Background The impact of gout on patients’ lives is still largely unknown.
Objectives We performed a systematic review of the baseline characteristics of participants of acute and chronic gout trials as an indirect measure of the burden of gout.
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. To assess burden, we extracted all reported baseline characteristics, and how each domain was measured. For each included trial we quantified the number of OMERACT defined domains that had been included and reported at baseline. We compared the number of OMERACT baseline domains 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.
Results We screened 9517 articles and 113 ACR/EULAR abstracts. Sixty-four publications fulfilled inclusion criteria (36 acute gout trials (AT), 28 chronic gout trials (CT)). Burden was incompletely captured across trials; there was no uniformity in what baseline characteristics were reported; many different measures were used to capture the same domain, as presented in more detail in Table 1. Certain OMERACT domains were seldom reported, such as patient global assessment of disease (AT: 3 (7.9%); CT: 0), disability (AT: 3 (7.9%); CT: 3 (7.1%)) and health-related quality of life (AT: 2 (5.3%), CT: 0). There was a statistically significant trend for CT with low RoB (LRoB) to report more baseline characteristics in comparison to studies judged to be at unclear or high RoB (UHRoB) (LRoB: 3.6 (1.4) vs. UHRoB: 2.0 (1.4), p=0.017). This tendency came close to statistical significance in AT (LRoB: 1.9 (1.2) vs. UHRoB: 1.2 (1.0), p=0.078). Similarly, there was a non significant trend for trials recruiting participants after publication of the OMERACT guidelines to report more baseline characteristics (AT: 2.0 (1.7) vs. 1.4 (1.1), p=0.410; CT: 3.5 (1.9) vs. 2.2 (1.4), p=0.129).
Conclusions Burden of gout in both acute and chronic trials is incompletely captured and using heterogeneous measures. While there was a trend towards more complete assessment of core domains of burden after the publication of OMERACT recommendations, many domains were still absent or poorly reported.
Disclosure of Interest None Declared