cochrane纳入地RCT文献高质量评价与衡量(风险偏倚评估工具)中英文对照版..

1、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后可比性.生成随机序列/、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,以决干顶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/、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,防止其了解根信息的所有举措.提供任何与所实施的盲法是台启效地相关信息.参与者和实施者了解干

2、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根信息的所有举措.提供任何与所实施的盲法是否启效地相关信息.结局评估者了解分配的K举措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拟,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

3、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

4、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 基丁实验室检查或系列测试的结果分配 基于汗颉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局风险或低风险分配隐藏分配前/、充足的分配隐藏导致选择偏倚Table8.5.d:CriteriaforjudgingriskofbiasintheassessmenttoolRiskofbias'低风险判断标准参与者以及纳入参与者的研究者因以下掩盖分配的方法或相当的方法,事先不了解分配情况 中央分配包括,网络,药房限制随机 相同外形的顺序编号的药物容器； 顺序编号、不透明、密封的信封高

5、风险判断标准参与者以及纳入参与者的研究者可能事先知道分配,因而引入选择偏倚,譬如基于如卜方法的分配： 使用摊开的随机分配表如随机序列清单 分发信封但没有适宜的平安保证如透明、非密封、非顺序编号 交替或循环 出生日期 病后号 其它明确的非隐藏过程风险未知没有足够信息判断为低风险或高风险.通常因分配隐藏的方法未描述或描述不充分.例如描述为使用信封分配,但为描述信封是否透明？密封？顺序编号？对参与者和实施者的盲法因参与者和实施者解干预情况而导致实施偏倚偏倚低风险标准任何如下标准：无盲法或盲法不充分,但系统评价员判断结局不太可能受到缺乏盲法的影响参与者和主要实施者均实施可靠的盲法,且盲法不太可能被打破

6、偏倚局风险标准任何如下标准：无盲法或盲法不充分,但系统评价员判断结局很可能受到缺乏盲法的影响尝试对关键的参与者和实施者行盲法,但盲法很可能被打破,结局很可能受到缺乏盲法的影响风险未知任何如下标准：没有足够信息判断为低风险或高风险研究未描述此情况对结局评价实施营法结局评价者了解日分配信息将导致测量偏倚偏倚低风险标准任何如下标准：无盲法或盲法不充分,但系统评价员判断结局不太可能受到缺乏盲法的影响参与者和主要实施者均实施可靠的盲法,且盲法不太可能被打破高风险判断标准任何如下标准：无盲法或盲法不充分,但系统评价员判断结局很可能受到缺乏盲法的影响尝试对关键的参与者和实施者行盲法,但盲法很可能被打破,结局

7、很可能受到缺乏盲法的影响风险未知任何如下标准：没有足够信息判断为低风险或高风险研究未描述此情况结局数据不完整不全结局数据的数量,性质,处理方式导致失访偏倚偏倚低风险标准任何如下标准： 无缺失数据 缺失数据的产生不大可能匕真实结局相关对于生存数据,删失不大可能引入偏倚 缺失数据的数目在各根组相当,且各组缺失原因类似 对二分类变量,与观察事件的发生风险相比,缺失比例缺乏以影响预估的根效应 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；缺失的数据用适宜的方法进行估算高风险判断标准任何如下标准： 缺失数据的产生很大可能匕真实结局相关,缺失数据的数目及缺失原因在各

8、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根效应 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举措与随机分配的十块相违背的情况 对缺失数据进行简单的不适宜的估算风险未知任何如下标准：没肩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：实验的方案书可获取,系统评价感兴趣的所有首要或次要结局均按方案书预先说明的方式报道实验方案书不可得,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

9、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/、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,貌似大局部研究会被分为此类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口也存在漏倚风险,但存在以卜两种中的一种没有足够信息评估是

10、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/、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f的疑心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

11、究Highriskofbias.偏倚严重削弱结果的可信度一类或多类偏倚为局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stoolforassessingriskofbias英文:DomainSupportforjudgementReviewauthors'judgementSelectionbias.Randomsequence.Describethemethodusedtogeneratetheallocationsequenceinsufficientdetailtoallowanassessmentofwhetheritshouldproducecomparablegrou

12、ps.Selectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.Allocationconcealment.Describethemethodusedtoconcealtheallocationsequenceinsufficientdetailtodeterminewhethernterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolment.Selectionbias(biaseda

13、llocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.Performancebias.BlindingofparticipantsandpersonnelAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).Describeallmeasuresused,ifany,toblindstudyparticipantsandpersonnelfromknowledgeofwhichnterventionaparticipa

