Universidade Federal de São Paulo, São Paulo, BrazilUniversidade Federal de São Paulo, EPM, São Paulo, BrazilWeb of Scienc

Castro, Rodrigo de Aquino [UNIFESP]

Fonseca, Eliana Suelotto Machado [UNIFESP]

Fonseca, Marcelo Cunio Machado [UNIFESP]

Girão, Manoel João Batista Castello [UNIFESP]

Sartori, Marair Gracio Ferreira [UNIFESP]

Souza, Carolina Chaves da Cunha e [UNIFESP]

Value in Health

Repositório Institucional UNIFESP

Abstracts A201PUK16THE BRAZILIAN PORTUGUESE VALIDATION OF THE URINARYINCONTINENCE-SPECIFIC QUALITY OF LIFE INSTRUMENT- I-QOLSouza CC1, Fonseca ESM2, Fonseca MCM2, Sartori MGF2, Girão MJBC2, Castro RA21Federal University of São Paulo, São Paulo, Brazil, 2UNIFESP – Federal University of SaoPaulo, Sao Paulo, Sao Paulo, BrazilOBJECTIVES: The objective of this study was to cross-culturally adapt and validate the Incontinence-Speciﬁ c Quality of Life instrument (I-QOL) for Brazilian women with urinary incontinence. METHODS: The I-QOL is a scale devised to assess quality of life impairment due to urinary incontinence. This questionnaire has been used in numerous studies to evaluate the consequences of the disease in daily life or the effectsof different treatments. Seventy patients with urinary incontinence, were enrolled fromthe outpatient clinic of the Uroginecology and Vaginal Surgery Section of the Gynecol-ogy Department of the Federal University of São Paulo (UNIFESP). Initially, we translated the I-QOL into Brazilian Portuguese language following international meth-odological recommendations. Due to language and cultural differences we performedcultural, structural, conceptual, and semantic adaptation on the I-QOL, in order thatpatients were able to fully understand the questions. All patients answered I-QOL twice on the same day with an interval of 30 minutes, applied by two different inter-viewers. Also the Kingxs Health Questionnaire (KHQ), already translated and vali-dated to Brazilian Portuguese was applied to the patients. After 7 to 15 days, by phoneinterview, only I-QOL was applied again. Reliability (intra and inter observer internalconsistency), construct and discriminative validity were tested. RESULTS: Severalcultural adaptations were necessary until we reached the ﬁ nal version. The intra-observer internal consistence (alpha of Cronbachxs) of the several dimensions variedfrom moderate to high (0.77–0.93), and the inter observer internal consistence variedfrom 0.65 to 0.88. Moderate to strong correlation was detected among the I-QOLdominions and the validated Brazilian Portuguese version of KHQ. CONCLUSIONS:I-QOL was adapted to the Portuguese language and to the Brazilian culture, showinggood reliability and validity. This questionnaire is now being evaluated in clinical trialson new therapeutic strategies for urinary incontinence in Brazil.PUK17THE FDA DRAFT GUIDANCE ON PATIENT-REPORTED OUTCOMES CANBE USED TO IMPROVE THE ESTIMATION OF UTILITIES. A CASE STUDYIN CHRONIC KIDNEY DISEASELloyd A1, Falconer S1, Halton J2, Pandya B3, Pang F21Oxford Outcomes Ltd, Oxford, UK, 2Takeda Global Research and Development (Europe), London, UK, 3Takeda Pharmaceuticals North America, Inc, Deerﬁ eld, IL, USAOBJECTIVES: The FDA draft guidance on patient-reported outcomes (PROs) outlinesmethods for developing disease-speciﬁ c PROs. The aim of the present study was todevelop and validate vignette descriptions of health-related quality of life (HRQL) in people who have anemia associated with chronic kidney disease (CKD) by adapting the FDA methods for developing PROs to derive health state utilities. METHODS:Interviews with people with CKD (n  12) provided detailed qualitative data regardingpatients’ HRQL. Qualitative analysis identiﬁ ed how HRQL varied by three levels of anemia (mild  12.5 g/dL; moderate 12.5–10.5 g/dL, and severe  10.5 g/dL; setaccording to the recent National Institute of Clinical Excellence [NICE] clinical guide-lines on CKD) and three states of CKD (pre-dialysis, peritoneal dialysis, and hemodi-alysis). Vignette descriptions of