bluuebunny/crossref_metadata_2025 huggingface dataset:
Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings
Authors: O’Brien Kieran S , Byanju Raghunandan , Kandel Ram Prasad , Poudyal Bimal , Gautam Mariya , Gonzales John A , Porco Travis C , Whitcher John P , Srinivasan Muthiah , Upadhyay Madan , Lietman Thomas M , Keenan Jeremy D
Published: August 2018

Introduction

Corneal opacity is a leading cause of blindness worldwide. In resource-limited settings, untreated traumatic corneal abrasions may result in infection and ultimately, opacity. Although antimicrobial treatment of corneal ulcers may successfully cure infections, the scarring that accompanies the resolution of infection can still result in visual impairment. Prevention may be the optimal approach for reducing corneal blindness. Studies have employed community health workers to provide prompt administration of antimicrobials after corneal abrasions to prevent infections, but these studies were not designed to determine the effectiveness of such a programme.

Methods and analysis

The Village-Integrated Eye Worker trial (VIEW) is a cluster-randomised trial designed to assess the effectiveness of a community health worker intervention to prevent corneal ulcers. Twenty-four Village Development Committees (VDCs) in Nepal were randomised to receive a corneal ulcer prevention programme or to no intervention. Female Community Health Volunteers (FCHVs) in intervention VDCs are trained to diagnose corneal abrasions, provide antimicrobials and to refer participants when needed. An annual census is conducted over 3 years in all study VDCs to assess the incidence of corneal ulceration via corneal photography (primary outcome). Masked outcome assessors grade corneal photographs to determine the presence or absence of incident corneal opacities. The primary analysis is negative binomial regression to compare the incidence of corneal ulceration by study arm.

Ethics and dissemination

The University of California San Francisco Committee on Human Research, Nepal Netra Jyoti Sangh and the Nepal Health Research Council have given ethical approval for the trial. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.

Trial registration number

NCT01969786; Pre-results.
Morita Therapy for depression (Morita Trial): a pilot randomised controlled trial
Authors: Sugg Holly Victoria Rose , Richards David A , Frost Julia
Published: August 2018

Objective

To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.

Design

Pilot parallel group randomised controlled feasibility trial.

Setting and participants

Participants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.

Interventions

We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8–12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).

Outcomes

Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.

Results

We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.

Conclusions

A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.

Trial registration number

ISRCTN17544090; Pre-results.
Efficacy and tolerance of early administration of tranexamic acid in patients with cirrhosis presenting with acute upper gastrointestinal bleeding: a study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (the EXARHOSE study)
Authors: Heidet Matthieu , Amathieu Roland , Audureau Etienne , Augusto Oriane , Nicolazo de Barmon Violaine , Rialland Amandine , Schmitz David , Pierrang François , Marty Jean , Chollet-Xémard Charlotte , Thirion Olivier , Jacob Line
Published: August 2018

Introduction

The management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB in patients with cirrhosis.

Methods and analysis

This study is a multicentre, randomised, double-blind, placebo-controlled trial, for adult patients with cirrhosis presenting with an acute UGIB and allocated to one of two arms: TXA or placebo (saline). Physicians from emergency mobile services, emergency departments (EDs) or intensive care units (ICUs) can include patients. Besides study intervention, standard care for UGIB will be performed as recommended. Intervention will consist an intravenous infusion of 10 mL of TXA (1 g) or saline, immediately followed by three identical intravenous infusions over 8 hours each (total dose of 4 g of TXA or 40 mL of placebo over 24 hours). Main analyses will be conducted in intention to treat on every patient included, then in modified intention to treat on patients with underlying lesion of portal hypertension visualised by endoscopy. The main objective is to show efficacy of TXA until day 5 on a composite criterion (bleeding control, rebleeding episodes and mortality). Secondary objectives aim at showing the efficacy of TXA on each individual component of the main outcome measure and others at 6 weeks and later (transjugular intrahepatic portosystemic shunt procedure, cirrhosis-specific complications, length of stay in ICU and in hospital, safety and tolerance of TXA, liver transplantation). Included patients will be followed up to 1 year after inclusion.

500 patients will be necessary to show a reduction in the prevalence of the primary outcome from 30% to 18% with a bilateral alpha risk of 5% and a power of 80%.

Ethics and dissemination

Ethical approval has been obtained from the Comité de Protection des Personnes Ile-de-France 1 (CPP-IDF1). Results will be disseminated via publications in peer-review medical journals and scientific forums.

