The psychometric validation of the OAB family impact measure (OAB-FIM).

AIMS: Although overactive bladder (OAB) impacts patient health-related quality of life, the impact of OAB on family members is not known. Presently, no validated instruments exist to assess family impact, thus we examined the psychometric properties of a new instrument, the overactive bladder family impact measure (OAB-FIM). METHODS: Dyads of OAB patient-family members and control patient-family members were recruited from clinics. Family members (spouses, significant others, or daughters) completed the 32-item draft OAB-FIM. Patients completed the overactive bladder questionnaire (OAB-q) and the patient perception of bladder condition (PPBC). Both patients and family members completed two validated relationship measures. Item and exploratory factor analyses were performed to determine subscale structure; reliability and validity were assessed. RESULTS: One hundred ninety-three patient-family member dyads (163 OAB, 30 control) participated. OAB patients were mostly women (82%); the control group was younger with fewer women (53%). Family members were predominantly men (OAB, 58%; control, 52%), and control family members were younger than OAB family members. Thirteen items were deleted from the draft OAB-FIM based on item performance and factor structure based on exploratory factor analyses, leaving 19-items in the final OAB-FIM. Four subscales (Irritation, Activities, Travel, Concern) were derived for use among all family members; two additional subscales (Sleep, Sex) were derived for use with spouses/significant others. The OAB-FIM discriminated between OAB and control family members with OAB family members demonstrating significant impact (all P < 0.0001). Internal consistency reliability (Cronbach's alpha >0.70) and 2-week test-retest reliability (intraclass correlation coefficients >0.73) were high for all subscales. Concurrent validity of the OAB-FIM was demonstrated through statistically significant (P < 0.001) Spearman correlations with the OAB-q (0.35-0.58) and the PPBC (0.31-0.56). The OAB-FIM also demonstrated known-groups validity, distinguishing between family members of OAB patients and family members of control patients. CONCLUSIONS: This study supports the reliability and validity of a new measure to assess the impact of OAB on family members and demonstrates that family members are affected by another's medical condition.

"We have to stop again?!": The impact of overactive bladder on family members.

AIMS: Overactive bladder (OAB), characterized by urinary urgency, with or without incontinence, and urinary frequency and nocturia, has a significant impact on patients' lives. Given the social context inherent in OAB, the purpose of this study was to identify issues faced by OAB family members. METHODS: Incontinent OAB patients and their family members were recruited from a urology clinic. Continent OAB family members were recruited via newspaper advertisements. Focus groups were conducted to evaluate family impact; content analysis was used to analyze data. RESULTS: Participants included 14 dyads consisting of incontinent OAB patients and their family members (partners or daughters) and 17 continent OAB family members. Urinary frequency was the most bothersome symptom for family members as family members reported that their partners' urinary frequency significantly altered their lives by limiting activities (e.g., travel, social activities) and impacting time because of persistent, and urgent, need to find a toilet. Nocturia caused sleep disruption and fatigue for both patients and their partners. Family members indicated that their partner's OAB fostered significant emotions including embarrassment, anxiety, anger, worry, frustration, and sympathy. Several spouses reported that OAB limited their sexual interactions and intimacy. CONCLUSIONS: OAB has a significant impact on OAB patients' family members, regardless of whether the patient and family member live together. Consequently, it is important to assess the family impact of symptomatic conditions such as OAB to fully understand the outcomes of disease and treatment.

Utilities and disutilities for type 2 diabetes treatment-related attributes.

INTRODUCTION: Although cost-utility analyses are frequently used to estimate treatment outcomes for type 2 diabetes, utilities are not available for key medication-related attributes. The purpose of this study was to identify the utility or disutility of diabetes medication-related attributes (weight change, gastrointestinal side effects, fear of hypoglycemia) that may influence patient preference. METHODS: Patients with type 2 diabetes in Scotland and England completed standard gamble (SG) interviews to assess utility of hypothetical health states and their own current health state. The EQ-5D, PGWB, and Appraisal of Diabetes Symptoms were administered. Construct validity and differences among health states were examined with correlations, t-tests, and ANOVAs. RESULTS: A total of 129 patients (51 Scotland; 78 England) completed interviews. Mean utility of diabetes without complications was 0.89. Greater body weight was associated with disutility, and lower body weight with added utility (e.g., 3% higher = -0.04; 3% lower = +0.02). Gastrointestinal side effects and fear of hypoglycemia were associated with significant disutility (p < 0.001). SG utility of current health (mean = 0.87) demonstrated construct validity through correlations with patient-reported outcome measures (r = 0.08-0.31). DISCUSSION: The vignette-based approach was feasible and useful for assessing added utility or disutility of medication-related attributes.

Evaluating the impact of overactive bladder on sexual health in women: what is relevant?