14、ntreceived.Provideanyinformationrelatingtowhethertheintendedblindingwaseffective.Performancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Detectionbias.BlindingofoutcomeassessmentDescribeallmeasuresused,ifany,toblindoutcomeassessorsfromDetectionbiasduetoknowle

15、dgeoftheallocatedTable8.5.a:TheCochraneCollaborationAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).knowledgeofwhichinterventionaparticipantreceived.Perventionsbyoutcomeassessors.Attritionbias.ncompleteoutcomedataAsse

16、ssmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).Describethecompletenessofoutcomedataforeachmainoutcome,includingattritionandexclusionsfromtheanalysis.Statewhetherattritionandexclusionswerereported,thenumbersneachinterventiongroup(comparedwithtotalrandomizedparticipants),reasonsforattrition/

17、exclusionswherereported,andanyre-inclusionsnanalysesperformedbythereviewauthors.Attritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Reportingbias.Selectivereporting.Statehowthepossibilityofselectiveoutcomereportingwasexaminedbythereviewauthors,andwhatwasfound.Reportingbiasduetoselective

18、outcomereporting.Otherbias.Othersourcesofbias.Stateanyimportantconcernsaboutbiasnotaddressedintheotherdomainsinthetool.fparticularquestions/entrieswerepre-specifiedinthereview'sprotocol,responsesshouldbeprovidedforeachquestion/entry.Biasduetoproblemsnotcoveredelsewhereinthetable.Table8.5.d:Crite

19、riaforjudgingriskofbiasinthe'Riskofbias'assessmenttoolRANDOMSEQUENCEGENERATIONSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.CriteriaforaTheinvestigatorsdescribearandomcomponentinthesequenceudgementof'Low"isk'ofbias.generationprocess

20、suchas: Referringtoarandomnumbertable; Usingacomputerrandomnumbergenerator; Cointossing; Shufflingcardsorenvelopes; Throwingdice; Drawingoflots; Minimization*.*Minimizationmaybeimplementedwithoutarandomelement,ancthisisconsideredtobeequivalenttobeingrandom.Criteriafortheudgementof'High"isk&

21、#39;ofbias.Theinvestigatorsdescribeanon-randomcomponentinthesequencegenerationprocess.Usually,thedescriptionwouldinvolvesomesystematic,non-randomapproach,forexample: Sequencegeneratedbyoddorevendateofbirth; Sequencegeneratedbysomerulebasedondate(orday)ofadmission; Sequencegeneratedbysomerulebasedonh

22、ospitalorclinicrecordnumber.Othernon-randomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobvious.Theyusuallyinvolvejudgementorsomemethodofnon-randomcategorizationofparticipants,forexample: Allocationbyjudgementoftheclinician; Allocationbypreferenceofthepartici

23、pant; Allocationbasedontheresultsofalaboratorytestoraseriesoftests; Allocationbyavailabilityoftheintervention.Criteriafortheudgementof'Unclearrisk'ofbias.nsufficientinformationaboutthesequencegenerationprocesstopermitjudgementof'Lowrisk'or'Highrisk'.ALLOCATIONCONCEALMENTSelec

24、tionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.Criteriaforaudgementof'Low"isk'ofbias.Participantsandinvestigatorsenrollingparticipantscouldnotforeseeassignmentbecauseoneofthefollowing,oranequivalentmethod,wasusedtoconcealallocation: Cen

25、tralallocation(includingtelephone,web-basedandpharmacy-controlledrandomization); Sequentiallynumbereddrugcontainersofidenticalappearance; Sequentiallynumbered,opaque,sealedenvelopes.Criteriafortheudgementof'HighIsk'ofbias.Participantsorinvestigatorsenrollingparticipantscouldpossiblyforeseeas

26、signmentsandthusintroduceselectionbias,suchasallocationbasedon: Usinganopenrandomallocationschedule(e.g.alistofrandomnumbers); Assignmentenvelopeswereusedwithoutappropriatesafeguards(e.g.ifenvelopeswereunsealedornonopaqueornotsequentiallynumbered); Alternationorrotation; Dateofbirth; Caserecordnumbe

27、r; Anyotherexplicitlyunconcealedprocedure.Criteriafortheudgementof'Unclearrisk'ofbias.nsufficientinformationtopermitjudgementof'Lowrisk'or'Highrisk'.Thisisusuallythecaseifthemethodofconcealmentisnotdescribedornotdescribedinsufficientdetailtoallowadefinitejudgementforexampleif

28、theuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealed.BLINDINGOFPARTICIPANTSANDPERSONNELPerformancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Criteriaforaudgementof'LowIsk'ofbias.Anyoneoft

