cochre纳入的RCT文献质量评价英文原版

1、cochre 纳入的 RCT 文献 质量评价英文原版 oP Prcparedrcpared onon 2222 NovemberNovember 20202020DomainDomainSupportSupport forfor judgementjudgementReviewReview authorsauthors judgementjudgementSelection bias.Random sequencegeneration*Describe the method used to generatethe allocation sequence in sufficientdetail

2、to allow an assessment ofwhether it should produce comparablegroups.Selection bias (biasedallocation tointerventions) due toinadequate generation of arandomised sequence.Allocationconcealment.Describe the method used to concealthe allocation sequence in sufficientdetail to determine whetherintervent

3、ion allocations could havebeen foreseen in advance of, or during,enrolment.Selection bias (biasedallocation tointerventions) due toinadequate concealment ofallocations prior toassignment.Performance bias.Blinding ofparticipants andpersonnelAssessments shouldbe made for each mainoutcome (or class ofo

4、utcomes) Describe all measures used, if any, toblind study participants and personnelfrom knowledge of which intervention aparticipant received. Provide anyinformation relating to whether theintended blinding was effective.Performance bias due toknowledge of the allocatedinterventions byparticipants

5、 and personnelduring the study.Detection bias.Blinding of outcomeassessmentAssessments shouldbe made for each mainoutcome (or class ofoutcomes).Describe all measures used, if any, toblind outcome assessors from knowledgeof which intervention a participantreceived. Provide any informationrelating to

6、whether the intendedblinding was effective.Detection bias due toknowledge of the allocatedinterventions by outcomeassessors.Attrition bias.Incomplete outcomedataAssessmentsshould be made foreach main outcome(or class ofDescribe the completeness of outcomedata for each main outcome, includingattritio

7、n and exclusions from theanalysis. State whether attrition andexclusions were reported, the numbersin each interventionAttrition bias due toamount, nature or handlingof incomplete outcome data.outcomes).group (compared with total randomizedparticipants) reasons forattrition/exclusions where reported

8、,and any reinclusions in analysesperformed by the review authors.Reporting bias.SelectiveSelectivereporting.reporting.State how the possibility of selectiveoutcome reporting was examined by thereview authors, and what was found.Reporting bias due toselective outcomereporting.Other bias.OtherOther so

9、urcessources ofofbias.bias.State any important concerns aboutbias not addressed in the otherdomains in the tool.If particular questions/entries werepre-specified in the review* sprotocol, responses should beprovided for each question/entry.Bias due to problems notcovered elsewhere in thetable.RANDOM

10、RANDOM SEQUENCESEQUENCE GENERATIONGENERATIONSelectionSelection biasbias (biased(biased allocationallocation toto interventions)interventions) duedue toto inadequateinadequate generationgeneration ofofa a randomisedrandomised sequence.sequence.Criteria for ajudgement ofLow risk of bias.The investigat

11、ors describe a random component in the sequencegeneration process such as:Referring to a random number table;Using a computer random number generator;Coin tossing;Shuffling cards or envelopes;Throwing dice;Drawing of lots;Minimization*.Minimization may be implemented without a random element, andthi

12、s is considered to be equivalent to being random.Criteria for thejudgement ofHigh risk* ofbias.The investigators describe a non-random component in the sequencegeneration process. Usually, the description would involve somesystematic, non-random approach, for example: Sequence generated by odd or ev

13、en date of birth;Sequence generated by some rule based on date (or day) ofadmission;Sequence generated by some rule based on hospital or clinicrecord number.Other non-random approaches happen much less frequently than thesystematic approaches mentioned above and tend to be obvious. Theyusually invol

14、ve judgement or some method of non-randomcategorization of participants, for example:Allocation by judgement of the clinician;Allocation by preference of the participant;Allocation based on the results of a laboratory test or aseries of tests;Allocation by availability of the intervention.Insufficie

