Validation of the American English Acute Cystitis Symptom Score

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

10.20944/preprints202011.0484.v1 ◽

2020 ◽

Author(s):

Jakhongir F. Alidjanov ◽

Kurt G. Naber ◽

Adrian Pilatz ◽

Florian M. Wagenlehner

Keyword(s):

Symptom Score ◽

Clinical Success ◽

American English ◽

Reliability And Validity ◽

Clinical Success Rate ◽

English Version ◽

Acute Cystitis ◽

Female Patients ◽

Sum Score ◽

Patient Reported

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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Greek Version of the Acute Cystitis Symptom Score. Part I: Linguistic Validation

10.20944/preprints202012.0735.v1 ◽

2020 ◽

Author(s):

Konstantinos Stamatiou ◽

Evangelia Samara ◽

Jakhongir F. Alidjanov ◽

Kurt G. Naber ◽

Adrian Pilatz ◽

...

Keyword(s):

Symptom Score ◽

Healthcare Professionals ◽

American English ◽

Greek Version ◽

Linguistic Validation ◽

Acute Cystitis ◽

Original Language ◽

Acute Uncomplicated Cystitis ◽

Uncomplicated Cystitis ◽

Self Reporting Questionnaire

Objective: The Acute Cystitis Symptom Score (ACSS) was developed and validated as a self-reporting questionnaire for diagnosing and monitoring acute, uncomplicated cystitis (AC) in female patients. The study aims at the translation of the ACSS into Greek from original Russian as a source and American English as a new master version and at its linguistic validation. Material and Methods: Three independent professional native Greek translators, two of them experts in Russian and one in English, translated the ACSS from Russian and American English into Greek. The second group of three translators translated each of the three versions back into the original language to detect or correct any important discrepancies. These three Greek versions were then used for linguistic validation. Results: The English to Greek translation reflected more the spoken language, the two Russian to Greek translations more the written, formal language. A total of 60 randomly selected females and 30 healthcare professionals was asked about their preferences and to comment on each of the three translations. Considering all comments the scientific committee (SC) developed the Greek consensus version. For cognitive assessment additional 30 healthcare professionals and 30 females were asked to comment on the intelligibility of all items. Considering their comments the linguistically validated Greek study version was established by the SC. Conclusion: The linguistically validated Greek version of the ACSS can now be used for the clinical validation study.

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Acute Cystitis Symptom Score questionnaire for measuring patient-reported outcomes in women with acute uncomplicated cystitis: Clinical validation as part of a phase III trial comparing antibiotic and nonantibiotic therapy

Investigative and Clinical Urology ◽

10.4111/icu.20200060 ◽

2020 ◽

Vol 61 (5) ◽

pp. 498

Author(s):

Jakhongir F. Alidjanov ◽

Andre Overesch ◽

Dimitri Abramov-Sommariva ◽

Martina Hoeller ◽

Hubert Steindl ◽

...

Keyword(s):

Symptom Score ◽

Patient Reported Outcomes ◽

Phase Iii ◽

Clinical Validation ◽

Acute Cystitis ◽

Phase Iii Trial ◽

Patient Reported ◽

Acute Uncomplicated Cystitis ◽

Uncomplicated Cystitis

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Reevaluation of the Acute Cystitis Symptom Score, a Self-Reporting Questionnaire. Part II. Patient-Reported Outcome Assessment

Antibiotics ◽

10.3390/antibiotics7020043 ◽

2018 ◽

Vol 7 (2) ◽

pp. 43 ◽

Cited By ~ 5

Author(s):

Jakhongir Alidjanov ◽

Kurt Naber ◽

Ulugbek Abdufattaev ◽

Adrian Pilatz ◽

Florian Wagenlehner

Keyword(s):

Outcome Assessment ◽

Symptom Score ◽

Patient Reported Outcome ◽

Acute Cystitis ◽

Patient Reported ◽

Self Reporting Questionnaire

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

Antibiotics ◽

10.3390/antibiotics9030104 ◽

2020 ◽

Vol 9 (3) ◽

pp. 104 ◽

Cited By ~ 2

Author(s):

Tommaso Di Vico ◽

Riccardo Morganti ◽

Tommaso Cai ◽

Kurt G. Naber ◽

Florian M.E. Wagenlehner ◽

...

