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Matthew J. Jackson a,*, John Sciberras b, Altaf Mangera c, Andrew Brett d, Nick Watkin d,
James M.O. N’Dow e, Christopher R. Chapple c, Daniela E. Andrich b, Robert S. Pickard f,
Anthony R. Mundy b
a
Department of Urology, Newcastle upon Tyne NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK
b
Institute of Urology, University College London Hospital, London, UK
c
Department of Urology, Royal Hallamshire Hospital, Sheffield, UK
d
Department of Urology, St. George’s Hospital, London, UK
e
Academic Urology Unit, University of Aberdeen, Aberdeen, UK
f
Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
Article history: Background: A systematic literature review did not identify a formally validated patient-
Accepted March 1, 2011 reported outcome measure (PROM) for urethral stricture surgery.
Published online ahead of Objective: Devise a PROM for urethral stricture surgery and evaluate its psychometric
properties in a pilot study to determine suitability for wider implementation.
print on March 11, 2011
Design, setting, and participants: Constructs were identified from existing condition-specific
and health-related quality of life (HRQoL) instruments. Men scheduled for urethroplasty were
Keywords:
prospectively enrolled at five centres.
Urethral stricture Intervention: Participants self-completed the draft PROM before and 6 mo after surgery.
Urethral surgery Measurements: Question sets underwent psychometric assessment targeting criterion and
Urethroplasty content validity, test-retest reliability, internal consistency, acceptability, and responsiveness.
Outcome assessment (health Results and limitations: A total of 85 men completed the preoperative PROM, with 49 also
care) completing the postoperative PROM at a median of 146 d; and 31 the preoperative PROM twice at a
Quality of life median interval of 22 d for test-retest analysis. Expert opinion and patient feedback supported
Patient-reported outcome content validity. Excellent correlation between voiding symptom scores and maximum flow rate
(r = 0.75), supported by parallel improvements in EQ-5D visual analogue and time trade-off
measure
scores, established criterion validity. Test-retest intraclass correlation coefficients ranged from
0.83 to 0.91 for the total voiding score and 0.93 for the construct overall; Cronbach’s a was 0.80,
ranging from 0.76 to 0.80 with any one item deleted. Item-total correlations ranged from 0.44 to
0.63. These values surpassed our predefined thresholds for item inclusion. Significant improve-
ments in condition-specific and HRQoL components following urethroplasty demonstrated
responsiveness to change ( p < 0.0001). Wider implementation and review of the PROM will
be required to establish generalisability across different disease states and for more complex
interventions.
Conclusions: This pilot study has defined a succinct, practical, and psychometrically robust
PROM designed specifically to quantify changes in voiding symptoms and HRQoL following
urethral stricture surgery.
# 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
* Corresponding author. Department of Urology, Freeman Hospital, Newcastle upon Tyne, NE7 7DN,
United Kingdom. Tel. +44 0 191 233 6161; Fax: +44 0 191 213 7127.
E-mail address: matthewjackson@me.com (M.J. Jackson).
0302-2838/$ – see back matter # 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2011.03.003
EUROPEAN UROLOGY 60 (2011) 60–68 61
[()TD$FIG]
Fig. 1 – Scatter plot of lower urinary tract symptoms (LUTS) score versus
maximum flow rate (Qmax).
Table 1 – Correlation statistics for lower urinary tract symptoms 3.1.5. Responsiveness
score versus maximum flow rate Total LUTS scores decreased from a median (mean) of 12
Pearson r Two-tailed p 95% CI (11.8) preoperatively to 1 (3.0) postoperatively ( p < 0.0001;
95% CI, 6.8–11.5; Table 3 and Fig. 3). Peeling’s stream
Preoperative LUTS vs Qmax 0.82 0.0002 0.94 to 0.52
picture scores followed a similar pattern: median (mean)
Postoperative LUTS vs Qmax 0.65 0.0091 0.87 to 0.20
All LUTS vs Qmax 0.75 <0.0001 0.88 to 0.54 scores fell from 4 (3.7) preoperatively to 2 (1.8) postopera-
tively ( p < 0.0001, 95% CI, 1.3–2.1; Fig. 4). These figures
CI = confidence interval; LUTS = lower urinary tract symptoms; Qmax =
corroborate a 1 scale point improvement in the Likert-
maximum flow rate.
type condition-specific QoL question in 37 of 49 men (76%);
EUROPEAN UROLOGY 60 (2011) 60–68 63
Construct Item Preoperative mean Postoperative mean p Mean of differences 95% CI of mean of differences
[()TD$FIG] [()TD$FIG]
piloting in an appropriate patient cohort before and after symptomatic and clinical outcomes in men undergoing
surgery; and abbreviated psychometric testing. We also urethroplasty. They found that AUA-7 scores fell markedly
predefined statistical thresholds for the psychometric after surgery, which correlated with Qmax and urethro-
properties of responsiveness to change, acceptability to graphic appearance indicating criterion validity and sensi-
patients, content and criterion validity, test-retest reliabili- tivity to change [23]. A subsequent study reported good
ty, and internal consistency [21,22]. correlation between total AUA-7 scores and Qmax as
For routine clinical use, PROM questionnaires should preoperative measures of disease severity [24]. We elected
remain concise and focused to encourage uptake and to use the ICIQ MLUTS voiding construct because it
clear-cut analysis, and only items pertaining to patient- incorporates hesitancy and postmicturition dribble as
centred benefit should be included. In this study clinician and additional domains, both of which patients identified as
patient opinion substantiated baseline psychometric analy- important and both of which performed well in psycho-
sis, indicating that items tackling storage LUTS, sexual metric testing. Kessler et al provided further evidence of the
function, and cosmesis were not of prime importance, and need for a urethral stricture surgery PROM in 2002 by
on this basis they were not included in the final PROM. reporting clear discordance between clinician- and patient-
Broader implementation and appraisal may ultimately reported success in 20% of 267 men following urethroplasty
testify to their importance in specific disease states such [25]. This study lacks preoperative data, however, and men
as men requiring complex reconstruction of the distal penile were surveyed at varying intervals from 2 to 8 yr after
urethra. And although the generic HRQoL measure should surgery. In our study all patients completed the postopera-
have captured severe deleterious effects, bolt-on constructs tive questionnaire at the same predefined and clinically
addressing sexual function and cosmesis may be required. relevant time interval [1].
