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2.
Palliat Med ; 36(2): 342-347, 2022 02.
Article in English | MEDLINE | ID: mdl-34920691

ABSTRACT

BACKGROUND: Advance care planning allows patients to share their preferences for medical care with the aim of ensuring goal-concordant care in times of serious illness. The morbidity and mortality of the COVID-19 pandemic has increased the importance and public visibility of advance care planning. However, little is known about the frequency and quality of advance care planning documentation during the pandemic. AIM: This study examined the frequency, quality, and predictors of advance care planning documentation among hospitalized medical patients with and without COVID-19. DESIGN: This retrospective cohort analysis used multivariate logistic regression to identify factors associated with advance care planning documentation. SETTING/PARTICIPANTS: This study included all adult patients tested for COVID-19 and admitted to a tertiary medical center in San Francisco, CA during March 2020. RESULTS: Among 262 patients, 31 (11.8%) tested positive and 231 (88.2%) tested negative for SARS-CoV-2. The rate of advance care planning documentation was 38.7% in patients with COVID-19 and 46.8% in patients without COVID-19 (p = 0.45). Documentation consistently addressed code status (100% and 94.4% for COVID-positive and COVID-negative, respectively), but less often named a surrogate decision maker, discussed prognosis, or elaborated on other wishes for care. Palliative care consultation was associated with increased advance care planning documentation (OR: 6.93, p = 0.004). CONCLUSION: This study found low rates of advance care planning documentation for patients both with and without COVID-19 during an evolving global pandemic. Advance care planning documentation was associated with palliative care consultation, highlighting the importance of such consultation to ensure timely, patient-centered advance care planning.


Subject(s)
Advance Care Planning , COVID-19 , Academic Medical Centers , Adult , Documentation , Humans , Pandemics , Retrospective Studies , SARS-CoV-2
3.
J Gen Intern Med ; 36(6): 1568-1575, 2021 06.
Article in English | MEDLINE | ID: mdl-33532957

ABSTRACT

BACKGROUND: Safely and effectively discharging a patient from the hospital requires working within a multidisciplinary team. However, little is known about how perceptions of responsibility among the team impact discharge communication practices. OBJECTIVE: Our study attempts to understand residents' perceptions of who is primarily responsible for discharge education, how these perceptions affect their own reported communication with patients, and how residents envision improving multidisciplinary communication around discharges. DESIGN: A multi-institutional cross-sectional survey. PARTICIPANTS: Internal medicine (IM) residents from seven US residency programs at academic medical centers were invited to participate between March and May 2019, via email of an electronic link to the survey. MAIN MEASURES: Data collected included resident perception of who on the multidisciplinary team is primarily responsible for discharge communication, their own reported discharge communication practices, and open-ended comments on ways discharge multidisciplinary team communication could be improved. KEY RESULTS: Of the 613 resident responses (63% response rate), 35% reported they were unsure which member of the multidisciplinary team is primarily responsible for discharge education. Residents who believed it was either the intern's or the resident's primary responsibility had 4.28 (95% CI, 2.51-7.30) and 3.01 (95% CI, 1.66-5.71) times the odds, respectively, of reporting doing discharge communication practices frequently compared to those who were not sure who was primarily responsible. To improve multidisciplinary discharge communication, residents called for the following among team members: (1) clarifying roles and responsibilities for communication with patients, (2) setting expectations for communication among multidisciplinary team members, and (3) redefining culture around discharges. CONCLUSIONS: Residents report a lack of understanding of who is responsible for discharge education. This diffusion of ownership impacts how much residents invest in patient education, with more perceived responsibility associated with more frequent discharge communication.


Subject(s)
Internship and Residency , Patient Discharge , Communication , Cross-Sectional Studies , Educational Status , Hospitals , Humans
4.
Eur Urol Focus ; 7(5): 1176-1183, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33451958

