2022年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講課講稿

1、中文： Table 8.5.a: The Cochrane Collaboration s tool for assessing risk of bias 偏倚類型 判定指標 評判員的判定 選擇偏倚 隨機序列的產生 足夠詳細的描述用于生成支配序 生成隨機序列不充分, 列的方法,以評估產生的分組是否 具有可比性； 足夠詳細的描述隱發(fā)生選擇偏倚 支配隱匿 匿支配序列的 方法,以準備干預支配前支配隱匿不充分 實施偏倚 的支配在納入之 前或納入過程中是 發(fā)生選擇偏倚 否可見 實施者和參與者 假如有,描述對參與者和實施者行 參與者和實施者明白干 雙盲 應對每個主 盲法,防止其明白干預信息的全部 預的相關

2、信息導致實施 措施；供應任何與所實施的盲法是 偏倚 要結局進行評估 （或分類結局） 否有效地相關信息； 測量偏倚 結局評估中的盲 假如有, 描述對結局者行盲法, 避 結局評估者明白支配的 法 每個主要結局 免其明白自己所接受的干預信息 干預措施將導致測量偏 的全部措施； 供應任何與所實施的 倚 均應評估（或分類 盲法是否有效地相關信息； 結局） 失訪偏倚 不全結局數(shù)據(jù) 每 描述每個主要結局數(shù)據(jù)的完整性, 不全結局數(shù)據(jù)的數(shù)量, 個主要結局均應 包括分析中的自然缺失和排除； 這 性質,處理方式導致失 評估（或分類結 訪偏倚 些缺失數(shù)據(jù)是否報告, 在各個干預 局） 組的數(shù)目（并與總樣本量比較）, 數(shù)

3、據(jù)缺失以及重新納入分析的原 因 發(fā)表偏倚 Selective說明如何審查選擇性報道結局的 選擇性報道結局導致發(fā) reporting.其可能性,以及審查結果 表偏倚 它偏倚 其它偏倚來源 說明不包括在上述偏倚中的其它 不包括在上述各項中的 重要偏倚 偏倚 假如特定的問題或條目事先在計 劃書中指出,應對每一項說明 第 1 頁,共 14 頁Table 8.5.d: Criteria for judging risk of bias in the Risk of bias assessment tool 隨機序列的產生 隨機序列產生不充分導致選擇偏倚 判定為低風險的標準 爭論者描述隨機序列產生過程譬如

4、 : . 參考隨機數(shù)字表 . 使用運算機隨機數(shù)字生成器 . 扔硬幣 . 洗牌的卡片 和信封 . 擲骰子 . 抽簽 . 最小化 * 最小化,可實現(xiàn)無隨機元素, 被認為相當于是隨機的； 判定為高風險的標準 爭論者描述序列的產生使用的是非隨機的方法；通常是 系統(tǒng)的非隨機方法,例如： . 通過奇偶或產生日期產生序列 . 通過入院日期產生序列 . 通過類似住院號或門診號產生序列 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定或非隨機的 方法,例如 : . 臨床醫(yī)生判定如何支配 . 參與者判定如何支配 . 基于試驗室檢查或系列測試的結果支配 . 基于干預的可獵取性

5、進行支配 偏倚風險不清楚的判 沒有足夠的信息判定隨機序列的產生存在高風險或低風 斷標準 險 支配隱匿 支配前不充分的支配隱匿導致選擇偏倚 第 2 頁,共 14 頁低風險判定標準 參與者以及納入?yún)⑴c者的爭論者因以下掩蓋支配的方法 或相當?shù)姆椒?事先不明白支配情形 . 中心支配（包括電話,網(wǎng)絡,藥房把握隨機） . 相同外形的次序編號的藥物容器； . 次序編號,不透亮,密封的信封 高風險判定標準 參與者以及納入?yún)⑴c者的爭論者可能事先知道支配,因 而引入選擇偏倚,譬如基于如下方法的支配 : . 使用攤開的隨機支配表（如隨機序列清單） . 分發(fā)信封但沒有合適的安全保證（如透亮,非密 封,非次序編號） .

