Randomized Controlled Trials and Ph.D. Level Training in Educational Research

This invited paper reviews recent initiatives in teaching about randomized field trials at the graduate level in education research. Reports in a book on randomized trials by Mosteller and Boruch are used as a benchmark. The initiatives have been driven heavily by recent governmental emphasis on ＂evidence based policy＂ in education, criminology, welfare and other sectors. This policy has been backed, in the US at least, by substantial investments in mounting randomized controlled trials to evaluate curriculum packages and programs in grades K-12, crime prevention programs, welfare, and other work. Accelerated growth in randomized trials has entailed cross discipline pre-doctoral and post-doctoral institutes and graduate education programs aimed at enhancing the quality in trial design, execution, and analysis of results. Specific illustrations of graduate education in this area of statistics are taken mainly from experience at the University of Pennsylvania＇s Graduate School of Education and selected other institutions.

RESEARCH ANNOUNCEMENTS——Random Attractors for a Dissipative Quasi-geostrophic Dynamical System Under Stochastic Forcing

We consider the two-dimensional stochastic quasi-geostrophic equation ■=1/(R_e)△~2■-r/2△■+f(x,y,t)(1.1) on a regular bounded open domain D ■,where ■ is the stream function,F Froude Number (F≈O(1)),R_e Reynolds number(R_e■10~2),β_0 a positive constant(β_0≈O(10^(-1)),r the Ekman dissipation constant(r≈o(1)),the external forcing term f(x,y,t)=-(dW)/(dt)(the definition of W will be given later)a Gaussian random field,white noise in time,subject to the

Incisional Negative Pressure Wound Therapy in the Prevention of Surgical Site Infection after Vascular Surgery with Inguinal Incisions: Rationale and Design of a Randomized Controlled Trial (INVIPS-Trial)

Background/Aims: Inguinal incisions are a common route of access in vascular surgery. Due to anatomical challenges and a diverse bacterial flora in this area, surgical site infections (SSI) represent a common, debilitating and sometimes life-threatening complication. The INVIPS-Trial evaluates the role of Negative Pressure Wound Therapy (NPWT) on closed inguinal incisions in elective vascular surgery to prevent SSI and other wound complications. Methods: This randomized controlled trial (RCT) registered at ClinicalTrials.gov (Identifier: NCT01913132) compares the effects of a NPWT dressing (PICO, Smith & Nephew, UK) and the center’s standard wound dressing (Vitri Pad, ViTri Medical, Sweden) on postoperative wound complications, especially SSI. The study includes two distinct vascular procedures with different SSI risk profiles: endovascular aortic repair (EVAR) and open surgical approaches involving the common femoral artery (OPEN). Results: Four hundred ninety-five groin incisions in both treatment arms are anticipated to be included in the EVAR group and 147 inguinal incisions in both treatment arms in the OPEN group. Since a large percentage of inguinal vascular procedures in both groups but especially in the EVAR group are performed bilaterally, many patients can serve as their own control by randomly receiving NPWT on one and the standard dressing on the contralateral inguinal incision. Conclusions: This ongoing RCT attempts to elucidate the potential benefit of NPWT on closed inguinal incisions after different vascular procedures. Outcome and conclusions of this trial could have implications on postoperative wound care of patients in both vascular surgery and other surgical specialties.

Optimization study of station track utilization in high-speed railroad based on constraints of control in random origin and process

