TMIS实证医学个案讨论会简报范例课件

李文欽醫師實證醫學中心主任2013/11/08實證醫學與個案討論簡報大綱簡述實證醫學五大步驟如何問問題及形成PICO的內容資料搜尋的策略、使用資料庫及搜尋結果對資料的評讀如何落實實證醫學於個案討論過去

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現在

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未來當一個醫生該具備的的能力三日不讀書，面目可憎醫病照護教學研究2000年Sackett將實證醫學定義為“整合最佳研究證據、臨床經驗以及病患價值以達成病患最佳治療的過程”實證醫學的實行是一種終身的、自發的、以問題為導向的學習過程實證醫學的重要性臨床經驗病患價值最佳研究證據實證醫療Sackettetal2000實證醫學的五個步驟1.Askingananswerablequestion(提出可回答的臨床問題)2.Trackingdownthebestevidence

(搜尋最佳實證文獻資料)3.Criticalappraisal

(嚴謹的文獻評讀)4.Integratingtheappraisalwithclinicalexpertiseandpatients’preference

(將臨床專業與病人價值觀相結合)5.Evaluationtheeffectivenessandefficiencyinexecutingsteps1-4(評估改善)

AstrokepatientwhohaslongtermgoutyarthritisDoesgoutcauseahigherriskofstoke?痛風會增加中風的風險嗎？找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAskingEBM的步驟SirAustinBradfordHill(1897-1991),EnglishepidemiologistandstatisticianHedescribedtheclinicaltrialasbeing‘aCAREFULLY,andETHICALLY,describedexperimentwiththeaimofansweringsomePRECISELYFRAMEDQUESTIONGreaterprecisionisrequiredintheobjectives.WeneedtohaveAdefinedpopulationDefinedendpointsRelativelyfewquestiontobeanswered.問題要怎麼問？1.形成問題

(ClinicalQuestion)Doesgoutcauseahigherriskofstoke?痛風會增加中風的風險嗎？臨床的問題模型(PICO)P:Patient,Population指此病人或族群的年齡層、體質、疾病史、過去史等I:Intervention指治療、診斷、預後、成本效益分析等，為研究的主題C:Comparison指做與不做或不同處置間的比較O:Outcome指預後或與目前問題有關的比較基準找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAskingEBM的步驟PICO1Doesgoutcauseahigherriskofstoke?PICOtype:TherapyPatient:老年人Intervention:痛風Comparison:無痛風Outcome:中風的風險問題要怎麼問？2.Trackingdownthebestevidence直接使用實證醫學資料庫(secondarydatabases)如ACPjournalclub,CochraneLibrary,UpToDate,MDConsult,PracticeGuideline找初步篩選的資料庫(primarydatabases)PubMed,OVID,Proquest未經篩選的資料庫~如Google可搜尋實證醫學的資料庫

如何尋找與EBM相關的館藏資源？主題切入

本院一般綜合性資料庫

1.PudMed：可查出abstract2.Ovid：可查出abstract、Fulltext 3.Proquest：可查出abstract、Fulltext 4.Clinicalkey：可查出abstract、Fulltext找實證醫學資料時可加上

SystemicReview(系統性評論)、Meta-analysis(整合分析)、RandomizedControlledTrial(隨機對照臨床試驗研究)、

ControlledTrials利用資料庫功能鍵MeSHtoidentifyeverytermforexample找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAskingSearchingStrategy

FindingoutTheCorrectKeywords原始關鍵字PrimaryTerm或MeSHTerm同義字1同義字2P(oror)andI(GoutorHyperuricemiaor)andC(oror)andO(strokeoror)找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAskingSearchingStrategy

FindingoutTheCorrectKeywordsKeywordsfromPICOitem:(“gout”OR“hyperuricemia”)AND“stroke”MeSHtoidentifyeverytermforexample找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAsking善用搜尋Systematicreview˙關鍵字:(“gout”OR“hyperuricemia”)AND(“stroke”OR“cardiovasculardisease”)找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAskingTheEvidencePyramidV.AnimalresearchV.