ABSTRACT

BACKGROUND: An advisory board concluded that a new, comprehensive overactive bladder (OAB) patient-reported outcome (PRO) measure should be developed in accordance with regulatory guidelines. The OAB-Bladder Assessment Tool (OAB-BAT) was developed with qualitative input from OAB patients and experts to measure symptoms, bother, impacts, and satisfaction with treatment. OBJECTIVE: Psychometric evaluation of the OAB-BAT assessing PRO OAB symptoms, bother, and impacts during a 7-d recall period. DESIGN, SETTING, AND PARTICIPANTS: Psychometric testing was conducted for a 28-d observational study of 170 OAB patients. Eligibility criteria included clinician-confirmed OAB diagnosis with at least eight micturitions per day. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Assessments included the OAB-BAT, a 7-d bladder diary, and co-validating OAB PROs. Analysis included classical and modern test theories. A scoring algorithm was developed and psychometric properties were assessed. RESULTS AND LIMITATIONS: The majority of participants were women (72.4%) with moderate OAB symptom severity (53.5%). More than one-third of participants (34.1%) were incontinent. Responses were well balanced across bother and impact items, while symptom frequency items showed sparse responses. Analysis supported an eight-item unidimensional model based on bother and impacts. No items performed differently by gender or continence status. The OAB-BAT showed internal consistency (ω=0.918), retest reliability (two-way random intraclass correlation coefficient=0.81), and convergent validity with the OAB-q (r>0.4). Known groups showed the expected trend. Comparisons between OAB-BAT scores and components of the bladder diary showed a moderate effect size (r>0.4). CONCLUSIONS: The eight-item OAB-BAT with 7-d recall is valid and reliable as an OAB PRO measure. Structural modeling, balanced with content validity considerations, produced robust scores. The OAB-BAT is a useful addition to the clinical assessment of patients, designed to complement the use of bladder diaries for monitoring OAB outcomes, in clinical trial and clinical practice environments. Future studies will need to assess the treatment satisfaction items in a larger sample of patients receiving OAB treatment. PATIENT SUMMARY: We tested a questionnaire designed to assess overactive bladder (OAB) symptoms, bother, satisfaction, and impacts by asking patients to complete it on a weekly basis. We found that the questionnaire accurately captures the symptoms and impacts that are most important to patients with OAB. We conclude that the questionnaire could be a useful instrument and, after further assessment in clinical practice and research, a possible alternative to a bladder diary in measuring OAB outcomes.


Subject(s)
Urinary Bladder, Overactive , Female , Humans , Male , Quality of Life , Reproducibility of Results , Surveys and Questionnaires , Urinary Bladder , Urinary Bladder, Overactive/diagnosis , Urinary Bladder, Overactive/drug therapy
5.
Acad Med ; 96(7): 1043-1049, 2021 07 01.
Article in English | MEDLINE | ID: mdl-33332907

ABSTRACT

PURPOSE: To characterize residents' practices around hospital discharge communication and their exposure to transitions-of-care instruction in graduate medical education (GME). METHOD: In 2019, internal medicine residents at 7 academic medical centers completed a cross-sectional survey reporting the types of transitions-of-care instruction they experienced during GME training and the frequency with which they performed 6 key discharge communication practices. The authors calculated a mean discharge communication score for each resident, and, using multiple logistic regression, they analyzed the relationship between exposure to types of educational experiences and discharge communication practices residents reported they performed frequently (> 60% of time). The authors used content analysis to explore factors that motivated residents to change their discharge practices. RESULTS: The response rate was 63.5% (613/966). Resident discharge communication practices varied. Notably, only 17.0% (n = 104) reported routinely asking patients to "teach-back" or explain their understanding of the discharge plans. The odds of frequently performing key discharge communication practices were greater if residents received instruction based on observation of and feedback regarding their communication (adjusted odds ratio 1.73; 95% confidence interval [CI], 1.07-2.81) or if they received explicit on-rounds teaching (adjusted OR 1.46; 95% CI, 1.04-2.23). In open-ended comments, residents reported that experiencing adverse patient events at some point in the postdischarge continuum was a major impetus for practice change. CONCLUSIONS: This study exposes gaps in hospital discharge communication with patients, highlights the benefits of workplace-based instruction on discharge communication skills, and reveals the influence of adverse events as a source of hidden curricula. The results suggest that developing faculty to incorporate transitions-of-care instruction in their rounds teaching and integrating experiences across the postdischarge continuum into residents' education may foster physicians-in-training who are champions of effective transitions of care within the fragmented health care system.


Subject(s)
Education, Medical, Graduate/methods , Internal Medicine/education , Internship and Residency/statistics & numerical data , Problem-Based Learning/statistics & numerical data , Clinical Competence/statistics & numerical data , Communication , Cross-Sectional Studies , Educational Status , Humans , Logistic Models , Patient Discharge , Patient Transfer/methods , Problem-Based Learning/trends , Surveys and Questionnaires , Teaching Rounds/methods
6.
South Med J ; 113(6): 261-266, 2020 06.
Article in English | MEDLINE | ID: mdl-32483634

ABSTRACT

OBJECTIVES: Hepatitis C virus (HCV) is highly curable with antiviral therapy, and traditionally, treatment adherence has been critical for treatment success. We sought to determine whether assessing HCV treatment readiness with a structured treatment readiness tool was associated with increased rates of adherence and cure among patients at a safety-net HCV clinic. METHODS: We administered the Psychosocial Readiness Evaluation and Preparation for HCV Treatment (PREP-C) tool to 50 patients and compared them with 50 patients who received the usual care. The outcome measures included achievement of treatment milestones (eg, adherence to treatment, clinic visit attendance) and sustained virologic response (cure). RESULTS: We found no association between receiving the PREP-C assessment and outcomes, including referral to or starting HCV treatment, adherence to treatment, and HCV cure. CONCLUSIONS: We found that receiving the PREP-C assessment did not improve treatment outcomes, suggesting that targeted pretreatment assessment is unnecessary even in a medically and psychosocially complex population.


