循证医学(Evidence-based Medicine)——临床研究与实践的新时代

80年代以来的大规模、随机、双盲、多中心、安慰剂对照临床试验证明,以经验和推论,如以一些临床化验指标为依据的传统临床试验不能反映病人的长期预后。为了对新药和已上市药物作出恰当的评价,应当从所谓“众说纷坛”转向注重和评价病人预后,包括总死亡率、重要心脑血管事件、生活质量、卫生经济学等的“循证医学”。反过来,“循证医学”和临床治疗指南的发展将对新药的研究与开发、医生的临床实践、药物经济学、医疗保健服务决策等带来积极和正面的影响。

Under the narrative medicine theory to establish the evidence-based medical record written by doctors and patients through integrated therapy of traditional Chinese and western on digestive system diseases

目的:遵循叙事循证医学理念,抽提医患共建式循证病历的理论,建立医患共建式循证病历的范本.方法:检索Pubmed等重要医学数据库,参照叙事医学的理念,咨询中西医消化内科及循证医学专家,初步达成共识.结果:本研究是一次叙事循证医学指导下医患共建式循证病历建立的有益尝试.思考与展望:医患共建式病历有可能成为叙事医学指导下的中西医合作治疗脾胃病相关疗效评价方法学体系的内容.

Factor Analytical Examination of the Evidence-Based Practice Beliefs Scale: Indications of a Two-Factor Structure

Background: Promotion of Evidence-Based Practice (EBP) in nursing appears to be developing slowly. Research indicates that nurses’ beliefs in EBP may play an even more significant role than knowledge and resources in making implementation feasible. To address this issue, measurement of nurses’ beliefs regarding EBP is paramount. Aims and objectives: This study explores the internal consistency reliability and the construct factor structure of the Norwegian version of the original Evidence-Based Practice Beliefs Scale (EBP-BS). Methods: The study has a Non-experimental exploratory survey design. A Norwegian translation of the EBP-BS was tested in a convenience sample of 118 healthcare professionals (95% nurses) attending a continuing education program at a University College in Norway. The response rate was 95% (n = 112). The internal consistency of the scale was measured by Cronbach’s alpha, and an explorative Principal Component Analysis (PCA) was used to explore the construct structure. Results: The overall internal consistency of the EBP-BS was acceptable. The PCA indicated a four-factor structure. The psychometric properties of two of the factors were too weak for expanding to a four-factor model. Based on our investigation of the EBP-BS, we suggest a two-factor structure model. The factors were named 1) General knowledge and confidence concerning EBP and 2) Task specific beliefs in EBP. This finding differs from previous results that indicated a unidimensional structure. Conclusion: As a starting point, reliable and valid measurement of nurses’ beliefs about EBP is required in order to identify possible obstacles and to optimize implementation in the individual clinical setting. Our results indicate that the EBP-BS has a two-factor structure. Further exploration of the factor structure is needed. Further empirical research may contribute to the resolving of controversies concerning basic understandings of the concept of EBP.

Operational effectiveness evaluation based on the reduced conjunctive belief rule base

To address the issue of rule premise combination explosion in the construction of the traditional complete conjunctive belief rule base(BRB),this paper introduces an orthogonal design method to reduce the conjunctive BRB.The reasoning method based on reduced conjunctive BRB is designed with the help of the conversion technology from conjunctive BRB to disjunctive BRB.Finally,the operational mission effectiveness evaluation is taken as an example to verify the proposed method.The results show that the method proposed in this paper is feasible and effective.

基于循证实践的“V-EBP”专业学位研究生教育质量增值评价体系研究

高质量的专业学位研究生是推动我国社会经济发展的重要力量,其教育质量评价一直是普遍关注的问题。随着时代发展与教育理念的革新,传统评价方式已经不能全面衡量专业学位研究生教育质量,增值评价为问题解决提供了新视角。基于此,本研究在分析增值评价对于专业学位研究生教育质量评价亟待改革内容的意义,以及阐释循证实践对支持该评价体系的改进的价值与可行性分析的基础上,构建了基线测评、过程监控、证据采集、终结测评以及增值分析五位一体的“V-EBP”专业研究生教育质量评价体系,提出了注重大数据技术使用,实现多模态数据融合分析;合理选择评价分析工具,坚持量化与质性描述结合;基于实践适当调整,推进理想化增值评价体系的实施建议。

Standardizing Individualized Efficacy Evaluation to Optimize Evidence-Using Pattern in Traditional Chinese Medicine-Preliminarily Establishing Traditional Chinese Medicine Evidence-based Case Reporting System