29、hefollowing: Noblindingorincompleteblinding,butthereviewauthorsjudgethattheoutcomeisnotlikelytobeinfluencedbylackofblinding; Blindingofparticipantsandkeystudypersonnelensured,andunlikelythattheblindingcouldhavebeenbroken.Criteriafortheudgementof'High"isk'ofbias.Anyoneofthefollowing: Nob

30、lindingorincompleteblinding,andtheoutcomeislikelytobeinfluencedbylackofblinding; Blindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomeislikelytobeinfluencedbylackofblinding.Criteriafortheudgementof'Unclearrisk'ofbias.Anyoneofthefollowin

31、g: Insufficientinformationtopermitjudgementof'Lowrisk'or'Highrisk' Thestudydidnotaddressthisoutcome.BLINDINGOFOUTCOMEASSESSMENTDetectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessors.Criteriaforaudgementof'LowIsk'ofbias.Anyoneofthefollowing: Noblindingofoutco

32、meassessment,butthereviewauthorsjudgethattheoutcomemeasurementisnotlikelytobeinfluencedbylackofblinding; Blindingofoutcomeassessmentensured,andunlikelythattheblindingcouldhavebeenbroken.Criteriafortheudgementof'HighIsk'ofbias.Anyoneofthefollowing: Noblindingofoutcomeassessment,andtheoutcomem

33、easurementislikelytobeinfluencedbylackofblinding; Blindingofoutcomeassessment,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding.Criteriafortheudgementof'Unclearrisk'ofbias.Anyoneofthefollowing: Insufficientinformationtopermitjudgemento

34、f'Lowrisk'or'Highrisk' Thestudydidnotaddressthisoutcome.INCOMPLETEOUTCOMEDATAAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.Criteriaforaudgementof'Low"isk'ofbias.Anyoneofthefollowing: Nomissingoutcomedata; Reasonsformissingoutcomedataunlikelytoberelated

35、totrueoutcome(forsurvivaldata,censoringunlikelytobeintroducingbias); Missingoutcomedatabalancedinnumbersacrossinterventiongroups,withsimilarreasonsformissingdataacrossgroups; Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventrisknotenoughtohaveaclinicallyrelevantimpact

36、ontheinterventioneffectestimate; Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesnotenoughtohaveaclinicallyrelevantimpactonobservedeffectsize; Missingdatahavebeenimputedusingappropriatemethods.Criteriafortheudgementof'HighIsk'

37、ofbias.Anyoneofthefollowing: Reasonformissingoutcomedatalikelytoberelatedtotrueoutcome,witheitherimbalanceinnumbersorreasonsformissingdataacrossinterventiongroups; Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventriskenoughtoinduceclinicallyrelevantbiasininterventione

38、ffectestimate; Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesenoughtoinduceclinicallyrelevantbiasinobservedeffectsize; (As-treated'analysisdonewithsubstantialdepartureoftheinterventionreceivedfromthatassignedatrandomization; Pot

39、entiallyinappropriateapplicationofsimpleimputation.Criteriafortheudgementof'Unclearrisk'ofbias.Anyoneofthefollowing:Insufficientreportingofattrition/exclusionstopermitjudgementof'Lowrisk'or'Highrisk'(e.g.numberrandomizednotstated,noreasonsformissingdataprovided);Thestudydidno

40、taddressthisoutcome.SELECTIVEREPORTINGReportingbiasduetoselectiveoutcomereporting.Criteriaforaudgementof'Lowrisk'ofbias.Anyofthefollowing:Thestudyprotocolisavailableandallofthestudy'spre-specified(primaryandsecondary)outcomesthatareofinterestinthereviewhavebeenreportedinthepre-specifiedw

41、ay;Thestudyprotocolisnotavailablebutitisclearthatthepublishedreportsincludeallexpectedoutcomes,includingthosethatwerepre-specified(convincingtextofthisnaturemaybeuncommon).Criteriafortheudgementof'Highrisk'ofbias.Anyoneofthefollowing: Notallofthestudy'spre-specifiedprimaryoutcomeshavebee

42、nreported; Oneormoreprimaryoutcomesisreportedusingmeasurements,analysismethodsorsubsetsofthedata(e.g.subscales)thatwerenotpre-specified; Oneormorereportedprimaryoutcomeswerenotpre-specified(unlessclearjustificationfortheirreportingisprovided,suchasanunexpectedadverseeffect); Oneormoreoutcomesofinterestinthereviewarereportedincompletelysothattheycannotbeenteredinameta-analysis; Thestudyreportfailstoincluderesultsforakeyoutcomethatwouldbeexpectedtohavebeenreportedforsuchastudy.Criteriafortheudgementof'Unclearrisk'ofbias.