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Evidence-BasedMedicine循证医学Evidence-basedPractice(EBP)Models•TraditionalpracticeModel(×)•Model1:Usethehighestqualityinformationtoguideclin

icaldecisions•Model2:Search,evaluate,andmakeavailablespecialtyspecificbestavailableevidence•Model3:Cr

eateoriginalresearchorsystematicreviewsEBMPractice-FivestepsPatientHistoryandPE……•QuestionAskingAnswerableClinicalQuestions.

•SearchSearchingforthebestcurrentevidence.•AppraiseCritically-appraisingtheevidence.•Application:Integratingth

eevidencewithourexpertiseandourpatient’suniquebiologyandvalues•AuditEvaluatingourperformanceStep1AskingAnswerableClinicalQuestions•EBMstartswit

haclearclinicalquestion•Well-builtclinicalquestionsguidethewholeEBMprocess•Typeofquestion?–Causation/etiology–Intervention–Diagnosis–Prognos

is•TypeofStudy?–Whatwouldbethebeststudydesigninordertoanswerthequestion?–studydesignsshouldlimitbiasStep1AskingAnswerableCl

inicalQuestions•Questioncomponents:PICO–WhattypesofParticipants?–WhattypesofInterventions?–WhattypesofComparison?–WhattypesofOutcomes?Step1AskingAn

swerableClinicalQuestions•Whattypesofparticipants?–Diseaseorconditionofinterest–Potentialco-morbidity–Setting–Demographicfa

ctors–TaskofclinicalproblemStep1AskingAnswerableClinicalQuestions•Whattypesofintervention?–Typesoftreatment–Type

ofdiagnostictest–Typeofcausativeagent–TypeofprognosticfactorStep1AskingAnswerableClinicalQuestions•Whattypesofoutcomes?–Forcausation,out

comeisdisease–Fordiagnostictest,outcomeindiseaseofinterest–Fortreatmentincludealloutcomesimportanttopeoplemakingdecision

stodefinesuccessoftherapy–Forprognosis,outcomeisthechosenendpointofthediseaseStep1AskingAnswerableClinica

lQuestions•Broadornarrowquestions–Broad•Dogefinitibimprovesurvivalinlungadenocarcinoma?–Narrow•Dogefini

tibimprovesurvivalinfemallungadenocarcinomarefractorytofirst-linechemo?Step1AskingAnswerableClinicalQue

stions•Causation–People-Exposure-Comparison-Outcomes•Doesheavysmokerhavehigherincidenceoflungcancer?–Prognosis:People-Exposure

-Comparison-Outcomes•IslungadenocarcinomawithhighlevelofCEAaremorelikelytohaverecurrentdisease?Step2Searchingforthebestcurrentevidence•Textbook–An

nuallyrevised–Usehighlevelevidences–Withreference•Guidelines•CochraneLibrary•MedlineNationalGuidelineClearinghouse(http://w

ww.guideline.gov/)Step2Toomuch?•即使是小的问题也有相关指南Step2Step2CochraneLibrary•Advantage–highestqualityevidencewe’lleverhav

eontheeffectivenessofhealthcare•Disadvantage–notyetmanysystemicreviews–necessarilyomitsthenewesttreatmentStep2EBPModels•Traditi

onalpracticeModel(×)•Model1:Usethehighestqualityinformationtoguideclinicaldecisions•Model2:Search,evaluate,andmakeavailablespecialtyspecificLevel1

information•Model3:CreateoriginalresearchorsystematicreviewsStep2PubMed/MEDLINE•http://www.ncbi.nlm.nih.gov/PubmedStep2Medline-PubMedAdvan

tage–exhaustiveness,flexibilityofsearching–journalcoverage,currency(on-lineversions)–widespreadavailabilityandsupportDisadvantage–havetod

oyourownqualityfiltering–puttingtogethergoodsearchesisdifficult–gapsincoverage(medical,geographicalandlinguistic)Step2Step2Step2Step

2Step2Step2Step2Searchingforthebestcurrentevidence•Forprimaryliterature–Notjustabstract!–TrytogetFull-textStep3Critically-appraisingtheevidence•Valid

?–Designandmethodology:logical?–Sample–ExperimentorMeasure:carriedoutinasoundwayandConvincible？Follow-uprate?–Analysis–Co

nclusion–Ethical?•Importance?–Clinicalsignificance？–Cost-effective？•Applicable?–Willtheresultshelplocally

