Developing a PROM for Recurrent Urinary Tract Infection
NCT ID: NCT05086900
Last Updated: 2021-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
145 participants
OBSERVATIONAL
2021-05-01
2021-12-01
Brief Summary
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Detailed Description
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There are currently no validated patient-reported outcome measures to assess recurrent UTI symptoms and impact. These measures are much needed to encourage a more patient-centred approach to recurrent UTI treatment and care, which could be especially important given evidence that current routine testing approaches, and thus treatment approaches, are not sufficient alone.
This mixed-methods study aims to consult both clinicians and patients in order to develop and validate the first set of patient-reported outcome measures for recurrent UTI.
Outline:
Phase I: Concept elicitation Conduct a literature review and examine the findings of an international qualitative study exploring the experience of over 2,000 people living with recurrent UTI.
Phase II: Initial development and item generation Develop draft questionnaire items, instructions, and scale response options in line with current healthcare guidance and conclusions from Phase I.
Phase III: Modified Delphi method with 10-20 expert clinicians Screen the draft questionnaires by two rounds of a modified Delphi method, assessing item and instruction clarity and relevance for recurrent UTI.
Use qualitative comments, content validity indices, and consensus scores to refine existing items, and remove or add new ones where appropriate.
Phase IV: Cognitive interviews with 25-30 patients Conduct one-to-one cognitive interviews using a think aloud and verbal probing procedure to verify the content validity and clarity of the new measures from the patient's perspective.
Summarise and analyse the interview transcripts using the Questionnaire Appraisal System and content analysis, used to refine the measures before Phase V.
Phase V: Two-part online pilot with 100+ patients Conduct a cross-sectional survey in which participants complete the new recurrent UTI measures and comparable existing standardised measures for each subscale (e.g. UTI Symptom Assessment). Participants will complete this twice, 24 hours apart.
Verify the psychometric properties of the new measures, including exploratory factor analysis, internal consistency, test-retest reliability, and criterion validity.
Optimise the measures for clinical and research purposes based on these analyses.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Non-interventional Cross-sectional Patient Reported Outcome Measure Development
Development of Patient Reported Outcome Measure
Eligibility Criteria
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Inclusion Criteria
* Aged at least 18 years old.
* Specialist doctor or nurse in the field of urology or a closely related discipline OR general health doctor or nurse.
* Minimum of 3 years of direct experience treating patients with recurrent UTI.
Patients:
* Aged at least 18 years old.
* Experiences recurrent UTI as defined by the European Association of Urology: minimum of 2 UTIs in 6 months or minimum of 3 UTIs in 12 months.
Exclusion Criteria
* Current diagnosis of interstitial cystitis.
* Non-fluent or non-advanced level of English.
* Current pregnancy.
* Current use of urinary catheterisation.
18 Years
ALL
No
Sponsors
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Live UTI Free
UNKNOWN
University of Buckingham
UNKNOWN
University of Reading
OTHER
Responsible Party
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Katherine Finlay
Lecturer in Psychology
Principal Investigators
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Katherine A Finlay, PhD
Role: STUDY_DIRECTOR
University of Reading
Locations
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University of Reading
Reading, Berkshire, United Kingdom
Countries
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References
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Newlands AF, Roberts L, Maxwell K, Kramer M, Price JL, Finlay KA. Development and psychometric validation of a patient-reported outcome measure of recurrent urinary tract infection impact: the Recurrent UTI Impact Questionnaire. Qual Life Res. 2023 Jun;32(6):1745-1758. doi: 10.1007/s11136-023-03348-7. Epub 2023 Feb 6.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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RUTI01-KF-2021
Identifier Type: -
Identifier Source: org_study_id