles, California, United States ; mroth@mednet.ucla.edu. FAU - Tashkin, Donald P AU - Tashkin DP AD - UCLA School Of Medicine, Los Angeles, California, United States ; dtashkin@mednet.ucla.edu. FAU - Khanna, Dinesh AU - Khanna D AD - University of Michigan, Ann Arbor, Michigan, United States ; khannad@umich.edu. LA - eng SI - ClinicalTrials.gov/NCT00004563 SI - ClinicalTrials.gov/NCT00883129 GR - R01 HL089758/HL/NHLBI NIH HHS/United States GR - U01 HL060587/HL/NHLBI NIH HHS/United States GR - R01 HL089901/HL/NHLBI NIH HHS/United States GR - K24 AR063120/AR/NIAMS NIH HHS/United States GR - UL1 TR001881/TR/NCATS NIH HHS/United States GR - U01 HL060606/HL/NHLBI NIH HHS/United States GR - R01 AR070470/AR/NIAMS NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20171103 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. 2018 Mar 1;197(5):553-554. PMID: 29186664 MH - Cohort Studies MH - Disease Progression MH - Female MH - Humans MH - Lung/physiopathology MH - Lung Diseases, Interstitial/*physiopathology MH - Male MH - Middle Aged MH - *Minimal Clinically Important Difference MH - Reproducibility of Results MH - Scleroderma, Systemic/*physiopathology MH - Vital Capacity/physiology PMC - PMC6008871 EDAT- 2017/11/04 06:00 MHDA- 2019/07/10 06:00 PMCR- 2019/03/01 CRDT- 2017/11/04 06:00 PHST- 2017/11/04 06:00 [entrez] PHST- 2017/11/04 06:00 [pubmed] PHST- 2019/07/10 06:00 [medline] PHST- 2019/03/01 00:00 [pmc-release] AID - 10.1164/rccm.201709-1845OC [doi] PST - ppublish SO - Am J Respir Crit Care Med. 2018 Mar 1;197(5):644-652. doi: 10.1164/rccm.201709-1845OC. Epub 2017 Nov 3.