title: How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0.
abstract: OBJECTIVE
  The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0."
  
  
  METHODS
  Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework.
  
  
  RESULTS
  After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook."
  
  
  CONCLUSIONS
  Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.
authors.affiliation: From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Université Pierre et Marie Curie (UPMC) - Paris 6, GRC-UMPC 08 (EEMOIS), Paris, France; APHP, Hôpital Pitié-Salpêtrière, Rhumatologie; University of Leeds and UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK; Department of Rheumatology, APHP, Ambroise Paré Hospital, UPRES EA 2506 Université Versailles-Saint Quentin En Yvelines, Boulogne-Billancourt, France; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; Australian Health Workforce Institute, School of Population Health, University of Melbourne, Melbourne, Australia; Academic Medical Center University of Amsterdam and Atrium Medical Center Heerlen, Heerlen, The Netherlands; Institute of Bone and Joint Research and Sydney Medical School and School of Public Health, University of Sydney, and Department of Rheumatology, Royal North Shore, St. Leonards, NSW, Australia; SDG LLC, Cambridge, Massachusetts; University of Alabama at Birmingham; Veterans Affairs Medical Center, Birmingham, Alabama; Mayo Clinic College of Medicine, Rochester, Minnesota; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Department of Epidemiology and Community Medicine, and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.forename: John R
authors.initials: JR
authors.lastname: Kirwan
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.forename: Maria-Antonietta
authors.initials: MA
authors.lastname: D'Agostino
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.forename: Peter M
authors.initials: PM
authors.lastname: Brooks
authors.forename: Robert
authors.initials: R
authors.lastname: Landewé
authors.forename: Lyn
authors.initials: L
authors.lastname: March
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: George A
authors.initials: GA
authors.lastname: Wells
authors.forename: Peter
authors.initials: P
authors.lastname: Tugwell
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D064887:Observational Studies as Topic / Q000592:standards*; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D012216:Rheumatic Diseases / Q000628:therapy*; D012219:Rheumatology / Q000592:standards*
keywords: CLINICAL TRIALS; CORE OUTCOME SETS; OMERACT FILTER; OUTCOME AND PROCESS ASSESSMENT