EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints

被引：28

作者：

Bertsias, G. K. ^{[4
]}

Ioannidis, J. P. A. ^{[5
]}

Boletis, J. ^{[6
]}

Bombardieri, S. ^{[7
]}

Cervera, R. ^{[8
]}

Dostal, C. ^{[9
]}

Font, J. ^{[8
]}

Gilboe, I. M. ^{[10
]}

Houssiau, F. ^{[11
]}

Huizinga, T. ^{[12
]}

Isenberg, D. ^{[13
]}

Kallenberg, C. G. M. ^{[14
]}

Khamashta, M. ^{[15
]}

Piette, J. C. ^{[16
]}

Schneider, M. ^{[17
]}

Smolen, J. ^{[18
]}

Sturfelt, G. ^{[19
]}

Tincani, A. ^{[2
]}

van Vollenhoven, R. ^{[3
]}

Boumpas, D. T. ^{[4
]}

Gordon, C. ^{[1
]}

机构：

[1] Univ Birmingham, Div Immun & Infect, Sch Med, Rheumatol Res Grp, Birmingham B15 2TT, W Midlands, England

[2] Karolinska Univ Hosp, Karolinska Inst, Dept Med, Rheumatol Unit, Solna, Sweden

[3] Osped Civile, Rheumatol & Immunol Clin, Brescia, Italy

[4] Univ Crete, Sch Med, Iraklion, Greece

[5] Univ Ioannina, Sch Med, Clin Trials & Evidence Based Med Unit, Dept Hyg & Epidemiol, GR-45110 Ioannina, Greece

[6] Laiko Hosp, Dept Nephrol & Transplantat Med, Athens, Greece

[7] Univ Pisa, Cattedra Reumatol, Pisa, Italy

[8] Hosp Clin Barcelona, Dept Autoimmune Dis, Barcelona, Catalonia, Spain

[9] Inst Rheumatol, Prague, Czech Republic

[10] Univ Oslo, Rikshosp, Dept Rheumatol, N-0027 Oslo, Norway

[11] Catholic Univ Louvain, Clin Univ St Luc, Dept Rheumatol, B-1200 Brussels, Belgium

[12] Leiden Univ, Med Ctr, Dept Rheumatol, Leiden, Netherlands

[13] Univ Coll London Hosp, Ctr Rheumatol, London, England

[14] Univ Groningen, Univ Med Ctr Groningen, Dept Clin Immunol, NL-9713 AV Groningen, Netherlands

[15] St Thomas Hosp, Rayne Inst, Lupus Res Unit, London SE1 7EH, England

[16] Grp Hosp Pitie Salpetriere, Serv Med Interne, F-75634 Paris, France

[17] Univ Dusseldorf, Clin Endocrinol Diabetol & Rheumatol, Dusseldorf, Germany

[18] Med Univ Vienna, Dept Rheumatol, Vienna, Austria

[19] Univ Lund Hosp, Dept Rheumatol, S-22185 Lund, Sweden

来源：

ANNALS OF THE RHEUMATIC DISEASES | 2009年 / 68卷 / 04期

关键词：

QUALITY-OF-LIFE; 3; ETHNIC-GROUPS; RANDOMIZED CONTROLLED-TRIAL; DISEASE-ACTIVITY INDEXES; TERM-FOLLOW-UP; DOUBLE-BLIND; IMMUNOSUPPRESSIVE THERAPY; MYCOPHENOLATE-MOFETIL; RENAL-DISEASE; HEALTH-STATUS;

D O I：

10.1136/ard.2007.083030

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective: To assess available evidence on the use of end-points ( outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE. Methods: The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists. Results: Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken. Conclusion: This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.

引用

页码：477 / 483

页数：7

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