학술논문
The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis
Document Type
Academic Journal
Author
Khanna, Dinesh; Berrocal, Veronica J.; Giannini, Edward H.; Seibold, James R.; Merkel, Peter A.; Mayes, Maureen D.; Baron, Murray; Clements, Philip J.; Steen, Virginia; Assassi, Shervin; Schiopu, Elena; Phillips, Kristine; Simms, Robert W.; Allanore, Yannick; Denton, Christopher P.; Distler, Oliver; Johnson, Sindhu R.; Matucci-Cerinic, Marco; Pope, Janet E.; Proudman, Susanna M.; Siegel, Jeffrey; Wong, Weng Kee; Wells, Athol U.; Furst, Daniel E.
Source
Arthritis & Rheumatology. Feb 01, 2016 68(2):299-311
Subject
Language
English
ISSN
2326-5191
Abstract
OBJECTIVE.: METHODS.: RESULTS.: Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982–0.983) and specificity was 0.931 (95% confidence interval 0.930–0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT (P = 0.02). CONCLUSION.