bluuebunny/crossref_metadata_2025 huggingface dataset:
Validity, reliability, and calibration of the physical activity unit 7 item screener (PAU-7S) at population scale
Authors: Schröder Helmut , Subirana Isaac , Wärnberg Julia , Medrano María , González-Gross Marcela , Gusi Narcis , Aznar Susana , Alcaraz Pedro E. , González-Valeiro Miguel A. , Serra-Majem Lluis , Terrados Nicolás , Tur Josep A. , Segú Marta , Homs Clara , Garcia-Álvarez Alicia , Benavente-Marín Juan C. , Barón-López F. Javier , Labayen Idoia , Zapico Augusto G. , Sánchez-Gómez Jesús , Jiménez-Zazo Fabio , Marín-Cascales Elena , Sevilla-Sanchez Marta , Herrera-Ramos Estefanía , Pulgar Susana , del Mar Bibiloni María , Sistac-Sorigué Clara , Gómez Santiago F.
Published: July 2021

Background

Validation of self-reported tools, such as physical activity (PA) questionnaires, is crucial. The aim of this study was to determine test-retest reliability, internal consistency, and the concurrent, construct, and predictive validity of the short semi-quantitative Physical Activity Unit 7 item Screener (PAU-7S), using accelerometry as the reference measurement. The effect of linear calibration on PAU-7S validity was tested.

Methods

A randomized sample of 321 healthy children aged 8–16 years (149 boys, 172 girls) from the nationwide representative PASOS study completed the PAU-7S before and after wearing an accelerometer for at least 7 consecutive days. Weight, height, and waist circumference were measured. Cronbach alpha was calculated for internal consistency. Test-retest reliability was determined by intra-class correlation (ICC). Concurrent validity was assessed by ICC and Spearman correlation coefficient between moderate to vigorous PA (MVPA) derived by the PAU-7S and by accelerometer. Concordance between both methods was analyzed by absolute agreement, weighted kappa, and Bland-Altman statistics. Multiple linear regression models were fitted for construct validity and predictive validity was determined by leave-one-out cross-validation.

Results

The PAU-7S overestimated MVPA by 18%, compared to accelerometers (106.5 ± 77.0 vs 95.2 ± 33.2 min/day, respectively). A Cronbach alpha of 0.76 showed an acceptable internal consistency of the PAU-7S. Test-retest reliability was good (ICC 0.71p < 0.001). Spearman correlation and ICC coefficients of MVPA derived by the PAU-7S and accelerometers increased from 0.31 to 0.62 and 0.20 to 0.62, respectively, after calibration of the PAU-7S. Between-methods concordance improved from a weighted kappa of 0.24 to 0.50 after calibration. A slight reduction in ICC, from 0.62 to 0.60, yielded good predictive validity. Multiple linear regression models showed an inverse association of MVPA with standardized body mass index (β − 0.162;p < 0.077) and waist to height ratio (β − 0.010;p < 0.014). All validity dimensions were somewhat stronger in boys compared to girls.

Conclusion

The PAU-7S shows a good test-retest reliability and acceptable internal consistency. All dimensions of validity increased from poor/fair to moderate/good after calibration. The PAU-7S is a valid instrument for measuring MVPA in children and adolescents.

Trial registration

Trial registration numberISRCTN34251612.
GPR110 ligands reduce chronic optic tract gliosis and visual deficit following repetitive mild traumatic brain injury in mice
Authors: Chen Huazhen , Kevala Karl , Aflaki Elma , Marugan Juan , Kim Hee-Yong
Published: July 2021

Background

Repetitive mild traumatic brain injury (mTBI) can result in chronic visual dysfunction. G-protein receptor 110 (GPR110, ADGRF1) is the target receptor of N-docosahexaenoylethanolamine (synaptamide) mediating the anti-neuroinflammatory function of synaptamide. In this study, we evaluated the effect of an endogenous and a synthetic ligand of GPR110, synaptamide and (4Z,7Z,10Z,13Z,16Z,19Z)-N-(2-hydroxy-2-methylpropyl) docosa-4,7,10,13,16,19-hexaenamide (dimethylsynaptamide, A8), on the mTBI-induced long-term optic tract histopathology and visual dysfunction using Closed-Head Impact Model of Engineered Rotational Acceleration (CHIMERA), a clinically relevant model of mTBI.

Methods

The brain injury in wild-type (WT) and GPR110 knockout (KO) mice was induced by CHIMERA applied daily for 3 days, and GPR110 ligands were intraperitoneally injected immediately following each impact. The expression of GPR110 and proinflammatory mediator tumor necrosis factor (TNF) in the brain was measured by using real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) in an acute phase. Chronic inflammatory responses in the optic tract and visual dysfunction were assessed by immunostaining for Iba-1 and GFAP and visual evoked potential (VEP), respectively. The effect of GPR110 ligands in vitro was evaluated by the cyclic adenosine monophosphate (cAMP) production in primary microglia isolated from adult WT or KO mouse brains.

