A useful tool to assess quality of LIFE in rheumatoid arthritis patients that does not require a license: QOL-RA II.

To validate the Quality of Life-Rheumatoid Arthritis Scale II (QOL-RA II) in an Argentinean cohort of patients with rheumatoid arthritis (RA). Patients ≥ 18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria, were included in a cross-sectional study. Sociodemographic data, comorbidities, RA characteristics, disease activity, and current treatment were registered. Questionnaires were administered, including EQ-5D-3 L, QOL-RA II, HAQ-A, and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Four hundred and thirty patients were included. Median QOL-RA was 6.6 (IQR 5.3-8). Mean time to complete it was 1.7 ± 0.57 min and to calculate it was 12 ± 1.7 s. It showed very good reliability (Cronbach's alpha 0.97), reproducibility (ICC, 0.96), and good correlation between the different items and the total questionnaire, without evidence of redundancy. Besides, QOL-RA II presented good correlation with EQ-5D-3L (Rho, 0.6) and moderate with DAS28 (Rho, 0.38), and CDAI (Rho, 0.46). Worse quality of life was observed in patients not doing physical activity, unemployed, and current smokers. Patients with higher disease activity had a significant poorer quality of life. Adjusting by age, sex and disease duration, unemployment, higher disease activity, disability, and the presence of depression were independently associated to worse quality of life. QOL-RA II demonstrated good construct validity, reproducibility, and reliability. It was easy to complete and calculate and does not require a license for its use, thus making it the optimal tool for assessing the quality of life in Spanish-speaking patients with RA. Key Points • The evaluation of quality of life is very important in patients with Rheumatoid Arthritis. • Most of the questionnaires used to assess the quality of life require a license to use. • QOL-RA II is a valid and simple questionnaire to evaluate the quality of life of patients with RA and does not require a license for its use.

Una nueva herramienta para valorar la calidad de vida de pacientes con artritis reumatoidea que no requiere licencia: el cuestionario QOL-RA II (Quality of Life-Rheumatoid Arthritis Scale-II) / A new tool to assess quality of life in patients with rheumatoid arthritis that does not require a license: QOL-RA II (Quality of Life-Rheumatoid Arthritis Scale-II)

Recientemente, validamos el cuestionario Quality of Life-Rheumatoid Arthritis Scale (QOL-RA) y detectamos la presencia de algunas limitaciones. Por esta razón, con la autorización de la autora, cambiamos dos preguntas y desarrollamos una nueva versión en español: el QOL-RA II. Objetivo: Validar el QOL-RA II en una cohorte argentina de pacientes con Artritis Reumatoidea (AR). Material y métodos: Estudio de corte transversal. Se incluyeron pacientes ≥18 años de edad, con diagnóstico de AR según criterios ACR-EULAR 2010. Se consignaron datos sociodemográficos, comorbilidades, características clínicas y actividad de la enfermedad. Se administraron los cuestionarios EQ-5D-3L, QOL-RA II, HAQ-A y PHQ-9. A 20 pacientes se les re-administró el cuestionario a los 7 días de haber completado el primero para evaluar reproducibilidad. Análisis estadístico: Test T de Student, ANOVA, Chi². Correlación de Spearman. Alpha de Cronbach. Coeficiente de correlación intraclase. Regresión Logística Multinomial con modelo factorial completo. Regresión lineal múltiple. Resultados: Se incluyeron 430 pacientes, con un tiempo mediano (m) de evolución de 9 años (RIC: 4-16). La m del QOL-RA II fue 6,7 (RIC: 5,3-8). El tiempo promedio para completarlo fue de 1,7±0,57 minutos y para su cálculo de 12±1,7 segundos. Solo 9 (2,1%) pacientes no contestaron alguna pregunta. El cuestionario presentó excelente confiabilidad (α de Cronbach 0,97), reproducibilidad (CCI: 0,96) y buena correlación entre los diferentes ítems y el cuestionario total, sin evidencia de redundancia. QOL-RA II presentó además, buena correlación con EQ-5D-3L (Rho: 0,6), HAQ-A (Rho: 0,55) y PHQ-9 (Rho: 0,56) y moderada con los índices de actividad de la enfermedad DAS28-ERS (Rho: 0,38) y CDAI (Rho: 0,46). Se evidenció peor calidad de vida en aquellos pacientes que no realizaban actividad física (X 6,4±1,9 vs. 7±1,8, p <0,0001), en los desocupados (X 6,1±1,9 vs. 7±1,8, p <0,0001) y en los tabaquistas (X 6,2±1,7 vs. 6,7±1,9, p=0,03). Se observó una tendencia significativa a empeorar la calidad de vida a mayor actividad de la enfermedad. Ajustando por edad, sexo y tiempo de evolución de la enfermedad, las variables que se asociaron significativamente a peor calidad de vida fueron la desocupación, la mayor actividad de la enfermedad, la discapacidad funcional y la presencia de depresión. Conclusión: El QOL-RA II demostró buena validez de constructo, reproducibilidad. Fue fácil de completar y calcular. No se observó redundancia entre las preguntas ni influencia por la edad ni el tiempo de evolución de la enfermedad.

We have recently validated the Quality of Life-Rheumatoid Arthritis Scale (QOL-RA). We have found some limitations, that is why, with the author's permission, we have changed two questions and developed a new Spanish version, QOL-RA II. Objective: To validate the QOL-RA II in an Argentinean cohort of patients with Rheumatoid Arthritis (RA). Material and methods: Cross-sectional study. Patients ≥18 years old, with a diagnosis of RA according to ACR-EULAR 2010 criteria were included. Sociodemographic data, comorbidities, RA characteristics, disease activity current treatment were registered. Questionnaires were administered: EQ-5D-3L, QOL-RA, HAQ-A and PHQ-9. The QOL-RA II was re-administered in 20 patients to evaluate reproducibility. Statistical analysis: Student's T, ANOVA and Chi² tests. Spearman correlation. Cronbach's alpha. Reproducibility using ICC. Multinomial logistic regression with completed factorial model. Multiple linear regression. Results: 430 patients were included, with a median (m) disease duration of 8.9 years (IQR: 4-16). QOL-RA was m 6.6 (IQR: 5.3-8). Mean time to complete it was 1.7±0.57 minutes and to calculate it 12±17 seconds. Only 2.1% of the questionnaires presented missing answers. It showed very good reliability (Cronbach's alpha 0.97), reproducibility (ICC: 0.96) and good correlation between the different items and the total questionnaire, without evidence of redundancy. Besides, QOL-RA II presented good correlation with EQ-5D-3L (Rho: 0.6), HAQ-A (Rho: 0.55) and PHQ-9 (Rho: 0.56) and moderate with DAS28-ESR (Rho: 0.38) and CDAI (Rho: 0.46). Worse quality of life was observed in patients not doing physical activity (X 6.4±1.9 vs. 7±1.8, p <0.0001), unemployed (X 6.1±1.9 vs. 7±1.8, p <0.0001) and current smokers (X 6.2±1.7 vs. 6.7±1.9, p=0.03). Patients with higher disease activity had a significant poorer quality of life. Adjusting by age, sex and disease duration, unemployment, higher disease activity, disability and the presence of depression were independently associated to worse quality of life. Conclusions: QOL-RA II demonstrated good construct validity, reproducibility and reliability. It was easy to complete and calculate. There were no redundancy between questions and it was not influenced by age and disease duration.