Validation of the Spanish Acute Cystitis Symptoms Score (ACSS) in native Spanish-speaking women of Europe and Latin America.

INTRODUCTION AND OBJECTIVES: The Acute Cystitis Symptom Score (ACSS) is a patient self-reporting questionnaire for clinical diagnostics and patient-reported outcome (PRO), which may assess the symptoms and the effect on the quality of life in women with acute cystitis (AC). The current study aimed to create a validated Spanish version of the ACSS questionnaire. MATERIAL AND METHODS: The process of linguistic validation of the Spanish version of the ACSS consisted of the independent forward and backward translations, revision and reconciliation, and cognitive assessment. Clinical evaluation of the study version of the ACSS was carried out in clinics in Spain and Latin America. Statistical tests included the calculation of Cronbach's α, split-half reliability, specificity, sensitivity, diagnostic odds ratio, positive and negative likelihood ratio, and area under the receiver-operating characteristic curve (AUC). RESULTS: The study was performed on 132 patients [age (mean;SD) 45.0;17.8 years] with AC and 55 controls (44.5;12.2 years). Cronbach's α of the ACSS was 0.86, and the split-half reliability was 0.82. The summary scores of the ACSS domains were significantly higher in patients than in controls, 16.0 and 2.0 (p < 0.001), respectively. The predefined cut-off point of ≥6 for a summary score of the "Typical" domain resulted in a specificity of 83.6% and a sensitivity of 99.2% for the Spanish version of the ACSS. AUC was 0.91 [0.85; 0.97]. CONCLUSIONS: The validated Spanish ACSS questionnaire evaluates the symptoms and clinical outcomes of patients with AC. It can be used as a patient's self-diagnosis of AC, as a PRO measure tool, and help to rule out other pathologies in patients with voiding syndrome.

Linguistic and Clinical Validation of the Tajik Acute Cystitis Symptom Score for Diagnosis and Patient-Reported Outcome in Acute Uncomplicated Cystitis.

Background and Objectives: Acute Cystitis Symptom Score (ACSS) is a self-reporting questionnaire for clinical diagnosis and follow-up of acute uncomplicated cystitis (AC) in women. The ACSS, originally developed in Uzbek and Russian, both considered original languages, is now available in several other languages. This study aimed to translate and validate the ACSS in the Tajik language. Material and Methods: Linguistic validation was carried out according to the Linguistic Validation Manual for Patient-Reported Outcomes Instruments guidelines. Clinical validation was performed by enrolling fifty-four Tajik-speaking women. All women included in this study were first interviewed about the understandability of all questions and statements in the final Tajik ACSS and were asked to fill in form A at the first visit (diagnostics) and form B at any follow-up visit (patient-reported outcome). Results: Thirty-three women, median (range) age of 35 (18-77), were diagnosed with AC (patient group), while twenty-one women, median (range) age of 34 (20-61) (p = 0.109), were enrolled as the control group without any other urological disease. For the diagnostics of AC, a summary score of the six typical symptoms ("Typical" domain) showed the best balance between sensitivity (0.73) and specificity (0.71) at 5 and above. Cronbach's alpha [95% CI] and split-half reliability [95%] were 0.82 [0.76; 0.98] and 0.84 [0.77; 0.87], respectively. At the follow-up visit, the patients reported a significant reduction in the "Typical" domain and an improvement in the "Quality of Life" domain. Conclusion: The Tajik ACSS showed good reliability and diagnostic values and may be used as a reliable tool for the diagnosis and patient-reported outcome in women with AC in clinical and epidemiological studies and for daily practice.

The negative aftermath of prostate biopsy: prophylaxis, complications and antimicrobial stewardship: results of the global prevalence study of infections in urology 2010-2019.

