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Overactive bladder (OAB)--a syndrome characterized by urinary urgency, with or without urge incontinence, urinary frequency and nocturia--is estimated to affect 10% to 20% of the US and European populations. This study was carried out to validate a patient-administered screening awareness tool to identify patients with bothersome OAB symptoms. Patients were recruited from 12 primary care and 1 gynecology practice during regularly scheduled appointments. Enrollees completed an 8-item questionnaire assessing the amount of "bother" they associated with OAB symptoms. Clinicians then asked the patients 4 questions regarding urinary frequency, urgency, nocturia, and incontinence. If the screening was positive for symptoms of OAB or if the patient provided positive responses to the urinary symptom questions, the clinician asked additional questions regarding lifestyle and coping behaviors. The clinician then diagnosed the patient, placing him or her in the "No OAB," "Possible OAB," or "Probable OAB" category. Multivariable logistic regressions controlling for age and sex were performed to assess the applicability of the tool for identifying patients with OAB. A total of 1,299 patients were enrolled, and 1,260 provided complete data. Patients were aged 51.6+/-17.0 years, 62% were female, most (89%) were Caucasian, 22% experienced urinary urgency, and 18% experienced urge incontinence. The prevalence of Probable OAB was 12%. The c-index of the model identifying patients with a diagnosis of Probable OAB was 0.96, with a sensitivity and specificity of 98.0 and 82.7. For OAB-V8 scores >or=8, the odds ratio for Probable OAB was 95.7 (95% CI: 29.3; 312.4). The OAB-V8 performed well in helping clinicians identify patients with bothersome OAB symptoms in a primary care setting and will assist clinicians in identifying patients who may benefit from treatment. [ABSTRACT FROM AUTHOR]

The comparative antihypertensive efficacy and tolerability of the angiotensin II receptor blocker candesartan cilexetil and the calcium channel blocker amlodipine were evaluated in an 8-week, multicenter, double-blind, randomized, parallel-group, forced-titration study in 251 adult patients (45% women, 16% black) with mild hypertension (stage 1). Following a 4- to 5-week placebo run-in period, patients with sitting diastolic blood pressure (BP) of 90 to 99 mm Hg received candesartan cilexetil 16 mg (n = 123) or amlodipine 5 mg (n = 128) once daily. After 4 weeks of double-blind treatment, patients were uptitrated to candesartan cilexetil 32 mg or amlodipine 10 mg once daily. There were no significant differences between the candesartan cilexetil and amlodipine regimens for reducing BP; mean systolic BP/diastolic BP reductions were -15.2/-10.2 mm Hg versus -15.4/-11.3 mm Hg, respectively (p = 0.88/0.25). Overall, 79% of patients on candesartan cilexetil and 87% of those on amlodipine were controlled (diastolic BP <90 mm Hg). A total of 3.3% of patients on candesartan cilexetil discontinued treatment, compared with 9.4% of patients on amlodipine, including 2.4% versus 4.7% for adverse events and 0% versus 1.6% for peripheral edema, respectively. Peripheral edema, the prespecified primary tolerability end point, occurred with significantly greater frequency in patients on amlodipine (22.1%; mild 8.7%, moderate 11.8%, severe 1.6%) versus patients on candesartan cilexetil (8.9%; mild 8.1%, moderate 0.8%) (p = 0.005). Candesartan cilexetil and amlodipine are both highly effective in controlling BP in patients with mild hypertension. Candesartan cilexetil offers a significant tolerability advantage with respect to less risk of developing peripheral edema. [ABSTRACT FROM AUTHOR]

Treatment of relapsed/refractory multiple myeloma (RRMM) aims to prolong survival while maintaining health-related quality of life (HRQoL) by managing disease-related symptoms and complications-one of the most frequent and debilitating being bone pain. In the ELOQUENT-2 study (NCT01239797), which evaluated the addition of elotuzumab to lenalidomide plus dexamethasone versus lenalidomide plus dexamethasone, pain and HRQoL were assessed in patients with relapsed/refractory disease using the Brief Pain Inventory-Short Form (BPI-SF) and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 module (QLQ-C30) and myeloma-specific module (QLQ-MY20). Mean baseline pain scores were low and remained so throughout treatment with both regimens; mean HRQoL scores did not change substantially from baseline. A significantly higher proportion of patients with objective response than without had clinically meaningful improvements in worst pain over two consecutive treatment cycles (29 versus 12%; p < 0.001). Patients with very good partial response (VGPR) or better reported reduced scores for pain severity and worst pain; those with progressive disease reported increased scores for these domains and pain interference. These findings show that previously reported improvements in progression-free survival and response rate with elotuzumab are achieved without detriment to HRQoL, which is maintained over time.

