cochrane納入的RCT文獻(xiàn)質(zhì)量評(píng)價(jià)風(fēng)險(xiǎn)偏倚評(píng)估工具中英文對(duì)照版..

1、中文：Table 8.5.a: The Cochrane Collaborations tool for assessing risk of bias 偏倚類型判斷指標(biāo)評(píng)價(jià)員的判斷選擇偏倚 隨機(jī)序列的產(chǎn)生足夠詳細(xì)的描述用于生成分配序列的方法，以評(píng)估產(chǎn)生的分組是否具有可比性。生成隨機(jī)序列不充分，發(fā)生選擇偏倚分配隱藏足夠詳細(xì)的描述隱藏分配序列的方法，以決定干預(yù)的分配在納入之前或納入過程中是否可見分配前分配隱藏不充分發(fā)生選擇偏倚實(shí)施偏倚 實(shí)施者和參與者雙盲 應(yīng)對(duì)每個(gè)主要結(jié)局進(jìn)行評(píng)估（或分類結(jié)局） 如果有，描述對(duì)參與者和實(shí)施者行盲法，避免其了解干預(yù)信息的所有措施。提供任何與所實(shí)施的盲法是否有效地相關(guān)信

2、息。參與者和實(shí)施者了解干預(yù)的相關(guān)信息導(dǎo)致實(shí)施偏倚測(cè)量偏倚 結(jié)局評(píng)估中的盲法 每個(gè)主要結(jié)局均應(yīng)評(píng)估（或分類結(jié)局）如果有，描述對(duì)結(jié)局者行盲法，避免其了解自己所接受的干預(yù)信息的所有措施。提供任何與所實(shí)施的盲法是否有效地相關(guān)信息。結(jié)局評(píng)估者了解分配的干預(yù)措施將導(dǎo)致測(cè)量偏倚失訪偏倚 不全結(jié)局?jǐn)?shù)據(jù)每個(gè)主要結(jié)局均應(yīng)評(píng)估（或分類結(jié)局）描述每個(gè)主要結(jié)局?jǐn)?shù)據(jù)的完整性，包括分析中的自然缺失和排除。這些缺失數(shù)據(jù)是否報(bào)告，在各個(gè)干預(yù)組的數(shù)目（并與總樣本量比較），數(shù)據(jù)缺失以及重新納入分析的原因不全結(jié)局?jǐn)?shù)據(jù)的數(shù)量，性質(zhì)，處理方式導(dǎo)致失訪偏倚發(fā)表偏倚 Selective reporting. 說明如何審查選擇性報(bào)道結(jié)局的可能

3、性，以及審查結(jié)果選擇性報(bào)道結(jié)局導(dǎo)致發(fā)表偏倚其它偏倚 其它偏倚來源說明不包括在上述偏倚中的其它重要偏倚如果特定的問題或條目事先在計(jì)劃書中指出，應(yīng)對(duì)每一項(xiàng)說明不包括在上述各項(xiàng)中的偏倚Table 8.5.d: Criteria for judging risk of bias in the Risk of bias assessment tool 隨機(jī)序列的產(chǎn)生隨機(jī)序列產(chǎn)生不充分導(dǎo)致選擇偏倚判斷為低風(fēng)險(xiǎn)的標(biāo)準(zhǔn)研究者描述隨機(jī)序列產(chǎn)生過程譬如: 參考隨機(jī)數(shù)字表 使用計(jì)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(shí)現(xiàn)無隨機(jī)元素，被認(rèn)為相當(dāng)于是隨機(jī)的。判斷為高風(fēng)險(xiǎn)的標(biāo)準(zhǔn)研究

