UTI Reference Standard: Delphi Method

Leiden University Medical Center47 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Urinary Tract Infections

Interventions

Delphi-procedure consisting of four survey roundsOTHER

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

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, an average of 7 months

Data from ClinicalTrials.gov

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