临床研究设计方法.ppt

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临床研究设计方法北京协和医院普通内科方卫纲

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Epidemiology.2001,12(1):114-122.CausationofBias:TheEpiscopeFIGURE1.“TheEpiscope.”Auserofepidemiologicevidenceseesa“known”RD(kRD)thatresultsfrominformationtransmitted,likelightraysthroughatelescope,fromacausal(“aetiologic”)RD(aRD)inatargetpopulation,throughlayersof“lenses”and“filters.”Eachlayerisadistinctdomainwherecertaintypesofbiasesoperate,potentiallyaddingadditionaldistortionstotheassociationofinterest.DomainsathroughkareillustratedinFigures2-10.

A.Theoriginalcauseoftheimagetransmittedthroughtheepiscopeistheassociation(ifitexists)betweenthecausalagentandmorbidity.B.Otherbackgroundfactorscloudtheassociationrandomly.C.Inthesourcepopulation,theassociationofinterestcanbefurtherdistortedbycorrelatedcauses.Noneoftheabovephenomenaisobservablewithoutdiagnosesandexposuremeasurements,whichareproducedasfollows:D.Morbidityisacontributingcauseofdiagnoses,whicharerecordedinmedicalchartsordeathcertificates,aswellasself-reportedonquestionnaires.Thesediagnosesandrecordingshavevaryingsensitivitiesandspecificities.E.Theoccurrenceofthecausalagentisacontributingcauseoftheoccurrenceofevidenceofexposure,whichisrecordedviainterviews,self-administeredquestionnaires,administrativeforms,andotherinstrumentswithvaryingsensitivitiesandspecificities.

F.Dataondiagnosesandexposuresarecollatedbyvariousmeansintofilesanddatabases,usuallyforadministrativepurposesandsometimesspecificallyforepidemiologicstudies.G.Inadescriptivestudy,theselectionusuallyinvolvesgroupingsubjectsintovariousexposurelevelsandexaminingdiseaserates.Foracohortstudy,thedatabasemaybeusedforchoosingspecificexposuregroupstofollow.H.Thencomestheharvestingofnewcasesinacohortstudyor,analogously,t

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