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Evidence-BasedMedicine循证医学Evidence-basedPractice(EBP)Models•TraditionalpracticeModel(×)•Model1:Usethehighestqualityinforma
tiontoguideclinicaldecisions•Model2:Search,evaluate,andmakeavailablespecialtyspecificbestavailableevidence•Model3:C
reateoriginalresearchorsystematicreviewsEBMPractice-FivestepsPatientHistoryandPE……•QuestionAskingAnswerableClinicalQuestions.•Sea
rchSearchingforthebestcurrentevidence.•AppraiseCritically-appraisingtheevidence.•Application:Integrating
theevidencewithourexpertiseandourpatient’suniquebiologyandvalues•AuditEvaluatingourperformanceStep1AskingAns
werableClinicalQuestions•EBMstartswithaclearclinicalquestion•Well-builtclinicalquestionsguidethewholeEBMprocess•Typeofquestion?–
Causation/etiology–Intervention–Diagnosis–Prognosis•TypeofStudy?–Whatwouldbethebeststudydesigninordertoanswerthequestion?
–studydesignsshouldlimitbiasStep1AskingAnswerableClinicalQuestions•Questioncomponents:PICO–WhattypesofParticipants?–WhattypesofInterventions?–What
typesofComparison?–WhattypesofOutcomes?Step1AskingAnswerableClinicalQuestions•Whattypesofparticipants?–Diseas
eorconditionofinterest–Potentialco-morbidity–Setting–Demographicfactors–TaskofclinicalproblemStep1AskingAnswerableClini
calQuestions•Whattypesofintervention?–Typesoftreatment–Typeofdiagnostictest–Typeofcausativeagent–Typeofp
rognosticfactorStep1AskingAnswerableClinicalQuestions•Whattypesofoutcomes?–Forcausation,outcomeisdis
ease–Fordiagnostictest,outcomeindiseaseofinterest–Fortreatmentincludealloutcomesimportanttopeoplemakingdecisionstodefinesucc
essoftherapy–Forprognosis,outcomeisthechosenendpointofthediseaseStep1AskingAnswerableClinicalQuestions•Broadornarrowquestio
ns–Broad•Dogefinitibimprovesurvivalinlungadenocarcinoma?–Narrow•Dogefinitibimprovesurvivalinfemallungadenocarcinomarefractorytofirst-linechemo?S
tep1AskingAnswerableClinicalQuestions•Causation–People-Exposure-Comparison-Outcomes•Doesheavysmokerhavehigherincidenceoflungcance
r?–Prognosis:People-Exposure-Comparison-Outcomes•IslungadenocarcinomawithhighlevelofCEAaremorelikelyto
haverecurrentdisease?Step2Searchingforthebestcurrentevidence•Textbook–Annuallyrevised–Usehighlevelevidences–Withreference•Guidelines•Coc
hraneLibrary•MedlineNationalGuidelineClearinghouse(http://www.guideline.gov/)Step2Toomuch?•即使是小的问题也有相关
指南Step2Step2CochraneLibrary•Advantage–highestqualityevidencewe’lleverhaveontheeffectivenessofhealthcare•Disadvantage–noty
etmanysystemicreviews–necessarilyomitsthenewesttreatmentStep2EBPModels•TraditionalpracticeModel(×)•Model1:Usethehighestqualityinformati
ontoguideclinicaldecisions•Model2:Search,evaluate,andmakeavailablespecialtyspecificLevel1information•Model
3:CreateoriginalresearchorsystematicreviewsStep2PubMed/MEDLINE•http://www.ncbi.nlm.nih.gov/PubmedStep2Medline-PubMedAdvantage–ex
haustiveness,flexibilityofsearching–journalcoverage,currency(on-lineversions)–widespreadavailabilityandsupportDisadvantage–havetodoyourownqualityfilt
ering–puttingtogethergoodsearchesisdifficult–gapsincoverage(medical,geographicalandlinguistic)Step2Step2Step2Step2Step2Step2Step2Searching
forthebestcurrentevidence•Forprimaryliterature–Notjustabstract!–TrytogetFull-textStep3Critically-appraisingtheevidence•Valid?–Designandmethodol
ogy:logical?–Sample–ExperimentorMeasure:carriedoutinasoundwayandConvincible?Follow-uprate?–Analysis–Conclus
ion–Ethical?•Importance?–Clinicalsignificance?–Cost-effective?•Applicable?–Willtheresultshelplocally?Step3Criti
cally-appraisingtheevidence•Quickscreeningbytitle,abstractandrelatemessage–Authors•Well-known?Pastrecord?C
reditable?–Institute•Competencetodothisstudy?Well-known?–Specialty•Hasorhadpublishedincorejournals?Yourpractice?Valuable?•GoforFull-textDiscrimi
nation?Rational?EBM?Step3Critically-appraisingtheevidenceTypeofQuestionSuggestedbesttypeofStudyTherapyRCT>cohort>casecontrol>caseseriesDiagnos
isProspective,blindcomparisontoagoldstandardEtiology/HarmRCT>cohort>casecontrol>caseseriesPrognosisCohortstudy>casecont
rol>caseseriesPreventionRCT>cohortstudy>casecontrol>caseseriesClinicalExamProspective,blindcomparisontogoldstandardCostEconomicanalysisRightmetho
dsiscrucialTheEvidencePyramidHierarchyofevidence:arrangesstudydesignsbytheirsusceptibilitytobiasPrimaryResearchExperimentalobservationalSecondaryRese
arch•Forquantitativestudies•ForqualitativestudiesNoconsensusabouttherelativerigourofdifferentmethodsSystematicreviewStep3Critically
