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

1、中文：Table The Cochrane Collaboration s tool for assessing risk of bias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臧不充分 发生选择偏倚实施偏倚头施者和参与者 双盲应对每个主 要结局进行评估（或分类结局）如果有，描述对参与者和头施者仃 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

2、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Selective report ing.

3、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20Table Criteria for judgi ng risk of bias in the Risk of bias assessme nt tool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：*参考随机数字表使用计算机随机数字生成器扔硬币*洗牌的卡片和信圭寸掷骰子* 抽签最小化*最小化，可实现无随机元素，被认为相当于是随

4、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：通过奇偶或出生日期产生序列通过入院日期产生序列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：临床医生判断如何分配参与者判断如何分配基于实验室检查或系列测试的结果分配*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

5、况中心分配（包括电话，网络，药房控制随机）相同外形的顺序编号的药物容器；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：使用摊开的随机分配表（如随机序列清单）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）交替或循环*出生日期病历号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：* 无盲法或

6、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咼风险标准任何如下标准：*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：没有足够信息判断为低风险或高风险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：* 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

7、何如下标准：*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：没有足够信息判断为低风险或高风险*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：无缺失数据*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）缺失数据的数目在各干预组相当，且各组缺失原 因类似对二分类变量，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）

8、不会大到影响观察的效应规 模；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：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； 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：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）*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

9、险标准任何如下标准：*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：不是所有的预先说明的首要结局均被报道 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OTHER BIAS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

10、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：具有与特殊试验设计相关的潜在偏倚来源或被指欺诈或其它问题风险未知可能存在偏倚风险，但存在以卜两种中的一种没有足够信息评估是否存在其它重要的偏倚风险没有足够的证据认为发现的问题会引入偏倚Table Possible approach for summaryassessments of the risk of bias for each importa nt outcome (across doma ins) withi n and across studiesRisk of bias解释对单个研究对多个研究整体Low risk of

11、bias.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Un clear risk of bias.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High risk of bias.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:Table The Cochrane Collaboration s tool for assessing risk of biasDomai nSupport for judgeme ntReview

12、 authors judgementSelecti on bias.Random sequenee gen erati on.Describe the method used to gen erate the allocati on seque nee in sufficie nt detail to allow an assessme nt of whether t should produce comparable groups.Selecti on bias (biased allocati on to in terve nti ons) due to in adequate gen e

13、rati on of a ran domised seque nee.Allocati on con cealme nt.Describe the method used to con ceal the allocati on seque nee in sufficie nt detail to determ ine whether in terve nti on allocati ons could have bee n foresee n in adva nee of, or duri ng, en rolme nt.Selecti on bias (biased allocati on

14、to in terve nti ons) due to in adequate eon cealme nt of allocati ons prior to assig nment.Performa nee bias.Bli nding of participa nts and pers onnel Assessme nts should be made for each main outcome (or class of outcomes).Describe all measures used, if any, to bli nd study participa nts and pers o

15、nnel from kno wledge of which in terve nti on a participa nt received. Provide any nformation relating to whether the nten ded bli nding was effective.Performa nee bias due to kno wledge of the allocated in terve nti ons by participa nts and pers onnel duri ng the study.Detecti on bias.Bli nding of

16、outcome assessme nt Assessme nts should be made for eachDescribe all measures used, if any, to bli nd outcome assessors from kno wledge of which in terve nti on a participa nt received. Provide anyDetecti on bias due to kno wledge of the allocated in terve nti ons by outcomemain outcome (or class of

17、 outcomes).nformation relating to whether the nten ded bli nding was effective.assessors.Attrition bias.n complete outcome data Assessments should be made for each main outcome (or class of outcomes).Describe the complete ness of outcome data for each main outcome, including attriti on and exclusi o

18、ns from the an alysis. State whether attriti on and exclusi ons were reported, the n umbers n each in terve nti on group (compared with total ran domized participa nts), ”eas ons for attriti on /exclusi ons where reported, and any re-i nclusi ons in an alyses performed by the review authors.Attritio

19、n bias due to amount, n ature or han dli ng of in complete outcome data.Reporting bias.Selective report ing.State how the possibility of selective outcome report ing was exam ined by the review authors, and what was found.Report ing bias due to selective outcome report ing.Other bias.Other sources o

