The test-retest reliability of the Peyronie's disease questionnaire.

INTRODUCTION: The Peyronie's Disease Questionnaire (PDQ) is a disease-specific, patient-reported outcome instrument designed to measure the psychosexual consequences and treatment outcomes of Peyronie's disease (PD). AIM: The aim of this study was to evaluate the test-retest reliability of the PDQ. METHODS: Adult men with PD were recruited through eight clinical sites across the United States. Participants completed the PDQ during two study visits scheduled 7 (± 3) days apart. At Visit 1, participants completed a sociodemographic questionnaire, the PDQ, and the International Index of Erectile Function (IIEF). At Visit 2, participants repeated the PDQ and completed an Overall Treatment Effect (OTE) scale. Test-retest reliability of the PDQ was assessed in a stable subsample (as determined by responses to the OTE). Intraclass correlation coefficients (ICCs) were calculated to evaluate the degree of association between the three PDQ subscale scores at Visits 1 and 2. Internal consistency of the subscales was also evaluated using Cronbach's alpha. MAIN OUTCOME MEASURE: The main outcome measure was the PDQ. RESULTS: Of the 61 PD patients (mean age 59.3) who took part in the study, the majority were not receiving treatment for their PD (n=35, 57.4%). The sample's mean score on the erectile function domain of IIEF was 19.7 (± 8.2), indicating mild-moderate dysfunction. Nearly two-thirds reported penile pain at baseline (n=37, 63.8%). Of the participants with baseline PDQ data and who had engaged in vaginal intercourse in the past 3 months, 57 completed both study visits. The PDQ demonstrated excellent test-retest reliability in 53 stable patients. The ICC was 0.85 for the Psychological and Physical Symptom subscale, 0.89 for the Peyronie's Symptom Bother subscale, and 0.88 for the Penile Pain subscale. The Cronbach's alpha estimates for all three subscales were acceptable at the >0.70 level. CONCLUSIONS: The PDQ is a highly reproducible measure of PD and can be an effective end point in clinical trials evaluating treatments for PD.

Responsiveness of the Peyronie's Disease Questionnaire (PDQ).

INTRODUCTION: In order to reliably assess treatment effectiveness, patient-reported outcome instruments must demonstrate adequate psychometric properties. AIM: To assess the responsiveness of the Peyronie's Disease Questionnaire (PDQ) using data from two Phase 3 trials of collagenase clostridium histolyticum for Peyronie's disease (PD). METHODS: Both trials recruited adult males with PD who were in a stable relationship with a female partner for at least 3 months. Patients completed the PDQ, International Index of Erectile Function (IIEF), and a global assessment of PD (GAPD) questionnaire at baseline and Weeks 24 and 52. Anchor- and distribution-based methods were used to evaluate the responsiveness of the PDQ. MAIN OUTCOME MEASURE: Peyronie's Disease Questionnaire. RESULTS: The number of men available with baseline and Week 52 data was 267 for Study 1 and 270 for Study 2. The mean age was 58.0 for Study 1 and 57.4 for Study 2; the majority were white (95.2% and 97.3%, respectively). Mean PDQ subscale change scores from baseline to Week 52 for both studies ranged from -1.5 to -4.6 (P < 0.0001). In Study 1, effect sizes were moderate to large on the Psychological and Physical Symptoms (-0.56) and Symptom Bother subscales (-0.84). For patients with penile pain at baseline, the effect size was large (-1.05) for the Penile Pain subscale. Similar effect sizes were seen in Study 2. The Psychological and Physical Symptoms and Symptom Bother subscales significantly discriminated patient improvement ratings of GAPD and degree of penile curvature at Weeks 24 and 52. CONCLUSIONS: The PDQ is highly responsive to change in men with PD.

An overactive bladder symptom and health-related quality of life short-form: validation of the OAB-q SF.

