AB127. Translation, adaptation and validation of Acute Cystitis Symptom Score’s German version

INTRODUCTION: The Uzbek and Russian versions of the Acute Cystitis Symptom Score (ACSS) were developed as a simple self-reporting questionnaire helping to assess the typical and differential symptoms of AUC, their impact on quality of life and possible changes after therapy. OBJECTIVES: We aimed to translate the previously described ACSS questionnaire into German language and to validate the German version of the ACSS in a group of German speaking female patients. MATERIALS AND METHODS: The ACSS was developed as a simple 18-item self-reporting questionnaire containing of: (I) six items asking about “typical” AUC symptoms in women, ranged from most common to less; (II) four items helping to differential diagnosis; (III) three items on quality of life; and (IV) five items on additional conditions, which may affect therapy. These were divided into four subscales: “Typical”, “Differential”, “QoL” and “Additional” respectively. Translation and cultural adaptation of the ACSS into German language were performed according to approved translation guidelines by MAPI Research Institute (Lyon, France) and guidelines for the translation and cultural adaptation process of the ISPOR. This process was supported by following steps: (I) conceptual definition; (II) forward translation; (III) backward translation; (IV) pilot testing—(i) cognitive interviews; (ii) review by clinicians; (V) international Harmonization; and (VI) proofreading. German-speaking female patients among the citizens of Germany were invited to be the respondents of the study. All participants of the study signed written consent approved by the pilot institution’s Ethical Committee. Demographic information, including age, ethnic origin, and primary language, was obtained from the respondents. Women included into the study were then asked to fill up the questionnaires. All the required routine laboratory investigations (such as urine dipstick test, microbiological investigation of the urine with antibiotic susceptibility test, ultrasound, etc.) were performed to make a diagnosis. Respondents were then divided into ‘Patients’ and ‘Controls’ according to the results of clinical investigation. Measurements of reliability and validity, predictive ability and responsiveness were performed. Mann-Whitney’s U test was used for comparing scores of the groups. P values less than 0.05 were considered statistically significant. RESULTS: A total of 36 German speaking women among whom 30 (83.3%) were inborn Germans, admitted to Clinic and Polyclinic of Urology, Paediatric Urology and Andrology of Justus-Liebig-University (Giessen, Germany) were included to the study. Mean age of the respondents (Mean ± SD) was 40.4±19.1 years. Among them 19 were recognized as having AUC and included into ‘Patients’ group. Cronbach’s alpha for German ACSS total scale was 0.86 (0.85 for standardized items), split-half reliability was 0.81 and 0.73 for first and second halves respectively, correlation between first and second half was 0.64 and coefficient of Spearman-Brown prophecy was 0.84. Interclass correlation coefficient was 0.86 for average measures (P<0.001). Mann-Whitney U test revealed significant differences scores of the “typical” domain between patients and controls (U=17.5, N1=19, N2=17, P<0.001). The optimal threshold was a score of six points and more in “typical” subscale with a sensitivity of 94.7% and specificity of 82.4% to predict AUC. False positive result rate was 14.3% and false negative result rate was 6.7%, thus calculated predictive values of positive and negative results were as high as 85.7% and 93.3% respectively. And accordingly calculated efficiency of a test result was found to be equal to 88.9%. CONCLUSIONS: German version of ACSS has a high level of reliability and validity. Results of our analysis demonstrated excellent levels of predictive ability and efficiency of the test results of the tool, and that makes German version of the questionnaire ideal to use in the clinical practice for diagnostic procedures and therapeutic monitoring of German female patients suffering from symptomatic urinary tract infections.