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UTI Reference Standard: Delphi Method

NCT05365906 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2023-03-08

No results posted yet for this study

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

OTHER

Delphi-procedure consisting of four survey rounds

This 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.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Manu Bilsen, MD · Leiden University Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2023-02-23
Completion
2023-02-23

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365906 on ClinicalTrials.gov