15、nt information about the sequence generation processto permit judgement of Low risk or High risk一 二 ALLOCATIONALLOCATION CONCEALMENTCONCEALMENTSelection bias (biased allocation to interventions) due toinadequate concealment of allocations prior to assignment.Participants and investigators enrolling

16、participants could not foresee assignmentbecause one of the following, or an equivalent method, was used toconceal allocation:Central allocation (including telephone, web-based andpharmacy-controlled randomization);Sequentially numbered drug containers of identicalappearance;Sequentially numbered, o

17、paque, sealed envelopes.Participants or investigators enrolling participants couldpossibly foresee assignments and thus introduce selection bias,such as allocation based on:Using an open random allocation schedule a list of randomnumbers);二 Assignment envelopes were used without appropriatesafeguard

18、s if envelopes were unsealed or nonopaque or notsequentially numbered);Criteria for thejudgement ofUnclear risk*of bias.Criteria for ajudgement ofLowriskofbias.Criteria for thejudgement ofHigh risk* ofbias.Alternation or rotation;Date of birth;Case record number;Any other explicitly unconcealed proc

19、edure.Criteria for thejudgement ofUnclear risk* ofbias.Insufficient information to permit judgement of Low risk orHigh risk This is usually the case if the method of concealmentis not described or not described in sufficient detail to allowa definite judgement - for example if the use of assignmente

20、nvelopes is described, but it remains unclear whether envelopeswere sequentially numbered, opaque and sealed.BLINDINGBLINDING OFOF PARTICIPANTSPARTICIPANTS ANDAND PERSONNELPERSONNELPerformance bias due to knowledge of the allocated interventions by participants andpersonnel during the study.Criteria

21、 for ajudgement of Lowrisk of bias.Any one of the following:No blinding or incomplete blinding, but the review authorsjudge that the outcome is not likely to be influenced bylack of blinding;Blinding of participants and key study personnel ensured,and unlikely that the blinding could have been broke

22、n.Criteria for thejudgement ofHigh risk* ofbias.Any one of the following:No blinding or incomplete blinding, and the outcome islikely to be influenced by lack of blinding;Blinding of key study participants and personnelattempted, but likely that the blinding could have beenbroken, and the outcome is

23、 likely to be influenced by lackof blinding.Criteria for thejudgement ofUnclear risk* ofbias.Any one of the following:Insufficient information to permit judgement ofLow risk or High risk* ;The study did not address this outcome.BLINDINGBLINDING OFOF OUTCOMEOUTCOME ASSESSMENTASSESSMENTDetection bias

24、due to knowledge of the allocated interventions by outcome assessors.Any one of the following:No blinding of outcome assessment, but the review authorsjudge that the outcome measurement is not likely to beinfluenced by lack of blinding;Blinding of outcome assessment ensured, and unlikely thatthe bli

25、nding could have been broken.Any one of the following:No blinding of outcome assessment, and the outcomemeasurement is likely to be influenced by lack ofblinding;Blinding of outcome assessment, but likely that theblinding could have been broken, and the outcomemeasurement is likely to be influenced

26、by lack ofblinding.Any one of the following:Insufficient information to permit judgement ofLow risk三 四 or High risk* ;Any one of the following:No missing outcome data;Reasons for missing outcome data unlikely to be relatedto true outcome (for survival data, censoring unlikely tobe introducing bias);

27、Missing outcome data balanced in numbers acrossintervention groups, with similar reasons for missingdata across groups;For dichotomous outcome data, the proportion of missingoutcomes compared with observed event risk not enough tohave a clinically relevant impact on the interventioneffect estimate;四

28、 For continuous outcome data, plausible effect size(difference in means or standardized difference in means)among missing outcomes not enough to have a clinicallyrelevant impact on observed effect size;Missing data have been imputed using appropriateThe study protocol is available and all of the stu

29、dy* spre-specified (primary and secondary) outcomes that areof interest in the review have been reported in thepre-specified way;Criteria for ajudgement of Lowrisk of bias.Criteria for thejudgement ofHigh risk* ofbias.Criteria for thejudgement of*Unclear riskof bias.The study did not address this ou

