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Background: Varenicline is a smoking cessation medication. Objectives: We analyzed patients’ out-of-pocket costs and utilization of and persistence with varenicline. Methods: De-identified claims data in the MarketScan® Commercial Claims and Encounters Database were analyzed retrospectively. Participants were all patients at least 18 years of age continuously enrolled in plans during 2009. Plans were categorized according to restriction (no coverage; prior authorization; smoking cessation program requirement; no restrictions) and out-of-pocket cost for a 30-day supply (low

Adherence with oral medication for overactive bladder syndrome is suboptimal. To improve adherence, the YourWay plan was developed to assist patients and health care providers in defining treatment expectations and facilitating communication.To evaluate medication adherence among patients with overactive bladder syndrome enrolled in the YourWay patient support plan, patient adoption of behavioral interventions, patient satisfaction with the plan, and physician experience with the plan.In this 13-week, single-arm, open-label, multicenter, noninterventional study, fesoterodine-naïve patients received a prescription for fesoterodine 4 or 8 mg and a packet including a 14-day fesoterodine sample, educational materials, and progress tracker. Patients registered for the YourWay plan, which included an educational resource kit, interactive voice-response calls, and optional online and mail support. The primary end point was the proportion of patients who filled a prescription for a ≥ 90-day supply of fesoterodine within 90 days of enrollment. Secondary end points were the proportion of patients who filled ≥ 1 prescription and ≥ 2 prescriptions (post hoc), patient evaluation of their experience and satisfaction with the YourWay plan, and differences between prescription fillers and nonfillers in plan adoption and assessment (post hoc). We surveyed an independent sample of physicians to assess their experience with YourWay.Of 500 study completers, 10.4% filled a prescription for a ≥ 90-day supply of fesoterodine. Of those filling a prescription, 26.2% filled ≥ 1 prescription and among those, 61.0% refilled their prescription at least once. Many behavioral recommendations were adopted by 82% to 94% of patients. Fillers were more likely to take fesoterodine as directed, whereas adoption of behavioral recommendations or plan satisfaction did not differ between fillers and nonfillers. Most patients reported that the plan was informative and feasible to implement, and that they were satisfied with various aspects of the plan. Physicians also reported positive experiences.Most patients adopted YourWay components and viewed the plan positively, although adherence remained a challenge.

When analyzing the randomized controlled trial, we may employ various statistical methods to adjust for baseline measures. Depending on the method chosen to adjust for baseline measures, inferential results can vary. We investigate the Type 1 error and statistical power of tests comparing treatment outcomes based on parametric and nonparametic methods. We also explore the increasing levels of correlation between baseline and changes from the baseline, with or without underlying normality. These methods are illustrated and compared via simulations.

OBJECTIVE Quantify incremental employee medical, pharmacy, sick leave, short- and long-term disability, and workers' compensation costs, absence days, and turnover associated with urge urinary incontinence (UUI) in employees. METHODS This retrospective 2001-2011 database comparison of employees with UUI versus those without UUI (controls) included employees aged 18.5 to 64.0 years at index, with 6-month preindex and 12-month postindex health plan enrollment. Logistic and generalized linear models measured postindex costs, absences, and turnover. RESULTS The study included 1448 employees with UUI and 337,796 controls. Employees with UUI had statistically significantly higher medical (131% higher), pharmacy (52%), sick leave (30%), and short-term disability (74%) costs and more sick leave (22%) and short-term disability (99%) days than controls (all P < 0.02). CONCLUSIONS Employees with UUI had 117% greater medical and pharmacy costs, 47% greater total absence costs, and 63% more absence days than employees without UUI.

Summary Objective To evaluate the impact of treating urge urinary incontinence (UUI), including mixed urinary incontinence (MUI), on healthcare resource utilisation, productivity, activity impairment and associated costs. Methods The study used data from the 2011 U.S. National Health and Wellness Survey, an Internet-based questionnaire of a nationwide sample of adults. UUI or MUI respondents were identified via three Incontinence Questions. Respondents with stress urinary incontinence only, prostate cancer or (medication for) benign prostatic hyperplasia were excluded. UUI/MUI respondents were categorised as Rx users for overactive bladder (OAB) and non-Rx users (who never used Rx and whose condition reportedly interfered with life activities or was difficult to manage). Outcome measures included healthcare utilisation and Work Productivity and Activity Impairment questionnaire-based scores. Direct and indirect costs were estimated using 2010 labour and 2008 medical expenditure data sources. Generalised linear models predicted resource use and productivity as a function of treatment status, adjusting for covariates (e.g. sociodemographics, OAB severity, comorbid status) that may also predict impairment. Results Rx (vs. non-Rx) users were more likely to be female (80.7% vs. 70.0%), older (mean = 62.7 vs. 53.1) and reporting more moderate-to-severe OAB (70.9% vs. 52.6%; all p

To assess the impact of access restrictions on varenicline utilization.Employer-sponsored health plans contributing to the MarketScan Commercial Claims and Encounters Database were categorized according to 2009 varenicline access restrictions: no coverage; prior authorization; smoking cessation program requirement; no restrictions. The cohort comprised all adults continuously enrolled in plans during 2009. Each restriction cohort was compared with the no restrictions cohort using descriptive analyses. Data were assessed using logistic regression; demographic and clinical characteristics were covariates.In this study (no coverage, n = 454,419; prior authorization, n = 171,530; smoking cessation program, n = 108,181; no restrictions, n = 607,389), compared with the no restrictions cohort, the odds of treatment were 71% lower (odds ratio: 0.29; 95% CI: 0.26, 0.31) in the smoking cessation program cohort (p0.001) and 80% lower (odds ratio: 0.20; 95% CI: 0.19, 0.22) in the prior authorization cohort (p0.001).Access restrictions were associated with significantly lower odds for varenicline utilization.

INTRODUCTION Concerns exist that varenicline may cause neuropsychiatric side effects. Some of these symptoms (e.g., depression, irritability) have been measured in clinical trials using nicotine withdrawal scales. This study assessed the effect of varenicline on neuropsychiatric and other symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). METHODS We analyzed weekly individual MNWS symptom ratings in 8 randomized double-blind, placebo-controlled smoking cessation trials funded by Pfizer with similar methodology (n = 2,403 varenicline; n = 1,434 placebo). Ratings for the past 24hr were obtained prior to quitting and starting treatment and at Weeks 1-6 and 11 after the quit date. RESULTS In repeated measures analyses controlling for baseline values, ratings for 5 neuropsychiatric symptoms (depressed mood, irritability, anxiety, difficulty concentrating, and restlessness) and urge to smoke were lower (p < .01) for varenicline than placebo at each timepoint. Worsening in scores from 0-2 (baseline) to 4 was less frequent on varenicline than placebo for all ratings except appetite- (significantly more frequent for varenicline, p < .0001) and sleep-related items. Repeated measures analysis for individuals with low levels of exhaled carbon monoxide revealed similar patterns except for a nonsignificant difference for increased appetite. CONCLUSIONS Use of varenicline while trying to quit smoking reduces and does not increase neuropsychiatric symptoms such as depressed mood and irritability measured on the MNWS in smokers without current psychiatric disorders. It is associated with increases in sleep disturbance and appetite although the latter appears due to enabling more subjects to abstain from smoking.

