Clinical Trials Directory

Trials / Completed

CompletedNCT05365906

UTI Reference Standard: Delphi Method

Development of a Research Reference Standard for Urinary Tract Infection Using a Modified Delphi Technique

Status
Completed
Phase
Study type
Observational
Enrollment
47 (actual)
Sponsor
Leiden University Medical Center · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

This study is set up by an international core group consisting of infectious disease specialists, geriatricians, urologists, microbiologists, emergency physicians and primary care physicians to develop a consensus-based research definition of urinary tract infections. The absence of such a reference standard leads to misclassification bias and heterogeneity between studies making progress in the field of UTI difficult, for example with much needed near patient diagnostic tests.

Conditions

Interventions

TypeNameDescription
OTHERDelphi-procedure consisting of four survey roundsThis study will use a modified Delphi approach, consisting of a set of iterative questionnaires. In round 1, an expert panel will grade the relevance of UTI-related items, after which a smaller core research team will compose a reference standard in a series of (online) meetings. In round 2, clinical vignettes will be used to party validate the reference standard and expert panel agreement with the new reference standard will be assessed.

Timeline

Start date
2022-04-12
Primary completion
2023-02-23
Completion
2023-02-23
First posted
2022-05-09
Last updated
2023-03-08

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05365906. Inclusion in this directory is not an endorsement.