Validation of the Overactive Bladder-Bladder Assessment Tool (OAB-BAT): A Potential Alternative to the Standard Bladder Diary for Monitoring OAB Outcomes.

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.

Pretreatment Assessment of Psychosocial Readiness Is Not Associated with Improved Treatment Outcomes in a Safety-Net HCV Treatment Clinic.

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.

Looking to the Future: Medical Students' Views on Health Care Reform and Professional Responsibility.

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.

Development of an overactive bladder assessment tool (BAT): A potential improvement to the standard bladder diary.

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.

Moving towards a comprehensive assessment of lower urinary tract symptoms (LUTS).

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.

Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States.

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.

Goal attainment scaling in patients with lower urinary tract symptoms: development and pilot testing of the Self-Assessment Goal Achievement (SAGA) questionnaire.

INTRODUCTION AND HYPOTHESIS: The Self-Assessment Goal Achievement (SAGA) questionnaire was developed to identify treatment goals and assess goal-achievement in patients with lower urinary tract symptoms (LUTS). METHODS: This study consisted of (1) gathering information on goal setting/attainment concepts, (2) goal elicitation (n = 41 patients with LUTS), (3) cognitive debriefing of draft questionnaire (n = 11), and (4) pilot testing (n = 104). RESULTS: SAGA consists of baseline (goal-assessment; ranking) and follow-up (goal-achievement) modules. In addition to goals most frequently mentioned, patients can list up to five open goals. Goals most commonly reported as "very important" in pilot testing included reducing urgency (72%), incontinence (65%), and nocturia (64%). Treatment goals spontaneously reported as "very important" were reducing incontinence (45%), nocturia (40%), and frequency (26%). CONCLUSIONS: SAGA may be used to identify treatment goals and assess goal-achievement in patients with LUTS in the clinic and for research (with additional validation). This information may promote patient-physician interaction and help patients establish realistic treatment goals, which may in turn improve treatment adherence and outcomes.

Implications of recent epidemiology studies for the clinical management of lower urinary tract symptoms.

Lower urinary tract symptoms (LUTS) include storage, voiding, and postmicturition symptoms, and occur commonly in both men and women. Findings from two recent epidemiological studies, the Epidemiology of LUTS study and the Boston Area Community Health survey, further extend the understanding of the prevalence of individual LUTS, the overlap of LUTS in men and women, the associations of LUTS with other comorbid conditions, the impact of LUTS on health-related quality of life (HRQL), and the relationships between frequency and bother of LUTS and treatment-seeking behaviour. Examining the clinical implications of these findings might provide directions to physicians for managing their patients with LUTS. For example, common findings of separate patient groups spanning a spectrum from those with typically one urinary symptom of mild to moderate severity to those with multiple more severe LUTS and frequent comorbidities might further encourage the diagnosis and treatment of comorbid conditions as a standard part of the management of patients with LUTS. Likewise, understanding that the impact of LUTS on HRQL and the degree of bother, rather than the frequency of LUTS, are significant drivers for treatment seeking might aid in assisting patients to make decisions about treatment.

The economic impact of overactive bladder syndrome in six Western countries.

OBJECTIVE: To calculate up-to-date estimates of the economic impact of overactive bladder syndrome (OAB) with and without urgency urinary incontinence (UUI) on the health sector of six countries (Canada, Germany, Italy, Spain, Sweden and the UK), as OAB is a significant health concern for adults aged >18 years living in Western countries. MATERIALS AND METHODS: The prevalence data derived from the EPIC study were combined with healthcare resource-use data to derive current direct and indirect 1-year or annual cost of illness estimates for OAB including UUI in Canada, Germany, Italy, Spain, Sweden and the UK. This model estimates the direct healthcare costs attributed to OAB, as well as the impact of work absenteeism. RESULTS: The estimated average annual direct cost of OAB per patient ranged between 262 in Spain and 619 in Sweden. The estimated total direct cost burden for OAB per country ranges between 333 million in Sweden and 1.2 billion in Germany and the total annual direct cost burden of OAB in these six countries is estimated at 3.9 billion. In addition, nursing home costs were estimated at 4.7 billion per year and it was estimated that work absenteeism related to OAB costs 1.1 billion per year. CONCLUSIONS: The cost of illness for OAB is a substantial economic and human burden. This study may under-estimate the true economic burden, as not all costs for sequelae associated with OAB have been included. Cost-effective treatments and management strategies that can reduce the burden of OAB and in particular UUI have the potential to significantly reduce this economic burden.

The current and future burden and cost of overactive bladder in five European countries.

