Arlandis-Guzmán, S

Errando-Smet, C

Lizarraga, I

Rejas, J

Ruiz, MA

Villacampa-Aubá, F

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13th Euro Abstracts A479
PUK30
MAPPING THE OVERACTIVE BLADDER QUESTIONNAIRE-SHORT FORM 
(OABQ-SF) TO EQ-5D PATIENT PREFERENCES IN PATIENTS WITH 
OVERACTIVE BLADDER IN SPAIN
Villacampa-Aubá F1, Ruiz MA2, Arlandis-Guzmán S3, Errando-Smet C4, Lizarraga I5, Rejas J6
1Department of Urology, Hospital 12 de Octubre, Madrid, Spain; 2Universidad Autonoma de 
Madrid, Madrid, Spain; 3Department of Urology, Hospital Universitario La Fe, Valencia, Spain; 
4Department of Urology, Fundación Puigvert, Barcelona, Spain; 5Medical Unit, Pﬁ zer España, 
Alcobendas, Madrid, Spain; 6Pﬁ zer España, Alcobendas/Madrid, Spain
OBJECTIVES: To develop a mapping algorithm to transform the Overactive Bladder 
questionnaire-Short Form (OABq-SF) questionnaire responses into EQ-5D derived utili-
ties in patients with OAB in Spain. METHODS: The culturally adapted Spanish versions 
of OABq-SF and EQ-5D questionnaires were self-administered on two occasions 3 
months apart to a set of patients of both genders, above 18 years, diagnosed of OAB 
according with standard criteria and a score > 8 in the OAB-V8 scale and able to 
understand PRO instruments written in Spanish. Patients were recruited consecutively 
in clinics of Urology all over the country. Linear correlations between symptoms severity 
and health-related quality-of-life (HRQoL) domains of the OABq-SF and EQ-5D (VAS 
and TTO-tariffs) were computed. a combined score of both domains of OABq-SF was 
used to obtain a unique scoring per patient, although mapping was developed for both 
combined and separated punctuations of the OABq-SF using regression modelling. 
RESULTS: A total of 199 OAB patients (58.4 years, 74% women, 99% Caucasian, 
37% workers and 36% primary schooling) from 18 urological clinics were evaluated. 
Utility values ranged from 1 to 0.01; mean value = 0.7623 (SD = 0.2292) and median 
= 0.79. Correlations with EQ-5D were −0.282 and −0.301 for the severity of symptoms 
domain at baseline an after 3 months of a medical intervention, and 0.329 and 0.369 
for the HRQoL domain, respectively. Pearson coefﬁ cients for combined scoring were 
−0.331 and −0.351, respectively. All coefﬁ cients were signiﬁ cant at P < 0.001 level. 
Observed relation between utilities and combined score followed a linear although 
heterocedastic pattern. Utilities distribution was clearly positively skewed with benign 
utilities prevailing. CONCLUSIONS: Utilities values for Spanish patients with OAB 
were mostly mild to moderate in the 0–1 range. a utility map was obtained for different 
levels of scoring in the OABq-SF questionnaire, which is useful to derive Quality-
adjusted Life-year gain in economic evaluations.
PUK31
PSYCHOMETRIC VALIDATION OF THE SPANISH VERSION OF THE 
OVERACTIVE BLADDER QUESTIONNAIRE SHORT-FORM (OABQ-SF) TO 
ASSESS SEVERITY OF SYMPTOMS AND PATIENT HEALTH RELATED 
QUALITY OF LIFE IN SUBJECTS WITH OVERACTIVE BLADDER
Arlandis-Guzmán S1, Ruiz MA2, Errando-Smet C3, Villacampa-Aubá F4, García-Vargas M5, 
Arumi D6
1Department of Urology, Hospital Universitario La Fe, Valencia, Spain; 2Universidad 
Autonoma de Madrid, Madrid, Spain; 3Department of Urology, Fundación Puigvert, 
Barcelona, Spain; 4Department of Urology, Hospital 12 de Octubre, Madrid, Spain; 5Health 
Outcomes Research Department, Corporate Affairs and Market Access Unit, Pﬁ zer Spain, 
Alcobendas, Madrid, Spain; 6Pﬁ zer Inc., Madrid, Spain, Alcobendas, Madrid, Spain
OBJECTIVES: To carry out the psychometric validation of the Spanish version of the 
self-administered OABq-SF questionnaire, a tool measuring severity of symptoms and 
health-related quality of life (HRQoL) of patients with symptomatic overactive 
bladder (OAB). METHODS: The culturally adapted Spanish version of OABq-SF was 
administered on two occasions separately 3 months to a set of patients of both genders, 
above 18 years old, diagnosed of OAB according with standard criteria and a score 
> 8 in the OAB-V8 scale and able to understand PRO instruments written in Spanish. 
Patients were recruited consecutively in clinics of Urology all over the country. Feasi-
