bluuebunny/crossref_metadata_2025 huggingface dataset:
Optimality criteria for futility stopping boundaries for group sequential designs with a continuous endpoint
Authors: Li Xieran , Herrmann Carolin , Rauch Geraldine
Published: November 2020

Background

In clinical trials with fixed study designs, statistical inference is only made when the trial is completed. In contrast, group sequential designs allow an early stopping of the trial at interim, either for efficacy when the treatment effect is significant or for futility when the treatment effect seems too small to justify a continuation of the trial. Efficacy stopping boundaries based on alpha spending functions have been widely discussed in the statistical literature, and there is also solid work on the choice of adequate futility stopping boundaries. Still, futility boundaries are often chosen with little or completely without theoretical justification, in particular in investigator initiated trails. Some authors contributed to fill this gap. In here, we rely on an idea of Schüler et al. (2017) who discuss optimality criteria for futility boundaries for the special case of trials with (multiple) time-to-event endpoints. Their concept can be adopted to define “optimal” futility boundaries (with respect to given performance indicators) for continuous endpoints.

Methods

We extend Schülers’ definition for “optimal” futility boundaries to the most common study situation of a single continuous primary endpoint compared between two groups. First, we introduce the analytic algorithm to derive these futility boundaries. Second, the new concept is applied to a real clinical trial example. Finally, the performance of a study design with an “optimal” futility boundary is compared to designs with arbitrarily chosen futility boundaries.

Results

The presented concept of deriving futility boundaries allows to control the probability of wrongly stopping for futility, that means stopping for futility even if the treatment effect is promizing. At the same time, the loss in power is also controlled by this approach. Moreover, “optimal” futility boundaries improve the probability of correctly stopping for futility under the null hypothesis of no difference between two groups.

Conclusions

The choice of futility boundaries should be thoroughly investigated at the planning stage. The sometimes met, arbitrary choice of futility boundaries can lead to a substantial negative impact on performance. Applying futility boundaries with predefined optimization criteria increases efficiency of group sequential designs. Other optimization criteria than proposed in here might be incorporated.
Effect of complementary feeding behavior change communication delivered through community-level actors on the time of initiation of complementary foods in rural communities of West Gojjam zone, Northwest Ethiopia: a cluster-randomized controlled trial
Authors: Abiyu Chalachew , Belachew Tefera
Published: November 2020

Background

Attaining the recommended level of complementary feeding practices remains a serious challenge in many developing countries. Complementary foods are usually untimely initiated, which has adverse consequences on the growth, development, and survival of infants. The focus of most studies conducted worldwide seemed to be on the effect of behavior change interventions on the adequacy of complementary diets; but not on the timing of initiations. Moreover, many of the interventions targeted only mothers/caregivers of infants, and studies that engaged the family members are scarce. This study aimed to evaluate the effectiveness of complementary feeding behavior change communication delivered through women development army leaderson the time of initiation of complementary foods.

Methods

We conducted a cluster-randomized controlled trial in rural communities of West Gojjam Zone, Northwest Ethiopia from February 2017 to March 2018. A total of 16 geographic clusters were selected. Trial participants in the intervention group received complementary feeding behavior change intervention for 9 months whereas those in the control group received only the usual health care. Trained women development army leaders delivered the intervention. A pre-tested, structured interviewer-administered questionnaire was used for data collection. Generalized estimated equation (GEE) regression and survival analyses were used to test differences in time of initiation of complementary food between the study groups.

Results

The intervention significantly improved the likelihood of timely initiation of complementary food by 22 percentage points [RR: 2.6; 95% CI: 1.78–5.86], and reduced the risk of late initiations by 19 percentage points [RR: 2.8; 95% CI: 1.83–4.37]. The complementary food initiation survival curve for the control group after 6 months was constantly above the curve than for the intervention group. The median age at the introduction of complementary food for infants was 6 months in the intervention group, and 6.7 months in the control group and the difference was statistically significant (P-value < 0.001).

Conclusions

Complementary feeding behavior change communication improved the rate of timely initiation of complementary foods and reduced the risk of late initiations.

Trial registration

ClinicalTrials.gov,NCT03488680. Registered 5 April 2018-Retrospectively registered,https://clinicaltrials.gov/ct2/show/NCT03488680.
A new fluoroscopic view for evaluation of anteromedial cortex reduction quality during cephalomedullary nailing for intertrochanteric femur fractures: the 30° oblique tangential projection
Authors: Chen Shi-Yi , Chang Shi-Min , Tuladhar Rujan , Wei Zhen , Xiong Wen-Feng , Hu Sun-Jun , Du Shou-Chao
Published: November 2020

Background

Anteromedial cortex-to-cortex reduction is a key parameter for stable reconstruction of the fracture fragments during the intertrochanteric fracture fixation. This paper introduces the oblique fluoroscopic projection as a novel method to evaluate the quality of anteromedial cortical apposition.

Methods

Three proximal femur specimens were marked with steel wires along five anatomic landmarks: Greater trochanter, Lesser trochanter, Intertrochanteric line, Anterolateral tubercle and the Anteromedial cortical line. After obtaining the standard femoral neck AP and lateral fluoroscopic images, the C-arm was rotated by every 5°increments until a clear tangential view of the antero-medial-inferior corner cortex was observed. 98 cases of intertrochanteric hip fractures were enrolled from April 2018 to October 2019. After fixation with the nails, the intra-operative anteromedial cortex reduction quality was evaluated from the AP, the true lateral, and the new anteromedial oblique fluoroscopic images. The fluoroscopic results were compared with the post-operative 3D-CT reconstruction images.

