Updating the OMERACT filter: Implications for imaging and soluble biomarkers

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 Bingham, Peter M. Brooks, Dorcas E. Beaton, Frederique Gandjbakhch, Laure Gossec, Francis Guillemin, Sarah E. Hewlett, Margreet Kloppenburg, Lyn MarchPhilip J. Mease, Ingrid Moller, Lee S. Simon, Jasvinder A. Singh, Vibeke Strand, Richard J. Wakefield, George A. Wells, Peter Tugwell, Philip G. Conaghan

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1016-1024
Number of pages9
JournalJournal of Rheumatology
Volume41
Issue number5
DOIs
StatePublished - 2014

Fingerprint

Biomarkers
Rheumatology
Outcome Assessment (Health Care)
Knee Osteoarthritis
Rheumatoid Arthritis
Clinical Trials
Research
Therapeutics

Keywords

  • Biomarkers
  • Imaging
  • Omeract filter
  • Outcome and process assessment
  • Validation framework

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy
  • Medicine(all)

Cite this

D'Agostino, M. A., Boers, M., Kirwan, J., Van Der Heijde, D., Østergaard, M., Schett, G., ... 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

Updating the OMERACT filter : Implications for imaging and soluble biomarkers. / D'Agostino, Maria Antonietta; Boers, Maarten; Kirwan, John; Van Der Heijde, Désirée; Østergaard, Mikkel; Schett, Georg; Landewé, Robert B.; Maksymowych, Walter P.; Naredo, Esperanza; Dougados, Maxime; Iagnocco, Annamaria; Bingham, Clifton; Brooks, Peter M.; Beaton, Dorcas E.; Gandjbakhch, Frederique; Gossec, Laure; Guillemin, Francis; Hewlett, Sarah E.; 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.

In: Journal of Rheumatology, Vol. 41, No. 5, 2014, p. 1016-1024.

Research output: Contribution to journalArticle

D'Agostino, MA, Boers, M, Kirwan, J, Van Der Heijde, D, Østergaard, M, Schett, G, Landewé, RB, Maksymowych, WP, Naredo, E, Dougados, M, Iagnocco, A, Bingham, C, Brooks, PM, Beaton, DE, Gandjbakhch, F, Gossec, L, Guillemin, F, Hewlett, SE, Kloppenburg, M, March, L, Mease, PJ, Moller, I, Simon, LS, Singh, JA, Strand, V, Wakefield, RJ, Wells, GA, Tugwell, P & Conaghan, PG 2014, 'Updating the OMERACT filter: Implications for imaging and soluble biomarkers', Journal of Rheumatology, vol. 41, no. 5, pp. 1016-1024. https://doi.org/10.3899/jrheum.131313
D'Agostino MA, Boers M, Kirwan J, Van Der Heijde D, Østergaard M, Schett G et al. Updating the OMERACT filter: Implications for imaging and soluble biomarkers. Journal of Rheumatology. 2014;41(5):1016-1024. https://doi.org/10.3899/jrheum.131313
D'Agostino, Maria Antonietta ; Boers, Maarten ; Kirwan, John ; Van Der Heijde, Désirée ; Østergaard, Mikkel ; Schett, Georg ; Landewé, Robert B. ; Maksymowych, Walter P. ; Naredo, Esperanza ; Dougados, Maxime ; Iagnocco, Annamaria ; Bingham, Clifton ; Brooks, Peter M. ; Beaton, Dorcas E. ; Gandjbakhch, Frederique ; Gossec, Laure ; Guillemin, Francis ; Hewlett, Sarah E. ; 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. / Updating the OMERACT filter : Implications for imaging and soluble biomarkers. In: Journal of Rheumatology. 2014 ; Vol. 41, No. 5. pp. 1016-1024.
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T2 - Implications for imaging and soluble biomarkers

AU - D'Agostino, Maria Antonietta

AU - Boers, Maarten

AU - Kirwan, John

AU - Van Der Heijde, Désirée

AU - Østergaard, Mikkel

AU - Schett, Georg

AU - Landewé, Robert B.

AU - Maksymowych, Walter P.

AU - Naredo, Esperanza

AU - Dougados, Maxime

AU - Iagnocco, Annamaria

AU - Bingham, Clifton

AU - Brooks, Peter M.

AU - Beaton, Dorcas E.

AU - Gandjbakhch, Frederique

AU - Gossec, Laure

AU - Guillemin, Francis

AU - Hewlett, Sarah E.

AU - Kloppenburg, Margreet

AU - March, Lyn

AU - Mease, Philip J.

AU - Moller, Ingrid

AU - Simon, Lee S.

AU - Singh, Jasvinder A.

AU - Strand, Vibeke

AU - Wakefield, Richard J.

AU - Wells, George A.

AU - Tugwell, Peter

AU - Conaghan, Philip G.

PY - 2014

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N2 - 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.

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