Development and validation of a patient-reported gout attack intensity score for use in gout clinical studies.

ABSTRACT

OBJECTIVE: Inflammation-related symptoms such as pain, swelling and tenderness of the affected joint are frequently assessed using 5-point diary rating scales in gout clinical trials. Combining these into a single gout attack symptom intensity score may be a useful summary measure for these data, which is potentially more responsive to change compared with the individual components. The objective of this study was to develop a patient-reported gout flare intensity score, the Gout Attack Intensity Score (GAIS), for use in clinical studies, that includes components for gout-related pain, swelling and tenderness. METHODS: Data from a randomized controlled trial comparing anakinra to standard of care for the treatment of acute gout attacks were used for this study. A 7-day flare diary was completed by patients, including questions relating to intensity of pain, swelling and tenderness (5-point rating scales). Scalability of these items was assessed using Mokken Scale Analysis, and reliability using greatest lower bound reliability coefficients. Known-groups validity was evaluated, as well as the responsiveness to change and the presence of floor and ceiling effects. RESULTS: Scalability of the single items was supported, and GAIS scores were reliable (greatest lower bound >0.80). GAIS scores demonstrated responsiveness to change with high effect sizes (>0.8), and discriminated better between responders and non-responders compared with its single-item components. No floor and ceiling effects were found. CONCLUSION: The GAIS seems to be a reliable and responsive instrument for assessing patient-reported gout attack intensity that may be used in gout clinical studies.