title: Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.
abstract: BACKGROUND
  Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process.
  
  
  METHODS
  Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology.
  
  
  RESULTS
  To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n=125) at the OMERACT 11 consensus conference endorsed this model and process.
  
  
  CONCLUSIONS
  The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 165, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: eb@vumc.nl.
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.affiliation: University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, United Kingdom.
authors.forename: John R
authors.initials: JR
authors.lastname: Kirwan
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Wells
authors.affiliation: Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Dorcas
authors.initials: D
authors.lastname: Beaton
authors.affiliation: Department of Rheumatology, Université Pierre et Marie Curie (UPMC), Paris 6, GRC-UMPC 08 (EEMOIS), and Assistance Publique Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.affiliation: Department of Rheumatology, Université Versailles-Saint Quentin en Yvelines, Ambroise Pare Hospital, Boulogne-Billancourt, France.
authors.forename: Maria-Antonietta
authors.initials: MA
authors.lastname: d'Agostino
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.affiliation: Division of Rheumatology, Johns Hopkins University, Baltimore, MD 21224, USA.
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.affiliation: School of Population and Global Health, University of Melbourne, Melbourne, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Brooks
authors.affiliation: Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Robert
authors.initials: R
authors.lastname: Landewé
authors.affiliation: Institute of Bone and Joint Research, Kolling Institute of Medical Research, University of Sydney, Sydney, Australia; Department of Rheumatology, Royal North Shore Hospital, St. Leonards, New South Wales, Australia.
authors.forename: Lyn
authors.initials: L
authors.lastname: March
authors.affiliation: SDG LLC, Cambridge, MA 02138, USA.
authors.forename: Lee S
authors.initials: LS
authors.lastname: Simon
authors.affiliation: Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL 35294, USA; Veterans Affairs Medical Center, Birmingham, AL 35294, USA.
authors.forename: Jasvinder A
authors.initials: JA
authors.lastname: Singh
authors.affiliation: Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA 94028, USA.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.affiliation: Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Tugwell
mesh_terms: D032921:Consensus; D018849:Controlled Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D006282:Health Personnel; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000592:standards*; D012216:Rheumatic Diseases / Q000628:therapy; D012219:Rheumatology / Q000379:methods / Q000592:standards; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: Biological markers; Clinical trial; Outcome assessment (health care); Reference Standards; Research design; Rheumatology