bluuebunny/crossref_metadata_2025 huggingface dataset:
IMpower132: Atezolizumab plus platinum‐based chemotherapy vs chemotherapy for advanced NSCLC in Japanese patients
Authors: Nishio Makoto , Saito Haruhiro , Goto Koichi , Watanabe Satoshi , Sueoka‐Aragane Naoko , Okuma Yusuke , Kasahara Kazuo , Chikamori Kenichi , Nakagawa Yuki , Kawakami Tomohisa
Published: January 2021

IMpower132 explored the safety and efficacy of atezolizumab plus pemetrexed and platinum‐based chemotherapy as first‐line treatment for advanced non‐small‐cell lung cancer (NSCLC). Key eligibility criteria for the phase 3, open‐label, IMpower132 study included age ≥18 y, histologically or cytologically confirmed advanced non‐squamous NSCLC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status of 0/1, and no prior systemic treatment for stage IV NSCLC. Patients received atezolizumab (1200 mg) plus pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) or carboplatin (area under the concentration curve, 6 mg/mL/min) (APP arm) or chemotherapy alone (PP arm). The co‐primary study endpoints were overall survival (OS) and investigator‐assessed progression‐free survival (PFS) per RECIST 1.1 in the intention‐to‐treat population. A subgroup analysis was conducted in Japanese patients. In the Japanese subgroup (n = 101), median OS was 30.8 (95% CI, 24.3 to not estimable) mo in the APP arm (n = 48) and 22.2 (95% CI, 15.7‐30.8) mo in the PP arm (n = 53; hazard ratio [HR], 0.63 [95% CI, 0.36‐1.14]). PFS was 12.8 (95% CI, 8.6‐16.6) mo in the APP arm vs 4.5 (95% CI, 4.1‐6.7) mo in the PP arm (HR, 0.33 [95% CI, 0.21‐0.58]). Grade 3/4 treatment‐related adverse events (TRAEs) occurred in 68.8% of APP arm patients and 44.2% of PP arm patients. Consistent with global study results, atezolizumab plus pemetrexed and platinum‐based chemotherapy improved efficacy and was well tolerated in Japanese patients with advanced NSCLC despite a higher incidence of grade 3/4 TRAEs.
Children in the United States and Peru Pay to Correct Gender‐Based Inequality
Authors: Corbit John , Lamirato Katie , McAuliffe Katherine
Published: January 2021

We explore the developmental origins of intervention against gender‐based pay inequality in 4‐ to 9‐year‐old children in the United States (N = 123; Study 1) and Peru (N = 115; Study 2), two countries characterized by different norms surrounding gender pay equity. We presented children with scenarios that featured gender‐based pay inequality, and they could intervene at a cost to redistribute the earnings. We examined whether children favor equality or show gender bias in intervention depending on the direction of gender pay inequality. Across both societies, both girls and boys intervened against gender inequality regardless of its direction, a tendency that grew stronger with age. These findings suggest that despite developing in societies with existing gender pay inequalities, children strongly privilege equality.
A multidisciplinary framework to assess the sustainability and acceptability of wildlife tourism operations
Authors: Meyer Lauren , Apps Kirin , Bryars Simon , Clarke Thomas , Hayden Barry , Pelton Grant , Simes Brett , Vaughan Lewis M. , Whitmarsh Sasha K. , Huveneers Charlie
Published: January 2021

Wildlife tourism is growing in popularity, diversity of target species, and type of tours. This presents difficulties for management policy that must balance the complex trade‐offs between conservation, animal welfare, and pragmatic concerns for tourist satisfaction and economic value. Here, we provide a widely applicable, multidisciplinary framework to assess the impacts of wildlife tourism focusing on industry tractability, socioeconomic values, and their effects on conservation, animal welfare, and ecosystem impacts. The framework accommodates and quantifies the complexity of factors influencing wildlife tourism management, including direct and indirect effects on target and nontarget species, and identifies priorities for future biological, socioeconomic, and cultural heritage research. When applied to white shark cage‐diving as a case study, the output demonstrates the utility of the framework for researchers, managers, and policy makers, and highlights the benefits of undertaking the assessment as an inclusive workshop to facilitate a more multidisciplinary assessment of wildlife tourism industries. The use of a universally applicable assessment framework will enable the identification of relevant factors to account for when managing wildlife tourism, provide an inventory of current knowledge, identify research needs, and semiquantitatively compare categories and target and nontarget species, leading to improved conservation outcomes for species and ecosystems.
Combined exenatide and dapagliflozin has no additive effects on reduction of hepatocellular lipids despite better glycaemic control in patients with type 2 diabetes mellitus treated with metformin: EXENDA, a 24‐week, prospective, randomized, placebo‐controlled pilot trial
Authors: Harreiter Jürgen , Just Ivica , Leutner Michael , Bastian Magdalena , Brath Helmut , Schelkshorn Christian , Klepochova Radka , Krššák Martin , Kautzky‐Willer Alexandra
Published: January 2021

Aims

To investigate the potential synergistic effects of combined exenatide (EXE) and dapagliflozin (DAPA) versus (PLAC) placebo and DAPA on hepatocellular lipid (HCL) reduction after 24 weeks of treatment.