Subject(s)
Antiviral Agents/therapeutic use , Cognition , Hepatitis C, Chronic/drug therapy , Medication Adherence , Motivation , Social Support , Sustained Virologic Response , Aged , Alcohol Drinking/epidemiology , Appointments and Schedules , Hepatitis C, Chronic/psychology , Humans , Male , Mental Disorders/epidemiology , Mental Health , Middle Aged , No-Show Patients , Safety-net Providers , Self Efficacy , Single-Blind Method , Substance-Related Disorders/epidemiology , Surveys and Questionnaires , Treatment Outcome
7.
Acad Med ; 94(9): 1361-1368, 2019 09.
Article in English | MEDLINE | ID: mdl-31460934

ABSTRACT

PURPOSE: Although medical students will influence the future U.S. health care system, their opinions on the Patient Protection and Affordable Care Act (ACA) have not been assessed since the 2016 presidential election and elimination of key ACA provisions. Understanding medical students' views on health care policy and professional obligations can provide insight into issues that will be shaped by the next generation of physicians. METHOD: From October 2017 to November 2017, the authors conducted an electronic survey of medical students from seven U.S. institutions to elicit opinions regarding the ACA and their professional responsibility to address health policy. Participant demographics and responses were tabulated, and multiple logistic regression models were used to assess the associations of demographic characteristics with student opinions. RESULTS: Completed surveys were returned by 1,660/4,503 (36.9%) eligible medical students. Respondent demographics were similar to national estimates. In total, 89.1% (1,475/1,660) supported the ACA, and 82.0% (1,362/1,660) reported that they understood the health care law. Knowledge of the law's provisions was positively associated with support for the ACA (P < .001). Most students (85.8%; 1,423/1,660) reported addressing health policy to be a professional responsibility. Political affiliation was consistently associated with student opinions. CONCLUSIONS: Most medical students support the ACA, with greater levels of support among medical students who demonstrated higher levels of objective knowledge about the law. Furthermore, students indicated a professional responsibility to engage in health policy, suggesting that tomorrow's physicians are likely to participate in future health care reform efforts.


Subject(s)
Attitude of Health Personnel , Health Care Reform , Health Policy , Politics , Professional Role/psychology , Students, Medical/psychology , Adult , Female , Humans , Male , Middle Aged , Patient Protection and Affordable Care Act , Surveys and Questionnaires , United States , Young Adult
8.
Neurourol Urodyn ; 37(5): 1701-1710, 2018 06.
Article in English | MEDLINE | ID: mdl-29360189

ABSTRACT

AIMS: To develop a comprehensive patient-reported bladder assessment tool (BAT) for assessing overactive bladder (OAB) symptoms, bother, impacts, and satisfaction with treatment. METHODS: Subjects were consented and eligibility was confirmed by a recruiting physician; subjects were then scheduled for in-person interviews. For concept elicitation and cognitive interviews, 30 and 20 subjects, respectively, were targeted for recruitment from US sites. All interviews were conducted face-to-face, audio-recorded, transcribed verbatim, anonymized, and analyzed using a qualitative data analysis software program. A draft BAT was created based on the results of the concept elicitation interviews and further revised based on cognitive interviews as well as feedback from an advisory board of clinical and patient-reported outcome (PRO) experts. RESULTS: Nocturia, daytime frequency, and urgency were reported by all subjects (n = 30, 100.0%), and incontinence was reported by most subjects (n = 25, 83.3%). The most frequently reported impacts were waking up to urinate (n = 30, 100.0%), embarrassment/shame (n = 24, 80.0%), stress/anxiety (n = 23, 76.7%), and lack of control (n = 23, 76.7%). Following analysis, item generation, cognitive interviews, and advisory board feedback, the resulting BAT contains four hypothesized domains (symptom frequency, symptom bother, impacts, and satisfaction with treatment) and 17 items with a 7-day recall period. CONCLUSIONS: The BAT has been developed in multiple stages with input from both OAB patients and clinical experts following the recommended processes included in the FDA PRO Guidance for Industry. Once fully validated, we believe it will offer a superior alternative to use of the bladder diary and other PROs for monitoring OAB patients in clinical trials and clinical practice.