Chronic, low-grade adverse events are common in patients with chronic myeloid leukemia who are treated with imatinib. These events may decrease patient quality of life and adherence, and may ultimately contribute to a suboptimal response. Alternative, second-generation tyrosine kinase inhibitors, such as dasatinib, are available with the potential to reduce adverse events, improve tolerability, and support long-term treatment goals. We present the final, primary analysis of DASPERSE/CA180-400 (NCT01660906), an open-label, multicenter, phase IV study designed to determine whether chronic, low-grade nonhematologic adverse events in imatinib-treated patients improve after switching to dasatinib, without affecting efficacy. Of the 121 chronic, grade 1/2, imatinib-related adverse events identified at baseline in 39 patients, 77% resolved or improved within 3 months after switching to dasatinib. Dasatinib maintained a consistent safety profile; headache (33%), pleural effusion (26%), fatigue (23%), and rash (23%) were the most common treatment-related adverse events after the switch. Patients either maintained (56%) or improved (44%) their molecular response on dasatinib. Patients who switched to dasatinib also experienced improved patient-reported symptom burden from baseline as assessed by the MD Anderson Symptom Inventory for chronic myeloid leukemia (on a 1-10 scale, mean change in disease-specific score was - 2.24 and core symptom severity score was - 1.06). Overall, the efficacy and quality of life/symptom burden improved in many patients, despite the onset of dasatinib-related adverse events in most patients. This suggests that imatinib-treated patients with chronic, low-grade adverse events could benefit from switching to treatment with dasatinib.

Achieving successful outcomes in chronic phase-chronic myeloid leukemia (CP-CML) requires careful monitoring of cytogenetic/molecular responses (CyR/MR). SIMPLICITY (NCT01244750) is an observational study exploring tyrosine kinase inhibitor use and management patterns in patients with CP-CML receiving first-line imatinib (n = 416), dasatinib (n = 418) or nilotinib (n = 408) in the US and 6 European countries in routine clinical practice. Twelve-month follow-up data of 1242 prospective patients (enrolled October 01 2010-September 02 2015) are reported. 81% of patients had baseline comorbidities. Treatment selection was based on perceived efficacy over patient comorbidity profile. There was a predominance of imatinib-treated patients enrolled earlier in the study, with subsequent shift toward dasatinib- and nilotinib-treated patients by 2013/2014. Monitoring for either CyR/MR improved over time and was documented for 36%, 82%, and 95% of patients by 3, 6, and 12 months, respectively; 5% had no documentation of CyR/MR monitoring during the first year of therapy. Documentation of MR/CyR testing was higher in Europe than the US (P < .001) and at academic versus community practices (P = .001). Age <65 years, patients being followed at sites within Europe, those followed at academic centers and patients no longer on first-line therapy were more likely to be monitored by 12 months. SIMPLICITY demonstrates that the NCCN and ELN recommendations on response monitoring have not been consistently translated into routine clinical practice. In the absence of appropriate monitoring practices, clinical response to TKI therapy cannot be established, any needed changes to treatment strategy will thus not be implemented, and long-term patient outcomes are likely to be impacted., (© 2017 The Authors American Journal of Hematology Published by Wiley Periodicals, Inc.)

Survival has increased dramatically for patients with chronic phase chronic myeloid leukemia (CP-CML) using BCR-ABL targeted tyrosine kinase inhibitors, such that life expectancy is expected to approximate that of patients without CP-CML. Randomized controlled trials (RCTs) and observational studies provide valuable insights into the management of chronic diseases such as CP-CML. RCTs are undoubtedly the backbone of clinical research, and the 'gold standard' for evaluating the efficacy and safety of new therapies. However, many questions surrounding the optimal management of patients with CML remain unanswered, and it is widely accepted that these questions will be best answered by evaluating the use of available therapies in clinical practice. Observational studies can extend the knowledge base beyond the clinical trial setting and thus capture a more accurate picture of everyday clinical practice, particularly patients' experiences of long-term CML treatment. There is therefore growing interest in and appreciation of the value of observational research. This review article will examine the relative merits of RCTs and observational studies in the setting of CML, highlighting those factors - such as the advancing age of the CML patient population and growing importance of patient-reported outcomes - that mean that observational studies should play an important role in shaping clinical practice. This article also provides an overview of what observational studies have told us thus far about the optimal management of patients with CML, outlines some of the key remaining unanswered clinical questions in CML, and summarizes ongoing observational studies designed to provide answers to these key questions.