?Step3Critically-appraisingtheevidence•Quickscreeningbytitle,abstractandrelatemessage–Authors•Well-known？Pastrecord？Cre

ditable？–Institute•Competencetodothisstudy？Well-known？–Specialty•Hasorhadpublishedincorejournals?Yourpractice？Valuable？•GoforFull-textD

iscrimination？Rational？EBM？Step3Critically-appraisingtheevidenceTypeofQuestionSuggestedbesttypeofStudyTherapyRCT>cohort>casecontrol>caseserie

sDiagnosisProspective,blindcomparisontoagoldstandardEtiology/HarmRCT>cohort>casecontrol>caseseriesPrognosisCohortstu

dy>casecontrol>caseseriesPreventionRCT>cohortstudy>casecontrol>caseseriesClinicalExamProspective,blindcomparisontogold

standardCostEconomicanalysisRightmethodsiscrucialTheEvidencePyramidHierarchyofevidence:arrangesstudydesign

sbytheirsusceptibilitytobiasPrimaryResearchExperimentalobservationalSecondaryResearch•Forquantitativestudies•Forqualitativ

estudiesNoconsensusabouttherelativerigourofdifferentmethodsSystematicreviewStep3Critically-appraisingtheevi

denceImprovedsurvivalandsamplesizedControlSurvival（%）5%10%15%101,290394134151,894544208202,444676328252,9

26788374PhaseIIIRCTheadtoheadComparesurvivalAdequatesamplesizeStep3Critically-appraisingtheevidence•Measure

–Objective：Labtest，Radiology–Subjective：pain，symptoms•Endpoint–alternative：relieveofsymptom,shrinkoftumor–Gol

dStandard：prolongsurvivalStep3Critically-appraisingtheevidence•Conclusion–Basedonthedata?–New?•Updated?•Comparewithotherstudy

•And,Whatnext?Step3Critically-appraisingtheevidence•Attention!–Don’ttrustitjustbecauseitisfromabigboss,meta-analysis,RCT,orgu

ideline.–Evidenceshouldbeinconsistencewithknownmedicalscience(physiology,pathology,pharmacology,etc）Usageofscientificlanguageisnotnece

ssarilymeanscientificbasedScientificmethodscreditNotalltheevidencesarethesameimportanceHollingworth&Jarvik,Radiology2007;244:31-3

8Flowchartofcost-effectivenessateachlevelofTAhierarchyTechnicalPerformanceDiagnosticPerformanceDiagnosticImpactTherapeuticImp

actImpactonHealthStep4Application•Integratingtheevidencewithourexpertiseandourpatient’suniquebiologyandvalues–Yourquestion–Yourpatient–Yourexperti

se–Yourhospital–Howto……Step5Evaluatingourperformance•Follow-up•Evaluate–Thepatientsbenefit……?•Next……•……Oragainanother5steps•

CollectdataandwriteanarticleEBPModels•TraditionalpracticeModel(×)•Model1:Usethehighestqualityinformationtoguidec

linicaldecisions•Model2:Search,evaluate,andmakeavailablespecialtyspecificbestavailableevidence•Model3:Createoriginalresearchorsy

stematicreviewsSelectiveEBP•Maynotneedtocarryoutall5steps•1.AskingAnswerableClinicalQuestions.•X2.Searchingforthebestcurrentevidence.•X3.Critically-

appraisingtheevidence.•4.Application:Integratingtheevidencewithourexpertiseandourpatient’suniquebiologyandvalues•5.Evalu

atingourperformanceSelectiveEBP•3differentmodesofEBP–Searching&appraising•providesE-Bcare,butisexpensiveintimeandresources–Searchingonly

•much,quicker,andifcarriedoutamongE-Bresources,canprovideE-Bcare–Replicatingthepracticeofexperts•quicke

st,butmaynotdistinguishevidence-basedfromego-basedrecommendationsSelectiveEBP•EvenfullyEBM-trainedcliniciansworkinall3modes–Searching&appra

ising•fortheproblemsIencounterdaily.–Searchingonly•forproblemsIencounteronceamonth.–Replicating•forproblemsIencounteronceadecade(and

crossingmyfingers!).Case1•Male,ZSUProfessor，62yearsold•Smallcelllungcancer,limiteddisease,chemofor6cycleswithcom

pleteresponse–Medicaloncologist：prophylacticcranialirradiation（PCI）notimporvesurvival,andwithAE！–Radio-oncologist：PCIimprovesurv

ival,andtolerable•Question:Why?ShouldthepatientbegivePCI?Improvesurvival?Howmuch?Sideeffect？When?How?TextbookPublish20061.Chanc

eofSCLCbrainmet：50%-80%for2years2.1995，aMETA-analysis：SCLCwithCR,PCIimprove3yearsurvival15%-21%，butnotanalysisthecomplication3.Reducebrainmet

from30%→5%☆Conclusion：SCLCwithCR,PCIisrecommendafter2cyclesofchemoComplications?case1Guideline&SR•NC

