Urinary Tract InfectionsORACLENCT05365906
UTI Reference Standard: Delphi Method
An observational study of Urinary Tract Infections, run by Leiden University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Delphi-procedure consisting of four survey rounds
- How many people
- 47 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2022to 23 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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'.
Who may be able to join
- 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
Who cannot join
- Residency not completed yet
- Working in a different field than described above
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Official title: Development of a Research Reference Standard for Urinary Tract Infection Using a Modified Delphi Technique
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
- Being tested
- Delphi-procedure consisting of four survey rounds
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start12 Apr 2022
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manu Bilsen, MD, Leiden University Medical Center
- Investigators
- Manu Bilsen, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365906
- Sponsor's protocol ID
- nWMODIV2_2022007
- Acronym
- ORACLE
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38458204
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Research Reference Standard for Urinary Tract Infection Using a Modified Delphi Technique
- ClinicalTrials.gov ID
- NCT05365906
- Acronym / sponsor ID
- ORACLE / nWMODIV2_2022007
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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'.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Residency not completed yet
- Working in a different field than described above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi-procedure consisting of four survey roundsThis 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. | Other | – |
Primary outcome
Consensus
Time frame: Through study completion, an average of 7 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 38458204Bilsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manu Bilsen, MD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus (time frame: Through study completion, an average of 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.