EUROPEAN UROLOGY 60 (2011) 6068

available at www.sciencedirect.com
journal homepage: www.europeanurology.com

Platinum Priority Reconstructive Urology

Editorial by Guido Barbagli and Massimo Lazzeri on pp. 6971 of this issue

Defining a Patient-Reported Outcome Measure for Urethral

Stricture Surgery
Matthew J. Jackson a,*, John Sciberras b, Altaf Mangera c, Andrew Brett d, Nick Watkin d,
James M.O. NDow 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

Institute of Urology, University College London Hospital, London, UK

Department of Urology, Royal Hallamshire Hospital, Sheffield, UK

Department of Urology, St. Georges Hospital, London, UK

Academic Urology Unit, University of Aberdeen, Aberdeen, UK

Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK

Article info

Abstract

Article history:
Accepted March 1, 2011
Published online ahead of
print on March 11, 2011

Background: A systematic literature review did not identify a formally validated patientreported outcome measure (PROM) for urethral stricture surgery.
Objective: Devise a PROM for urethral stricture surgery and evaluate its psychometric
properties in a pilot study to determine suitability for wider implementation.
Design, setting, and participants: Constructs were identied from existing condition-specic
and health-related quality of life (HRQoL) instruments. Men scheduled for urethroplasty were
prospectively enrolled at ve centres.
Intervention: Participants self-completed the draft PROM before and 6 mo after surgery.
Measurements: Question sets underwent psychometric assessment targeting criterion and
content validity, test-retest reliability, internal consistency, acceptability, and responsiveness.
Results and limitations: A total of 85 men completed the preoperative PROM, with 49 also
completing the postoperative PROM at a median of 146 d; and 31 the preoperative PROM twice at a
median interval of 22 d for test-retest analysis. Expert opinion and patient feedback supported
content validity. Excellent correlation between voiding symptom scores and maximum ow rate
(r = 0.75), supported by parallel improvements in EQ-5D visual analogue and time trade-off
scores, established criterion validity. Test-retest intraclass correlation coefcients ranged from
0.83 to 0.91 for the total voiding score and 0.93 for the construct overall; Cronbachs 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 predened thresholds for item inclusion. Signicant improvements in condition-specic 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 dened a succinct, practical, and psychometrically robust
PROM designed specically to quantify changes in voiding symptoms and HRQoL following
urethral stricture surgery.

Keywords:
Urethral stricture
Urethral surgery
Urethroplasty
Outcome assessment (health
care)
Quality of life
Patient-reported outcome
measure

# 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) 6068

1.

Introduction

61

derived from the International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ MLUTS) module [15,16] to

Patient-reported outcome measures (PROMs) are health

questionnaires that patients complete before and after an
intervention to determine whether their symptoms or
health-related quality of life (HRQoL) have changed [1,2].
PROMs indicate patient-perceived benefit from surgery and
are necessary for preoperative patient counselling, performance benchmarking, and resource allocation [3], as
emphasised in health care policy statements by the UK
and US governments [4,5].
Urethral stricture disease is a common and recurring
condition that affects approximately 300 per 100 000 men
[6]. Surgical interventions, including urethral dilatation,
endoscopic urethrotomy, and urethroplasty, aim to return
patients to a state of normal voiding. A recent Cochrane
review [7] identified only two direct comparative studies of
these options, both of which employed clinician-driven
outcome measures such as time to recurrence or change in
maximum flow rate (Qmax) to gauge success. A robust PROM
will allow urologic surgeons to measure directly the benefit
that patients derive from their interventions and facilitate
comparative studies of effectiveness.
A systematic literature review failed to identify a
condition-specific PROM sufficiently robust for use in
urethral stricture surgery [8]. Therefore we set out to
define a pragmatic instrument and pilot it in a group of men
undergoing urethroplasty. Aims of this study were to
identify transferable question sets from existing validated
instruments, to reevaluate their psychometric properties
against an established checklist [9,10], and to refine the
content of the draft PROM in a stepwise fashion to produce a
final version ready for widespread implementation and
further review.

generate a total score between 0 (asymptomatic) and 24 (most

symptomatic); a separate LUTS-specic quality-of-life (QoL) question
from the ICIQ MLUTS (Appendix A, Q7); and Peelings voiding picture [17]
(Appendix A, Q8). The EQ-5D [18] was included to assess overall HRQoL.
The postoperative PROM is supplemented with two further questions
addressing overall patient satisfaction (Appendix A, Q9 and 10).

