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.doc

1、中文： Table 8.5.a: The Cochrane Collaborations 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 分配前分配隐藏不充分 发生选择偏倚 实施偏倚 实施者和参与者 双盲 应对每个主 要结局进行评估 （或分类结局） 如果有，描述对参与者和实施者 行盲法，避免其了解干预信息的 所有措

2、施。提供任何与所实施的 盲法是否有效地相关信息。 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

3、式导致失 访偏倚 发表偏倚 Selective reporting. 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 Table 8.5.d: Criteria for judging risk of bias in the Risk of bias assessment 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

4、数字生成器 扔硬币 洗牌的卡片和信封 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

5、 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

6、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 偏倚高风险标准 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

7、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，

8、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）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

9、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

10、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，但存在以下两种中的一种 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 8.7.a: Possible approac

11、h for summary assessments of the risk of bias for each important outcome (across domains) within and across studies Risk of bias 解释 对单个研究 对多个研究整体 Low risk of 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 Unclear 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 ri

12、sk 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 8.5.a: The Cochrane Collaborations tool for assessing risk of bias Domain Support for judgement Review authors judgement Selection bias. Random sequence generation. Describe the method used to generate the allocation sequence

13、 in sufficient detail to allow an assessment of whether it should produce comparable groups. Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence. Allocation concealment. Describe the method used to conceal the allocation sequence in sufficient de

14、tail to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment. Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment. Performance bias. Blinding of participants and personnel Assessments

15、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 participant received. Provide any information relating to whether the intended blinding was effective. Performance bias du

16、e to knowledge of the allocated interventions by participants and personnel during the study. Detection bias. Blinding of outcome assessment Describe all measures used, if any, to blind outcome assessors from Detection bias due to knowledge of the allocated Assessments should be made for each main o

17、utcome (or class of outcomes). knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective. interventions by outcome assessors. Attrition bias. Incomplete outcome data Assessments should be made for each main outcome (or cla

18、ss 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 reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/ex

19、clusions 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. Selective reporting. State how the possibility of selective outcome reporting was examined by the review authors, a

20、nd 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 particular questions/entries were pre- specified in the reviews protocol, responses should be provided f

21、or 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 tool RANDOM SEQUENCE GENERATION Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence. Cr

22、iteria for a judgement The investigators describe a random component in the sequence of Low risk of bias. generation 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

23、*. *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-random component in the sequence generation process. Usually, the description would involve some sy

24、stematic, 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 hospital or clinic record number. Other non-random approaches happen much less frequently than th

25、e 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 clinician; Allocation by preference of the participant; Allocation based on the results of a labora

26、tory 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 judgement of Low risk or High risk. ALLOCATION CONCEALMENT Selection bias (biased allocation to

27、 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 because one of the following, or an equivalent method, was used to conceal allocation: Ce

28、ntral allocation (including telephone, web-based and pharmacy-controlled randomization); Sequentially numbered drug containers of identical appearance; Sequentially numbered, opaque, sealed envelopes. Criteria for the judgement of High risk of bias. Participants or investigators enrolling participan

29、ts 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 appropriate safeguards (e.g. if envelopes were unsealed or nonopaque or not sequentia

30、lly 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 of Low risk or High risk. This is usually the case if the method of concealment is n

31、ot 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 and sealed. BLINDING OF PARTICIPANTS AND PERSONNEL Performance bias due to knowled

32、ge 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 that the outcome is not likely to be influenced by lack of blinding; Blinding of

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

34、rticipants 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 following: Insufficient information to permit judgement of Low risk or High risk

35、; The study did not address this outcome. BLINDING OF OUTCOME ASSESSMENT Detection 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: No blinding of outcome assessment, but the review authors judge that t

36、he 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 the following: No blinding of outcome assessment, and the outcome meas

37、urement 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 the judgement of Unclear risk of bias. Any one of the following: Insuf

38、ficient information to permit judgement of Low risk or 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 of Low risk of bias. Any one of the following: No missing outcome da

39、ta; 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 missing data across groups; For dichotomous outcome data, the prop

40、ortion 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) among missing outcomes not enough to have a c

41、linically 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 true outcome, with either imbalance in numbers or reasons fo

42、r 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 data, plausible effect size (difference in means or standard

43、ized 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; Potentially inappropriate application of simple imputation. Criter

44、ia 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); The study did not address this outcome. SELECTIVE REPORTING R

45、eporting 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 the review have been reported in the pre-specified way;

46、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. Any one of the following: Not all of the studys pre

47、-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- specified (unless clear justification for their repor

48、ting 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 of Low risk or High risk. It is likely that the majority of studies will fall into this category. OTHER BIAS Bias due to problems not covered elsewhere in the table. Criteria