Hugh de Lautour1, William J Taylor2, Ade Adebajo3, Rieke Alten4, Ruben Burgos-Vargas5, Peter Chapman6, Marco A Cimmino7, Geraldo da Rocha Castelar Pinheiro8, Ric Day9, Leslie R Harrold10, Philip Helliwell11, Matthijs Janssen12, Gail Kerr13, Arthur Kavanaugh14, Dinesh Khanna15, Puja P Khanna16, Chingtsai Lin17, Worawit Louthrenoo18, Geraldine McCarthy19, Janitzia Vazquez-Mellado5, Ted R Mikuls20, Tuhina Neogi21, Alexis Ogdie22, Fernando Perez-Ruiz23, Naomi Schlesinger24, H Ralph Schumacher22, Carlo A Scirè25, Jasvinder A Singh26, Francisca Sivera27, Ole Slot28, Lisa K Stamp29, Anne-Kathrin Tausche30, Robert Terkeltaub31, Till Uhlig32, Mart van de Laar33, Douglas White34, Hisashi Yamanaka35, Xuejun Zeng36, Nicola Dalbeth37. 1. Auckland District Health Board, Auckland, New Zealand. 2. University of Otago, Wellington, New Zealand. 3. University of Sheffield, Sheffield, UK. 4. Schlosspark-Klinik, Charité, University Medicine Berlin, Berlin, Germany. 5. Hospital General de México, Mexico City, Mexico. 6. Christchurch Hospital, Christchurch, New Zealand. 7. Università di Genova, Genova, Italy. 8. Pedro Ernesto University Hospital, Rio de Janeiro, Brazil. 9. University of New South Wales and St Vincent's Hospital, Sydney, Australia. 10. University of Massachusetts Medical School, Worcester, and Corrona, LLC, Southborough. 11. Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK. 12. Rijnstate Hospital, Arnhem, The Netherlands. 13. Veterans Affairs Medical Center, Georgetown and Howard University Hospitals, Washington, DC. 14. University of California School of Medicine, San Diego. 15. University of Michigan, Ann Arbor. 16. University of Michigan and Ann Arbor VA Medical Center, Ann Arbor. 17. Taichung Veteran's General Hospital, Taichung, Taiwan. 18. Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. 19. Mater Misericordiae University Hospital and University College, Dublin, Ireland. 20. Nebraska-Western Iowa Health Care System and University of Nebraska Medical Center, Omaha. 21. Boston University School of Medicine, Boston, Massachusetts. 22. University of Pennsylvania, Philadelphia. 23. Hospital Universitario Cruces, OSI-EEC, and Biocruces Health Research Institute, Biscay, Spain. 24. Rutgers University Robert Wood Johnson Medical School, New Brunswick, New Jersey. 25. IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy. 26. University of Alabama at Birmingham and the Birmingham VA Medical Center, Birmingham. 27. Hospital General Universitario Elda, Elda, Spain. 28. Copenhagen University Hospital Glostrup, Glostrup, Denmark. 29. University of Otago, Christchurch, New Zealand. 30. University Hospital Carl Gustav Carus, Dresden, Germany. 31. University of California San Diego VA Medical Center, La Jolla. 32. National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. 33. Universiteit Twente, Erschede, The Netherlands. 34. Waikato DHB and Waikato Clinical School, University of Auckland, Hamilton, New Zealand. 35. Tokyo Women's Medical University, Tokyo, Japan. 36. Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China. 37. University of Auckland and Auckland District Health Board, Auckland, New Zealand.
Abstract
OBJECTIVE: To establish consensus for potential remission criteria to use in clinical trials of gout. METHODS: Experts (n = 88) in gout from multiple countries were invited to participate in a web-based questionnaire study. Three rounds of Delphi consensus exercises were conducted using SurveyMonkey, followed by a discrete-choice experiment using 1000Minds software. The exercises focused on identifying domains, definitions for each domain, and the timeframe over which remission should be defined. RESULTS: There were 49 respondents (56% response) to the initial survey, with subsequent response rates ranging from 57% to 90%. Consensus was reached for the inclusion of serum urate (98% agreement), flares (96%), tophi (92%), pain (83%), and patient global assessment of disease activity (93%) as measurement domains in remission criteria. Consensus was also reached for domain definitions, including serum urate (<0.36 mm), pain (<2 on a 10-point scale), and patient global assessment (<2 on a 10-point scale), all of which should be measured at least twice over a set time interval. Consensus was not achieved in the Delphi exercise for the timeframe for remission, with equal responses for 6 months (51%) and 1 year (49%). In the discrete-choice experiment, there was a preference towards 12 months as a timeframe for remission. CONCLUSION: These consensus exercises have identified domains and provisional definitions for gout remission criteria. Based on the results of these exercises, preliminary remission criteria are proposed with domains of serum urate, acute flares, tophus, pain, and patient global assessment. These preliminary criteria now require testing in clinical data sets.
