bluuebunny/crossref_metadata_2025 huggingface dataset:
Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: a cluster randomized controlled trial study protocol
Authors: Aifah Angela A. , Odubela Oluwatosin , Rakhra Ashlin , Onakomaiya Deborah , Hu Jiyuan , Nwaozuru Ucheoma , Oladele David A. , Odusola Aina Olufemi , Idigbe Ifeoma , Musa Adesola Z. , Akere Ayodeji , Tayo Bamidele , Ogedegbe Gbenga , Iwelunmor Juliet , Ezechi Oliver
Published: November 2021

Background

In regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, Nigeria.

Design

Guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: (1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; (2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and (3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses.

Discussion

This study is one of few, if any trials, to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, system-level hypertension control intervention into HIV care and treatment.

Trial registration

ClinicalTrials.gov (NCT04704336). Registered on 11 January 2021.
Simultaneous radiosurgery for multiple brain metastases: technical overview of the UCLA experience
Authors: Agazaryan Nzhde , Tenn Steve , Lee Chul , Steinberg Michael , Hegde John , Chin Robert , Pouratian Nader , Yang Isaac , Kim Won , Kaprealian Tania
Published: November 2021

Purpose/objective(s)

To communicate our institutional experience with single isocenter radiosurgery treatments for multiple brain metastases, including challenges with determining planning target volume (PTV) margins and resulting consequences, image-guidance translational and rotational tolerances, intra-fraction patient motion, and prescription considerations with larger PTV margins.

Materials/methods

Eight patient treatments with 51 targets were planned with various margins using Elements Multiple Brain Mets SRS treatment planning software (Brainlab, Munich, Germany). Forty-eight plans with 0 mm, 1 mm and 2 mm margins were created, including plans with variable margins, where targets more than 6 cm away from the isocenter were planned with larger margins. The dosimetric impact of the margins were analyzed with V5Gy, V8Gy, V10Gy, V12Gy values. Additionally, 12 patient motion data were analyzed to determine both the impact of the repositioning threshold and the distributions of the patient translational and rotational movements.

Results

The V5Gy, V8Gy, V10Gy, V12Gy volumes approximately doubled when margins change from 0 to 1 mm and tripled when change from 0 to 2 mm. With variable margins, the aggregated results are similar to results from plans using the lower of two margins, since only 12.2% of the targets were more than 6 cm away from the isocenter. With 0.5 mm re-positioning threshold, 57.4% of the time the patients are repositioned. Reducing the threshold to 0.25 mm results in 91.7% repositioning rate, due to limitations of the fusion algorithm and actual patient motion. The 90th percentile of translational movements in all directions is 0.7 mm, while the 90th percentile of rotational movements in all directions is 0.6 degrees. Median translations and rotations are 0.2 mm and 0.2 degrees, respectively.

Conclusions

Based on the data presented, we have switched our modus operandi from 2 to 1 mm PTV margins, with an eventual goal of using 0.5 and 1.0 mm variable margins when an automated margin assignment method becomes available. The 0.5 mm and 0.5 degrees repositioning thresholds are clinically appropriate with small residual patient movements.
The effect of self-reported knee instability on plantar pressure and postural sways in women with knee osteoarthritis
Authors: Chaharmahali Liana , Gandomi Farzaneh , Yalfani Ali , Fazaeli Alireza
Published: November 2021

Background

Giving way and knee instability are common problems in patients with knee osteoarthritis, disrupting the daily activities and balance of the affected individual. The present study aimed to evaluate the postural control status of women with knee osteoarthritis with and without self-report knee instability (KI).

Methods

This cross-sectional, single-blind study was conducted on 57 female patients with knee osteoarthritis. The patients were selected based on the inclusion and exclusion criteria and divided into two groups of with KI (n = 26) and without KI (n = 31). Fear of movement was assessed using the Tampa questionnaire, the degree of knee instability was measured based on the Fitzgard scale, the static and dynamic balance of the subjects were evaluated with open and closed eyes using a Biodex balance device, and foot pressure distribution situation was measured using a FDM-S-Zebris device.

Results

Mean comparison showed a significant difference between the subjects with and without KI in static balance only in anterior–posterior direction with open eyes (p = 0.01) and closed eyes (p = 0.0001). In the dynamic balance test, the subjects in both groups had significant differences in terms of all the indicators of anterior–posterior stability (p = 0.001), medial–lateral stability (p = 0.0001), and overall stability (p = 0.0001) with closed eyes. However, no significant difference was observed with open eyes (p > 0.05). Multiple regression also indicated significant positive correlations between pain intensity and disease duration with the degree of KI (p < 0.05).

