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

被引：34

作者：

Maksymowych, Walter P. ^{[1
]}

Landewe, Robert ^{[21
]}

Tak, Paul-Peter ^{[2
]}

Ritchlin, Christopher J. ^{[3
]}

Ostergaard, Mikkel ^{[4
,5
,6
]}

Mease, Philip J. ^{[7
]}

El-Gabalawy, Hani ^{[8
]}

Garnero, Patrick ^{[9
,10
]}

Gladman, Dafna D. ^{[11
]}

Fitzgerald, Oliver ^{[12
]}

Aletaha, Daniel ^{[13
]}

Bykerk, Vivien P. ^{[14
]}

Bathon, Joan M. ^{[15
]}

Syversen, Silje W. ^{[16
]}

Boers, Maarten ^{[17
]}

Geusens, Piet ^{[18
,19
]}

Inman, Robert D.

Kraus, Virginia B. ^{[20
]}

Kvien, Tore K.

Taylor, William J. ^{[22
]}

Wells, George A. ^{[23
,24
]}

van der Heijde, Desiree ^{[25
]}

机构：

[1] Univ Alberta, Dept Med, Edmonton, AB T6G 2S2, Canada

[2] Univ Amsterdam, Acad Med Ctr, Div Clin Immunol & Rheumatol, NL-1012 WX Amsterdam, Netherlands

[3] Univ Rochester, Med Ctr, Clin Immunol Res Ctr, Rochester, NY 14642 USA

[4] Copenhagen Univ Hosp, Dept Rheumatol, Copenhagen, Denmark

[5] Copenhagen Univ Hosp, Dept Rheumatol, Herlev, Denmark

[6] Copenhagen Univ Hosp, Dept Rheumatol, Hvidovre, Denmark

[7] Swedish Med Ctr, Seattle, WA USA

[8] Univ Manitoba, Winnipeg, MB, Canada

[9] INSERM, Res Unit 664, F-69008 Lyon, France

[10] CCBR SYNARC, Lyon, France

[11] Univ Toronto, Toronto Western Res Inst, Univ Hlth Network, Toronto, ON, Canada

[12] St Vincents Univ Hosp, Dublin 4, Ireland

[13] Med Univ Vienna, Dept Internal Med 3, Div Rheumatol, Vienna, Austria

[14] Univ Toronto, Mt Sinai Hosp, Univ Hlth Network, Rebecca MacDonald Ctr Arthrit & Autoimmune Dis, Toronto, ON M5G 1X5, Canada

[15] Johns Hopkins Univ, Sch Med, Dept Med, Div Rheumatol, Baltimore, MD 21205 USA

[16] Univ Oslo, Diakonhjemmet Hosp, Dept Rheumatol, Oslo, Norway

[17] Vrije Univ Amsterdam, Med Ctr, Dept Clin Epidemiol & Biostat, Amsterdam, Netherlands

[18] Maastricht Univ, Med Ctr, Maastricht, Netherlands

[19] Univ Hasselt, Biomed Res Ctr, Hasselt, Belgium

[20] Duke Univ, Med Ctr, Durham, NC USA

[21] Univ Hosp Maastricht, Maastricht, Netherlands

[22] Univ Otago, Rehabil Teaching & Res Unit, Wellington, New Zealand

[23] Univ Ottawa, Dept Epidemiol & Community Med, Ottawa, ON, Canada

[24] Ottawa Hlth Res Inst, Ottawa, ON, Canada

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

来源：

JOURNAL OF RHEUMATOLOGY | 2009年 / 36卷 / 08期

关键词：

RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; ANKYLOSING SPONDYLITIS; BIOMARKERS; VALIDATION CRITERIA; STRUCTURAL DAMAGE; TRIALS;

D O I：

10.3899/jrheum.090346

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (13) Formal debate its well as group discussion centered oil 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 addressin the OMERACT Filter elements of discrimination 9 (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. (J Rheumatol 2009; 36:1785-91. doi: 10.3899/jrheum.090346)

引用

页码：1785 / 1791

页数：7

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