Background: Docetaxel has been a standard of care for castration-resistant prostate cancer (CRPC) in the United States since 2004, yet little has been reported on its patterns of use in routine practice. To help understand these patterns, a retrospective study was conducted and is reported here. Methods: Medical records from 394 patients treated in the United States were reviewed. Data were collected by 48 physicians from oncology (patient N=344) and 8 physicians from urology (patient N=50) practices. Inclusion criteria were: CRPC diagnosed between 2004 and 2010; received docetaxel; discontinued docetaxel due to rising prostate-specific antigen (PSA), progression of bone lesions, or progression of nodal or visceral metastases. Data were collected from physicians using an internet-based case report form. We evaluated patient demographics, characteristics of the docetaxel regimen, and other treatments used until docetaxel discontinuation. Results: Patients had a mean [±SD] age of 66.5 [8.9] years, the majority (63%) were white, and geographic dispersion was similar to the US population. The majority of patients initiated docetaxel between 2008 and 2010. After CRPC diagnosis, 8% of patients had initiated another cancer-directed therapy before starting docetaxel. Most (78.9%) patients initiated docetaxel with prednisone, while 18.5% initiated docetaxel alone and 2.6% initiated with other medications. Half of patients initiated docetaxel within 1 month after CRPC diagnosis, while 25% started ≥6 months later. Other non-chemotherapy treatments used with docetaxel were hormonal therapy (22.8%), radiotherapy (17.3%), and surgery (4.1%). Most patients (75%) received ≥4 docetaxel cycles, half received ≥6 cycles, 25% received ≥8 cycles and 10% received ≥10 cycles. Increased tumor mass, with/without new bone lesions or rising PSA, was the most common reason for docetaxel discontinuation (74% of patients). Conclusions: Concordant with guidelines, docetaxel and prednisone was the preferred first-line chemotherapy regimen in CRPC patients reviewed for this study. However, one quarter of patients did not initiate docetaxel until ≥6 months after CRPC diagnosis and total exposure varied considerably, with only 10% receiving ≥10 cycles. Future studies are needed to describe specific reasons explaining timing of docetaxel initiation and duration of exposure in some CRPC patients.

Objectives: This study examined resource utilisation, charges and mortality among congestive heart failure (CHF) patients over the course of the first year following initial hospital discharge for CHF in the US., Methods: The Medicare Standard Analytic Files for the years 1998 through to 2001 were used for the analysis. The study sample included patients with an inpatient hospitalisation between the 1st January 1999 and the 31st December 2000 with a primary ICD-9 diagnosis code of CHF. Statistical analysis including univariate and multivariate regression analysis were conducted., Results: Within 1 year following initial CHF discharge, 50% of patients had at least one all-cause readmission and 20% had at least one CHF-related readmission. The mean total charges among all patients was $36,230 (SD $55,086). Of the patients 20% incurred more than $55,000 in medical charges during the year after discharge; 10% incurred charges exceeding $90,000. More than one-half of the CHF patients visited the emergency department within 3 months of hospital discharge, and within 1 year almost one-third of the CHF patients (31.4%) died., Conclusions: The charges, morbidity and mortality associated with CHF patients are significant. Reducing these risks through more effective disease management offers the potential for substantial cost savings.

Purpose: The comparative cost-effectiveness of voriconazole and amphotericin B in the treatment of invasive pulmonary aspergillosis (IPA) was examined., Methods: A decision-tree model was constructed comparing 12-week treatment outcomes in a subset of patients enrolled in a clinical trial comparing initial treatment of IPA with amphotericin B versus voriconazole. Patients included those with IPA who underwent a thoracic computed tomographic (CT) scan at baseline. Cost and survival were estimated for those with and without a halo sign at baseline. Incremental cost-effectiveness ratios comparing voriconazole with amphotericin B were calculated for both patient subgroups., Results: Patients with a halo sign had similar costs and better survival rates than those without the sign. Within the subgroup of patients with the sign, total costs were lower and survival rates higher for those treated with voriconazole than for those treated with amphotericin B. For patients without a halo sign, total costs and survival rates were higher for those treated with voriconazole versus amphotericin B., Conclusion: Among patients treated for IPA, those with a baseline CT halo sign, an early indicator of the condition, appeared to have better survival rates and lower health care costs compared with patients without the sign. In patients with the halo sign, survival rates were higher and costs were lower when voriconazole rather than amphotericin B was used as first-line treatment; survival was better with voriconazole than with amphotericin B when the halo sign was not present. Voriconazole was cost-effective compared with amphotericin B when the halo sign was present, but voriconazole's cost-effectiveness when the sign was not present depended on the cost per life saved.

