ABSTRACT
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group seeks to develop validated outcome measures for use in trials for large-vessel vasculitis (LVV). METHODS: An international Delphi exercise conducted among investigators identified items considered important to measure active disease. In parallel, qualitative research with patients was conducted, including interviews and focus groups. RESULTS: Next steps prioritized by the group for LVV include (1) defining disease states (remission, flare, and patient-acceptable symptom state) and (2) selection of patient-reported outcome tools. CONCLUSION: The ultimate goal is to develop an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV.
Subject(s)
Giant Cell Arteritis/diagnosis , Takayasu Arteritis/diagnosis , Humans , Outcome Assessment, Health Care , Patient Reported Outcome Measures , Rheumatology , Severity of Illness IndexABSTRACT
OBJECTIVE: To understand the effects of glucocorticoids (GC), which are of importance to patients. METHODS: The results of 2 literature reviews, a patient survey, and a qualitative study were presented. RESULTS: No validated instrument exists to evaluate GC effect on patients. Survey data revealed skin thinning/bruising, sleep disturbance, and weight gain as the most frequent adverse effects. The qualitative research yielded rich data covering rapid benefits and physical and emotional consequences of GC. CONCLUSION: It was agreed that a patient-reported outcome to measure GC effect was required and a research agenda was developed for this goal.
