循证医学医学知识讲座.ppt

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,*,文档仅供参考，不能作为科学依据，请勿模仿；如有不当之处，请联系网站或本人删除。,Misguide Media,Cell or animal model,Only in the,LAB,No test in human,Misguide Ad.,1997,年,上海医科大学中西医结合研究所完成的“中华灵芝宝”,动物实验,证实：该药物具有抑瘤作用、保护免疫功能和放化疗减毒增效作用。,中国科学院上海药物研究所完成“中华灵芝宝对多种培养人癌细胞生长的作用”。课题，结论证实该药物对,多种白血病和人体实体癌细胞,具有明显的抑制作用，并呈现较好的量效关系。,1999,年,中国科学院上海生物研究所丁健研究员等实验表明，中华灵芝宝（现名：双灵固本散）能抑制拓扑异构酶,I,和拓扑异构酶,II,，造成癌细胞,DNA,单链或双链断裂，阻断癌细胞的无限制繁殖，导致癌细胞破裂凋亡。,2001,年,上海预防医学研究院以,Ames,试验和骨髓微核试验,作了研究，结果表明中华灵芝宝具有抗突变作用。,2002,年,国家药品监督管理局（,SDA,）批准中华灵芝宝转为“国药准字”,B20020428,，并更名为“双灵固本散”。,2007,年,国食药监注,2007253,号 注销西安绿谷制药有限公司“双灵固本散”批准文号,Cell or animal study apply to human,Background,Longer life,Chronic diseases or malignancy,Increasing medical costs,The patient knows more,and questions more!,Background,To keep up to date in Internal Medicine,I need to read 17 articles a day,365 days a year,More studies,more articles,much more information,20,000 RCTs published annually,，,6000 articles enter Medline monthly,1 study report published every hour,More diasgnostic tools,more drugs,more treatment methods,“,Half of what you are taught as medical students will in,10 years,have been shown to be wrong.And the trouble is,non of your teachers knows which half.,”,Background-False evidence,Anesthesia and Analgesia,2007 IF 2.214,2007 Total Cites 15960,Background-Inadequate tools,Background-Journals&Papers,We received input from 23 scientists(heads of laboratories)and collected data from 67 projects,most of them(47)from the field of oncology.This analysis revealed that only in,2025%,of the projects were the relevant published data completely in line with our in-house findings(Fig.1c).,-Nature Reviews Drug Discovery 10,712(September 2011),Background,Traditional practice Model,Clinicians are use convenient sources,Factors that influence decision making.,Senior doctors,Patient request,Pharmaceutical representatives recommendation,Local expert-based CME,Outdate!,Definition,Evidence Based Medicine,is the conscientious(,自觉,),explicit(,明确,),and judicious(,审慎,)use of current best evidence in making decisions about the care of individual patients.,Sackett,D.L.BMJ 1996,Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values,Sackett,D.L.,2001,Definition,EBM:A Practical Definition,When there is evidence of benefit and value,do it.,When there is evidence of no benefit,harm or poor value,dont do it.,When there is insufficient evidence to know for sure,be conservative.,And whatever we do,do it right!,David Eddy,Definition,Clinical expertise,临床技能,外部证据,External evidences,Patient Values and Preferences,病人价值,Clinicians,Individual clinical expertise,the increasing proficiency and judgement that individual clinicians acquire through clinical experience and clinical practice.,Clinicians,EBM is a Lifelong learning model,lifelong,self-directed,problem-based learning,EBM propose methods to find and evaluate evidence.,EBM converts the abstract exercise of reading and appraising the literature into the pragmatic process of using the literature to benefit individual patients while simultaneously expanding the clinicians knowledge base.,Bordley,D.R,Clinicians,The basic for