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：偏倚种类判断指标议论员的判断选择偏倚随机序列的产生足够详尽的描绘用于生成分派序生成随机序列不充分，列的方法，以评估产生的分组能否发生选择偏倚拥有可比性。分派隐蔽足够详尽的描绘隐蔽分派序列的分派前分派隐蔽不充分方法，以决定干涉的分派在归入之发生选择偏倚前或归入过程中能否可见实行偏倚实行者和参加者假如有，描绘对参加者和实行者行参加者和实行者认识干双盲对付每个主盲法，防范其认识干涉信息的全部预的有关信息以致实行要结局进行评估措施。供给任何与所实行的盲法是偏倚（或分类结局）否有效地有关信息。丈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）失访偏倚

假如有，描绘对结局者行盲法，避结局评估者认识分派的免其认识自己所接受的干涉信息干涉措施将以致丈量偏的全部措施。供给任何与所实行的倚盲法能否有效地有关信息。不全结局数据每个主要结局均应评估（或分类结局）发布偏倚

描绘每个主要结局数据的完好性，不全结局数据的数目，包含分析中的自然缺失和除去。这性质，办理方式以致失些缺失数据能否报告，在各个干涉访偏倚组的数目（并与总样本量比较），数据缺失以及从头归入分析的原因Selective说明如何审察选择性报导结局的选择性报导结局以致发reporting.可能性，以及审察结果表偏倚其他偏倚其他偏倚根源说明不包含在上述偏倚中的其他不包含在上述各项中的重要偏倚偏倚假如特定的问题或条目早先在计划书中指出，对付每一项说明随机序列的产生随机序列产生不充分以致选择偏倚判断为低风险的标准研究者描绘随机序列产生过程比如:参照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，被以为相当于是随机的。判断为高风险的标准研究者描绘序列的产生使用的是非随机的方法。平常是系统的非随机方法，比方：经过奇偶或出诞辰期产生序列经过住院日期产生序列经过近似住院号或门诊号产生序列有关于上边提到的系统方法，其他非随机的方法少见的多，也更显然。平常包含对参加者进行判断或非随机的方法，比方:临床医生判断如何分派参加者判断如何分派鉴于实验室检查或系列测试的结果分派鉴于干涉的可获得性进行分派偏倚风险不清楚的判没有足够的信息判断随机序列的产生计在高风险或低风断标准险分派隐蔽分派前不充分的分派隐蔽以致选择偏倚低风险判断标准参加者以及归入参加者的研究者因以下掩饰分派的方法或相当的方法，早先不认识分派状况中心分派（包含电话，网络，药房控制随机）同样外形的次序编号的药物容器；次序编号、不透明、密封的信封高风险判断标准参加者以及归入参加者的研究者可能早先知道分派，因而引当选择偏倚，比如鉴于以下方法的分派:?使用摊开的随机分派表（如随机序列清单）?发散信封但没有适合的安全保障（如透明、非密封、非次序编号）?交替或循环?出诞辰期?病历号?其他明确的非隐蔽过程风险未知没有足够信息判断为低风险或高风险。平常因分派隐蔽的方法未描绘或描绘不充分。比方描绘为使用信封分派，但为描绘信封能否透明？密封？次序编号？对参加者和实行者的盲法因参加者和实行者认识干涉状况而以致实行偏倚偏倚低风险标准任何以下标准:无盲法或盲法不充分，但系统议论员判断结局不太可能遇到缺少盲法的影响参加者和主要实行者均实行靠谱的盲法，且盲法不太可能被打破偏倚高风险标准任何以下标准:无盲法或盲法不充分，但系统议论员判断结局很可能遇到缺少盲法的影响试试对要点的参加者和实行者行盲法，但盲法很可能被打破，结局很可能遇到缺少盲法的影响风险未知任何以下标准:没有足够信息判断为低风险或高风险研究未描绘此状况对结局议论实行盲法结局议论者认识干涉分派信息将以致丈量偏倚偏倚低风险标准任何以下标准:无盲法或盲法不充分，但系统议论员判断结局不太可能遇到缺少盲法的影响参加者和主要实行者均实行靠谱的盲法，且盲法不太可能被打破高风险判断标准任何以下标准:无盲法或盲法不充分，但系统议论员判断结局很可能遇到缺少盲法的影响试试对要点的参加者和实行者行盲法，但盲法很可能被打破，结局很可能遇到缺少盲法的影响风险未知任何以下标准:没有足够信息判断为低风险或高风险研究未描绘此状况结局数据不完好不全结局数据的数目，性质，办理方式以致失访偏倚偏倚低风险标准任何以下标准:无缺失数据缺失数据的产生不大可能与真切结局有关（关于生计数据，删失不大可能引入偏倚）缺失数据的数目在各干涉组相当，且各组缺失原由近似对二分类变量，与观察事件的发生风险对比，缺失比率不足以影响预估的干涉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）不会大到影响观察的效应规模;缺失的数据用适合的方法进行估量高风险判断标准任何以下标准:????

