Search

Background: The FACE-Q, a validated, modular patient-reported outcome measure with global uptake, currently does not have a scale to measure the appearance of the temples. Objectives of our study were to develop a new FACE-Q scale for appearance of temples and assess content validity of two existing FACE-Q scales in the context of temple hollowing: Satisfaction with Facial Appearance and Psychological Function., Methods: A heterogeneous sample of adults who were seeking or had received treatments for temple hollowing was recruited from three outpatient clinics in the United States. Semi-structured interviews using an interpretive description approach were completed to elicit concepts and generate an item pool and assess content validity of the two existing FACE-Q scales. The item pool data were used to develop preliminary Temple scale, which was refined based on patient and expert feedback., Results: Participants (N = 15, 55 ± 9 years) described a range of esthetic concerns related to temple hollowing and its treatment. The data were used to draft the FACE-Q Satisfaction with Temples scale, which was refined through input from patients (N = 12) and clinicians (N = 5), resulting in a 16-item FACE-Q Satisfaction with Temples scale. The scale covers concepts of fullness, harmony, scenarios (eg, mirror, bright lights), age, and shape. Content validity of the two existing FACE-Q scales was substantiated., Conclusion: The FACE-Q Satisfaction with Temples scale fills an important gap in patient-reported outcome measurement in facial esthetics. The scale will be field-tested to finalize content and develop the scoring algorithm prior to implementation in clinical practice and research., (© 2021 Wiley Periodicals LLC.)

Aims: Lower urinary tract symptoms are commonly experienced among patients with multiple sclerosis (MS), however, their impact on health-related quality of life (HRQOL) has not been well characterized. Herein the incremental impact of lower urinary tract symptoms on HRQOL among patients with MS has been evaluated., Methods: A cross-sectional online survey was administered to US residents with a self-reported MS diagnosis. Data pertaining to demographics, disease history, urinary symptoms, and HRQOL, including the Short Form 36, version 2 (SF-36v2), were collected. Patients were stratified into four urinary symptom groups: no/minimal urinary symptoms, urinary urgency (UU), urinary urgency incontinence (UUI), and other lower urinary tract symptoms. Multiple linear regression models evaluated the impact of these symptoms., Results: Out of the 1,052 respondents, mean age was 47.8 ± 10.6 years; mean time since MS diagnosis was 8.5 ± 7.8 years. UUI and UU subgroups showed the greatest adjusted HRQOL decrement compared with the no/minimal urinary symptoms group, scoring 2.8 (SE ± 0.7, UUI) and 3.5 (SE ± 0.8, UU) points lower on SF-36v2 Physical Component Summary, respectively, and 3.7 (SE ± 1.0, UUI) and 5.0 (SE ± 1.2, UU) points lower on SF-36v2 Mental Component Summary (P < 0.001 for all), respectively., Conclusions: Both UU and UUI symptoms contribute to a decrement in HRQOL among patients with MS., (The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.)

Background: Neurogenic detrusor overactivity (NDO) leads to impaired health-related quality of life (HRQoL), productivity, and greater healthcare resource burden. The humanistic and economic burden may be more apparent in NDO patients with urinary incontinence (UI). The objective of this study was to compare the HRQoL, productivity, and health resource use (HRU) between continent and incontinent NDO patients., Methods: A retrospective database analysis was conducted using the Adelphi Overactive Bladder (OAB)/UI Disease Specific Programme, a multi-national, cross-sectional survey reported from both patients' and physicians' perspectives. The population for this analysis included NDO patients with or without UI. General and disease-specific HRQoL were assessed using the EuroQoL-5D (EQ-5D), Incontinence Quality of Life questionnaire (I-QOL), and the Overactive Bladder Questionnaire (OAB-q). Productivity and daily activity impairment were measured using the Work Productivity and Activity Impairment (WPAI) questionnaire. HRU indicators included OAB-related surgery, OAB-related hospitalizations, incontinence pad usage, switching anticholinergics used for OAB due to inadequate response or adverse effects, and OAB-related physician visits. Bivariate analyses, multivariate ordinary least squares (OLS) regression analyses and published minimal clinically important differences (MCID) were used to assess relationships between incontinent status and the aforementioned outcome measures., Results: A total of 324 NDO patients with or without urinary incontinence were included, averaging 54 years of age (SD 16), of whom 43.8 percent were male. Bivariate analyses detected no significant relationship between incontinent status and HRU variables. Regression analyses revealed that incontinent patients had clinically and statistically lower disease-specific HRQoL and greater impairment in daily activities as compared to continent patients. On average, incontinent patients scored 10 points lower on the I-QOL total score, 9 points lower on the OAB-q HRQoL score, 15 points higher on OAB-q symptom severity, and experienced 8.2 percent higher activity impairment due to their bladder condition (all p < 0.001)., Conclusions: Incontinent NDO patients experience significantly lower HRQoL and activity impairment as compared to continent NDO patients.