Conclusions

According to the results, there were significant differences between the mean pain scores, static and dynamic balance, and the rate of fall between the women with knee osteoarthritis with and without the KI index. Therefore, patients with knee osteoarthritis, which also has an index of KI, are more susceptible to falls, and proper strategies are required to reduce the level of KI in these patients.
Evaluating Diuretics in Normal Care (EVIDENCE): protocol of a cluster randomised controlled equivalence trial of prescribing policy to compare the effectiveness of thiazide-type diuretics in hypertension
Authors: Rogers Amy , Flynn Angela , Mackenzie Isla S. , McConnachie Lewis , Barr Rebecca , Flynn Robert W. V. , Morant Steve , MacDonald Thomas M. , Doney Alexander
Published: November 2021

Introduction

Healthcare systems must use treatments that are effective and safe. Regulators licensed many currently used older medications before introducing the stringent evidential requirements imposed on modern treatments. Also, there has been little encouragement to carry out within-class, head-to-head comparisons of licensed medicines. For commonly prescribed drugs, even small differences in effectiveness or safety could have significant public health implications. However, conventional clinical trials that randomise individual subjects are costly and unwieldy. Such trials are also often criticised as having low external validity. We describe an approach to rapidly generate externally valid evidence of comparative safety and effectiveness using the example of two widely used diuretics for the management of hypertension.

Methods and analysis

The EVIDENCE (Evaluating Diuretics in Normal Care) study has a prospective, cluster-randomised, open-label, blinded end-point design. By randomising prescribing policy in primary care practices, the study compares the safety and effectiveness of commonly used diuretics in treating hypertension. Participating practices are randomised 1:1 to a policy of prescribing either indapamide or bendroflumethiazide when clinically indicated. Suitable patients who are not already taking the policy diuretic are switched accordingly. All patients taking the study medications are written to explaining the rationale for changing the prescribing policy and notifying them they can opt-out of any switch. The prescribing policies’ effectiveness and safety will be compared using rates of major adverse cardiovascular events (hospitalisation with myocardial infarction, heart failure or stroke or cardiovascular death), routinely collected in national healthcare administrative datasets. The study will seek to recruit 250 practices to provide a study population of approximately 50,000 individuals with a mean follow-up time of two years. A primary intention-to-treat time-to-event analysis will be used to estimate the relative effect of the two policies.

Ethics and dissemination

EVIDENCE has been approved by the East of Scotland Research Ethics Service (17/ES/0016, current approved protocol version 5, 26 August 2021). The results will be disseminated widely in peer reviewed journals, guideline committees, National Health Service (NHS) organisations and patient groups.

Trial registration

ISRCTN46635087. Registered on 11 August 2017 (pre-recruitment).
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
Authors: Swanson Matthew J. , Johnston James L. , Ross Joseph S.
Published: November 2021

Background

Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA)-approved medical devices. The purpose of this study is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (class III) cardiovascular devices before and after the FDA Amendment Act (FDAAA) was enacted in 2007.

Methods

Using publicly available data from ClinicalTrials.gov, FDA summaries, and PubMed, we determined registration, publication, and reporting of findings for all pivotal clinical studies supporting FDA approval of new high-risk cardiovascular devices between 2005 and 2020, before and after FDAAA. For published studies, we compared both the primary efficacy outcome with the FDA’s Premarket Approval (PMA) primary efficacy outcome and the published interpretation of findings with the FDA reviewer’s interpretation (positive, equivocal, or negative).

Results

Between 2005 and 2020, the FDA approved 156 high-risk cardiovascular devices on the basis of 165 pivotal trials, 48 (29%) of which were categorized as pre-FDAAA and 117 (71%) as post-FDAAA. Post-FDAAA, pivotal clinical trials were more likely to be registered (115 of 117 (98%) vs 24 of 48 (50%); p < 0.001), to report results (98 of 117 (87%) vs 7 of 48 (15%); p < 0.001) on ClinicalTrials.gov, and to be published (100 or 117 (85%) vs 28 of 48 (58%); p < 0.001) in peer-reviewed literature when compared to pre-FDAAA. Among published trials, rates of concordant primary efficacy outcome reporting were not significantly different between pre-FDAAA trials and post-FDAAA trials (24 of 28 (86%) vs 96 of 100 (96%); p = 0.07), nor were rates of concordant trial interpretation (27 of 28 (96%) vs 93 of 100 (93%); p = 0.44).

Conclusions

FDAAA was associated with increased registration, result reporting, and publication for trials supporting FDA approval of high-risk medical devices. Among published trials, rates of accurate primary efficacy outcome reporting and trial interpretation were high and no different post-FDAAA.
Pediculus humanus capitis: a study of the male genitalia using a combined stereoscopic, confocal laser scanning, and scanning electron microscopy approach
Authors: Álvarez-Fernández Blanca E. , Morales-Suárez-Varela María , Nogueda-Torres Benjamín , Valero M. Adela
Published: November 2021

Background

The male genital structures of arthropods are key features in the taxonomic and phylogenetic study of these organisms. The male genitalia of the head lousePediculus humanus capitisare complex organs which are partly composed of structures that dynamically extrude during copulation.

Methods

Here, we describe the morphology of the genitalia ofP. humanus capitisat the copulation stage, and at rest, by using stereoscopic microscopy, confocal laser scanning microscopy (CLSM), and scanning electron microscopy (SEM).

