1、Evidence-Based Medicine 循證醫學Evidence-Based Medicine 循證醫學Background1997年上海醫科大學中西醫結合研究所完成的“中華靈芝寶”動物實驗證實：該藥物具有抑瘤作用、保護免疫功能和放化療減毒增效作用。中國科學院上海藥物研究所完成“中華靈芝寶對多種培養人癌細胞生長的作用”。課題，結論證實該藥物對多種白血病和人體實體癌細胞具有明顯的抑制作用，并呈現較好的量效關系。1999年中國科學院上海生物研究所丁健研究員等實驗表明，中華靈芝寶（現名：雙靈固本散）能抑制拓撲異構酶I和拓撲異構酶II，造成癌細胞DNA單鏈或雙鏈斷裂，阻斷癌細胞的無限制繁殖，導

2、致癌細胞破裂凋亡。2001年上海預防醫學研究院以Ames試驗和骨髓微核試驗作了研究，結果表明中華靈芝寶具有抗突變作用。2002年國家藥品監督管理局（SDA）批準中華靈芝寶轉為“國藥準字”B20020428，并更名為“雙靈固本散”。Cell or animal is equal to humanBackground1997年Cell or animal BackgroundTraditional practice ModelClinicians are use convenient sourcesFactors that influence decision making.Senior doct

3、orsPatient requestPharmaceutical representatives recommendationLocal expert-based CMEOutdate!BackgroundTraditional practice循證醫學概論課件循證醫學概論課件BackgroundFalse evidenceAnesthesia and Analgesia 2007 IF 2.2142007 Total Cites 15960BackgroundFalse evidence循證醫學概論課件循證醫學概論課件循證醫學概論課件循證醫學概論課件循證醫學概論課件循證醫學概論課件Defin

4、itionEvidence Based Medicine is the conscientious, explicit, and judicious 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 Sa

5、ckett, D. L. 2001DefinitionEvidence Based MedicDefinitionEBM: A Practical DefinitionWhen 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

6、right!David EddyDefinitionEBM: A Practical DefDefinition Clinical expertise臨床技能外部證據External evidencesPatient Values and Preferences病人價值DefinitionClinical expertise外部CliniciansIndividual clinical expertisethe increasing proficiency and judgement that individual clinicians acquire through clinical exp

7、erience and clinical practice. CliniciansIndividual clinical CliniciansEBM is a Lifelong learning modellifelong, self-directed, problem-based learningEBM propose methods to find and evaluate evidence.EBM converts the abstract exercise of reading and appraising the literature into the pragmatic proce

8、ss of using the literature to benefit individual patients while simultaneously expanding the clinicians knowledge base. Bordley, D.RCliniciansEBM is a Lifelong leCliniciansThe basic for EBMCliniciansThe basic for EBMDefinition Clinical expertise臨床技能外部證據External evidencesPatient Values and Preference

9、s病人價值DefinitionClinical expertise外部External evidencesBest available external clinical evidence: clinically relevant researchbasic sciences of medicinepatient-centred researchExternal clinical evidence has a short doubling-time, and both invalidates previously accepted diagnostic tests and treatments

10、 and replaces them with new ones that are more powerful, more accurate, more efficacious, and saferExternal evidencesBest availabExternal evidencesIs All Evidence Created Equal?Oxford Centre for Evidence-based Medicine Levels of EvidenceExternal evidencesIs All Evide循證醫學概論課件The Evidence PyramidHiera

11、rchy of evidence: arranges study designs by their susceptibility to biasPrimary ResearchExperimentalobservationalSecondaryResearchFor quantitative studiesFor qualitative studies No consensus about the relative rigour of different methodsSystematic review雙靈固本散The Evidence PyramidHierarchy Appraise ev

12、idencesType of QuestionSuggested best type of StudyTherapyRCTcohort case control case seriesDiagnosisProspective, blind comparison to a gold standardEtiology/HarmRCT cohort case control case seriesPrognosisCohort study case control case seriesPreventionRCTcohort study case control case seriesClinica

