Sibel Zehra Aydin1, Haner Direskeneli1, Antoine Sreih1, Fatma Alibaz-Oner1, Ahmet Gul1, Sevil Kamali1, Gulen Hatemi1, Tanaz Kermani1, Sarah L Mackie1, Alfred Mahr1, Alexa Meara1, Nataliya Milman1, Heidi Nugent1, Joanna Robson1, Gunnar Tomasson1, Peter A Merkel1. 1. From the Division of Rheumatology, Koc University Faculty of Medicine, Istanbul; Division of Rheumatology, Marmara University Faculty of Medicine, Istanbul, Turkey; Division of Rheumatology, and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Division of Rheumatology, Istanbul University Istanbul Faculty of Medicine; Division of Rheumatology, Istanbul University Cerrahpasa Faculty of Medicine, Istanbul, Turkey; Division of Rheumatology, University of California, Los Angeles, California, USA; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Department of Internal Medicine, University Paris Diderot, Paris, France; Division of Rheumatology, Ohio State University, Columbus, Ohio, USA; Division of Rheumatology, University of Ottawa, Ottawa, Ontario, Canada; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Department of Public Health Sciences, University of Iceland, Reykjavik, Iceland.S.Z. Aydin, MD, Associate Professor, Division of Rheumatology, Koc University Faculty of Medicine; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University Faculty of Medicine; A. Sreih, MD, Assistant Professor of Medicine, Division of Rheumatology, University of Pennsylvania; F. Alibaz-Oner, MD, Division of Rheumatology, Marmara University Faculty of Medicine; A. Gul, Professor, Division of Rheumatology, Istanbul University Istanbul Faculty of Medicine; S. Kamali, Professor, Division of Rheumatology, Marmara University Faculty of Medicine; G. Hatemi, Associate Professor, Division of Rheumatology, Istanbul University Cerrahpasa Faculty of Medicine; T. Kermani, MD, MS, Assistant Clinical Professor, Division of Rheumatology, University of California at Los Angeles; S.L. Mackie, BM, BCh, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; A. Mahr, MD, PhD, Professo
Abstract
OBJECTIVE: The rarity of large vessel vasculitis (LVV) is a major factor limiting randomized controlled trials in LVV, resulting in treatment choices in these diseases that are guided mainly by observational studies and expert opinion. Further complicating trials in LVV is the absence of validated and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group initiated the Large Vessel Vasculitis task force in 2009 to develop data-driven, validated outcome tools for clinical investigation in LVV. This report summarizes the progress that has been made on a disease activity assessment tool and patient-reported outcomes in LVV as well as the group's research agenda. METHODS: The OMERACT LVV task force brought an international group of investigators and patient research partners together to work collaboratively on developing outcome tools. The group initially focused on disease activity assessment tools in LVV. Following a systematic literature review, an international Delphi exercise was conducted to obtain expert opinion on principles and domains for disease assessment. The OMERACT vasculitis working group's LVV task force is also conducting qualitative research with patients, including interviews, focus groups, and engaging patients as research partners, all to ensure that the approach to disease assessment includes measures of patients' perspectives and that patients have input into the research agenda and process. RESULTS: The preliminary results of both the Delphi exercise and the qualitative interviews were discussed at the OMERACT 12 (2014) meeting and the completion of the analyses will produce an initial set of domains and instruments to form the basis of next steps in the research agenda. CONCLUSION: The research agenda continues to evolve, with the ultimate goal of developing an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV.
OBJECTIVE: The rarity of large vessel vasculitis (LVV) is a major factor limiting randomized controlled trials in LVV, resulting in treatment choices in these diseases that are guided mainly by observational studies and expert opinion. Further complicating trials in LVV is the absence of validated and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group initiated the Large Vessel Vasculitis task force in 2009 to develop data-driven, validated outcome tools for clinical investigation in LVV. This report summarizes the progress that has been made on a disease activity assessment tool and patient-reported outcomes in LVV as well as the group's research agenda. METHODS: The OMERACT LVV task force brought an international group of investigators and patient research partners together to work collaboratively on developing outcome tools. The group initially focused on disease activity assessment tools in LVV. Following a systematic literature review, an international Delphi exercise was conducted to obtain expert opinion on principles and domains for disease assessment. The OMERACT vasculitis working group's LVV task force is also conducting qualitative research with patients, including interviews, focus groups, and engaging patients as research partners, all to ensure that the approach to disease assessment includes measures of patients' perspectives and that patients have input into the research agenda and process. RESULTS: The preliminary results of both the Delphi exercise and the qualitative interviews were discussed at the OMERACT 12 (2014) meeting and the completion of the analyses will produce an initial set of domains and instruments to form the basis of next steps in the research agenda. CONCLUSION: The research agenda continues to evolve, with the ultimate goal of developing an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV.