缺失数据的产生很大可能与真切结局有关,缺失数据的数目及缺失原由在各干涉组相差较大对二分类变量，与观察事件的发生风险对比，缺失比率足以影响预估的干涉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;意愿治疗分析中存在实质干涉措施与随机分派的干涉相违反的状况对缺失数据进行简单的不适合的估量风险未知任何以下标准:没有报导缺失或除去的状况，没法判断高风险或低风险（如未说明随机的数目，未供给数据缺失的原由）研究未描绘此状况选择性发布选择性发布以致发布偏倚偏倚低风险标准任何以下标准:?实验的计划书可获得，系统议论感兴趣的全部首要或次要结局均按计划书早先说明的方式报导?实验计划书不行得，但很显然发布的报告包含所有的结局，包含早先说明的结局（这类性质的有说服力的文字可能少见）高风险判断标准任何以下标准:?不是全部的早先说明的首要结局均被报导?一个或多个首要结局为采纳早先说明的丈量方法、分析方法或数据子集来报导?系统议论感兴趣的一个或多个首要结局报导不全，以致于不可以归入meta分析?研究未报导此研究应该包含的主要要点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不包含在以上五种的其他偏倚偏倚低风险标准研究应未引入其他根源的偏倚高风险判断标准最罕有一种重要的偏倚风险，比方：拥有与特别试验设计有关的潜伏偏倚根源或被指欺骗或其他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能否存在其他重要的偏倚风险没有足够的凭证以为发现的问题会引入偏倚Possibleapproachforsummaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossdomains)withinandacrossstudiesRiskofbias解说对单个研究对多个研究整体Lowriskof合理的偏倚不太每一类偏倚均为绝大部分信息均来bias.可能严重改变结低风险自偏倚低风险的研果究Unclearriskof合理的偏倚会对一类或多类偏倚绝大部分信息均来bias.结果产生必定的风险未知自偏倚低风险或风思疑险未知的研究Highriskof偏倚严重削弱结一类或多类偏倚来自高偏倚风险研bias.果的可信度为高风险究的信息比率足以影响结果的解说英文：TableDomainSupportforjudgementSelectionbias.RandomsequenceDescribethemethodusedtogeneratethegeneration.allocationsequenceinsufficientdetailtoallowanassessmentofwhetheritshouldproducecomparablegroups.AllocationDescribethemethodusedtoconcealtheconcealment.allocationsequenceinsufficientdetailtodeterminewhetherinterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolment.Performancebias.

Reviewauthors’judgementSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.Selectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.BlindingofDescribeallmeasuresused,ifany,toblindparticipantsandstudyparticipantsandpersonnelfrompersonnelknowledgeofwhichinterventionaAssessmentsshouldbeparticipantreceived.Provideanymadeforeachmaininformationrelatingtowhethertheintendedoutcome(orclassofblindingwaseffective.outcomes).Detectionbias.

Performancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.BlindingofoutcomeDescribeallmeasuresused,ifany,toblindDetectionbiasduetoknowledgeassessmentoutcomeassessorsfromknowledgeofAssessmentsshouldbewhichinterventionaparticipantreceived.madeforeachmainProvideanyinformationrelatingtowhetheroutcome(orclassoftheintendedblindingwaseffective.outcomes).Attritionbias.

oftheallocatedinterventionsbyoutcomeassessors.IncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).Reportingbias.