Injuries and the resultant costs of injuries in today's healthcare environment are driving the need for healthcare to adopt measures to improve workplace safety for employees and increase safety for patients. Many imaging departments and facilities have implemented or are implementing safer engineering controls in an attempt to improve workplace safety. Newer options in contrast media packaging can provide alternative options engineered to improve workplace safety, avoiding risks with hidden physical and financial costs.

SUMMARY Contrast-induced nephropathy (CIN) is the third most common cause of hospital-acquired acute renal failure. There is increasing evidence that CIN has a significant adverse impact on patient morbidity and mortality. The objective of this study was to estimate the in-hospital and 1-year direct healthcare costs related to CIN. Using the values obtained from the literature review, a decision analytic model was developed to estimate the in-hospital and 1-year costs of CIN. Patients who develop CIN are more likely to experience adverse events, to undergo prolonged dialysis, to have longer hospital and intensive care unit stays and to have higher mortality rates. The average in-hospital cost of CIN is $10,345. The 1-year cost of treating a patient with CIN is $11,812. Overall, the economic burden associated with CIN is high. Adopting targeted interventions will reduce the incidence of CIN and its overall economic burden.

Objectives: To provide a descriptive overview of the elderly, nursing home patient population with urinary incontinence (UI)., Methods: This study was a descriptive, cross-sectional database analysis (2002-2003) examining UI prevalence, demographic and clinical characteristics of UI patients, and UI pharmacotherapy prevalence in the nursing home setting., Results: Of the 29 645 eligible subjects, 8995 experienced some level of UI at the time the minimum data set (MDS) was completed (30%). Compared with continent residents, a greater percentage of incontinent residents were older, white women and had a longer length of stay. Incontinent residents also had more indicators of frailty than those who were continent; they were more impaired on activities of daily living and cognitive performance scale scores, were hospitalized more frequently, and had more urinary tract infections, pressure ulcers, and depression. More incontinent residents were using pads/briefs and had bladder retraining and scheduled toileting. Only 8.7% of those residents rated as having the most severe level of incontinence (MDS level 4) were being treated with pharmacotherapy. Of the 8995 residents with a UI rating of 1 to 4, only 8% (n = 731) had pharmacotherapy., Conclusion: There is a high prevalence of UI among nursing home residents and having this condition is negatively correlated with measures of resident health status and healthcare utilization. A variety of interventions are used in this setting to treat UI, and use of pharmacologic therapy appears to be quite low. Appropriate use of interventional strategies that may include drug treatment for UI in the nursing home may reduce the substantial personal and cost burdens associated with this condition. However, clinicians may need population-specific scientific evidence in determining which nursing home patients will benefit most from pharmacotherapy.

Statement of Problem and Rationale: The management of chronic conditions, such as overactive bladder (OAB), is often limited by lack of patient adherence to medication. This article compares persistence rates among Medicaid patients who were prescribed 1 of 3 drugs for treatment of OAB: 2 long-acting agents with once-daily dosing, tolterodine tartrate extended-release capsules (tolterodine ER) and oxybutynin chloride extended release (oxybutynin ER), and oxybutynin immediate release (oxybutynin IR), requiring 3 tablets daily., Methodology: The study population was comprised of continuously enrolled Medicaid managed care patients filling prescriptions for tolterodine ER, oxybutynin ER, or oxybutynin IR between January 1, 2000, and December 31, 2003. Patients taking any OAB drug in the first 6 months of their observed period of enrollment were excluded to capture new users only. Using survival analyses adjusted for age, sex, and race, the rates of persistence by drug were analyzed. Possession time, the degree to which patients keep medication available even though they may not be taking it daily as prescribed, was also measured., Results: Of 1637 patients (75% women, 45% African American, 26% younger than 18 years of age), 182 were started on tolterodine ER, 215 on oxybutynin ER, and 1240 on oxybutynin IR. Only 32% of those taking oxybutynin IR and 44% of those taking either long-acting agent remained adherent past 30 days. Of those remaining after 30 days, the risk of nonadherence was higher for oxybutynin ER than for tolterodine ER (hazard ratio = 1.47; 95% confidence interval, 1.01-2.14)., Conclusion: Persistence rates are better for patients taking drugs with once-daily dosing, but there is a need for a better understanding of non-persistent patients.