4、者描述序列的產(chǎn)生使用的是非隨機(jī)的方法。通常是系統(tǒng)的非隨機(jī)方法，例如： 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(hào)或門診號(hào)產(chǎn)生序列 相對(duì)于上面提到的系統(tǒng)方法，其它非隨機(jī)的方法少見的多，也更明顯。通常包括對(duì)參與者進(jìn)行判斷或非隨機(jī)的方法，例如: 臨床醫(yī)生判斷如何分配 參與者判斷如何分配 基于實(shí)驗(yàn)室檢查或系列測(cè)試的結(jié)果分配 基于干預(yù)的可獲取性進(jìn)行分配偏倚風(fēng)險(xiǎn)不清楚的判斷標(biāo)準(zhǔn)沒有足夠的信息判斷隨機(jī)序列的產(chǎn)生存在高風(fēng)險(xiǎn)或低風(fēng)險(xiǎn) 分配隱藏分配前不充足的分配隱藏導(dǎo)致選擇偏倚 低風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)參與者以及納入?yún)⑴c者的研究者因以下掩蓋分配的方法或相當(dāng)?shù)姆椒?，事先不了解分配情況 中心分配（包括電話

5、，網(wǎng)絡(luò)，藥房控制隨機(jī)） 相同外形的順序編號(hào)的藥物容器； 順序編號(hào)、不透明、密封的信封高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)參與者以及納入?yún)⑴c者的研究者可能事先知道分配，因而引入選擇偏倚，譬如基于如下方法的分配: 使用攤開的隨機(jī)分配表（如隨機(jī)序列清單） 分發(fā)信封但沒有合適的安全保障（如透明、非密封、非順序編號(hào)） 交替或循環(huán) 出生日期 病歷號(hào) 其它明確的非隱藏過程風(fēng)險(xiǎn)未知沒有足夠信息判斷為低風(fēng)險(xiǎn)或高風(fēng)險(xiǎn)。通常因分配隱藏的方法未描述或描述不充分。例如描述為使用信封分配，但為描述信封是否透明？密封？順序編號(hào)？ 對(duì)參與者和實(shí)施者的盲法因參與者和實(shí)施者了解干預(yù)情況而導(dǎo)致實(shí)施偏倚 偏倚低風(fēng)險(xiǎn)標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn): 無盲法或盲法不充分，

6、但系統(tǒng)評(píng)價(jià)員判斷結(jié)局不太可能受到缺乏盲法的影響 參與者和主要實(shí)施者均實(shí)施可靠的盲法，且盲法不太可能被打破偏倚高風(fēng)險(xiǎn)標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn): 無盲法或盲法不充分，但系統(tǒng)評(píng)價(jià)員判斷結(jié)局很可能受到缺乏盲法的影響 嘗試對(duì)關(guān)鍵的參與者和實(shí)施者行盲法，但盲法很可能被打破，結(jié)局很可能受到缺乏盲法的影響 風(fēng)險(xiǎn)未知任何如下標(biāo)準(zhǔn): 沒有足夠信息判斷為低風(fēng)險(xiǎn)或高風(fēng)險(xiǎn) 研究未描述此情況 對(duì)結(jié)局評(píng)價(jià)實(shí)施盲法結(jié)局評(píng)價(jià)者了解干預(yù)分配信息將導(dǎo)致測(cè)量偏倚偏倚低風(fēng)險(xiǎn)標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn): 無盲法或盲法不充分，但系統(tǒng)評(píng)價(jià)員判斷結(jié)局不太可能受到缺乏盲法的影響 參與者和主要實(shí)施者均實(shí)施可靠的盲法，且盲法不太可能被打破高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn):