6、 交替或循環(huán) . 產生日期 . 病歷號 . 其它明確的非隱匿過程 風險未知 沒有足夠信息判定為低風險或高風險；通常因支配隱匿 的方法未描述或描述不充分； 例如描述為使用信封支配, 但為描述信封是否透亮？密封？次序編號？ 對參與者和實施者的盲法 因參與者和實施者明白干預情形而導致實施偏倚 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)評判員判定結局不 太可能受到缺乏盲法的影響 . 參與者和主要實施者均實施牢靠的盲法,且盲法 不太可能被打破 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)評判員判定結局很 可能受到缺乏盲法的影響 . 嘗試對關鍵的參與者和實施者行盲

7、法,但盲法很 可能被打破,結局很可能受到缺乏盲法的影響 風險未知 任何如下標準 : . 沒有足夠信息判定為低風險或高風險 第 3 頁,共 14 頁. 爭論未描述此情形 對結局評判實施盲法 結局評判者明白干預支配信息將導致測量偏倚 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)評判員判定結局不 太可能受到缺乏盲法的影響 . 參與者和主要實施者均實施牢靠的盲法,且盲法 不太可能被打破 高風險判定標準 任何如下標準 : . 無盲法或盲法不充分,但系統(tǒng)評判員判定結局很 可能受到缺乏盲法的影響 嘗試對關鍵的參與者. 和實施者行盲法,但盲法很 可能被打破,結局很可能受到缺乏盲法的影響 風

8、險未知 任何如下標準 : . 沒有足夠信息判定為低風險或高風險 . 爭論未描述此情形 結局數(shù)據(jù)不完整 不全結局數(shù)據(jù)的數(shù)量,性質,處理方式導致失訪偏倚 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)的產生不大可能與真實結局相關（對于 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. 在各干預組相當,且各組缺失原 因類似 對二分類變量,與觀看大事的發(fā)生風險相比,缺 失比例不足. 以影響預估的干預效應 對連續(xù)性結局數(shù)據(jù), 缺失數(shù)據(jù)的合理效應規(guī)模 （均 數(shù)差或標準均數(shù)差）不. 會大到影響觀看的效應規(guī) 模; 第 4 頁,共 14 頁高風險判定標準 . 缺失的數(shù)據(jù)用合適的方法進行估算 缺

9、失 任何如下標準 : .缺失數(shù)據(jù)的產生很大可能與真實結局相關 , 數(shù)據(jù)的數(shù)目及缺失緣由在各干預組相差較大 . 對二分類變量,與觀看大事的發(fā)生風險相比,缺 失比例足以影響預估的干預效應 . 對連續(xù)性結局數(shù)據(jù), 缺失數(shù)據(jù)的合理效應規(guī)模 （均 數(shù)差或標準均數(shù)差）足以影響觀看的效應規(guī)模 ; . 意向治療分析中存在實際干預措施與隨機支配 的干預相違反的情形 對缺失數(shù)據(jù)進行簡潔的不. 合適的估算 風險未知 任何如下標準 : . 沒有報道缺失或排除的情形,無法判定高風險或 低風險（如未說明隨機的數(shù)量,未供應數(shù)據(jù)缺失 的緣由） . 爭論未描述此情形 選擇性發(fā)表 選擇性發(fā)表導致發(fā)表偏倚 偏倚低風險標準 任何如下

10、標準 : . 試驗的方案書可獵取,系統(tǒng)評判感愛好的全部首 要或次要結局均按方案書預先說明的方式報道 . 試驗方案書不行得,但很明顯發(fā)表的報告包括所 有的結局,包括預先說明的結局（這種性質的有 說服力的文字可能少見） 高風險判定標準 任何如下標準 : . 不是全部的預先說明的首要結局均被報道 . 一個或多個首要結局為接受預先說明的測量方 法,分析方法或數(shù)據(jù)子集來報道 . 系統(tǒng)評判感愛好的一個或多個首要結局報道不 全,以至于不能納入 meta 分析 . 爭論未報道此爭論應當包含的主要關鍵結局 風險未知 沒有足夠信息判定高風險或低風險,貌似大部分爭論會 第 5 頁,共 14 頁被分為此類 OTHER

11、 BIAS 不包括在以上五種的其它偏倚 偏倚低風險標準 爭論應未引入其它來源的偏倚 高風險判定標準 至少有一種重要的偏倚風險,例如： . 具有與特殊試驗設計相關的潛在偏倚來源 . 或被指欺詐 . 或其它問題 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)覺的問題會引入偏倚 第 6 頁,共 14 頁Table 8.7.a: Possible approach for summaryassessments of the risk of bias for each important outcome across doma

