bluuebunny/crossref_metadata_2025 huggingface dataset:
Ethical and Legal Implications of Remote Monitoring of Medical Devices
Authors: COHEN I. GLENN , GERKE SARA , KRAMER DANIEL B.
Published: October 2020

Policy Points

Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers.

Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device‐collected data.

Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices.

Context

Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored.

Methods

Using pacemakers and implantable cardioverter‐defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and European privacy regulations for patient access to either summary or raw device data. Lastly, we evaluate ethical arguments for or against providing patients access to data beyond the summaries presented in medical records.

Findings

Our analysis of applicable health privacy laws indicates that US patients may have little access to their raw data collected and held by device manufacturers in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation (GDPR) grants greater access to device‐collected data when the processing of personal data falls under the GDPR's territorial scope. The California Consumer Privacy Act, the “little sister” of the GDPR, also grants greater rights to California residents. By contrast, our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Smartphone applications are increasingly involved in the collection, relay, retrieval, and documentation of these data. Therefore, we argue that smartphone user agreements are an emerging but potentially underutilized opportunity for clarifying both legal and ethical claims for device‐derived data.

Conclusions

Current health privacy legislation incompletely supports patients’ normative claims for access to digital health data.
Extended shelf life milk processing: Effect of simulated cleaning in place on the germination and attachment of Bacillus cereus spores
Authors: Pretorius Chané , Buys Elna Maria
Published: October 2020

The effect of simulated cleaning in place (CIP) was determined on the structure, attachment and growth of Bacillus cereus spores isolated from raw milk and biofilms in filler nozzles from extended shelf life (ESL) milk processing lines. Simulated CIP treatment structurally affected >98% of B. cereus spores, while 0.1% remained intact. Following simulated CIP treatment, B. cereus spores were able to attach to stainless steel coupons and form biofilms. B. cereus spores were capable of germination and growth under refrigerated conditions for more than 28 days. Contamination with B. cereus spores may lead to a reduced shelf life and potentially be a safety risk in ESL milk with a prolonged shelf life.
Ultrasound‐assisted enzymatic extraction of anthocyanins from grape skins: optimization, identification, and antitumor activity
Authors: Tan Jiaqi , Li Qian , Xue Hongkun , Tang Jintian
Published: October 2020

Grape skins produced during the grape juice production and processing contain abundant anthocyanins and other active compounds. Consequently, this study optimized the extraction conditions for ultrasound‐assisted enzymatic extraction (UAEE) of anthocyanins from grape skins via response surface methodology coupled with genetic algorithm. The optimum extraction parameters to achieve the highest anthocyanins yield (3.01 ± 0.04) mg/g from grape skins by UAEE were obtained under an extraction temperature of 50 °C, ultrasonic power of 400 W, pectinase dosage of 0.16%, and extraction time of 28 min. The AB‐8 macroporous resin combined Sephadex LH‐20 techniques were further employed to purify the anthocyanins extracts obtained under optimum extraction conditions (AEOEC), and the main anthocyanins were identified using high‐performance liquid chromatography tandem mass spectrometry. The purified anthocyanins contained two anthocyanins in terms of delphinidin‐3,5‐O‐diglucoside and cyanidin‐3‐O‐rutinoside with purity of 91.35% and 92.64%, respectively. Ultimately, we further evaluated the antitumor activity of AEOEC and two purified anthocyanins on breast cancer. The results indicated that the antitumor effect of AEOEC on breast cancer MCF‐7 cells was better than that of two purified anthocyanins. In addition, AEOEC could memorably increase intracellular reactive oxygen species levels and apoptosis of MCF‐7 cells, and arrest MCF‐7 cells in the G2/M phases. The findings provide an effective and feasible method for anthocyanins extraction and reduce the environmental burden of this waste.
Clinical characterization of glioblastoma patients living longer than 2 years: A retrospective analysis of two Italian institutions
Authors: Anselmo Paola , Maranzano Ernesto , Selimi Adelina , Lupattelli Marco , Palumbo Isabella , Bini Vittorio , Casale Michelina , Trippa Fabio , Bufi Alessandro , Arcidiacono Fabio , Aristei Cynthia
Published: October 2020

Aim: Despite the advances in surgery and radio‐chemotherapy, the prognosis of glioblastoma (GBM) remains poor with about 13% of patients alive at 24 months.

Methods: A total of 75 long‐term survivors (LTS), defined as alive at least 24 months from diagnosis, were retrospectively analyzed. Overall survival (OS) and recurrence‐free‐survival (RFS) were calculated and related to patient characteristics and treatment received.

Results: Median age and Karnofsky performance status (KPS) were 56 years and 100%, respectively. After surgery (gross tumor resection‐GTR in 62, 83% patients), all LTS received concomitant temozolomide (TMZ) with radiotherapy and 70 (93%) adjuvant TMZ. Of these, 10 (13%) discontinued TMZ prior the completion of 6 cycles, 37 (49%) received 6 cycles and 23 (31%) >6 cycles. Sixty‐nine (92%) patients experienced a first tumor recurrence at a median time of 21 months. Of these, 32 (46%) were submitted to a second surgery, 34 (49%) to other no‐surgical treatments and 3 (5%) only supportive care. At multivariate analysis, OS was significantly improved by second surgery after first recurrence (P = 0.0032) and by cycles of adjuvant TMZ > 6 versus ≤6 (P = 0.05). More than six cycles of TMZ significantly conditioned also first RFS (P = 0.011) and second RFS (P = 0.033).

