随机对照研究质量评价——Cochrane偏倚风险评估工具2.0 (Risk of Bias 2.0, RoB 2.0)(一)

发布于 2024年6月15日 星期六 14:32:16 浏览:375
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随机对照试验(Randomized controlled trial, RCT)作为药械产品有效性和安全性评价的金标准,其研究结果的真实性和可靠性取决于在设计和实施过程中是否较好的避免了潜在偏倚。因此使用权威且规范的偏倚评价工具对RCT实施过程中的偏倚风险进行客观评价尤为重要。本文重点介绍Cochrane偏倚风险评估工具2.0 (Risk of Bias 2.0, Rob2.0)的使用方法及评估清单,评估清单详细内容详见随机对照研究质量评价——Cochrane偏倚风险评估工具2.0 (Risk of Bias 2.0, RoB 2.0)(二)

Cochrane偏倚风险评估工具2.0设置5个模块,分别从不同方面评价RCT研究产生偏倚的可能性。包括:随机过程中产生的偏倚、偏离既定干预的偏倚(分为干预分配和干预依从)、结局数据缺失的偏倚、结局测量的偏倚以及结果选择性报告的偏倚。

每个待评价的模块下设置多个问题条目,引导研究者做出判断,最终根据5个模块的评价结果对整体偏倚风险进行评价。

  • 如果5个模块中的偏倚评价均为低风险,则整体偏倚风险评价为低风险;
  • 如果5个模块均未被评估为高风险,但至少1个模块的评价结果为可能存在风险,则整体偏倚风险评价为可能存在风险;
  • 如果5个模块中至少1个模块的偏倚评价为高风险,或多个模块的评价结果为可能存在风险,则整体评价为高风险。

各个条目的回答选项有:是(Yes, Y),可能是(Probably yes, PY),可能否(Probably no, PN),否(No, N),未知(No information, NI)。如果根据前一个条目的结果判断现在条目为无需回答或可跳过,则备选答案中新增“不适用”(Not applicable, NA)选项。

二、RoB 2.0评估清单

Version 2 of the Cochrane risk-of-bias assessment tool for randomised trials: bias domains, signalling questions, response options, and risk-of-bias judgments
译文:Cochrane随机试验偏倚风险评估工具版本2:偏倚域、条目、回答选项和偏倚风险判断
Bias domain and signalling question*
(偏倚域和条目*)
Response options (回答选项)
Lower risk of bias
(低偏倚风险)
Higher risk of bias
(高偏倚风险)
Other (其他)
1. Bias arising from the randomisation process
1. 译文:随机化过程中产生的偏倚
1.1 Was the allocation sequence random?Y/PYN/PNNI
1.1译文:研究对象是否随机分配?是/可能是否/可能否未知
    
1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?Y/PYN/PNNI
1.2译文:在受试者入组前是否实施分配隐藏?是/可能是否/可能否未知
    
1.3 Did baseline differences between intervention groups suggest a problem with the randomisation process?N/PNY/PYNI
1.3译文:随机化过程是否导致了基线间的不均衡?否/可能否是/可能是未知
    
Risk-of-bias judgment (low/high/some concerns)
译文:偏倚风险判断 (低/高/可能存在风险)
Optional: What is the predicted direction of bias arising from the randomisation process?
译文:可选项:随机化过程中产生的偏倚方向是什么?
    
2. Bias due to deviations from intended interventions
2. 译文:偏离既定干预的偏倚
2.1 Were participants aware of their assigned intervention during the trial?N/PNY/PYNI
2.1译文:研究对象是否在试验过程中知晓自己的分组?否/可能否是/可能是未知
    
2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?N/PNY/PYNI
2.2译文:医护人员或试验实施者是否在试验过程中知晓分组?否/可能否是/可能是未知
    
2.3 If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?N/PNY/PYNA/NI
2.3译文:如果2.1或者2.2回答“Y/PY/NI”,是否由于试验环境而导致出现了偏离预期干预的情况?否/可能否是/可能是不适用/未知
    
2.4 If Y/PY/NI to 2.3: Were these deviations likely to have affected the outcome?N/PNY/PYNA/NI
2.4译文:如果2.3回答“Y/PY/NI”,这些偏离是否会影响结局?否/可能否是/可能是不适用/未知
    
2.5 If Y/PY to 2.4: Were these deviations from intended intervention balanced between groups?Y/PYN/PNNA/NI
2.5译文:如果2.4回答了“Y/PY”,偏离既定干预的情况在各组间是否均衡?是/可能是否/可能否不适用/未知
    
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?Y/PYN/PNNI
2.6译文:评价干预效果的分析方法是否恰当?是/可能是否/可能否未知
    
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomised?N/PNY/PYNA/NI
2.7译文:如果2.6回答“N/PN/NI”,无法按照事先随机分组对研究对象进行分析是否可能会对结局产生较大影响?否/可能否是/可能是不适用/未知
    
Risk-of-bias judgment (low/high/some concerns)
译文:偏倚风险判断 (低/高/可能存在风险)
Optional: What is the predicted direction of bias due to deviations from intended interventions?
译文:可选项:偏离既定干预导致的偏倚方向是什么?
    
