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Analyticexperimentalstudies 10. Controllingbiasandconfounding Research Design it is the strategy of the researcher in answering the research objectiveand how the research is to be conducted a plan that describes in detail the procedure to follow to arrive at an answertotheresearchquestion theBlueprintofResearch Classificationofresearchdesigns Accordingto: 1. General aim/objective of the study a. Descriptive Design it describe the characteristics of aphenomenon/event It is also concerned with patterns of disease occurrence: magnitude anddistribution Use to Generate hypothesis
EpidemiologicVariables:Person+Place +Time b. Analytic Design it determine if an association/relationshipexists toidentifyEtiology,FactorOutcome Relationship there should be at least two variables Use to test a hypothesis of relationship 2. Classification According to the ManipulationofExposureVariable a. ObservationalResearch The researcher just Observes Observewithoutaltering b.ExperimentalResearch
researcher Manipulates the EXPOSURE Variables Presence / Absence of Exposure Variable have limited use in determining Cause of Diseases because we are the ones that administer the Exposures, therefore, experiments are not done to establish cause & effect relationships for Safety Reasons (has limited use) main objective: assessing effectivenessofacertaindrug(not todeterminecauseofdisease)
a.RetrospectiveStudy startsfromthediseaseandlooks backwardatsuspectedcause Sequenceforstudying&Hierarchyofevidence (Exposure) forcauseeffectrelationships welookbackintime(Wehavethe disease,thenweassessthefactors Descriptivestudies causingthedisease) Case report generatehypotheses ex)InapersonwithArthrisis(the Case series disease),welookatthecertain Ecologic Analyticobservational factorsthatcausedArthritis Cross-sectional studiestesthypotheses Case-control b.ProspectiveResearch Cohort Quasi- experiment Analyticexperimental startsatsuspectedcauseand Randomized studiestesthypotheses/ looksforwardatdisease controlled trial establishrelationship subjectshavetheExposureFactors causingadisease(butdonthave thedisease..yet)sowefollow Considerations in choosing the appropriate theirlives/future researchdesign ex)Welookatpeoplewhoare Researchobjective Obese,thenwellobserveifthey Feasibility willdevelopArthritisinthefuture Ethicalconsiderations
ExternalValidity degreetowhichconclusioncanbe GENERALIZED InternalValidity Degree to w/c the conclusions correctly describe what actually happenedinthestudy
CC: PE:
representthefirstcluesinthe identificationofnewdiseasesoradverse effectsofexposure Example: 35-yo farmer lossofweight,anorexia,soretongue, indigestion,diarrhea malnourished;symmetricbilateral erythematouspruriticlesionsonhands andforearms
Diet: mainlycorn,rarelyfreshmeat
DESCRIPTIVESTUDIES
Generatehypothesis dietasthecauseofthedisease:Pellagra
CaseSeries Provideinitialinformationabout: Newdiseases more than one patient (3 or more Riskfactorsfordiseases patients) describepatternsofdisease collectionofindividualcasereportswhich (eventorphenomenon) may occur within a fairly short period of occurrenceaccordingto time population usedasameanstoidentifythebeginning animportantstepinthesearch orpresenceofanepidemic fordeterminantsorriskfactors Example: providefirstcluesin:Recognition 3deathsduetoangiosarcomaoftheliver ofDisease+IdentificationofRisk previouslyemployedinapolyvinylchloride Factors plant Output=DataLeadtoformulation ofHYPOTHESIS(relationship Generatehypothesis betweenfactorandoutcome) occupationalexposuretopolyvinylchloride causeshepaticangiosarcoma I.TYPESOFDESCRIPTIVESTUDIES CaseReportandSeriesLimitations A.CaseReport Cannottestforstatisticalassociation B.CaseStudies Casereport:ariskfactormayonlybe C.EcologicStudy coincidental CaseReport
mostbasicdescriptivestudy careful,detailedreportontheprofileofa singlepatient documentsunusualmedicaloccurrences Caseseries:nocomparisongroup
EcologicStudy
comparesthefrequencyortrendof diagnosis/mortalitybetweenoramong groups
