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JOURNAL OF ENDOUROLOGY
Volume 28, Number 2, February 2014
Mary Ann Liebert, Inc.
Pp. 237242
DOI: 10.1089/end.2013.0325
Abstract
Background and Purpose: Ureteral Stent Symptoms Questionnaire (USSQ) is an intervention-specific healthrelated quality-of-life (HrQoL) measure. We describe development and validation of the Spanish version.
Materials and Methods: We followed established methods to develop the Spanish version of the original USSQ.
After pilot testing, we conducted a formal validation study; 70 patients, undergoing placement of ureteral stents,
successfully completed the Spanish USSQ as well as the EuroQoL-5D (male and female), the ICIQ male and
female lower urinary tract symptoms questionnaires at weeks 1 and 4 after stent insertions, and at week 4 after
their removal. In addition, 40 healthy people acted as a control group and completed the same questionnaires
twice at 3-week intervals. Statistical analyses were performed to evaluate reliability, validity, and sensitivity to
change of the Spanish USSQ.
Results: After revision of the initial two drafts after translation, back translation, and pilot testing, a final draft
was developed that underwent field testing. Psychometric analyses revealed satisfactory internal consistencies
(Cronbach alpha coefficients: 0.730. 85) and test-retest reliability (Spearman correlation coefficient: > 0.6) for the
domains of urinary symptom, body pain, and general health. It demonstrated satisfactory discriminant validity
(sensitivity to change, p < 0.01), convergent validity (good correlations between the domains of the USSQ and
existing validated questionnaires), and testretest reliability (p < 0.001). Analysis of the domains of the sexual
matter (21.4%) and work performance (35.7%) were limited because of the small proportion of the study
population for whom it was applicable.
Conclusions: Results of our development and validation study demonstrate that the new Spanish version of the
USSQ is a psychometrically valid intervention-specific measurer for use in the second most common language in
the world. It is a reliable outcome measure that could be used for both clinical and research purposes.
Introduction
signs and materials for stents or testing different pharmacologic agents (alpha-blocker and anticholinergic) to control the
symptoms.35
Joshi and associates6 developed the Ureteral Stent Symptom Questionnaire (USSQ), a psychometrically valid measure
to evaluate symptoms and impact on QoL of ureteral stents. It
consists of six domains, exploring stent-specific matters in
three (urinary symptoms, pain, and additional problems) and
general matters in the other three (general health, work performance, and sexual matters).
The USSQ has been adopted as a reliable outcome measure
in several trials, allowing better understanding of the results
and its application for meta-analysis.4,79 No validated
237
238
versions of non-English USSQ have been used in some studies, however, thus limiting the strength of their results.1012
Accordingly, linguistic validation in different languages and
across cultures is needed for USSQ global validation and
wider use.
Currently, validated versions of the USSQ have been
published in Italian and Korean, while validations in several
other languages are ongoing.13,14
This study was conducted to provide a validated version of
the USSQ in Spanish, the language most widely spread in the
world and the second most common language in the United
States.
Materials and Methods
SANGUEDOLCE ET AL.
with alpha-blockers, anticholinergics, analgesics, and other
drugs, possibly interfering with lower urinary tract function
or pain assessment, in men and women. We also excluded
cases of complicated ureteroscopy, defined as (1) mucosal
injury edema, or perforation, (2) multiple, large (more than
2 cm) or impacted stones.
In both institutions, the same type of 6F Double-J ureteral
stent was inserted in all cases by experienced urologists, using
three different lengths (26, 28, and 30 cm, respectively) according to ureteral length.
All subjects were fully informed about the purpose of the
study, which was approved by the Institutional Review
Board, and all provided written informed consent.
During the same period, 40 healthy people were recruited
at Fundacio Puigvert in Barcelona as a control group.
Data collection
The Spanish version of the USSQ-in situ was self-administered by all patients at weeks 1 and 4 after stent placement.
The USSQ-poststent version was self-administered at week 4
after stent removal, considering this interval of time adequate
for the patients to come back to the prestent condition. This
was the time frame used during validation of the original
questionnaire.
Scores for urinary symptoms, body pain, general health,
work performance, and sexual matters domains were computed according to the original author (HBJ) instructions. No
score was recorded for the additional problems domain,
because this is a descriptive/qualitative domain, and the
global QoL domain was scored on the basis of a single
question.
