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首页 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

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.doc

cochrane纳入的RCT文献质量评价(风险偏倚评估工具)中…

wang小丽春
2019-01-17 0人阅读 举报 0 0 暂无简介

简介:本文档为《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doc》,可适用于医药卫生领域

中文:Tablea: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   Tabled: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:l参考随机数字表l使用计算机随机数字生成器l扔硬币l洗牌的卡片和信封l掷骰子l抽签l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:l通过奇偶或出生日期产生序列l通过入院日期产生序列l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:l临床医生判断如何分配l参与者判断如何分配l基于实验室检查或系列测试的结果分配l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l中心分配(包括电话网络药房控制随机)l相同外形的顺序编号的药物容器l顺序编号、不透明、密封的信封高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下方法的分配:l使用摊开的随机分配表(如随机序列清单)l分发信封但没有合适的安全保障(如透明、非密封、非顺序编号)l交替或循环l出生日期l病历号l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了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:l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l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偏倚高风险标准任何如下标准:l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l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:l没有足够信息判断为低风险或高风险l研究未描述此情况对结局评价实施盲法结局评价者了解干预分配信息将导致测量偏倚偏倚低风险标准任何如下标准:l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l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:l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l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:l没有足够信息判断为低风险或高风险l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:l无缺失数据l缺失数据的产生不大可能与真实结局相关(对于生存数据删失不大可能引入偏倚)l缺失数据的数目在各干预组相当且各组缺失原因类似l对二分类变量与观察事件的发生风险相比缺失比例不足以影响预估的干预效应l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l缺失的数据用合适的方法进行估算高风险判断标准任何如下标准:l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l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l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l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l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:l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)l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:l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l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:l不是所有的预先说明的首要结局均被报道l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l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l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:l具有与特殊试验设计相关的潜在偏倚来源l或被指欺诈l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l没有足够信息评估是否存在其它重要的偏倚风险l没有足够的证据认为发现的问题会引入偏倚  Tablea: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:Tablea:TheCochraneCollaboration’stoolforassessingriskofbiasDomainSupportforjudgementReviewauthors’judgementSelectionbiasRandomsequencegenerationDescribethemethodusedtogeneratetheallocationsequenceinsufficientdetailtoallowanassessmentofwhetheritshouldproducecomparablegroupsSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequenceAllocationconcealmentDescribethemethodusedtoconcealtheallocationsequenceinsufficientdetailtodeterminewhetherinterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolmentSelectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignmentPerformancebiasBlindingofparticipantsandpersonnelAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes)Describeallmeasuresused,ifany,toblindstudyparticipantsandpersonnelfromknowledgeofwhichinterventionaparticipantreceivedProvideanyinformationrelatingtowhethertheintendedblindingwaseffectivePerformancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudyDetectionbiasBlindingofoutcomeassessmentAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes)Describeallmeasuresused,ifany,toblindoutcomeassessorsfromknowledgeofwhichinterventionaparticipantreceivedProvideanyinformationrelatingtowhethertheintendedblindingwaseffectiveDetectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessorsAttritionbiasIncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes)Describethecompletenessofoutcomedataforeachmainoutcome,includingattritionandexclusionsfromtheanalysisStatewhetherattritionandexclusionswerereported,thenumbersineachinterventiongroup(comparedwithtotalrandomizedparticipants),reasonsforattritionexclusionswherereported,andanyreinclusionsinanalysesperformedbythereviewauthorsAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedataReportingbiasSelectivereportingStatehowthepossibilityofselectiveoutcomereportingwasexaminedbythereviewauthors,andwhatwasfoundReportingbiasduetoselectiveoutcomereportingOtherbiasOthersourcesofbiasStateanyimportantconcernsaboutbiasnotaddressedintheotherdomainsinthetoolIfparticularquestionsentrieswereprespecifiedinthereview’sprotocol,responsesshouldbeprovidedforeachquestionentryBiasduetoproblemsnotcoveredelsewhereinthetable   