PURPOSE: To evaluate and report the complications, and to analyse antimicrobial stewardship aspects following prostate biopsies (P-Bx) based on the data from a 9-year global study. METHODS: The primary outcome was to compare complications after P-Bx between patients of two cohorts: 2010-2014 and 2016-2019. Primary outcomes included symptoms of lower and severe/systemic urinary tract infection (LUTIS and SUTIS, respectively), and positive urine culture. Readmission to hospital after P-Bx, need for additional antimicrobial therapy, consumption of different antimicrobial agents for prophylaxis and therapy were evaluated. Students t test and chi-square test were used for comparative analyses. RESULTS: Outcome data were available for 1615 men. Fluoroquinolones-based prophylaxis rate increased from 72.0% in 2010-2014 to 78.6% in 2015-2019. Overall rates of complications increased from 6 to 11.7% including an increase in symptomatic complications from 4.7 to 10.2%, mainly due to an increase in LUTIS. Rates of patients seeking additional medical help in primary care after P-Bx increased from 7.4 to 14.4%; cases requiring post P-Bx antibiotic treatment increased from 6.1 to 9.7%, most of which received fluoroquinolones. Transperineal P-Bx was significantly associated with LUTIS. Following transrectal P-Bx, 2.8% developed febrile infections and 4.0% required hospitalisation. Two men (0.12%) died after transrectal P-Bx due to sepsis. CONCLUSIONS: The rates of complications after P-Bx tended to increase in time, as well as rates of patients seeking additional medical help in the post-P-Bx period. To reduce the risk of infectious complications and to comply with the principles of antibiotic stewardship, clinicians should switch to the transperineal biopsy route.

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

INTRODUCTION AND HYPOTHESIS: The Global Prevalence Study of Infections in Urinary tract in Community Setting (GPIU.COM) includes epidemiological aspects of acute cystitis (AC) in women in Germany and Switzerland. The primary study relates to the German version of the Acute Cystitis Symptom Score (ACSS), a self-reporting questionnaire for self-diagnosis and monitoring the symptomatic course of AC in women. The current study aimed to analyze the validity and reliability of the German ACSS in German-speaking female patients with AC in Switzerland. METHODS: Anonymized patient data were collected and analyzed from women with AC at the first visit (diagnosis) and follow-up visits as baseline and controls, respectively. Data from 97 patients with a median age of 41 years underwent analysis. Psychometric and diagnostic characteristics of the ACSS were measured and statistically analyzed. RESULTS: Average internal consistency of the ACSS resulted in a Cronbach's alpha (95% CI) of 0.86 (0.83; 0.89) and did not differ significantly between the Swiss and German cohorts. Diagnostic values of the ACSS for the Swiss cohort were relatively lower than for the German cohort, possible due to discrepancies between definitions of UTI in national guidelines. CONCLUSIONS: The analysis showed that the German version of the ACSS is also suitable for use in the German-speaking female population of Switzerland. Minor differences in definitions of AC between German and Swiss guidelines explain the observed discrepancies in diagnostic values of the ACSS between cohorts.

Changes in the management of urinary tract infections in women: impact of the new recommendations on antibiotic prescribing behavior in France, between 2014 and 2019.

BACKGROUND: Urinary tract infections (UTIs) are among the most common infections that require antibiotic therapy. In December 2015, new guidelines for UTI management were published in France with the aim of reducing antibiotic misuse and the risk of antimicrobial resistance. OBJECTIVES: To analyze changes in antibiotic prescribing behavior for acute uncomplicated UTI in women in France from 2014 to 2019. METHODS: Retrospective study using data extracted from the medico-administrative database 'OpenMedic' that is linked to the French National Health Data System and collects data on the reimbursement of prescribed drugs. The analyses focused on the number of boxes of antibiotics delivered by community pharmacies, the molecule class, and the prescriber's specialty. RESULTS: Overall, antibiotic dispensing by community pharmacies increased by 2% between 2014 and 2019, but with differences in function of the antibiotic class. The use of antibiotics recommended as first-line and second-line treatment increased (+ 41% for fosfomycin and + 7430% for pivmecillinam). Conversely, the dispensing of lomefloxacin and norfloxacin decreased by 80%, and that of ciprofloxacin by 26%. Some antibiotics were mostly prescribed by general practitioners (lomefloxacin, pivmecillinam) and others by secondary care physicians (ofloxacin). Dispensing increased for antibiotics prescribed by secondary care physicians (+ 13% between 2014 and 2019) and decreased for antibiotics prescribed by GPs (- 2% for the same period). CONCLUSION: These data suggest that the new recommendations are followed, as indicated by the increased prescription of fosfomycin and pivmecillinam and decreased prescription of fluoroquinolones. However, the efficient transmission and implementation of new recommendations by practitioners requires time, means and dedicated tools.

Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women.