Results

The specimen study showed that internal rotation of the C-arm to approximately 30 ° can remove all the obscure shadows and clearly display the antero-medial-inferior cortical tangent line. Clinically,the positive, neutral and negative apposition of different cortices via intra-operative fluoroscopic images showed79, 19 and 0 cases of medial cortical apposition in AP views; 2, 68 and 28 cases of anterior cortices in lateral views;and 22, 51 and 25cases of anteromedial cortical apposition in oblique views respectively. The post-operative 3D-CT reconstruction images revealed that the final anteromedial cortical contact was noted in 62 cases (63.3%), and lost in 36 cases (36.7%). The overall coincidence rate between intra-operative fluoroscopy and post-operative 3D-CT was 63.3% (62/98) in AP view,79.6% (78/98) in lateral view, and 86.7% (85/98) in oblique view(p < 0.001). Negative cortical apposition in oblique view was highly predictive of a final loss of cortical support on 3D CT (24/25 cases, 96%).And non-negative cortical apposition in oblique view was highly associated with true cortical support on 3D CT images (61/73 cases, 83.6%) (p < 0.001).

Conclusions

Besides the AP and lateral projections, an anteromedial oblique view of 30° certifies to be a very useful means for evaluation of the fracture reduction quality of anteromedial cortical apposition.
Quality of recovery after total hip and knee arthroplasty in South Africa: a national prospective observational cohort study
Authors: Plenge Ulla , Parker Romy , Davids Shamiela , Davies Gareth L. , Fullerton Zahnne , Gray Lindsay , Groenewald Penelope , Isaacs Refqah , Kauta Ntambue , Louw Frederik M. , Mazibuko Andile , North David M. , Nortje Marc , Nunes Glen M. , Pebane Neo , Rajah Chantal , Roos John , Ryan Paul , September Winlecia V. , Shanahan Heidi , Siebritz Ruth E. , Smit Rian W. , Sombili Simon , Torborg Alexandra , van der Merwe Johan F. , van der Westhuizen Nico , Biccard Bruce
Published: November 2020

Background

Encouraged by the widespread adoption of enhanced recovery protocols (ERPs) for elective total hip and knee arthroplasty (THA/TKA) in high-income countries, our nationwide multidisciplinary research group first performed a Delphi study to establish the framework for a unified ERP for THA/TKA in South Africa. The objectives of this second phase of changing practice were to document quality of patient recovery, record patient characteristics and audit standard perioperative practice.

Methods

From May to December 2018, nine South African public hospitals conducted a 10-week prospective observational study of patients undergoing THA/TKA. The primary outcome was ‘days alive and at home up to 30 days after surgery’ (DAH30) as a patient-centred measure of quality of recovery incorporating early death, hospital length of stay (LOS), discharge destination and readmission during the first 30 days after surgery. Preoperative patient characteristics and perioperative care were documented to audit practice.

Results

Twenty-one (10.1%) out of 207 enrolled patients had their surgery cancelled or postponed resulting in 186 study patients. No fatalities were recorded, median LOS was 4 (inter-quartile-range (IQR), 3–5) days and 30-day readmission rate was 3.8%, leading to a median DAH30 of 26 (25–27) days. Forty patients (21.5%) had pre-existing anaemia and 24 (12.9%) were morbidly obese. In the preoperative period, standard care involved assessment in an optimisation clinic, multidisciplinary education and full-body antiseptic wash for 67 (36.2%), 74 (40.0%) and 55 (30.1%) patients, respectively. On the first postoperative day, out-of-bed mobilisation was achieved by 69 (38.1%) patients while multimodal analgesic regimens (paracetamol and Non-Steroid-Anti-Inflammatory-Drugs) were administered to 29 patients (16.0%).

Conclusion

Quality of recovery measured by a median DAH30 of 26 days justifies performance of THA/TKA in South African public hospitals. That said, perioperative practice, including optimisation of modifiable risk factors, lacked standardisation suggesting that quality of patient care and postoperative recovery may improve with implementation of ERP principles. Notwithstanding the limited resources available, we anticipate that a change of practice for THA/TKA is feasible if ‘buy-in’ from the involved multidisciplinary units is obtained in the next phase of our nationwide ERP initiative.

Trial registration

The study was registered with ClinicalTrials.gov (NCT03540667).
Association between coarse particulate matter and inflammatory and hemostatic markers in a cohort of midlife women
Authors: Davis Emilie , Malig Brian , Broadwin Rachel , Ebisu Keita , Basu Rupa , Gold Ellen B. , Qi Lihong , Derby Carol A. , Park Sung Kyun , Wu Xiangmei (May)
Published: November 2020

Background

Exposure to particulate matter air pollution has been associated with cardiovascular disease (CVD) morbidity and mortality; however, most studies have focused on fine particulate matter (PM2.5) exposure and CVD. Coarse particulate matter (PM10–2.5) exposure has not been extensively studied, particularly for long-term exposure, and the biological mechanisms remain uncertain.