bility, internal consistency (Cronbach’s alpha), test-retest reliability, structure of 
instrument, criteria and construct validity and responsiveness were examined using 
classic test theory statistics. Minimally Important Difference (MID) was also calcu-
lated. RESULTS: Data from 199 OAB patients (58.4 years, 74% women, 99% 
Caucasian, 37% workers and 36% primary schooling) from 18 urological clinics were 
evaluated. Floor and ceiling effect ranged between 0.5% and 31.2%, and missing items 
was below 1%. Cronbach’s alphas attained 0.795 and 0.923 for severity and HRQoL 
domains. These two instrument domains showed to be one-dimensional with explained 
variances above 50% in both domains, which correlated moderately with EQ-5D 
[−0.335 and +0.405, respectively (P < 0.01 in both cases)] and with self-perceived 
general valuation symptoms of OAB. a signiﬁ cant change in OABq-SF domains scoring 
[−23.3 (−26.0; −20.6) and +17.1 (14.7; 19.5), P < 0.001 in both cases (effect sizes: 
1.34 and 1.50)] were observed after a 3-month medical intervention. MID values were, 
respectively, 6.6 and 8.1 for severity and HRQoL domains. CONCLUSIONS: The 
Spanish version of OABq-SF demonstrated strong reliability, validity and responsive-
ness psychometric properties to be used in the measurement of severity and Health-
related Quality of life symptoms of OAB.
PUK32
CONTENT VALIDITY OF A PATIENT-REPORTED URINARY URGENCY 
RATING SCALE: RESULTS OF A COGNITIVE INTERVIEW STUDY
Chen WH1, Notte S1, Marshall TS2, Lee M2, Hakimi Z3, Revicki DA1
1United BioSource Corporation, Bethesda, MD, USA; 2Astellas Pharma Global 
Development—US, Deerﬁ eld, IL, USA; 3Astellas Pharma Global Development—EU, AC 
Leiderdorp, The Netherlands
OBJECTIVES: The Patient Perception of Intensity of Urgency Scale (PPIUS) measures the 
urgency severity of urinary episodes, and was developed based on the deﬁ nition of urgency 
presented by the International Continence Society (ICS) (Abrams et al. 2002) as well as 
recommendations from the Committee for Proprietary Medical Products (CPMP) (EMA 
2002). The PPIUS is a single item scale with ﬁ ve levels of urgency severity, from “No 
urgency” to “Urge incontinence,” each with its deﬁ nition provided. While the PPIUS has 
been used in previous trials, its content validity has not been established in overactive 
bladder (OAB) patients. The objective of this study was to determine comprehensibility 
and understanding of the scale through cognitive interviews with OAB patients. 
METHODS: Forty-one OAB patients participated in a non-interventional study 
assessing reproducibility of the PPIUS by completing a three-day micturition diary 
each week for three consecutive weeks. Following successful completion of the test-
retest study, twelve participants were selected to participate in a 30-minute in-person 
interview discussing their experience with the PPIUS. Interviews were conducted by a 
trained interviewer and followed a semi-structured guide with think-aloud approach. 
RESULTS: N = 12; mean (SD) age = 61.6 (13.5) years; 66.7% Caucasian; 91.7% 
female; mean (SD) years with symptoms = 5.8 (4.6); 83.3% reported medication use 
for treatment. Nine participants found it simple to choose a PPIUS rating for each of 
their daily micturition episodes. Most agreed with the deﬁ nitions provided for the 
ratings of “No urgency” (n = 9), “Mild urgency” (n = 7), “Moderate urgency” (n = 
8), “Severe urgency” (n = 9) and “Urge incontinence” (n = 9). Three suggested distinc-
tion between daytime and nighttime episodes could be made clearer. CONCLUSIONS: 
Content validity of the PPIUS was supported by the results of the cognitive interviews. 
PPIUS was well understood and the urgency deﬁ nitions were generally accepted. 
Participants found the diary easy to complete and did not have difﬁ culty selecting their 
ratings.
PUK33
TEST-RETEST RELIABILITY AND ACCLIMATION EFFECT OF PATIENT 
PERCEPTION OF INTENSITY OF URGENCY SCALE (PPIUS) FOR 
OVERACTIVE BLADDER
Chen WH1, Notte S1, Marshall TS2, Lee M2, Hakimi Z3, Revicki DA1
1United BioSource Corporation, Bethesda, MD, USA; 2Astellas Pharma Global 
Development—US, Deerﬁ eld, IL, USA; 3Astellas Pharma Global Development—EU, AC 
