UTI Reference Standard: Delphi Method

NCT05365906 | Completed

• 1 other identifier: nWMODIV2_2022007
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Delphi-procedure consisting of four survey rounds OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

National and international experts will be invited by email to participate in the Delphi process. Since a heterogeneous expert panel is an important feature of Delphi studies, all relevant specialties will be represented in the panel, including infectious diseases, urology, geriatric medicine, acute/emergency medicine, intensive care medicine, microbiology, and primary care. To avoid selection bias when composing the expert panel and to create a sufficiently large panel, experts will be recruited through various platforms. Experts will be allowed to invite other experts, so called 'snowballing'.

You may qualify if:

• 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

You may not qualify if:

• Residency not completed yet
• Working in a different field than described above

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Manu Bilsen, MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student, Department of Infectious Diseases, Principle Investigator

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 9, 2022
• Study Start: April 12, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

NL (1)