HRQL were developed for each state, and patients and clinicians assessed content validity. Vignettes were rated by 100 members of thegeneral public in the UK using the time trade-off interview to estimate health state utilities. RESULTS: The qualitative data produced very detailed vignettes that were determined by patients and clinicians to have good content validity. Utilities varied for pre-dialysis (0.787–0.431), peritoneal dialysis (0.725–0.351), and hemodialysis(0.629–0.331) between mild to severe levels of anemia, respectively. CONCLUSIONS:The vignette descriptions were based upon qualitative data and validated throughcontent validation interviews with clinicians and patients. To our knowledge, this isthe ﬁ rst study in which vignettes have been developed entirely based on qualitativedata from patient interviews. This is a useful method for estimating utilities when no data from generic instruments are available.PUK18PATIENT PREFERENCE FOR TAMSULOSIN OCAS (ORAL CONTROLLED ABSORPTION SYSTEM) OVER TAMSULOSIN MODIFIED RELEASE CAPSULESKhastgir J1, Odeyemi I2, Sidhu M21Morriston Hospital ABM University Hospitals Trust, Swansea, Wales, UK, 2Astellas Pharma Europe Ltd, Staines, Middlesex, UKOBJECTIVES: Tamsulosin Ocas (oral controlled absorption system) is an improvedformulation of tamsulosin modiﬁ ed release (MR) capsules, providing a smoother 24hplasma concentration proﬁ le, improved Cmax/C24h ratio, and independence fromoral food intake [1]. The formulations are similarly effective, but tamsulosin Ocas is associated with a lower incidence of orthostatic hypotension and abnormal ejaculation [2,3]. Our objective was to determine if patients preferred tamsulosin Ocas over tam-sulosin MR. METHODS: Discrete Choice Analysis based on 12 hypothetical pairedscenarios was used to compare patient preferences in 50 men aged q45 years withLUTS/BPH. Each scenario included convenience of administration with/without food, frequency of orthostatic hypotension, ejaculatory dysfunction, and out-of-pocketexpenses; one mandatory pair tested for irrationality. Disease severity and health-related quality of life were assessed by IPSS and EuroQol EQ-5D. RESULTS: 56% of the trial population had moderate and 26% had severe symptoms on IPSS scores;mean EQ-5D was 0.78. Five respondents with irrational responses were excluded.Respondents were signiﬁ cantly more likely to prefer tamsulosin Ocas over MR overall (OR 19.45; 95% CI 6.27, 60.39; p  0.001). Orthostatic hypotension was the mostimportant factor driving this preference (OR 9.07; 95% CI 4.61, 17.82; p  0.001). On average, participants would have been willing to pay an extra 72.00GBP per month (range 32.40–144.40) for tamsulosin Ocas over MR; orthostatic hypotension contributed 76% to the choice for overall WTP. CONCLUSIONS: There was a strong patient preference for tamsulosin Ocas over tamsulosin MR that was primarily drivenby the orthostatic hypotension attribute. This preference equated to patients being willing to pay about 72GBP more per month for tamsulosin OCAS; the actual cost differential between the two formulations is 11.27GBP. REFERENCES: [1] ChappleCR, Chartier-Kastler E. BJU Int 2006;29Suppl.):S9–12.; [2] Chapple CR, et al. Eur Urol 2005;4(Suppl.):S33–44; [3] Michel MC, et al. Eur Urol 2005;4(Supp.):S53–60.PUK19IMPACT OF SOLIFENACIN ON SYMPTOM BOTHER, HEALTH-RELATEDQUALITY OF LIFE, WORK PRODUCTIVITY, TREATMENT SATISFACTION, AND SYMPTOMS IN PATIENTS WITH OVERACTIVE BLADDER: RESULTSFROM VIBRANTMitcheson HD1, Roy JB2, Gilmet G3, Marshall TS3, Shannon JB41Bay State Clinical Trials, Inc, Watertown, MA, USA, 2Edmond Medical Center, Edmond, OK, USA, 3Astellas Pharma US, Inc., Deerﬁ eld, IL, USA, 4GlaxoSmithKline, Research Triangle Park, NC, USAOBJECTIVES: To assess the efﬁ cacy of solifenacin on patient-reported outcomes anddiary-documented Overactive Bladder (OAB) symptoms. METHODS: 768 patients with OAB for q3 months were randomized to ﬂ exibly dosed solifenacin (5–10 mg) or placebo for 12 weeks; dose modiﬁ cations were permitted