ArticleWorld journal of urology2020
Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women.
Article in World journal of urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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Who cites it
21 citing papers in PubMed.
- 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 · 2020Trial
- First Randomized Controlled Trial Comparing D-Mannose to Fosfomycin in Acute Uncomplicated Lower Urinary Tract Infections.Antibiotics (Basel, Switzerland) · 2026Article
- Proposed guidelines on the evaluation of non-antibiotic versus antibiotic agents indicated for treatment of uncomplicated acute cystitis in adult female patients.GMS infectious diseases · 2026Article
- New evidence for content validity of the German version of the Acute Cystitis Symptom Score: cognitive interview study among patients and experts.World journal of urology · 2025Article
- Effects of a supplement associatingInvestigative and clinical urology · 2025Article
- Therapeutic strategies for uncomplicated cystitis in women.GMS infectious diseases · 2024Review
- Linguistic and Clinical Validation of the Tajik Acute Cystitis Symptom Score for Diagnosis and Patient-Reported Outcome in Acute Uncomplicated Cystitis.Medicina (Kaunas, Lithuania) · 2023Article
- Validation of the Spanish Acute Cystitis Symptoms Score (ACSS) in native Spanish-speaking women of Europe and Latin America.Neurourology and urodynamics · 2023Article
- Polish version of the Acute Cystitis Symptom Score for patients with acute uncomplicated cystitis.Central European journal of urology · 2023Article
- Why d-Mannose May Be as Efficient as Antibiotics in the Treatment of Acute Uncomplicated Lower Urinary Tract Infections-Preliminary Considerations and Conclusions from a Non-Interventional Study.Antibiotics (Basel, Switzerland) · 2022Article
- Linguistic and clinical validation of the acute cystitis symptom score in German-speaking Swiss women with acute cystitis.International urogynecology journal · 2021Article
- Clinical Validation of the Greek Version of the Acute Cystitis Symptom Score (ACSS)-Part II.Antibiotics (Basel, Switzerland) · 2021Article
- Nanomaterials for the Diagnosis and Treatment of Urinary Tract Infections.Nanomaterials (Basel, Switzerland) · 2021Review
- Validation of the American English Acute Cystitis Symptom Score.Antibiotics (Basel, Switzerland) · 2020Article
- Epidemiology, definition and treatment of complicated urinary tract infections.Nature reviews. Urology · 2020Review
- 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 · 2020Article
- Acute Cystitis Symptom Score (ACSS): Clinical Validation of the Italian Version.Antibiotics (Basel, Switzerland) · 2020Article
- Recent research in urological infections.Nature reviews. Urology · 2020Article
- Urogenital infections.World journal of urology · 2020Article
- Biomarkers in urinary tract infections - which ones are suitable for diagnostics and follow-up?GMS infectious diseases · 2020Review
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8 authors.
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Abstract
purposeTo 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).
methodsThe 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.
resultsThe 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.
conclusionsNot 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.
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