Results

CHIMERA injury acutely upregulated the GPR110 and TNF gene level in mouse brain. Repetitive CHIMERA (rCHIMERA) increased the GFAP and Iba-1 immunostaining of glia cells and silver staining of degenerating axons in the optic tract with significant reduction of N1 amplitude of visual evoked potential at up to 3.5 months after injury. Both GPR110 ligands dose- and GPR110-dependently increased cAMP in cultured primary microglia with A8, a ligand with improved stability, being more effective than synaptamide. Intraperitoneal injection of A8 at 1 mg/kg or synaptamide at 5 mg/kg significantly reduced the acute expression of TNF mRNA in the brain and ameliorated chronic optic tract microgliosis, astrogliosis, and axonal degeneration as well as visual deficit caused by injury in WT but not in GPR110 KO mice.

Conclusion

Our data demonstrate that ligand-induced activation of the GPR110/cAMP system upregulated after injury ameliorates the long-term optic tract histopathology and visual impairment caused by rCHIMERA. Based on the anti-inflammatory nature of GPR110 activation, we suggest that GPR110 ligands may have therapeutic potential for chronic visual dysfunction associated with mTBI.
Intravenous administration of LPS activates the kynurenine pathway in healthy male human subjects: a prospective placebo-controlled cross-over trial
Authors: Millischer Vincent , Heinzl Matthias , Faka Anthi , Resl Michael , Trepci Ada , Klammer Carmen , Egger Margot , Dieplinger Benjamin , Clodi Martin , Schwieler Lilly
Published: July 2021

Background

Administration of lipopolysaccharide (LPS) from Gram-negative bacteria, also known as the human endotoxemia model, is a standardized and safe model of human inflammation. Experimental studies have revealed that peripheral administration of LPS leads to induction of the kynurenine pathway followed by depressive-like behavior and cognitive dysfunction in animals. The aim of the present study is to investigate how acute intravenous LPS administration affects the kynurenine pathway in healthy male human subjects.

Methods

The present study is a prospective, single-blinded, randomized, placebo-controlled cross-over study to investigate the effects of intravenously administered LPS (Escherichia coli O113, 2 ng/kg) on tryptophan and kynurenine metabolites over 48 h and their association with interleukin-6 (IL-6) and C-reactive protein (CRP). The study included 10 healthy, non-smoking men (18–40 years) free from medication. Statistical differences in tryptophan and kynurenine metabolites as well as associations with IL-6 and CRP in LPS and placebo treated subjects were assessed with linear mixed-effects models.

Results

Systemic injection of LPS was associated with significantly lower concentrations of plasma tryptophan and kynurenine after 4 h, as well as higher concentrations of quinolinic acid (QUIN) after 48 h compared to the placebo injection. No differences were found in kynurenic acid (KYNA) or picolinic acid plasma concentrations between LPS or placebo treatment. The KYNA/kynurenine ratio peaked at 6 h post LPS injection while QUIN/kynurenine maintained significantly higher from 3 h post LPS injection until 24 h. The kynurenine/tryptophan ratio was higher at 24 h and 48 h post LPS treatment. Finally, we report an association between the kynurenine/tryptophan ratio and CRP.

Conclusions

Our findings strongly support the concept that an inflammatory challenge with LPS induces the kynurenine pathway in humans, activating both the neurotoxic (QUIN) and neuroprotective (KYNA) branch of the kynurenine pathway.

Trial registration

This study is based on a study registered at ClinicalTrials.gov,NCT03392701. Registered 21 December 2017.
Calcium channel blockers do not protect against saturated fatty acid-induced ER stress and apoptosis in human pancreatic β-cells
Authors: Šrámek Jan , Němcová Vlasta , Kovář Jan
Published: July 2021

It was evidenced that saturated fatty acids (FAs) have a detrimental effect on pancreatic β-cells function and survival, leading to endoplasmic reticulum (ER) calcium release, ER stress, and apoptosis. In the present study, we have tested the effect of three calcium influx inhibitors, i.e., diazoxide, nifedipine, and verapamil, on the apoptosis-inducing effect of saturated stearic acid (SA) in the human pancreatic β-cell lines NES2Y and 1.1B4. We have demonstrated that the application of all three calcium influx inhibitors tested has no inhibitory effect on SA-induced ER stress and apoptosis in both tested cell lines. Moreover, these inhibitors have pro-apoptotic potential per se at higher concentrations. Interestingly, these findings are in contradiction with those obtained with rodent cell lines and islets. Thus our data obtained with human β-cell lines suggest that the prospective usage of calcium channel blockers for prevention and therapy of type 2 diabetes mellitus, developed with the contribution of the saturated FA-induced apoptosis of β-cells, seems rather unlikely.
Exploring perceived effects from loss of PEPFAR support for outreach in Kenya and Uganda
Authors: Qiu Mary , Paina Ligia , Rodríguez Daniela C. , Wilhelm Jess A. , Eze-Ajoku Ezinne , Searle Alexandra , Zakumumpa Henry , Ssengooba Freddie , MacKenzie Caroline , Bennett Sara
Published: July 2021

Introduction

In 2015, the President’s Emergency Plan for AIDS Relief undertook policy shifts to increase efficiencies in its programming, including transitioning HIV/AIDS funding away from low burden areas. We examine the impact of these changes on HIV outreach in Kenya and Uganda.