Results

CLSM and SEM images revealed that the vesica is composed of two distinct anatomical parts, the proximal lobe and the distal lobe. Both lobes have short and narrow spines, as well as long and wide scales with either sharp or rounded tips. The rounded scales vary in size and have a wavy base and rounded tips, and thus resemble a tongue in appearance. We identified a gland-like area on the penis with 11 shallow circular depressions, and a flat area with 14–16 exit orifices. The apical end of the penis has a foliaceous trifurcation and serves to expel the contents of the ejaculatory duct. These characteristics were recorded for all the specimens analyzed, indicating that these structures are highly conserved; to our knowledge, they have not been previously reported for any suborder of lice.

Conclusions

To the best of our knowledge, our results reveal for the first time the morphological details, and complexity, of the male genitalia of the head louseP. humanus capitisat different stages of copulation. The new approach described here provided information that should be taken into consideration in future research on the genitalia of lice. Application of this approach will also impact the taxonomic and phylogenetic study of other insect taxa.

Graphical Abstract
Acaricidal efficacy of ultraviolet-C irradiation of Tetranychus urticae adults and eggs using a pulsed krypton fluoride excimer laser
Authors: Gala Jean-Luc , Rebane Ott , Ambroise Jérôme , Babichenko Sergey , Nyabi Omar , Hance Thierry
Published: November 2021

Background

Pulsed ultraviolet (UV)-C light sources, such as excimer lasers, are used in emerging non-thermal food-decontamination methods and also have high potential for use in a wide range of microbial decontamination applications. The acaricidal effect of an experimental UV-C irradiation device was assessed using female adults and eggs of a model organism, the two-spotted spider miteTetranychus urticae.

Methods

UV-C light was generated by a pulsed krypton fluoride excimer laser operating at 248-nm emission wavelength. The pulse energy and pulse repetition rate were 5 mJ and up to 100 Hz, respectively. The distance from the light source to the target was 150 mm; the target surface area was 2.16 cm2. The exposure time for the mites and fresh eggs varied from 1 to 4 min at 5–300 mW, which corresponded to UV doses of 5–80 kJ/m2. Post-irradiation acaricidal effects (mite mortality) were assessed immediately and also measured at 24 h. The effects of UV-C irradiation on the hatchability of eggs were observed daily for up to 12 days post-irradiation.

Results

The mortality of mites at 5 and 40 kJ/m2was 26% and 92%, respectively. Mite mortality reached 98% at 80 kJ/m2. The effect of exposure duration on mortality was minimal. The effect of irradiation on egg hatchability was even more significant than that on adult mite mortality, i.e. about 100% egg mortality at an accumulated dose of as little as 5 kJ/m2for each exposure time.

Conclusions

A high rate of mite mortality and lethal egg damage were observed after less than 1 min of exposure to 5 mJ UV-C pulsed irradiation at 60 Hz. Pending further developments (such as beam steering, beam shaping and miniaturisation) and feasibility studies (such as testing with mites in real-life situations), the reported results and characteristics of the UV-C generator (modulation of energy output and adaptability to varying spot sizes) open up the use of this technology for a vast field of acaricidal applications that require long-range radiation.

Graphical Abstract
Evaluating the potential for respiratory metagenomics to improve treatment of secondary infection and detection of nosocomial transmission on expanded COVID-19 intensive care units
Authors: Charalampous Themoula , Alcolea-Medina Adela , Snell Luke B. , Williams Tom G. S. , Batra Rahul , Alder Christopher , Telatin Andrea , Camporota Luigi , Meadows Christopher I. S. , Wyncoll Duncan , Barrett Nicholas A. , Hemsley Carolyn J. , Bryan Lisa , Newsholme William , Boyd Sara E. , Green Anna , Mahadeva Ula , Patel Amita , Cliff Penelope R. , Page Andrew J. , O’Grady Justin , Edgeworth Jonathan D.
Published: November 2021

Background

Clinical metagenomics (CMg) has the potential to be translated from a research tool into routine service to improve antimicrobial treatment and infection control decisions. The SARS-CoV-2 pandemic provides added impetus to realise these benefits, given the increased risk of secondary infection and nosocomial transmission of multi-drug-resistant (MDR) pathogens linked with the expansion of critical care capacity.

Methods

CMg using nanopore sequencing was evaluated in a proof-of-concept study on 43 respiratory samples from 34 intubated patients across seven intensive care units (ICUs) over a 9-week period during the first COVID-19 pandemic wave.

Results

An 8-h CMg workflow was 92% sensitive (95% CI, 75–99%) and 82% specific (95% CI, 57–96%) for bacterial identification based on culture-positive and culture-negative samples, respectively. CMg sequencing reported the presence or absence of β-lactam-resistant genes carried by Enterobacterales that would modify the initial guideline-recommended antibiotics in every case. CMg was also 100% concordant with quantitative PCR for detecting Aspergillus fumigatus from 4 positive and 39 negative samples. Molecular typing using 24-h sequencing data identified an MDR-K. pneumoniae ST307 outbreak involving 4 patients and an MDR-C. striatum outbreak involving 14 patients across three ICUs.

