title: Current status of outcome measure development in vasculitis.
abstract: The conduct of randomized controlled trials for vasculitis, especially for the antineutrophil cytoplasmic antibody-associated vasculitides [AAV, granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis], has been greatly advanced by the development, use, and acceptance of validated outcome measures. Trials have subsequently provided the opportunity to validate and refine reliable, valid outcome measures for these multisystemic and relapsing rare diseases. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group was formed in 2004 to foster development of validated and widely accepted outcomes in vasculitis using data-driven analyses, a dedication to building consensus, and adherence to, and guidance by, the principles of the OMERACT approach. This work led to the endorsement by OMERACT of the core set of domains and associated outcome measures for AAV. Next steps for the study of existing outcome tools in AAV include better definition of response criteria through development of more data-driven weighting of the elements of activity and damage assessment. The Working Group is now also embarking on a series of linked projects to develop validated patient-reported outcomes for use in clinical research in vasculitis. Additionally, the Working Group is studying how current methods of disease assessment and plans for new outcomes can be informed by the conceptual framework of the International Classification of Function of the World Health Organization. The success of the Group's work in AAV has also led to a formal process for developing outcomes for the large vessel vasculitides (Takayasu arteritis and giant cell arteritis) and Behçet disease.
authors.affiliation: From the Division of Rheumatology and Department of Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Department of Rheumatology, Istanbul Medeniyet University, Istanbul, Goztepe Training and Research Hospital, Istanbul, Turkey; Department of Epidemiology and Biostatistics, VU University Medical Center; Amsterdam, The Netherlands; Department of Rheumatology, Marmara University School of Medicine, Istanbul, Turkey; Department of Otolaryngology, Ohio State University Medical Center, Columbus, Ohio, USA; Division of Rheumatology, Department of Internal Medicine, Cerrahpasa Medical School, Istanbul University, Istanbul, Turkey; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Division of Rheumatology, and Division of Epidemiology, Mayo Clinic College of Medicine, Rochester, Minnesota, USA; Division of Rheumatology, University of Ottawa, Ottawa, Ontario, Canada; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; University of Iceland, Reykjavik, Iceland.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Merkel
authors.forename: Sibel Z
authors.initials: SZ
authors.lastname: Aydin
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.forename: Christina
authors.initials: C
authors.lastname: Cornell
authors.forename: Haner
authors.initials: H
authors.lastname: Direskeneli
authors.forename: Don
authors.initials: D
authors.lastname: Gebhart
authors.forename: Gulen
authors.initials: G
authors.lastname: Hatemi
authors.forename: Raashid
authors.initials: R
authors.lastname: Luqmani
authors.forename: Eric L
authors.initials: EL
authors.lastname: Matteson
authors.forename: Nataliya
authors.initials: N
authors.lastname: Milman
authors.forename: Joanna
authors.initials: J
authors.lastname: Robson
authors.forename: Philip
authors.initials: P
authors.lastname: Seo
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tomasson
mesh_terms: D006801:Humans; D017063:Outcome Assessment, Health Care; D015203:Reproducibility of Results; D012219:Rheumatology; D016896:Treatment Outcome; D014657:Vasculitis / Q000175:diagnosis / Q000503:physiopathology*
keywords: ASSESSMENT; OUTCOMES; VASCULITIS