The identification of relevant existing validated instru-
ments meant that extensive field testing of novel items 5. Conclusions
generated through work with focus groups of men with
urethral strictures was not needed. Our more restricted This study demonstrates that it is feasible to construct a
approach, comprising semistructured interviews with robust PROM within a short time frame by identifying and
patients and clinicians together with quantification of reevaluating constructs from existing patient-completed
changes following urethroplasty, rapidly established that instruments. The next step will involve broader deployment
the chosen question sets fulfilled criteria for suitability as a and review to establish generalisability across interventions
PROM for this group of patients. A potential drawback is and health care systems.
neglecting other causes of voiding symptoms, such as
benign prostatic enlargement (BPE), when they coexist with Author contributions: Matthew J. Jackson had full access to all the data in
a urethral stricture. Men in this study did not have evidence the study and takes responsibility for the integrity of the data and the
of symptomatic BPE before surgery and gained a high accuracy of the data analysis.
degree of benefit from urethroplasty, making concurrent
Study concept and design: Mundy, Pickard, Andrich, Chapple, Watkin,
occult BPE unlikely. Jackson, Sciberras, N’Dow.
We elected to pilot the prototype PROM in a group of men Acquisition of data: Sciberras, Jackson, Mangera, Brett.
with the most common disease location (anterior urethra) Analysis and interpretation of data: Jackson, Sciberras, Pickard, Mundy.
who were undergoing an intervention (urethroplasty) with a Drafting of the manuscript: Jackson, Sciberras, Pickard, Mundy, Andrich.
high likelihood of benefit at the preset postoperative Critical revision of the manuscript for important intellectual content:
measurement time point of 6 mo. This standardisation was Jackson, Sciberras, Mangera, Watkin, N’Dow, Chapple, Andrich, Pickard,
necessary to establish psychometric validity and reliability. Mundy.
Statistical analysis: Jackson, Sciberras.
The size of the patient sample was governed partly by
Obtaining funding: None.
estimates based on previous studies [23] and partly by
Administrative, technical, or material support: None.
statistical thresholds that established when each desired
Supervision: Pickard, Mundy, Andrich.
psychometric property had been achieved. Once these Other (specify): None.
conditions had been met it was not necessary to continue
data collection, and for this reason the sample size varies Financial disclosures: I certify that all conflicts of interest, including
according to the property being tested. specific financial interests and relationships and affiliations relevant to the
subject matter or materials discussed in the manuscript (eg, employment/
Wide-scale deployment of this PROM will allow stratifi-
affiliation, grants or funding, consultancies, honoraria, stock ownership or
cation of outcomes according to a spectrum of factors
options, expert testimony, royalties, or patents filed, received, or pending),
including but not limited to patient age, comorbidity, and
are the following: Matthew J. Jackson has received financial support from
body mass index; stricture length and location; and surgical the UK Government National Institute for Health Research.
competence. The performance of this PROM in the context
of various interventions such as urethrotomy and other Funding/Support and role of the sponsor: None.
types of urethroplasty deserves further assessment.
Acknowledgement statement: We thank Dr. Tom Chadwick, clinical trials
Systematic literature review did not identify any statistician at Newcastle University, who advised our selection of the
previous studies defining a validated PROM for urethral statistical tests used in this study. We thank the International
stricture disease. Morey et al used the American Urological Consultation on Incontinence Modular Questionnaire Advisory Board
Association (AUA)-7 questionnaire in 1998 to compare [26] and EuroQoL for the use of specific question sets.
EUROPEAN UROLOGY 60 (2011) 60–68 65
Appendix A
Thank you for completing this questionnaire. The following questions are designed to measure the effect that urethral
strictures have on patients’ lives.
Some questions may look the same but each one is different. Please take time to read and answer each question carefully,
and tick the box that best describes your symptoms over the past 4 weeks.
If you currently have a urethral or suprapubic catheter (a catheter through the lower abdomen) please start at page 4.
2 Would you say that the strength of your urinary stream is…
Normal
Occasionally reduced
Sometimes reduced
Reduced most of the time
Reduced all of the time
4 Do you stop and start more than once while you urinate?
Never
Occasionally
Sometimes
Most of the time
All of the time
5 How often do you feel your bladder has not emptied properly after you have urinated?
Never
Occasionally
Sometimes
Most of the time
All of the time
6 How often have you had a slight wetting of your pants a few minutes after you had
finished urinating and had dressed yourself?
Never
Occasionally
Sometimes
Most of the time
All of the time
66 EUROPEAN UROLOGY 60 (2011) 60–68
7 Overall, how much do your urinary symptoms interfere with your life?
Not at all
A little
Somewhat
A lot
8 Please ring the number that corresponds with the strength of your urinary stream over
the past month.
Which is it?
4 3 2 1
(From Peeling 1989)
By placing a tick in one box in each group below, please indicate which
statements best describe your own health state today.
Mobility
I have no problems in walking about
I have some problems in walking about
I am confined to bed
Self-Care
I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself
EUROPEAN UROLOGY 60 (2011) 60–68 67
Pain/Discomfort
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort
Anxiety/Depression
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed
Best
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