Conclusion

CMg testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance. The provision of this technology in a service setting could fundamentally change the multi-disciplinary team approach to managing ICU infections. The potential to improve the initial targeted treatment and rapidly detect unsuspected outbreaks of MDR-pathogens justifies further expedited clinical assessment of CMg.
Pneumonic-type lung adenocarcinoma with different ranges exhibiting different clinical, imaging, and pathological characteristics
Authors: Huo Ji-wen , Huang Xing-tao , Li Xian , Gong Jun-wei , Luo Tian-you , Li Qi
Published: November 2021

Background

Pneumonic-type lung adenocarcinoma (PLADC) with different ranges might exhibit different imaging and clinicopathological features. This study divided PLADC into localized PLADC (L-PLADC) and diffuse PLADC (D-PLADC) based on imaging and aimed to clarify the differences in clinical, imaging, and pathologic characteristics between the two new subtypes.

Results

The data of 131 patients with L-PLADC and 117 patients with D-PLADC who were pathologically confirmed and underwent chest computed tomography (CT) at our institute from December 2014 to December 2020 were retrospectively collected. Patients with L-PLADC were predominantly female, non-smokers, and without respiratory symptoms and elevated white blood cell count and C-reactive protein level, whereas those with D-PLADC were predominantly male, smokers, and had respiratory symptoms and elevated white blood cell count and C-reactive protein level (all p < 0.05). Pleural retraction was more common in L-PLADC, whereas interlobular fissure bulging, hypodense sign, air space, CT angiogram sign, coexisting nodules, pleural effusion, and lymphadenopathy were more frequent in D-PLADC (all p < 0.001). Among the 129 patients with surgically resected PLADC, the most common histological subtype of L-PLADC was acinar-predominant growth pattern (76.7%, 79/103), whereas that of D-PLADC was invasive mucinous adenocarcinoma (80.8%, 21/26). Among the 136 patients with EGFR mutation status, L-PLADC had a significantly higher EGFR mutation rate than D-PLADC (p < 0.001).

Conclusions

L-PLADC and D-PLADC have different clinical, imaging, and pathological characteristics. This new imaging-based classification may help improve our understanding of PLADC and develop personalized treatment plans, with concomitant implications for patient outcomes.
Existence of positive solutions for a system of nonlinear Caputo type fractional differential equations with two parameters
Authors: Chen Yang , Li Hongyu
Published: November 2021

The main purpose of this paper is to prove the existence of positive solutions for a system of nonlinear Caputo-type fractional differential equations with two parameters. By using the Guo–Krasnosel’skii fixed point theorem, some existence theorems of positive solutions are obtained in terms of different values of parameters. Two examples are given to illustrate the main results.
The German research consortium for the study of bipolar disorder (BipoLife): a magnetic resonance imaging study protocol
Authors: Vogelbacher Christoph , Sommer Jens , Schuster Verena , Bopp Miriam H. A. , Falkenberg Irina , Ritter Philipp S. , Bermpohl Felix , Hindi Attar Catherine , Rauer Lisa , Einenkel Karolin E. , Treutlein Jens , Gruber Oliver , Juckel Georg , Flasbeck Vera , Mulert Christoph , Hautzinger Martin , Pfennig Andrea , Matura Silke , Reif Andreas , Grotegerd Dominik , Dannlowski Udo , Kircher Tilo , Bauer Michael , Jansen Andreas
Published: November 2021

Background

Bipolar disorder is one of the most severe mental disorders. Its chronic course is associated with high rates of morbidity and mortality, a high risk of suicide and poor social and occupational outcomes. Despite the great advances over the last decades in understanding mental disorders, the mechanisms underlying bipolar disorder at the neural network level still remain elusive. This has severe consequences for clinical practice, for instance by inadequate diagnoses or delayed treatments. The German research consortium BipoLife aims to shed light on the mechanisms underlying bipolar disorders. It was established in 2015 and incorporates ten university hospitals across Germany. Its research projects focus in particular on individuals at high risk of bipolar disorder, young patients in the early stages of the disease and patients with an unstable highly relapsing course and/or with acute suicidal ideation.

Methods

Functional and structural magnetic resonance imaging (MRI) data was acquired across nine sites within three different studies. Obtaining neuroimaging data in a multicenter setting requires among others the harmonization of the acquisition protocol, the standardization of paradigms and the implementation of regular quality control procedures. The present article outlines the MRI imaging protocols, the acquisition parameters, the imaging paradigms, the neuroimaging quality assessment procedures and the number of recruited subjects.