PURPOSE: To reassess the diagnostic values of the "draft" guidelines for the clinical diagnosis of acute uncomplicated cystitis (AC), recently proposed by US Food and Drug Administration (FDA) and European Medicines Agency (EMA). METHODS: The data of 517 female respondents (patients with acute cystitis and controls) derived from the e-USQOLAT database were analyzed and used for the validation of proposed "draft" guidelines of FDA and EMA, compared to the Acute Cystitis Symptom Score (ACSS) questionnaire. The diagnostic values of the proposals concerning signs, symptoms and their severity were assessed and compared. RESULTS: The six "typical" symptoms of the ACSS were strongly associated with the diagnosis of AC. The number of positive "typical" symptoms differed significantly between patients and controls: median 5 (IQR 4-6) vs 1 (IQR 0-3) respectively. Scored severity of "typical" symptoms also differed significantly between groups of patients and controls: median (IQR) 10 (7-13) vs 1 (0-4), respectively. The best balance between sensitivity and specificity is shown by the ACSS cut-off value of 6 scores and more of the "Typical" domain, followed by an approach proposed by FDA and EMA, justifying ACSS to be used as a diagnostic criterion for the clinical diagnosis of AC. CONCLUSIONS: Not only the presence but also the severity of the symptoms is important for an accurate diagnosis of AC. The ACSS, even without urinalysis is at least as favourable as the draft diagnostic proposals by FDA and EMA. The ACSS can be recommended for epidemiological and interventional studies, and allows women to establish self-diagnosis of AC, making the ACSS also cost-effective for healthcare.

Reliability of Symptom-Based Diagnosis of Uncomplicated Cystitis.

BACKGROUND AND OBJECTIVES: Acute uncomplicated cystitis (AC) is common among women. Acute onset of specific typical symptoms may serve as reliable criteria for developing a cost-effective strategy to make an accurate diagnosis of AC. We aimed to evaluate the diagnostic values of most common symptoms and signs of AC depending on their presence and severity. METHODS: The current trial was designed as a case-control study. Data derived from the Acute Cystitis Symptom Score (ACSS) database were analyzed. Diagnostic values of the symptoms and their severity were assessed via the calculations of the sensitivity and specificity, odds ratio, positive and negative likelihood ratios. The strength of associations was estimated by the coefficient of correlation (Pearson's R). RESULTS: Data from 819 female subjects (423 Patients, 396 controls) with the mean age of 37.1 ± 15.3 were analyzed. Highest diagnostic values for AC in this study belonged to dysuria, urgency, and frequency. Interestingly, complaints of vaginal discharge was not found to decrease the odds for having AC in the study population. CONCLUSIONS: The severity of the symptom is even more essential than just its presence for an accurate diagnosis. The ACSS is an accurate tool and may be recommended for clinical practice and studies for diagnosis of AC in women. Further studies and unification of terms are need.

The Acute Cystitis Symptom Score for Patient-Reported Outcome Assessment.

OBJECTIVES: The Acute Cystitis Symptom Score (ACSS) was developed as a self-reporting questionnaire for clinical diagnosis of acute uncomplicated cystitis (AUC) and symptomatic changes in female patients. The aim of the present study was to assess the utility of the different domains of ACSS including the 'dynamics' domain after therapy. The applicability of these domains in assessing changes in symptoms, as a function of time, in this population was investigated. MATERIALS AND METHODS: During the validation process of the ACSS in Uzbek and Russian languages, a subgroup of patients (n = 63) returned after therapy and filled in part B of ACSS. Descriptive statistics were used, where suitable. RESULTS: The reduction of typical symptoms and quality of life (QoL) assessment between first and follow-up visit correlated significantly with answers in the 'dynamics' domain. Success/cure and non-success/failure could be clearly differentiated by the scores obtained in 'typical' and 'QoL' domains. CONCLUSION: The ACSS has proven to be a useful instrument to clinically diagnose AUC in women. It is also a suitable instrument for patient-reported outcome assessment, with applicability in both daily practice and in clinical studies. Slight modifications in the 'dynamics' domain will even increase the applicability.

New self-reporting questionnaire to assess urinary tract infections and differential diagnosis: acute cystitis symptom score.

