bluuebunny/crossref_metadata_2025 huggingface dataset:
Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE
Authors: Cohan Stanley , Kappos Ludwig , Giovannoni Gavin , Wiendl Heinz , Selmaj Krzysztof , Havrdová Eva Kubala , Rose John , Greenberg Steven , Phillips Glenn , Ma Wei , Wang Ping , Lima Gabriel , Sabatella Guido
Published: October 2017

Background:

Demonstration of clinical benefits on disability progression measures is an important attribute of effective multiple sclerosis (MS) treatments.

Objective:

Examine efficacy of daclizumab beta versus intramuscular (IM) interferon beta-1a on measures of disability progression in patient subgroups from DECIDE.

Methods:

Twenty-four-week confirmed disability progression (CDP), 24-week sustained worsening on a modified Multiple Sclerosis Functional Composite (MSFCS) where 3-Second Paced Auditory Serial Addition Test was replaced by Symbol Digit Modalities Test, and proportion of patients with clinically meaningful worsening in 29-Item Multiple Sclerosis Impact Scale physical impact subscale (MSIS-29 PHYS) score from baseline to week 96 were examined in the overall population and subgroups defined by baseline demographic/disease characteristics.

Results:

Daclizumab beta significantly reduced risk of 24-week CDP (hazard ratio (HR), 0.73; 95% confidence interval (95% CI), 0.55–0.98), risk of 24-week sustained MSFCS progression (HR, 0.80; 95% CI, 0.67–0.95), and odds of clinically meaningful worsening in MSIS-29 PHYS (odds ratio, 0.76; 95% CI, 0.60–0.95) versus IM interferon beta-1a. Point estimates showed trends favoring daclizumab beta over IM interferon beta-1a across several patient subgroups for all three outcome measures.

Conclusion:

Daclizumab beta showed consistent benefit versus IM interferon beta-1a across measures assessing patient disability/function and across a range of clinical baseline characteristics in patients with relapsing-remitting MS.
Epidemiology of NMOSD in Catalonia: Influence of the new 2015 criteria in incidence and prevalence estimates
Authors: Sepúlveda Maria , Aldea Marta , Escudero Domingo , Llufriu Sara , Arrambide Georgina , Otero-Romero Susana , Sastre-Garriga J , Romero-Pinel Lucía , Martínez-Yélamos Sergio , Sola-Valls N , Armangué Thais , Sotoca Javier , Escartín Antonio , Robles-Cedeño René , Ramió-Torrentà Lluís , Presas-Rodríguez Silvia , Ramo-Tello Cristina , Munteis Elvira , Pelayo Raúl , Gubieras Laura , Brieva Luis , Ortiz Nicolau , Hervás Mariona , Mañé-Martínez Maria Alba , Cano Antonio , Vela Emili , Tintoré Mar , Blanco Yolanda , Montalban Xavier , Graus Francesc , Saiz Albert
Published: October 2017

Background:

Population-based studies on neuromyelitis optica spectrum disorders (NMOSD) are limited, and it is unclear whether the rates have changed with the implementation of the new 2015 criteria.

Objectives:

To estimate the incidence and prevalence of NMOSD in Catalonia (Spain), using both the 2006 and the 2015 criteria.

Methods:

In this clinic-based retrospective study, patients diagnosed with NMOSD between 2006 and 2015 were identified using multiple sources, including direct contact to all Catalan hospitals, identification of cases through the Catalan Health Surveillance System, and registry of antibodies to aquaporin-4 (AQP4-IgG) and myelin oligodendrocyte glycoprotein (MOG-IgG) in a reference laboratory. The incidence rate was calculated for the period 1 January 2006–1 January 2016 and prevalence for the date 1 January 2016.

Results:

We identified 74 patients (by the 2015 criteria). Most patients were Caucasian (81%), and female (76%) with a median age at disease onset of 42 years (range, 10–76 years). In total, 54 (73%) patients were positive for AQP4-IgG, 11 (15%) double-seronegative, and 9 (12%) MOG-IgG-positive. Rates of incidence and prevalence (0.63/1,000,000 person-years and 0.89/100,000, respectively) were 1.5-fold higher than those reported by the 2006 criteria. Lowest rates were seen in children and elder people and highest in women and middle-aged people (40–59 years). The female predominance was lost in incident AQP4-IgG-seronegative children and AQP4-IgG-positive elder people. MOG-IgG and double-seronegativity contributed similarly but did not influence the long-term outcome.