Objective: To evaluate the impact of urinary incontinence (UI) on healthcare resource utilization (HRU), health-related quality of life (HRQoL) and productivity measures in patients with overactive bladder (OAB)., Patients and Methods: This retrospective, cross-sectional study used data from the Adelphi OAB/UI Disease Specific Programme, a multinational survey of patient- and physician-reported data, fielded between November 2010 and February 2011. The primary patient groups of interest were those with OAB, both with and without UI. Health-related quality of life and productivity measures were derived from the EuroQoL-5D, the Incontinence Quality of Life questionnaire, the Overactive Bladder Questionnaire, and the Work Productivity and Activity Impairment Questionnaire. Measures of HRU included OAB-related surgeries, OAB-related hospitalizations, incontinence pads, anticholinergic use and physician visits. Multivariate linear regression models and literature-based minimal clinically important differences were used to assess statistically significant and clinically meaningful differences in HRQoL and productivity measures between patients with OAB with UI and those without UI., Results: A total of 1 730 patients were identified, with a mean age of 60.7 years, and 77.0% of them were women, 84.2% were non-Hispanic whites, and 71% were incontinent. Bivariate analyses showed that HRU was significantly higher among patients with OAB with UI than among those without UI in all categories except for the number of OAB-related physician visits. In both bivariate and multivariate analyses, incontinent patients presented with clinically and statistically significantly lower HRQoL and productivity measures with respect to all study endpoints, except for percentage of work time missed due to their OAB/UI., Conclusions: Urinary incontinence was associated with significantly higher HRU and lower HRQoL and productivity in this population of patients with OAB from five different countries. In addition to clinical considerations, the economic and humanistic impact of UI should be taken into account when evaluating treatment options for patients with OAB., (© 2013 The Authors. BJU International © 2013 BJU International.)

Objective: To evaluate the effects of onabotulinumtoxinA on patient-reported outcomes including health-related quality of life (HRQOL), treatment satisfaction, and treatment goal attainment in patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO)., Methods: In this multicenter, double-blind, randomized, placebo-controlled, phase III, 52-week study (ClinicalTrials.gov NCT00311376), patients with UI due to NDO who were not adequately managed with anticholinergic therapy were treated with intradetrusor injections of onabotulinumtoxinA (200 or 300 U) or placebo (0.9% saline). HRQOL measures included the Incontinence Quality of Life (I-QOL) Questionnaire total score, and the 3 domain scores (avoidance and limiting behavior, psychosocial, and social embarrassment), the modified Overactive Bladder Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ), and Patient Global Assessment. Assessments were made at baseline, posttreatment week 6 (primary time point), week 12, and at 12-week intervals., Results: Patients (mean age of 46 years with 30.5 weekly UI episodes at baseline) were randomized to receive placebo (n = 149) or onabotulinumtoxinA (200 U [n = 135] or 300 U [n = 132]). At week 6, improvements from baseline in I-QOL Questionnaire total score were greater (p < 0.001) in both onabotulinumtoxinA-treated groups vs placebo. Responses to the OAB-PSTQ also demonstrated greater mean improvements from baseline (p < 0.001) in both onabotulinumtoxinA-treated groups vs placebo at week 6. Patients who received onabotulinumtoxinA also reported greater improvement in the Patient Global Assessment than those in the placebo group (p ≤ 0.001 vs placebo)., Conclusions: Patients with UI due to NDO reported greater improvement in HRQOL and treatment satisfaction with onabotulinumtoxinA than with placebo consistently across several patient-reported outcome instruments., Classification of Evidence: This study provides Class I evidence that onabotulinumtoxinA intradetrusor injections (200 or 300 U) can improve quality of life measures in patients with NDO not adequately managed with anticholinergic therapy.

