special是什么意思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

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

,

< br>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

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

高风险判断标准

研究应未引入其它来源的偏倚

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

Possible approach for

summary assessments

of the risk of bias for each important

outcome (across domains) within and across studies

Risk of bias

Low risk of

bias.

解释

合理的

偏倚不太

可能严重改变结

果

对单个研究

每一类偏倚均为

低风险

对多个研究整体

绝大多数信息均来< /p>

自偏倚低风险的研

究

Unclear risk of

合理的偏倚会对

bias.

结果产生一定的

怀疑

High risk of

bias.

偏倚严重削弱结

果的可信度

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

一类或多类偏倚

为高风险

究的信息比例足以

影响结果的解 释

英文：

Table

Domain

Support for judgement

Review

authors’

judgement

Selection bias.

Random sequence

generation.

Describe

the

method

used

to

generate

Selection bias (biased

the allocation sequence in

allocation to

sufficient detail to allow an

assessment of whether it should

produce comparable groups.

interventions) due to

inadequate

generation of

a

randomised sequence.

Allocation

concealment.

Describe the method used to conceal

Selection bias (biased

the allocation sequence in

sufficient detail to determine

allocation to

interventions) due to

whether intervention allocations

inadequate concealment of

could have been foreseen in advance

allocations prior to

of, or during, enrolment.

assignment.

Performance bias.

Blinding of

Describe all measures used, if any,

Performance bias due to

knowledge

of the allocated

participants and

to blind study participants and

personnel

personnel from knowledge of which

interventions by

Assessments should

intervention

a

participant

received.

participants

and

personnel

be made for each

Provide any information relating to

during the study.

main outcome (or

whether the intended blinding was

class of

outcomes).

?

effective.

Detection bias.

Blinding

of

outcome

Describe all measures used, if any,

Detection bias due to

assessment

to blind outcome assessors from

knowledge

of the allocated

Assessments should

knowledge of which intervention a

interventions by outcome

be made for each

participant received. Provide any

assessors.

main outcome (or

information relating to whether the

class

of

outcomes)

.

intended blinding was effective.

Attrition bias.

Incomplete outcome

Describe

the

completeness

of

outcome

Attrition bias due to

data

Assessments

data

for

each

main

outcome,

including

amount,

nature or handling

should be made for

attrition and exclusions from the

of incomplete outcome

each main outcome

analysis. State whether attrition

data.

(or class of

outcomes).

?

and exclusions were reported, 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.

Reporting bias.

Selective

reporting.

State how the possibility of

selective outcome reporting was

Reporting bias due to

selective outcome

examined by the review authors, and

reporting.

what was found.

Other bias.

Other sources of

State any important concerns about

Bias due to problems not

bias.

bias not addressed in the other

domains in the tool.

covered elsewhere in the

table.

If

particular

questions/entries

were

pre-

specified in the review’s

protocol, responses should be

provided for each question/entry.

RANDOM SEQUENCE GENERATION

Selection

bias (biased allocation to interventions) due to inadequate generation

of a randomised sequence.

Criteria for a

The investigators describe a random component in the sequence