EBM,Authors,证据提供者,Users,证据应用者,Define clinical questions,确定医疗问题,+,+,Task,任务,收集,/,评价,/,写作论文,提供最佳证据,Use evidence,正确地应用证据,Knowhow,Clinical training,医疗实践,+,+,临床流行病学（,DME,）,+,+,Statistics,医学统计学,+,+,Medical economics,卫生经济学,+,+,Literature Search,+,+,Role,Group,团队,Individual,个人,External evidences,Best available external clinical evidence:,clinically relevant research,basic sciences of medicine,patient-centred research,External clinical evidence has a short doubling-time,and both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful,more accurate,more efficacious,and safer,External evidences,Is All Evidence Created Equal?,Oxford Centre for Evidence-based Medicine Levels of Evidence,The Evidence Pyramid,Hierarchy of evidence:arranges study designs by their susceptibility to bias,Primary Research,Experimental,observational,Secondary,Research,For quantitative studies,For qualitative studies,No consensus about the relative rigour of different methods,Systematic review,双灵固本散,Clinical trial and real world,临床试验中认为是有效可能在真实世界中无效,Not all the evidences are the same importance,Hollingworth 244:31-38,GRADE,（Grading of recommendations assessment,development and evaluation),推荐分级的评价、制定与评估,Code,Quality of Evidence,Definition,A,High,Further research is very unlikely to change our confidence in the estimate of effect.,Several high-quality studies with consistent results,In special cases:one large,high-quality multi-centre trial,B,Moderate,Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.,One high-quality study,Several studies with some limitations,C,Low,Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.,One or more studies with severe limitations,D,Very Low,Any estimate of effect is very uncertain.,Expert opinion,No direct research evidence,One or more studies with very severe limitations,Right methods is crucial,Type of Question,Suggested best type of Study,Therapy,RCTcohort case control case series,Diagnosis,Prospective,blind comparison to a gold standard,Etiology/Harm,RCT cohort case control case series,Prognosis,Cohort study case control case series,Prevention,RCTcohort study case control case series,Clinical Exam,Prospective,blind comparison to gold standard,Cost,Economic analysis,External evidences,疗效的大小,疗效可信度估计,I,类,证据和,/,或达成一致意见认为某治疗,/,操作是有用,/,有效的。,II,类,对某治疗,/,操作的有用,/,有效性存在相互矛盾的证据或者分歧,III,类无效,#,或,III,类有害,证据和,/,或达成一致意见认为某治疗,/,操作的无用,/,无效，在某些情况下可能有害,IIa,类,证据和共识赞同有用,/,有效,IIb,类,证据和共识对于有用,/,有效性不那么确定,获益,风险,治疗,/,操作,应该,执行,获益,风险,需要增加更多的证据,应用某治疗,/,操作是合理的,获益,风险,需要更为广泛的证据，注册资料也是有益的,可考虑应用某治疗,/,操作,风险,获益,不需要更加证据,某治疗,/,操作不应使用，因为无益且可能有害,A,级,已有大样本量研究,数据来自多个,RCT#,或者,meta,分析,认为治疗,/,操作有用,/,有效。,已有足够证据，来自多个,RCT,或者,meta,分析,支持治疗,/,操作有用,/,有效。,来自多个,RCT,或者,meta,分析存在某些矛盾,治疗,/,操作的有用,/,有效性不确定,来自多个,RCT,或者,meta,分析存在较大的矛盾,认为某治疗,/,操作无用,/,无效，某些情况下可能有害,已有足够证据，来自多个,RCT,或者,meta,分析,B,级,较小样本量的研究,数据来自单个,RCT,或者多个非,RCT,确认治疗,/,操作有用,/,有效。,证据来自单个,RCT,或者多个非,RCT,支持治疗,/,操作有用,/,有效。,来自单个,RCT,或者多个非,RCT,存在某些矛盾,治疗,/,操作的有用,/,有效性不确定,来自单个,RCT,或者多个非,RCT,存在较大的矛盾,认为某治疗,/,操作无用,/,无效，某些情况下可能有害,证据来自单个,RCT,或者多个非,RCT,C,级,小样本量的研究仅有专家讨论共识，病例报告，或标准治疗,确认治疗,/,操作有用,/,有效。,证据来自专家讨论共识，病例报告，或标准治疗,支持治疗,/,操作有用,/,有效。