Conclusion: The large majority of LTS had <65 years, had a high KPS and received GTR. OS and RFS resulted significantly related to an extended administration of adjuvant TMZ (>6 cycles) and a second surgery in case of recurrence.
Failure patterns and prognostic factors for cervical node‐negative nasopharyngeal carcinoma in the intensity‐modulated radiotherapy era
Authors: Wu Zheng , Wang Lei , Xie De‐Huan , Lv Shao‐Wen , Su Yong , Shi Ying‐Rui
Published: October 2020

Background

To evaluate the failure patterns and prognostic factors in patients with cervical node‐negative nasopharyngeal carcinoma (NPC) in the intensity‐modulated radiotherapy (IMRT) era.

Methods

Patients with cervical node‐negative NPC treated with IMRT at the Sun Yat‐sen University Cancer Center between February 2001 and December 2008 were retrospectively reviewed. The failure patterns, prognostic factors, and efficacy of additional chemotherapy were assessed.

Results

The median follow‐up time was 78 months for 298 patients. The 5‐year local recurrence‐free survival (LRFS), nodal recurrence‐free survival (NRFS), distant metastasis‐free survival (DMFS), failure‐free survival (FFS), and overall survival (OS) were 95.2%, 99.3%, 94.8%, 89.8%, and 92.9%, respectively. The rate of treatment failure remained high in patients with T4 disease (35.4%, 17/48), including eight of local recurrence, two of nodal recurrence, and seven of distant metastasis. Multivariate analyses showed that the primary gross tumor volume (GTVp) was significantly associated with LRFS, DMFS, FFS, and OS. Subgroup analysis revealed that patients with GTVp ≤ 42.5 cc had better 5‐year LRFS (98.7% vs 81.4%, P < .001), 5‐year DMFS (97.8% vs 82.5%, P < .001), 5‐year FFS (96.1% vs 65.4%, P < .001), and 5‐year OS (96.6% vs 78.2%, P < .001) than patients with GTVp > 42.5 cc. However, additional chemotherapy showed no significant survival benefit in stratification analysis.

Conclusions

Cervical node‐negative NPC has a good prognosis in the IMRT era, and the primary tumor volume is the most important prognostic factor. Further exploration is needed to determine the optimal treatment strategy for patients with a high tumor burden.
Covid‐19: What is the best approach in gynecological oncology patient management during the coronavirus pandemic?
Authors: Hasanzadeh Malihe , Azad Afrooz , Farazestanian Marjaneh , Mousavi Seresht Leila
Published: October 2020

Coronavirus (COVID‐19) infection is a new major concern and a global emergency in almost all countries worldwide; due to the higher sensibility of cancer patients, they are more susceptible to severe and fatal infections, being nearly 10 times more likely than in healthy individuals infected with this virus. Although the aggressive nature of a cancer is a matter of concern, our exact role as oncologists in this time of restricted resources is not fully clarified. Regarding some consensus recommendation for postponing surgery, there is still an essential need for a single approved protocol regarding each type of malignancy. Iran, as one of the first involved countries in this crisis in Asia, which also has a high prevalence of gynecological malignancies, will certainly require an individualized decision‐making schedule based on the most accepted global consensus opinion. Considering our restricted health system resources, herein we tried to introduce a logical gynecologic cancer management protocol based on the stage and survival expectancy of each tumor, along with reviewing all recent recommendations. The limited statistics published in this short period of time have obliged us to mainly focus on expert opinions, and the individualized clinical judgments should be agreed upon by multidisciplinary tumor board consensus. In conclusion, the COVID‐19 pandemic overshadows all aspects of medicine, and decision making in gynecological oncology patients requires precise and appropriate judgment based on the available local resources.
Revisiting the lead isotopic compositions of the Shang bronzes at Hanzhong and the new hypothesis of Qinling as the source of highly radiogenic lead
Authors: Zhangsun Y. Z. , Jin Z. Y. , Feng F. Z. , Tian J. H. , Wang H. G. , Zhao C. C. , Huang F. , Wu X. T.
Published: October 2020

The provenance of the highly radiogenic lead (HRL) contained in Chinese Shang bronzes has attracted great scholarly attention in recent years. A new study of the Hanzhong Shang bronzes has put forward a hypothesis that the HRL metal may come from the adjacent Qinling Mountains. This article reanalyses the lead isotope ratios and alloy compositions of the Hanzhong bronzes. Combining the analytical results, the modern ore data and the slags from Guanzhong area, we propose that there is no direct evidence to identify Qinling as the provenance of HRL metal (especially lead). Whilst over 80% of the Hanzhong bronzes contain HRL, the indigenous artefacts containing both HRL and special alloying elements (As, Sb, Ni) account only for minor portions. This fact cannot verify that HRL originates from Qinling, and even makes it difficult to prove that most of the Hanzhong bronzes use local metal resources. An alternative argument might be that the HRL used in Hanzhong derived from the Shang dynasty. The use of HRL reflects a unified system for allocating metal resources centred on the Shang kingdom, which has great significance for further understanding of the resource circulation patterns among different bronze cultures and locations during the Shang period.
Intraoperative aerosol viral transmission in minimally invasive surgery: a scoping review and impact on clinical guidelines and practice during the onset of the coronavirus disease 2019 (COVID‐19) pandemic
Authors: Mun Dong‐Ho , Pradere Benjamin , Shariat Shahrokh F. , Remzi Mesut
Published: October 2020

Objective

To identify the available evidence on aerosol viral transmission risk during minimally invasive surgery (MIS) and evaluate its impact on guidelines development and clinical activity worldwide during the coronavirus disease 2019 (COVID‐19) pandemic.