Leiderdorp, The Netherlands
OBJECTIVES: A three-day micturition diary has been designed to capture information 
on the number of urinary and incontinence episodes in overactive bladder (OAB) 
patients. Within the diary is the Patient Perception of Intensity of Urgency Scale 
(PPIUS), which captures the urgency associated with each episode. The PPIUS is a 
single item with ﬁ ve levels of urgency severity: “No urgency,” “Mild urgency” “Mod-
erate urgency,” “Severe urgency,” and “Urge incontinence.” The objective of this 
study was to assess the test-retest reliability and acclimation effect of the PPIUS. 
METHODS: OAB patients were recruited from ﬁ ve sites in the US for a non-inter-
ventional two-visit study. At the Screening Visit, participants were trained on how to 
complete the three-day diary at home for three consecutive weeks. In the diary, par-
ticipants recorded the time of each micturition, a corresponding PPIUS rating, and 
whether the episode was accompanied by incontinence. Participants and clinicians 
completed overall treatment effect (OTE) questions at the Final Visit asking whether 
their bladder condition had changed since the Screening Visit. RESULTS: N = 39; 
mean age = 59.1 years; 69.2% Caucasian; 82.1% female; mean (SD) years with 
symptoms = 6.7 (6.78); 94.9% reported medication use for treatment. The mean 
number of micturitions per 24-hours = 10.5, mean number of incontinence episodes 
per 24-hours = 1.8; mean level of urgency severity = 1.9. There were 34 (87.2%) and 
35 (89.7%) stable patients as deﬁ ned by OTE-Patient and OTE-Clinician, respectively. 
Using Weeks 2 and 3 data from stable patients, the intra-class correlation (ICC) was 
0.95 and the Spearman correlation was 0.89. The difference between the average 
ratings of any two weeks was non-signiﬁ cant using paired t-test. CONCLUSIONS: 
The PPIUS demonstrated excellent test-retest reliability as evidenced by ICC = 0.95. 
Acclimation effect was not observed in the PPIUS, as evidenced by non-signiﬁ cant 
differences in the average ratings across three weeks.
PUK34
PSYCHOMETRIC VALIDATION OF THE SPANISH VERSION OF THE 
TREATMENT BENEFIT SCALE (TBS) FOR ASSESSING SUBJECTIVE 
OUTCOMES IN TREATING PATIENTS WITH OVERACTIVE BLADDER
Errando-Smet C1, Ruiz MA2, Villacampa-Aubá F3, Arlandis-Guzmán S4, García-Vargas M5, 
Arumi D6
1Department of Urology, Fundación Puigvert, Barcelona, Spain; 2Universidad Autonoma de 
Madrid, Madrid, Spain; 3Department of Urology, Hospital 12 de Octubre, Madrid, Spain; 
4Department of Urology, Hospital Universitario La Fe, Valencia, Spain; 5Health Outcomes 
Research Department, Corporate Affairs and Market Access Unit, Pﬁ zer Spain, Alcobendas, 
Madrid, Spain; 6Pﬁ zer Inc., Madrid, Spain, Alcobendas, Madrid, Spain
OBJECTIVES: To carry out the psychometric validation of the Spanish version of the 
self-administered TBS scale, a tool assessing subjective outcomes in the treatment of 
subjects with overactive bladder (OAB). METHODS: The culturally adapted Spanish 
version of TBS was administered at the end-of-trial visit after 3 months of a medical 
intervention for OAB. Responses to the instruments were recorded in a set of patients 
of both genders, above 18 years old, diagnosed of OAB according with standard 
criteria and a score > 8 in the OAB-V8 scale, and able to understand PRO instruments 
written in Spanish. Patients were recruited consecutively in clinics of Urology all over 
the country. Scale variability, criteria, known-groups and construct validity and 
responsiveness (effect size) were examined using classic test theory statistics. RESULTS: 
Data from 199 OAB patients (58.4 years, 74% women, 99% Caucasian, 37% workers 
and 36% primary schooling) from 18 urological clinics were evaluated. The 2.5% of 


PUK30 MAPPING THE OVERACTIVE BLADDER QUESTIONNAIRE-SHORT FORM (OABQ-SF) TO EQ-5D PATIENT PREFERENCES IN PATIENTS WITH OVERACTIVE BLADDER IN SPAIN 

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PUK30 MAPPING THE OVERACTIVE BLADDER QUESTIONNAIRE-SHORT FORM (OABQ-SF) TO EQ-5D PATIENT PREFERENCES IN PATIENTS WITH OVERACTIVE BLADDER IN SPAIN

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