Methods

We examined the association between ambient concentrations of PM10–2.5 and inflammatory and hemostatic makers that have been linked to CVD. Annual questionnaire and clinical data were obtained from 1694 women (≥ 55 years old in 1999) enrolled in the longitudinal Study of Women’s Health Across the Nation (SWAN) at six study sites from 1999 to 2004. Residential locations and the USEPA air monitoring network measurements were used to assign exposure to one-year PM10–2.5, as well as co-pollutants. Linear mixed-effects regression models were used to describe the association between PM10–2.5 exposure and markers, including demographic, health and other covariates.

Results

Each interquartile (4 μg/m3) increase in one-year PM10–2.5 exposure was associated with a 5.5% (95% confidence interval [CI]: 1.8, 9.4%) increase in levels of plasminogen activator inhibitor-1 (PAI-1) and 4.1% (95% CI: − 0.1, 8.6%) increase in high-sensitivity C-creative Protein (hs-CRP). Stratified analyses suggested that the association with PAI-1 was particularly strong in some subgroups, including women who were peri-menopausal, were less educated, had a body mass index lower than 25, and reported low alcohol consumption. The association between PM10–2.5 and PAI-1 remained unchanged with adjustment for PM2.5, ozone, nitrogen dioxide, and carbon monoxide.

Conclusions

Long-term PM10–2.5 exposure may be associated with changes in coagulation independently from PM2.5, and thus, contribute to CVD risk in midlife women.
Projecting supply and demand for pharmacists in pharmacies based on the number of prescriptions and system dynamics modeling
Authors: Morii Yasuhiro , Furuta Seiichi , Ishikawa Tomoki , Fujiwara Kensuke , Yamashina Hiroko , Ogasawara Katsuhiko
Published: November 2020

Background

Pharmacists play an important role in promoting people’s health in Japan, which has an aging population. Hence, it is necessary that the distribution of pharmacists meets the population’s needs in each region. This study projects the future supply and demand for pharmacists in pharmacies to consider an optimal distribution of pharmacists.

Methods

The future supply of pharmacists working in pharmacies in Hokkaido is projected using system dynamics modeling, according to their career path. The demand is projected based on the number of prescriptions, sourced from publicly available sources. The analysis period is 2015–2040. The estimated demand is converted into the number of pharmacists and the sufficiency is evaluated using sufficiency ratio (supply/demand ratio). Sensitivity analyses of the sufficiency ratio were conducted to estimate the effects of changes in parameters such as national exam pass rate, enrollments, attrition rates, the number of prescriptions per pharmacist, and diffusion of newly licensed pharmacists.

Results

The projected supply, in 2025 and 2040, is 1.24 and 1.56 times, respectively, as that in 2015 and the demand is 1.11 and 0.98 times, respectively. In 2015, although the sufficiency ratio in Hokkaido overall is 1.19, the ratios are higher in urban medical areas and lower than 1 in rural medical areas, such as Minamihiyama, Emmon, and Nemuro. By 2040, the sufficiency ratios are greater than 1 for all areas except for Emmon and higher than 2 in some areas. The sensitivity analyses found that the sufficiency ratio was most sensitive to diffusion of newly licensed pharmacists and the number of prescriptions per pharmacist.

Conclusion

Optimal distribution should be considered, as the results reveal a possible shortage in the number of pharmacists in rural medical areas in 2015–2025. Conversely, as the demand is projected to decrease after 2025 with a population decrease, future supply should be determined in order not to cause an oversupply after 2025. Refinements of the projection model should be conducted since the related factors such as the roles of pharmacists will change over time.
Discernment between candidate mechanisms for KRAS G13D colorectal cancer sensitivity to EGFR inhibitors
Authors: McFall Thomas , Schomburg Noah K. , Rossman Kent L. , Stites Edward C.
Published: November 2020

Phase three clinical trial evidence suggests that colorectal cancers with the KRAS G13D mutation may benefit from EGFR inhibitors, like cetuximab, in contrast to the other most common KRAS mutations. A mechanism to explain why this mutation behaves differently from other KRAS mutations had long been lacking. Two recent studies have reproduced KRAS G13D specific sensitivity to cetuximab in cellular models, and both have implicated the tumor suppressor NF1 as a critical variable in determining sensitivity and resistance. One study proposes a mechanism that focuses on the inhibition of active, GTP-bound wild-type RAS, which is proposed to occur to a greater extent in KRAS G13D tumors due to the inability of KRAS G13D to bind NF1 well. The other study suggests NF1 can convert GTP-bound KRAS G13D to inactive, GDP-bound KRAS G13D. Here, we report an inability to reproduce cellular and biophysical studies that suggested NF1 has strong GTPase activity on KRAS G13D. We also report additional data that further suggests only WT RAS-GTP levels are reduced with EGFR inhibition and that KRAS G13D is impaired in binding to NF1. These new experiments further support a mechanism in which cetuximab inhibits wild-type (HRAS and NRAS) signals in KRAS G13D colorectal cancers.
Consecutive intra-gingival injections of lipopolysaccharide and butyric acid to mice induce abnormal behavior and changes in cytokine concentrations
Authors: Tsukahara Takamitsu , Toyoda Atsushi , Kawase Takahiro , Nakamura Shin-ichi , Ochiai Kuniyasu
Published: November 2020

Background

Periodontopathic bacteria such asPorphyromonas gingivalisproduce several metabolites, including lipopolysaccharide (LPS) andn-butyric acid (BA). Past work suggested that periodontal infection may cause cognitive impairment in mice.

Aims

To elucidate the mechanisms by which metabolites such as LPS and BA, resulting fromPorphyromonas gingivalisactivity, induce immunological and physiological abnormalities in mice.

