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)

Khanna, Dinesh, Distler, Oliver, Avouac, Jerome, Behrens, Frank, Clements, Philip J., Denton, Christopher, Foeldvari, Ivan, Giannini, Edward, Huscher, Doerte, Kowal-Bielecka, Otylia, Lovell, Daniel, Matucci-Cerinic, Marco, Mayes, Maureen, Merkel, Peter A., Nash, Peter, Opitz, Christian F., Pittrow, David, Rubin, Lewis, Seibold, James R., Steen, Virginia, Strand, C. Vibeke, Tugwell, Peter S., Varga, John, Zink, Angela and Furst, Daniel E. (2009). 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). In: Proceedings of OMERACT 9: International Consensus Conference on Outcome Measures in Rheumatology. OMERACT 9: 9th International Consensus Conference on Outcome Measures in Rheumatology Clinical Trails, Kananaskis Village, AB, Canada, (2356-2361). 27-31 May, 2008. doi:10.3899/jrheum.090372


Author Khanna, Dinesh
Distler, Oliver
Avouac, Jerome
Behrens, Frank
Clements, Philip J.
Denton, Christopher
Foeldvari, Ivan
Giannini, Edward
Huscher, Doerte
Kowal-Bielecka, Otylia
Lovell, Daniel
Matucci-Cerinic, Marco
Mayes, Maureen
Merkel, Peter A.
Nash, Peter
Opitz, Christian F.
Pittrow, David
Rubin, Lewis
Seibold, James R.
Steen, Virginia
Strand, C. Vibeke
Tugwell, Peter S.
Varga, John
Zink, Angela
Furst, Daniel E.
Title of paper 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)
Conference name OMERACT 9: 9th International Consensus Conference on Outcome Measures in Rheumatology Clinical Trails
Conference location Kananaskis Village, AB, Canada
Conference dates 27-31 May, 2008
Proceedings title Proceedings of OMERACT 9: International Consensus Conference on Outcome Measures in Rheumatology   Check publisher's open access policy
Journal name Journal of Rheumatology   Check publisher's open access policy
Place of Publication Toronto, ON, Canada
Publisher Journal of Rheumatology Publishing
Publication Year 2009
Sub-type Fully published paper
DOI 10.3899/jrheum.090372
ISSN 0315-162X
1499-2752
Volume 36
Issue 10
Start page 2356
End page 2361
Total pages 6
Language eng
Formatted Abstract/Summary
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.
Subjects 2403 Immunology
2723 Immunology and Allergy
2745 Rheumatology
Keyword Omeract
Scleroderma
Criss
Eposs
Outcomes
Clinical trials
Q-Index Code E1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Conference Paper
Collection: School of Medicine Publications
 
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