Discussion

The careful implementation of a MRI study protocol as well as the adherence to well-defined quality assessment procedures is one key benchmark in the evaluation of the overall quality of large-scale multicenter imaging studies. This article contributes to the BipoLife project by outlining the rationale and the design of the MRI study protocol. It helps to set the necessary standards for follow-up analyses and provides the technical details for an in-depth understanding of follow-up publications.
The sensory-reactivity PROM set: identification of a parent reported outcome measure set for autism spectrum disorder
Authors: van Andel Dorinde M. , van Stel Henk F. , Scheepers Floortje E. , Oostrom Kim J. , Haverman Lotte , Bruining Hilgo
Published: November 2021

Background

Most children with autism spectrum disorder (ASD) suffer from aberrant responses to sensory stimuli that significantly impact the quality of life. To develop sensory interventions, individually tailored outcome measures are crucially needed for the domain of sensory reactivity problems. Here, we describe the identification of relevant sensory themes according to caregivers of children with ASD according to the guidelines for developing a (parent proxy) patient-reported outcome measure set. Subsequently, we identify parallels between these themes and a well-validated and supported PROMIS® portal to facilitate implementation. Interviews with clinicians and focus groups and interviews with parents of children with ASD were used in the initial phase for concept elicitation. Codes and themes were generated by qualitative thematic data analysis on the transcripts and cognitive interviews with different parents were used for revisions. The resulting themes were compared to existing generic PROMIS-item banks and other existing questionnaires.

Results

A total of 11 parent-reported outcomes were identified that could be either classified as directly or indirectly related to sensory reactivity. Directly related themes comprised of: (1) sensory stimulation tolerance and (2) sensitivity to sensory stimuli. Indirectly related themes were: (3) irritable behavior (4) anxiety problems (5) mood problems (6) sleep problems (7) fatigue (8) physical complaints (9) daily functioning and participation (10) routines, structure and dealing with change and (11) problems in social interaction and communication. Seven out of 11 themes could be measured with generic PROMIS item banks. The four remaining outcomes (sensory stimulation tolerance; irritable behaviour; routines, structure and dealing with change; and sensitivity to sensory stimuli) were found suitable to be inventoried by existing PROMs.

Conclusion

The majority of parent-reported problems seemed related to indirect consequences of sensory reactivity, which are suitable to be measured with generic item banks. In sum, we identified a sensory-reactivity PROM (parent-proxy) set consisting of PROMIS® item banks and additional domains that together form a comprehensive and readily available outcome set for sensory reactivity problems in children with ASD.
Evolution of dental age estimation methods in adults over the years from occlusal wear to more sophisticated recent techniques
Authors: Phulari Rashmi G. S. , Dave Esha J.
Published: November 2021

Background

Age estimation has been an integral part of forensic science, and age estimation by dental means is by far the most commonly employed method. Dental age estimation in children is more accurate and straightforward as most methods use the chronological stages of odontogenesis that are highly systematic, reducing the chances of dispersed results. In contrast, estimation of age in adults becomes tricky and less accurate with varied approaches since tooth formation is already complete.

Main body

The methods of adult dental age estimation have come a long way from a calculated guess based on crude visual observation of teeth to radiological methods and to more recent sophisticated methods. Technological advances have opened up molecular and genetic methods by utilizing DNA methylation and telomere length to improve the accuracy of age estimation by reducing error chances.

Conclusions

Although dental age estimation methods in children and adolescents have been extensively reviewed, various adult age estimation methods are not reviewed as a whole. The aim of this review is to appraise the evolution of dental age estimation methods in adults over the years from mere visualization of dental attrition to employing more sophisticated means such as radioactive carbon dating and genetics. This comprehensive review also attempts to add an account of the accuracy and suitability of various adult dental age estimation methods.
A double-blind placebo-controlled study of brexpiprazole for the treatment of borderline personality disorder
Authors: Grant Jon E. , Valle Stephanie , Chesivoir Eve , Ehsan Dustin , Chamberlain Samuel R.
Published: November 2021

Background

Borderline personality disorder is associated with impaired quality of life and has a number of untoward public health associations. There is no established first-line pharmacological treatment for borderline personality disorder, and available options are not suitable for all individuals.

Aims

To evaluate brexpiprazole, which has effects on the dopaminergic and serotonergic systems, for the reduction of borderline personality disorder symptoms.

Method

Eighty adults with borderline personality disorder were recruited for a randomised, double-blind placebo-controlled study. Participants received 12-week treatment with brexpiprazole (1 mg/day for 1 week, then increasing to 2 mg/day) or placebo in a parallel design. The primary efficacy outcome measure was the clinician-rated Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). Safety data were collected. Effects of active versus placebo treatment were characterised with linear repeated measures models.

Results

There was a significant interaction between treatment and time on the ZAN-BPD scale (P = 0.0031), solely because of differentiation specifically at week 12. Brexpiprazole was generally well tolerated. Secondary measures did not result in statistically significant differences from placebo.

