Validation of the American English Acute Cystitis Symptom Score

Abstract

The diagnosis of acute uncomplicated cystitis (UC) is usually based on clinical symptoms. The study aims to develop and validate the American-English Acute Cystitis Symptom Score (ACSS), a self-reporting questionnaire for diagnosis and patient-reported outcome in women with acute uncomplicated cystitis (UC). After certified translation into American-English and cognitive assessment, the clinical validation of the ACSS was performed embedded in a US phase-II trial. 167 female patients with typical symptoms of UC were included in the study following US Food and Drug Administration (FDA) guidance. At Day 1 (diagnosis), the mean (SD) sum score of the six ACSS typical symptoms reached 10.60 (2.51). Of 100 patients followed-up last time on Day 5 or 6 (End-of-treatment, EoT), 91 patients showed clinical success according to the favored ACSS criteria (sum score of typical symptoms 0.98 (1.94)). There was no correlation between the severity of symptoms on Day 1 or between clinical success rate at EoT and level of bacteriuria on Day 1. The American-English ACSS showed high predictive ability and responsiveness and excellent levels of reliability and validity. It can now be recommended as the new master version in clinical and epidemiological studies, in clinical practice, or for self-diagnosis of women with symptoms of UC.

Clinical Validation of the Greek Version of the Acute Cystitis Symptom Score (ACSS). Part II

“…After translation and cognitive assessment [13], the Greek version of the ACSS was now also tested clinically in 53 female patients diagnosed with AC by the treating physician according to national and international guidelines and compared with the results of 39 controls without a suspected diagnosis of UTI. As expected for the prevalence and severity of typical symptoms of AC there was a significant statistical difference between the two groups in which also for the Greek patients a sum score of >6 of the typical symptoms showed the best diagnostic odds ratio as with other languages in which the ACSS was tested clinically as well [14][15][16][17][18][19]. Therefore, the ACSS could now also be used in multilingual studies, in which the ACSS was validated linguistically and also tested clinically.…”

“…Such differences may become of interest if different treatment modalities are compared in double-blind, prospectively randomized clinical trials. As has been shown earlier [18] there was no correlation between summary scores of any of the ACSS domains and the amount of bacteriuria when entering the study, which renders the insistence on certain significant bacteriuria as an inclusion criterion irrelevant. Interestingly, we again did not find evidence that the presence of complaints about vaginal discharge plays a significant role in the rejection of the diagnosis of AC, which may serve as another confirmation of our previously expressed hypothesis that the presence of vaginal discharge does not reduce the likelihood of the presence of AC in women [24].…”

Linguistic and clinical validation of the acute cystitis symptom score in German-speaking Swiss women with acute cystitis

“…Second, although homogeneous in the main demographic characteristics, patients of the two cohorts may have differed in clinical variables, such as the results of urine tests and summary scores of the ACSS domains (Table 1). These parameters could serve as co-factors and lead to selection biases during recruitment between the study cohorts, as observed and reported earlier [50]. Such dissimilarity of recommendations may affect the study results and clinical practice [44,46].…”

The role of Acute Cystitis Symptom Score questionnaire for research and antimicrobial stewardship. Validation of the Hungarian version

“…The validated British English version was taken into account as a reference before the final Hungarian version was accepted. The process of translation and linguistic validation was published by our workgroup in details earlier [12][13][14][15][16]18].…”

“…Thereafter, the ACSS was translated into and validated in German and British English languages. The ACSS and its scoring system has demonstrated high values of reliability, validity and discriminative abilities in all studies held in Uzbekistan, Germany and Great Britain [12][13][14][15][16]. The evaluation of the ACSS in other languages, such as Polish, Romanian, Ukrainian, and American English is in preparation.…”