30、tcome.INCOMPLETEINCOMPLETE OUTCOMEOUTCOME DATADATAAttrition bias due to amount, nature or handling of incomplete outcome data.Criteria for ajudgement ofLowriskofbias.Any one of the following:Reason for missing outcome data likely to be related totrue outcome, with either imbalance in numbers or reas

31、onsfor missing data across intervention groups;For dichotomous outcome data, the proportion of missingoutcomes compared with observed event risk enough toinduce clinically relevant bias in intervention effectestimate;For continuous outcome data, plausible effect size(difference in means or standardi

32、zed difference in means)among missing outcomes enough to induce clinicallyrelevant bias in observed effect size;五As-treated* analysis done with substantial departureof the intervention received from that assigned atrandomization;Potentially inappropriate application of simpleimputation.Any one of th

33、e following:Insufficient reporting of attrition/exclusions to permitjudgement of Low risk or High risk* number randomizednot stated, no reasons for missing data provided);The study did not address this outcome.There may be a risk of bias, but there is either:Insufficient information to assesswhether

34、 an important risk of bias exists;orInsufficient rationale or evidence thatan identified problem will introducebias.methods.Criteria for thejudgement ofHigh risk* ofbias.Criteria for thejudgement of*Unclear riskof bias.SELECTIVESELECTIVE REPORTINGREPORTINGReporting bias due to selective outcome repo

35、rting.Criteria for ajudgement ofLowriskofbias.Any of the following:Any one of the following:Not all of the study* s pre-specified primary outcomes havebeen reported;One or more primary outcomes is reported usingmeasurements, analysis methods or subsets of the data subscales) that were not pre-specif

36、ied;One or more reported primary outcomes were notprespecified (unless clear justification for theirreporting is provided, such as an unexpected adverseeffect);One or more outcomes of interest in the review are reportedincompletely so that they cannot be entered in ameta-analysis;The study report fa

37、ils to include results for a key outcomethat would be expected to have been reported for such astudy.Insufficient information to permit judgement of Low risk or Highrisk* It is likely that the majority of studies will fall intothis category.Bias due to problems not covered elsewhere in the table.The

38、 study appears to be free of other sources of bias.There is at least one important risk of bias. For example, thestudy:Had a potential source of bias related to the specificstudy design used; orHas been claimed to have been fraudulent; orHad some other problem.Criteria for thejudgement ofHigh risk*

39、ofbias.Criteria for thejudgement ofUnclear risk*of bias.OTHEROTHER BIASBIASCriteria for ajudgement of Lowrisk* of bias._Criteria for thejudgement of Highrisk* of bias.Criteria for thejudgement ofUnclear risk* ofbias.summary assessmentsof the risk of bias for each important outcome (across domains)wi

40、thin and across studiesRiskRisk ofof biasbiasInterpretationInterpretationWithinWithin a a studystudyAcrossAcross studiesstudiesLow risk of bias. Plausible biasunlikely toseriously alterthe results.Low risk of bias forall key domains.Most information isfrom studies at lowrisk of bias.Unclear risk ofb

41、ias.Plausible biasthat raises somedoubt about theresults.Unclear risk ofbias for one or morekey domains.Most information isfrom studies at lowor unclear risk ofbias.High risk of bias. Plausible biasthat seriouslyweakensconfidence in theresults.High risk of biasfor one or more keydomains.The proporti

42、on ofinformation fromstudies at high riskof bias is sufficientto affect theinterpretation ofresults.EntryEntryJudgementJudgementSupportSupport forfor judgementjudgementRandom sequencegeneration (selectionbias)Low risk.Quote: patients were randomlyallocated. ”Comment: Probably done, since earlierreports from the same investigators clearlydescribe use of random sequences(Cartwright 1980)Allocation concealment(selection bias)High risk.Quote: using a table of random numbers.Comment: Probably no