Invitro(testtube)researchIV.Caseseries/ReportsV.Ideas,Editorials,OpinionsIII.CaseControlStudiesII.CohortstudiesI.RandomizedControlledStudies(RCT)I.RandomizedControlledDoubleBlindStudies

Meta-analysis統計方法Meta-analysis

圖示結果Forestplot*Hierarchyofevidence:arrangesstudydesignsbytheirsusceptibilitytobias.(LevelI~V)From:OxfordCenterforEBM研究設計與證據強度LevelTherapy/Prevention,Aetiology/HarmPrognosisDiagnosisDifferentialdiagnosis/symptomprevalencestudyEconomicanddecisionanalyses1aSR(withhomogeneity*)ofRCTsSR(withhomogeneity*)ofinceptioncohortstudies;CDR†validatedindifferentpopulationsSR(withhomogeneity*)ofLevel1diagnosticstudies;CDR†with1bstudiesfromdifferentclinicalcentresSR(withhomogeneity*)ofprospectivecohortstudiesSR(withhomogeneity*)ofLevel1economicstudies1bIndividualRCT(withnarrowConfidenceInterval‡)Individualinceptioncohortstudywith>80%follow-up;CDR†validatedinasinglepopulationValidating**cohortstudywithgood†††referencestandards;orCDR†testedwithinoneclinicalcentreProspectivecohortstudywithgoodfollow-up****Analysisbasedonclinicallysensiblecostsoralternatives;systematicreview(s)oftheevidence;andincludingmulti-waysensitivityanalyses1cAllornone§Allornonecase-seriesAbsoluteSpPinsandSnNouts††Allornonecase-seriesAbsolutebetter-valueorworse-valueanalyses††††2aSR(withhomogeneity*)ofcohortstudiesSR(withhomogeneity*)ofeitherretrospectivecohortstudiesoruntreatedcontrolgroupsinRCTsSR(withhomogeneity*)ofLevel>2diagnosticstudiesSR(withhomogeneity*)of2bandbetterstudiesSR(withhomogeneity*)ofLevel>2economicstudies2bIndividualcohortstudy(includinglowqualityRCT;e.g.,<80%follow-up)Retrospectivecohortstudyorfollow-upofuntreatedcontrolpatientsinanRCT;DerivationofCDR†orvalidatedonsplit-sample§§§onlyExploratory**cohortstudywithgood†††referencestandards;CDR†afterderivation,orvalidatedonlyonsplit-sample§§§ordatabasesRetrospectivecohortstudy,orpoorfollow-upAnalysisbasedonclinicallysensiblecostsoralternatives;limitedreview(s)oftheevidence,orsinglestudies;andincludingmulti-waysensitivityanalyses2c"Outcomes"Research;Ecologicalstudies"Outcomes"ResearchEcologicalstudiesAuditoroutcomesresearch3aSR(withhomogeneity*)ofcase-controlstudiesSR(withhomogeneity*)of3bandbetterstudiesSR(withhomogeneity*)of3bandbetterstudiesSR(withhomogeneity*)of3bandbetterstudies3bIndividualCase-ControlStudyNon-consecutivestudy;orwithoutconsistentlyappliedreferencestandardsNon-consecutivecohort

study,orverylimitedpopulationAnalysisbasedonlimitedalternativesorcosts,poorqualityestimatesofdata,butincludingsensitivityanalysesincorporatingclinicallysensiblevariations.4Case-series(andpoorqualitycohortandcase-controlstudies§§)Case-series(andpoorqualityprognosticcohortstudies***)Case-controlstudy,poorornon-independentreferencestandardCase-seriesorsupersededreferencestandardsAnalysiswithnosensitivityanalysis5Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedoneconomictheoryor"firstprinciples"OxfordCentreforEvidence-basedMedicine-LevelsofEvidence(March2009)

/index.aspx?o=1025文獻依其研究架構，大致分成5級實證醫學證據等級。Level1：有顯著意義的隨機對照研究報告（Randomizedcontrolledtrials,RCT）。Level2：世代研究（Cohortstudy）。Level3：病例及對照組研究（Case-controlstudy）。Level4：病例報告（Caseseries）。Level5：專家意見（Expertopinion）。