OBJECTIVE: Development and validation of a simple and standardized self-reporting questionnaire for acute uncomplicated cystitis (AUC) assessing typical and differential symptoms, quality of life and possible changes after therapy in female patients with AUC. MATERIALS AND METHODS: Literature research, development and evaluation of the Acute Cystitis Symptom Score (ACSS), an 18-item self-reporting questionnaire including (a) six questions about 'typical' symptoms of AUC, (b) four questions regarding differential diagnoses, (c) three questions on quality of life and (d) five questions on additional conditions which may affect therapy. The ACSS was evaluated in 286 women (mean age 32.3 ± 12.3 years) in the Russian and Uzbek language. Measurements of reliability, validity, predictive ability and responsiveness were performed. RESULTS: Cronbach's alpha for the ACSS was 0.89, split-half reliability was 0.92 and correlation between halves was 0.85. Mann-Whitney test revealed significant difference scores of the 'typical' domain between patients and controls (10.75 vs. 2.02, p < 0.001). The optimal threshold score was 6 points, with a 94% sensitivity and 90% specificity to predict AUC. The symptom score decreased significantly when comparing before and after therapy (10.7 vs. 2.1, p < 0.001). CONCLUSION: The new validated ACSS is accurate enough and can be recommended for clinical studies and practice for initial diagnosis and monitoring treatment of AUC. Evaluation in other languages is in progress.

Therapeutic strategies for uncomplicated cystitis in women.

Uncomplicated cystitis is affecting many women of all ages and has a great impact on the quality of life, especially in women suffering from recurrent, uncomplicated cystitis. By far the most frequent uropathogen, E. coli, may have acquired increasing resistance against a variety of oral antibiotics, which may differ between countries and regions. Therefore, local resistance data are important to be considered. On the other hand, non-antibiotic therapy has also become an option which should be discussed and offered to the patient. In patients suffering from recurrent uncomplicated cystitis, individual risk factors and possible behavioral changes should first be taken into account. Non-antimicrobial prophylactic strategies shown to be successful in well-designed clinical studies are the next options. Long term antibiotic prophylaxis, however, should only be considered as a last option. For some of those patients self-diagnosis and self-treatment may be suitable, e.g. by using a recognized questionnaire.

Polish version of the Acute Cystitis Symptom Score for patients with acute uncomplicated cystitis.

Introduction: The Acute Cystitis Symptom Score (ACSS) is a self-reporting questionnaire to evaluate the symptoms and quality of life in women with uncomplicated acute cystitis (AC). The aim of the current study was the additional cognitive and clinical validation of the Polish version. Material and methods: Professional forward and backward translations from original Russian to Polish were performed by Mapi SAS. For cognitive assessment, women with different ages and educational levels were asked to comment on each item of the Polish ACSS to establish the final study version. The clinical validation was performed as a prospective, non-interventional cohort study. Women with AC (Patients) and those without (Controls) filled in the Polish ACSS during their visits to a physician's office and at a follow-up visit. Statistical analysis included ordinary descriptive values, calculation of reliability, validity, discriminative ability, responsiveness (sensitivity, specificity), and comparative analysis. Results: The cognitive assessment was performed in 60 women with a median (range) age of 44.5 (21-88) years and different educational levels: grade school (n = 8), high school (n = 25), college (n = 22), and postgraduate education (n = 5). Forty-three patients were recruited for the clinical validation study along with 34 controls. Statistical analyses resulted in excellent values of internal consistency, discriminative ability, and validity for diagnosis of AC. At a summary score of 6 and higher in the ´Typical´ domain, positive and negative predictive values were 97% and 79%, and sensitivity and specificity were 79% and 97%, respectively. Conclusions: The Polish version of the ACSS has demonstrated benefits for diagnosis and patient-reported outcome assessment. It is objective, fast, and cost-effective, and it may help to easily confirm the accurate diagnosis of AC. The Polish ASCSS can now be recommended for use in clinical and epidemiological studies, in clinical practice, or for self-diagnosis and patient-reported outcome in women with symptoms of AC.

Diagnosis of acute cystitis in primary care: symptom-based versus urinalysis-based diagnosis.

