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Measure PDF
Measure PDF
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Department of Urology, Newcastle upon Tyne NHS Foundation Trust, Freeman Hospital, 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: [email protected] (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
1.
Introduction
61
derived from the International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ MLUTS) module [15,16] to
2.2.
Patients
2.3.
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.
2.1.
Selection of constructs
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].
3.
Results
62
[()TD$FIG]
Q1
Q2
Q3
Q4
Q5
Q6
Item-total
correlation
0.85
0.91
0.87
0.88
0.83
0.89
0.52
0.54
0.61
0.63
0.61
0.44
Cronbachs a with
item deleted
0.78
0.78
0.76
0.76
0.76
0.80
[()TD$FIG]
Fig. 1 Scatter plot of lower urinary tract symptoms (LUTS) score versus
maximum flow rate (Qmax).
3.1.
Psychometric evaluation
3.1.1.
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
Internal consistency
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
Test-retest reliability
Responsiveness
63
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
[()TD$FIG]
[()TD$FIG]
[()TD$FIG]
Discussion
64
Conclusions
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
66
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)
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
67
Best
imaginable
health state
100
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Your own
health state
today
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0
Worst
imaginable
health state
68
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