Methods

We performed a scoping review on PubMed, Cochrane, the Excerpta Medica dataBASE (EMBASE), Clinical Trial Register, and the Grey Literature Repository databases, to identify reports on viral transmission via surgical smoke or aerosolisation. A systematic review of all available national and international guidelines was also performed to report their recommendations. Additionally, a worldwide transdisciplinary survey was performed to capture the actual compliance to dedicated guidelines and their impact on MIS activity.

Results

Based on a selection of 17 studies, there was no evidence to support the concerns of an intraoperative viral transmission via pneumoperitoneum aerosolisation. Most national surgical and urological societies either did address this topic or referred to international guidelines. The guidelines of the American College of Surgery, the Royal College of Surgeons, and the European Association of Urology Robotic Urology Section, recommended an avoidance of MIS due to an increased risk of intraoperative aerosol‐enhanced transmission. The results of the survey completed by 334 respondents, from different surgical abdominal specialties, suggested a lack of compliance with the guidelines.

Conclusion

There seems to be a dissonance between contemporary guidelines and ongoing surgical activity, possibly due to the perceived lack of evidence. Recommendations regarding changes in clinical practice should be based on the best available research evidence and experience. A scoping review of the evidence and an assessment of the benefits and harms together with a survey showed that laparoscopic procedures do not seem to increase the risk of viral transmission. Nevertheless, the few publications and low quality of existing evidence limits the validity of the review.
Small intestinal glucose and sodium absorption through calcium‐induced calcium release and store‐operated Ca2+ entry mechanisms
Authors: Zhang Fenglian , Wan Hanxing , Chu Fenglan , Lu Cheng , Chen Jun , Dong Hui
Published: October 2020

Background and Purpose

Luminal glucose enhances intestinal Ca2+ absorption through apical Cav1.3 channels necessary for GLUT2‐mediated glucose absorption. As these reciprocal mechanisms are not well understood, we investigated the regulatory mechanisms of intestinal [Ca2+]cyt and SGLT1‐mediated Na+‐glucose co‐transports.

Experimental Approach

Glucose absorption and channel expression were examined in mouse upper jejunal epithelium using an Ussing chamber, immunocytochemistry and Ca2+ and Na+ imaging in single intestinal epithelial cells.

Key Results

Glucose induced jejunal Isc via Na+‐glucose cotransporter 1 (SGLT1) operated more efficiently in the presence of extracellular Ca2+. A crosstalk between luminal Ca2+ entry via plasma Cav1.3 channels and the ER Ca2+ release through ryanodine receptor (RYR) activation in small intestinal epithelial cell (IEC) or Ca2+‐induced Ca2+ release (CICR) mechanism was involve in Ca2+‐mediated jejunal glucose absorption. The ER Ca2+ release through RyR triggered basolateral Ca2+ entry or store‐operated Ca2+ entry (SOCE) mechanism and the subsequent Ca2+ entry via Na+/Ca2+ exchanger 1 (NCX1) were found to be critical in Na+‐glucose cotransporter‐mediated glucose absorption. Blocking RyR, SOCE and NCX1 inhibited glucose induced [Na+]cyt and [Ca2+]cyt in single IEC and protein expression and co‐localization of STIM1/Orai1, RyR1 and NCX1 were detected in IEC and jejunal mucosa.

Conclusion and Implications

Luminal Ca2+ influx through Cav1.3 triggers the CICR through RyR1 to deplete the ER Ca2+, which induces the basolateral STIM1/Orai1‐mediated SOCE mechanism and the subsequent Ca2+ entry via NCX1 to regulate intestinal glucose uptake via Ca2+ signalling. Targeting these mechanisms in IEC may help to modulate blood glucose and sodium in the metabolic disease.
Zafirlukast is a broad‐spectrum thiol isomerase inhibitor that inhibits thrombosis without altering bleeding times
Authors: Holbrook Lisa‐Marie , Keeton Shirley J. , Sasikumar Parvathy , Nock Sophie , Gelzinis Justine , Brunt Elizabeth , Ryan Sarah , Pantos Megan M. , Verbetsky Christina A. , Gibbins Jonathan M. , Kennedy Daniel R.
Published: October 2020

Background and Purpose

Multiple members of the thiol isomerase (TI) family of enzymes are present in and released by platelets. Inhibition of these enzymes results in diminished platelet responses, aggregation, adhesion and thrombus formation. Recently, the therapeutic potential of TI inhibition has been recognised and drug‐development technologies were used to identify selective small molecule inhibitors. To date, few pan‐TI inhibitors have been characterised and the most studied, bacitracin, is known to be nephrotoxic, which prohibits its systemic therapeutic usage.

Experimental Approach

We therefore sought to identify novel broad‐spectrum inhibitors of these enzymes and test their effects in vivo. A total of 3,641 compounds were screened for inhibitory effects on the redox activity of ERp5, protein disulphide isomerase (PDI), ERp57, ERp72 and thioredoxin in an insulin turbidity assay. Of the lead compounds identified, zafirlukast was selected for further investigation.

