RESEARCHDESIGNS(outline) 1. DefinitionofResearchDesign 2. Classification 3. Summaryofresearchdesigns 4. Sequence for studying cause effect relationships 5. Choosingtheappropriatedesign 6. Descriptivestudies 7. Approachestohypothesisgeneration 8. Analyticobservationalstudies 9.

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

Subject:ComMedII Topic:ResearchDesigns1 Lecturer:Dr.JosephineCarnate DateofLecture:06/28/2011 Transcriptionist&Editor:AngryBirds NoofPage:7

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)

3. ClassificationAccordingtoTemporal Sequenceinanalyzingtherelationship betweentheeffectandthepresumed cause(ExposureFactorvs.Disease) a. Retrospective:ED b. Prospective:ED c. CrossSectional:ED

c.CrossSectionalResearch coexistencebetweenExposure FactorandDisease ex)PatientisObese,andhas Arthritis(Hypothesis:Obeseleads toArthritis)weidentifypeople withArthritis(Disease),thenwe determineifObesecausesArthritis

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

Maximization of internal and external validity

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

c) Timetrendsinagestandardizedmortality rate(/100,000popn)forpoliomyelitisin relationtointroductionofvaccine

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

Absentintheother) FactormaybeassociatedwithDisease Example:

D.MethodofAnalogy

Generatehypothesis exposuretoasbestosmaybethecause oftheinterstitiallungdisease B.MethodofAgreement

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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