AIMS: The Overactive Bladder Questionnaire (OAB-q) has demonstrated robust psychometric properties in continent and incontinent OAB patients. However, there is a need for a short-form of this instrument for settings where completing the full OAB-q may be too burdensome. The purpose of this manuscript is to describe the validation of the OAB-q short-form. METHODS: Three studies were used to derive and validate the OAB-q SF: a 12-week, multicenter, open-label clinical trial of tolterodine ER (N = 865 incontinent OAB [I-OAB]; the "Noble Nested Case-Control" [NCC] study; N = 523 healthy controls; N = 396 OAB); and a test-retest validation study (N = 47). Rasch analysis and confirmatory factor analysis (CFA) were performed to assess the subscale structure, and the psychometric performance of the resulting scales was evaluated. RESULTS: Based on the Rasch analysis, 6-items were retained in the OAB-q SF Symptom Bother Scale and 13-items were retained in the HRQL scale. CFAs showed excellent model fit and internal consistency in the study populations. Both scales demonstrated good convergent validity, discriminant validity, internal reliability, reproducibility, and responsiveness to change. The OAB-q SF scales clearly differentiated among I-OAB, C-OAB, and healthy controls. CONCLUSION: The OAB-q SF captures the full spectrum of OAB Symptom Bother and HRQL impact with good reliability, validity, and responsiveness, while being less time-consuming for patients to complete.

The relationship between BMI and urinary incontinence subgroups: results from EpiLUTS.

AIMS: To evaluate the relationship between body mass index (BMI) and urinary incontinence (UI) in adults ≥40 from the United States, United Kingdom, and Sweden. METHODS: This was a secondary analysis of EpiLUTS-a population-representative, cross-sectional, Internet-based survey conducted to assess the prevalence and HRQL impact of urinary symptoms. UI was evaluated by the LUTS Tool and categorized by subgroups: no UI, urgency urinary incontinence (UUI), stress urinary incontinence (SUI), mixed urinary incontinence (MUI) (UUI + SUI), UUI + other UI (OI), SUI + OI, and OI. Descriptive statistics were used. Logistic regressions examined the relationship of BMI to UI controlling for demographics and comorbid conditions. RESULTS: Response rate was 59%; 10,070 men and 13,178 women were included. Significant differences in BMI were found across UI subgroups. Obesity rates were highest among those with MUI (men and women), SUI + OI (women), UUI and UUI + OI (men). Logistic regressions of each UI subgroup showed that BMI ≥ 30 (obese) was associated with UI in general and MUI (women) and UUI + OI (men). Among women, being obese increased the odds of having SUI and SUI + OI. Women with BMI 25-29.9 (overweight) were more likely to have UI in general and SUI with and without other incontinence (SUI, MUI, and SUI + OI). Being overweight was unrelated to any form of UI in men. CONCLUSIONS: Results were consistent with prior research showing BMI is associated with higher risk of UI. These findings indicate substantial differences in obesity by gender and UI subtype, suggesting different mechanisms for UI other than purely mechanical stress on the bladder.

The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL.

AIMS: To estimate the prevalence of LUTS and OAB in a large, ethnically diverse US study. METHODS: This cross-sectional, population-representative survey was conducted via the Internet in the US among 10,000 men and women aged 18-70 (2,000 African-Americans [AA], 2,000 Hispanics, 6,000 whites). The LUTS tool assessed how often participants experienced LUTS during the past 4 weeks on a five-point Likert scale. OAB was defined by the presence of urinary urgency ≥ "sometimes" or ≥ "often," and/or the presence of urgency urinary incontinence (UUI). Descriptive statistics were used to evaluate group differences. Logistic regression analyses were conducted to examine the impact of racial/ethnic group on OAB. RESULTS: Response rate, 56.7%. Prevalent LUTS included terminal dribble and nocturia across gender, post-micturition leaking (men), and stress incontinence (women). Prevalence of OAB ≥ "sometimes" and ≥ "often" were 17% and 8% in men and 30% and 20% in women--with significantly higher rates among AA men and women. A similar trend was found for UUI among men (AA, 10%; Hispanic and whites, 6%), while AA and white women had higher prevalence of UUI (19%) as compared to Hispanic women (16%). In logistic regression analyses, AA and Hispanic men and women were significantly more likely than whites to have OAB despite having lower prevalence of self-reported comorbid conditions and risk factors. CONCLUSIONS: LUTS and OAB are highly prevalent in both men and women and increase with advancing age. Further, racial/ethnic group is a robust predictor of OAB in men and women.

