bluuebunny/crossref_metadata_2025 huggingface dataset:
Pharmacotherapeutic Management of Neuropathic Pain in End-Stage Renal Disease
Authors: Raouf Mena , Bettinger Jeffrey , Wegrzyn Erica W. , Mathew Roy O. , Fudin Jeffrey J.
Published: January 2020

Background: Chronic noncancer pain is pervasive throughout the general patient population, transcending all chronic disease states. Patients with end-stage renal disease (ESRD) present a complicated population for which medication management requires careful consideration of the pathogenesis of ESRD and intimate knowledge of pharmacology. The origin of pain must also guide treatment options. As such, the presentation of neuropathic pain in ESRD can present a challenging case. The authors aim to provide a review of available classes of medications and considerations for the treatment of neuropathic pain in ESRD. Summary: In this narrative review, the authors discuss important strategies and considerations for the treatment of neuropathic pain in ESRD, including the pathogenesis of neuropathic pain, physiological changes for consideration in ESRD patients, and disease-specific consideration for medication selection. Pharmacotherapeutic classes discussed include: anticonvulsants, antiarrhythmics, antidepressants, topicals, and opioids. Key Message: Pain management in ESRD patients requires careful assessment of drug-specific properties, accumulation, metabolism (presence of active/toxic metabolites), extraction by dialysis, and presence of drug – drug interactions. In the absence of pharmacokinetic data in ESRD patients, therapeutic window and potential risks should be factored in the decision making along with continued monitoring throughout therapy.
Palliative Care of Malignant Fibrous Histiocytoma of Spine with Cord Compression and Multiple Bone Metastases Treated by Multidisciplinary Therapy: Case Report
Authors: Sekiguchi Ivan , Takeda Naoki , Ishida Naoki
Published: January 2020

Malignant fibrous histiocytoma (MFH) of the spine is rare, with only a few dozen cases reported in the literature. A 60-year-old male was referred to us with symptoms of thoracic myelopathy. A solid tumor in the Th8 right costovertebral junction invading the spinal canal and compressing the spinal cord, and multiple bony metastases were discovered. Biopsy confirmed MFH. The thoracic spine tumor showed good response to irradiation followed by embolization and partial resection. The patient was followed until his death 22 months later. A good quality of life was sustained for more than 18 months. Despite a poor prognosis and an aggressive course of MFH of the spine, a good quality of life could be sustained for more than a year with palliative interventions.
Cancer-Related Pneumopericardium: A Case Report and Literature Review
Authors: Hirani Samina , Velez Martinez Carol S. , Patan Shajadi , Kavanaugh Mindie
Published: January 2020

Pneumopericardium is a relatively rare entity mostly described in the literature as a result of causes such as penetrating/blunt trauma and iatrogenic causes during cardiothoracic procedures. We are presenting a case of pneumopericardium as a complication of progressed gastroesophageal junction tumor along with a literature review of all cancer-related pneumopericardium cases reported in the last decade. We present the case of a 65-year-old male with a past medical history significant for locally advanced gastroesophageal junction adenocarcinoma who presented to the hospital with complaints of shortness of breath and fever. A chest X-ray showed an intact esophageal stent along with radiolucency around the cardiac silhouette which suggested pneumopericardium. Computed tomography scan of the chest confirmed the presence of pneumopericardium in posterior pericardium with foci of gas above the esophageal stent likely to be communicating with the pericardium. An echocardiogram was obtained which showed no signs of tamponade. Given the advanced nature of the disease we applied a conservative management given that the pneumopericardium was deemed to be small with no tamponade. Goals of care were discussed with the patient and his family and the patient opted for comfort care measures. This case report prompted us to perform an extensive literature review of cancer-related pneumopericardium from 2008 to 2019. We found 11 cases where it was reported secondary to malignancies of different kinds. Our aim is to compile a review for clinicians to view varied presentations and better direct therapy dependent on the individual case and clinical presentation in patients with cancer-related pneumopericardium. Moreover, although pneumopericardium is rare, it should be considered in differential diagnosis in patients presenting with shortness of breath or chest pain especially with cancers involving the cardiothoracic region.
Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke
Authors: Shkirkova Kristina , Schuberg Samuel , Balouzian Emma , Starkman Sidney , Eckstein Marc , Stratton Samuel , Pratt Franklin D. , Hamilton Scott , Sharma Latisha , Liebeskind David S. , Conwit Robin , Saver Jeffrey L. , Sanossian Nerses ,   for the FAST-MAG Investigators and Coordinators
Published: January 2020

Background and Purpose—

The prehospital setting is a promising site for therapeutic intervention in stroke, but current stroke screening tools do not account for the evolution of neurological symptoms in this early period. We developed and validated the Paramedic Global Impression of Change (PGIC) Scale in a large, prospective, randomized trial.