BACKGROUND: Varenicline, a selective α4β2 nicotinic acetylcholine receptor partial agonist, is a pharmacotherapy indicated for smoking cessation treatment. To our knowledge, no studies have described varenicline treatment adherence and efficacy from real-world treatment patterns in a U.S. primary care setting. OBJECTIVE: To estimate adherence to varenicline prescription orders and subsequent quit rates among smokers in a primary care setting. METHODS: In this retrospective cohort study, eligible patients were enrolled with Geisinger Health Plan, had an initial varenicline prescription written by a Geisinger provider between January 1, 2006, and December 31, 2009, and had a follow-up clinic visit within the subsequent 12 months. Adherence was derived from linking electronic prescriptions with adjudicated pharmacy claims. Smoking status was collected at each health care encounter. RESULTS: Of the 1,477 eligible patients, 823 (55.7%) were primary nonadherent, having failed to initiate on the prescribed varenicline therapy. Of the remaining 654 patients, 359 (54.9%) were adherent, having completed a full 12-week course of therapy, and 295 (45.1%) were partially adherent, having initiated but not completed the full course of therapy. A total of 521 patients (35.3%) ceased smoking during the 12-month follow-up period: 182 (50.7%) of the adherent cohort, 82 (27.8%) of the partially adherent population, and 257 (31.2%) of the nonadherent cohort. No significant difference was found in quit rates between the partially adherent and nonadherent patient cohorts (adjusted HR 0.88 [95% CI = 0.69-1.13]). However, patients adherent to the varenicline regimen were almost twice as likely to succeed in quitting smoking compared with completely nonadherent patients (HR 1.93 [95% CI = 1.59-2.33]). CONCLUSION: Smoking cessation occurred more often among individuals adherent to varenicline therapy; however, medication nonadherence was common. After prescribing varenicline, clinicians and payers could consider active patient follow-up to maximize adherence and optimize treatment outcomes.

With the growing focus on comparative effectiveness research and personalized medicine, receiver-operating characteristic analysis can continue to play an important role in health care decision making. Specific applications of receiver-operating characteristic analysis include predictive model assessment and validation, biomarker diagnostics, responder analysis in patient-reported outcomes, and comparison of alternative treatment options. The authors present a survey of the potential applications of the method and briefly review several relevant extensions. Given the level of attention paid to biomarker validation, personalized medicine and comparative effectiveness research, it is highly likely that the receiver-operating characteristic analysis will remain an important visual and analytic tool for medical research and evidence-based medicine in the foreseeable future.

Objectives: Although much has been published about the demographic and clinical characteristics of elderly patients with overactive bladder (OAB) who were enrolled in clinical trials, very little is known about the general population of elderly Americans with OAB. We update this gap in the literature by using real-world data to describe this population. Methods: We used Medicare claims and the Medicare Current Beneficiary Surveys from 2006 to 2011 to identify patients with OAB. We describe the demographic characteristics, functional impairment and physical limitations, concurrent medical conditions, Charlson Comorbidity Index (CCI) scores, and concomitant medication use of patients with OAB; these characteristics are also described by sex and age group (65–74 vs. ≥75 years). We also compare the characteristics of OAB with non-OAB patients. Results: We identified 415 elderly patients with OAB (average age 79 years; 71% female) and 6868 without OAB (average age 77 years; 62% female). Patients with OAB reported high levels of functional impairment as measured by the Activities of Daily Living (44% vs. 33% for non-OAB patients), Instrumental ADL (53% vs. 40% for non-OAB patients), and physical functioning limitation (90% vs. 81% for non-OAB patients) scales. Elderly patients with OAB also experienced high levels of comorbidity burden, as measured by the number of medical conditions (18 vs. 11 for non-OAB patients), CCI (2.1 vs. 1.4 for non-OAB patients), and number of non-OAB-related concomitant medications used (11 vs. 8 for non-OAB patients). Conclusions: Elderly patients with OAB in the general population have high levels of functional impairment and physical limitations, comorbidity, and concomitant medication use. These characteristics should be taken into consideration when managing OAB symptoms and designing future clinical studies. These results, which are representative of elderly patients with OAB in the general US population, should, however, be interpreted in light of the key limitations of the data we used: patients may have been misclassified and medical conditions overestimated due to artifacts of diagnosis coding and our results can only be generalized to patients who were enrolled in Medicare Parts A, B, and D for at least 12 continuous months.

What's known on the subject? and What does the study add? Studies on erectile dysfunction (ED) therapies rely heavily on patient-reported outcomes (PROs) to measure efficacy on treatment response. A challenge when using PROs is interpretation of the clinical meaning of changes in scores. A responder analysis provides a threshold score to indicate whether a change in score qualifies a patient as a responder. However, a major consideration with responder analysis is the sometimes arbitrary nature of defining the threshold for a response. By contrast, cumulative response curves (CRCs) display patient response rates over a continuum of possible thresholds, thus eliminating problems with a rigid threshold definition, allowing for a variety of response thresholds to be examined simultaneously, and encompassing all data. With respect to the psychosocial factors addressed in the Self-Esteem And Relationship questionnaire in ED, CRCs clearly, distinctly, and meaningfully highlighted the favourable profiles of responses to sildenafil compared with placebo. CRCs for PROs in urology can provide a clear, transparent and meaningful visual depiction of efficacy data that can supplement and complement other analyses. OBJECTIVE • To use cumulative response curves (CRCs) to enrich meaning and enhance interpretation of scores on the Self-Esteem And Relationship (SEAR) questionnaire with respect to treatment differences for men with erectile dysfunction (ED). PATIENTS AND METHODS • This post hoc analysis used data from all patients who took at least one dose of study drug and had at least one post-baseline efficacy evaluation in a previously published 12-week, multicentre, randomized, double-blind, placebo-controlled trial of flexible-dose (25, 50, or 100 mg) sildenafil citrate (Viagra) in adult men with ED who had scored ≤ 75 out of 100 on the Self-Esteem subscale of the SEAR questionnaire. • CRCs were used on the numeric change in transformed SEAR scores from baseline to end-of-study for each SEAR component. • The horizontal axis of the CRC represented change from baseline on the SEAR score, and the vertical axis represented the percentage of patients experiencing that change or greater. • The differences between CRCs for the sildenafil group vs the placebo group were assessed using the Kolmogorov–Smirov test. RESULTS • For each of the SEAR components, there was essentially no overlap in the CRCs between the sildenafil group (n= 113) and placebo group (n= 115 or 116, depending on the component), showing that a greater percentage of sildenafil recipients compared with placebo recipients had a more favourable change across the spectrum of response thresholds (P≤ 0.01). • Previous research showed that a 10-point score increase is the minimal clinically meaningful improvement for most SEAR components. In the sildenafil vs placebo groups, a ≥10-point score increase occurred in 72 vs 37% of patients, respectively, on the Sexual Relationship Satisfaction domain, 71 vs 41% on the Confidence domain, 76 vs 49% on the Self-Esteem subscale, 60 vs 44% on the Overall Relationship Satisfaction subscale, and 75 vs 38% on the Overall score. CONCLUSIONS • With respect to the psychosocial factors addressed in the SEAR questionnaire, CRCs clearly, distinctly, and meaningfully highlighted the favourable profiles of responses to sildenafil compared with placebo. • CRCs for patient-reported outcomes in urology can provide a clear, transparent, and meaningful visual depiction of efficacy data that can supplement and complement other analyses.