3. Bias due to missing outcome data
3. 译文:结局数据缺失偏倚
3.1 Were data for this outcome available for all, or nearly all, participants randomised?Y/PYN/PNNI
3.1译文:是否所有或几乎所有随机化分组的研究对象都获得了结局数据?是/可能是否/可能否未知
    
3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?Y/PYN/PNNA
3.2译文:如果3.1回答“N/PN/NI”,是否有证据表明结果不受到缺失的结局数据的影响?是/可能是否/可能否不适用
    
3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?N/PNY/PYNA/NI
3.3译文:如果3.2回答“N/PN”,结局变量的缺失与结局本身是否相关?否/可能否是/可能是不适用/未知
    
3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?N/PNY/PYNA/NI
3.4译文:如果3.3回答“Y/PY/NI”,结局变量的缺失是否可能与结局本身相关?否/可能否是/可能是不适用/未知
    
Risk-of-bias judgment (low/high/some concerns)
译文:偏倚风险判断 (低/高/可能存在风险)
Optional: What is the predicted direction of bias due to missing outcome data?
译文:可选项:结局数据缺失导致的偏倚方向是什么?
    
4. Bias in measurement of the outcome
4. 译文:结局测量偏倚
4.1 Was the method of measuring the outcome inappropriate?N/PNY/PYNI
4.1译文:结局测量方法是否不恰当?否/可能否是/可能是未知
    
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?N/PNY/PYNI
4.2译文:结局的测量或确证方法是否在两组间存在差异?否/可能否是/可能是未知
    
4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?N/PNY/PYNI
4.3译文:如果4.1或4.2回答“N/PN/NI”,结局测量者是否知晓研究对象接受的干预?否/可能否是/可能是未知
    
4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?N/PNY/PYNA/NI
4.4译文:如果4.3回答“Y/PY/NI”,知晓干预措施是否影响了结局变量的测量?否/可能否是/可能是不适用/未知
    
4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?N/PNY/PYNA/NI
4.5译文:如果4.4回答“Y/PY/NI”,知晓干预措施是否可能影响结局变量的测量?否/可能否是/可能是不适用/未知
    
Risk-of-bias judgment (low/high/some concerns)
译文:偏倚风险判断 (低/高/可能存在风险)
Optional: What is the predicted direction of bias in measurement of the outcome?
译文:可选项:结局测量导致的偏倚方向是什么?
    
5. Bias in selection of the reported result
5. 译文:结果选择性报告偏倚
5.1 Were the data that produced this result analysed in accordance with a prespecified analysis plan that was finalised before unblinded outcome data were available for analysis?Y/PYN/PNNI
5.1译文:试验分析方法是否与数据对分析者揭盲前所制订的研究计划一致?是/可能是否/可能否未知
    
Is the numerical result being assessed likely to have been selected, on the basis of the results, from:
译文:所评估的数值结果是否可能基于下列情况而选择的:
5.2 Multiple eligible outcome measurements (eg, scales, definitions, time points) within the outcome domain?N/PNY/PYNI
5.2译文:是否进行了多种结局测量(如量表、不同的定义、不同时点)?否/可能否是/可能是未知
    
5.3 Multiple eligible analyses of the data?N/PNY/PYNI
5.3译文:是否采取了多种分析方式?否/可能否是/可能是未知
    
Risk-of-bias judgment (low/high/some concerns)
译文:偏倚风险判断 (低/高/可能存在风险)
Optional: What is the predicted direction bias due to selection of the reported results?
译文:可选项:结果选择性报告导致的偏倚方向是什么?
    
Overall bias
译文:总体偏倚
Risk-of-bias judgment (low/high/some concerns)
译文:偏倚风险判断 (低/高/可能存在风险)
Optional: What is the overall predicted direction of bias for this outcome?
译文:可选项:总体偏倚方向是什么?
    
Y=yes; PY=probably yes; PN=probably no; N=no; NA=not applicable; NI=no information.
译文:Y=是; PY=可能是; PN=可能否; N=否; NA=不适用; NI=未知.
    
*Signalling questions for bias due to deviations from intended interventions relate to the effect of assignment to intervention.
译文:*偏离既定干预措施而导致的偏倚条目与干预措施的影响(干预分配还是干预依从)有关

注:本文内容是参考相关文献后对Cochrane偏倚风险评估工具2.0 (Risk of Bias 2.0, RoB 2.0)的概述,仅代表本网站观点。关于RoB 2.0的更多内容详见网站(https://methods.cochrane.org/bias/resources/rob-2-revised-cochrane-risk-bias-tool-randomized-trials)或论文RoB 2: a revised tool for assessing risk of bias in randomised trials (https://pubmed.ncbi.nlm.nih.gov/31462531/)。

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