Purpose-The purpose of this paper is to eliminate the fluctuations in train arrival and departure times caused by skewed distributions in interval operation times.These fluctuations arise from random origin and process factors during interval operations and can accumulate over multiple intervals.The aim is to enhance the robustness of high-speed rail station arrival and departure track utilization schemes.Design/methodologylapproach-To achieve this objective,the paper simulates actual train operations,incorporating the fluctuations in interval operation times into the utilization of arrival and departure tracks at the station.The Monte Carlo simulation method is adopted to solve this problem.This approach transforms a nonlinear model,which includes constraints from probability distribution functions and is difficult to solve directly,into a linear programming model that is easier to handle.The method then linearly weights two objectives to optimize the solution.Findings-Through the application of Monte Carlo simulation,the study successfully converts the complex nonlinear model with probability distribution function constraints into a manageable linear programming model.By continuously adjusting the weighting coefficients of the linear objectives,the method is able to optimize the Pareto solution.Notably,this approach does not require extensive scene data to obtain a satisfactory Pareto solution set.Originality/value-The paper contributes to the field by introducing a novel method for optimizing high-speed rail station arrival and departure track utilization in the presence of fluctuations in interval operation times.The use of Monte Carlo simulation to transform the problem into a tractable linear programming model represents a significant advancement.Furthermore,the method's ability to produce satisfactory Pareto solutions without relying on extensive data sets adds to its practical value and applicability in real-world scenarios.

Construction of databases:advances and significance in clinical research

Widely used in clinical research, the database is a new type of data management automation technology and the most efficient tool for data management. In this article, we first explain some basic concepts, such as the definition, classification, and establishment of databases. Afterward, the workflow for establishing databases, inputting data, verifying data, and managing databases is presented. Meanwhile, by discussing the application of databases in clinical research, we illuminate the important role of databases in clinical research practice. Lastly, we introduce the reanalysis of randomized controlled trials(RCTs) and cloud computing techniques, showing the most recent advancements of databases in clinical research.

IESRL:An information extraction system for research level

Purpose:In order to annotate the semantic information and extract the research level information of research papers,we attempt to seek a method to develop an information extraction system.Design/methodology/approach:Semantic dictionary and conditional random field model(CRFM)were used to annotate the semantic information of research papers.Based on the annotation results,the research level information was extracted through regular expression.All the functions were implemented on Sybase platform.Findings:According to the result of our experiment in carbon nanotube research,the precision and recall rates reached 65.13%and 57.75%,respectively after the semantic properties of word class have been labeled,and F-measure increased dramatically from less than 50%to60.18%while added with semantic features.Our experiment also showed that the information extraction system for research level(IESRL)can extract performance indicators from research papers rapidly and effectively.Research limitations:Some text information,such as that of format and chart,might have been lost due to the extraction processing of text format from PDF to TXT files.Semantic labeling on sentences could be insufficient due to the rich meaning of lexicons in the semantic dictionary.Research implications:The established system can help researchers rapidly compare the level of different research papers and find out their implicit innovation values.It could also be used as an auxiliary tool for analyzing research levels of various research institutions.Originality/value:In this work,we have successfully established an information extraction system for research papers by a revised semantic annotation method based on CRFM and the semantic dictionary.Our system can analyze the information extraction problem from two levels,i.e.from the sentence level and noun(phrase)level of research papers.Compared with the extraction method based on knowledge engineering and that on machine learning,our system shows advantages of the both.

瘀滞型肩关节周围炎中医优化方案筛选研究

目的基于随机对照试验进行中医临床治疗优化方案的筛选研究,明确中医治疗瘀滞型肩关节周围炎的最佳临床方案。方法选取2020年6月-2021年12月在长春中医药大学附属医院门诊就诊的瘀滞型肩关节周围炎患者99例,随机分为A、B、C组,3组常规进行推拿及功能锻炼治疗,在此基础上A组联合药物疗法,B组联合针灸疗法,C组联合药物疗法及针灸疗法,疗程2周,于治疗后1周、2周及3个月对患者进行随访。以视觉模拟标尺评分(visual analogue scale,VAS评分)、Constant-Murley肩关节评分量表、肩关节活动范围、红细胞沉降率(erythrocyte sedimentation rate,ESR)及生化指标评价疗效和安全性。结果共92例患者完成研究。相较于本组治疗前,3组在治疗后1周、2周及3个月VAS评分、Constant-Murley肩关节评分、肩关节活动范围有显著改善(P<0.05),完成治疗后ESR有显著改善(P<0.05),肝肾生化指标无统计学意义(P>0.05)。3组组间比较,治疗后1周疗效无统计学意义(P>0.05),C组2周后及3个月效果明显优于A、B组(P<0.05)。完成治疗后的ESR及肝肾生化指标水平无统计学意义(P>0.05)。3组均未发现严重不良事件,不良反应发生率3组比较,差异无统计学意义(P>0.05)。结论针刺、中药内服及外用等疗法对于瘀滞型肩关节周围炎患者的疼痛和活动受限具有显著疗效,能明显地提高患者的生活质量,综合应用中医治疗手段2周后的中远期疗效明显优于单一手段。

