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Evaluating the quality of life impact of recurrent urinary tract infection: Validation and refinement of the Recurrent UTI Impact Questionnaire (RUTIIQ)

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Abstract

Background and Aims Recurrent urinary tract infection (rUTI) has significant negative consequences for a wide variety of quality of life (QoL) domains. Without adequate validation and assessment of the unique insights of people living with rUTI, clinical results cannot be fully understood. The Recurrent UTI Impact Questionnaire (RUTIIQ), a novel patient‐reported outcome measure of rUTI psychosocial impact, has been robustly developed with extensive patient and clinician input to facilitate enhanced rUTI management and research. This study aimed to confirm the structural validity of the RUTIIQ, assessing its strength and bifactor model fit. Methods A sample of 389 adults experiencing rUTI (96.9% female, aged 18–87 years) completed an online cross‐sectional survey comprising a demographic questionnaire and the RUTIIQ. A bifactor graded response model was fitted to the data, optimizing the questionnaire structure based on item fit, discrimination capability, local dependence, and differential item functioning. Results The final RUTIIQ demonstrated excellent bifactor model fit (RMSEA = 0.054, CFI = 0.99, SRMSR = 0.052), and mean‐square fit indices indicated that all included items were productive for measurement (MNSQ = 0.52–1.41). The final questionnaire comprised an 18‐item general “rUTI QoL impact” factor, and five subfactor domains measuring “personal wellbeing” (three items), “social wellbeing” (four items), “work and activity interference” (four items), “patient satisfaction” (four items), and “sexual wellbeing” (three items). Together, the general factor and five subfactors explained 81.6% of the common model variance. All factor loadings were greater than 0.30 and communalities greater than 0.60, indicating good model fit and structural validity. Conclusions The 18‐item RUTIIQ is a robust, patient‐tested questionnaire with excellent psychometric properties, which capably assesses the patient experience of rUTI‐related impact to QoL and healthcare satisfaction. Facilitating standardized patient monitoring and improved shared decision‐making, the RUTIIQ delivers the unique opportunity to improve patient‐centered care.
Received: 29 August 2023
|
Accepted: 5 February 2024
DOI: 10.1002/nau.25426
CLINICAL ARTICLE
Evaluating the quality of life impact of recurrent urinary
tract infection: Validation and refinement of the
Recurrent UTI Impact Questionnaire (RUTIIQ)
Abigail F. Newlands BSc, MSc
1
|Melissa Kramer BBus, BA
2
|
Lindsey Roberts BSc, MSc, PhD, CPsychol
3
|Kayleigh Maxwell BSc, MSc
4
|
Jessica L. Price
2
|Katherine A. Finlay PhD, CPsychol, AFBPsS
1
1
School of Psychology and Clinical
Language Sciences, University of
Reading, Reading, UK
2
Live UTI Free Ltd, Sandyford, Dublin,
Ireland
3
School of Psychology, University of
Buckingham, Buckingham, UK
4
Department of Psychology, Faculty of
Natural Sciences, University of Stirling,
Stirling, UK
Correspondence
Katherine A. Finlay, PhD, CPsychol,
AFBPsS, School of Psychology and
Clinical Language Sciences, University of
Reading, Reading, RG6 7BE, UK.
Email: katherine.finlay@reading.ac.uk
Abstract
Background and Aims: Recurrent urinary tract infection (rUTI) has
significant negative consequences for a wide variety of quality of life (QoL)
domains. Without adequate validation and assessment of the unique insights
of people living with rUTI, clinical results cannot be fully understood. The
Recurrent UTI Impact Questionnaire (RUTIIQ), a novel patientreported
outcome measure of rUTI psychosocial impact, has been robustly developed
with extensive patient and clinician input to facilitate enhanced rUTI
management and research. This study aimed to confirm the structural validity
of the RUTIIQ, assessing its strength and bifactor model fit.
Methods: A sample of 389 adults experiencing rUTI (96.9% female, aged
1887 years) completed an online crosssectional survey comprising a
demographic questionnaire and the RUTIIQ. A bifactor graded response
model was fitted to the data, optimizing the questionnaire structure based on
item fit, discrimination capability, local dependence, and differential item
functioning.
Results: The final RUTIIQ demonstrated excellent bifactor model fit
(RMSEA = 0.054, CFI = 0.99, SRMSR = 0.052), and meansquare fit indices
indicated that all included items were productive for measurement
(MNSQ = 0.521.41). The final questionnaire comprised an 18item general
rUTI QoL impactfactor, and five subfactor domains measuring personal
wellbeing(three items), social wellbeing(four items), work and activity
interference(four items), patient satisfaction(four items), and sexual
Neurourol Urodyn. 2024;113. wileyonlinelibrary.com/journal/nau
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1
This is an open access article under the terms of the Creative Commons AttributionNonCommercialNoDerivs License, which permits use and distribution in any
medium, provided the original work is properly cited, the use is noncommercial and no modifications or adaptations are made.
© 2024 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.
Abbreviations: CFI, comparative fit index; DIF, differential item functioning; EFA, exploratory factor analysis; GRM, graded response model; IRT,
item response theory; MHRM, MetropolisHastings RobbinsMonro (estimation method); MNSQ, mean square; QoL, quality of life; RMSEA, root
mean square error of approximation; rUTI, recurrent urinary tract infection; RUTIIQ, Recurrent Urinary Tract Infection Impact Questionnaire;
RUTISS, Recurrent Urinary Tract Infection Symptom Scale; SRMSR, standardized root mean square residual.
wellbeing(three items). Together, the general factor and five subfactors
explained 81.6% of the common model variance. All factor loadings were
greater than 0.30 and communalities greater than 0.60, indicating good model
fit and structural validity.
Conclusions: The 18item RUTIIQ is a robust, patienttested questionnaire
with excellent psychometric properties, which capably assesses the patient
experience of rUTIrelated impact to QoL and healthcare satisfaction.
Facilitating standardized patient monitoring and improved shared decision
making, the RUTIIQ delivers the unique opportunity to improve patient
centered care.
KEYWORDS
bifactor model, chronic pain, item response theory, patient experience, patientreported
outcomes, psychosocial outcomes, women's health
1|INTRODUCTION
Recurrent urinary tract infection (rUTI) is defined as
experiencing two or more UTIs in six months or three or
more in a year,
1
and affects more than 100 million people
worldwide annually.
2
Given considerable negative
impact to a broad range of quality of life (QoL)
domains,
36
and significant socioeconomic implica-
tions,
4,79
there is an urgent need to validate the unique
rUTI patient experience and incorporate QoL assessment
into clinical management and research.
5,1012
Without
the inclusion of rUTIspecific patientreported outcome
measures (PROMs), evaluation of clinical testing out-
comes and symptoms are limited in their realworld
application. Such tools are required to improve patient
monitoring, shared decisionmaking, and rUTI
management.
13,14
The Recurrent UTI Impact Questionnaire (RUTIIQ)
is a new PROM evaluating rUTIrelated impact to QoL.
15
The RUTIIQ was developed in accordance with gold
standard PROM development recommendations by the
COnsensusbased Standards for the selection of health
Measurement INstruments (COSMIN) initiative,
16,17
with extensive, international expert clinician and patient
input (see Figure 1for methodology; Stages IIV have
been published in Newlands et al., 2023).
15
A fivefactor
structure was identified by exploratory factor analysis
(EFA) of pilot data, comprising: personal wellbeing,
social wellbeing,”“work and activity interference,
patient satisfaction,and sexual wellbeing.
15
The
RUTIIQ demonstrates excellent psychometric properties,
including strong testretest reliability (intraclass correla-
tion coefficient, ICC = 0.660.91; computed based on a
singlerating, absoluteagreement, twoway mixed effects
model
18
), internal consistency (Cronbach's α=0.810.96),
content validity (item content validity indices, ICVI =
0.751.00), and concurrent validity with related QoL
measures (Spearman's ρ=0.690.76).