,存在分歧的专家讨论共识，病例报告，或标准治疗,治疗,/,操作的有用,/,有效性不确定,存在分歧的专家讨论共识，病例报告，或标准治疗,认为某治疗,/,操作无用,/,无效，某些情况下可能有害,证据来自专家讨论共识，病例报告，或标准治疗,建议书写推荐时使用的语句,应该,/,推荐,/,有指征,有用,/,有效,/,有益,合理的,可能是有用,/,有效,/,有益的,可能推荐或者有指征,可以考虑,也许是合理的,有用和有效性未知,/,不明,/,不确定或者未很好地确认,III,类无效,不推荐,/,无指征,/,不应使用,无用,/,无效,/,无益,/,III,类有害,可能有害,/,有危害,不应使用,可能增加并发症,/,死亡,有效性比较语句,$,治疗,/,策略,A,较,B,更推荐,/,更有指征,选择治疗,/,策略,A,优于,B,治疗,/,策略,A,可能,较,B,更推荐,/,更有指征,选择治疗,/,策略,A,可能,优于,B,ACCF/AHA,指南推荐强度和证据级别的应用,Adequate sample size,Phase III RCT head to head Compare survival,Control,Survival,（,%,）,Improved survival and sample sized,5%,10%,15%,10,1,290,394,134,15,1,894,544,208,20,2,444,676,328,25,2,926,788,374,科学引文索引,Science Citation Index,，,SCI,Impact factor,This is the mean citation rate of all articles contained in the journal,Published annually in the SCI Journal Citation reports,a,quantitative,measure of the frequency with which the average article published in a given scholarly journal has been cited in a particular year or period;,The impact factor is a measure of importance of scientific journals,Find Journals,查杂志,Find a paper,查论文,Find who cite the paper,查引用,Cited and quality of study,被引,/他引与论文的质量,Source of Medical Information,Primary,MEDLINE,，,CBM,Secondary,Guidelines,，,Cochrane Lib,Much more likely(than personal search and critical appraisal)to be true,Saves the clinicians time,Textbook,Others,？,Conference,Institutional or personal experience,Source of Medical Information,Interest group or organization,Commercial Companys News or Brief,Google,Yahoo!,Open Mind and Be Very Carefully,Quick Information,Guidelines,Explicit evidence-based,Evidence-based,Research-based(highly referenced),Opinion-based,“,expert consensus,”,National Guideline Clearinghouse,(,www.guideline.gov/,),Quick Information,Cochrane Library-The Cochrane Collaboration,Systematic reviews,The current resource with the highest methodological rigor,For each clinical question,all of the English literature meticulously searched for randomized trials,Large systematic reviews with valid methods+collaborative effort,Conclusions are based on all the evidence from valid randomized trials,Cochrane Library,Advantage,highest quality evidence well ever have on the effectiveness of health care,Disadvantage,not yet many systemic reviews,necessarily omits the newest treatment,Step 2,PDQ(Physician Data Query),www.cancer.gov/cancer_information/pdq/,Clinical Trial Database,Current Controlled Trials,www.controlled-,NIH ClinicalTrials.gov,PubMed,/MEDLINE,www.ncbi.nlm.nih.gov/Pubmed,Step 2,Step 2,Step 2,Step 2,Step 2,Medline-PubMed,Advantage,exhaustiveness,flexibility of searching,journal coverage,currency(on-line versions),widespread availability and support,Disadvantage,have to do your own quality filtering,putting together good searches is difficult,gaps in coverage(medical,geographical and linguistic),Step 2,The Patients,Individualize,个体化；,Compliance,依从性；,Informed consent,知情同意,Value,Definition,Clinical expertise,临床技能,Patient Values and Preferences,病人价值,外部证据,External evidences,Other factors,1.Regulations,2.Medical insurance,Evidence-based Medicine,Bases action on best evidence synthesis,Good doctors use both individual clinical expertise and the best available external evidence,and neither alone is enough.,EBM is not restricted to randomised trials,