混合式教学随机对照试验研究的医学教育论文质量分析

目的 分析我国医学教育领域混合式教学随机对照试验研究的期刊论文质量,以规范混合式教学随机对照试验研究论文的写作和提高混合式教学随机对照试验研究论文的水平。方法 在中国知网、万方数据知识服务平台、维普网、Scopus数据库检索相关论文,共纳入自建库起至2023年12月31日发表的我国医学教育领域混合式教学随机对照试验研究论文73篇。参考CONSORT规范的条目自制论文质量分析量表。量表包含5个主题内容22个条目:文题和摘要主题(含2个条目)、引言主题(含2个条目)、方法主题(含13个条目)、结果主题(含3个条目)、讨论和其他主题(含2个条目)。若论文中具有符合或描述此条目的内容,计1分,否则计0分,各条目的评分相加得出论文的总分。同时,比较核心期刊论文与非核心期刊论文、双一流高校论文与非双一流高校论文之间的评分差异。结果 本研究最终纳入73篇中文论文进行分析。73篇论文整体评分为(12.02±3.79)分,最低评分为5分,最高评分为17分。在22个条目中,有10个条目的论文符合率低于50.0%。其中,以下5个条目中的论文符合率最低:“文题能够识别是随机对照试验”和“随机化后脱落的例数和原因”的论文符合率均为0%;“研究所需要的样本量”的论文符合率为1.4%(1/73);“受试者合格的纳入标准”的论文符合率为13.7%(10/73);“随机序列产生的方法”的论文符合率为21.9%(16/73)。核心期刊论文与非核心期刊论文(t=0.304,P=0.605)、双一流高校论文与非双一流高校论文(t=1.674,P=0.532)之间的评分差异均无统计学意义。结论 我国医学教育领域混合式教学随机对照试验研究的论文整体质量不高。其中,研究者对“文题能够识别是随机对照试验”、“随机化后脱落的例数和原因”、“研究所需要的样本量”、“受试者合格的纳入标准”和“随机序列产生的方法”等条目描述得较少,需要研究者在研究设计、研究实施和论文写作阶段都予以重视并加以改进。

随机配置网络研究进展

随机配置网络(stochastic configuration network,SCN)是一种新兴的增量式神经网络模型,与其他随机化神经网络方法不同,它能够通过监督机制进行隐含层节点参数配置,保证了模型的快速收敛性能.因其具有学习效率高、人为干预程度低和泛化能力强等优点,自2017年提出以来,SCN吸引了大量国内外学者的研究兴趣,得到了快速的推广和发展.从SCN的基础理论、典型算法变体、应用领域以及未来研究方向等方面切入,全面地概述SCN研究进展.首先,从理论的角度分析SCN的算法原理、通用逼近性能及其优点;其次,重点研究深度SCN、二维SCN、鲁棒SCN、集成SCN、分布式并行SCN、正则化SCN等典型变体;随后介绍SCN在硬件实现、计算机视觉、医学数据分析、故障检测与诊断、系统建模预测等不同领域的应用进展;最后指出SCN在卷积神经网络架构、半监督学习、无监督学习、多视图学习、模糊神经网络、循环神经网络等研究方向的发展潜力.

近十年电针治疗失眠的临床研究综述

目的:评述近十年电针治疗失眠的临床研究现状。方法:检索国家知识基础设施数据库(CNKI)、中国生物医学文献数据库(CBM)、中国学术期刊数据库(CSPD)及中文科技期刊数据库(CCD)、PubMed、Cochrane Library、Embase关于电针治疗失眠的随机对照试验。检索年限从2012年1月1日至2021年12月31日。提取文献诊断标准、治疗方法、腧穴选择与归经、电针参数、治疗时间与疗程、疗效观察指标等。结果:共纳入文献55篇。研究发现电针治疗失眠干预手段主要分为单纯使用电针、电针配合其他外治法、电针配合口服药3类。诊断标准及疗效评价指标的使用缺乏统一标准,治疗方法差异较大,实验设计不够完善。选取穴位以足太阳膀胱经、督脉、足少阳胆经、足阳明胃经所属经穴较多,多位于头部、四肢末端及背部。结论:目前电针治疗失眠的临床研究总体质量偏低,在诊断标准、治疗方法、疗效评价指标及试验设计方面都不甚完善,影响临床研究结果的可重复性及临床结论可信度。

预压量对橡胶减振器减振效果的影响分析

本文以橡胶的硬度和预压量作为变量,共设计八种减振器,分别安装于箱体上进行振动试验,对比不同减振器的减振效果。试验结果显示,当预压量为0.5 mm时,减振器在水平纵向和垂直方向振动下的减振效果均优于其他预压量,但在振动过程中由于安装间隙会发生额外的摩擦,其中硬度为43的橡胶上更容易产生明显的裂痕,降低了橡胶的使用寿命。当预压量增加到2.5 mm或2.0 mm时,橡胶上的裂痕较浅,使用寿命更长。综上所述,橡胶减振器的使用过程应适当增加预压量,减振效果的降低并不明显且减振器的使用寿命将提高。

基于VOSviewer和CiteSpace的针灸治疗功能性消化不良随机对照试验的可视化分析

目的基于VOSviewer、CiteSpace对针灸治疗功能性消化不良的随机对照试验(RCT)文献进行可视化分析,总结该领域的研究现状、热点及未来发展趋势。方法检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、PubMed、Web of Science核心合集数据库中有关针灸治疗功能性消化不良的RCT文献,检索时限为2004年1月至2023年12月,利用VOSviewer、CiteSpace对该领域作者、机构、关键词进行可视化分析。结果最终纳入中文文献565篇、英文文献12篇。发文量排名前3位的作者为周利、刘存志、常小荣;发文最多的机构为湖北中医药大学;主要关键词为功能性消化不良、针刺、临床疗效;关键词聚类共10类;突现强度最大的关键词为辨证。结论针灸治疗功能性消化不良临床RCT研究目前正处于蓬勃发展阶段,不同疗法及穴位的选择是当前研究热点,研究趋势包括评价指标的选取及效应机制的探索。

基于随机森林算法的科研项目经费计算方法评价分析

通过收集来自电网项目的上千份经费数据,挖掘科研跨度和科技研发价值的特征因素,构建科技项目样本集。使用实体嵌入的方式,将离散变量向量化,再基于随机森林,通过迭代计算测定科技研发价值与科研项目金额的关联规律性,形成能反映科技研发价值的科研项目经费计列方法。研究结果表明,随机森林在预测科技研发价值与科研项目金额关联方面具有显著优势。通过构建多棵决策树,减少单一模型的过拟合风险,提升预测的准确性和稳定性。在此基础上评估各特征变量的重要性,能够有效识别对科研经费预测影响较大的因素,从而为科研经费分配提供科学依据。

孟德尔随机化分析联合PBL教学模式在《牙周病学》本科教学中的探索

目的:将分析疾病因果关系的孟德尔随机化(MR)分析联合以问题为导向的教学方法(PBL)的教学模式应用于《牙周病学》教学,引导学生了解探究牙周病与全身因素之间的关联性,并研究此模式在牙周病教学中的应用效果。方法:以《牙周病学》教材为主,教授学生MR分析手段为辅,引导学生进行科研探究,提升科研思维和文献查阅能力。选取温州医科大学2019级两个班级的口腔医学专业学生,随机按照班级分为实验组(MR分析联合PBL教学模式)与对照组(课堂授课联合PBL教学模式),实验组53人、对照组54人。课程结束后通过学生课堂表现评分、考试成绩和科研创新思维能力对两种教学模式进行考核评价。结果:经过MR分析联合PBL教学后,实验组学生理论成绩优于对照组,实验组学生试题平均分为84.9±4.6,而对照组的试题平均分为79.2±4.3,差异有统计学意义(P<0.05)。同时,实验组学生课堂表现评分为96.7±5.7,而对照组评分为91.2±4.8,差异有统计学意义(P<0.001)。此外,实验组学生科研创新思维能力优于对照组,具体表现为参与更多科研项目及论文撰写发表。结论:采用MR分析联合PBL的教学模式进行《牙周病学》教学,可加深学生对于牙周疾病与全身疾病关联性的理解与掌握。学生通过查阅科研文献,深入探究补充牙周病与全身疾病之间的关联性,可有效提升学生科研思维能力及文献查阅能力。

数字化失眠症低阻抗意念导入疗法治疗失眠的疗效观察

目的:探究数字化失眠症低阻抗意念导入疗法(dTIP-I)治疗失眠的临床疗效。方法:选取2021年12月至2023年6月中国中医科学院广安门医院心理科收治的轻中度失眠患者80例作为研究对象,按照随机数字表法随机分为对照组和观察组,每组40例。对照组采用线下中医睡眠调控技术,由经过专业培训的研究人员进行治疗,约60 min/次,2次/周,共治疗2周。观察组采用dTIP-I治疗,患者接受线上自助调节,配合使用健康教育课程,约30 min/次,4次/周,共治疗2周。比较2组患者治疗前后失眠严重程度指数量表(ISI)、匹兹堡睡眠质量指数量表(PSQI)评分变化及有效率。结果:2组患者治疗后及随访与治疗前比较,ISI、PSQI评分组内差异均有统计学意义(均P<0.05),2组治疗后及随访ISI、PSQI评分组间差异无统计学意义(P>0.05)。结论:dTIP-I可以有效改善轻中度失眠患者的睡眠质量,提高患者睡眠满意度,与线下中医睡眠调控技术疗效相当。

政府引导下的应急科研攻关效能何以提升——面向攻关项目实施的随机演化博弈分析

为厘清影响应急科研攻关效能的主要因素,面向应急科研攻关项目实施中核心环节的基本特征,构建基于政府部门与科研攻关团队的应急科研攻关博弈系统。考虑应急科研攻关中的不确定性,构建受到随机干扰的应急科研攻关随机演化博弈模型。进一步地,引用仿真分析考察影响博弈系统演化与博弈主体策略选择的主要因素。研究结果表明,应急技术成果储备效益、应急科研攻关支持强度、应急技术需求反馈系数、攻关项目流程优化系数、应急技术成果适用系数均能推动应急科研攻关博弈系统形成积极部署引导与高效研发的策略组合。提升应急科研攻关管理强度虽能提高科研攻关团队选择高效研发策略的概率,但亦会降低政府部门选择积极部署引导策略的主动性。在此基础上,从加强常态化应急技术储备、实施多元化项目扶持举措、适应差异化应急实践场景、夯实制度化安全管理模式提出了提升应急科研攻关效能的对策建议。

中成药临床随机对照试验文献分析报告(2021)

目的通过检索和整理2021年发表在中、英文期刊的中成药随机对照试验(Randomized controlled trial,RCT),对中成药临床证据的生产和转化进行阶段性总结和评价,为后续临床疗效评价研究的开展和证据的合理化应用提供参考。方法基于中医药循证研究证据库系统(Evidence Database System,EVDS)旗下中成药临床证据数据库收录,并补充检索中国知网(China National Knowledge Infrastructure,CNKI)、万方(Wan Fang Data)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、Cochrane Library、PubMed、EMbase数据库,全面获取2021年发表的中成药RCTs,对其研究特征和方法学质量进行分析、评价。结果共纳入文献2215篇(中文2206篇、英文9篇),包括237379例受试者,覆盖中成药750种(口服中成药619种、中药注射剂91种、外用中成药40种),涉及疾病类型26类,研究热点疾病为循环系统疾病、呼吸系统疾病及神经系统疾病,研究热点病种为缺血性脑卒中、冠心病、心绞痛。研究规模方面,纳入研究样本量最小30例,最大8000例,59.01%的研究样本量<100例;病例来源以单中心研究为主。方法学方面,分配隐藏、盲法的实施仍未被重视。结论总体而言,与2020年相比,2021年RCT发文数量有所上升,对神经系统疾病研究的关注度有所提高,研究设计和实施过程中的质量控制和规范化管理仍需要改善,以期产出更多高质量的临床证据,加快证据转化应用。

Postrandomization Confounding Challenges the Applicability of Randomized Clinical Trials in Comparative Effectiveness Research

Different from trials for regulatory approvals of new interventions aimed to test the efficacy, comparative effectiveness research （CER） is the direct comparison of existing health-care interventions （compared with active controls） to examine which treatment works best, for whom,

多中心护理干预随机对照试验的设计与实施——以乳腺癌患者回归家庭干预为例

目的:探索多中心护理干预随机对照试验课题管理模式,为临床护理科研培训及实践提供经验。方法:严格按照临床试验管理规范,从课题的评估、计划、实施与评价4个阶段详细阐述多中心护理干预随机对照试验课题管理模式。采用患者招募率、留存率、护士参与留存率、培训依从率,评价多中心护理干预随机对照试验课题管理模式的可行性及科研培训效果。结果:患者招募率为73.3%,干预组患者留存率为96.4%,护士参与留存率为89.3%,培训依从率为78.6%。结论:回归家庭干预多中心随机对照试验的课题管理模式具有可行性,为临床护士和护理专业研究生设计和实施多中心随机对照试验提供了经验参考,同时以课题实践为导向的科研培训能够激发护士科研兴趣,提高其科研能力。

Research trends of worldwide ophthalmologic randomized controlled trials in the 21st century:A bibliometric study

Background:Randomized controlled trials(RCTs)are often considered the gold standard and the cornerstone for clinical practice.However,bibliometric studies on worldwide RCTs of ophthalmology published in the 21st century have not been reported in detail yet.This study aims to perform a bibliometric study and visualization analysis of worldwide ophthalmologic RCTs in the 21st century.Methods:Global ophthalmologic RCTs from 2000 to 2022 were searched in the Web of Science Core Collection.The number of publications,country/region,institution,author,journal,and research hotspots of RCTs were analyzed using HistCite,VOSviewer,CiteSpace,and Excel software.Results:2366 institutions and 90 journals from 83 countries/regions participated in the publication of 1769 global ophthalmologic RCTs,with the United States leading in the number of volumes and research field,and the Moorfields Eye Hospital contributing to the most publications.Ophthalmology received the greatest number of publications and co-citations.Jeffrey S.Heier owned the most publications and Jost B.Jonas owned the most cocitations.The knowledge foundations of global ophthalmologic RCTs were mainly retinopathy,glaucoma,dry eye disease(DED),and cataracts,and anti-vascular endothelial growth factor(VEGF)therapy(ranibizumab),topical ocular hypotensive medication,laser trabeculoplasty.Anti-VEGF therapy for age-related macular degeneration(AMD),DME(diabetic macular edema),and DED,the use of new diagnostic tools,and myopia were the hottest research highlights.Anti-VEGF therapy,prompt laser,triamcinolone,and verteporfin photodynamic therapy for AMD,DME,and CNV(choroidal neovascularization),DED,myopia,and open-angle glaucoma were the research hotspots with the longest duration.The future research hotspots might be DED and the prevention and control of myopia.Conclusions:Overall,the number of global ophthalmologic RCTs in the 21st century was keeping growing,there was an imbalance between the regions and institutions,and more efforts are required to raise the quantity,quality,and global impact of high-quality clinical evidence in developing countries/regions.