cochrane纳入的RCT文献质量评价(风险偏倚评估工具)中英文对照版

中文：Table8.5.a:TheCochraneCollaboration’stoolforassessingriskofbias偏倚类型判断指标评价员的判断选择偏倚

随机序列的产生足够详细的描述用于生成分配序列的方法，以评估产生的分组是否具有可比性。生成随机序列不充分，发生选择偏倚分配隐藏足够详细的描述隐藏分配序列的方法，以决定干预的分配在纳入之前或纳入过程中是否可见分配前分配隐藏不充分发生选择偏倚实施偏倚

实施者和参与者双盲应对每个主要结局进行评估（或分类结局）

如果有，描述对参与者和实施者行盲法，避免其了解干预信息的所有措施。提供任何与所实施的盲法是否有效地相关信息。参与者和实施者了解干预的相关信息导致实施偏倚测量偏倚

结局评估中的盲法每个主要结局均应评估（或分类结局）如果有，描述对结局者行盲法，避免其了解自己所接受的干预信息的所有措施。提供任何与所实施的盲法是否有效地相关信息。结局评估者了解分配的干预措施将导致测量偏倚失访偏倚

不全结局数据每个主要结局均应评估（或分类结局）描述每个主要结局数据的完整性，包括分析中的自然缺失和排除。这些缺失数据是否报告，在各个干预组的数目（并与总样本量比较），数据缺失以及重新纳入分析的原因不全结局数据的数量，性质，处理方式导致失访偏倚发表偏倚

Selectivereporting.说明如何审查选择性报道结局的可能性，以及审查结果选择性报道结局导致发表偏倚其它偏倚

其它偏倚来源说明不包括在上述偏倚中的其它重要偏倚如果特定的问题或条目事先在计划书中指出，应对每一项说明不包括在上述各项中的偏倚

Table8.5.d:Criteriaforjudgingriskofbiasinthe‘Riskofbias’assessmenttool

随机序列的产生随机序列产生不充分导致选择偏倚判断为低风险的标准研究者描述随机序列产生过程譬如:参考随机数字表使用计算机随机数字生成器扔硬币洗牌的卡片和信封掷骰子抽签最小化

*最小化，可实现无随机元素，被认为相当于是随机的。判断为高风险的标准研究者描述序列的产生使用的是非随机的方法。通常是系统的非随机方法，例如：通过奇偶或出生日期产生序列通过入院日期产生序列通过类似住院号或门诊号产生序列

相对于上面提到的系统方法，其它非随机的方法少见的多，也更明显。通常包括对参与者进行判断或非随机的方法，例如:临床医生判断如何分配参与者判断如何分配基于实验室检查或系列测试的结果分配基于干预的可获取性进行分配偏倚风险不清楚的判断标准没有足够的信息判断随机序列的产生存在高风险或低风险

分配隐藏分配前不充足的分配隐藏导致选择偏倚高风险判断标准任何如下标准:缺失数据的产生很大可能与真实结局相关,缺失数据的数目及缺失原因在各干预组相差较大对二分类变量，与观察事件的发生风险相比，缺失比例足以影响预估的干预效应对连续性结局数据，缺失数据的合理效应规模（均数差或标准均数差）足以影响观察的效应规模;意向治疗分析中存在实际干预措施与随机分配的干预相违背的情况对缺失数据进行简单的不合适的估算风险未知任何如下标准:没有报道缺失或排除的情况，无法判断高风险或低风险（如未说明随机的数量，未提供数据缺失的原因）研究未描述此情况

选择性发表选择性发表导致发表偏倚偏倚低风险标准任何如下标准:实验的计划书可获取，系统评价感兴趣的所有首要或次要结局均按计划书预先说明的方式报道实验计划书不可得，但很明显发表的报告包括所有的结局，包括预先说明的结局（这种性质的有说服力的文字可能少见）高风险判断标准任何如下标准:不是所有的预先说明的首要结局均被报道一个或多个首要结局为采用预先说明的测量方法、分析方法或数据子集来报道系统评价感兴趣的一个或多个首要结局报道不全，以至于不能纳入meta分析研究未报道此研究应当包含的主要关键结局风险未知没有足够信息判断高风险或低风险，貌似大部分研究会被分为此类

OTHERBIAS

不包括在以上五种的其它偏倚偏倚低风险标准研究应未引入其它来源的偏倚高风险判断标准至少有一种重要的偏倚风险，例如：具有与特殊试验设计相关的潜在偏倚来源或被指欺诈或其它问题风险未知可能存在偏倚风险，但存在以下两种中的一种没有足够信息评估是否存在其它重要的偏倚风险没有足够的证据认为发现的问题会引入偏倚

Table8.7.a:Possibleapproachforsummaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossdomains)withinandacrossstudiesRiskofbias解释对单个研究对多个研究整体Lowriskofbias.合理的偏倚不太可能严重改变结果每一类偏倚均为低风险绝大多数信息均来自偏倚低风险的研究Unclearriskofbias.合理的偏倚会对结果产生一定的怀疑一类或多类偏倚风险未知绝大多数信息均来自偏倚低风险或风险未知的研究Highriskofbias.偏倚严重削弱结果的可信度一类或多类偏倚为高风险来自高偏倚风险研究的信息比例足以影响结果的解释英文：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.