Acute Cystitis Symptom Score (ACSS): Clinical Validation of the Italian Version

Vico, T. Di; Morganti, Riccardo; Cai, Tommaso; Naber, Kurt G.; Wagenlehner, Florian M. E.; Pilatz, Adrian; Alidjanov, Jakhongir F; Morelli, Girolamo; Bartoletti, Riccardo

doi:10.3390/antibiotics9030104

Cited by 22 publications

(24 citation statements)

References 20 publications

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“…Psychometric parameters and diagnostic values of the American English ACSS showed good-to-excellent results, which are comparable to the Russian as source and other versions as previously translated and validated in different languages [ 8 , 9 , 10 , 14 , 15 , 16 , 17 , 18 ].…”

Section: Discussionsupporting

confidence: 70%

Validation of the American English Acute Cystitis Symptom Score

et al. 2020

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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.

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Section: Discussionsupporting

confidence: 70%

Validation of the American English Acute Cystitis Symptom Score

et al. 2020

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“…Psychometric parameters and diagnostic values of the American English ACSS showed good-toexcellent values which were comparable to those of the source language, Russian, and other versions as previously translated and validated in different languages, as well as other results obtained during this study [8-10, [14][15][16][17][18] Comparing the results obtained by the ACSS for diagnostics of acute UC and EoT showed again, that the diagnostic value depends not only on the presence, but very much also on the severity (scoring) of the symptoms, which may be typical, but not specific for acute UC because some of the symptoms can also be caused by other urological diseases. It also could be shown that for clinical diagnostics the best balance between sensitivity and specificity can be obtained using a sum score of 6 or higher of all six ACSS typical symptoms as compared to the presence or severity of single symptoms or a selection of 3 or 4 so-called typical symptoms according to the EMA [12] or FDA [11] guidance, respectively, as has been shown earlier as well [8,9,15].…”

Section: Discussionsupporting

confidence: 84%

Validation of the American English Version of The Acute Cystitis Symptom Score

Alidjanov¹,

Naber²,

Pilatz³

et al. 2020

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Background To develop and validate the American-English version of the self-reporting Acute Cystitis Symptom Score (ACSS), a suitable tool for diagnosis and patient-reported outcome in female patients with acute uncomplicated cystitis (UC). Methods After certified translation into American-English and cognitive assessment, the clinical validation of the ACSS was performed as an embedded study in a US phase II trial (ClinicalTrials.gov Identifier: NCT03129295). Results A total of 167 female patients with typical symptoms of UC were included in the study following 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 favoured 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. Conclusion 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.

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“…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.…”

Section: Discussionmentioning

confidence: 67%

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

Stamatiou¹,

Samara²,

Alidjanov³

et al. 2021

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The Acute Cystitis Symptom Score (ACSS) is a patient self-reporting questionnaire for the clinical diagnosis and patient-reported outcome (PRO) in women with acute uncomplicated cystitis (AC). The aim of the current study (part II) was the clinical validation of the Greek ACSS questionnaire. After linguistic validation according to internationally accepted guidelines and cognitive assessment (part I), the clinical validation was performed after ethical approval by using the Greek ACSS study version in 92 evaluable female participants including 53 patients with symptoms suspicious of AC and 39 controls. The clinical outcome using the ACSS questionnaire at different time points after the start of treatment was demonstrated as well. The age (mean±SD) of the 53 patients (44.7±17.0) and 39 controls (49.3±15.9) and their additional conditions at baseline visits, such as menstruation, premenstrual syndrome, pregnancy, menopause, diabetes mellitus, were comparable. There was, however, a significant difference (p&lt;0.001) between patients and controls at baseline visit regarding sum score of the ACSS domains, such as typical symptoms and quality of life. The clinical outcome of up to 7 days showed a fast reduction of the symptom scores and improvement of quality of life. The optimal thresholds for the patient-reported outcome of successful therapy could be established. The linguistically and clinically validated Greek ACSS questionnaire can now be used for clinical or epidemiological studies and also for patient’s self-diagnosis of AC and as a PRO measure tool.

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Acute Cystitis Symptom Score (ACSS): Clinical Validation of the Italian Version

Cited by 22 publications

References 20 publications

Validation of the American English Acute Cystitis Symptom Score

Validation of the American English Acute Cystitis Symptom Score

Validation of the American English Version of The Acute Cystitis Symptom Score

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

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