UTI Reference Standard: Delphi Method

Urinary Tract Infections Clinical Trial

— ORACLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05365906
• Other study ID #: nWMODIV2_2022007
• Status: Completed
• Start date: April 12, 2022
• Est. completion date: February 23, 2023

Study information

• Verified date: March 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Medical specialist working in the following fields: infectious diseases, urology, geriatric medicine, acute/emergency medicine, intensive care medicine, microbiology, and primary care

• Clinical and/or research experience with urinary tract infections

Exclusion criteria:

• Residency not completed yet

• Working in a different field than described above

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	South Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consensus	The primary study endpoint is the degree of consensus among the expert panel regarding the ORACLE reference standard.; In round 1, consensus is defined as follows: An item is deemed indicative of UTI in case of a panel median of 7-9, without disagreement; uncertain in case of a panel median of 4-6 OR any median with disagreement; and not indicative of UTI in case of a panel median of 1-3, without disagreement. Disagreement exists when more than a third of responses are in the upper and the lower tertiles for the item in question; In round 2, consensus is not predefined (i.e. with a minimum percentage). Instead, the level of agreement with a preliminary reference standard will be assessed by a dichotomous yes/no question and experts will have the possibility to give feedback on the reference standard. Thereafter, the adjusted reference standard will be presented and the level of agreement (and relative improvement) will be assessed by a dichotomous yes/no question again.	Through study completion, an average of 7 months