Materials and methods

Thirty patients with type 2 diabetes were randomized to weekly EXE and daily DAPA (n = 16) or weekly PLAC and daily DAPA (n = 14). Inclusion criteria were glycated haemoglobin (HbA1c) 48 to 97 mmol/mol (6.5‐11%), age 18 to 75 years, body mass index (BMI) ≥25 kg/m2 and metformin ≥1000 mg. The primary endpoint, HCL levels, were measured at baseline and after 24 weeks of treatment using magnetic resonance spectroscopy. Between‐group effects were analysed using general linear models, adjusted for baseline outcome variables, age, sex and BMI. Within‐group differences were assessed using a paired t‐test.

Results

After 24 weeks, HCLs were reduced in both treatment groups (absolute change from baseline: EXE + DAPA −4.4%, 95% confidence interval [CI] −8.2, −0.7, P < 0.05; PLAC + DAPA −3.9%, 95% CI −6.0, −1.7, P < 0.01; relative change: EXE + DAPA −35.6%, PLAC + DAPA −32.3%) with no difference between groups. Similar findings were observed for subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT). HbA1c (EXE + DAPA −17.8 mmol/mol, [95% CI −24.8, −10.8], P <0.001; PLAC + DAPA −6.9 mmol/mol, [95% CI −10.5, −3.3], P = 0.001) and fasting glucose significantly decreased in both groups, although EXE + DAPA achieved better glycaemic control than PLAC + DAPA (adjusted difference: HbA1c −6.0 mmol/mol [95% CI −9.7, −2.2], P < 0.01). Body weight was reduced in both treatment groups (EXE + DAPA −7.3 kg, 95% CI −9.9, −4.8, P <0.001; PLAC + DAPA −4.6 kg, 95% CI −7.4, −1.8, P <0.01) with comparable results between groups. Changes in HCLs and weight, hip and waist circumference, VAT and SAT were positively associated.

Conclusion

After 24 weeks, HCLs were significantly but comparably reduced in the EXE + DAPA and PLAC + DAPA groups, despite significantly better glycaemic control in the combined group EXE + DAPA. Changes in HCLs were associated with weight loss and reduction of visceral adiposity, but not with glucose control. Further studies are necessary to evaluate possible additional long‐term effects of a combined treatment.
Evaluating predictive performance of statistical models explaining wild bee abundance in a mass‐flowering crop
Authors: Blasi Maria , Bartomeus Ignasi , Bommarco Riccardo , Gagic Vesna , Garratt Michael , Holzschuh Andrea , Kleijn David , Lindström Sandra A. M. , Olsson Peter , Polce Chiara , Potts Simon G. , Rundlöf Maj , Scheper Jeroen , Smith Henrik G. , Steffan‐Dewenter Ingolf , Clough Yann
Published: January 2021

Wild bee populations are threatened by current agricultural practices in many parts of the world, which may put pollination services and crop yields at risk. Loss of pollination services can potentially be predicted by models that link bee abundances with landscape‐scale land‐use, but there is little knowledge on the degree to which these statistical models are transferable across time and space. This study assesses the transferability of models for wild bee abundance in a mass‐flowering crop across space (from one region to another) and across time (from one year to another). The models used existing data on bumblebee and solitary bee abundance in winter oilseed rape fields, together with high‐resolution land‐use crop‐cover and semi‐natural habitats data, from studies conducted in five different regions located in four countries (Sweden, Germany, Netherlands and the UK), in three different years (2011, 2012, 2013). We developed a hierarchical model combining all studies and evaluated the transferability using cross‐validation. We found that both the landscape‐scale cover of mass‐flowering crops and permanent semi‐natural habitats, including grasslands and forests, are important drivers of wild bee abundance in all regions. However, while the negative effect of increasing mass‐flowering crops on the density of the pollinators is consistent between studies, the direction of the effect of semi‐natural habitat is variable between studies. The transferability of these statistical models is limited, especially across regions, but also across time. Our study demonstrates the limits of using statistical models in conjunction with widely available land‐use crop‐cover classes for extrapolating pollinator density across years and regions, likely in part because input variables such as cover of semi‐natural habitats poorly capture variability in pollinator resources between regions and years.
Non‐suicidal self‐injury is associated with psychotic like experiences, depression, and bullying in Korean adolescents
Authors: Lee Ju‐Yeon , Kim Honey , Kim Seon‐Young , Kim Jae‐Min , Shin Il‐Seon , Kim Sung‐Wan
Published: January 2021

Aim

Non‐suicidal self‐injury (NSSI) is common among adolescents, and several different factors can affect its prevalence. The present study examined the associated characteristics predicting NSSI among adolescents in South Korea.

Methods

In total, 1674 high school students were recruited for a cross‐sectional survey. They completed self‐reported assessments, including the Deliberate Self‐Harm Inventory (DSHI), the Center for Epidemiological Studies Depression Scale (CESD), the State‐Trait Anxiety Inventory for Children (STAIC), and the Prodromal Questionnaire‐16 (PQ‐16), as well as their bullying experience. The NSSI group was defined as the sample group with at least one NSSI behaviour on the DSHI scale. A logistic regression analysis was performed using the NSSI group as the dependent variable.

Results

The prevalence of NSSI was 28.3% (boys, 30.4%; girls, 24.4%) among adolescents. The most common type of NSSI behaviour among adolescents was interference with wound healing and sex differences in the method were examined. The CES‐D, STAIC‐trait, and PQ‐16 scores were significantly higher and the RSES score was significantly lower in the NSSI group than those in the non‐NSSI group. Participants' experience with bullying, such as being victims, bullies, bully‐victims, and witness to bullying, were more likely to be in the NSSI group. In a logistic regression analysis, NSSI was significantly associated with male sex, low academic achievement, higher depression, psychotic‐like experiences, being bullied, and witnessing bullying.