而當這些實證醫學文獻的證據等級應用在病人身上時，分成四個建議等級（Gradingsystemforrecommendations）臨床上就可根據此建議等級，而形成臨床指引：GradeA：根據Level1證據所做的建議。GradeB：根據Level2證據所做的建議。GradeC：根據Level3證據所做的建議。GradeD：根據Level3以下等級證據所做的建議。證據等級及建議等級

證據證據等級及建議強度建議強度證據等級LevelTherapy/Prevention,Aetiology/HarmPrognosisDiagnosisDifferentialdiagnosis/symptomprevalencestudyEconomicanddecisionanalyses1aSR(withhomogeneity*)ofRCTsSR(withhomogeneity*)ofinceptioncohortstudies;CDR†validatedindifferentpopulationsSR(withhomogeneity*)ofLevel1diagnosticstudies;CDR†with1bstudiesfromdifferentclinicalcentresSR(withhomogeneity*)ofprospectivecohortstudiesSR(withhomogeneity*)ofLevel1economicstudies1bIndividualRCT(withnarrowConfidenceInterval‡)Individualinceptioncohortstudywith>80%follow-up;CDR†validatedinasinglepopulationValidating**cohortstudywithgood†††referencestandards;orCDR†testedwithinoneclinicalcentreProspectivecohortstudywithgoodfollow-up****Analysisbasedonclinicallysensiblecostsoralternatives;systematicreview(s)oftheevidence;andincludingmulti-waysensitivityanalyses1cAllornone§Allornonecase-seriesAbsoluteSpPinsandSnNouts††Allornonecase-seriesAbsolutebetter-valueorworse-valueanalyses††††2aSR(withhomogeneity*)ofcohortstudiesSR(withhomogeneity*)ofeitherretrospectivecohortstudiesoruntreatedcontrolgroupsinRCTsSR(withhomogeneity*)ofLevel>2diagnosticstudiesSR(withhomogeneity*)of2bandbetterstudiesSR(withhomogeneity*)ofLevel>2economicstudies2bIndividualcohortstudy(includinglowqualityRCT;e.g.,<80%follow-up)Retrospectivecohortstudyorfollow-upofuntreatedcontrolpatientsinanRCT;DerivationofCDR†orvalidatedonsplit-sample§§§onlyExploratory**cohortstudywithgood†††referencestandards;CDR†afterderivation,orvalidatedonlyonsplit-sample§§§ordatabasesRetrospectivecohortstudy,orpoorfollow-upAnalysisbasedonclinicallysensiblecostsoralternatives;limitedreview(s)oftheevidence,orsinglestudies;andincludingmulti-waysensitivityanalyses2c"Outcomes"Research;Ecologicalstudies"Outcomes"ResearchEcologicalstudiesAuditoroutcomesresearch3aSR(withhomogeneity*)ofcase-controlstudiesSR(withhomogeneity*)of3bandbetterstudiesSR(withhomogeneity*)of3bandbetterstudiesSR(withhomogeneity*)of3bandbetterstudies3bIndividualCase-ControlStudyNon-consecutivestudy;orwithoutconsistentlyappliedreferencestandardsNon-consecutivecohort

study,orverylimitedpopulationAnalysisbasedonlimitedalternativesorcosts,poorqualityestimatesofdata,butincludingsensitivityanalysesincorporatingclinicallysensiblevariations.4Case-series(andpoorqualitycohortandcase-controlstudies§§)Case-series(andpoorqualityprognosticcohortstudies***)Case-controlstudy,poorornon-independentreferencestandardCase-seriesorsupersededreferencestandardsAnalysiswithnosensitivityanalysis5Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedonphysiology,benchresearchor"firstprinciples"Expertopinionwithoutexplicitcriticalappraisal,orbasedoneconomictheoryor"firstprinciples"OxfordCentreforEvidence-basedMedicine-LevelsofEvidence(March2009)

