bluuebunny/crossref_metadata_2025 huggingface dataset:
How Do Different Faces of Paternalistic Leaders Facilitate or Impair Task and Innovative Performance? Opening the Black Box
Authors: Karakitapoğlu-Aygün Zahide , Gumusluoglu Lale , Scandura Terri A.
Published: March 2019

There is a growing amount of research integrating leadership and positive organizational behavior literatures in order to understand the processes through which leadership contributes to performance. One such mechanism through which leaders influence performance is psychological capital (PsyCap). Particularly, paternalistic leadership, which is a leadership style that combines discipline, authority, and power with fatherly benevolence, may be a critical antecedent to the development of followers’ PsyCap. Yet no studies to date have investigated how paternalistic leaders affect followers’ PsyCap, which, in turn, influences their task and innovative performance. To this end, based on a sample of 409 Turkish employees and their 72 leaders, the current study investigates the effects of three dimensions of paternalistic leadership (i.e., benevolent, authoritarian, and authoritative) on followers’ leader-rated task and innovative performance. While there were no significant mediation effects for task performance, the results revealed that both benevolent and authoritative leadership positively influenced innovative performance through enhancing followers’ PsyCap. Authoritarian leadership, however, has negative effects on PsyCap, which, in turn, mediates the effect on innovative performance of followers. The theoretical and practical implications of our findings, along with suggestions for future research, are discussed.
Considerations for Building a Prosperous and Self-Determining Osage Nation Through Education
Authors: RedCorn Alex
Published: March 2019

This case introduces the current educational leadership context found in the executive branch of the Osage Nation, which is experiencing an era of rapid growth in the wake of a constitutional reform effort in 2004 to 2006. Utilizing a specific narrative that puts an Osage educational leader in charge of developing a 10-year plan that will guide the development of an emerging Osage Nation Birth-12th grade school system, this case helps educational leaders consider the various dynamics associated with building schools and educational programming from the perspective of the Osage Nation executive branch.
How geopolitical becomes personal: Method acting, war films and affect
Authors: Eken M Evren
Published: March 2019

This article is about weaponisation of emotions through visual culture. It interrogates how geopolitics trickles down to everyday life and becomes personal through the embodiment of screen actors. While International Relations is attempting to move beyond the limits of existing disciplinary methods and methodologies to better grasp the emotional depths of world politics, this article delves into the ‘method’ in performance arts to understand how visual culture diffuses emotional narratives of the state to the population and affectively enables people to experience the international from the perspective of the United States. In this sense, focusing on ‘method acting’ which revolutionised performance arts in the United States from the 1950s, the article examines the mundane encounters in visual culture through which screen/state actors emotionally situate the audience to make them viscerally experience geopolitics, personally feel like a state/warrior and embody a commitment to the war effort at an emotional level.
Delta Xtend reverse shoulder arthroplasty – Results at a minimum of five years
Authors: Ball Craig M
Published: March 2019

Background

Reverse shoulder arthroplasty provides predictable pain relief and improvements in function, but concerns remain regarding complication rates and there is little long-term outcome data. The aim of this study was to review the clinical and radiographic outcomes of the Delta Xtend reverse shoulder arthroplasty at a minimum of five years.

Methods

Ninety-six Delta Xtend reverse shoulder arthroplasty procedures were performed in 93 patients. There were 41 males and 52 females with an average age of 74.9 years. All available patients returned for clinical and radiographic analysis, including completion of patient reported outcome measures.

Results

The complication rate was 9.4%. There were three revisions (3.1%) and two other reoperations (2.1%). Fifty-nine shoulders were available for review at an average of 81 months. Average forward flexion was 142°. Average American Shoulder and Elbow Assessment Score improved from 27.6 to 78.5 (p<0.001). Radiolucent lines and/or proximal bone resorption was seen in 35.4%. Scapula notching was observed in 69.1%, with Grade III or IV notching in 20%. These findings had no effect on patient reported outcome measures.

Discussion

This study confirms the clinical benefits of reverse shoulder arthroplasty, with improvements maintained out to 10 years. The high rate of scapula notching remains a concern. Further study is needed to fully understand the clinical significance of notching, as well as the potential benefits of newer implant designs.
The Expanding Role of Real-World Evidence Trials in Health Care Decision Making
Authors: Klonoff David C.
Published: March 2019

Real-world evidence (RWE) is the clinical evidence about benefits or risks of medical products derived from analyzing real world data (RWD), which are data collected through routine clinical practice. This article discusses the advantages and disadvantages of RWE studies, how these studies differ from randomized controlled trials (RCTs), how to overcome barriers to current skepticism about RWE, how FDA is using RWE, how to improve the quality of RWE, and finally the future of RWE trials.
Assessment of literacy and numeracy skills related to non-steroidal anti-inflammatory drug labels
Authors: Jang Soo Min , Jiang Ruixin , Grabe Darren , Pai Amy Barton
Published: March 2019

Background:

Non-steroidal anti-inflammatory drugs are widely used and have a potential for over-the-counter misuse. Limited health literacy is associated with poor health outcomes. Identification of new strategies to assess literacy and numeracy could be useful in targeting effective education initiatives.

Objective:

To characterize numeracy and literacy skills related to non-steroidal anti-inflammatory drug labels in primary care patients.

