title: The OMERACT core set of outcome measures for use in clinical trials of ANCA-associated vasculitis.
abstract: There has been a marked increase in the past 15 years in the number and quality of clinical trials in the idiopathic inflammatory vasculitides, especially the small-vessel vasculitides known as antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis [AAV; granulomatosis, with polyangiitis (Wegener's)]. These trials have been conducted by multicenter, international groups in Europe and the United States with financial support provided by government agencies and biopharmaceutical companies. This increased clinical trial activity in vasculitis has been accompanied by the development and validation of new outcome measures--a challenging process for these complex, multiorgan system diseases. The international OMERACT Vasculitis Working Group has developed and implemented an iterative research agenda that has utilized accumulated experience and datasets from several multicenter clinical trials and large cohort studies. This work has led to the development, evaluation, validation, and endorsement, through the OMERACT consensus and validation processes, of a "core set" of outcome measurements for use in clinical trials of AAV. The core set includes domains of disease activity, damage assessment, patient-reported outcomes, and mortality; there is at least one validated outcome measurement instrument available for each domain. This report reviews the domains of illness in AAV included in the OMERACT core set, describes the instruments validated to measure these domains, and presents the approved core set.
authors: Section of Rheumatology and the Clinical Epidemiology Unit, Boston University School of Medicine, Boston, MA, USA. pmerkel@bu.edu
authors: Peter A
authors: PA
authors: Merkel
authors: Sibel Z
authors: SZ
authors: Aydin
authors: Maarten
authors: M
authors: Boers
authors: Haner
authors: H
authors: Direskeneli
authors: Karen
authors: K
authors: Herlyn
authors: Philip
authors: P
authors: Seo
authors: Ravi
authors: R
authors: Suppiah
authors: Gunnar
authors: G
authors: Tomasson
authors: Raashid A
authors: RA
authors: Luqmani
mesh_terms: D056648:Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / Q000628:therapy*; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D006801:Humans; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011788:Quality of Life; D015203:Reproducibility of Results; D016896:Treatment Outcome