Small-vessel disease is a common MRI finding that can be difficult to differentiate from other white matter (WM) diseases because of the lack of a specific pattern of brain involvement. The purpose of our study was to evaluate medial lemniscus hyperintensity seen on FLAIR images as an imaging marker for small-vessel disease.Two blinded neuroradiologists retrospectively reviewed 103 consecutive outpatient brain MRI studies. Medial lemniscus signal in the dorsal pons was evaluated visually on FLAIR images and after placing regions of interest (ROIs) on T2-weighted images. On the basis of the original interpretations, scans were divided into three categories: small-vessel disease, multiple sclerosis (MS), and normal or nonspecific WM changes. Cardiovascular risk factors were recorded. Analysis of variance and Fisher exact tests were used to determine group differences, and kappa statistics was used to determine interrater agreement.Thirty-seven patients had small-vessel disease, 14 patients had MS, and 52 had nonspecific WM changes. Medial lemniscus hyperintensity was seen in about 20% of patients with small-vessel disease and was generally bilateral. Although ROI analyses identified a slightly higher number of patients with medial lemniscus signal20% of adjacent to normal-appearing brainstem, interrater reliability was moderate, and there were false-positive and false-negative cases in comparison with visual data. When small-vessel disease patients were further subdivided into mild or advanced subgroups, medial lemniscus hyperintensity was selectively seen in advanced small-vessel disease. Patients with medial lemniscus hyperintensity were older (p0.001) and had higher prevalence of diabetes (p = 0.03), hypertension (p = 0.009), and hypercholesterolemia (p = 0.03).Medial lemniscus hyperintensity seen on FLAIR images is a reliable radiologic marker of advanced small-vessel disease.

We compare several nonparametric and parametric weighting methods for the adjustment of the effect of strata. In particular, we focus on the adjustment methods in the context of receiver-operating characteristic (ROC) analysis. Nonparametrically, rank-based van Elteren's test and inverse-variance (IV) weighting using the area under the ROC curve (AUC) are examined. Parametrically, the stratified t-test and IV AUC weighted method are applied based on a binormal monotone transformation model. Stratum-specific, pooled, and adjusted estimates are obtained. The pooled and adjusted AUCs are estimated. We illustrate and compare these weighting methods on a multi-center diagnostic trial and through extensive Monte-Carlo simulations.

To address the gap in knowledge about the impact of chronic obstructive pulmonary disease (COPD) on older working adults, this study examined quality of life, worker productivity, and healthcare resource utilization among employed adults aged 65 and older with and without COPD. Among 2009 National Health and Wellness Survey (a cross-sectional, internet-based survey representative of the US adult population) respondents, employed adults aged 65 years and older, with COPD (n = 297) and without COPD (n = 3061), were included in analyses. Impact of self-reported COPD diagnosis on mean quality of life (using health utilities and mental, MCS, and physical, PCS, component summary scores from SF-12v2), work productivity and activity impairment (using the WPAI questionnaire), and resource use were examined. Adjusting for demographic and health characteristics such as co-morbidities (weighted to project to the US population) in regression models (linear, negative binomial, or logistic, as appropriate given the outcome measure), older workers with COPD reported significantly lower MCS (52.1 vs. 53.4, p < .05), PCS (40.3 vs. 47.2, p < .05), and health utilities (0.72 vs. 0.79, p < .05) than those without COPD, and significantly greater percentages of impairment while at work (presenteeism) (12.6% vs. 8.7%, p < .0001), overall work impairment (absenteeism and presenteeism combined) (19.3% vs. 10.0%, p < .05), and impairment in daily activities (23.9% vs. 13.7%, p < .05). There were no significant differences in absenteeism or healthcare use. Quality of life and work productivity suffered among employed adults aged 65 years and older with COPD, emphasizing the need for disease management in this population.

We examined diagnostic tests and treatment patterns in men with new onset benign prostatic hyperplasia using consolidated national electronic health record data.The Humedica® electronic health record database consists of de-identified patient records from approximately 25 million patients in the United States. Using this database, men with a new benign prostatic hyperplasia diagnosis (benign prostatic hyperplasia, bladder neck obstruction, urinary retention and incomplete bladder emptying) between July 1, 2009 and June 30, 2012 were included in study. Exclusion criteria included conditions such as genitourinary cancers, radiation cystitis, neurogenic bladder and urological pain diagnoses. Diagnostic tests and treatments were summarized and stratified by age (less than 65 vs 65 years or greater) and serum prostate specific antigen level.A total of 38,252 men met inclusion criteria. Mean followup was 1,020 days. Serum creatinine in 92% of patients, serum prostate specific antigen in 76% and urinalysis in 52% were the most common tests. Invasive testing was obtained in less than 20% of patients. Treatments included watchful waiting in 40% of patients, pharmacological therapy in 59.4% and surgery in 2.2%. α-Blockers were prescribed in 50.7% of men. Men older than 65 years and with higher prostate specific antigen levels were less likely to be treated with watchful waiting. Therapy with a 5-ARI (5-α reductase inhibitor) was prescribed in 23% to 29% of men across all prostate specific antigen categories.The majority of clinical care for new onset benign prostatic hyperplasia was in concordance with guideline recommendations. Based on prostate specific antigen values, 5-ARI therapy was underutilized in men with large prostates and was over utilized in men with small prostates.

Summary Aim: The aim of this study was to characterise the natural course of smoking cessation behaviour in a web-based survey of current and former cigarette smokers (CS and FS) in the United States. Methods: A web-based survey of CS and FS was conducted in April 2009; demographic and socioeconomic characteristics and smoking history (including the number of lifetime and length of latest quit attempts, aids used and time to relapse) were collated. The surveyed cohort was selected from prescreened CS and FS panellists and matched for age, race and education, to be representative of the US population. Descriptive statistics and time-to-event analyses using Kaplan–Meier curves were applied in the analysis of this report. Results: The final cohort comprised 512 CS and 566 FS (n = 1078). A larger proportion of FS than CS reported a longest smoke-free period of > 1 year (78.8% vs. 22.4%, respectively). As a greater variety of smoking cessation products became available over time, the proportion of unassisted quit attempts decreased from 76.1% prior to 1983 to 43.9% after 2006 for CS and from 79.3% to 50.3% for FS. The cumulative proportion of subjects relapsing was 31.3% by 1 week and 79.3% by 6 months. The estimated median time to next quit attempt was approximately 360 days. Conclusions: These data confirm that relapse is common and that as the variety of cessation modalities increase, the proportion of unassisted quit attempts decreases. Self-help or cold-turkey methods still provide significant alternatives even when pharmacotherapy is available. This study provides data related to the smoking history and smoking cessation patterns of a large, nationally representative sample of CS and FS.

