cochrane纳入的RCT文献质量评价英文原版

1、DomainSupportforjudgementReviewauthors'judgementSelectionbias.Randomsequencegeneration.Describethemethodusedtogeneratetheallocationsequenceinsufficientdetailtoallowanassessmentofwhetheritshouldproducecomparablegroups.Selectionbias(biasedallocationtointerventions)duetoinadequategenerationofarando

2、misedsequence.Allocationconcealment.Describethemethodusedtoconcealtheallocationsequenceinsufficientdetailtodeterminewhetherinterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolment.Selectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment

3、.Performancebias.BlindingofparticipantsandpersonnelAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).?Describeallmeasuresused,ifany,toblindstudyparticipantsandpersonnelfromknowledgeofwhichinterventionaparticipantreceived.Provideanyinformationrelatingtowhethertheintendedblindingwaseffectiv

4、e.Performancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Detectionbias.BlindingofoutcomeassessmentAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).Describeallmeasuresused,ifany,toblindoutcomeassessorsfromknowledgeofwhichinterventionaparticipantre

5、ceived.Provideanyinformationrelatingtowhethertheintendedblindingwaseffective.Detectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessors.Attritionbias.IncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).?Describethecompletenessofoutcomedataforeachmainoutcom

6、e,includingattritionandexclusionsfromtheanalysis.Statewhetherattritionandexclusionswerereported,thenumbersineachinterventiongroup(comparedwithtotalrandomizedparticipants),Attritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.reasonsforattrition/exclusionswherereported,andanyre-inclusionsi

7、nanalysesperformedbythereviewauthors.Reportingbias.Selectivereporting.Statehowthepossibilityofselectiveoutcomereportingwasexaminedbythereviewauthors,andwhatwasfound.Reportingbiasduetoselectiveoutcomereporting.Otherbias.Othersourcesofbias.Stateanyimportantconcernsaboutbiasnotaddressedintheotherdomain

8、sinthetool.Ifparticularquestions/entrieswerepre-specifiedinthereview'sprotocol,responsesshouldbeprovidedforeachquestion/entry.Biasduetoproblemsnotcoveredelsewhereinthetable.RANDOMSEQUENCEGENERATIONSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.Criter

9、iaforajudgementof'Lowrisk'ofbias.Theinvestigatorsdescribearandomcomponentinthe/sequencegenerationprocesssuchas:* Referringtoarandomnumbertable;* Usingacomputerrandomnumbergenerator;* Cointossing;* Shufflingcardsorenvelopes;* Throwingdice;* Drawingoflots;* Minimization*.?*Minimizationmaybeimp

10、lementedwithoutarandomelement,andthisisconsideredtobeequivalenttobeingrandom.Criteriaforthejudgementof'Highrisk'ofbias.Theinvestigatorsdescribeanon-randomcomponentinthesequencegenerationprocess.Usually,thedescriptionwouldinvolvesomesystematic,non-randomapproach,forexample:Sequencegeneratedby

11、oddorevendateofbirth; Sequencegeneratedbysomerulebasedondate(orday)ofadmission; Sequencegeneratedbysomerulebasedonhospitalorclinicrecordnumber.Othernon-randomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobvious.?Theyusuallyinvolvejudgementorsomemethodofnon-ra

12、ndomcategorizationofparticipants,forexample: Allocationbyjudgementoftheclinician; Allocationbypreferenceoftheparticipant; Allocationbasedontheresultsofalaboratorytestoraseriesoftests; Allocationbyavailabilityoftheintervention.Criteriaforthejudgementof?'Unclearrisk'ofbias.Insufficientinformat

13、ionaboutthesequencegenerationprocesstopermitjudgementof'Lowrisk'or'Highrisk'.ALLOCATIONCONCEALMENTSelectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.Criteriaforajudgementof'Lowrisk'ofbias.Participantsandinvestigatorsenrollin

14、gparticipantscouldnotforeseeassignmentbecauseoneofthefollowing,oranequivalentmethod,wasusedtoconcealallocation:* Centralallocation(includingtelephone,web-basedandpharmacy-controlledrandomization);* Sequentiallynumbereddrugcontainersofidenticalappearance;* Sequentiallynumbered,opaque,sealedenvelopes.

15、Criteriaforthejudgementof'Highrisk'ofbias.Participantsorinvestigatorsenrollingparticipantscouldpossiblyforeseeassignmentsandthusintroduceselectionbias,suchasallocationbasedon:*Usinganopenrandomallocationschedule(e.g.alistofrandomnumbers);Assignmentenvelopeswereusedwithoutappropriatesafeguard

16、s(e.g.ifenvelopeswereunsealedornonopaqueornotsequentiallynumbered); Alternationorrotation; Dateofbirth; Caserecordnumber; Anyotherexplicitlyunconcealedprocedure.Criteriaforthejudgementof?'Unclearrisk'ofbias.Insufficientinformationtopermitjudgementof'Lowrisk'or'Highrisk'.Thisi

17、susuallythecaseifthemethodofconcealmentisnotdescribedornotdescribedinsufficientdetailtoallowadefinitejudgement-forexampleiftheuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealed.BLINDINGOFPARTICIPANTSANDPERSONNELPerformancebiasduetoknowledg

18、eoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.CriteriaforaAnyoneofthefollowing:judgementof'Lowrisk'ofbias.Noblindingorincompleteblinding,butthereviewauthorsjudgethattheoutcomeisnotlikelytobeinfluencedbylackofblinding;*Blindingofparticipantsandkeystudypersonnelensured,a

19、ndunlikelythattheblindingcouldhavebeenbroken.Criteriaforthejudgementof'Highrisk'ofbias.Anyoneofthefollowing:Noblindingorincompleteblinding,andtheoutcomeislikelytobeinfluencedbylackofblinding;*Blindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken,andt

20、heoutcomeislikelytobeinfluencedbylackofblinding.Criteriaforthejudgementof?(Unclearrisk'ofbias.Anyoneofthefollowing:* Insufficientinformationtopermitjudgementof'Lowrisk'or'Highrisk'* Thestudydidnotaddressthisoutcome.BLINDINGOFOUTCOMEASSESSMENTDetectionbiasduetoknowledgeofthealloca

21、tedinterventionsbyoutcomeassessors.Criteriaforajudgementof'Lowrisk'ofbias.Anyoneofthefollowing: Noblindingofoutcomeassessment,butthereviewauthorsjudgethattheoutcomemeasurementisnotlikelytobeinfluencedbylackofblinding; Blindingofoutcomeassessmentensured,andunlikelythattheblindingcouldhavebeen

22、broken.Criteriaforthejudgementof'Highrisk'ofbias.Anyoneofthefollowing: Noblindingofoutcomeassessment,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding; Blindingofoutcomeassessment,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomemeasurementislikelytobeinfluencedbylackofb

23、linding.Criteriaforthejudgementof?(Unclearrisk'ofbias.Anyoneofthefollowing: Insufficientinformationtopermitjudgementof'Lowrisk'or'Highrisk' Thestudydidnotaddressthisoutcome.INCOMPLETEOUTCOMEDATAAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Criteriaforajudgement

24、of'Lowrisk'ofbias.Anyoneofthefollowing: Nomissingoutcomedata; Reasonsformissingoutcomedataunlikelytoberelatedtotrueoutcome(forsurvivaldata,censoringunlikelytobeintroducingbias); Missingoutcomedatabalancedinnumbersacrossinterventiongroups,withsimilarreasonsformissingdataacrossgroups; Fordicho

25、tomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventrisknotenoughtohaveaclinicallyrelevantimpactontheinterventioneffectestimate; Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesnotenoughtohaveaclinicallyrelevantim

26、pactonobservedeffectsize;Missingdatahavebeenimputedusingappropriatemethods.Criteriaforthejudgementof'Highrisk'ofbias.Anyoneofthefollowing: Reasonformissingoutcomedatalikelytoberelatedtotrueoutcome,witheitherimbalanceinnumbersorreasonsformissingdataacrossinterventiongroups; Fordichotomousoutc