2.2.

Patients

Men scheduled for bulbar or one- or two-stage penile urethroplasty

were identied from ve specialist urology centres. We asked them
to self-complete the draft PROM preoperatively and 46 mo following
one-stage or the second stage of a two-stage urethroplasty. Patients
completed the paper questionnaire unaided, and anonymised responses
were collated in an online database.
We estimated that 40 participants were required to complete both the
pre- and postoperative PROM at 6 mo to establish responsiveness [19] and
that 30 patients were required to test-retest the questionnaire to establish
reliability. To ensure these numbers were achieved allowing for a 6-mo
follow-up lead time, we recruited 85 men, all of whom completed the
preoperative PROM for assessment of internal consistency.

2.3.

Psychometric criteria for evaluation of patient-reported

outcome measures
Validity is the degree to which the content of a questionnaire covers the
conceptual domain it intends to measure. Content validity was assessed
in rounds of expert consensus meetings, document circulation, patient
interviews, and by identifying areas of missing response data and
criterion validity by correlating LUTS construct scores with Qmax and
overall satisfaction.
Test-retest reliability is a questionnaires ability to be stable or
reproducible with time. Thirty-one men agreed to complete the draft
PROM twice preoperatively for test-retest analysis. Agreement was
assessed using Bland-Altman plots [20] and intraclass correlation
coefcients (ICCs); an ICC >0.70 was the predened threshold for

2.

Patients and methods

2.1.

Selection of constructs

A group of UK urethral surgeons convened to identify symptoms

reported by men with anterior urethral stricture disease which are
expected to improve following surgery. We identied relevant validated
English-language question sets, symptom and bother scores, and HRQoL
measures from two online resources [11,12]. We began with a set of
constructs that encompassed voiding, postmicturition, and storage
lower urinary tract symptoms (LUTS); sexual and ejaculatory function;

inclusion [21,22].
Internal consistency is the extent to which question items within the
same construct measure the same conceptual domain and thus whether
it is valid to sum those item scores. Cronbachs a statistics and item-total
correlations were employed to assess the interrelationship between
question items within the LUTS construct (Appendix A, Q16). We
predened values >0.70 and 0.20, respectively, as thresholds for
acceptability [13,19,21,22].
Responsiveness was addressed by examining LUTS and HRQoL
construct scores before and after urethroplasty for statistically signicant changes using the paired Student t test [22].

and symptom-specic and generic HRQoL measures. We went on to

rene this long list in consensus-building meetings of the clinician group

3.

Results

according to patients views elicited in semistructured interviews.

Patients and clinicians agreed that questions targeting storage LUTS
were not of specic importance in describing the expected benets of
urethral stricture treatment. Similarly, questions relating to sexual
function were insensitive to change owing to a low baseline incidence
and lack of deterioration following urethroplasty. Following this
elimination process we dened an item-reduced PROM comprising
voiding and postmicturition LUTS, together with condition-specic and
generic HRQoL measures, which was interrogated according to welldescribed psychometric techniques [9,10,13,14].
The nal urethral surgery PROM (Appendix A) comprises a LUTS
construct consisting of six summative questions (Appendix A, Q16)

A total of 85 men (median age: 42.5 yr; range: 1672 yr)

enrolled in this study: 68 (80%) underwent a one-stage
bulbar procedure and 17 (20%) a one- or two-stage penile
urethroplasty. Forty-nine men completed both the pre- and
postoperative PROM at a median interval of 146 d following
completion of their urethroplasty. Thirty-six men completed the preoperative PROM but were awaiting surgery when
interim psychometric analysis confirmed that preset
significance levels had been achieved, and thus they were
not asked to complete the postoperative PROM.

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EUROPEAN UROLOGY 60 (2011) 6068

[()TD$FIG]

Table 2 Reliability statistics for six-question summative lower

urinary tract symptoms construct
ICC

Q1
Q2
Q3
Q4
Q5
Q6

Item-total
correlation

0.85
0.91
0.87
0.88
0.83
0.89

0.52
0.54
0.61
0.63
0.61
0.44

Cronbachs a with
item deleted
0.78
0.78
0.76
0.76
0.76
0.80

ICC = intraclass correlation coefcient.

