bluuebunny/crossref_metadata_2025_split huggingface dataset:
Statistical issues in the design, conduct and analysis of two large safety studies
Authors: Gaffney Michael 
Published: July 2016

Background/Aims: The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Methods: Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Results: Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost–benefit of relative trial size. Conclusion: A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called “pragmatic,” they are examples of best real-world designs to address safety and regulatory concerns.
Ultrasound-guided radiofrequency ablation for cT1a renal masses in poor surgical candidates: mid-term, single-center outcomes
Authors: Zachos Ioannis , Dimitropoulos Konstantinos , Karatzas Anastasios , Samarinas Michael , Petsiti Argiro , Tassoudis Vassilios , Tzortzis Vassilios 
Published: July 2016

Objectives: Surgical management of small renal masses can be challenging in frail patients and thus modalities such as radiofrequency ablation (RFA) have emerged as valid alternative options. The aim of the current study was to present mid-term oncological and functional results on a series of patients with cT1a renal cell carcinomas (RCCs) who were unfit for surgery and underwent RFA using ultrasound guidance under local anesthesia. Methods: Data from patients fulfilling the study selection criteria were retrospectively collected. RENAL nephrometry score was used for tumor description. Parametric tests were used for data analysis and survival curves were estimated using the Kaplan–Meier method. Results: Overall, 32 patients (mean±standard deviation age, 72.4 ± 7.6 years) with biopsy-proven RCCs (tumor size, 23.75 ± 10.44 mm and RENAL score, 5.28 ± 1.33) underwent 32 RFA sessions. Twenty-seven patients (84.4%) had low complexity masses and five patients had masses of intermediate complexity (15.6%) according to RENAL score categorization. Over a follow-up period of 22.1 ± 13.7 months, one case of primary treatment failure was recognized (primary technical success 97.0%), and overall, three patients were diagnosed with residual disease (primary technique effectiveness 90.6%). No major complications occurred during the postprocedure 90-day follow up, while no difference was found in serum creatinine and estimated glomerular filtration rate pre and post procedure. Patients with intermediate-complexity renal lesions had shorter time to recurrence in comparison to low-complexity masses ( p = 0.002). All patients were alive at the time of study data analysis without diagnosed metastases. Conclusions: Percutaneous RFA of small RCCs using ultrasound-based guidance under local anesthesia can be an effective alternative method for managing patients who are unfit for surgery.
Introducing purposeful activity kits in a hand rehabilitation practice: Effects on clinical practice patterns and job satisfaction among occupational therapy practitioners
Authors: Dy Laura B , Yancosek Kathleen E 
Published: July 2016

Introduction Facilitating function through occupation and purposeful activity is the basic tenet of occupational therapy. However, the majority of research in hand rehabilitation clinics continues to focus on biomechanical interventions. The purpose of this research was to study practice patterns and personal opinions of occupational therapy practitioners before and after providing purposeful activity kits to an outpatient occupational therapy hand clinic. Methods Mixed-method design to evaluate an 8-week intervention of providing purposeful activity kits to a busy, military outpatient hand clinic. A paper survey was administered to nine occupational therapy practitioners before and after the intervention. Qualitative data were gathered through semi-structured interviews. Results A descriptive analysis indicated an increase in the use of activities, crafts, and occupation after the introduction of the purposeful activity kits. Practitioners consistently reported time as the top factor in their inability to incorporate more purposeful activities. Qualitative results support use of the new activities during both intervention and evaluation due to the focus on function and ease of use of the kits. Conclusion Purposeful activities can enhance any rehabilitation clinic in an organized, cost-effective manner. Practitioners responded positively toward the added equipment; however, it will take time and effort to adjust the theoretical decision making of practitioners. Additional participants and length of intervention is needed.
The effect of adenotonsillectomy for childhood sleep apnoea on cardiorespiratory control
Authors: Baumert Mathias , Pamula Yvonne , Martin James , Kennedy Declan , Ganesan Anand , Kabir Muammar , Kohler Mark , Immanuel Sarah A. 
Published: July 2016