Individualized treatment is a basic feature of Traditional Chinese Medicine(TCM), and individualized efficacy evaluation is also emphasized in TCM clinical practice. Individualized evaluation is in favor of improving intervention continuously, and optimizing the TCM evidenceusing pattern gradually. Traditional case reports can better demonstrate the efficacy of individual, but lack of standardized design, making such evidence show a lower quality. Meanings, objectives and design elements of TCM individualized evaluation were discussed in this paper.Then based on the original work, design ideas and framework of TCM evidence-based case reporting system were established preliminarily.This work will improve the methodology of TCM individualized evaluation to realize the goal of optimizing TCM clinical evidence-using pattern.

Technology-Driven and Evidence-Based Genomic Analysis for Integrated Pediatric and Prenatal Genetics Evaluation

The first decade since the completion of the Human Genome Project has been marked with rapid development of genomic technologies and their immediate clinical applications. Genomic analysis using oligonucleotide array comparative genomic hybridization （aCGH） or single nucleotide polymorphism （SNP） chips has been applied to pediatric patients with developmental and intellectual disabilities （DD/ ID）, multiple congenital anomalies （MCA） and autistic spectrum disorders （ASD）. Evaluation of analytical and clinical validities of aCGH showed 〉 99% sensitivity and specificity and increased analytical resolution by higher density probe coverage. Reviews of case series, multi-center comparison and large patient-control studies demonstrated a diagnostic yield of 12%--20%; approximately 60% of these abnormalities were recurrent genomic disorders. This pediatric experience has been extended toward prenatal diagnosis. A series of reports indicated approximately 10% of pregnancies with ultrasound-detected structural anomalies and normal cytogenetic findings had genomic abnormalities, and 30% of these abnormalities were syndromic genomic disorders. Evidence-based practice guidelines and standards for implementing genomic analysis and web-delivered knowledge resources for interpreting genomic findings have been established. The progress from this technology-driven and evidence-based genomic analysis provides not only opportunities to dissect disease-causing mechanisms and develop rational therapeutic interventions but also important lessons for integrating genomic sequencing into pediatric and prenatal genetic evaluation.

Methods and Practices for Institutional Benchmarking based on Research Impact and Competitiveness: A Case Study of ShanghaiTech University

Purpose: To develop and test a mission-oriented and multi-dimensional benchmarking method for a small scale university aiming for internationally first-class basic research.Design/methodology/approach: An individualized evidence-based assessment scheme was employed to benchmark ShanghaiTech University against selected top research institutions,focusing on research impact and competitiveness at the institutional and disciplinary levels.Topic maps opposing ShanghaiTech and corresponding top institutions were produced for the main research disciplines of ShanghaiTech. This provides opportunities for further exploration of strengths and weakness. Findings: This study establishes a preliminary framework for assessing the mission of the university. It further provides assessment principles, assessment questions, and indicators.Analytical methods and data sources were tested and proved to be applicable and efficient.Research limitations: To better fit the selective research focuses of this university, its schema of research disciplines needs to be re-organized and benchmarking targets should include disciplinary top institutions and not necessarily those universities leading overall rankings.Current reliance on research articles and certain databases may neglect important research output types.Practical implications: This study provides a working framework and practical methods for mission-oriented, individual, and multi-dimensional benchmarking that ShanghaiTech decided to use for periodical assessments. It also offers a working reference for other institutions to adapt. Further needs are identified so that ShanghaiTech can tackle them for future benchmarking.Originality/value: This is an effort to develop a mission-oriented, individually designed,systematically structured, and multi-dimensional assessment methodology which differs from often used composite indices.

循证支持的校长效能评价:维度与特点--以克利福德校长评价系统为例

基础教育问责制、教育赋权管理体制、科学主义和实用主义相结合的认识论基础,这三重力量共同推动美国校长评价向循证支持的校长效能评价转变。美国循证支持的校长效能评价以克利福德校长评价系统为典型代表,它包含校长行为效能和校长结果效能两个维度,呈现出重视校长结果效能的评价、以州为主体的校长评价职责分配、将校长效能评价建立在可靠证据基础上3个典型特征。辩证地看待并借鉴该评价系统,我国校长评价要以专业标准为准绳提升科学性与客观性,设立校长评价专门化研究中心促进校长评价的专业化和专门化,拓宽校长评价维度提高校长评价的综合性与准确性,还要特别注重研究循证支持的校长效能评价在中国情境下的适切性。

