This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Strand, V Articles by Tugwell, P Search for Related Content PubMed PubMed Citation Articles by Strand, V Articles by Tugwell, P Social Bookmarking                         What's this?

Endpoints: consensus recommendations from OMERACT IV

Division of Immunology, Stanford University, San Francisco, CA, USA

D Gladman

Centre for Prognosis Studies in The Rheumatic Diseases, The Toronto Hospital, Toronto, Ontario, Canada

D Isenberg

Center for Rheumatology, Department of Medicine, University College London, London, UK

M Petri

Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA

J Smolen

2nd Department of Medicine Krankenhaus Lainz, Vienna, Austria

P Tugwell

Department of Medicine, University of Ottawa, Ottawa, Canada

The goal of the ‘Outcome Measures in Rheumatology’ (OMERACT) process is to select domains and/or outcome measures for clinical trials in each defined disease category according to truth, discrimination and feasibility. OMERACT IV, held in Cancun, Mexico, April 1998, included the module ‘Systemic Lupus Erythematosus (SLE)’, designed to define a preliminary core set of outcome domains for randomized controlled trials and longitudinal observational studies (LOS). Although specific measures to be used in clinical trials of SLE have yet to be determined, both randomized controlled trials and longitudinal observation studies groups recommended that outcome be assessed in terms of disease activity and damage in all organ systems involved, as well as by health related quality of life, meaningful to patients, and adverse events. These recommendations were ratified by the majority of participants. In a heterogeneous patient population such as SLE, it is recognized that any individual measure of clinical response may reflect only a portion of what might be termed the ‘true outcome’. A responder index could integrate such relatively independent measures of outcome into a single assessment, potentially increasing statistical power and decreasing sample size. Results from randomized controlled trials currently underway assessing these outcome domains are eagerly awaited, and are expected to rapidly advance the field

Key Words: outcome measures • disease activity • damage • HRQOL

Lupus, Vol. 9, No. 5, 322-327 (2000)
DOI: 10.1191/096120300678828424


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				C Gordon, G Bertsias, J P A Ioannidis, J Boletis, S Bombardieri, R Cervera, C Dostal, J Font, I-M Gilboe, F Houssiau, et al. EULAR points to consider for conducting clinical trials in systemic lupus erythematosus Ann Rheum Dis, April 1, 2009; 68(4): 470 - 476. [Abstract] [Full Text] [PDF]

				G K Bertsias, J P A Ioannidis, J Boletis, S Bombardieri, R Cervera, C Dostal, J Font, I M Gilboe, F Houssiau, T Huizinga, et al. EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints Ann Rheum Dis, April 1, 2009; 68(4): 477 - 483. [Abstract] [Full Text] [PDF]

				W J Taylor, H R Schumacher Jr, H S B Baraf, P Chapman, L Stamp, M Doherty, F McQueen, N Dalbeth, N Schlesinger, D E Furst, et al. A modified Delphi exercise to determine the extent of consensus with OMERACT outcome domains for studies of acute and chronic gout Ann Rheum Dis, June 1, 2008; 67(6): 888 - 891. [Abstract] [Full Text] [PDF]

				A. Sinclair, G. Appel, M.A. Dooley, E. Ginzler, D. Isenberg, D. Jayne, D. Wofsy, and N. Solomons Mycophenolate mofetil as induction and maintenance therapy for lupus nephritis: rationale and protocol for the randomized, controlled Aspreva Lupus Management Study (ALMS) Lupus, December 1, 2007; 16(12): 972 - 980. [Abstract] [PDF]

				R. Fischer-Betz and M. Schneider Connective tissue diseases: evaluation of clinical response Rheumatology, October 1, 2006; 45(suppl_3): iii5 - iii7. [Abstract] [Full Text] [PDF]

				G H Stummvoll, M Aringer, J S Smolen, S Schmaldienst, E Jimenez-Boj, W H Horl, W B Graninger, and K Derfler IgG immunoadsorption reduces systemic lupus erythematosus activity and proteinuria: a long term observational study Ann Rheum Dis, July 1, 2005; 64(7): 1015 - 1021. [Abstract] [Full Text] [PDF]

				R Ariza-Ariza, B Hernandez-Cruz, and F Navarro-Sarabia Letter to the Editor Lupus, April 1, 2005; 14(4): 334 - 335. [PDF]

				J E Balow Clinical presentation and monitoring of lupus nephritis Lupus, January 1, 2005; 14(1): 25 - 30. [Abstract] [PDF]

				M Aringer and J S Smolen Tumour necrosis factor and other proinflammatory cytokines in systemic lupus erythematosus: a rationale for therapeutic intervention Lupus, May 1, 2004; 13(5): 344 - 347. [Abstract] [PDF]

				J Schiffenbauer and L S Simon Randomized controlled trials in systemic lupus erythematosus: what has been done and what do we need to do? Lupus, May 1, 2004; 13(5): 398 - 405. [Abstract] [PDF]