Subject(s)
Nocturia/diagnosis , Urinary Bladder, Overactive/diagnosis , Urinary Incontinence/diagnosis , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Nocturia/drug therapy , Patient Satisfaction , Physical Examination , Quality of Life , Surveys and Questionnaires , Treatment Outcome , Urinary Bladder, Overactive/drug therapy , Urinary Incontinence/drug therapy , Urination
9.
Eur Urol ; 70(5): 799-805, 2016 11.
Article in English | MEDLINE | ID: mdl-27160948

ABSTRACT

CONTEXT: Debate exists on overactive bladder (OAB) treatment-response assessment in clinical trials and the nature and shortcomings of the different endpoints used in OAB clinical research. OBJECTIVE: To evaluate current evidence and tools that measure OAB treatment response in clinical trials and to inform the development of a new multidimensional patient-reported outcome (PRO) that could be used as a primary endpoint in OAB trials. EVIDENCE ACQUISITION: We conducted a narrative review of OAB literature available in the PubMed database published between January 1, 2004 and June 30, 2015. Eighty articles were selected for full text review. EVIDENCE SYNTHESIS: The assessment of treatment outcomes in OAB is challenging due to the heterogeneity of symptoms and reliance on PROs. OAB studies report a high level of placebo effect and the placebo response is poorly understood. We found significant correlations between PRO measures and bladder diaries. There is evidence of several issues with the bladder diary: burden, over/underestimation, recall period, and lack of validation. Trials for other conditions-interstitial cystitis, benign prostatic hyperplasia, headache, and restless legs syndrome-have used symptom scales rather than diaries to measure treatment outcomes and some now incorporate PRO measures as primary, coprimary, and secondary endpoints. The International Consultation on Incontinence Research Society recommends evaluation of satisfaction, symptoms, health-related quality of life, and adverse events. CONCLUSIONS: There is strong evidence of the shortcomings in current approaches to measuring OAB outcomes in clinical trials and recognition that a new simpler approach which incorporates symptom and health-related quality of life assessment could provide a more comprehensive, standardized approach to OAB assessment. PATIENT SUMMARY: Overactive bladder is a urinary syndrome. Individuals experience different symptoms to varying degrees, which poses difficulties in accurately measuring the effect of treatment. This review found evidence and recommendations that propose a simpler but more comprehensive way to measure treatment outcomes.


Subject(s)
Patient Reported Outcome Measures , Quality of Life , Urinary Bladder, Overactive , Disease Management , Humans , Patient Preference , Treatment Outcome , Urinary Bladder, Overactive/psychology , Urinary Bladder, Overactive/therapy
10.
Front Immunol ; 6: 17, 2015.
Article in English | MEDLINE | ID: mdl-25688244

ABSTRACT

It is well understood that multiple antimicrobial peptides (AMPs) are constitutively deployed by the epithelium to bolster the innate defenses along the entire length of the intestines. In addition to this constitutive/homeostatic production, AMPs may be inducible and levels changed during disease. In contrast to this level of knowledge on AMP sources and roles in the intestines, our understanding of the complement cascade in the healthy and diseased intestines is rudimentary. Epithelial cells make many complement proteins and there is compelling evidence that complement becomes activated in the lumen. With the common goal of defending the host against microbes, the opportunities for cross-talk between these two processes is great, both in terms of actions on the target microbes but also on regulating the synthesis and secretion of the alternate family of molecules. This possibility is beginning to become apparent with the finding that colonic epithelial cells possess anaphylatoxin receptors. There still remains much to be learned about the possible points of collaboration between AMPs and complement, for example, whether there is reciprocal control over expression in the intestinal mucosa in homeostasis and restoring the balance following infection and inflammation.

11.
Am J Alzheimers Dis Other Demen ; 28(8): 738-49, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24363071

ABSTRACT

INTRODUCTION: The Dependence Scale (DS) was designed to measure dependence on others among patients with Alzheimer's disease (AD). The objectives of this research were primarily to strengthen the psychometric evidence for the use of the DS in AD studies. METHODS: Patients with mild to moderately severe AD were examined in 3 study databases. Within each data set, internal consistency, validity, and responsiveness were examined, and structural equation models were fit. RESULTS: The DS has strong psychometric properties. The DS scores differed significantly across known groups and demonstrated moderate to strong correlations with measures hypothesized to be related to dependence (|r| ≥ .31). Structural equation modeling supported the validity of the DS concept. An anchor-based DS responder definition to interpret a treatment benefit over time was identified. DISCUSSION: The DS is a reliable, valid, and interpretable measure of dependence associated with AD and is shown to be related to--but provides information distinct from--cognition, functioning, and behavior.