The definitive version can be found at : http://onlinelibrary.wiley.com/ Copyright Wiley-Blackwell [Full text of this article is not available in the UHRA]

A fine-needle aspiration sample composed exclusively of Hurthle cells is interpreted as “suspicious for a follicular neoplasm, Hurthle cell type” (SFNHCT). Because some nonneoplastic Hurthle cell proliferations in Hashimoto thyroiditis (HT) mimic this cytologic pattern, we examined the positive predictive value (PPV) for malignancy of SFNHCT in patients with HT. Between 1992 and 2007, 401 patients with cytologic findings of SFNHCT were identified at 3 institutions. Histologic follow-up was available for 287 (71.6%), and malignancy was diagnosed in 69 (24.0%). Malignancy was present in 2 (PPV = 9.5%) of 21 patients with HT compared with 67 (PPV = 25.2%) of 266 patients without HT ( P = .081). Although the difference in the rate of malignancy between the HT and non-HT cohorts did not reach statistical significance, the lower risk of malignancy in the HT cohort more closely approximates the risk of cases interpreted as “atypia of undetermined significance.” For this reason, it might be appropriate for Hurthle cell–only aspirates from patients with HT to be categorized as either atypia of undetermined significance or SFNHCT.

To evaluate chronic obstructive pulmonary disease (COPD)-related expenditure and hospitalisation in COPD patients treated with tiotropium versus alternative long-acting bronchodilators (LABDs).Data were from the Thomson Reuters MarketScan Research Databases. COPD patients ≥ 35 years with at least one LABD claim between July 1, 2004 and June 30, 2006 were classified into five cohorts based on index LABD: monotherapy with tiotropium, salmeterol/fluticasone propionate, formoterol fumarate, or salmeterol or combination therapy. Demographic and clinical characteristics were evaluated for a 6-month pre-period and COPD-related utilisation and total costs were evaluated for a 12-month follow-up period. LABD relationship to COPD-related costs and hospitalisations were estimated by multivariate generalised linear modelling (GLM) and multivariate logistic regression, respectively.Of 52,274 patients, 53% (n = 27,457) were male, 71% (n = 37,271) were ≥ 65 years, and three LABD cohorts accounted for over 90% of the sample [53% (n = 27,654) salmeterol/fluticasone propionate, 23% (n = 11,762) tiotropium, and 15% (n = 7755) combination therapy]. Patients treated with salmeterol/fluticasone propionate (p0.001), formoterol fumarate (p = 0.032), salmeterol (p = 0.004), or with combination therapy (p0.001) had higher COPD-related costs and a greater risk of inpatient admission (p0.01 for all) versus tiotropium.These data are based on administrative claims and as such do not include clinical information or information on risk factors, like smoking status, that are relevant to this population.Patients treated with tiotropim had lower COPD-related expenditures and risk of hospitalisation than patients treated with other LABDs.

Lucas MA Goossens1, Christine L Baker2, Brigitta U Monz3, Kelly H Zou2, Maureen PMH Rutten-van Mölken11Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands; 2Pfizer Inc, New York City, NY, USA; 3Boehringer Ingelheim International GmbH, Ingelheim am Rhein, GermanyPurpose: When comparing chronic obstructive lung disease (COPD) interventions in database research, it is important to adjust for severity. Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines grade severity according to lung function. Most databases lack data on lung function. Previous database research has approximated COPD severity using demographics and healthcare utilization. This study aims to derive an algorithm for COPD severity using baseline data from a large respiratory trial (UPLIFT).Methods: Partial proportional odds logit models were developed for probabilities of being in GOLD stages II, III and IV. Concordance between predicted and observed stage was assessed using kappa-statistics. Models were estimated in a random selection of 2/3 of patients and validated in the remainder. The analysis was repeated in a subsample with a balanced distribution across severity stages. Univariate associations of COPD severity with the covariates were tested as well.Results: More severe COPD was associated with being male and younger, having quit smoking, lower BMI, osteoporosis, hospitalizations, using certain medications, and oxygen. After adjusting for these variables, co-morbidities, previous healthcare resource use (eg, emergency room, hospitalizations) and inhaled corticosteroids, xanthines, or mucolytics were no longer independently associated with COPD severity, although they were in univariate tests. The concordance was poor (kappa = 0.151) and only slightly better in the balanced sample (kappa = 0.215).Conclusion: COPD severity cannot be reliably predicted from demographics and healthcare use. This limitation should be considered when interpreting findings from database studies, and additional research should explore other methods to account for COPD severity.Keywords: GOLD, healthcare resource use, partial proportional odds logit

Aims To assess the prevalence of overactive bladder (OAB) among medically complex vulnerable elderly (MCVE) patients in the United States and to compare health status measures, functional status, healthcare events, use of healthcare services and costs between MCVE patients with and without OAB. Methods Using the 2001-2010 Medicare Current Beneficiary Surveys, we defined the MCVE as those respondents who were ≥65 years old with scores ≥3 on the Vulnerable Elders Survey-13. OAB diagnosis codes or self-reported use of antimuscarinic medications were used to identify MCVE individuals with OAB. Multiple regression analyses were used to estimate the adjusted relationship between OAB and the outcome measures. Results The annual prevalence of OAB among the MCVE increased from 9.6% in 2001 to 13.5% in 2010. MCVE individuals with OAB were more likely to have experienced falls or fractures (odds ratio [OR] = 1.6; 95% confidence interval [CI]: 1.3-2.0), urinary tract infections (OR = 4.3; 95% CI: 3.5-5.4), institutionalization (OR = 1.9; 95% CI: 1.4-2.5), limitations in activity of daily living (ADL) (OR = 1.4; 95% CI: 1.1-1.7) and instrumental ADL (OR = 1.5; 95% CI: 1.2-2.0), hospital admission (OR = 1.6; 95% CI: 1.3-2.0) and emergency department admissions (OR = 1.6; 95% CI: 1.3-2.0) than those without OAB. MCVE individuals with OAB incurred, on average, $7188 (2013 dollars) more in healthcare costs than those without OAB. Discussion/conclusions The prevalence of OAB in the MCVE population increased over time. OAB is associated with substantial clinical and economic burden. Further research is warranted to understand whether better management of the MCVE population with OAB may reduce healthcare resource use.

