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.
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.
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Authors: Maria-Antonietta D'Agostino; Maarten Boers; John Kirwan; Désirée van der Heijde; Mikkel Østergaard; Georg Schett; Robert B Landewé; Walter P Maksymowych; Esperanza Naredo; Maxime Dougados; Annamaria Iagnocco; Clifton O Bingham; Peter M Brooks; Dorcas E Beaton; Frederique Gandjbakhch; Laure Gossec; Francis Guillemin; Sarah E Hewlett; Margreet Kloppenburg; Lyn March; Philip J Mease; Ingrid Moller; Lee S Simon; Jasvinder A Singh; Vibeke Strand; Richard J Wakefield; George A Wells; Peter Tugwell; Philip G Conaghan Journal: J Rheumatol Date: 2014-03-01 Impact factor: 4.666
Authors: Nicola Dalbeth; Bregina Pool; Timothy Smith; Karen E Callon; Maria Lobo; William J Taylor; Peter B Jones; Jillian Cornish; Fiona M McQueen Journal: Arthritis Res Ther Date: 2010-08-26 Impact factor: 5.156
Authors: Anne C Bay-Jensen; Stephanie Wichuk; Inger Byrjalsen; Diana J Leeming; Nathalie Morency; Claus Christiansen; Morten A Karsdal; Walter P Maksymowych Journal: PLoS One Date: 2013-01-24 Impact factor: 3.240
Authors: Suzanne Arends; Anneke Spoorenberg; Monique Efde; Reinhard Bos; Martha K Leijsma; Hendrika Bootsma; Nic J G M Veeger; Elisabeth Brouwer; Eveline van der Veer Journal: PLoS One Date: 2014-06-11 Impact factor: 3.240