Methods—

In the prehospital FAST-MAG (Field Administration of Stroke Therapy-Magnesium) randomized trial conducted from 2005 to 2013, EMS providers were asked to complete the PGIC Scale (5-point Likert scale values: 1-much improved, 2-mildly improved, 3-unchanged, 4-mildly worsened, 5-much worsened) for neurological symptom change during transport for consecutive patients transported by ambulance within 2 hours of onset. We analyzed PGIC concurrent validity (compared with change in Glasgow Coma Scale, Los Angeles Motor Scale), convergent validity (compared with National Institutes of Health Stroke Scale severity measure performed in the emergency department), and predictive validity (of neurological deterioration after hospital arrival and of final 90-day functional outcome). We used PGIC to characterize differential prehospital course among stroke subtypes.

Results—

Paramedics completed the PGIC in 1691 of 1700 subjects (99.5%), among whom 635 (37.5%) had neurological deficit evolution (32% improvement, 5.5% worsening) during a median prehospital care period of 33 (IQR, 27–39) minutes. Improvement was associated with diagnosis of cerebral ischemia rather than intracranial hemorrhage, milder stroke deficits on emergency department arrival, and more frequent nondisabled and independent 3-month outcomes. Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months.

Conclusions—

The PGIC scale is a simple, validated measure of prehospital patient course that has the potential to provide information useful to emergency department decision-making.

Registration—

URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT00059332.
Predicted and Projected Water Resources Changes in the Chari Catchment, the Lake Chad Basin, Africa
Authors: Mahmood Rashid , Jia Shaofeng , Mahmood Tariq , Mehmood Asif
Published: January 2020

The water resources of the Chari River basin, contributing more than 90% of the water to one of the largest lakes in Africa, known as Lake Chad, are highly vulnerable to natural and anthropogenic changes. Therefore, the changes in water resources were predicted for the next 20 years (i.e., 2016–35) by using the harmonic regression model (HRM), one of the most sophisticated time series methods, and also projected under representative concentration pathways (RCPs) by using the multimodel approach for the periods 2021–50, 2051–80, and 2081–2100, with respect to the baseline period (1971–2001). The Tropical Rainfall Measuring Mission (TRMM), Climatic Research Unit (CRU), and dynamically downscaled climatic data were used in the analysis of the present study. The results showed that under MME-RCP2.6 (multimodel ensemble of RCMs), low flow (average of low-flow months, December–July), high flow (August–November), and annual flow were projected to decrease in the future. In contrast, under MME-RCP4.5 and MME-RCP8.5, high and annual flows were projected to increase in all three time horizons, while low flow will decrease except in 2021–50 under MME-RCP8.5. In the next two decades, the HRM showed decrease in all type of flows (low, high, and annual), very similar to the results under MME-RCP2.6 for the same period. In contrast, almost all flows are expected to increase under MME-RCP4.5 and MME-RCP8.5 in the next two decades. On the whole, the flows are expected to decrease under the HRM and RCP2.6 but to increase under RCP4.5 and RCP8.5.
Numerical Study of the 6 May 2012 Tsukuba Supercell Tornado: Vorticity Sources Responsible for Tornadogenesis
Authors: Tao Tao , Tamura Tetsuro
Published: January 2020

Remarkable progress has been achieved in understanding the vorticity source responsible for tornadogenesis. Nevertheless, the answer to this question remains elusive, particularly after introducing surface friction in realistic tornado simulations. In this study, a simulation using the Weather Research and Forecasting (WRF) Model is conducted based on the F3 supercell tornado that hit Tsukuba City, Japan, on 6 May 2012. The simulation uses triply nested domains, and the tornado is successfully reproduced in the innermost domain with 50-m horizontal grid spacing. The circulation analyses reveal that the frictional term is the dominant vorticity source responsible for the vortices at both the pretornadic and tornadogenesis times. The detailed vorticity source analyses of the air parcels show that the vorticity of the tornado at the genesis time mainly originates from the frictionally generated crosswise vorticity near the ground. The crosswise vorticity is directly tilted (or first exchanged into streamwise vorticity and then tilted) into vertical vorticity when the air parcels enter the tornado. A rear-flank downdraft (RFD) surge from the south and west sides of a primary low-level mesocyclone (LMC) may trigger tornadogenesis by increasing the convergence near the ground. The RFD surge is not necessarily associated with the baroclinically generated vorticity. In this study, the baroclinity is weak across the hook echo, which may cause a lack of baroclinically generated vorticity in the RFD surge.
The Framework for Assimilating All-Sky GPM Microwave Imager Brightness Temperature Data in the NASA GEOS Data Assimilation System
Authors: Kim Min-Jeong , Jin Jianjun , El Akkraoui Amal , McCarty Will , Todling Ricardo , Gu Wei , Gelaro Ronald
Published: January 2020

