Significant Finding
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PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0255093
Joyce M. Hoek ◽  
Sarahanne M. Field ◽  
Ymkje Anna de Vries ◽  
Maximilian Linde ◽  
Merle-Marie Pittelkow ◽  

Background Following testing in clinical trials, the use of remdesivir for treatment of COVID-19 has been authorized for use in parts of the world, including the USA and Europe. Early authorizations were largely based on results from two clinical trials. A third study published by Wang et al. was underpowered and deemed inconclusive. Although regulators have shown an interest in interpreting the Wang et al. study, under a frequentist framework it is difficult to determine if the non-significant finding was caused by a lack of power or by the absence of an effect. Bayesian hypothesis testing does allow for quantification of evidence in favor of the absence of an effect. Findings Results of our Bayesian reanalysis of the three trials show ambiguous evidence for the primary outcome of clinical improvement and moderate evidence against the secondary outcome of decreased mortality rate. Additional analyses of three studies published after initial marketing approval support these findings. Conclusions We recommend that regulatory bodies take all available evidence into account for endorsement decisions. A Bayesian approach can be beneficial, in particular in case of statistically non-significant results. This is especially pressing when limited clinical efficacy data is available.

2021 ◽  
Vol 11 (1) ◽  
Min-Hao Lo ◽  
Cheng-Hui Lin ◽  
Chi-Huan Wu ◽  
Yung-Kuan Tsou ◽  
Mu-Hsien Lee ◽  

AbstractEndoscopic retrograde cholangiopancreatography is not always successful even with needle knife precut sphincterotomy (NKPS). How to manage these patients with initial NKPS failure has not been well studied. We report the outcomes of patients who received endoscopic and non-endoscopic rescue treatment after the initial NKPS failure. During the 15 years from 2004 to 2018, 87 patients with initial NKPS failure received interval endoscopic treatment (IET group, n = 43), percutaneous transhepatic biliary drainage (PTBD group, n = 25), or bile duct surgery (BDS group, n = 19) were retrospectively studied. Compared with the PTBD group, the prevalence of choledocholithiasis was higher (69.8% vs. 16.0%, p < 0.001), and malignant bile duct stricture were lower (20.9% vs. 76.0%, p < 0.001) in the IET group. Furthermore, the IET group had a significantly longer time interval between the first and second treatment procedures (4 days vs. 2 days, p = 0.001), a lower technique success rate (79.1% vs. 100%, p = 0.021), and a shorter length of hospital stay (7 days vs. 18 days, p < 0.001). Compared to the BDS group, the only significant finding was that the patients in the IET group were older. Although not statistically significant, the complication rate was lowest in the IET group (7.0%) while highest in the BDS group (15.8%). Complications in the IET group were also mild, as compared with the other two groups. In conclusion, IET should be considered after initial failed NKPS for deep biliary cannulation before contemplating more invasive treatment such as BDS. PTBD may be the alternative therapy for patients with malignant biliary obstruction.

Cristina M. Farkas-Skiles ◽  
Robert B. Ettenger ◽  
Jonathan E. Zuckerman ◽  
Meghan Pearl ◽  
Robert S. Venick ◽  

Abstract Background We propose a novel clinically significant finding, de novo lupus-like glomerulonephritis (DNLLGN), in patients with autoantibodies and kidney abnormalities in pediatric liver transplant (LT) and intestinal inclusive transplants (ITx). Methods We describe the clinical, serologic, and histopathologic presentation and kidney outcomes in eight patients from our center found to have DNLLGN on kidney biopsy. Results Pediatric recipients of non-kidney solid organ transplants developed an unusual de novo immune complex glomerulonephritis with morphologic similarity to lupus nephritis. Six had isolated LT (0.9% of all pediatric LT at our center) and two had ITx (2.1% of all ITx). Five (63%) presented with nephrotic syndrome. Five patients had autoantibodies. Patients underwent kidney biopsy at a mean of 11.5 years in LT and 2.8 years in ITx after the index transplant. Biopsies demonstrated changes similar to focal or diffuse active lupus. Follow-up eGFR at a mean of 6 years after biopsy showed a mean decrease of 30 ml/min/1.73 m2 in all patients (p = 0.11). Conclusions DNLLGN has not been previously recognized in this clinical setting, yet 8 kidney biopsies from pediatric recipients of LT and ITx at our center in 25 years demonstrated this finding. DNLLGN appears to be an under-reported phenomenon of clinical significance. Graphical abstract

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Masood Tadi ◽  
Irina Kortchemski