The efficacy of adenotonsillectomy for relieving obstructive sleep apnoea symptoms in children has been firmly established, but its precise effects on cardiorespiratory control are poorly understood.In 375 children enrolled in the Childhood Adenotonsillectomy Trial, randomised to undergo either adenotonsillectomy (n=194) or a strategy of watching waiting (n=181), respiratory rate, respiratory sinus arrhythmia and heart rate were analysed during quiet, non-apnoeic and non-hypopnoeic breathing throughout sleep at baseline and at 7 months using overnight polysomnography.Children who underwent early adenotonsillectomy demonstrated an increase in respiratory rate post-surgery while the watchful waiting group showed no change. Heart rate and respiratory sinus arrhythmia were comparable between both arms. On assessing cardiorespiratory variables with regard to normalisation of clinical polysomnography findings during follow-up, heart rate was reduced in children who had resolution of obstructive sleep apnoea syndrome, while no differences in their respiratory rate or respiratory sinus arrhythmia were observed.Adenotonsillectomy for obstructive sleep apnoea increases baseline respiratory rate during sleep. Normalisation of apnoea–hypopnoea index, spontaneously orviasurgery, lowers heart rate. Considering the small average effect size, the clinical significance is uncertain.
Improving patient care through CPD: revised guidance from the Royal College of Psychiatrists
Authors: Brookes Guy 
Published: July 2016

SummaryContinued learning is essential to doctors' safe and effective practice throughout their careers. To improve the care they provide, they need not only to acquire new knowledge and skills but also to consider how their current practice compares and what they need to change. Such reflection is not usually automatic; time, and often help from peers, is needed to make it effective; formalised, this is continuing professional development (CPD). Revised guidance from the Royal College of Psychiatrists emphasises the importance of linking learning to improved practice through reflection and promotes the CPD peer group's role in supporting psychiatrists to do this.
Lessons from akrasia in substance misuse: a clinicophilosophical discussion
Authors: Radoilska Lubomira , Fletcher Keron D. 
Published: July 2016

SummaryThis article explores the philosophical concept of akrasia, also known as weakness of will, and demonstrates its relevance to clinical practice. In particular, it challenges an implicit notion of control over one's actions that might impede recovery from substance misuse. Reflecting on three fictional case vignettes, we show how philosophical work on akrasia helps avoid this potentially harmful notion of control by supporting a holistic engagement with people for whom substance misuse is a problem. We argue that such engagement enhances their prospects of recovery by focusing on agency over time, as opposed to individual lapses.
Why do we need a social psychiatry?
Authors: Ventriglio Antonio , Gupta Susham , Bhugra Dinesh 
Published: July 2016

SummaryHuman beings are social animals, and familial or social relationships can cause a variety of difficulties as well as providing support in our social functioning. The traditional way of looking at mental illness has focused on abnormal thoughts, actions and behaviours in response to internal causes (such as biological factors) as well as external ones such as social determinants and social stressors. We contend that psychiatry is social. Mental illness and interventions in psychiatry should be considered in the framework of social context where patients live and factors they face on a daily basis.
Negative results in phase III trials of complex interventions:
Cause for concern or just good science?
Authors: Crawford Mike J. , Barnicot Kirsten , Patterson Sue , Gold Christian 
Published: July 2016

SummaryNot all interventions that show promise in exploratory trials will be
supported in phase III studies. But the high failure rate in recent trials
of complex mental health interventions is a concern. Proper consideration of
trial processes and greater use of adaptive trial designs could ensure
better use of available resources.
Case Report: 84 year-old woman with alien hand syndrome
Authors: Qureshi Ihtesham Aatif , Korya Daniel , Kassar Darine , Moussavi Mohammed 
Published: July 2016

