TY - JOUR T1 - Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process JF - The Journal of Rheumatology JO - J Rheumatol SP - 2204 LP - 2209 DO - 10.3899/jrheum.141143 VL - 42 IS - 11 AU - Joanna C. Robson AU - Nataliya Milman AU - Gunnar Tomasson AU - Jill Dawson AU - Peter F. Cronholm AU - Katherine Kellom AU - Judy Shea AU - Susan Ashdown AU - Maarten Boers AU - Annelies Boonen AU - George C. Casey AU - John T. Farrar AU - Don Gebhart AU - Jeffrey Krischer AU - Georgia Lanier AU - Carol A. McAlear AU - Jacqueline Peck AU - Antoine G. Sreih AU - Peter S. Tugwell AU - Raashid A. Luqmani AU - Peter A. Merkel Y1 - 2015/11/01 UR - http://www.jrheum.org/content/42/11/2204.abstract N2 - Objective. Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV.Methods. Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV.Results. The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility.Conclusion. The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. ER -