13、l ExamProspective, blind comparison to gold standardCostEconomic analysisRight methods is crucialAppraise evidencesType of QuesAppraise evidencesMeasureObjective：SurvivalLab testRadiologySubjective：PainSymptomsAppraise evidencesMeasureExternal evidencesCategories of Consensus In NCCN clinical guidel

14、ineCategory 1: There is uniform NCCN consensus, based on high-level evidence, that the recommendation is appropriate.Category 2: There is uniform NCCN consensus(or non-uniform NCCN consensusbut no major disagreement), based on lower-level evidence including clinical experience, that the recommendati

15、on is appropriate.Category 3: There is major NCCN disagreement that the recommendation is appropriate.External evidencesCategories oAppraise evidencesEndpointalternative：relieve of symptomshrink of tumorGold Standard：cureprolong survivalAppraise evidencesEndpointNot all the evidences are the same im

16、portanceHollingworth & Jarvik, Radiology 2007;244:31-38Flowchart of cost-effectiveness at each level of TA hierarchyTechnical PerformanceDiagnostic PerformanceDiagnostic ImpactTherapeutic ImpactImpact on HealthNot all the evidences are the Source of Medical InformationColleaguesConferencesDrug RepsT

17、extbooksJournalsInternet/PatientsSource of Medical InformationCSource of Medical InformationPrimaryMEDLINE，CBMSecondaryGuidelines，Cochrane LibMuch more likely (than personal search and critical appraisal) to be trueSaves the clinicians timeTextbookOthers？ConferenceInstitutional or personal experienc

18、eSource of Medical InformationPSource of Medical InformationInterest group or organizationCommercial Companys News or BriefGoogle, Yahoo! Open Mind and Be Very CarefullySource of Medical InformationIQuick InformationGuidelinesExplicit evidence-basedEvidence-basedResearch-based (highly referenced)Opi

19、nion-based“expert consensus”Quick InformationGuidelinesNational Guideline Clearinghouse(/)National Guideline ClearinghouCancer Care Ontarios Program in Evidence-Based Care (PEBC) and the Cancer Care Ontario Practice Guidelines Initiative (CCOPGI) http:/www.ccopebc.ca/Cancer Care Ontarios ProgramQuic

20、k InformationCochrane Library- The Cochrane CollaborationSystematic reviewsThe current resource with the highest methodological rigorFor each clinical question, all of the English literature meticulously searched for randomized trialsLarge systematic reviews with valid methods + collaborative effort

21、Conclusions are based on all the evidence from valid randomized trialsQuick InformationCochrane Libr循證醫學概論課件PDQ (Physician Data Query)/cancer_information/pdq/PDQ (Physician Data Query)Clinical Trial DatabaseCurrent Controlled Trials NIH ClinicalT Clinical Trial DatabaseCurrent循證醫學概論課件循證醫學概論課件PubMed

22、/MEDLINE/PubmedPubMed /MEDLINEhttp:/www.ncbiEvidence-based MedicineBases action on best evidence synthesisGood doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without the former, practice risks becoming evidence-tyrannised, for ev

23、en excellent external evidence may be inapplicable or inappropriate for an individual patient. Without the latter, practice risks becoming rapidly out of date, to the detriment of patients and patient-care.Evidence-based MedicineBases aDefinition Clinical expertise臨床技能Patient Values and Preferences病

24、人價值外部證據External evidencesDefinitionClinical expertisePaThe PatientsIndividualize 個體化；Compliance 依從性；Informed consent 知情同意Value The PatientsIndividualize 個體化；Definition Clinical expertise臨床技能Patient Values and Preferences病人價值外部證據External evidencesOther factors 1.Regulations 2.Medical insuranceDefinitionClinical expertisePaWhat EBM is NotEBM is not cook-book medicineEvidence needs extrapolation to the patients unique biology and valuesEBM requires that the best external evidence be integrated with individual clinical expertise and patient-choice