Conclusion

The results of this study suggest the need to identify and manage related psychologic factors in adolescents with NSSI, including psychotic‐like symptoms.
Mobile EEG reveals functionally dissociable dynamic processes supporting real‐world ambulatory obstacle avoidance: Evidence for early proactive control
Authors: Mustile Magda , Kourtis Dimitrios , Ladouce Simon , Learmonth Gemma , Edwards Martin G. , Donaldson David I. , Ietswaart Magdalena
Published: January 2021

The ability to safely negotiate the world on foot takes humans years to develop, reflecting the extensive cognitive demands associated with real‐time planning and control of walking. Despite the importance of walking, methodological limitations mean that surprisingly little is known about the neural and cognitive processes that support ambulatory motor control. Here, we report mobile EEG data recorded from 32 healthy young adults during real‐world ambulatory obstacle avoidance. Participants walked along a path while stepping over expected and unexpected obstacles projected on the floor, allowing us to capture the dynamic oscillatory response to changes in environmental demands. Compared to obstacle‐free walking, time–frequency analysis of the EEG data revealed clear neural markers of proactive and reactive forms of movement control (occurring before and after crossing an obstacle), visible as increases in frontal theta and centro‐parietal beta power respectively. Critically, the temporal profile of changes in frontal theta allowed us to arbitrate between early selection and late adaptation mechanisms of proactive control. Our data show that motor plans are updated as soon as an upcoming obstacle appears, rather than when the obstacle is reached. In addition, regardless of whether motor plans required updating, a clear beta rebound was present after obstacles were crossed, reflecting the resetting of the motor system. Overall, mobile EEG recorded during real‐world walking provides novel insight into the cognitive and neural basis of dynamic motor control in humans, suggesting new routes to the monitoring and rehabilitation of motor disorders such as dyspraxia and Parkinson's disease.
Preliminary evidence for a two‐for‐one deal: Wetland restoration for a threatened frog may benefit a threatened bat
Authors: Beranek Chad T. , Xu Giorginna , Clulow John , Mahony Michael
Published: January 2021

Habitat restoration is an integral feature of wildlife conservation. However, funding and opportunities for habitat restoration are limited, and therefore, it is useful for targeted restoration to provide positive outcomes for non‐target species. Here, we investigate the possibility of habitat creation and management benefitting two threatened wetland specialists: the Green and Golden Bell Frog (Litoria aurea) and the Large‐footed Myotis (Myotis macropus). This study involved two components: (i) assessing co‐occurrence patterns of these species in a wetland complex created for the Green and Golden Bell Frog (n = 9) using counts, and (ii) comparing foraging activity of Large‐footed Myotis in wetlands with low and high aquatic vegetation (n = 6 and 7, respectively) using echolocation metres. Since Large‐footed Myotis possesses a unique foraging behaviour of trawling for aquatic prey, we hypothesised that foraging activity of this species would be higher in wetlands with low aquatic vegetation coverage. Additionally, we provide observations of its potential prey items. We identified one created wetland where both species were found in relatively high numbers, and this wetland had a permanent hydrology, was free of the introduced fish Gambusia (Gambusia holbrooki) and had low aquatic vegetation coverage. We also found that Myotis feeding activity was significantly higher in low aquatic vegetation coverage wetlands (x̅ = 65.72 ± 27.56 SE) compared to high (x̅ = 0.33 ± 0.33 SE, P = 0.0000). Although this is a preliminary study, it seems likely that Green and Golden Bell Frog and Large‐footed Myotis would gain mutual benefit from wetlands that are constructed to be permanent, that are Gambusia free, low in aquatic vegetation coverage, and are located in close to suitable roosting habitat for Large‐footed Myotis. We encourage adaptive aquatic vegetation removal for Green and Golden Bell frog as this may have benefits for Large‐footed Myotis. The evidence suggests that the former may be a suitable umbrella species for the latter.
Video quality using outpatient smartphone videos in epilepsy: Results from the OSmartViE study
Authors: Tatum William O. , Hirsch Lawrence J. , Gelfand Michael A. , Acton Emily K. , LaFrance W. Curt , Duckrow Robert B. , Chen David , Blum Andrew S. , Hixson John , Drazkowski Joe , Benbadis Selim , Cascino Gregory D. ,   The OSmartViE Collaborators
Published: January 2021

Background and purpose

The aim of this study was to evaluate the quality of smartphone videos (SVs) of neurologic events in adult epilepsy outpatients. The use of home video recording in patients with neurological disease states is increasing. Experts interpretation of outpatient smartphone videos of seizures and neurological events has demonstrated similar diagnostic accuracy to inpatient video‐electroencephalography (EEG) monitoring.

Methods

A prospective, multicenter cohort study was conducted to evaluate SV quality in patients with paroxysmal neurologic events from August 15, 2015 through August 31, 2018. Epileptic seizures (ESs), psychogenic nonepileptic attacks (PNEAs), and physiologic nonepileptic events (PhysNEEs) were confirmed by video‐EEG monitoring. Experts and senior neurology residents blindly viewed cloud‐based SVs without clinical information. Quality ratings with regard to technical and operator‐driven metrics were provided in responses to a survey.

