cochrane納入的rct文獻(xiàn)質(zhì)量評價風(fēng)險偏倚評估工具中英文對照版

中文：偏倚種類判斷指標(biāo)議論員的判斷選擇偏倚隨機(jī)序列的產(chǎn)生足夠詳盡的描繪用于生成分派序生成隨機(jī)序列不充分，列的方法，以評估產(chǎn)生的分組能否發(fā)生選擇偏倚擁有可比性。分派隱蔽足夠詳盡的描繪隱蔽分派序列的分派前分派隱蔽不充分方法，以決定干涉的分派在歸入之發(fā)生選擇偏倚前或歸入過程中能否可見實行偏倚實行者和參加者假如有，描繪對參加者和實行者行參加者和實行者認(rèn)識干雙盲對付每個主盲法，防范其認(rèn)識干涉信息的全部預(yù)的有關(guān)信息以致實行要結(jié)局進(jìn)行評估措施。供給任何與所實行的盲法是偏倚（或分類結(jié)局）否有效地有關(guān)信息。丈量偏倚結(jié)局評估中的盲法每個主要結(jié)局均應(yīng)評估（或分類結(jié)局）失訪偏倚

假如有，描繪對結(jié)局者行盲法，避結(jié)局評估者認(rèn)識分派的免其認(rèn)識自己所接受的干涉信息干涉措施將以致丈量偏的全部措施。供給任何與所實行的倚盲法能否有效地有關(guān)信息。不全結(jié)局?jǐn)?shù)據(jù)每個主要結(jié)局均應(yīng)評估（或分類結(jié)局）發(fā)布偏倚

描繪每個主要結(jié)局?jǐn)?shù)據(jù)的完好性，不全結(jié)局?jǐn)?shù)據(jù)的數(shù)目，包含分析中的自然缺失和除去。這性質(zhì)，辦理方式以致失些缺失數(shù)據(jù)能否報告，在各個干涉訪偏倚組的數(shù)目（并與總樣本量比較），數(shù)據(jù)缺失以及從頭歸入分析的原因Selective說明如何審察選擇性報導(dǎo)結(jié)局的選擇性報導(dǎo)結(jié)局以致發(fā)reporting.可能性，以及審察結(jié)果表偏倚其他偏倚其他偏倚根源說明不包含在上述偏倚中的其他不包含在上述各項中的重要偏倚偏倚假如特定的問題或條目早先在計劃書中指出，對付每一項說明隨機(jī)序列的產(chǎn)生隨機(jī)序列產(chǎn)生不充分以致選擇偏倚判斷為低風(fēng)險的標(biāo)準(zhǔn)研究者描繪隨機(jī)序列產(chǎn)生過程比如:參照隨機(jī)數(shù)字表使用計算機(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，可實現(xiàn)無隨機(jī)元素，被以為相當(dāng)于是隨機(jī)的。判斷為高風(fēng)險的標(biāo)準(zhǔn)研究者描繪序列的產(chǎn)生使用的是非隨機(jī)的方法。平常是系統(tǒng)的非隨機(jī)方法，比方：經(jīng)過奇偶或出誕辰期產(chǎn)生序列經(jīng)過住院日期產(chǎn)生序列經(jīng)過近似住院號或門診號產(chǎn)生序列有關(guān)于上邊提到的系統(tǒng)方法，其他非隨機(jī)的方法少見的多，也更顯然。平常包含對參加者進(jìn)行判斷或非隨機(jī)的方法，比方:臨床醫(yī)生判斷如何分派參加者判斷如何分派鑒于實驗室檢查或系列測試的結(jié)果分派鑒于干涉的可獲得性進(jìn)行分派偏倚風(fēng)險不清楚的判沒有足夠的信息判斷隨機(jī)序列的產(chǎn)生計在高風(fēng)險或低風(fēng)斷標(biāo)準(zhǔn)險分派隱蔽分派前不充分的分派隱蔽以致選擇偏倚低風(fēng)險判斷標(biāo)準(zhǔn)參加者以及歸入?yún)⒓诱叩难芯空咭蛞韵卵陲椃峙傻姆椒ɑ蛳喈?dāng)?shù)姆椒?，早先不認(rèn)識分派狀況中心分派（包含電話，網(wǎng)絡(luò)，藥房控制隨機(jī)）同樣外形的次序編號的藥物容器；次序編號、不透明、密封的信封高風(fēng)險判斷標(biāo)準(zhǔn)參加者以及歸入?yún)⒓诱叩难芯空呖赡茉缦戎婪峙?，因而引?dāng)選擇偏倚，比如鑒于以下方法的分派:?使用攤開的隨機(jī)分派表（如隨機(jī)序列清單）?發(fā)散信封但沒有適合的安全保障（如透明、非密封、非次序編號）?交替或循環(huán)?出誕辰期?病歷號?其他明確的非隱蔽過程風(fēng)險未知沒有足夠信息判斷為低風(fēng)險或高風(fēng)險。平常因分派隱蔽的方法未描繪或描繪不充分。比方描繪為使用信封分派，但為描繪信封能否透明？密封？次序編號？對參加者和實行者的盲法因參加者和實行者認(rèn)識干涉狀況而以致實行偏倚偏倚低風(fēng)險標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):無盲法或盲法不充分，但系統(tǒng)議論員判斷結(jié)局不太可能遇到缺少盲法的影響參加者和主要實行者均實行靠譜的盲法，且盲法不太可能被打破偏倚高風(fēng)險標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):無盲法或盲法不充分，但系統(tǒng)議論員判斷結(jié)局很可能遇到缺少盲法的影響試試對要點(diǎn)的參加者和實行者行盲法，但盲法很可能被打破，結(jié)局很可能遇到缺少盲法的影響風(fēng)險未知任何以下標(biāo)準(zhǔn):沒有足夠信息判斷為低風(fēng)險或高風(fēng)險研究未描繪此狀況對結(jié)局議論實行盲法結(jié)局議論者認(rèn)識干涉分派信息將以致丈量偏倚偏倚低風(fēng)險標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):無盲法或盲法不充分，但系統(tǒng)議論員判斷結(jié)局不太可能遇到缺少盲法的影響參加者和主要實行者均實行靠譜的盲法，且盲法不太可能被打破高風(fēng)險判斷標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):無盲法或盲法不充分，但系統(tǒng)議論員判斷結(jié)局很可能遇到缺少盲法的影響試試對要點(diǎn)的參加者和實行者行盲法，但盲法很可能被打破，結(jié)局很可能遇到缺少盲法的影響風(fēng)險未知任何以下標(biāo)準(zhǔn):沒有足夠信息判斷為低風(fēng)險或高風(fēng)險研究未描繪此狀況結(jié)局?jǐn)?shù)據(jù)不完好不全結(jié)局?jǐn)?shù)據(jù)的數(shù)目，性質(zhì)，辦理方式以致失訪偏倚偏倚低風(fēng)險標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):無缺失數(shù)據(jù)缺失數(shù)據(jù)的產(chǎn)生不大可能與真切結(jié)局有關(guān)（關(guān)于生計數(shù)據(jù)，刪失不大可能引入偏倚）缺失數(shù)據(jù)的數(shù)目在各干涉組相當(dāng)，且各組缺失原由近似對二分類變量，與觀察事件的發(fā)生風(fēng)險對比，缺失比率不足以影響預(yù)估的干涉效應(yīng)對連續(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）不會大到影響觀察的效應(yīng)規(guī)模;缺失的數(shù)據(jù)用適合的方法進(jìn)行估量高風(fēng)險判斷標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):????

