The Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ)

Urinary Tract infections (UTI) affect more than 400 million people every year globally, with over 100 million people suffering from recurrent UTI (rUTI). Recurrent UTIs are defined by the European Association of Urology (EAU) and the American Urological Association (AUA) as experiencing 2 or more UTIs in 6 months, or 3 or more in a year.

Research has demonstrated that rUTI can severely impact quality of life, with negative consequences for mental health, socialising, work and other daily activities, and sexual wellbeing. Previously there was no validated PRO measure for clinicians and researchers to evaluate the unique impact of living with rUTI on quality of life. Now, with the development of the RUTIIQ, there is the opportunity to capture the breadth of challenges experienced by people living with rUTI, enhancing patient-centred care through standardised exploration of the patient perspective beyond examination of symptoms alone. The RUTIIQ was developed in collaboration with researchers at the University of Reading, Live UTI Free, and Patient-Centred Research and Data Insights (PARED Insights). Live UTI Free is a research and patient advocacy organisation that creates and delivers evidence-based resources about recurrent and chronic UTI to the vast UTI patient community, whilst also driving forward patient-focused UTI research and recruitment. PARED Insights provides advanced health psychology and PRO research expertise to researchers and clinicians working in urology and other women’s health areas and is dedicated to highlighting the patient voice and perspective.

Associated Symptom Scale

The RUTIIQ is designed to be used independently, or alongside the Recurrent Urinary Tract Infection Symptom Scale (RUTISS). The RUTISS is a 15-item PROM designed to measure the patient experience of rUTI symptom and pain/discomfort severity. It is recommended that the RUTISS and RUTIIQ are administered together, to capture a full evaluation of both patient-reported rUTI symptoms and quality of life impact.

A simple to use scoring system is utilised throughout, with the added flexibility of scoring and reporting across individual domains, as well as an overall RUTIIQ impact score. A scoring table and calculation tool are provided in the RUTIIQ scoring guide.

• Individual domain scores can be computed by summing the scored responses within a single domain (e.g., personal wellbeing). Higher scores indicate greater negative impact to quality of life and lower patient satisfaction with UTI-related medical care. As the 'sexual wellbeing' domain is optional, it may not generate a score.
• The RUTIIQ impact score is computed by summing the individual domain scores, dividing this by the number of completed items (18 if all questions were completed, or 15 if the optional ‘sexual wellbeing’ domain was skipped), and then multiplying this figure by 10. This will generate a range from 0 to 100, with higher scores indicating greater negative impact.

Further written guidance on scoring and administration of the RUTIIQ are provided upon obtaining a licence to use the RUTIIQ.

The RUTIIQ was designed, developed, and validated in accordance with the best practice methods recommended by the U.S. Food and Drug Administration (FDA) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative. A five-stage approach was employed:

• In Stage 1, concept elicitation was conducted via qualitative framework analysis of the quality of life experiences of 1,983 people living with rUTI. An initial pool of items was generated based on the identified thematic framework.
• Stage 2 utilised the Delphi consensus method to gain feedback on the initial RUTIIQ items from expert rUTI clinicians in the UK, USA, and Canada.
• Stage 3 involved one-to-one cognitive interviews with 28 people living with rUTI, gaining their feedback on the relevance and clarity of RUTIIQ items in order to make refinements.
• In Stage 4, 240 people living with rUTI in 24 countries participated in an online pilot study, completing the draft RUTIIQ and other existing related measures to allow for exploratory psychometric testing of the RUTIIQ.
• Stage 5 collected further RUTIIQ data from a new test sample, comprising 389 people living with rUTI in 37 countries. This final stage facilitated confirmatory psychometric analysis and refinement of the RUTIIQ, resulting in the optimised 18-item questionnaire that is available to licence.

Further details of the development and validation methodology employed to create the RUTIIQ can be found in the publication referenced on the right-hand side of this page, under ‘Key references’.

The RUTIIQ has been applied to monitor people living with rUTI within research studies and as part of routine clinical practice. The rigorous psychometric validation of the RUTIIQ provides confidence in its application in urology, primary care, and wider healthcare and research settings. The RUTIIQ enables clinicians and researchers to quantitatively calibrate any psychosocial challenges requiring intervention beyond UTI symptom experiences, additionally offering an assessment of the effectiveness of interventions.

• Paper and pen completion.
• Digital (eCOA) completion, upon request. See drop down menu below (Modes of Administration) for further information on eCOA / digital migrations.

Please enquire.

REDCap files of the RUTIIQ are availble to licensed users.

Vitaccess are an authorsied provider of an eCOA version of the RUTIIQ.

Please ensure that if your proposed use of the RUTIIQ involves a digital reproduction, then when you request a licecnce to use the RUTIIQ you must inform us of your intention to create a digitised (eCOA) version. 

Digital versions (eCOA) will be subject to review and if successful authorisation by InSpired Health Outcomes (IHO) prior to use an eCOA version. The review by IHO will be of screenshots you provide to IHO in English.

A comprehensive (17 page) guide is available from IHO to assist you in your faithful migration of teh RUTIIQ to eCOA.

Fees may be applicable to eCOA reviews, please do enquire but any fees will be made clear during the licence process. If fees are applicable, then they are for a maximum of 2 review rounds. If further rounds of review are required, then those extra reviews are billable at £250 per round. 

IHO endeavour to respond to (commercial) eCOA review requests within 5 working days.

A scoring system is availbel for licensed users

A comprehensive (17 page) eCOA guide is available to those licensed to migrate the RUTIIQ to digitial delivery mode (eCOA). 

© 2023 PARED Insights. All rights reserved.
Standard licenses are available at no cost for most academic research and other non-commercial uses. For other uses, we will advise on any licensing costs based on the details you provide in the Licence Request Form.