Results

Forty‐four patients (31 women, age 45.1 years [r = 20–82]) were included and 530 SVs were viewed by a mean of seven experts and six residents; one video per patient was reviewed for a mean of 133.8 s (r = 9–543). In all, 30 patients had PNEAs, 11 had ESs, and three had PhysNEEs. Quality was suitable in 70.8% of SVs (375/530 total views), with 36/44 (81.8%) patient SVs rated as adequate by the majority of reviewers. Accuracy improved with the presence of convulsive features from 72.4% to 98.2% in ESs and from 71.1% to 95.7% in PNEAs. An accurate diagnosis was given by all reviewers (100%) in 11/44 SVs (all PNEAs). Audio was rated as good by 86.2% of reviewers for these SVs compared with 75.4% for the remaining SVs (p = 0.01). Lighting was better in SVs associated with high accuracy (p = 0.06), but clarity was not (p = 0.59). Poor video quality yielded unknown diagnoses in 24.2% of the SVs reviewed. Features hindering diagnosis were limited interactivity, restricted field of view and short video duration.

Conclusions

Smartphone video quality is adequate for clinical interpretation in the majority of patients with paroxysmal neurologic events. Quality can be optimized by encouraging interactivity with the patient, adequate duration of the SV, and enlarged field of view during videography. Quality limitations were primarily operational though accuracy remained for SV review of ESs and PNEAs.
Preictal state detection using prodromal symptoms: A machine learning approach
Authors: Cousyn Louis , Navarro Vincent , Chavez Mario
Published: January 2021

A reliable identification of a high‐risk state for upcoming seizures may allow for preemptive treatment and improve the quality of patients' lives. We evaluated the ability of prodromal symptoms to predict preictal states using a machine learning (ML) approach. Twenty‐four patients with drug‐resistant epilepsy were admitted for continuous video‐electroencephalographic monitoring and filled out a daily four‐point questionnaire on prodromal symptoms. Data were then classified into (1) a preictal group for questionnaires completed in a 24‐h period prior to at least one seizure (n1 = 58) and (2) an interictal group for questionnaires completed in a 24‐h period without seizures (n2 = 190). Our prediction model was based on a support vector machine classifier and compared to a Fisher's linear classifier. The combination of all the prodromal symptoms yielded a good prediction performance (area under the curve [AUC] = .72, 95% confidence interval [CI] = .61–.81). This performance was significantly enhanced by selecting a subset of the most relevant symptoms (AUC = .80, 95% CI = .69–.88). In comparison, the linear classifier systematically failed (AUCs < .6). Our findings indicate that the ML analysis of prodromal symptoms is a promising approach to identifying preictal states prior to seizures. This could pave the way for development of clinical strategies in seizure prevention and even a noninvasive alarm system.
Importance of Self‐Esteem for the Parental Couple: Testing for Actor and Partner Effects
Authors: El Ghaziri Nahema , Darwiche Joëlle , Antonietti Jean‐Philippe , Orth Ulrich
Published: January 2021

Objective

This study investigated the actor and partner effects of self‐esteem on the quality of the parental couple relationships: the romantic relationship and the coparental relationship. The mediating role of romantic quality also was considered.

Background

Previous findings suggest that self‐esteem affects the quality of the romantic relationship. Yet few studies have focused on self‐esteem in the parental couple or explored self‐esteem related to the coparental relationship, both of which play a significant role in the nature of the family unit.

Method

Using data from two independent samples (including 2,549 couples), actor–partner interdependence models were tested to analyze the effects of self‐esteem on both relationships of the parental couple.

Results

Parents with high self‐esteem reported higher romantic quality, as did their partner. Self‐esteem also showed actor and partner effects on negative coparenting. Accordingly, parents with high self‐esteem reported fewer conflicts about the child and fewer undermining behaviors. In contrast, the link between self‐esteem and positive coparenting received little support. However, when mothers had high self‐esteem, they engaged more frequently in positive coparental behaviors, such as including the father. Finally, romantic relationship quality mediated the actor and partner effects of self‐esteem on negative coparenting.

Conclusion

Having high self‐esteem appears to be a couple resource with beneficial effects for both parents.

Implications

Improving parents' self‐esteem could be an important gateway for enhancing the functioning of families with romantic and coparental difficulties.
Functional partnership between carbonic anhydrase and malic enzyme in promoting gluconeogenesis in Leishmania major
Authors: Mondal Dipon Kumar , Pal Dhiman Sankar , Abbasi Mazharul , Datta Rupak
Published: January 2021

Leishmania has a remarkable ability to proliferate under widely fluctuating levels of essential nutrients, such as glucose. For this, the parasite is heavily dependent on its gluconeogenic machinery. One perplexing aspect of gluconeogenesis in Leishmania is the lack of the crucial gene for pyruvate carboxylase (PC). PC‐catalyzed conversion of pyruvate to oxaloacetate is a key entry point through which gluconeogenic amino acids are funneled into this pathway. The absence of PC in Leishmania thus raises question about the mechanism of pyruvate entry into the gluconeogenic route. In the present study, we report that this task is accomplished in Leishmania major through a novel functional partnership between its mitochondrial malic enzyme (LmME) and carbonic anhydrase 1 (LmCA1). Using a combination of pharmacological inhibition studies with genetic manipulation, we show that both of these enzymes are necessary for promoting gluconeogenesis and supporting parasite growth under glucose‐limiting conditions. Functional cross‐talk between LmME and LmCA1 was evident when it was observed that the growth retardation caused by inhibition of any one of these enzymes could be protected to a significant extent by overexpressing the other enzyme. We also found that, although LmCA1 exhibited constitutive expression, the LmME protein level was strongly upregulated under low glucose conditions. Notably, both LmME and LmCA1 were found to be important for survival of Leishmania amastigotes within host macrophages. Taken together, our results indicate that LmCA1 by virtue of its CO2 concentrating ability stimulates LmME‐catalyzed pyruvate carboxylation, thereby driving gluconeogenesis through the pyruvate–malate–oxaloacetate bypass pathway. Additionally, our study establishes LmCA1 and LmME as promising therapeutic targets.
Diet and acne: review of the evidence from 2009 to 2020
Authors: Dall’Oglio Federica , Nasca Maria Rita , Fiorentini Federica , Micali Giuseppe
Published: January 2021