Methods

Qualitative data collection was conducted as a part of a broader mixed-methods evaluation. Two rounds of facility-level case studies and national-level interviews were conducted in Kenya and Uganda, with health facility, sub-national and central Ministry of Health staff, HIV clients, and implementing partners.

Results

In both countries, the loss of outreach support affected community-based HIV/AIDS education, testing, peer support, and defaulter tracing.

Discussion

Loss of external support for outreach raises concerns for countries’ ability to reach the 90–90-90 UNAIDS target, as key linkages between vulnerable communities and health systems can be adversely affected.

Conclusion

Development partners should consider how to mitigate potential consequences of transition policies to prevent negative effects at the community level.
A large consanguineous family with a homozygous Metabotropic Glutamate Receptor 7 (mGlu7) variant and developmental epileptic encephalopathy: Effect on protein structure and ligand affinity
Authors: Jdila Marwa Ben , Mignon-Ravix Cécile , Ncir Sihem Ben , Kammoun Fatma , Fakhfakh Faiza , Villard Laurent , Triki Chahnez
Published: July 2021

Background

Developmental and epileptic encephalopathies (DEE) are chronic neurological conditions where epileptic activity contributes to the progressive disruption of brain function, frequently leading to impaired motor, cognitive and sensory development.

Patients and methods

The present study reports a clinical investigation and a molecular analysis by Next Generation Sequencing (NGS) of a large consanguineous family comprising several cases of developmental and epileptic encephalopathy. Bioinformatic prediction and molecular docking analysis were also carried out.

Results

The majority of patients in our studied family had severe developmental impairments, early-onset seizures, brain malformations such as cortical atrophy and microcephaly, developmental delays and intellectual disabilities. The molecular investigations revealed a novel homozygous variant c.1411G>A (p.Gly471Arg) in theGRM7gene which was segregating with the disease in the family. Bioinformatic tools predicted its pathogenicity and docking analysis revealed its potential effects on mGlu7 protein binding to its ligand.

Conclusion

Our results contribute to a better understanding of the impact ofGRM7variants for the newly described associated phenotype.
Selection of CT variables and prognostic models for outcome prediction in patients with traumatic brain injury
Authors: Khaki Djino , Hietanen Virpi , Corell Alba , Hergès Helena Odenstedt , Ljungqvist Johan
Published: July 2021

Background

Traumatic brain injuries (TBI) are associated with high risk of morbidity and mortality. Early outcome prediction in patients with TBI require reliable data input and stable prognostic models. The aim of this investigation was to analyze different CT classification systems and prognostic calculators in a representative population of TBI-patients, with known outcomes, in a neurointensive care unit (NICU), to identify the most suitable CT scoring system for continued research.

Materials and methods

We retrospectively included 158 consecutive patients with TBI admitted to the NICU at a level 1 trauma center in Sweden from 2012 to 2016. Baseline data on admission was recorded, CT scans were reviewed, and patient outcome one year after trauma was assessed according to Glasgow Outcome Scale (GOS). The Marshall classification, Rotterdam scoring system, Helsinki CT score and Stockholm CT score were tested, in addition to the IMPACT and CRASH prognostic calculators. The results were then compared with the actual outcomes.

Results

Glasgow Coma Scale score on admission was 3–8 in 38%, 9–13 in 27.2%, and 14–15 in 34.8% of the patients. GOS after one year showed good recovery in 15.8%, moderate disability in 27.2%, severe disability in 24.7%, vegetative state in 1.3% and death in 29.7%. When adding the variables from the IMPACT base model to the CT scoring systems, the Stockholm CT score yielded the strongest relationship to actual outcome. The results from the prognostic calculators IMPACT and CRASH were divided into two subgroups of mortality (percentages); ≤50% (favorable outcome) and > 50% (unfavorable outcome). This yielded favorable IMPACT and CRASH scores in 54.4 and 38.0% respectively.

Conclusion

The Stockholm CT score and the Helsinki score yielded the closest relationship between the models and the actual outcomes in this consecutive patient series, representative of a NICU TBI-population. Furthermore, the Stockholm CT score yielded the strongest overall relationship when adding variables from the IMPACT base model and would be our method of choice for continued research when using any of the current available CT score models.
Panton-valentine leukocidin Staphylococcus aureus severe infection in an infant: a case report and a review of the literature
Authors: Castellazzi Massimo Luca , Bosis Samantha , Borzani Irene , Tagliabue Claudia , Pinzani Raffaella , Marchisio Paola , di Pietro Giada Maria
Published: July 2021

Background

Panton-Valentine leukocidin (PVL) is one of the major virulence factor of Staphylococcus aureus (SA) that might be associated with invasive life-threating infections. A prompt diagnosis and adequate treatment are essential in achieving the best outcome and avoiding serious sequelae. We describe a case of severe invasive PVL-SA infection in an infant. A literature review starting from 2010 was also performed in order to discuss clinical presentations, radiological findings, treatment and outcome.