Subject(s)
Alzheimer Disease/diagnosis , Dependency, Psychological , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Psychometrics/instrumentation , Reproducibility of Results
12.
Neurourol Urodyn ; 32(1): 75-81, 2013 Jan.
Article in English | MEDLINE | ID: mdl-22674460

ABSTRACT

AIM: To linguistically validate the translation of the Lower Urinary Tract Symptoms (LUTS) Tool from English to 10 European languages and assess whether the translations adequately reflected the concepts in the original version and if urological terms and the individual items were readily understood. METHODS: Residents of the target countries who spoke the native language and had LUTS were asked to evaluate a harmonized translation of the LUTS Tool, which was developed in 10 languages: Danish (Denmark), Dutch (Belgium, Netherlands), Finnish (Finland), French (Belgium, France, Luxembourg, and Switzerland), German (Germany, Switzerland), Greek (Greece), Icelandic (Iceland), Italian (Italy), Norwegian (Norway), and Spanish (Spain). After reviewing the language-appropriate version, participants were asked to explain why any words were difficult to understand and to paraphrase each sentence during a standardized cognitive debriefing interview. Linguistic validation teams (original translators, back translator, project manager, interviewer, and survey research expert) conducted a qualitative analysis of the cognitive debriefing findings. RESULTS: The terminology and concepts in the English-language version of the LUTS Tool were adequately captured in all language translations. The overall item comprehension rate, across languages, was 98.5%. Terms related to storage, voiding, and post-micturition LUTS were comprehensible. Minor difficulties with comprehension were identified in 9 of 10 translations, and those changes were made to improve clarity. CONCLUSIONS: Individuals with LUTS from 10 countries understood the individual items captured in translated versions of the LUTS Tool. The overall comprehension rate was high. Most changes were made to improve conceptual clarity based on country-specific linguistic and cultural nuances.


Subject(s)
Lower Urinary Tract Symptoms/diagnosis , Adolescent , Adult , Aged , Aged, 80 and over , Europe , Female , Humans , Male , Middle Aged , Psychometrics , Severity of Illness Index , Surveys and Questionnaires , Translations
13.
Urology ; 80(1): 90-6, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22748867

ABSTRACT

OBJECTIVE: To determine the bother associated with overactive bladder (OAB) symptoms and its influence on health-related quality of life (HRQL), anxiety, depression, and treatment seeking in adults in the United States. METHODS: Data from U.S. respondents aged ≥ 40 years participating in the Epidemiology of Lower Urinary Tract Symptoms survey, a population-based, cross-sectional Internet survey, were analyzed to assess OAB prevalence, OAB-associated bother, and effect of OAB on HRQL, anxiety, depression, and healthcare use. Likert data were categorized as no/minimal OAB symptoms, OAB without bother, and OAB with bother at least "somewhat." RESULTS: Of 31 588 completed surveys, 20 000 participants (9416 men and 10 584 women) were randomly selected and matched to U.S. census demographics. Of the respondents with OAB at least "sometimes," the women were more likely than the men to be bothered by OAB, with 68% of the women and 60% of the men bothered at least "somewhat." Men and women with OAB with bother were more likely to report that their bladder condition caused at least some problems; had worse scores on HRQL, anxiety, and depression assessments; and had the greatest number of healthcare visits annually compared with those with OAB without bother and those with no/minimal symptoms. The strongest correlation between bother and symptom frequency was seen for urinary urgency, followed by urgency urinary incontinence and nocturia. CONCLUSION: OAB symptoms can be quite bothersome, especially for women, and can negatively affect HRQL, increase anxiety and depression, and increase healthcare usage. In the present study, the strongest predictor of OAB-associated bother was urinary urgency.


Subject(s)
Anxiety/etiology , Depression/etiology , Patient Acceptance of Health Care , Quality of Life , Urinary Bladder, Overactive/complications , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , United States , Urinary Bladder, Overactive/diagnosis , Urinary Bladder, Overactive/therapy
14.
Neurourol Urodyn ; 31(4): 448-54, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22396308

ABSTRACT

AIMS: To evaluate the utility of the International Prostate Symptom Score (IPSS) and the LUTS Tool when assessing lower urinary tract symptoms (LUTS). Secondary objectives were to examine associations of LUTS and treatment seeking. METHODS: Analyses were performed using EpiLUTS data, a population-based, cross-sectional, Internet survey of men and women (aged ≥40) in Sweden, UK, and US with a sample of 30,000 participants. Participants completed the IPSS and the LUTS Tool. Prevalence rates of symptoms captured by the LUTS Tool were compared using IPSS summary scores: 0, 1-7, 8-19, and ≥20. LUTS Tool subscale scores were calculated. Pearson correlations between the LUTS Tool symptoms and subscales and IPSS symptoms were performed. Logistic regressions evaluated the associations of IPSS scores and LUTS Tool subscales with treatment seeking for LUTS. RESULTS: The IPSS did not assess some symptoms (i.e., incontinence) for which there was a high prevalence among participants. Correlations between the 7 symptoms assessed by the IPSS and LUTS Tool were moderate to high ranging between 0.37 (nocturia women) and 0.77 (weak stream men), indicating concordance. While the LUTS Tool subscales and the total IPSS score were all significantly associated with treatment seeking, the LUTS Tool OAB subscale in men and Voiding subscale in women most strongly predicted treatment seeking. CONCLUSION: LUTS that are excluded from the IPSS, most notably incontinence, were prevalent even among mildly symptomatic participants. Since storage symptoms appear to drive treatment seeking, identifying, and treating these symptoms is essential when caring for patients with LUTS.