Keyword(s):

Symptom Score ◽

Control Group ◽

Clinical Validation ◽

Italian Version ◽

Roc Curve Analysis ◽

Linguistic Validation ◽

Acute Cystitis ◽

Patient Reported ◽

Self Reporting Questionnaire

Acute Cystitis Symptom Score (ACSS) is an 18-item self-reporting questionnaire for clinical diagnosis and follow-up of acute uncomplicated cystitis (AUC) in women. The ACSS, originally developed in Uzbek and Russian languages, is now available in several languages. The purpose of the study was to validate the ACSS questionnaire in the Italian language. Linguistic validation was carried out according to Linguistic Validation Manual for Patient-Reported Outcomes Instruments guidelines. Clinical validation was carried out by enrolling one hundred Italian-speaking women. All women were asked to fill in the ACSS questionnaire during their medical visit. Fifty-four women, median age 36 (Inter Quartile Range 28–49), were diagnosed with AUC, while 46 women, median age 38 (IQR 29–45), were enrolled as the control group attending the hospital’s fertility center for couples. The most frequently isolated pathogen in AUC was Escherichia coli (40; 74.0%) followed by Enterococcus faecalis (7; 13.0%) and Staphylococcus saprophyticus (3; 5.6%). Receiver operating characteristic (ROC) curve analysis performed at the first diagnostic visit on a typical symptoms domain cut-off score of 6 revealed a sensitivity of 92.5% and specificity of 97.8%. The Italian version of the ACSS has proved to be a reliable tool with a high accuracy in diagnosis and follow-up in women with AUC. The ACSS may also be useful for clinical and epidemiological studies.

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

10.20944/preprints202109.0108.v1 ◽

2021 ◽

Author(s):

Konstantinos Stamatiou ◽

Evangelia Samara ◽

Jakhongir F. Alidjanov ◽

Adrian M. E. Pilatz ◽

Kurt G. Naber ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Outcome ◽

Symptom Score ◽

Patient Reported Outcome ◽

Clinical Validation ◽

Acute Cystitis ◽

Significant Difference ◽

Patient Reported ◽

Self Reporting Questionnaire

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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Additional assessment of Acute Cystitis Symptom Score questionnaire for patient-reported outcome measure in female patients with acute uncomplicated cystitis: part II

World Journal of Urology ◽

10.1007/s00345-019-02948-8 ◽

2019 ◽

Vol 38 (8) ◽

pp. 1977-1988 ◽

Cited By ~ 3

Author(s):

J. F. Alidjanov ◽

K. G. Naber ◽

A. Pilatz ◽

A. Radzhabov ◽

M. Zamuddinov ◽

...

Keyword(s):

Clinical Cure ◽

Missing Values ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Summary Score ◽

Acute Cystitis ◽

Female Patients ◽

Patient Reported ◽

Acute Uncomplicated Cystitis ◽

Uncomplicated Cystitis

Abstract Purpose Since symptomatic, non-antibiotic therapy has become an alternative approach to treat acute cystitis (AC) in women, suitable patient-reported outcome measures (PROM) are urgently needed. The aim of this part II of a larger non-interventional, case–control study was the additional assessment of the ACSS as a suitable PROM. Methods Data from 134 female patients with diagnosed acute uncomplicated cystitis were included in the current analysis with (1) a summary score of “Typical” domain of 6 and more; (2) at least one follow-up evaluation after the baseline visit; (3) no missing values in the ACSS questionnaire data. Six different predefined thresholds based on the scoring of the ACSS items were evaluated to define “clinical cure”, also considering the draft FDA and EMA guidelines. Results Of the six different thresholds tested, a summary score of the five typical symptoms of 5 and lower with no symptom more than 1 (mild), without visible blood in urine, with or without including QoL issues was favoured, which partially also could be adapted to the draft FDA and EMA guidelines. The overall patient’s clinical assessment (“Dynamic” domain) alone was not sensitive enough for a suitable PROM. Conclusions Scoring of the severity of symptoms is needed not only for diagnosis, but also for PROM to define “clinical cure” of any intervention, which could be combined with QoL issues. Results of the study demonstrated that the ACSS questionnaire has the potential to be used as a suitable PROM and should further be tested in prospective clinical studies.

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

Antibiotics ◽

10.3390/antibiotics10101253 ◽

2021 ◽

Vol 10 (10) ◽

pp. 1253

Author(s):

Konstantinos Stamatiou ◽

Evangelia Samara ◽

Jakhongir F. Alidjanov ◽

Adrian M. E. Pilatz ◽

Kurt G. Naber ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Outcome ◽

Symptom Score ◽

Patient Reported Outcome ◽

Clinical Validation ◽

Acute Cystitis ◽

Significant Difference ◽

Patient Reported ◽

Self Reporting Questionnaire

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) is 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 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 points in time after the start of treatment was demonstrated as well. The age (mean ± SD) of the 53 patients (44.7 ± 17.0 years) and 39 controls (49.3 ± 15.9 years) 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 < 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 patients’ self-diagnosis of AC and as a PRO measure tool.

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