Purpose This paper aims to demonstrate a dynamic cointegration-based pairs trading strategy, including an optimal look-back window framework in the cryptocurrency market and evaluate its return and risk by applying three different scenarios. Design/methodology/approach This study uses the Engle-Granger methodology, the Kapetanios-Snell-Shin test and the Johansen test as cointegration tests in different scenarios. This study calibrates the mean-reversion speed of the Ornstein-Uhlenbeck process to obtain the half-life used for the asset selection phase and look-back window estimation. Findings By considering the main limitations in the market microstructure, the strategy of this paper exceeds the naive buy-and-hold approach in the Bitmex exchange. Another significant finding is that this study implements a numerous collection of cryptocurrency coins to formulate the model’s spread, which improves the risk-adjusted profitability of the pairs trading strategy. Besides, the strategy’s maximum drawdown level is reasonably low, which makes it useful to be deployed. The results also indicate that a class of coins has better potential arbitrage opportunities than others. Originality/value This research has some noticeable advantages, making it stand out from similar studies in the cryptocurrency market. First is the accuracy of data in which minute-binned data create the signals in the formation period. Besides, to backtest the strategy during the trading period, this study simulates the trading signals using best bid/ask quotes and market trades. This study exclusively takes the order execution into account when the asset size is already available at its quoted price (with one or more period gaps after signal generation). This action makes the backtesting much more realistic.

2021 ◽  
pp. 089826432110313
Karlene K. Ball ◽  
Olivio J. Clay ◽  
Jerri D. Edwards ◽  
Bernadette A. Fausto ◽  
Katie M. Wheeler ◽  

Objective: This study aims to examine indicators of crash risk longitudinally in older adults ( n = 486). Method: This study applied secondary data analyses of the 10 years of follow-up for the ACTIVE study combined with state-recorded crash records from five of the six participating sites. Cox proportional hazards models were first used to examine the effect of each variable of interest at baseline after controlling for miles driven and then to assess the three cognitive composites as predictors of time to at-fault crash in covariate-adjusted models. Results: Older age, male sex, and site location were each predictive of higher crash risk. Additionally, worse scores on the speed of processing cognitive composite were associated with higher crash risk. Discussion: Results support previous findings that both age and male sex are associated with higher crash risk. Our significant finding of site location could be attributed to the population density of our testing sites and transportation availability.

2021 ◽  
Vol 8 ◽  
Diana X. Cao ◽  
Kimberly Maiton ◽  
Javed M. Nasir ◽  
N. A. Mark Estes ◽  
Sachin A. Shah

An increasing number of cardiovascular adverse effects, emergency room visits, and deaths have been linked to energy drinks. In this review, we summarized available published literature assessing electrophysiological and ischemic adverse effects associated with energy drink consumption. Overall, 32 case reports and 19 clinical trials are included in this review. Ventricular arrhythmia, supraventricular arrhythmia, and myocardial ischemia were amongst the most commonly reported in case reports with 3 having a fatal outcome. Although serious ischemic changes, arrhythmias, or death were not observed in clinical trials, significant electrophysiological changes, such as PR/PQ interval shortening/prolongation, QT/QTc shortening/prolongation, and ST-T changes, were noted. QT/QTc interval prolongation appears to be the most significant finding in clinical trials, and there appears to be a dose-response relationship between energy drink consumption and QTc prolongation. The exact mechanisms and the particular combination of ingredients behind energy drink-induced cardiac abnormalities require further evaluation. Until more information is available, energy drink use should be considered as part of the differential diagnosis in appropriate patients presenting with electrocardiographic changes. Further, certain patient populations should exercise caution and limit their energy drink consumption.