Introduction Men may choose to bypass the healthcare system to obtain a phosphodiesterase type 5 inhibitor (PDE5i). Aim Evaluate the characteristics and purchasing patterns of men obtaining a PDE5i without prior healthcare professional (HCP) interaction. Main Outcome Measures Prior HCP interaction, defined as having a prescription for any PDE5i, having a PDE5i sample from a physician, or buying the PDE5i in a retail pharmacy; and erectile dysfunction (ED, the Massachusetts Male Aging Study single-item question) were assessed. A multivariate regression analysis determined predictive factors for PDE5i purchase without prior HCP interaction. Methods A Web-based observational study was conducted in the United Kingdom, Germany, and Italy. Results Of the 11,899 participants, 1,252 (10.5% [95% CI, 10.0–11.1%]) reported PDE5i use in the last 6 months. PDE5is were obtained without prior HCP interaction by 403 users (32.3% [95% CI, 29.6–34.8%]); 65.5% of them had ED. Overall prevalence of men using PDE5is without HCP interaction was 3.0% (95% CI, 2.6–3.5%), 4.1% (95% CI, 3.5–4.6%), and 2.8% (95% CI, 2.1–3.5%) for men aged 18–34, 35–50, and >50 years, respectively (P = 0.0045). Predictive factors for obtaining a PDE5i without prior HCP interaction were embarrassment to speak to a physician (P = 0.0009) and the perception that this would be the cheapest way to get the medicine (P = 0.03). Conclusions Based on these findings, it can be estimated that approximately 6 million men in Europe might currently bypass the healthcare system to obtain a PDE5i. In addition to the risks associated with use of PDE5is from uncontrolled sources, because most of these men have ED, they also miss the opportunity for important health information or medical follow-up. HCPs should actively address ED and offer treatment to discourage men from seeking uncontrolled sources of ED medicines.

The objective of our study was to describe the T1 and T2 signal intensity characteristics of papillary renal cell carcinoma (RCC) and clear cell RCC with pathologic correlation.Of 539 RCCs, 49 tumors (21 papillary RCCs and 28 clear cell RCCs) in 45 patients were examined with MRI. Two radiologists retrospectively and independently assessed each tumor's T1 and T2 signal intensity qualitatively and quantitatively (i.e., the signal intensity [SI] ratio [tumor SI / renal cortex SI]). Of the 49 tumors, 37 (76%) were assessed for pathology features including tumor architecture and the presence of hemosiderin, ferritin, necrosis, and fibrosis. MRI findings and pathology features were correlated. Statistical methods included summary statistics and Wilcoxon's rank sum test for signal intensity, contingency tables for assessing reader agreement, concordance rate between the two readers with 95% CIs, and Fisher's exact test for independence, all stratified by RCC type.Papillary RCCs and clear cell RCCs had a similar appearance and signal intensity ratio on T1-weighted images. On T2-weighted images, most papillary RCCs were hypointense (reader 1, 13/21; reader 2, 14/21), with an average mean signal intensity ratio for both readers of 0.67 +/- 0.2, and none was hyperintense, whereas most clear cell RCCs were hyperintense (reader 1, 21/28; reader 2, 17/28), with an average mean signal intensity ratio for both readers of 1.41 +/- 0.4 (p0.05). A tumor T2 signal intensity ratio ofor = 0.66 had a specificity of 100% and sensitivity of 54% for papillary RCC. Most T2 hypointense tumors exhibited predominant papillary architecture; most T2 hyperintense tumors had a predominant nested architecture (p0.05).On T2-weighted images, most papillary RCCs are hypointense and clear cell RCCs, hyperintense. The T2 hypointense appearance of papillary RCCs correlated with a predominant papillary architecture at pathology.

While the use of p-values in evidence-based medicine (EBM) is consistent and well-defined, the application of statistical information in health law varies greatly. A comparative literature review of clinical and legal medical decision making using Medline (PubMed) and LexisNexis reveals large disparities in the mode and frequency with which statistical evidence is used in EBM when compared with health law. We present the historical background of the p-value in the statistical literature and legal case law, including several medical malpractice cases, and then compare the use of the p-value as statistical evidence in health law and clinical research. We suggest that health law may consider the establishment of statistical criteria for appropriate applications.

To prospectively determine in a fetal pig model whether diagnostic performance comparable to that of high-detail screen-film imaging can be achieved with computed radiography for the detection of simulated classic metaphyseal lesions (CMLs), by using Faxitron digital images as the reference standard, and whether radiation dose reduction is possible.This study was granted exempt status by the institutional review board and the animal care and use committee. Fractures simulating the CML were produced in distal femurs of 20 deceased fetal pigs. Twenty normal femurs served as control femurs. Femurs were imaged with a standard single-side-read 100-microm pixel sampling imaging plate (IP), a high-resolution dual-side-read 50-microm pixel sampling IP, and a high-detail screen-film imaging system. Eight tube current-time product settings (0.5-10.0 mAs) and two tube voltage selections (56 and 70 kVp) were employed. Two pediatric radiologists evaluated 920 images for fracture by using a five-point Likert scale. Area under the receiver operating characteristic curve (A(z)) values for the imaging systems were compared by using nonparametric chi(2) tests (all P.05).For pooled rater data, performance of computed radiography was comparable to that of screen-film imaging, and superior performance (P = .04) was achieved with the more experienced rater. The A(z) value tended to increase as the tube current-time product setting was increased. Within each system, there was no significant difference in A(z) values for all images obtained at 56 and 70 kVp (dual-side-read IP, P = .63; single-side-read IP, P = .25; screen-film imaging system, P = .5). At 56 kVp, a dose reduction of up to 69% was achieved, and accuracy of computed radiography was comparable to that of screen-film imaging.Findings in this study suggest that computed radiography can replace screen-film imaging in the detection of CMLs and may permit dose reduction.

The purpose of our study was to assess the utility of performing routine pelvic and lower extremity CT venography (CTV) along with pulmonary CT angiography (CTA) in all patients evaluated for pulmonary embolism.Eight hundred twenty-nine consecutive patients (281 men and 548 women) underwent CTA-CTV for pulmonary embolism. Reports were evaluated as follows: positive or negative for pulmonary embolism with or without deep venous thrombosis (DVT) or with nondiagnostic CTV. Coexisting factors of malignancy, previous venous thromboembolism (VTE), recent surgery, and cardiovascular disease comprised the high-risk group of 446 patients. The remaining 383 patients formed the low-risk group. Statistical analysis included four binary predictors (previous VTE, malignancy, cardiovascular disease, and surgery) and three binary outcome variables (pulmonary embolism, DVT, and VTE). Chi-square test and univariate and multivariate regression analyses were performed.VTE, pulmonary embolism, and DVT occurred in 152 (18.3%), 124 (15.0%), and 61 (7.3%) of 829 patients, respectively. Between the high-risk and low-risk groups, prevalence of VTE was 114 (25.6%) of 446 and 38 (9.9%) of 383 patients, respectively (p0.001); prevalence of pulmonary embolism was 92 (20.6%) of 446 and 32 (8.3%) of 383 patients, respectively (p0.001). Isolated DVT was found in 28 (3.4%) of 829 patients. The incremental value of CTV for the entire cohort was 3.4%, 0.72% in the low-risk group (six of 829) and 2.6% (22 of 829) in the high-risk group. For outcome variable VTE, malignancy and previous VTE were statistically significant (p = 0.04 and p0.001, respectively); for pulmonary embolism, malignancy and previous VTE were statistically significant (p = 0.03 and p = 0.005, respectively); for DVT, only previous VTE was statistically significant (p0.001).CTV should not be performed routinely in all patients evaluated for pulmonary embolism and may only be useful in patients with a high probability of pulmonary embolism, including those with a history of VTE and possible malignancy.

