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The Recurrent Urinary Tract Infection Symptom Scale (RUTISS)

The RUTISS is a brief Patient-Reported Outcome (PRO) Measure (or PROM) for evaluating the patient experience of recurrent urinary tract infection (rUTI) symptom severity. Developed for clinical and research application, this 15-item questionnaire has excellent reliability and validity in assessing patient-reported rUTI symptom and pain severity. The RUTISS facilitates a fuller picture of the rUTI patient experience than clinical assessment alone, via rapid standardised evaluation of key rUTI symptoms.

The RUTISS is simple and quick to administer and score, and a scoring guide accompanies the measure once a licence is provided. Additional support packages are available from the developers on request, including assistance with study design, application of the RUTISS, and scoring and analysis of RUTISS data. Please contact us for further information.

Key Characteristics

Pathology: Urology

Disease / condition: Recurrent Urinary Tract Infection (rUTI)

Objective: To measure the patient experience of rUTI symptom and pain severity

Respondent / target population age: 18 years and above

Type of Clinical Outcome Assessment: PRO

Number of items: 15 in total, comprised of:

· Section A - UTI symptom frequency, 3 items;

· Section B - global rating of change in symptom severity, 1 item;

· Section C - severity of UTI symptoms and pain/discomfort, 11 items.

Response scales: Section B of the RUTISS is a single item global rating of change in symptom severity, employing an 11-point Likert scale, with the central response (zero) representing “No change”, the left ranging from -1 to -5 (“Very much worse”), and the right ranging from +1 to +5 (“Very much better”). Section C of the RUTISS, that specifically focuses on assessing severity of symptoms and pain, uses an 11-point numerical rating scale (NRS) ranging from 0 – 10, with 0 = “Not present”, 1 = “Very mild”, and 10 = “Extremely severe”.

Domains / Concepts measured: Frequency of UTI symptoms (Section A), global change in UTI symptom severity (Section B), and severity of urinary symptoms and pain/discomfort (Section C). Section C contains 4 further sub-domains: ‘urinary symptoms’ (3 items), ‘urinary presentation’ (3 items), ‘UTI pain or discomfort’ (2 items), and ‘bodily sensations’ (3 items).
These domains perform robustly as statistically separate unidimensional scales and may be administered separately if required.

Recall period: Past 24 hours, for both Sections B (global change in severity of symptoms) and C (symptom severity).

Administration time: 3-5 minutes

Original (Development) language: English (multi-national)

Associated instruments: The Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ). The RUTIIQ is designed to measure the patient experience of the psychosocial impact of living with rUTI, and it is recommended that this is used alongside the RUTISS to capture a full evaluation of both patient-reported rUTI symptoms and quality of life impact. More information is provided below.

Urinary Tract infections (UTIs) affect more than 400 million people every year globally, with over 100 million people suffering from recurrent UTIs (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.

Previously, there were no validated PROMs that specifically assess the patient experience of living with rUTI. Although other PROMs have been developed to assess symptoms of acute UTI, they fail to measure the frequency of UTI symptoms, or cover the breadth of symptoms experienced by people with rUTI.

The RUTISS 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 Impact Questionnaire

The RUTISS is designed to be used independently, or alongside the Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ). The RUTIIQ is designed to measure the patient experience of the psychosocial impact of living with rUTI. The RUTIIQ is an 18-item measure developed to evaluate the patient-reported impact of rUTI on key quality of life domains, including personal wellbeing and mental health, socialising, work and activity engagement, sexual wellbeing, and patient satisfaction with rUTI healthcare. It is recommended that the RUTISS and RUTIIQ are administered together, in order 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 RUTISS severity score. A scoring table and calculation tool are provided in the RUTISS scoring guide.

  • Section B – A single global rating of change in symptom severity score, scored from -5 (“Very much worse”) to 0 (“No change”) to +5 (“Very much better”). A positive score indicates an improvement in symptoms within the past 24 hours, whilst a negative score indicates relative worsening.
  • Section C – Individual domain scores can be computed by summing the scored responses within a single domain (e.g., urinary symptoms). A RUTISS severity score can be obtained from the sum of all section C responses, divided by 11, and multiplied by 10. This will generate a range from 0 to 100, with higher scores indicating greater overall severity of UTI symptoms and pain.

Further written guidance on scoring and administration of the RUTISS are provided on completion of a licence to use the RUTISS.

The RUTISS was designed, developed and validated in accordance with the best practice methods recommended by the Food and Drug Administration (FDA) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative. A four-stage approach followed the initial development of the RUTISS items, informed by literature review and current UTI diagnostic guidelines.

  • Stage 1 utilised the Delphi consensus method to gain feedback on the initial RUTISS items from expert rUTI clinicians in the UK, USA, and Canada.
  • Stage 2 involved one-to-one cognitive interviews with people living with recurrent UTI, gaining their feedback on the relevance and clarity of RUTISS items in order to make refinements.
  • In Stage 3, 240 people living with rUTI in 24 countries participated in an online pilot study, completing the draft RUTISS and other existing measures to for exploratory psychometric testing of the RUTISS.
  • Stage 4 collected further RUTISS 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 RUTISS, resulting in the optimised 15-item questionnaire that is available to licence.

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

The RUTISS has been applied to monitor people living with rUTI within research studies and as part of routine clinical practice. Using the RUTISS facilitates evaluation and monitoring of key patient-reported outcomes, identifying opportunities to enhance rUTI care and management, as well as informing patient-clinician interactions to improve shared decision making on care pathways and patient-centred care. The RUTISS may be used to determine the success of new and existing treatment options and interventions.

  • Paper and pen completion
  • Digital (eCOA) completion, upon request.

Please enquire.

  • Scoring and administration instructions
  • Concept Elaboration Document (to assist in translating the RUTISS)

Standard licences are available at no cost for most academic research and other non-commercial uses. We will advise on any licensing costs based on the details provided in the licence request form.

Development Team

Abigail Newlands*

Katherine Finlay*

Melissa Kramer*

Lindsey Roberts

Kayleigh Maxwell

Jessica Price

*Primary authors for contacting purposes

Key references

Newlands AF, Roberts L, Maxwell K, Kramer M, Price JL, Finlay KA. The Recurrent Urinary Tract Infection Symptom Scale: Development and validation of a patient-reported outcome measure. BJUI Compass. 2023;4(3):285-297. https://doi.org/10.1002/bco2.222  

Newlands, A. F., Kramer, M., Roberts, L., Maxwell, K., Price, J. L., & Finlay, K. A. (2024). Confirmatory structural validation and refinement of the Recurrent Urinary Tract Infection Symptom Scale. BJUI Compass, 5(2), 240-252. https://doi.org/10.1002/bco2.297 

 

 

Date added: 28/11/2023

Last update: 22/03/2024