15
As the required next step in the PROM development
process, in preparation for ongoing work to determine
the questionnaire's clinical responsiveness to interven-
tion, the current study aimed to build on preliminary
testing of the RUTIIQ by confirming its structural
validity and identifying areas for refinement.
16
A bifactor
structure was hypothesized, expecting a general rUTI
QoL impactfactor that explains the common variance
between all items, and five specific, uncorrelated
subfactors aligning with the factors identified through
EFA, each explaining the unique influence of a specific
construct beyond the general factor.
19,20
Bifactor model-
ling enables the evaluation of general scores based on all
items represented by a general trait, as well as individual
domain scores for items represented by specific
traits.
1921
2|MATERIALS AND METHODS
2.1 |Study design and participants
Adults meeting the diagnostic criteria for rUTI,
1
with
advanced or proficient fluency in English based on the
Common European Framework of Reference for Lan-
guages,
22
participated in an online crosssectional survey
(N= 389, 96.9% female biological sex; see Table 1for
characteristics). Definition of rUTI was presented to
participants using the Recurrent UTI Symptom Scale
(RUTISS),
23,24
with participants required to report at
2
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least two symptomatic episodes of UTI in the past six
months or at least three in the past year.
1
Inclusion of
participants based on selfreport of symptoms reflected
recent microbiological findings that standard urine
culture misses up to 58% of true infections and published
recommendations regarding the need to prioritize patient
symptom reporting.
2527
This approach enabled access to
the larger, more heterogeneous sample required for item
response theory (IRT) analysis. Exclusion criteria com-
prised a current diagnosis of interstitial cystitis. Aiming
to validate the confirmatory factor structure and make
refinements to minimize respondent burden, RUTIIQ
data were collected for psychometric analyses including
IRT (see Section 2.3).
19,28,29
At least 250 participants were required to facilitate
multidimensional IRT analysis with a graded response
model (GRM) for ordered polytomous data
30
; sampling
adequacy was exceeded (see Figure S1 for sampling flow
diagram). Participants were mostly recruited via news-
letters and social media posts from a key UTI stakeholder
group, Live UTI Free (84.8%, n= 300), participants and
clinicians sharing the study information on social media
or by word of mouth (9.51%, n= 37), and online UTI
focused support groups (5.66%, n= 22).
2.2 |Procedure
After reviewing the study information and ethical
considerations, participants gave electronic consent and
completed a screening questionnaire to confirm elig-
ibility to participate (see Figure S1). Eligible participants
completed the preliminary RUTIIQ, a 30item selfreport
questionnaire assessing rUTIrelated impact to QoL with
five domains: personal wellbeing,”“social wellbeing,
work and activity interference,”“patient satisfaction
with UTIrelated medical care, and sexual wellbeing
(optional domain, preceded by a prequalifying question:
Do you feel your UTI(s) has/have impacted your sex life
in the past 2 weeks?).
15
Participants used an 11point
Likert scale ranging from 0 (strongly disagree)to10
(strongly agree) to rate their level of agreement with
FIGURE 1 Methodology employed to develop and validate the Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ). The
current study reports the methodology and findings from Stage V. Results from Stages IIV are published in Newlands et al., 2023.
15
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statements about rUTI impact. After completing the
RUTIIQ, a debrief form signposted participants to
support resources.
2.3 |Data handling and statistical
analysis
The final sample comprised 389 participants (Figure S1).
Eightynine participants did not complete the optional
sexual wellbeingquestions, responding noor prefer
not to sayto the prequalifying question. This left a total
of 300 included datapoints for multidimensional IRT
analysis. Responses to the patient satisfactionquestions
were reverse scored, thus higher scores indicated higher
levels of rUTI QoL impact for all domains. As outlined in
this section, a preliminary model was identified, making
refinements based on item and model fit, before
reconducting IRT analysis with a final model. Statistical
terminology definitions are available in Table S1.
TABLE 1 Participant demographic characteristics.
Characteristic n%
Biological sex
Female 377 96.9
Male 12 3.08
Gender
Female 374 96.1
Male 12 3.08
Nonbinary 2 0.51
Prefer not to say 1 0.26
Country of residence
United Kingdom 153 39.3
United States 147 37.8
Canada 26 6.68
Australia 8 2.06
Ireland 5 1.29
Greece 4 1.03
India 4 1.03
Spain 4 1.03
Other
a
38 9.77
Ethnicity
Asian (including Asian American,
Asian British)
10 2.57
Black (including African, African
American, Caribbean, Black British)
3 0.77
Hispanic or Latino American 5 1.29
Mixed ethnicity or multiple ethnic groups 4 1.03
Native Hawaiian or other Pacific Islander 2 0.51
White (including Caucasian,
White British, White European)
340 87.4
Other ethnicity 4 1.03
Prefer not to say 21 5.40
Fluency in English
Native or bilingual 337 86.6
Advanced or proficient 52 13.4
Relationship status
Married or in a civil partnership 199 51.2
In a relationship (unmarried) 117 30.1
Single 44 11.3
Divorced 14 3.60
Widowed 6 1.54
Separated 5 1.29
Other 2 0.51
TABLE 1 (Continued)
Characteristic n%
Prefer not to say 2 0.51
Highest level of education
Some high school/secondary school 7 1.80
High school/secondary school 65 16.7
Bachelor's degree or equivalent 168 43.2
Master's degree or equivalent 104 26.7
Doctoral level training or equivalent 16 4.11
Other professional qualification(s) 22 5.66
Prefer not to say 7 1.80
Annual household income (GBP)
No current income 12 3.08
£1£9999 15 3.86
£10 000£24 999 37 9.51
£25 000£49 999 102 26.2
£50 000£74 999 48 12.4
£75 000£99 999 40 10.3
£100 000 or more 59 15.2
Prefer not to say 76 19.5
Note:N= 389.
a
Other countries where n3 comprise the following 29 countries listed
alphabetically: Angola, Argentina, Austria, The Bahamas, Belgium, Croatia,
Czech Republic, Denmark, Finland, France, Germany, Iceland, Israel, Italy,
Jersey, Malawi, Mexico, Netherlands, New Zealand, Nigeria, Norway,
Romania, Serbia, Slovakia, South Africa, Sweden, Thailand, Turkey, and
Ukraine.
4
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2.3.1 |Preliminary model identification
IRT analysis was conducted in R using the mirt
package,
31
fitting a confirmatory bifactor model to assess
the plausibility of assessing and scoring a general,
overarching factor as well as individual domains (sub-
factors).
19,21
The confirmatory model specified one
general factor onto which all 30 items were expected to
load (rUTI QoL impact), and five orthogonal subfactors
aligning with the factors identified during EFA
15
:
personal wellbeing(items A1A4), social wellbeing
(items B1B5), work and activity interference(items
C1C7), sexual wellbeing(items D1D4), and patient
satisfaction(items E1E10). Recommendations for IRT
modelling with polytomous scales (i.e. scales with more
than two response options) by Toland et al. and by Reeve
and Fayers were followed, identifying a suitable
approach based on the RUTIIQ's ordered, polytomous
Likerttype scale which successively increases from 0
(strongly disagree)to10(strongly agree).
19,30,32
A
bifactor GRM for ordered polytomous scales was thus
fitted, which is also specifically recommended for PROM
evaluation.
30,32,33
The MetropolisHastings Robbins
Monro (MHRM) estimation method, the mathematical
algorithm recommended to estimate multidimensional
IRT models with more than three expected factors, was
employed to estimate item and model parameters.
19
2.3.2 |Model assumption checks
The intercept parameters, which govern the choice of the
next response category over the previous one (e.g.,
responding 10 vs. 9), were examined to assess partici-
pants' use of the 11point Likert scale.
19
It was expected
that the parameters would successively decrease as the
response categories (therefore the latent trait of QoL
impact) increased.
19
IRT analysis assumes that there is local independence
of items after controlling for a latent construct. In other
words, after controlling for the factor influencing a
respondent's choice of response, there should be no
statistically significant association or correlation between
items.