Methods

In the present work, 28 male ICR mice were placed in an open-field arena and the total distance (cm/600 s) they covered was recorded. Based on their moving distances, mice were divided into 4 groups (n= 7) and injected the following substances into their gingival tissues for 32 consecutive days: saline (C), 5 mmol/L of BA (B), 1 μg/mouse of LPS (L), and BA-LPS (BL) solutions. Distances covered by mice were also measured on days 14 and 21, with their habituation scores considered as “(moving distance on day 14 or 21)/(moving distance on day 0)”. Afterwards, mice were dissected, and hippocampal gene expression and the concentrations of short-chain fatty acids, neurotransmitters and cytokines in their blood plasma and brains were analyzed. In addition, mouse brain and liver tissues were fixed and visually assessed for histopathological abnormalities.

Results

Group BL had significantly higher habituation scores than C and B on day 14. LPS induced higher habituation scores on day 21. LPS induced significant decreases in the mRNA levels of interleukin (IL)-6 and brain-derived neurotrophic factors, and an increase in neurotrophic tyrosine kinase receptor type 2. In both plasma and brain, LPS induced a significant acetate increase. Moreover, LPS significantly increased acetylcholine in brain. In plasma alone, LPS and BA significantly decreased monocyte chemoattractant protein 1 (MCP-1). However, while LPS significantly decreased tyrosine, BA significantly increased it. Lastly, LPS significantly decreased IL-6 and tumor necrosis factor in plasma. No histopathological abnormalities were detected in liver or brain tissues of mice.

Conclusion

We showed that injections of LPS and/or BA induced mice to move seemingly tireless and that both LPS and BA injections strongly induced a reduction of MCP-1 in blood plasma. We concluded that LPS and BA may have been crucial to induce and/or aggravate abnormal behavior in mice.
Pediatric craniospinal irradiation with a short partial-arc VMAT technique for medulloblastoma tumors in dosimetric comparison
Authors: Pollul Gerhard , Bostel Tilman , Grossmann Sascha , Akbaba Sati , Karle Heiko , Stockinger Marcus , Schmidberger Heinz
Published: November 2020

Background

This study aimed to contrast four different irradiation methods for pediatric medulloblastoma tumors in a dosimetric comparison regarding planning target volume (PTV) coverage and sparing of organs at risk (OARs).

Methods

In sum 24 treatment plans for 6 pediatric patients were realized. Besides the clinical standard of a 3D-conformal radiotherapy (3D-CRT) treatment plan taken as a reference, volumetric modulated arc therapy (VMAT) treatment plans (“VMAT_AVD” vs. “noAVD” vs. “FullArc”) were optimized and calculated for each patient. For the thoracic and abdominal region, the short partial-arc VMAT_AVD technique uses an arc setup with reduced arc-length by 100°, using posterior and lateral beam entries. The noAVD uses a half 180° (posterior to lateral directions) and the FullArc uses a full 360° arc setup arrangement. The prescription dose was set to 35.2 Gy.

Results

We identified a more conformal dose coverage for PTVs and a better sparing of OARs with used VMAT methods. For VMAT_AVD mean dose reductions in organs at risk can be realized, from 16 to 6.6 Gy, from 27.1 to 8.7 Gy and from 8.0 to 1.9 Gy for the heart, the thyroid and the gonads respectively, compared to the 3D-CRT treatment method. In addition we have found out a superiority of VMAT_AVD compared to the noAVD and FullArc trials with lower exposure to low-dose radiation to the lungs and breasts.

Conclusions

With the short partial-arc VMAT_AVD technique, dose exposures to radiosensitive OARS like the heart, the thyroid or the gonads can be reduced and therefore, maybe the occurrence of late sequelae is less likely. Furthermore the PTV conformity is increased. The advantages of the VMAT_AVD have to be weighed against the potentially risks induced by an increased low dose exposure compared to the 3D-CRT method.
Mandibular involvement in SAPHO syndrome: a retrospective study
Authors: Wang Mu , Li Yueting , Cao Yihan , Lu Xinyu , Liu Yuchen , Zhao Jizhi , Zhang Wen , Li Chen
Published: November 2020

Background

Mandible osteomyelitis can occur in synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome, a rare chronic inflammatory disease; however, few studies have explored its characteristics and management.

Methods

We reviewed the medical records of consecutive SAPHO patients with mandible involvement diagnosed in Peking Union Medical College Hospital from September 2014 to July 2019. Demographic, clinical, laboratory, and imaging data were collected at baseline. Prescription data and follow-up magnetic resonance imaging (MRI) and cone beam computed tomography (CBCT) images were collected from the hospital information system. An electronic questionnaire was distributed to all patients to obtain their latest symptoms.

Results

A total of 26 SAPHO patients with mandibular involvement were involved, all of whom responded to the questionnaire (38.5% male; median age, 28 years; median follow-up duration, 2.1 years). Ten patients (38.5%) had undergone an oral procedure 1 month before the onset of mandibular symptoms. All 14 of the patients who underwent a surgical intervention relapsed within a median duration of 2 months (range 0.25–4.0 months), and 24 patients (92.3%) achieved improvement with conservative treatment. Following bisphosphonate treatment, remission of bone marrow oedema and osteolysis was observed on MRI and CBCT, and 5 patients receiving bisphosphonates with follow-up CBCT after remission did not relapse in 5.4 months (mean 6.0, range 3.2–9.9 months).