The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS.

OBJECTIVE: To evaluate the impact of lower urinary tract symptoms (LUTS) on urinary-specific health-related quality of life (HRQL), generic health indices, depression and anxiety in a population-representative sample of men and women, as research has linked LUTS with reduced HRQL and depression, but little is known about the effects of individual LUTS on HRQL, depression and anxiety. SUBJECTS AND METHODS: A cross-sectional population-representative survey was conducted via the Internet in the USA, the UK and Sweden. Participants rated the frequency and symptom-specific bother of individual LUTS and condition-specific HRQL, generic health status, anxiety and depression. Descriptive statistics were used to evaluate outcome differences by International Continence Society LUTS subgroups; logistic regressions were used to determine associations of LUTS and perception of bladder problems, anxiety and depression. RESULTS: The overall survey response rate was 59.2%; 30 000 subjects (14 139 men and 15 861 women) participated. Men and women with LUTS in the all LUTS subgroup (storage, voiding and postmicturition) reported the lowest levels of HRQL and highest levels of anxiety and depression, with 35.9% of men and 53.3% of women meeting self-reported screening criteria for clinical anxiety (Hospital Anxiety and Depression Scale, HADS, Anxiety > or =8), and 29.8% of men and 37.6% of women meeting self-reported criteria for clinical depression (HADS Depression > or =8). In both men and women, storage symptoms were significantly associated with greater perceived bladder impact, whereas voiding symptoms were not. Significant predictors of anxiety included nocturia, urgency, stress urinary incontinence, leaking during sexual activity, weak stream and split stream in women; and nocturia, urgency, incomplete emptying and bladder pain in men. For depression, weak stream, urgency and stress urinary incontinence were significant for women, and perceived frequency and incomplete emptying were significant for men. CONCLUSION: The negative effect of LUTS is apparent across several domains of HRQL and on overall perception of bladder problems, general health status and mental health. The high level of psychiatric morbidity in patients with multiple LUTS has important implications for treatment and highlights the need for further research to pinpoint specific mechanisms underlying this association.

The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study.

OBJECTIVE: To estimate and compare the prevalence and associated bother of lower urinary tract symptoms (LUTS) in the general populations of the USA, UK and Sweden using current International Continence Society (ICS) definitions, as no previous population-based studies evaluating the prevalence of LUTS in the USA, using the 2002 ICS definitions, have been conducted. SUBJECTS AND METHODS: This cross-sectional, population-representative survey was conducted via the Internet in the USA, the UK and Sweden. Members of Internet-based panels were randomly selected to receive an e-mailed invitation to participate. If interested, respondents selected a link to an informed consent page, followed by the survey. Participants were asked to rate how often they experienced individual LUTS during the previous 4 weeks, on a five-point Likert scale, and, if experienced, how much the symptom bothered them. Descriptive statistics were used to summarize and present the data. RESULTS: Responses rates for the USA, the UK and Sweden were 59.6%, 60.6% and 52.3%, respectively, with a final sample of 30,000 (USA 20,000; UK 7500; Sweden 2500). The mean age (range) of the participants was 56.6 (40-99) years; the mean percentages for race were 82.9% white, 6.7% black, 6.0% Hispanic and 4.4% Asian/other. The prevalence of LUTS was defined by two symptom frequency thresholds, i.e. at least 'sometimes' and at least 'often' for all LUTS except incontinence, where frequency thresholds were at least 'a few times per month' and at least 'a few times per week'. The prevalence of at least one LUTS at least 'sometimes' was 72.3% for men and 76.3% for women, and 47.9% and 52.5% for at least 'often' for men and women, respectively. For most LUTS, at least half of the participants were bothered 'somewhat' or more using a frequency threshold of at least 'sometimes'. For a threshold of at least 'often', 'somewhat' or more bother was reported by > or =70% of participants except for terminal dribble in men and split stream in women. CONCLUSION: In this large population study of three countries, LUTS are highly prevalent among men and women aged >40 years. In general, LUTS experienced 'often' or more are bothersome to most people.

The responsiveness of the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL).