3436
Item pairs that do not meet this assumption
are said to exhibit local item dependence, or LID. Yen's
Q
3
statistics were computed for each item pair within the
bifactor model, with values above 0.50 indicating
LID.
3436
It was expected that the Yen's Q
3
statistics
should be less than 0.50 for all item pairs except those in
which both items measure the same subfactor or testlet
trait (e.g., A1A2, B1B2, etc.).
19,37
Finally, it is assumed that an item should be
interpreted in the same way across different subgroups,
known as item invariance.
38
Likelihood ratio χ
2
analysis
was conducted to check for item invariance, or the
absence of differential item functioning (DIF).
38
This
examined the extent to which each item performs
differently within the model based on biological sex
(female vs. male), age (older vs. younger than the
median, 42 years old), household income (> £25 000 vs.
< £25 000), level of education (university degree or above
vs. school or lower), and current antibiotic use (yes vs.
no).
38
Model parameters were freely estimated across
categorical groups and pvalues were adjusted using the
Bonferroni correction.
39
A statistically significant group
difference (χ
2
,p
adj
< 0.05) indicated the presence of
DIF.
38
2.3.3 |Model fit and performance
Standardized item factor loadings were expected to be
greater than 0.30 and communalities greater than 0.60,
indicating good fit and structural validity.
40
Meansquare
(MNSQ) outfit statistics were examined to evaluate item
fit, with values between 0.50 and 2.00 indicating
acceptability for measurement.
41
Item slope (discrimina-
tion) parameters (α), which can be interpreted similarly
to factor loadings in classical factor analysis,
42
suggested
which items performed best within the model in terms of
differentiating between respondents' level of QoL
impact.
19,43
Minimum α= 0.65 was expected to suggest
at least moderatediscrimination capability, with high-
er values indicating better performance.
43
Overall model fit was evaluated by computing the C
2
statistic of goodness of fit for ordinal data, with a non
statistically significant result suggesting good model fit.
44
This test is sensitive to sample size, thus making model
fit inferences based on the following indices is usual: root
mean square error of approximation (RMSEA
C2
;good
fit0.06), Comparative Fit Index (CFI; good fit0.95),
and standardized root mean square residual (SRMSR;
good fit0.06).
44,45
2.3.4 |Model refinement
The RUTIIQ was thus refined and finalized applying the
following strategy.
19,3441,4345
First, an item was proposed
for deletion if it: (i) demonstrated statistically significant
DIF (p
adj
< 0.05), (ii) showed poor item fit (MNSQ < 0.50 or
>2.00), (iii) indicated low discrimination capability
(α< 0.65), (iv) demonstrated poor factor loading (<0.30),
or (v) contributed insufficiently to the common model
variance (communality, h
2
< 0.60). While some level of LID
was expected due to related items within subfactors or
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testlets (e.g., items A1A4),
19,37
in cases of LID (Q
3
> 0.50)
between item across different subfactors (e.g., items
A1B1), one item from the pair was considered for deletion
based on which demonstrated stronger performance and fit.
Finally, the RMSEA, CFI, and SRMSR model fit indices
were assessed.
IRT analysis was reconducted iteratively after mak-
ing each proposed deletion until a confirmed model was
reached. The final, refined version of the RUTIIQ was
created according to this (see Table 2for included items;
the full RUTIIQ and scoring instructions are available
from the corresponding author).
2.3.5 |Reliability
The internal consistency of the final RUTIIQ was
evaluated by computing Cronbach's alpha (α) coefficients
for the general rUTI QoL impactfactor and for
each subfactor, with α> 0.70 indicating acceptable
reliability.
46
2.3.6 |Readability
The minimum literacy level for comprehension of the
final RUTIIQ was estimated with the Automated
Reliability Index (ARI), a readability assessment tool
suitable for nonnarrative text such as PROMs.
47
3|RESULTS
3.1 |Participants
Most participants reported female biological sex (96.9%,
n= 377; Table 1), and were aged between 18 and 87 years
old (M= 45.4, SD = 17.1). Participants resided in 37
countries, mainly the United Kingdom (39.3%, n= 153)
and United States (37.8%, n= 147). Approximately three
quarters (74.0%, n= 288) reported a bachelor's degree or
higher, and approximately a third (37.8%, n= 147)
reported an annual household income above £50 000.
Participants reported an average of 3.62 UTIs in the past
6 months (SD = 2.90), and 7.06 in the past year
(SD = 5.91).
3.2 |Preliminary bifactor model
The preliminary bifactor model, composed of one general
factor and five orthogonal subfactors, converged success-
fully with MHRM estimation.
3.2.1 |Preliminary model assumption checks
All model assumption checks were passed: (i) successively
decreasing model intercept parameters confirmed consist-
ent use of the 11point Likert scale (see Table S2); (ii) no
TABLE 2 List of final 18 items included in the Recurrent
Urinary Tract Infection Impact Questionnaire (RUTIIQ).
Updated item
number Item
Because of my UTI(s)
A1 I have experienced feelings of anxiety.
A2 I have experienced feelings of low mood or
depression.
A3 I have felt hopeless about the future.
B1 I have avoided socializing more than I used to.
B2 I have felt embarrassed in social situations.
B3 I have felt that I am no longer close to anyone.
B4 I have felt anxious in social situations.
C1 I regularly missed full or partial days of work,
home responsibilities or studying.
C2 The kind or amount of work I could do was
limited.
C3 It was more difficult than usual to concentrate
on my work.
C4 It was more difficult than usual to handle my
workload.
Thinking about my UTIrelated medical care
D1 I have felt confident about being able to get the
medical care I need.
D2 I have felt like my medical concerns are taken
seriously.
D3 I have felt I could access UTI testing and
treatment quickly enough.
D4 I have had easy access to the medical
specialists I need.
E1*I have avoided sexual activity to minimize risk
of developing or worsening UTI symptoms.
E2*I have felt unable to enjoy sexual activity due
to my UTI(s).
E3*I have been concerned about the impact of my
UTI(s) on my sex life and/or sexual
relationship(s).
Note: The full RUTIIQ and scoring instructions are available from the
corresponding author.
*Questions about sexual wellbeing (items E1E3) are optional and only to be
answered by respondents who report that their UTI(s) has/have impacted
their sex life in the past 2 weeks. The Thinking about my UTIrelated
medical careprompt only applies to items D1D4, and not to items E1E3.
6
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LID was identified between items within different
subfactors, meeting the assumption of local independence
of items (Q
3
< 0.50), (iii) no DIF was identified based on
age, biological sex, household income, education level, or
current antibiotic use, meeting the assumption of item
invariance (χ
2
,p
adj
> 0.05; see Table S3).
3.2.2 |Preliminary model fit and
performance
The common variance was strongly represented, with
model and item fit suggesting necessary areas for refine-
ment. The general rUTI QoL impactfactor and the five
subfactors collectively accounted for 79.5% of the common
variance, with the general factor accounting for 35.6% and
subfactors accounting for between 2.00% and 19.1% each
(Table S2). All items loaded onto the general factor and one
subfactor with standardized factor loadings above 0.30
(range = 0.320.84, Table S2), indicating strong fit and
structural validity, except item A4 assessing sleep disrup-
tion (general factor loading = 0.69, subfactor loading =
0.11). All items contributed sufficiently to the common
model variance, demonstrating communalities above 0.60
(Table S2), except item A4 (h
2
= 0.49) and item C3 assessing
selfpressure to work despite illness (h
2
= 0.57).
All item MNSQ fit statistics were between 0.50 and 2.00
for good fit, except item E4 assessing confidence in treatment
decisions (MNSQ = 2.54; see Table S2). All except one item
(A4) indicated at least moderatediscrimination capability,
demonstrated by slope parameters α> 0.64, with 25 items
(83.3%) indicating at least highdiscrimination (α> 1.35).
