Reporting Disease Activity in Clinical Trials of Patients With Rheumatoid Arthritis: EULAR/ACR Collaborative Recommendations

被引：186

作者：

Aletaha, D. ^{[1
]}

Landewe, R. ^{[2
]}

Karonitsch, T.

Bathon, J. ^{[3
]}

Boers, M. ^{[4
]}

Bombardier, C. ^{[5
]}

Bombardieri, S. ^{[6
]}

Choi, H. ^{[7
]}

Combe, B. ^{[8
]}

Dougados, M. ^{[9
]}

Emery, P. ^{[10
]}

Gomez-Reino, J. ^{[11
]}

Keystone, E. ^{[12
]}

Koch, G. ^{[13
]}

Kvien, T. K. ^{[14
]}

Martin-Mola, E. ^{[15
]}

Matucci-Cerinic, M. ^{[16
]}

Michaud, K. ^{[17
]}

O'Dell, J. ^{[17
]}

Paulus, H. ^{[18
]}

Pincus, T. ^{[19
]}

Richards, P. ^{[20
]}

Simon, L. ^{[21
]}

Siegel, J. ^{[22
]}

Smolen, J. S. ^{[23
,24
]}

Sokka, T. ^{[25
]}

Strand, V. ^{[26
]}

Tugwell, P. ^{[27
]}

van der Heijde, D. ^{[28
]}

van Riel, P. ^{[29
]}

Vlad, S. ^{[30
]}

van Vollenhoven, R. ^{[31
]}

Ward, M. ^{[32
]}

Weinblatt, M. ^{[33
]}

Wells, G. ^{[34
]}

White, B. ^{[35
]}

Wolfe, F. ^{[36
]}

Zhang, B. ^{[30
]}

Zink, A. ^{[37
]}

Felson, D. ^{[30
]}

机构：

[1] Med Univ Vienna, Div Rheumatol, A-1090 Vienna, Austria

[2] Univ Hosp Maastricht, Maastricht, Netherlands

[3] Johns Hopkins Univ, Baltimore, MD USA

[4] Vrije Univ Amsterdam, Med Ctr, Amsterdam, Netherlands

[5] Inst Work & Hlth, Toronto, ON, Canada

[6] Univ Pisa, Pisa, Italy

[7] Univ British Columbia, Vancouver, BC V5Z 1M9, Canada

[8] CHU Montpellier, Montpellier, France

[9] Paris Descartes Univ, Paris, France

[10] Univ Leeds, Leeds, W Yorkshire, England

[11] Univ Santiago de Compostela, Sch Med, Santiago, Spain

[12] Univ Toronto, Toronto, ON, Canada

[13] Univ N Carolina, Chapel Hill, NC USA

[14] Diakonhjemmet Hosp, Oslo, Norway

[15] Hosp Univ La Paz, Madrid, Spain

[16] Univ Florence, Florence, Italy

[17] Univ Nebraska, Omaha, NE 68182 USA

[18] Univ Calif Los Angeles, Los Angeles, CA USA

[19] NYU, Hosp Joint Dis, New York, NY USA

[20] Univ Bristol, Bristol, Avon, England

[21] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[22] US FDA, Rockville, MD 20857 USA

[23] Med Univ Vienna, Vienna, Austria

[24] Hietzing Hosp, Vienna, Austria

[25] Jyvaskyla Cent Hosp, Jyvaskyla, Finland

[26] Stanford Univ, Portola Valley, CA USA

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

[28] Leiden Univ, Med Ctr, Leiden, Netherlands

[29] Radboud Univ Nijmegen, Med Ctr, NL-6525 ED Nijmegen, Netherlands

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

[31] Karolinska Univ Hosp, Stockholm, Sweden

[32] NIH, Bethesda, MD 20892 USA

[33] Brigham & Womens Hosp, Boston, MA 02115 USA

[34] Univ Ottawa, Ottawa, ON, Canada

[35] Medimmune Inc, Gaithersburg, MD 20878 USA

[36] Natl Data Bank Rheumat Dis, Wichita, KS USA

[37] Charite, Berlin, Germany

来源：

ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH | 2008年 / 59卷 / 10期

关键词：

D O I：

10.1002/art.24123

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective. To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Methods. The project followed the EULAR standardized operating procedures, which use a three-step approach: 1) expert-based definition of relevant research questions (November 2006); 2) systematic literature search (November 2006 to May 2007); and 3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007). Results. Eleven relevant questions were identified for the literature search. Based on the evidence from the literature, the expert panel recommended that each trial should report the following items: 1) disease activity response and disease activity states; 2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; 3) baseline disease activity levels (in general); 4) the percentage of patients achieving a low disease activity state and remission; 5) time to onset of the primary outcome; 6) sustainability of the primary outcome; 7) fatigue. Conclusion. These recommendations endorsed by EULAR and ACR will help harmonize the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.

引用

页码：1371 / 1377

页数：7

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