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Updating the OMERACT filter: Implications for imaging and soluble biomarkers

Landewé, Robert B.; D'Agostino, Maria Antonietta; Østergaard, Mikkel; Boers, Maarten; Kirwan, John; Van Der Heijde, Désirée; Schett, Georg; Maksymowych, Walter P.; Naredo, Esperanza; Dougados, Maxime; Iagnocco, Annamaria; Bingham, Clifton O.; Brooks, Peter M.; Hewlett, Sarah; Beaton, Dorcas E.; Gandjbakhch, Frederique; Gossec, Laure; Guillemin, Francis; Kloppenburg, Margreet; March, Lyn; Mease, Philip J.; Moller, Ingrid; Simon, Lee S.; Singh, Jasvinder A.; Strand, Vibeke; Wakefield, Richard J.; Wells, George A.; Tugwell, Peter; Conaghan, Philip G.

Authors

Robert B. Landewé

Maria Antonietta D'Agostino

Mikkel Østergaard

Maarten Boers

John Kirwan

Désirée Van Der Heijde

Georg Schett

Walter P. Maksymowych

Esperanza Naredo

Maxime Dougados

Annamaria Iagnocco

Clifton O. Bingham

Peter M. Brooks

Dorcas E. Beaton

Frederique Gandjbakhch

Laure Gossec

Francis Guillemin

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



Abstract

Objective. The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. Methods. A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. Results. Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. Conclusion. General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0. © 2014. All rights reserved.

Journal Article Type Article
Publication Date Jan 1, 2014
Journal Journal of Rheumatology
Print ISSN 0315-162X
Electronic ISSN 1499-2752
Publisher Journal of Rheumatology
Peer Reviewed Peer Reviewed
Volume 41
Issue 5
Pages 1016-1024
APA6 Citation Hewlett, S. E., Landewé, R. B., Østergaard, M., D'Agostino, M. A., D'Agostino, M., Boers, M., …Conaghan, P. G. (2014). Updating the OMERACT filter: Implications for imaging and soluble biomarkers. Journal of Rheumatology, 41(5), 1016-1024. https://doi.org/10.3899/jrheum.131313
DOI https://doi.org/10.3899/jrheum.131313
Keywords biomarkers, imaging, outcome and process assessment, OMERACT filter, validation framework
Publisher URL http://dx.doi.org/10.3899/jrheum.131313
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