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

Abstract

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 cutoff 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.

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

“…The ACSS questionnaire has proven to be a simple, easy, and affordable diagnostic tool that can be used in general medical practice and research, such as in well-designed clinical and epidemiological studies [23], for the diagnosis of AUC and as a patient-reported outcome measure.…”

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

“…The current study was planned as a non-interventional within-subject design and can be considered as part II of the recent publication [15], which mainly analysed the diagnostic values of the ACSS as compared to the recently published draft guidelines of FDA and EMA [16,17].…”

Effect of a Herbal Therapy on Clinical Symptoms of Acute Lower Uncomplicated Urinary Tract Infections in Women: Secondary Analysis from a Randomized Controlled Trial

“…This means that the following patients were excluded from microPP: patients whose bacterial count was less than 10 4 CFU/mL at the time of inclusion patients whose urine cultures were contaminated and, therefore, not evaluable patients who took concomitant medication that could influence the results of the urine cultures. For this secondary analysis, we defined a new patient-relevant clinical endpoint (i.e., clinical improvement of symptoms) based on the Acute Cystitis Symptom Score (ACSS) (Table S3), a validated, standardized self-reporting questionnaire used to evaluate the symptoms of acute uncomplicated cystitis in women [22][23][24][25][26]. In addition, we analyzed whether the herbal combination reduced the rate of antibiotic use.…”

“…To this end, new symptomatic endpoints based on the Acute Cystitis Symptom Score (ACSS) were defined. The ACSS is a validated, standardized self-reporting questionnaire used to evaluate the symptoms of acute uncomplicated cystitis in women, which can be used for clinical diagnostics and patient-reported outcome assessment [22][23][24][25]. In addition, the proportion of patients who required additional antibiotic therapy to treat their acute lower uUTIs was analyzed more closely.…”