Conclusion

Mandibular involvement of SAPHO syndrome predominantly occurs in young women. Dental procedures are a possible risk factor. Conservative treatment, especially intravenous bisphosphonates, can lead to oral improvement.
Effects of strategies to improve general practitioner-nurse collaboration and communication in regard to hospital admissions of nursing home residents (interprof ACT): study protocol for a cluster randomised controlled trial
Authors: Müller Christiane , Hesjedal-Streller Berit , Fleischmann Nina , Tetzlaff Britta , Mallon Tina , Scherer Martin , Köpke Sascha , Balzer Katrin , Gärtner Linda , Maurer Indre , Friede Tim , König Hans-Helmut , Hummers Eva
Published: November 2020

Background

In Germany, up to 50% of nursing home residents are admitted to a hospital at least once a year. It is often unclear whether this is beneficial or even harmful. Successful interprofessional collaboration and communication involving general practitioners (GPs) and nurses may improve medical care of nursing home residents. In the previous interprof study, the six-component intervention package interprof ACT was developed to facilitate collaboration of GPs and nurses in nursing homes. The aim of this study is to evaluate the effectiveness of the interprof ACT intervention.

Methods

This multicentre, cluster randomised controlled trial compares nursing homes receiving the interprof ACT intervention package for a duration of 12 months (e.g. comprising appointment of mutual contact persons, shared goal setting, standardised GPs’ home visits) with a control group (care as usual). A total of 34 nursing homes are randomised, and overall 680 residents recruited. The intervention package is presented in a kick-off meeting to GPs, nurses, residents/relatives or their representatives. Nursing home nurses act as change agents to support local adaption and implementation of the intervention measures. Primary outcome is the cumulative incidence of hospitalisation within 12 months. Secondary outcomes include admissions to hospital, days admitted to hospital, use of other medical services, prevalence of potentially inappropriate medication and quality of life. Additionally, health economic and a mixed methods process evaluation will be performed.

Discussion

This study investigates a complex intervention tailored to local needs of nursing homes. Outcomes reflect the healthcare and health of nursing home residents, as well as the feasibility of the intervention package and its impact on interprofessional communication and collaboration. Because of its systematic development and its flexible nature, interprof ACT is expected to be viable for large-scale implementation in routine care services regardless of local organisational conditions and resources available for medical care for nursing home residents on a regular basis. Recommendations will be made for an improved organisation of primary care for nursing home residents. In addition, the results may provide important knowledge and data for the development and evaluation of further strategies to improve outpatient care for elderly care-receivers.

Trial registration

ClinicalTrials.gov NCT03426475. Initially registered on 7 February 2018.
Ensemble mobility predictor based on random forest and Markovian property using LBSN data
Authors: Araújo Felipe , Araújo Fábio , Machado Kássio , Rosário Denis , Cerqueira Eduardo , Villas Leandro A.
Published: November 2020

The ubiquitous connectivity of Location-Based Systems (LBS) allows people to share individual location-related data anytime. In this sense, Location-Based Social Networks (LBSN) provides valuable information to be available in large-scale and low-cost fashion via traditional data collection methods. Moreover, this data contains spatial, temporal, and social features of user activity, enabling a system to predict user mobility. In this sense, mobility prediction plays crucial roles in urban planning, traffic forecasting, advertising, and recommendations, and has thus attracted lots of attention in the past decade. In this article, we introduce the Ensemble Random Forest-Markov (ERFM) mobility prediction model, a two-layer ensemble learner approach, in which the base learners are also ensemble learning models. In the inner layer, ERFM considers the Markovian property (memoryless) to build trajectories of different lengths, and the Random Forest algorithm to predict the user’s next location for each trajectory set. In the outer layer, the outputs from the first layer are aggregated based on the classification performance of each weak learner. The experimental results on the real user trajectory dataset highlight a higher accuracy and f1-score of ERFM compared to five state-of-the-art predictors.
A case of aggressive aortic prosthetic valve endocarditis aggressive caused by Staphylococcus lugdunensis
Authors: Yamazaki Kazuhiro , Minakata Kenji , Sakamoto Kazuhisa , Sakai Jiro , Ide Yujiro , Kawatou Masahide , Kanemitsu Hideo , Ikeda Tadashi , Minatoya Kenji , Sakata Ryuzo
Published: November 2020

Background

Staphylococcus lugdunensis is a coagulase-negative Staphylococcus species, which are weak pathogenic bacteria generally. However, the acute and severe pathogenicity of Staphylococcus lugdunensis infective endocarditis may be due to the rapid growth of large vegetation and consequent valve destruction.

Case presentation

The patient was an 81-year-old male who visited our hospital with chief complaints of low back pain and high fever. Four years before this visit, he had undergone aortic valve replacement for aortic regurgitation. He was found to be hypotensive. Although there is no heart murmur on auscultation and echocardiography revealed negative findings with aortic valve, a blood test showed increases in the white blood cell count and C-reactive protein concentration. On the next day, Gram-positive cocci were detected in a blood culture and echocardiography detected a large vegetation on the prosthetic valve with increased flow velocity. Therefore, he underwent redo aortic valve replacement emergently. Staphylococcus lugdunensis was identified in blood samples and vegetation culture. Consequently, the patient was treated with antibiotics for 5 weeks after the operation and discharged home.

