cochrane納入的RCT文獻(xiàn)質(zhì)量評(píng)價(jià)(風(fēng)險(xiǎn)偏倚評(píng)估工具)中英文對(duì)照版

中文：Table8.5.a:TheCochraneCollaboration’stoolforassessingriskofbias偏倚類(lèi)型判斷指標(biāo)評(píng)價(jià)員的判斷選擇偏倚

隨機(jī)序列的產(chǎn)生足夠詳細(xì)的描述用于生成分配序列的方法，以評(píng)估產(chǎn)生的分組是否具有可比性。生成隨機(jī)序列不充分，發(fā)生選擇偏倚分配隱藏足夠詳細(xì)的描述隱藏分配序列的方法，以決定干預(yù)的分配在納入之前或納入過(guò)程中是否可見(jiàn)分配前分配隱藏不充分發(fā)生選擇偏倚實(shí)施偏倚

實(shí)施者和參與者雙盲應(yīng)對(duì)每個(gè)主要結(jié)局進(jìn)行評(píng)估（或分類(lèi)結(jié)局）

如果有，描述對(duì)參與者和實(shí)施者行盲法，避免其了解干預(yù)信息的所有措施。提供任何與所實(shí)施的盲法是否有效地相關(guān)信息。參與者和實(shí)施者了解干預(yù)的相關(guān)信息導(dǎo)致實(shí)施偏倚測(cè)量偏倚

結(jié)局評(píng)估中的盲法每個(gè)主要結(jié)局均應(yīng)評(píng)估（或分類(lèi)結(jié)局）如果有，描述對(duì)結(jié)局者行盲法，避免其了解自己所接受的干預(yù)信息的所有措施。提供任何與所實(shí)施的盲法是否有效地相關(guān)信息。結(jié)局評(píng)估者了解分配的干預(yù)措施將導(dǎo)致測(cè)量偏倚失訪偏倚

不全結(jié)局?jǐn)?shù)據(jù)每個(gè)主要結(jié)局均應(yīng)評(píng)估（或分類(lèi)結(jié)局）描述每個(gè)主要結(jié)局?jǐn)?shù)據(jù)的完整性，包括分析中的自然缺失和排除。這些缺失數(shù)據(jù)是否報(bào)告，在各個(gè)干預(yù)組的數(shù)目（并與總樣本量比較），數(shù)據(jù)缺失以及重新納入分析的原因不全結(jié)局?jǐn)?shù)據(jù)的數(shù)量，性質(zhì)，處理方式導(dǎo)致失訪偏倚發(fā)表偏倚

Selectivereporting.說(shuō)明如何審查選擇性報(bào)道結(jié)局的可能性，以及審查結(jié)果選擇性報(bào)道結(jié)局導(dǎo)致發(fā)表偏倚其它偏倚

其它偏倚來(lái)源說(shuō)明不包括在上述偏倚中的其它重要偏倚如果特定的問(wèn)題或條目事先在計(jì)劃書(shū)中指出，應(yīng)對(duì)每一項(xiàng)說(shuō)明不包括在上述各項(xiàng)中的偏倚

Table8.5.d:Criteriaforjudgingriskofbiasinthe‘Riskofbias’assessmenttool

隨機(jī)序列的產(chǎn)生隨機(jī)序列產(chǎn)生不充分導(dǎo)致選擇偏倚判斷為低風(fēng)險(xiǎn)的標(biāo)準(zhǔn)研究者描述隨機(jī)序列產(chǎn)生過(guò)程譬如:參考隨機(jī)數(shù)字表使用計(jì)算機(jī)隨機(jī)數(shù)字生成器扔硬幣洗牌的卡片和信封擲骰子抽簽最小化