Conclusions

Brexpiprazole appears to have some possible effect on borderline personality disorder symptoms, but further studies are needed because of the significant effects evident, specifically at the final time point. These findings also need to be viewed cautiously, given the small sample size, large drop-out rate and robust placebo response.
Real-World Data on the Prevalence of Anaplastic Lymphoma Kinase–Positive Non–Small-Cell Lung Cancer in the Middle East and North Africa
Authors: Jazieh Abdul Rahman , Gaafar Rabab , Errihani Hassan , Jaafar Hassan , Al Dayel Fouad , Bahnassy Abeer A. , El Kadi Hatem , Abdallah Mohamed Magdy , Zaatari Ghazi
Published: November 2021

PURPOSE

Anaplastic lymphoma kinase ( ALK) gene alterations are potent oncogenic drivers in non–small-cell lung cancer (NSCLC). Tyrosine kinase inhibitors targeting the ALK pathway are effective in treating ALK-positive NSCLC. Around 5% of Asian and White patients with NSCLC have ALK-positive tumors, but ALK rearrangement prevalence data in the Middle East and North Africa (MENA) region are limited.

METHODS

In this noninterventional epidemiology study, histologically confirmed nonsquamous NSCLC samples retained for < 5 years in tissue banks at six centers in MENA were retrospectively analyzed for ALK rearrangement using the VENTANA immunohistochemistry (IHC) method. Patient characteristics obtained were analyzed for association with ALK rearrangement. Concordance between IHC and Vysis fluorescence in situ hybridization (FISH) ALK detection methods was assessed in a subset of samples.

RESULTS

Four hundred forty-eight tissue samples were analyzed using IHC: 137 (30.6%) in Lebanon, 104 (23.2%) in Saudi Arabia, 97 (21.7%) in Egypt, 80 (17.9%) in the United Arab Emirates, and 30 (6.7%) in Morocco. On the basis of IHC, the prevalence was 8.7% (95% CI, 6.3 to 11.7) for ALK-positivity and 91.3% (95% CI, 88.3 to 93.7) for ALK-negativity. On the basis of FISH (n = 148), the prevalence was 5.4% positivity and 81.8% negativity (12.8% nonevaluable). Concordance between IHC and FISH (n = 129) was 98.4% (95% CI, 94.2 to 99.8) for negative agreement and 98.5% (95% CI, 94.5 to 99.8) for overall agreement. Univariate analysis showed that ALK rearrangement was significantly associated with epidermal growth factor receptor wild-type status ( P = .03) but was not significantly associated with sex, race, smoking history, or histologic subtype.

CONCLUSION

Our findings suggest that ALK rearrangements are more prevalent in MENA than other geographic regions. High concordance was found between FISH and IHC. Except for epidermal growth factor receptor wild-type status, no clinicopathologic characteristics were associated with ALK-positive NSCLC.
How Do We Look?
Authors: Rony Fatimah Tobing
Published: November 2021

In How Do We Look? Fatimah Tobing Rony draws on transnational images of Indonesian women as a way to theorize what she calls visual biopolitics—the ways visual representation determines which lives are made to matter more than others. Rony outlines the mechanisms of visual biopolitics by examining Paul Gauguin’s 1893 portrait of Annah la Javanaise—a trafficked thirteen-year-old girl found wandering the streets of Paris—as well as US ethnographic and documentary films. In each instance, the figure of the Indonesian woman is inextricably tied to discourses of primitivism, savagery, colonialism, exoticism, and genocide. Rony also focuses on acts of resistance to visual biopolitics in film, writing, and photography. These works, such as Rachmi Diyah Larasati’s The Dance that Makes You Vanish, Vincent Monnikendam’s Mother Dao (1995), and the collaborative films of Nia Dinata, challenge the naturalized methods of seeing that justify exploitation, dehumanization, and early death of people of color. By theorizing the mechanisms of visual biopolitics, Rony elucidates both its violence and its vulnerability.
Dreams of Flight
Authors: Martin Fran
Published: November 2021

In Dreams of Flight, Fran Martin explores how young Chinese women negotiate competing pressures on their identity while studying abroad. On one hand, unmarried middle-class women in the single-child generations are encouraged to develop themselves as professional human capital through international education, molding themselves into independent, cosmopolitan, career-oriented individuals. On the other, strong neotraditionalist state, social, and familial pressures of the post-Mao era push them back toward marriage and family by age thirty. Martin examines these women’s motivations for studying in Australia and traces their embodied and emotional experiences of urban life, social media worlds, work in low-skilled and professional jobs, romantic relationships, religion, Chinese patriotism, and changed self-understanding after study abroad. Martin illustrates how emerging forms of gender, class, and mobility fundamentally transform the basis of identity for a whole generation of Chinese women.
Single-cell reconstruction with spatial context of migrating neural crest cells and their microenvironments during vertebrate head and neck formation
Authors: Morrison Jason A. , McLennan Rebecca , Teddy Jessica M. , Scott Allison R. , Kasemeier-Kulesa Jennifer C. , Gogol Madelaine M. , Kulesa Paul M.
Published: November 2021

