RT Journal Article SR Electronic T1 Measures of Response in Clinical Trials of Systemic Sclerosis: The Combined Response Index for Systemic Sclerosis (CRISS) and Outcome Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis (EPOSS) JF The Journal of Rheumatology JO J Rheumatol FD The Journal of Rheumatology SP 2356 OP 2361 DO 10.3899/jrheum.090372 VO 36 IS 10 A1 DINESH KHANNA A1 OLIVER DISTLER A1 JEROME AVOUAC A1 FRANK BEHRENS A1 PHILIP J. CLEMENTS A1 CHRISTOPHER DENTON A1 IVAN FOELDVARI A1 EDWARD GIANNINI A1 DOERTE HUSCHER A1 OTYLIA KOWAL-BIELECKA A1 DANIEL LOVELL A1 MARCO MATUCCI-CERINIC A1 MAUREEN MAYES A1 PETER A. MERKEL A1 PETER NASH A1 CHRISTIAN F. OPITZ A1 DAVID PITTROW A1 LEWIS RUBIN A1 JAMES R. SEIBOLD A1 VIRGINIA STEEN A1 C. VIBEKE STRAND A1 PETER S. TUGWELL A1 JOHN VARGA A1 ANGELA ZINK A1 DANIEL E. FURST YR 2009 UL http://www.jrheum.org/content/36/10/2356.abstract AB There have been steady efforts to develop a combined response index for systemic sclerosis (CRISS). A parallel and equally successful effort has been made by an Expert Panel on Outcome Measures in PAH related to Systemic Sclerosis (EPOSS) to measure effect in treatment of pulmonary arterial hypertension of systemic sclerosis (PAH-SSc). CRISS conducted a Delphi process combined with expert review to identify 11 candidate domains for inclusion in a core set of outcomes for SSc clinical trials: soluble biomarkers, cardiac, digital ulcers, gastrointestinal, global health, health related quality of life (HRQOL) and function, musculoskeletal, pulmonary, Raynaud’s, renal, and skin. Tools within domains were also agreed upon. Concentrating on one aspect of disease, PAH, EPOSS also conducted a Delphi process and judged the following domains as the most appropriate for randomized controlled trials in PAH-SSc: lung vascular/pulmonary arterial pressure, cardiac function, exercise testing; severity of dyspnea, discontinuation of treatment; quality of life/activities of daily living; global state; and survival. Possible useful tools within each domain were also agreed on. Patient derived, physician derived, and objective measures of response will be included and combined with the idea that each reflects different aspects of PAH (EPOSS) and overall disease (CRISS) although this assumption may not prove true and can be separated if statistically and clinically valid to do so. In either case, prospective studies will require measurement of all domains, and tools are required and will be developed to define appropriate combined measures of response. CRISS and EPOSS are being developed through the OMERACT process. Through Delphi process and literature review significant progress has been made for both indices, and prospective data are being collected.