title: Updating the OMERACT filter: implications for imaging and soluble biomarkers.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: From Versailles-Saint Quentin En Yvelines University, Department of Rheumatology, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, France; Departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Glostrup, Copenhagen, Denmark; Department of Internal Medicine 3 and Institute for Clinical Immunology, University of Erlangen-Nuremberg, Erlangen, Germany; Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam and Atrium Medical Center, Amsterdam, The Netherlands; Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; Department of Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Paris-Descartes University, Medicine Faculty, APHP, Cochin Hospital, Rheumatology B, Paris, France; Rheumatology Unit, Sapienza Università di Roma, Rome, Italy; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; University of Melbourne, Medicine, Dentistry and Health Sciences, Melbourne, Australia; St. Michael's Hospital, Mobility Program Clinical Research Unit; Institute for Work and Health; University of Toronto, Department of Health Policy, Management and Evaluation, Department of Rehabilitation Science and Department of Occupational Science and Occupational Therapy, Toronto, Ontario, Canada; Pierre et Marie Curie University (UPMC) - Paris, GRC-UPMC 08 (EEMOIS); AP-HP Pitié Salpêtrière Hospital, Department of Rheumatology, Paris; Université de Lorraine, Université Paris Descartes, EA 4360 APEMAC, Nancy and Inserm CIC-EC, CHU de Nancy, Nancy, France; Department of Nursing, University of the West of England, Bris
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mesh_terms: D015415:Biomarkers / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000592:standards; D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000592:standards* / Q000639:trends*; D015203:Reproducibility of Results; D012216:Rheumatic Diseases / Q000175:diagnosis* / Q000378:metabolism* / Q000628:therapy; D012219:Rheumatology / Q000592:standards*
chemical_list: D015415:Biomarkers
keywords: BIOMARKERS; IMAGING; OMERACT FILTER; OUTCOME AND PROCESS ASSESSMENT; VALIDATION FRAMEWORK