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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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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'.
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| Name | Affiliation | Role |
|---|---|---|
| Manu Bilsen, MD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458204 | Derived | Bilsen MP, Conroy SP, Schneeberger C, Platteel TN, van Nieuwkoop C, Mody L, Caterino JM, Geerlings SE, Koves B, Wagenlehner F, Kunneman M, Visser LG, Lambregts MMC; UTI Reference Standard Consensus Group. A reference standard for urinary tract infection research: a multidisciplinary Delphi consensus study. Lancet Infect Dis. 2024 Aug;24(8):e513-e521. doi: 10.1016/S1473-3099(23)00778-8. Epub 2024 Mar 5. |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |