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5. Development and First Validation of a Disease Activity Score for Gout

Author

Scirè, Carlo A., Carrara, Greta, Viroli, Cinzia, Cimmino, Marco A., Taylor, William J., Manara, Maria, Govoni, Marcello, Salaffi, Fausto, Punzi, Leonardo, Montecucco, Carlomaurizio, Matucci‐Cerinic, Marco, Minisola, Giovanni, Ariani, Alarico, Galossi, Alessandra, Lauriti, Ciro, Fracassi, Elena, Idolazzi, Luca, Bardelli, Marco, Selvi, Enrico, Tirri, Enrico, Furini, Federica, Inverardi, Flora, Calabrò, Andrea, Porta, Francesco, Bittelli, Raffaele, Venturino, Francesco, Capsoni, Franco, Prevete, Immacolata, Sebastiani, Giandomenico, Selmi, Carlo, Fabbriciani, Gianluigi, D'Avola, Giovanni, Botticella, Giulia, Serale, Francesca, Seminara, Giulia, D'Alessandro, Giuseppe, Santo, Leonardo, Longato, Lorena, Zaccara, Eleonora, Sinigaglia, Luigi, Atteritano, Marco, Broggini, Marco, Caprioli, Marta, Favero, Marta, Sallì, Salvatore, Scarati, Marco, Parisi, Simone, Malavolta, Nazzarena, Corvaglia, Stefania, Scarpato, Salvatore, and Veneto, Vittorio

Abstract

To develop a new composite disease activity score for gout and provide its first validation. Disease activity has been defined as the ongoing presence of urate deposits that lead to acute arthritis and joint damage. Every measure for each Outcome Measures in Rheumatology core domain was considered. A 3‐step approach (factor analysis, linear discriminant analysis, and linear regression) was applied to derive the Gout Activity Score (GAS). Decision to change treatment or 6‐month flare count were used as the surrogate criteria of high disease activity. Baseline and 12‐month followup data of 446 patients included in the Kick‐Off of the Italian Network for Gout cohort were used. Construct‐ and criterion‐related validity were tested. External validation on an independent sample is reported. Factor analysis identified 5 factors: patient‐reported outcomes, joint examination, flares, tophi, and serum uric acid (sUA). Discriminant function analysis resulted in a correct classification of 79%. Linear regression analysis identified a first candidate GAS including 12‐month flare count, sUA, visual analog scale (VAS) of pain, VAS global activity assessment, swollen and tender joint counts, and a cumulative measure of tophi. Alternative scores were also developed. The developed GAS demonstrated a good correlation with functional disability (criterion validity) and discrimination between patient‐ and physician‐reported measures of active disease (construct validity). The results were reproduced in the external sample. This study developed and validated a composite measure of disease activity in gout. Further testing is required to confirm its generalizability, responsiveness, and usefulness in assisting with clinical decisions.

Published
2016
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6. Development and first validation of a disease activity score for gout

Author

Scirè, Ca1, Carrara, G2, Viroli, C3, Cimmino, Ma4, Taylor, Wj5, Manara, M2, Govoni, M6, Salaffi, F7, Punzi, L8, Montecucco, C9, Matucci Cerinic M10, Minisola, G11, Collaborators Ariani A, Study Group for the Kick Off of the Italian Network for Gout S. t. u. d. y., Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabrò, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, Marco, Broggini, M, Caprioli, M, Favero, M, Sallì, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V., Scire, C, Carrara, G, Viroli, C, Cimmino, M, Taylor, W, Manara, M, Govoni, M, Salaffi, F, Punzi, L, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Scirè, Carlo A, Carrara, Greta, Viroli, Cinzia, Cimmino, Marco A., Taylor, William J., Manara, Maria, Govoni, Marcello, Salaffi, Fausto, Punzi, Leonardo, Montecucco, Carlomaurizio, Matucci-Cerinic, Marco, Minisola, Giovanni, Ariani, Alarico, Galossi, Alessandra, Lauriti, Ciro, Fracassi, Elena, Idolazzi, Luca, Bardelli, Marco, Selvi, Enrico, Tirri, Enrico, Furini, Federica, Inverardi, Flora, Calabrò, Andrea, Porta, Francesco, Bittelli, Raffaele, Venturino, Francesco, Capsoni, Franco, Prevete, Immacolata, Sebastiani, Giandomenico, Selmi, Carlo, Fabbriciani, Gianluigi, D'Avola, Giovanni, Botticella, Giulia, Serale, Francesca, Seminara, Giulia, D'Alessandro, Giuseppe, Santo, Leonardo, Longato, Lorena, Zaccara, Eleonora, Sinigaglia, Luigi, Atteritano, Marco, Broggini, Marco, Caprioli, Marta, Favero, Marta, Sallì, Salvatore, Scarati, Marco, Parisi, Simone, Malavolta, Nazzarena, Corvaglia, Stefania, Scarpato, Salvatore, and Veneto, Vittorio

Subjects
Male, medicine.medical_specialty, Visual analogue scale, Aged, Arthralgia, Factor Analysis, Statistical, Female, Follow-Up Studies, Gout, Humans, Joints, Linear Models, Middle Aged, Pain Measurement, Patient Reported Outcome Measures, Regression Analysis, Reproducibility of Results, Uric Acid, Disease Progression, Severity of Illness Index, NO, disease activity, gout, patient perspective, 03 medical and health sciences, 0302 clinical medicine, gout, Rheumatology, Discriminant function analysis, Linear regression, Criterion validity, medicine, 030212 general & internal medicine, 030203 arthritis & rheumatology, business.industry, Construct validity, Regression analysis, Statistical, medicine.disease, Linear discriminant analysis, patient perspective, Physical therapy, Rheumatology, Factor Analysis, business, Factor Analysis, disease activity
Abstract

Objective To develop a new composite disease activity score for gout and provide its first validation. Methods Disease activity has been defined as the ongoing presence of urate deposits that lead to acute arthritis and joint damage. Every measure for each Outcome Measures in Rheumatology core domain was considered. A 3-step approach (factor analysis, linear discriminant analysis, and linear regression) was applied to derive the Gout Activity Score (GAS). Decision to change treatment or 6-month flare count were used as the surrogate criteria of high disease activity. Baseline and 12-month followup data of 446 patients included in the Kick-Off of the Italian Network for Gout cohort were used. Construct- and criterion-related validity were tested. External validation on an independent sample is reported. Results Factor analysis identified 5 factors: patient-reported outcomes, joint examination, flares, tophi, and serum uric acid (sUA). Discriminant function analysis resulted in a correct classification of 79%. Linear regression analysis identified a first candidate GAS including 12-month flare count, sUA, visual analog scale (VAS) of pain, VAS global activity assessment, swollen and tender joint counts, and a cumulative measure of tophi. Alternative scores were also developed. The developed GAS demonstrated a good correlation with functional disability (criterion validity) and discrimination between patient- and physician-reported measures of active disease (construct validity). The results were reproduced in the external sample. Conclusion This study developed and validated a composite measure of disease activity in gout. Further testing is required to confirm its generalizability, responsiveness, and usefulness in assisting with clinical decisions.

Published
2016

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