Conclusion:

The new criteria increase the estimates, but NMOSD remains as a rare disease. The differences in age- and sex-specific estimates highlight the importance of the serologic classification.
Testing the 2 × 2 model of perfectionism in Ecuadorian adolescent population
Authors: Vicent María , Inglés Cándido J , Gonzálvez Carolina , Sanmartín Ricardo , Ortega-Sandoval Virginia Narcisa , García-Fernández José Manuel
Published: October 2017

This study aimed to test the 2 × 2 model of dispositional perfectionism in an Ecuadorian sample of 1562 students aged between 12 and 17 years ( M = 14.83 years, standard deviation  = 1.86 years). The Child and Adolescent Perfectionism Scale and the brief 21-item version of the Depression Anxiety Stress Scales were used. Cluster analysis revealed four profiles: Pure Self-Oriented Perfectionism, Pure Socially Prescribed Perfectionism, Mixed Perfectionism, and Non-perfectionism. Mixed Perfectionism and Non-perfectionism obtained, respectively, the highest and lowest scores in anxiety, depression, and stress. The results are discussed in light of cultural differences in the interpretation and consequences of perfectionism.
School technology leadership in a Spanish secondary school: The TEI model
Authors: Gallego-Arrufat María-Jesús , Gutiérrez-Santiuste Elba , Campaña-Jiménez Rafael Luis
Published: October 2017

This study analyzes the perception that teachers and management team members in secondary school education have of technology-based educational innovation (TEI). Two questionnaires and in-depth interviews permit us to analyze leaders’ perspective of planning, development, and evaluation. The school leaders’ view diverges from that of the regional/national education policy makers and is closer to the view developed in pedagogy for leading the process of introducing technology in classrooms and influencing innovation in teachers’ practice. Based on reflection on the leadership–technology–innovation relationship, we derive a top-down model for use by teachers, schools, the community, and education authorities.
Carbon fiber–reinforced polymer rod panels for strengthening concrete bridges
Authors: Peiris Abheetha , Harik Issam
Published: October 2017

The practice of using fiber-reinforced polymer laminates and fabric to repair and strengthen concrete structures is well established. What limits the application of fiber-reinforced polymer materials, especially in flexural strengthening, is the equipment and man power needed for continuous application when retrofits take place over waterways or multilane roadways. A carbon fiber–reinforced polymer rod panel system consisting of 1220-mm (48-in) panels made continuous through a finger joint/splice was developed to overcome these limitations. The system’s performance hinges on whether forces can be transferred from one panel to another. This study investigated the bond characteristics of carbon fiber–reinforced polymer rods, as well as the flexural behavior of concrete members strengthened with carbon fiber–reinforced polymer rod panels, to improve knowledge of the finger joint’s behavior. Bond tests were conducted using double-lap shear specimens on individual rods with both steel and concrete substrates. Further bond tests were performed on small carbon fiber–reinforced polymer rod panels on steel substrate. Flexural tests were carried out under four-point bending on small-scale reinforced concrete beams that were strengthened using continuous carbon fiber–reinforced polymer rod panels and carbon fiber–reinforced polymer rod panels spliced using a finger joint. Case studies of four field applications are presented to provide a better understanding of the system. The new carbon fiber–reinforced polymer rod panels effectively reduce labor and equipment costs for work conducted on bridges with limited access, as they enabled the performance of repair/retrofit operations by a small crew working out of a single work platform.
Building a digital Girl Army: The cultivation of feminist safe spaces online
Authors: Clark-Parsons Rosemary
Published: October 2017

“Safe spaces” emerged as an important activist tactic in the late twentieth-century United States with the rise of feminist, queer, and anti-racist movements. However, the term’s ambiguity, while denoting its wide applicability across movements, has led “safe space” to become overused but undertheorized. In both theory and praxis, “safe space” has been treated as a closed concept, erasing the context-specific relational work required to construct and maintain its material and symbolic boundaries. The emergence of online communities promising safety for marginalized groups calls for renewed investigations into the construction of these activist spaces. In this article, I draw on ethnographic fieldwork to consider the cultivation of safe space within Girl Army, a Philadelphia-based feminist Facebook group. Through participant observation and interviews with Girl Army members, I trace the group’s technical and discursive enforcement of safety and the role this space plays in members’ activism and everyday lives.
How framing of nationally and locally sensitive issues varies? A content analysis of news from party and nonparty newspapers in China
Authors: Kuang Xianwen , Wei Rining
Published: October 2017

This study investigates how party and nonparty newspapers in China frame sensitive political issues differently, depending on their geographic relevance. Extant studies indicate that political control influences how news organizations present an issue. The assumption is that the framing of nationally sensitive issues is similar across Chinese news outlets, while the framing of locally sensitive issues diverges. An examination of the news frames used by six newspapers in Guangzhou in their coverage of a nationally sensitive issue and a locally sensitive issue confirms this assumption. In the coverage of the nationally sensitive issue, all newspapers use more leadership frames and factual information than responsibility, conflict and human interest frames. Contrastingly, the party newspapers use more leadership frames, whereas nonparty newspapers use more conflict frames in the reporting of the locally sensitive issue.
New data, old tensions: Big data, personalized learning, and the challenges of progressive education
Authors: Dishon Gideon
Published: October 2017

