RT Journal Article
SR Electronic
T1 Reappraisal of OMERACT 8 Draft Validation Criteria for a Soluble Biomarker Reflecting Structural Damage Endpoints in Rheumatoid Arthritis, Psoriatic Arthritis, and Spondyloarthritis: The OMERACT 9 v2 Criteria
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1785
OP 1791
DO 10.3899/jrheum.090346
VO 36
IS 8
A1 WALTER P. MAKSYMOWYCH
A1 ROBERT LANDEWÉ
A1 PAUL-PETER TAK
A1 CHRISTOPHER J. RITCHLIN
A1 MIKKEL ØSTERGAARD
A1 PHILIP J. MEASE
A1 HANI EL-GABALAWY
A1 PATRICK GARNERO
A1 DAFNA D. GLADMAN
A1 OLIVER FITZGERALD
A1 DANIEL ALETAHA
A1 VIVIEN P. BYKERK
A1 JOAN M. BATHON
A1 SILJE W. SYVERSEN
A1 MAARTEN BOERS
A1 PIET GEUSENS
A1 ROBERT D. INMAN
A1 VIRGINIA B. KRAUS
A1 TORE K. KVIEN
A1 WILLIAM J. TAYLOR
A1 GEORGE A. WELLS
A1 DÉSIRÉE van der HEIJDE
YR 2009
UL http://www.jrheum.org/content/36/8/1785.abstract
AB Objectives. A draft set of criteria for the validation of soluble biomarkers reflecting damage endpoints was proposed at OMERACT 8. At OMERACT 9 we aimed to scrutinize the necessity for each of these criteria according to the objectives of the working group. Methods. The OMERACT 8 draft criteria and the principle objectives of the validation process were clarified at a meeting of the working group in London, December 2007. A new framework was proposed after the following steps were conducted: (A) A systematic review of the literature focusing on the draft criteria and a preselected group of biomarkers (MMP3, CTX-II, RANKL, OPG, CTX-I) followed by a Delphi consensus exercise addressing the importance of individual criteria and identification of omissions in the draft set. (B) Formal debate as well as group discussion centered on the key arguments for inclusion/exclusion of specific criteria. (C) Onsite interactive electronic voting on the importance of specific criteria. The framework was presented and discussed at OMERACT 9 in both breakout and plenary sessions followed by a vote on its acceptance. Results. The objectives of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis biomarkers in relation to their predictive validity for damage endpoints was clarified and supported by OMERACT 9 participants. The OMERACT 8 draft validation criteria were reformulated into an essential category focused on criteria addressing the OMERACT Filter elements of discrimination (incorporating truth) and feasibility, and a desirable but nonessential category of other criteria addressing truth. This revised draft set was endorsed by participants at OMERACT 9. Conclusion. A revised set of validation criteria has been drafted by consensus at OMERACT 9 that focuses on the performance characteristics of biomarker assays, the importance of addressing potential confounders, and the essential requirement for clinical validation studies.