Using serum urate as a validated surrogate end point for flares in patients with gout: protocol for a systematic review and meta-regression analysis

Show simple item record Morillon, MB en Stamp, L en Taylor, W en Fransen, J en Dalbeth, Nicola en Singh, JA en Christensen, R en Lassere, M en
dc.coverage.spatial England en 2016-12-08T21:17:25Z en 2016-08-30 en 2016-09-20 en
dc.identifier.citation BMJ Open, 20 September 2016, 6 (9), Article number e012026 en
dc.identifier.uri en
dc.description.abstract INTRODUCTION: Gout is the most common inflammatory arthritis in men over 40 years of age. Long-term urate-lowering therapy is considered a key strategy for effective gout management. The primary outcome measure for efficacy in clinical trials of urate-lowering therapy is serum urate levels, effectively acting as a surrogate for patient-centred outcomes such as frequency of gout attacks or pain. Yet it is not clearly demonstrated that the strength of the relationship between serum urate and clinically relevant outcomes is sufficiently strong for serum urate to be considered an adequate surrogate. Our objective is to investigate the strength of the relationship between changes in serum urate in randomised controlled trials and changes in clinically relevant outcomes according to the 'Biomarker-Surrogacy Evaluation Schema version 3' (BSES3), documenting the validity of selected instruments by applying the 'OMERACT Filter 2.0'. METHODS AND ANALYSIS: A systematic review described in terms of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines will identify all relevant studies. Standardised data elements will be extracted from each study by 2 independent reviewers and disagreements are resolved by discussion. The data will be analysed by meta-regression of the between-arm differences in the change in serum urate level (independent variable) from baseline to 3 months (or 6 and 12 months if 3-month values are not available) against flare rate, tophus size and number and pain at the final study visit (dependent variables). ETHICS AND DISSEMINATION: This study will not require specific ethics approval since it is based on analysis of published (aggregated) data. The intended audience will include healthcare researchers, policymakers and clinicians. Results of the study will be disseminated by peer-reviewed publications. TRIAL REGISTRATION NUMBER: CRD42016026991. en
dc.description.uri en
dc.language English en
dc.publisher BMJ Publishing Group en
dc.relation.ispartofseries BMJ Open 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. Details obtained from en
dc.rights.uri en
dc.rights.uri en
dc.subject BIOMARKER en
dc.subject GOUT en
dc.subject OUTCOME en
dc.subject RHEUMATOLOGY en
dc.subject SURROGATE en
dc.title Using serum urate as a validated surrogate end point for flares in patients with gout: protocol for a systematic review and meta-regression analysis en
dc.type Journal Article en
dc.identifier.doi 10.1136/bmjopen-2016-012026 en
pubs.issue 9 en
pubs.volume 6 en
dc.description.version VoR - Version of Record en
dc.identifier.pmid 27650765 en en
pubs.publication-status Published online en
dc.rights.accessrights en
pubs.subtype Article en
pubs.elements-id 542090 en Medical and Health Sciences en School of Medicine en Medicine Department en
dc.identifier.eissn 2044-6055 en
dc.identifier.pii bmjopen-2016-012026 en
pubs.number e012026 en
pubs.record-created-at-source-date 2016-12-09 en
pubs.dimensions-id 27650765 en

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