Personalized learning has become the most notable application of big data in primary and secondary schools in the United States. The combination of big data and adaptive technological platforms is heralded as a revolution that could transform education, overcoming the outdated classroom model, and realizing the progressive vision of interest-driven and self-initiated learning. Yet, even supporters concede that, in practice, personalized learning is geared toward behaviorist models of learning. This article explores how this gap between expectation and reality concerning big data can be understood as a reflection of existing tensions within progressive education. To explain the tension, I examine the interplay between Rousseau and Dewey’s theories of education, and the novel opportunities offered by big data. I hold that personalized learning could be understood as an iteration of Rousseau’s vision of well-regulated freedom, in which students’ freedom is perceived as a means toward increasing the effectiveness of their learning. The relegation of decision making to algorithms renders this regulation more feasible and justifiable. Dewey’s critique of Rousseau’s individualized and teleological model of education offers the contours of an alternative role for big data in education, which prioritizes social interaction and the cultivation of democratic citizens. Moreover, due to the increased capacity to operationalize complex learning processes in naturalistic learning environments, big data could allow tackling some of the lingering challenges to implementing Dewey’s approach.
Public Library Staff as Community Health Partners: Training Program Design and Evaluation
Authors: Morgan Anna U. , D’Alonzo Bernadette A. , Dupuis Roxanne , Whiteman Eliza D. , Kallem Stacey , McClintock Autumn , Fein Joel A. , Klusaritz Heather , Cannuscio Carolyn C.
Published: October 2017

Public libraries are free and open to all—and accessed at high rates by vulnerable populations—which positions them to be key public health allies. However, library staff themselves often feel ill-equipped to address the health and social concerns of their patrons. To fill this gap, we developed a case-based training curriculum to help library staff recognize, engage, and refer vulnerable patrons to appropriate resources. Topics addressed in the training, including homelessness, mental health and substance use disorders, immigration, and trauma, were selected based on findings from a prior community needs assessment. Using a modified measure of self-efficacy, participants ( n = 33) were surveyed before and after each session. Several participants ( n = 7) were also interviewed 4 months after the training was completed. Overall, staff reported significant increases in comfort, confidence, and preparedness in assisting vulnerable patrons across all topic areas. Qualitative findings reflected positive perceived impact and value of the trainings. Staff felt training resources should be made more readily accessible. Improving library staff capacity to address the health and social needs of their patrons can further establish public libraries as partners in improving population health.
The Nonconformist Practices of Stuart Hall: Cultural Studies and the Politics of Emancipation
Authors: Winter Rainer
Published: October 2017

Stuart Hall was a nonconformist intellectual in the tradition of the New Left whose work was inspired by the writings of Antonio Gramsci. Drawing on Hall’s deconstruction of the popular, and his critical analysis of, ideological struggles in media and society, my article examines his critique of capitalistic society and his political visions within the framework of the concept of hegemony. The central question of my contribution concerns what we can learn from Hall’s work today with regard to the following aspects: First, we have to recognize the importance of intellectual interventions to change the world. The second aspect follows his creative way of using and combining theories and concepts. Against this background, I conclude by addressing the ways in which we can understand our present age and look for more democratic alternatives.
Brown Body of Knowledge: A Tale of Erasure
Authors: Cruz Joëlle M.
Published: October 2017

In this autoethnographic piece, I offer five short poems reading as a “tale of erasure” in the academy. The poems document how my particular identities—Brown, immigrant, female, professor—came to bear during the negotiation of immigration status. This tale illuminates the particular intersection of these layered identities with institutional silencing processes. Beyond my immediate story, poetic prose helps to document experiences of silencing and annihilation, which are particularly difficult to put into words. In addition, the narratives offer insight into the specific complexities faced by foreign faculty in the U.S. academy.
Val66Met Polymorphism in BDNF Has No Sexual and APOE ε4 Status-Based Dimorphic Effects on Susceptibility to Alzheimer’s Disease: Evidence From an Updated Meta-Analysis of Case–Control Studies and High-Throughput Genotyping Cohorts
Authors: Zhao Qingnan , Shen Yaqi , Zhao Yanli , Si Lining , Jiang Shan , Qiu Yu ,   Alzheimer’s Disease Neuroimaging Initiative (ADNI)
Published: October 2017

Some studies showed that Val66Met polymorphism of brain-derived neurotrophic factor (BDNF) conveys susceptibility to Alzheimer’s disease (AD) in females only. However, the confounding effects of some risk factors for AD were omitted in these studies. The aim of this meta-analysis comprising 19 604 patients with AD and 26 333 controls was to reexamine the association between Val66Met and AD by conditioning the effects of age, sex, and/or apolipoprotein E ( APOE) ε4 status. In agreement with the previous meta-analysis, Val66Met was associated with AD in females without confounding adjustment (odds ratio [OR], 1.08; 95% confidence interval [CI], 1.03-1.14; P = .003). Nevertheless, after adjusting for age and APOE ε4 status, Val66Met was not associated with AD in females (OR, 1.02; 95% CI, 0.94-1.11; P = .57). This comprehensive meta-analysis with the largest sample size demonstrated no association could be observed between Val66Met and AD in general or by dividing samples based on sex or APOE ε4.
Examining the Relations Between Instructional-Level Data and Intervention Response in Early Writing
Authors: Parker David C. , Burns Matthew K. , McMaster Kristen L. , Al Otaiba Stephanie , Medhanie Amanuel
Published: October 2017