12、ins within and across studies Risk of bias 說明 對單個爭論 對多個爭論整體 Low risk of 合理的 偏倚不太 每一類偏倚均為 絕大多數(shù)信息均來 bias. 可能嚴肅轉變結 低風險 自偏倚低風險的研 Unclear risk of 果 合理的偏倚一類或多類偏倚 究 絕大多數(shù)信息會對 結果產生均來 自偏倚低風bias. 確定的 懷疑 偏風險未知 險或風 險未知的High risk of 倚嚴肅減弱結 一類或多類偏倚 爭論 來自高偏倚果的可信度 風險研 究的信息bias. 為高風險 比例足以 影響結果的說明 英文： Table 8.5.a: The

13、 Cochrane Collaboration s tool for assessing risk of bias Domain Support for judgement Review authors judgemen t Selection bias. Random sequence Describe the method used to generate Selection bias biased generation. the allocation sequence in sufficient allocation to interventions detail to allow an

14、 assessment of whether it should produce comparable groups. due to inadequate generation of a randomised sequence. Allocation Describe the method used to conceal Selection bias biased concealment. the allocation sequence in sufficient allocation to interventionsPerformance bias. detail to determine

15、whether intervention due to inadequateallocations could have been foreseen in concealment of allocations advance of, or during, enrolment. prior to assignment. Blinding of Describe all measures used, if any, to Performance bias due to participants andblind study participants and personnelknowledge o

16、f the allocatedpersonnelfrom knowledge of which intervention ainterventions by participantsAssessments shouldparticipant received. Provide anyand personnel during the be made for eachinformation relating to whether the study. main outcome or intended blinding was effective. class of outcomes. Detect

17、ion bias. Blinding of outcome Describe all measures used, if any, to Detection bias due to assessmentblind outcome assessors from knowledge of the allocatedAssessments shouldknowledge of which intervention ainterventions by outcome be made for each participant received. Provide any 第 7 頁,共 14 頁main

18、outcome or . information relating to whether the assessors. class of outcomes intended blinding was effective. Attrition bias. Incomplete outcome Describe the completeness of outcome Attrition bias due to amount, data Assessments data for each main outcome, includingnature or handling of should be m

19、ade for attrition and exclusions from the incomplete outcome data. each main outcomeanalysis. State whether attrition andor class of exclusions were reported, the numbersoutcomes. in each intervention group comparedwith total randomized participants, reasons for attrition/exclusions where reported,

20、and any re-inclusions in analyses performed by the review authors. Reporting bias. Selective reporting. State how the possibility of selective Reporting bias due to Other bias. outcome reporting was examined by the selective outcome reporting. review authors, and what was found. Other sources of Sta

21、te any important concerns about bias Bias due to problems not bias. not addressed in the other domains incovered elsewhere in the the tool. table. If particular questions/entries were pre- specified in the review s protocol, responses should be provided for each question/entry. Table 8.5.d: Criteria

22、 for judging risk of bias in the Risk of bias assessment tool RANDOM SEQUENCE GENERATION Selection bias biased allocation to interventions due to inadequate generation of a randomised sequence. Criteria for a judgement The investigators describe a random component in the sequence of Low risk of bias

23、. generation process such as: . Referring to a random number table; . Using a computer random number generator; 第 8 頁,共 14 頁. Coin tossing; . Shuffling cards or envelopes; . Throwing dice; . Drawing of lots; . Minimization*. *Minimization may be implemented without a random element, and this is cons

24、idered to be equivalent to being random. Criteria for the The investigators describe a non-random component in the sequence judgement of High riskgeneration process. Usually, the description would involve some of bias. systematic, non-random approach, for example: . Sequence generated by odd or even

25、 date of birth; . Sequence generated by some rule based on date or day of admission; . Sequence generated by some rule based on hospital or clinic record number. Other non-random approaches happen much less frequently than the systematic approaches mentioned above and tend to beobvious. They usually

26、 involve judgement or some method of non-random categorization 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 a series of tests; . Allocation by availability of the int

27、ervention. Criteria for the Insufficient information about the sequence generation process to judgement of Unclear permit judgement of Low risk or High risk . risk of bias. ALLOCATION CONCEALMENT Selection bias biased allocation to interventions due to inadequate concealment of allocations prior to