缺失數(shù)據(jù)的產(chǎn)生很大可能與真切結(jié)局有關(guān),缺失數(shù)據(jù)的數(shù)目及缺失原由在各干涉組相差較大對二分類變量，與觀察事件的發(fā)生風(fēng)險對比，缺失比率足以影響預(yù)估的干涉效應(yīng)對連續(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;意愿治療分析中存在實質(zhì)干涉措施與隨機(jī)分派的干涉相違反的狀況對缺失數(shù)據(jù)進(jìn)行簡單的不適合的估量風(fēng)險未知任何以下標(biāo)準(zhǔn):沒有報導(dǎo)缺失或除去的狀況，沒法判斷高風(fēng)險或低風(fēng)險（如未說明隨機(jī)的數(shù)目，未供給數(shù)據(jù)缺失的原由）研究未描繪此狀況選擇性發(fā)布選擇性發(fā)布以致發(fā)布偏倚偏倚低風(fēng)險標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):?實驗的計劃書可獲得，系統(tǒng)議論感興趣的全部首要或次要結(jié)局均按計劃書早先說明的方式報導(dǎo)?實驗計劃書不行得，但很顯然發(fā)布的報告包含所有的結(jié)局，包含早先說明的結(jié)局（這類性質(zhì)的有說服力的文字可能少見）高風(fēng)險判斷標(biāo)準(zhǔn)任何以下標(biāo)準(zhǔn):?不是全部的早先說明的首要結(jié)局均被報導(dǎo)?一個或多個首要結(jié)局為采納早先說明的丈量方法、分析方法或數(shù)據(jù)子集來報導(dǎo)?系統(tǒng)議論感興趣的一個或多個首要結(jié)局報導(dǎo)不全，以致于不可以歸入meta分析?研究未報導(dǎo)此研究應(yīng)該包含的主要要點(diǎn)結(jié)局風(fēng)險未知沒有足夠信息判斷高風(fēng)險或低風(fēng)險，貌似大部分研究會被分為此類OTHERBIAS不包含在以上五種的其他偏倚偏倚低風(fēng)險標(biāo)準(zhǔn)研究應(yīng)未引入其他根源的偏倚高風(fēng)險判斷標(biāo)準(zhǔn)最罕有一種重要的偏倚風(fēng)險，比方：擁有與特別試驗設(shè)計有關(guān)的潛伏偏倚根源或被指欺騙或其他問題風(fēng)險未知可能存在偏倚風(fēng)險，但存在以下兩種中的一種沒有足夠信息評估能否存在其他重要的偏倚風(fēng)險沒有足夠的憑證以為發(fā)現(xiàn)的問題會引入偏倚Possibleapproachforsummaryassessmentsoftheriskofbiasforeachimportantoutcome(acrossdomains)withinandacrossstudiesRiskofbias解說對單個研究對多個研究整體Lowriskof合理的偏倚不太每一類偏倚均為絕大部分信息均來bias.可能嚴(yán)重改變結(jié)低風(fēng)險自偏倚低風(fēng)險的研果究Unclearriskof合理的偏倚會對一類或多類偏倚絕大部分信息均來bias.結(jié)果產(chǎn)生必定的風(fēng)險未知自偏倚低風(fēng)險或風(fēng)思疑險未知的研究Highriskof偏倚嚴(yán)重削弱結(jié)一類或多類偏倚來自高偏倚風(fēng)險研bias.果的可信度為高風(fēng)險究的信息比率足以影響結(jié)果的解說英文：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