cochrane納入的RCT文獻質(zhì)量評價(風險偏倚評估工具)中英文對照版

1足夠詳細的描述用于生成分配序足夠詳細的描述隱藏分配序列的前或納入過程中是否可見分配前分配隱藏不充分發(fā)生選擇偏倚雙盲應對每個主要結(jié)局進行評估(或分類結(jié)局)配的法每個主要結(jié)局了解自己所接受的干預信息干預措施將導致測量偏均應評估(或分類倚不全結(jié)局數(shù)據(jù)每個主要結(jié)局均應處理方式導致失評估(或分類結(jié)組的數(shù)目(并與總樣本量比較)，據(jù)缺失以及重新納入分析的原因不包括在上述偏倚中的其它如果特定的問題或條目事先在計劃書中指出，應對每一項說明的2assessmenttool的產(chǎn)生倚判斷為低風險的標準研究者描述隨機序列產(chǎn)生過程譬如.參考隨機數(shù)字表.使用計算機隨機數(shù)字生成器.扔硬幣.洗牌的卡片和信封.擲骰子.抽簽.最小化高風險的標準研究者描述序列的產(chǎn)生使用的是非隨機的方法。通常是不清楚的判.通過奇偶或出生日期產(chǎn)生序列.通過入院日期產(chǎn)生序列.通過類似住院號或門診號產(chǎn)生序列相對于上面提到的系統(tǒng)方法，其它非隨機的方法少見的多，也更明顯。通常包括對參與者進行判斷或非隨機的.臨床醫(yī)生判斷如何分配.參與者判斷如何分配.基于實驗室檢查或系列測試的結(jié)果分配.基于干預的可獲取性進行分配沒有足夠的信息判斷隨機序列的產(chǎn)生存在高風險或低風險分配隱藏分配前不充足的分配隱藏導致選擇偏倚3法.中心分配(包括電話，網(wǎng)絡，藥房控制隨機)藥物容器；.順序編號、不透明、密封的信封因.使用攤開的隨機分配表(如隨機序列清單).分發(fā)信封但沒有合適的安全保障(如透明、非密.交替或循環(huán).出生日期.病歷號.其它明確的非隱藏過程信封是否透明？密封？順序編號？對參與者和實施者的盲法偏倚低風險標準任何如下標準.統(tǒng)評價員判斷結(jié)局不偏倚高風險標準任何如下標準.無盲法或盲法不充分，但系統(tǒng)評價員判斷結(jié)局很.嘗試對關(guān)鍵的參與者和實施者行盲法，但盲法很可能受到缺乏盲法的影響風險未知任何如下標準.沒有足夠信息判斷為低風險或高風險4.研究未描述此情況對結(jié)局評價實施盲法偏倚低風險標準任何如下標準.無盲法或盲法不充分，但系統(tǒng)評價員判斷結(jié)局不.參與者和主要實施者均實施可靠的盲法，且盲法高風險判斷標準任何如下標準.無盲法或盲法不充分，但系統(tǒng)評價員判斷結(jié)局很.嘗試對關(guān)鍵的參與者和實施者行盲法，但盲法很風險未知任何如下標準.沒有足夠信息判斷為低風險或高風險.研究未描述此情況結(jié)局數(shù)據(jù)不完整偏倚低風險標準任何如下標準.無缺失數(shù)據(jù).缺失數(shù)據(jù)的產(chǎn)生不大可能與真實結(jié)局相關(guān)(對于.缺失數(shù)據(jù)的數(shù)目在各干預組相當，且各組缺失原.對二分類變量，與觀察事件的發(fā)生風險相比，缺數(shù)差或標準均數(shù)差)不會大到影響觀察的效應規(guī)模5.缺失的數(shù)據(jù)用合適的方法進行估算.大缺失.對二分類變量，與觀察事件的發(fā)生風險相比，缺數(shù)差或標準均數(shù)差)足以影響觀察的效應規(guī)模.意向治療分析中存在實際干預措施與隨機分配.對缺失數(shù)據(jù)進行簡單的不合適的估算.研究未描述此情況選擇性發(fā)表偏倚低風險標準任何如下標準.首.實驗計劃書不可得，但很明顯發(fā)表的報告包括所高風險判斷標準任何如下標準.不是所有的預先說明的首要結(jié)局均被報道.一個或多個首要結(jié)局為采用預先說明的測量方.系統(tǒng)評價感興趣的一個或多個首要結(jié)局報道不納入分析.研究未報道此研究應當包含的主要關(guān)鍵結(jié)局6.具有與特殊試驗設計相關(guān)的潛在偏倚來源.或被指欺詐.或其它問題風險，但存在以下兩種中的一種.沒有足夠信息評估是否存在其它重要的偏倚風險.沒有足夠的證據(jù)認為發(fā)現(xiàn)的問題會引入偏倚7果均為研究整體均來的研究hraneCollaborationstoolforassessingriskofbiasSupportSupportforjudgementReviewauthors’judgementDescribethemethodusedtogenerateSelectionbias(biasedtheallocationsequenceinsufficientallocationtointerventions)detailtoallowanassessmentofwhetherduetoinadequategenerationitshouldproducecomparablegroups.Describethemethodusedtoconcealtheallocationsequenceinsufficientdetailtodeterminewhetherinterventionallocationscouldhavebeenforeseeninadvanceof,orduring,enrolment.ofarandomisedsequence.Selectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.Describeallmeasuresused,ifany,toblindstudyparticipantsandpersonnelfromknowledgeofwhichinterventionaparticipantreceived.Provideanyinformationrelatingtowhethertheintendedblindingwaseffective.Performancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.Describeallmeasuresused,ifany,toblindoutcomeassessorsfromknowledgeofwhichinterventionaparticipantreceived.ProvideanyDetectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeDomainSelectionbias.Randomsequencegeneration.Allocationconcealment.Performancebias.BlindingofparticipantsandpersonnelAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).Detectionbias.BlindingofoutcomeassessmentAssessmentsshouldbemadeforeach8informationinformationrelatingtowhethertheintendedblindingwaseffective.Describethecompletenessofoutcomedataforeachmainoutcome,includingattritionandexclusionsfromtheanalysis.Statewhetherattritionandexclusionswerereported,thenumbersineachinterventiongroup(comparedwithtotalrandomizedparticipants),reasonsforattrition/exclusionswhereAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.reported,andanyre-inclusionsinanalysesperformedbythereviewauthors.StatehowthepossibilityofselectiveReportingbiasduetooutcomereportingwasexaminedbytheselectiveoutcomereporting.reviewauthors,andwhatwasfound.StateanyimportantconcernsaboutbiasBiasduetoproblemsnotnotaddressedintheotherdomainsincoveredelsewhereinthethetool.table.Ifparticularquestions/entrieswerepre-specifiedinthereview’sprotocol,responsesshouldbeprovidedforeachquestion/entry.mainoutcome(orclassofoutcomes).Attritionbias.IncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).Reportingbias.Selectivereporting.Otherbias.Othersourcesofbias.assessors.TableCriteriaforjudgingriskofbiasinthe‘Riskofbias’assessmenttoolSelectionbias(biasedallocationtointerventions)duetoinadequategenerationofarandomisedsequence.CriteriaforajudgementTheinvestigatorsdescribearandomcomponentinthesequenceof‘Lowrisk’ofbias.generationprocesssuchas:.Referringtoarandomnumbertable;.Usingacomputerrandomnumbergenerator;9.Cointossing;.Shufflingcardsorenvelopes;.Throwingdice;.Drawingoflots;.Minimization*.*Minimizationmaybeimplementedwithoutarandomelement,andthisisconsideredtobeequivalenttobeingrandom.CriteriafortheTheinvestigatorsdescribeanon-randomcomponentinthesequencejudgementof‘Highrisk’generationprocess.Usually,thedescriptionwouldinvolvesomeofbias.systematic,non-randomapproach,forexample:.Sequencegeneratedbyoddorevendateofbirth;.Sequencegeneratedbysomerulebasedondate(orday)ofadmission;.Sequencegeneratedbysomerulebasedonhospitalorclinicrecordnumber.Othernon-randomapproacheshappenmuchlessfrequentlythanthesystematicapproachesmentionedaboveandtendtobeobvious.Theyusuallyinvolvejudgementorsomemethodofnon-randomcategorizationofparticipants,forexample:.Allocationbyjudgementoftheclinician;.Allocationbypreferenceoftheparticipant;.Allocationbasedontheresultsofalaboratorytestoraseriesoftests;.Allocationbyavailabilityoftheintervention.CriteriafortheInsufficientinformationaboutthesequencegenerationprocesstojudgementof‘Unclearpermitjudgementof‘Lowrisk’or‘Highrisk’.risk’ofbias.IONCONCEALMENTSelectionbias(biasedallocationtointerventions)duetoinadequateconcealmentofallocationspriortoassignment.CriteriaforajudgementParticipantsandinvestigatorsenrollingparticipantscouldnotforeseeof‘Lowrisk’ofbias.assignmentbecauseoneofthefollowing,oranequivalentmethod,wasusedtoconcealallocation:.Centralallocation(includingtelephone,web-basedandpharmacy-controlledrandomization);.Sequentiallynumbereddrugcontainersofidenticalappearance;.Sequentiallynumbered,opaque,sealedenvelopes.CriteriafortheParticipantsorinvestigatorsenrollingparticipantscouldpossiblyjudgementof‘Highrisk’foreseeassignmentsandthusintroduceselectionbias,suchasofbias.allocationbasedon:.Usinganopenrandomallocationschedule(e.g.alistofrandomnumbers);.Assignmentenvelopeswereusedwithoutappropriatesafeguards(e.g.ifenvelopeswereunsealedornonopaqueornotsequentiallynumbered);.Alternationorrotation;.Dateofbirth;.Caserecordnumber;.Anyotherexplicitlyunconcealedprocedure.CriteriafortheInsufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’.judgementof‘UnclearThisisusuallythecaseifthemethodofconcealmentisnotdescribedrisk’ofbias.ornotdescribedinsufficientdetailtoallowadefinitejudgement–forexampleiftheuseofassignmentenvelopesisdescribed,butitremainsunclearwhetherenvelopesweresequentiallynumbered,opaqueandsealed.RSONNELPerformancebiasduetoknowledgeoftheallocatedinterventionsbyparticipantsandpersonnelduringthestudy.CriteriaforajudgementAnyoneofthefollowing:of‘Lowrisk’ofbias.Criteriaforthejudgementof‘Highrisk’ofbias..Noblindingorincompleteblinding,butthereviewauthorsjudgethattheoutcomeisnotlikelytobeinfluencedbylackofblinding;.Blindingofparticipantsandkeystudypersonnelensured,andunlikelythattheblindingcouldhavebeenbroken.Anyoneofthefollowing:.Noblindingorincompleteblinding,andtheoutcomeislikelytobeinfluencedbylackofblinding;.Blindingofkeystudyparticipantsandpersonnelattempted,butlikelythattheblindingcouldhavebeenbroken,andtheCriteriaforthejudgementof‘Unclearrisk’ofbias.outcomeislikelytobeinfluencedbylackofblinding.Anyoneofthefollowing:.Insufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’;.Thestudydidnotaddressthisoutcome.Detectionbiasduetoknowledgeoftheallocatedinterventionsbyoutcomeassessors.CriteriaforajudgementAnyoneofthefollowing:of‘Lowrisk’ofbias..Noblindingofoutcomeassessment,butthereviewauthorsjudgethattheoutcomemeasurementisnotlikelytobeinfluencedbylackofblinding;Criteriaforthejudgementof‘Highrisk’ofbias..Blindingofoutcomeassessmentensured,andunlikelythattheblindingcouldhavebeenbroken.Anyoneofthefollowing:.Noblindingofoutcomeassessment,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding;.Blindingofoutcomeassessment,butlikelythattheblindingcouldhavebeenbroken,andtheoutcomemeasurementislikelytobeinfluencedbylackofblinding.Criteriaforthejudgementof‘Unclearrisk’ofbias.Anyoneofthefollowing:.Insufficientinformationtopermitjudgementof‘Lowrisk’or‘Highrisk’;.Thestudydidnotaddressthisoutcome.OMEDATAAttritionbiasduetoamount,natureorhandlingofincompleteoutcomedata.CriteriaforajudgementAnyoneofthefollowing:of‘Lowrisk’ofbias..Nomissingoutcomedata;.Reasonsformissingoutcomedataunlikelytoberelatedtotrueoutcome(forsurvivaldata,censoringunlikelytobeintroducingbias);.Missingoutcomedatabalancedinnumbersacrossinterventiongroups,withsimilarreasonsformissingdataacrossgroups;.Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventrisknotenoughtohaveaclinicallyrelevantimpactontheinterventioneffectestimate;.Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesnotenoughtohaveaclinicallyrelevantimpactonobservedeffectsize;.Missingdatahavebeenimputedusingappropriatemethods.Criteriaforthejudgementof‘Highrisk’ofbias.Anyoneofthefollowing:.Reasonformissingoutcomedatalikelytoberelatedtotrueoutcome,witheitherimbalanceinnumbersorreasonsformissingdataacrossinterventiongroups;.Fordichotomousoutcomedata,theproportionofmissingoutcomescomparedwithobservedeventriskenoughtoinduceclinicallyrelevantbiasininterventioneffectestimate;.Forcontinuousoutcomedata,plausibleeffectsize(differenceinmeansorstandardizeddifferenceinmeans)amongmissingoutcomesenoughtoinduceclinicallyrelevantbiasinobservedeffectsize;.‘As-treated’analysisdonewithsubstantialdepartureoftheinterventionreceivedfromthatassignedatrandomization;.Potentiallyinappropriateapplicationofsimpleimputation.Criteriaforthejudgementof‘Unclearrisk’ofbias.Anyoneofthefollowing:.Insufficientreportingofattrition/exclusionstopermitjudgementof‘Lowrisk’or‘Highrisk’(e.g.numberrandomizednotstated,noreasonsformissingdataprovided);.Thestudydidnotaddressthisoutcome.EPORTINGReportingbiasduetoselectiveoutcomereporting.CriteriaforajudgementAnyofthefollowing:of‘Lowrisk’ofbias..Thestudyprotocolisavailableandallofthestudy’spre-specified(primaryandsecondary)outcomesthatareofinterestinthereviewhavebeenreportedinthepre-specifiedway;.Thestudyprotocolisnotavailablebutitisclearthatthepublishedreportsincludeallexpectedoutcomes,includingCriteriaforthejudgementof‘Highrisk’ofbias.Criteriaforthejudgementof‘Unclearrisk’ofbias.thosethatwerepre-specified(convincingtextofthisnaturemaybeuncommon).Anyoneofthefollowing:.Notallofthestudy’spre-specifiedprimaryoutcomeshavebeenreported;.Oneormoreprimaryoutcomesisreportedusingmeasurements,analysismethodsorsubsetsofthedata(e.g.subscales)thatwerenotpre-specified;.Oneormorereportedprimaryoutcomeswerenotpre-specified(unlessclearjustificationfortheirreportingisprovided,suchasanunexpectedadverseeffect);.Oneormoreoutcomesofinterestinthereviewarereportedincompletelysothattheycannotbeenteredinameta-analysis;.Thestudyreportfailstoincluderesultsforakeyoutcomethatwouldbeexpectedtohavebeenreportedforsuchas