Validation and cultural adaptation of the qualisex questionnaire in patients with axial spondyloarthritis in Argentina.

The Qualisex questionnaire was developed and validated to assess sexuality in patients with rheumatoid arthritis. To the best of our knowledge, there is no instrument to evaluate sexuality in axial spondyloarthritis (axSpA). For this reason, the objective of this study was to validate and adapt the Qualisex questionnaire in axSpA and evaluate the impact of the disease on patients' sexuality. Cross sectional study. Consecutive patients, with ≥ 21 years of age, diagnosed with axSpA according to ASAS'09 criteria were included. Sexual health was assessed using the Qualisex questionnaire. The original version was translated to Spanish and adapted to axSpA. Internal consistency, and test re-test reliability was calculated. Criterion and construct validity were assessed by comparing the Qualisex with parameters of disease activity functional capacity and quality of life. 61 patients were invited to participate in the study, 11 of whom refused. 50 patients were included; 40 (80%) were males, with a median age of 47 years (IQR 21-72) and a median disease duration of 13 years (IQR 1-46). Reproducibility was excellent with an ICC of 0.99 (95% CI 0.65-1). The Qualisex had a good correlation with different disease evaluation parameters. The Qualisex was significantly higher among women (5.4 in women vs. 2.5 in men, p = 0.02), unemployed (4.7 in unemployed vs. 2.3 in employed, p = 0.01), in patients with higher disease activity (4.2 in active patients vs. 1.6 in inactive patients, p = 0.01), and it was lower in patients receiving biologic therapy (BT) (1.9 with BT vs. 3.8 without BT, p = 0.01). Multivariable analysis showed that female sex, longer disease duration and higher disease activity were independently associated with a greater impact on sexuality. The Qualisex adapted to axSpA is a valid and reliable questionnaire. Female axSpA patients, those with longer disease duration and higher disease activity presented a worse sexual life.

Validación del cuestionario RAPID3 en la cohorte argentina ESPAXIA de pacientes con espondiloartritis axial / Validation of RAPID3 questionnaire in ESPAXIA Argentina cohort of patients with axial spondyloarthritis

Introducción: El RAPID3 (Routine Assessment of Patient Index Data 3) es un cuestionario sencillo, rápido y de cálculo simple que mostró un buen rendimiento en Artritis Reumatoidea, siendo capaz de reflejar el estado de enfermedad y la calidad de vida en estos pacientes. Objetivo: Validar el cuestionario RAPID3 en una cohorte de pacientes con EsP axial y evaluar su asociación con otras medidas de evaluación de la enfermedad. Materiales y métodos: Se incluyeron pacientes consecutivos ≥18 años de edad con diagnóstico de EsP axial (según criterios NY modificados 1987 y/o ASAS 2009). Todos los pacientes completaron los cuestionarios RAPID3, ASQoL, BASDAI y BASFI. La evaluación global de la enfermedad, tanto por el paciente como por el médico, se determinó mediante escala visual análoga (EVA). Se realizó examen físico con recuento articular (44) y evaluación de entesis (MASES). Se obtuvieron muestras de sangre para determinación de HLA-B27 y ERS. Se calculó ASDAS-ERS y SASDAS-ERS. Evaluación radiológica por BASRI por un evaluador ciego al estado clínico de los pacientes (CCI=>0,92). Se utilizó la versión traducida y validada en Argentina del RAPID3, el cual consiste en 10 preguntas acerca de capacidad funcional y 2 preguntas acerca de dolor y evaluación global de la enfermedad, con sus puntos de corte preestablecidos. Se determinó el tiempo para completar el cuestionario por parte del paciente y el tiempo para calcularlo por parte del médico. Resultados: Se incluyeron 51 pacientes, 39 de sexo masculino (76,5%), con una edad mediana 42 años (RIC 33-51) y tiempo mediano de evolución de la enfermedad de 20 años (RIC 10,3-27,6). El 90,5% presentaba HLA-B27. La mediana del RAPID3 fue 9 (RIC 3-12,8), BASDAI 3,35 (RIC 1,6-6), BASFI 3,4 (RIC 1,1-5,6), ASQoL 5 (RIC 1-9), SASDAS-ERS 15,9 (RIC 8-22,6), MASES 1 (RIC 0-3) y BASRI 4,5 (RIC 0-11). El cuestionario tuvo excelente reproducibilidad (CCI=0,97). El tiempo mediano para completar el RAPID3 fue de 2 minutos (RIC 0,91-3), y para calcularlo de 10 segundos (RIC 6-15). Se observó muy buena correlación del RAPID3 con SASDAS ERS (r:0,87), BASDAI (r:0,89), BASFI (r:0,8) y ASQoL (r:0,83) y buena con el MASES (r:0,58). Al evaluar los puntos de corte preestablecidos del RAPID3 y el SASDAS ERS, observamos buena concordancia entre los mismos (Kappa:0,5, p=0,0001). También encontramos muy buena asociación de los puntos de corte del RAPID3 y el BASDAI (p=0,0001). En la regresión lineal múltiple, utilizando como variable dependiente el puntaje total RAPID-3, ajustando por edad, sexo y tiempo de evolución de la enfermedad, se observó una asociación significativa con BASDAI (coef β: 0,55, p=0,0001), BASFI (coef β0,25, p=0,008), ASQoL (coef β: 0,22, p=0,02), como también con SASDAS ERS (coef β: 0,42, p=0,001). Conclusión: El RAPID3 es un cuestionario válido, confiable y reproducible para ser utilizado en EsP axial, simple para completar y calcular. Y además, tiene la ventaja de reflejar el estado de tres aspectos importantes de la enfermedad: actividad, capacidad funcional y calidad de vida.