CN–LungcancerandProphylacticcranialirradiation1–2002TheCochraneLibrary,Issue2•Prophylacticcranialirradiationsignific

antlyimprovessurvivalanddisease-freesurvivalforpatientswithsmallcelllungcancerincompleteremission.case1例1FromSec

ondarySource•PCIshouldstartearlyafterchemo•complications：–notRCT–2studyreportnodifferenceinmentalorneurologicaldi

sorder,butonlystudypartofthestudypatients，40%and60%（1995，1997）•N=300•N=314–InoneRCT（N=46）,reportamentaldisorder（1997）case1PUB

MED•"CranialIrradiation"[MESH]ANDlungneoplasms[mh]•("CranialIrradiation/adverseeffects"[MESH]OR"CranialIrradiation/mortality"[ME

SH])ANDlungneoplasms[mh]☆25papers，3papersafter2006，onrelatepaper（level5）例1PUBMED•2009,JCOpeer-review•Com

plications•Mentalandneurological•Increasebyconcurrentchemoirradiation•Increaseindoselevel≥40Gy，nomore

than30Gy，recommend20Gy–SupportPCIinSCLClimiteddiseasewithchemoCR.例1Conclusion&Decision•PCIreducebrainmet,improvesurvival•WhenRT<30GY

,rarecomplications•Morebenefitthanharm•Recommendation：PCI，rightnowcase1EventsLikeThis……Sanlubabyformulamilkpowdercontami

natewithmelamine•Jul.16,2008–甘肃省卫生厅接电话报告，称今年该院收治的婴儿患肾结石病例明显增多，近几个月已达十几例，经了解均食用了三鹿牌配方奶粉。•Sept.11,2008–新华社报道：“高度怀疑”三鹿公司生产的三鹿牌婴幼儿配方奶粉受到

三聚氰胺污染。case2Sanlubabyformulamilkpowdercontaminatewithmelamine•Sept.17,2008国务院有关部门负责人和科学家–国家质检总局局长李长江：……共检验了109家企业的491批次产品，有22家企业的69个批次

的产品检出了三聚氰胺，检出不合格产品的企业约为20％……需要指出的是，这次被检出含有三聚氰胺产品的企业，不是所有批次的婴幼儿奶粉都有问题，比如，伊利、蒙牛、雅士利、施恩等企业被抽检的产品有几十个批次，

但有问题的只有几个批次。case2Sanlubabyformulamilkpowdercontaminatewithmelamine–卫生部陈竺部长：三聚氰胺……主要对膀胱和肾脏有影响，引发动物膀胱炎、膀胱结石、肾脏炎症等，但没有发现对

人类有致癌作用。婴幼儿食用……出现不明原因的哭闹、呕吐、发热、尿液混浊、血尿、少尿或无尿等症状，应立即就近到医疗机构筛查就诊。食用含有三聚氰胺的其他品牌婴幼儿奶粉，只有出现上述症状时，才需要立即到医院筛查就诊。–从2008年9月12日至17日8时，各地报告临床诊

断患儿一共有6244例。其中，4917例患儿症状轻微，生命体征稳定，正在进行院外随访治疗或已经治愈。现仍留院观察治疗患儿有1327人。所有临床诊断病历中，有158人发生过急性肾功能衰竭，占总病例数的2.5%。经有效治疗，目前158例重症患儿当中，已经有94人病情平稳或已经治愈出院。此外

，回顾性的调查发现有3例死亡病例，其中甘肃省有2名，浙江有1名，不包括在刚才提到的6244名诊断病例之中。case2TheEvidencePyramidHierarchyofevidence:arrangesstudydesignsbytheirsusceptibility

tobiasPrimaryResearchExperimentalobservationalSecondaryResearch•Forquantitativestudies•ForqualitativestudiesNoconsensusabouttherela

tiverigourofdifferentmethodsSystematicreviewSanlubabyformulamilkpowdercontaminatewithmelamine•Celloranimali

snoequaltohuman•Butthereareanycorelation?•Noevidencedoesnotmeannoharm!•Howshouldweact?Summary•EBMisa

Lifelonglearningmodel–lifelong,self-directed,problem-basedlearning•Know-howinfinding,appraising,andapplying

evidenceFurtherReadingonEvidenceBasedMedicine