RT Journal Article
SR Electronic
T1 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
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1792
OP 1799
DO 10.3899/jrheum090347
VO 36
IS 8
A1 WALTER P. MAKSYMOWYCH
A1 OLIVER FITZGERALD
A1 GEORGE A. WELLS
A1 DAFNA D. GLADMAN
A1 ROBERT LANDEWÉ
A1 MIKKEL ØSTERGAARD
A1 WILLIAM J. TAYLOR
A1 ROBIN CHRISTENSEN
A1 PAUL-PETER TAK
A1 MAARTEN BOERS
A1 SILJE W. SYVERSEN
A1 JOAN M. BATHON
A1 CHRISTOPHER J. RITCHLIN
A1 PHILIP J. MEASE
A1 VIVIEN P. BYKERK
A1 PATRICK GARNERO
A1 PIET GEUSENS
A1 HANI EL-GABALAWY
A1 DANIEL ALETAHA
A1 ROBERT D. INMAN
A1 VIRGINIA BYERS KRAUS
A1 TORE K. KVIEN
A1 DÉSIRÉE van der HEIJDE
YR 2009
UL http://www.jrheum.org/content/36/8/1792.abstract
AB 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.