Tabled:Criteriaforjudgingriskofbiasinthe‘Riskofbias’assessmenttoolRANDOMSEQUENCEGENERATIONSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequenceCriteriaforajudgementof‘Lowrisk’ofbiasTheinvestigatorsdescribearandomcomponentinthesequencegenerationprocesssuchas:lReferringtoarandomnumbertablelUsingacomputerrandomnumbergeneratorlCointossinglShufflingcardsorenvelopeslThrowingdicelDrawingoflotslMinimization**Minimizationmaybeimplementedwithoutarandomelement,andthisisconsideredtobeequivalenttobeingrandomCriteriaforthejudgementof‘Highrisk’ofbiasTheinvestigatorsdescribeanonrandomcomponentinthesequencegenerationprocessUsually,thedescriptionwouldinvolvesomesystematic,nonrandomapproach,forexample:lSequencegeneratedbyoddorevendateofbirthlSequencegeneratedbysomerulebasedondate(orday)ofadmissionlSequencegeneratedbysomerulebasedonhospitalorclinicrecordnumberOthernonrandomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobviousTheyusuallyinvolvejudgementorsomemethodofnonrandomcategorizationofparticipants,forexample:lAllocationbyjudgementoftheclinicianlAllocationbypreferenceoftheparticipantlAllocationbasedontheresultsofalaboratorytestoraseriesoftestslAllocationbyavailabilityoftheinterventionCriteriaforthejudgementof‘Unclearrisk’ofbiasInsufficientinformationaboutthesequencegenerationprocesstopermitjudgementof‘Lowrisk’or‘Highrisk’ALLOCATIONCONCEALMENTSelectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignmentCriteriaforajudgementof‘Lowrisk’ofbiasParticipantsandinvestigatorsenrollingparticipantscouldnotforeseeassignmentbecauseoneofthefollowing,oranequivalentmethod,wasusedtoconcealallocation:lCentralallocation(includingtelephone,webbasedandpharmacycontrolledrandomization)lSequentiallynumbereddrugcontainersofidenticalappearancelSequentiallynumbered,opaque,sealedenvelopesCriteriaforthejudgementof‘Highrisk’ofbiasParticipantsorinvestigatorsenrollingparticipantscouldpossiblyforeseeassignmentsandthusintroduceselectionbias,suchasallocationbasedon:lUsinganopenrandomallocationschedule(egalistofrandomnumbers)lAssignmentenvelopeswereusedwithoutappropriatesafeguards(egifenvelopeswereunsealedornonopaqueornotsequentiallynumbered)lAlternationorrotationlDateofbirthlCaserecordnumberlAnyotherexplicitlyunconcealedprocedureCriteriaforthejudgementof‘Unclearrisk’ofbiasInsufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’Thisisusuallythecaseifthemethodofconcealmentisnotdescribedornotdescribedinsufficientdetailtoallowadefinitejudgement–forexampleiftheuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealedBLINDINGOFPARTICIPANTSANDPERSONNELPerformancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudyCriteriaforajudgementof‘Lowrisk’ofbiasAnyoneofthefollowing:lNoblindingorincompleteblinding,butthereviewauthorsjudgethattheoutcomeisnotlikelytobeinfluencedbylackofblindinglBlindingofparticipantsandkeystudypersonnelensured,andunlikelythattheblindingcouldhavebeenbrokenCriteriaforthejudgementof‘Highrisk’ofbiasAnyoneofthefollowing:lNoblindingorincompleteblinding,andtheoutcomeislikelytobeinfluencedbylackofblindinglBlindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomeislikelytobeinfluencedbylackofblindingCriteriaforthejudgementof‘Unclearrisk’ofbiasAnyoneofthefollowing:lInsufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’lThestudydidnotaddressthisoutcomeBLINDINGOFOUTCOMEASSESSMENTDetectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessorsCriteriaforajudgementof‘Lowrisk’ofbiasAnyoneofthefollowing:lNoblindingofoutcomeassessment,butthereviewauthorsjudgethattheoutcomemeasurementisnotlikelytobeinfluencedbylackofblindinglBlindingofoutcomeassessmentensured,andunlikelythattheblindingcouldhavebeenbrokenCriteriaforthejudgementof‘Highrisk’ofbiasAnyoneofthefollowing:lNoblindingofoutcomeassessment,andtheoutcomemeasurementislikelytobeinfluencedbylackofblindinglBlindingofoutcomeassessment,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomemeasurementislikelytobeinfluencedbylackofblindingCriteriaforthejudgementof‘Unclearrisk’ofbiasAnyoneofthefollowing:lInsufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’lThestudydidnotaddressthisoutcomeINCOMPLETEOUTCOMEDATAAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedataCriteriaforajudgementof‘Lowrisk’ofbiasAnyoneofthefollowing:lNomissingoutcomedatalReasonsformissingoutcomedataunlikelytoberelatedtotrueoutcome(forsurvivaldata,censoringunlikelytobeintroducingbias)lMissingoutcomedatabalancedinnumbersacrossinterventiongroups,withsimilarreasonsformissingdataacrossgroupslFordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventrisknotenoughtohaveaclinicallyrelevantimpactontheinterventioneffectestimatelForcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesnotenoughtohaveaclinicallyrelevantimpactonobservedeffectsizelMissingdatahavebeenimputedusingappropriatemethodsCriteriaforthejudgementof‘Highrisk’ofbiasAnyoneofthefollowing:lReasonformissingoutcomedatalikelytoberelatedtotrueoutcome,witheitherimbalanceinnumbersorreasonsformissingdataacrossinterventiongroupslFordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventriskenoughtoinduceclinicallyrelevantbiasininterventioneffectestimatelForcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesenoughtoinduceclinicallyrelevantbiasinobservedeffectsizel‘Astreated’analysisdonewithsubstantialdepartureoftheinterventionreceivedfromthatassignedatrandomizationlPotentiallyinappropriateapplicationofsimpleimputationCriteriaforthejudgementof‘Unclearrisk’ofbiasAnyoneofthefollowing:lInsufficientreportingofattritionexclusionstopermitjudgementof‘Lowrisk’or‘Highrisk’(egnumberrandomizednotstated,noreasonsformissingdataprovided)lThestudydidnotaddressthisoutcomeSELECTIVEREPORTINGReportingbiasduetoselectiveoutcomereportingCriteriaforajudgementof‘Lowrisk’ofbiasAnyofthefollowing:lThestudyprotocolisavailableandallofthestudy’sprespecified(primaryandsecondary)outcomesthatareofinterestinthereviewhavebeenreportedintheprespecifiedwaylThestudyprotocolisnotavailablebutitisclearthatthepublishedreportsincludeallexpectedoutcomes,includingthosethatwereprespecified(convincingtextofthisnaturemaybeuncommon)Criteriaforthejudgementof‘Highrisk’ofbiasAnyoneofthefollowing:lNotallofthestudy’sprespecifiedprimaryoutcomeshavebeenreportedlOneormoreprimaryoutcomesisreportedusingmeasurements,analysismethodsorsubsetsofthedata(egsubscales)thatwerenotprespecifiedlOneormorereportedprimaryoutcomeswerenotprespecified(unlessclearjustificationfortheirreportingisprovided,suchasanunexpectedadverseeffect)lOneormoreoutcomesofinterestinthereviewarereportedincompletelysothattheycannotbeenteredinametaanalysislThestudyreportfailstoincluderesultsforakeyoutcomethatwouldbeexpectedtohavebeenreportedforsuchastudyCriteriaforthejudgementof‘Unclearrisk’ofbiasInsufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’ItislikelythatthemajorityofstudieswillfallintothiscategoryOTHERBIASBiasduetoproblemsnotcoveredelsewhereinthetableCriteriaforajudgementof‘Lowrisk’ofbiasThestudyappearstobefreeofothersourcesofbiasCriteriaforthejudgementof‘Highrisk’ofbiasThereisatleastoneimportantriskofbiasForexample,thestudy:lHadapotentialsourceofbiasrelatedtothespecificstudydesignusedorlHasbeenclaimedtohavebeenfraudulentorlHadsomeotherproblemCriteriaforthejudgementof‘Unclearrisk’ofbiasTheremaybeariskofbias,butthereiseither:lInsufficientinformationtoassesswhetheranimportantriskofbiasexistsorlInsufficientrationaleorevidencethatanidentifiedproblemwillintroducebias  Tablea:Possibleapproachforsummaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossdomains)withinandacrossstudiesRiskofbiasInterpretationWithinastudyAcrossstudiesLowriskofbiasPlausiblebiasunlikelytoseriouslyaltertheresultsLowriskofbiasforallkeydomainsMostinformationisfromstudiesatlowriskofbiasUnclearriskofbiasPlausiblebiasthatraisessomedoubtabouttheresultsUnclearriskofbiasforoneormorekeydomainsMostinformationisfromstudiesatloworunclearriskofbiasHighriskofbiasPlausiblebiasthatseriouslyweakensconfidenceintheresultsHighriskofbiasforoneormorekeydomainsTheproportionofinformationfromstudiesathighriskofbiasissufficienttoaffecttheinterpretationofresults    

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