The dynamics of multipotent neural crest cell differentiation and invasion as cells travel throughout the vertebrate embryo remain unclear. Here, we preserve spatial information to derive the transcriptional states of migrating neural crest cells and the cellular landscape of the first four chick cranial to cardiac branchial arches (BA1-4) using label-free, unsorted single-cell RNA sequencing. The faithful capture of branchial arch-specific genes led to identification of novel markers of migrating neural crest cells and 266 invasion genes common to all BA1-4 streams. Perturbation analysis of a small subset of invasion genes and time-lapse imaging identified their functional role to regulate neural crest cell behaviors. Comparison of the neural crest invasion signature to other cell invasion phenomena revealed a shared set of 45 genes, a subset of which showed direct relevance to human neuroblastoma cell lines analyzed after exposure to the in vivo chick embryonic neural crest microenvironment. Our data define an important spatio-temporal reference resource to address patterning of the vertebrate head and neck, and previously unidentified cell invasion genes with the potential for broad impact.
Safety factors as a ‘design’ principle of animal form and function: an historical perspective
Authors: Hicks James W. , Wang Tobias
Published: November 2021

For well over 150 years, factors of safety (also known as safety factors) have been a fundamental engineering concept that expresses how much stronger a system is compared with the intended load. The pioneering work of Robert McNeill Alexander in the early 1980s applied this engineering concept to biomechanics. Over the next decade, evidence from comparative biomechanics supported the idea that safety factors are a fundamental principle of animal form and function. In terms of physiology, Jared Diamond related the maximal capacity of a physiological process to normal functional demands and incorporated evolutionary thinking into the concept of safety factors. It was proposed that evolutionary reasoning is required to understand the magnitudes of biological reserve capacities, an idea called ‘quantitative evolutionary design’. However, the general idea of safety factors as related to organismal form and function is much older. In 1906, Samuel James Meltzer, a physiologist and physician, presented the 5th Harvey Lecture to the New York Academy of Medicine; a lecture entitled ‘The Factors of Safety in Animal Structure and Animal Economy’, which was later published in Science in 1907. The 1907 paper is rarely cited and has never been cited within comparative biomechanics or comparative physiology. The purpose of this Commentary is to highlight Meltzer's historical contribution to the concept of safety factors as a general principle of organismal ‘design’.
Sex differences in behavioural and anatomical estimates of visual acuity in the green swordtail, Xiphophorus helleri
Authors: Caves Eleanor M. , de Busserolles Fanny , Kelley Laura A.
Published: November 2021

Among fishes in the family Poeciliidae, signals such as colour patterns, ornaments and courtship displays play important roles in mate choice and male–male competition. Despite this, visual capabilities in poeciliids are understudied, in particular, visual acuity, the ability to resolve detail. We used three methods to quantify visual acuity in male and female green swordtails (Xiphophorus helleri), a species in which body size and the length of the male's extended caudal fin (‘sword’) serve as assessment signals during mate choice and agonistic encounters. Topographic distribution of retinal ganglion cells (RGCs) was similar in all individuals and was characterized by areas of high cell densities located centro-temporally and nasally, as well as a weak horizontal streak. Based on the peak density of RGCs in the centro-temporal area, anatomical acuity was estimated to be approximately 3 cycles per degree (cpd) in both sexes. However, a behavioural optomotor assay found significantly lower mean acuity in males (0.8 cpd) than females (3.0 cpd), which was not explained by differences in eye size between males and females. An additional behavioural assay, in which we trained individuals to discriminate striped gratings from grey stimuli of the same mean luminance, also showed lower acuity in males (1–2 cpd) than females (2–3 cpd). Thus, although retinal anatomy predicts identical acuity in males and females, two behavioural assays found higher acuity in females than males, a sexual dimorphism that is rare outside of invertebrates. Overall, our results have implications for understanding how poeciliids perceive visual signals during mate choice and agonistic encounters.
Θεωρητική επισκόπηση και εμπειρική αξιολόγηση της Εταιρικής Κοινωνικής Ευθύνης
Authors: Κεφαλλωνίτη Μαρία
Published: November 2021

Η διδακτορική διατριβή μελετά την αιτιώδη συνάφεια μεταξύ της Εταιρικής Κοινωνικής Ευθύνης (ΕΚΕ) και της Οικονομικής Αποδοτικότητας. Συγκεκριμένα, την επιρροή που ασκεί η ΕΚΕ στην Οικονομική Αποδοτικότητα και τον τρόπο άσκησής της.Ακολουθώντας προσεγγίσεις που συναντώνται εκτεταμένα στη διεθνή βιβλιογραφία ως αποτέλεσμα βιβλιογραφικής επισκόπησης και συστηματικής βιβλιογραφικής επισκόπησης, αναπτύσσονται μεθοδολογικές τεχνικές στα πλαίσια των οποίων η ΕΚΕ και η Οικονομική Αποδοτικότητα προσεγγίζονται σε συνδυασμό με τα χαρακτηριστικά των οργανισμών προς ανάλυση.Από τον σκοπό απορρέει το κύριο ερευνητικό ερώτημα, το οποίο είναι σύνθετο και έχει ως εξής: «Η Εταιρική Κοινωνική Ευθύνη επηρεάζει την Οικονομική Αποδοτικότητα ενός οργανισμού και με ποιόν τρόπο; Οι οργανισμοί που εφαρμόζουν εκτεταμένα δράσεις ΕΚΕ έχουν υψηλή Οικονομική Αποδοτικότητα;».Σε συνάρτηση με το ερώτημα αυτό, βασικός στόχος είναι (α) η θεωρητική και μεθοδολογική προσέγγιση της ΕΚΕ σε ένα εκτεταμένο πλαίσιο, λαμβάνοντας υπόψιν τις προεκτάσεις της έννοιας και τις θεωρίες που αναπτύσσονται γύρω από αυτή και (β) η περιγραφή των πλαισίων της εμπειρικής προσέγγισης βάσει της οποίας διαπιστώνεται η κατάσταση που επικρατεί στα ελληνικά δεδομένα.
Scientific Expertise of Profiling Programs: Algorithmization of Students' Success
Authors: Bychkov Anatoliy
Published: November 2021