Methods:

Patients were recruited and consented over an 8-month period after their regular primary care visit. Demographic information was collected and two instruments were administered to assess literacy and numeracy skills: (1) a medication label literacy instrument focused on non-steroidal anti-inflammatory drugs (MedLit-NSAID) and (2) a general healthy literacy-screening tool, the Newest Vital Sign. Two questions on the MedLit-NSAID instrument evaluated understanding of the Food and Drug Administration medication guide for non-steroidal anti-inflammatory drugs and the Food and Drug Administration approved over-the-counter label.

Results:

A total of 145 patients were enrolled. Mean MedLit-NSAID and Newest Vital Sign scores were 6.8 (scale range 0–8) and 4.2 (scale range 0–6), respectively. Higher education level was associated with higher scores for both tools (p ⩽ 0.05). Total MedLit-NSAID scores on average were higher in females compared with males (6.5 vs 6, p = 0.05). Patients with decreased kidney function (n = 18) had significantly lower MedLit-NSAID scores (p ⩽ 0.05). Test–retest scores were not significantly different for MedLit-NSAID (p = 0.32). The correlation between the tools was 0.54 and internal consistency MedLit-NSAID was 0.61.

Conclusion:

A medication information focused instrument provided specific information to assess health literacy related to non-steroidal anti-inflammatory drug labels. This information could be utilized to develop patient education initiatives for medication label comprehension.
The Bilateral Bidirectional Glenn Operation as a Risk Factor Prior to Fontan Completion in Complex Congenital Heart Disease Patients
Authors: Keizman Eitan , Tejman-Yarden Shai , Mishali David , Levine Shany , Borik Sharon , Pollak Uri , Katz Uriel , Serraf Alain E.
Published: March 2019

Introduction:

The Glenn procedure is generally performed as a second-stage palliative procedure toward the completion of Fontan circulation in patients with a functionally univentricular heart. Safe Fontan completion requires normal ventricular function, competent atrioventricular valves, normal pulmonary arteries anatomy, and low pulmonary vascular resistances (PVRs), which is merely an estimation that considers both lungs as a single unit. Clinical observations revealed that patients who previously underwent bilateral bidirectional cavopulmonary anastomosis (b-BCPA) had a stormier postoperative course in respect to other patients with previous unilateral BCPA (u-BCPA) postoperatively after Fontan completion. This retrospective study was designed to compare and analyze the outcomes of patients following Fontan completion with previous u-BCPA versus b-BCPA.

Patients and Methods:

A total of 98 patients were divided into two groups based on the presence or absence of bilateral superior vena cava (SVC). Group 1 included 80 patients with unilateral SVC, and group 2 included 18 patients with bilateral SVC. Univariate and multivariate (SPSS) analyses were performed with regard to mortality and failure. P value of <.05 was considered as significant.

Results:

Prior to the total cavopulmonary anastomosis operation, the G1 and G2 had similar demographic and physiological findings, ages and weights were 4.3 ± 1.72 years and 15.0 ± 3.71 kg in G1 and 4.8 ± 3.21 years and 17.5 ± 9.76 kg in G2. Mean end-diastolic ventricular pressures (in mm Hg) were 10.50 ± 2.86 in G1 and 10.28 ± 3.07 in G2 and the mean PVRs (in Woods units) were 1.66 ± 1.29 in G1 and 1.49 ± 0.82 in G2. The Stormy postoperative course, Fontan failure, and early mortality were all significantly higher in G2 in respect to G1 ( P value <.05). G1 mortality rate was 3.7%, 3 patients of 80, while in G2, the mortality rate was 22%, 4 patients of 18. Late Fontan failure rates were 6% for G1 patients where two patients developed pulmonary hypertension, two patients developed heart failure, and one patient had protein losing enteropathy (PLE), and 22% for the G2 patients of which two patients developed heart failure, one patient had PLE, and one patient had persistent low systemic venous saturation.

Conclusions:

Our results have demonstrated that patients after b-BCPA might have a tendency for worse outcomes upon Fontan completion. The b-BCPA is associated with pulmonary artery bifurcation stenosis and presents multiple sources of pulmonary blood flow where conventional PVR calculation might be imprecise and misleading since it considers the lungs as a single unit. Therefore, b-BCPA engenders correction of the conventional PVR calculation to consider each lung separately. Furthermore, the surgical approach for patients with persistent left SVC and univentricular heart should be modified.
Porcine Versus Pericardial Pulmonary Valve Replacement in Adults With Prior Congenital Cardiac Surgery: Midterm Outcomes
Authors: Yuen Chi Sum , Lee Kwok Fai Lucius , Bhatia Inderjeet , Yam Nicholson , Rocha Barnabe Antonio , Yung Tak-cheung , Chow Pak-cheong , Au Wing-Kuk Timmy
Published: March 2019

Background:

Postcongenital heart surgery pulmonary regurgitation requires subsequent pulmonary valve replacement. We sought to compare the outcomes of pulmonary valve replacement after using bioprosthetic valves, porcine versus pericardial bioprosthesis.

Method:

Retrospective single-center study of consecutive pulmonary valve replacement in patients with pulmonary regurgitation following initial congenital cardiac surgery. From 2004 to 2016, 82 adult patients (53 males, 29 females) underwent pulmonary valve replacement at a mean age of 28.7 ± 8 years (range 18-52 years) with a mean time to pulmonary valve replacement of 24 ± 7 years (range 13-43 years). Porcine bioprosthetic valves (group 1, n = 32) and pericardial valves (group 2, n = 50) were used. Cardiac magnetic resonance imaging was performed (n = 54) at a mean of 18 ± 13 months before and 24 ± 21 months after pulmonary valve replacement.