Background

Dietary habits may play a non‐negligible role in the development, duration, and severity of acne, as shown in past critical review articles on such association.

Methods

The aim of this systematic review is to supplement data available on scientific literature spanning the last 10 years by inserting the keywords “acne” or “acne vulgaris” and “diet”, “nutrition”, “food”, “chocolate”, “dairy”, “whey protein”, “fatty acid”, or “drink” in the timeframe “January 2009‐April 2020” within the PubMed database.

Results

Fifty‐three reviewed articles met eligibility criteria. They included 11 interventional clinical trials (seven randomized controlled trials and four uncontrolled open label studies) and 42 observational studies (17 case‐control and 22 cross‐sectional studies, and three descriptive studies).

Conclusions

This review reinforces the notion of a rapidly growing exponential trend of interest in this subject by the scientific community. Acne‐promoting factors include high GI/GL food, dairy products, fat food, and chocolate, whereas acne‐protective factors include fatty acids, fruit, and vegetable intake. The role played by specific dietary components pertaining to different foods, as done for milk (full‐fat/whole, reduced‐fat, low‐fat/skim milk), dairy products (milk cream, ice cream, yogurt, cheese, etc.), or chocolate (cocoa, dark/milk chocolate), remains an unsolved issue and objective of future research.
The effect of uncoated paper application on skin moisture, risk of pressure injury and incidence of pressure injury in neurologic intensive care unit patients: A randomized controlled trial
Authors: Choi Yoo‐Hyung , Kim Sung Reul
Published: January 2021

Aim

This study aimed to evaluate the effects of uncoated paper on skin moisture, pressure injury risk and pressure injury incidence in neurological intensive care unit patients.

Methods

A randomized controlled design was used. The experimental group (n = 68) received usual care (repositioning every 2 h and use of an air mattress) and application of uncoated paper on the sacral area for 5 days, whereas the control group (n = 67) received only usual care. A repeated measures analysis of variance was used to determine changes in the skin moisture and risk of pressure injury between the groups. A chi‐squared test was used to determine the change in the incidence of pressure injuries for sacral area. Data were collected from 20 October 2017 to 6 March 2018.

Results

There were statistically significant differences in the skin moisture and risk of pressure injuries between the experimental and control groups. However, a significant difference was not observed in the incidence of pressure injuries between the groups.

Conclusion

The use of uncoated paper may be a valid nursing intervention for the prevention of pressure injuries in neurological intensive care unit patients.
Safety of rapid injection of undiluted ferric carboxymaltose to patients with iron‐deficiency anaemia: a Phase II single‐arm study
Authors: Pasricha Sant‐Rayn , Gilbertson Michael , Indran Tishya , Bennett Ashwini , van Dam Matthew , Coughlin Elizabeth , Dev Anouk , Chunilal Sanjeev , Opat Stephen
Published: January 2021

Background

Ferric carboxymaltose is increasingly utilised to treat iron deficiency and is usually diluted in saline and administered as an intravenous infusion over 15 min. Although this is highly convenient compared with older formulations, we hypothesised the drug could be administered, safely given as a rapid bolus injection.

Aims

To define the risk of serious adverse events following administration of an undiluted, rapid, high‐dose ferric carboxymaltose injection. Secondary aims included all other adverse events, as well as longitudinal effects on haemoglobin, iron stores, phosphate and hepcidin.

Methods

In a single‐arm, Phase II study in 121 patients with iron‐deficiency anaemia, we administered up to 1000 mg of ferric carboxymaltose as a rapid undiluted bolus injection, and recorded adverse events and collected blood samples over the first hour, and again at 2 and 4 weeks post‐treatment.

Results

No patient experienced a serious adverse event. Flushing during the injection was common, as was a transient headache in the subsequent weeks. One patient experienced Grade 3 chest tightness, necessitating emergency department assessment but not admission or treatment. Treatment produced an average 12.3 g/L improvement in haemoglobin within 2 weeks, but commonly caused reductions in serum phosphate (although none of these was clinically symptomatic). Parenteral iron caused elevations in hepcidin sustained to 4 weeks post‐injection. Patients stated they would be prepared to receive the treatment again.

Conclusion

Rapid injection of undiluted ferric carboxymaltose is well tolerated and could provide an approach to treat patients in the ambulatory setting.
Validation of Australian and Victorian guidelines for colonoscopy triage
Authors: Emery Jon D. , Kyriakides Mary , Faragher Ian , Ewing Hamish , Moss Alan
Published: January 2021

Background

Managing the growing demand for colonoscopies is challenging.

Aims

To assess the diagnostic performance of National and Victorian colonoscopy triage guidelines and potential redistribution of triage categories.

