Abstract

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.

Highlights

  • Acute uncomplicated cystitis (AC) is the most widespread inflammation of the bladder in women

  • The clinical diagnosis of AC was confirmed by the treating physician according to national and international guidelines

  • All of the questions of the Greek version of the Acute Cystitis Symptom Score (ACSS) and the possible answers were understandable to all surveyed respondents (Figure 1)

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Summary

Introduction

Acute uncomplicated cystitis (AC) is the most widespread inflammation of the bladder in women. Well-drawn disease-specific questionnaires are easy-to-handle self-evaluation tools and may serve as appropriate smart instruments for gathering information from a large population of people within a short time For this reason, they should be designed in such a way that data can be collected with the most optimal accuracy and the results are interpretable and generalisable. The Acute Cystitis Symptom Score (ACSS) was properly designed as an evaluation tool for AC It is a simple and standardised self-reporting questionnaire assessing typical and differential symptoms, burden of symptoms, quality of life and evaluating possible changes in subjective well-being after treatment. It was originally developed in the Uzbek and Russian languages and has demonstrated high reliability and validity [9,10]. The present study was aimed to develop a Greek version of the ACSS questionnaire for clinical research, diagnosis of primary AC and monitoring the outcome and effectiveness of the treatment

Results
13. Impact on social life positive None Mild Moderate Severe
Materials and Methods
Statistical Tests
Sample Size Calculation
Conclusions
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