Use and reporting of outcome measures in randomized trials for anti-neutrophil cytoplasmic antibody-associated vasculitis: A systematic literature review
Seminars in Arthritis and Rheumatism Dec 14, 2020
Monti S, Quinn KA, Christensen R, et al. - Researchers performed a systematic literature review of outcome measures (as specified in the methods section as primary and/or secondary outcomes) in randomized controlled trials (RCTs) of ANCA-associated vasculitis (AAV). They carried out to search Medline, Cochrane CENTRAL, and ClinicalTrials.gov from inception until April 30, 2019, for RCTs enrolling patients with granulomatosis with polyangiitis and/or microscopic polyangiitis. According to domains (e.g. disease activity) and instruments [e.g. Birmingham Vasculitis Activity Score (BVAS)], outcome measures were organized. In the analysis, 68 RCTs were eligible out of 1101 identified records. This study’s findings revealed that the outcome measures applied in trials in AAV commonly included vasculitis-specific tools for disease assessment, but with heterogeneity in endpoint-definitions and timing of assessments. The results demonstrated that in AAV, the other core outcomes, including PROs, and damage measures, are often omitted in AAV trials.
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