Protocol version

This protocol is based on the latest version, as established on 11 October 2017 and validated by the IRB CPP Ile-de-France 1.

Trial registration number

NCT03023189.
Social tenants’ health: evaluating the effectiveness of landlord interventions
Authors: Cheshire Paul Charles , Gibbons Stephen , Mouland Jemma
Published: August 2018

Background

The National Health Service (NHS) scores well internationally on access to healthcare. But access has been measured on methods likely to undersample the more disadvantaged. Social landlords have access to more disadvantaged groups and may be able to improve health outcomes for their tenants and reduce their NHS usage by simple interventions.

Methods

This is a randomised controlled trial of 547 London social housing ‘general needs’ tenants over 50 years of age. Participants were given a health assessment, then split into a control group or one of two treated groups. Following early assessment 25 participants had to be withdrawn to receive intensive treatment because of currently untreated major health problems. Participants were followed up over 18 months and changes in health outcomes and NHS usage measured.

Results

Compared with the control the most intensively treated group showed non-significant improvements on health outcomes but a significant reduction in NHS resource use, on conventional costings worth some £760 per person. All 25 participants transferred to the most intensively treated group after their early health assessments showed improvement on all health outcomes at final assessment, but these improvements were not statistically significant.

Conclusions

Drawing a sample from disadvantaged but not the most seriously disadvantaged groups in London revealed 4.5% of the population to have very serious untreated health problems. The reason for lack of treatment was mainly non-registration with a general practitioner or psychiatric issues. Simple interventions to a targeted group were found to produce significant reductions in NHS usage and other, although non-significant, health benefits.

Trial registration number

IDISRCTN96259142.
Synthetic control methodology as a tool for evaluating population-level health interventions
Authors: Bouttell Janet , Craig Peter , Lewsey James , Robinson Mark , Popham Frank
Published: August 2018

Background

Many public health interventions cannot be evaluated using randomised controlled trials so they rely on the assessment of observational data. Techniques for evaluating public health interventions using observational data include interrupted time series analysis, panel data regression-based approaches, regression discontinuity and instrumental variable approaches. The inclusion of a counterfactual improves causal inference for approaches based on time series analysis, but the selection of a suitable counterfactual or control area can be problematic. The synthetic control method builds a counterfactual using a weighted combination of potential control units.

Methods

We explain the synthetic control method, summarise its use in health research to date, set out its advantages, assumptions and limitations and describe its implementation through a case study of life expectancy following German reunification.

Results

Advantages of the synthetic control method are that it offers an approach suitable when there is a small number of treated units and control units and it does not rely on parallel preimplementation trends like difference in difference methods. The credibility of the result relies on achieving a good preimplementation fit for the outcome of interest between treated unit and synthetic control. If a good preimplementation fit is established over an extended period of time, a discrepancy in the outcome variable following the intervention can be interpreted as an intervention effect. It is critical that the synthetic control is built from a pool of potential controls that are similar to the treated unit. There is currently no consensus on what constitutes a ‘good fit’ or how to judge similarity. Traditional statistical inference is not appropriate with this approach, although alternatives are available. From our review, we noted that the synthetic control method has been underused in public health.

Conclusions

Synthetic control methods are a valuable addition to the range of approaches for evaluating public health interventions when randomisation is impractical. They deserve to be more widely applied, ideally in combination with other methods so that the dependence of findings on particular assumptions can be assessed.
Towards secondary prevention of early knee osteoarthritis
Authors: Mahmoudian Armaghan , Van Assche Dieter , Herzog Walter , Luyten Frank P
Published: August 2018

Osteoarthritis (OA) of the knee is the most common arthritic disease, yet a convincing drug treatment is not available. The current narrative review focuses on integration of scientific evidence and professional experience to illustrate which management approaches can be taken for prototypical individual patient profiles with early knee OA. Animal models suggest that: (1) OA can progress even in the presence of fully recovered movement kinetics, kinematics and muscle activation patterns; (2) muscle weakness is an independent risk factor for the onset and possibly the rate of progression of knee OA; (3) onset and progression of OA are not related to body weight but appear to depend on the percentage of body fat. From studies in the human model, one could postulate that risk factors associated with progression of knee OA include genetic traits, preceding traumatic events, obesity, intensity of pain at baseline, static and dynamic joint malalignment and reduced muscle strength. Taken this into account, an individual can be identified as early knee OA at high risk for disease progression. A holistic patient-tailored management including education, supportive medication, weight loss, exercise therapy (aerobic, strengthening and neuromuscular) and behavioural approaches to improve self-management of early knee OA is discussed in individual prototypic patients. Secondary prevention of early knee OA provides a window of opportunity to slow down or even reverse the disease process. Yet, as the sheer number of patients early in the OA disease process is probably large, a more structured approach is needed to provide appropriate care depending on the patient’s individual risk profile.
At-risk children with asthma (ARC): a systematic review
Authors: Buelo Audrey , McLean Susannah , Julious Steven , Flores-Kim Javier , Bush Andy , Henderson John , Paton James Y , Sheikh Aziz , Shields Michael , Pinnock Hilary
Published: August 2018

