Developing a PROM for Recurrent Urinary Tract Infection

Pain, Chronic Clinical Trial

Official title: Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection

Status Enrolling by invitation

Clinical Trial Summary

This study aims to develop and validate the first set of patient-reported outcome measures for recurrent urinary tract infection (UTI): the Recurrent UTI Symptom Scale and the Recurrent UTI Impact Questionnaire. These tools could be used in clinical practice, clinical trials and research to gather an insight into a patient's perspective of their recurrent UTI symptom severity and its impact on their life, as well as determining any possible improvement or other change in their condition due to interventions (e.g. antibiotic treatment).

Clinical Trial Description

Urinary tract infection (UTI) is a highly prevalent infection, most frequently affecting females. Recurrent UTI, a chronic condition defined as experiencing two or more UTIs in six months or three or more in twelve months, is associated with significant symptom burden and lowered quality of life. In addition to this personal impact, the effects span more widely to issues such as increased healthcare costs, work absenteeism, and antimicrobial resistance.

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. ;

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Patient Satisfaction
• Sexual Dysfunction
• Urinary Tract Infections
• Urologic Diseases

• NCT number: NCT05086900
• Study type: Observational
• Source: University of Reading
• Status: Enrolling by invitation
• Start date: May 1, 2021
• Completion date: December 1, 2021