Satellite radiance observations combine global coverage with high temporal and spatial resolution, and bring vital information to NWP analyses especially in areas where conventional data are sparse. However, most satellite observations that are actively assimilated have been limited to clear-sky conditions due to difficulties associated with accounting for non-Gaussian error characteristics, nonlinearity, and the development of appropriate observation operators for cloud- and precipitation-affected satellite radiance data. This article provides an overview of the development of the Gridpoint Statistical Interpolation (GSI) configurations to assimilate all-sky data from microwave imagers such as the GPM Microwave Imager (GMI) in the NASA Goddard Earth Observing System (GEOS). Electromagnetic characteristics associated with their wavelengths allow microwave imager data to be highly sensitive to precipitation. Therefore, all-sky data assimilation efforts described in this study are primarily focused on utilizing these data in precipitating regions. To utilize data in cloudy and precipitating regions, state and analysis variables have been added for ice cloud, liquid cloud, rain, and snow. This required enhancing the observation operator to simulate radiances in heavy precipitation, including frozen precipitation. Background error covariances in both the central analysis and EnKF analysis in the GEOS hybrid 4D-EnVar system have been expanded to include hydrometeors. In addition, the bias correction scheme was enhanced to reduce biases associated with thick clouds and precipitation. The results from single observation experiments demonstrate the capability of assimilating all-sky microwave brightness temperature data in GEOS both when the model forecast produces excessive precipitation and too little precipitation. Additional experiments show that hydrometeors and dynamic variables such as winds and pressure are adjusted in physically consistent ways in response to the assimilation.
Association Between Serum Cotinine and Severe Abdominal Aortic Calcification in US Adults
Authors: Wen Xiaoxiao , Xia Yanjie , Guo Min , Zhao Liancheng , Zhou Long
Published: January 2020

This study aims to explore the association between serum cotinine and severe abdominal aortic calcification (AAC) in the US adults. We examined 2840 participants with a weighted mean age of 57.4 years from the National Health and Nutrition Examination Survey 2013-2014. Serum cotinine was analyzed as the main exposure both continuously and categorically (tertiles). Abdominal aortic calcification detected with dual-energy X-ray absorptiometry was quantified using the Kauppila score system. Severe AAC was detected in 252 (8.9%) participants. The multivariable-adjusted odds ratios and 95% confidence intervals (CIs) of the middle and top cotinine categories were 1.14 (0.79-1.64) and 1.80 (1.21-2.68), respectively, P for trend = .004. Per unit increase in log-transformed serum cotinine was associated with 10% (95% CI: 6%-15%) higher odds of severe AAC when serum cotinine was analyzed as a continuous variable. The association was consistent across sex and ethnic groups. In conclusion, elevated serum cotinine level was associated with higher odds for severe AAC in a representative sample of US adults.
Systematic review and meta-analysis of rates of clozapine-associated myocarditis and cardiomyopathy
Authors: Siskind Dan , Sidhu Ashneet , Cross John , Chua Yee-Tat , Myles Nicholas , Cohen Dan , Kisely Steve
Published: January 2020

Background:

Clozapine is the most effective medication for treatment refractory schizophrenia, but is associated with cardiac adverse drug reactions. Myocarditis and cardiomyopathy are the most serious cardiac adverse drug reactions although reported rates of these conditions vary in the literature. We systematically reviewed and meta-analysed the event rates, the absolute death rates and case fatality rates of myocarditis and cardiomyopathy associated with clozapine.

Methods:

PubMed, EMBASE and PsycINFO were searched for studies that reported on the incidence of cardiomyopathy or myocarditis in people exposed to clozapine. Data were meta-analysed using a random effects model, with subgroup analysis on study size, time frame, region, quality, retrospective vs prospective, and diagnostic criteria of myocarditis or cardiomyopathy.

Results:

28 studies of 258,961 people exposed to clozapine were included. The event rate of myocarditis was 0.007 (95% confidence interval [CI] = [0.003, 0.016]), absolute death rate was 0.0004 (95% CI = [0.0002, 0.0009]) and case fatality rate was 0.127 (95% CI = [0.034, 0.377]). The cardiomyopathy event rate was 0.006 (95% CI = [0.002, 0.023]), absolute death rate was 0.0003 (95% CI = [0.0001, 0.0012]) and case fatality rate was 0.078 (95% CI = [0.018, 0.285]). Few included studies provided information on criteria for diagnosis of myocarditis and cardiomyopathy. Event rates of cardiomyopathy and myocarditis were higher in Australia.