Introduction

Asthma attacks are responsible for considerable morbidity and may be fatal. We aimed to identify and weight risk factors for asthma attacks in children (5–12 years) in order to inform and prioritise care.

Methods

We systematically searched six databases (May 2016; updated with forward citations January 2017) with no language/date restrictions. Two reviewers independently selected studies for inclusion, assessed study quality and extracted data. Heterogeneity precluded meta-analysis. Weighting was undertaken by an Expert Panel who independently assessed each variable for degree of risk and confidence in the assessment (based on study quality and size, effect sizes, biological plausibility and consistency of results) and then achieved consensus by discussion. Assessments were finally presented, discussed and agreed at a multidisciplinary workshop.

Results

From 16 109 records, we included 68 papers (28 cohort; 4 case-control; 36 cross-sectional studies). Previous asthma attacks were associated with greatly increased risk of attack (ORs between 2.0 and 4.1). Persistent symptoms (ORs between 1.4 and 7.8) and poor access to care (ORs between 1.2 and 2.3) were associated with moderately/greatly increased risk. A moderately increased risk was associated with suboptimal drug regimen, comorbid atopic/allergic disease, African-American ethnicity (USA), poverty and vitamin D deficiency. Environmental tobacco smoke exposure, younger age, obesity and low parental education were associated with slightly increased risk.

Discussion

Assessment of the clinical and demographic features identified in this review may help clinicians to focus risk reduction management on the high-risk child. Population level factors may be used by health service planners and policymakers to target healthcare initiatives.

Trial registration number

CRD42016037464.
Worms make risky choices too: the effect of starvation on foraging in the common earthworm (Lumbricus terrestris)
Authors: Sandhu P. , Shura O. , Murray R.L. , Guy C.
Published: August 2018

Species should avoid risks to protect accumulated fitness. However, when faced with starvation, organisms may accept risks to enhance future reproductive opportunities. We investigated the effect of starvation on risk-taking behaviour in the common earthworm (Lumbricus terrestris Linnaeus, 1758). Lumbricus terrestris are negatively phototactic annelids that feed on decaying plant matter at the soil surface. Feeding in high-light conditions is a potentially riskier choice, given the threats of visual predators and desiccation. We predicted that starvation in L. terrestris would increase risk-taking behaviour and decrease time taken (latency) to make choices. We manipulated the starvation level of L. terrestris individuals (nonstarved, half-starved, and fully starved) and presented them with a binary foraging choice. Lumbricus terrestris could choose either a low-food and dark condition (low-risk condition) or a high-food and light condition (high-risk condition). We found that starved individuals selected the high-risk condition more often than nonstarved individuals. Starved individuals also had a decreased latency to first choice. Risk-taking did not scale with level of starvation; there was no difference in foraging choice and latency between half- and fully starved individuals. Our results indicate that L. terrestris makes state-dependent foraging choices, providing insight into the importance of fundamental life-history trade-offs in this understudied species.
Fiber ring-cavity laser based on semiconductor optical amplifier
Authors: Luo Min , Cao Wei , Chen Haiyan
Published: August 2018

A fiber ring-cavity laser based on InP/InGaAsP multi-quantum wells semiconductor optical amplifier is proposed and experimentally demonstrated. The laser uses InP/InGaAsP multi-quantum as well as the gain medium and fiber Bragg grating as the wavelength selector. It’s demonstrated that the center wavelength of the output amplified spontaneous emission spectrum for the InP/InGaAsP multiple-quantum wells appears blue shift when its injection current increases. A lasing at central wavelength of 1549.66 nm with the maximum output power of 1.524 mW is obtained with electro-optical efficiency of 1.1% at injection current of 220 mA and the fiber Bragg grating operating temperature of 23[Formula: see text]C. The threshold injection current of the laser is 78 mA. When the operating temperature of fiber Bragg grating increases from 8[Formula: see text]C to 28[Formula: see text]C, the center wavelength of output laser increases from 1549.27 to 1549.59 nm. It shows that the laser has good temperature stability.
Counting Multiplicities in a Hypersurface over Number Fields
Authors: Wen Hao , Liu Chunhui
Published: August 2018

