• Joanna C Robson, Gunnar Tomasson, Nataliya Milman, Sue Ashdown, Annelies Boonen, George C Casey, Peter F Cronholm, David Cuthbertson, Jill Dawson, Haner Direskeneli, Ebony Easley, Tanaz A Kermani, John T Farrar, Don Gebhart, Georgia Lanier, Raashid A Luqmani, Alfred Mahr, Carol A McAlear, Jacqueline Peck, Beverley Shea, Judy A Shea, Antoine G Sreih, Peter S Tugwell, and Peter A Merkel.
• From the University of the West of England; University of Bristol; University Hospitals Bristol UK National Health Service (NHS) Trust, Bristol; Nuffield Department of Population Health, University of Oxford; Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Department of Public Health Sciences, University of Iceland, Reykjavik, Iceland; Division of Rheumatology, University of Ottawa; Division of Rheumatology, The Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute; Ottawa Hospital Research Institute, School of Epidemiology, Public Health and Preventative Medicine, Faculty of Medicine, University of Ottawa; Department of Medicine, Faculty of Medicine, University of Ottawa; Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa, Ontario, Canada; Division of Rheumatology, Maastricht University Medical Centre; Caphri Graduate School, Maastricht, the Netherlands; Vasculitis Foundation, Denver, Colorado; Department of Family Medicine and Community Health, University of Pennsylvania; Epidemiology, Neurology, and Anesthesiology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania; Department of Medicine, University of Pennsylvania; Clinical Medicine, Division of Rheumatology, University of Pennsylvania; Medicine and Epidemiology, Division of Rheumatology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Biostatistics and Informatics, Department of Pediatrics, University of South Florida, Tampa, Florida; Division of Rheumatology, Department of Medicine, University of California, Los Angeles, USA; Division of Rheumatology, Marmara University, School of Medicine, Marmara, Turkey; Medicine, Hopital Saint Louis, Paris, France.
• J Rheumatol. 2017 Oct 1; 44 (10): 1529-1535.

ObjectiveThe antineutrophil cytoplasmic antibody-associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016.MethodsA novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented.ResultsOMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement).ConclusionThe OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial.

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