Case presentation

This is a case of a 6-month-old boy who rapidly developed high fever and poor general condition. He was diagnosed as having multiple muscular abscesses, multiple foci of osteomyelitis and bloodstream infections caused by Panton-Valentine leukocidin Methicillin-resistant Staphylococcus aureus. He received intravenous antibiotics and surgical drainage of the abscess with progressive recovery.

Conclusion

Our report highlights the importance of improving awareness of this severe infection, as a prompt diagnosis and adequate manage is essential in order to save life and to prevent serious complications.
Impact of cumulative fluid balance on the pharmacokinetics of extended infusion meropenem in critically ill patients with sepsis
Authors: Pařízková Renata Černá , Martínková Jiřina , Havel Eduard , Šafránek Petr , Kaška Milan , Astapenko David , Bezouška Jan , Chládek Jaroslav , Černý Vladimír
Published: July 2021

Background

Meropenem dosing for septic critically patients is difficult due to pathophysiological changes associated with sepsis as well as supportive symptomatic therapies. A prospective single-center study assessed whether fluid retention alters meropenem pharmacokinetics and the achievement of the pharmacokinetic/pharmacodynamic (PK/PD) targets for efficacy.

Methods

Twenty-five septic ICU patients (19 m, 6f) aged 32–86 years with the mean APACHE II score of 20.2 (range 11–33), suffering mainly from perioperative intra-abdominal or respiratory infections and septic shock (n = 18), were investigated over three days after the start of extended 3-h i.v. infusions of meropenem q8h. Urinary creatinine clearance (CLcr) and cumulative fluid balance (CFB) were measured daily. Plasma meropenem was measured, and Bayesian estimates of PK parameters were calculated.

Results

Eleven patients (9 with peritonitis) were classified as fluid overload (FO) based on a positive day 1 CFB of more than 10% body weight. Compared to NoFO patients (n = 14, 11 with pneumonia), the FO patients had a lower meropenem clearance (CLme 8.5 ± 3.2 vs 11.5 ± 3.5 L/h), higher volume of distribution (V1 14.9 ± 3.5 vs 13.5 ± 4.1 L) and longer half-life (t1/2 1.4 ± 0.63 vs 0.92 ± 0.54 h) (p < 0.05). Over three days, the CFB of the FO patients decreased (11.7 ± 3.3 vs 6.7 ± 4.3 L, p < 0.05) and the PK parameters reached the values comparable with NoFO patients (CLme 12.4 ± 3.8 vs 11.5 ± 2.0 L/h, V1 13.7 ± 2.0 vs 14.0 ± 5.1 L, t1/2 0.81 ± 0.23 vs 0.87 ± 0.40 h). The CLcr and Cockroft–Gault CLcr were stable in time and comparable. The correlation with CLme was weak to moderate (CLcr, day 3 CGCLcr) or absent (day 1 and 2 CGCLcr). Dosing with 2 g meropenem q8h ensured adequate concentrations to treat infections with sensitive pathogens (MIC 2 mg/L). The proportion of pre-dose concentrations exceeding the MIC 8 mg/L and the fraction time with a target-exceeding concentration were higher in the FO group (day 1–3 f Cmin > MIC: 67 vs 27%, p < 0.001; day 1%f T > MIC: 79 ± 17 vs 58 ± 17, p < 0.05).

Conclusions

These findings emphasize the importance of TDM and a cautious approach to augmented maintenance dosing of meropenem to patients with FO infected with less susceptible pathogens, if guided by population covariate relationships between CLme and creatinine clearance.
Altered cholesterol homeostasis in critical illness-induced muscle weakness: effect of exogenous 3-hydroxybutyrate
Authors: Goossens Chloë , Weckx Ruben , Derde Sarah , Vander Perre Sarah , Derese Inge , Van Veldhoven Paul P. , Ghesquière Bart , Van den Berghe Greet , Langouche Lies
Published: July 2021

Background

Muscle weakness is a complication of critical illness which hampers recovery. In critically ill mice, supplementation with the ketone body 3-hydroxybutyrate has been shown to improve muscle force and to normalize illness-induced hypocholesterolemia. We hypothesized that altered cholesterol homeostasis is involved in development of critical illness-induced muscle weakness and that this pathway can be affected by 3-hydroxybutyrate.

Methods

In both human critically ill patients and septic mice, the association between circulating cholesterol concentrations and muscle weakness was assessed. In septic mice, the impact of 3-hydroxybutyrate supplementation on cholesterol homeostasis was evaluated with use of tracer technology and through analysis of markers of cholesterol metabolism and downstream pathways.

