Risk of bias assessment tool 2.0 for cluster-randomized trials and crossover trials (revised version 2021): an interpretation_Chinese Journal of Evidence-Based Medicine

Authors：

ZHU Tao , LIU Jinchi , LIU Chang ,  HUA Chengge

State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of General Dentistry & Department of Evidence-Based Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

HUA Chengge, Email: huacg@163.com

Keywords：

Cluster randomized trial; Crossover trial; Risk of bias; Assessment tool; Systematic review

DOI：

10.7507/1672-2531.202201070

Video：

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The risk of bias assessment tool 2.0 (RoB 2.0) for analyzing cluster randomized trials and crossover trials (revised version 2021) has been updated. The current paper briefly delineates the history of the RoB 2.0 tool and includes an explanation and interpretation of the updated contents and software operation process for use with cluster randomized trials and crossover trials. Compared with the previous versions, the updated RoB 2.0 tool (revised version 2021) has the advantage of precise language and is easily understood. Thus, the updated RoB 2.0 tool merits popularization and further general application.

Citation： ZHU Tao, LIU Jinchi, LIU Chang, HUA Chengge. Risk of bias assessment tool 2.0 for cluster-randomized trials and crossover trials (revised version 2021): an interpretation. Chinese Journal of Evidence-Based Medicine, 2022, 22(7): 842-852. doi: 10.7507/1672-2531.202201070 Copy

1.	Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
2.	Higgins JPT, Savović J, Page MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0)(20 October 2016). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/archive-rob-2-0-2016.
3.	Higgins JPT, Savović J, Page MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2)(9 October 2018). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2.
4.	Higgins JPT, Savović J, Page MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2)(22 August 2019). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2.
5.	Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019, 366: l4898.
6.	杨智荣, 孙凤, 詹思延. 偏倚风险评估系列: (二)平行设计随机对照试验偏倚评估工具2. 0介绍. 中华流行病学杂志, 2017, 38(9): 1285-1291.
7.	刘括, 孙殿钦, 廖星, 等. 随机对照试验偏倚风险评估工具2. 0修订版解读. 中国循证心血管医学杂志, 2019, 11(3): 284-291.
8.	刘津池, 刘畅, 华成舸. 随机对照试验偏倚风险评价工具RoB2(2019修订版)解读. 中国循证医学杂志, 2021, 21(6): 737-744.
9.	Eldridge S, Campbell M, Campbell M, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0): Additional considerations for cluster-randomized trials (21 October 2016). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/archive-rob-2-0-cluster-randomized-trials-2016.
10.	Higgins JPT. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0): additional considerations for cross-over trials (20 October 2016). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/archive-rob-2-0-cross-over-trials-2016.
11.	Eldridge S, Campbell MK, Campbell MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for cluster-randomized trials (RoB 2 CRT)(10 November 2020). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-cluster-randomized-trials.
12.	Higgins JPT, Li T, Sterne J. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for crossover trials (Preliminary tool version, 8 December 2020). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-crossover-trials.
13.	Eldridge S, Campbell MK, Campbell MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for cluster-randomized trials (RoB 2 CRT)(18 March 2021). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-cluster-randomized-trials.
14.	Higgins JPT, Li T, Sterne J. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for crossover trials (Preliminary tool version, 18 March 2021). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-crossover-trials.
15.	吕晓珍, 孙凤, 詹思延. 偏倚风险评估系列: (四)整群设计随机对照试验. 中华流行病学杂志, 2018, 39(2): 240-244.
16.	武珊珊, 孙凤, 詹思延. 偏倚风险评估系列: (三)交叉设计随机对照试验. 中华流行病学杂志, 2017, 38(10): 1436-1440.
17.	Liu C, Cao Y, Lin J, et al. Oral care measures for preventing nursing home-acquired pneumonia. Cochrane Database Syst Rev, 2018, (9): CD012416.

1. Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
2. Higgins JPT, Savović J, Page MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0)(20 October 2016). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/archive-rob-2-0-2016.
3. Higgins JPT, Savović J, Page MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2)(9 October 2018). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2.
4. Higgins JPT, Savović J, Page MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2)(22 August 2019). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2.
5. Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019, 366: l4898.
6. 杨智荣, 孙凤, 詹思延. 偏倚风险评估系列: (二)平行设计随机对照试验偏倚评估工具2. 0介绍. 中华流行病学杂志, 2017, 38(9): 1285-1291.
7. 刘括, 孙殿钦, 廖星, 等. 随机对照试验偏倚风险评估工具2. 0修订版解读. 中国循证心血管医学杂志, 2019, 11(3): 284-291.
8. 刘津池, 刘畅, 华成舸. 随机对照试验偏倚风险评价工具RoB2(2019修订版)解读. 中国循证医学杂志, 2021, 21(6): 737-744.
9. Eldridge S, Campbell M, Campbell M, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0): Additional considerations for cluster-randomized trials (21 October 2016). Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/archive-rob-2-0-cluster-randomized-trials-2016.
10. Higgins JPT. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0): additional considerations for cross-over trials (20 October 2016). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/archive-rob-2-0-cross-over-trials-2016.
11. Eldridge S, Campbell MK, Campbell MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for cluster-randomized trials (RoB 2 CRT)(10 November 2020). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-cluster-randomized-trials.
12. Higgins JPT, Li T, Sterne J. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for crossover trials (Preliminary tool version, 8 December 2020). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-crossover-trials.
13. Eldridge S, Campbell MK, Campbell MJ, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for cluster-randomized trials (RoB 2 CRT)(18 March 2021). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-cluster-randomized-trials.
14. Higgins JPT, Li T, Sterne J. Revised Cochrane risk of bias tool for randomized trials (RoB 2): additional considerations for crossover trials (Preliminary tool version, 18 March 2021). available at: https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-crossover-trials.
15. 吕晓珍, 孙凤, 詹思延. 偏倚风险评估系列: (四)整群设计随机对照试验. 中华流行病学杂志, 2018, 39(2): 240-244.
16. 武珊珊, 孙凤, 詹思延. 偏倚风险评估系列: (三)交叉设计随机对照试验. 中华流行病学杂志, 2017, 38(10): 1436-1440.
17. Liu C, Cao Y, Lin J, et al. Oral care measures for preventing nursing home-acquired pneumonia. Cochrane Database Syst Rev, 2018, (9): CD012416.

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Risk of bias assessment tool 2.0 for cluster-randomized trials and crossover trials (revised version 2021): an interpretation

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