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ExtensionsoftheParallelDesign:FactorialandLarge,SimpleDesigns,SectionB,Copyright2013JohnsHopkinsUniversityandLeaDrye.AllRightsReserved.,FactorialDesign,2,Twointerventionstestedsimultaneously,eitheras.Economicalwaytotesttwotreatmentssimultaneously,orMethodtotestfortreatmentinteractionFortestingtwotreatmentssimultaneously,assumptionisofnointeractionTreatmentshaveindependentmodeofactionMoreplausibleifdifferentoutcome,阳叫D,巴,3,imiQ,TreatmentB+,A，w/woB,NoA，w/woB,+,vcvm,NoB，w/woA,B，w/woA,FactorialDesign:Comparisons,4,Estimationofmaineffects,ifnointeractionexpectedUsenumbersinthemarginsAvs.noA,regardlessofassignmenttoBBvs.noB,regardlessofassignmenttoADetermineresponseAssessmentforinteractionIsresponseinAandnoAdifferentamongthosereceivingBornoB?Mayhavelimitedpowertodetectinteraction,5,阳叫D巴ignGraph,TreatmentB+A，w/woBNoA，w/woB,+,F川C忘,NoB，w/woA,B，w/woA,FactorialDesignExample:ISIS-3,6,InternationalStudyofInfarctSurvival3Factorialdesign:3x2Aspirin+heparinvs.aspirinalone(antithrombotic)Streptokinasevs.tPAvs.APSAC(fibrinolytic)Large,simpletrial41,299patients914hospitals20countries,7,5ource:1515-3CollaborativeGroup(1992).Lancet339:753-770.,II-Tr创ments,SubtotalA:13，780patientsallocatedSK,SubtotalB:13，746patientsallocatedtPA,SubtotalC:13，773patientsallocatedAPSAC,Subtotal1:20，656patientsallocatedaspirinplusheparin,F飞d-L,创,陪,hL同,甜,i,hM,剖,P础a,-L、JJun,o4三-,MAN.叫m,uOUS,F3句，,aa,Total:41，299patients,Large,SimpleDesign,8,FeaturesVerylargenumberofpatients(manystudysites)BroadeligibilitycriteriaMinimaldatacollectionrequirementsRationaleModestbenefitsrequirelargesamplesizesTreatmentinteractionsunlikely,sobaselinecharacteristicsandinterimresponsevariablesarenotneededLessprecision(moreerror,increasedvariance)istolerated;counteredwithlargenumbers,Large,SimpleDesign:Requirements,9,EasilyadministeredinterventionShort-termadherenceNotreatmentadjustmentNoongoingmonitoringforadverseeventsEasilyascertainedoutcomeShort-termfollow-up?NocomplexbaselinemeasurementsSimpledataarepersuasiveenough,ISIS-3Methods,10,Source:ISIS-3CollaborativeGroup(1992).Lancet339:753-770.,Nobaselineform,randomizationbyphonecallTreatmentconvenientlypackagedUseofancillarytreatmentnot
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