title: Updating the OMERACT filter: implications for patient-reported outcomes.
abstract: OBJECTIVE
  At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the "Truth" statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied.
  
  
  METHODS
  Following overview presentations, discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed PRO development framework, whether these observations had a more general application, and what issues remained to be resolved.
  
  
  RESULTS
  Several aspects of PRO development were recognized as particularly important, and the need to directly involve patients at every stage of an iterative PRO development program was endorsed. This included recognition that patients contribute as partners in the research and not merely as subjects. Correct communication of concepts with the words used in questionnaires was central to their performance as measuring instruments, and ensuring this understanding crossed cultural and linguistic boundaries was important in international studies or comparisons.
  
  
  CONCLUSIONS
  Participants recognized, endorsed, and were generally already putting into practice the principles of PRO development presented in the plenary session. Further work is needed on some existing instruments and on establishing widespread good practice for working in close collaboration with patients.
authors.affiliation: From the University of Bristol, Academic Rheumatology Unit, and the University of the West of England, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Department of Medicine, McGill University, Montreal, Quebec, Canada; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; Department of Occupational Sciences and Occupational Therapy, Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Departments of Epidemiology and Biostatistics, and Rheumatology, and Department of Medical Humanities, VU University Medical Center, Amsterdam, The Netherlands; National Rheumatoid Arthritis Society, Maidenhead, Berkshire, UK; Faculty of Health Sciences, University of Queensland, Royal Brisbane and Women's Hospital, Herston, Brisbane, Australia; Section of Rheumatology, Cardiff University School of Medicine, Cardiff, UK; Université de Lorraine, Université Paris Descartes, Paris, France; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam and Atrium Medical Center Heerlen, Amsterdam, The Netherlands; Healthy Motivation, Bone and Joint Decade, Santa Barbara, California, USA; Cochrane Musculoskeletal Group, Institute of Population Health, Ottawa, Ontario, Canada; Department of Rheumatology, Royal North Shore Hospital, St. Leonards, New South Wales, Australia; Consumer Advisory Board, Arthritis Research Centre of Canada, Richmond, British Columbia, Canada; UCB Pharma S.A., Brussels, Belgium; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Université Pierre et Marie Curie (UPMC) - Paris 6, GRC-UMPC 08 (EEMOIS); AP-HP Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France.
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mesh_terms: D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000592:standards* / Q000639:trends*; D010358:Patient Participation; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D012216:Rheumatic Diseases / Q000628:therapy*; D012219:Rheumatology / Q000592:standards*; D057566:Self Report / Q000592:standards*
keywords: OUTCOME AND PROCESS ASSESSMENT; PATIENT-REPORTED OUTCOMES; RANDOMIZED CONTROLLED TRIALS