7、 無盲法或盲法不充分，但系統(tǒng)評(píng)價(jià)員判斷結(jié)局很可能受到缺乏盲法的影響 嘗試對(duì)關(guān)鍵的參與者和實(shí)施者行盲法，但盲法很可能被打破，結(jié)局很可能受到缺乏盲法的影響風(fēng)險(xiǎn)未知任何如下標(biāo)準(zhǔn): 沒有足夠信息判斷為低風(fēng)險(xiǎn)或高風(fēng)險(xiǎn) 研究未描述此情況 結(jié)局?jǐn)?shù)據(jù)不完整 不全結(jié)局?jǐn)?shù)據(jù)的數(shù)量，性質(zhì)，處理方式導(dǎo)致失訪偏倚偏倚低風(fēng)險(xiǎn)標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn): 無缺失數(shù)據(jù) 缺失數(shù)據(jù)的產(chǎn)生不大可能與真實(shí)結(jié)局相關(guān)（對(duì)于生存數(shù)據(jù)，刪失不大可能引入偏倚） 缺失數(shù)據(jù)的數(shù)目在各干預(yù)組相當(dāng)，且各組缺失原因類似 對(duì)二分類變量，與觀察事件的發(fā)生風(fēng)險(xiǎn)相比，缺失比例不足以影響預(yù)估的干預(yù)效應(yīng) 對(duì)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(huì)大到

8、影響觀察的效應(yīng)規(guī)模; 缺失的數(shù)據(jù)用合適的方法進(jìn)行估算高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn): 缺失數(shù)據(jù)的產(chǎn)生很大可能與真實(shí)結(jié)局相關(guān), 缺失數(shù)據(jù)的數(shù)目及缺失原因在各干預(yù)組相差較大 對(duì)二分類變量，與觀察事件的發(fā)生風(fēng)險(xiǎn)相比，缺失比例足以影響預(yù)估的干預(yù)效應(yīng) 對(duì)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; 意向治療分析中存在實(shí)際干預(yù)措施與隨機(jī)分配的干預(yù)相違背的情況 對(duì)缺失數(shù)據(jù)進(jìn)行簡(jiǎn)單的不合適的估算 風(fēng)險(xiǎn)未知任何如下標(biāo)準(zhǔn): 沒有報(bào)道缺失或排除的情況，無法判斷高風(fēng)險(xiǎn)或低風(fēng)險(xiǎn)（如未說明隨機(jī)的數(shù)量，未提供數(shù)據(jù)缺失的原因） 研究未描述此情況 選擇性發(fā)表 選擇性發(fā)表導(dǎo)致發(fā)表偏倚 偏倚低風(fēng)

9、險(xiǎn)標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn): 實(shí)驗(yàn)的計(jì)劃書可獲取，系統(tǒng)評(píng)價(jià)感興趣的所有首要或次要結(jié)局均按計(jì)劃書預(yù)先說明的方式報(bào)道 實(shí)驗(yàn)計(jì)劃書不可得，但很明顯發(fā)表的報(bào)告包括所有的結(jié)局，包括預(yù)先說明的結(jié)局（這種性質(zhì)的有說服力的文字可能少見）高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)任何如下標(biāo)準(zhǔn): 不是所有的預(yù)先說明的首要結(jié)局均被報(bào)道 一個(gè)或多個(gè)首要結(jié)局為采用預(yù)先說明的測(cè)量方法、分析方法或數(shù)據(jù)子集來報(bào)道 系統(tǒng)評(píng)價(jià)感興趣的一個(gè)或多個(gè)首要結(jié)局報(bào)道不全，以至于不能納入meta分析 研究未報(bào)道此研究應(yīng)當(dāng)包含的主要關(guān)鍵結(jié)局風(fēng)險(xiǎn)未知沒有足夠信息判斷高風(fēng)險(xiǎn)或低風(fēng)險(xiǎn)，貌似大部分研究會(huì)被分為此類 OTHER BIAS 不包括在以上五種的其它偏倚偏倚低風(fēng)險(xiǎn)標(biāo)準(zhǔn)研究應(yīng)未引