The current study determined growth patterns during an 8-week writing intervention and then examined the association between growth pattern and students’ initial skills as determined by instructional-level data. One hundred forty-seven first-grade students struggling with early literacy skills received a writing intervention at one of two tiers of support and completed progress assessments at regular intervals. Results indicated that students followed more than one type of growth pattern. A moderate correspondence was found between growth pattern and instructional-level data. Current results are contextualized within previous research. Implications for adapting writing interventions based on student data and theoretical models of writing development are discussed.
“I’ve Risen Up From the Ashes That I Created”: Record Clearance and Gendered Narratives of Self-Reinvention and Reintegration
Authors: Chen Elsa Y. , Adams Ericka B.
Published: October 2017

Record clearance allows some individuals to redesignate or remove certain minor convictions from their criminal records. This interview-based study finds that both men and women seek opportunities for personal gain through record clearance, but women are more motivated by moral and religious influences and concern about reputation. Women are also more likely than men to acknowledge personal flaws, and to desire to replace criminal identities with law-abiding identities. As women redefine their identities, caregiving is especially important as a personal obligation and professional aspiration. Record clearance is particularly compatible with women’s motivations, willingness to change, and personal and professional goals.
Patient satisfaction with chronic HIV care provided through an innovative pharmacist/nurse-managed clinic and a multidisciplinary clinic
Authors: Kielly Jason , Kelly Deborah V. , Asghari Shabnam , Burt Kim , Biggin Jessica
Published: October 2017

Background:

Pharmacist/nurse-led clinics are an established model for many chronic diseases but not yet for HIV. At our centre, patients with HIV are seen by a multidisciplinary team (physician, nurse, pharmacist, social worker) at least yearly. Some attend an HIV-specialist pharmacist/nurse clinic (or “nonphysician clinic,” NPC) for alternate biannual visits. Our objective was to assess patient satisfaction with care received through both clinics.

Methods:

The Patient Satisfaction Survey for HIV Ambulatory Care (assesses satisfaction with access to care, clinic visits and quality of care) was administered by telephone to adults who attended either clinic between January and July 2014. Descriptive statistics described patient characteristics and satisfaction scores. Fisher’s exact test compared satisfaction scores between the NPC and multidisciplinary clinic (MDC). Multivariate logistic regression examined associations between overall satisfaction with care and clinic type and patient characteristics (e.g., age, disease duration).

Results:

Respondents were very satisfied with the overall quality of HIV care in both the NPC and MDC (89% vs 93%, respectively, p = 0.6). Patients from both clinics expressed satisfaction with access to care, treatment plan input, their provider’s knowledge of the newest developments in HIV care and explanation of medication side effects, with no significant differences noted. Significantly more MDC patients reported being asked about housing/finances, alcohol/drug use and whether they needed help disclosing their status. Patient characteristics were not significantly associated with satisfaction with overall quality of care.

Conclusion:

Patients are satisfied with both clinics, supporting NPC as an innovative model for chronic HIV care. Comparison of outcomes between clinics is needed to ensure high-quality care.
Primary care physicians’ attitudes and beliefs about cancer clinical trials
Authors: Bylund Carma L , Weiss Elisa S , Michaels Margo , Patel Shilpa , D’Agostino Thomas A , Peterson Emily B , Binz-Scharf Maria Christina , Blakeney Natasha , McKee M Diane
Published: October 2017

Background/Aims:

Cancer clinical trials give patients access to state-of-the-art treatments and facilitate the translation of findings into mainstream clinical care. However, patients from racial and ethnic minority groups remain underrepresented in clinical trials. Primary care physicians are a trusted source of information for patients, yet their role in decision-making about cancer treatment and referrals to trial participation has received little attention. The aim of this study was to determine physicians’ knowledge, attitudes, and beliefs about cancer clinical trials, their experience with trials, and their interest in appropriate training about trials.

Methods:

A total of 613 physicians in the New York City area primarily serving patients from ethnic and racial minority groups were invited via email to participate in a 20-min online survey. Physicians were asked about their patient population, trial knowledge and attitudes, interest in training, and personal demographics. Using calculated scale variables, we used descriptive statistical analyses to better understand physicians’ knowledge, attitudes, and beliefs about trials.

Results:

A total of 127 physicians completed the survey. Overall, they had low knowledge about and little experience with trials. However, they generally had positive attitudes toward trials, with 41.4% indicating a strong interest in learning more about their role in trials, and 35.7% indicating that they might be interested. Results suggest that Black and Latino physicians and those with more positive attitudes and beliefs were more likely to be interested in future training opportunities.

Conclusion:

Primary care physicians may be an important group to target in trying to improve cancer clinical trial participation among minority patients. Future work should explore methods of educational intervention for such interested providers.
Phase 1 healthy volunteer willingness to participate and enrollment preferences
Authors: Chen Stephanie C , Sinaii Ninet , Bedarida Gabriella , Gregorio Mark A , Emanuel Ezekiel , Grady Christine
Published: October 2017

Background/aims:

Healthy volunteers in phase 1 clinical trials contribute to the development of safe drugs and other biologics and accept risks and burdens without anticipated health benefits from participation. Although emerging data have shown that healthy volunteers are influenced by risk, some still worry that financial incentives lead them to take on unreasonable risk. Yet little is known about healthy volunteers’ preferences and how they make choices about enrolling in research studies.