Results

Serum cholesterol concentrations were lower in weak than in non-weak critically ill patients, and in multivariable analysis adjusting for baseline risk factors, serum cholesterol was inversely correlated with weakness. In septic mice, plasma cholesterol correlated positively with muscle force. In septic mice, exogenous 3-hydroxybutyrate increased plasma cholesterol and altered cholesterol homeostasis, by normalization of plasma mevalonate and elevation of muscular, but not hepatic, expression of cholesterol synthesis genes. In septic mice, tracer technology revealed that 3-hydroxybutyrate was preferentially taken up by muscle and metabolized into cholesterol precursor mevalonate, rather than TCA metabolites. The 3-hydroxybutyrate protection against weakness was not related to ubiquinone or downstream myofiber mitochondrial function, whereas cholesterol content in myofibers was increased.

Conclusions

These findings point to a role for low cholesterol in critical illness-induced muscle weakness and to a protective mechanism-of-action for 3-hydroxybutyrate supplementation.
Impact of Oncotype DX testing on ER+ breast cancer treatment and survival in the first decade of use
Authors: Schaafsma Evelien , Zhang Baoyi , Schaafsma Merit , Tong Chun-Yip , Zhang Lanjing , Cheng Chao
Published: July 2021

Background

The Oncotype DX breast recurrence score has been introduced more than a decade ago to aid physicians in determining the need for systemic adjuvant chemotherapy in patients with early-stage, estrogen receptor (ER)+, lymph node-negative breast cancer.

Methods

In this study, we utilized data from The Surveillance, Epidemiology, and End Results (SEER) Program to investigate temporal trends in Oncotype DX usage among US breast cancer patients in the first decade after the introduction of the Oncotype DX assay.

Results

We found that the use of Oncotype DX has steadily increased in the first decade of use and that this increase is associated with a decreased usage of chemotherapy. Patients who utilized the Oncotype DX test tended to have improved survival compared to patients who did not use the assay even after adjusting for clinical variables associated with prognosis. In addition, chemotherapy usage in patients with high-risk scores is associated with significantly longer overall and breast cancer-specific survival compared to high-risk patients who did not receive chemotherapy. On the contrary, patients with low-risk scores who were treated with chemotherapy tended to have shorter overall survival compared to low-risk patients who forwent chemotherapy.

Conclusion

We have provided a comprehensive temporal overview of the use of Oncotype DX in breast cancer patients in the first decade after Oncotype DX was introduced. Our results suggest that the use of Oncotype DX is increasing in ER+ breast cancer and that the Oncotype DX test results provide valuable information for patient treatment and prognosis.
Can bag-valve mask ventilation with positive end-expiratory pressure reduce hypoxia during intubation? A prospective, randomized, double-blind trial
Authors: Dai Yili , Dai Jiayuan , Walline Joseph Harold , Fu Yangyang , Zhu Huadong , Xu Jun , Yu Xuezhong
Published: July 2021

Background

Hypoxia is one of the life-threatening complications of endotracheal intubation. Supplemental oxygen and ventilation play a vital role in preventing hypoxia. Bag-valve mask (BVM) ventilation is frequently used before intubation, and its ability to improve oxygenation was recently confirmed. It is still unclear if positive end-expiratory pressure (PEEP) added to BVM ventilation can further reduce hypoxia during intubation.

Methods

This will be a prospective, randomized, double-blind trial to determine if PEEP combined with BVM ventilation can reduce the incidence of hypoxia during intubation compared with conventional BVM ventilation. The lowest oxygen saturation and incidence of complications will be compiled to verify the comparative effectiveness and safety of the two groups.

Discussion

BMV ventilation with PEEP is hoped to further reduce the incidence of hypoxia during intubation.

Trial registration

Chinese Clinical Trial Registry ChiCTR2000035156. Registered on August 2, 2020. It had begun enrollment after passing ethical review but before registration.
Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
Authors: Scantlebury Arabella , McDaid Catriona , Brealey Stephen , Cook Elizabeth , Sharma Hemant , Ranganathan Arun , Adamson Joy ,   on behalf of the ACTIVE and PRESTO study teams
Published: July 2021

Background

Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.

Design

Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically.

Setting

NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone.

Participants

Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed.

Results

We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated.

Conclusions

A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials.

Trial registration

ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018,
Design and validation of a food frequency questionnaire to assess the dietary intake for adults in pastoral settings in Northern Tanzania
Authors: Khamis Ahmed Gharib , Mwanri Akwilina Wendelin , Ntwenya Julius Edward , Senkoro Mbazi , Kreppel Katharina , Bonfoh Bassirou , Mfinanga Sayoki Godfrey , Kwesigabo Gideon
Published: July 2021

Objective

Food frequency questionnaires are widely used as a dietary assessment tool in nutritional epidemiology to determine the relationship between diet and diseases. In Tanzania, there are several cultural variations in food intake which makes it necessary to design and validate a culture-specific food frequency questionnaire (CFFQ). Therefore, we designed a 27-items CFFQ and examine its validity in pastoral communities. Validity of CFFQ was assessed by comparing nutrient intake estimated from the CFFQ against the average from two 24-h diet recall (2R24). Spearman’s correlation coefficients, cross classification and Bland–Altman’s methods were used to assess the validity of CFFQ.

