Outcomes assessed in trials of gout and accordance with OMERACT-proposed domains: a systematic literature review.
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.


CONCLUSIONS
We found no appreciable impact of the OMERACT recommendations for gout trials to date.
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.
Filipe
F
Araújo
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.
Inês
I
Cordeiro
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.
Sofia
S
Ramiro
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.
Louise
L
Falzon
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.
Jaime C
JC
Branco
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.
Rachelle
R
Buchbinder
D000208:Acute Disease; D002908:Chronic Disease; D006073:Gout / Q000188:drug therapy*; D006801:Humans; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
gout; outcomes research; patient perspective