Results:

No significant difference was seen between the groups except that the mean follow-up was longer for group 1 (5.02 ± 2.06 vs 4.08 ± 3.21 years). In-hospital mortality was 1.1%. Follow-up completeness was 100% with no late death. Mean right ventricular end-systolic and end-diastolic volumes reduced significantly in both the groups ( P < .001), whereas right ventricular ejection fraction remained unchanged (group 1, P = .129; group 2, P = .675) . Only the left ventricular end-diastolic volume increased in both the groups, but the increase was significant for group 2 only (group 1, P = .070; group 2, P = .015), whereas the left ventricular end-systolic and ejection fraction remained unchanged in both the groups. There was no reoperation for pulmonary valve replacement. Freedom from intervention was 93.8% (group 1) and 100% (group 2) at eight years after pulmonary valve replacement ( P = .407).

Conclusion:

Midterm outcomes of pulmonary valve replacement in our adult cohort were satisfactory. Both types of bioprosthetic valves performed comparably for eight years and were a good option in adults.
Program Evaluation Model: Training Future School Counselors Through Community Partnership
Authors: Hausheer Robin
Published: March 2019

This article presents an in-depth model to train school counseling students in program evaluation. Steps outlined in the model include partnering with a local nonprofit organization, conducting a literature review, developing a research question and hypothesis, detailing the evaluation instrument selection process, and outlining the program evaluation presentation. I provide an example of the model in action to illustrate each step and discuss benefits of model implementation and implications for school counselors, counselor educators, and future research.
Development and Validation of the College Admissions Knowledge Evaluation
Authors: Poynton Timothy A. , Ruiz Bernalyn , Lapan Richard T.
Published: March 2019

This article describes the process used to develop a new measure of college knowledge and the findings from an initial study to examine the measure’s construct validity. We employed common test construction (item response theory, classical test theory) and factor analytic (exploratory factor analysis, confirmatory factor analysis) approaches to analyzing the data from 519 graduating high school seniors; these analyses support the construct validity of the measure. We discuss the importance of college knowledge in the college decision-making process and implications for school counseling practice and research.
The Effect of Capital Structure on Profitability: An Empirical Panel Data Study
Authors: Singh Narinder Pal , Bagga Mahima
Published: March 2019

One of the most perplexing issues faced by finance managers is to know about the effect of capital structure on the profitability of firm. Many studies have been carried out to examine the effect of capital structure on the profitability of firms, but most of them belong to other parts of the world, and only few studies have been conducted in India. Thus, the present study has been undertaken to evaluate the effect of capital structure on the profitability of Nifty 50 companies listed on National Stock Exchange of India from 2008 – 2017. The data has been analyzed by using descriptive statistics, correlation and multiple panel data regression models. Four different regression models have been used to study the relationship between capital structure and profitability. In these models, we study the individual effect of total debt and total equity ratios on profitability, that is, ROA and ROE. All four models have been tested with pooled OLS, fixed effects, and random effects. We conclude that there is significant positive impact of capital structure on firm’s profitability.
Student Perceptions of Learning and Engagement in a Flipped Versus Lecture Course
Authors: Garner Benjamin , Chan Mark
Published: March 2019

Current literature suggests that students have equal or higher learning outcomes in a “flipped” classroom compared with a traditional lecture. However, there are few robust analyses of the flipped-class teaching method. This research uses a yearlong, quasiexperimental study across six sections of a business communication course to track student outcomes and perceptions of student engagement and learning. The results indicate that there were no significant differences between flipped and traditional classes across the learning and engagement variables in how students perceived these different conditions. However, the flipped condition produced better outcomes for oral and written assignments.
Opening the Black Box: A Multilevel Framework for Studying Group Processes
Authors: Lang Jonas W. B. , Bliese Paul D. , Adler Amy B.
Published: March 2019

Over time, groups can change in at least two important ways. First, they can display different trajectories (e.g., increases or decreases) on constructs of interest. Second, the configuration of group members’ responses within a group can change, such that the members become more or less similar to each other. Psychologists have historically been interested in understanding changes in groups over time; however, there is currently no comprehensive quantitative framework for studying and modeling group processes over time. We present a multilevel framework for such research—the multilevel group-process framework (MGPF). The MGPF builds on a statistical approach developed to capture whether individual members of a group develop a shared climate over time, but we extend the core ideas in two important ways. First, we describe how researchers can gain insights into group phenomena such as group leniency, group learning, groupthink, group extremity, group forming, group freezing, and group adjourning through modeling change in latent mean levels and consensus. Second, we present a sequence of model-testing steps that enable researchers to systematically study and contrast different group processes. We describe how the MGPF can lead to novel research questions and illustrate its use in two example data sets.
Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019
Authors: Singh Dave , Agusti Alvar , Anzueto Antonio , Barnes Peter J. , Bourbeau Jean , Celli Bartolome R. , Criner Gerard J. , Frith Peter , Halpin David M.G. , Han Meilan , López Varela M. Victorina , Martinez Fernando , Montes de Oca Maria , Papi Alberto , Pavord Ian D. , Roche Nicolas , Sin Donald D. , Stockley Robert , Vestbo Jørgen , Wedzicha Jadwiga A. , Vogelmeier Claus
Published: March 2019

Precision medicine is a patient-specific approach that integrates all relevant clinical, genetic and biological information in order to optimise the therapeutic benefit relative to the possibility of side-effects for each individual. Recent clinical trials have shown that higher blood eosinophil counts are associated with a greater efficacy of inhaled corticosteroids (ICSs) in chronic obstructive pulmonary disease (COPD) patients. Blood eosinophil counts are a biomarker with potential to be used in clinical practice, to help target ICS treatment with more precision in COPD patients with a history of exacerbations despite appropriate bronchodilator treatment.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 pharmacological treatment algorithms, based on the ABCD assessment, can be applied relatively easily to treatment-naive individuals at initial presentation. However, their use is more problematic during follow-up in patients who are already on maintenance treatment. There is a need for a different system to guide COPD pharmacological management during follow-up.