Conclusion:

Clarity of diagnostic criteria for myocarditis remains a challenge. Observation bias may, in part, influence higher reported rates in Australia. Monitoring for myocarditis is warranted in the first 4 weeks, and treatment of comorbid metabolic syndrome and diabetes may reduce the risk of cardiomyopathy. The risks of myocarditis and cardiomyopathy are low and should not present a barrier to people with treatment refractory schizophrenia being offered a monitored trial of clozapine.
Multiple Sclerosis Presenting as an Anterior Semicircular Canal Benign Paroxysmal Positional Vertigo: Case Report
Authors: Musat Gabriela C. , Musat Andreea A. M.
Published: January 2020

We present the case of a 31-year-old woman with isolated symptomatology accusing positional vertigo. The videonystagmography (VNG) including Dix-Hallpike testing we have performed, highlighted atypical eye movements. We have observed a positional downbeating nystagmus with characteristics that could be accounted for anterior semicircular canal benign paroxysmal positional vertigo. Furthermore, examining the atypical nystagmus at the measurements performed during VNG recordings, we suspicioned a central positional vertigo. The abnormalities observed at the positional nystagmus were the lack of latency period, the downbeating component not limited in time, and the atypical torsional component. The magnetic resonance imaging examination recommended showed multiple white matter lesions characteristic for multiple sclerosis. The patient was referred to the neurology department for further evaluation and treatment. The diagnosis was unexpected because the patient did not have any other symptom that could have been linked to multiple sclerosis.
BBC’s Documentary “Stadiums of Hate” and Manufacturing of the News: Case Study in Moral Panics and Media Manipulation
Authors: Rek-Woźniak Magdalena , Woźniak Wojciech
Published: January 2020

The article is based on a critical case study of the BBC’s investigative documentary titled Stadiums of Hate and the public’s response to it. The documentary was broadcasted 11 days before the kickoff of Euro 2012 (UEFA [Union of European Football Associations] European Championships in Football), the first sport mega event hosted in Poland and Ukraine. The main theme was football-related racism and violence allegedly threatening the safety of the fans coming to the tournament. The article follows Amanda Rohloff’s proposal combining the Eliasian conceptual framework of civilizing processes with the moral panics approach to describe the effort to amplify the spiral of public outcry toward the hosts of Euro 2012 in an attempt to modernize and civilize the Eastern European world of football. The moral panics spiral was brought to an end by the tournament which did not justify grim predictions. The article combines analysis of media content and the public statements with interviews conducted with some of the informants of the BBC journalists.
T-shaped linear-stapled cervical esophagogastric anastomosis for minimally invasive esophagectomy: a pilot study
Authors: Li Xinju , Wang Zhe , Zhang Guangjian , Fu Junke , Wu Qifei
Published: January 2020

Background:

Minimally invasive esophagectomy (MIE) has become a good option in the surgical treatment of esophageal cancer. Cervical esophagogastric anastomoses (CEGA) are widely used during esophagectomy. However, CEGA are related with a higher incidence of anastomotic complications. In the present study, a new procedure of T-shaped linear-stapled cervical esophagogastric anastomosis was used during MIE and the short-term outcomes are presented.

Methods:

From May 2014 to December 2018, 32 consecutive patients with esophageal cancer who underwent total MIE followed by T-shaped linear-stapled cervical esophagogastric anastomosis were included. Postoperative outcomes were analyzed.

Results:

Fifteen men and 17 women were included this pilot study. The histology of all cases was squamous cell carcinoma. Mean operation time of T-shaped linear-stapled cervical esophagogastric anastomosis was 17.6 minutes. There were no early or late mortalities. A minor cervical anastomotic leakage occurred in 1 patient. No complications of anastomotic stenosis occurred in this study.

Conclusion:

The T-shaped linear-stapled cervical esophagogastric anastomosis is efficient, reliable, easy to perform, and associated with lower postoperative complication rate.
Mentoring Experiences and Perceptions of Latino Male Faculty in Higher Education
Authors: Salinas Cristobal , Riley Patrick , Camacho Lazaro , Floyd Deborah L.
Published: January 2020

