[Sensitivity to change and minimally important difference of the Spanish version of the life-satisfaction questionnaire LISAT-8 in male patients with erectile dysfunction]. / Sensibilidad al cambio y diferencia mínimamente importante de la versión española del cuestionario de satisfacción con la vida LISAT-8 en pacientes varones con disfunción eréctil.

BACKGROUND AND OBJECTIVE: We determined the sensitivity to change and minimally important difference (MID) of the Spanish version of the life-satisfaction check list LISAT-8. PATIENTS AND METHOD: We included a random sample obtained from an open, naturalistic, prospective and multicenter study, which assessed the effectiveness of sildenafil as erectile dysfunction (ED) therapy. A total of 537 patients, males older than 18 years, with ED and > active sexual desire, received flexible and at demand doses of sildenafil for 10 weeks. IIEF and LISAT-8 questionnaires were used. MID was determined from the patient's classification according to change in erectile function domain of the IIEF after treatment as follows: no change (< 5 pts), small change (6 to 10 pts), moderate change (11 to 15 pts) and big change (> 15 pts). RESULTS: Sildenafil significantly modified the baseline punctuation of the LISAT 8 from a crude value of 30.2 (5.9) pts (mean [standard deviation]), at baseline, to 34.7 (5.6) pts after treatment., and from 55.4% (14.7%) to 66.8% (14.3%) in standardized punctuation (p < 0.0001 in both cases). Sildenafil responders showed a response increase of the total punctuation which was significantly higher than non-responders: 12.5% versus 4.3% (p < 0.001). MID was 3.2 pts as crude punctuation, and 8.1% in normalized score. Statistically significant correlations were found between changes in LISAT-8 and changes in IIEF. CONCLUSIONS: The Spanish version of the LISAT-8 showed to be responsive to change in male ED patients. Meaningful MID was 3.1 pts (crude) and 8.1% (normalized).

Sensibilidad al cambio y diferencia mínimamente importante de la versión española del cuestionario de satisfacción con la vida LISAT-8 en pacientes varones con disfunción eréctil / Sensitivity to change and minimally important diference of the Spanish version of the Life-Satisfaction questionnaire LISAT-8 in male patients with erectile dysfunction

FUNDAMENTO Y OBJETIVO: Determinar la sensibilidad al cambio y la diferencia mínimamente importante de la versión española del cuestionario de satisfacción con la vida LISAT-8. PACIENTES Y MÉTODO: Se utilizó una muestra aleatoria, de un estudio observacional, prospectivo y multicéntrico, que evaluaba la efectividad del sildenafilo en el tratamiento de la disfunción eréctil. Se analizó a 537 pacientes varones de 18 años de edad o mayores con disfunción eréctil y deseo sexual activo. Se administraron el Índice Internacional de Función Eréctil (IIEF) y elLISAT-8 antes y después del tratamiento. Los valores ancla para determinar la diferencia mínimamente importante del LISAT-8 se obtuvieron a partir del cambio en la dimensión función eréctil del IIEF tras tratamiento: sin cambio (5 o menos puntos), cambio pequeño (6 a 10 puntos),cambio moderado (11 a 15 puntos) y cambio grande (más de 15 puntos). La sensibilidad al cambio se midió mediante la variación de respuesta del LISAT-8 después del tratamien Se valoró la correlación entre los cambios experimentados por el LISAT-8 y el IIEF. RESULTADOS: El sildenafilo incrementó la puntuación del LISAT-8 de una media (desviación estándar) de 30,2 (5,9) a 34,7 (5,6) puntos (puntuación bruta, p < 0,0001), o del 55,4%(14,7%) al 66,8% (14,3%) (puntuación normalizada, p < 0,0001). Quienes respondieron al tratamiento mostraron un mayor incremento de la respuesta (el 12,5 frente al 4,3%; p <0,001). La diferencia mínimamente importante en puntuación bruta fue 3,2 puntos, y en normalizada, del 8,1%. Se observó una correlación significativa entre los cambios de respuesta del LISAT-8 y el IIEF. CONCLUSIONES: La versión española del LISAT-8 es sensible al cambio en población con disfunción eréctil. La diferencia mínimamente importante considerada como relevante es de 3,1 puntos en puntuación bruta y de un 8,1% en normalizada

BACKGROUND AND OBJECTIVE: We determined the sensitivity to change and minimally important difference (MID) of the Spanish version of the life-satisfaction check list LISAT-8. PATIENTS AND METHOD: We included a random sample obtained from an open, naturalistic, prospective and multicenter study, which assessed the effectiveness of sildenafil as erectiledys function (ED) therapy. A total of 537 patients, males older than 18 years, with ED and >active sexual desire, received flexible and at demand doses of sildenafil for 10 weeks. IIEF andLISAT-8 questionnaires were used. MID was determined from the patient’s classification according to change in erectile function domain of the IIEF after treatment as follows: nochange ( 15 pts). RESULTS: Sildenafil significantly modified the baseline punctuation of the LISAT 8 from a crude value of 30.2 (5.9) pts (mean [standard deviation]), at baseline, to 34.7 (5.6) pts after treatment., and from 55.4% (14.7%) to 66.8% (14.3%) in standardized punctuation (p <0.00 1 in both cases). Sildenafil responders showed a response increase of the total punctuation which was significantly higher than non-responders: 12.5% versus 4.3% (p <0.001). MID was 3.2 pts as crude punctuation, and 8.1% in normalized score. Statistically significant correlations were found between changes in LISAT-8 and changes in IIEF. CONCLUSIONS: The Spanish version of the LISAT-8 showed to be responsive to change in male ED patients. Meaningful MID was 3.1 pts (crude) and 8.1% (normalized)