Key Results

When applied to platelets, zafirlukast diminished platelet responses in vitro. Zafirlukast was antithrombotic in murine models of thrombosis but did not impair responses in a model of haemostasis. Since TIs are known to modulate adhesion receptor function, we explored the effects of zafirlukast on cell migration. This was inhibited independently of cysteinyl LT receptor expression and was associated with modulation of cell‐surface free thiol levels consistent with alterations in redox activity on the cell surface.

Conclusion and Implications

We identify zafirlukast to be a novel, potent, broad‐spectrum TI inhibitor, with wide‐ranging effects on platelet function, thrombosis and integrin‐mediated cell migration. Zafirlukast is antithrombotic but does not cause bleeding.
Eosinophil prognostic scores for patients with head and neck squamous cell carcinoma treated with nivolumab
Authors: Nishikawa Daisuke , Suzuki Hidenori , Beppu Shintaro , Terada Hoshino , Sawabe Michi , Kadowaki Shigenori , Sone Michihiko , Hanai Nobuhiro
Published: October 2020

Although nivolumab, a programmed cell death 1 (PD‐1) inhibitor, is a standard therapy for platinum‐refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), no definitive biomarkers have been reported thus far. This study aimed to select promising prognostic markers in nivolumab therapy and to create a novel prognostic scoring system. In this retrospective cohort study, we reviewed patients with R/M HNSCC who were treated with nivolumab from April 2017 to April 2019. We developed a prognostic score for immune checkpoint inhibitor (ICI) therapy that was weighed using hazard ratio–based scoring algorithms. Significant variables were selected from the multivariate Cox proportional hazard analyses on overall survival (OS). A total of 85 patients with HNSCC were analyzed in the present study. The relative eosinophil count (REC), the ratio of eosinophil increase (REI), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) were selected as variables affecting the prognostic score. The patients were divided into four groups: very good (score = 0), good (score = 1), intermediate (score = 2), and poor (score = 3). The OS hazard ratios were 2.77, 10.18, and 33.21 for the good, intermediate, and poor risk groups compared with the very good risk group, respectively. The Eosinophil Prognostic Score is a novel prognostic score that is effective for predicting the prognosis of HNSCC patients treated with nivolumab. This score is more precise as it includes changes in biomarkers before and after the treatment.
Rectus femoris transfer in children with cerebral palsy: comparing a propensity score‐matched observational study to a randomized controlled trial
Authors: Schwartz Michael H , Ries Andrew J
Published: October 2020

Aim

To test whether an observational study employing propensity score matching could accurately estimate the causal treatment effects of rectus femoris transfer (RFT) as part of single‐event multilevel surgery (SEMLS) in ambulatory children with cerebral palsy.

Method

We used a large clinical database to derive a propensity score for treatment assignment (SEMLS±RFT) and used this score to generate a matched patient cohort. We compared the causal treatment effects estimated from this matched cohort with a previously published randomized controlled trial (RCT).

Results

The treated arms of the observational study and RCT were well matched. There were 129 limbs (81 males) with a mean age of 10 years 7 months (4y 7mo) in the treated arm of the observational study, and 129 limbs (68 males) with a mean age of 10 years 2 months (3y 9mo) in the control arm of the observational study. Differences between the observational study and RCT cohorts were clinically meaningless for knee flexion kinematics (1–4°), timing of knee angle extrema (<3% gait cycle), and speed (<5mm/s). Postoperative changes in the observational study matched those from the RCT. All but one of the observational study confidence intervals were completely contained within the corresponding RCT confidence interval; there were no meaningful differences in magnitude or sign of key outcomes related to stiff knee gait.

Interpretation

Propensity score matching is an accurate method for estimating the causal treatment effects of RFT as part of an SEMLS. It seems reasonable to extend this approach to other common components of SEMLS treatment in this population.

What this paper adds

Propensity score matching is an accurate method for estimating the causal treatment effects of rectus femoris transfer (RFT) in ambulatory children with cerebral palsy (CP).

The causal treatment effects for RFT surgery in ambulatory children diagnosed with CP were validated.
Risk navigation for Thinking and Working Politically: The work and disappearance of Sombath Somphone
Authors: Sims Kearrin
Published: October 2020

Motivation

On December 15, 2012 Sombath Somphone was abducted at a police checkpoint in his home city of Vientiane, the capital of Laos; his whereabouts remain unknown. This article considers his work and disappearance through the lens of Thinking and Working Politically (TWP) approaches to development. The article is supportive of TWP, but emphasizes the significant risks of politicized programming in authoritarian contexts.

Purpose

By examining the case of Sombath Somphone, the article seeks to offer insights for safer, and more effective, TWP programming. It considers how specific events in authoritarian contexts can suddenly reposition development workers and/or organizations as political dissidents.

Approaches and Methods

The argument draws on analysis of grey literature; conversational and observational knowledge accrued during 18 months of fieldwork in Laos between 2011 and 2018; on‐going formal and informal interviews with members of Laos’ civil society sector; and extensive dialogue with Sombath Somphone’s wife, Ng Shui Meng.

Findings

The article identifies four key factors that contributed to the enforced disappearance of Sombath Somphone: international exposure; timing; particular elites; and strategies of oppression. It highlights the need for further consideration of how to anticipate and mitigate the dangers of politically oriented development work, as well as the different forms of risk experienced by local and international development actors working in authoritarian contexts.