Results

A total of 130 adults aged 18 years and above completed both CFFQ and 2R24. Correlation coefficients between CFFQ and 2R24 ranged from low (r = − 0.07) to moderate (r = 0.37). The correlation coefficients were moderately significant for kilocalories (r = 0.31,p < 0.001), carbohydrate (r = 0.33,p < 0.001), magnesium (r = 0.37,p < 0.001), and iron (r = 0.34,p < 0.001). On average, about 69% of participants were correctly classified into the same or adjacent quartile of energy and nutrient intake, while 9% were misclassified by the CFFQ. Bland–Altman’s plot demonstrated that the CFFQ had acceptable agreement with the 2R24.
Impact of Bacillus in fermented soybean foods on human health
Authors: Gopikrishna Trishala , Suresh Kumar Harini Keerthana , Perumal Kumar , Elangovan Elavarashi
Published: July 2021

Purpose

Fermented soybean foods (FSF) is popularly consumed in the South-East Asian countries. Bacillus species, a predominant microorganism present in these foods, have demonstrated beneficial and deleterious impacts on human health. These microorganisms produce bioactive compounds during fermentation that have beneficial impacts in improving human health. However, the health risks associated with FSF, food pathogens, biogenic amines (BAs) production, and late-onset anaphylaxis, remain a concern. The purpose of this review is to present an in-depth analysis of positive and negative impacts as a result of consumption of FSF along with the measures to alleviate health risks for human consumption.

Methods

This review was composed by scrutinizing contemporary literature of peer-reviewed publications related to Bacillus and FSF. Based on the results from academic journals, this review paper was categorized into FSF, role of Bacillus species in these foods, process of fermentation, beneficial, and adverse influence of these foods along with methods to improve food safety. Special emphasis was given to the potential benefits of bioactive compounds released during fermentation of soybean by Bacillus species.

Results

The nutritional and functional properties of FSF are well-appreciated, due to the release of peptides and mucilage, which have shown health benefits: in managing cardiac disease, gastric disease, cancer, allergies, hepatic disease, obesity, immune disorders, and especially microbial infections due to the presence of probiotic property, which is a potential alternative to antibiotics. Efficient interventions were established to mitigate pitfalls like the techniques to reduce BAs and food pathogens and by using a defined starter culture to improve the safety and quality of these foods.

Conclusion

Despite some of the detrimental effects produced by these foods, potential health benefits have been observed. Therefore, soybean foods fermented by Bacillus can be a promising food by integrating effective measures for maintaining safety and quality for human consumption. Further, in vivo analysis on the activity and dietary interventions of bioactive compounds among animal models and human volunteers are yet to be achieved which is essential to commercialize them for safe consumption by humans, especially immunocompromised patients.
Demographic characteristics associated with food allergy in a Nationwide Canadian Study
Authors: Clarke Ann E. , Elliott Susan J. , St. Pierre Yvan , Soller Lianne , La Vieille Sebastien , Ben-Shoshan Moshe
Published: July 2021

Introduction

We conducted a nationwide Canadian telephone survey on food allergy prevalence between February 2016 and January 2017, targeting vulnerable populations (New, Indigenous, and lower-income Canadians).

Objective

To examine the independent effect of demographic characteristics on food allergy.

Methods

Canadian households with vulnerable populations were targeted using Canadian Census data and the household respondent reported whether each household member had a perceived (self-reported) or probable (self-report of a convincing history or physician diagnosis) food allergy. The association between perceived and probable food allergy and demographic characteristics was assessed through weighted multivariable random effects logistic regressions.

Results

Children, females, Canadian-born participants, adults with post-secondary education, and those residing in smaller households were more likely to report perceived or probable food allergy. Although immigrant parents self-reported less food allergy, Canadian-born children of Southeast/East Asian immigrant versus other immigrant or Canadian-born parents reported more food allergy.

Conclusion

We have demonstrated clear associations between demographic characteristics and food allergy, which may provide important clues to the environmental determinants of food allergy.
Phlebosclerotic colitis in a non-Asian patient: a case report
Authors: Mohigefer J. , Gómez-Millán P. , Borrero J. J.
Published: July 2021

Background

Phlebosclerotic colitis is a rare condition with a high mortality. It has been seen almost exclusively in Asian patients who are ≥ 60 years old, with a slight male predominance. Although it predominantly affects the right colon and seems to be related in some cases to using natural herbal medicines, neither its etiology nor its pathogenesis are known.

Case presentation

We present an extremely rare case of a 62-year-old Spanish white man patient of non-Asian ethnicity with no history of using natural medications, who was diagnosed with phlebosclerotic colitis of submucosal veins.