Background: Alien hand syndrome [AHS] is a rare and ill-defined neurological disorder. It produces complex, goal-directed motion of one hand that is involuntarily instigated. This syndrome characteristically arises after brain trauma, brain surgery, stroke or encephalitis. We describe a case of AHS in a patient who had a previous episode of subarachnoid hemorrhage affecting the left frontal lobe and corpus callosum. Case presentation: An 84-year-old woman presented to the emergency department complaining of headaches and several episodes of her left arm moving as if it was groping around trying to grab at her own body. A computed tomography scan of the head demonstrated an acute left superior frontal hemorrhage with compression of the corpus callosum. Transcranial Doppler report showed no significant abnormality in the insonated vessels. After being stabilized for the acute bleed, she was treated with clonazepam 0.5 mgat night for the uncontrolled hand movements. Her movements resolved by her next month follow up. The diagnosis of AHS was made based on her clinical presentation, characterization of the movement and localization correlating with findings in neuroimaging. Conclusion: We document a rare neurologic disorder seen in patients presenting with a history of previous strokes and a typical description of involuntary and unintentional, uncontrolled unilateral arm movements with repetitive grasping. The present case has a combination of frontal and callosal lesions. These findings appear to support a potential destruction leading to the rare syndrome.
Transnationalism and nostalgia: Gianfranco Pannone’s ‘American Trilogy’
Authors: Brioni Simone 
Published: July 2016

Abstract
The article examines Gianfranco Pannone’s ‘American Trilogy’ – Piccola America. Gente del Nord a Sud di Roma/‘Little America. People from the North to the South of Rome’ (1991), Lettere dall’America/‘Letters from America’ (1995) and L’America a Roma/‘America in Rome’ (1998) – showing how the trilogy employs the documentary genre not only as a way to inform the audience, but to question the way in which imagination shapes reality and vice versa. First, Lettere dall’America is examined in light of the topos of letter writing in other literary and cinematic works featuring the Italian emigration to the United States. Second, the article analyses how the migration from north-east Italy to the Pontine Marshes in central Italy is represented in Piccola America. Third, I discuss how L’America a Roma highlights the presence of southern migrants interpreting Mexicans in Italian westerns. Pannone uses documentaries to interrogate the fictional construction of America, and questions the view that narratives of migration are the objective reflection of ‘real’ experiences. Investigating the connection between nostalgia and the narration of history, this article also shows how the presence of a nostalgic vein in the trilogy is aimed at rethinking ‘Italian’ national history in a transnational dimension.
Book Reviews
Authors: Minier Márta , O’Leary Alan , Bonifazio Paola , Benci Jacopo , O’Rawe Catherine 
Published: July 2016

Abstract
Mussolini’S Dream Factory: Film Stardom in Fascist Italy, Stephen Gundle (2013) New York and Oxford: Berghahn, 336 pp., ISBN: 9781782382447, h/bk, ISBN: 9781782382454, institutional e-book, £28.04
Un Nuovo Cinema Politico Italiano? Vol I: Lavoro, Migrazione, Relazioni Di Genere, Luciana D’Arcangeli, William Hope and Silvana Serra (EDS) (2013) Kibworth Beauchamp: Troubadour, 304 pp., ISBN: 9781780885414, p/bk, £14.95
Un Nuovo Cinema Politico Italiano? Volume II: Il Passato Sociopolitico, Il Potere Istituzionale, La Marginalizzazione, William Hope, Silvana Serra and Luciana D’Arcangeli (EDS) (2014) Leicester: Troubador, 270 pp., ISBN: 9781783065318, p/bk, £ 14.95
Blow-Up. Antonioni’s Classic Film and Photography, Walter Moser and Klaus Albrecht Schröder (EDS) (2014) Ostfildern: Hatje Cantz Verlag, 280 pp., ISBN: 9783775737371, p/bk, €35.00
The Operatic and the Everyday in Post-War Italian Film Melodrama, Louis Bayman (2014) Edinburgh: Edinburgh University Press, 240 pp., ISBN: 0748656424, h/bk, £70
Research on the Relative Stable Time and Stable Value of Concrete Creep
Authors: Zheng W. , Tang C. , Wang Y. 
Published: July 2016