Policy Implications

TWP has much to offer to development practice, but its contributions should not threaten the safety of local development actors. More attention must be given to preventing and mitigating such risks.
Assessment of biventricular function by three‐dimensional speckle‐tracking echocardiography in clinically well pediatric heart transplantation patients
Authors: Lv Qing , Li Meng , Li He , Wu Chun , Dong Nianguo , Li Yuman , Zhang Li , Xie Mingxing
Published: October 2020

Background

The biventricular function plays an important role in the prognosis of pediatric heart transplantation (HTx) patients. Therefore, in this study, we aimed to evaluate the biventricular function of pediatric HTx patients by three‐dimensional (3D) speckle‐tracking echocardiography (3D‐STE).

Methods

We enrolled 30 clinically well pediatric HTx patients and 30 healthy controls with a similar distribution of sex and age to the HTx. All participants underwent comprehensive two‐dimensional (2D) and 3D echocardiography. Left ventricular (LV) global longitudinal strain (GLS), global circumferential strain (GCS), left and right ventricular ejection fraction (LVEF and RVEF, respectively), and right ventricular free wall longitudinal strain (RV FWLS) were acquired by 3D‐STE. Moreover, the correlations between strains and clinical data were explored.

Results

Compared with controls, LV GLS was decreased in pediatric HTx patients (P < .05), while LV GCS and LVEF showed no difference. LV GLS showed a weak correlation with cold ischemic time in HTx group (r = 0.396, P < .05). Meanwhile, RVEF and RV FWLS were significantly lower in the HTx group (P < .05). In the HTx group, RV FWLS showed a weak correlation with the preoperative mean pulmonary artery pressure (r = 0.420, P < .05) and postoperative pulmonary artery systolic pressure (r = 0.465, P < .05).

Conclusion

The 3D‐biventricular mechanical functions were decreased in clinically well pediatric HTx patients. The provided characteristics and appropriate normal values of biventricular mechanical functions can be the basis in subsequent studies in the pediatric HTx patients.
Morphological matching and phenological overlap promote niche partitioning and shape a mutualistic plant–hawkmoth network
Authors: Lautenschleger Andreza , Vizentin‐Bugoni Jeferson , Cavalheiro Lis B. , Iserhard Cristiano A.
Published: October 2020

1. Species interact with one another in communities forming complex interaction networks which are shaped by multiple non‐exclusive processes. Although plant–hawkmoth interactions have been studied for over a century, how processes underlying species' specialisation influence community‐level patterns of niche partitioning and contribute to the emergence of network structures remains poorly investigated.

2. This study described a mutualistic plant–hawkmoth network sampled for 18 consecutive months in Southern Brazil and tested (i) whether it presents modular and/or nested structures and (ii) what drivers (morphologies, phenologies, or abundances) are more important in defining interaction intensities.

3. Network structure was modular, presenting three distinct modules, and had a nestedness value lower than null model expectations. Interaction frequencies were primarily defined by morphological matching and phenological overlap but were not importantly influenced by species' relative abundances. Module composition reinforced the importance of morphological matching, as well as barriers imposed by morphology, and also suggested that modularity may be a consequence of other factors, such as timing between hawkmoth flight period and plants' anthesis.

4. This study's data contribute to filling the shortage of plant‐centred interaction networks involving hawkmoths and plants and reveal that modularity emerges likely as a consequence of processes thought to shape niche partitioning in this system, as well as in other pollination networks. The findings of this study are in agreement with the neutral‐niche continuum model, which predicts that, in systems with high trait functional variation (morphologies and phenologies in this case), niche‐based processes such as trait matching must be relatively more important than abundances as drivers of interspecific interactions.
Effect of allelopathy on plant performance: a meta‐analysis
Authors: Zhang Zhijie , Liu Yanjie , Yuan Ling , Weber Ewald , van Kleunen Mark
Published: October 2020

Allelopathy (i.e. chemical interactions between plants) is known to affect individual performance, community structure and plant invasions. Yet, a quantitative synthesis is lacking. Here, we performed a meta‐analysis of 384 studies that measured allelopathic effects of one species (allelopathy plant) on another species or itself (test plant). Overall, allelopathy reduced plant performance by 25%, but the variation in allelopathy was high. The type of method affected the allelopathic effect: compared to leachates, allelopathy was more negative when residues of allelopathy plants were applied, and less negative when soil conditioned by allelopathy plants was applied. The negative effects of allelopathy diminished with study duration, and increased with concentrations of leachates or residues. Although allelopathy was not significantly related to lifespan, life form or domestication of the interacting plants, it became more negative with increasing phylogenetic distance. Moreover, native plants suffered more from leachates of naturalised alien plants than from leachates of other native plants. Our synthesis reveals that allelopathy could contribute to success of alien plants. The negative relationship between phylogenetic distance and allelopathy indicates that allelopathy might contribute to coexistence of closely related species (i.e. convergence) or dominance of single species.
Whispering dysphonia in TUBB4A‐related disorders responsive to bipallidal deep brain stimulation
Authors: Delorme Cécile , Roze Emmanuel , Karachi Carine , Vidailhet Marie , Hainque Elodie
Published: October 2020

Background

Mutations in TUBB4A are associated with a wide phenotypic spectrum including generalized dystonia with whispering dysphonia (DYT‐TUBB4A).

Methods

We report the case of a 44‐year‐old patient with DYT‐TUBB4A with a clinical presentation of disabling progressive dystonia, with a prominent laryngeal, cervical and facial involvement.

