RT Journal Article
SR Electronic
T1 Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) — Report from OMERACT CTD-ILD Working Group
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2168
OP 2171
DO 10.3899/jrheum.141182
VO 42
IS 11
A1 Dinesh Khanna
A1 Shikha Mittoo
A1 Rohit Aggarwal
A1 Susanna M. Proudman
A1 Nicola Dalbeth
A1 Eric L. Matteson
A1 Kevin Brown
A1 Kevin Flaherty
A1 Athol U. Wells
A1 James R. Seibold
A1 Vibeke Strand
YR 2015
UL http://www.jrheum.org/content/42/11/2168.abstract
AB Objective. Interstitial lung disease (ILD) is common in connective tissue disease (CTD) and is the leading cause of mortality. Investigators have used certain outcome measures in randomized controlled trials (RCT) in CTD-ILD, but the lack of a systematically developed, CTD-specific index that captures all measures relevant and meaningful to patients with CTD-ILD has left a large and conspicuous gap in CTD-ILD research.Methods. The CTD-ILD working group, under the aegis of the Outcome Measures in Rheumatology (OMERACT) initiative, has completed a consensus group exercise to reach harmony on core domains and items for inclusion in RCT in CTD-ILD. During the OMERACT 12 meeting, consensus was sought on domains and core items for inclusion in RCT. In addition, consensus was pursued on a definition of response in RCT. Consensus was defined as ≥ 75% agreement among the participants.Results. OMERACT 12 participants endorsed the domains with minimal modifications. Clinically meaningful progression for CTD-ILD was proposed as ≥ 10% relative decline in forced vital capacity (FVC) or ≥ 5% to < 10% relative decline in FVC and ≥ 15% relative decline in DLCO.Conclusion. There is consensus on domains for inclusion in RCT in CTD-ILD and on a definition of clinically meaningful progression. Data-driven approaches to validate these results in different cohorts and RCT are needed.