On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical Trials

Due to ethical and logistical concerns it is common for data monitoring committees to periodically monitor accruing clinical trial data to assess the safety, and possibly efficacy, of a new experimental treatment. When formalized, monitoring is typically implemented using group sequential methods. In some cases regulatory agencies have required that primary trial analyses should be based solely on the judgment of an independent review committee (IRC). The IRC assessments can produce difficulties for trial monitoring given the time lag typically associated with receiving assessments from the IRC. This results in a missing data problem wherein a surrogate measure of response may provide useful information for interim decisions and future monitoring strategies. In this paper, we present statistical tools that are helpful for monitoring a group sequential clinical trial with missing IRC data. We illustrate the proposed methodology in the case of binary endpoints under various missingness mechanisms including missing completely at random assessments and when missingness depends on the IRC’s measurement.

Two Cases of Complicated Rectovaginal Fistula Treated by Hanging Line Method Were Reported and Reviewed in the Literature

This paper retrospectively analyzes the complicated rectovaginal fistula in 2 cases after the successful treatment. Through literatures collected, with the difficulties and contradictions of the treatment of complicated rectovaginal fistula as the starting point, the currently used hanging line method, the advantage and deficiency of surgical treatment in recent years, and the change of treatment method were reviewed. We wish to explore which current treatments could be a better choice.

Infiltration by monocytes of the central nervous system and its role in multiple sclerosis: reflections on therapeutic strategies

Mononuclear macrophage infiltration in the central nervous system is a prominent feature of neuroinflammation. Recent studies on the pathogenesis and progression of multiple sclerosis have highlighted the multiple roles of mononuclear macrophages in the neuroinflammatory process. Monocytes play a significant role in neuroinflammation, and managing neuroinflammation by manipulating peripheral monocytes stands out as an effective strategy for the treatment of multiple sclerosis, leading to improved patient outcomes. This review outlines the steps involved in the entry of myeloid monocytes into the central nervous system that are targets for effective intervention: the activation of bone marrow hematopoiesis, migration of monocytes in the blood, and penetration of the blood–brain barrier by monocytes. Finally, we summarize the different monocyte subpopulations and their effects on the central nervous system based on phenotypic differences. As activated microglia resemble monocyte-derived macrophages, it is important to accurately identify the role of monocyte-derived macrophages in disease. Depending on the roles played by monocyte-derived macrophages at different stages of the disease, several of these processes can be interrupted to limit neuroinflammation and improve patient prognosis. Here, we discuss possible strategies to target monocytes in neurological diseases, focusing on three key aspects of monocyte infiltration into the central nervous system, to provide new ideas for the treatment of neurodegenerative diseases.

TOWARDS EXPLORING WHEN AND WHAT PEOPLE REVIEWED FOR THEIR ONLINE SHOPPING EXPERIENCES

Web 2.0 technologies have attracted an increasing number of people with various backgrounds to become active online writers and viewers. As a result, exploring reviewers＇ opinions from a huge number of online reviews has become more important and simultaneously more difficult than ever before. In this paper, we first present a methodological framework to study the ＂purchasing-reviewing＂ behavior dynamics of online customers. Then, we propose a review-to-aspect mapping method to explore reviewers＇ opinions from the massive and sparse online reviews. The analytical and experimental results with real data demonstrate that online customers can be sectioned into groups in accordance with their reviewing behaviors and that people within the same group may have similar reviewing motivations and concerns for an online shopping experience.

Design and science:Content analysis of published peer-reviewed research over the last four decades

The relationship between design and science in architecture continually receives attention from scholars,but to our knowledge,no substantial and systematic literature reviews have been undertaken to generate insights into how the relationship between the two has developed in recent times.As most of the related debate remains theoretical,this paper presents evidence acquired through content analysis of selected 782 peer-reviewed papers published in the last four decades,a period in which design requirements continue to grow in complexity and research efforts increasingly concentrate on design methods.In response,this study departs from the two keywords,architectural science and building science,and develops search strings to support examination of the relationship between science and architectural design since the 1980s,when research that addresses the building environment started to intensify.The analysis employs tools based on machine learning algorithms for text analytics in combination with traditional content analysis methods.The presented research method is fully replicable and stands as one of the contributions of this study.The findings capture the expansion of the research context concerned with the built environment through a careful selection of defining terms,and generate an informed discussion on how the role of science in the architectural design process has changed.

Reviewer Locator模块在科技期刊中的应用实践与发展前景——以《中国肺癌杂志》为例

科技期刊作为科技传播的重要力量,其对重要科研成果的发布速度影响着科学技术的传播效力,而编辑工作效率直接决定稿件发表周期,提高编辑工作效率是科技期刊发展的推进器。为此,从同行评议审稿人储备和遴选方面入手,重点阐述如何准确高效地多维度遴选优质审稿人,归纳并探析Reviewer Locator模块在科技期刊办刊工作中的实际应用经验,助力出版业实现质量更好、效率更高的发展。

Colorectal cancer screening:A review of current knowledge and progress in research

Colorectal cancer(CRC)is one of the most prevalent malignancies worldwide,being the third most commonly diagnosed malignancy and the second leading cause of cancer-related deaths globally.Despite the progress in screening,early diagnosis,and treatment,approximately 20%-25%of CRC patients still present with metastatic disease at the time of their initial diagnosis.Furthermore,the burden of disease is still expected to increase,especially in individuals younger than 50 years old,among whom early-onset CRC incidence has been increasing.Screening and early detection are pivotal to improve CRC-related outcomes.It is well established that CRC screening not only reduces incidence,but also decreases deaths from CRC.Diverse screening strategies have proven effective in decreasing both CRC incidence and mortality,though variations in efficacy have been reported across the literature.However,uncertainties persist regarding the optimal screening method,age intervals and periodicity.Moreover,adherence to CRC screening remains globally low.In recent years,emerging technologies,notably artificial intelligence,and non-invasive biomarkers,have been developed to overcome these barriers.However,controversy exists over the actual impact of some of the new discoveries on CRC-related outcomes and how to effectively integrate them into daily practice.In this review,we aim to cover the current evidence surrounding CRC screening.We will further critically assess novel approaches under investigation,in an effort to differentiate promising inno-vations from mere novelties.

Association between physical activity and risk of gastroesophageal reflux disease:A systematic review and meta-analysis

Background:Lifestyle plays an important role in preventing and managing gastroesophageal reflux disease(GERD).In response to the conflicting results in previous studies,we performed a systematic review and meta-analysis to investigate this association.Methods:Relevant studies published until January 2023 were retrieved from 6 databases,and the prevalence of symptomatic gastroesophageal reflux(GER)or GERD was determined from the original studies.A random effects model was employed to meta-analyze the association by computing the pooled relative risk(RR)with 95%confidence intervals(95%CIs).Furthermore,subgroup and dose-response analyses were performed to explore subgroup differences and the association between cumulative physical activity(PA)time and GERD.Results:This meta-analysis included 33 studies comprising 242,850 participants.A significant negative association was observed between PA and the prevalence of symptomatic GER(RR=0.74,95%CI:0.66-0.83;p<0.01)or GERD(RR=0.80,95%CI:0.76-0.84;p<0.01),suggesting that engaging in PA might confer a protective benefit against GERD.Subgroup analyses consistently indicated the presence of this association across nearly all subgroups,particularly among the older individuals(RR_(<40 years):RR_(≥40 years)=0.85:0.69,p<0.01)and smokers(RR_(smoker):RR_(non-smoker)=0.67:0.82,p=0.03).Furthermore,a dose-response analysis revealed that individuals who engaged in 150 min of PA per week had a 72.09%lower risk of developing GERD.Conclusion:Maintaining high levels of PA decreased the risk of GERD,particularly among older adults and smokers.Meeting the recommended PA level of 150 min per week may significantly decrease the prevalence of GERD.

Systematic review and network meta-analysis of different nonsteroidal anti-inflammatory drugs for juvenile idiopathic arthritis

BACKGROUND Various non-steroidal anti-inflammatory drugs(NSAIDs)have been used for juvenile idiopathic arthritis(JIA).However,the optimal method for JIA has not yet been developed.AIM To perform a systematic review and network meta-analysis to determine the optimal instructions.METHODS We searched for randomized controlled trials(RCTs)from PubMed,EMBASE,Google Scholar,CNKI,and Wanfang without restriction for publication date or language at August,2023.Any RCTs that comparing the effectiveness of NSAIDs with each other or placebo for JIA were included in this network meta-analysis.The surface under the cumulative ranking curve(SUCRA)analysis was used to rank the treatments.P value less than 0.05 was identified as statistically significant.RESULTS We included 8 RCTs(1127 patients)comparing 8 different instructions including meloxicam(0.125 qd and 0.250 qd),Celecoxib(3 mg/kg bid and 6 mg/kg bid),piroxicam,Naproxen(5.0 mg/kg/d,7.5 mg/kg/d and 12.5 mg/kg/d),inuprofen(30-40 mg/kg/d),Aspirin(60-80 mg/kg/d,75 mg/kg/d,and 55 mg/kg/d),Tolmetin(15 mg/kg/d),Rofecoxib,and placebo.There were no significant differences between any two NSAIDs regarding ACR Pedi 30 response.The SUCRA shows that celecoxib(6 mg/kg bid)ranked first(SUCRA,88.9%),rofecoxib ranked second(SUCRA,68.1%),Celecoxib(3 mg/kg bid)ranked third(SUCRA,51.0%).There were no significant differences between any two NSAIDs regarding adverse events.The SUCRA shows that placebo ranked first(SUCRA,88.2%),piroxicam ranked second(SUCRA,60.5%),rofecoxib(0.6 mg/kg qd)ranked third(SUCRA,56.1%),meloxicam(0.125 mg/kg qd)ranked fourth(SUCRA,56.1%),and rofecoxib(0.3 mg/kg qd)ranked fifth(SUCRA,56.1%).CONCLUSION In summary,celecoxib(6 mg/kg bid)was found to be the most effective NSAID for treating JIA.Rofecoxib,piroxicam,and meloxicam may be safer options,but further research is needed to confirm these findings in larger trials with higher quality studies.

Neurophysiological, histological, and behavioral characterization of animal models of distraction spinal cord injury: a systematic review

Distraction spinal cord injury is caused by some degree of distraction or longitudinal tension on the spinal cord and commonly occurs in patients who undergo corrective operation for severe spinal deformity.With the increased degree and duration of distraction,spinal cord injuries become more serious in terms of their neurophysiology,histology,and behavior.Very few studies have been published on the specific characteristics of distraction spinal cord injury.In this study,we systematically review 22 related studies involving animal models of distraction spinal cord injury,focusing particularly on the neurophysiological,histological,and behavioral characteristics of this disease.In addition,we summarize the mechanisms underlying primary and secondary injuries caused by distraction spinal cord injury and clarify the effects of different degrees and durations of distraction on the primary injuries associated with spinal cord injury.We provide new concepts for the establishment of a model of distraction spinal cord injury and related basic research,and provide reference guidelines for the clinical diagnosis and treatment of this disease.

The influence of resistance exercise training prescription variables on skeletal muscle mass,strength,and physical function in healthy adults:An umbrella review

Purpose:The aim of this umbrella review was to determine the impact of resistance training(RT)and individual RT prescription variables on muscle mass,strength,and physical function in healthy adults.Methods:Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)guidelines,we systematically searched and screened eligible systematic reviews reporting the effects of differing RT prescription variables on muscle mass(or its proxies),strength,and/or physical function in healthy adults aged>18 years.Results:We identified 44 systematic reviews that met our inclusion criteria.The methodological quality of these reviews was assessed using A Measurement Tool to Assess Systematic Reviews;standardized effectiveness statements were generated.We found that RT was consistently a potent stimulus for increasing skeletal muscle mass(4/4 reviews provide some or sufficient evidence),strength(4/6 reviews provided some or sufficient evidence),and physical function(1/1 review provided some evidence).RT load(6/8 reviews provided some or sufficient evidence),weekly frequency(2/4 reviews provided some or sufficient evidence),volume(3/7 reviews provided some or sufficient evidence),and exercise order(1/1 review provided some evidence)impacted RT-induced increases in muscular strength.We discovered that 2/3 reviews provided some or sufficient evidence that RT volume and contraction velocity influenced skeletal muscle mass,while 4/7 reviews provided insufficient evidence in favor of RT load impacting skeletal muscle mass.There was insufficient evidence to conclude that time of day,periodization,inter-set rest,set configuration,set end point,contraction velocity/time under tension,or exercise order(only pertaining to hypertrophy)influenced skeletal muscle adaptations.A paucity of data limited insights into the impact of RT prescription variables on physical function.Conclusion:Overall,RT increased muscle mass,strength,and physical function compared to no exercise.RT intensity(load)and weekly frequency impacted RT-induced increases in muscular strength but not muscle hypertrophy.RT volume(number of sets)influenced muscular strength and hypertrophy.

The History of Controlling and Treating Infectious Diseases in Ancient China

Infectious diseases are the common enemies of mankind.In the course of historical development,they persistently threaten human health and safety.Even today,despite the developments in medical science,we cannot escape the fear and suffering caused by infectious diseases.Whether in ancient or modern times,the source of infection,route of transmission,and a susceptible population are the three key conditions for the prevalence and spread of infectious diseases.All factors closely related to these three conditions can affect the prevalence of infectious diseases.China is one of the cradles of world civilization.The ancient people accumulated a great deal of experience and lessons in the long struggle against infectious diseases.In the face of the current threat posed by widespread infectious disease,it is imperative to review and summarize ancient Chinese ideas and health policies on epidemic prevention and control to inspire contemporary efforts in the prevention and control of infectious disease.The combination of prevention-oriented epidemic prevention ideology and traditional medicine provides valuable insights,especially for impoverished and medically underserved regions.

Knee osteoarthritis:A review of animal models and intervention of traditional Chinese medicine

Background:Knee osteoarthritis(KOA)characterized by degeneration of knee cartilage and subsequent bone hyperplasia is a prevalent joint condition primarily affecting aging adults.The pathophysiology of KOA remains poorly understood,as it involves complex mechanisms that result in the same outcome.Consequently,researchers are interested in studying KOA and require appropriate animal models for basic research.Chinese herbal compounds,which consist of multiple herbs with diverse pharmacological properties,possess characteristics such as multicomponent,multipathway,and multitarget effects.The potential benefits in the treatment of KOA continue to attract attention.Purpose:This study aims to provide a comprehensive overview of the advantages,limitations,and specific considerations in selecting different species and methods for KOA animal models.This will help researchers make informed decisions when choosing an animal model.Methods:Online academic databases(e.g.,PubMed,Google Scholar,Web of Science,and CNKI)were searched using the search terms“knee osteoarthritis,”“animal models,”“traditional Chinese medicine,”and their combinations,primarily including KOA studies published from 2010 to 2023.Results:Based on literature retrieval,this review provides a comprehensive overview of the methods of establishing KOA animal models;introduces the current status of advantages and disadvantages of various animal models,including mice,rats,rabbits,dogs,and sheep/goats;and presents the current status of methods used to establish KOA animal models.Conclusion:This study provides a review of the animal models used in recent KOA research,discusses the common modeling methods,and emphasizes the role of traditional Chinese medicine compounds in the treatment of KOA.

Liquefaction susceptibility and deformation characteristics of saturated coral sandy soils subjected to cyclic loadings-a critical review

Coral sandy soils widely exist in coral island reefs and seashores in tropical and subtropical regions.Due to the unique marine depositional environment of coral sandy soils,the engineering characteristics and responses of these soils subjected to monotonic and cyclic loadings have been a subject of intense interest among the geotechnical and earthquake engineering communities.This paper critically reviews the progress of experimental investigations on the undrained behavior of coral sandy soils under monotonic and cyclic loadings over the last three decades.The focus of coverage includes the contractive-dilative behavior,the pattern of excess pore-water pressure(EPWP)generation and the liquefaction mechanism and liquefaction resistance,the small-strain shear modulus and strain-dependent shear modulus and damping,the cyclic softening feature,and the anisotropic characteristics of undrained responses of saturated coral sandy soils.In particular,the advances made in the past decades are reviewed from the following aspects:(1)the characterization of factors that impact the mechanism and patterns of EPWP build-up;(2)the identification of liquefaction triggering in terms of the apparent viscosity and the average flow coefficient;(3)the establishment of the invariable form of strain-based,stress-based,or energy-based EPWP ratio formulas and the unique relationship between the new proxy of liquefaction resistance and the number of cycles required to reach liquefaction;(4)the establishment of the invariable form of the predictive formulas of small strain modulus and strain-dependent shear modulus;and(5)the investigation on the effects of stress-induced anisotropy on liquefaction susceptibility and dynamic deformation characteristics.Insights gained through the critical review of these advances in the past decades offer a perspective for future research to further resolve the fundamental issues concerning the liquefaction mechanism and responses of coral sandy sites subjected to cyclic loadings associated with seismic events in marine environments.

Current status of magnetic resonance imaging radiomics in hepatocellular carcinoma:A quantitative review with Radiomics Quality Score

BACKGROUND Radiomics is a promising tool that may increase the value of magnetic resonance imaging(MRI)for different tasks related to the management of patients with hepatocellular carcinoma(HCC).However,its implementation in clinical practice is still far,with many issues related to the methodological quality of radiomic studies.AIM To systematically review the current status of MRI radiomic studies concerning HCC using the Radiomics Quality Score(RQS).METHODS A systematic literature search of PubMed,Google Scholar,and Web of Science databases was performed to identify original articles focusing on the use of MRI radiomics for HCC management published between 2017 and 2023.The methodological quality of radiomic studies was assessed using the RQS tool.Spearman’s correlation(ρ)analysis was performed to explore if RQS was correlated with journal metrics and characteristics of the studies.The level of statistical significance was set at P<0.05.RESULTS One hundred and twenty-seven articles were included,of which 43 focused on HCC prognosis,39 on prediction of pathological findings,16 on prediction of the expression of molecular markers outcomes,18 had a diagnostic purpose,and 11 had multiple purposes.The mean RQS was 8±6.22,and the corresponding percentage was 24.15%±15.25%(ranging from 0.0% to 58.33%).RQS was positively correlated with journal impact factor(IF;ρ=0.36,P=2.98×10^(-5)),5-years IF(ρ=0.33,P=1.56×10^(-4)),number of patients included in the study(ρ=0.51,P<9.37×10^(-10))and number of radiomics features extracted in the study(ρ=0.59,P<4.59×10^(-13)),and time of publication(ρ=-0.23,P<0.0072).CONCLUSION Although MRI radiomics in HCC represents a promising tool to develop adequate personalized treatment as a noninvasive approach in HCC patients,our study revealed that studies in this field still lack the quality required to allow its introduction into clinical practice.

Impact of frailty on outcomes of elderly patients undergoing percutaneous coronary intervention: A systematic review and metaanalysis

BACKGROUND Frailty is a common condition in elderly patients who receive percutaneous coronary intervention(PCI).However,how frailty affects clinical outcomes in this group is unclear.AIM To assess the link between frailty and the outcomes,such as in-hospital complic-ations,post-procedural complications,and mortality,in elderly patients post-PCI.METHODS The PubMed/MEDLINE,EMBASE,Cochrane Library,and Web of Science databases were screened for publications up to August 2023.The primary outcomes assessed were in-hospital and all-cause mortality,major adverse cardiovascular events(MACEs),and major bleeding.The Newcastle-Ottawa Scale was used for quality assessment.RESULTS Twenty-one studies with 739693 elderly patients undergoing PCI were included.Frailty was consistently associated with adverse outcomes.Frail patients had significantly higher risks of in-hospital mortality[risk ratio:3.45,95%confidence interval(95%CI):1.90-6.25],all-cause mortality[hazard ratio(HR):2.08,95%CI:1.78-2.43],MACEs(HR:2.92,95%CI:1.85-4.60),and major bleeding(HR:4.60,95%CI:2.89-7.32)compared to non-frail patients.CONCLUSION Frailty is a pivotal determinant in the prediction of risk of mortality,development of MACEs,and major bleeding in elderly individuals undergoing percutaneous coronary intervention.

