Table Info

Table 1.

Baseline characteristics of participants

Characteristic	2-monthly monitoring (n = 40)	Annual monitoring (n = 27)
Age (yrs)	57.3 (11.3)	52.8 (17.2)
Gender	36 cisgender men (90%) 3 cisgender women (7.5%) 1 transgender woman (2.5%)	25 cisgender men (92.6%) 2 cisgender women (7.4%)
Ethnicity	36/40 White (90%) 3/40 Asian (7.5%) 1/40 Black (2.5%)	26/27 White (96.3%) 1/27 Asian (3.7%)
Flares (in 12 months)	3.2 (4.71)	5.3 (5.34)
Duration of gout (yrs)	11.45 (10.57)	9.21 (6.42)
Tophi	12/40 (30%) Tophus number 4.8 Max size 13.6 (14.7) mm	8/27 (29.6%) Tophus number 4.8 Max size 14.4 (14.8) mm
Urate level (mmol/L)	0.28 (0.075) (Study entry) 0.26 (0.04) (Optimised)	0.37 (0.12) (Study entry) 0.29 (0.04) (Optimised)
Urate lowering therapy	Allopurinol 39/40 (mean dose 410 mg) Febuxostat 1/40 (120 mg)	Allopurinol 27/27 (mean dose 322 mg)
Co-existing conditions
Obesity (BMI ≥ 30)	17/40 (42.50%)	15/27 (55.56%)
eGFR < 60 mL/min per 1.73 m²	3/40 (7.50%)	1/27 (3.70%)
Type 2 diabetes	2/40 (5.00%)	3/27 (11.11%)
Hypertension	16/40 (40.00%)	9/27 (33.33%)
Hyperlipidaemia	8/40 (20.00%)	7/27 (25.93%)

Baseline characteristics of participants are reported as mean (standard deviation) for continuous variables or total number (percentage) for categorical variables. Note that all participants achieved urate target following dose optimisation at study entry before commencing randomised monitoring allocation

Supplementary materials

The supplementary table for this article is available at: https://www.explorationpub.com/uploads/Article/file/100775_sup_1.pdf.

Declarations

Acknowledgments

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.

Copyright

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