Subject(s)
Lower Urinary Tract Symptoms/diagnosis , Severity of Illness Index , Urination Disorders/diagnosis , Adult , Aged , Aged, 80 and over , Cross-Sectional Studies , Female , Health Surveys , Humans , Lower Urinary Tract Symptoms/epidemiology , Male , Middle Aged , Prevalence , Quality of Life , Surveys and Questionnaires , Sweden/epidemiology , Urination/physiology , Urination Disorders/epidemiology
15.
Neurourol Urodyn ; 31(3): 400-3, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22415657

ABSTRACT

A think tank was convened at the third ICI-RS meeting held in the UK, June 2011, to consider the best outcome measures when assessing treatments for lower urinary tract dysfunction (LUTD). Given the vast array of measures available a focus on questionnaires was decided upon, which continued to highlight a plethora of available tools. The decision was therefore taken to approach this topic from an alternative perspective and instead ask the audience of gathered experts in this field to consider, "What we need to ask as a minimum in order to capture the most fundamental parameters when evaluating new treatments for LUTD?" Discussions highlighted the need for inclusion of a global measure in all outcome evaluations in order to increase comparability between different treatment evaluations and different populations. More specific categories of evaluation identified were: treatment satisfaction, symptom quantification, health related quality of life and adverse events. Further optional components were identified for inclusion where relevant, such as health economic, goal setting and psychosocial evaluation. A "Minimum Outcome Set for Testing (MOST)" was therefore proposed by selecting a health outcome measure from each category while not being prescriptive about specific outcome measurement selection. The 'MOST' toolkit is therefore proposed to promote standardized evaluation in this field and represents a useful starting point for further consideration of this concept.


Subject(s)
Lower Urinary Tract Symptoms/therapy , Diagnostic Techniques, Urological , Endpoint Determination , Evidence-Based Medicine , Health Status Indicators , Humans , Lower Urinary Tract Symptoms/diagnosis , Lower Urinary Tract Symptoms/physiopathology , Predictive Value of Tests , Risk Assessment , Risk Factors , Surveys and Questionnaires , Treatment Outcome
16.
BJU Int ; 110(3): 392-400, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22129365

ABSTRACT

OBJECTIVES: • To evaluate the effects of long-term fesoterodine treatment on health-related quality of life (HRQL) and treatment satisfaction in subjects with overactive bladder (OAB) symptoms. • To determine the impact of gender and age on these effects. PATIENTS AND METHODS: • This is a post hoc analysis of data pooled from identically designed open-label extensions of two randomized, double-blind, 12-week fesoterodine studies. • Initial treatment was once-daily fesoterodine 8 mg; subjects had the opportunity to receive open-label fesoterodine for ≥24 months. • After 1 month, subjects could elect dose reduction to 4 mg and subsequent re-escalation to 8 mg; dose reduction and re-escalation were each allowed once annually. • Changes in scores on the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a Likert scale evaluating severity of bladder-related problems were assessed at open-label baseline and months 12 and 24; treatment satisfaction was assessed at open-label baseline and at months 4, 12 and 24. RESULTS: • A total of 864 enrolled subjects were included (men, n= 182; women, n= 682; aged <45 years, n= 134; 45-64 years, n= 432; 65-74 years, n= 204; ≥75 years, n= 94); most subjects (77%) who continued treatment maintained the 8-mg dose. • Among subjects in the overall population, there were significant improvements in all KHQ domains, ICIQ-SF scores, and bladder-related problems at open-label baseline vs double-blind baseline (P < 0.05); additional significant improvements were observed at months 12 and 24 vs open-label baseline in all outcomes (P < 0.05) except for the KHQ General Health Perception domain. • When data were stratified by gender or age, significant improvements at open-label baseline vs double-blind baseline were further significantly enhanced or sustained at months 12 and 24 for most KHQ domains, and for ICIQ-SF scores and bladder-related problems for all groups. Women had significantly greater improvements than men in the KHQ Emotion (P= 0.0173) and Severity/Coping (P= 0.0112) domains and ICIQ-SF scores (P= 0.0276) during open-label treatment. Subjects aged <45 years had significantly greater improvement in the Personal Relationships domain compared with those aged 45-64 years (P= 0.0357) and in the Sleep/Energy domain compared with all other groups (all P < 0.02). • Treatment satisfaction was high (≥92%) throughout open-label treatment regardless of gender or age. CONCLUSIONS: • Long-term fesoterodine treatment was associated with sustained improvement in measures of health-related quality of life and bladder-related problems and with high treatment satisfaction in subjects with overactive bladder symptoms. • Effects of gender and age were minimal.


