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

Jakhongir F. Alidjanov, Kurt G. Naber, Adrian Pilatz, Abdukhamid Radzhabov, Musluhuddin Zamuddinov, András Magyar, P. Tenke, Florian M. Wagenlehner

Research output: Article

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 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.

Original languageEnglish
JournalWorld Journal of Urology
DOIs
Publication statusPublished - jan. 1 2019

Fingerprint

Cystitis
United States Food and Drug Administration
Guidelines
Urinalysis
Health Care Costs
Signs and Symptoms
Epidemiologic Studies

ASJC Scopus subject areas

  • Urology

Cite this

Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women. / Alidjanov, Jakhongir F.; Naber, Kurt G.; Pilatz, Adrian; Radzhabov, Abdukhamid; Zamuddinov, Musluhuddin; Magyar, András; Tenke, P.; Wagenlehner, Florian M.

In: World Journal of Urology, 01.01.2019.

Research output: Article

Alidjanov, Jakhongir F. ; Naber, Kurt G. ; Pilatz, Adrian ; Radzhabov, Abdukhamid ; Zamuddinov, Musluhuddin ; Magyar, András ; Tenke, P. ; Wagenlehner, Florian M. / Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women. In: World Journal of Urology. 2019.
@article{96a6ee9c1714441081982b5aa4a5604c,
title = "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 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.",
keywords = "ACSS, Acute Cystitis Symptom Score, Cystitis, Diagnosis, Guidelines, Urinary tract infection",
author = "Alidjanov, {Jakhongir F.} and Naber, {Kurt G.} and Adrian Pilatz and Abdukhamid Radzhabov and Musluhuddin Zamuddinov and Andr{\'a}s Magyar and P. Tenke and Wagenlehner, {Florian M.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s00345-019-02761-3",
language = "English",
journal = "World Journal of Urology",
issn = "0724-4983",
publisher = "Springer Verlag",

}

TY - JOUR

T1 - Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women

AU - Alidjanov, Jakhongir F.

AU - Naber, Kurt G.

AU - Pilatz, Adrian

AU - Radzhabov, Abdukhamid

AU - Zamuddinov, Musluhuddin

AU - Magyar, András

AU - Tenke, P.

AU - Wagenlehner, Florian M.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - ACSS

KW - Acute Cystitis Symptom Score

KW - Cystitis

KW - Diagnosis

KW - Guidelines

KW - Urinary tract infection

UR - http://www.scopus.com/inward/record.url?scp=85064697011&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85064697011&partnerID=8YFLogxK

U2 - 10.1007/s00345-019-02761-3

DO - 10.1007/s00345-019-02761-3

M3 - Article

AN - SCOPUS:85064697011

JO - World Journal of Urology

JF - World Journal of Urology

SN - 0724-4983

ER -