Quantifying Data Quality for Clinical Trials Using Electronic Data Capture 英文参考文献.docVIP

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Quantifying Data Quality for Clinical Trials Using Electronic Data Capture 英文参考文献.doc

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Quantifying Data Quality for Clinical Trials Using Electronic Data Capture 英文参考文献

QuantifyingDataQualityforClinicalTrialsUsing ElectronicDataCapture MeredithL.Nahm1*,CarlF.Pieper2,MaureenM.Cunningham3 1Duke Translational Medicine Institute, Durham, North Carolina, United States of America, 2Department of Biostatistics and Bioinformatics, Duke University Medical Center,Durham,NorthCarolina,UnitedStatesofAmerica,3DukeClinicalResearchInstitute,Durham,NorthCarolina,UnitedStatesofAmerica Abstract Background:Historically,onlypartialassessmentsofdataqualityhavebeenperformedinclinicaltrials,forwhichthemost commonmethodofmeasuringdatabaseerrorrateshasbeentocomparethecasereportform(CRF)todatabaseentries andcountdiscrepancies.Importantly,errorsarisingfrommedicalrecordabstractionandtranscriptionarerarelyevaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typicallyleveragedforqualitymeasurementarenotusedinEDCprocesses. MethodsandPrincipalFindings:TheNationalInstituteonDrugAbuseTreatmentClinicalTrialsNetworkhasdeveloped, implemented,andevaluatedmethodologyforholisticallyassessingdataqualityonEDCtrials.Wecharacterizetheaverage source-to-databaseerrorrate(14.3errorsper10,000fields)forthefirstyearofuseofthenewevaluationmethod.Thiserror ratewassignificantlylowerthantheaverageofpublishederrorratesforsource-to-databaseaudits,andwassimilartoCRF- to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstractiononthetrialsweexamined,andtoanoutpatientsettingcharacterizedbylessacutepatientconditions. Conclusions:Historically,medicalrecordabstractionisthemostsignificantsourceoferrorbyanorderofmagnitude,and shouldbemeasuredandmanagedduringthecourseofclinicaltrials.Source-to-databaseerrorratesarehighlydependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependenciesthatshouldbeconsideredwhendevelopingdataqualitybenchmarks. Citation: Nahm ML, Pieper CF, Cunningham