PSYCHOMETRIC VALIDATION OF THE SPANISH VERSION OF THE TREATMENT BENEFIT SCALE (TBS) FOR ASSESSING SUBJECTIVE OUTCOMES IN TREATING PATIENTS WITH OVERACTIVE BLADDER.

Author(s)

Errando-Smet C1, Ruiz MA2, Villacampa-Aubá F3, Arlandis-Guzmán S4, García-Vargas M5, Arumi D61Department of Urology, Fundación Puigvert, Barcelona, Spain, 2Universidad Autonoma de Madrid, Madrid, Spain, 3Department of Urology, Hospital 12 de Octubre, Madrid, Spain, 4Department of Urology, Hospital Universitario La Fe, Valencia, Spain, 5Health Outcomes Research Department, Corporate Affairs and Market Access Unit, Pfizer Spain, Alcobendas, Madrid, Spain, 6Pfizer Inc., Madrid, Spain, Alcobendas, Madrid, Spain

OBJECTIVES: To carry out the psychometric validation of the Spanish version of the self-administered TBS scale, a tool assessing subjective outcomes in the treatment of subjects with overactive bladder (OAB).  METHODS: The culturally adapted Spanish version of TBS was administered at the end-of-trial visit after 3 months of a medical intervention for OAB. Responses to the instruments were recorded in a set of patients of  both genders, above 18 years old, diagnosed of OAB according with standard criteria and a score > 8 in the OAB-V8 scale, and able to understand PRO instruments written in Spanish. Patients were recruited consecutively in clinics of Urology all over the country. Scale variability, criteria, known-groups and construct validity and responsiveness (effect size) were examined using classic test theory statistics.  RESULTS: Data from 199 OAB patients (58.4 years, 74% women, 99% Caucasian, 37% workers and 36% primary schooling) from 18 urological clinics were evaluated. The 2.5% of patients did not fill  in the scale, only 31% greatly improved, 57% improved, 10% did not changed and 2% worsened during medical intervention. TBS correlated moderately with clinical judgement of change; 0.749, p<0.001, and also, linearity was observed, with changes at end-of-trial visit in both domains of the OABq-SF; Flineal=23.02, p<0.001 and Flineal=31.02, p<0.001. TBS was able to differentiate groups of patients with different levels of change in symptoms severity and health-related quality of life of the OABq-SF questionnaire; F=8.09, p<0.001 and F=10.5, p<0.001, respectively, with effect sizes between 1.69 and -0.44. CONCLUSIONS: The Spanish version of TBS scale demonstrated strong validity and responsiveness psychometric properties to be used in the subjective assessment of outcomes related with treatment of OAB.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PUK34

Disease

Urinary/Kidney Disorders

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