Validation of treatment benefit scale for assessing subjective outcomes in treatment of overactive bladder

Urology
S ColmanU Massow

Abstract

The assessment of patient-reported treatment benefits is a new efficacy outcome measure in overactive bladder (OAB) clinical trials. We conducted a retrospective psychometric validation of the Treatment Benefit Scale (TBS), a single-item scale used to assess the patient-reported benefits of treatment of OAB. The data were collected in the context of 2 large Phase III, randomized, double-blind, placebo-controlled, clinical trials of an antimuscarinic treatment of patients with OAB. Psychometric validation was conducted by examining (a) scale variability, (b) construct validity, (c) divergent validity, (d) known-group validity, and (e) responsiveness of the TBS. The data from 1766 patients were evaluated. The TBS correlated significantly with the expected domains of the King's Health Questionnaire, International Consultation on Incontinence Questionnaire-Short Form, and other patient-reported assessments, providing evidence of construct validity. Divergent validity was supported by a lower correlation between the TBS and unrelated domains of the KHQ. Statistically significant differences in the TBS scores between patients who received active OAB treatment and those receiving placebo provided evidence of known-group validity. Scal...Continue Reading

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