The Recurrent Urinary Tract Infection Impact Questionnaire

Recurrent urinary tract infection (rUTI) is defined by the European Association of Urology (EAU)⁴ and the American Urological Association (AUA)⁵ as experiencing a minimum of two episodes of UTI within six months, or three episodes within a year.

Recent research estimates that over 400 million people experience UTI each year worldwide,⁶ over 90% of whom are female.⁷ Up to 50% of females who experience a UTI are likely to experience a recurrent infection within a year.⁷

All five sections of the RUTIIQ use an 11-point scale ranging from 0 to 10, with 0 representing “strongly disagree”, and 10 representing “strongly agree”.

The RUTIIQ facilitates a comprehensive UTI assessment and exploration of five key quality of life and health impact domains:

A. Personal wellbeing
B. Social wellbeing
C. Work and activity interference
D. Satisfaction with UTI-related medical care
E. Sexual wellbeing*

*The sexual wellbeing domain is optional, and is preceded by a qualifying question to assess whether the respondent feels that rUTI has impacted their sexual wellbeing within the relevant period, and if they wish to continue with these questions or alternatively would prefer not to answer. Please see the sample copy here for more information.

These five domains perform robustly as statistically separate unidimensional scales and may be administered separately if required.

All five sections of this UTI questionnaire assess rUTI impact over the past two weeks.

Respondents typically complete the RUTIIQ within 3-5 minutes.

Developed to address the urgent need to improve assessment for UTI, the RUTIIQ provides a simple approach to collecting patient-reported outcomes (PROs) in both research and clinical practice. As a PROM, this tool is intended as a self-report measure for patients to complete without clinician or proxy involvement, and the language has been validated with a diverse patient sample (see development methodology).

An introductory paragraph provides respondents with initial guidance about the UTI questionnaire’s focus and defines key terms used and the two-week recall period. Instructions are provided, and simple checkboxes are used for numerical scale response options. A closing statement is provided at the end to signal that there are no further questions.

Upon completion of a licence for the RUTIIQ, administrators will be provided with scoring and administration instructions and, where applicable, a concept elaboration document to assist in translation development. A sample copy of the RUTIIQ is available to view here.

Currently, the RUTIIQ can be administered either via paper and pen completion, or electronically as an ePROM (please get in touch to find out more).

To facilitate simple UTI assessment and monitoring, a straightforward scoring system was developed for the RUTIIQ. Scores from individual domains (e.g., personal wellbeing) may be computed in isolation, and/or alongside computation of an overall RUTIIQ impact score. A full scoring guide and calculation tool are available upon completion of a licence.

Individual domain scores may be calculated by summing the scored responses within a single domain (e.g., personal wellbeing). Higher scores suggest greater negative rUTI impact to quality of life and lower patient satisfaction with UTI-related medical care. Since the sexual wellbeing domain is optional, there may not always be a domain score for this section.

The RUTIIQ impact score can be computed by 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. The resultant scores will range between 0 and 100, with higher scores indicating greater overall negative impact to quality of life.

The RUTIIQ may be administered independently to capture rUTI impact to quality of life and psychosocial challenges, or alongside additional generic and/or rUTI-specific measures.

Also developed by PARED Insights, the Recurrent UTI Symptom Scale (RUTISS) is a complementary validated rUTI-specific PROM which explores key rUTI symptoms and pain. Incorporating a UTI pain scale and UTI symptom scale, the RUTISS is a brief 15-item UTI questionnaire assessing UTI symptom frequency, change in UTI symptoms, and severity of key rUTI symptoms and pain.

In order to capture a full assessment for UTI, exploring both rUTI symptoms and quality of life experiences from the patient perspective, it is recommended that the RUTISS and the RUTIIQ are administered together. It is possible to request a licence for both measures at the same time.

The RUTIIQ was developed and validated in accordance with best practice recommendations by the US Food and Drug Administration (FDA)⁸ and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative.^9,10 A five-stage methodology was employed to facilitate iterative refinement and a high level of patient and public involvement (PPIE).

To identify the relevant target concepts to be incorporated into the RUTIIQ, a qualitative framework analysis was conducted of the quality of life experiences of 1,983 people living with rUTI.¹¹ Framework analysis of the participants’ qualitative responses resulted in a conceptual framework comprising five key components: personal wellbeing, social wellbeing, work and activity interference, satisfaction with UTI-related care, and sexual wellbeing. These were selected for exploration as five subscales in the RUTIIQ, with initial items based on their subcomponents.