Aims: OnabotulinumtoxinA significantly reduces urinary incontinence (UI) and improves bladder management in patients with neurogenic detrusor overactivity (NDO). We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes (PROs) in patients with UI due to NDO in a double-blind, placebo-controlled study., Methods: Patients with UI due to NDO (from multiple sclerosis or spinal cord injury) were randomized to intradetrusor placebo (n = 92) or onabotulinumtoxinA 200 U (n = 92) or 300 U (n = 91). PROs included Incontinence Quality of Life (I-QOL) Questionnaire to assess health-related quality of life (HRQoL), the 16-item modified Overactive Bladder-Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) to assess treatment satisfaction, and Patient Global Assessment to assess treatment goal achievement., Results: Mean improvement in I-QOL total score at weeks 6 and 12 was significantly greater with both onabotulinumtoxinA 200 U and 300 U versus placebo (Δ12.3 for 200 U and Δ14.9 for 300 U vs. placebo; P < 0.001), and was clinically meaningful. For those patients who completed the OAB-PSTQ, improvement in satisfaction at weeks 6 and 12 was significantly greater for onabotulinumtoxinA versus placebo (P < 0.001, all comparisons). At 6 weeks, greater proportions of onabotulinumtoxinA-treated patients than placebo reported being somewhat or very satisfied (200 U, 77.5% and 300 U, 67.8% vs. placebo, 39.5%), and significant progress toward or complete achievement of primary treatment goal (200 U, 62.9% and 300 U, 61.6% vs. placebo, 16.5%)., Conclusions: NDO patients treated with onabotulinumtoxinA 200 or 300 U had significantly greater improvement in HRQoL and greater treatment satisfaction compared with placebo-treated patients, with no clinically relevant differences between onabotulinumtoxinA doses., (Copyright © 2012 Wiley Periodicals, Inc.)

Objective: To evaluate the psychometric properties of the Glaucoma Symptom Identifier (GSI), a tool designed to assess multiple possible glaucoma symptoms and their impact on quality of life in clinical practice. We sought to address the need for better methods to assess visual function related to quality of life of glaucoma patients with a tool to show to both physicians and their patients that glaucoma is not an asymptomatic disease. The development process was to provide comprehensive assessment in 1 page of the impact of glaucoma on patients' quality of life by including an exhaustive list of unique and nonredundant items., Design: Cross-sectional online survey., Participants: Seven hundred and eighteen individuals with a self-reported diagnosis of glaucoma, who were at least 40 years of age., Methods: The impact of glaucoma was assessed by asking study participants the degree of difficulty they experience on a number of tasks. Item response theory was used to psychometrically evaluate the GSI. Scores on the GSI and the SF-12, a generic quality-of-life instrument, were compared., Main Outcome Measures: Items in the GSI were categorized in terms of their ability to capture glaucoma impact on quality of life across the population range of subjects from mild-to-severe glaucoma severity., Results: The GSI showed good reliability, and convergent and discriminant validity. Items in the GSI captured glaucoma impact on quality of life over an adequate range of disease severity. Potential improvements to the existing questionnaire were identified using item response theory modeling results and respondents' feedback on the survey., Conclusions: Our findings suggest that the GSI is a psychometrically valid tool, adequate for glaucoma patients' self-administration within a clinician's routine practice to help both the patient and physician assess the patient's current and potential future symptoms of glaucoma.