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

Attritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Selectivereporting.Otherbias.Othersourcesofbias.

StatehowthepossibilityofselectiveReportingbiasduetoselectiveoutcomereportingwasexaminedbytheoutcomereporting.reviewauthors,andwhatwasfound.StateanyimportantconcernsaboutbiasnotBiasduetoproblemsnotaddressedintheotherdomainsinthetool.coveredelsewhereinthetable.Ifparticularquestions/entrieswerepre-specifiedinthereview’sprotocol,responsesshouldbeprovidedforeachquestion/entry.RANDOMSEQUENCEGENERATIONSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.CriteriaforajudgementTheinvestigatorsdescribearandomcomponentinthesequencegenerationof‘Lowrisk’cesssuchas:?Referringtoarandomnumbertable;?Usingacomputerrandomnumbergenerator;?Cointossing;?Shufflingcardsorenvelopes;Throwingdice;Drawingoflots;Minimization*.Criteriaforthejudgementofofbias.

‘Highrisk

*Minimizationmaybeimplementedwithoutarandomelement,andthisisconsideredtobeequivalenttobeingrandom.Theinvestigatorsdescribeanon-randomcomponentinthesequencegeneration’process.Usually,thedescriptionwouldinvolvesomesystematic,non-randomapproach,forexample:?Sequencegeneratedbyoddorevendateofbirth;?Sequencegeneratedbysomerulebasedondate(orday)ofadmission;?Sequencegeneratedbysomerulebasedonhospitalorclinicrecordnumber.Othernon-randomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobvious.Theyusuallyinvolvejudgementorsomemethodofnon-randomcategorizationofparticipants,forexample:?Allocationbyjudgementoftheclinician;?Allocationbypreferenceoftheparticipant;?Allocationbasedontheresultsofalaboratorytestoraseriesoftests;?Allocationbyavailabilityoftheintervention.Criteriaforthejudgementofrisk’ofbias.

‘Unclear

Insufficientinformationaboutthesequencegenerationprocesstopermitjudgementof‘Lowrisk’or‘Highrisk’.ALLOCATIONCONCEALMENTSelectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.CriteriaforajudgementParticipantsandinvestigatorsenrollingparticipantscouldnotforeseeof‘Lowrisk’ofbias.assignmentbecauseoneofthefollowing,oranequivalentmethod,wasusedtoconcealallocation:?Centralallocation(includingtelephone,web-basedandpharmacy-controlledrandomization);?Sequentiallynumbereddrugcontainersofidenticalappearance;?Sequentiallynumbered,opaque,sealedenvelopes.CriteriafortheParticipantsorinvestigatorsenrollingparticipantscouldpossiblyforeseejudgementof‘Highrisk’ofbias.assignmentsandthusintroduceselectionbias,suchasallocationbasedon:Usinganopenrandomallocationschedule(e.g.alistofrandomnumbers);Assignmentenvelopeswereusedwithoutappropriatesafeguards(e.g.ifenvelopeswereunsealedornonopaqueornotsequentiallynumbered);Alternationorrotation;Dateofbirth;Caserecordnumber;Anyotherexplicitlyunconcealedprocedure.CriteriafortheInsufficientinformationtopermitjudgementof‘Low‘riskHighrisk’or’.Thisisjudgementof‘Unclearusuallythecaseifthemethodofconcealmentisnotdescribedornotrisk’ofbias.describedinsufficientdetailtoallowadefinitejudgement–forexampleiftheuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealed.BLINDINGOFPARTICIPANTSANDPERSONNELPerformancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Criteriaforajudgementof‘Lowrisk’ofbias.Criteriaforthejudgementof‘Highriskofbias.

