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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/9909

Title: Proposal for Levels of Evidence Schema for Validation of a Soluble Biomarker Reflecting Damage Endpoints in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis, and Recommendations for Study Design
Authors: Maksymowych, Walter P.
Fitzgerald, Oliver
Wells, George A.
Gladman, Dafna D.
Landewe, Robert
Ostergaard, Mikkel
Taylor, William J.
Christensen, Robin
Tak, Paul-Peter
Boers, Maarten
Syversen, Silje W.
Bathon, Joan M.
Ritchlin, Christopher J.
Mease, Philip J.
Bykerk, Vivien P.
Garnero, Patrick
El-Gabalawy, Hani
Aletaha, Daniel
Inman, Robert D.
Kraus, Virginia Byers
Kvien, Tore K.
van der Heijde, D.
Issue Date: 2009
Citation: JOURNAL OF RHEUMATOLOGY, 36(8). p. 1792-1799
Abstract: Objective. At OMERACT 8 a framework for levels of evidence was proposed for the validation of biomarkers as surrogate outcome measures. We aimed to adapt this scheme in order to apply it in the setting Of Soluble biomarkers proposed to replace the measurement of damage endpoints in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). We also aimed to generate consensus on minimum standards for the design of longitudinal Studies aimed at validating biomarkers. Methods. Before the meeting, the Soluble Biomarker Working Group prepared a preliminary framework and discussed various models for association and prediction related to the statistical strength domain. In addition, 3 Delphi exercises addressing longitudinal study design for RA, PsA. and AS were conducted within the working group and members of the Assessments in SpondyloArthritis International Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). This formed the basis for discussions among OMERACT 9 participants. Results. The proposed framework was accepted by consensus. In the study design domain a requirement for both prospective observational Studies and randomized controlled trials (RCT) in different drug classes was noted. A template for determining the level of statistical strength was proposed. The addition of a new domain on biomarker assay performance was considered essential, and participants suggested that for any biomarker this domain should be addressed first, i.e., before starting clinical validation studies. Participants agreed on most elements of a longitudinal study design template. Where consensus was lacking the working group has drafted solutions that constitute a basis for prospective validation studies. Conclusion. The OMERACT 9 Soluble Biomarker Group has successfully formulated a levels of evidence scheme and a study design template that will provide guidance to conduct validation studies in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in RA, PsA, and AS. (J Rheumatol 2009:36:1792-9;, doi. 10.3899/jrheum.090347)
Notes: [Maksymowych, Walter P.] Univ Alberta, Dept Med, Edmonton, AB T6G 2S2, Canada. [Fitzgerald, Oliver] St Vincents Univ Hosp, Dublin 4, Ireland. [Wells, George A.] Univ Ottawa, Dept Epidemiol & Community Med, Ottawa, ON, Canada. [Wells, George A.] Ottawa Hlth Res Inst, Ottawa, ON, Canada. [Gladman, Dafna D.] Univ Toronto, Toronto Western Res Inst, Univ Hlth Network, Toronto, ON, Canada. [Landewe, Robert] Univ Hosp Maastricht, Maastricht, Netherlands. [Ostergaard, Mikkel] Copenhagen Univ Hosp, Dept Rheumatol, Copenhagen, Denmark. [Ostergaard, Mikkel] Copenhagen Univ Hosp, Dept Rheumatol, Hvidovre, Denmark. [Ostergaard, Mikkel] Copenhagen Univ Hosp, Dept Rheumatol, Herlev, Denmark. [Mease, Philip J.] Swedish Med Ctr, Seattle, WA USA. [Taylor, William J.] Univ Otago, Rehabil Teaching & Res Unit, Wellington, New Zealand. [Christensen, Robin] Frederiksberg Univ Hosp, Parker Inst, Musculoskeletal Stat Unit, Frederiksberg, Denmark. [Tak, Paul-Peter] Univ Amsterdam, Acad Med Ctr, Div Clin Immunol & Rheumatol, NL-1105 AZ Amsterdam, Netherlands. [Boers, Maarten] Vrije Univ Amsterdam, Med Ctr, Dept Clin Epidemiol & Biostat, Amsterdam, Netherlands. [Syversen, Silje W.] Univ Oslo, Diakonhjemmet Hosp, Dept Rheumatol, Oslo, Norway. [Bathon, Joan M.] Johns Hopkins Univ, Sch Med, Dept Med, Div Rheumatol, Baltimore, MD 21205 USA. [Ritchlin, Christopher J.] Univ Rochester, Med Ctr, Clin Immunol Res Ctr, Rochester, NY 14642 USA. Mt Sinai Hosp, Univ Hlth Network, Rebecca MacDonald Ctr Arthrit & Autoimmune Dis, Toronto, ON M5G 1X5, Canada. [Garnero, Patrick] INSERM, Res Unit 664, F-69008 Lyon, France. [Garnero, Patrick] CCBR SYNARC, Lyon, France. [Geusens, Piet] Maastricht Univ, Med Ctr, Maastricht, Netherlands. [Geusens, Piet] Univ Hasselt, Biomed Res Ctr, Flanders, Belgium. [El-Gabalawy, Hani] Univ Manitoba, Winnipeg, MB, Canada. [Aletaha, Daniel] Med Univ Vienna, Dept Internal Med 3, Div Rheumatol, Vienna, Austria. [Kraus, Virginia Byers] Duke Univ, Med Ctr, Durham, NC USA. [van der Heijde, Desiree] Leiden Univ, Med Ctr, Leiden, Netherlands.
URI: http://hdl.handle.net/1942/9909
DOI: 10.3899/jrheum.090347
ISI #: 000269164700040
ISSN: 0315-162X
Category: A1
Type: Journal Contribution
Validation: ecoom, 2010
Appears in Collections: Research publications

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