Conclusion

To date, this is the only case reported in Spain, and only the second reported for Europe, in the literature. Due to the nonspecific symptoms and insidious radiological findings of this disease (both in early and mild stages) as well as exclusive submucosal involvement presented here, it is necessary that the treating physician has a high level of suspicion for its diagnosis.
Noise reduction for radio map crowdsourcing building in WLAN indoor localization system
Authors: Zhang Liye , Wang Zhuang , Meng Xiaoliang , Fang Chao , Liu Cong
Published: July 2021

Recent years have witnessed a growing interest in using WLAN fingerprint-based method for indoor localization system because of its cost-effectiveness and availability compared to other localization systems. In order to rapidly deploy WLAN indoor localization system, the crowdsourcing method is applied to alternate the traditional deployment method. In this paper, we proposed a fast radio map building method utilizing the sensors inside the mobile device and the Multidimensional Scaling (MDS) method. The crowdsourcing method collects RSS and sensor data while the user is walking along a straight line and computes the position information using the sensor data. In order to reduce the noise in the location space of the radio map, the short-term Fourier transform (STFT) method is used to detect the usage mode switching to improve the step determination accuracy. When building a radio map, much fewer RSS values are needed using the crowdsourcing method compared to conventional methods, which lends greater influence to noises and erroneous measurements in RSS values. Accordingly, an imprecise radio map is built based on these imprecise RSS values. In order to acquire a smoother radio map and improve the localization accuracy, the MDS method is used to infer an optimal RSS value at each location by exploiting the correlation of RSS values at nearby locations. Experimental results show that the expected goal is achieved by the proposed method.
Spatial and temporal learning representation for end-to-end recording device identification
Authors: Zeng Chunyan , Zhu Dongliang , Wang Zhifeng , Wu Minghu , Xiong Wei , Zhao Nan
Published: July 2021

Deep learning techniques have achieved specific results in recording device source identification. The recording device source features include spatial information and certain temporal information. However, most recording device source identification methods based on deep learning only use spatial representation learning from recording device source features, which cannot make full use of recording device source information. Therefore, in this paper, to fully explore the spatial information and temporal information of recording device source, we propose a new method for recording device source identification based on the fusion of spatial feature information and temporal feature information by using an end-to-end framework. From a feature perspective, we designed two kinds of networks to extract recording device source spatial and temporal information. Afterward, we use the attention mechanism to adaptively assign the weight of spatial information and temporal information to obtain fusion features. From a model perspective, our model uses an end-to-end framework to learn the deep representation from spatial feature and temporal feature and train using deep and shallow loss to joint optimize our network. This method is compared with our previous work and baseline system. The results show that the proposed method is better than our previous work and baseline system under general conditions.
Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis
Authors: Ascef Bruna O. , Almeida Matheus O. , de Medeiros Ribeiro Ana Cristina , Andrade Danieli C. O. , de Oliveira Júnior Haliton A. , Pereira Tiago V. , de Soárez Patrícia C.
Published: July 2021

Background

Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. This paper aims to outline the protocol of a systematic review that will investigate the efficacy and safety profile of biosimilars compared to biologics (objective 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (objective 2).

Methods

We will investigate the effects of any biosimilars of adalimumab, etanercept, and infliximab on RA patients. We will include randomized controlled trials (RCTs) or quasi-RCTs to assess efficacy and safety outcomes and RCTs with two- or multiple-part designs to evaluate the consequences of switching from reference biologics to biosimilar drugs (and vice-versa). Electronic searches will be performed through MEDLINE (via PubMed), EMBASE, LILACS, and CENTRAL (from inception to April 2021). Two independent reviewers will screen studies, extract data, and evaluate the risk of bias. The latter will be carried out considering specific domains from equivalence trials and switching studies. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20), and the co-primary outcome will be the Health Assessment Questionnaire—Disability Index (HAQ-DI). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of the evidence will be assessed based on the GRADE system.

Discussion

The present investigation proposes a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. Our results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA.

Systematic review registration

PROSPERO CRD42019137152 and CRD42019137155
Some identities and reciprocity relationsof unipoly-Dedekind type DC sums
Authors: Kim Hye Kyung , Lee Dae Sik
Published: July 2021

Dedekind type DC sums and their generalizations are defined in terms of Euler functions and their generalization. Recently, Ma et al. (Adv. Differ. Equ. 2021:30 2021) introduced the poly-Dedekind type DC sums by replacing the Euler function appearing in Dedekind sums, and they were shown to satisfy a reciprocity relation. In this paper, we consider two kinds of new generalizations of the poly-Dedekind type DC sums. One is a unipoly-Dedekind type DC sum associated with the type 2 unipoly-Euler functions expressed in the type 2 unipoly-Euler polynomials using the modified polyexponential function, and we study some identities and the reciprocity relation for these unipoly-Dedekind type DC sums. The other is a unipoly-Dedekind sums type DC associated with the poly-Euler functions expressed in the unipoly-Euler polynomials using the polylogarithm function, and we derive some identities and the reciprocity relation for those unipoly-Dedekind type DC sums.
Socioeconomic determinants of micro and small enterprise growth in North Wollo and Waghimira Zone selected towns
Authors: Kassa Erstu Tarko
Published: July 2021