Recent large randomised controlled trials have provided important new information concerning the therapeutic effects of ICSs and long-acting bronchodilators on exacerbations. The new evidence regarding blood eosinophils and inhaled treatments, and the need to distinguish between initial and follow-up pharmacological management, led to changes in the GOLD pharmacological treatment recommendations. This article explains the evidence and rationale for the GOLD 2019 pharmacological treatment recommendations.
Effects of exercise and airway clearance (positive expiratory pressure) on mucus clearance in cystic fibrosis: a randomised crossover trial
Authors: Dwyer Tiffany J. , Daviskas Evangelia , Zainuldin Rahizan , Verschuer Jordan , Eberl Stefan , Bye Peter T.P. , Alison Jennifer A.
Published: March 2019

Exercise improves mucus clearance in people without lung disease and those with chronic bronchitis. No study has investigated exercise alone for mucus clearance in cystic fibrosis (CF). The aim of this study was to compare the effects of treadmill exercise to resting breathing and airway clearance with positive expiratory pressure (PEP) therapy on mucus clearance in adults with CF.

This 3-day randomised, controlled, crossover trial included 14 adults with mild to severe CF lung disease (forced expiratory volume in 1 s % predicted 31–113%). Interventions were 20 min of resting breathing (control), treadmill exercise at 60% of the participant's peak oxygen consumption or PEP therapy (including huffing and coughing). Mucus clearance was measured using the radioaerosol technique and gamma camera imaging.

Treadmill exercise improved whole lung mucus clearance compared to resting breathing (mean difference 3%, 95% CI 2–4); however, exercise alone was less effective than PEP therapy (mean difference −7%, 95% CI −6– −8). When comparing treadmill exercise to PEP therapy, there were no significant differences in mucus clearance from the intermediate and peripheral lung regions, but significantly less clearance from the central lung region (likely reflecting the huffing and coughing that was only in PEP therapy).

It is recommended that huffing and coughing are included to maximise mucus clearance with exercise.
Alterations in bacterial communities, SCFA and biomarkers in an elderly HIV-positive and HIV-negative population in western Mexico
Authors: González-Hernández Luz A. , Ruiz-Briseño Mariana del Rocio , Sánchez-Reyes Karina , Alvarez-Zavala Monserrat , Vega-Magaña Natali , López-Iñiguez Alvaro , Díaz-Ramos Julio A. , Martínez-Ayala Pedro , Soria-Rodriguez RA , Ramos-Solano Moises , Andrade-Villanueva Jaime F.
Published: March 2019

Background

The study of stool microbiota has taken great relevance in the last years, given its role in the maintenance of the intestinal metabolic, physiological, and immunological homeostasis, as well as, its effect over HIV biomarkers levels such as CD4/CD8 ratio, high sensitivity C-Reactive Protein (hs-CRP), related to poor outcomes (rapid progression to AIDS). Several efforts have been made to characterize the gut microbiome. In HIV infection, most of the studies report the presence of a dysbiotic pattern; however, few of them have made an approach in elderly HIV-positive subjects despite the fact that nowadays this subgroup is rising. In this study, we compared the composition of faecal microbiota, Short Chain Fatty Acids (SCFAs), and systemic biomarkers between elderly HIV-positive and HIV-negative subjects.

Methods

A cross-sectional study with 18 HIV-negative controls and 20 HIV-positive patients. The quantification of Bacteroidetes, Firmicutes, Proteobacteria, Actinobacteria, Lactobacillus, Enterobacteriaceae, Bifidobacterium, Escherichia coli, Clostridium leptum, Clostridium coccoides was performed in faecal samples by qPCR. The analysis was performed by calculating the ΔCq of each microorganism using 16S rDNA as a reference gene. Faecal SCFAs were measured by HPLC. The hs-CRP and sCD14 were performed by ELISA.

Results

An increase in the Firmicutes/Bacteroidetes ratio, coupled with a significant increase in the proteobacteria phylum was detected in HIV-positive subjects. In contrast, a decrease in the Clostridium leptum group was observed. Nevertheless, these elderly HIV-positive patients showed higher levels of total SCFAs mainly by an augmented propionic acid values, compared to HIV-negative subjects. Whereas high levels of hs-CRP were positively correlated with sCD14 in the HIV-positive group.

Conclusions

Alterations in bacterial communities reveals a dysbiotic state related to an unbalance of faecal SCFAs. Therefore, these intestinal conditions might drive an increase of poor prognostic biomarkers in elderly HIV-positive subjects.
Telepsychiatry in intellectual disability psychiatry: literature review
Authors: Madhavan Giri
Published: March 2019

Aims and Method

The aims of this review were to explore the effectiveness and patient and provider acceptability of telepsychiatry consultations in intellectual disability, contrasting this with direct face-to-face consultations and proposing avenues for further research and innovation. Computerised searches of databases including AMED and EMBASE were conducted.