While some higher education institutions attempt to help support and retain Latino students until graduation, these same institutions often neglect the experiences of Latino faculty members. The main challenges Latino faculties encounter in higher education include cultural taxation, discrimination, and feelings of isolation. Research is limited on the experiences and role of mentorship for Latino male faculty. This phenomenological study examines how Latino male faculty members in higher education perceive mentoring both as a mentee and as a mentor. This study also examines the impact of mentoring on professional development and the path of Latino male faculty. Findings illustrate that family values, mentoring in higher education, and desire to pay forward the mentoring experience are factors that impact Latino male faculty perception of mentorship.
Looking Before Leaping: Can We Afford an Unlimited Trade War Between the World’s Two Largest Economies
Authors: Sun Xihui
Published: January 2020

The Trump administration launched the world’s biggest trade war with China, which is suggestive of its distinctive governing philosophy. Consequently, the trade war with China is not only part of the US policies on China, but also part of the Indo-Pacific strategy of the administration, with aims of both money and containment. In response, China has adopted both hardline and moderate approaches, resolutely fighting back the pressure from the USA and exhibiting restraint in retaliation. However, China and the USA have their own advantages, and the end of the trade war depends on the resolution, willpower, and judgment of the situation. Presently, China is the only country that has the ability and resolution to stand up to the USA to stay the course in the trade war; China’s perseverance and retaliation to the US’ extreme pressure in the trade war temporarily eased the pressure on other countries from the USA. The trade war is damaging to the world and will cause more harm if it goes unchecked. The USA dominates the direction of Sino-US relations, but China’s response also shapes Sino-US relations to a certain extent.
Condition-Specific Oral Health Impacts in Thai Children and Adolescents: Findings From the National Oral Health–Related Quality of Life Survey
Authors: Prasertsom Piyada , Kaewkamnerdpong Issarapong , Krisdapong Sudaduang
Published: January 2020

This study was a part of the 7th National Oral Health Survey of Thailand and aimed to assess overall and condition-specific oral health–related quality of life of 12 and 15 year olds. Oral impacts were assessed using the Child-Oral Impacts on Daily Performances Index for 12 year olds and the Oral Impacts on Daily Performances index for 15 year olds. Overall oral impacts and condition-specific oral impacts (CS-impacts) were calculated. Detailed characteristics of CS-impacts were analyzed. Seventy-five percent of 12 year olds and 70.1% of 15 year olds had one or more oral impacts. CS-impacts attributed to dental caries were 37.8% and 36.5% for 12 and 15 year olds, respectively, followed by CS-impacts attributed to periodontal diseases and oral lesions. Dental caries was the most important cause of oral impacts. The severe impacts on daily performances of 12 year olds were mainly caused by dental caries, while those of 15 year olds related to dental caries and oral lesions. The majority of Thai children and adolescents experienced oral impacts. CS-impacts attributed to dental caries were most prevalent and most severe.
Association Between Electronic Cigarette Use and Levels of High-Sensitivity C-Reactive Protein and Uric Acid
Authors: Moon Jihyun , Lee Hyowon , Kong Mihee , Kim Hyeonju , Oh Yunhwan
Published: January 2020

The present study investigated whether electronic cigarette use, which is becoming increasingly common, was related to systemic inflammation that may lead to cardiovascular disease, similar to conventional cigarette smoking. The study included 1208 men (19-65 years old) who participated in the 7th Korean National Health and Nutrition Examination Survey (2016). The participants were categorized as electronic cigarette users, conventional cigarette users, and nonsmokers. Serum high-sensitivity C-reactive protein was used as an inflammatory index, and uric acid level was used as a metabolic indicator. After adjusting for confounding factors, electronic cigarette use was significantly associated with elevated serum high-sensitivity C-reactive protein levels (β = 1.326, P = .002), uric acid levels (β = 0.400, P = .042), and hyperuricemia (uric acid level of >7 mg/mL; odds ratio = 2.67, 95% confidence interval = 1.27-5.58). These findings suggest that electronic cigarette use may be associated with systemic inflammation markers, similar to conventional cigarette use.
The Effects of Systematic Instruction on Preschoolers’ Use of Stay-Play-Talk With Their Peers With Social Delays
Authors: Milam Molly E. , Hemmeter Mary Louise , Barton Erin E.
Published: January 2020

Using a multiple probe design across peer buddy–target child dyads, we evaluated the effects of an intervention package (i.e., brief training, system of least prompts, visual supports) on peer buddies’ use of stay-play-talk (SPT) with their classmates who were socially isolated (target children). All six peer buddies increased their use of SPT after the intervention package was introduced. Peer buddies also maintained SPT strategy use when adult supports were faded but did not generalize implementation of SPT strategies to other settings. We also examined the relation between peer buddy use of SPT and the duration of social play for target children. The social engagement of all three target children increased after intervention commenced with peer buddies. Target children increased, maintained, and generalized their duration of social play across settings. Teachers reported the SPT strategies were feasible and perceived socially significant increases in the social engagement of the target children.
The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation
Authors: Khoruts Alexander , Hoffmann Diane E. , Palumbo Francis B.
Published: January 2020