Methods:

We surveyed 654 healthy volunteers at the end of their participation in a phase 1 Pfizer trial in the United States, Belgium, and Singapore to examine their reported willingness to enroll in studies of different types, with various procedures, and with possible side-effects.

Results:

The majority of respondents were willing to join many kinds of studies, but fewer were willing to participate in first-in-human vaccine studies or studies of psychiatric drugs than in other study types. With regard to procedures, a substantial proportion were unwilling to participate in studies that involved invasive procedures, such as a lumbar puncture (45.4%) and bone marrow biopsy (42.3%), but willing to participate in studies with less invasive procedures such as a computed tomography scan of the heart (86.8%), magnetic resonance imaging (87.4%), and skin allergy testing (86.8%). Although there was some variation by gender and region, the majority were willing to participate in studies with side-effects like pain (80%) or nausea and vomiting (64%), but only a minority were willing to join if the research drug would result in their having a one in a million chance of death (34.4%), a small chance of kidney damage (16.7%), or influence how their mind works (23.2%; Figure 4).

Conclusion:

Our results suggest that healthy volunteers are willing to participate in a wide range of types of phase 1 clinical trials, and express preferences for low risk and familiar studies and study procedures, preferences which are partially affected by offers of payment.
Isotonic designs for phase I trials in partially ordered groups
Authors: Conaway Mark
Published: October 2017

Background/aims:

Dose-finding trials can be conducted such that patients are first stratified into multiple risk groups before doses are allocated. The risk groups are often completely ordered in that, for a fixed dose, the probability of toxicity is monotonically increasing across groups. In some trials, the groups are only partially ordered. For example, one of several groups in a trial may be known to have the least risk of toxicity for a given dose, but the ordering of the risk among the remaining groups may not be known. The aim of the article is to introduce a method for designing dose-finding trials of cytotoxic agents in completely or partially ordered groups of patients.

Methods:

This article presents a method for dose-finding that combines previously proposed mathematical models, augmented with results using order restricted inference. The resulting method is computationally convenient and allows for dose-finding in trials with completely or partially ordered groups. Extensive simulations are done to evaluate the performance of the method, using randomly generated dose–toxicity curves where, within each group, the risk of toxicity is an increasing function of dose.

Results:

Our simulations show that the hybrid method, in which order-restricted estimation is applied to parameters of a parsimonious mathematical model, gives results that are similar to previously proposed methods for completely ordered groups. Our method generalizes to a wide range of partial orders among the groups.

Conclusion:

The problem of dose-finding in partially ordered groups has not been extensively studied in the statistical literature. The proposed method is computationally feasible, and provides a potential solution to the design of dose-finding studies in completely or partially ordered groups.
Testing many treatments within a single protocol over 10 years at MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols
Authors: Parmar Mahesh KB , Sydes Matthew R , Cafferty Fay H , Choodari-Oskooei Babak , Langley Ruth E , Brown Louise , Phillips Patrick PJ , Spears Melissa R , Rowley Sam , Kaplan Richard , James Nicholas D , Maughan Timothy , Paton Nicholas , Royston Patrick J
Published: October 2017

There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone often we find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this article, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Time to institutional review board approval with local versus central review in a multicenter pragmatic trial
Authors: Neuman Mark D , Gaskins Lakisha J , Ziolek Tracy ,   the REGAIN Investigators
Published: October 2017

Background/aims:

Central institutional review board (IRB) review will be required for National Institutes of Health–funded multisite human subjects research as of January 2018, with similar requirements extending to most US multisite human research in 2020. Nonetheless, little is known regarding the relative efficiency of central versus local IRB review for multicenter studies. We compared the amount of time required for central versus local IRB review and approval for sites in one ongoing multicenter randomized trial.

Methods:

The REGAIN Trial (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; clinicaltrials.gov number: NCT02507505) is an ongoing randomized trial comparing standard-care spinal anesthesia to standard-care general anesthesia for patients undergoing hip fracture surgery. After approval of the protocol by the sponsor IRB, each participating US site opted either to submit the protocol for local IRB review or to designate the sponsor IRB as the IRB of record (i.e. central IRB) via an authorization agreement after a limited local review. For each US REGAIN site approved through 18 April 2017, we assessed (1) the time in calendar days from protocol receipt to IRB submission, (2) the time in calendar days from IRB submission to IRB approval, and (3) the total time in calendar days from protocol receipt to IRB approval (i.e. time from protocol receipt to IRB submission plus time from IRB submission to IRB approval).