In addition, all the patients were asked to complete the
EuroQoL-5D, ICIQ-MLUTS (male) and ICIQ-FLUTS (female)
questionnaires at the same time; all these questionnaires
were validated in Spanish and provided by the corresponding
authors.15,16
70
56.8 (15)
32:38
58
2
1
2
1
3
(82)
(2.8)
(1.4)
(2.8)
(1.4)
(4.3)
3 (4.3)
3
25
13
15
14
(4.3)
(35.7)
(18.5)
(21.5)
(20)
Control
40
42 (12)
20:20
36 (90)
1 (2.5)
1 (2.5)
2 (5)
40 (100)
Internal consistency
(Cronbach a)
Domain
Urinary symptoms
Body pain
General health
Work performance
Global QoL
Week 1
Week 4
0.82
0.73
0.77
0.70
N.A.
0.85
0.73
0.85
0.60
N.A.
Testretest
reliability
Spearman
correlation
coefficient p-Value
0.64
0.62
0.63
0.47
0.66
0.0001
0.0001
0.0001
0.014
0.0001
239
used to compare scores with the stent in situ and after removal (sensitivity to change) and the results of patients
at week 4 with those of the healthy group (discriminant
validity).
Data were collected and analyzed under the supervision of
a statistician member of the Iberoamerican Cochrane Centre
at Barcelona; the software SPSS 20.0 for Windows (SPSS,
Chicago, IL) was used for the study purposes and results were
two-sided with p < 0.05.
Results
The demographic characteristics are shown in Table 1. A
total of 70 patients completed all the questionnaires; 8 patients
dropped out of the study because of consent form retrieved
(n = 4), detection of malignancy (n = 1), recurrent acute urinary
retention during the observation period (n = 1), displacement
of the stent (n = 1), and lost to follow-up before completion of
the study (n = 1).
In eight (11%) cases, a small number (1 to 4) of unanswered
questions were detected; the missing data were uniformly
distributed throughout the domains. No entire domains remained unanswered.
Only a small proportion of the study population were
sexually active [n = 15 (21.4%) at week 1 and n = 18 (25.75%) at
week 4 with the stent in situ] when compared with n = 37 after
stent removal.
Although this clearly indicates difficulty with sexual
function with the stent in situ, the results of the statistical
analysis might not be reliable because of small numbers and
hence were omitted from presentation in the final draft.
Reliability and validity
Internal consistency was high for the urinary symptoms and
body pain domains, and satisfactory for general health and
work performance domains (Table 2), both at weeks 1 and 4.
Test-retest reliability was always significant for all the domains compared at weeks 1 and 4, with weaker Spearman
correlation coefficients recorded for body pain and work
performance domains.
Similarly, test-retest reliability was significant for all the
domains in the control group, including also the sexual matter
domain, which was applicable because all the subjects were
sexually active (Spearman correlation coefficient 0.71, p 0.0001).
Domain structure and convergent validity
Most USSQ domains showed moderate correlations with
each other (Table 3).
For the convergent validity, when comparing the USSQ
urinary symptom domains with the ICIQ male and female
Urinary symptom
Body pain
General health
Work performance
Global QoL
QoL = qualify of life.
Urinary symptom
Body pain
General health
Work performance
Global QoL
1.00/1.00
0.34/0.60
0.45/0.51
0.26/0.14
0.50/0.49
1.00/1.00
0.35/0.51
0.53/0.31
0.26/0.32
1.00/1.00
0.27/0.20
0.29/0.41
1.00/1.00
0.27/0.20
1.00/1.00
240
SANGUEDOLCE ET AL.
Table 4. Convergent Validity
0.40
0.41
0.16
0.014
0.012
0.36
0.65
0.35
0.57
0.0001
0.047
0.0001
0.53
0.51
0.49
0.001
0.003
0.006
0.70
0.47
0.43
0.0001
0.007
0.013
0.54
0.001
0.44
0.013
0.52
- 0.41
0.0001
0.001
0.62
- 0.58
0.0001
0.0001
Cases (week 4
with stent)
Controls
p-Value
score (IQR)
27 (2334)
19 (1722)
14 (10.517.5)
7 (69)
16 (1317)
0
7 (69.5)
3 (33)
0.0001
0.0001
0.0001
0.004
29
19.5
13
6
5
(2334)
(1523)
(1016.5)
(39)
(46)
Week 4
27
19
14
7
4
(2334)
(1722)
(10.517.5)
(69)
(44)
Week 1 vs
4 poststent
Week 4 vs
4 poststent
19 (1622)
0
9 (712)
3 (34)
1.5 (12)
0.0001
0.0001
0.003
0.0004
0.0001
0.0001
0.0001
0.0001
0.001
0.0001
241
Finally, the absence of any problem with reading or comprehension of the text by overseas patients recruited in our
study suggests the suitability of our Spanish USSQ for use in
any Spanish-speaking country of the world.
Conclusion
The Spanish version of the USSQ is a reliable and robust
instrument that can be self-administered by Spanishspeaking patients worldwide to investigate the impact of
ureteral stents in different clinical aspects. Validation in
other languages would be useful to increase the worldwide
population of patients undergoing the placement of a ureteral stent who could be evaluated for clinical and research
purposes.