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug (IND) application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation.
The Ethics of Fecal Microbiota Transplant as a Tool for Antimicrobial Stewardship Programs
Authors: Murray Thomas S. , Herbst Jennifer
Published: January 2020

Multidrug resistant organisms (MDROs) are a public health threat that have reduced the effectiveness of many available antibiotics. Antimicrobial stewardship programs (ASPs) have been tasked with reducing antibiotic use and therefore the emergence of MDROs. While fecal microbiota transplant (FMT) has been proposed as therapy to reduce patient colonization of MDROs, this will require additional evidence to support an expansion of the current clinical indication for FMT. This article discusses the evidence and ethics of the expanded utilization of FMT by ASPs for reasons other than severe recurrent or refractoryClostridioides(formerlyClostridium)difficileinfection.
Vaginal Microbiota Transplantation: The Next Frontier
Authors: DeLong Kevin , Zulfiqar Fareeha , Hoffmann Diane E. , Tarzian Anita J. , Ensign Laura M.
Published: January 2020

The success of fecal microbiota transplantation (FMT) as a treatment for Clostrioides difficile infection (CDI) has stirred excitement about the potential for microbiota transplantation as a therapy for a wide range of diseases and conditions. In this article, we discuss vaginal microbiota transplantation (VMT) as “the next frontier” in microbiota transplantation and identify the medical, regulatory, and ethical challenges related to this nascent field. We further discuss what we anticipate will be the first context for testing VMT in clinical trials, prevention of the recurrence of a condition referred to as bacterial vaginosis (BV). We also compare clinical aspects of VMT with FMT and comment on how VMT may be similar to or different from FMT in ways that may affect research design and regulatory decisions.
Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies
Authors: Mueller Noel T. , Hourigan Suchitra K. , Hoffmann Diane E. , Levy Lauren , von Rosenvinge Erik C. , Chou Betty , Dominguez-Bello Maria-Gloria
Published: January 2020

Several lines of evidence suggest that children born via Cesarean section (C-section) are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients.
The Case for Disclosure of Biologics Manufacturing Information
Authors: Heled Yaniv
Published: January 2020

Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.

As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.

This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.
Factor Structure, Convergent, and Divergent Validity of the Prodromal Questionnaire–Negative Symptom Subscale
Authors: Pierce Katherine M. , Maxwell Seth D. , Olino Thomas M. , Cooper Shanna , Ellman Lauren M.
Published: January 2020

Negative symptoms such as anhedonia are associated with psychosis risk and poorer outcomes. The Prodromal Questionnaire (PQ) is a self-report questionnaire used to screen for psychosis spectrum symptoms. However, the convergent and divergent validity and underlying factor structure of the PQ–negative symptom subscale (PQ-N) have yet to be examined. Undergraduates ( N = 1,556) completed the PQ, Temporal Experience of Pleasure Scale, and measures assessing anxiety, depression, and motivation. An exploratory factor analysis conducted on the PQ-N yielded a two-factor solution, reflecting subdimensions of social expression and dissociative–depressive experiences, contrary to previous research examining the factor structure of negative symptoms. Associations between the PQ-N, its two factors, and measures of negative symptoms and other psychopathology were examined. Results indicated that the PQ-N and its factors were more strongly correlated with measures of depression and anxiety than with measures of negative symptoms relating to motivation and pleasure, suggesting poor convergent and divergent validity.
Parecoxib as an adjunct therapy for the treatment of refractory non-surgical cancer pain
Authors: Thakerar Arti , Dines-Muntaner Seamus , Trifunovich Tijana , Alexander Marliese , Fullerton Sonia
Published: January 2020

Background

Evidence for the use of short-term daily parenteral parecoxib for refractory or uncontrolled non-surgical cancer pain is limited. This study aimed to characterise the real-world off-label use and report on clinical experiences in an Australian cancer cohort.

Methods

Eligible patients received at least one dose of parecoxib of an intended three-day course between October 2015 and December 2018. Data were collected to characterise the parecoxib treatment cohort (cancer diagnosis, metastases, sites and types of pain and prior analgesia). Parecoxib-related adverse events, pain scores (worst and median), and concurrent opioid use were assessed at 24 h pre (T0) and 24 (T1), 48 (T2), 72 (T3) and 96 h (T4) post first parecoxib dose.