打开同行评议的“黑匣子”:专家评审行为特征分析

传统同行评议制度由于数据不透明、缺乏监督等问题饱受诟病,开放同行评议为揭开同行评议的黑盒、加强同行评议过程监督、规范评审行为提供了契机。文章基于Open Review平台2017-2019年ICLR会议的2,534篇论文及7,602份专家评审意见,结合定量和定性的方法从专家自信度、评审模式和论文评议结果等3个维度分析专家的评审行为特征分布。研究发现:在专家自信度上,自信度高的评审专家更了解论文的研究内容,更能给出差异化的评审打分和针对性的评审意见;在评审模式上,相较于单盲评审,双盲评审模式下评审专家打分更加严格,更少提及论文语言表达方面的不足;在评审决议结果维度上,评审专家对论文核心内容的评价是决定论文最终评议的重要依据,在实验设计和原创水平方面得到更多正面评价的论文,更有可能获得更好的评审决议。文章从评审专家的遴选、评审模式的选择和评审指标的设置等3个方面提出建议,以提高同行评议质量、推动同行评议改革。

Research progress of ferroptosis regulating lipid peroxidation and metabolism in occurrence and development of primary liver cancer

As a highly aggressive tumor,the pathophysiological mechanism of primary liver cancer has attracted much attention.In recent years,factors such as ferroptosis regulation,lipid peroxidation and metabolic abnormalities have emerged in the study of liver cancer,providing a new perspective for understanding the development of liver cancer.Ferroptosis regulation,lipid peroxidation and metabolic abnormalities play important roles in the occurrence and development of liver cancer.The regulation of ferroptosis is involved in apoptosis and necrosis,affecting cell survival and death.Lipid peroxidation promotes oxidative damage and promotes the invasion of liver cancer cells.Metabolic abnormalities,especially the disorders of glucose and lipid metabolism,directly affect the proliferation and growth of liver cancer cells.Studies of ferroptosis regulation and lipid peroxidation may help to discover new therapeutic targets and improve therapeutic outcomes.The understanding of metabolic abnormalities can provide new ideas for the prevention of liver cancer,and reduce the risk of disease by adjusting the metabolic process.This review focuses on the key roles of ferroptosis regulation,lipid peroxidation and metabolic abnormalities in this process.

Chinese herbal medicine combined with Western medicine for Mycoplasma pneumoniae pneumonia in children:An overview of systematic reviews

Objective:To summarize the characteristics and evaluate the quality of the methodology and evidence within systematic reviews(SRs)of Chinese herbal medicine(CHM)for Mycoplasma pneumoniae pneumonia(MPP)inchildren.Methods:SRs of randomized controlled trials were searched using PubMed,the Cochrane Library,Embase,the Chinese National Knowledge Infrastructure Databases(CNKI),the Chinese Scientific Journals Database(VIP),Wanfang,and the SinoMed Database.SRs on the use of CHM alone or in combination with Western medications for MPP in children were included.The study compared the effects of Western medicine alone with those of CHM.The evidence quality using the A Measurement Tool to Assess Systematic Reviews(AMSTAR)2,the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)2020,and the Grading of Recommendations,Assessment,Development,and Evaluation(GRADE)criteria.The primary indicators were the total effective rate,fever subsidence time,and cough disappearance time.The secondary outcomes were pulmonary rale disappearance time,average hospitalization time,lung X-ray infiltrate disappearance time,immunological indices,and inflammatory cytokine levels.Results:Twelve relevant SRs were included;75%(9/12)were assessed as very low quality,and 25%(3/12)Were rated as low quality using the AMSTAR 2 criteria.According to the PRISMA 2020 checklist,the average SR score was 20.3 out of a 27 point maximum.In all SRs,CHM demonstrated improvement in symptoms and signs among children with MPP.The evidence quality using the GRADE criteria ranged from"very low"(>50%)to"moderate"(<5%).The most common downgrading factor was imprecision,followed by publication bias and inconsistency.Conclusion:This overview highlights the limited quality of the methodology and evidence of the included SRs.Although the included studies showed the beneficial effects of CHM on MPP in children,it was difficult to draw firm conclusions owing to methodological flaws.