Conclusions

We experienced rapidly progressive prosthetic valve endocarditis caused by Staphylococcus lugdunensis. Hence, Staphylococcus lugdunensis infective endocarditis requires aggressive treatment, and the pathogenicity of this coagulase-negative Staphylococcus with high drug susceptibility should not be underestimated.
Pediatric tuina for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in preschool children: study protocol for a pilot randomized controlled trial
Authors: Chen Shu-Cheng , Yu Juan , Suen Lorna Kwai-Ping , Sun Yan , Pang Ya-Zheng , Wang Dong-Dong , Zhao Wen-Xia , Yeung Wing-Fai
Published: November 2020

Background

Medication and behavior therapy are the conventional treatments for attention deficit hyperactivity disorder (ADHD), but they have limitations for preschool children. Evidence suggests that pediatric tuina, which is a modality of traditional Chinese medicine, might have beneficial effects on this condition.

Objective

To assess the feasibility of conducting an RCT in terms of recruitment, use, and acceptability of the parent-administered pediatric tuina for ADHD symptoms in preschoolers.

Methods

It is a single-center, two-arm, parallel, open-label, pilot randomized controlled trial (RCT). Sixty children with pre-specified ADHD symptoms (hyperactivity, anxiety, and sleep disturbance) together with one of their parents will be recruited and randomized into two groups at a 1:1 ratio. Parents in the parent-administered tuina group (intervention group, n = 30) will attend an online training program to learn pediatric tuina skills for ADHD symptoms and conduct this treatment on their children at home. Parents in the parent-child interaction group (comparison group, n = 30) will attend an online training about progressive muscle relaxation exercise and do this exercise with their children at home. Additional teaching materials will be provided to the participants in both groups. Both interventions should be carried out every other day during a 2-month treatment period, with each time around 20 min. Assessment will be performed at baseline, week 4, and week 8. The primary outcome measure is the Swanson, Nolan, and Pelham parent scale; the secondary outcomes include preschool anxiety scale, children’s sleep habits questionnaire, and parental stress scale. A process evaluation embedded within the outcome evaluation will be performed. Differences in the scale scores and test parameters between groups will be examined using a linear mixed-effects model. Qualitative data will be analyzed using thematic content analysis, facilitated by QSR NVivo.

Discussion

This study will provide evidence on the acceptability and feasibility of pediatric tuina for ADHD in preschool children. The process evaluation will help to better understand the facilitators and barriers of the intervention functioning.

Trial registration

The study was registered at ClinicalTrials.gov (Identifier: NCT04237259) on 14 February 2020.

Protocol version: 2; date, 23 June 2020
Use of Sacubitril/valsartan in patients with cardio toxicity and heart failure due to chemotherapy
Authors: Gregorietti Vanesa , Fernandez Teresa Lopez , Costa Diego , Chahla Elías Ortega , Daniele Andrés J.
Published: November 2020

Background

Cancer therapy-related cardiac dysfunction (CTRCD) is a critical problem with an impact on both oncological and cardiovascular prognosis, especially when it prevents patients from receiving cancer treatment. Standard therapy for heart failure (HF) is recommended for CTRCD, but there is no well-established evidence on how sacubitril/valsartan may help cancer patients with cardiotoxicity.

Objectives

The aim of this trial was to study the effectiveness of sacubitril-valsartan in patients with CTRCD treated in cardio-oncology units.

Methods

We enrolled 635 patients with breast cancer and followed them with echocardiography and NT- proBNP. Patients who developed left ventricular dysfunction and heart failure were treated with angiotensin-converting enzyme inhibitors (ACEI) (enalapril) or angiotensin receptor blockers (ARB) (valsartan), aldosterone antagonists (eplerenone), digitalis and diuretics (furosemide), as needed. When patients remained symptomatic and met the PARADIGM-HF inclusion criteria, sacubitril/valsartan was started instead of enalapril or valsartan.

We analyzed clinical, laboratory and echocardiographic variables to determine the beneficial effects of sacubitril/valsartan on left ventricular remodeling (improvement of left ventricular ejection fraction (LVEF), left ventricle internal diameter in diastole), diastolic dysfunction (E/e’ ratio), reduction in NT-proBNP levels, New York Heart Association (NHYA) class and improvement in the 6-min walk test.

Also, we analyzed serum creatinine and potassium levels to determine treatmentsafety in this population. Median follow-up was 20 months.

Results

Twenty-eight patients developed cardiotoxicity and were treated with sacubitril/valsartan. The sacubitril/valsartan dose was 100 mg (sacubitril 49 mg/valsartan 51 mg) in 12 patients (42.85%) and 200 mg (sacubitril 97 mg/valsartan 103 mg) in 16 patients (57.15%). No deaths were reported, and one patient underwent heart transplantation.

Baseline median NT-proBNP was 997.5 pg/ml (IQR 663.8 — 2380.8), which decreased to a median of 416.5 pg/ml (IQR 192.0–798.2) on follow-up with p < 0.001.

Baseline NYHA functional class was III (78.6%) or IV (21.4%), and it improved to I (57.1%) or II (42.9%) on follow-up. LVEF increased with treatment from 26.7 ± 5.4% to 32.3 ± 5.5% (p < 0.001). There were also significant improvements in left ventricle internal diameter in diastole (LVIDD), diastolic function, 6-min walk test, and mitral valve regurgitation. There were no differences between basal and follow-up levels of serum creatinine or potassium.