We fix a counting function of multiplicities of algebraic points in a projective hypersurface over a number field, and take the sum over all algebraic points of bounded height and fixed degree. An upper bound for the sum with respect to this counting function will be given in terms of the degree of the hypersurface, the dimension of the singular locus, the upper bounds of height, and the degree of the field of definition.
A Corotational Formulation Based on Hamilton’s Principle for Geometrically Nonlinear Thin and Thick Planar Beams and Frames
Authors: Elkaranshawy Hesham A. , Elerian Ahmed A. H. , Hussien Walied I.
Published: August 2018

A corotational finite element formulation for two-dimensional beam elements with geometrically nonlinear behavior is presented. The formulation separates the rigid body motion from the pure deformation which is always small relative to the corotational element frame. The stiffness matrices and the mass matrices are evaluated using both Euler-Bernoulli and Timoshenko beam models to reveal the shear effect in thin and thick beams and frames. The nonlinear equilibrium equations are developed using Hamilton’s principle and are defined in the global coordinate system. A MATLAB code is developed for the numerical solution. In static analysis, the code employed an iterative method based on the full Newton-Raphson method without incremental loading, while, in dynamic analysis, the Newmark direct integration implicit method is also utilized. Several examples of flexible beams and frames with large displacements are presented. Not only is the method simple and time-saving, but it is also highly effective and highly accurate.
Kub5-HeraRPRD1B Deficiency Promotes “BRCAness” and Vulnerability to PARP Inhibition in BRCA-proficient Breast Cancers
Authors: Motea Edward A. , Fattah Farjana J. , Xiao Ling , Girard Luc , Rommel Amy , Morales Julio C. , Patidar Praveen , Zhou Yunyun , Porter Andrew , Xie Yang , Minna John D. , Boothman David A.
Published: August 2018

Purpose:

Identification of novel strategies to expand the use of PARP inhibitors beyond BRCA deficiency is of great interest in personalized medicine. Here, we investigated the unannotated role of Kub5-HeraRPRD1B (K-H) in homologous recombination (HR) repair and its potential clinical significance in targeted cancer therapy.

Experimental Design:

Functional characterization of K-H alterations on HR repair of double-strand breaks (DSB) were assessed by targeted gene silencing, plasmid reporter assays, immunofluorescence, and Western blots. Cell survival with PARP inhibitors was evaluated through colony-forming assays and statistically analyzed for correlation with K-H expression in various BRCA1/2 nonmutated breast cancers. Gene expression microarray/qPCR analyses, chromatin immunoprecipitation, and rescue experiments were used to investigate molecular mechanisms of action.

Results:

K-H expression loss correlates with rucaparib LD50 values in a panel of BRCA1/2 nonmutated breast cancers. Mechanistically, K-H depletion promotes BRCAness, where extensive upregulation of PARP1 activity was required for the survival of breast cancer cells. PARP inhibition in these cells led to synthetic lethality that was rescued by wild-type K-H reexpression, but not by a mutant K-H (p.R106A) that weakly binds RNAPII. K-H mediates HR by facilitating recruitment of RNAPII to the promoter region of a critical DNA damage response and repair effector, cyclin-dependent kinase 1 (CDK1).

Conclusions:

Cancer cells with low K-H expression may have exploitable BRCAness properties that greatly expand the use of PARP inhibitors beyond BRCA mutations. Our results suggest that aberrant K-H alterations may have vital translational implications in cellular responses/survival to DNA damage, carcinogenesis, and personalized medicine.
A Novel GDF6 Mutation in a Family with Multiple Synostoses Syndrome without Hearing Loss
Authors: Drage Berentsen Ragnhild , Haukanes Bjørn I. , Júlíusson Pétur B. , Rosendahl Karen , Houge Gunnar
Published: August 2018