[()TD$FIG]
Fig. 1 Scatter plot of lower urinary tract symptoms (LUTS) score versus
maximum flow rate (Qmax).

3.1.

Psychometric evaluation

3.1.1.

Content validity and acceptability

Contemporary expert opinion, consensus-building meetings of the research group, patient interviews, and literature
review strongly supported the content validity of the PROM.
For every question item we encountered a nonresponse rate
of 1%, and nonresponses were distributed across the
question items such that no one item could be identified as
weak, indicating acceptability to patients.
3.1.2.

Criterion validity

Uroflowmetry with a purposively sampled heterogeneous

subgroup of 15 patients established strong negative
correlation between Qmax and total voiding LUTS scores
both pre- and postoperatively (Fig. 1 and Table 1). We
encountered a ceiling effect in the postoperative data; 7 of
15 men (47%) were asymptomatic (score zero) following
urethroplasty. Forty-seven of 49 men (96%) who completed
the postoperative questionnaire reported being satisfied or
very satisfied with the outcome of their operation, 38 of
whom (81%) felt their residual voiding symptoms interfered
with their HRQoL a little or not at all.
3.1.3.

Internal consistency

For the summative LUTS voiding construct (Appendix A,

Q16), Cronbachs a was 0.80 and ranged from 0.76 to 0.80
with any one item deleted. Item-total correlations were

Table 1 Correlation statistics for lower urinary tract symptoms

score versus maximum flow rate
Pearson r
Preoperative LUTS vs Qmax
Postoperative LUTS vs Qmax
All LUTS vs Qmax

0.82
0.65
0.75

Two-tailed p
0.0002
0.0091
<0.0001

95% CI
0.94 to 0.52
0.87 to 0.20
0.88 to 0.54

CI = condence interval; LUTS = lower urinary tract symptoms; Qmax =

maximum ow rate.

Fig. 2 Bland-Altman plot of test-retest lower urinary tract symptoms

(LUTS) scores. The difference between test and retest scores is plotted
against the test-retest average (mean) for each patient. Plots are
interpreted qualitatively. In this case variability remains consistent as
average LUTS scores increase, and the average difference between test
and retest scores (bias) is small (0.11). For future measurements the
difference between test and retest scores should lie between the limits of
agreement (+6 to S6) 95% of the time.

similarly high: Pearson correlation coefficients between any

one item and the total score of the remaining items ranged
from 0.44 to 0.61 (Table 2).
3.1.4.

Test-retest reliability

The median test-retest interval was 22 d, which was

expected to be too short a period for individual patients
disease to progress appreciably. For the summative LUTS
voiding construct (scored 024), 95% limits of agreement
were between +6 and 6 with a bias of 0.11 (standard
deviation of bias: 3.2) (Fig. 2). ICCs ranged from 0.83 to 0.91
for each of the LUTS question items (Table 2) and 0.93 (95%
confidence interval [CI], 0.870.96) for the total scores, all of
which exceeded our predefined threshold of 0.70.
3.1.5.

Responsiveness

Total LUTS scores decreased from a median (mean) of 12

(11.8) preoperatively to 1 (3.0) postoperatively ( p < 0.0001;
95% CI, 6.811.5; Table 3 and Fig. 3). Peelings stream
picture scores followed a similar pattern: median (mean)
scores fell from 4 (3.7) preoperatively to 2 (1.8) postoperatively ( p < 0.0001, 95% CI, 1.32.1; Fig. 4). These figures
corroborate a 1 scale point improvement in the Likerttype condition-specific QoL question in 37 of 49 men (76%);

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EUROPEAN UROLOGY 60 (2011) 6068

Table 3 Responsiveness statistics for constructs generating a numerical score

Construct

Item

Preoperative mean

6-Q LUTS

Q1
Q2
Q3
Q4
Q5
Q6
Q8
EQVAS
TTO

1.60
2.91
2.00
2.02
2.07
1.31
3.57
71
0.77

Peeling
EQ-5D

Postoperative mean

0.58
0.42
0.39
0.47
0.43
0.82
1.81
81
0.87

<0.0001
<0.0001
<0.0001
<0.0001
<0.0001
0.07
<0.0001
0.0006
0.003

Mean of differences
1.09
2.61
1.61
1.61
1.61
0.48
1.69
10
0.10

95% CI of mean of differences

0.601.59
2.113.12
1.102.11
1.132.08
1.112.20
0.051.00
1.332.05
415
0.170.03

CI = condence interval; LUTS = lower urinary tract symptoms.