Methods

This is a diagnostic validation study comparing colonoscopy triage guidelines against a reference colonoscopy dataset. Participants were a reference dataset of 2378 colonoscopies from 1 October 2014 to 30 June 2016. Comparison with triage categorisation determined using National Cancer Council Australia guidelines; Victorian triage guidelines; Optimal Cancer Care Pathways recommendations. Main outcome measures were as follows: (i) proportion of colonoscopies assigned to each triage category; (ii) detection rate (proportion of cancers assigned to triage Category 1); and (iii) conversion rate (proportion of triage Category 1 colonoscopies that diagnose a cancer).

Results

After adjusting for data absent in referrals, the National and Victorian guidelines reduced the proportion of Category 1 colonoscopies compared with the reference triage (National 76.3% vs 58.6%; 95% CI for difference 15.0–20.3%, P < 0.0001. Victorian 76.3% vs 66.3%; 95% CI for difference 7.4–12.6%, P < 0.0001). Victorian guidelines were associated with the highest detection rate (91.4%) and a conversion rate of 5.4% although the number of cancers limited the power to detect significant differences on these metrics. There was a higher proportion of unclassifiable colonoscopies using the National guidelines than the Victorian ones due to their focus on symptomatic indications.

Conclusions

The Victorian guidelines could reduce the proportion of Category 1 colonoscopies by 10% without reducing conversion or detection rates. This would require improvements in the quality of referrals and ordering faecal occult blood tests in 6% of symptomatic patients.
Documentation of adverse drug reactions to opioids in an electronic health record
Authors: Inglis Joshua M. , Caughey Gillian E. , Smith William , Shakib Sepehr
Published: January 2021

Background

Allergy to opioids is the second most common drug allergy label in electronic health records (EHR). Adverse drug reactions (ADR) to opioids cause significant morbidity and contribute to healthcare costs, while incorrect opioid allergy labels may unnecessarily complicate patient management.

Aims

To examine the documentation of opioid ADR in a large‐scale hospital‐based EHR.

Methods

A cross‐sectional retrospective review of EHR documentation of opioid ADR at four public hospitals in South Australia was conducted. Data were extracted from all ADR entries including the reported allergen, ADR category (allergy or intolerance) and reaction details. Expert criteria were used to determine consistency of ADR categorisation as allergy or intolerance.

Results

Of 86 727 unique ADR reports, there were 13 781 ADR to opioids with most being entered as allergy (n = 8913, 64.7%) rather than intolerance (n = 4868, 35.3%). The most commonly documented reactions were nausea/vomiting (n = 3912, 28%), rash (n = 647, 5%), itch (n = 642, 5%) and hallucinations (n = 527, 4%). There were 362 (3%) ADR labels of anaphylaxis. Of those ADR containing a reaction description (n = 11 868), 89% of reports entered as allergy had a reaction description that was consistent with intolerance and 8% of the entered intolerances had descriptions consistent with allergy when assessed using predefined criteria.

Conclusions

This large EHR‐based study demonstrates the high rate of opioid ADR labels in EHR. The majority of these labels were for symptoms suggestive of pharmacological intolerance. Reactions consistent with true allergy were uncommon. Systematic review of ADR by a dedicated clinical service would improve the accuracy of documentation.
Dry matter partitioning to leaves differentiates African and Asian rice genotypes exposed to elevated CO2
Authors: Masuya Yusuke , Kumagai Etsushi , Matsunami Maya , Shimono Hiroyuki
Published: January 2021

Intraspecific variation of response to elevated CO2 (eCO2) is a powerful option to improve crop productivity under the future climate. We evaluated genotypic variation in the biomass response to eCO2, at 200 μmol/mol above ambient CO2 (aCO2) 33 to 38 days after transplanting in 7 African rice (Oryza glaberrima Steud.) genotypes and 10 Asian rice (Oryza sativa L.) genotypes during a 3‐year experiment. A comparison at vegetative growth at aCO2, African rice genotypes showed 60% to 76% greater biomass than Asian rice genotypes. eCO2 significantly increased biomass of both species, and the magnitude of the increase was similar between the African (by 12% to 19% of averaged over three years) and Asian accessions (7 to 24%). The genotypic variation in the biomass response to eCO2 could be explained by the leaf area response rather than by the efficiency of biomass production per unit leaf area or leaf photosynthesis across the species. Dry matter partitioning to leaves determines biomass responsiveness to elevated atmospheric CO2 in comparison between African and Asian rice genotypes.
Breaking Barriers: Educating Design Students about Inclusive Design through an Authentic Learning Framework
Authors: Rieger Janice , Rolfe Annie
Published: January 2021

Current studies in design education suggest that students and educators base their designs on what they already know about themselves and their peers, or on stereotypical notions of others. This article presents a critical examination of a pedagogical approach employed in several architecture and interior design studios to determine how best to develop student understanding of how to design for real users and users with abilities different from themselves. This authentic learning approach with spatial design students and teachers from the School of Design, Queensland University of Technology, Australia and with people with differing abilities, used qualitative and quantitative questionnaires, student journals and design studio projects to create a multimodal data set. While there are no simple conclusions, or easy answers to unravel the complexity in creating inclusive designs, our findings point towards enabling new engagements and knowledge processes and scaffolding these activities around authentic learning, so that design students and educators can begin to understand the differing ways of designing for/with people with disabilities. The significance of this research is that it opens up new approaches for teaching design students about inclusive design beyond fake personas, building codes and anthropometric data, and provides evidence of the need for a more holistic, authentic and scaffolded approach.
The Rise of Corporate Lobbying in the European Union: An Agenda for Future Research
Authors: Hanegraaff Marcel , Poletti Arlo
Published: January 2021

