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2014 ; 41
(3
): 593-8
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Current status of outcome measure development in vasculitis
#MMPMID24429177
Merkel PA
; Aydin SZ
; Boers M
; Cornell C
; Direskeneli H
; Gebhart D
; Hatemi G
; Luqmani R
; Matteson EL
; Milman N
; Robson J
; Seo P
; Tomasson G
J Rheumatol
2014[Mar]; 41
(3
): 593-8
PMID24429177
show ga
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.