[()TD$FIG]

[()TD$FIG]

Fig. 3 Pre- versus postoperative lower urinary tract symptoms scores

(mean and 95% confidence interval).
Fig. 5 Pre- versus postoperative EQ-5D visual analogue scores (EQVAS)
scores (mean and 95% confidence interval).

2 scale point improvement in 20 men (41%), and a 3 scale

point improvement in 9 men (18%).
EQ-5D visual analogue scores improved from a preoperative median (mean) of 80 (71) to 90 (81) postoperatively ( p
= 0.0006; 95% CI of the mean of difference, 414; Table 3 and
Fig. 5). EQ-5D time trade-off (TTO) scores were calculated
from UK-weighted value sets corresponding to one of 243
possible five-digit health states generated by EQ-5D.
Following urethroplasty, TTO scores improved from a mean

[()TD$FIG]

Fig. 4 Pre- versus postoperative picture scores (mean and 95%

confidence interval).

of 0.77 preoperatively to 0.87 postoperatively ( p = 0.003;

95% CI of the mean of the difference, 0.040.18).
4.

Discussion

Interventions targeting urethral strictures aim to improve

symptoms and reduce risk of recurrence. Their success
should be measured in transparent and transferable terms
that testify to the benefit conferred to an individual patient
and allow comparisons of clinical and cost effectiveness
between surgeons, competing surgical procedures, and
health care providers [2]. Recurrence rate, Qmax, and
urethrography are the established clinician-orientated measures, but a validated tool designed to measure patientreported benefit from urethral stricture surgery was lacking.
In this study we defined a fit-for-purpose PROM for
urethral stricture surgery by mapping constructs from
existing instruments designed for symptomatically related
conditions. We have demonstrated in a pilot study
involving men undergoing urethroplasty for anterior
urethral strictures that the resultant tool is valid and
reliable according to established psychometric criteria.
The development process followed in our study adheres
to the key phases of: identification of relevant content from
expert opinion, literature review, and patient feedback;

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EUROPEAN UROLOGY 60 (2011) 6068

piloting in an appropriate patient cohort before and after

surgery; and abbreviated psychometric testing. We also
predefined statistical thresholds for the psychometric
properties of responsiveness to change, acceptability to
patients, content and criterion validity, test-retest reliability, and internal consistency [21,22].
For routine clinical use, PROM questionnaires should
remain concise and focused to encourage uptake and
clear-cut analysis, and only items pertaining to patientcentred benefit should be included. In this study clinician and
patient opinion substantiated baseline psychometric analysis, indicating that items tackling storage LUTS, sexual
function, and cosmesis were not of prime importance, and
on this basis they were not included in the final PROM.
Broader implementation and appraisal may ultimately
testify to their importance in specific disease states such
as men requiring complex reconstruction of the distal penile
urethra. And although the generic HRQoL measure should
have captured severe deleterious effects, bolt-on constructs
addressing sexual function and cosmesis may be required.
The identification of relevant existing validated instruments meant that extensive field testing of novel items
generated through work with focus groups of men with
urethral strictures was not needed. Our more restricted
approach, comprising semistructured interviews with
patients and clinicians together with quantification of
changes following urethroplasty, rapidly established that
the chosen question sets fulfilled criteria for suitability as a
PROM for this group of patients. A potential drawback is
neglecting other causes of voiding symptoms, such as
benign prostatic enlargement (BPE), when they coexist with
a urethral stricture. Men in this study did not have evidence
of symptomatic BPE before surgery and gained a high
degree of benefit from urethroplasty, making concurrent
occult BPE unlikely.
We elected to pilot the prototype PROM in a group of men
with the most common disease location (anterior urethra)
who were undergoing an intervention (urethroplasty) with a
high likelihood of benefit at the preset postoperative
measurement time point of 6 mo. This standardisation was
necessary to establish psychometric validity and reliability.
The size of the patient sample was governed partly by
estimates based on previous studies [23] and partly by
statistical thresholds that established when each desired
psychometric property had been achieved. Once these
conditions had been met it was not necessary to continue
data collection, and for this reason the sample size varies
according to the property being tested.
Wide-scale deployment of this PROM will allow stratification of outcomes according to a spectrum of factors
including but not limited to patient age, comorbidity, and
body mass index; stricture length and location; and surgical
competence. The performance of this PROM in the context
of various interventions such as urethrotomy and other
types of urethroplasty deserves further assessment.
Systematic literature review did not identify any
previous studies defining a validated PROM for urethral
stricture disease. Morey et al used the American Urological
Association (AUA)-7 questionnaire in 1998 to compare