证据驱动的循证决策国际进展、趋势与展望

起源于上世纪90年中期英国政府的循证实践,近年来在全球战略规划制定、国际学术交流、国际合作网络搭建、跨部门协作等方面涌现出诸多新进展,推动了循证决策的快速发展。上述新进展显示出循证决策已成为全球治理和政策制定的共同愿景、循证决策制度化成为全球共同追求的治理创新、证据流动系统成为循证决策的基础遵循、多元化证据产品贯穿于循证决策全过程等发展趋势。随着循证决策助推国际战略规划制定更加科学和有效,证据获取体系、证据评估系统、多样化证据产品将得到快速发展,政府决策者的循证决策能力将得到快速提升。

部分嵌套式设计在中医药“同病异治”疗效评价中的应用及方法学探索

目的本研究针对中医学同病异治、辨证论治的特征,引入部分嵌套式设计。方法部分嵌套式设计以复杂干预对照标准化治疗,中医组按“证型-治法-方药”分割为多个子集(存在嵌套结构),对照组采用标准化西医治疗(无嵌套结构);并以一项溃疡性结肠炎“同病异治”数据为例,套用该设计类型并采用多水平模型分析。结果部分嵌套式设计符合“同病异治”诊疗特征并满足循证评价的设计要求,通过多水平模型可实现类似数据结构的分析。结论利用部分嵌套式设计能实现对“同病异治”整体效果的评价,可为中医药临床疗效评价提供方法学参考。

Joint Development of Evidence-Based Medical Record by Doctors and Patients through Integrated Chinese and Western Medicine on Digestive System Diseases

Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system.A literature search on the practice of evidence-based evaluation was conducted in key biomedical databases,i.e.PubMed,Excerpt Medica Database,China Biology Medicine disc and China National Knowledge Infrastructure.However,no relevant study on the subjects of interest was identified.Therefore,drawing on the principles of narrative medicine and expert opinion from systems of Chinese medicine and Western medicine,we propose to develop and pilot-test a novel evidence-based medical record format that captures the perspectives of both patients and doctors in a clinical trial.Further,we seek to evaluate a strategic therapeutic approach that integrates the wisdom of Chinese medicine with the scientific basis of Western medicine in the treatment of digestive system disorders.Evaluation of therapeutic efficacy of remedies under the system of Chinese medicine is an imperative ongoing research.The present study intends to identify a novel approach to assess the synergistic benefits achievable from an integrated therapeutic approach combining Chinese and Western system of medicine to treat digestive system disorders.

从感知到证据:循证教学评价的结构体系与实践进路

改进教学评估是新时代教育评价改革进程中教育工作者需要解决的一个重要命题。在全面推进教育数字化转型的战略行动中,教学评价的动力结构得到进一步转变,教学评价的模式与机制也在逐步实现结构重组与流程再造。通过对循证教育发展的系统化分析,阐释循证教学评价的内涵与意蕴,其主要特征表现为材料与数据的实质融通、证据与事实的关联推论、评价与发展的动态循环。循证教学评价在结构体系上是以立德树人、教师发展、教学证据、循证实践、教师效能为理念遵循,以循证评价意识与思维、循证评价知识与能力、循证评价实践与规范、循证评价改进与决策为构成要素,以六类复杂创生的多源证据为评价支撑,通过建立实践渐进与迭代共生的运行机制来保障评价的稳定运转。循证教学评价的运行机制以证据导向和迭代循环为整体运行原则,通过循证规划、证据推论、后效评价形成以循证实践为运行秩序的动态评价循环系统。为此,需要通过提升循证素养、构造循证评价模式、探索智能化评测、创建评价证据库、强化共同体循证实践等方式,实现教学评价从感知走向证据的理念与范式转换。

2013-2014年度高血压临床指南的现状分析及循证临床指南评价

目的调查分析2013-2014年国内外公布的新版高血压临床指南,采用AGREEⅡ工具评价高血压防治指南质量,为我国高血压临床指南的制定提供参考。方法计算机检索CNKI、Wanfang Data、Pub Med、Medline及相关机构认可和授权的网站,收集2013-2014年国内外公开发表的高血压临床指南,及2009至2014年国内外公开发表的高血压防治临床指南相关资料,按照纳入和排除标准筛选文献。描述性分析纳入指南名称、发表年份、机构、开发方法、参考文献数目等内容。采用AGREEⅡ工具评价2013-2014年国内外新版高血压临床指南的质量。结果共纳入高血压防治临床指南10部。评价结果表明,2013-2014年国内外高血压临床指南在表达的清晰性上得分最高,平均得分83.6%;其次为范围和目的,平均得分79.2%;参与人员项平均得分65.8%;适用性平均得分63.6%;编辑的独立性平均得分63.3%;严谨程度平均得分最低,为60.1%。指南总体评估显示,欧洲2013版、加拿大2013版、中国2013版、2014 JNC8版、2014 ASH/ISH版、日本2014版、2013 AHA/ACC/CDC版为积极推荐使用的指南,法国2013版、印度2013版、2013中国RH指南为推荐使用的指南(尚需补充和改进),没有不推荐或不确定的指南。结论 2013-2014年国内外高血压防治指南总体质量较高,发展中国家制定的指南质量明显提高,但与目前公认的循证医学要求仍存在差距,指南制定方法尚需规范。而建立科学、规范、适合国情的临床指南制定和评价体系,同期公布多版本的成套临床指南,有利于临床指南的推广实施。

住院患者跌倒预防相关临床实践指南的质量评价及推荐意见总结

目的对国内外住院患者跌倒预防相关临床实践指南进行质量评价和推荐意见总结。方法系统检索国内外指南网、医学文献数据库以及专业学术网站,应用相应评价工具对纳入指南和专家共识进行质量评价,并汇总相关推荐内容。检索时限为建库至2022年12月13日。结果共纳入9篇指南和5篇专家共识,9篇指南在AGREE II 6个领域得分为范围和目的94.03%、清晰性73.86%、参与人员76.07%、严谨性80.19%、应用性69.34%、独立性63.88%,其中5篇为A级推荐、4篇为B级推荐;3篇专家共识中的质量评价结果中条目1~6均为“是”,其余2篇条目1~4均为“是”,条目5~6分别为“否”和“不清楚”,5篇专家共识质量评价结果均为“纳入”。经内容整理,住院患者跌倒预防相关内容包括环境改善、跌倒风险评估、跌倒干预及跌倒后处理、药物审查、物理训练、保护器具的使用、营养支持、健康宣教8个方面,28项内容。结论本研究纳入的住院患者跌倒预防指南整体质量较好但仍有待提高,对临床护理人员预防患者跌倒、提高护理质量有一定的指导意义。

利伐沙班超说明书用药情况调研及循证评价

目的评价住院患者利伐沙班超说明书用药的合理性。方法从医院信息系统获取2021年1—6月于中国医学科学院北京协和医学院北京协和医院住院治疗并使用利伐沙班的病例信息,依据当时国内说明书判断其是否存在超说明书用药情况,并检索国外药品说明书、Micromedex数据库及相关指南文献等证据,对收集到的超说明书用法的合理性进行循证评价。结果2021年1—6月于中国医学科学院北京协和医学院北京协和医院使用利伐沙班的住院患者共计1755例,其中,860例(49.00%)存在超说明书用法,涉及917例次超说明书使用条目。发生频率最高的超说明书用法前3位分别是肿瘤患者住院期间预防性抗凝(193例次,21.05%)、在VTE防治过程中使用低于说明书推荐剂量(181例次,19.74%)以及将每日1次标准维持剂量替换为分次服用(136例次,14.83%)。经过循证评价,12.98%的超说明书用法符合国外已批准的说明书用法,24.32%的超说明书用法已被Micromedex数据库收录,19.96%的超说明书用法有国内外权威指南共识或高质量临床研究支持,35.01%的超说明书用法是否推荐尚存在争议,仍有7.74%的超说明书用法为证据不推荐或未检索到相关证据的不合理用法。结论利伐沙班超说明书用药现象普遍存在,药师应运用科学循证理念促进高风险药物的临床用药合理性提升。

儿童青少年慢性疾病用药自我管理评估工具的循证评价

目的:系统评价儿童青少年慢性疾病(慢病)用药自我管理评价工具的现状,为保障儿童青少年慢病患者的治疗效果提供循证医学证据。方法:系统检索PubMed、EMBase、the Cochrane Library、CBM、CNKI、维普和万方等国内外数据库,检索时限为建库至2023年3月,纳入儿童慢性疾病用药自我管理评价工具的文献。采用描述性方法对结果进行分析。结果:针对疾病类型共纳入16篇文献,43.75%(7/16)为糖尿病自我管理量表、18.75%(3/16)为儿童哮喘自我管理量表、12.50%(2/16)为青少年通用自我管理量表、6.25%(1/16)为儿童胰岛素治疗自我管理量表、6.25%(1/16)为儿童癫痫用药自我管理量表。25.00%(4/16)量表设计有理论依据和中文版。纳入的量表领域为1~8(3.69±1.74)个,量表条目为14~52(27.81±10.24)个。纳入量表中,用药管理条目缺乏,主要包括遵医嘱用药、调整药物剂量、药物不良反应、服药的方便性和服药责任感等内容。结论:目前我国缺乏自主开发的儿童青少年慢性疾病用药管理评价工具,评价工具角度单一,缺乏个人、家庭、医疗系统和社会不同层面的整合,建议开发与验证适用于我国儿童青少年慢性疾病患者的自我管理评价工具,为临床实施自我管理计划提供参考。