28、assignment. Criteria for a judgement Participants and investigators enrolling participants could not foresee of Low risk of bias. assignment because one of the following, or an equivalent method, was used to conceal allocation: . Central allocation including telephone, web-based and 第 9 頁,共 14 頁phar

29、macy-controlled randomization; . Sequentially numbered drug containers of identical appearance; . Sequentially numbered, opaque, sealed envelopes. Criteria for the Participants or investigators enrolling participants could possibly judgement of High riskforesee assignments and thus introduce selecti

30、on bias, such as of bias. allocation based on: . Using an open random allocation schedule e.g. a list of random numbers; . Assignment envelopes were used without appropriate safeguards e.g. if envelopes were unsealed or nonopaque or not sequentially numbered; Criteria for the .Alternation or rotatio

31、n; High risk . .Date of birth; .Case record number; .Any other explicitly unconcealed procedure. Insufficient information to permit judgement of Low risk or judgement of Unclear This is usually the case if the method of concealment is not described risk of bias. or not described in sufficient detail

32、 to allow a definite judgementfor example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed. BLINDING OF PARTICIPANTS AND PERSONNEL Performance bias due to knowledge of the allocated interventions by participants a

33、nd personnel during the study. Criteria for a judgement Any one of the following: of Low risk of bias. . No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding; . Blinding of participants and key study personnel ensured, a

34、nd unlikely that the blinding could have been broken. Criteria for the judgement of of bias. Any one of the following: High risk .No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding; .Blinding of key study participants and personnel attempted, but likel

35、y that the blinding could have been broken, and the 第 10 頁,共 14 頁outcome is likely to be influenced by lack of blinding. Criteria for the UnclearAny one of the following: Low risk or judgement of .Insufficient information to permit judgement of risk of bias. High risk ; .The study did not address th

36、is outcome. BLINDING OF OUTCOME ASSESSMENT Detection bias due to knowledge of the allocated interventions by outcome assessors. Criteria for a judgement Any one of the following: of Low risk of bias. . No blinding of outcome assessment, but the review authors judge that the outcome measurement is no

37、t likely to beinfluenced by lack of blinding; . Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken. Criteria for the judgement of of bias. Any one of the following: High risk .No blinding of outcome assessment, and the outcome measurement is likely to be in

38、fluenced 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 the Any one of the following: Low risk or judgement of Unclear .Insufficient information to per

39、mit judgement of risk of bias. High risk ; .The study did not address this outcome. INCOMPLETE OUTCOME DATA Attrition bias due to amount, nature or handling of incomplete outcome data. Criteria for a judgement Any one of the following: of Low risk of bias. . No missing outcome data; . Reasons for mi

40、ssing outcome data unlikely to be related to true outcome for survival data, censoring unlikely to beintroducing bias; . Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing dataacross groups; 第 11 頁,共 14 頁. For dichotomous outcome data, the proportio

41、n 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 difference in means amongmissing outcomes not enough to have a clinica

42、lly relevantimpact on observed effect size; Criteria for the judgement of of bias. .Missing data have been imputed using appropriate methods. Any one of the following: High risk .Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for mis

43、sing 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 data, plausible effect size difference in means or standardiz

44、ed difference in means amongmissing outcomes enough to induce clinically relevant bias in observed effect size; . A-streated analysis done with substantial departure of the intervention received from that assigned at randomization; Criteria for the judgement of risk of bias. .Potentially inappropria

45、te application of simple imputation. Any one of the following: Unclear .Insufficient reporting of attrition/exclusions to permit judgement of Low risk or High risk e.g. nduommbiezer drannot stated, no reasons for missing data provided; . The study did not address this outcome. SELECTIVE REPORTING Re

46、porting bias due to selective outcome reporting. Criteria for a judgement Any of the following: s of Low risk of bias. .The study p rotocol is available and all of the study pre-specified primary and secondary outcomes that are of interest in the review have been reported in the pre-specifiedway; .

47、The study protocol is not available but it is clear that the published reports include all expected outcomes, including 第 12 頁,共 14 頁those that were pre-specified convincing text of this nature may be uncommon. Criteria for the judgement of of bias. Any one of the following: High risk .Not all of th

48、e study -spsepcrifeiedprimaryoutcomeshavebeen 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-specified unless clear justification for thei

49、r reporting isprovided, 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 ameta-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 Insufficient information to permit judgement of Low risk or High risk .