How flare prevention outcomes are reported in gout studies: A systematic review and content analysis of randomized controlled trials.

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dc.contributor.author Stewart, Sarah en
dc.contributor.author Tallon, Amy en
dc.contributor.author Taylor, William J en
dc.contributor.author Gaffo, Angelo en
dc.contributor.author Dalbeth, Nicola en
dc.date.accessioned 2020-02-11T23:05:25Z en
dc.date.issued 2020-04 en
dc.identifier.issn 0049-0172 en
dc.identifier.uri http://hdl.handle.net/2292/49923 en
dc.description.abstract OBJECTIVES:There are many potential ways that gout flares could be reported in clinical trials. The aim of this study was to describe the methods used to measure and report gout flare prevention outcomes in randomized controlled trials (RCTs). METHODS:A systematic search of electronic databases was conducted. Articles published between 2008 and 2018 were included if they were RCTs or articles reporting on analyses of RCT data (i.e. open label extension studies) and reported the impact of an intervention on the prevention of flares in people with gout. The modified-Jadad scale was used to assess study quality. Methods used to measure and report gout flare outcomes were extracted and synthesised separately for studies of anti-inflammatory prophylaxis and urate lowering/other long term therapy. RESULTS:A total of 38 articles were included, with 10 reporting outcomes for anti-inflammatory prophylaxis and 28 for urate lowering/other long term therapies. The overall quality score of all articles was good. There was marked heterogeneity across trials in gout flare definitions, data capture methods, reporting methods and time periods used to report flares. Anti-inflammatory prophylaxis studies used multiple methods to report gout flare outcomes (mean (SD) 4.3 (2.5) methods/article), while the majority of urate lowering/other long term therapy studies used a single method to report gout flare outcomes. The most common reporting method in anti-inflammatory prophylaxis studies was the mean number of gout flares per patient (n = =9 articles), and in urate lowering/other long term therapy studies was the proportion of patients with at least one gout flare (n = =22 articles). Only studies of anti-inflammatory prophylaxis therapy reported flare duration or pain during flare. CONCLUSION:There is wide variation in methods used to measure and report gout flare prevention outcomes in long-term RCTs. These findings highlight the need for standardized methods for studies in which gout flare prevention is an outcome of interest. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.relation.ispartofseries Seminars in arthritis and rheumatism en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.title How flare prevention outcomes are reported in gout studies: A systematic review and content analysis of randomized controlled trials. en
dc.type Journal Article en
dc.identifier.doi 10.1016/j.semarthrit.2019.11.002 en
pubs.issue 2 en
pubs.begin-page 303 en
pubs.volume 50 en
dc.rights.holder Copyright: The author en
pubs.end-page 313 en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/RestrictedAccess en
pubs.subtype Journal Article en
pubs.elements-id 789235 en
pubs.org-id Medical and Health Sciences en
pubs.org-id School of Medicine en
pubs.org-id Medicine Department en
dc.identifier.eissn 1532-866X en
pubs.record-created-at-source-date 2019-12-05 en
pubs.dimensions-id 31796212 en


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