Anyoneofthefollowing:Noblindingorincompleteblinding,butthereviewauthorsjudgethattheoutcomeisnotlikelytobeinfluencedbylackofblinding;Blindingofparticipantsandkeystudypersonnelensured,andunlikelythattheblindingcouldhavebeenbroken.Anyoneofthefollowing:’?Noblindingorincompleteblinding,andtheoutcomeislikelytobeinfluencedbylackofblinding;Blindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomeislikelytobeinfluencedbylackofblinding.CriteriafortheAnyoneofthefollowing:judgementof‘Unclear?Insufficientinformationtopermitjudgementof‘Lowighrisk’or‘Hrisk’ofbias.risk’;?Thestudydidnotaddressthisoutcome.BLINDINGOFOUTCOMEASSESSMENTDetectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessors.CriteriaforajudgementAnyoneofthefollowing:of‘Lowrisk’ofbias.?Noblindingofoutcomeassessment,butthereviewauthorsjudgethattheoutcomemeasurementisnotlikelytobeinfluencedbylackofblinding;?Blindingofoutcomeassessmentensured,andunlikelythattheblindingcouldhavebeenbroken.Criteriaforthejudgementof‘Highriskofbias.Criteriaforthejudgementof‘Unclearrisk’ofbias.

Anyoneofthefollowing:’?Noblindingofoutcomeassessment,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding;Blindingofoutcomeassessment,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding.Anyoneofthefollowing:?Insufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’;?Thestudydidnotaddressthisoutcome.INCOMPLETEOUTCOMEDATAAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Criteriaforajudgementof‘Lowrisk’ofbias.Criteriaforthejudgementof‘Highriskofbias.

Anyoneofthefollowing:Nomissingoutcomedata;Reasonsformissingoutcomedataunlikelytoberelatedtotrueoutcome(forsurvivaldata,censoringunlikelytobeintroducingbias);Missingoutcomedatabalancedinnumbersacrossinterventiongroups,withsimilarreasonsformissingdataacrossgroups;Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventrisknotenoughtohaveaclinicallyrelevantimpactontheinterventioneffectestimate;Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesnotenoughtohaveaclinicallyrelevantimpactonobservedeffectsize;Missingdatahavebeenimputedusingappropriatemethods.Anyoneofthefollowing:’?Reasonformissingoutcomedatalikelytoberelatedtotrueoutcome,witheitherimbalanceinnumbersorreasonsformissingdataacrossinterventiongroups;Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventriskenoughtoinduceclinicallyrelevantbiasininterventioneffectestimate;Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesenoughtoinduceclinicallyrelevantbiasinobservedeffectsize;?‘As-treatedanalysis’donewithsubstantialdepartureoftheinterventionreceivedfromthatassignedatrandomization;?Potentiallyinappropriateapplicationofsimpleimputation.CriteriafortheAnyoneofthefollowing:judgementof‘Unclear?Insufficientreportingofattrition/exclusionstopermitjudgementofrisk’ofbias.‘Lowrisk’or‘Highrisk’(e.g.numberrandomizednotstated,noreasonsformissingdataprovided);?Thestudydidnotaddressthisoutcome.SELECTIVEREPORTINGReportingbiasduetoselectiveoutcomereporting.Criteriaforajudgementof‘Lowrisk’ofbias.

Anyofthefollowing:?Thestudyprotocolisavailableandallofthestudy-specified’spre(primaryandsecondary)outcomesthatareofinterestinthereviewhavebeenreportedinthepre-specifiedway;Thestudyprotocolisnotavailablebutitisclearthatthepublishedreportsincludeallexpectedoutcomes,includingthosethatwerepre-specified(convincingtextofthisnaturemaybeuncommon).Criteriaforthejudgementofofbias.

Anyoneofthefollowing:‘Highrisk’?Notallofthestudy’-specifiedpreprimaryoutcomeshavebeenreported;Oneormoreprimaryoutcomesisreportedusingmeasurements,analysismethodsorsubsetsofthedata(e.g.subscales)thatwerenotpre-specified;Oneormorereportedprimaryoutcomeswerenotpre-specified(unlessclearjustificationfortheirreportingisprovided,suchasanunexpectedadverseeffect);Oneormoreoutcomesofinterestinthereviewarereportedincompletelysothattheycannotbeenteredinameta-analysis;Thestudyreportfailstoincluderesultsforakeyoutcomethatwouldbeexpectedtohavebeenreportedforsuchastudy.CriteriafortheInsufficientinformation