A 4-generation family with multiple synostoses syndrome type 4 (SYNS4) is reported, the third family identified so far. The phenotype segregated with a previously undescribed Asn399Lys (c.1197C>A) substitution in GDF6. N399 is part of a hydrophobic pocket critical for binding the BMP/GDF antagonist noggin. The N399K substitution renders GDF6 more similar to noggin-resistant members of the BMP family, namely GDF2 and BMP10, both of which contain lysine in the corresponding position. To further define the SYNS4 phenotype, we examined 6 of 9 affected family members. The phenotype was carpal and tarsal synostoses with painful feet after walking, but the condition could also be asymptomatic. Interestingly, unlike the previous SYNS4 families, the family presented here has no history of hearing loss, and a 73-year-old mutation carrier had normal audiometry for his age. Based on structure modelling, BMPR2 binding should not be affected by the GDF6-N399K substitution, unlike the S429R and Y444N mutations found in the 2 other families. Hypothetically, this difference may be related to lack of hearing loss.
The Role of the Constitutional Court in the Development of the Rule of Law in Kosovo
Authors: Hasani Enver
Published: August 2018

Kosovo’s Constitutional Court has played a role of paramount importance in the country’s recent history. The author uses a comparative analysis to discuss the role of the Court in light of the work and history of other European constitutional courts. This approach sheds light on the Court’s current role by analyzing Kosovo’s constitutional history, which shows that there has been a radical break with the past. This approach reveals the fact that Kosovo’s current Constitution does not reflect the material culture of the society of Kosovo. This radical break with the past is a result of the country’s tragic history, in which case the fight for constitutionalism means a fight for human dignity. In this battle for constitutionalism, the Court has been given very broad jurisdiction and a role to play in paving the way for Kosovo to move toward Euro-Atlantic integration in all spheres of life. Before reaching this conclusion, the author discusses the specificities of Kosovo’s transition, comparing it with other former communist countries. Among the specific features of constitutionalism in Kosovo are the role and position of the international community in the process of constitution-making and the overall design of constitutional justice in Kosovo. Throughout the article, a conclusion emerges that puts Kosovo’s Constitutional Court at the forefront of the fight for the rule of law and constitutionalism of liberal Western provenance.
International Legal Cooperation between Kosovo and Other States and Organizations
Authors: Kuçi Hajredin
Published: August 2018

Building a rule-of-law-based democracy is a challenge for post-communist and post-war societies. Rule of law is a priority for these societies and also one of the membership criteria required by international organizations, in particular the European Union. As such, an aspiring country like Kosovo has to face the challenge of building a legal system that is compatible with that of the European Union member states while also developing its legal cooperation with other countries. Through international legal cooperation, countries strengthen the fight against criminal actions that are punishable in all modern states and also exchange experience in combating cross-border crime, trafficking, corruption, terrorism, and other violations of criminal law. In this regard, Kosovo faces many challenges in the field of international legal cooperation, not only with regard to those missions operating in Kosovo itself (such as EULEX, UNMIK, etc.), but also with other international organizations, especially due to Kosovo’s lack of membership in them. Another challenge is cooperation with countries that have not yet recognized Kosovo as a state. This article emphasizes the efforts made by Kosovo’s institutions to engage in international legal cooperation as one of the prerequisites for building the rule of law at home. The main issues tackled in the article are how these problems are addressed in practice, which obstacles arise, what the ad hoc means are of engaging in international legal cooperation, and what the specificities and prospects are for Kosovo’s international legal cooperation. As such, the aim of the article is to examine some of the legal peculiarities and uncertainties that have been created over the years as the result of limitations on Kosovo’s international personality and to consider innovative means to ensure Kosovo’s legal cooperation with other countries.
Consolidation of Statehood through Membership in the UN: Some Remarks on Kosovo, Democracy and International Law
Authors: Islami Iliriana , Istrefi Remzije
Published: August 2018

Kosovo declared its independence on 17 February 2008. Subsequently, one of the aims of Kosovo’s foreign policy was to further consolidate this position and to justify Kosovo’s prospective membership in the United Nations. This article examines the issue of recognition, elucidating how Kosovo is different from other countries and comparing it with the case of the former Yugoslavia. Other aspects in the state-building process such as ‘building constitutionalism’ will be presented as a step toward justifying recognition and membership. Furthermore, the Advisory Opinion of the International Court of Justice (ICJ) of 8 October 2008 will be presented as evidence of Kosovo’s strengthening international position in its quest for further recognition. Thus, the article will discuss and analyze the arguments in favor of Kosovo being admitted to the UN.
Some Critical Comments on Zimmerman’s Ignorance and Moral Obligation
Authors: Bykvist Krister
Published: August 2018