INTRODUCTION: To assess sexual health, relevant, valid, and reliable questionnaires need to be used. AIM: To assess the relevance and content validity of three sexual health questionnaires in women with overactive bladder (OAB) and urinary incontinence. MAIN OUTCOME MEASURES: Sexual Quality of Life Questionnaire--Female (SQoL-F), Sexual Function Questionnaire (SFQ), and Pelvic Organ Prolapse-Incontinence Sexual Function Questionnaire (PISQ). METHODS: Women with OAB and urinary incontinence were recruited from five urology clinics in the United States; those who were interested in participating were mailed questionnaire packets with instructions. Each questionnaire item was followed by three questions regarding the understandability, relevance, and impact of bladder condition when responding to the question. Patients returned the completed questionnaires by mail; clinical information was obtained from chart review. RESULTS: A total of 129 patients (74% response) returned the questionnaires. The mean age was 56 years; 78% were white; 64% were married. In this sample, 64% had urge incontinence; 32% had mixed incontinence; and 4% had stress incontinence. Participants experienced bladder symptoms for a mean of 12.2 years with the following treatments: surgery (43%), bladder training (26%), exercise/biofeedback (42%), and medications (67%). SQoL-F items were understood by more than 97% of the respondents, more than 89% for SFQ, and more than 82% for PISQ. There were two SQoL-F items, one SFQ item, and 11 PISQ items that less than 60% of the respondents deemed relevant to their bladder condition. Correlations among questionnaire items and relevance to bladder condition ranged from 0.04 to 0.64 for the SQoL-F, 0.04 to 0.47 for the SFQ, and 0.01 to 0.58 for the PISQ. CONCLUSION: Women with OAB found the majority of items on all three questionnaires to be relevant to their bladder condition. Of these questionnaires, the SQoL-F had the highest understandability, fewest questions considered irrelevant, and correlated well with OAB symptoms.

Measuring changes in functional status among patients with schizophrenia: the link with cognitive impairment.

Cognitive impairment associated with schizophrenia (CIAS) includes neuropsychological deficits in attention, working memory, verbal learning, and problem solving. These deficits have been shown to be linked to impairment in functional status (eg, social behavior, work performance, and activities of daily living) among patients with schizophrenia in cross-sectional studies. Less is known about the relationship between cognitive and functional change over time, such as potential functional implications of treatment-related improvement in CIAS. The purpose of this review is to summarize research on the association between change in CIAS and change in functional status, to discuss responsiveness of functional outcomes measures, and to provide recommendations for future research and measure development. Nine longitudinal studies were located on the link between CIAS and functional status, and 8 functional outcomes measures were used across these studies. The 9 studies offer initial support for a link between change in cognitive function and change in functional status. However, inconsistent findings across studies indicate that available research is preliminary, and substantial questions remain unanswered. Shortcomings of functional status measures are noted: most instruments were not developed for the target population, and none have demonstrated responsiveness to cognitive change among schizophrenic patients. It is recommended that new functional outcome measures be developed that are specifically designed to be responsive to change in cognition, with domains previously shown to be related to cognitive ability. When creating new functional outcomes measures for assessment of patients with schizophrenia, responsiveness to change in CIAS should be evaluated as part of the development and validation process.

Willingness to pay for sensory attributes of intranasal corticosteroids among patients with allergic rhinitis.

OBJECTIVE: Sensory attributes of intranasal corticosteroids (INSs) differ by product based on chemical composition. We previously reported that patients are able to demonstrate preferences for certain INS sensory attributes, which may affect their willingness to adhere to therapy. As part of the same study, we also sought to determine if these same patients are willing to pay for products not containing certain sensory attributes. METHODS: We conducted a 2-part cross-sectional study of 120 patients with allergic rhinitis at 4 allergy and immunology clinics in the United States in November and December 2003. In the first part of the study, the patients chose between pairs of hypothetical INS products that differed in the intensity of 6 sensory attributes (smell, taste, aftertaste, throat rundown, nose runout, and feel of spray in nose/throat; results were reported in the Annals of Allergy, Asthma & Immunology [2004;93:345-50]). In the second part of the study, reported here, discrete choice experiment methodology was used in which the patients chose among hypothetical INS products that differed in the intensity of the 6 sensory attributes and monthly copayments of dollar 15, dollar 30, and dollar 50. Each sensory attribute was characterized by 3 intensity levels, e.g., no aftertaste (mild intensity), weak aftertaste (moderate intensity), or strong aftertaste (severe intensity). The strength of preferences, shown as marginal willingness to pay to avoid certain sensory attributes, was measured in U.S. dollars per month. We also evaluated the effect of annual household income on willingness to pay. RESULTS: Demographic results indicated that 86.7% of participants had prior experience with at least 2 INS products. Seven patients (5.8%) were excluded from the willingness-to-pay analysis due to inconsistent responses to the logic checks used to confirm patient engagement in the study instrument. On average, the 113 remaining patients were willing to pay $11 (95% confidence interval [CI], dollar 9-dollar 13) per month in 2003 dollars to get an INS with no smell instead of strong smell, dollar 12 (95% CI, dollar 10-dollar 14) for no taste instead of strong taste, dollar 20 (95% CI, dollar 18-dollar 22) for no aftertaste instead of strong aftertaste, dollar 10 (95% CI, dollar 9-dollar 12) for no throat rundown instead of a lot of throat rundown, dollar 11 (95% CI, dollar 9-dollar 13) for no nose runout instead of a lot of nose runout, and dollar 6 (95% CI, dolalr 4-dollar 8) for a spray with a wet feel instead of a dry feel. Comparing moderate intensity levels of each sensory attribute with the mildest, only 3 attributes had statistically significant willingness to pay: aftertaste, throat rundown, and nose runout. Patients with a higher income were willing to pay more to avoid a lot of throat rundown and nose runout than those with a low income (P <0.01), but this relationship did not hold for the other sensory attributes. CONCLUSION: Patients demonstrated significant willingness to pay to avoid certain sensory attributes of INSs. Sensory attributes of INS products appear to be potentially important considerations when evaluating alternative INS products for drug therapy selection or formulary placement.

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.