A Delphi consensus method was utilised to systematically gain quantitative and qualitative feedback on the RUTIIQ from 15 expert rUTI clinicians.¹¹ Clinicians were based in the UK, USA, and Canada, and demonstrated diverse expertise including from both general practice and specialist backgrounds (e.g., in urology and urogynaecology).

Two rounds of feedback facilitated consensus building, calculation of content validity indices, and identification of potential areas for refinement. Item refinements were implemented based on clinician feedback prior to Stage 3.

One-to-one cognitive interviews were conducted with a heterogeneous sample of 28 people living with rUTI, aged between 18 and 82 years old (approximately 47 years old on average).¹¹ Participants were English-speaking and based in 10 countries, predominantly the UK and USA.

A cognitive debriefing methodology, including ‘think aloud’ techniques, was applied to generate qualitative feedback on the RUTIIQ from the patient perspective. Interviews facilitated evaluation of the relevance and clarity of each item and questionnaire instruction, and identification of potential areas for refinement.

Interviews were conducted in two phases to allow iterative refinements, with an opportunity to validate revisions made after the first phase during the second phase.

A pilot evaluation of the preliminary RUTIIQ was conducted online, facilitating exploratory psychometric analysis and item refinements.¹¹ A total of 240 people living with rUTI, aged between 18 and 84 years old (45 years old on average), completed the RUTIIQ and existing measures of related constructs (e.g., work productivity and activity impairment). Questionnaires were completed twice to facilitate test-retest analysis. Participants were English-speaking and resided in 24 countries in total.

Exploratory factor analysis determined the latent factor structure (structural validity) of the RUTIIQ. Item reduction was implemented to improve performance, resulting in a preliminary 30-item RUTIIQ. Five factors were identified: ‘personal wellbeing’, social wellbeing’, work and activity interference’, ‘satisfaction with UTI-related medical care’, and ‘sexual wellbeing’. These factors represented a strong fit for the data and collectively account for 73.8% of the total variance in scores.

Internal consistency of the RUTIIQ domains was excellent (Cronbach’s alpha coefficients, ɑ, were 0.81 and above), and test-retest reliability was strong (intraclass correlation coefficients, ICC, were 0.66 and above). Construct validity, assessed via comparison with existing related measures of quality of life, was similarly strong (Spearman’s rho coefficients, ⍴, were 0.69 and above).

This stage collected further RUTIIQ data from a new sample, of 389 people living with rUTI in 37 countries.¹²Participants were aged between 18 and 87 years old, with an average age of approximately 45.

This new data facilitated confirmatory psychometric analysis, including bifactor modelling and item response theory analysis. From this, final item reduction was implemented which resulted in an optimised 18-item recurrent UTI questionnaire (see sample copy here). The final RUTIIQ comprises an 18-item general ‘rUTI quality of life impact’ factor with five subdomains. These subdomains assess ‘personal wellbeing’, social wellbeing’, work and activity interference’, ‘satisfaction with UTI-related medical care’, and ‘sexual wellbeing’. Please see the key characteristics of the RUTIIQ above.

You can view our publication history here →

Clinicians and researchers may utilise PROMs to capture health outcomes directly from patients themselves, going beyond dependence on clinician-reported assessment and clinical tests and procedures alone. Patients are the most accurate and reliable in describing their own symptoms, pain, quality of life, and healthcare satisfaction,¹³ thus it is essential to incorporate the patient perspective in both clinical management and research settings.

PROMs can facilitate:

• Standardised assessment and quantification of patient-reported outcomes
• Patient monitoring
• Shared decision-making
• Patient-centred and value-based care
• Improved patient-clinician communication
• Identification of target symptoms and other health outcomes that may require intervention and/or additional support
• Identification of change (improvement or deterioration) in response to treatment and interventions
• Assessment of new and existing health interventions (e.g., in clinical trials)
• Evaluation of healthcare quality and patient satisfaction
• Quality improvement
• Electronic data collection and longitudinal reporting

Effective PROMs should be developed and validated using rigorous procedures, such as those outlined by the US Food and Drug Administration (FDA)8 and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative.^9,10

To ensure the resultant measures are truly patient-centred and reflect the health outcomes which are both relevant and important for those responding, a high level of patient and public involvement and engagement (PPIE) should be maintained throughout all stages of development and validation.^10,14

Effective development methodologies typically include both qualitative and quantitative assessment of new PROMs, including cognitive debriefing techniques with patients to identify areas for improvement from the patient perspective. Refinements are made iteratively throughout development to continually optimise the measure’s psychometric performance before finalisation.

Robust statistical testing should be implemented to validate PROMs,^9,10 including assessment of:

You can find out more about the measurement properties of the RUTIIQ in our development and validation publications. Please get in touch if you have any questions.