OBJECTIVE: To estimate and compare the current and future direct cost of overactive bladder (OAB) to the health care systems of five European countries. METHOD: A health economic model was created to estimate the number of people currently affected by OAB symptoms, the expected number to be affected in the future, and the resultant economic burden on health care systems in Germany, Italy, Spain, Sweden, and the United Kingdom. RESULTS: The model estimated that in 2000, 20.2 million people over age 40 in the five countries experienced the symptoms of OAB; 7 million of these had urgency with urge incontinence. This figure is expected to rise to 25.5 million by 2020, including 9 million who will have urgency with urge incontinence. Average annual direct costs of OAB management ranged from euro269 to euro706 per patient per year. The largest cost was the use of incontinence pads, accounting for an average of 63% of the annual per patient cost of OAB management. Total cost to health care systems across all five countries was estimated at euro4.2 billion in 2000, and by 2020, the expected total cost was estimated to be euro5.2 billion, an increase of euro1 billion (26%). CONCLUSION: OAB is prevalent, with a substantial direct cost that is anticipated to increase in the future in line with aging populations. The overall burden, including indirect costs, may be considerably larger, and will fall predominantly on the elderly OAB population with urge incontinence. Recommended medical treatments could help manage those costs and should be evaluated.

A pharmacoeconomic evaluation of results from the Coronary Angioplasty Amlodipine Restenosis Study (CAPARES) in Norway and Canada.

INTRODUCTION: The objective of this analysis was to evaluate the health economic benefits of using amlodipine in patients undergoing angioplasty procedures in Canada and Norway. METHODS: A decision tree model was constructed to find the total expected cost per patient for a 4-month time period following an initial angioplasty. The model used clinical data from the Coronary Angioplasty Amlodipine Restenosis Study (CAPARES), a prospective, randomized, double blind, placebo-controlled trial conducted to investigate the effects of amlodipine on restenosis and clinical events in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). Outcomes of interest to this analysis included MI, repeat PTCA, CABG, and all-cause mortality. Clinical experts from Canada and Norway were enlisted and a modified Delphi study approach was used to quantify healthcare resources consumed for each clinical outcome. RESULTS: The use of amlodipine decreased the rates of MI, PTCA, and CABG by 2.0, 4.7, and 2.7%, respectively. The total expected cost per patient using amlodipine was $6,398.30 (US$4,323) in Canada and kr 59,993.27 (US$6,846) in Norway. The total expected cost per patient not using amlodipine was $6,519.37 (US$4,405) in Canada and kr 64,292.17 (US$7,337) in Norway. The model demonstrated potential cost-savings over a 4-month follow up period resulting from the improved clinical outcomes for patients using amlodipine with PTCA--$121,071 (US$81,844) per 1000 patients in Canada and kr 4,298,899 (US$490,074) per 1000 patients in Norway. CONCLUSIONS: The adjunctive use of amlodipine is a cost-effective therapeutic strategy to achieve more favorable clinical outcomes in patients undergoing PTCAs in Canada and Norway.

Excess morbidity and cost of failure to achieve targets for blood pressure control in Europe.

AIM: To estimate the burden of failing to achieve targets for blood pressure (BP) control in France, Germany, Italy, Sweden and the UK. METHODS: A cost of illness model was constructed to estimate the impact of uncontrolled hypertension to each national healthcare system. Prevalence of uncontrolled hypertension was taken from published data. Relationships between achieved BP and the cardiovascular events of symptomatic acute myocardial infarction, congestive heart failure and stroke were estimated from the HOT study. Costs were taken from public sources. The acute medical costs of these events were estimated at current prevalence of uncontrolled hypertension and if BP were treated to target. RESULTS: The model estimated that 29 million adults in the five countries (13% population) have BP levels above 160/95 mmHg, and an additional 46 million (21% population) have BP in the range 140/90-160/95 mmHg. The model estimated that healthcare system costs of 1.26 billion euros could be avoided if hypertension management did achieve BP targets. This does not consider the cost of interventions required to reduce the risk of cardiovascular disease. CONCLUSIONS: Failing to achieve BP targets contributes substantially to healthcare system costs and preventable events in the countries studies.

Effect of a standardized nurse case-management telephone intervention on resource use in patients with chronic heart failure.

BACKGROUND: Case management is believed to promote continuity of care and decrease hospitalization rates, although few controlled trials have tested this approach. OBJECTIVE: To assess the effectiveness of a standardized telephonic case-management intervention in decreasing resource use in patients with chronic heart failure. METHODS: A randomized controlled clinical trial was used to assess the effect of telephonic case management on resource use. Patients were identified at hospitalization and assigned to receive 6 months of intervention (n = 130) or usual care (n = 228) based on the group to which their physician was randomized. Hospitalization rates, readmission rates, hospital days, days to first rehospitalization, multiple readmissions, emergency department visits, inpatient costs, outpatient resource use, and patient satisfaction were measured at 3 and 6 months. RESULTS: The heart failure hospitalization rate was 45.7% lower in the intervention group at 3 months (P =.03) and 47.8% lower at 6 months (P =.01). Heart failure hospital days (P =.03) and multiple readmissions (P =.03) were significantly lower in the intervention group at 6 months. Inpatient heart failure costs were 45.5% lower at 6 months (P =.04). A cost saving was realized even after intervention costs were deducted. There was no evidence of cost shifting to the outpatient setting. Patient satisfaction with care was higher in the intervention group. CONCLUSIONS: The reduction in hospitalizations, costs, and other resource use achieved using standardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches.