STARD checklist-诊断研究

STARDchecklistforreportingofstudiesofdiagnosticaccuracySectionandTopicItem#Onpage#TITLE/ABSTRACT/KEYWORDS1Identifythearticleasastudyofdiagnosticaccuracy(recommendMeSHheading'sensitivityandspecificity').INTRODUCTION2Statetheresearchquestionsorstudyaims,suchasestimatingdiagnosticaccuracyorcomparingaccuracybetweentestsoracrossparticipantgroups.METHODSParticipants3Thestudypopulation:Theinclusionandexclusioncriteria,settingandlocationswheredatawerecollected.4Participantrecruitment:Wasrecruitmentbasedonpresentingsymptoms,resultsfromprevioustests,orthefactthattheparticipantshadreceivedtheindextestsorthereferencestandard?5Participantsampling:Wasthestudypopulationaconsecutiveseriesofparticipantsdefinedbytheselectioncriteriainitem3and4?Ifnot,specifyhowparticipantswerefurtherselected.6Datacollection:Wasdatacollectionplannedbeforetheindextestandreferencestandardwereperformed(prospectivestudy)orafter(retrospectivestudy)?Testmethods7Thereferencestandardanditsrationale.8Technicalspecificationsofmaterialandmethodsinvolvedincludinghowandwhenmeasurementsweretaken,and/orcitereferencesforindextestsandreferencestandard.9Definitionofandrationalefortheunits,cut-offsand/orcategoriesoftheresultsoftheindextestsandthereferencestandard.10Thenumber,trainingandexpertiseofthepersonsexecutingandreadingtheindextestsandthereferencestandard.11Whetherornotthereadersoftheindextestsandreferencestandardwereblind(masked)totheresultsoftheothertestanddescribeanyotherclinicalinformationavailabletothereaders.Statisticalmethods12Methodsforcalculatingorcomparingmeasuresofdiagnosticaccuracy,andthestatisticalmethodsusedtoquantifyuncertainty(e.g.95%confidenceintervals).13Methodsforcalculatingtestreproducibility,ifdone.RESULTSParticipants14Whenstudywasperformed,includingbeginningandenddatesofrecruitment.15Clinicalanddemographiccharacteristicsofthestudypopulation(atleastinformationonage,gender,spectrumofpresentingsymptoms).16Thenumberofparticipantssatisfyingthecriteriaforinclusionwhodidordidnotundergotheindextestsand/orthereferencestandard;describewhyparticipantsfailedtoundergoeithertest(aflowdiagramisstronglyrecommended).Testresults17Time-intervalbetweentheindextestsandthereferencestandard,andanytreatmentadministeredinbetween.18Distributionofseverityofdisease(definecriteria)inthosewiththetargetcondition;otherdiagnosesinparticipantswithoutthetargetcondition.19Acrosstabulationoftheresultsoftheindextests(includingindeterminateandmissingresults)bytheresultsofthereferencestandard;forcontinuousresults,thedistributionofthetestresultsbytheresultsofthereferencestandard.20Anyadverseeventsfromperformingtheindextestsorthereferencestandard.Estimates21Estimatesofdiagnosticaccuracyandmeasuresofstatisticaluncertainty(e.g.95%confidenceintervals).22Howindeterminateresults,missingdataandoutliersoftheindextestswerehandled.23Estimatesofvariabilityofdiagnosticaccuracybetweensubgroupsofparticipants,readersorcenters,ifdone.24Estimatesoftestreproducibility,ifdone.DISCUSSION25Discusstheclinicalapplicabilityofthestudyfindings.