While the interest group literature suggests there is a consistent trend towards more corporate lobbying in various political systems, it remains unclear whether this also applies to EU lobbying. This study addresses this debate in three ways. Firstly, it takes stock of the extant literature and discusses some of the methodological hurdles that have rendered it difficult to provide conclusive evidence for the rise of corporate lobbying in the EU. Secondly, it offers some suggestions on how to address these problems and delivers some stylized facts by relying on two original datasets providing 7information on lobbying activities in the EU. In line with what has been observed in other political systems, our analysis shows that the EU lobbying community has experienced a quite dramatic increase of firm lobbying over the past ten years. Finally, it reflects on how to begin developing a systematic understanding of the factors explaining this phenomenon.
How ‘Smart’ Are Smart Specialization Strategies?
Authors: Di Cataldo Marco , Monastiriotis Vassilis , Rodríguez‐Pose Andrés
Published: January 2021

The introduction of smart specialization (S3) as a fundamental pillar of the 2014 reform of the EU cohesion policy is a significant strategic shift in European development intervention. S3 strategies aimed at mobilizing the economic potential of each country and region of the EU by allowing a more place‐based and bottom‐up approach to development. However, despite the salience that S3 has acquired in a short period of time, there has been no European‐wide evaluation of the extent to which S3 strategies truly reflect the economic characteristics and potential of the territories where they are being implemented. This article examines the characteristics of S3 strategies across Europe – by focusing on their development axes, economic or scientific domains and policy priorities – to assess whether this is the case. The results show that S3 strategies display a proliferation of objectives, a problem that particularly affects areas with weaker quality of government. Moreover, strategies are generally loosely connected with the intrinsic conditions of each region and mostly mimic what neighbouring areas are doing. The lack of more concise and focused S3 strategies is likely to undermine the effectiveness of what is, otherwise, a very interesting and worthwhile policy experiment.
Ultrasonographic tissue perfusion analysis at implant and palatal donor sites following soft tissue augmentation: A clinical pilot study
Authors: Tavelli Lorenzo , Barootchi Shayan , Majzoub Jad , Chan Hsun‐Liang , Giannobile William V. , Wang Hom‐Lay , Kripfgans Oliver D.
Published: January 2021

Aim

To describe the application of power Doppler Ultrasonography (US) for evaluating blood flow at implant and palatal donor sites following soft tissue augmentation with the connective tissue graft (CTG).

Materials and Methods

Five patients exhibiting a peri‐implant soft tissue dehiscence received treatment with a coronally advanced flap and corresponding CTG. Power Doppler US was used for assessing blood volume at baseline, 1 week, 1 month, 6 months and 12 months post‐surgery for assessing blood‐flow dynamics at the implant and palatal donor sites. The speed‐weighted and power‐weighted colour pixel density (CPPD) were computed from colour velocity (CV) and colour power (CP), respectively.

Results

A mean increase in CV of 199.25% was observed at the midfacial region of the implant sites after 1 week compared to baseline. CV and CP were increased in all sites at 1 week and 1 month. At 6 and 12 months, the mean CV appeared lower than baseline at the implant sites. CCPD was increased at the palatal donor sites and at the great palatine foramen areas at the 1‐week and 1‐month post‐operative evaluations.

Conclusions

Power Doppler US is a non‐invasive and valuable tool for estimating tissue perfusion and CPPD variation during different phases of intra‐oral soft tissue graft healing.
Biology and associated fungi of an emerging bark beetle pest, the sweetgum inscriber Acanthotomicus suncei (Coleoptera: Curculionidae)
Authors: Gao Lei , Li You , Wang Zhang‐Xun , Zhao Jie , Hulcr Jiri , Wang Jian‐Guo , Li Yue‐Zhong , Ju Rui‐Ting
Published: January 2021

The sweetgum inscriber (SI) Acanthotomicus suncei Cognato is an emerging bark beetle pest that seriously damages American sweetgum trees (Liquidambar styraciflua) and Chinese sweetgum trees (L. formosana) in China. Since 2013, SI has killed more than 30,000 sweetgum trees in Shanghai and adjacent areas. In Shanghai, SI was observed to emerge from infested wood between April–September and exhibited two generations per year. Both the flying populations and those in colonized logs were female‐biased. After the parental adult initiates a gallery, the emergence of new adults required 73.4 ± 0.7 days at 30°C and 163.5 ± 0.9 days at 20°C. SI could not sustain population development at constant temperatures ≤15°C. The fungi Geosmithia spp. and Phaeoacremonium tuscanum were common associates of SI. The results suggest that SI has a long flight period, and its development is sensitive to low temperatures. Fungi associated with SI were not pathogenic to American sweetgum trees, but their presence may indirectly increase the probability of tree mortality. Our findings contribute to the prevention and control of this important emerging bark beetle pest.
Data‐driven modeling for crystal size distribution parameters in cane sugar crystallization process
Authors: Meng Yanmei , Yao Tao , Yu Shuangshuang , Qin Johnny , Zhang Jinlai , Wu Jianfan
Published: January 2021