10、入其它來源的偏倚高風(fēng)險(xiǎn)判斷標(biāo)準(zhǔn)至少有一種重要的偏倚風(fēng)險(xiǎn)，例如： 具有與特殊試驗(yàn)設(shè)計(jì)相關(guān)的潛在偏倚來源 或被指欺詐 或其它問題風(fēng)險(xiǎn)未知可能存在偏倚風(fēng)險(xiǎn)，但存在以下兩種中的一種 沒有足夠信息評(píng)估是否存在其它重要的偏倚風(fēng)險(xiǎn) 沒有足夠的證據(jù)認(rèn)為發(fā)現(xiàn)的問題會(huì)引入偏倚Table 8.7.a: Possible approach for summary assessments of the risk of bias for each important outcome (across domains) within and across studies Risk of bias 解釋 對(duì)單個(gè)研究對(duì)多個(gè)研究整

11、體Low risk of bias. 合理的偏倚不太可能嚴(yán)重改變結(jié)果每一類偏倚均為低風(fēng)險(xiǎn) 絕大多數(shù)信息均來自偏倚低風(fēng)險(xiǎn)的研究 Unclear risk of bias. 合理的偏倚會(huì)對(duì)結(jié)果產(chǎn)生一定的懷疑 一類或多類偏倚風(fēng)險(xiǎn)未知 絕大多數(shù)信息均來自偏倚低風(fēng)險(xiǎn)或風(fēng)險(xiǎn)未知的研究High risk of bias. 偏倚嚴(yán)重削弱結(jié)果的可信度一類或多類偏倚為高風(fēng)險(xiǎn)來自高偏倚風(fēng)險(xiǎn)研究的信息比例足以影響結(jié)果的解釋英文：Table 8.5.a: The Cochrane Collaborations tool for assessing risk of biasDomainSupport for judgem

12、entReview authors judgementSelection bias.Random sequence generation.Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.Selection bias (biased allocation to interventions) due to inadequate generatio

13、n of a randomised sequence.Allocation concealment.Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment.Selection bias (biased allocation to interventions) due to ina

14、dequate concealment of allocations prior to assignment.Performance bias.Blinding of participants and personnel Assessments should be made for each main outcome (or class of outcomes).Describe all measures used, if any, to blind study participants and personnel from knowledge of which intervention a

15、participant received. Provide any information relating to whether the intended blinding was effective.Performance bias due to knowledge of the allocated interventions by participants and personnel during the study.Detection bias.Blinding of outcome assessment Assessments should be made for each main

16、 outcome (or class of outcomes).Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.Detection bias due to knowledge of the allocated interventions b

17、y outcome assessors.Attrition bias.Incomplete outcome data Assessments should be made for each main outcome (or class of outcomes).Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were report

18、ed, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.Attrition bias due to amount, nature or handling of incomplete outcome data.Reporting bias.Sele

19、ctive reporting.State how the possibility of selective outcome reporting was examined by the review authors, and what was found.Reporting bias due to selective outcome reporting.Other bias.Other sources of bias.State any important concerns about bias not addressed in the other domains in the tool.If

20、 particular questions/entries were pre-specified in the reviews protocol, responses should be provided for each question/entry.Bias due to problems not covered elsewhere in the table.Table 8.5.d: Criteria for judging risk of bias in the Risk of bias assessment toolRANDOM SEQUENCE GENERATION Selectio

21、n bias (biased allocation to interventions) due to inadequate generation of a randomised sequence.Criteria for a judgement of Low risk of bias.The investigators describe a random component in the sequence generation process such as: Referring to a random number table; Using a computer random number

22、generator; Coin tossing; Shuffling cards or envelopes; Throwing dice; Drawing of lots; Minimization*.*Minimization may be implemented without a random element, and this is considered to be equivalent to being random.Criteria for the judgement of High risk of bias.The investigators describe a non-ran

23、dom component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example: Sequence generated by odd or even date of birth; Sequence generated by some rule based on date (or day) of admission; Sequence generated by some rule based on h

24、ospital or clinic record number.Other non-random approaches happen much less frequently than the systematic approaches mentioned above and tend to be obvious.They usually involve judgement or some method of non-random categorization of participants, for example: Allocation by judgement of the clinic

