[Establishment and content validity assessment of evaluation index system for development value of traditional Chinese medicine preparations in medical institutions].

The development of traditional Chinese medicine(TCM) preparations as an incubator for new drugs in medical institutions has flourished, while an evaluation index system remains to be established for comprehensively assessing the development value of these prescriptions. This study established an item pool through literature research, employed the Delphi method to determine the content of evaluation indexes, and adopted the superiority chart to determine the weight of each index. Two-level evaluation index system for the development value of TCM preparations in medical institutions was established, which included 7 first-level items and 36 se-cond-level items, demonstrating scientific validity. The first-level items(weight) were inheritance(10.61%), effectiveness(23.22%), safety(22.71%), innovation(13.21%), economy(10.00%), suitability(8.57%), and accessibility(11.68%). The top three second-level items in terms of weight distribution were adverse reaction monitoring(6.73%), evidence of therapeutic effect(5.71%), and clinical response rate(4.75%). The bottom three second-level items were production advantages(0.86%), medicinal dosage(0.48%), and medicinal smell or taste(0.18%). The content validity of the established system was assessed, which revealed that the index system was reliable, with the overall and average content validity indexes of 0.47 and 0.90, respectively. Furthermore, the established evaluation index system was used to evaluate six TCM preparations in a city-level hospital of TCM in Sichuan Province, which demonstrated that the system had operability. The results indicate that the evaluation index system is scientific, reliable, and operable, providing a reference for developers to selectively develop TCM preparations in medical institutions. In practical application, the system can be adjusted regarding the index weights according to actual conditions.

Applying the Estimand Framework to Non­Inferiority Trials.

Most published applications of the estimand framework have focused on superiority trials. However, non-inferiority trials present specific challenges compared to superiority trials. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use notes in their addendum on estimands and sensitivity analysis in clinical trials that there may be special considerations to the implementation of estimands in clinical trials with a non-inferiority objective yet provides little guidance. This paper discusses considerations that trial teams should make when defining estimands for a clinical trial with a non-inferiority objective. We discuss how the pre-addendum way of establishing non-inferiority can be embraced by the estimand framework including a discussion of the role of the Per Protocol analysis set. We examine what clinical questions of interest can be formulated in the context of non-inferiority trials and outline why we do not think it is sensible to describe an estimand as 'conservative'. The impact of the estimand framework on key considerations in non-inferiority trials such as whether trials should have more than one primary estimand, the choice of non-inferiority margin, assay sensitivity, switching from non-inferiority to superiority and estimation are discussed. We conclude by providing a list of recommendations, and important considerations for defining estimands for trials with a non-inferiority objective.

Ecological niche contributes to the persistence of the western × glaucous-winged gull hybrid zone.

Hybrid zones occur in nature when populations with limited reproductive barriers overlap in space. Many hybrid zones persist over time, and different models have been proposed to explain how selection can maintain hybrid zone stability. More empirical studies are needed to elucidate the role of ecological adaptation in maintaining stable hybrid zones. Here, we investigated the role of exogenous factors in maintaining a hybrid zone between western gulls (Larus occidentalis) and glaucous-winged gulls (L. glaucescens). We used ecological niche models (ENMs) and niche similarity tests to quantify and examine the ecological niches of western gulls, glaucous-winged gulls, and their hybrids. We found evidence of niche divergence between all three groups. Our results support the bounded superiority model, providing further evidence that exogenous selection favoring hybrids may be an important factor in maintaining this stable hybrid zone.

Morality, Social Inclusion, and In-Group Superiority: The Differential Role of Individualizing and Binding Foundations in Perceptions of the Social Identity of In-Group and Out-Group Members.

Research into social identity and morality judgments typically focuses on how the former influences the latter. We approach this theme from the opposite direction, establishing the influence of morality on perceptions of social identity. In three studies, conducted in two cultures, we show that in-group members acting immorally are excluded from the group. Extending this investigation to the overlooked study of out-group-on-out-group behavior, in Studies 2 and 3, we compare perceptions of social inclusion for in-group members following (im)moral behavior toward the in-group with perceptions of out-group members following (im)moral behavior toward the out-group. We show that people treat in-group and out-group members alike with respect to binding morals, which concern preservation and protection of the group, but not individualizing morals, which concern preservation and protection of individual rights. Finally, in Study 3, we confirm the underlying motivating mechanism of reasserting in-group superiority by affirming the positive distinctiveness of one's own group.

Revisiting superiority and stability metrics of cultivar performances using genomic data: derivations of new estimators.

The selection of highly productive genotypes with stable performance across environments is a major challenge of plant breeding programs due to genotype-by-environment (GE) interactions. Over the years, different metrics have been proposed that aim at characterizing the superiority and/or stability of genotype performance across environments. However, these metrics are traditionally estimated using phenotypic values only and are not well suited to an unbalanced design in which genotypes are not observed in all environments. The objective of this research was to propose and evaluate new estimators of the following GE metrics: Ecovalence, Environmental Variance, Finlay-Wilkinson regression coefficient, and Lin-Binns superiority measure. Drawing from a multi-environment genomic prediction model, we derived the best linear unbiased prediction for each GE metric. These derivations included both a squared expectation and a variance term. To assess the effectiveness of our new estimators, we conducted simulations that varied in traits and environment parameters. In our results, new estimators consistently outperformed traditional phenotype-based estimators in terms of accuracy. By incorporating a variance term into our new estimators, in addition to the squared expectation term, we were able to improve the precision of our estimates, particularly for Ecovalence in situations where heritability was low and/or sparseness was high. All methods are implemented in a new R-package: GEmetrics. These genomic-based estimators enable estimating GE metrics in unbalanced designs and predicting GE metrics for new genotypes, which should help improve the selection efficiency of high-performance and stable genotypes across environments.

The word superiority effect overcomes crowding.

Crowding and the word superiority effect are two perceptual phenomena that influence reading. The identification of the inner letters of a word can be hindered by crowding from adjacent letters, but it can be facilitated by the word context itself (the word superiority effect). In the present study, strings of four-letters (words and non-words) with different inter-letter spacings (ranging from an optimal spacing to produce crowding to a spacing too large to produce crowding) were presented briefly in the periphery and participants were asked to identify the third letter of the string. Each word had a partner word that was identical except for its third letter (e.g., COLD, CORD) so that guessing as the source of the improved performance for words could be ruled out. Unsurprisingly, letter identification accuracy for words was better than non-words. For non-words, it was lowest at closer spacings, confirming crowding. However, for words, accuracy remained high at all inter-letter spacings showing that crowding did not prevent identification of the inner letters. This result supports models of "holistic" word recognition where partial cues can lead to recognition without first identifying individual letters. Once the word is recognized, its inner letters can be recovered, despite their feature loss produced by crowding.

Application of deep eutectic solvents on extraction of flavonoids.

Deep eutectic solvents (DESs), as a new type of eco-friendly solvent, have attracted increasing attention on the extraction and separation of flavonoid compounds from various samples, owing to their excellent properties such as biodegradability and ease of handling with very low toxicity. This article provides a status review of the applications of DESs in the extraction of flavonoids, including the introduction of flavonoid compounds, the properties and superiority of DESs, and extraction methods (ultrasonic-assisted extraction, heating reflux extraction, matrix solid-phase dispersion, and solid-phase extraction). Finally, prospects and challenges in the application of DESs on extraction and separation are extensively elucidated and critically reviewed.

Sentence superiority in the reading brain.

When a sequence of written words is briefly presented and participants are asked to identify just one word at a post-cued location, then word identification accuracy is higher when the word is presented in a grammatically correct sequence compared with an ungrammatical sequence. This sentence superiority effect has been reported in several behavioral studies and two EEG investigations. Taken together, the results of these studies support the hypothesis that the sentence superiority effect is primarily driven by rapid access to a sentence-level representation via partial word identification processes that operate in parallel over several words. Here we used MEG to examine the neural structures involved in this early stage of written sentence processing, and to further specify the timing of the different processes involved. Source activities over time showed grammatical vs. ungrammatical differences first in the left inferior frontal gyrus (IFG: 321-406 ms), then the left anterior temporal lobe (ATL: 466-531 ms), and finally in both left IFG (549-602 ms) and left posterior superior temporal gyrus (pSTG: 553-622 ms). We interpret the early IFG activity as reflecting the rapid bottom-up activation of sentence-level representations, including syntax, enabled by partly parallel word processing. Subsequent activity in ATL and pSTG is thought to reflect the constraints imposed by such sentence-level representations on on-going word-based semantic activation (ATL), and the subsequent development of a more detailed sentence-level representation (pSTG). These results provide further support for a cascaded interactive-activation account of sentence reading.

Confidence intervals for odds ratio from multistage randomized phase II trials.

A multi-stage randomized trial design can significantly improve efficiency by allowing early termination of the trial when the experimental arm exhibits either low or high efficacy compared to the control arm during the study. However, proper inference methods are necessary because the underlying distribution of the target statistic changes due to the multi-stage structure. This article focuses on multi-stage randomized phase II trials with a dichotomous outcome, such as treatment response, and proposes exact conditional confidence intervals for the odds ratio. The usual single-stage confidence intervals are invalid when used in multi-stage trials. To address this issue, we propose a linear ordering of all possible outcomes. This ordering is conditioned on the total number of responders in each stage and utilizes the exact conditional distribution function of the outcomes. This approach enables the estimation of an exact confidence interval accounting for the multi-stage designs.

Estimation of the odds ratio from multi-stage randomized trials.

A multi-stage design for a randomized trial is to allow early termination of the study when the experimental arm is found to have low or high efficacy compared to the control during the study. In such a trial, an early stopping rule results in bias in the maximum likelihood estimator of the treatment effect. We consider multi-stage randomized trials on a dichotomous outcome, such as treatment response, and investigate the estimation of the odds ratio. Typically, randomized phase II cancer clinical trials have two-stage designs with small sample sizes, which makes the estimation of odds ratio more challenging. In this paper, we evaluate several existing estimation methods of odds ratio and propose bias-corrected estimators for randomized multi-stage trials, including randomized phase II cancer clinical trials. Through numerical studies, the proposed estimators are shown to have a smaller bias and a smaller mean squared error overall.

Overlapping yet dissociable contributions of superiority illusion features to Ponzo illusion strength and metacognitive performance.

Humans are typically inept at evaluating their abilities and predispositions. People dismiss such a lack of metacognitive insight into their capacities while even enhancing (albeit illusorily) self-evaluation such that they should have more desirable traits than an average peer. This superiority illusion helps maintain a healthy mental state. However, the scope and range of its influence on broader human behavior, especially perceptual tasks, remain elusive. As belief shapes the way people perceive and recognize, the illusory self-superiority belief potentially regulates our perceptual and metacognitive performance. In this study, we used hierarchical Bayesian estimation and machine learning of signal detection theoretic measures to understand how the superiority illusion influences visual perception and metacognition for the Ponzo illusion. Our results demonstrated that the superiority illusion correlated with the Ponzo illusion magnitude and metacognitive performance. Next, we combined principal component analysis and cross-validated regularized regression (relaxed elastic net) to identify which superiority components contributed to the correlations. We revealed that the "extraversion" superiority dimension tapped into the Ponzo illusion magnitude and metacognitive ability. In contrast, the "honesty-humility" and "neuroticism" dimensions only predicted Ponzo illusion magnitude and metacognitive ability, respectively. These results suggest common and distinct influences of superiority features on perceptual sensitivity and metacognition. Our findings contribute to the accumulating body of evidence indicating that the leverage of superiority illusion is far-reaching, even to visual perception.

Niche and phenotypic differentiation in fern hybrid speciation, a case study of Pteris fauriei (Pteridaceae).

BACKGROUND AND AIMS: Niche differentiation is a crucial issue in speciation. Although it has a well-known role in adaptive processes of hybrid angiosperms, it is less understood in hybrid ferns. Here, we investigate whether an intermediate ecological niche of a fern hybrid is a novel adaptation that provides insights into fern hybrid speciation. METHODS: Pteris fauriei (Pteridaceae) is a natural hybrid fern, occurring in environments between its parent species. The maternal Pteris minor is found in sunny areas, but the habitat of the paternal Pteris latipinna is shady. We combined data from morphology, leaf anatomy and photosynthetic traits to explore adaptation and differentiation, along with measuring the environmental features of their niches. We also performed experiments in a common garden to understand ecological plasticity. KEY RESULTS: The hybrid P. fauriei was intermediate between the parent species in stomatal density, leaf anatomical features and photosynthetic characteristics in both natural habitats and a common garden. Interestingly, the maternal P. minor showed significant environmental plasticity and was more similar to the hybrid P. fauriei in the common garden, suggesting that the maternal species experiences stress in its natural habitats but thrives in environments similar to those of the hybrid. CONCLUSIONS: Based on the similar niche preferences of the hybrid and parents, we propose hybrid superiority. Our results indicate that the hybrid P. fauriei exhibits greater fitness and can compete with and occupy the initial niches of the maternal P. minor. Consequently, we suggest that the maternal P. minor has experienced a niche shift, elucidating the pattern of niche differentiation in this hybrid group. These findings offer a potential explanation for the frequent occurrence of hybridization in ferns and provide new insights into fern hybrid speciation, enhancing our understanding of fern diversity.

Acquisition of educational values at the Real Madrid Foundation's social-sports schools.

The objective of this study was to analyse the impact of the educational programme of the Real Madrid Foundation (RMF) on the acquisition of educational values at social-sports football and basketball schools among children aged between 12 and 16 years in Italy, Romania, Spain and the United Kingdom. The most significant results showed that: (a) between the 20-21 and 21-22 seasons, there were statistically significant increases in personal and team success, self-fulfilment, personal and group superiority, health and physical fitness, and peaceful behaviour; and (b) the increase in variables being studied was different according to the country analysed in such a way that: in the per-sonal and team success dimension there was a rise in the United Kingdom and Italy; in self-fulfilment there was an increase in the United Kingdom; in the personal and group superiority dimension there was a rise in Italy and Romania; in the health and physical fitness dimension there was an increase in social-sports schools in the United Kingdom and Italy; in the peaceful behaviour dimension there was a rise in social-sports schools in the United Kingdom and a drop in social-sports schools in Romania. There were very significant improvements in the majority of dimensions and countries, although the development of the various dimensions is different and specific to every one of the distinct countries, meaning that it is necessary to keep adapting the educational programme of the Real Madrid Foundation in line with the sociocultural characteristics of each of the countries in which it is implemented.

Are the tests overpowered or underpowered? A unified solution to correctly specify type I errors in design of clinical trials for two sample proportions.

As one of the most commonly used data types, methods in testing or designing a trial for binary endpoints from two independent populations are still being developed until recently. However, the power and the minimum required sample size comparisons between different tests may not be valid if their type I errors are not controlled at the same level. In this article, we unify all related testing procedures into a decision framework, including both frequentist and Bayesian methods. Sufficient conditions of the type I error attained at the boundary of hypotheses are derived, which help reduce the magnitude of the exact calculations and lay out a foundation for developing computational algorithms to correctly specify the actual type I error. The efficient algorithms are thus proposed to calculate the cutoff value in a deterministic decision rule and the probability value in a randomized decision rule, such that the actual type I error is under but closest to, or equal to, the intended level, respectively. The algorithm may also be used to calculate the sample size to achieve the prespecified type I error and power. The usefulness of the proposed methodology is further demonstrated in the power calculation for designing superiority and noninferiority trials.

Distinctiveness, not dual coding, explains the picture-superiority effect.

The picture-superiority effect is the finding that memory for pictures exceeds memory for words on many tasks. According to dual-coding theory, the pictures' mnemonic advantage stems from their greater likelihood to be labelled relative to words being imaged. In contrast, distinctiveness accounts hold that the greater variability of pictures compared to words leads to their mnemonic advantage. Ensor, Surprenant, et al. tested these accounts in old/new and forced-choice recognition by increasing the physical distinctiveness of words and decreasing the physical distinctiveness of pictures. Half of the words were presented in standard black font, and half were presented in varying font styles, font sizes, font colours, and capitalisation patterns. Half of the pictures were presented in black and white and half in colour. Consistent with the physical-distinctiveness account but contrary to the dual-coding account, the picture-superiority effect was eliminated when comparing the black-and-white pictures to distinctive words. In the present study, we extend Ensor, Surprenant, et al.'s results to associative recognition and free recall. Results were consistent with physical distinctiveness. We argue that dual-coding theory is no longer a viable explanation of the picture-superiority effect.

¿Ensayos clínicos de superioridad, equivalencia o no inferioridad? / ¿Clinical trials of superiority, non-inferiority or equivalence?

La eficacia de una nueva intervención se establece generalmente a través de ensayos clínicos (EC) con asignación aleatoria (AA). Sin embargo, entre otros tantos desafíos metodológicos, el especificar la hipótesis de un EC con AA, sigue siendo un problema complejo de resolver para los investigadores clínicos. En este manuscrito discutimos las características de tres variantes de los EC con AA: EC de superioridad (ECS), EC de no-inferioridad (ECNI), y EC de equivalencia (ECE). Estos tres tipos de EC tienen supuestos diferentes sobre los efectos de una intervención, por lo que plantear hipótesis y definir objetivos requiere conocer algunos supuestos subyacentes a estos EC, incluso hasta elementos relacionados con la estimación del tamaño de muestra para cada cual. El objetivo de este manuscrito fue describir las diferencias metodológicas entre ECS, ECNI y ECE.

Efficacy and effectivity of new interventions are generally established through randomized clinical trials (RCTs). However, among many other methodological challenges, specifying the hypothesis of a RCT remains complex problem for clinical researchers. In this manuscript we discuss the characteristics of three variants of RCTs: superiority RCT (SRCT), non-inferiority RCT (NIRCT), and equivalence RCT (ERCT). These three types of RCT have different assumptions about the effects of an intervention, so setting hypotheses and defining objectives requires knowing some assumptions underlying these RCTs, including elements related to the estimation of the sample size for each one. The aim of this manuscript was to describe methodological differences between SRCT, NIRCT and ERCT.

Adapting power calculations to include a superiority margin: what are the implications?

This paper examines the application of super-superiority margins in study power calculations. Unlike traditional power calculations, which primarily aim to reject the null hypothesis by any margin, a super-superiority margin establishes a clinically significant threshold. Despite potential benefits, this approach, akin to a non-inferiority calculation but in an opposing direction, is rarely used. Implementing a super-superiority margin separates the notion of the likely difference between two groups (the effect size) from the minimum clinically significant difference, without which inconsistent positions could be held. However, these are often used interchangeably. In an audit of 30 recent randomized controlled trial power calculations, four studies utilized the minimal acceptable difference, and nine utilized the expected difference. In the other studies, this was unclarified. In the post hoc scenario, this approach can shed light on the value of undertaking further studies, which is not apparent from the standard power calculation. The acceptance and rejection of the alternate hypothesis for super-superiority, non-inferiority, equivalence, and standard superiority studies have been compared. When a fixed minimal acceptable difference is applied, a study result will be in one of seven logical positions with regards to the simultaneous application of these hypotheses. The trend for increased trial size and the mirror approach of non-inferiority studies implies that newer interventions may be becoming less effective. Powering for superiority could counter this and ensure that a pre-trial evaluation of clinical significance has taken place, which is necessary to confirm that interventions are beneficial.

Age-dependent changes in the anger superiority effect: Evidence from a visual search task.

The perception of threatening facial expressions is a critical skill necessary for detecting the emotional states of others and responding appropriately. The anger superiority effect hypothesis suggests that individuals are better at processing and identifying angry faces compared with other nonthreatening facial expressions. In adults, the anger superiority effect is present even after controlling for the bottom-up visual saliency, and when ecologically valid stimuli are used. However, it is as yet unclear whether this effect is present in children. To fill this gap, we tested the anger superiority effect in children ages 6-14 years in a visual search task by using emotional dynamic stimuli and equating the visual salience of target and distractors. The results suggest that in childhood, the angry superiority effect consists of improved accuracy in detecting angry faces, while in adolescence, the ability to discriminate angry faces undergoes further development, enabling faster and more accurate threat detection.

Efficacy of Zhumian Tang formula granules combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial.

OBJECTIVE: To evaluate the efficacy and safety of Zhumian Tang formula granules combined with eszopiclone for treating poor sleep quality. METHODS: This multi-center, dynamic block-randomized, parallel-group superiority clinical trial included 130 patients. The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment, and the control group received eszopiclone treatment only. The group allocation ratio was 1∶1. The duration of treatment was 2 weeks. Participants were asked to complete questionnaires before treatment, after 1 week of the intervention, after 2 weeks of the intervention, and at the follow-up on week 3. The primary outcomes were the Pittsburgh Sleep Quality Index (PSQI) score and the total effective rate of treatment. The secondary outcome was the rate of adverse effects. RESULTS: Compared with the eszopiclone treatment group, the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention (6.98 vs 8.26, P < 0.05). However, there was no significant difference in the mean PSQI score after 1 week of the intervention (9.89 vs 9.15, P = 0.124). After the follow-up on week 3, the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group (6.12 vs 8.31, P < 0.001). The total effective rates of treatment of the combined group and the eszopiclone group were 36.92% vs 35.38% (Z = 0.033, P = 0.855) after 1 week of the intervention, 83.08% vs 58.46% (Z = 9.519, P < 0.05) after 2 weeks of the intervention, and 83.08% vs 61.54% (Z = 7.530, P < 0.05) and after the follow-up on week 3, respectively. There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups (21.53% vs 31.8%, P = 0.318). CONCLUSION: The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone. Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.

Quercetin stimulates an accelerated burst of oviposition-based reproductive strategy in codling moth controlled by juvenile hormone signaling pathway.

The advantageous characteristics of invasive pests, particularly their ability to reproduce and adapt to the environment, have been observed. However, it remains unclear what specific inherent superiority enables fruit pests to successfully invade and dominate in interactions with other species. In this study, we report that Cydia pomonella (Linnaeus), a notorious invasive pest of pome fruits and walnuts globally, employs unique reproductive strategies in response to quercetin, a plant compound in host fruits. By monitoring adult dynamics and fruit infestation rates, we observed a competitive relationship between C. pomonella and the native species Grapholita molesta (Busck). C. pomonella was able to occupy vacant niches to ensure its population growth. We also found that quercetin had different effects on the reproductive capacity and population growth of C. pomonella and G. molesta. While quercetin stimulated the fecundity and population growth of G. molesta, it inhibited C. pomonella. However, C. pomonella was able to rapidly increase its population after exposure to quercetin by adopting an 'accelerated burst' of oviposition strategy, with each individual making a greater reproductive contribution compared to the control. We further demonstrated that the effect of quercetin on oviposition is regulated by the juvenile hormone (JH) signaling pathway in C. pomonella, allowing it to prioritize survival. The enhanced reproductive fitness of G. molesta in response to quercetin is attributed to the regulation of JH titers and key genes such as Met and Kr-h1, which in turn up-regulate reproduction-related genes Vg and VgR. In contrast, C. pomonella is inhibited. These findings shed light on the mechanisms interspecific competition and help to improve our understanding of the global spread of C. pomonella, which can be attributed to its inherent superiority in terms of reproductive strategy.