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    COHORT STUDYCOHORT STUDY

    PREPARED BY:PREPARED BY:MioleMiole,Mary Rose,Mary RoseOcionesOciones,, JovelJovel RoseRosePamisanPamisan, SheilaMay, SheilaMayRosario, Donna LeiRosario, Donna Lei

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    CohortstudyisundertakentosupporttheCohortstudyisundertakentosupporttheexistenceofassociation betweensuspectedexistenceofassociation betweensuspected

    causeanddiseasecauseanddisease A majorlimitationofcrossA majorlimitationofcross--sectionalsurveysandsectionalsurveysand

    casecase--controlstudiesisdifficultyindeterminingifcontrolstudiesisdifficultyindeterminingif

    exposureexposure ororriskfactorriskfactor precededtheprecededthediseasedisease oror

    outcomeoutcome..

    CohortStudy:CohortStudy:

    Key Point:Key Point:

    PresenceorabsenceofriskfactorisPresenceorabsenceofriskfactorisdetermineddetermined beforebeforeoutcomeoccurs.outcomeoccurs.

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    WHAT IS COHORTWHAT IS COHORT

    Ancient RomanmilitaryAncient Romanmilitaryunit, A bandofwarriors.unit, A bandofwarriors.

    referstoagroupofreferstoagroupof

    peoplethathaveapeoplethathaveacommonsimilarity.commonsimilarity.

    Persons bandedtogether.Persons bandedtogether.

    Groupofpersonswith aGroupofpersonswith a

    common statisticalcommon statisticalcharacteristic. [Latin]characteristic. [Latin]

    E.g.age, birth dateE.g.age, birth date,,

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    C

    ohortstudiesC

    ohortstudies longitudinallongitudinal

    ProspectivestudiesProspectivestudies

    ForwardlookingstudyForwardlookingstudy IncidencestudyIncidencestudy

    startswith peoplefreeofdiseasestartswith peoplefreeofdisease

    assessesexposureatbaselineassessesexposureatbaseline assessesdiseasestatusatfollowassessesdiseasestatusatfollow--upup

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    Itisimportanttoemphasizethatacohortstudy,

    isnotanexperiment, butmerelyobservesthesubjectsofthestudywithoutinterveningexcepttoask questionsorconductphysicalexaminationsandlaboratorytestsatvariousintervals.

    Obviously,theinformedconsentofallparticipantsmustbeobtained,andincohortstudiesofverylongdurationitisusuallynecessarytoobtaininformedconsentbeforeeach subsequentphase

    ofthestudy.

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    INDICATION OF A COHORT STUDYINDICATION OF A COHORT STUDY

    WhenthereisgoodevidenceofexposureWhenthereisgoodevidenceofexposureanddisease.anddisease.

    Whenexposureisrare butincidenceofWhenexposureisrare butincidenceofdiseaseis higheramongexposeddiseaseis higheramongexposed

    WhenfollowWhenfollow--upiseasy,cohortisstableupiseasy,cohortisstable

    Whenamplefundsareavailable

    Whenamplefundsareavailable

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    GeneralconsiderationwhileselectionGeneralconsiderationwhileselection

    ofcohortsofcohorts Both thecohortsarefreeofthedisease.Both thecohortsarefreeofthedisease.

    Both thegroupsshouldequallysusceptibleBoth thegroupsshouldequallysusceptible

    todiseasetodisease Both thegroupsshould becomparableBoth thegroupsshould becomparable

    DiagnosticandeligibilitycriteriafortheDiagnosticandeligibilitycriteriaforthe

    diseaseshould bedefinedwellinadvance.diseaseshould bedefinedwellinadvance.

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    ElementsofcohortstudyElementsofcohortstudy

    SelectionofstudysubjectsSelectionofstudysubjects ObtainingdataonexposureObtainingdataonexposure

    SelectionofcomparisongroupSelectionofcomparisongroup

    FollowupFollowupAnalysisAnalysis

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    SelectionofstudysubjectsSelectionofstudysubjects

    GeneralpopulationGeneralpopulation

    WholepopulationinanareaWholepopulationinanarea

    A representativesampleA representativesample

    Special groupofpopulationSpecial groupofpopulation

    SelectgroupSelectgroup

    occupationgroup / professionalgroup (Dollsstudy )occupationgroup / professionalgroup (Dollsstudy )

    ExposuregroupsExposuregroups

    Person havingexposuretosomephysical,chemicalorPerson havingexposuretosomephysical,chemicalorbiologicalagentbiologicalagent

    e.g. Xe.g. X--ray exposuretoradiologistsray exposuretoradiologists

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    ObtainingdataonexposureObtainingdataonexposure

    Personalinterviews / mailed questionnairePersonalinterviews / mailed questionnaire ReviewsofrecordsReviewsofrecords

    Doseofdrug,radiation,typeofsurgeryetcDoseofdrug,radiation,typeofsurgeryetc

    MedicalexaminationorspecialtestMedicalexaminationorspecialtest Bloodpressure,serumcholesterolBloodpressure,serumcholesterol

    EnvironmentalsurveyEnvironmentalsurvey

    ByobtainingthedataofexposurewecanByobtainingthedataofexposurewecanclassifycohortsasclassifycohortsas ExposedandnonexposedandExposedandnonexposedand Bydegreeexposurewecansub classifycohortsBydegreeexposurewecansub classifycohorts

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    SelectionofcomparisongroupSelectionofcomparisongroup InternalcomparisonInternalcomparison

    OnlyonecohortinvolvedinstudyOnlyonecohortinvolvedinstudy

    Sub classifiedandinternalcomparisondoneSub classifiedandinternalcomparisondone

    ExternalcomparisonExternalcomparison MorethanonecohortinthestudyforthepurposeofMorethanonecohortinthestudyforthepurposeof

    comparisoncomparison e.g.Cohortofradiologistcomparedwithe.g.Cohortofradiologistcomparedwith

    ophthalmologistsophthalmologists

    Comparisonwith generalpopulationratesComparisonwith generalpopulationrates

    IfnocomparisongroupisavailablewecancompareIfnocomparisongroupisavailablewecancomparetheratesofstudycohortwith generalpopulation.theratesofstudycohortwith generalpopulation.

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    FollowFollow--upup Toobtaindataaboutoutcometo bedeterminedToobtaindataaboutoutcometo bedetermined

    (morbidityordeath)(morbidityordeath) Mailed questionnaire,telephonecalls,personalMailed questionnaire,telephonecalls,personal

    interviewsinterviews PeriodicmedicalexaminationPeriodicmedicalexamination ReviewingrecordsReviewingrecords Surveillanceofdeath recordsSurveillanceofdeath records FollowupisthemostcriticalpartofthestudyFollowupisthemostcriticalpartofthestudy

    SomelosstofollowupisinevitableduetodeathSomelosstofollowupisinevitableduetodeath

    changeofaddress,migration,changeofchangeofaddress,migration,changeofoccupation.occupation. LosstofollowLosstofollow--upisoneofthedrawupisoneofthedraw--backofthebackofthe

    cohortstudy.cohortstudy.

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    ANALYSISANALYSIS

    CalculationofincidenceratesamongCalculationofincidenceratesamong

    exposedandnonexposedgroupsexposedandnonexposedgroups

    EstimationofriskEstimationofrisk

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    TypesofCohortStudyTypesofCohortStudy

    ProspectivecohortstudyProspectivecohortstudy

    Retrospective (historical) cohortstudyRetrospective (historical) cohortstudy

    CombinationofRetrospectiveandCombinationofRetrospectiveandProspectivecohortstudy.Prospectivecohortstudy.

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    CohortstudiesCohortstudies

    StrengthsStrengths WecanfindoutWecanfindout

    incidencerateandincidencerateandriskrisk

    MorethanoneMorethanonediseaserelatedtodiseaserelatedtosingleexposuresingleexposure

    canestablish causecanestablish cause--

    effecteffect goodwhenexposuregoodwhenexposure

    israreisrare

    minimizesselectionminimizesselection

    andinformation biasandinformation bias

    WeaknessesWeaknesses lossestofollowlossestofollow--upup

    oftenrequireslargeoftenrequireslarge

    samplesample ineffectiveforrareineffectiveforrare

    diseasesdiseases

    longtimetocompletelongtimetocomplete

    expensiveexpensive

    EthicalissuesEthicalissues

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    USES OF COHORT STUDYUSES OF COHORT STUDY

    1.Todescribethenatural historyofthe1.Todescribethenatural historyofthe

    disease.disease. 2.Toidentifythenumberofnewcases2.Toidentifythenumberofnewcases

    occurring.occurring.

    3.Todeterminetheetiologicfactors3.Todeterminetheetiologicfactorsassociatedwith theonsetofthedisease.associatedwith theonsetofthedisease.

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    4.Investigatelateand4.Investigatelateandchronicchronic effect.effect.

    5.Measurestheassociation betweenrisk5.Measurestheassociation betweenrisk

    factorsanddisease.factorsanddisease.

    6.Usetostudyrareexposures6.Usetostudyrareexposures

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    TYPES OFCOHORT STUDYTYPES OFCOHORT STUDY

    1.PROSPECTIVE COHORT1.PROSPECTIVE COHORT

    --relevantexposuremayormaynothaverelevantexposuremayormaynothave

    occurred bythattimethestudyisinitiatedoccurred bythattimethestudyisinitiatedbutoutcome havedefinitelynotoccurred.butoutcome havedefinitelynotoccurred.

    --followedintothefuturetoassessthefollowedintothefuturetoassessthe

    incidentrateofthedisease.incidentrateofthedisease. Ex: Effectofbreastfeedingamonginfants.Ex: Effectofbreastfeedingamonginfants.