Background: Psoriasis adversely affects health-related quality of life (HRQoL) in adults; however, little information exists about its impact on children and adolescents., Objective: The effect of etanercept therapy on HRQoL compared with placebo was evaluated in children and adolescents with moderate to severe plaque psoriasis., Methods: HRQoL data were collected from patients 4 to 17 years of age in a randomized, double-blind, placebo-controlled, North American, phase III study of etanercept. Instruments for assessing HRQoL included the Children's Dermatology Life Quality Index (CDLQI), Pediatric Quality of Life Inventory (PedsQL), Stein Impact on Family Scale, and Harter Self-Perception Profile for Children., Results: Baseline CDLQI and PedsQL scores revealed reduced HRQoL in patients with psoriasis relative to comparative populations. Patients treated with etanercept demonstrated significantly higher mean percentage improvement in total CDLQI scores from baseline to week 12 compared with those treated with placebo (52.3% etanercept vs 17.5% placebo [P = .0001]). At week 12, patients who achieved 75% improvement in their Psoriasis Area and Severity Index score had higher percentage improvements from baseline in total CDLQI scores than those who did not have 75% improvement in Psoriasis Area and Severity Index score., Limitations: The PedsQL, Stein scale, and Harter profile demonstrated limited improvement in patients' HRQoL, suggesting that these scales may not be sensitive to issues that are relevant to children with psoriasis and their families., Conclusion: Etanercept therapy had a clinically and statistically meaningful impact on disease-specific quality of life (CDLQI) and a clinically meaningful impact on general quality of life (PedsQL) in children and adolescents with moderate to severe plaque psoriasis., (Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)

Objective: To examine the longterm effect of etanercept (ETN) therapy on health-related quality of life (HRQOL) and utility in patients with ankylosing spondylitis., Methods: Patients completing a 24-week placebo-controlled trial were continued on ETN in a 72-week open-label extension study. Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and EuroQOL visual analog scale (EQ-VAS) scores were collected at open-label baseline and every 12 weeks thereafter. Mental and physical component scores (MCS and PCS) of the SF-36, EQ-5D and SF-6D utility scores, and quality-adjusted life-years (QALY) were calculated., Results: 257 patients [129 previous placebo (PLA) and 128 ETN recipients] enrolled in this open-label extension study, and 85% completed the 72-week followup. PCS, EQ-5D and SF-6D utilities, and EQ-VAS were significantly lower at open-label baseline in the previous PLA group (PLA/ETN group) than in the previous ETN group (ETN/ETN group; all p < 0.001). At week 12, PCS and MCS, EQ-5D and SF-6D utility scores, and EQ-VAS were similar in the PLA/ETN and ETN/ETN groups. As expected, mean change in EQ-5D in the PLA/ETN group was significantly greater than that for SF-6D (0.18 vs 0.06; p < 0.0001). HRQOL and utility improvements were maintained in both groups for up to 72 weeks. The average 72-week QALY gain per person in the PLA/ETN group was 0.24 and 0.10 for EQ-5D and SF-6D, respectively., Conclusion: Patients continuing ETN therapy sustained HRQOL and utility improvements attained during the original PLA-controlled trial. Patients previously taking PLA showed rapid and sustained improvements in HRQOL and utility and substantial QALY gain with ETN therapy.

Background Neurogenic detrusor overactivity (NDO) leads to impaired health-related quality of life (HRQoL), productivity, and greater healthcare resource burden. The humanistic and economic burden may be more apparent in NDO patients with urinary incontinence (UI). The objective of this study was to compare the HRQoL, productivity, and health resource use (HRU) between continent and incontinent NDO patients. Methods A retrospective database analysis was conducted using the Adelphi Overactive Bladder (OAB)/UI Disease Specific Programme, a multi-national, cross-sectional survey reported from both patients' and physicians' perspectives. The population for this analysis included NDO patients with or without UI. General and disease-specific HRQoL were assessed using the EuroQoL-5D (EQ-5D), Incontinence Quality of Life questionnaire (I-QOL), and the Overactive Bladder Questionnaire (OAB-q). Productivity and daily activity impairment were measured using the Work Productivity and Activity Impairment (WPAI) questionnaire. HRU indicators included OAB-related surgery, OAB-related hospitalizations, incontinence pad usage, switching anticholinergics used for OAB due to inadequate response or adverse effects, and OAB-related physician visits. Bivariate analyses, multivariate ordinary least squares (OLS) regression analyses and published minimal clinically important differences (MCID) were used to assess relationships between incontinent status and the aforementioned outcome measures. Results A total of 324 NDO patients with or without urinary incontinence were included, averaging 54 years of age (SD 16), of whom 43.8 percent were male. Bivariate analyses detected no significant relationship between incontinent status and HRU variables. Regression analyses revealed that incontinent patients had clinically and statistically lower disease-specific HRQoL and greater impairment in daily activities as compared to continent patients. On average, incontinent patients scored 10 points lower on the I-QOL total score, 9 points lower on the OAB-q HRQoL score, 15 points higher on OAB-q symptom severity, and experienced 8.2 percent higher activity impairment due to their bladder condition (all p < 0.001). Conclusions Incontinent NDO patients experience significantly lower HRQoL and activity impairment as compared to continent NDO patients. [ABSTRACT FROM AUTHOR]

Provides information on the progress of women's lives in South Asia. History and geography of the region's religion and culture; Information on women entering in the workforce and gaining advances in education; Discussions regarding the novel 'Shabanu: Daughter of the Wind,' by Suzanne Fisher Staples.