Results

Bipallidal deep brain stimulation (DBS) resulted in a 55% reduction of dystonia severity assessed by the Burke–Fahn−Marsden scale score 6 months after surgery. The effect was obvious on the cervical and facial components of dystonia.

Conclusion

We suggest that bipallidal DBS should be considered in patients with disabling dystonia related to TUBB4A variants.
Institutional investor sentiment and aggregate stock returns
Authors: Gao Xiang , Gu Chen , Koedijk Kees
Published: October 2020

This paper examines the equity market return predictability of institutional investor sentiment, in comparison to individual investor sentiment. Our findings suggest that institutional traders are informed and that their sentiment helps to tilt stock prices towards the intrinsic value. This is because the sentiment of institutions encompasses news regarding expectations on future cash flows of underlying firms that impounds itself into future price expectations. In this study, we add to the large number of studies that investigate the role and implications of investor sentiment, which has long been viewed as a pure behavioural phenomenon, on market efficiency and price discovery.
A global analysis of complexity–biodiversity relationships on marine artificial structures
Authors: Strain Elisabeth M. A. , Steinberg Peter D. , Vozzo Maria , Johnston Emma L. , Abbiati Marco , Aguilera Moises A. , Airoldi Laura , Aguirre J. David , Ashton Gail , Bernardi Maritina , Brooks Paul , Chan Benny K. K. , Cheah Chee B. , Chee Su Yin , Coutinho Ricardo , Crowe Tasman , Davey Adam , Firth Louise B. , Fraser Clarissa , Hanley Mick E. , Hawkins Stephen J. , Knick Kathleen E. , Lau Edward T. C. , Leung Kenneth M. Y. , McKenzie Connor , Macleod Catriona , Mafanya Sandisiwe , Mancuso Francesco P. , Messano Luciana V. R. , Naval‐Xavier Lais P. D. , Ng Terrence P. T. , O'Shaughnessy Kathryn A. , Pattrick Paula , Perkins Mathew J. , Perkol‐Finkel Shimrit , Porri Francesca , Ross Donald J. , Ruiz Gregory , Sella Ido , Seitz Rochelle , Shirazi Raviv , Thiel Martin , Thompson Richard C. , Yee Jean C. , Zabin Chela , Bishop Melanie J.
Published: October 2020

Aim

Topographic complexity is widely accepted as a key driver of biodiversity, but at the patch‐scale, complexity–biodiversity relationships may vary spatially and temporally according to the environmental stressors complexity mitigates, and the species richness and identity of potential colonists. Using a manipulative experiment, we assessed spatial variation in patch‐scale effects of complexity on intertidal biodiversity.

Location

27 sites within 14 estuaries/bays distributed globally.

Time period

2015–2017.

Major taxa studied

Functional groups of algae, sessile and mobile invertebrates.

Methods

Concrete tiles of differing complexity (flat; 2.5‐cm or 5‐cm complex) were affixed at low–high intertidal elevation on coastal defence structures, and the richness and abundance of the colonizing taxa were quantified after 12 months.

Results

The patch‐scale effects of complexity varied spatially and among functional groups. Complexity had neutral to positive effects on total, invertebrate and algal taxa richness, and invertebrate abundances. However, effects on the abundance of algae ranged from positive to negative, depending on location and functional group. The tidal elevation at which tiles were placed accounted for some variation. The total and invertebrate richness were greater at low or mid than at high intertidal elevations. Latitude was also an important source of spatial variation, with the effects of complexity on total richness and mobile mollusc abundance greatest at lower latitudes, whilst the cover of sessile invertebrates and sessile molluscs responded most strongly to complexity at higher latitudes.

Conclusions

After 12 months, patch‐scale relationships between biodiversity and habitat complexity were not universally positive. Instead, the relationship varied among functional groups and according to local abiotic and biotic conditions. This result challenges the assumption that effects of complexity on biodiversity are universally positive. The variable effect of complexity has ramifications for community and applied ecology, including eco‐engineering and restoration that seek to bolster biodiversity through the addition of complexity.
Tourmaline Reference Materials for the In Situ Analysis of Oxygen and Lithium Isotope Ratio Compositions
Authors: Wiedenbeck Michael , Trumbull Robert B. , Rosner Martin , Boyce Adrian , Fournelle John H. , Franchi Ian A. , Halama Ralf , Harris Chris , Lacey Jack H. , Marschall Horst , Meixner Anette , Pack Andreas , Pogge von Strandmann Philip A.E. , Spicuzza Michael J. , Valley John W. , Wilke Franziska D.H.
Published: October 2020