43
The CFI suggested good model fit (0.97). As the C
2
goodness of fit test (C
2
(375, N= 300) = 1124.26, p< 0.05),
RMSEA (0.082, 95% CI [.076, 0.087]) and SRMSR (0.064)
suggested inadequate model fit, results indicated it was
necessary to refine the model.
3.2.3 |Preliminary model refinement
The refinement strategy outlined in Section 2.3 was
applied, removing poor fitting items one at a time, and
rerunning the analysis after each proposed deletion to
assess the impact on model and item fit. Overall, 12 items
were removed: A4, B1, C2, C3, C6, D4, E1, E4, E6, E8, E9,
and E10 (see Table S4).
3.3 |Final bifactor model
A final 18item confirmatory bifactor model was identi-
fied (see Figure 2), comprising one general rUTI QoL
impactfactor and five orthogonal subfactors. The final
18item RUTIIQ was created in line with this model with
updated item numbering (see Table 2for final included
items; the full RUTIIQ and scoring instructions are
available from the corresponding author). This briefer
measure demonstrates strong psychometric properties
while seeking to minimize respondent burden.
As detailed in the scoring instructions that accom-
pany the RUTIIQ (available from the corresponding
author), an overall RUTIIQ impact score and five
individual domain scores for specific QoL traits may be
computed. Individual domain scores are computed by
summing the item scores relevant to each domain,
48
with
a maximum possible score range of 030 for the
personal wellbeingand sexual wellbeingdomains,
and 040 for the social wellbeing,”“work and activity
interference,and patient satisfactiondomains. There
may be no individual score for the sexual wellbeing
domain since it is optional. The overall RUTIIQ impact
score, a transformed score with maximum range 0100
may be computed to simplify interpretation and compar-
ison, especially in cases where respondents have opted
not to answer the optional sexual wellbeingitems.
48
To
calculate a RUTIIQ impact score, administrators may
sum each individual domain score, divide this sum by the
number of completed items, and then multiply this by 10.
The observed scores in this sample (N= 389) demon-
strated heterogeneity in rUTIspecific QoL impact,
ranging the full breadth of possible scores (Table 3).
3.3.1 |Final model assumption checks
All model assumption checks were passed: (i) evidence of
successively decreasing intercept parameters and no
disordered thresholds (Table 4); (ii) no LID was
identified between items within different subfactors,
meeting the assumption of local independence of items
(Q
3
< 0.50); (iii) the assumption of item invariance was
satisfied, evidenced by finding no DIF based on age,
biological sex, household income, education, or current
antibiotic use, meeting the assumption of item invariance
(χ
2
,p
adj
> 0.05; Table S5).
3.3.2 |Final model fit and performance
The common variance was strongly represented, and
both model and item fit were excellent. The general
rUTI QoL impactfactor and five subfactors collectively
accounted for 81.6% of the common variance (Table 4).
The general factor accounted for 41.2% of the common
variance, and the subfactors accounted for between 3.8%
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and 13.2% each. All standardized factor loadings and
communalities were greater than 0.30 and 0.60, respec-
tively, indicating excellent fit and structural validity
(Table 4). All item MNSQ fit statistics indicated
productivity for measurement, falling between 0.52 and
1.41 (M= 0.81, SD = 0.24; see Table 4). All items
indicated at least moderatediscrimination capability
(α> 0.64), with 15 (91.7%) demonstrating at least high
capability and performance (α> 1.35; Table 4).
43
The model RMSEA (0.054, 95% CI [.042, 0.064]),
SRMSR (0.052) and CFI (0.99) demonstrated excellent
model fit.
44,45
While the C
2
goodness of fit test produced a
statistically significant result (C
2
(117, N= 300) = 217.87,
p< 0.05), model fit inferences were based on the RMSEA,
SRMSR and CFI due to the test's sensitivity to sample
size.
44,45
3.3.3 |Reliability
Internal consistency was excellent for the 18item general
rUTI QoL impact' factor (α= 0.92).
46
Reliability was
similarly strong for the five subfactors, with findings
ranging from α= 0.800.93 (Table S6).
FIGURE 2 This diagram demonstrates the bifactor structure represented by the 18 items included in the Recurrent Urinary Tract
Infection Impact Questionnaire (RUTIIQ). All items load onto the general factor colored in blue on the left: rUTI quality of life impact.
Each item also loads onto a subfactor colored in yellow on the right, each assessing a specific recurrent urinary tract infection (rUTI) quality
of life trait. Standardized factor loadings (>0.30), communalities (>0.60), and model fit indices (RMSEA = 0.054, CFI = 0.99,
SRMSR = 0.052) indicate excellent fit and structural validity (see Table 4).
8
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3.3.4 |Readability
The ARI for the final RUTIIQ is 7.0, demonstrating that
this PROM is appropriate for people with a reading age of
12 years old or above (approximately US 7th grade, UK
Key Stage 3/year 8).
47
4|DISCUSSION
The RUTIIQ is a psychometrically strong measure of
patientreported QoL outcomes and rUTI healthcare
experience. A rigorous PROM development methodology
following bestpractice recommendations by COSMIN
maximized international patient and clinician input
throughout,
16,17
with exploratory analysis indicating
excellent internal consistency, testretest reliability,
content validity, construct validity, and structural valid-
ity.
15
The highquality statistical approaches utilized to
refine the RUTIIQ demonstrated the strength of its factor
structure.
The final, optimized 18item RUTIIQ demonstrates a
wellfitted bifactor structure that minimizes respondent
burden. A general factor evaluates rUTI QoL impact,
with five subfactors measuring personal wellbeing,
social wellbeing,”“work and activity interference,
patient satisfaction,and sexual wellbeing.Simple
scoring and administration instructions are provided
with the questionnaire, available from the corresponding
author. The RUTIIQ can be utilized within a number of
clinical and research contexts, including providing rapid
quantitative insights into key QoL domains impacted by
rUTI, assessing longitudinal change in patient QoL
outcomes in response to new and existing interventions,
exploring patientspecific responses to antibiotic treat-
ment approaches, and identifying underlying domains
that may benefit from targeted medical and/or psycho-
social management and intervention. It is recommended
that in both clinical and research settings, the RUTIIQ is
administered alongside a validated rUTIspecific patient
reported outcome measure of rUTI symptom presenta-
tion to capture the full breadth of the rUTI patient
perspective, such as the 15item Recurrent UTI Symptom
Scale (RUTISS).
23,24
The bifactor model and item fit statistics were
excellent,
44,45
highlighting the strength of the RUTIIQ
and its structural validity. The final 18 items each loaded
highly onto a specific subfactor in addition to the general
factor, demonstrating that they can also be assessed as
separate, individual domains.
44,45
Internal consistency
and reliability of the general factor and subfactors were
high, meeting goldstandard recommendations.
17
Further research would address certain limitations. It
is recognized that most participants were Caucasian and
reported a high level of education and household income,
thus further research is necessary to establish cross
validation of the RUTIIQ and develop translations for
nonEnglish speaking populations or lower socio-
economic status respondents. It is acknowledged that
some RUTIIQ respondents may opt not to complete the
sexual wellbeing items; this is in accordance with the
APA Ethics Code and UK Government Social Research
published recommendations on asking personal ques-
tions,
49,50
and the remaining subscales maintain validity.
Although rUTI is significantly more prevalent in
females,
8
additional testing of the RUTIIQ would be
TABLE 3 Observed Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ) scores.
Score Items*NMSD Observed range
Overall RUTIIQ impact score A1E3 389 61.4 23.3 0100
Individual domain scores
Personal wellbeing A1A3 389 20.1 8.94 030
Social wellbeing B1B4 389 17.8 13.0 040
Work and activity interference C1C4 389 21.2 13.7 040
Patient satisfaction
a
D1D4 389 28.3 10.6 040
Sexual wellbeing
b
E1E3 300 26.0 5.63 030
Note: Higher scores indicate greater level of rUTIrelated impact to quality of life. All observed scores ranges align with the maximum possible ranges for each
score type.