BACKGROUND: A number of noninvasive alternatives to hysterectomy have become available as treatments for uterine fibroids. These alternative therapies, however, may not relieve all symptoms. Consequently, the need for patient-reported outcomes to assess symptom reduction of uterine fibroids has become increasingly important to evaluate the clinical success of patients who choose these alternative therapies. The purpose of the study was to examine the responsiveness of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) with treatment of uterine fibroids. METHODS: The responsiveness of the UFS-QOL was assessed as a post-hoc analysis of patients treated with MRI-guided focused ultrasound thermal ablation (MRgFUS) for uterine fibroids. The UFS-QOL and SF-36 were completed at baseline and months 1, 3, and 6. Patient perceived overall treatment effect (OTE) was assessed at month 3, while satisfaction with treatment was collected at month 6. The responsiveness of the UFS-QOL was examined using effect sizes and change scores by patient-reported overall treatment effect and satisfaction. RESULTS: A total of 102 women with complete UFS-QOL data were included in the analysis; the mean age was 45 years and 79% were Caucasian. From baseline to 6 months, significant improvements were observed in UFS-QOL Symptom Severity and all Health-Related Quality of Life (HRQL) subscale scores (p < 0.0001). When examining change in general health status over the 6-month follow-up period, significant improvements were noted in all 8 SF-36 subscales. The UFS-QOL was highly responsive with subscale effect sizes ranging from 0.74 for Sexual Function to -1.9 for Symptom Severity. Improvements in UFS-QOL subscales were associated with patient perceptions of perceived benefit and treatment satisfaction. CONCLUSION: The UFS-QOL is responsive to treatment for uterine fibroids and is a useful outcome measure for uterine-sparing uterine fibroid treatments.

Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire.

OBJECTIVE: To assess the psychometric performance of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire (UFS-QoL), a patient measure of the severity of uterine fibroid (UF) symptoms and their impact on health-related quality of life (HRQL). METHODS: This was a retrospective analysis of phase 2a data from pre-menopausal women with heavy menstrual bleeding associated with UF. Participants completed the UFS-QoL at Baseline, Treatment Month 3, and Follow-up Month 3 and a daily diary with a Menstrual Bleeding Scale and the UF Daily Symptom Scale throughout the study duration. Descriptive statistics were performed on patient demographic characteristics; analyses were conducted to assess the internal consistency reliability, validity, and responsiveness of the UFS-QoL 4 week recall version. RESULTS: A total of 271 women were enrolled with a mean age of 41.8 years; 74% were black. The UFS-QoL demonstrated excellent internal consistency reliability, with Cronbach's alpha coefficient values >0.70 for each subscale at each study visit. Results indicated good concurrent validity with the UF Daily Symptom Scale items. The women with amenorrhea at Treatment Month 3 had significantly better scores on all UFS-QoL subscales and HRQL Total than women with menstrual bleeding, indicating acceptable discriminant validity. Mean subscale change scores from Baseline to Treatment Month 3 were 19.2 to 39.8. Effect sizes were moderate to large (0.53 to 1.86), demonstrating responsiveness to change. LIMITATIONS: As this study is a post hoc validation of the 4 week recall UFS-QOL, it is limited to the clinical trial data available and does not include a direct comparison to the 3 month recall version of UFS-QOL. CONCLUSIONS: The 4 week recall version of the UFS-QoL demonstrated good internal consistency reliability, concurrent validity, and responsiveness and is psychometrically comparable to the original 3 month recall UFS-QoL. CLINICAL TRIAL REGISTRATION: Data from a phase 2a, cohort design proof of concept study (trial M12-663); ClinicalTrials.gov identifier NCT01441635. Date of Registration: 6 September 2011.

Laxative utilization over time in chronic pain patients with opioid-induced constipation.

AIM: To determine laxative utilization over time among chronic noncancer pain patients with opioid-induced constipation (OIC). SETTING: A prospective longitudinal study conducted in the USA, Canada, Germany and UK. METHODS: Patients on daily opioid therapy for treatment of chronic noncancer pain with OIC were recruited from clinics to complete a survey at Baseline and weeks 2, 4, 6, 8, 12, 16, 20 and 24. RESULTS: 489 patients completed baseline with 452 completing one or more follow-up visits. 128 (28%) were nonlaxative users, 112 (25%) were insufficient laxative users and 212 (47%) were sufficient laxative users. The consistent sufficient laxative users reported the most bowel movements per week. CONCLUSION: The majority of OIC patients do not take or only intermittently take laxatives.