This study aims to investigate the socioeconomic determinant factors that affect the growth of micro and small enterprises (MSEs) in North Wollo and Waghimira Zone selected towns. In this study, a cross-sectional research design with both descriptive and explanatory research design has been employed, and 303 owners of enterprises have participated. The towns were selected purposely, and the respondents were also selected by using a simple random sampling technique. The data were analyzed by using STATA v-14 and applied descriptive and binary logistic regression analysis (odds ratio). The finding of the study revealed that age of the owner, access to finance, family business background, and interest rate most likely affect the growth of the enterprises with the statistically significant level. On the contrary, entrepreneurship training, the experience of the owner, the inflation rate, and competition less likely affect the growth of the enterprises with a statistical significant level. The remaining factors such as gender of the owners, education background, business age, business type, business location, social responsibility, tax rate, and social attitude were not statistically significant to determine the growth of MSEs.
Plumbagin can potently enhance the activity of xanthine oxidase: in vitro, in vivo and in silico studies
Authors: Yue Liang , Jiang Nan , Wu Anguo , Qiu Wenqiao , Shen Xin , Qin Dalian , Li Hong , Lin Jing , Liang Sicheng , Wu Jianming
Published: July 2021

Background

Abnormally elevated xanthine oxidase (XO) activity has been verified to cause various pathological processes, such as gout, oxidative stress injury and metabolic syndrome. Thus, XO activators may exhibit above potential toxicological properties. Plumbagin (PLB) is an important active compound in traditional Chinese medicine (TCM), while its obvious toxic effects have been reported, including diarrhea, skin rashes and hepatic toxicity. However, the potential toxicity associated with enhancement of XO activity has not been fully illuminated so far.

Methods

The present study investigated the effect of PLB on XO activity by culturing mouse liver S9 (MLS9), human liver S9 (HLS9), XO monoenzyme system with PLB and xanthine. Then, the molecular docking and biolayer interferometry analysis were adopted to study the binding properties between PLB and XO. Finally, the in vivo acceleration effect also investigated by injected intraperitoneally PLB to KM mice for 3 days.

Results

PLB could obviously accelerate xanthine oxidation in the above three incubation systems. Both the Vmax values and intrinsic clearance values (CLint, Vmax/Km) of XO in the three incubation systems increased along with elevated PLB concentration. In addition, the molecular docking study and label-free biolayer interferometry assay displayed that PLB was well bound to XO. In addition, the in vivo results showed that PLB (2 and 10 mg/kg) significantly increased serum uric acid levels and enhanced serum XO activity in mice.

Conclusion

In summary, this study outlines a potential source of toxicity for PLB due to the powerful enhancement of XO activity, which may provide the crucial reminding for the PLB-containing preparation development and clinical application.
The Taxonomy of Opportunities to Learn (TxOTL): a tool for understanding the learning potential and substance of interactions in faculty (online) learning community meetings
Authors: Lau Alexandra C. , Martin Makenna , Corrales Adriana , Turpen Chandra , Goldberg Fred , Price Edward
Published: July 2021

Background

While many research-based instructional strategies in STEM have been developed, faculty need support in implementing and sustaining use of these strategies. A number of STEM faculty professional development programs aim to provide such pedagogical support, and it is necessary to understand the activity and learning process for faculty in these settings. In this paper, a taxonomy for describing the learning opportunities in faculty (online) learning community meetings is presented. Faculty learning communities, meeting either in-person or (increasingly) online, are a common form of professional development. They aim to develop the pedagogical and reflective skills of participants through regular meetings centered on conversations about teaching and learning.

Results

The tool presented in this paper, the Taxonomy of Opportunities to Learn (TxOTL), provides a structured approach to making sense of the dynamic interactions that occur during faculty learning community meetings. The origins and development of the TxOTL are described, followed by a detailed presentation of the constructs that make up the TxOTL: communicative approach used in a conversation, the concepts developed, and the meeting segment category. The TxOTL characterizes the learning opportunities presented by a faculty learning community conversation through describing the content of the conversation as well as how participants engage in the conversation. Examples of the tool in use are provided through an application to a faculty online learning community serving instructors of a physical science curriculum. A visual representation used to compactly display the results of applying the taxonomy to a meeting is detailed as well. These examples serve to illustrate the types of claims the TxOTL facilitates.

Conclusions

The TxOTL allows one to examine learning opportunities available to a faculty learning community group, analyze concept development present in their conversations, track change over time in a given group, and identify patterns between meeting segment categories and communicative approaches. It is useful for researchers as well as facilitators of these STEM faculty professional development groups. The taxonomy is most applicable to faculty (online) learning communities, with limited use for workshops and K-12 professional development contexts.