Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05086900
Status:
UNKNOWN
Last Update Posted:
2021-10-21
First Post:
2021-08-17
Brief Title:
Developing a PROM for Recurrent Urinary Tract Infection
Sponsor:
University of Reading
Organization:
University of Reading
Study Overview
Official Title:
Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 eg antibiotic treatment
Detailed 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 2000 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 patients 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 eg 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
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 2000 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 patients 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None