*最小化，可實(shí)現(xiàn)無(wú)隨機(jī)元素，被認(rèn)為相當(dāng)于是隨機(jī)的。判斷為高風(fēng)險(xiǎn)的標(biāo)準(zhǔn)研究者描述序列的產(chǎn)生使用的是非隨機(jī)的方法。通常是系統(tǒng)的非隨機(jī)方法，例如：通過(guò)奇偶或出生日期產(chǎn)生序列通過(guò)入院日期產(chǎn)生序列通過(guò)類(lèi)似住院號(hào)或門(mén)診號(hào)產(chǎn)生序列

相對(duì)于上面提到的系統(tǒng)方法，其它非隨機(jī)的方法少見(jiàn)的多，也更明顯。通常包括對(duì)參與者進(jìn)行判斷或非隨機(jī)的方法，例如:臨床醫(yī)生判斷如何分配參與者判斷如何分配基于實(shí)驗(yàn)室檢查或系列測(cè)試的結(jié)果分配基于干預(yù)的可獲取性進(jìn)行分配偏倚風(fēng)險(xiǎn)不清楚的判斷標(biāo)準(zhǔn)沒(méi)有足夠的信息判斷隨機(jī)序列的產(chǎn)生存在高風(fēng)險(xiǎn)或低風(fēng)險(xiǎn)

分配隱藏分配前不充足的分配隱藏導(dǎo)致選擇偏倚高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn):缺失數(shù)據(jù)的產(chǎn)生很大可能與真實(shí)結(jié)局相關(guān),缺失數(shù)據(jù)的數(shù)目及缺失原因在各干預(yù)組相差較大對(duì)二分類(lèi)變量，與觀察事件的發(fā)生風(fēng)險(xiǎn)相比，缺失比例足以影響預(yù)估的干預(yù)效應(yīng)對(duì)連續(xù)性結(jié)局?jǐn)?shù)據(jù)，缺失數(shù)據(jù)的合理效應(yīng)規(guī)模（均數(shù)差或標(biāo)準(zhǔn)均數(shù)差）足以影響觀察的效應(yīng)規(guī)模;意向治療分析中存在實(shí)際干預(yù)措施與隨機(jī)分配的干預(yù)相違背的情況對(duì)缺失數(shù)據(jù)進(jìn)行簡(jiǎn)單的不合適的估算風(fēng)險(xiǎn)未知任何如下標(biāo)準(zhǔn):沒(méi)有報(bào)道缺失或排除的情況，無(wú)法判斷高風(fēng)險(xiǎn)或低風(fēng)險(xiǎn)（如未說(shuō)明隨機(jī)的數(shù)量，未提供數(shù)據(jù)缺失的原因）研究未描述此情況

選擇性發(fā)表選擇性發(fā)表導(dǎo)致發(fā)表偏倚偏倚低風(fēng)險(xiǎn)標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn):實(shí)驗(yàn)的計(jì)劃書(shū)可獲取，系統(tǒng)評(píng)價(jià)感興趣的所有首要或次要結(jié)局均按計(jì)劃書(shū)預(yù)先說(shuō)明的方式報(bào)道實(shí)驗(yàn)計(jì)劃書(shū)不可得，但很明顯發(fā)表的報(bào)告包括所有的結(jié)局，包括預(yù)先說(shuō)明的結(jié)局（這種性質(zhì)的有說(shuō)服力的文字可能少見(jiàn)）高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn):不是所有的預(yù)先說(shuō)明的首要結(jié)局均被報(bào)道一個(gè)或多個(gè)首要結(jié)局為采用預(yù)先說(shuō)明的測(cè)量方法、分析方法或數(shù)據(jù)子集來(lái)報(bào)道系統(tǒng)評(píng)價(jià)感興趣的一個(gè)或多個(gè)首要結(jié)局報(bào)道不全，以至于不能納入meta分析研究未報(bào)道此研究應(yīng)當(dāng)包含的主要關(guān)鍵結(jié)局風(fēng)險(xiǎn)未知沒(méi)有足夠信息判斷高風(fēng)險(xiǎn)或低風(fēng)險(xiǎn)，貌似大部分研究會(huì)被分為此類(lèi)

OTHERBIAS

不包括在以上五種的其它偏倚偏倚低風(fēng)險(xiǎn)標(biāo)準(zhǔn)研究應(yīng)未引入其它來(lái)源的偏倚高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)至少有一種重要的偏倚風(fēng)險(xiǎn)，例如：具有與特殊試驗(yàn)設(shè)計(jì)相關(guān)的潛在偏倚來(lái)源或被指欺詐或其它問(wèn)題風(fēng)險(xiǎn)未知可能存在偏倚風(fēng)險(xiǎn)，但存在以下兩種中的一種沒(méi)有足夠信息評(píng)估是否存在其它重要的偏倚風(fēng)險(xiǎn)沒(méi)有足夠的證據(jù)認(rèn)為發(fā)現(xiàn)的問(wèn)題會(huì)引入偏倚

Table8.7.a:Possibleapproachforsummaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossdomains)withinandacrossstudiesRiskofbias解釋對(duì)單個(gè)研究對(duì)多個(gè)研究整體Lowriskofbias.合理的偏倚不太可能?chē)?yán)重改變結(jié)果每一類(lèi)偏倚均為低風(fēng)險(xiǎn)絕大多數(shù)信息均來(lái)自偏倚低風(fēng)險(xiǎn)的研究Unclearriskofbias.合理的偏倚會(huì)對(duì)結(jié)果產(chǎn)生一定的懷疑一類(lèi)或多類(lèi)偏倚風(fēng)險(xiǎn)未知絕大多數(shù)信息均來(lái)自偏倚低風(fēng)險(xiǎn)或風(fēng)險(xiǎn)未知的研究Highriskofbias.偏倚嚴(yán)重削弱結(jié)果的可信度一類(lèi)或多類(lèi)偏倚為高風(fēng)險(xiǎn)來(lái)自高偏倚風(fēng)險(xiǎn)研究的信息比例足以影響結(jié)果的解釋英文：Table8.5.a:TheCochraneCollaboration’stoolforassessingriskofbiasDomainSupportforjudgementReviewauthors’judgementSelectionbias.

Randomsequencegeneration.Describethemethodusedtogeneratetheallocationsequenceinsufficientdetailtoallowanassessmentofwhetheritshouldproducecomparablegroups.Selectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.Allocationconcealment.Describethemethodusedtoconcealtheallocationsequenceinsufficientdetailtodeterminewhetherinterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolment.Selectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.Performancebias.

BlindingofparticipantsandpersonnelAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).

Describeallmeasuresused,ifany,toblindstudyparticipantsandpersonnelfromknowledgeofwhichinterventionaparticipantreceived.Provideanyinformationrelatingtowhethertheintendedblindingwaseffective.Performancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Detectionbias.

BlindingofoutcomeassessmentAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).Describeallmeasuresused,ifany,toblindoutcomeassessorsfromknowledgeofwhichinterventionaparticipantreceived.Provideanyinformationrelatingtowhethertheintendedblindingwaseffective.Detectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessors.Attritionbias.

IncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).

Describethecompletenessofoutcomedataforeachmainoutcome,includingattritionandexclusionsfromtheanalysis.Statewhetherattritionandexclusionswerereported,thenumbersineachinterventiongroup(comparedwithtotalrandomizedparticipants),reasonsforattrition/exclusionswherereported,andanyre-inclusionsinanalysesperformedbythereviewauthors.Attritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Reportingbias.

Selectivereporting.Statehowthepossibilityofselectiveoutcomereportingwasexaminedbythereviewauthors,andwhatwasfound.Reportingbiasduetoselectiveoutcomereporting.Otherbias.

Othersourcesofbias.Stateanyimportantconcernsaboutbiasnotaddressedintheotherdomainsinthetool.Ifparticularquestions/entrieswerepre-specifiedinthereview’sprotocol,responsesshouldbeprovidedforeachquestion/entry.Biasduetoproblemsnotcoveredelsewhereinthetable.