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.

The Vital Signs Quality of Life Questionnaire (VSQLQ) is a condition- and culture-specific measure designed to assess health-related quality of life (HRQL) in black patients with hypertension. This study examined the instrument's reliability and validity when administered via personal interview to patients with mild systemic hypertension. Data were gathered from 304 black patients during the screening visit of a multicenter trial evaluating the efficacy of candesartan cilexetil (ATACAND). In addition to internal consistency and reproducibility, validity was assessed by correlating the VSQLQ with the Short Form-36 (SF-36). Sensitivity to sociodemographic effects and responsiveness to change was also examined. Cronbach's alpha levels were high (0.90, 0.92, 0.92 for frequency, intensity and combined scores, respectively) and the instrument was stable in patients reporting no health change over 8 weeks (ICC = 0.79, 0.79, and 0.80). Correlations between the VSQLQ and the SF-36 were moderate to high (0.32 to - 0.69) and statistically significant (p < 0.001). VSQLQ scores varied by gender, education, and income (p < 0.05). Patients who reported improvement in their general health status also reported significant improvements on the VSQLQ (n = 90; p < 0.05). Results support the reliability and validity of VSQLQ administered via personal interview to black patients with mild systemic hypertension.

Economic and human costs associated with untreated or inadequately controlled hypertension and its complications continue to be an issue in the United States despite the availability of numerous antihypertensive agents. Knowledge of hypertension, product profiles, tolerability concerns, convenience of dosing, health-related quality of life effects, and cost of therapy are some of the factors that may influence the compliance of patients to their medication regimens. Recent reports on patient noncompliance have focused on patient-provider relationships, psychosocial barriers, home blood pressure monitoring, and electronic monitoring systems to improve blood pressure control. The use of health-related quality of life assessment in antihypertensive studies and in routine clinical practice provides another opportunity to optimize a patient's regimen for short- and long-term hypertension control in a cost-effective manner.

Tolerability is an important consideration in evaluating a new antihypertensive agent. This can be assessed informally by conventional patient interviews or more formally with the use of validated health-related quality of life (HRQL) measures assessing the patient's perception of the agent's tolerability. HRQL was a secondary end point of a 12-week, multicenter, double-blind, randomized, placebo-controlled study of the efficacy and tolerability of candesartan cilexetil in black patients with systemic hypertension. HRQL was evaluated using the generic Medical Outcomes Study 36-Item Short Form (SF-36) and population- and condition-specific Vital Signs Quality of Life Questionnaire (VSQLQ). Data were gathered via face-to-face interviews at screening, baseline, and weeks 8 and 12. Of the 304 patients randomized, 268 were evaluable for the HRQL analysis. Clinical results, reported in the companion article, found that candesartan cilexetil initiated at 16 mg once daily and titrated to 32 mg once daily as needed, with the subsequent addition of hydrochlorothiazide 12.5 mg as needed, was effective for lowering diastolic and systolic blood pressure and was well tolerated based on office interviews. Analyses of patients' perceptions of tolerability found that HRQL was maintained during the 12-week study period, with no significant differences between treatment and placebo groups at the end of double-blind treatment. These results indicate that the HRQL of black patients with systemic hypertension is maintained during treatment with candesartan cilexetil.

Congestive heart failure (CHF) is a chronic disorder characterised by fatigue, shortness of breath and congestion. Treatment is designed to relieve symptoms, halt or delay progression of the disease, prolong life and, ultimately, improve quality of life. The purpose of this paper is to identify recent trends in the assessment of health-related quality-of-life (HR-QOL) outcomes in randomised, controlled trials evaluating treatment effectiveness in patients with CHF. 41 studies using HR-QOL as an explicit outcome and published in English between 1990 and September 1998 were reviewed. Trends in the measurement of HR-QOL and evidence of treatment effectiveness are presented followed by a discussion of the implications for future research. Results suggest that pharmacological and nonpharmacological treatment regimens can have a positive impact on HR-QOL. However, treatment-related improvement in exercise capacity in patients with CHF was not consistently associated with improvement in all domains of HR-QOL. The primary HR-QOL domain affected by treatment appears to be the performance of daily activities, which may or may not be accompanied by enhanced well-being. This suggests that functional status should be considered a primary HR-QOL end-point in clinical intervention trials. Preference-based or utility assessment, ethnic group differences in treatment effectiveness, caregiver burden and cost effectiveness are understudied outcomes in CHF research.