Conclusion

Sacubitril/valsartan might be a promising treatment option in patients with refractory CTRCD.
Body Mass Index, Chemotherapy-Related Weight Changes, and Disease-Free Survival in Haitian Women With Nonmetastatic Breast Cancer
Authors: Fadelu Temidayo , Damuse Ruth , Lormil Joarly , Pecan Elizabeth , Greenberg Lauren , Dubuisson Cyrille , Pierre Viergela , Triedman Scott A. , Shulman Lawrence N. , Rebbeck Timothy R.
Published: November 2020

PURPOSE

Few studies have explored the relationship between body habitus and breast cancer outcomes in Caribbean women of African ancestry. This study evaluates the association between body mass index (BMI) and disease-free survival (DFS) in a retrospective cohort of 224 female Haitian patients with nonmetastatic breast cancer.

PATIENTS AND METHODS

BMI was obtained from the medical records and categorized as normal weight (< 25 kg/m2), overweight (25-29.9 kg/m2), and obese (≥ 30 kg/m2). DFS was defined as time from surgical resection to disease recurrence, death, or censoring. Kaplan-Meier survival curves were generated, and the association between BMI and DFS was evaluated using Cox proportional hazard models to control for multiple confounders. Exploratory analyses were conducted on weight changes during adjuvant chemotherapy.

RESULTS

Eighty-three patients (37.1%) were normal weight, 66 (29.5%) were overweight, and 75 (33.5%) were obese. There were no statistical differences in baseline characteristics or treatments received by BMI group. Twenty-six patients died and 73 had disease recurrence. Median DFS was 41.1 months. Kaplan-Meier estimates showed no significant DFS differences by BMI categories. After controlling for confounders, normal weight patients, when compared with overweight and obese patients, had adjusted hazard ratios of 0.85 (95% CI, 0.49 to 1.49) and 0.90 (95% CI, 0.52 to 1.55), respectively. Overall, mean weight loss of 2% of body weight was noted over the course of adjuvant chemotherapy. Patients who were postmenopausal ( P = .007) and obese ( P = .05) lost more weight than other groups. However, chemotherapy-related weight changes did not have an impact on DFS.

CONCLUSION

Baseline BMI and weight changes during adjuvant chemotherapy did not have an impact on DFS in this cohort. Future prospective studies in similar Caribbean breast cancer cohorts are needed to verify study findings.
Militant Ethics
Authors: Koutsourakis Angelos
Published: November 2020

The publication of Rainer Werner Fassbinder’s play Der Müll, die Stadt und der Tod (Garbage, the City, and Death; 1976) constitutes one of the major scandals in German cultural history. The play was accused of being anti-Semitic, because one of its key characters, a real estate speculator, was merely called the Rich Jew. Furthermore, some (negative) dramatis personae in the play openly express anti-Semitic views. When asked to respond, Fassbinder retorted that philo-Semites (in the West Germany of the time) are in fact anti-Semites, because they refuse to see how the victims of oppression can at times assume the roles and positions assigned to them by pernicious social structures. Fassbinder’s vilification on the part of the right-wing press prevented the play’s staging; subsequently, in 1984 and 1985–86 two Frankfurt productions were banned due to the reaction on the part of the local Jewish community. A similar controversy sparked off by the film adaptation of the play Shadow of Angels by Daniel Schmid. During the film’s screening at the Cannes Film Festival the Israeli delegation walked out, while there was also rumor of censorship in France. Gilles Deleuze wrote an article for Le Monde titled “The Rich Jew” defending the film and the director. Deleuze’s article triggered a furious reaction from Shoah (1985) director, Claude Lanzmann, who responded in Le Monde and attacked the cultural snobbery and “endemic terrorism” of the left-wing cinephile community. Lanzmann saw the film as wholly anti-Semitic and suggested that it identifies the Jew—all Jews—with money. While the author acknowledges the complexity of the subject, he revisits the debate and the film to unpack its ethical/aesthetic intricacy and propose a pathway that can potentially enable us to think of ways that political incorrectness can function as a means of exposing the persistence of historical and ethical questions that are ostentatiously resolved. He does this by drawing on Alain Badiou’s idea of militant ethics and Jacques Rancière’s redefinition of critical art as one that produces dissensus.
Emerging roles of non-coding RNAs in vector-borne infections
Authors: Bensaoud Chaima , Martins Larissa Almeida , Aounallah Hajer , Hackenberg Michael , Kotsyfakis Michail
Published: November 2020

Non-coding RNAs (ncRNAs) are nucleotide sequences that are known to assume regulatory roles previously thought to be reserved for proteins. Their functions include the regulation of protein activity and localization and the organization of subcellular structures. Sequencing studies have now identified thousands of ncRNAs encoded within the prokaryotic and eukaryotic genomes, leading to advances in several fields including parasitology. ncRNAs play major roles in several aspects of vector–host–pathogen interactions. Arthropod vector ncRNAs are secreted through extracellular vesicles into vertebrate hosts to counteract host defense systems and ensure arthropod survival. Conversely, hosts can use specific ncRNAs as one of several strategies to overcome arthropod vector invasion. In addition, pathogens transmitted through vector saliva into vertebrate hosts also possess ncRNAs thought to contribute to their pathogenicity. Recent studies have addressed ncRNAs in vectors or vertebrate hosts, with relatively few studies investigating the role of ncRNAs derived from pathogens and their involvement in establishing infections, especially in the context of vector-borne diseases. This Review summarizes recent data focusing on pathogen-derived ncRNAs and their role in modulating the cellular responses that favor pathogen survival in the vertebrate host and the arthropod vector, as well as host ncRNAs that interact with vector-borne pathogens.
Monitoring of Personnel Loyalty of Enterprises: Theoretical-Methodical and Applied Aspects
Authors: Milyaeva L.
Published: November 2020