27、omedata,theproportionofmissingoutcomescomparedwithobservedeventriskenoughtoinduceclinicallyrelevantbiasininterventioneffectestimate; Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesenoughtoinduceclinicallyrelevantbiasinobservedeffects

28、ize; (As-treated'analysisdonewithsubstantialdepartureoftheinterventionreceivedfromthatassignedatrandomization; Potentiallyinappropriateapplicationofsimpleimputation.Criteriaforthejudgementof?'Unclearrisk'ofbias.Anyoneofthefollowing:*Insufficientreportingofattrition/exclusionstopermitjudg

29、ementof'Lowrisk'or'Highrisk'(e.g.numberrandomizednotstated,noreasonsformissingdataprovided);Thestudydidnotaddressthisoutcome.SELECTIVEREPORTINGCriteria for a judgement of ' Low risk ' of bias.Any of the following:Reportingbiasduetoselectiveoutcomereporting. Thestudyprotocolis

30、availableandallofthestudy'spre-specified(primaryandsecondary)outcomesthatareofinterestinthereviewhavebeenreportedinthepre-specifiedway; Thestudyprotocolisnotavailablebutitisclearthatthepublishedreportsincludeallexpectedoutcomes,includingthosethatwerepre-specified(convincingtextofthisnaturemaybeu

31、ncommon).Criteriaforthejudgementof'Highrisk'ofbias.Anyoneofthefollowing: Notallofthestudy'spre-specifiedprimaryoutcomeshavebeenreported; Oneormoreprimaryoutcomesisreportedusingmeasurements,analysismethodsorsubsetsofthedata(e.g.subscales)thatwerenotpre-specified; Oneormorereportedprimaryo

32、utcomeswerenotpre-specified(unlessclearjustificationfortheirreportingisprovided,suchasanunexpectedadverseeffect); Oneormoreoutcomesofinterestinthereviewarereportedincompletelysothattheycannotbeenteredinameta-analysis; Thestudyreportfailstoincluderesultsforakeyoutcomethatwouldbeexpectedtohavebeenrepo

33、rtedforsuchastudy.Criteriaforthejudgementof?'Unclearrisk'ofbias.Insufficientinformationtopermitjudgementof'Lowrisk'or'Highrisk'.Itislikelythatthemajorityofstudieswillfallintothiscategory.OTHERBIASBiasduetoproblemsnotcoveredelsewhereinthetable.Criteriaforajudgementof'Lowri

34、sk'ofbias.Thestudyappearstobefreeofothersourcesofbias.Criteriaforthejudgementof'Highrisk'ofbias.Thereisatleastoneimportantriskofbias.Forexample,thestudy:* Hadapotentialsourceofbiasrelatedtothespecificstudydesignused;or* Hasbeenclaimedtohavebeenfraudulent;or* Hadsomeotherproblem.Criteriaf

35、orthejudgementof?'UnclearTheremaybeariskofbias,butthereiseither:Insufficientinformationtoassesswhetheranrisk'ofbias.importantriskofbiasexists;orInsufficientrationaleorevidencethatanidentifiedproblemwillintroducebias.summaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossdomains)withi

36、nandacrossstudiesRiskofbiasInterpretationWithinastudyAcrossstudiesLowriskofbias.Plausiblebiasunlikelytoseriouslyaltertheresults.Lowriskofbiasforallkeydomains.Mostinformationisfromstudiesatlowriskofbias.Unclearriskofbias.Plausiblebiasthatraisessomedoubtabouttheresults.Unclearriskofbiasforoneormorekey

37、domains.Mostinformationisfromstudiesatloworunclearriskofbias.Highriskofbias.Plausiblebiasthatseriouslyweakensconfidenceintheresults.Highriskofbiasforoneormorekeydomains.Theproportionofinformationfromstudiesathighriskofbiasissufficienttoaffecttheinterpretationofresults.EntryJudgementSupportforjudgementRandomsequencegeneration(selectionbias)Lowrisk.Quote:"patientswererandomlyallocated.”Comment:Probablydone,sinceearlierreportsfromthesameinvestigatorsclearlydescribeuseofrandomsequences(Cartwrig