AIM: This study aimed to provide insight into the congruity of acute cystitis (AC) diagnosis in women, measured both by the Acute Cystitis Symptom Score (ACSS) questionnaire and urine test(s). BACKGROUND: The ACSS questionnaire was developed as a self-administering tool for assessing urinary symptoms, quality of life (QoL) and treatment outcomes in healthy, nonpregnant female patients. METHODS: This prospective observational cohort study compared AC diagnosis based on the questionnaire with a GP diagnosis based on dipstick/dipslide test(s). ACSS questionnaire form A (typical and differential symptoms, QoL and relevant conditions) was filled in by the patient group, women suspected for AC visiting a GP practice with a urine sample, and the reference group, women visiting a community pharmacy for any medication. Analyses were performed assuming that the GP diagnosis based on urine test(s) was correct. Divergent result(s) of urine test(s) and ACSS questionnaire were analysed for scores of all individual questionnaire domains. Statistical analyses included descriptive statistics and the positive predictive value (PPV) and the negative predictive value (NPV) of the ACSS questionnaire and the urine test(s). FINDINGS: In the patient group, 59 women were included, 38 of whom a GP positively diagnosed for AC. The reference group included 70 women. The PPV of the ACSS questionnaire was 77.3%, and the NPV was 73.3%. Analysis of patient data for divergent results showed that differential symptoms, QoL and relevant conditions explained false-positive and false-negative results. Revised results (most probable diagnosis) based on this analysis showed a PPV and NPV of 88.6% and 73.3% for the ACSS questionnaire and 100% and 76.2% for the urine test(s). For use in primary care, a reduction in false-positive and false-negative results can be achieved by including scores for differential symptoms, QoL and relevant conditions, alongside a total typical symptoms score of 6 or higher.

Translation and validation of the Korean version of acute cystitis symptom score.

PURPOSE: Acute Cystitis Symptom Score (ACSS) is a simple self-reporting questionnaire initially developed in Uzbek language to help diagnose acute uncomplicated cystitis (AUC). The purpose of this study was to translate the ACSS to Korean and validate the Korean version of ACSS using Korean-speaking women. MATERIALS AND METHODS: The original version of ACSS in Uzbek was translated into the target (Korean) version according to internationally accepted guidelines for the translation and cultural adaptation. Cognitive interviews were then conducted for five women with symptoms of AUC and five women without AUC who were native speakers of the Korean language to investigate the clarity, understandability, and acceptability of the translation. The final Korean version of the ACSS was tested in 50 women (31 AUC patients and 19 controls) for clinical validation. RESULTS: Reliability test for 9 questions (6 questions about typical symptoms of AUC, and 3 questions on quality of life) showed high values (Cronbach's alpha=0.853). The sum score of typical symptoms showed the highest balance for diagnostic sensitivity and specificity (area under the ROC curve=0.935). Sensitivity and specificity to predict AUC were 90.3% and 89.5% at cut-off score 6 of the typical domain. CONCLUSIONS: The Korean version of the ACSS showed high levels of reliability and validity, similar to other validated versions in different languages. It will play an important role in practice and/or clinical research for diagnosis and treatment efficacy monitoring of Korean-speaking women suffering from AUC.

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

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.

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.

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.

PURPOSE: The Acute Cystitis Symptom Score (ACSS) used in a clinical trial comparing the phytodrug Canephron®N (BNO 1045) with an antibacterial agent (fosfomycin trometamol [FT]) in the treatment of acute uncomplicated cystitis (AC) in women was evaluated as a patient-reported outcome measure in a post hoc analysis. MATERIALS AND METHODS: This double-blind, randomized, multicenter, phase III noninferiority trial was performed in 51 centers in Europe. The ACSS questionnaire was used to assess severity and course of symptoms. RESULTS: The post hoc analysis included 325 patients treated with BNO 1045 and 332 patients treated with FT (total of 657 patients). The mean sum-scores of the ACSS-typical domain were comparable between groups on day 1 (BNO 1045: 10.2; FT: 10.1), and then decreased on day 4 (BNO 1045: 5.1; FT: 4.5), at end of treatment on day 8 (BNO 1045: 2.1; FT: 2.1), and at late follow-up on day 38 (BNO 1045: 0.8; FT: 0.9). Predefined thresholds using the scoring system of the ACSS could be established and validated to define "clinical cure." CONCLUSIONS: Evaluating not only antibacterial but also nonantibacterial agents indicated for the treatment of AC in women, clinical criteria for diagnostics, and measures of patient-reported outcomes are more important as main objectives than microbiological criteria. In this post hoc evaluation, we showed that the ACSS questionnaire, validated in several languages, has the potential to be used as a suitable instrument for diagnostics and patient-reported outcomes in well-designed, international, clinical studies investigating different treatment modalities of uncomplicated urinary tract infections.