-appraisingtheevidenceImprovedsurvivalandsamplesizedControlSurvival(%)5%10%15%101,290394134151,894544208202,444676328252,926788374PhaseIIIRCTheadto
headComparesurvivalAdequatesamplesizeStep3Critically-appraisingtheevidence•Measure–Objective:Labtest,Radiology–Subjective:pain,symptoms•Endpoint
–alternative:relieveofsymptom,shrinkoftumor–GoldStandard:prolongsurvivalStep3Critically-appraisingtheevidence•Conclusion–Basedonth
edata?–New?•Updated?•Comparewithotherstudy•And,Whatnext?Step3Critically-appraisingtheevidence•Attention!–Don’ttrustitjustbecauseitisfro
mabigboss,meta-analysis,RCT,orguideline.–Evidenceshouldbeinconsistencewithknownmedicalscience(physiology,pathology,pharmacology,etc)Usageofscie
ntificlanguageisnotnecessarilymeanscientificbasedScientificmethodscreditNotalltheevidencesarethesameimport
anceHollingworth&Jarvik,Radiology2007;244:31-38Flowchartofcost-effectivenessateachlevelofTAhierarchyTechnicalPerfor
manceDiagnosticPerformanceDiagnosticImpactTherapeuticImpactImpactonHealthStep4Application•Integratingtheevidencewithou
rexpertiseandourpatient’suniquebiologyandvalues–Yourquestion–Yourpatient–Yourexpertise–Yourhospital–Howto……Step5Evaluatingourp
erformance•Follow-up•Evaluate–Thepatientsbenefit……?•Next……•……Oragainanother5steps•CollectdataandwriteanarticleEBPModels•Traditionalpra
cticeModel(×)•Model1:Usethehighestqualityinformationtoguideclinicaldecisions•Model2:Search,evaluate,andmakeavailablespecialtyspecificbestavailableev
idence•Model3:CreateoriginalresearchorsystematicreviewsSelectiveEBP•Maynotneedtocarryoutall5steps•1.AskingAnswerableClinic
alQuestions.•X2.Searchingforthebestcurrentevidence.•X3.Critically-appraisingtheevidence.•4.Applicatio
n:Integratingtheevidencewithourexpertiseandourpatient’suniquebiologyandvalues•5.EvaluatingourperformanceSelec
tiveEBP•3differentmodesofEBP–Searching&appraising•providesE-Bcare,butisexpensiveintimeandresources–Searchingonly•much,quicker,an
difcarriedoutamongE-Bresources,canprovideE-Bcare–Replicatingthepracticeofexperts•quickest,butmaynotdistinguishevidence-basedfromego-bas
edrecommendationsSelectiveEBP•EvenfullyEBM-trainedcliniciansworkinall3modes–Searching&appraising•fortheproblemsIencounterdaily.–Searchingonl
y•forproblemsIencounteronceamonth.–Replicating•forproblemsIencounteronceadecade(andcrossingmyfingers!).Case1•Male,ZSUProfessor,62yea
rsold•Smallcelllungcancer,limiteddisease,chemofor6cycleswithcompleteresponse–Medicaloncologist:prophylacticcranialirradiation(PC
I)notimporvesurvival,andwithAE!–Radio-oncologist:PCIimprovesurvival,andtolerable•Question:Why?Shouldt
hepatientbegivePCI?Improvesurvival?Howmuch?Sideeffect?When?How?TextbookPublish20061.ChanceofSCLCbrainmet:50%-80%for2years2.1995,aMETA-analysis:SCLCw
ithCR,PCIimprove3yearsurvival15%-21%,butnotanalysisthecomplication3.Reducebrainmetfrom30%→5%☆Conclusion:SCLCwi
thCR,PCIisrecommendafter2cyclesofchemoComplications?case1Guideline&SR•NCCN–LungcancerandProphylacticcranialirrad
iation1–2002TheCochraneLibrary,Issue2•Prophylacticcranialirradiationsignificantlyimprovessurvivalanddisease-freesurvivalforpa
tientswithsmallcelllungcancerincompleteremission.case1例1FromSecondarySource•PCIshouldstartearlyafterchemo•complications:–notRCT–2studyr
eportnodifferenceinmentalorneurologicaldisorder,butonlystudypartofthestudypatients,40%and60%(1995,1997)•N=300•N=314–InoneRCT(
N=46),reportamentaldisorder(1997)case1PUBMED•"CranialIrradiation"[MESH]ANDlungneoplasms[mh]•("CranialIrradiation/adverseeffects"[MESH]OR"
CranialIrradiation/mortality"[MESH])ANDlungneoplasms[mh]☆25papers,3papersafter2006,onrelatepaper(level5)例1PUBMED•2009,JCOp
eer-review•Complications•Mentalandneurological•Increasebyconcurrentchemoirradiation•Increaseindoselevel≥40Gy,nomorethan30Gy,recommend20Gy
–SupportPCIinSCLClimiteddiseasewithchemoCR.例1Conclusion&Decision•PCIreducebrainmet,improvesurvival•WhenRT<30GY,rarecom
plications•Morebenefitthanharm•Recommendation:PCI,rightnowcase1EventsLikeThis……Sanlubabyformulamilkpowdercontaminatew
ithmelamine•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:arrangesstudydesignsbytheirsusceptibilitytobiasP
rimaryResearchExperimentalobservationalSecondaryResearch•Forquantitativestudies•ForqualitativestudiesNocon
sensusabouttherelativerigourofdifferentmethodsSystematicreviewSanlubabyformulamilkpowdercontaminatewithmelamine•Celloranimalisnoequaltohuman•But
thereareanycorelation?•Noevidencedoesnotmeannoharm!•Howshouldweact?Summary•EBMisaLifelonglearningmodel–lif
elong,self-directed,problem-basedlearning•Know-howinfinding,appraising,andapplyingevidenceFurtherReading
onEvidenceBasedMedicine