cochrane评分表.docx
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cochrane评分表.docx
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cochrane评分表
Riskofbias
Item
Authors'judgement
Description
Adequatesequencegeneration?
Yes
Prinicipalauthorstatedthatcomputergeneratedallocationwasused
Allocationconcealment?
Yes
Prinicipalauthorstatedthatallocationwasconcealed
Blinding?
Unclear
Nomentionofstudypersonnelorparticipantsbeingblindtotreatmentgroup
Incompleteoutcomedataaddressed?
Yes
Allparticipantsaccountedfor,one'dropout'recordedbutincludedbyusinanalysis
Freeofotherbias?
Unclear
Possibleunevendistributionofcompleteandincompleteparalysisatstartofstudybetweenthetwotreatmentgroups
CochraneRCT质量评价标准:
①随机方法是否正确。
②是否隐蔽分组。
③盲法的使用情况。
④失访或退出描述情况,有无采用意向性(ITT)分析。
以上质量标准中,如所有标准均为“充分”,则发生各种偏倚的可能性很小;如其中一条为不清楚,则有发生相应偏倚的中等度可能性;如其中一条为“不充分”或“未采用”,则有发生相应偏倚的高度可能性。
可参见:
RCT的质量评价标准选择总结
Qualityassessment
ThequalityofthetrialswasassessedandgradedindependentlybytwoauthorsaccordingtothecriteriadescribedinTheCochraneHandbook4.2.6(Higgins2006).Gradingswerecomparedandanyinconsistenciesbetweentheauthorsintheinterpretationofinclusioncriteriaandtheirsignificancetotheselectedstudywerediscussedandresolved.
Theselectedstudywasassessedforthefollowingcharacteristics:
1.Theadequacyoftherandomisationprocess(possibleselectionbias).Adequaterandomisationincludesanyoneofthefollowingmethods:
computergeneratedortableofrandomnumbers,drawingoflots,coin-toss,shufflingcardsorthrowofadice.Inadequatemethodsofrandomisationincludethefollowing:
caserecordnumber,dateofbirthoralternatenumbers.
2.Theadequacyoftheallocationconcealment(possibleselectionbias).Adequatemethodsofallocationconcealmentincludeeithercentralrandomisation(i.e.separatetootheraspectsoftrialadministration)orsequentiallynumberedsealedopaqueenvelopes.Inadequateconcealmentmeansanopenallocationsequenceinwhicheitherparticipantsortrialistswereabletoforeseetheupcomingassignment.
3.Theblindingofoutcomeassessors(i.e.whetherthepersonsassessingtheoutcomeofcarewereawareofwhichtreatmenttheparticipanthadreceived-possibleperformancebias).
4.Theextentandhandlingoflossestofollowup(possibleattritionbias).Adequatehandlingoflossestofollowupinvolvesacleardescriptionandexplanationbeinggivenofanysignificantdifferencebetweenthelossesoftheinterventiongroups.Anunacceptablelossinanyoneinterventiongroupwasconsideredtobelossgreaterthan20%.
StudygradingsA,BorCwereemployedforoverallqualityasfollows.
A:
Minimisationofbiasinallfourcategoriesabove:
i.e.adequaterandomisation,fewlossestofollowupandintention-to-treatanalysis,blindingofoutcomeassessors,highqualityoutcomeassessment;
B:
EachofthecriteriainApartiallymet;
C:
OneormoreofthecriteriainAnotmet.
Riskofbiasinincludedstudies
WeclassifiedthisstudyasgradeCbecauseoftheuncertaintyaboutblinding.Thepossibilityofanunevendistributionofcompleteandincompletepalsiesbetweenthetwogroupsisanotherpotentialsourceofbiasandweconcludeoverallthatthisisalowqualitystudy.
Table8.5.a:
TheCochraneCollaboration’stoolforassessingriskofbias
Domain
Description
Reviewauthors’judgement
Sequencegeneration.
Describethemethodusedtogeneratetheallocationsequenceinsufficientdetailtoallowanassessmentofwhetheritshouldproducecomparablegroups.
Wastheallocationsequenceadequatelygenerated?
Allocationconcealment.
Describethemethodusedtoconcealtheallocationsequenceinsufficientdetailtodeterminewhetherinterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolment.
Wasallocationadequatelyconcealed?
Blindingofparticipants,personnelandoutcomeassessorsAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).
Describeallmeasuresused,ifany,toblindstudyparticipantsandpersonnelfromknowledgeofwhichinterventionaparticipantreceived.Provideanyinformationrelatingtowhethertheintendedblindingwaseffective.
Wasknowledgeoftheallocatedinterventionadequatelypreventedduringthestudy?
IncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).
Describethecompletenessofoutcomedataforeachmainoutcome,includingattritionandexclusionsfromtheanalysis.Statewhetherattritionandexclusionswerereported,thenumbersineachinterventiongroup(comparedwithtotalrandomizedparticipants),reasonsforattrition/exclusionswherereported,andanyre-inclusionsinanalysesperformedbythereviewauthors.
Wereincompleteoutcomedataadequatelyaddressed?
Selectiveoutcomereporting.
Statehowthepossibilityofselectiveoutcomereportingwasexaminedbythereviewauthors,andwhatwasfound.