The goal of modern specialized training is to increase the human potential – the sustainable development of schoolchildren in the process of becoming professional adaptability – the ability to cope with the challenges of civilization and globalization in production activities, the active introduction of students into socio-economic life, the formation of satisfaction with the process and results of training that create a positive attitude as a factor for ensuring life success both during school education and in later life.

Profiling of training is the development of programs aimed at meeting the needs of students in professional self-determination.

Algorithmization of training profiling (building of educational material in a scientifically based sequence) it helps to increase the effectiveness of the educational process aimed at the formation of social and professional success of students.

Scientific expertise of specialized training programs is a mechanism for managing the personal success of students in a specialized school. During the examination, an active qualitative analysis of the didactic materials and educational technologies proposed by the developer takes place, methods of their improvement are recommended. This is the activity essence of pedagogical expertise.
Il Tagikistan sovietico negli scritti di Bruno Jasieński e Ryszard Kapuściński
Authors: Gurgul Monika
Published: November 2021

The political situation in Central Asia involved in the development of European imperialism in the XIX-XX centuries, was reflected by different Polish authors. The article is dedicated to the image of Tajikistan created by Bruno Jasieński and Ryszard Kapuściński in different moments of Soviet domination: the time when the new regime was born, the period of its decline in the ’60s, and during perestroika.
Effects of Social Information on Risk Taking and Performance: Understanding Others’ Decisions vs. Comparing Oneself with Others in Short-Term Performance
Authors: Pittnauer Sabine , Hohnisch Martin , Ostermaier Andreas , Pfingsten Andreas
Published: November 2021

When a problem leaves decision makers uncertain as to how to approach it, observing others’ decisions can improve one’s own decisions by promoting more accurate judgments and a better insight into the problem. However, observing others’ decisions may also activate motives that prevent this potential from being realized, for instance, ego concerns that prompt excessive risk taking. Our experimental study investigates how two features of the social environment influence the effect of observing others’ decisions on individual risk taking and performance. We manipulated (1) the psychological distance to others whose decisions could be observed (and thereby the tendency to seek self-enhancing social comparison) and (2) the opportunity for interaction (and thereby for a cumulative effect of any such tendency on decisions over time and for an effect on social information itself). Because the two features covary in real-world settings, we designed two treatments corresponding to the two natural combinations. Both treatments provided participants with two other participants’ period decisions in a multiperiod problem under uncertainty. No new objective information about the problem could be inferred from these decisions. We predicted that participants who observed the decisions of distant others (who had solved the same problem earlier) would perform better than participants in a control sample without any information about others’ decisions and that participants who observed the decisions of proximal others (with whom interaction could arise) would take more risk and perform worse than those who observed distant others’ decisions. The data corroborate our predictions. We discuss implications for organizational learning.

History: This paper has been accepted for the Organization Science Special Issue on Experiments in Organizational Theory.

Funding: The research was made possible by funding from the Nordrhein-Westfälische Akademie der Wissenschaften und der Künste through the Akademienprogramm of the German Academies of Sciences and Humanities (2006–2015). Hohnisch and Pittnauer gratefully acknowledge funding from the Stiftung der Freunde und Förderer der NRW-Akademie der Wissenschaften und der Künste (2016).

Supplemental Material: The supplemental material is available at https://doi.org/10.1287/orsc.2021.1507 .
Coarse structures on groups defined by conjugations
Authors:   Taras Shevchenko National University of Kyiv, Protasov I. , Protasova K. ,   Taras Shevchenko National University of Kyiv
Published: November 2021

For a group G, we denote by G↔ the coarse space on G endowed with the coarse structure with the base {{(x,y)∈G×G:y∈xF}:F∈[G]<ω}, xF={z−1xz:z∈F}. Our goal is to explore interplays between algebraic properties of G and asymptotic properties of G↔. In particular, we show that asdim G↔=0 if and only if G/ZG is locally finite, ZG is the center of G. For an infinite group G, the coarse space of subgroups of G is discrete if and only if G is a Dedekind group.