Misdiagnosed patients with bipolar disorder: comorbidities, treatment patterns, and direct treatment costs.

OBJECTIVE: The purpose of this study was to examine comorbidities, treatment patterns, and direct treatment costs of patients with bipolar disorder who are misdiagnosed with unipolar depression. METHOD: This study is a retrospective analysis of data from the MarketScan Commercial Claims and Encounters (CCE) database. Logistic regressions and analyses of variance were used to compare the misdiagnosis cohort to 3 age- and gender-matched comparison cohorts (recognized bipolar, depression, and no psychiatric disorders based on ICD-9-CM criteria) during the year 2000. RESULTS: Each cohort had 769 individuals (68.0% female; mean age of roughly 42 years). The misdiagnosis cohort had higher rates of several psychiatric comorbidities than the depression cohort (e.g., personality disorders, alcohol abuse, psychotic disorder) and the bipolar cohort (e.g., generalized anxiety disorder, panic) but a lower rate of psychotic disorders than the bipolar cohort (p < .05). Compared with the bipolar cohort, the misdiagnosis cohort was more likely to receive antidepressants, but less likely to receive anticonvulsants, antipsychotics, or lithium (all p < .001). Antidepressant rates were similar among the misdiagnosis and depression cohorts. Group differences were found in mean annual costs for anticonvulsants, antipsychotics, lithium, antidepressants, and total treatment costs: bipolar (USD $442, $310, $67, $497, $8600); misdiagnosis (USD $221, $185, $20, $704, $8761); depression (USD $70, $74, $5, $657, $7288). CONCLUSION: Misdiagnosed bipolar patients received inappropriate and costly treatment regimens involving overuse of antidepressants and underuse of potentially effective medications. Patterns of psychiatric comorbidity suggest one possible strategy for improving recognition of bipolar disorder among patients presenting with depressive symptoms. Patients who present with the observed pattern of comorbidities may benefit from additional screening for bipolar disorder. It is recommended that steps be taken to minimize misdiagnosis in clinical settings.

The impact of OAB on physical activity in the United States: results from OAB-POLL.

OBJECTIVE: To provide data on physical activity among those with and without overactive bladder (OAB) in a large, ethnically diverse U.S. sample. METHODS: A cross-sectional survey was conducted via the Internet among 10,000 men and women aged 18-70 (2000 African Americans, 2000 Hispanics, and 6000 whites) using the lower urinary tract symptoms (LUTS) tool and questions from the 2007-2008 National Health and Nutrition Examination Survey (NHANES). OAB cases and those with no/minimal symptoms (NMS) were compared on federal guidelines of indices of physical activity: 2008 guidelines and 2010 Healthy People. Descriptive statistics were used to evaluate differences between OAB and NMS. Logistic regressions examined the impact of OAB on physical activity. RESULTS: Response rate, 57%; 818 men and 1505 women with OAB, and 1857 men and 1615 women with NMS. Respondents with other LUTS were excluded from this analysis (2302 men and 1904 women). Those with OAB were significantly less likely to report moderate and vigorous physical activities in their leisure time and to satisfy recommended physical activity levels compared to those with NMS. Symptoms of OAB (men and women: urgency and urinary frequency; women: urinary urge incontinence) were associated with limitations in physical activity in the logistic regressions. CONCLUSION: This study benchmarks physical activity levels among people with OAB. Men and women with OAB were significantly less likely to achieve recommended physical activity levels than people with NMS. More research is needed to further evaluate how OAB affects physical activity and health status and to determine causal relationships.

Impact of overactive bladder on work productivity.