Results:

The main study protocol was submitted to the sponsor IRB on 25 May 2015 and approved on 8 July 2015 (44 days). Out of 34 sites, 9 received initial approval from the central (sponsor) IRB; 25 sought initial approval via local review. The median time from protocol receipt to IRB submission was 39 days for sites approved by the central IRB (interquartile range: 35–134) versus 58 days for sites approved via local review (interquartile range: 41–105; p = 0.711). The median time from IRB submission to IRB approval for sites approved by the central IRB was 27 days (interquartile range: 14–32) versus 66 days (interquartile range: 29–138) for sites approved via local review (p = 0.026). The median total time from protocol receipt to IRB approval was 100 days (interquartile range: 71–148) for centrally approved sites versus 132 days (interquartile range: 87–209) for locally approved sites (p = 0.191).

Conclusion:

While central IRB review was associated with a shorter time from IRB submission to IRB approval compared to local IRB review, the total time from protocol receipt to IRB approval varied markedly across sites.
Leadership for learning in the preschool: Preschool managers’ perspectives on strategies and actions in the systematic quality work
Authors: Håkansson Jan
Published: October 2017

This article presents the results of a qualitative study with the aim of contributing to an understanding of preschool managers’ leadership in systematic quality work in a Swedish context. In line with the Education Act and the preschool curriculum, systematic quality work is compulsory in all Swedish preschools. This consists of several steps, including data collection, documentation and self-evaluation for the purpose of professional development and quality improvement. With the aid of interviews, preschool managers’ perspectives on leadership actions, with an emphasis on a leadership for learning, have been analysed in relation to local conditions and previous research. The results show that preschool managers balance the demands for loyalty to the municipality’s quality system’s requirements with their own preschool’s independence in the systematic quality work. In different ways they emphasise the organisational, content-related and methodological aspects of their long-term strategies, but also use relational and organisational leadership actions and feedback to show how they expect the staff to carry out their work with the children and collaborate with colleagues. The preschool’s conditions, such as the staff’s education levels, affect how the systematic quality work is organised and led. The importance of preschool managers’ professional knowledge – a content-related dimension – is discussed in relation to previous research on the concept of leadership for learning. One of the study’s conclusions is that the preschool’s leadership emphasis on organisational solutions could impede the preschool’s quality development.
Biological and clinical implications of telomere dysfunction in myeloid malignancies
Authors: Kishtagari Ashwin , Watts Justin
Published: October 2017

Telomeres at the ends of linear chromosomes protect the genome. Telomeres shorten with each round of cell division, placing a finite limit on cell growth. Telomere attrition is associated with cell senescence and apoptosis. Telomerase, a specialized ribonucleoprotein complex, maintains telomeres homeostasis through repeat addition of telomere sequences to the 3′ telomeric overhang. Telomere biology is closely related to cancer and normal aging. Upregulation of telomerase or activation of the alternative pathway of telomere lengthening is a hallmark of cancer cells, making telomerase an attractive target for cancer therapeutics. In this review, we will discuss telomere biology and the prognostic implications of telomere length in acute myeloid leukemia, and review exciting new investigational approaches using telomerase inhibitors in acute myeloid leukemia and other myeloid malignancies.
Membrane-like structure in the urinary bladder neck of a young cat: diagnosis and treatment using balloon dilatation and a balloon-expandable metallic stent
Authors: Ruiz-Drebing Matias , Yap Fui , Seth Mayank , Dennis Ruth , Dominguez Elisabet
Published: October 2017

Case summary

A 33-month-old, spayed female domestic shorthair cat was referred to the Animal Health Trust for the investigation of urinary incontinence and straining to urinate. A membrane-like structure was detected in the bladder neck, which caused partial obstruction of the urinary bladder. A combination of different imaging techniques, including ultrasonography, radiography, CT and fluoroscopy, was essential in the diagnosis, surgical planning and treatment of this intravesicular stricture. During retrograde vaginourethrocystogram, unexpected subcapsular accumulation of contrast medium was seen around both kidneys on radiographs and confirmed with CT. Three different treatments were performed, including surgical debridement, balloon dilatation and placement of a self-expanding metallic stent across the stricture. Histopathology of the membrane was unable to differentiate whether the lesion was congenital or acquired. No urinary incontinence was observed 5 months after placement of the metallic stent.

Relevance and novel information

This is the first reported case using fluoroscopic-guided balloon dilatation of the bladder neck for the treatment of a bladder neck stricture. Presence of renal subcapsular contrast medium secondary to a retrograde vaginourethrocystogram due to partial obstruction at the bladder neck in a cat has not been previously described.
Intubation following high-dose rocuronium in a cat with protracted laryngospasm
Authors: Doodnaught Graeme M , Pang Daniel SJ
Published: October 2017

Case summary

An 11-year-old spayed female domestic shorthair cat with a history of laryngospasm at induction of general anesthesia presented for dental evaluation and treatment. The cat was premedicated with hydromorphone (0.05 mg/kg) and alfaxalone (0.5 mg/kg) intravenously, pre-oxygenated for 5 mins (3 l/min, face mask) and anesthesia was induced with alfaxalone (to effect) intravenously. Lidocaine (0.1 ml, 2%) was applied topically to the arytenoid cartilages following loss of jaw tone. Laryngospasm was not noted during or immediately following lidocaine application. However, after waiting 60 s for the onset of effect of the topical lidocaine, laryngospasm was apparent. Orotracheal intubation by direct visualization was unsuccessful after four attempts by three anesthetists (with increasing levels of experience). At this point, a failed intubation was declared and the non-depolarising neuromuscular blocking agent rocuronium (1 mg/kg IV) given, resulting in arytenoid abduction and appropriate conditions for intubation. Successful intubation occurred 9 mins after induction of anesthesia. Oxygen was continuously supplemented throughout and arterial hemoglobin saturation with oxygen was never <94%.