Crystal size distribution (CSD) is important in evaluating crystal quality in cane sugar crystallization process. Due to the complex non‐linearity, time‐delay and strong coupling in cane sugar crystallization process, it is difficult to directly modeling in the mechanism of cane sugar crystallization process to obtain CSD parameters. In order to obtain two main CSD parameters so that to achieve better control and production of cane sugar, this article constructs a data‐driven model based on least squares support vector regression (LSSVR) and particle swarm optimization (PSO). Based on LSSVR, the model takes the easy to measureable variables (massecuite brix, massecuite level, massecuite temperature, steam pressure, feeding volume, and vacuum degree) as input variables, and outputs sugar CSD parameters (crystal average size, coefficient of variation of crystal size). PSO algorithm is used to optimize the key parameters of primary model to get better modeling performance. Compared with other modeling methods such as back propagation, extreme learning machine, radial basis function, and SVR, the constructed PSO‐LSSVR model has obvious advantages over other models in learning speed and predictive effect, generalization ability. This model has potential to be applied to the control system of cane sugar crystallization process and get better product of sugar.

Practical applications

The constructed model uses the measureable variables to obtain main crystal size distribution (CSD) parameters (which is not easy to be measured online directly), and the measureable variables can be easy to control. According the relation between the measureable variables and CSD parameters, the model is useful to set up better operation conditions, and form better crystallization environment, and improve the quality of sugar crystal. So, this method will benefit the control system of cane sugar crystallization process and improve the quality and efficiency of cane sugar crystallization process, and the model is also useful for the study of continuous sugar crystallization process.
Low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol diet in patients with diarrhea‐predominant irritable bowel syndrome: A prospective, randomized trial
Authors: Goyal Omesh , Batta Shaveta , Nohria Sahil , Kishore Harsh , Goyal Prerna , Sehgal Rishabh , Sood Ajit
Published: January 2021

Background and Aim

Low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diet improves irritable bowel syndrome (IBS) symptoms. Data on long‐term “modified” FODMAP diet are emerging. We aimed to assess efficacy and acceptability of short‐term “strict” low FODMAP diet (LFD) and long‐term “modified” FODMAP diet in patients with diarrhea‐predominant IBS (IBS‐D).

Methods

This prospective randomized trial included patients with IBS‐D (Rome IV) and IBS severity scoring system (IBS‐SSS) ≥ 175. In phase I (4 weeks), patients were randomized to strict LFD and traditional dietary advice (TDA) groups. From 4 to 16 weeks, LFD group was advised systematic reintroduction of FODMAPs (“modified” FODMAP diet). Response was defined as > 50‐point reduction in IBS‐SSS.

Results

Of the total 166 patients with IBS‐D screened, 101 (mean age 41.9 ± 17.1 years, 58% male) were randomized to LFD (n = 52) and TDA (n = 49) groups. Both at 4 and 16 weeks, total IBS‐SSS and IBS quality of life score reduced significantly in both groups, but there was significantly greater reduction in LFD group. By intention‐to‐treat analysis, responders in LFD group were significantly higher than TDA group (4 weeks—62.7% [32/51] vs 40.8% [20/49], respectively, P = 0.0448; 16 weeks—52.9% [27/51] vs 30.6% [15/49], respectively; P = 0.0274). Compliance to LFD was 93% at 4 weeks and 64% at 16 weeks. Energy, carbohydrate, fat, and fiber intake showed reduction in LFD group at 4 weeks, which improved till 16 weeks.

Conclusions

Strict LFD for short‐term and “modified” LFD for long term in IBS‐D patients is acceptable and leads to significant improvement in symptoms and quality of life.
ACE2 in the second act of COVID‐19 syndrome: Peptide dysregulation and possible correction with oestrogen
Authors: Zhang Limei , Zetter Mario A. , Guerra Enrique C. , Hernández Vito S. , Mahata Sushil K. , Eiden Lee E.
Published: January 2021

Coronavirus disease 2019 (COVID‐19) has become the most critical pandemic of the 21st Century and the most severe since the 1918 influenza pandemic. Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infects the host by binding to angiotensin‐converting enzyme 2 (ACE2). The role of ACE2 in the pathophysiology of coronavirus disease 2019 (COVID‐19) is a topic of debate, with clinical and experimental evidence indicating a multifaceted relationship between ACE2 activity and disease severity. Here, we review the mechanisms by which the peptidergic substrates and products of ACE and ACE2 contribute to physiological and pathophysiological processes and hypothesise how down‐regulation of ACE2 by SARS‐CoV‐2 cellular entry disrupts homeostasis. A better understanding of the endocrinology of the disease, in particular the neuroendocrinology of ACE2 during COVID‐19, may contribute to the timely design of new therapeutic strategies, including the regulation of ACE2 itself by steroid hormones, to ameliorate the severity of COVID‐19.
Intermediary trading and the transformation of marketplaces in Papua New Guinea
Authors: Sharp Timothy L. M.
Published: January 2021

Trade in marketplaces is central to the domestic distribution of food and other goods throughout the developing world. The commodity networks involved are often complex with numerous intermediate transactions between producer and consumer. By contrast, in the Pacific nation of Papua New Guinea (PNG), marketplace trade has historically occurred through very short commodity networks. This article examines the appearance and growing significance of intermediary trading in PNG's marketplaces and associated trade networks. Reselling is supporting urban livelihoods at a time when making a living in town is increasingly precarious, but the transformation of marketplaces, I argue, also threatens to reduce the agency of rural producers and erode the incomes of certain producers. Growing intermediation may also see men increasingly involved in an economic domain where women have been central. The emergence of intermediaries is globally an important historical development, and this article provides a rare study of this process within the contemporary era.