Entities:
Keywords:
GIANT CELL ARTERITIS; LARGE VESSEL; OUTCOMES; TAKAYASU ARTERITIS; VASCULITIS
Authors: Gunnar Tomasson; Maarten Boers; Michael Walsh; Michael LaValley; David Cuthbertson; Simon Carette; John C Davis; Gary S Hoffman; Nader A Khalidi; Carol A Langford; Carol A McAlear; W Joseph McCune; Paul A Monach; Philip Seo; Ulrich Specks; Robert Spiera; E William St Clair; John H Stone; Steven R Ytterberg; Peter A Merkel Journal: Arthritis Care Res (Hoboken) Date: 2012-02 Impact factor: 4.794
Authors: M J Kupersmith; R Speira; R Langer; M Richmond; M Peterson; H Speira; H Mitnick; S Paget Journal: J Neuroophthalmol Date: 2001-12 Impact factor: 3.042
Authors: Haner Direskeneli; Sibel Z Aydin; Tanaz A Kermani; Eric L Matteson; Maarten Boers; Karen Herlyn; Raashid A Luqmani; Tuhina Neogi; Philip Seo; Ravi Suppiah; Gunnar Tomasson; Peter A Merkel Journal: J Rheumatol Date: 2011-07 Impact factor: 4.666
Authors: Peter C Grayson; Kathleen Maksimowicz-McKinnon; Tiffany M Clark; Gunnar Tomasson; David Cuthbertson; Simon Carette; Nader A Khalidi; Carol A Langford; Paul A Monach; Philip Seo; Kenneth J Warrington; Steven R Ytterberg; Gary S Hoffman; Peter A Merkel Journal: Ann Rheum Dis Date: 2012-02-10 Impact factor: 19.103
Authors: David B Hellmann; Misty L Uhlfelder; John H Stone; Mollie W Jenckes; Maria C Cid; Loic Guillevin; Larry Moreland; Paul F Dellaripa; Gary S Hoffman; Peter A Merkel; Robert Spiera; Lin Brown; José Hernández-Rodríguez; Haya R Rubin Journal: Arthritis Rheum Date: 2003-12-15
Authors: Tanaz A Kermani; Sehriban Diab; Antoine G Sreih; David Cuthbertson; Renée Borchin; Simon Carette; Lindsy Forbess; Curry L Koening; Carol A McAlear; Paul A Monach; Larry Moreland; Christian Pagnoux; Philip Seo; Robert F Spiera; Kenneth J Warrington; Steven R Ytterberg; Carol A Langford; Peter A Merkel; Nader A Khalidi Journal: Semin Arthritis Rheum Date: 2018-05-09 Impact factor: 5.532
Authors: Carol A Langford; David Cuthbertson; Steven R Ytterberg; Nader Khalidi; Paul A Monach; Simon Carette; Philip Seo; Larry W Moreland; Michael Weisman; Curry L Koening; Antoine G Sreih; Robert Spiera; Carol A McAlear; Kenneth J Warrington; Christian Pagnoux; Kathleen McKinnon; Lindsy J Forbess; Gary S Hoffman; Renée Borchin; Jeffrey P Krischer; Peter A Merkel Journal: Arthritis Rheumatol Date: 2017-03-08 Impact factor: 10.995
Authors: Carol A Langford; David Cuthbertson; Steven R Ytterberg; Nader Khalidi; Paul A Monach; Simon Carette; Philip Seo; Larry W Moreland; Michael Weisman; Curry L Koening; Antoine G Sreih; Robert Spiera; Carol A McAlear; Kenneth J Warrington; Christian Pagnoux; Kathleen McKinnon; Lindsy J Forbess; Gary S Hoffman; Renée Borchin; Jeffrey P Krischer; Peter A Merkel Journal: Arthritis Rheumatol Date: 2017-03-03 Impact factor: 10.995
Authors: Gunnar Tomasson; John T Farrar; David Cuthbertson; Carol A McAlear; Susan Ashdown; Peter F Cronholm; Jill Dawson; Don Gebhart; Georgia Lanier; Raashid A Luqmani; Nataliya Milman; Jacqueline Peck; Joanna C Robson; Judy A Shea; Simon Carette; Nader Khalidi; Curry L Koening; Carol A Langford; Paul A Monach; Larry Moreland; Christian Pagnoux; Ulrich Specks; Antoine G Sreih; Steven R Ytterberg; Peter A Merkel Journal: J Rheumatol Date: 2019-03-01 Impact factor: 4.666
Authors: Sibel Z Aydin; Joanna C Robson; Antoine G Sreih; Catherine Hill; Fatma Alibaz-Oner; Sarah Mackie; Susan Beard; Ahmet Gul; Gülen Hatemi; Tanaz A Kermani; Alfred Mahr; Alexa Meara; Nataliya Milman; Beverley Shea; Gunnar Tómasson; Peter Tugwell; Haner Direskeneli; Peter A Merkel Journal: J Rheumatol Date: 2019-03-15 Impact factor: 4.666
Authors: Antoine G Sreih; Fatma Alibaz-Oner; Tanaz A Kermani; Sibel Z Aydin; Peter F Cronholm; Trocon Davis; Ebony Easley; Ahmet Gul; Alfred Mahr; Carol A McAlear; Nataliya Milman; Joanna C Robson; Gunnar Tomasson; Haner Direskeneli; Peter A Merkel Journal: J Rheumatol Date: 2017-09-01 Impact factor: 4.666
Authors: Tanaz A Kermani; Antoine G Sreih; David Cuthbertson; Simon Carette; Gary S Hoffman; Nader A Khalidi; Curry L Koening; Carol A Langford; Carol A McAlear; Paul A Monach; Larry Moreland; Christian Pagnoux; Philip Seo; Kenneth J Warrington; Steven R Ytterberg; Peter A Merkel Journal: Rheumatology (Oxford) Date: 2018-02-01 Impact factor: 7.580