at Weeks 4 and 8. At baseline and Week 12, patients completed the Overactive Bladder Questionnaire (OAB-q),comprised of a Symptom Bother scale (primary endpoint) and Health-Related Quality of Life (HRQL) scale with 4 domains (Coping, Concern, Sleep, Social Interactions),Work Productivity and Activity Impairment (WPAI) Questionnaire, which assesses the impact of bladder-related problems on absenteeism (work time missed), presenteeism(impairment at work), work productivity loss, and activity impairment, a 100-mmTreatment Satisfaction Visual Analog Scale (TS-VAS; higher values indicate greater satisfaction) and 3-day bladder diaries for recording episodes of urgency, incontinence,micturition frequency, and nocturia. RESULTS: By study end, solifenacin versus placebo signiﬁ cantly improved mean OAB-q Symptom Bother (29.9 vs 20.4, P 0.0001), HRQL total (25.3 vs 16.7, P  0.0001) and all domain scores (all Ps 0.0001). WPAI results revealed that solifenacin versus placebo signiﬁ cantly improved presenteeism (14.6% vs 8.7%), work productivity loss (12.9% vs 8.2%), and activity impairment (18.1% vs 14.7%; all Ps  0.01), but not absenteeism (0.5 vs 0.1; P  0.50), likely because baseline levels were low (1.1% vs. 1.4%). On the TS-VAS, mean change from baseline was signiﬁ cantly larger among solifenacin versusplacebo patients (38.2 vs 18.4; P  0.0001). Solifenacin vs placebo also signiﬁ cantly reduced mean daily episodes of urgency (3.05 vs 1.84; P  0.0001), incontinence(1.85 vs 1.24; P  0.003), and frequency (2.23 vs 1.36; P  0.0001), but not nocturia (0.63 vs 0.48; P  0.34). CONCLUSIONS: Flexibly dosed solifenacin sig-niﬁ cantly improved OAB symptom bother, HRQL, work productivity, and OAB symptoms. Patients who received solifenacin versus placebo also showed a signiﬁ cantly greater increase in overall treatment satisfaction.URINARY/KIDNEY DISORDERS – Health Care Use & Policy StudiesPUK20PROFILING COMMON CO-MORBIDITIES AND MEDICATIONSPRESCRIBED AMONG PATIENTS WITH CHRONIC KIDNEY DISEASERasu R1, Karve S2, Abercrombie M3, Balkrishnan R21University of Missouri- Kansas City, Kansas City, MO, USA, 2Ohio State University, Columbus, OH, USA, 3University of Missouri Kansas City, Kansas City, MO, USAOBJECTIVES: Patients with chronic kidney disease (CKD) often have ﬁ ve to six otherco-morbid conditions thus requiring extensive therapeutic treatment. Therefore, theobjective of this study was to examine the most common co-morbid conditions andmedications prescribed among patients with CKD, using a recent national population based ambulatory care survey. METHODS: This study utilized the National Ambula-tory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) data from 2002 through 2005. The NAMCS and NHAMCSare national probability surveys of visits to ofﬁ ce-based physicians and ambulatoryservices in hospital outpatient and emergency departments. CKD-related visits were identiﬁ ed using diagnosis codes (ICD-9-CM: 016.0, 572.4, 580–588, 591, 593.9,572.4, 753.1, 753.3, 753.2, V18.6,794.4) or prescription for CKD speciﬁ c medica-tions (brand and generic drug codes: calcium acetate,sevelamer,lanthanum car-bonate,cinacalcet). Frequency analysis of the CKD visits by setting and demographiccharacteristics was performed. Similarly, frequency analysis was performed to identifythe most common co-morbid diagnosis and medications prescribed among CKD patients. National estimates on visits were estimated using patient visits weights pro-vided in the NAMCS and NHAMCS. RESULTS: In, 2005 there were 9.7million visitsrelated to CKD, 8.1 million physician ofﬁ ce visits, 0.9 million emergency department,and 0.7 million outpatient hospital department visits, representing a 140% increase compared to 7.1 million visits in 2002. The most common co-morbid conditionsamong CKD patients were essential hypertension (22.3%), diabetes mellitus (17.5%),

THE BRAZILIAN PORTUGUESE VALIDATION of the URINARY INCONTINENCE-SPECIFIC QUALITY of LIFE INSTRUMENT- I-QOL

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