Results

Sixty-five patients (39 males and 26 females) and 68 courses of parecoxib (three patients treated twice) were included in analyses: metastatic disease (86%), bone pain (54%) and taking ≥3 classes of analgesic medications (69%). Pain types varied (46% non-specific, 22% neuropathic and 32% other). Most (94%) received parecoxib by subcutaneous administration. Following parecoxib, median 24-h pain scores and worst pain scores improved for 59% (40/68) and 50% (34/68) of patients, respectively. In the first 24 h (T0 to T1), median (4 vs. 2, p < 0.01) and worst (6 vs. 5, p < 0.01) pain scores were reduced and sustained to T4 (4 vs. 2.5, p = 0.01). Breakthrough analgesia requirements reduced for 63% (43/68) of patients, while total concurrent opioid use remained constant. Mean/median oral morphine equivalence for T0 vs. T1 was 111 mg/75 mg vs. 162 mg/90 mg, (p > 0.8). Two patients ceased parecoxib due to renal/liver function abnormalities and two experienced mild injection-site reactions.

Conclusions

In this real-world study, parecoxib was utilised as adjunctive therapy in a select patient cohort to contribute to reduced pain scores with no new safety signals. Prospective randomised studies in larger cohorts would improve understanding of the effects of parecoxib.
Being Culturally Responsive in a Formative Evaluation of a Professional Development School: Successes and Missed Opportunities of an Educative, Values-Engaged Evaluation
Authors: Hall Jori N. , Freeman Melissa , Colomer Soria E.
Published: January 2020

While evaluators have explored the implementation of culturally responsive evaluation (CRE), the failures of applying CRE are less often told. In this article, we use a reflective case narrative to explore our successes and failures in implementing our CRE approach, including an educative stance. We draw on a formative evaluation of a district–university partnership during its first year. Our analysis of the reflective case narrative makes transparent how our culturally responsive, educative approach was sufficient to employ culturally responsive methods. Yet, our culturally responsive, educative stance failed to provide critical midcourse feedback, which worked against the development of the district–university partnership. The lessons learned from the formative evaluation are important to draw attention to the intersections between the cultural characteristics of the evaluand and how the evaluation contributes to educative insights.
Serological, molecular and clinicopathological findings associated with Leishmania infantum infection in cats in Northern Italy
Authors: Urbani Lorenza , Tirolo Alessandro , Salvatore Daniela , Tumbarello Michele , Segatore Sofia , Battilani Mara , Balboni Andrea , Dondi Francesco
Published: January 2020

Objectives

The aims of this study were to investigate the prevalence of Leishmania species infection in cats in Northern Italy and to evaluate the associations between infection and signalment and clinicopathological data.

Methods

The study was carried out in a veterinary university hospital from June to November 2017. Blood, urine, conjunctival swabs and hair were collected from all randomly selected cats. Leishmania species infection was evaluated using the indirect fluorescent antibody test (IFAT), setting a cut-off value of 1:80, and using real-time PCR on blood, conjunctival and hair samples. A complete blood count, serum chemistry profile, serum electrophoresis and urinalysis were also carried out. The cats were grouped on the basis of the results of the diagnostic criteria adopted in positive, negative and unconfirmed Leishmania cases. Non-parametric variables and continuous data were compared among the study groups using the χ2 test and the Mann–Whitney U-test, respectively.

Results

One hundred and fifty-two cats were included. Nineteen of the 152 (12.5%) cats were positive (18/152 [11.8%] showed an IFAT titre of ⩾1:80 and 1/152 [0.7%] was real-time PCR-positive from a hair sample); 106/152 (69.7%) cats were negative; and 27/152 (17.8%) cats were unconfirmed for Leishmania species. Total proteins, beta2-globulin and gamma-globulin were significantly increased in the positive Leishmania group compared with the negative group.

Conclusions and relevance

The results of the present study demonstrated the spread of Leishmania infantum infection in cats in Northern Italy. Hyperproteinaemia and hypergammaglobulinaemia appeared to be significant clinicopathological abnormalities in this population of cats with L infantum infection.
People who teach regularly: What do we know from PIAAC about their professionalization?
Authors: Grotlüschen Anke , Stammer Christopher , Sork Thomas J
Published: January 2020

Professionalization in adult education is necessary, and several initiatives are underway to improve the professional situation as well as the competences and skills of adult educators. The relevance and importance of adult education is often stated. Large-scale assessments such as the Programme for the International Assessment of Adult Competences show how important adult education is for societies and economies. They give information on participation and participants. At first glance, the Programme for the International Assessment of Adult Competences lacks detailed information on adult education institutions and professions. A second glance allows explore what people do as part of their work. Those who state that they teach regularly or occasionally will be explored here in more detail. Findings from this study reveal several characteristics of people who teach, including age, gender, academic background and industries. In particular, our analysis suggests that more than 80% of those who teach did not have formal degrees in education sciences. Moreover, those who teach frequently have higher skills, older ages and they have better job positions than those who do not teach. The majority of those who teach are males. Lastly, the results indicate that seniority and prestige in all 14 countries examined in this study are highly relevant to people who teach.
Associations Between Teacher Ratings and Direct Assessment of Elementary Students’ Speech and Language Skills
Authors: Chow Jason C. , Frey Jennifer R. , Naples Lauren H.
Published: January 2020