symptomatic and clinical outcomes in men undergoing

urethroplasty. They found that AUA-7 scores fell markedly
after surgery, which correlated with Qmax and urethrographic appearance indicating criterion validity and sensitivity to change [23]. A subsequent study reported good
correlation between total AUA-7 scores and Qmax as
preoperative measures of disease severity [24]. We elected
to use the ICIQ MLUTS voiding construct because it
incorporates hesitancy and postmicturition dribble as
additional domains, both of which patients identified as
important and both of which performed well in psychometric testing. Kessler et al provided further evidence of the
need for a urethral stricture surgery PROM in 2002 by
reporting clear discordance between clinician- and patientreported success in 20% of 267 men following urethroplasty
[25]. This study lacks preoperative data, however, and men
were surveyed at varying intervals from 2 to 8 yr after
surgery. In our study all patients completed the postoperative questionnaire at the same predefined and clinically
relevant time interval [1].
5.

Conclusions

This study demonstrates that it is feasible to construct a

robust PROM within a short time frame by identifying and
reevaluating constructs from existing patient-completed
instruments. The next step will involve broader deployment
and review to establish generalisability across interventions
and health care systems.
Author contributions: Matthew J. Jackson had full access to all the data in
the study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Mundy, Pickard, Andrich, Chapple, Watkin,
Jackson, Sciberras, NDow.
Acquisition of data: Sciberras, Jackson, Mangera, Brett.
Analysis and interpretation of data: Jackson, Sciberras, Pickard, Mundy.
Drafting of the manuscript: Jackson, Sciberras, Pickard, Mundy, Andrich.
Critical revision of the manuscript for important intellectual content:
Jackson, Sciberras, Mangera, Watkin, NDow, Chapple, Andrich, Pickard,
Mundy.
Statistical analysis: Jackson, Sciberras.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: Pickard, Mundy, Andrich.
Other (specify): None.
Financial disclosures: I certify that all conicts of interest, including
specic nancial interests and relationships and afliations relevant to the
subject matter or materials discussed in the manuscript (eg, employment/
afliation, grants or funding, consultancies, honoraria, stock ownership or
options, expert testimony, royalties, or patents led, received, or pending),
are the following: Matthew J. Jackson has received nancial support from
the UK Government National Institute for Health Research.
Funding/Support and role of the sponsor: None.
Acknowledgement statement: We thank Dr. Tom Chadwick, clinical trials
statistician at Newcastle University, who advised our selection of the
statistical tests used in this study. We thank the International
Consultation on Incontinence Modular Questionnaire Advisory Board
[26] and EuroQoL for the use of specic question sets.

EUROPEAN UROLOGY 60 (2011) 6068

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.
1 Is there a delay before you start to urinate?
Never
Occasionally
Sometimes
Most of the time
All of the time
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
3 Do you have to strain to continue urinating?
Never
Occasionally
Sometimes
Most of the time
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

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EUROPEAN UROLOGY 60 (2011) 6068

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?

1
(From Peeling 1989)

9 Are you satisfied with the outcome of your operation?

Yes, very satisfied
Yes, satisfied
No, unsatisfied
No, very unsatisfied
10 If you were unsatisfied or very unsatisfied is that because:
The urinary condition did not improve
The urinary condition improved but there was some other problem
The urinary condition did not improve and there was some other
problem as well

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) 6068

67

Usual Activities (e.g. work, study, housework, family or

leisure activities)
I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities
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

To help people say how good or bad a health state is,

we have drawn a scale (rather like a thermometer)
on which the best state you can imagine is marked
100 and the worst state you can imagine is marked 0.
We would like you to indicate on this scale how
good or bad your own health is today, in your
opinion. Please do this by drawing a line from the
box below to whichever point on the scale indicates
how good or bad your health state is today.

Best
imaginable
health state
100

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