cochrane评分表.docx

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

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:

∙Insufficientinformationtopermitjudgementof‘Yes’or‘No’;

∙Thestudydidnotaddressthisoutcome.

INCOMPLETEOUTCOMEDATA 

Wereincompleteoutcomedataadequatelyaddressed?

[Shortform:

Incompleteoutcomedataaddressed?

]

Criteriaforajudgementof‘YES’（i.e