Abbreviations: M, mean; SD, standard deviation.
a
Reverse scored.
b
The sexual wellbeingdomain is optional, therefore not all participants responded to these questions.
*Item numbers as per the refined, final version of the RUTIIQ (see Table 2; the full RUTIIQ and scoring instructions are available from the corresponding
author).
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TABLE 4 Bifactor graded response model item parameter estimates, fit statistics, and factor structure of the 18item Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ).
Item*
Slope Intercept Standardized factor loading
h
2
Item MNSQ
outfitα
G
α
S1
α
S2
α
S3
α
S4
α
S5
c
1
c
2
c
3
c
4
c
5
c
6
c
7
c
8
c
9
c
10
GS1 S2 S3 S4 S5
A1 2.54 1.22 7.39 5.64 4.96 4.62 3.97 3.26 2.12 1.08 0.32 1.23 0.77 0.37 0.73 0.78
A2 5.51 3.84 13.0 10.5 8.70 7.56 6.34 4.87 3.69 1.67 0.87 3.05 0.80 0.56 0.94 0.56
A3 3.37 2.15 6.90 5.26 4.41 3.84 3.20 2.47 1.50 0.20 1.04 2.27 0.78 0.50 0.85 0.75
B1 4.01 1.87 5.80 4.48 3.52 2.93 2.50 1.57 0.68 0.33 1.94 3.03 0.85 0.39 0.87 0.69
B2 2.34 2.44 3.52 1.88 1.20 0.57 0.24 0.38 1.02 1.74 2.75 3.63 0.62 0.64 0.80 0.75
B3 1.79 1.61 1.44 0.50 0.01 0.39 0.89 1.43 1.91 2.36 3.09 3.37 0.61 0.55 0.67 0.73
B4 4.45 3.32 5.70 3.85 2.56 1.95 1.23 0.36 0.65 2.00 3.42 4.54 0.77 0.57 0.92 0.60
C1 2.45 1.90 3.43 2.32 1.74 1.17 0.85 0.11 0.50 1.14 1.79 2.33 0.69 0.54 0.77 0.98
C2 3.69 3.15 5.94 4.64 3.72 2.93 2.18 1.36 0.72 0.22 1.54 2.57 0.72 0.61 0.89 0.72
C3 3.72 2.95 6.92 5.85 4.64 3.74 2.76 1.98 1.29 0.50 1.00 2.05 0.74 0.59 0.89 0.71
C4 3.49 2.80 5.94 4.64 3.72 2.93 2.18 1.36 0.72 0.22 1.54 2.57 0.73 0.58 0.87 1.03
D1 2.42 4.64 11.3 9.18 7.76 6.71 5.46 4.50 3.24 2.04 0.23 2.14 0.44 0.84 0.90 0.72
D2 1.37 2.87 6.39 5.36 3.97 3.23 2.76 1.80 1.17 0.76 0.59 1.73 0.38 0.80 0.78 1.03
D3 1.30 2.03 5.14 4.36 3.67 3.15 2.64 2.07 1.47 0.82 0.05 1.01 0.44 0.69 0.67 1.19
D4 1.26 2.39 6.17 5.49 4.24 3.27 3.04 2.12 1.59 0.86 0.19 1.21 0.40 0.75 0.72 0.88
E1 2.28 4.11 10.5 9.67 8.71 8.11 7.13 6.35 6.05 4.77 3.02 1.49 0.46 0.82 0.88 0.52
E2 2.55 4.27 9.84 9.34 8.53 7.65 6.91 5.75 5.03 4.06 2.66 0.85 0.49 0.81 0.90 0.55
E3 1.72 1.73 7.37 6.22 5.68 4.80 4.29 3.90 3.18 2.33 1.12 0.13 0.58 0.58 0.67 1.41
ECV 0.41 0.04 0.07 0.08 0.13 0.09
Note:α= slope (or discrimination) parameters; higher slopes indicate greater discrimination. moderatediscrimination capability: α= 0.651.34; highdiscrimination capability: α= 1.351.69; very high
discrimination capability: α1.70.
41
c
1
c
10
= intercept parameters; these should successively decrease in value between c
1
and c
10
to demonstrate consistent use of the 11point scale.
19
Item MNSQ fit statistics
between 0.50 and 2.00 are interpreted as acceptable for measurement, with statistics closer to 1.0 indicating best fit to the model with the least distortion.
40
Abbreviations: ECV, explained common variance; G, general factor (rUTI quality of life impact); h
2
, communality; MNSQ, mean square (item fit statistics); S1, subfactor 1 (personal wellbeing); S2, subfactor 2 (social
wellbeing); S3, subfactor 3 (work and activity interference); S4, subfactor 4 (patient satisfaction); S5, subfactor 5 (sexual wellbeing).
*Item numbers as per the refined, final version of the RUTIIQ (see Table 2; the full RUTIIQ and scoring instructions are available from the corresponding author). Items D1D4 (patient satisfaction) have been reverse
scored.
10
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beneficial to better understand its psychometric propert-
ies in males. Early indications suggest that the RUTIIQ is
accessible and appropriate for use by males living with
rUTI, however it should be noted the small proportions
of males recruited for this study mean that broader
extrapolation of the RUTIIQ to malespecific rUTI
presentation is currently limited, reflective of a paucity
of malespecific literature in UTI. While the sample size
was adequate, a larger sample may have further
improved the model parameter estimates, thus future
research could seek to validate the model within a larger
patient sample and in a clinical context.
30
The next stage
in PROM development, assessing the responsiveness and
clinical interpretability of the RUTIIQ, is ongoing.
16
5|CONCLUSION
The RUTIIQ is a psychometrically valid 18item ques-
tionnaire assessing patientreported personal wellbeing,
social wellbeing, work and activity interference, patient
satisfaction, and sexual wellbeing. Its simple scoring
facilitates standardized patient monitoring and quantifi-
cation of QoL impact. This brief patientreported
outcome measure offers a unique opportunity to
critically assess and prioritize the rUTI patient perspec-
tive, supplementing clinical management by improving
shared decisionmaking and highlighting psychosocial
challenges requiring intervention.
AUTHOR CONTRIBUTIONS
All authors contributed to the study conceptualization
and methodological design. Abigail F. Newlands under-
took the study investigation, data collection, and project
administration. Abigail F. Newlands and Katherine A.
Finlay conducted formal data analysis and interpretation.
Melissa Kramer and Jessica L. Price contributed to the
study resources and participant recruitment. Abigail F.
Newlands prepared the original draft manuscript, and all
authors reviewed and approved the final manuscript.
ACKNOWLEDGMENTS
We would like to thank Live UTI Free for supporting this
study and recruitment.
CONFLICT OF INTEREST STATEMENT
Melissa Kramer is CEO of Live UTI Free Ltd.; however,
no financial incentives have been received.
DATA AVAILABILITY STATEMENT
The datasets used and analyzed during the current study
are available from the corresponding author on reason-
able request.
ETHICS STATEMENT
Ethical approval was granted by the School of Psychology
and Clinical Language Sciences Research Ethics Committee,
University of Reading (project reference no.: 2022115KF).
All participants were provided with study information sheets
and debrief forms, and electronically signed their consent to
take part before participation.
ORCID
Abigail F. Newlands http://orcid.org/0000-0002-
4718-0075
Melissa Kramer http://orcid.org/0000-0002-9242-5203
Lindsey Roberts http://orcid.org/0000-0001-5277-2377
Kayleigh Maxwell http://orcid.org/0000-0002-
8747-7201
Jessica L. Price http://orcid.org/0000-0002-0487-0826
Katherine A. Finlay http://orcid.org/0000-0002-
8997-2652
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SUPPORTING INFORMATION
Additional supporting information can be found online
in the Supporting Information section at the end of this
article.
How to cite this article: Newlands AF, Kramer
M, Roberts L, Maxwell K, Price JL, Finlay KA.