Relevance and novel information

To the authors’ knowledge, this is the first report of the use of high-dose rocuronium to successfully resolve prolonged laryngospasm at induction of general anesthesia in a cat. Despite laryngospasm and a delay in achieving orotracheal intubation, low values for arterial hemoglobin saturation with oxygen (indicative of hypoxemia) were not observed, highlighting the benefits of pre-oxygenation and apneic oxygenation. The principles of the Difficult Airway Society 2015 guidelines were followed in managing this difficult intubation.
FDG avid breast cancer bone metastases silent on CT and scintigraphy: a case report with radiologic-pathologic correlation
Authors: Jeong Daniel , Bui Marilyn , Peterson Daniel , Montilla-Soler Jaime , Gage Kenneth L
Published: October 2017

Bone is the one of the most common distant metastatic sites in breast cancer. Routine initial breast cancer staging evaluation typically includes computed tomography (CT) and skeletal scintigraphy while 18F fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) is reserved for clinically high-risk cases. Since FDG PET-CT is not routinely performed during staging or surveillance evaluations, it is important for radiologists and clinicians to appreciate the limitations of bone metastasis detection on CT and scintigraphy. We present a case of bony metastases of invasive ductal carcinoma of the breast which were not detected on diagnostic CT or skeletal scintigraphy but were metabolically active on FDG PET-CT and evident on magnetic resonance. We provide a review of the literature and radiologic–pathologic correlation to explain the discordant imaging findings.
Negative Urgency Mediates the Relation Between Genetically Influenced Serotonin Functioning and Alcohol Problems
Authors: Wang Frances L. , Chassin Laurie
Published: October 2017

Serotonin (5-HT) functioning is associated with alcohol problems. However, the mechanisms underlying this association remain unclear. In the current study the authors tested whether five separate dimensions of impulsivity (UPPS-P) mediated the relation between a polygenic score indexing 5-HT functioning and alcohol problems and whether any of these paths were moderated by age. Results showed that a 5-HT polygenic score predicted alcohol problems indirectly through negative urgency, but not any other facet of impulsivity. The 5-HT polygenic score also directly predicted alcohol problems. No age moderation was found. Findings suggest that negative urgency might be one important mechanism underlying the relation between genetically influenced 5-HT functioning and alcohol problems. However, genetically influenced 5-HT functioning likely influences alcohol problems through additional mechanisms. More broadly, results suggest that the previously observed transdiagnostic nature of 5-HT functioning on diverse types of psychopathology might be, in part, explained by its effect on negative urgency.
Analysis of Risk Factors for New Vertebral Fracture After Percutaneous Vertebroplasty
Authors: Borensztein Matias , Camino Willhuber Gaston O. , Posadas Martinez Maria Lourdes , Gruenberg Marcelo , Sola Carlos A. , Velan Osvaldo
Published: October 2017

Study Design:

Retrospective analysis. Level of evidence III.

Objectives:

Low-energy vertebral compression fractures are an increasing socioeconomic problem among elderly patients. Percutaneous vertebroplasty has been extensively used for the treatment of painful fractures because of its effectiveness. However, some complications have been described; among them, new vertebral compression fractures, whether adjacent or not to the treated vertebra, are commonly reported complications (8% to 52%).

Methods:

We retrospectively analyzed epidemiological and technical variables presumably associated with new vertebral compression fractures. To determine the relationship between new vertebral compression fracture and percutaneous vertebroplasty, 30 patients (study group) with this complication were compared with 60 patients treated with percutaneous vertebroplasty without this condition (control group).

Results:

A higher cement percentage was found in the study group (40.3%) compared with the control group (30.5%). Initial vertebral kyphosis was significantly higher in the first group (15°) compared with the control group (9°). Epidemiological factors were similar in both groups.

Conclusions:

In our study, increased cement percentage injected and a higher kyphosis were associated with new vertebral compression fractures.
Return to Play in Adolescent Athletes With Symptomatic Spondylolysis Without Listhesis: A Meta-Analysis
Authors: Overley Samuel C. , McAnany Steven J. , Andelman Steve , Kim Jun , Merrill Robert K. , Cho Samuel K. , Qureshi Sheeraz A. , Hecht Andrew C.
Published: October 2017

Study Design:

Meta-analysis.

Objectives:

To assess return to play (RTP) rates in adolescent athletes with lumbar spondylolysis without spondylolisthesis treated conservatively or operatively.

