Abstract
BACKGROUND: Uncomplicated urinary tract infections (UTIs) in women are among the most common bacterial infections in primary care. Given the health threats related to the overuse of antibiotics, alternative options are of increasing importance. Patient-reported outcome measures are valuable tools for including the patients' perspective when evaluating the efficacy of these strategies. Aiming to identify a suitable instrument to measure the severity and bothersomeness of UTI symptoms in women, we performed a systematic review of the literature and identified the Holm and Cordoba Urinary Tract Infection Score (HCUTI), which measures the severity, bothersomeness, and impact of uncomplicated UTIs on daily activities. This instrument showed sufficient content validity but needs translation and further validation before it can be used in German research. OBJECTIVE: For use in the German setting, we aim (1) to perform translation and linguistic validation of the HCUTI and (2) to evaluate content validity and psychometric properties of the German version of the HCUTI in a population of women with uncomplicated UTIs. METHODS: The HCUTI will be translated and linguistically validated using the dual-panel method. This process involves a bilingual translation panel and a lay panel to check the comprehensibility of the translation. Content validity of the translated questionnaire will be assessed using cognitive interviews according to the criteria for good content validity as recommended by the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) group involving women with uncomplicated UTIs and health care professionals. Subsequent psychometric validation of the German version of the HCUTI in a population of women with uncomplicated UTIs will include the assessment of structural validity, internal consistency, test-retest reliability, construct validity, responsiveness, and interpretability. RESULTS: Results of the translation and linguistic validation process and the results of the content validity study were obtained in September 2023 and will be published separately. Data on the psychometric properties of the German version of the HCUTI are anticipated in mid-2024. CONCLUSIONS: We expect that data from the content validity study will provide important suggestions for potential modifications of the HCUTI for use in the German setting. The final version of the questionnaire will be used for the assessment of its psychometric properties in a large population of women with uncomplicated UTIs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/49903.