OBJECTIVE: To evaluate the impact of overactive bladder (OAB) on work productivity in a large, population-based study in the United States, with an overrepresentation of minorities. METHODS: This cross-sectional, Internet-based survey was conducted among men and women aged 18-70. The lower urinary tract symptoms (LUTS) tool was used to assess symptoms over past 4 weeks. OAB was defined by urinary urgency of at least "sometimes" and/or urgency urinary incontinence (UUI). Outcomes included work status, Work Productivity and Activity Impairment Questionnaire--General Health (WPAI-GH) and Specific Health (WPAI-SH), and questions about the impact of urinary symptoms on work. Descriptive statistics were used to evaluate group differences (no/minimal symptoms [NMS] vs OAB). Logistic regressions evaluated predictors of unemployment status controlling for comorbid conditions, risk factors, and demographic variables. RESULTS: The response rate was 57%. A total of 5795 men and women were included in the analysis (OAB, 2323; NMS, 3472). OAB cases were significantly more likely to be unemployed (men, 44%; women, 54%) compared to those with NMS (men, 24%; women, 41%). Mean work productivity and activity impairment (WPAI) percent impairment while working was as follows: 19% and 21% among men and women with OAB; NMS, 4% and 7%. Significant differences were found for all urinary-specific WPAI-SHP items and other condition-specific outcomes. Men with OAB were 1.5 times more likely to be unemployed as compared to those with NMS when covariates were controlled for, whereas the association between OAB and unemployment in multivariate analysis was nonsignificant among women. CONCLUSION: Comparison with other outcomes suggests that OAB impairs work at levels comparable to other serious chronic conditions, including rheumatoid arthritis and asthma.

Major symptom score utility index for patients with acute rhinosinusitis.

BACKGROUND: Evaluation of acute rhinosinusitis treatment effectiveness is based on patient-reported relief of symptoms. This study was designed to develop a multiattribute utility scoring algorithm for the Major Symptom Score (MSS) and secondarily to evaluate the psychometric characteristics (i.e., validity and responsiveness) of the MSS Utility Index (MSSUI). METHODS: Adult patients with acute rhinosinusitis were recruited for this longitudinal observational study through primary care and specialist physician offices. One hundred ninety patients participated in a preference elicitation exercise for MSS health states. Resulting preference data were used to generate a utility scoring algorithm for the MSS. Participants completed the MSS and 20-Question Sino-Nasal Outcome Test (SNOT-20) at baseline and completed the MSS twice daily for 15 days via daily diary. On days 7 and 15, participants completed the MSS, SNOT-20, and Overall Treatment Effect scale and were evaluated by physicians via the Physician Global Improvement Scale (PGIS). RESULTS: At baseline, the mean ± SD. MSSUI score was 0.51 ± 0.17 and was negatively correlated with SNOT-20 scores (r = -0.58; p < 0.001). Days 2-8 average MSSUI scores were negatively correlated with day 7 SNOT-20 (r = -0.46; p < 0.001) and PGIS (r = -0.22; p < 0.001) scores; whereas days 9-15 average MSSUI scores were inversely related to day 15 SNOT-20 (r = -0.40; p < 0.001) and PGIS (r = -0.32, p < 0.001) scores. Mean MSSUI scores improved from baseline with effect sizes at days 7 and 15 of 0.82 and 1.20, respectively. CONCLUSION: The MSSUI represents an acceptable and psychometrically sound patient-reported end point for clinical trials comparing treatments for acute rhinosinusitis.

Determining the importance of change in the overactive bladder questionnaire.

PURPOSE: The overactive bladder questionnaire assesses symptom bother and health related quality of life in patients with overactive bladder. It has been shown to be reliable, valid and responsive. We established the minimally important difference of the overactive bladder questionnaire. MATERIALS AND METHODS: Post hoc analyses from 2 clinical trials were performed. Distribution based, eg effect size, and anchor based analyses using perception of treatment benefit and clinical variables were used. RESULTS: The mean age of the 2 study populations was 58.8 and 58.7 years, respectively. Patients were predominantly female (51.8% and 75.1%) and white (83.9% and 87%, respectively). Half SD of the overactive bladder questionnaire symptom bother subscale was 9.1 to 9.3, and half SD of the overactive bladder questionnaire health related quality of life subscales (coping, concern, sleep and social interaction) was 9.8 to 13.2. Questionnaire subscales had moderate to large effect sizes with the largest effect sizes for symptom bother (-0.85 to -1.09). Anchor based analyses showed that significantly greater change scores were associated with greater patient perceived treatment benefit and satisfaction. The difference between change scores in patients perceiving no and little benefit was 7.4 to 16.5 for all questionnaire scales except social interaction with the majority greater than 10 points. Greater change scores were consistently associated with greater improvements in micturition diary variables. CONCLUSIONS: Multiple methodologies provide strong justification for the recommendation of a 10-point minimally important difference for all overactive bladder questionnaire subscales. This minimally important difference may be conservative for some subscales, although a uniform minimally important difference is recommended to facilitate interpretation of the overactive bladder questionnaire.