Evaluating the quality of life impact of recurrent
urinary tract infection: Validation and refinement
of the Recurrent UTI Impact Questionnaire
(RUTIIQ). Neurourol Urodyn. 2024.
doi:10.1002/nau.25426
NEWLANDS ET AL.
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... There is a major gap in the efficacy of clinical care for complicated and recurrent UTIs due to the significant limitations of the current standard of care diagnostic tests, leading to high rates of hospitalization and ER/Urgent Care visits [47]. Equally important, these patients have a significantly reduced quality of life due to the persistence and recurrence of symptoms, including pain [53][54][55][56][57][58][59][60][61][62][63]. Prior published studies have already demonstrated that the M-PCR/P-AST diagnostic test is associated with reduced hospitalizations, ER visits, Urgent Care visits, and the recurrence of UTI symptoms [47,48]. ...
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Background/Objectives: We aimed to compare the prescribing behavior and clinical experience of urology providers when using the combined multiplex polymerase chain reaction (M-PCR)/Pooled Antibiotic Susceptibility Testing (P-AST) diagnostic test versus the standard urine culture (SUC) in the same set of patients previously reported to have improved clinical outcomes with M-PCR/P-AST. Methods: We conducted a multi-centered, prospective, observational study (clinical trial registration: NCT05091931) with Western Institutional Review Board (IRB) approval (20214705). Adult subjects were split between the M-PCR/P-AST (n = 250) and SUC arms (n = 135). Treatment details were determined by clinician and subject surveys. Differences in prescribed antibiotics were compared using the Chi-square or Fisher’s exact test. Results: There was no significant difference in the overall use of “access” antibiotics (p = 1.0) or first-line drugs (p = 0.4483) between M-PCR/P-AST and SUC. Nitrofurantoin (p = 0.0172) and metronidazole (p = 0.0309) were more frequently used with M-PCR/P-AST, while amoxicillin/clavulanate (p = 0.0008), cefuroxime (p = 0.0378), and ertapenem (p = 0.0378) were more frequently used with SUC. Conclusions: The use of M-PCR/P-AST to guide complicated UTI management was not associated with the increased use of non-first-line antibiotics, such as carbapenems, compared to SUC. Combined with the prior reported evidence of improved patient outcomes in this same set of patients, this test should be considered for utilization when managing complicated UTI cases.
... 73 Very recently, the Recurrent UTI Impact Questionnaire (RUTIIQ), was validated and optimized for assessing the patient-reported psychosocial impact of living with recurrent UTI symptoms and pain as a unique tool to improve patientcentered care. 74,75 Physician and patient perspectives of recurrent UTI demonstrate a number of commonly recognized areas for improvement. First, many physicians report feeling that they have insufficient knowledge of guideline recommendations for recurrent UTI management, especially for peri-and post-menopausal women. ...
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This article aims to bring clinicians’ awareness to the widespread impact of urinary tract infection (UTI) on the lives of women and to the advances that offer hope for future improvements in the diagnosis and management of UTI. Thanks to physiological, anatomical, and lifestyle factor differences, women face heightened vulnerability to UTIs compared to men. In fact, women are four times more likely than men to develop a UTI and around half of these women encounter UTI recurrence, which is a significant source of both physical and psychosocial burdens. Despite the current shortcomings in diagnosis and management, emerging diagnostic technologies promise to identify UTIs more accurately and rapidly, offering women hope for a revolution in UTI management. Meanwhile, clinicians have the opportunity to reduce the psychosocial burden by recognizing the value of patients’ lived experiences and ensuring their care plan is in alignment with their patients’ goals and expectations for medical care.
Article
Background Urinary tract infections (UTIs) significantly impact quality of life and can also lead to changes in sexual function. Aim This study aims to assess the symptoms associated with recurrent urinary tract infections (rUTIs) and their influence on both quality of life and sexual activity. Methods A case–control study was conducted, involving 383 patients with rUTIs and 161 healthy controls. The Acute Cystitis Symptom Score (ACSS) and Female Sexual Function Index (FSFI) questionnaires were utilized, with all surveys completed online through Google Forms. Outcomes The ACSS and FSFI were collected using online surveys designed through Google Forms. Results A higher prevalence of constipation was observed in the rUTI group compared to controls (37.6% vs 31.7%). rUTIs caused moderate to severe interference with work activities in 55.5% of cases, while 59% reported interference with social life. Sexual life assessment revealed that all FSFI domains were significantly affected in patients with rUTIs. Sexual desire was rated as low or very low in 61.9% of rUTI cases compared to 48.1% of controls (P < .001). Additionally, 35.3% of rUTI patients reported low or very low confidence in becoming sexually aroused, compared to 7.5% of controls (P < .001). Difficulty reaching orgasm was reported by 29.6% of rUTI patients versus 20.7% of controls (P < .001). Pain or discomfort following vaginal penetration was reported more than half the time by 43.9% of rUTI patients, compared to 19.6% of controls (P < .001). Dissatisfaction with sexual intercourse was noted in 53.6% of rUTI patients versus 15.8% of controls (P < .001). Clinical Implications The assessment of sexual health should be integrated into the management of patients with rUTIs. Interventions targeting UTI management must also address strategies to improve sexual function and satisfaction. Strengths and Limitations This study provides insight into the impact of rUTIs on sexual function across both pre- and post-menopausal women, allowing for an evaluation of how sexual perceptions evolve with age. However, the study's limitations include the lack of assessment of sexual practices, which may influence the risk of rUTIs and affect FSFI results. Conclusions Women with rUTIs report significantly lower sexual satisfaction and higher rates of sexual dysfunction. It is essential to evaluate the sexual function of patients with rUTIs, and management strategies must consider ways to improve sexual health as part of the overall treatment plan.
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BACKGROUND: Questionnaires allow to objectify and quantify the disease severity, especially at the patient’s initial visit, its impact on the patients’ quality of life, as well as the dynamics of symptoms during treatment. AIM: To validate the Russian version of the Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF scale; C.L. Parsons, 2000) for patients with chronic recurrent uncomplicated cystitis. MATERIALS AND METHODS: The Russian version of the PUF Scale was suggested to two respondent groups aged 19 to 53 years: relatively healthy volunteers, 15 women who did not complains of urinary disorders or pain/discomfort in the bladder, and 14 patients with verified diagnosis of chronic recurrent uncomplicated cystitis. RESULTS: The resulting data demonstrate the validity of the proposed Russian version of the PUF Scale. Statistically significant differences were noted in the answers to most of the questionnaire issues between two respondent groups: conditionally healthy volunteers and patients with chronic recurrent uncomplicated cystitis. A high level of internal consistency of the questionnaire was found. Cronbach’s alpha coefficient in the main group was 0.888, in the control group — 0.819. CONCLUSIONS: The study findings proved that the Russian version of the Pelvic Pain and Urgency/Frequency Patient Symptom Scale (C.L. Parsons, 2000) is a valid tool for subjective assessment of the severity of chronic recurrent uncomplicated cystitis symptoms.
Article
Introduction: Urinary tract infection (UTI) is a major global health concern. While acute UTIs can usually be effectively treated, recurrent UTIs (rUTIs) impact patients for years, causing significant morbidity and can become refractory to front-line antibiotics. Areas covered: This review discusses the risk factors associated with rUTI, current rUTI treatment paradigms, prophylactic strategies, and challenges in rUTI diagnostics. We specifically discuss common risk factors for rUTI, including biological sex, age, menopause status, and diabetes mellitus. We also review recently available evidence for commonly used treatments, from oral antibiotic therapy to intravesical antimicrobials, electrofulguration of chronic cystitis, and the last-resort treatment, cystectomy. We discuss the most current literature evaluating prophylactic strategies for rUTI including long-term antibiotic prophylaxis, estrogen hormone therapy, and dietary supplements. Finally, we address the important role of UTI diagnostics in effective rUTI management and review the strengths and limitations of both current and emerging UTI diagnostic platforms as well as their ability to operate at point-of-care. Expert opinion: We discuss the current challenges faced by clinicians in managing rUTI in women and the steps that should be taken so that clinicians, scientists, and patients can work together to better understand the disease and develop better strategies for its management.