We reviewed our experience with 2 indicators of cytopathologist performance: the relative frequency of the interpretations atypical squamous cells of undetermined significance (ASC-US) and squamous intraepithelial lesion (SIL) and the frequency of positive test results for high-risk human papillomavirus (HR-HPV) DNA associated with a cytologic interpretation of ASC-US. Data derived for 9 cytopathologists were reviewed. ASC-US/SIL ranged from 0.99 to 4.02 (mean, 1.77) in 2005 and from 0.82 to 3.68 (mean, 1.81) in 2006. The HR-HPV+ rate for ASC-US ranged from 31.5% to 54.6% for individual cytopathologists (mean, 46.1%) in 2005 and from 29.6% to 61.8% (mean, 45.8%) in 2006. Combined data from both years showed only a slight negative correlation for these 2 variables. Both indicators together provide useful feedback to cytopathologists. We provide a working schema for interpreting perturbations in these indicators to assist in improving the quality of gynecologic cytology interpretations.

The aim of the study was to retrospectively determine the potential for radiation dose reduction at multidetector computed tomography (CT) of the paranasal sinus by using computer simulation of the effect of low–radiation dose acquisition on diagnostic image quality. This HIPAA compliant study was approved by the institutional human research committee. The need for informed patient consent was waived. Twenty patients underwent four-section CT at 120 kV, 170 mAs, and 4 × 1-mm collimation. Artificial image noise was added to the CT raw data by using a dedicated software platform. Acquisitions with effective tube currents of 134, 100, 67, and 33 mAs were simulated. Each raw data set was reconstructed with bone and soft-tissue algorithms, and two radiologists independently rated the images in blinded fashion. A two-sided paired Student t test was used for statistical analysis. The lowest radiation dose that still provided diagnostic quality was ≤67 effective mAs for osseous structures and ≤134 effective mAs f...

Receiver-operating characteristic (ROC) analysis was originally developed during World War II to analyze classification accuracy in differentiating signal from noise in radar detection.1 Recently, the methodology has been adapted to several clinical areas heavily dependent on screening and diagnostic tests,2–4 in particular, laboratory testing,5 epidemiology,6 radiology,7–9 and bioinformatics.10 ROC analysis is a useful tool for evaluating the performance of diagnostic tests and more generally for evaluating the accuracy of a statistical model (eg, logistic regression, linear discriminant analysis) that classifies subjects into 1 of 2 categories, diseased or nondiseased. Its function as a simple graphical tool for displaying the accuracy of a medical diagnostic test is one of the most well-known applications of ROC curve analysis. In Circulation from January 1, 1995, through December 5, 2005, 309 articles were published with the key phrase “receiver operating characteristic.” In cardiology, diagnostic testing plays a fundamental role in clinical practice (eg, serum markers of myocardial necrosis, cardiac imaging tests). Predictive modeling to estimate expected outcomes such as mortality or adverse cardiac events based on patient risk characteristics also is common in cardiovascular research. ROC analysis is a useful tool in both of these situations. In this article, we begin by reviewing the measures of accuracy—sensitivity, specificity, and area under the curve (AUC)—that use the ROC curve. We also illustrate how these measures can be applied using the evaluation of a hypothetical new diagnostic test as an example. A diagnostic classification test typically yields binary, ordinal, or continuous outcomes. The simplest type, binary outcomes, arises from a screening test indicating whether the patient is nondiseased (Dx=0) or diseased (Dx=1). The screening test indicates whether the patient is likely to be diseased or not. When >2 categories are used, the test data can be on an ordinal rating …

Purpose: To quantify needle placement accuracy of magnetic resonance image (MRI)-guided core needle biopsy of the prostate. Materials and Methods: A total of 10 biopsies were performed with 18-gauge (G) core biopsy needle via a percutaneous transperineal approach. Needle placement error was assessed by comparing the coordinates of preplanned targets with the needle tip measured from the intraprocedural coherent gradient echo images. The source of these errors was subsequently investigated by measuring displacement caused by needle deflection and needle susceptibility artifact shift in controlled phantom studies. Needle placement error due to misalignment of the needle template guide was also evaluated. Results: The mean and standard deviation (SD) of errors in targeted biopsies was 6.5 3.5 mm. Phantom experiments showed significant placement error due to needle deflection with a needle with an asymmetrically beveled tip (3.2– 8.7 mm depending on tissue type) but significantly smaller error with a symmetrical bevel (0.6 –1.1 mm). Needle susceptibility artifacts observed a shift of 1.6 0.4 mm from the true needle axis. Misalignment of the needle template guide contributed an error of 1.5 0.3 mm. Conclusion: Needle placement error was clinically significant in MRI-guided biopsy for diagnosis of prostate cancer. Needle placement error due to needle deflection was the most significant cause of error, especially for needles with an asymmetrical bevel.

To assess the costs of treating overactive bladder (OAB) with fesoterodine compared to no OAB pharmacotherapy among vulnerable elderly from the US payer perspective.A decision analytic cost model was developed to estimate the 52-week costs of a cohort of vulnerable elderly with OAB initiating treatment with fesoterodine or no OAB pharmacotherapy. Vulnerable elderly OAB patients were defined as those aged ≥65 years with self-reported urge urinary incontinence (UUI) symptoms for ≥3 months, 2-15 UUI episodes/day, and at risk of deteriorating health by a score of ≥3 on the Vulnerable Elders Survey (VES)-13. Patients were evaluated for fesoterodine treatment response (defined as no UUI episodes) and persistence at weeks 12, 26, and 52. The model included a hypothetical health plan with 100,000 elderly members. A total of 7096 vulnerable elderly subjects were identified as the model target population based on the percentage of vulnerable elderly and annual prevalence of OAB among vulnerable elderly. OAB-related costs included fesoterodine drug acquisition costs, healthcare resource use (inpatient hospitalization, outpatient visits, and physician office visits), and OAB-related co-morbidities (falls/fractures, urinary tract infections, depression, and nursing home admissions). All costs were inflated to 2013 US$ using the medical care component of the consumer price index (CPI).When 7096 vulnerable elderly OAB patients were treated with fesoterodine, US healthcare payers could save $11,463,981 per year, or $1616 per patient vs no OAB pharmacotherapy. Univariate one-way sensitivity analyses supported the robustness of the findings and showed results were most sensitive to changes in fesoterodine efficacy followed by annual costs of inpatient hospitalization.From a US payer perspective, treating vulnerable elderly OAB patients with fesoterodine was cost-saving compared to no OAB pharmacotherapy.

