Symptom burden and its functional impact in patients with "symptomatic" relapsed or refractory multiple myeloma.

PURPOSE: Relapsed or refractory multiple myeloma (RRMM) is labeled "symptomatic" based on laboratory values, but not relevant to quantitative measure of patient's perspectives. This study aimed to describe symptom burden, health status, and quality of life in RRMM patients. METHODS: The cross-sectional study included 184 MM patients (141 RRMM cases and 43 MM patients on follow-up without diagnosis/treatment of RRMM disease as controls), while 64 RRMM patients also provided longitudinal patient-reported outcomes (PROs) data. Symptomatic status was based on clinical measures of disease activity. PROs included the MD Anderson Symptom Inventory multiple myeloma module (MDASI-MM), single-item quality of life (SIQOL), and EuroQol-5D (EQ-5D). Wilcoxon rank test and effect size were used for comparisons. Regression models were used to describe symptom trajectory and to identify predictors of high symptom burden during 3 months of RRMM therapy. RESULTS: Most patients were clinically identified as symptomatic (93%). RRMM patients tended to report more severe symptoms, with significantly lower QOL scores and more severe fatigue, poor appetite, and lower enjoyment of life compared with controls (all p < 0.05). In RRMM patients, lower hemoglobin and higher B-2 microglobulin levels significantly correlated with higher burdens of fatigue, pain, and muscle weakness and also with lower QOL and EQ-5D scores (all p < 0.05). During RRMM therapy, being female, with any comorbidity, ≥ 65 years old, and ≥ 5 years MM history, contributed to high symptoms burden and poor QOL status (each p < 0.05). CONCLUSIONS: MDASI-MM modules were sensitive to detect the RRMM-related symptoms burden, which correlated with objective clinical measures. RRMM patients reported a more compromised QOL.

Tumor mutational burden in lung cancer: a systematic literature review.

Purpose: To assess the association of tumor mutational burden (TMB) with clinical outcomes, other biomarkers and patient/disease characteristics in patients receiving therapy for lung cancer. Results: In total, 4,303 publications were identified; 81 publications were included. The majority of publications assessing clinical efficacy of immunotherapy reported an association with high TMB, particularly when assessing progression-free survival and objective response rate. High TMB was consistently associated with TP53 alterations, and negatively associated with EGFR mutations. High TMB was also associated with smoking, squamous cell non-small cell lung carcinoma, and being male. Methods: A systematic literature review based upon an a priori protocol was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Cochrane methodologies. Searches were conducted in EMBASE, SCOPUS, Ovid MEDLINE®, and Emcare (from January 2012 until April 2018) and in two clinical trial registries. Conference abstracts were identified in EMBASE, and in targeted searches of recent major conference proceedings (from January 2016 until April 2018). Publications reporting data in patients receiving therapy for lung cancer that reported TMB and its association with clinical efficacy, or with other biomarkers or patient/disease characteristics, were included. Results are presented descriptively. Conclusion: This systematic literature review identified several clinical outcomes, biomarkers, and patient/disease characteristics associated with high TMB, and highlights the need for standardized definitions and testing practices. Further studies using standardized methodology are required to inform treatment decisions.

Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY.

SIMPLICITY (NCT01244750) is an observational study exploring tyrosine kinase inhibitor (TKI) use and management patterns in patients with chronic phase-chronic myeloid leukemia in the US and Europe in routine clinical practice. Herein we describe interruptions, discontinuations and switching of TKI therapy during the initial 2 years of treatment among 1121 patients prospectively enrolled between October 1, 2010 and March 7, 2017. Patient characteristics were broadly similar between the imatinib (n = 370), dasatinib (n = 376), and nilotinib (n = 375) cohorts. Treatment interruptions occurred in 16.4% (year 1) and 4.0% (year 2) of patients, mainly attributed to hematologic intolerances. Treatment discontinuations occurred in 21.8% (year 1) and 10.2% (year 2) of patients, with the highest rate within the first 3 months for intolerance. Switching of TKI was seen in 17.8% (year 1) and 9.5% (year 2) of patients. Significant associations were found between TKI switching and female gender (year 1), age ≥65 years at diagnosis (year 2) and treatment with imatinib (year 2). Intolerance was the most common reason given for patients discontinuing and for switching TKI therapy; however resistance was also cited. Lack of response monitoring in routine clinical practice may have resulted in lower identification of resistance in this dataset. Data from SIMPLICITY suggest that, in routine clinical practice, intolerance and resistance to TKIs influence decisions to change treatment. Changes in TKI therapy are frequent, with nearly a third of patients discontinuing their first-line TKI.

Impact of elotuzumab treatment on pain and health-related quality of life in patients with relapsed or refractory multiple myeloma: results from the ELOQUENT-2 study.

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.

Outcomes of switching to dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase: the DASPERSE study.

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.

First-line treatment selection and early monitoring patterns in chronic phase-chronic myeloid leukemia in routine clinical practice: SIMPLICITY.

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.

Lost Labor Productivity Costs of Prostate Cancer to Patients and Their Spouses: Evidence From US National Survey Data.

OBJECTIVE: The aim of the study is to estimate lost labor productivity costs of prostate cancer (PC) to patients and their spouses. METHODS: This study used a nationally representative database from the United States, the Medical Expenditure Panel Survey, to estimate lost productivity costs attributable to PC for patients and their spouses. We used multivariate methods that controlled for sociodemographic factors and comorbid diseases. Sensitivity analyses were used to mitigate the tendency for prevalence rates to be underreported in surveys. RESULTS: PC patients had an aggregate national annual lost productivity cost of $5.4 billion ($3601 per individual), whereas their spouses had an aggregate annual lost productivity cost of $3.0 billion ($4013 per individual). CONCLUSIONS: These results enhance our knowledge of lost labor productivity costs of PC morbidity and may inform the management and treatment of PC from an employer's perspective.