Subject(s)
Benzhydryl Compounds/therapeutic use , Muscarinic Antagonists/therapeutic use , Urinary Bladder, Overactive/drug therapy , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Patient Satisfaction , Quality of Life , Randomized Controlled Trials as Topic , Surveys and Questionnaires , Treatment Outcome
17.
Eur Urol ; 61(1): 88-95, 2012 Jan.
Article in English | MEDLINE | ID: mdl-21831517

ABSTRACT

BACKGROUND: Differences in health burden associated with urinary incontinence (UI) subtypes have been previously described, but the majority of studies are in women. Additional research is needed to examine the prevalence and burden of UI subtype including postmicturition incontinence, nocturnal enuresis, coital incontinence, and incontinence for unspecified reasons. OBJECTIVE: Examine the burden of UI in men and women in Sweden, the United Kingdom, and the United States. DESIGN, SETTING, AND PARTICIPANTS: Secondary analyses of the Epidemiology of Lower Urinary Tract Symptoms (EpiLUTS), a cross-sectional Internet survey, were performed. Participants who reported UI were categorized as (1) urgency urinary incontinence (UUI) only, (2) stress urinary incontinence (SUI) only, (3) mixed urinary incontinence (MUI), (4) UUI plus other incontinence (OI), (5) SUI plus OI, or (6) OI. Differences in health outcomes across UI groups were explored by gender using descriptive statistics and general linear models. MEASUREMENTS: Outcomes included treatment seeking for urinary symptoms, perception of bladder condition, depression, anxiety, and health-related quality of life (HRQL). RESULTS AND LIMITATIONS: Of 14 140 men and 15 860 women, 6479 men (45.8%) and 10 717 women (67.6%) reported UI. The most prevalent UI subgroups were OI in men and SUI in women. MUI and SUI plus OI had the greatest treatment seeking among men, whereas MUI and UUI plus OI had the greatest treatment seeking among women. Men with MUI had the highest rates of anxiety, followed by those with UUI plus OI and SUI plus OI, and OI with a similar trend observed for depression. Anxiety and depression were highest in SUI plus OI and MUI women. MUI and UUI plus OI men and women had significantly lower HRQL compared with other UI groups. CONCLUSIONS: UI is common in men and women aged >40. Individuals with UUI combined with SUI or OI bear a greater mental health burden and report poorer HRQL.


Subject(s)
Anxiety/psychology , Depression/psychology , Mental Health , Quality of Life , Urinary Incontinence/psychology , Adult , Aged , Anxiety/epidemiology , Anxiety/physiopathology , Anxiety/therapy , Comorbidity , Cost of Illness , Cross-Sectional Studies , Depression/epidemiology , Depression/physiopathology , Depression/therapy , Female , Health Behavior , Health Knowledge, Attitudes, Practice , Health Surveys , Humans , Internet , Linear Models , Male , Middle Aged , Patient Acceptance of Health Care , Perception , Prevalence , Risk Assessment , Risk Factors , Surveys and Questionnaires , Sweden/epidemiology , United Kingdom/epidemiology , United States/epidemiology , Urinary Incontinence/epidemiology , Urinary Incontinence/physiopathology , Urinary Incontinence/therapy
18.
Urology ; 79(1): 95-101, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22055692

ABSTRACT

OBJECTIVES: To estimate the prevalence of overactive bladder (OAB) in men and women in the United States (US) to determine whether there were racial differences. METHODS: This was a secondary analysis of data from the EpiLUTS (Epidemiology of Lower Urinary Tract Symptoms) survey, an Internet-based cross-sectional, population-representative epidemiologic survey conducted in the US, UK, and Sweden. These analyses were limited to the data of men and women aged 40 and older from the US. The presence of OAB was defined as experiencing urinary urgency or urinary urgency incontinence. Case definitions of OAB symptoms were categorized as occurring at least "sometimes." Prevalence rates of OAB were estimated by race. Logistic regression analyses were conducted for each gender to examine the role of race on OAB status, controlling for risk factors and comorbid conditions. RESULTS: The response rate in the US was 59.6%. A total of 9237 men and 10,407 women self-identified their race and were included in the analytic sample. The prevalence of OAB at least "sometimes" ranged from 26% in Asian men to 33% in African American men. Similarly, the prevalence of OAB at least "sometimes" was lowest in Asian women (27%) and highest in African American women (46%). Race was predictive of OAB in men but not for women. CONCLUSIONS: The prevalence of OAB ranged from 26-33% across races for men and from 27-46% across races for women. African American and Hispanic race is predictive of OAB for men but not for women.