Results

Four USA studies of intellectual disability telepsychiatry services have been reported. The majority (75%) focused on children with intellectual disability. Sample sizes ranged from 38 to 900 participants, with follow-up from 1 to 6 years. Outcome measures varied considerably and included cost savings to patients and healthcare providers, patient and carer satisfaction and new diagnoses.

Clinical implications

The innovations summarised suggest a requirement to further explore telepsychiatry models. Despite some promising outcomes, there is a relative dearth in the existing literature. Further studies in other healthcare systems are required before concluding that telepsychiatry in intellectual disability is the best approach for providing psychiatric services to this population.

Declaration of interest

None.
Mental health professionals' knowledge, skills and attitudes on domestic violence and abuse in the Netherlands: cross-sectional study
Authors: Ruijne Roos E. , Kamperman Astrid M. , Trevillion Kylee , Garofalo Carlo , Jongejan Femke E. , Bogaerts Stefan , Howard Louise M. , Mulder Niels L.
Published: March 2019

Background

Despite the high prevalence of domestic violence and abuse (DVA) among patients with psychiatric conditions, detection rates are low. Limited knowledge and skills on DVA in mental healthcare (MHC) professionals might contribute to poor identification.

Aims

To assess the level of, and factors associated with, DVA knowledge and skills among MHC professionals.

Method

A total of 278 professionals in Dutch MHC institutions completed a survey assessing factual knowledge, perceived knowledge, perceived skills and attitudes about DVA.

Results

On average, low scores were reported for perceived skills and knowledge. MHC professionals in primary care scored higher than those working with individuals with severe mental illness (P<0.005). Levels of factual knowledge were higher; levels of attitudes moderate. Previous training was positively associated with skills (odds ratios (OR) = 3.0) and attitudes (OR = 2.7). Years of work was negatively associated with factual knowledge (OR = 0.97). Larger case-loads predicted higher scores on skills (OR = 2.1).

Conclusions

Training is needed, particularly for clinicians working with patients with severe mental illness.

Declaration of interest

None.
Active surveillance and watchful waiting for low-risk prostate cancer in black patients: A population-based analysis.
Authors: Butler Santino , Muralidhar Vinayak , D'Amico Anthony Victor , Nguyen Paul L. , Rebbeck Timothy , Mahal Brandon Arvin Virgil
Published: March 2019

10

Background: Evidence from clinical trials supports conservative management as an acceptable alternative to definitive therapy for low-risk prostate cancer (LRPC). The optimal approach for Black men, however, remains unclear given trial underrepresentation and concern about racial differences in disease aggressiveness. We therefore sought to determine U.S. conservative management utilization rates for Black men with LRPC. Methods: The Surveillance, Epidemiology, and End Results (SEER) Program Prostate with Active Surveillance/Watchful Waiting (AS/WW) Database queried 50,302 LRPC patients (N = 5218 Black), diagnosed from 2010-2015. Trends in AS/WW utilization over time were determined, stratified by race (Black versus non-Black) and number of positive biopsy cores (≤2 versus ≥3). Results: From 2010 to 2015, AS/WW utilization increased from 12.6% to 36.4% among Black men (Ptrend< 0.001) and from 14.8% to 43.3% among non-Black men (Ptrend< 0.001). AS/WW rates reached 52.0% and 57.3% by 2015 for Black (Ptrend< 0.001) and non-Black (Ptrend< 0.001) men with ≤2 positive biopsy cores, respectively. Rates continually increased for all subgroups except Black men with ≥3 positive biopsy cores, where rates plateaued at 22.9% by 2013. Conclusions: In this report from the largest U.S. population of Black LRPC patients with quality assured AS/WW data, AS/WW rates have nearly tripled for Black men from 2010-2015, suggesting AS/WW is viewed as a safe management option in all races.
Risk factors for postprostate biopsy infection.
Authors: Shoag Jonathan , Sun Tianyi , Pantuck Morgan , Gorin Michael A. , Schaeffer Edward M. , Sedrakyan Art , Hu Jim
Published: March 2019

103

Background: Prostate biopsy is a common procedure that many U.S. men endure during their lifetime. Evidence suggests that the risk of post-biopsy infections is increasing. We aimed to characterize risk factors for post-biopsy infections using nationally representative data. Methods: We analyzed Surveillance, Epidemiology and End Results (SEER)-Medicare data to identify 246,299 male Medicare beneficiaries aged over 65 years who underwent prostate biopsy between 2001 and 2013. Multivariable logistic regression was used to assess risk factors for post-biopsy infection.The primary outcomes were any infection within 30 days of prostate biopsy, and infections requiring hospital admission within 30 days of biopsy. Results: In this cohort, 7.0% of men developed an infection within 30 days and 1.0% required hospital admission for infection. The vast majority of biopsies were performed transrectally (99.5%) without a rectal swab culture performed prior to biopsy to direct antimicrobial prophylaxis (99.7%). Risk factors for post-biopsy infection and hospitalization on multivariable analysis included age over 80 years, odds ratio (OR) 1.23 (95% confidence interval (CI) 1.17 to 1.29, for any infection, and OR 1.71 (95% CI 1.52 to 1.92) for infection requiring hospitalization, Black race, OR 1.29 (95% CI 1.23 to 1.35) for any infection, and OR 1.41 (95% CI 1.25 to 1.58) for hospitalization, and Hispanic ethnicity, OR 1.61 (95% CI 1.46 to 1.77) for any infection, and OR 1.92 (95% CI 1.52 to 2.42) for hospitalization. The risk of infection also increased with Charlson score of 3 or greater, OR 1.32 (95% CI 1.25 to 1.39), and OR 2.04 (95% CI 1.73 to 2.40) for any infection or hospitalization, respectively. High surgeon volume (>11.6 cases) was protective, OR 0.92 (95% CI 0.88 to 0.96) for any infection, and OR 0.76 (95% CI 0.69 to 0.85) for hospitalization. Conclusions: Among other factors, we identify patient age, Charlson score, race, ethnicity, and surgeon volume as significant predictors of post-prostate biopsy infection and hospitalization. These results should aid in identifying patients who may benefit from alternative techniques, such as targeted or augmented antimicrobial prophylaxis, or transperineal biopsy, to minimize this common source of morbidity.
One and done?: Utility of PSA density as a predictor of number of cores needed to detect clinically significant prostate cancer.
Authors: Hale Graham , Bloom Jonathan , Lebastchi Amir H , Gold Samuel A , Mehralivand Sherif , Shih Joanna H. , Turkbey Baris , Pinto Peter A.
Published: March 2019

