The development of a patient-reported outcome measure for real-time symptom assessment in a population with functional urologic complaints-A focus group study.

AIMS: In the current diagnostic process for overactive bladder syndrome (OAB), biased retrospective questionnaires are often used. There is a need for a new assessment tool that embraces the heterogeneity of the OAB complex. A momentary assessment tool, the Experience Sampling Method (ESM) is promising, capturing random repetitive measurements during the day in the context of daily life and is capable to measure potential contextual triggers and psychological aspects. A focus group study was set up to evaluate which items should be implemented in a urological ESM.

METHODS: Focus group interviews were arranged, to assess the suitability and comprehensibility of a newly developed urological patient-reported outcome measurement (PROM), "Uromate." "Uromate" was created based on ESM literature. A multidisciplinary expert meeting was conducted to gain consensus on item relevance.

RESULTS: The initial ESM questionnaire contained 58 items, but was eventually reduced to 39 items after focus group sessions and expert meeting. Thirty-seven items are repeated questions, including three gender-dependent items. Two items are one-time questions about the use of incontinence material. Additionally, a morning questionnaire was included. Depending on the symptom pattern, a minimum of 26 items and a maximum of 36 items will be repeatedly assessed with "Uromate."

CONCLUSION: There is a need for a modern assessment tool for OAB which overcomes the limitations of today's retrospective questionnaires. Therefore, a urological ESM tool, the "Uromate," is being developed as a PROM, following the FDA PROM development guidelines, to measure real-time symptoms in the context of daily life.