title: Updating the OMERACT filter: core areas as a basis for defining core outcome sets.
abstract: OBJECTIVE
  The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter presupposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework.
  
  
  METHODS
  Discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed framework, whether these observations had a more general application, and what issues remained to be resolved.
  
  
  RESULTS
  Although there was broad acceptance of the framework in general, several important areas of construction, presentation, and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues.
  
  
  CONCLUSIONS
  These issues will require resolution to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome Domains and hence appropriate Core Outcome Sets for clinical trials.
authors.affiliation: From the University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands; University of the West of England, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Department of Occupational Sciences and Occupational Therapy, Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; Section of Rheumatology, Cardiff University School of Medicine, Cardiff, UK; Division of Musculoskeletal Disease, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK; Versailles-Saint Quentin En Yvelines University, Department of Rheumatology, Ambroise Paré Hospital, APHP, Boulogne-Billancourt; Paris-Descartes University, Medicine Faculty, APHP, Cochin Hospital, Rheumatology B, Paris, France; University of California, Geffen School of Medicine, Los Angeles, California, USA; Université de Lorraine, Université Paris Descartes, Nancy; Université Pierre et Marie Curie (UPMC), Paris; AP-HP Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam and Atrium Medical Center Heerlen, the Netherlands; NIHR-Leeds Musculoskeletal Biomedical Research Unit, Division of Rheumatic and Musculoskeletal Diseases, University of Leeds, Leeds, UK; Division of Rheumatology, Mayo Clinic College of Medicine, Rochester, Minnesota, USA; Seattle Rheumatology Associates, Swedish Medical Center Rheumatology Research Division, University of Washington School of Medicine, 
authors.forename: John R
authors.initials: JR
authors.lastname: Kirwan
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.forename: Sarah
authors.initials: S
authors.lastname: Hewlett
authors.forename: Dorcas
authors.initials: D
authors.lastname: Beaton
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.forename: Ernest
authors.initials: E
authors.lastname: Choy
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.forename: Maria-Antonietta
authors.initials: MA
authors.lastname: D'Agostino
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
authors.forename: Francis
authors.initials: F
authors.lastname: Guillemin
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.forename: Désirée M
authors.initials: DM
authors.lastname: van der Heijde
authors.forename: Margreet
authors.initials: M
authors.lastname: Kloppenburg
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.forename: Robert B M
authors.initials: RB
authors.lastname: Landewé
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Mackie
authors.forename: Eric L
authors.initials: EL
authors.lastname: Matteson
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Mease
authors.forename: Peter A
authors.initials: PA
authors.lastname: Merkel
authors.forename: Mikkel
authors.initials: M
authors.lastname: Ostergaard
authors.forename: Lesley Ann
authors.initials: LA
authors.lastname: Saketkoo
authors.forename: Lee
authors.initials: L
authors.lastname: Simon
authors.forename: Jasvinder A
authors.initials: JA
authors.lastname: Singh
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.forename: Peter
authors.initials: P
authors.lastname: Tugwell
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000592:standards* / Q000639:trends*; D012216:Rheumatic Diseases / Q000628:therapy*; D012219:Rheumatology / Q000592:standards*
keywords: CLINICAL TRIALS; CONSENSUS DEVELOPMENT CONFERENCE; OUTCOME AND PROCESS ASSESSMENT; OUTCOME MEASURES IN RHEUMATOLOGY