/index.aspx?o=1025找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAsking˙Title:-Hyperuricemiaandriskofstroke:asystematicreviewandmeta-analysis.(2009)˙Source:ArthritisRheum.2009Jul15;61(7):885-92˙Level:2aLargeepidemiologicstudieshaveshownthathyperuricemiaisassociatedwithanincreasedincidenceofcoronaryheartdisease(CHD)andincreasedmortalityinthosewith

andwithout

preexistingCHD.FangJ,AldermanMH.SerumuricacidandcardiovascularmortalitytheNHANESIepidemiologicfollow-upstudy,1971-1992.NationalHealthandNutritionExaminationSurvey.JAMA2000;283:2404.FreedmanDS,WilliamsonDF,GunterEW,ByersT.Relationofserumuricacidtomortalityandischemicheartdisease.TheNHANESIEpidemiologicFollow-upStudy.AmJEpidemiol1995;141:637.BrandFN,McGeeDL,KannelWB,etal.Hyperuricemiaasariskfactorofcoronaryheartdisease:TheFraminghamStudy.AmJEpidemiol1985;121:11.NiskanenLK,LaaksonenDE,NyyssönenK,etal.Uricacidlevelasariskfactorforcardiovascularandall-causemortalityinmiddle-agedmen:aprospectivecohortstudy.ArchInternMed2004;164:1546.ChoiHK,CurhanG.Independentimpactofgoutonmortalityandriskforcoronaryheartdisease.Circulation2007;116:894.Proposedmechanisms

forsuchanincreaseinriskincludethedevelopmentofhypertension

andoxidativestress.JohnsonRJ,SegalMS,SrinivasT,etal.Essentialhypertension,progressiverenaldisease,anduricacid:apathogeneticlink?JAmSocNephrol2005;16:1909.BakerJF,KrishnanE,ChenL,SchumacherHR.Serumuricacidandcardiovasculardisease:recentdevelopments,andwheredotheyleaveus?AmJMed2005;118:816.Itisunclearifhyperuricemiahasacausaleffector,ashasbeenmoreoftensuggested,issimplyamarkerforotherriskfactors,suchashypertension,dyslipidemia,anddiabetes.CulletonBF,LarsonMG,KannelWB,LevyD.Serumuricacidandriskforcardiovasculardiseaseanddeath:theFraminghamHeartStudy.AnnInternMed1999;131:7.WannametheeSG,ShaperAG,WhincupPH.Serumurateandtheriskofmajorcoronaryheartdiseaseevents.Heart1997;78:147.WheelerJG,JuzwishinKD,EiriksdottirG,etal.Serumuricacidandcoronaryheartdiseasein9,458incidentcasesand155,084controls:prospectivestudyandmeta-analysis.PLoSMed2005;2:e76.FeigDI,KangDH,JohnsonRJ.Uricacidandcardiovascularrisk.NEnglJMed2008;359:1811.文獻評讀三部曲文獻評讀最主要的三個步驟，即是VIPV：Validity/Reliability;效度/信度我們能相信這篇文章嗎?I：Importance/Impact;重要性我們相信它，但這個結論重要嗎?P：Practice/Applicability;臨床適用性如果我們相信它，這個結論可以應用在我們所照護的病患嗎?找資料來回答問題Acquire嚴格評讀文獻Appraisal是否可應用到病人身上Apply將病人的問題寫成PICOAskingAccordingto“SharonE.Strausetal,Evidence-basedmedicine:howtopracticeandteachEBM,Elsevier,2005:33-7.“ValidityImportanceApplicabilityResultsfromsecondarydatabaseResultsfromprimarydatabaseAppraisedbyexpertsNeededtobeappraisedResults(NNT)ResultsConsiderpopulationandfeasibilityConsiderpopulationandfeasibility效度(Validity)：可以用RAM-bo方式審視效度研究族群是否有隨機分配(Randomized)？隨機分配的方法是否適當(Accounted)？結果的衡量(Measurement)，

即是否依照盲法(blind)及客觀(objective)二要素操作治療意圖分析(Intention-to-treatanalysis,ITT)隨機試驗的一種分析方法所有被分配在治療組/對照組的病人無論是否完成該項治療/安慰劑都應該被放進治療組/對照組(原分派組別)中做分析文獻評讀三部曲重要性(Importance/Impact)：研究結果是什麼?研究結果如何被估計?經過多久的時間?文獻結果的評估方式：勝算比(oddsratio)代表生物學上的影響。相對危險(relativ