104

Background: MRI/US fusion guided prostate biopsy (FBx) has been shown to detect clinically significant prostate cancer (csCaP) at higher rates and with fewer cores than standard prostate biopsy. However, the number of targeted cores needed to accurately characterize lesions identified on multiparametric MRI (mpMRI) is unknown. This study sought to determine factors that predict the number of cores needed to accurately characterize lesions during FBx of patients on active surveillance. Methods: A retrospective analysis of a prospectively maintained database of all patients undergoing FBx at an academic referral center between May 2014 and January 2018 was conducted. At least two FBx cores were taken from each lesion identified on mpMRI. Patient and lesion specific factors were analyzed to determine factors that predict the necessity to obtain additional cores to detect csCaP. GEE-based univariate logistic regression model with exchangeable correlation was used to estimate the effects of clinical characteristics including race, BMI, PSA, PSA density (PSAD), lesion location, and PI-RADS score on the proportion of positive and negative agreement. Predictability of a significant continuous predictor was quantified by AUC. The most significant patient-level predictor (PSAD) was further analyzed to determine thresholds at which multiple cores per lesion are needed to avoid missing csCaP. Results: An analysis of a total of 1141 FBx were performed during the study time interval. PSA (OR=1.57, 1.20-2.05, p<0.01) and PSAD (OR=1.43, 1.11-1.85, p<0.01) significantly predicted positive agreement of csCaP. AUC for positive and negative agreement was 57.4 and 61.0 for PSA and 56.4 and 72.3 for PSAD, respectively. Using these thresholds, only 56% lesions would need double core targeted biopsy. In other words, up to 44% of lesions would be accurately characterized with a single biopsy core of the targeted lesion. Conclusions: These data indicate that in patients with a PSAD less than 0.11 ng/ml2 or greater than 0.26 ng/ml2, lesions may be acceptably characterized with a single targeted biopsy core.
The cost of prostate cancer care to society and to patients in the United States.
Authors: Zaorsky Nicholas George , Lin John , Ba Djibril , Segel Joel E , Mackley Heath B. , Drabick Joseph , Liu Guodong , Leslie Doug
Published: March 2019

116

Background: Our objectives are to characterize prostate cancer patient resource consumption and cost (I) to society, in 1 calendar year; and (II) to the patient, 1 year after his diagnosis. Methods: The MarketScan database was used to summarize cost, including gross payment to provider for service, copayment, and deductibles. We identified the top 20 Current Procedural Terminology (CPT) codes to characterize which procedures drove costs for both objectives. For Objective I, diagnoses were identified in 1 calendar year (2014); codes and their costs for all patients were calculated. For Objective II, diagnoses were set at time = 0, and all CPT and International Classification of Diseases codes were characterized 1 year after diagnosis (2012-2013). Results: For objective I, there were 95,642 procedures totalling $38,696,423. The plurality of procedures were hospital consultations, level 2 (i.e. history + physical + straightforward decision-making; 17,103 performed, average $80 each, total $1,418,954) and level 3 (+ low complexity decision-making; 9,726 performed; average $127 each, total $1,232,928). The most costly procedure to society was a radical prostatectomy (8,883 performed, average $2,003 each, total $17,694,508) with accompanying anesthesia (7,960 performed, average $1262 each, total $10,048,653). For objective II (characterized in Table), the mean payment per month was $2,794, including mean gross cost $2,673, mean copayment $32, and mean deductible $46. Conclusions: The typical cost of therapy to a prostate cancer patient is $2,800/month after diagnosis, primarily from surgery (constituting the majority of cost to society) and subsequently from office visits (constituting the plurality of procedures). Societal measures to reduce cost should be aimed at the operating room and consultations.[Table: see text]
Significance of tertiary pattern 5 in patients with gleason score 7 after radical prostatectomy.
Authors: Li Jiakun , Guo Yaochuan , Qiu Shi , He Mingjing , Jin Kun , Liao Xinyang , Zheng Xiaonan , Tu Xiang , Yang Lu , Wei Qiang
Published: March 2019