2021 ◽  
Ashley Renae Chin Aleong ◽  
Rodney R. Jagai

Abstract Incineration is a method of waste management, which is quickly taking a prominent role in munic ipa l authorities all over the world. The introduction of smokeless incinerators aids in decreasing adverse environmental impacts, making this technology a viable alternative to landfills. Modern designs and advancements in incineration processes focus on enhancements in energy efficiency and reductions in emissions of CO2, thus creating an avenue for sustainable energy. It is a means to combat organic substances in waste and separate dangerous gases and particulates from flue gas. Modern incinerators have efficient emission control systems that use multiple techniques for the elimination, at source, of potentially hazardous emissions and automatically control the rate of combustion. Smokeless combustion can be achieved through a combination of temperature, time and turbulence. The range of test incinerators used for this study covers a broad spectrum of usage reduces munic ipa l solid waste to a mere 0.3% of its original state. Reductions in CO2 are directly correlated to decreases in the amount of waste to be transported to off-site landfills, thus reducing the number of trips to and from same. Such reductions are in tandem with the goal of carbon neutrality, or rather, carbon net-zero, which requires the sequestration of an equal amount of CO2 produced. Comparisons are provided for reductions of CO2 as a result of the reduction in the burning of diesel by backload refuse trucks. Case studies are presented for communities with a significant general waste generation where CO2 emission from the waste pickup and transport to and from landfills are compared to that of CO2 emissions after the installation of a smokeless incinerator unit in a central community area. The most significant finding is that CO2 emissions are reduced by approximately 50% in most cases, with the introduction of these units. The introduction of these smokeless incinerator units can combat waste management woes in a shorter space of time, in parallel with achieving environmental targets such as that of Carbon Neutrality.

2021 ◽  
Vol 35 (3) ◽  
pp. 31-36
Fatima Khalid

Introduction: Ovarian teratomas include mature cystic teratoma (MCT), immature teratoma (IT) and monodermal teratoma (MoT). Malignant transformation (MT) can occur in MCT and MoT, which remains a diagnostic challenge. Aims & Objectives: To discuss the morphological spectrum of ovarian teratomas reported during the last six years at our specialized diagnostic institute and determine the frequency of MT in MCT and MoT. Place and duration of study: The study was carried out at Chughtai Institute of Pathology from January 2015 to December 2020. Material & Methods: A retrospective study was performed by retrieving 1018 cases of ovarian teratomas reported in last 6 years. SPSS version 20 was used for data analysis. Results: MCT was most frequent ovarian teratoma with frequency of 95.6% (n=973), 2.26% (n=23) being IT and 2.16% (n=22) being MoT. IT were mostly seen in pediatric age group. MT in benign MCT was seen in 0.72% of MCT (n=7). Squamous cell carcinoma was most frequent malignancy 71.4% (n=5). One case of MoT also showed MT into papillary thyroid carcinoma, classic type, with frequency of MT in Mot being 4.76% (n=1). All MT in MCT had age >30 years which was a significant finding (p <0.001). Conclusion: Ovarian masses in postmenopausal patients with suspicious radiological features, irrespective of lesional size warrant a thorough gross examination, extensive sampling and a careful microscopic evaluation.

Debra A. Dickson ◽  
Laura Gantt ◽  
Melvin Swanson

BACKGROUND Restraint and seclusion continue to be used with patients demonstrating aggressive and violent behaviors while in the emergency department and as inpatients in behavioral health (BH) units. The use of sensory interventions such as the weighted blanket (WB) is garnering interest as alternatives to aid in managing anxiety, anger, and aggressive behaviors. Reports of the effectiveness of the WB have primarily been anecdotal, and results of research with children have been mixed. Only one study has been conducted with the WB with adults on an inpatient psychiatric unit. OBJECTIVES The aim of this pilot study was to assess the effectiveness of the WB by determining whether it decreases anxiety and/or anger in adult emergency department patients with preexisting psychiatric diagnoses. METHODS The study used a quasi-experimental, nonequivalent control group design with pre- and posttests for anxiety and anger. The intervention was a 15-pound WB. Participants ( N = 15) were in one of three groups, which included no weighted blanket (NWB), WB for 15 minutes, or WB for 30 minutes. RESULTS All three groups showed a decrease in anxiety and anger scores. However, participants in the WB groups had a greater decrease in anxiety and anger posttest scores. CONCLUSIONS The small sample size in this study did not allow for the determination of any differences between groups on anxiety or anger scores that could be viewed as a significant finding.

Zeynep Çetin Köroğlu

As it is known formative assessment focuses on both the learning process and learner's performance. In this study digital formative assessment and traditional speaking tests were utilized comparatively to evaluate 52 upper-intermediate EFL learners' English language speaking skills. The study was designed as a mixed-method. The quantitative data were collected via achievement tests which had been administered both in traditional speaking tests and digital formative tests. The qualitative findings were collected with students' interviews which consisted of four open-ended questions. The results of the study showed that participants outperformed in digital formative tests in comparison to traditional speaking tests. Another significant finding of the study is that participants are satisfied with the digital formative assessments in terms of peer collaboration during tests, enriched test materials, and preparation time for the speaking test. Although they have positive views on digital formative assessment, participants are dissatisfied with it in terms of technical problems that they encountered during the administration of digital formative tests.

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