cochrane納入的RCT文獻(xiàn)質(zhì)量評價英文原版omainSupportforjudgementReviewauthors’Selectionbias.RandomsequenceDescribethemethodusedtoSelectionbias(biasedgeneration.generatetheallocationsequenceinsufficientdetailtoallowanassessmentofwhetheritshouldproducecomparablegroups.allocationtointerventions)duetoinadequategenerationofarandomisedsequence.AllocationDescribethemethodusedtoSelectionbias(biasedconcealment.concealtheallocationsequenceinsufficientdetailtodeterminewhetherinterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolment.allocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.Performancebias.BlindingofDescribeallmeasuresused,ifPerformancebiasduetoparticipantsandany,toblindstudyparticipantsknowledgeofthepersonnelandpersonnelfromknowledgeofallocatedinterventionsAssessmentswhichinterventionaparticipantbyparticipantsandemadereceived.Provideanypersonnelduringtheforeachmaininformationrelatingtowhetherstudy.outcome(ortheintendedblindingwasassofeffective.outcomes).Detectionbias.BlindingofDescribeallmeasuresused,ifDetectionbiasduetoany,toblindoutcomeassessorsknowledgeoftheessmentfromknowledgeofwhichallocatedinterventionsAssessmentsinterventionaparticipantbyoutcomeassessors.shouldbemadereceived.Provideanyforeachmaininformationrelatingtowhetheroutcome(ortheintendedblindingwasclassofeffective.outcomes).Attritionbias.DescribethecompletenessofAttritionbiasduetooutcomedataoutcomedataforeachmainamount,natureorAssessmentsoutcome,includingattritionandhandlingofincompleteshouldbemadeexclusionsfromtheanalysis.outcomedata.foreachmainStatewhetherattritionandoutcome(orexclusionswerereported,theclassofnumbersineachinterventionoutcomes).htotalrandomizedparticipants,reasonsforattrition/exclusionswherereportedandanyre-inclusionsinanalysesperformedbythereviewauthors.Reportingbias.ctiveStatehowthepossibilityofReportingbiasduetoreporting.selectiveoutcomereportingwasexaminedbythereviewauthors,andwhatwasfound.iveoutcomereporting.Otherbias.OthersourcesofStateanyimportantconcernsBiasduetoproblemsbias.aboutbiasnotaddressedintheotherdomainsinthetool.Ifparticularquestions/entrieswerepre-specifiedinthereview’sprotocol,responsesshouldbeprovidedforeachquestion/entry.notcoveredelsewhereinthetable.RANDOMSEQUENCEGENERATIONSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.Criteriaforaentofbias.Criteriafortheentofbias.Theinvestigatorsdescribearandomcomponentinthesequencegenerationprocesssuchas:???????Referringtoarandomnumbertable;Usingacomputerrandomnumbergenerator;Cointossing;Shufflingcardsorenvelopes;Throwingdice;Drawingoflots;Minimization*.*Minimizationmaybeimplementedwithoutarandomelement,andthisisconsideredtobeequivalenttobeingrandom.Theinvestigatorsdescribeanon-randomcomponentinthesequencegenerationprocess.Usually,thedescriptionwouldinvolvesomesystematic,non-randomapproach,forexample:?Sequencegeneratedbyoddorevendateofbirth;?Sequencegeneratedbysomerulebasedondate(or?Sequencegeneratedbysomerulebasedonhospitalorclinicrecordnumber.onrandomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobviousTheyusuallyinvolvejudgementorsomemethodofnonrandomcategorizationofparticipants,formple?Allocationbyjudgementoftheclinician;?Allocationbypreferenceoftheparticipant;?Allocationbasedontheresultsofalaboratoryoftests?Allocationbyavailabilityoftheintervention.CriteriafortheInsufficientinformationaboutthesequencegeneration‘Unclearrisk’risk’.ofbias.ALLOCATIONCONCEALMENTSelectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.iteriafor‘Lowrisk’bias.iteriafor‘Highrisk’bias.aParticipantsandinvestigatorsenrollingparticipantscouldnotforeseeassignmentbecauseoneoftheoffollowing,oranequivalentmethod,wasusedtoconcealtion?Centralallocation(includingtelephone,web-basedandpharmacy-controlledrandomization);?Sequentiallynumbereddrugcontainersofidenticalance?Sequentiallynumbered,opaque,sealedenvelopes.theParticipantsorinvestigatorsenrollingparticipantscouldpossiblyforeseeassignmentsandthusintroduceofselectionbias,suchasallocationbasedon:?Usinganopenrandomallocationschedule.alistofrandomnumbers);?Assignmentenvelopeswereusedwithoutappropriatesafeguards.ifenvelopeswereunsealedornon-opaqueornotsequentiallynumbered);??Alternationorrotation;?Dateofbirth;?Caserecordnumber;?Anyotherexplicitlyunconcealedprocedure.iteriaforthe‘Unclearrisk’ofbias.methodofconcealmentisnotdescribedornotdescribedinsufficientdetailtoallowadefinitejudgement–forexampleiftheuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealed.BLINDINGOFPARTICIPANTSANDPERSONNELPerformancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Criteriaforabias.riteriaforthebias.Criteriaforthe‘Unclearrisk’ofbias.Anyoneofthefollowing:?Noblindingorincompleteblinding,butthereviewauthorsjudgethattheoutcomeisnotlikelytobeinfluencedbylackofblinding;?Blindingofparticipantsandkeystudypersonnelensured,andunlikelythattheblindingcouldhavebeenbroken.Anyoneofthefollowing:?Noblindingorincompleteblinding,andtheoutcomeslikelytobeinfluencedbylackofblinding?Blindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomeislikelytobeinfluencedbylackofblinding.Anyoneofthefollowing:Insufficientinformationtopermitjudgementof?Thestudydidnotaddressthisoutcome.BLINDINGOFOUTCOMEASSESSMENTDetectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessors.Criteriaforabias.rthebias.iteriaforthe‘Unclearrisk’ofbias.Anyoneofthefollowing:?Noblindingofoutcomeassessment,butthereviewdgethattheoutcomemeasurementisnotobeinfluencedbylackofblinding?Blindingofoutcomeassessmentensured,andnlikelythattheblindingcouldhavebeenbrokenAnyoneofthefollowing:?Noblindingofoutcomeassessment,andtheoutcomemeasurementislikelytobeinfluencedbylackofnding?Blindingofoutcomeassessment,butlikelythattheblindingcouldhavebeenbrokenandtheoutcomemeasurementislikelytobeinfluencedbylackofblinding.Anyoneofthefollowing:ntopermitjudgementof?Thestudydidnotaddressthisoutcome.INCOMPLETEOUTCOMEDATAAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Criteriaforabias.Anyoneofthefollowing:?Nomissingoutcomedata;?Reasonsformissingoutcomedataunlikelytoberelatedtotrueoutcome(forsurvivaldata,censoringunlikelytobeintroducingbias);?Missingoutcomedatabalancedinnumbersacrossinterventiongroups,withsimilarreasonsformissingdataacrossgroups;?Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventrisknotenoughtohaveaclinicallyrelevantimpactontheinterventioneffectestimate;?Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesnotenoughtohaveaclinicallyrelevantimpactonobservedeffectsize;?Missingdatahavebeenimputedusingappropriatemethods.rthebias.Anyoneofthefollowing:?Reasonformissingoutcomedatalikelytobetedtotrueoutcomewitheitherimbalanceinsorreasonsformissingdataacrossntiongroups?Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventriskenoughtoinduceclinicallyrelevantbiasininterventioneffectestimate;?Forcontinuousoutcomedata,plausibleeffectsizedifferenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesenoughtoinduce??antbiasinobservedeffectsizeterventionreceivedfromthatndomizationtiallyinappropriateapplicationofsimpleiteriaforthe‘Unclearrisk’ofbias.Anyoneofthefollowing:ntreportingofattritionexclusionstonumberrandomizednotstatednoreasonsformissingdataprovided?Thestudydidnotaddressthisoutcome.SELECTIVEREPORTINGReportingbiasduetoselectiveoutcomereporting.Criteriaforabias.Anyofthefollowing:?Thestudyprotocolisavailableandallofthestudy’spre-specified(primaryandsecondary)outcomesthatareofinterestinthereviewhavebeenreportedinthepre-specifiedway;?Thestudyprotocolisnotavailablebutitisclearthatthepublishedreportsincludeallexpectedoutcomesincludingthosethatwerepre-specified(convincingtextofthisnaturemaybeuncommon).rthebias.Anyoneofthefollowing:?Notallofthestudy’spre-specifiedprimarybeenreported?Oneormoreprimaryoutcomesisreportedusingmeasurementsanalysismethodsorsubsetsofthedatasubscales)thatwerenotpre-specified;?Oneormorereportedprimaryoutcomeswerenotpre-iedunlessclearjustificationfortheirrtingisprovidedsuchasanunexpected??ectrmoreoutcomesofinterestinthereviewareedincompletelysothattheycannotbeedinametaanalysishestudyreportfailstoincluderesultsforakeymethatwouldbeexpectedtohavebeenreportedforsuchastudy.mentofLow‘Unclearrisk’ofstudieswillfallintothiscategory.ofbias.OTHERBIASBiasduetoproblemsnotcoveredelsewhereinthetable.eriaforf‘Lowrisk’riteriaforjudgementof‘Highrisk’bias.aCriteriaforthef‘Unclearrisk’ofbias.Thestudyappearstobefreeofothersourcesofbias.Thereisatleastoneimportantriskofbias.Forplethestudy?Hadapotentialsourceofbiasrelatedtothespecificstudydesignusedor?Hasbeenclaimedtohavebeenfraudulent;or?Hadsomeotherproblem.Theremaybeariskofbias,butthereiseither:??Insufficientinformationtoassesswhetheranimportantriskofbiasexists;orInsufficientrationaleorevidencethatanidentifiedproblemwillintroducebias.summaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossandacrossstudiesRiskofbiasLowriskofbias.Unclearriskofbias.Highriskofbias.InterpretationPlausiblebiasunlikelytoseriouslyaltertheresults.Plausiblebiasthatraisessomedoubtabouttheresults.Plausiblebiasthatseriouslyweakensconfidenceintheresults.EntryRandomsequencerationEntryRandomsequenceration(selectionbias)AllocationealmentBlindingofparticipantsandpersonnel(performancebias)ighkLowrisk.WithinastudyLowriskofbiasforallkeydomains.Unclearriskofbiasforoneormorekeydomains.Highriskofbiasforoneormorekeydomains.AcrossstudiesMostinformationisfromstudiesatlowriskofbias.Mostinformationisfromstudiesatloworunclearriskofbias.Theproportionofinformationfromstudiesathighriskofbiasissufficienttoaffectth