Abstract
The safety coefficients of structures change due to the creep behavior of concrete, which causes increased deformation and cracks in structures, redistribution of internal stresses, and the loss of prestress. It is an important and significant problem to determine when concrete creep is stable and how much of the creep will occur once it is stable over the projected life of the structure. The relationship between compressive concrete creep and time was obtained during creep experiments, which were conducted using the compressive concrete cube with stress levels of 0.160, 0.261, 0.370, 0.470, 0.568, and 0.668, a loading age of 126 days, and a time under loading of 589 days. The creep compliance function model of linear and non-linear compressive concrete creep under stress levels lower than 0.8 was unified by introducing a creep compliance function amplification coefficient Aj. Relative stable time and relative stable value of concrete creep, with different stress levels, were obtained according to the creep model and regular relative stable time.
Properties of distance spaces with power triangle inequalities
Authors: Greenhoe D. 
Published: July 2016

Metric spaces provide a framework for analysis and have several very useful properties. Many of these properties follow in part from the triangle inequality. However, there are several applications in which the triangle inequality does not hold but in which we may still like to perform analysis. This paper investigates what happens if the triangle inequality is removed all together, leaving what is called a distance space, and also what happens if the triangle inequality is replaced with a much more general two parameter relation, which is herein called the "power triangle inequality". The power triangle inequality represents an uncountably large class of inequalities, and includes the triangle inequality, relaxed triangle inequality, and inframetric inequality as special cases. The power triangle inequality is defined in terms of a function that is herein called the power triangle function. The power triangle function is itself a power mean, and as such is continuous and monotone with respect to its exponential parameter, and also includes the operations of maximum, minimum, mean square, arithmetic mean, geometric mean, and harmonic mean as special cases.
Percepción de los estudiantes en pre-práctica de la Facultad de Educación sobre el rol del profesional en bibliotecología escolar en el proceso de enseñanza y aprendizaje
Authors: Domínguez Flores Noraida , Adames Méndez Eileene R , Arocho Molina Damaris 
Published: July 2016

El presente artículo discute la necesidad de educar a futuros maestros sobre el rol de la biblioteca escolar en los procesos de enseñanza y aprendizaje. Específicamente, la necesidad de que los futuros maestros aprendan a cómocolaborar con los profesionales en bibliotecología escolar en la enseñanza de las competencias de información.Considerando esta necesidad, se desarrolló un proyecto de colaboración que fue integrado en un curso de prepráctica de la Facultad de Educación de la Universidad de Puerto Rico, con la participación de estudiantes del curso de Competencias Informaciones y Tecnológicas de la Escuela Graduada de Ciencias y Tecnologías de la Información del mismo recinto.Los hallazgos de esta investigación evidenciaron que los futuros maestros carecen de conocimiento en torno a las competencias de información, así como sobre el rol de los profesionales en bibliotecología escolar en los procesos de enseñanza y aprendizaje. Al finalizar el proyecto se evidenció un impacto positivo sobre la percepción de los futuros maestros hacia la biblioteca escolar y las futuras relaciones de colaboración que pueden desarrollarse, una vez iniciada su vida profesional como maestros.
The Creation of a Pediatric Hospital Medicine Dashboard: Performance Assessment for Improvement
Authors: Fox Lindsay Anne , Walsh Kathleen E. , Schainker Elisabeth G 
Published: July 2016

BACKGROUND AND OBJECTIVES:Leaders of pediatric hospital medicine (PHM) recommended a clinical dashboard to monitor clinical practice and make improvements. To date, however, no programs report implementing a dashboard including the proposed broad range of metrics across multiple sites. We sought to (1) develop and populate a clinical dashboard to demonstrate productivity, quality, group sustainability, and value added for an academic division of PHM across 4 inpatient sites; (2) share dashboard data with division members and administrations to improve performance and guide program development; and (3) revise the dashboard to optimize its utility.METHODS:Division members proposed a dashboard based on PHM recommendations. We assessed feasibility of data collection and defined and modified metrics to enable collection of comparable data across sites. We gathered data and shared the results with division members and administrations.RESULTS:We collected quarterly and annual data from October 2011 to September 2013. We found comparable metrics across all sites for descriptive, productivity, group sustainability, and value-added domains; only 72% of all quality metrics were tracked in a comparable fashion. After sharing the data, we saw increased timeliness of nursery discharges and an increase in hospital committee participation and grant funding.CONCLUSIONS:PHM dashboards have the potential to guide program development, mobilize faculty to improve care, and demonstrate program value to stakeholders. Dashboard implementation at other institutions and data sharing across sites may help to better define and strengthen the field of PHM by creating benchmarks and help improve the quality of pediatric hospital care.
Biphasic Positive Airway Pressure or Continuous Positive Airway Pressure: A Randomized Trial
Authors: Victor Suresh , Roberts Stephen A. , Mitchell Simon , Aziz Huma , Lavender Tina ,   on behalf of the Extubate Trial Group
Published: July 2016