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Objectives To confirm the structural validity of the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), determining whether a bifactor model appropriately fits the questionnaire's structure and identifying areas for refinement. Used in conjunction with established clinical testing methods, this patient‐reported outcome measure addresses the urgent need to validate the patient perspective. Patients and methods A clinically and demographically diverse sample of 389 people experiencing recurrent UTI across 37 countries (96.9% female biological sex, aged 18–87 years) completed the RUTISS online. A bifactor graded response model was fitted to the data, identifying potential items for deletion if they indicated significant differential item functioning (DIF) based on sociodemographic characteristics, contributed to local item dependence or demonstrated poor fit or discrimination capability. Results The final RUTISS comprised a 3‐item symptom frequency section, a 1‐item global rating of change scale and an 11‐item general ‘rUTI symptom and pain severity’ subscale with four sub‐factor domains measuring ‘urinary symptoms’, ‘urinary presentation’, ‘UTI pain and discomfort’ and ‘bodily sensations’. The bifactor model fit indices were excellent (root mean square error of approximation [RMSEA] = 0.041, comparative fit index [CFI] = 0.995, standardised root mean square residual [SRMSR] = 0.047), and the mean‐square fit statistics indicated that all items were productive for measurement (mean square fit indices [MNSQ] = 0.64 – 1.29). Eighty‐one per cent of the common model variance was accounted for by the general factor and sub‐factors collectively, and all factor loadings were greater than 0.30 and communalities greater than 0.60. Items indicated high discrimination capability (slope parameters > 1.35). Conclusion The 15‐item RUTISS is a patient‐generated, psychometrically robust questionnaire that dynamically assesses the patient experience of recurrent UTI symptoms and pain. This brief tool offers the unique opportunity to enhance patient‐centred care by supporting shared decision‐making and patient monitoring.
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Objectives Recurrent UTI (rUTI) is a debilitating health condition that is associated with persistent mental, physical, and social burdens. People living with rUTI face inconsistencies in diagnostic testing and fragmented treatment pathways alongside their symptoms, which are likely to add considerably to their illness-related burdens. This study aimed to characterize the factors negatively impacting this population using the qualitative perspectives of people living with the condition. Methods Qualitative data were collected via free-text responses using an online survey hosted by an rUTI patient advocacy website. Female participants with self-reported rUTI ( n = 1,983) described the factors that were most salient to their experience of living with the condition. Data were analyzed using a coding reliability approach to thematic analysis. Results Two overarching themes were identified: (1) the patient burden of rUTI, which describes the multifaceted biopsychosocial impact of the illness, and (2) healthcare disillusionment, which describes patient dissatisfaction with healthcare received, both in terms of the treatments offered and communication with healthcare professionals. The patient burden of rUTI encompassed four subordinate themes: facing ongoing uncertainty; symptom salience; sex is not simple anymore; and perceived UTI stigma. Healthcare disillusionment included three subordinate themes: discomfort with frequent antibiotic use; fragmented treatment pathways; and devalued patient perspectives. Conclusions The findings demonstrated that ambiguity in the diagnosis of rUTI and inconsistencies in the subsequent treatment pathway are exacerbated by poor patient–clinician communication. The extent of the female-specific burden of rUTI symptoms confirmed the harmful effects of illness-related stigma. This novel qualitative reporting of rUTI symptom burden and life impact highlights the urgent need for increased patient-centered care for those living with rUTI. More effective rUTI management could have a major impact on treatment outcomes and patient-reported psychosocial wellbeing.
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Diagnosis and treatment of urinary tract infections (UTIs) remains stagnant. The presumption that a patient either has a UTI or does not (binary choice) is inappropriately simplistic. Laboratory diagnostic tests have not advanced for decades. The goal of UTI treatment has not been rigorously defined and may increase the prescription of potentially harmful, inappropriate antibiotics. Despite the high incidence of UTI diagnoses, the high cost of UTI treatment, and increasing concerns associated with antimicrobial resistance, the development of novel and more accurate UTI tests has not been considered a priority, in part due to the general perception that current UTI care is already sufficient. In this review, we discuss the importance of improving UTI diagnostic testing to improve treatment outcomes. We discuss the problems associated with UTI diagnosis. Urinary microbes are alive and exist in both healthy and symptomatic individuals—urine is not sterile. We specifically outline the limitations of standard urine culture methods used by clinical microbiology laboratories, explaining clearly why such methods cannot be considered to be the “gold standard,” as standard culture methods underreport most of the urinary tract microbes, including some acknowledged and many emerging uropathogens. We do not recommend abandonment of this test, as no universally accepted substitute yet exists. However, we strongly encourage the development of new and improved diagnostic tests that can both improve outcomes and preserve antibiotic stewardship.
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Purpose: Recurrent urinary tract infection (rUTI) is a highly prevalent condition associated with significant poor quality of life outcomes. A patient-reported outcome measure (PROM) of rUTI-associated psychosocial impact is urgently required to supplement clinical evaluation and validate the challenges experienced by patients. This study therefore developed and validated the Recurrent UTI Impact Questionnaire (RUTIIQ). Methods: A rigorous four-stage methodology was followed: (I) concept elicitation through a qualitative survey of the experiences of people with rUTI (N = 1983); (II) Delphi expert screening of the RUTIIQ with expert rUTI clinicians (N = 15); (III) one-to-one cognitive interviews with people experiencing rUTI (N = 28) to evaluate the comprehensiveness and comprehensibility of the RUTIIQ, and (IV) full pilot testing of the RUTIIQ with people experiencing rUTI (N = 240) to perform final item reduction and psychometric analysis. Results: Exploratory factor analysis demonstrated a five-factor structure comprising: 'patient satisfaction', 'work and activity interference', 'social wellbeing', 'personal wellbeing', and 'sexual wellbeing', collectively accounting for 73.8% of the total variance in pilot scores. Results from expert clinicians and patients indicated strong item content validity (I-CVI > .75). The internal consistency and test-retest reliability of the RUTIIQ subscales were excellent (Cronbach's α = .81-.96, ICC = .66-.91), and construct validity was strong (Spearman's ρ > .69). Conclusion: The RUTIIQ is a 30-item questionnaire with excellent psychometric properties, assessing the patient-reported psychosocial impact of living with rUTI symptoms and pain. This new instrument delivers the unique opportunity to enhance patient-centred care through standardised observation and monitoring of rUTI patient outcomes. Trial registration: This study was pre-registered with ClinicalTrials.gov (identifier: NCT05086900).
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This study aimed to develop and validate a tailored patient‐reported outcome measure (PROM) evaluating the patient experience of recurrent urinary tract infection (rUTI) symptom severity. This measure was designed to supplement clinical testing methods, allowing full assessment of the patient experience of rUTI symptom burden, while enhancing patient‐centred UTI management and monitoring. The Recurrent Urinary Tract Infection Symptom Scale (RUTISS) was developed and validated using a three‐stage methodology, in accordance with gold‐standard recommendations. Firstly, a two‐round Delphi study was conducted to gain insights from 15 international expert clinicians working in rUTI, developing an initial pool of novel questionnaire items, assessing content validity and making item refinements. Next, two phases of one‐to‐one semi‐structured cognitive interviews were conducted with a diverse sample of 28 people experiencing rUTI to assess questionnaire comprehensiveness and comprehensibility, making refinements after each phase. Finally, a comprehensive pilot of the RUTISS was conducted with 240 people experiencing rUTI across 24 countries, providing data for psychometric testing and item reduction. Exploratory factor analysis indicated a four‐factor structure comprising: ‘urinary pain and discomfort’, ‘urinary urgency’, ‘bodily sensations’ and ‘urinary presentation’, together accounting for 75.4% of the total variance in data. Qualitative feedback from expert clinicians and patients indicated strong content validity for items, which was supported by high content validity indices in the Delphi study (I‐CVI > 0.75). Internal consistency and test–retest reliability of the RUTISS subscales were excellent (Cronbach's α = 0.87–0.94 and ICC = 0.73–0.82, respectively), and construct validity was strong (Spearman's ρ = 0.60–0.82). The RUTISS is a 28‐item questionnaire with excellent reliability and validity, which dynamically assesses patient‐reported rUTI symptoms and pain. This new PROM offers a unique opportunity to critically inform and strategically enhance the quality of rUTI management, patient‐clinician interactions, and shared‐decision making by monitoring key patient‐reported outcomes.