117

Background: To evaluate the association between tertiary Gleason pattern (TGP) 5 and the biochemical recurrence (BCR) in patients with prostate cancer (PCa) of Gleason score (GS) 7 after radical prostatectomy(RP). Methods: This retrospective study collected 387 patients received RP and diagnosed GS 7 (3+4 or 4+3) in the West China Hospital from January 2009 to December 2017.Regardlessly the first Gleason pattern, patients were divide into 2 groups: TGP5 absence and TGP5 presence. Furthermore, we added the primary Gleason pattern to divided patients into 4 groups: GS 3+4, GS 3+4/TGP 5, Gleason 4+3, Gleason 4+3/TGP 5. Cox proportional-hazards models was used to evaluate the association between the status of TGP5 and BCR after adjusting the confounding factors with follow-up time as the underlying time scale. All the analyses were conducted with the use of statistical software packages Rnand EmpowerStats and conducted as two sides and P values less than 0.05 were considered statistical significance. Results: In the results by using Cox proportional-hazards model, regardless the primary Gleason pattern, comparing TGP5 absence (89.7%) and presence (10.3%), the risk of BCR for patients with tertiary Gleason pattern 5 presence was statistically significantly higher than absence (P = 0.02, HR = 2.24, 95%Cl: 1.12-4.49). In terms of the patients with primary Gleason pattern 4, the risk of BCR for patients with Gleason 4+3/TGP5 was statistically significantly higher than Gleason 4+3.(P = 0.02, HR = 2.56, 95%Cl: 1.16-5.67). There was a marked trend that patients with Gleason 3+4/TGP 5 has a higher risk of BCR compared with patients with Gleason 3+4, although there was no statistical difference (P = 0.58, HR = 1.82, 95%Cl: 0.22-14.96). Conclusions: The TGP5 in patients with GS 7 had strong association with the risk of BCR and it was an independent predictor for BCR. This result was more obvious in patients with GS 7 (4+3) in our study. Further researches with larger data size were needed to confirm these funding.
State rurality does not increase risk of prostate cancer death.
Authors: Anderson Alexander Geoffrey Shaw , Murray Katie
Published: March 2019

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Background: Prostate cancer is the third most common cancer among men. PSA based screening for prostate cancer was introduced in the 1980s and resulted in a significant decline in prostate cancer mortality. Current AUA guidelines recommend PSA screening in average risk patients between the ages of 55 and 69. There are public health concerns in rural areas of the United States (US) potentially due to decreased access of care. In this study, we sought to evaluate the prevalence of prostate cancer screening and death rate in rural communities within the US. Methods: After IRB approval, data was collected from several different sources. Annual prostate cancer death rate (2011-2015) was obtained from the American Cancer Society. Data from the Behavioral Risk Factor Surveillance System regarding prostate cancer screening during this time interval was acquired. Data regarding populations was obtained from the US Census. Descriptive analyses were used to describe the population and Pearson Correlation Coefficient to determine screened, death rates and rurality correlations. All analyses were completed using SPSS. Results: The median percent of US population residing in rural and urban areas was 25.8% (IQR 22.1%) and 73.8% (IQR 22.1%), respectively. The median percent of male patients screened using PSA 50 years and older was 56.2% (IQR 7.0%). The median death rate (per 100,000) from prostate cancer per state was 19.5 (IQR 1.7%). Prostate cancer death rate was found to have no correlation to percent of population screened (p = 0.29) and percent rurality (p = 0.98). The percent rural population versus percent of screened men over the age of 50 was also not significant (p = 0.20). Conclusions: Neither death rate nor screening rate for prostate cancer using PSA demonstrated a significant association with the percent of patient’s living in rural communities. This is evidence that within the US, rural communities are following guidelines for PSA screening for prostate cancer and therefore there is no discrepancy in prostate cancer death in these areas compared to urban. This study is evidence that the barriers that may be associated with living in rural communities, such as decreased access to healthcare do not translate into worse outcomes related to prostate cancer.
Marijuana use history in patients presenting with localized prostate cancer.
Authors: Nichols Romaine Charles , Morris Christopher G , Bryant Curtis , Hoppe Bradford S. , Henderson Randal H. , Mendenhall William M. , Mendenhall Nancy Price
Published: March 2019

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Background: Determine the incidence of past marijuana use in a large cohort of men diagnosed with localized prostate cancer to determine if marijuana use was correlated with: patient age; pretreatment T stage; Prostate specific antigen (PSA); Gleason Score; or clinical risk group. Methods: From August, 2006 to October 2018, 4305 patients received treatment for localized prostate cancer and are included in an outcomes tracking protocol. All patients were requested to complete a pre treatment information form which included the question: “Have you ever used marijuana?” 4277 (97%) answered the question either affirmatively or negatively. Responses were stratified by: patient birth year; clinical T stage, PSA level; highest Gleason score; and clinical risk group. Results: 3.8% of men born before 1940 reported marijuana use compared to 17.4% born between 1940 and 1950 and 38.6% born after 1950 (p<0.0001). 19.8% of men with T1 tumors reported marijuana use compared to 18.1% of men with T2 tumors and 19.1% of men with T3 tumors (p=0.4494). 19.7% of men with a PSA less than 10 ng/ml reported marijuana use compared to 17.2% of men with a PSA between 10 and 20 ng/ml and 18.7% of men with a PSA over 20 ng/ml (p=0.4029). 20.8% of men with Gleason score of 6 or less reported marijuana use compared to 19.6% of men with a Gleason score of 7 and 13.5% with Gleason score of 8 or higher (p=0.0004). 20.8% of men with low risk presentation reported marijuana use compared to 19.9% of men with intermediate risk presentation and 14.1% of men with high risk presentation (p=0.0004). There was a significant positive association observed between increasing age and Gleason score (p<0.0001). Conclusions: Men presenting with higher Gleason score tumors and higher risk disease were significantly less likely to report past marijuana use. It is likely that this finding is due to the greater incidence of high grade tumors seen in older patients.
Late toxicity described using patient reported outcomes measures (PROMS) in men treated with salvage radiation following primary high intensity focal ultrasound (HIFU) for localized prostate cancer.
Authors: Davda Reena , Orczyk Clement , Prentice Mark , Sarova Aylin , Arya Manit , Ahmed Hashim , Emberton Mark , Moore Caroline , Mitra Anita , Payne Heather Ann
Published: March 2019

