Assessing Reliability of an Electronic Gout Flare Assessment Protocol.

Area of Science:

• Rheumatology
• Clinical Trials
• Digital Health

Background:

• Gout management trials often prioritize serum urate levels over direct symptom assessment.
• Accurate and reliable assessment of gout flares is challenging but crucial for effective treatment.

Purpose of the Study:

• To evaluate the reliability of electronic self-reported gout flare assessments.
• To compare electronic surveys against traditional staff-conducted telephone questionnaires for gout flare assessment.

Main Methods:

• Utilized data from the TRUST randomized clinical trial, involving biweekly electronic surveys and telephone assessments.
• Employed multiple statistical measures including percent agreement, Cohen's Kappa, and intraclass correlation coefficient (ICC).
• Accounted for repeated measures using mixed effects models to calculate a mixed effects ICC.

Main Results:

• A pilot study with 28 participants reported 23 flares via electronic surveys and 22 via phone.
• Demonstrated high agreement between modalities, with a raw percent agreement of 96%.
• Achieved a strong overall ICC of 0.880 and a mixed effects ICC of 0.746.

Conclusions:

• Electronic gout flare assessments exhibit strong concordance with telephone assessments.
• Supports the use of electronic surveys as a reliable and efficient alternative for gout flare monitoring in clinical settings.