Subject=GroupofPersons(school, community,barangay) unlikeCaseReports/CaseSeries(looks ateveryindividual),EcologicStudies looksatanentiregroup thereiscomparisonoffrequencyof disease/mortality ProxyVariablescanbeused(ex.Alcohol TaxisusedtomeasureAlcohol Consumption) UsesofEcologicStudies: a. TogenerateHypothesison DiseaseEtiology b. ToevaluateEffectivenessof PopulationIntervention PreventiveandPromotive TypesofEcologicStudies: 1.EcologicComparison
Generatehypothesis vaccinecausedthedropinpoliomyelitis mortalityrate 2.EcologicTrends(TimeSeries) assessmentoftrendsinoneormore groupsovertime changesinfrequencyofexposureand diseaseduringthestudyperiodare estimated ex)RateofCrimeinTownAandTownB from20002004 MajorLimitationsofEcologicStudies 1.Itcannotestablishanassociationbetween exposureanddisease(canonlysuggest)
simplecomparisonoffrequency measuresamonggroupsatonepointin time(duringONEPeriod) **Example a) RateofCrimebetweenTownAand TownBweshouldfindfactorsthat wouldaffectCrimeRateTownAhas highemployment;TownBhaslow employment *BarangayA:HighUnemploymentRate HighCrimeRate *BarangayB:LowUnemploymentRate LowCrimeRate b) Meatconsumptionandincidenceof coloncanceramongfemalesinseveral countries
2.EcologicFallacy inappropriateconclusionregarding relationshipsattheindividuallevelbased onecologicdata NOTE:wecannotmakeconclusionsinthe IndividualLevel Example: Hypothesis:HigherUnemploymenthas HigherCrimeRate However,weCANNOTConcludethat thoseUnemployedaretheones committingthecrime WecannotbaseitontheIndividual Level II.APPROACHESTOHYPOTHESISFORMULATION A.MethodofDifference frequencyofdiseaseismarkedlydifferent undertwodifferentconditions/group (FactorPresentinone;Factor
Generatehypothesis diethighinmeatcancausecoloncancer
D.MethodofAnalogy
afactoriscommontodifferentgroups withhighdiseasefrequenciesdisease iscausedbythefactorthat iscommon betweenthe2groups Factorcommontoanumberofdifferent circumstances FactormaybeassociatedwithDisease Example: CervicalCanceriscommonamong Prostitutes,PoorPeople,YoungGirls (commonfactoramongthethree groups = afflicted by STD) Example: Intravenousdrugusershigh incidenceof AIDS Hemophiliacshighincidenceof AIDS Generatehypothesis exposuretobloodmaybethecause ofAIDS C.MethodofConcomitantVariation
distributionofdiseasessufficiently similartothedistributionofanother diseasecauseofthediseasesmaybe common Factormaybeassociatedwithdisease Example: DiseaseXhasdistributionpatterns similartomalaria Generatehypothesis DiseaseXmaybeassociatedwiththe samecauseofmalaria
ANALYTICDESIGN
Testhypothesisofassociation/establish relationshipbetweentwovariables: INDEPENDENTandDEPENDENT VARIABLE UsesofAnalyticDesign identifydiseaseetiology identifyprotectivefactors assesseffectivenessofan intervention **BasicSchematicDiagram(Exposure Disease) a. Exposurea.k.aFactor,Cause, IndependentVariable b. Diseasea.k.aOutcome,Effect, DependentVariable c. KeyStrategy=Useofa ComparisonGroup(Control Group!)toestablishthata factorisassociatedwithan Outcome Ex) Smoking (Cause) Lung Cancer (Disease)
somefactorshavefrequencyorstrength thatvarieswiththefrequencyofdisease Factormaybeassociatedwiththe disease Example: Highcigarettesales highincidence Isthereaassociation/relationship oflungcancer between: Lowcigarettesales lowincidenceof independent dependent .lungcancer Generatehypothesis predictoroutcome cigarettesmokingmaybeassociated exposuredisease Keystrategyistheuseof withlungcancer comparisongroups
The analytic observational research designs Crosssectional Generalfeatures: Exposureanddiseasestatusat onepointintime Generatesprevalencedata Not appropriate for establishing causal associations or for investigations of disease etiology Example: Is there an association between malnutrition and incomplete immunization among children 1 6 yrs old in Dasmarinas, Cavite,2006
The analytic observational research designs Crosssectional Steps: 1. Definethetargetpopulation 2. Choosethestudypopulation(sample) 3. Classifyintodiseaseandexposurestatus 4. Computeformeasureofassociation 5. Interpretthemeasureofassociation Measureofassociation:PrevalenceRatio
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