北京大学医学部循证医学课程选课研究生课前学情调查

目的了解北京大学医学部网状Meta分析课程选课研究生课程前基础知识掌握、学习态度等学情情况。方法以2021—2023年选修《证据整合及应用:网状Meta分析》课程的研究生为研究对象,通过问卷评估选课研究生课程前对网状Meta分析的相关知识掌握、学习态度等情况,使用Kruskal-Wallis H检验对硕士研究生和博士研究生的差异进行组间比较。结果共84位研究生参与调查,其中硕士研究生54人,博士研究生30人。课程前选课研究生均具备一定的文献检索、阅读能力,硕士研究生和博士研究生间无统计学差异(P>0.05)。选课研究生对基本术语均有一定了解,但是对Meta分析的具体应用等知识掌握相对薄弱,不了解的比例为46.67%~61.11%。与博士研究生相比,硕士研究生对系统综述与传统综述的区别(P=0.014)、实施循证医学的基本步骤(P<0.001)理解较差,两组间差异有统计学意义。选课研究生整体具有较强的学习主动性和求知欲。结论《证据整合及应用:网状Meta分析》选课研究生文献检索及阅读能力较优,且准备以认真的态度进行此课程的学习,但仍需提升对Meta分析相关内容的掌握程度,调查结果为课程教学内容和模式的持续改进提供了指导。

声音对NICU早产儿生长发育影响的系统评价再评价

目的检索并再评价声音对NICU早产儿生长发育影响的系统评价,为临床医务人员临床决策及早产儿健康干预策略的持续改进提供参考。方法计算机检索The Cochrane Library、Embase、PubMed、Web of Science、万方、中国知网、维普和中国生物医学文献数据库,检索关于声音对NICU早产儿影响的系统评价/Meta分析/荟萃分析,检索时间为建库至2023年5月。2名研究人员应用AMSTAR对文献进行方法学质量评价后,通过GRADE进行证据整理与分级。结果初检文献405篇,最终纳入文献20篇,AMSTAR质量评价结果表明,高等质量文献有5篇,其余15篇均为中等质量,纳入文献的总体方法学质量较低。采用GRADE系统对20篇系统评价的79条结局指标的证据质量评价结果显示,12条证据为中等质量,34条证据为低等质量,33条证据为极低质量。结论声音干预有利于改善NICU早产儿的相关生理指标、睡眠效率、行为状态、神经行为及大脑发育,可促进早产儿健康恢复,但系统评价的方法学质量和证据的质量均较低,临床实践需谨慎采纳有关证据,并逐步进行更加规范、严谨的研究。

脑卒中后认知障碍风险预测模型的系统评价

目的:系统评价脑卒中后认知障碍的风险预测模型。方法:检索中国知网、万方数据库、维普网、中国生物医学文献服务系统、PubMed、EMbase、the Cochrane Library、Web of Science和EBSCO数据库中的脑卒中后认知障碍风险预测模型相关研究,检索时限为建库至2023年1月30日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险和适用性。结果:共纳入16项研究,包括19个脑卒中后认知障碍风险预测模型,其中,16个模型采用了Logistic回归分析方法,2个模型采用了随机森林的方法,1个模型采用了LASSO回归的方法。建模时受试者工作特征曲线下面积(AUC)为0.773~0.940。4个模型进行了Hosmer-Lemeshow(H-L)检验,其中2个模型报告了P值且P≥0.05。11个模型进行了内部验证,5个模型进行了外部验证,4个模型同时进行了内部验证和外部验证。16项研究适用性较好,但存在较高的偏倚风险,主要问题集中在分析领域。结论:脑卒中后认知障碍风险预测模型整体性能良好,但模型质量有待提高,在未来的研究中需优化研究设计、扩大样本量、根据临床需要选择合适的预测因子、改进统计分析方法,并注重模型的外部验证,以验证模型的泛化能力。