cochrane納入的rct文獻質量評價風險偏倚評估工具中英文對照版

中文：偏倚種類判斷指標議論員的判斷選擇偏倚隨機序列的產生足夠詳盡的描繪用于生成分派序生成隨機序列不充分，列的方法，以評估產生的分組能否發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識干雙盲對付每個主盲法，防范其認識干涉信息的全部預的有關信息以致實行要結局進行評估措施。供給任何與所實行的盲法是偏倚（或分類結局）否有效地有關信息。丈量偏倚結局評估中的盲法每個主要結局均應評估（或分類結局）失訪偏倚

假如有，描繪對結局者行盲法，避結局評估者認識分派的免其認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信息。不全結局數據每個主要結局均應評估（或分類結局）發布偏倚

描繪每個主要結局數據的完好性，不全結局數據的數目，包含分析中的自然缺失和除去。這性質，辦理方式以致失些缺失數據能否報告，在各個干涉訪偏倚組的數目（并與總樣本量比較），數據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結局的選擇性報導結局以致發reporting.可能性，以及審察結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序列的產生隨機序列產生不充分以致選擇偏倚判斷為低風險的標準研究者描繪隨機序列產生過程比如:參照隨機數字表使用計算機隨機數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，可實現無隨機元素，被以為相當于是隨機的。判斷為高風險的標準研究者描繪序列的產生使用的是非隨機的方法。平常是系統的非隨機方法，比方：經過奇偶或出誕辰期產生序列經過住院日期產生序列經過近似住院號或門診號產生序列有關于上邊提到的系統方法，其他非隨機的方法少見的多，也更顯然。平常包含對參加者進行判斷或非隨機的方法，比方:臨床醫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果分派鑒于干涉的可獲得性進行分派偏倚風險不清楚的判沒有足夠的信息判斷隨機序列的產生計在高風險或低風斷標準險分派隱蔽分派前不充分的分派隱蔽以致選擇偏倚低風險判斷標準參加者以及歸入參加者的研究者因以下掩飾分派的方法或相當的方法，早先不認識分派狀況中心分派（包含電話，網絡，藥房控制隨機）同樣外形的次序編號的藥物容器；次序編號、不透明、密封的信封高風險判斷標準參加者以及歸入參加者的研究者可能早先知道分派，因而引當選擇偏倚，比如鑒于以下方法的分派:?使用攤開的隨機分派表（如隨機序列清單）?發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?出誕辰期?病歷號?其他明確的非隱蔽過程風險未知沒有足夠信息判斷為低風險或高風險。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識干涉狀況而以致實行偏倚偏倚低風險標準任何以下標準:無盲法或盲法不充分，但系統議論員判斷結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險標準任何以下標準:無盲法或盲法不充分，但系統議論員判斷結局很可能遇到缺少盲法的影響試試對要點的參加者和實行者行盲法，但盲法很可能被打破，結局很可能遇到缺少盲法的影響風險未知任何以下標準:沒有足夠信息判斷為低風險或高風險研究未描繪此狀況對結局議論實行盲法結局議論者認識干涉分派信息將以致丈量偏倚偏倚低風險標準任何以下標準:無盲法或盲法不充分，但系統議論員判斷結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險判斷標準任何以下標準:無盲法或盲法不充分，但系統議論員判斷結局很可能遇到缺少盲法的影響試試對要點的參加者和實行者行盲法，但盲法很可能被打破，結局很可能遇到缺少盲法的影響風險未知任何以下標準:沒有足夠信息判斷為低風險或高風險研究未描繪此狀況結局數據不完好不全結局數據的數目，性質，辦理方式以致失訪偏倚偏倚低風險標準任何以下標準:無缺失數據缺失數據的產生不大可能與真切結局有關（關于生計數據，刪失不大可能引入偏倚）缺失數據的數目在各干涉組相當，且各組缺失原由近似對二分類變量，與觀察事件的發生風險對比，缺失比率不足以影響預估的干涉效應對連續性結局數據，缺失數據的合理效應規模（均數差或標準均數差）不會大到影響觀察的效應規模;缺失的數據用適合的方法進行估量高風險判斷標準任何以下標準:????

缺失數據的產生很大可能與真切結局有關,缺失數據的數目及缺失原由在各干涉組相差較大對二分類變量，與觀察事件的發生風險對比，缺失比率足以影響預估的干涉效應對連續性結局數據，缺失數據的合理效應規模（均數差或標準均數差）足以影響觀察的效應規模;意愿治療分析中存在實質干涉措施與隨機分派的干涉相違反的狀況對缺失數據進行簡單的不適合的估量風險未知任何以下標準:沒有報導缺失或除去的狀況，沒法判斷高風險或低風險（如未說明隨機的數目，未供給數據缺失的原由）研究未描繪此狀況選擇性發布選擇性發布以致發布偏倚偏倚低風險標準任何以下標準:?實驗的計劃書可獲得，系統議論感興趣的全部首要或次要結局均按計劃書早先說明的方式報導?實驗計劃書不行得，但很顯然發布的報告包含所有的結局，包含早先說明的結局（這類性質的有說服力的文字可能少見）高風險判斷標準任何以下標準:?不是全部的早先說明的首要結局均被報導?一個或多個首要結局為采納早先說明的丈量方法、分析方法或數據子集來報導?系統議論感興趣的一個或多個首要結局報導不全，以致于不可以歸入meta分析?研究未報導此研究應該包含的主要要點結局風險未知沒有足夠信息判斷高風險或低風險，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險標準研究應未引入其他根源的偏倚高風險判斷標準最罕有一種重要的偏倚風險，比方：擁有與特別試驗設計有關的潛伏偏倚根源或被指欺騙或其他問題風險未知可能存在偏倚風險，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險沒有足夠的憑證以為發現的問題會引入偏倚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.可能嚴重改變結低風險自偏倚低風險的研果究Unclearriskof合理的偏倚會對一類或多類偏倚絕大部分信息均來bias.結果產生必定的風險未知自偏倚低風險或風思疑險未知的研究Highriskof偏倚嚴重削弱結一類或多類偏倚來自高偏倚風險研bias.果的可信度為高風險究的信息比率足以影響結果的解說英文：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