Introduction: RAPID3 (Routine Assessment of Patient Index Data 3) is a simple, quick and simple calculation questionnaire that showed good performance in patients with rheumatoid arthritis, being able to reflect the state of disease and quality of life in these patients. Objective: To validate the RAPID3 questionnaire in a cohort of patients with axial spondyloarthritis (axSpa) and assess its association with other measures of the disease. Materials and methods: We included consecutive patients ≥18 years of age diagnosed with axSpa (according to modified NY criteria 1987 and/or ASAS 2009). All patients completed the RAPID3, ASQoL, BASDAI and BASFI questionnaires. The overall assessment of the disease both by the patient and the doctor was determined by visual analog scale (VAS). Physical examination was performed with joint count (44) and evaluation of enthesis (MASES). Blood samples for determination of HLA-B27 and ERS were obtained. ASDAS-ERS and SASDAS-ERS were calculated. X-rays were evaluated by BASRI by a blinded reader (CCI=>0.92). The translated and validated in Argentina RAPID3 version was calculated. Time to complete the questionnaire by the patient and time to calculate by the doctor were determined. Results: 51 patients were included, 39 were male (76.5%), median age 42 years (IQR 33-51) and median disease duration of 20 years (IQR 10.3-27.6). 90.5% had HLA-B27. Median RAPID3 was 9 (IQR 3-12.8), BASDAI 3.35 (IQR 1.6-6), BASFI 3.4 (IQR 1.1-5.6), ASQoL 5 (IQR 1-9), SASDAS-ESR 15.9 (IQR 8-22.6), MASES 1 (IQR 0-3) and BASRI 4.5 (IQR 0-11). The questionnaire had excellent reproducibility (ICC = 0.97). The median time to complete the RAPID3 was 2 minutes (IQR 0.91 to 3), and to calculate 10 seconds (IQR 6-15). RAPID3 had very good correlation with SASDAS ESR (r:0.87), BASDAI (r:0.89), BASFI (r=0.8) and ASQoL (r=0.83) and good with MASES (r:0.58). In multiple linear regression, using total RAPID score as dependent variable and adjusting for age, sex and disease duration, a significant association was observed with BASFI (β coeff 0.25, p=0.008), ASQoL (β coeff: 0.22, p=0.02), and mainly with SASDAS ERS (β coeff: 0.42, p=0.001) and BASDAI (0.55, p=0.0001). Conclusion: RAPID3 is a valid, reliable and reproducible questionnaire to be used in axSpa. It is simple to complete by the patient and to evaluate by the rheumatologist.