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)

被引：35

作者：

Khanna, Dinesh ^{[1
]}

Distler, Oliver ^{[2
]}

Avouac, Jerome ^{[3
]}

Behrens, Frank ^{[4
]}

Clements, Philip J. ^{[1
]}

Denton, Christopher ^{[5
]}

Foeldvari, Ivan ^{[6
]}

Giannini, Edward ^{[8
]}

Huscher, Doerte ^{[9
]}

Kowal-Bielecka, Otylia ^{[10
]}

Lovell, Daniel ^{[8
]}

Matucci-Cerinic, Marco ^{[11
]}

Mayes, Maureen ^{[12
]}

Merkel, Peter A. ^{[13
]}

Nash, Peter ^{[14
]}

Opitz, Cristian F. ^{[15
]}

Pittrow, David ^{[16
]}

Rubin, Lewis ^{[17
]}

Seibold, James R. ^{[18
]}

Steen, Virginia ^{[19
]}

Strand, C. Vibeke ^{[20
]}

Tugwell, Peter S. ^{[21
]}

Varga, John ^{[22
]}

Zink, Angela ^{[23
]}

Furst, Daniel E. ^{[7
]}

机构：

[1] Univ Calif Los Angeles, David Geffen Sch, Los Angeles, CA USA

[2] Univ Zurich Hosp, CH-8091 Zurich, Switzerland

[3] Paris Descartes Univ, Rheumatol Dept A, Cochin Hosp, AP HP, Paris, France

[4] Goethe Univ Frankfurt, Frankfurt, Germany

[5] Royal Free & Univ Coll Med Sch, London, England

[6] Gen Hosp Eilbek, Eilbek, Germany

[7] Univ Calif Los Angeles, Inst Rehabil, Los Angeles, CA 90025 USA

[8] Cincinnati Childrens Hosp, Med Ctr, Cincinnati, OH USA

[9] German Arthritis Res Ctr, Berlin, Germany

[10] Med Univ Bialystok, Dept Rheumatol & Internal Med, Bialystok, Poland

[11] Univ Florence, Div Med & Rheumatol, Florence, Italy

[12] Univ Texas Hlth Sci Ctr Houston, Houston, TX USA

[13] Boston Univ, Sch Med, Boston, MA 02118 USA

[14] Univ Queensland, Brisbane, Qld 4072, Australia

[15] Deutsch Herzzentrum Berlin, Berlin, Germany

[16] Tech Univ Dresden, Fac Med, Dept Clin Pharmacol, Dresden, Germany

[17] Univ Calif San Diego, Dept Med, San Diego, CA 92103 USA

[18] Univ Michigan, Dept Internal Med, Ann Arbor, MI 48109 USA

[19] Georgetown Univ Hosp, Div Rheumatol, Washington, DC 20007 USA

[20] Stanford Univ, Div Immunol, Portola Valley, CA USA

[21] Inst Populat Hlth, Ottawa, ON, Canada

[22] Northwestern Sch Med, Feinberg Sch Med, Chicago, IL USA

[23] German Rheumatism Res Ctr, Berlin, Germany

来源：

JOURNAL OF RHEUMATOLOGY | 2009年 / 36卷 / 10期

关键词：

OMERACT; SCLERODERMA; CRISS; EPOSS; OUTCOMES; CLINICAL TRIALS; SKIN THICKNESS SCORE; PRELIMINARY DEFINITION; SCLERODERMA; IMPROVEMENT; DISEASE;

D O I：

10.3899/jrheum.090372

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (J Rheumatol 2009;36:2356-61; doi: 10.3899/jrheum.090372)

引用

页码：2356 / 2361

页数：6

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