Arereportsofthestudyfreeofsuggestionofselectiveoutcomereporting?
Othersourcesofbias.
Stateanyimportantconcernsaboutbiasnotaddressedintheotherdomainsinthetool.
Ifparticularquestions/entrieswerepre-specifiedinthereview’sprotocol,responsesshouldbeprovidedforeachquestion/entry.
Wasthestudyapparentlyfreeofotherproblemsthatcouldputitatahighriskofbias?
Table8.5.c:
Criteriaforjudgingriskofbiasinthe‘Riskofbias’assessmenttool
SEQUENCEGENERATION
Wastheallocationsequenceadequatelygenerated?
[Shortform:
Adequatesequencegeneration?
]
Criteriaforajudgementof‘YES’(i.e.lowriskofbias).
Theinvestigatorsdescribearandomcomponentinthesequencegenerationprocesssuchas:
∙Referringtoarandomnumbertable;
∙Usingacomputerrandomnumbergenerator;
∙Cointossing;
∙Shufflingcardsorenvelopes;
∙Throwingdice;
∙Drawingoflots;
∙Minimization*.
*Minimizationmaybeimplementedwithoutarandomelement,andthisisconsideredtobeequivalenttobeingrandom.
Criteriaforthejudgementof‘NO’(i.e.highriskofbias).
Theinvestigatorsdescribeanon-randomcomponentinthesequencegenerationprocess.Usually,thedescriptionwouldinvolvesomesystematic,non-randomapproach,forexample:
∙Sequencegeneratedbyoddorevendateofbirth;
∙Sequencegeneratedbysomerulebasedondate(orday)ofadmission;
∙Sequencegeneratedbysomerulebasedonhospitalorclinicrecordnumber.
Othernon-randomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobvious. Theyusuallyinvolvejudgementorsomemethodofnon-randomcategorizationofparticipants,forexample:
∙Allocationbyjudgementoftheclinician;
∙Allocationbypreferenceoftheparticipant;
∙Allocationbasedontheresultsofalaboratorytestoraseriesoftests;
∙Allocationbyavailabilityoftheintervention.
Criteriaforthejudgementof‘UNCLEAR’(uncertainriskofbias).
Insufficientinformationaboutthesequencegenerationprocesstopermitjudgementof‘Yes’or‘No’.
ALLOCATIONCONCEALMENT
Wasallocationadequatelyconcealed?
[Shortform:
Allocationconcealment?
]
Criteriaforajudgementof‘YES’(i.e.lowriskofbias).
Participantsandinvestigatorsenrollingparticipantscouldnotforeseeassignmentbecauseoneofthefollowing,oranequivalentmethod,wasusedtoconcealallocation:
∙Centralallocation(includingtelephone,web-based,andpharmacy-controlled,randomization);
∙Sequentiallynumbereddrugcontainersofidenticalappearance;
∙Sequentiallynumbered,opaque,sealedenvelopes.
Criteriaforthejudgementof‘NO’(i.e.highriskofbias).
Participantsorinvestigatorsenrollingparticipantscouldpossiblyforeseeassignmentsandthusintroduceselectionbias,suchasallocationbasedon:
∙Usinganopenrandomallocationschedule(e.g.alistofrandomnumbers);
∙Assignmentenvelopeswereusedwithoutappropriatesafeguards(e.g.ifenvelopeswereunsealedornonopaqueornotsequentiallynumbered);
∙Alternationorrotation;
∙Dateofbirth;
∙Caserecordnumber;
∙Anyotherexplicitlyunconcealedprocedure.
Criteriaforthejudgementof‘UNCLEAR’(uncertainriskofbias).
Insufficientinformationtopermitjudgementof‘Yes’or‘No’.Thisisusuallythecaseifthemethodofconcealmentisnotdescribedornotdescribedinsufficientdetailtoallowadefinitejudgement–forexampleiftheuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealed.
BLINDINGOFPARTICIPANTS,PERSONNELANDOUTCOMEASSESSORS
Wasknowledgeoftheallocatedinterventionsadequatelypreventedduringthestudy?
[Shortform:
Blinding?
]
Criteriaforajudgementof‘YES’(i.e.lowriskofbias).
Anyoneofthefollowing:
∙Noblinding,butthereviewauthorsjudgethattheoutcomeandtheoutcomemeasurementarenotlikelytobeinfluencedbylackofblinding;
∙Blindingofparticipantsandkeystudypersonnelensured,andunlikelythattheblindingcouldhavebeenbroken;
∙Eitherparticipantsorsomekeystudypersonnelwerenotblinded,butoutcomeassessmentwasblindedandthenon-blindingofothersunlikelytointroducebias.
Criteriaforthejudgementof‘NO’(i.e.highriskofbias).
Anyoneofthefollowing:
∙Noblindingorincompleteblinding,andtheoutcomeoroutcomemeasurementislikelytobeinfluencedbylackofblinding;
∙Blindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken;
∙Eitherparticipantsorsomekeystudypersonnelwerenotblinded,andthenon-blindingofotherslikelytointroducebias.
Criteriaforthejudgementof‘UNCLEAR’(uncertainriskofbias).
Anyoneofthefollowing:
∙Insufficientinformationtopermitjudg
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