25、ian; Allocation by preference of the participant; Allocation based on the results of a laboratory test or a series of tests; Allocation by availability of the intervention.Criteria for the judgement of Unclear risk of bias.Insufficient information about the sequence generation process to permit judg

26、ement of Low risk or High risk.ALLOCATION CONCEALMENTSelection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment.Criteria for a judgement of Low risk of bias.Participants and investigators enrolling participants could not foresee assignment be

27、cause one of the following, or an equivalent method, was used to conceal allocation: Central allocation (including telephone, web-based and pharmacy-controlled randomization); Sequentially numbered drug containers of identical appearance; Sequentially numbered, opaque, sealed envelopes.Criteria for

28、the judgement of High risk of bias.Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: Using an open random allocation schedule (e.g. a list of random numbers); Assignment envelopes were used without

29、appropriate safeguards (e.g. if envelopes were unsealed or nonopaque or not sequentially numbered); Alternation or rotation; Date of birth; Case record number; Any other explicitly unconcealed procedure.Criteria for the judgement of Unclear risk of bias.Insufficient information to permit judgement o

30、f Low risk or High risk. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque

31、 and sealed.BLINDING OF PARTICIPANTS AND PERSONNELPerformance bias due to knowledge of the allocated interventions by participants and personnel during the study.Criteria for a judgement of Low risk of bias.Any one of the following: No blinding or incomplete blinding, but the review authors judge th

32、at the outcome is not likely to be influenced by lack of blinding; Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.Criteria for the judgement of High risk of bias.Any one of the following: No blinding or incomplete blinding, and the out

33、come is likely to be influenced by lack of blinding; Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding.Criteria for the judgement of Unclear risk of bias.Any one of the follo

34、wing: Insufficient information to permit judgement of Low risk or High risk; The study did not address this outcome.BLINDING OF OUTCOME ASSESSMENTDetection bias due to knowledge of the allocated interventions by outcome assessors.Criteria for a judgement of Low risk of bias.Any one of the following:

35、 No blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding; Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.Criteria for the judgement of High risk of bias.Any one of t

36、he following: No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; Blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding.Criteria for th

37、e judgement of Unclear risk of bias.Any one of the following: Insufficient information to permit judgement of Low risk or High risk; The study did not address this outcome.INCOMPLETE OUTCOME DATAAttrition bias due to amount, nature or handling of incomplete outcome data.Criteria for a judgement of L

38、ow risk of bias.Any one of the following: No missing outcome data; Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias); Missing outcome data balanced in numbers across intervention groups, with similar reasons for mis

39、sing data across groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; For continuous outcome data, plausible effect size (difference in means or standardized dif

40、ference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; Missing data have been imputed using appropriate methods.Criteria for the judgement of High risk of bias.Any one of the following: Reason for missing outcome data likely to be related to

41、 true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; For continuous outcome

42、 data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size; As-treated analysis done with substantial departure of the intervention received from that assigned at randomization; Poten

43、tially inappropriate application of simple imputation.Criteria for the judgement of Unclear risk of bias.Any one of the following: Insufficient reporting of attrition/exclusions to permit judgement of Low risk or High risk (e.g. number randomized not stated, no reasons for missing data provided); Th

44、e study did not address this outcome.SELECTIVE REPORTINGReporting bias due to selective outcome reporting.Criteria for a judgement of Low risk of bias.Any of the following: The study protocol is available and all of the studys pre-specified (primary and secondary) outcomes that are of interest in th

45、e review have been reported in the pre-specified way; The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specified (convincing text of this nature may be uncommon).Criteria for the judgement of High risk of bias

46、.Any one of the following: Not all of the studys pre-specified primary outcomes have been reported; One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified; One or more reported primary outcomes were not pre-sp

47、ecified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis; The study report fails to include results for a key outcome that would be expected to have been reported for such a study.Criteria for the judgement of Unclear risk of bias.Insufficient information to permit judgement o