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Background: In primary treatment of localised prostate cancer, minimally invasive ablative therapies such as HIFU aim to achieve cancer control whilst offering a potentially favourable toxicity profile. At 5 years median follow up, 12% of patients treated with focal HIFU require salvage therapy. PROMS using Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC‐CP) provide a validated and clinically relevant tool to assess and quantify side effects from pelvic radiotherapy. There is limited data on late toxicity using PROMs with salvage radiotherapy in this setting. Methods: Retrospective analysis from prospectively collected data of 28 patients who received salvage radiotherapy at our institution 2010-2018 was performed. Late bowel and urinary toxicity measured by EPIC-CP is reported. Results: Gleason score at diagnosis: 3+3 4/28; 3+4 22/28; 4+3 2/28. HIFU treatment received: focal: 9/28; whole gland: 6/28; focal and redo focal: 7/28; focal and redo whole gland: 1/28; whole gland and redo: 5/28. All patients had mpMRI and biopsy proven recurrence with median PSA 6.6 ng/ml (0.57- 30.89). Median age at radiation was 67 years (55-80). Patients received 74 Gy to the prostate and 4 patients received additional pelvic lymph node irradiation. Three men received conformal radiotherapy (multiphase technique) and 25 arcing intensity modulated radiotherapy with hormone therapy as per risk stratification. Cumulative incidence of toxicity is reported at median follow-up of 43 months (7-99). Overall urinary function: no problem 8/28; very small problem 4/28; small problem 7/28; moderate problem 5/28; big problem 4/28 Urinary Incontinence Symptom Score: 2.5/12 (0-12) Urinary Irritation /Obstructive Symptom Score: 3.1/12 (0-12) Bowel Symptom Score: 3.5/12 (0-11) Biochemical relapse has occurred in 2/28 patients. Conclusions: Functional and oncological outcomes for a greater number of patients treated with minimally invasive ablative therapies followed by salvage radiation are required, however this data suggests radiation is a well-tolerated and effective salvage option following primary HIFU.
A multicentric phase II randomized trial of docetaxel (D) plus enzalutamide (E) versus docetaxel (D) as first-line chemotherapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): CHEIRON study.
Authors: Caffo Orazio , Palesandro Erica , Nole Franco , Gasparro Donatello , Mucciarini Claudia , Aieta Michele , Zagonel Vittorina , Iacovelli Roberto , De Giorgi Ugo , Rossetti Sabrina , Fratino Lucia , Sacco Cosimo , Nicodemo Maurizio , Giordano Monica , Sartori Donata , Scapoli Daniela , Verri Elena , Kinspergher Stefania , Pappagallo Giovanni L. , Aglietta Massimo
Published: March 2019

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Background: D and E demonstrated to be efficacious in the treatment of mCRPC pts. Due to different antitumor mechanism of action of these agents, it could be postulated that their combination can improve disease control. CHEIRON study tried to demonstrate the candidate efficacy of chemo-hormonal combination D+E versus D in mCRPC first-line. Methods: Eligibility criteria included untreated mCRPC diagnosis, ECOG PS ≤ 2, adequate renal, hepatic and hematological functions. Pts were randomized to receive D 75 mg/m2 IV d1 q3w plus prednisone 5 mg PO BID for 8 courses alone or plus E 160 mg PO daily for 24 weeks. Stratification criteria were presence of pain and visceral metastases. The primary endpoint of the study was the rate of pts without disease progression (according to PCWG2) at 6 mos after randomization. Results: Between 09/2014 and 10/2017, 246 pts (median age 70 years, range 44-88, pain reported by 54 pts, visceral metastases present in 50 pts) were randomized to DE (120) or D (126). The rate of pts without disease progression at 6 mos was significantly higher in DE arm compared to D arm [87.3% (CI95% 64-80) vs 72.6% (CI95% 80-92); p = 0.006). Similarly, a higher proportion of DE pts achieved a PSA reduction ≥ 50% compared to the baseline values compared to the D pts [92.2%(CI95% 61-77) vs 70.0%(CI95% 86-96); p < 0.0001). No differences were observed in terms of objective response rate. Major haematological toxicities consisted of grade 3-4 anemia (3 pts DE – 1 pt D) and grade 3-4 neutropenia (23 pts DE – 19 pts D); febrile neutropenia was observed in 10 DE pts and in 5 D pts. At a median follow-up of 20 mos, the median progression free survival was 11.3 mos (CI95% 10.0-12.7) and 9.1 mos (CI95% 8.9-9.2) in DE and D arm, respectively (p = 0.004). In D arm the median overall survival was 30.5 mos (CI95% 24.1-36.8) compared to 28.7 mos (CI95% 20.7-36.6) of the experimental arm (p NS). Conclusions: From the present study, the first phase II randomized trial testing the addition of a new generation hormone agent to D, DE improved the 6-mo disease control with a prolongation of PFS compared to the standard chemotherapy. Clinical trial information: NCT02453009.