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    2.RETROSPECTIVE

    COH

    ORT2.RETROSPECTIVE

    COH

    ORT

    theexposureandoutcomeofinteresttheexposureandoutcomeofinterest

    havealreadyoccurredwhenthestudyishavealreadyoccurredwhenthestudyisinitiated.initiated.

    Example: DetermineifasbestosexposureExample: Determineifasbestosexposurecauselungcancer.causelungcancer.

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    Advantagesofthe Cohort Study:Advantagesofthe Cohort Study:

    1.Allowcompleteinformationonthesubjects1.Allowcompleteinformationonthesubjectsexposure,including qualitycontrolofdata,exposure,including qualitycontrolofdata,andexperiencethereafter.andexperiencethereafter.

    2.Provideacleartemporalsequenceof2.Provideacleartemporalsequenceofexposureanddisease.exposureanddisease.

    3.Giveanopportunitytostudymultiple3.Giveanopportunitytostudymultipleoutcomesrelatedtoaspecificexposure.outcomesrelatedtoaspecificexposure.

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    4.Permitcalculationofincidencerates4.Permitcalculationofincidencerates(absoluterisk) aswellasrelativerisk.(absoluterisk) aswellasrelativerisk.

    5.Methodologyandresultsareeasily5.Methodologyandresultsareeasilyunderstood bynonunderstood bynon--epidemiologists.epidemiologists.

    6.Enablethestudyofrelativelyrare6.Enablethestudyofrelativelyrareexposures.exposures.

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    Disadvantagesofthe Cohort Study:Disadvantagesofthe Cohort Study:

    Notsuitedforthestudyofrarediseases becauseaNotsuitedforthestudyofrarediseases becausea

    largenumberofsubjectsisrequired.largenumberofsubjectsisrequired.

    Notsuitedwhenthetime betweenexposureandNotsuitedwhenthetime betweenexposureand

    diseasemanifestationisverylong,although thisdiseasemanifestationisverylong,although thiscan beovercomein historicalcohortstudies.can beovercomein historicalcohortstudies.

    Exposurepatterns,forexamplethecompositionofExposurepatterns,forexamplethecompositionof

    oralcontraceptives,maychangeduringthecourseoralcontraceptives,maychangeduringthecourseofthestudyandmaketheresultsirrelevant.ofthestudyandmaketheresultsirrelevant.

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    Maintaining high ratesoffollowMaintaining high ratesoffollow--upcan beupcan bedifficult.difficult.

    ExpensivetocarryoutbecausealargeExpensivetocarryoutbecausealargenumberofsubjectsisusuallyrequired.numberofsubjectsisusuallyrequired.

    Baselinedatamay besparse becausetheBaselinedatamay besparse becausethelargenumberofsubjectsdoesnotallowforlargenumberofsubjectsdoesnotallowfor

    longinterviews.longinterviews.

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    MeasuresofdiseaseandassociationMeasuresofdiseaseandassociation

    ThemeasureofdiseaseincohortstudiesisThemeasureofdiseaseincohortstudiesis

    theincidencerate,which istheproportionoftheincidencerate,which istheproportionofsubjectswhodevelopthediseaseunderstudysubjectswhodevelopthediseaseunderstudywithinaspecifiedtimeperiod. Thenumeratorwithinaspecifiedtimeperiod. Thenumeratoroftherateisthenumberofdiseasedsubjectsoftherateisthenumberofdiseasedsubjectsandthedenominatorisusuallythenumberofandthedenominatorisusuallythenumberofpersonperson--yearsofobservation. Theincidenceyearsofobservation. Theincidenceratesforexposedandnonratesforexposedandnon--exposedsubjectsexposedsubjects

    arecalculatedseparately.arecalculatedseparately. Themeasureofassociation betweenexposureThemeasureofassociation betweenexposure

    anddiseaseincohortstudiesistherelativeanddiseaseincohortstudiesistherelative

    risk.risk.

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    TherelativeriskistheratiooftheincidenceTherelativeriskistheratiooftheincidencerateofindexsubjectstothatofcontrolrateofindexsubjectstothatofcontrol

    subjects. A relativeriskof1.0signifiesthatthesubjects. A relativeriskof1.0signifiesthattheincidencerateisthesameamongexposedandincidencerateisthesameamongexposedandnonnon--exposedsubjectsandindicatesalackofexposedsubjectsandindicatesalackof

    association betweenexposureanddisease. Aassociation betweenexposureanddisease. Arelativeriskoflessthan1.0providesevidencerelativeriskoflessthan1.0providesevidenceforaprotectiveeffectofexposure (theforaprotectiveeffectofexposure (theincidencerateofdiseaseamongexposedisincidencerateofdiseaseamongexposedis

    lowerthannonlowerthannon--exposed) whereasarelativeexposed) whereasarelativeriskabove1.0suggeststhatexposedpeopleriskabove1.0suggeststhatexposedpeopleareathigherriskofdiseasethannonareathigherriskofdiseasethannon--exposedexposed

    persons.persons.

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    THANK YOU