Abstract: Background: Patients with urgency urinary incontinence (UUI) due to overactive bladder (OAB) refractory to oral antimuscarinics have limited therapeutic options. OnabotulinumtoxinA appears to be an effective new treatment. Objective: Assess disease-specific quality-of-life outcomes and general health–related quality-of-life (HRQOL) outcomes following treatment with onabotulinumtoxinA in patients with idiopathic OAB and UUI inadequately managed with antimuscarinics. Design, setting, and participants: A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted at 40 sites from July 2005 to June 2008 with 313 patients (288 females) with idiopathic OAB experiencing eight or more UUI episodes per week and eight or more micturitions per day at baseline, with follow-up of 36 wk. Intervention: Intradetrusor onabotulinumtoxinA (50 U, 100 U, 150 U, 200 U, or 300 U) or placebo. Outcome measurements and statistical analysis: HRQOL was assessed using the urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL), the King''s Health Questionnaire (KHQ) symptom component, and the Medical Outcomes Study 36-Item Short-Form Health Survey. Descriptive statistics were used for absolute scores/changes from baseline. Within-group changes from baseline were assessed using paired t tests. Change from baseline for each onabotulinumtoxinA group compared with placebo was analyzed using an analysis of covariance model. Results and limitations: OnabotulinumtoxinA treatment at doses ≥100 U produced significantly greater improvements than placebo in the I-QOL total and subscale scores at all follow-up visits from week 2 through week 24 (p <0.05). OnabotulinumtoxinA doses ≥100 U produced significantly greater improvements than placebo in the KHQ symptom score at a majority of follow-up visits. HRQOL instruments demonstrated low to moderate correlations (Spearman correlation range: 0.01–0.51) with the symptoms of UUI recorded using daily diary data, with I-QOL demonstrating the highest correlations. A study limitation was that certain quality-of-life measures were exploratory and not validated. Conclusions: A single onabotulinumtoxinA treatment with doses ≥100 U resulted in statistically significant and clinically meaningful improvement in HRQOL by week 2 compared with placebo, and this improvement was sustained for ≤36 wk in patients with idiopathic OAB and UUI who were inadequately managed by oral antimuscarinics. Trial registration: ClinicalTrials.gov identifier: NCT00168454. [Copyright &y& Elsevier]

Objective: The 24-week Etanercept Assessment of Safety and Effectiveness (EASE) study evaluated the effectiveness and tolerability of continuous versus interrupted etanercept treatment in patients with moderate to severe plaque psoriasis. The objective of this analysis was to assess patient-reported outcomes (PROs) and health-care resource utilization (HRU) data from the EASE study. Methods: Patients received open-label etanercept 50 mg twice weekly for 12 weeks and then received either continued or interrupted (single round of discontinuation and re-treatment with etanercept) etanercept 50 mg once weekly for the second 12 weeks. PROs included the following: 1) the patient global assessments of psoriasis, joint pain, and itching scores; 2) the Dermatology Life Quality Index; 3) the Medical Outcomes Study Short Form 36 vitality domain; 4) the Beck Depression Inventory; 5) the European Quality-of-Life Group Feeling Thermometer; and 6) a patient satisfactionsurvey. HRU was evaluated using the Economic Implications of Psoriasis patient questionnaire. Results: Continuous treatment with etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks produced sustained and clinically important improvements in PROs and reductions in HRU. Reductions in some outcome measures after treatment discontinuation at week 12 were observed in the interrupted group; however, most changes did not revert to baseline levels, consistent with some residual clinical effect, and re-treatment produced improvements similar to week 12 levels. Conclusions: Continuous etanercept treatment provided greater sustained improvements in PROs than interrupted therapy; however, interrupting etanercept therapy, if needed, has predictable and manageable effects. [ABSTRACT FROM AUTHOR]