INTRODUCTION AND OBJECTIVES: Lower urinary tract symptoms associated with BPH are highly prevalent among aging men and place a large socioeconomic burden on the US health care system. Few nationally representative datasets are available that have evaluated patterns of non-surgical care for men with BPH. To examine national practice patterns for incident BPH in men age 18þ, stratified by age 30 days apart, based on International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes 600.x (BPH), 596.0 (bladder neck obstruction), 788.20 (urinary retention), and 788.21 (incomplete bladder emptying), were included between 7/1/2009 and 6/30/2012. Other inclusion criteria for incident BPH (vs prevalent disease) were continuous enrollment for 1 year before and 6 months after the first diagnosis date, and no BPH diagnosis during the previous year. Pts with ICD-9 diagnoses of neurologic conditions or urologic malignancy were excluded. Overall outcomes through 9/30/2013 were analyzed. Variables of interest included pt comorbidities, demographics, diagnostic tests, and medication prescriptions. RESULTS: A total of 38,252 men were included. The majority (24,814, 65%) were aged 65þ, and 41% had 1þ comorbid conditions. Diagnostic tests included post-void residual measurement in 21%, renal ultrasound in 9%, cystoscopy in 6%, prostate ultrasound in 3%, and urodynamics in 1% of pts. A total of 58% of men were prescribed BPH medications, including alpha blockers (50%) and/or 5-alpha reductase inhibitors (24%). Older men had higher rates of prescriptions for both alpha blockers and 5-alpha reductase inhibitors than younger men (Table 1). CONCLUSIONS: Men aged 65þ had higher rates of prescriptions overall, possibly due to more severe symptoms among older men. The relatively low rate of renal ultrasound and other diagnostic tests may reflect adherence to the 2010 American Urological Association BPH guidelines. Source of Funding: No financial support was received for this study.

According to the Agency for Healthcare Research and Quality, “comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care.” Since it is difficult to systematically review each study to generate the best evidence and practice based on the overall diagnostic accuracy, it is useful to conduct a meta-analysis of such studies. Our main aim is to synthesize and to combine studies that yield proportions in a two-sample setting according to a reference standard. Statistical methods for combining sensitivities, specificities, and log diagnostic odds ratios are compared. A summary receiver operating characteristic curve is constructed. Monte Carlo simulation studies are conducted under both homogeneity and heterogeneity assumptions. For illustration purposes, a publically available example in urology is provided.

Introduction Our purpose was to study the association between the intracranial arterial calcifications observed on head CT and brain infarcts demonstrated by MRI in patients presenting with acute stroke symptoms. Methods Institutional review board approval was obtained for this retrospective study which included 65 consecutive patients presenting acutely who had both head CT and MRI. Arterial calcifications of the vertebrobasilar system and the intracranial cavernous carotid arteries (intracranial carotid artery calcification, ICAC) were assigned a number (1 to 4) in the bone window images from CT scans. These four groups were then combined into high calcium (grades 3 and 4) and low calcium (grades 1 and 2) subgroups. Brain MRI was independently evaluated to identify acute and chronic large-vessel infarcts (LVI) and small-vessel infarcts (SVI). The relationship between ICAC and infarcts was evaluated before and after adjusting for demographics and cardiovascular risk factors. Results Statistical analysis could not be performed for the vertebrobasilar system due to an insufficient number of patients in the high calcium group. Of the 65 patients, 46 (71%) had a high ICAC grade on head CT. They were older and had a higher prevalence of cardiovascular risk factors. Acute SVI (P=0.006), chronic SVI (P=0.006) and acute LVI (P=0.04) were associated with a high ICAC grade. After adjustment for age and other risk factors, only acute SVI was associated with a high ICAC grade (P=0.002). Conclusion Although age emerged as the most important determinant of ischemic cerebral changes, there were rather complex interactions among multiple risk factors with different infarct types. A high ICAC grade demonstrated a correlation with acute SVI in our patients independent of these risk factors.

To retrospectively assess the main variables that affect the complete magnetic resonance (MR) imaging-guided resection of supratentorial low-grade gliomas.Institutional review board approval was obtained for this retrospective HIPAA-compliant study, with the requirement for informed consent waived. Data from 101 patients (61 men, 40 women; mean age, 39 years; age range, 18-72 years) who had nonenhancing supratentorial mass lesions that were histopathologically diagnosed as low-grade (World Health Organization grade II) gliomas and consecutively underwent surgery with intraoperative MR imaging guidance were analyzed. There were 21 low-grade astrocytomas, 64 oligodendrogliomas, and 16 mixed oligoastrocytomas. Initial and residual tumor volumes were measured on intraoperative T2-weighted MR images and three-dimensional spoiled gradient-echo MR images. The anatomic relationships between the tumor and eloquent cortical and/or subcortical regions and the influence of these relationships on the extent of resection were analyzed on the basis of preoperative MR imaging findings. Summary measures, univariate Fisher exact test and t test, and multivariate logistic regression analyses were performed.Tumor volume ranged from 2.7-231.0 mL. Univariate analyses revealed the following tumor characteristics to be significant predictive variables of incomplete tumor resection: diffuse tumor margin on T2-weighted MR images, oligodendroglioma or oligoastrocytoma histopathologic type, and large tumor volume (P.05 for all). Tumor involvement of the following structures was associated with incomplete resection: corpus callosum, corticospinal tract, insular lobe, middle cerebral artery, motor cortex, optic radiation, visual cortex, and basal ganglia (P.05 for all). Multivariate analyses revealed that incomplete tumor resection was due to tumor involvement of the corticospinal tract (P.01), large tumor volume (P.01), and oligodendroglioma histopathologic type (P = .02).The main variables associated with incomplete tumor resection in 101 patients were identified by using statistical predictive analyses.

Rationale and Objectives When diagnostic tests are repeated and combined, a number of schemes may be adopted. Guidelines for their interpretations are required. Materials and Methods Three combination schemes, “and” (A), “or” (O), and “majority” (M), are considered. To evaluate these schemes, dependency by specifying κ values quantifying repeated test agreement was structured. In a pilot study, the combined accuracies of magnetic resonance imaging using six different pulse sequences of medial collateral ligaments of the elbows of 28 cadavers, with eight having lesions artificially created surgically, were examined. Images were evaluated simultaneously by using a five-point ordinal scale. For each pulse sequence, individuals for whom the diagnosis varied from once to three repetitions were considered. Results Scheme M improves diagnostic accuracy when sensitivity and specificity of a single test exceed 0.5, with maximal improvement at 0.79. Under scheme A, sensitivity decreases to 0.38–0.59. Under scheme O, sensitivity increases to 0.53–0.79. Scheme M yields a small improvement, reaching 0.50–0.71. Under scheme A, specificity increases to 0.95–0.98. Under scheme O, specificity decreases to 0.91–0.98. Scheme M also yields a small improvement, reaching 0.94–0.98. Conclusion Scheme A is recommended for ruling in diagnoses, scheme O is recommended for ruling out diagnoses, and scheme M is neutral. Consequently, different schemes may be used to optimize the target diagnostic accuracy.