Three tourmaline reference materials sourced from the Harvard Mineralogical and Geological Museum (schorl 112566, dravite 108796 and elbaite 98144), which are already widely used for the calibration of in situ boron isotope measurements, are characterised here for their oxygen and lithium isotope compositions. Homogeneity tests by secondary ion mass spectrometry (SIMS) showed that at sub‐nanogram test portion masses, their 18O/16O and 7Li/6Li isotope ratios are constant within ± 0.27‰ and ± 2.2‰ (1s), respectively. The lithium mass fractions of the three materials vary over three orders of magnitude. SIMS homogeneity tests showed variations in 7Li/28Si between 8% and 14% (1s), which provides a measure of the heterogeneity of the Li contents in these three materials. Here, we provide recommended values for δ18O, Δ’17O and δ7Li for the three Harvard tourmaline reference materials based on results from bulk mineral analyses from multiple, independent laboratories using laser‐ and stepwise fluorination gas mass spectrometry (for O), and solution multi‐collector inductively coupled plasma‐mass spectroscopy (for Li). These bulk data also allow us to assess the degree of inter‐laboratory bias that might be present in such data sets. This work also re‐evaluates the major element chemical composition of the materials by electron probe microanalysis and investigates these presence of a chemical matrix effect on SIMS instrumental mass fractionation with regard to δ18O determinations, which was found to be < 1.6‰ between these three materials. The final table presented here provides a summary of the isotope ratio values that we have determined for these three materials. Depending on their starting mass, either 128 or 512 splits have been produced of each material, assuring their availability for many years into the future.
Determining meaningful health‐related quality‐of‐life improvement in persons with haemophilia A using the Haemophilia Quality of Life Questionnaire for Adults (Haem‐A‐QoL)
Authors: von Mackensen Sylvia , Catalani Olivier , Asikanius Elina , Paz‐Priel Ido , Lehle Michaela , Trask Peter
Published: October 2020

Introduction

The Haem‐A‐QoL is frequently utilized in haemophilia clinical trials and captures relevant aspects of disease impact. Thresholds for some domains ‘Physical Health’ (PH), ‘Sports & Leisure’ (S&L) and ‘Total Score’ (TS) have previously been identified to benchmark the amount of change that is meaningful to patients, but not been independently confirmed.

Aim

The objective of this analysis was to determine the clinically important responder (CIR) thresholds for these three domains.

Methods

CIR thresholds in adult persons with haemophilia A (PwHA) enrolled in HAVEN 1, 3 and 4 studies were determined for improvements from baseline to 24 weeks of emicizumab prophylaxis using anchor‐based methodology with the EQ‐5D‐5L as the validated anchor, cumulative distribution functions (CDF) and distribution‐based methodology. The results were compared with previously published thresholds.

Results

At baseline and after 24 weeks of emicizumab prophylaxis, Haem‐A‐QoL data from 241/258 patients were available. Concordance was observed between the Haem‐A‐QoL and EQ‐5D‐5L in patterns of improvement, deterioration or lack of change. CDF estimates of the Haem‐A‐QoL PH and TS grouped by response categories on the Mobility, Pain/Discomfort and Usual Activities EQ‐5D‐5L domains demonstrated the same pattern of responses to each scale; distribution‐based estimates were 11.9 for PH, 13.9 for S&L, and 8.3 for TS.

Conclusion

Our responder thresholds are mostly consistent with those proposed by Wyrwich et al (cut‐offs of −10 and −7 for PH and TS, respectively). The majority of responders to emicizumab prophylaxis had improvements greater than the previously reported 10‐point reduction in PH and 7‐point reduction in TS.
Cardiovascular outcome and home blood pressure in relation to silent myocardial ischemia in a clinical population: The J‐HOP study
Authors: Shimizu Hayato , Hoshide Satoshi , Kanegae Hiroshi , Kario Kazuomi
Published: October 2020

Several guidelines recommend measuring home blood pressure (BP) and lowering blood pressure than ever before. But several studies reported that lowering diastolic blood pressure (DBP) increased the incidence of coronary artery disease (CAD). We analyzed 3605 individuals who underwent both home and office BP monitoring over 14 days and baseline Hs‐cTnT measurement and identified follow‐up data of the Japan Morning Surge‐Home Blood Pressure (J‐HOP) study who had a history of or risk factors for cardiovascular disease. During a mean follow‐up period of 6.4 years (23 173 person‐years), 114 coronary artery disease and 81 stroke events occurred. Elevated Hs‐cTnT (≥0.014 ng/mL) was observed in 298 patients (8.3%). In the group with non‐elevated Hs‐cTnT (<0.014 ng/mL, n = 3307), an adjusted Cox hazard model showed that home systolic BP (SBP) was associated with a risk of stroke incidence (hazard ratio [HR] per 1 SD, 1.62; 95% confidence interval [CI], 1.29‐2.03). This association was also observed in office SBP (HR per 1 SD, 1.43; 95%CI, 1.07‐1.91). There was no association between office or home BP and CAD events in the group with non‐elevated Hs‐cTnT. In the group with elevated Hs‐cTnT, an adjusted Cox hazard model showed that home DBP was associated with a risk of CAD incidence (HR per 1 SD, 0.54; 95%CI, 0.30‐0.99). However, this association was not observed in office DBP. In patients with elevated Hs‐cTnT, which is a marker of subclinical myocardial ischemia, excessive lowering of home DBP may be associated with a risk of incident CAD.
Mediation effect of the duration of diabetes mellitus on the decrease in bioimpedance phase angles in ethnically Korean people: A multicenter clinical study
Authors: Jun Min‐Ho , Ku Boncho , Kim Jihye , Kim Keun Ho , Kim Jaeuk U
Published: October 2020

Aims/Introduction

We carried out a multicenter clinical study to investigate whether the decrease in segmental phase angles (PhA values) observed using bioelectrical impedance is useful in screening for diabetes mellitus and monitoring disease progression.

Materials and Methods

The segmental PhA values of the four limbs were acquired using multifrequency bioimpedance at 5, 50 and 250 kHz in three clinics. Differences in PhA values between the diabetes and control groups were analyzed using the two‐sample t‐test and analysis of variance (anova). Changes in PhA values with increasing durations of diabetes were analyzed using a moderated mediation model and multivariate linear regression analysis. We recruited 217 participants aged ≥40 years (diabetes 158, controls 59, men 106, women 111, A‐clinic 71, B‐clinic 70 and C‐clinic 76).