Table8.5.d:Criteriaforjudgingriskofbiasinthe‘Riskofbias’assessmenttool

RANDOMSEQUENCEGENERATIONSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.Criteriaforajudgementof‘Lowrisk’ofbias.Theinvestigatorsdescribearandomcomponentinthesequencegenerationprocesssuchas:Referringtoarandomnumbertable;Usingacomputerrandomnumbergenerator;Cointossing;Shufflingcardsorenvelopes;Throwingdice;Drawingoflots;Minimization*.

*Minimizationmaybeimplementedwithoutarandomelement,andthisisconsideredtobeequivalenttobeingrandom.Criteriaforthejudgementof‘Highrisk’ofbias.Theinvestigatorsdescribeanon-randomcomponentinthesequencegenerationprocess.Usually,thedescriptionwouldinvolvesomesystematic,non-randomapproach,forexample:Sequencegeneratedbyoddorevendateofbirth;Sequencegeneratedbysomerulebasedondate(orday)ofadmission;Sequencegeneratedbysomerulebasedonhospitalorclinicrecordnumber.

Othernon-randomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobvious.

Theyusuallyinvolvejudgementorsomemethodofnon-randomcategorizationofparticipants,forexample:Allocationbyjudgementoftheclinician;Allocationbypreferenceoftheparticipant;Allocationbasedontheresultsofalaboratorytestoraseriesoftests;Allocationbyavailabilityoftheintervention.Criteriaforthejudgementof

‘Unclearrisk’ofbias.Insufficientinformationaboutthesequencegenerationprocesstopermitjudgementof‘Lowrisk’or‘Highrisk’.

ALLOCATIONCONCEALMENT

Selectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.Criteriaforajudgementof‘Lowrisk’ofbias.Participantsandinvestigatorsenrollingparticipantscouldnotforeseeassignmentbecauseoneofthefollowing,oranequivalentmethod,wasusedtoconcealallocation:Centralallocation(includingtelephone,web-basedandpharmacy-controlledrandomization);Sequentiallynumbereddrugcontainersofidenticalappearance;Sequentiallynumbered,opaque,sealedenvelopes.Criteriaforthejudgementof‘Highrisk’ofbias.Participantsorinvestigatorsenrollingparticipantscouldpossiblyforeseeassignmentsandthusintroduceselectionbias,suchasallocationbasedon:Usinganopenrandomallocationschedule(e.g.alistofrandomnumbers);Assignmentenvelopeswereusedwithoutappropriatesafeguards(e.g.ifenvelopeswereunsealedornonopaqueornotsequentiallynumbered);Alternationorrotation;Dateofbirth;Caserecordnumber;Anyotherexplicitlyunconcealedprocedure.Criteriaforthejudgementof

‘Unclearrisk’ofbias.Insufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’.Thisisusuallythecaseifthemethodofconcealmentisnotdescribedornotdescribedinsufficientdetailtoallowadefinitejudgement–forexampleiftheuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealed.

BLINDINGOFPARTICIPANTSANDPERSONNELPerformancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Criteriaforajudgementof‘Lowrisk’ofbias.Anyoneofthefollowing:Noblindingorincompleteblinding,butthereviewauthorsjudgethattheoutcomeisnotlikelytobeinfluencedbylackofblinding;Blindingofparticipantsandkeystudypersonnelensured,andunlikelythattheblindingcouldhavebeenbroken.Criteriaforthejudgementof‘Highrisk’ofbias.Anyoneofthefollowing:Noblindingorincompleteblinding,andtheoutcomeislikelytobeinfluencedbylackofblinding;Blindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomeislikelytobeinfluencedbylackofblinding.Criteriaforthejudgementof

‘Unclearrisk’ofbias.Anyoneofthefollowing:Insufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’;Thestudydidnotaddressthisoutcome.

BLINDINGOFOUTCOMEASSESSMENTDetectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessors.Criteriaforajudgementof‘Lowrisk’ofbias.Anyoneofthefollowing:Noblindingofoutcomeassessment,butthereviewauthorsjudgethattheoutcomemeasurementisnotlikelytobeinfluencedbylackofblinding;Blindingofoutcomeassessmentensured,andunlikelythattheblindingcouldhavebeenbroken.Criteriaforthejudgementof‘Highrisk’ofbias.Anyoneofthefollowing:Noblindingofoutcomeassessment,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding;Blindingofoutcomeassessment,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding.Criteriaforthejudgementof

‘Unclearrisk’ofbias.Anyoneofthefollowing:Insufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’;Thestudydidnotaddressthisoutcome.

INCOMPLETEOUTCOMEDATA

Attritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Criteriaforajudgementof‘Lowrisk’ofbias.Anyoneofthefollowing:Nomissingoutcomedata;Reasonsformissingoutcomedataunlikelytoberelatedtotrueoutcome(forsurvivaldata,censoringunlikelytobeintroducingbias);Missingoutcomedatabalancedinnumbersacrossinterventiongroups,withsimilarreasonsformissingdataacrossgroups;Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventrisknotenoughtohaveaclinicallyrelevantimpactontheinterventioneffectestimate;Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesnotenoughtohaveaclinicallyrelevantimpactonobservedeffectsize;Missingdatahavebeenimputedusingappropriatemethods.Criteriaforthejudgementof‘Highrisk’ofbias.Anyoneofthefollowing:Reasonformissingoutcomedatalikelytoberelatedtotrueoutcome,witheitherimbalanceinnumbersorreasonsformissingdataacrossinterventiongroups;Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventriskenoughtoinduceclinicallyrelevantbiasininterventioneffectestimate;Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesenoughtoinduceclinicallyrelevantbiasinobservedeffectsize;‘As-treated’analysisdonewithsubstantialdepartureoftheinterventionreceivedfromthatassignedatrandomization;Potentiallyinappropriateapplicationofsimpleimputation.Criteriaforthejudgementof

‘Unclearrisk’ofbias.Anyoneofthefollowing:Insufficientreportingofattrition/exclusionstopermitjudgementof‘Lowrisk’or‘Highrisk’(e.g.numberrandomizednotstated,noreasonsformissingdataprovided);Thestudydidnotaddressthisoutcome.

SELECTIVEREPORTING

Reportingbiasduetoselectiveoutcomereporting.Criteriaforajudgementof‘Lowrisk’ofbias.Anyofthefollowing:Thestudyprotocolisavailableandallofthestudy’spre-specified(primaryandsecondary)outcomesthatareofinterestinthereviewhavebeenreportedinthepre-specifiedway;Thestudyprotocolisnotavailablebutitisclearthatthepublishedreportsincludeallexpectedoutcomes,includingthosethatwerepre-specified(convincingtextofthisnaturemaybeuncommon).Criteriaforthejudgementof‘Highrisk’ofbias.Anyoneofthefollowing:Notallofthestudy’spre-specifiedprimaryoutcomeshavebeenreported;Oneormoreprimaryoutcomesisreportedusingmeasurements,analysismethodsorsubsetsofthedata(e.g.subscales)thatwerenotpre-specified;Oneormorereportedprimaryoutcomeswerenotpre-specified(unlessclearjustificationfortheirreportingisprovided,suchasanunexpectedadverseeffect);Oneormoreoutcomesofinterestinthereviewarereportedincompletelysothattheycannotbeenteredinameta-analysis;Thestudyreportfailstoincluderesultsforakeyoutcomethatwouldbeexpectedtohavebeenreportedforsuchastudy.Criteriaforthejudgementof

‘Unclearrisk’ofbias.Insufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’.Itislikelythatthemajorityofstudieswillfallintothiscategory.