In his recent book, Michael Zimmerman continues to defend the Prospective View, according to which moral obligation depends on evidence about both empirical and evaluative factors. In my commentary, I shall first focus on Zimmerman’s framework in which different moral theories are defined and distinguished. I argue that Zimmerman fails to formulate a clear and coherent distinction between The Prospective View and the Objective View, which he rejects. Then I turn to the so-called constraint #2, a crucial premise in Zimmerman’s master argument against the Objective View. Here I argue that it should be given up so that we can give the right verdict in cases of fundamental moral uncertainty. More specifically, I shall argue that a morally conscientious agent can rationally choose the option that is guaranteed to be morally wrong in a Jackson-case of fundamental moral uncertainty. Finally, I shall argue that the Prospective View, in its most recent guise – according to which moral obligation depends on empirical and evaluative evidence the agent has actually availed herself of – has very troubling substantive implications that go against all traditional moral theories, as well as an earlier version of Zimmerman’s Prospective View.
Rediscovery of Dixa repanda Peters and description of its putative sister species, Dixa falcata sp. nov., from the south-central United States (Diptera: Dixidae)
Authors: MOULTON JOHN K.
Published: August 2018

Dixa repanda Peters, previously known only from the type series of three males, was rediscovered after targeted collections in the southcentral and midwestern United States. These collections also revealed the presence of its undescribed putative sister species, Dixa falcata sp. nov. The two species are sympatric in the Ozark Mountains. Adults of D. repanda are redescribed and those of Dixa falcata are described. Males of both species are distinguished from related, similarly colored species by a falcate gonostylus and extremely reduced cercus. Males of the two species are easily separated from each other by the shape and thickness of the gonostylus. Females are not reliably separable from each other or related species. Biological insights, including known distributions, of both species are provided.
Design of composite lattice materials combined with fabrication approaches
Authors: Xu Jun , Wu Yaobo , Gao Xiang , Wu Huaping , Nutt Steven , Yin Sha
Published: August 2018

Lattice materials can be designed through their microstructure while concurrently considering fabrication feasibility. Here, we propose two types of composite lattice materials with enhanced resistance to buckling: (a) hollow lattice materials fabricated by a newly developed bottom-up assembly technique and the previously developed thermal expansion molding technique and (b) hierarchical lattice materials with foam core sandwich trusses fabricated by interlocking assembly process. The mechanical performance of sandwich structures featuring the two types of lattice cores was tested and analyzed theoretically. For hollow lattice core material, samples from two different fabrication processes were compared and both failed by nodal rupture or debonding. In contrast, hierarchical lattice structures failed by shear buckling without interfacial failure in the sandwich struts. Calculations using established analytical models indicated that the shear strength of hollow lattice cores could be optimized by judicious selection of the thickness of patterned plates. Likewise, the shear strength of hierarchical foam core truss cores could be maximized (with minimal weight) through design of truss geometry. The bottom-up assembly technique could provide a feasible way for mass production of lattice cores, but the design about how to assembly is critical. Hierarchical lattice cores with foam sandwich trusses should be a suitable choice for future lightweight material application.
Tactical Knowledge, Decision-Making, and Brain Activation Among Volleyball Coaches of Varied Experience
Authors: Costa Gustavo C. , Castro Henrique O. , Mesquita Isabel R. , Afonso José , Lage Guilherme M. , Ugrinowitsch Herbert , Praça Gibson M. , Greco Pablo J.
Published: August 2018

This study compared decision-making (DM) of experienced and novice volleyball coaches while measuring blood flow brain activation with functional near-infrared spectroscopy. We sampled 34 coaches (mean [ M] age of 32.5, standard deviation [ SD] = 9.4 years) divided into two experience groups: (a) novice ( M = 2.8, SD = 1.9 years) and (b) experienced (M = 19, SD = 7.2 years). We evaluated coaches’ DM through their responses to video-based scenarios of attacks performed in the extremities of the net within the Declarative Tactical Knowledge Test in Volleyball. We found no significant DM differences between the two groups of coaches ( p = .063), though novice (vs. experienced) coaches showed greater blood flow of the prefrontal cortex when visualizing the game situations. While experienced coaches may have better prefrontal neural efficiency during DM in these situations, further research is needed to evaluate other cerebral areas; since blood flow is an indirect measure of neural efficiency, and activity in remaining cortical components was unknown in this study.
Electoral Participation, Disagreement, and Diversity in Social Networks: A Matter of Intimacy?
Authors: Ladini Riccardo , Mancosu Moreno , Vezzoni Cristiano
Published: August 2018