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

This study aimed to reevaluate the Acute Cystitis Symptom Score (ACSS). The ACSS is a self-reporting questionnaire for the clinical diagnosis of acute uncomplicated cystitis (AC) and the assessment of symptomatic changes after therapy in female patients with AC. The part II of the present study was to reevaluate the utility of the different domains of the ACSS after therapy. The applicability of these domains in assessing changes in symptoms, as a function of time, in this population was investigated. The ACSS was evaluated in 48 female patients (mean age 31.1 ± 10.6) in the Uzbek and Russian languages, who returned after therapy and filled in part B of the ACSS, which corresponds to part A with the additional “Dynamics” domain. Descriptive statistics were used, where suitable. The reduction of typical symptoms and quality of life assessment between first and follow-up visit correlated significantly with answers in the “Dynamics” domain. Success/Cure and Non-success/Failure could be clearly differentiated by the scores obtained in “Typical” and “Quality of Life” domains. The ACSS has proven to be a useful instrument to clinically diagnose AC in women. It is also a suitable instrument for patient-reported outcome measures, with applicability both in daily practice and clinical studies. Slight modifications in the “Dynamics” domain will even increase the applicability.

Reevaluation of the Acute Cystitis Symptom Score, a Self-Reporting Questionnaire. Part I. Development, Diagnosis and Differential Diagnosis.

This study aimed to reevaluate the Acute Cystitis Symptom Score (ACSS). The ACSS is a simple and standardized self-reporting questionnaire for the diagnosis of acute uncomplicated cystitis (AC) assessing typical and differential symptoms, quality of life, and possible changes after therapy in female patients with AC. This paper includes literature research, development and evaluation of the ACSS, an 18-item self-reporting questionnaire including (a) six questions about "typical" symptoms of AC, (b) four questions regarding differential diagnoses, (c) three questions on quality of life, and (d) five questions on additional conditions that may affect therapy. The ACSS was evaluated in 228 women (mean age 31.49 ± 11.71 years) in the Russian and Uzbek languages. Measurements of reliability, validity, predictive ability, and responsiveness were performed. Cronbach's alpha for ACSS was 0.89, split-half reliability was 0.76 and 0.79 for first and second halves, and the correlation between them was 0.87. Mann-Whitney U test revealed a significant difference in scores of the "typical" symptoms between patients and controls (10.50 vs. 2.07, p < 0.001). The optimal threshold score was 6 points, with a 94% sensitivity and 90% specificity to predict AC. The "typical" symptom score decreased significantly when comparing before and after therapy (10.4 and 2.5, p < 0.001). The reevaluated Russian and Uzbek ACSS are accurate enough and can be recommended for clinical studies and practice for initial diagnosis and monitoring the process of the treatment of AC in women. Evaluation in German, UK English, and Hungarian languages was also performed and in other languages evaluation of the ACSS is in progress.

Ceftazidime-avibactam: novel antimicrobial combination for the treatment of complicated urinary tract infections.

Ceftazidime-avibactam is a combination of a third-generation cephalosporin and a novel non-beta-lactam beta-lactamase inhibitor. This combination was recently recommended for the treatment of complicated urinary tract infections, including acute pyelonephritis, in adults with limited or no alternative treatment options. The current review is aimed to determine activity, efficacy and safety of ceftazidime-avibactam in the treatment of patients with complicated urinary tract infections.

Efficacy, pharmacokinetic and pharmacodynamic profile of ceftolozane + tazobactam in the treatment of complicated urinary tract infections.

INTRODUCTION: Urinary tract infections (UTIs) are the second most common nosocomially acquired infections, responsible for approximately 21% of healthcare-associated pyelonephritis and 10.5% of urosepsis. Worldwide trends of increasing resistance resulted in the urgent need for novel antimicrobials that would be active against bacterial resistance mechanisms as an alternative to carbapenems, which are considered last resort antibiotics. AREAS COVERED: The current review is based on a Medline search of published English language literature and contains summary information regarding the evaluation of pharmacologic properties, efficacy, safety and activity of ceftolozane+tazobactam against common bacterial resistance mechanisms. EXPERT OPINION: In vivo and vitro studies demonstrated high activity of ceftolozane+tazobactam in the combination of 2:1 against a variety of uropathogens, including ESBL-producers. Phase II and Phase III studies performed in patients with complicated UTIs showed good tolerability and safety of ceftolozane+tazobactam when prescribed intravenously 1.5 g every 8 h for 7 days and at least non-inferiority to a high dose (750 mg) of levofloxacin. The pharmacokinetics of ceftolozane+tazobactam makes it a worthy alternative to carbapenems in cases of complicated UTIs, also caused by multidrug resistant uropathogens.