The introduction and development, over the last three decades, of magnetic resonance (MR) imaging and MR spectroscopy technology for in vivo studies of the human brain represents a truly remarkable achievement, with enormous scientific and clinical ramifications. These effectively non-invasive techniques allow for studies of the anatomy, the function and the metabolism of the living human brain. They have allowed for new understandings of how the healthy brain works and have provided insights into the mechanisms underlying multiple disease processes which affect the brain. Different MR techniques have been developed for studying anatomy, function and metabolism. The primary focus of this review is to describe these different methodologies and to briefly review how they are being employed to more fully appreciate the intricacies associated with the organ, which most distinctly differentiates the human species from the other animal forms on earth.

Performance of automated methods to isolate brain from nonbrain tissues in magnetic resonance (MR) structural images may be influenced by MR signal inhomogeneities, type of MR image set, regional anatomy, and age and diagnosis of subjects studied. The present study compared the performance of four methods: Brain Extraction Tool (BET; Smith [2002]: Hum Brain Mapp 17:143–155); 3dIntracranial (Ward [1999] Milwaukee: Biophysics Research Institute, Medical College of Wisconsin; in AFNI); a Hybrid Watershed algorithm (HWA, Segonne et al. [2004] Neuroimage 22:1060–1075; in FreeSurfer); and Brain Surface Extractor (BSE, Sandor and Leahy [1997] IEEE Trans Med Imag 16:41–54; Shattuck et al. [2001] Neuroimage 13:856 – 876) to manually stripped images. The methods were applied to uncorrected and bias-corrected datasets; Legacy and Contemporary T1-weighted image sets; and four diagnostic groups (depressed, Alzheimer’s, young and elderly control). To provide a criterion for outcome assessment, two experts manually stripped six sagittal sections for each dataset in locations where brain and nonbrain tissue are difficult to distinguish. Methods were compared on Jaccard similarity coefficients, Hausdorff distances, and an Expectation-Maximization algorithm. Methods tended to perform better on contemporary datasets; bias correction did not significantly improve method performance. Mesial sections were most difficult for all methods. Although AD image sets were most difficult to strip, HWA and BSE were more robust across diagnostic groups compared with 3dIntracranial and BET. With respect to specificity, BSE tended to perform best across all groups, whereas HWA was more sensitive than other methods. The results of this study may direct users towards a method appropriate to their T1-weighted datasets and improve the efficiency of processing for large, multisite neuroimaging studies.

To prospectively investigate the factors--including subject, brain hemisphere, study site, field strength, imaging unit vendor, imaging run, and examination visit--affecting the reproducibility of functional magnetic resonance (MR) imaging activations based on a repeated sensory-motor (SM) task.The institutional review boards of all participating sites approved this HIPAA-compliant study. All subjects gave informed consent. Functional MR imaging data were repeatedly acquired from five healthy men aged 20-29 years who performed the same SM task at 10 sites. Five 1.5-T MR imaging units, four 3.0-T units, and one 4.0-T unit were used. The subjects performed bilateral finger tapping on button boxes with a 3-Hz audio cue and a reversing checkerboard. In a block design, 15-second epochs of alternating baseline and tasks yielded 85 acquisitions per run. Functional MR images were acquired with block-design echo-planar or spiral gradient-echo sequences. Brain activation maps standardized in a unit-sphere for the left and right hemispheres of each subject were constructed. Areas under the receiver operating characteristic curve, intraclass correlation coefficients, multiple regression analysis, and paired Student t tests were used for statistical analyses.Significant factors were subject (P.005), k-space (P.005), and field strength (P = .02) for sensitivity and subject (P = .03) and k-space (P = .05) for specificity. At 1.5-T MR imaging, mean sensitivities ranged from 7% to 32% and mean specificities were higher than 99%. At 3.0 T, mean sensitivities and specificities ranged from 42% to 85% and from 96% to 99%, respectively. At 4.0 T, mean sensitivities and specificities ranged from 41% to 73% and from 95% to 99%, respectively. Mean areas under the receiver operating characteristic curve (+/- their standard errors) were 0.77 +/- 0.05 at 1.5 T, 0.90 +/- 0.09 at 3.0 T, and 0.95 +/- 0.02 at 4.0 T, with significant differences between the 1.5- and 3.0-T examinations and between the 1.5- and 4.0-T examinations (P.01 for both comparisons). Intraclass correlation coefficients ranged from 0.49 to 0.71.MR imaging at 3.0- and 4.0-T yielded higher reproducibility across sites and significantly better results than 1.5-T imaging. The effects of subject, k-space, and field strength on examination reproducibility were significant.

Rationale and Objectives To determine and analyze the patterns of practice of nonvascular interventional procedures in academic centers in the United States. Materials and Methods A survey was administered via e-mail to the chief residents of 112 academic radiology departments in the United States. Recipients of the survey were asked to identify which sections within their respective radiology departments performed each of 43 types of nonvascular interventional procedures. An additional entry for performance of procedures by non-radiologists was provided. A total of 66 (59%) recipients responded. The statistical method used was the analysis of contingency tables. Results Percutaneous abdominal biopsies are performed mainly by abdominal and body imaging sections (43/66, 65%), followed by vascular/interventional sections (21/66, 32%). Percutaneous abdominal drainages are performed mostly by abdominal, body imaging, and computed tomography sections (40/66, 61%), followed by vascular/interventional sections. Fluoroscopically guided procedures were performed most commonly by vascular/interventional sections, including percutaneous gastrostomy (40/66, 61%), percutaneous nephrostomy (42/66, 64%), and biliary interventions such as percutaneous transhepatic cholangiography (47/66, 71%). Breast and musculoskeletal procedures are performed by their respective sections most frequently. Non-radiologists perform a significant portion of certain types of procedures: paracenteses, thoracenteses, biliary interventions (particularly stone extractions), enterostomies (particularly percutaneous jejunostomies and cecostomies), and certain biopsies (kidney and prostate). Conclusions Academic US radiology sections perform nonvascular interventional radiology procedures in a complex and nonuniform manner. The vascular/interventional sections and organ system and modality (especially CT) sections perform the bulk of the procedures included in the survey. Breast imaging sections predominate in procedures in their disciplines. A substantial number and amount of interventional radiology procedures are performed by non-radiologists.

Receiver operating characteristic (ROC) curves are frequently used in biomedical informatics research to evaluate classification and prediction models for decision support, diagnosis, and prognosis. ROC analysis investigates the accuracy of a model’s ability to separate positive from negative cases (such as predicting the presence or absence of disease), and the results are independent of the prevalence of positive cases in the study population. It is especially useful in evaluating predictive models or other tests that produce output values over a continuous range, since it captures the trade-off between sensitivity and specificity over that range. There are many ways to conduct an ROC analysis. The best approach depends on the experiment; an inappropriate approach can easily lead to incorrect conclusions. In this article, we review the basic concepts of ROC analysis, illustrate their use with sample calculations, make recommendations drawn from the literature, and list readily available software.