Assessment and Implication of Prognostic Imbalance in Randomized Controlled Trials with a Binary Outcome – A Simulation Study 英文参考文献.docVIP

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Assessment and Implication of Prognostic Imbalance in Randomized Controlled Trials with a Binary Outcome – A Simulation Study 英文参考文献.doc

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Assessment and Implication of Prognostic Imbalance in Randomized Controlled Trials with a Binary Outcome – A Simulation Study 英文参考文献

AssessmentandImplicationofPrognosticImbalancein RandomizedControlledTrialswithaBinaryOutcome–A SimulationStudy RongChu1*,StephenD.Walter1,GordonGuyatt1,P.J.Devereaux1,2,MichaelWalsh1,KristianThorlund1, LehanaThabane1,2,3,4 1Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada, 2Population Health Research Institute,HamiltonHealthSciences,Hamilton,Ontario,Canada,3BiostatisticsUnit,FatherSeanO’SullivanResearchCentre,StJoseph’sHealthcareHamilton,Hamilton, Ontario,Canada,4TheCentreforEvaluationofMedicines,StJoseph’sHealthcareHamilton,Hamilton,Ontario,Canada Abstract Background:Chanceimbalanceinbaselineprognosisofarandomizedcontrolledtrialcanleadtooverorunderestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1) evaluate the probability of imbalance in a binary prognostic factor (PF) between two treatment arms, (2) investigate the impact of prognostic imbalanceontheestimationofatreatmenteffect,and(3)examinetheeffectofsamplesize(n)inrelationtothefirsttwo objectives. Methods: We simulateddata fromparallel-group trials evaluatingabinary outcomeby varyingtherisk of theoutcome, effectofthetreatment,powerandprevalenceofthePF,andn.Logisticregressionmodelswithandwithoutadjustmentfor thePFwerecomparedintermsofbias,standarderror,coverageofconfidenceintervalandstatisticalpower. Results:ForaPFwithaprevalenceof0.5,theprobabilityofadifferenceinthefrequencyofthePF$5%reaches0.42with 125/arm.IgnoringastrongPF(relativerisk=5)leadstounderestimatingthestrengthofamoderatetreatmenteffect,and theunderestimateisindependentofnwhennis.50/arm.AdjustingforsuchPFincreasesstatisticalpower.IfthePFis weak(RR=2),adjustmentmakeslittledifferenceinstatisticalinference.Conditionalona5%imbalanceofapowerfulPF, adjustmentreducesthelikelihoodoflargebias.Ifanabsolutemeasureofimbalance$5%isdeemedimportant,including 1000patients/armprovidessufficientprotectionagainstsuchanimbalance.Twotho