Subject(s)
Racial Groups/statistics & numerical data , Urinary Bladder, Overactive/diagnosis , Urinary Bladder, Overactive/ethnology , Adult , Black or African American/statistics & numerical data , Age Distribution , Aged , Asian People/statistics & numerical data , Cross-Sectional Studies , Cystoscopy/methods , Databases, Factual , Epidemiologic Methods , Female , Hispanic or Latino/statistics & numerical data , Humans , Logistic Models , Lower Urinary Tract Symptoms/diagnosis , Lower Urinary Tract Symptoms/epidemiology , Male , Middle Aged , Prevalence , Prognosis , Severity of Illness Index , Sex Distribution , United States , Urinary Bladder, Overactive/epidemiology , Urodynamics , White People/statistics & numerical data
19.
Nat Rev Urol ; 8(9): 495-503, 2011 Jul 05.
Article in English | MEDLINE | ID: mdl-21727941

ABSTRACT

Overactive bladder syndrome (OAB) is a condition that involves urinary urgency and affected individuals are usually treated with behavioral therapy and antimuscarinic agents as first-line therapies. Existing evidence from clinical trial data suggests that a positive placebo effect occurs in patients receiving treatment for OAB. In our systematic Review of placebo-controlled, randomized trials in OAB, we show statistically significant improvements in three patient-reported outcomes-incontinence episodes per day, micturition episodes per day and mean micturition volume from baseline-after placebo in randomized studies for OAB. The findings could highlight the brain's role in the pathophysiology of OAB or the role of additional bladder training conducted as part of OAB clinical trials. More research is needed to determine the underlying mechanisms of the placebo effect in OAB.


Subject(s)
Placebo Effect , Urinary Bladder, Overactive/physiopathology , Urinary Bladder, Overactive/therapy , Animals , Humans , Randomized Controlled Trials as Topic/methods , Syndrome , Treatment Outcome , Urinary Bladder, Overactive/epidemiology , Urination/physiology
20.
Int Urogynecol J ; 22(12): 1555-63, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21739328

ABSTRACT

INTRODUCTION AND HYPOTHESIS: As shorter recall periods are sometimes preferable to longer recall periods, the objective of this study was to evaluate the psychometric characteristics and measurement properties of the 1-week recall version of the Overactive Bladder Questionnaire (OAB-q). METHODS: Secondary analyses were performed on data for three 12-week clinical trials of fesoterodine. Patients completed the Patient Perception of Bladder Condition (PPBC), the Patient Perception of Urgency Scale (PPUS), and 3-day bladder diaries in addition to the OAB-q at baseline, 4 and 12 weeks. Analyses were conducted to evaluate the reliability, concurrent and discriminant validity and responsiveness of the OAB-q 1-week recall version. RESULTS: The patients in the three studies (Study 1: N=516, Study 2: N=441; Study 3: N=882) had a mean age of 59.6, 59.4, and 59.9 years, respectively; and most of the patients were female (77.1%, 88.9%, and 82.9%) and White (76.6%, 90.0%, and 88.0%). Patients had been diagnosed with OAB for a mean of 5.2, 8.3, and 9.1 years, respectively. Cronbach's alpha values were greater than 0.85 across all samples and subscales. Correlations between the 1-week recall version of the OAB-q and the PPBC, PPUS, and most of the bladder diary variables were moderate to strong. Discriminant validity of the OAB-q was good, with significant differences in mean OAB-q scores across all response categories of the PPUS. The OAB-q was highly responsive to changes in patients' conditions as indicated by moderate to large effect sizes. The OAB-q 1-week recall version has a similar factor structure to the 4-week recall version with each subscale model demonstrating acceptable fit. CONCLUSION: The 1-week recall version of the OAB-q appears to be reliable, valid, and responsive and is psychometrically equivalent to the 4-week recall version. The validation of the 1-week recall version offers researchers and clinicians an additional option for using the OAB-q.


Subject(s)
Benzhydryl Compounds/therapeutic use , Mental Recall , Psychometrics/methods , Self Report , Surveys and Questionnaires , Urinary Bladder, Overactive/drug therapy , Aged , Female , Humans , Male , Middle Aged , Muscarinic Antagonists/therapeutic use , Quality of Life , Reproducibility of Results , Time Factors , Treatment Outcome
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