Background The OMERACT recommendations defined outcomes to be assessed in acute and chronic gout trials in 2005.
Objectives With the increasing number of trials investigating new treatments for gout, the aim of our study was to assess whether the OMERACT recommendations for acute and chronic gout trials have been adopted.
Methods We searched Medline, EMBASE and Cochrane databases as well as EULAR and ACR abstracts (2010-11) to identify all randomized clinical trials (RCTs) and quasi-RCTs on any intervention in adult patients with gout. We assessed risk of bias (RoB) according to Cochrane methods. We extracted all outcomes reported in all studies and categorized them as either an OMERACT recommended outcome domain for acute trials, for chronic trials, or a non-OMERACT domain. We compared the number of OMERACT outcomes included in trials according to RoB (low vs unclear and high) and according to recruitment starting before and after the publication of the OMERACT guidelines to determine their impact.
Results We screened 9517 articles and 113 ACR/EULAR abstracts and 64 publications fulfilled inclusion criteria (36 acute, 28 chronic trials). Table 1 displays the most commonly reported outcomes. Acute gout trials reported an average of 3.0 (SD 1.1) OMERACT outcomes (out of 5 recommended) and chronic gout trials reported on average of 2.4 (SD 1.0) OMERACT outcomes (out of 9 recommended). Joint damage imaging, health-related quality of life (HR-QoL), participation and musculoskeletal function were not assessed in any chronic gout trial, while patient global assessment was only reported in 33% of acute and 4% of chronic trials. Function was reported in 22% of acute gout trials. There was no significant difference between low RoB studies and high or unclear RoB studies in number of OMERACT domains reported (mean (SD): acute gout trials: 3.1 (1.1) vs 2.7 (1.2), P=0.329; chronic gout trials: 2.9 (1.1) vs 2.5 (1.1), P=0.331) or between trials recruiting participants before and after publication of OMERACT guidelines (mean (SD): acute gout trials: 3.0 (1.1) vs 2.0 (1.0), P=0.144; chronic gout trials: 2.7 (1.1) vs 2.3 (1.2), P=0.507).
Conclusions There is substantial heterogeneity in the measurement of outcomes in clinical trials of gout. To date there has been no appreciable impact of the published OMERACT recommendations in the assessment of outcomes in more recent gout trials. Function and patient global assessment is seldom assessed while participation and HR-QoL were not reported.
Disclosure of Interest None Declared
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