Development and validation of patient-reported outcomes measures for overactive bladder: a review of concepts.

Patient-reported outcome (PRO) measures are a valuable means for determining how a disease and its treatment affect patients, including effects on health-related quality of life (HRQL). To ensure that the results obtained with PROs are clinically useful, data must be gathered using valid and reliable instruments. Developing such instruments requires a multistep, structured process that incorporates cognitive psychology, psychometric theory, and patient and clinician input. The process begins by determining the intent and purpose of the PRO and culminates in studies that demonstrate the measure's validity, reliability, and responsiveness. Several valid and reliable PROs are available for assessing the effects of treatment on symptom severity, symptom bother, and HRQL in patients with overactive bladder.