Rheumatology: Current Research
Open Access
ISSN: 2161-1149 (Printed)
+44-20-4587-4809
ISSN: 2161-1149 (Printed)
+44-20-4587-4809
Ning Li
Tanzania
Research Article
Development of a Composite Outcome Measure for Systemic Sclerosis Related Interstitial Lung Disease
Author(s): Elizabeth R Volkmann, Donald P Tashkin, Ning Li, Daniel E Furst, Philip J Clements and Robert M ElashoffElizabeth R Volkmann, Donald P Tashkin, Ning Li, Daniel E Furst, Philip J Clements and Robert M Elashoff
Objective: While systemic sclerosis-related interstitial lung disease (SSc-ILD) trials predominantly use forced vital capacity (FVC) as the primary outcome, combining individual outcomes may lead to a more comprehensive measure of treatment response and minimize the risk of type 1 error. The present analysis aimed to develop a composite outcome measure to assess treatment response in SSc-ILD patients.
Methods: We used data from the Scleroderma Lung Study I (SLS-I) to create the composite outcome measure. SLS I was a multi-institutional, double-blind clinical trial, in which 158 patients with SSc-ILD were randomized to receive either oral cyclophosphamide (CYC) (titrated to 2.0 mg/kg once daily) or matching placebo for one year. To select the variables for inclusion in the composite outcome, we first performed a univariate analysis using all .. View More»
DOI:
10.4172/2161-1149.1000154