Methods:

A review of Medline, EMBASE, and Cochrane Reviews was performed. The pooled results were performed by calculating the effect size based on the logit event rate. Studies were weighted by the inverse of the variance. Confidence intervals were reported at 95%. Heterogeneity was assessed using the Q statistic and I2 value.

Results:

The initial literature search resulted in 724 articles, of which 29 were deemed relevant on abstract review. Overall, 11 studies provided data for 376 patients with a pars interarticularis defect. Return to athletic competition, based on logit event rate, was found to be statistically favored after both nonoperative and operative treatment (92.2% vs 90.3%). There was no heterogeneity noted among the studies reporting nonoperative treatment ( Q value of 4.99 and I2 value of 0). There was mild heterogeneity within the operative studies ( Q value of 3.54 and I2 value of 15.18).

Conclusions:

Adolescent athletes RTP 92.2% of the time with nonoperative management, compared with 90.3% when treated operatively, though both treatment groups strongly favor RTP. As this is the first study to pool results of all relevant literature, it provides strong evidence to guide decision making and help manage expectations in this unique patient population.
Low-Density Pedicle Screw Constructs for Adolescent Idiopathic Scoliosis: Evaluation of Effectiveness and Cost
Authors: Tannous Oliver O. , Banagan Kelly E. , Belin Eric J. , Jazini Ehsan , Weir Tristan B. , Ludwig Steven C. , Gelb Daniel E.
Published: October 2017

Study Design:

Retrospective cohort study.

Objective:

To determine whether a low-density (LD) screw construct can achieve curve correction similar to a high-density (HD) construct in adolescent scoliosis.

Methods:

Patients treated operatively for idiopathic scoliosis between 2007 and 2011 were identified through a database review. A consistent LD screw construct was used. Radiographic assessment included percent correction of major and fractional lumbar curves, T5-T12 kyphosis, and angle of lowest instrumented vertebra (LIV). Costs were compared with HD constructs.

Results:

Thirty-five patients were included in the analysis. Ages ranged from 12 to 19 years (mean = 14.9 years). Average screw density was 1.2 screws per level (range = 1.07-1.5 screws). Mean percent curve correction at latest follow-up: major curve, 66.9%; fractional lumbar curve, 63%. Average postoperative thoracic kyphosis: 29.5°. Mean LIV angle: 5.6°. Average construct cost was $14 871 per case compared with $23 840 per case if all levels had been instrumented with 2 screws, amounting to an average savings of $9000.

Conclusions:

Our LD screw construct is among the lowest density constructs reported and achieves curve correction comparable to HD constructs at substantially lower cost.
Evaluating Diabetes Care for Patients With Serious Mental Illness Using the Chronic Care Model
Authors: Vaez Kelly , Diegel-Vacek Lauren , Ryan Catherine , Martyn-Nemeth Pamela
Published: October 2017

People with serious mental illness (SMI) have a higher incidence of type 2 diabetes mellitus (T2DM) and shorter life span due to medical health problems. The chronic care model (CCM) has been used to improve care of patients with T2DM. One clinical organization that provided primary care to patients with SMI had excellent diabetes outcomes but did not have information on how they achieved those outcomes. Thus, we conducted a pilot study chart review for 30 patients with T2DM and SMI to determine how well the clinic’s system aligned with the overall CCM components and which components correlated with diabetes control. We also evaluated use of the CCM using the Assessment of Chronic Illness Care provider survey. Results showed that the clinic had an overall basic implementation level of the CCM, which allows opportunity for improvement. Two elements of the CCM were correlated with hemoglobin A1C and both were in an unexpected direction: self-management support in the variable of percentage of visits that included patient-specific goal-setting ( rs = .52; P = .004) and delivery system design in the variable of number of nurse practitioner visits per study period ( rs = .43; P = .02). These findings suggest that the clinic may have made more concentrated efforts to manage diabetes for patients who were not in good diabetes control. Providers noted the influence of SMI and social service organization support on these patients’ clinical outcomes. The findings will be reexamined after a fuller implementation of the CCM to further improve management in this population.
A New Dyslexia Reading Method and Visual Correction Position Method
Authors: Manilla George T. , de Braga Joe
Published: October 2017

Pediatricians and educators may interact daily with several dyslexic patients or students. One dyslexic author accidently developed a personal, effective, corrective reading method. Its effectiveness was evaluated in 3 schools. One school utilized 8 demonstration special education students. Over 3 months, one student grew one third year, 3 grew 1 year, and 4 grew 2 years. In another school, 6 sixth-, seventh-, and eighth-grade classroom teachers followed 45 treated dyslexic students. They all excelled and progressed beyond their classroom peers in 4 months. Using cyclovergence upper gaze, dyslexic reading problems disappeared at one of the Positional Reading Arc positions of 30°, 60°, 90°, 120°, or 150° for 10 dyslexics. Positional Reading Arc on 112 students of the second through eighth grades showed words read per minute, reading errors, and comprehension improved. Dyslexia was visually corrected by use of a new reading method and Positional Reading Arc positions.