We investigated the associations between teacher-rated and direct assessments of early elementary students’ speech and language skills to explore whether using teachers as primary screeners yielded assessment data that reliably identified young students with language difficulties who many need a more comprehensive evaluation. We assessed first- and second-grade students ( N = 365) on syntax, morphology, and vocabulary, screened for global speech and language development, and analyzed a teacher-completed norm-referenced communication rating scale. Teacher-rated language significantly predicted students’ latent language skills, and teachers’ ratings of students’ communication skills were not influenced by students’ gender, race/ethnicity, English language learner status, or special education status. We conclude with a discussion of implications for school-based research, assessment, and practice.
Latinx Community College Students’ Transition to a 4-Year Public Research-Intensive University
Authors: Solis Bertin , Durán Richard P.
Published: January 2020

This ethnographic case study examined how 16 Latinx community college students experienced the transition to a selective 4-year public research-intensive university. Participants encountered challenges with social isolation, adapting to a fast-paced quarter system and to large course sizes, limited access to information on resources, restricted access to majors, and maintaining healthy lifestyles while attending to academic achievement. Participants benefited from involvement with student organizations, family, and professors, and accessing selected university resources for transfer students.
‘Listen to me, his behaviour is erratic and I’m really worried for our safety . . .’: Help-seeking in the context of coercive control
Authors: Wydall Sarah , Zerk Rebecca
Published: January 2020

This article explores 12 female victim-survivors’ experiences of seeking protection from criminal justice agencies in Dyfed-Powys, an area in Wales. The discussion draws on rich qualitative data, from a series of narrative interviews held in 2015, which offers new insights into how coercive and controlling behaviours influence ‘help-seeking’. The findings suggest that for 12 women, deemed to be high-risk, the experience of actively engaging with criminal justice agencies, served to instil in them a sense that they were alone at the most dangerous period in their help-seeking journey, namely the juncture of leaving, without formal protection. Under-enforcement by justice agents resulted in what Stubbs terms ‘non-feasance’: a process whereby women are unable to access protection from the law, thus potentially increasing the propensity for lethal violence.
Short segment myelitis as the initial and only manifestation of aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorders
Authors: Fang* Wei , Zheng* Yang , Yang Fan , Cai Meng-Ting , Shen Chun-Hong , Liu Zhi-Rong , Zhang Yin-Xi , Ding Mei-Ping
Published: January 2020

Background:

Short segment myelitis (SSM, < 3 vertebral segments) is an under-recognized initial manifestation of neuromyelitis optica spectrum disorders (NMOSD). Though infrequent, failure to recognize SSM in patients with NMOSD would lead to incorrect diagnosis and treatment. Therefore, delineation of features of NMOSD-associated SSM is of paramount importance.

Objective:

Our study aimed to determine the demographic, clinical and radiological features of NMOSD-associated SSM, and compare those with NMOSD-associated longitudinally extensive transverse myelitis (LETM) and multiple sclerosis (MS)-associated SSM, respectively.

Methods:

Chinese patients presenting initially only with acute myelitis and diagnosed with NMOSD ( n = 46) and MS ( n = 11) were included. Clinical, serological, imaging and disability data were collected. Mann–Whitney U test or two-tailed Fisher’s exact tests were used to analyse the data.

Results:

Of the 46 enrolled NMOSD patients, 34 (74%) collectively had 38 LETM lesions, while 12 (26%) had 14 SSM lesions. When compared with LETM, NMOSD presenting with SSM were more likely to have a delayed diagnosis and a lower level of disability at nadir during the first attack. T1-weighted imaging hypointensity was more prominent in NMOSD-associated LETM lesions than NMOSD-associated SSM lesions. When compared with MS-associated SSM, NMOSD-associated SSM lesions were more likely to be centrally located, grey matter involving and transversally extensive on axial imaging and spanned no less than 2 vertebral segments on sagittal imaging.

Conclusion:

These findings suggest that SSM does not preclude the possibility of a NMOSD diagnosis. Testing for serum aquaporin-4 immunoglobulin G (AQP4-IgG) and careful study of lesions on spinal cord magnetic resonance imaging could aid in an earlier and correct diagnosis.