Filipe Araújo1, Inês Cordeiro2, Sofia Ramiro3, Louise Falzon2, Jaime C Branco3, Rachelle Buchbinder3. 1. Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Institute of Microbiology, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal, Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, Center for Behavioral Cardiovascular Health, Columbia University Medical Center, NY, USA, CEDOC, Faculdade de Ciências Médicas da Universidade Nova de Lisboa, Lisboa, Portugal, Monash Department of Clinical Epidemiology, Cabrini Hospital and Department of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Institute of Microbiology, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal, Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, Center for Behavioral Cardiovascular Health, Columbia University Medical Center, NY, USA, CEDOC, Faculdade de Ciências Médicas da Universidade Nova de Lisboa, Lisboa, Portugal, Monash Department of Clinical Epidemiology, Cabrini Hospital and Department of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia flipar@msn.com. 2. Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Institute of Microbiology, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal, Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, Center for Behavioral Cardiovascular Health, Columbia University Medical Center, NY, USA, CEDOC, Faculdade de Ciências Médicas da Universidade Nova de Lisboa, Lisboa, Portugal, Monash Department of Clinical Epidemiology, Cabrini Hospital and Department of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia. 3. Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Institute of Microbiology, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal, Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, Center for Behavioral Cardiovascular Health, Columbia University Medical Center, NY, USA, CEDOC, Faculdade de Ciências Médicas da Universidade Nova de Lisboa, Lisboa, Portugal, Monash Department of Clinical Epidemiology, Cabrini Hospital and Department of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Institute of Microbiology, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal, Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, Center for Behavioral Cardiovascular Health, Columbia University Medical Center, NY, USA, CEDOC, Faculdade de Ciências Médicas da Universidade Nova de Lisboa, Lisboa, Portugal, Monash Department of Clinical Epidemiology, Cabrini Hospital and Department of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia.
Abstract
OBJECTIVE: The aim of this study was to systematically review outcome domains and measurement tools used in gout trials and their accordance with the preliminary OMERACT gout recommendations published in 2005. METHODS: Randomized controlled trials (RCTs) and quasi-RCTs investigating any intervention for gout published up to February 2013 were included. Recruitment start dates and all measured outcomes were extracted. Risk of bias (RoB) was assessed with the Cochrane Collaboration tool. Numbers of OMERACT domains were compared for trials at low vs unclear/high RoB and for recruitment start date before 2005 or 2005 and later. RESULTS: Of 9784 articles screened, 38 acute and 30 chronic gout trials were included. Mean (s.d.) number of OMERACT outcomes was 2.9 (1.1) (out of 5) and 2.5 (1.2) (out of 9) for acute and chronic gout trials, respectively. Health-related quality of life, participation and joint damage imaging were not assessed in any trial. Tools used to measure individual domains varied widely. There were no differences in the number of OMERACT outcomes reported in acute or chronic gout trials recruiting before 2005 vs 2005 or later [mean (s.d.): 3.0 (1.1) vs 3.5 (1.3), P = 0.859 and 2.7 (1.1) vs 2.8 (1.4), P = 0.960, respectively]. While both acute and chronic trials at low RoB reported more OMERACT domains than trials at unclear/high RoB, these differences were not significant. Industry-funded trials and trials performed by OMERACT investigators reported more OMERACT outcome domains. CONCLUSION: We found no appreciable impact of the OMERACT recommendations for gout trials to date.
OBJECTIVE: The aim of this study was to systematically review outcome domains and measurement tools used in gout trials and their accordance with the preliminary OMERACT gout recommendations published in 2005. METHODS: Randomized controlled trials (RCTs) and quasi-RCTs investigating any intervention for gout published up to February 2013 were included. Recruitment start dates and all measured outcomes were extracted. Risk of bias (RoB) was assessed with the Cochrane Collaboration tool. Numbers of OMERACT domains were compared for trials at low vs unclear/high RoB and for recruitment start date before 2005 or 2005 and later. RESULTS: Of 9784 articles screened, 38 acute and 30 chronic gout trials were included. Mean (s.d.) number of OMERACT outcomes was 2.9 (1.1) (out of 5) and 2.5 (1.2) (out of 9) for acute and chronic gout trials, respectively. Health-related quality of life, participation and joint damage imaging were not assessed in any trial. Tools used to measure individual domains varied widely. There were no differences in the number of OMERACT outcomes reported in acute or chronic gout trials recruiting before 2005 vs 2005 or later [mean (s.d.): 3.0 (1.1) vs 3.5 (1.3), P = 0.859 and 2.7 (1.1) vs 2.8 (1.4), P = 0.960, respectively]. While both acute and chronic trials at low RoB reported more OMERACT domains than trials at unclear/high RoB, these differences were not significant. Industry-funded trials and trials performed by OMERACT investigators reported more OMERACT outcome domains. CONCLUSION: We found no appreciable impact of the OMERACT recommendations for gout trials to date.
Authors: Matthew J Page; Joanne E McKenzie; Sally E Green; Dorcas E Beaton; Nitin B Jain; Mario Lenza; Arianne P Verhagen; Stephen Surace; Jessica Deitch; Rachelle Buchbinder Journal: J Clin Epidemiol Date: 2015-06-16 Impact factor: 6.437
Authors: Allison Tong; Braden Manns; Angela Yee Moon Wang; Brenda Hemmelgarn; David C Wheeler; John Gill; Peter Tugwell; Robert Pecoits-Filho; Sally Crowe; Tess Harris; Wim Van Biesen; Wolfgang C Winkelmayer; Adeera Levin; Aliza Thompson; Vlado Perkovic; Angela Ju; Talia Gutman; Amelie Bernier-Jean; Andrea K Viecelli; Emma O'Lone; Jenny Shen; Michelle A Josephson; Yeoungjee Cho; David W Johnson; Bénédicte Sautenet; Marcello Tonelli; Jonathan C Craig Journal: Kidney Int Date: 2018-10-22 Impact factor: 10.612
Authors: Robert Froud; Shilpa Patel; Dévan Rajendran; Philip Bright; Tom Bjørkli; Rachelle Buchbinder; Sandra Eldridge; Martin Underwood Journal: PLoS One Date: 2016-10-24 Impact factor: 3.240
Authors: Allison Tong; Sally Crowe; John S Gill; Tess Harris; Brenda R Hemmelgarn; Braden Manns; Roberto Pecoits-Filho; Peter Tugwell; Wim van Biesen; Angela Yee Moon Wang; David C Wheeler; Wolfgang C Winkelmayer; Talia Gutman; Angela Ju; Emma O'Lone; Benedicte Sautenet; Andrea Viecelli; Jonathan C Craig Journal: BMJ Open Date: 2018-04-20 Impact factor: 2.692
Authors: Lisa K Stamp; Hamish Farquhar; Huai Leng Pisaniello; Ana B Vargas-Santos; Mark Fisher; David B Mount; Hyon K Choi; Robert Terkeltaub; Catherine L Hill; Angelo L Gaffo Journal: Nat Rev Rheumatol Date: 2021-07-30 Impact factor: 20.543