Project lead: Prof. Dr. Christian Apfelbacher PhD

Project member(s) and cooperation partners: Dr. Katharina Piontek, Sophie Nestler, M.A.

Funding: other, 01.10.2021 - 31.03.2024

The patients’ perspective is increasingly recognized in medical care. In recent years, a wide range of patient-reported outcome measures (PROMs) have been developed aiming to increase the patients’ voice and involvement in health care. PROMs are standardized questionnaires that collect data on health outcomes directly from the patient including symptoms, functional status, personal experience of care and health-related quality of life.

Uncomplicated urinary tract infections (UTIs) are among the most common types of bacterial infection in the outpatient setting and typically affect women. The aim of this research project is to develop a PROM for the assessment of the impact of uncomplicated UTIs for use in clinical trials. In the first year, a systematic review of all currently available PROMs for uncomplicated UTIs will be performed to identify the most appropriate instrument. This candidate instrument will be translated into German language followed by a content validity study among female patients with uncomplicated UTI and experts. In the second year, the translated candidate instrument will be psychometrically validated in a German population of female patients with uncomplicated UTI. To confirm the clinical applicability of the questionnaire, various measurement properties such as structural validity, internal consistency, test-retest reliability, construct validity, sensitivity to change and the smallest clinically significant difference will be determined. As a result, a valid and reliable PROM for the assessment of uncomplicated UTI is available in German language, which can be used in future clinical trials