Total 8 events in 5 (18.5%) individualsIncluding 2 deaths
0.40
Adverse events
Total of 37 events in 23 (57.5%) individuals
Total of 25 events in 13 (48.1%) individuals
> 0.99
Information on adverse events was collected prospectively and sought specifically at week 24 and 52 visits. No significant difference in rate of adverse events was seen between 2-monthly and annual urate arms, with significance calculated using a 2 sample Poisson rate test
Study results were presented as an oral communication at the 15th European Crystal Network workshop in 2024.
Author contributions
PLR: Investigation (principal investigator of the study), Supervision, Validation, Writing—original draft. DA: Methodology, Investigation (development of study documents and review of participants). CB: Investigation (obtained community prescribing data), Formal analysis, Validation. HA: Investigation (reviewed the hospital records for all participants). RH: Formal analysis, Writing—review & editing. AK: Software (developed the GoutSMART app and webportal), Data curation (provided IT support throughout the study). The corresponding author affirms that the manuscript is an accurate and transparent account of the study. All authors have had direct access to all study data and PLR has verified the findings presented. All authors have contributed to and approved the final manuscript.
Conflicts of interest
None of the authors have any conflicts of interest to declare.
Ethical approval
Ethical approval was obtained from South East Scotland Research Ethics Committee (Reference 18/SS/0031) and NHS Lothian Caldicott Guardian. The extension trial protocol has been uploaded with the results of the feasibility trial on ClinicalTrials.gov, NCT03274063.
Consent to participate
Informed consent to participate in the study was obtained from all participants.
Consent to publication
Not applicable.
Availability of data and materials
Data will be shared on reasonable request to the corresponding author. Study protocol is submitted as a supplementary file.
Funding
Support for development of the GoutSMART app and feasibility trial was provided by the NHS Lothian Charity. Conduct of the extension trial was supported by the Doris Hillier (2020) grant from the BMA Foundation for Medical Research including salary support for DA and AK. The funders had no role in the design, conduct, analysis or presentation of the study. The study was sponsored by the University of Edinburgh which reviewed all study documents but took no part in the collection, analysis, or interpretation of the data.
Safiri S, Kolahi A, Cross M, Carson-Chahhoud K, Hoy D, Almasi-Hashiani A, et al. Prevalence, Incidence, and Years Lived With Disability Due to Gout and Its Attributable Risk Factors for 195 Countries and Territories 1990-2017: A Systematic Analysis of the Global Burden of Disease Study 2017.Arthritis Rheumatol. 2020;72:1916–27. [DOI] [PubMed]
Hui M, Carr A, Cameron S, Davenport G, Doherty M, Forrester H, et al.; British Society for Rheumatology Standards, Audit and Guidelines Working Group. The British Society for Rheumatology Guideline for the Management of Gout.Rheumatology (Oxford). 2017;56:1246. [DOI] [PubMed]
Richette P, Doherty M, Pascual E, Barskova V, Becce F, Castañeda-Sanabria J, et al. 2016 updated EULAR evidence-based recommendations for the management of gout.Ann Rheum Dis. 2017;76:29–42. [DOI] [PubMed]
FitzGerald JD, Dalbeth N, Mikuls T, Brignardello-Petersen R, Guyatt G, Abeles AM, et al. 2020 American College of Rheumatology Guideline for the Management of Gout.Arthritis Care Res (Hoboken). 2020;72:744–60. [DOI] [PubMed] [PMC]
Mackenzie IS, Ford I, Nuki G, Hallas J, Hawkey CJ, Webster J, et al.; FAST Study Group. Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial.Lancet. 2020;396:1745–57. [DOI] [PubMed]
Doherty M, Jenkins W, Richardson H, Sarmanova A, Abhishek A, Ashton D, et al. Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial.Lancet. 2018;392:1403–12. [DOI] [PubMed] [PMC]
Dehlin M, Jacobsson L, Roddy E. Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors.Nat Rev Rheumatol. 2020;16:380–90. [DOI] [PubMed]
Briesacher BA, Andrade SE, Fouayzi H, Chan KA. Comparison of drug adherence rates among patients with seven different medical conditions.Pharmacotherapy. 2008;28:437–43. [DOI] [PubMed] [PMC]
Qaseem A, Harris RP, Forciea MA; Clinical Guidelines Committee of the American College of Physicians, Denberg TD; Denberg TD, Barry MJ, Boyd C, Chow RD, Humphrey LL, Kansagara D, et al. Management of Acute and Recurrent Gout: A Clinical Practice Guideline From the American College of Physicians.Ann Intern Med. 2017;166:58–68. [DOI] [PubMed]
Hammersley V, Parker R, Paterson M, Hanley J, Pinnock H, Padfield P, et al. Telemonitoring at scale for hypertension in primary care: An implementation study.PLoS Med. 2020;17:e1003124. [DOI] [PubMed] [PMC]
Paraskos J, Berke Z, Cook J, Miner JN, Braddock M, Platt A, et al. An analytical comparison between point-of-care uric acid testing meters.Expert Rev Mol Diagn. 2016;16:373–82. [DOI] [PubMed]
Riches PL, Sing K, Berg K. Point-of-care uric acid testing is useful in routine clinical care of gout.Arthritis Res Ther. 2019;21:117. [DOI] [PubMed] [PMC]
Riches PL, Alexander D, Hauser B, Kuske B, Krause A. Evaluation of supported self-management in gout (GoutSMART): a randomised controlled feasibility trial.Lancet Rheumatol. 2022;4:e320–8. [DOI] [PubMed]
Gaffo AL, Dalbeth N, Saag KG, Singh JA, Rahn EJ, Mudano AS, et al. Brief Report: Validation of a Definition of Flare in Patients With Established Gout.Arthritis Rheumatol. 2018;70:462–7. [DOI] [PubMed]
Perez-Ruiz F, Calabozo M, Pijoan JI, Herrero-Beites AM, Ruibal A. Effect of urate-lowering therapy on the velocity of size reduction of tophi in chronic gout.Arthritis Rheum. 2002;47:356–60. [DOI] [PubMed]
Yin R, Li L, Zhang G, Cui Y, Zhang L, Zhang Q, et al. Rate of adherence to urate-lowering therapy among patients with gout: a systematic review and meta-analysis.BMJ Open. 2018;8:e017542. [DOI] [PubMed] [PMC]
Abhishek A, Jenkins W, La-Crette J, Fernandes G, Doherty M. Long-term persistence and adherence on urate-lowering treatment can be maintained in primary care-5-year follow-up of a proof-of-concept study.Rheumatology (Oxford). 2017;56:529–33. [DOI] [PubMed]
Sheppard JP, Tucker KL, Davison WJ, Stevens R, Aekplakorn W, Bosworth HB, et al. Self-monitoring of Blood Pressure in Patients With Hypertension-Related Multi-morbidity: Systematic Review and Individual Patient Data Meta-analysis.Am J Hypertens. 2020;33:243–51. [DOI] [PubMed] [PMC]