20、f bias.Bias due to problems not covered elsewhere in the table.Risk of bias assessme nt toolState any importa nt concerns about bias not addressed in the other doma ins in:he tool.If particular questi on s/e ntries werepre- specified in the review s protoco esp on ses should be provided for each que

21、sti on/en try.Table Criteria for judgi ng risk of bias in theRANDOM SEQUENCE GENERATIONSelecti on bias (biased allocati on to in terve nti ons) due to in adequate gen erati on of a an domised seque nee.Criteria for a judgeme nt of Low risk of bias.The in vestigators describe a ran dom comp onent in

22、the seque nee gen erati on process such as:* Referri ng to a ran dom n umber table;* Using a computer ran dom n umber gen erator; Coi n toss ing; Shuffli ng cards or en velopes; Throw ing dice; Drawi ng of lots; Mini mizatio n*Mi ni mizatio n may be impleme nted without a ran dom eleme nt, and this

23、is con sidered to be equivale nt to being ran dom.Criteria for the udgement of High riskof bias.The in vestigators describe a non-ran dom comp onent in the seque nee gerierati on process. Usually, the descripti on would in volve some systematic, non-ra ndom approach, for example:* Seque nee gen erat

24、ed by odd or eve n date of birth;* Seque nee gen erated by some rule based on date (or day) of admissi on;* Seque nee gen erated by some rule based on hospital or cli nic record n umber.Other non-ran dom approaches happe n much less freque ntly tha n the systematic approaches men ti oned above and t

25、end to be obvious. They usually in volve judgeme nt or some method of non-random categorization of participants, for example:* Allocati on by judgeme nt of the cli nicia n;* Allocati on by prefere nee of the participa nt;* Allocati on based on the results of a laboratory test or a series of tests;*

26、Allocati on by availability of the in terve nti on.Criteria for theudgeme nt of Un clearisk of bias.n sufficie nt in formati on about the seque nee gen erati on process to permit judgement of Low risk or High risk .ALLOCATION CONCEALMENTSelecti on bias (biased allocati on to in terve nti ons) due to

27、 in adequate con cealme nt of allocati ons prior to assig nment.Criteria for a judgeme nt of Low risk of bias.Participa nts and in vestigators en rolli ng participa nts could not foresee assig nment because one of the follow ing, or an equivale nt method, was used to eon ceal allocati on:*Cen tral a

28、llocati on (in clud ing teleph one, web-based andpharmacy-c on trolled ran domizati on); Seque ntially n umbered drug containers of ide nticalappeara nee; Seque ntially n umbered, opaque, sealed en velopes.Criteria for theudgement of High riskof bias.Participants or investigators enrolling participa

29、nts could possibly foresee assig nments and thus in troduce selecti on bias, such as allocati on based on: Using an ope n ran dom allocati on schedule (e.g. a list of ran dom n umbers);* Assig nment en velopes were used without appropriate safeguards (e.g. if en velopes were un sealed or nono paque

30、or not seque ntially n umbered); Alter nati on or rotati on; Date of birth;* Case record n umber;* Any other explicitly uncon cealed procedure.Criteria for theudgeme nt of Un clearisk of bias.nsufficient information to permit judgement of Low risk crThis is usually the case if the method of concealm

31、ent is not described or not described in sufficie nt detail to allow a defi nite judgeme nt-forexample if the use of assignment envelopes is described, but itemai ns un clear whether en velopes were seque ntially n umbered, opaque and sealed.BLINDING OF PARTICIPANTS AND PERSONNELPerforma nee bias du

32、e to kno wledge of the allocated in terve nti ons by participa nts and pers onnel duri ng the study.Criteria for a judgeme nt of Low risk of bias.Any one of the following:* No bli nding or in complete bli nding, but the review authors judge that the outcome is not likely to be in flue need by lack o

33、f bli nding;* Bli nding of participa nts and key study pers onnel en sured, and un likely that the bli nding could have bee n broke n.Criteria for theudgement of High riskof bias.Any one of the following:* No bli ndi ng or in complete bli nding, and the outcome is likely to be in flue need by lack o