BACKGROUND:
There is currently no clear evidence that nasal-biphasic positive airway pressure (n-BiPAP) confers any advantage over nasal-continuous positive airway pressure (n-CPAP). Our hypothesis was that preterm infants born before 30 weeks' gestation and &lt;2 weeks old when extubated onto n-BiPAP will have a lower risk of extubation failure than infants extubated onto n-CPAP at equivalent mean airway pressure.

METHODS:
We conducted an unblinded multicenter randomized trial comparing n-CPAP with n-BiPAP in infants born &lt;30 weeks' gestation and &lt;2 weeks old. The primary outcome variable was the rate of extubation failure within 48 hours after the first attempt at extubation. Block randomization stratified by center and gestation (&lt;28 weeks or ≥28 weeks) was performed.

RESULTS:
A total of 540 infants (270 in each group) were eligible to be included in the statistical analysis; 57 (21%) of n-BiPAP group and 55 (20%) of n-CPAP group failed extubation at 48 hours postextubation (adjusted odds ratio 1.01; 95% confidence interval 0.65–1.56; P = .97). Subgroup analysis of infants born before and after 28 weeks’ gestation showed no significant differences between the 2 groups. There were no significant differences between arms in death; oxygen requirement at 28 days; oxygen requirement at 36 weeks' corrected gestation; or intraventricular hemorrhage, necrotizing enterocolitis requiring surgery, or pneumothorax.

CONCLUSIONS:
This trial shows that there is no added benefit to using n-BIPAP over n-CPAP at equivalent mean airway pressure in preventing extubation failures in infants born before 30 weeks' gestation and &lt;2 weeks old.
Pathogenesis of Warthin’s tumors
Authors: Kuzenko Yevhen V. , Romanuk Anatoly M. , Dyachenko Olena Olegivna , Hudymenko Olena 
Published: July 2016

Introduction
Warthin’s tumor, also known as papillary cystadenoma lymphomatosum, monomorphic adenoma, or adenolymphoma, is a benign cystic tumor of the salivary glands containing abundant lymphocytes and lymph node-like stroma. It is named after the pathologist Aldred Scott Warthin, who described two cases in 1929.

Objective
The aim of this study is to analyze the pathogenesis of Warthin’s tumor.

Methods
A total of 15 patients with Warthin’s tumor were studied. Hematoxylin and eosin stains, which have been used for at least a century and are still essential for recognizing various tissue types and the morphologic changes for cancer diagnosis, were used. Warthin’s tumor was evaluated for the expression of MGMT, CD3, HSP90AA1, MMP-1, Bcl-2, CD79A, IgG, Ki-67, p53, IgM, OPN, S100, myeloperoxidase, and VEGF by immunohistochemistry.

Results
Immunohistochemical staining confirmed that the immune cells within the follicles of Warthin’s tumor were positive for MGMT (10.0 ± 0.34%), Ki-67 (13.3 ± 0.45%), Bcl-2 (42.6 ± 8.33), and p53 (11.6 ± 2.3). The immune cells associated with CD3 were present at the stroma of residual cells (47.3 ± 3.89); however, they were not present in the epithelium cell layers. B cells (CD79A) consistent with germinal centers were present within the immune cells and formed follicles (43.2 ± 13.5%).

Conclusions
Histopathological analysis of the stroma and parenchyma revealed balanced distribution of epithelial and stromal component. Epithelial component of the Warthin’s tumor is the trigger for the tumor process. This study indicates that the Warthin tumor is a consequence of inflammatory etiology.