The role of observational studies in optimizing the clinical management of chronic myeloid leukemia.

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.

The Direct Healthcare Expenditures of Prostate Cancer by Disease Severity: Evidence from US National Survey Data.

Background: In the United States, approximately 2.8 million men have a history of prostate cancer (PC). Objective: This study quantified the effects of PC, overall and by disease severity on direct healthcare costs to insurers and patients. Methods: Using 1996-2010 data from the Medical Expenditure Panel Survey (MEPS), a large, nationally representative US database, multivariate analyses were used to assess the relationship between PC and direct annual healthcare costs to insurers and patients, at individual and US aggregate levels. Men aged 40 years and older with International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code 185 were identified. Disease severity was determined with clinical assistance and based, in part, on the data in MEPS. The cohorts were: localized cancer not treated with chemotherapy, localized cancer treated with chemotherapy, and metastatic cancer. Results: The MEPS database included 1297 patients with PC: 811 patients with localized PC not treated with chemotherapy, 426 patients with PC treated with chemotherapy, and 60 patients with metastatic PC. PC had a larger effect on incremental costs for metastatic patients, $20 357, vs $16 709 for localized PC with chemotherapy, and $5238 for localized PC with no chemotherapy. When aggregated to the US population, PC accounted for an incremental annual cost of $15 billion. The largest aggregate annual costs were incurred by patients with localized PC treated with chemotherapy ($8.6 billion), compared to those not treated with chemotherapy ($4.8 billion) and metastatic patients ($1.6 billion). Conclusions: The aggregate annual costs of PC are substantial for all groups examined and greatest for patients with localized cancer treated with chemotherapy. This reflects the relatively high prevalence and high per capita healthcare expenditures associated with this group. With a growing and aging population, the prevalence of PC is expected to rise, increasing the burden on public health.

Real-World Treatment Patterns in Men with Castration- Resistant Prostate Cancer Receiving Docetaxel.

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.

Resource utilisation, charges and mortality following hospital inpatient admission for congestive heart failure among the elderly in the US.

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.

Comparative cost-effectiveness of voriconazole and amphotericin B in treatment of invasive pulmonary aspergillosis.

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.

The economic and safety impact of glass versus polymer containers in a radiology department.

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.

Economic burden of contrast-induced nephropathy: implications for prevention strategies.

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.

Urinary incontinence in the nursing home: resident characteristics and prevalence of drug treatment.

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.

Persistence with overactive bladder pharmacotherapy in a Medicaid population.

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.

Test-retest reliability of four questionnaires for patients with overactive bladder: the overactive bladder questionnaire (OAB-q), patient perception of bladder condition (PPBC), urgency questionnaire (UQ), and the primary OAB symptom questionnaire (POSQ).

AIMS: This study examined test-retest reliability of four patient-reported outcome measures for patients with overactive bladder (OAB): Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), Urgency Questionnaire (UQ), and Primary OAB Symptom Questionnaire (POSQ). METHODS: Patients recruited from urology clinics were scheduled for two visits 2 weeks apart and completed all questionnaires at both visits. A demographic form was completed at Visit 1; and a treatment effect scale was completed at Visit 2. Test-retest reliability was examined among stable patients using intraclass correlations (ICC), Spearman's correlations, paired t-tests, Feldt's statistic, and kappas. RESULTS: A total of 47 patients enrolled (mean age = 66.0 years, 74.5% female), with 46 completing both visits; 35 were classified stable. Statistically significant correlations were present between Visits 1 and 2 (P < 0.05) for all subscales of the OAB-q, UQ, and POSQ. Subscale ICCs were moderate to high (OAB-q > or = 0.83, UQ > or = 0.46, POSQ continuous items > or = 0.68). No significant differences between Visit 1 and 2 were noted, except for the OAB-q symptom bother scale (change of 5.8 points on a 100-point scale). The multi-item subscales of the OAB-q and the UQ demonstrated good internal consistency (Cronbach's alpha > or = 0.83 for all subscales) across both visits. Test-retest reliability of the PPBC was somewhat weaker than the other three measures, but still acceptable for use as a global, single-item outcome measure. CONCLUSIONS: The OAB-q, POSQ, and UQ demonstrated good test-retest reliability, with ICCs roughly equivalent or superior to those previously reported for 7-day micturition diaries. Findings suggest that the four measures examined in this study demonstrate the necessary reproducibility for use as outcome measures for OAB treatments.

Validation of an overactive bladder awareness tool for use in primary care settings.

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.

A review of quality-of-life questionnaires for urinary incontinence and overactive bladder: which ones to use and why?

Overactive bladder (OAB) and stress urinary incontinence have a profound impact on patients' health-related quality of life (HRQL). The purpose of this article is to identify and describe condition-specific HRQL measures validated among patients with symptoms of OAB or stress urinary incontinence. A Medline literature search was performed to identify published articles or abstracts focusing on the development and psychometric validation of relevant instruments. Target populations and psychometric properties (reliability, validity, responsiveness to change) of 16 questionnaires are reviewed. A range of well-validated, condition-specific HRQL measures are available. Recommendations are provided regarding which measures to use in different situations. When choosing among instruments, psychometric evidence and the match of an instrument to the study population should be considered.