Results

PhA values at 50 kHz were significantly decreased in people with diabetes (PhA of the right arm in men: t‐value −4.0, P < 0.001; PhA of the right leg in women: t‐value −4.6 P < 0.001), and the difference was partially attributable to the duration of diabetes, as well as aging. Specifically, the mediation effect of the duration of diabetes on the decrease in PhA values was 29.8% in the left arm of men, 53.3% in the right arm of women, and 36.3% in the left arm of both sexes.

Conclusions

Phase angle values at 50 kHz decreased in people with diabetes, and the changes were exacerbated as the disease duration increased. Thus, bioimpedance PhA values represent a non‐invasive tool for monitoring the progression of diabetes mellitus.
The effects of environmental factors on the prevalence and diversity of bacteriophages lytic against the top six non‐O157 Shiga toxin‐producing Escherichia coli on an organic farm
Authors: Liao Yen‐Te , Lavenburg Valerie M. , Lennon Marion , Salvador Alexandra , Hsu Angeline L. , Wu Vivian C. H.
Published: October 2020

Bacteriophages (or phages) specific to Shiga toxin‐producing Escherichia coli (STEC) strains are frequently isolated from animal‐associated environments primarily because ruminant animals are the natural reservoir of STEC. However, little is known about these phages in produce‐growing environments. The objective of this study was to determine the effects of environmental factors on the prevalence of the phages lytic against O157 and the top six non‐O157 STEC on an organic farm. A total of 370 samples were collected from an organic farm, containing animal‐active and produce‐growing areas, for 1 year. A bacterial cocktail, including nonpathogenic and pathogenic E. coli strains, was used for phage isolation. Meanwhile, culture methods and PCR were used to isolate STEC strains. Weather information was also collected for each sampling trip. Twenty‐eight samples contained phages lytic against STEC (or STEC‐infecting phages), of which 26 were collected from the animal‐active area. Moreover, the winter season had a higher phage prevalence than other seasons, likely due to high rain precipitation. The phages belonging to the Myoviridae family and those lytic against STEC O103 were the most prevalent. One E. coli O103:H2 was isolated from a water sample where no STEC O103‐infecting phages were found. Additionally, no STEC O103 was present in the samples containing STEC O103‐infecting phages. The findings indicate that animal is the primary factor contributing to the prevalence of the STEC‐infecting phages in the surrounding environment of the organic farm, and the presence of these phages contributes to a negative correlation with their STEC hosts.
Effect of prucalopride on sildenafil‐induced inhibition of esophageal peristalsis in healthy adults
Authors: Wong Ming‐Wun , Liu Tso‐Tsai , Yi Chih‐Hsun , Hung Jui‐Sheng , Lei Wei‐Yi , Liang Shu‐Wei , Orr William C , Chen Chien‐Lin
Published: October 2020

Background and Aim

Prucalopride, a high‐affinity 5‐hydroxytryptamine 4 receptor agonist, promotes esophageal peristalsis, while phosphodiesterase type 5 inhibitor sildenafil inhibits esophageal peristalsis. The present study was aimed to evaluate whether prucalopride would augment esophageal peristalsis subsequent to the application of sildenafil.

Methods

Seventeen healthy adults underwent high‐resolution manometry by a catheter with one injection port located in the mid‐esophagus. Secondary peristalsis was assessed by rapid air injections after water swallows. Two sessions were randomly performed including acute administration of sildenafil 50 mg after pretreatment with prucalopride or the placebo.

Results

The frequency of primary peristalsis subsequent to the administration of sildenafil was significantly increased by prucalopride (P = 0.02). Prucalopride also significantly increased distal contractile integral of primary peristalsis subsequent to the administration of sildenafil (P = 0.03). No difference in the frequency of secondary peristalsis subsequent to the administration of sildenafil for air injects of 10 mL (P = 0.14) or 20 mL (P = 0.21) was found between prucalopride and placebo. Prucalopride did not change distal contractile integral of secondary peristalsis subsequent to the administration of sildenafil for air injections of 10 mL (P = 0.09) or 20 mL (P = 0.12).

Conclusions

Prucalopride modulates sildenafil‐induced inhibition of primary peristalsis by increasing its effectiveness and peristaltic wave amplitude. Our findings suggest that activation of 5‐hydroxytryptamine 4 receptors plays a role in mediating sildenafil‐induced inhibition of esophageal primary peristalsis rather than secondary peristalsis.
Shamanic Tourism in the Peruvian Lowlands: Critical and Ethical Considerations
Authors: Fotiou Evgenia
Published: October 2020

This article examines the phenomenon of shamanic tourism, which began in Amazonia in the 1980s. The author has researched the phenomenon since the early 2000s—while it was still at its infancy—in Iquitos, Peru, which is today considered the mecca of shamanic tourism. Contemporary Amazonian shamanism emerged as a response to the violent and disruptive process of the rubber boom; however, in the context of tourism, it is viewed as the healing force for bodily and mental ailments that stem from what is perceived as the West's spiritual impoverishment. The article reviews the phenomenon of shamanic tourism and the challenges it presents in the 21st century, situating it within larger scholarly conversations on ethnic tourism and cultural appropriation. Finally, potential avenues for future research are presented.