Copies of the questionnaire are available from the authors
on request.
Acknowledgments
The authors wish to sincerely thank Dr. Gianluca Giannarini (University of Udine) for his advice on study design;
Mrs. Dorothy Mulvey for the bilingual translation and
linguistic support; Prof. Francisco Rico (Real Academia
Espanola) for the linguistic revision of the Spanish USSQ;
Dr. Ignasi Gich (Iberoamerican Cochrane Centre, Barcelona)
for statistical support.
Disclosure Statement
No competing financial interests exist.
References
1. Chew BH, Knudsen BE, Denstedt JD. The use of stents in
contemporary urology. Curr Opin Urol 2004;14:111115.
2. Joshi HB, Stainthorpe A, MacDonagh RP, et al. Indwelling
ureteral stents: Evaluation of symptoms, quality of life and
utility. J Urol 2003;169:10651069.
3. Davenport K, Kumar V, Collins J, et al. New ureteral stent
design does not improve patient quality of life: A randomized, controlled trial. J Urol 2011;185:175178.
4. Yakoubi R, Lemdani M, Monga M, et al. Is there a role for
alpha-blockers in ureteral stent related symptoms? A systematic review and meta-analysis. J Urol 2011;186:928934.
5. Park SC, Jung SW, Lee JW, Rim JS. The effects of tolterodine
extended release and alfuzosin for the treatment of double-j
stent-related symptoms. J Endourol 2009;23:19131917.
6. Joshi HB, Newns N, Stainthorpe A, et al. Ureteral stent
symptom questionnaire: Development and validation of a
multidimensional quality of life measure. J Urol 2003;169:
10601064.
7. Lee C, Kuskowski M, Premoli J, et al. Randomized evaluation of Ureteral Stents using validated Symptom Questionnaire. J Endourol 2005;19:990993.
8. Giannarini G, Keeley FX Jr, Valent F, et al. Predictors of
morbidity in patients with indwelling ureteric stents: Results
of a prospective study using the validated Ureteric Stent
Symptoms Questionnaire. BJU Int 2011;107:648654.
9. Lamb AD, Vowler SL, Johnston R, et al. Meta-analysis
showing the beneficial effect of alpha-blockers on ureteric
stent discomfort. BJU Int 2011;108:18941902.
10. Deliveliotis C, Chrisofos M, Gougousis E, et al. Is there a role
for alpha1-blockers in treating double-J stent-related symptoms? Urology 2006;67:3539.
242
11. Ritter M, Krombach P, Knoll T, et al. Initial experience with a
newly developed antirefluxive ureter stent. Urol Res 2012;
40:349353.
12. Shao Y, Zhuo J, Sun XW, et al. Nonstented versus routine stented ureteroscopic holmium laser lithotripsy:
A prospective randomized trial. Urol Res 2008;36:259
263.
13. Giannarini G, Keeley, FX Jr, Valent F, et al. The Italian linguistic validation of the ureteral stent symptoms questionnaire. J Urol 2008;180:624628.
14. Park J, Shin DW, You C, et al. Cross-cultural application of
the Korean version of Ureteral Stent Symptoms Questionnaire. J Endourol 2012;26:15181522.
15. Badia X, Roset M, Montserrat S, et al. [The Spanish version
of EuroQol: A description and its applications. European
Quality of Life scale]. (Spa) Med Clin (Barc) 1999;
112(suppl 1):7985.
16. Abrams P, Avery K, Gardener N, Donovan J. The International Consultation on Incontinence Modular Questionnaire:
www.iciq.net. J Urol 2006;175:10631066.
17. Vega Vega A, Garcia Alonso D, Garcia Alonso CJ. [Characterization of urinary tract symptoms and quality of life in
patients with double-pig-tailed ureteral stents]. (Spa) Actas
Urol Esp 2007;31:738742.
18. Lewis MP, Simons GF, Fennig CD, eds. Ethnologue: Languages of the World. 17th ed.. SIL International, 2013.
SANGUEDOLCE ET AL.
19. Welles E. Foreign language enrollments in United Stated
Institution of Higher Education. Fall 2002. ADFL Bulletin
2004;35.23:7.
Abbreviations Used
EuroQoL European quality of life
ICIQ FLUTS International Consultation on Incontinence
Questionnaire Female Lower Urinary Tract
Symptoms Module
ICIQ MLUTS International Consultation on Incontinence
Questionnaire Male Lower Urinary Tract
Symptoms Module
QoL quality of life
USSQ Ureteral Stent Symptom Questionnaire
VAS visual analogue scale
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