The responsiveness of the Overactive Bladder Questionnaire (OAB-q).

PURPOSE: The purpose of this study was to examine the responsiveness of the Overactive Bladder questionnaire (OAB-q) during anti-muscarinic treatment. METHODS: OAB patients were treated with tolterodine ER 4 mg/day for 12 weeks. The OAB-q and 3-day micturition diaries were collected at baseline, 4, and 12 weeks. The patients' and physicians' perceptions of treatment benefit were assessed at 4 and 12 weeks. Responsiveness of the OAB-q was examined with effect sizes and comparisons to other measures using ANOVAs, t-tests, and correlations. RESULTS: A total of 865 patients completed the 12-week study (mean age 61 years; 73% female; 89% Caucasian). From baseline to 4 weeks, significant improvements (p < 0.0001) occurred in all OAB-q subscales, which were maintained through week 12. The OAB-q was highly responsive with subscale effect sizes ranging from 0.44 (social interaction) to 1.2 (symptom bother). Significant score changes in all OAB-q subscales (p < 0.05) were associated with reductions of > or = 3 urgency episodes, > or = 3 micturitions, or > or = 1 incontinence episode per day. Improvements in OAB-q scales were associated with changes in patient and physician perceptions of treatment benefit. CONCLUSIONS: The OAB-q was highly responsive and demonstrated responsiveness to reductions in urinary urgency, frequency, and incontinence during antimuscarinic treatment of OAB. The OAB-q appears to be a useful outcome measure for treatments of OAB.

Test-retest reliability of four questionnaires for patients with overactive bladder: the overactive bladder questionnaire (OAB-q), patient perception of bladder condition (PPBC), urgency questionnaire (UQ), and the primary OAB symptom questionnaire (POSQ).

AIMS: This study examined test-retest reliability of four patient-reported outcome measures for patients with overactive bladder (OAB): Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), Urgency Questionnaire (UQ), and Primary OAB Symptom Questionnaire (POSQ). METHODS: Patients recruited from urology clinics were scheduled for two visits 2 weeks apart and completed all questionnaires at both visits. A demographic form was completed at Visit 1; and a treatment effect scale was completed at Visit 2. Test-retest reliability was examined among stable patients using intraclass correlations (ICC), Spearman's correlations, paired t-tests, Feldt's statistic, and kappas. RESULTS: A total of 47 patients enrolled (mean age = 66.0 years, 74.5% female), with 46 completing both visits; 35 were classified stable. Statistically significant correlations were present between Visits 1 and 2 (P < 0.05) for all subscales of the OAB-q, UQ, and POSQ. Subscale ICCs were moderate to high (OAB-q > or = 0.83, UQ > or = 0.46, POSQ continuous items > or = 0.68). No significant differences between Visit 1 and 2 were noted, except for the OAB-q symptom bother scale (change of 5.8 points on a 100-point scale). The multi-item subscales of the OAB-q and the UQ demonstrated good internal consistency (Cronbach's alpha > or = 0.83 for all subscales) across both visits. Test-retest reliability of the PPBC was somewhat weaker than the other three measures, but still acceptable for use as a global, single-item outcome measure. CONCLUSIONS: The OAB-q, POSQ, and UQ demonstrated good test-retest reliability, with ICCs roughly equivalent or superior to those previously reported for 7-day micturition diaries. Findings suggest that the four measures examined in this study demonstrate the necessary reproducibility for use as outcome measures for OAB treatments.