OBJECTIVE: To establish consensus for potential remission criteria to use in clinical trials of gout. METHODS: Experts (n = 88) in gout from multiple countries were invited to participate in a web-based questionnaire study. Three rounds of Delphi consensus exercises were conducted using SurveyMonkey, followed by a discrete-choice experiment using 1000Minds software. The exercises focused on identifying domains, definitions for each domain, and the timeframe over which remission should be defined. RESULTS: There were 49 respondents (56% response) to the initial survey, with subsequent response rates ranging from 57% to 90%. Consensus was reached for the inclusion of serum urate (98% agreement), flares (96%), tophi (92%), pain (83%), and patient global assessment of disease activity (93%) as measurement domains in remission criteria. Consensus was also reached for domain definitions, including serum urate (<0.36 mm), pain (<2 on a 10-point scale), and patient global assessment (<2 on a 10-point scale), all of which should be measured at least twice over a set time interval. Consensus was not achieved in the Delphi exercise for the timeframe for remission, with equal responses for 6 months (51%) and 1 year (49%). In the discrete-choice experiment, there was a preference towards 12 months as a timeframe for remission. CONCLUSION: These consensus exercises have identified domains and provisional definitions for gout remission criteria. Based on the results of these exercises, preliminary remission criteria are proposed with domains of serum urate, acute flares, tophus, pain, and patient global assessment. These preliminary criteria now require testing in clinical data sets.
Authors: Lisa G Rider; Rohit Aggarwal; Pedro M Machado; Jean-Yves Hogrel; Ann M Reed; Lisa Christopher-Stine; Nicolino Ruperto Journal: Nat Rev Rheumatol Date: 2018-04-12 Impact factor: 20.543
Authors: Lisa G Rider; Rohit Aggarwal; Angela Pistorio; Nastaran Bayat; Brian Erman; Brian M Feldman; Adam M Huber; Rolando Cimaz; Rubén J Cuttica; Sheila Knupp de Oliveira; Carol B Lindsley; Clarissa A Pilkington; Marilynn Punaro; Angelo Ravelli; Ann M Reed; Kelly Rouster-Stevens; Annet van Royen-Kerkhof; Frank Dressler; Claudia Saad Magalhaes; Tamás Constantin; Joyce E Davidson; Bo Magnusson; Ricardo Russo; Luca Villa; Mariangela Rinaldi; Howard Rockette; Peter A Lachenbruch; Frederick W Miller; Jiri Vencovsky; Nicolino Ruperto Journal: Ann Rheum Dis Date: 2017-05 Impact factor: 19.103
Authors: Rohit Aggarwal; Lisa G Rider; Nicolino Ruperto; Nastaran Bayat; Brian Erman; Brian M Feldman; Chester V Oddis; Anthony A Amato; Hector Chinoy; Robert G Cooper; Maryam Dastmalchi; David Fiorentino; David Isenberg; James D Katz; Andrew Mammen; Marianne de Visser; Steven R Ytterberg; Ingrid E Lundberg; Lorinda Chung; Katalin Danko; Ignacio García-De la Torre; Yeong Wook Song; Luca Villa; Mariangela Rinaldi; Howard Rockette; Peter A Lachenbruch; Frederick W Miller; Jiri Vencovsky Journal: Arthritis Rheumatol Date: 2017-04-06 Impact factor: 10.995
Authors: Lisa G Rider; Rohit Aggarwal; Angela Pistorio; Nastaran Bayat; Brian Erman; Brian M Feldman; Adam M Huber; Rolando Cimaz; Rubén J Cuttica; Sheila Knupp de Oliveira; Carol B Lindsley; Clarissa A Pilkington; Marilynn Punaro; Angelo Ravelli; Ann M Reed; Kelly Rouster-Stevens; Annet van Royen-Kerkhof; Frank Dressler; Claudia Saad Magalhaes; Tamás Constantin; Joyce E Davidson; Bo Magnusson; Ricardo Russo; Luca Villa; Mariangela Rinaldi; Howard Rockette; Peter A Lachenbruch; Frederick W Miller; Jiri Vencovsky; Nicolino Ruperto Journal: Arthritis Rheumatol Date: 2017-04-06 Impact factor: 10.995
Authors: Rohit Aggarwal; Lisa G Rider; Nicolino Ruperto; Nastaran Bayat; Brian Erman; Brian M Feldman; Chester V Oddis; Anthony A Amato; Hector Chinoy; Robert G Cooper; Maryam Dastmalchi; David Fiorentino; David Isenberg; James D Katz; Andrew Mammen; Marianne de Visser; Steven R Ytterberg; Ingrid E Lundberg; Lorinda Chung; Katalin Danko; Ignacio García-De la Torre; Yeong Wook Song; Luca Villa; Mariangela Rinaldi; Howard Rockette; Peter A Lachenbruch; Frederick W Miller; Jiri Vencovsky Journal: Ann Rheum Dis Date: 2017-05 Impact factor: 19.103