General consensus concerning the nature of the relationship between political disagreement and turnout has not yet been reached: while several studies have demonstrated the demobilizing effect of disagreement, others have found no significant evidence for this. Recently, scholars have argued that diversity — a situation in which some people are in agreement with ego and some are not — can boost electoral participation. The present article argues that the insights of previous studies are the result of two differentiated effects that depend on the level of intimacy of the discussants to which one is exposed. By employing a set of linear regression models on Italian National Election Study 2013 pre-electoral survey ( N > 8,000), we show that mixed political views among friends boost electoral participation. For what concerns relatives, the likelihood to vote decreases linearly with increasing disagreement.
How the 21st Century Cures Act Can Mitigate the Ever Growing Problem of Mass Incarceration
Authors: Bard Jennifer S.
Published: August 2018

By the time this article is published, our collective memory of the school shooting in Parkland, Florida could have faded or, even worse, been superseded by another mass shooting. Although details are still sparse, the perpetrator appears to be a 19-year-old man with a well-documented history of behavior disturbing enough to invoke referrals to mental health treatment, but not so disturbing as to warrant either commitment or even arrest. Unfortunately, the picture presented is one most familiar in the public imagination of how people with mental illness interact with the criminal justice system. In actuality, the violence of the perpetrator's crime makes him very untypical of the vast majority of people with mental illness who are no more likely to be violent than any other member of the general public.

This Article will first describe the current situation in which people with mental illness have become part of the growing mass incarceration problem in the United States.
Practice-Based Research Networks and the Mandate for Real-World Evidence
Authors: Hall-Lipsy Elizabeth , Barraza Leila , Robertson Christopher
Published: August 2018

The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.
Real-World Data Analytics Fit for Regulatory Decision-Making
Authors: Schneeweiss Sebastian , Glynn Robert J.
Published: August 2018

Healthcare database analyses (claims, electronic health records) have been identified by various regulatory initiatives, including the 21st Century Cures Act and Prescription Drug User Fee Act (“PDUFA”), as useful supplements to randomized clinical trials to generate evidence on the effectiveness, harm, and value of medical products in routine care. Specific applications include accelerated drug approval pathways and secondary indications for approved medical products. Such real-world data (“RWD”) analyses reflect how medical products impact health outside a highly controlled research environment. A constant stream of data from the routine operation of modern healthcare systems that can be analyzed in rapid cycles enables incremental evidence development for regulatory decision-making.

Key evidentiary needs by regulators include 1) monitoring of medication performance in routine care, including the effectiveness, safety and value; 2) identifying new patient strata in which a drug may have added value or unacceptable harms; and 3) monitoring targeted utilization. Four broad requirements have been proposed to enable successful regulatory decision-making based on healthcare database analyses (collectively, “MVET”): Meaningful evidence that provides relevant and context-informed evidence sufficient for interpretation, drawing conclusions, and making decisions; valid evidence that meets scientific and technical quality standards to allow causal interpretations; expedited evidence that provides incremental evidence that is synchronized with the decision-making process; and transparent evidence that is audible, reproducible, robust, and ultimately trusted by decision-makers.

Evidence generation systems that satisfy MVET requirements to a high degree will contribute to effective regulatory decision-making. Rapid-cycle analytics of healthcare databases is maturing at a time when regulatory overhaul increasingly demands such evidence. Governance, regulations, and data quality are catching up as the utility of this resource is demonstrated in multiple contexts.
Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health
Authors: Sinha Michael S. , Jain Nina , Hwang Thomas , Kesselheim Aaron S.
Published: August 2018

The U.S. federal government awards a priority review voucher (“PRV”) to a pharmaceutical manufacturer after the Food and Drug Administration (“FDA”) approves a product for one of a list of voucher-eligible indications. The voucher, which can be transferred or sold, allows the company to accelerate the review timeline of another product for any indication. The PRV program was proposed in 2006 as an incentive for research and development for neglected diseases, such as dengue and leishmaniasis.

Neglected tropical diseases (“NTDs”) predominantly affect the world’s poorest populations and are associated with significant morbidity and mortality. Despite their global public health importance, neglected diseases were estimated to account for less than 1% of pharmaceutical research and development expenditures. The voucher program was intended to address this gap between investment and disease burden: “[t]he major obstacle to stimulating the R&D of new medicines for neglected diseases is lowincome nations' inability to pay for such medicines.” The voucher would provide an additional financial incentive to fund clinical development of these products without requiring additional appropriations from Congress.
The Growing Importance of Mental Health Parity
Authors: Scarbrough Jessica A.
Published: August 2018