34、f bli nding;* Bli nding of key study participa nts and pers onnel attempted, but likely that the bli nding could have bee n broke n, and theHigh riskoutcome is likely to be in flue need by lack of bli nding.Criteria for the udgeme nt of risk of bias.Un clearAny one of the following:In sufficie nt in

35、 formati on to permit judgeme nt ofHigh risk ；w riskor The study did not address this outcome.BLINDING OF OUTCOME ASSESSMENTDetection bias due to kno wledge of the allocated in terve nti ons by outcome assessors.Criteria for a judgeme nt of Low risk of bias.Any one of the following:No bli nding of o

36、utcome assessme nt, but the review authors judge that the outcome measureme nt is not likely to be in flue need by lack of bli nding;Bli nding of outcome assessme nt en sured, and un likely that the bli nding could have bee n broke n.Criteria for theAny one of the following:udgement of High riskof b

37、ias.No bli nding of outcome assessme nt, and the outcome measureme nt is likely to be in flue need by lack of bli nding;Bli nding of outcome assessme nt, but likely that the bli nding could have bee n broke n, and the outcome measureme nt islikely to be in flue need by lack of bli nding.Criteria for

38、 theAny one of the following:udgeme nt of Un clearrisk of bias.In sufficie nt in formati on to permit judgeme nt of High risk ；w riskor* The study did not address this outcome.NCOMPLETE OUTCOME DATAAttrition bias due to amou nt, n ature or han dli ng of in complete outcome data.Criteria for a judgem

39、e ntAny one of the following:of Low risk of bias.* No miss ing outcome data;*Reas ons for miss ing outcome data un likely to be related totrue outcome (for survival data, censoring unlikely to be in troduc ing bias);* Miss ing outcome data bala need in n umbers across in terve nti on groups, with si

40、milar reas ons for miss ing data across groups; For dichotomous outcome data, the proporti on of miss ing outcomes compared with observed eve nt risk not en ough to have a cli ni cally releva nt impact on the in terve nti on effect estimate;For contin uous outcome data, plausible effect size (differ

41、e neein means or sta ndardized differe nee in means) among miss ing outcomes not eno ugh to have a cli ni cally releva nt impact on observed effect size;Miss ing data have bee n imputed using appropriate methods.Criteria for the udgeme nt of of bias.Any one of the following:High riskReas on for miss

42、 ing outcome data likely to be related to trueoutcome, with either imbalance in numbers or reasons formiss ing data across in terve nti on groups;* For dichotomous outcome data, the proporti on of miss ing outcomes compared with observed eve nt risk eno ugh to in duce cli ni cally releva nt bias in

43、in terve nti on effect estimate;* For contin uous outcome data, plausible effect size (differe nce in means or sta ndardized differe nce in means) amongmissi ng outcomes en ough to in duce cli ni cally releva nt bias in observed effect size;* A-sreated analysis done with substantial departure of the

44、 in terve nti on received from that assig ned at ran domizati on;Criteria for the udgeme nt of risk of bias.* Pote ntially in appropriate applicati on of simple imputati on.Any one of the following:* Insufficient reporting of attrition/exclusions to permitjudgement of Low risk or High risk (e.g. num

45、ber ranot stated, no reas ons for miss ing data provided);ndomized The study did not address this outcome.SELECTIVE REPORTINGReporting bias due to selective outcome report ing.Criteria for a judgeme nt of Low risk of bias.Any of the followi ng:* The study protocol is available and all o f the study

46、pre-specified (primary and sec on dary) outcomes that are ofin terest in the review have bee n reported in the pre-specifiedway;* The study protocol is not available but it is clear that the published reports in clude all expected outcomes, in clud ingthose that were pre-specified (convincing text o

47、f this n ature may be un com mon).Criteria for theudgement of High riskof bias.Any one of the following: Not all of the study-spepifed primary outcomes havebee n reported; One or more primary outcomes is reported using measureme nts, an alysis methods or subsets of the data (e.g. subscales) that wer

48、e not pre-specified; One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an un expected adverse effect); One or more outcomes of in terest in the review are reported in completely so that they cannot be en tered in ameta-a nalysis; The study report fails to in clude results for a key outcome that would be expected to have bee n reported for such a study.Criteria for theudgeme nt of Un clearisk of bias.nsufficient information to permit jud