The article argues for the circumstances that make it extremely urgent to diagnose and monitor staff loyalty in a crisis economy. Based on the results of a comparative critical analysis of known specialized methods, the need for developing a method suitable for monitoring loyalty is justified. The work clarified the conceptual aspects of staff loyalty assessment; presented the original methodology of a comprehensive loyalty analysis associated with identifying the level and profile of staff loyalty, diagnosing the level of well-being of the situation; describes the application aspects of its use in human resources management practices.
Transformation of Scientific and Technical Personnel Management System As a Key Factor for the Improvement of Hi-Tech Aerospace Company
Authors: Norova A.
Published: November 2020

The article describes major problems of R&D personnel management in the aerospace industry. This paper considers actual personnel policy of Russian research enterprise, which is one of the world is leading spacecraft companies.

Continued rapid growth of Industry 4.0 reveals the readiness of a modern society to accept new business conditions and use new ways of communication. The largest companies in each industry sector, in turn, are taking significant steps to reorganize technological processes, integrate new business mechanisms, as well as improve tools for managing resources, including human resources. Aerospace is undoubtedly the most high-tech manufacturing sector, which requires its participants to constantly develop innovative potential, develop new technical and technological solutions and their useful practical application. Therefore, the possibility of success in this area depends directly on scientists.

The author carried out a sociological research by polling R&D employees of this company and its findings revealed significant shortcomings of the existing personnel management system such as incorrect tools for assessing the innovative performance of R&D personnel. These shortcomings inhibit reaching the goals and aims of the company. Therefore, the main steps to improve the existing R&D personnel management system in the aerospace industry are proposed.
Amplifying Hope in Times of Despair: Introduction
Authors: McArthur-Blair Joan , Cockell Jeanie
Published: November 2020

Authors in this issue, from around the world, have contributed to finding hope in times of despair with writings from the deeply personal to the theoretical. In an April 2020 blog, David Cooperrider wrote, ‘It’s not about positive or negative human experience but inquiry into life: the task of AI is the quest and search for what gives life and deep meaning – even in the midst of the tragic.’ These articles join that quest.
The Art of Reframing: Conjuring Contemporary Covid-19 Words and Phrases
Authors: Kenny-Blanchard Sharon
Published: November 2020

This article provides insights into the contemporary terms and phrases used by government agencies’ and their protocols to manage Covid-19. The author considers whether the terms and phrases used could pose a current and future threat to our mental health and wellbeing, and posits the opportunity to reframe the moment, to begin to describe our time as sheltering in our home instead of being locked down in a bubble.
Dawn Work: Building a Relational Foundation for Appreciative Inquiry
Authors: de Witt Lorna , Lopez Kimberly , Dupuis Sherry L. , McAiney Carrie , Ploeg Jenny , Carson Jennifer
Published: November 2020

Appreciative Inquiry models identify diverse ways that AI initiatives may commence. Our Partnerships in Dementia Care Alliance AI early phase experience required a focus on key underlying relational processes, work that we call ‘Dawn,’ before we could begin. We identify and demonstrate these relational processes with examples from the PiDC Alliance culture change work on improving dementia care in diverse long-term and community healthcare settings.
Using Our Influence to Seek Safety and Connection Through Despair and Grief: A Conversation About the Impacts of Disease and Violence, and the Pathways of Hope and Healing
Authors: Using Our Influence Collective
Published: November 2020

This article is an exploration of Critical Appreciative Inquiry and the practice of appreciative resiliency in the face of violence, tragedy and Covid-19. We investigate, through video documentary, how sharing stories and sharing pain can create opportunities for hope, trust and resilience. We explore spaces of safety and connection where experiences of violence against women and girls can be prevented, heard or healed. Together we move from despair and hopelessness to healing, forgiveness and constructive action.
Reinventing Connection with Students and Families: Conversations Worth Having for Educators in the Midst of Covid-19
Authors: Emmart Michael , Emmart Jodi
Published: November 2020

The closure of schools due to Covid-19 and the resulting transition to home-based learning for children throughout the world left educators in despair about curricular goals, the limitations of technology and the wellbeing of their students. It was also an unprecedented opportunity for reinventing connection with families. The authors provided a series of free webinars using the Conversations Worth Having framework to support homeschool connections through the principles of Appreciative Inquiry.
EFL students’ attitudes towards learner autonomy in English vocabulary learning
Authors: Tran Thao Quoc
Published: November 2020

Whether EFL learners can use English well or not depends much on vocabulary they possess. Learner autonomy (LA), however, plays a pivotal role in amassing EFL learners’ vocabulary. This study endeavored to explore students’ attitudes towards LA in English vocabulary learning. Two hundred English majors from a Ho Chi Minh City based higher institution, Vietnam got involved in answering the closed-ended questionnaire, and ten students took part in semi-structured interviews. The findings indicated that participants were cognitively aware of the importance of LA in English vocabulary learning, but affectively and behaviorally they showed low interest in LA in English vocabulary learning. Such findings may shed light on how to improve the teaching and learning of the English language in general and English vocabulary in particular at the research context and other similar EFL contexts.