Mental health is currently one of the most expensive health care issues. The cost of treating mental illness’s effects not only impacts the health care industry as a whole, but also imposes indirect costs on businesses through absenteeism, lower productivity, and reduced earnings. Mental illness, and the effects of mental illness, costs the U.S. economy several billion dollars in losses every year, with predictions suggesting that these costs will only continue to rise in the next two decades. Between 2006 and 2009 alone the costs of mental health care rose from approximately $57 billion to more than $150 billion. These numbers will likely be exacerbated due to the mental health problems that are continuing to rise within the United States as teenagers and adolescents are experiencing mental illness at escalating rates. Despite the rapid growth of mental illness, mental health coverage has not been expanding to meet the increasing demand for treatment. It is estimated that about 28% of the U.S. population has a diagnosable mental illness, even though only 8% actually seek treatment.
The Relation Between Interest Congruence and College Major Satisfaction: Evidence From the Basic Interest Measures
Authors: Bai Lili , Liao Hsin-Ya
Published: August 2018

The relation between the degree of interest congruence (i.e., person–environment fit in interest domain) and career satisfaction has been inconsistent and generally low across studies. Interest congruence is typically measured at the broadband general interest level, bound within Holland’s Realistic, Investigative, Artistic, Social, Enterprising, and Conventional (RIASEC) framework, and largely based on the match of the high-point interest codes between persons and environments. Using two cross-cultural college samples, we reexamined the congruence–satisfaction relation with a refined congruence index by using narrowband basic interest measures and considering the entire basic interest profiles. As a comparison, we used three additional congruence indices based on the entire general interest RIASEC profiles or the high-point RIASEC codes. Findings showed stronger congruence–satisfaction relations when the basic interest measure and/or complete interest profiles were used to generate interest congruence indices. Implications for research and career practice are discussed.
Object personification in autism: This paper will be very sad if you don’t read it
Authors: White Rebekah C , Remington Anna
Published: August 2018

Object personification is the attribution of human characteristics to non-human agents. In online forums, autistic individuals commonly report experiencing this phenomenon. Given that approximately half of all autistic individuals experience difficulties identifying their own emotions, the suggestion that object personification may be a feature of autism seems almost paradoxical. Why would a person experience sympathy for objects, when they struggle to understand and verbalise the emotions of other people as well as their own? An online survey was used to assess tendency for personification in 87 autistic and 263 non-autistic adults. Together, our results indicate that object personification occurs commonly among autistic individuals, and perhaps more often (and later in life) than in the general population. Given that in many cases, autistic people report their personification experiences as distressing, it is important to consider the reasons for the increased personification and identify structures for support.
Working in violence: Moral narratives of paramilitaries in Colombia
Authors: Manrique Rueda Gabriela
Published: August 2018

This article reflects on the morality of violence workers through an analysis of the narratives of 12 former low-ranking men of the paramilitary group Heroes of Montes de Maria in Colombia. By exploring their physical and social experiences in the space of the group, and the meaning given to their actions, I argue that violence should be considered dirty work in which members construct moral representations to deal with the illegality of the group. Despite the immorality of violent actions against civilians, whose bodies were dismembered and buried in mass graves, the paramilitaries represented their mission as necessary dirty work enabling the state to guarantee civilians’ security, and creating moral obligations toward their fellows, families and communities.
A performance metric for additively manufactured microlattice structures under different loading conditions
Authors: Després Nathaniel , Cyr Edward , Mohammadi Mohsen
Published: August 2018

A rapidly evolving design technology in additive manufacturing is microlattice (or microarchitectured) materials. Investigating the performance of microlattices under different loading conditions is a key element for implementing this new technology into mechanical components used in different industries. In this paper, the mechanical behavior of five different microlattices under four standard modes of loading along with a combined loading scenario was investigated. The four standard modes of loading that were considered are tension, compression, simple shear, and bending. The combined loading scenario was simultaneous shear and compression. The lattice structures (i.e. octet-truss, diamond, pyramid, block lattice truss, and cubic truss) were modeled and meshed using Autodesk Inventor and Fusion 360. Constraints and the elastic loading conditions for the structures were applied to the models in Fusion 360 and static finite element simulations were performed using Autodesk Nastran software. The results of all simulations were collated and a performance function was derived from the maximum stress and stiffness results and mass of the structures. The two highest performing structures (octet-truss and cubic lattice) according to the derived metric were then combined. The octet lattice performed well under shear and the combined loading cases, while the cubic lattice performed well under tension, compression, and bending. Simulations were repeated and the performance metric was then used to show that the combination of these structures, known as the Warren truss, had improved performance as a result.