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Background While many studies address the clinical management of participants with uncomplicated urinary tract infection (uUTI), the emotional impact of uUTIs has been investigated less often. The aim of this qualitative study was to understand the emotional experience of women with uUTIs. Methods This was a qualitative, exploratory, in-depth interview-based study conducted among women in the United States (US) and Germany. Women aged ≥ 18 years with at least one uUTI treated with antibiotics in the past year were recruited through a patient community panel and physician referrals. Participants were recruited using purposive sampling to include an equal split of those with 1 or ≥ 2 antibiotics, and an equal split of those treated for a single or recurrent uUTIs (≥ 2 uUTIs in the past year). A structured telephone interview included questions about symptoms, diagnosis, treatment, and retreatment (if any). Each participant was queried about her emotions and the impact of the uUTI on life activities. Thematic analysis of responses was carried out to identify common themes. Results A total of 65 participants completed the interview, 40 (61.5%) from the US and 25 (38.5%) from Germany. Major themes that emerged from the analyses included (1) a wide range of negative emotions were experienced due to uUTI symptoms, interference with activities of daily life, and effects on relationships and sleep; (2) varied emotions and understanding related to uUTI treatment and management approaches; (3) treatment failure caused frustration, worry, and anger; and (4) the prospect of recurrent uUTIs provoked dread and helplessness. Conclusion Our research uncovered emotions of helplessness and dread experienced by women in the context of uUTI clinical treatment failure and recurrent uUTIs. Knowing patients’ perspectives on UTI management will help guide the development of patient education and improve shared decision-making.
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Introduction: Urinary tract infections (UTI) are a leading cause of bacterial infections in women. Despite acute treatment, 30–50% of women who have a UTI will experience a recurrence within 6–12 months. In this review, the focus will be on the personal psychosocial impacts of recurrent UTI. Methods: A PubMed/MEDLINE literature search was carried out from 2000 to 2020 in order to identify any recent high-quality meta-analyses or systematic reviews on these topics. Results: One systematic review was found appropriate for this manuscript. Concerning impact on quality of life (QoL) and daily activities, a reduced quality of both intimate and social relationships, self-esteem, and capacity for work was found due to recurrent UTI. Social function was substantially more reduced than physical function. In one study, the greatest reduction overall was in mental role functioning, whereas in another study, mental health reductions were not substantially greater than those of physical health. About one third of women suffered from UTI very often or often after sexual intercourse, and more than half of the patients stated that sexual relations were negatively influenced by UTI. Data from the GESPRIT study suggest that prophylaxis for recurrent UTI is underutilized, because less than 40% of the study population were offered prophylaxis after experiencing three UTI per year, despite all surveyed participants being willing to undertake at least one of the prophylactic measures listed in the survey. Conclusions: Little data on the psychosocial impact of recurrent UTI are available. Therefore, future studies must also incorporate QoL assessments as key outcome measures.
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Measurement is fundamental to all research in psychology and should be accorded greater scrutiny than typically occurs. Among other claims, McNeish and Wolf (Thinking twice about sum scores. Behavior Research Methods , 52 , 2287-2305) argued that use of sum scores (a) implies that a highly constrained latent variable model underlies items comprising a scale, and (b) may misrepresent or bias relations with other criteria. The central claim by McNeish and Wolf that use of sum scores requires the assumption that a parallel test model underlies item responses is incorrect and without psychometric merit. Instead, if a set of items is unidimensional, estimators of reliability are available even if the factor model underlying the set of items does not have a highly constrained form. Thus, dimensionality of a set of items is the key issue, and whether strict constraints on parameter estimates do or do not hold dictate the appropriate way to estimate reliability. McNeish and Wolf also claimed that more precise forms of scoring, such as estimating factor scores, would be preferable to sum scores. We provide analytic bases for reliability estimation and then provide several demonstrations of reliability estimation and the relative advantages of sum scores and factor scores. We contend that several claims by McNeish and Wolf are questionable and that, as a result, multiple recommendations they made and conclusions they drew are incorrect. The upshot is that, once the dimensional structure of a set of items is verified, sum scores often have a solid psychometric basis and therefore are frequently quite adequate for psychological research.
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Objective To test and compare the efficacy of methenamine hippurate for prevention of recurrent urinary tract infections with the current standard prophylaxis of daily low dose antibiotics. Design Multicentre, open label, randomised, non-inferiority trial. Setting Eight centres in the UK, recruiting from June 2016 to June 2018. Participants Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment. Interventions Random assignment (1:1, using permuted blocks of variable length via a web based system) to receive antibiotic prophylaxis or methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed. Main outcome measure Absolute difference in incidence of symptomatic, antibiotic treated, urinary tract infections during treatment. A patient and public involvement group predefined the non-inferiority margin as one episode of urinary tract infection per person year. Analyses performed in a modified intention-to-treat population comprised all participants observed for at least six months. Results Participants were randomly assigned to antibiotic prophylaxis (n=120) or methenamine hippurate (n=120). The modified intention-to-treat analysis comprised 205 (85%) participants (antibiotics, n=102 (85%); methenamine hippurate, n=103 (86%)). Incidence of antibiotic treated urinary tract infections during the 12 month treatment period was 0.89 episodes per person year (95% confidence interval 0.65 to 1.12) in the antibiotics group and 1.38 (1.05 to 1.72) in the methenamine hippurate group, with an absolute difference of 0.49 (90% confidence interval 0.15 to 0.84) confirming non-inferiority. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the methenamine group and most reactions were mild. Conclusion Non-antibiotic prophylactic treatment with methenamine hippurate might be appropriate for women with a history of recurrent episodes of urinary tract infections, informed by patient preferences and antibiotic stewardship initiatives, given the demonstration of non-inferiority to daily antibiotic prophylaxis seen in this trial. Trial registration ISRCTN70219762 .
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Purpose We aimed to estimate the burden of UTIs by age, sex, and socioeconomic status in 204 countries and territories from 1990 to 2019. Methods We used data from Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 to analyse the incidence, mortality, and disability-adjusted life-years (DALYs) due to UTIs at the global, regional, and national levels. Estimates are presented as numbers and age-standardised or age-specific rates per 100,000 population, with 95% uncertainty intervals (UIs). We further explored the associations between the incidence, mortality, DALYs, and socio-demographic index (SDI) as a proxy for the development status of regions and countries. Results In 2019, more than 404.6 million (95% UI 359.4–446.5) individuals had UTIs globally and nearly 236,786 people (198,433–259,034) died of UTIs, contributing to 5.2 million (4.5–5.7) DALYs. The age-standardised incidence rate increased from 4715.0 (4174.2–5220.6) per 100,000 population in 1990 to 5229.3 (4645.3–5771.2) per 100,000 population in 2019. At the GBD regional level, the highest age-standardised incidence rate in 2019 occurred in Tropical Latin America (13,852.9 [12,135.6–15,480.3] per 100,000 population). At the national level, Ecuador had the highest age-standardised incidence rate (15,511.3 [13,685.0–17,375.6] per 100,000 population). The age-standardised death rates were highest in Barbados (19.5 [13.7–23.5] per 100,000 population). In addition, age-standardised incidence, death, and DALY rates generally increased across the SDI. Conclusions Our study results suggest a globally rising trend of UTI burden between 1990 and 2019.