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, G?tzsche 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, Savovi? J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019, 366: l4898.
6.	楊智榮, 孫鳳, 詹思延. 偏倚風險評估系列: (二)平行設計隨機對照試驗偏倚評估工具2. 0介紹. 中華流行病學雜志, 2017, 38(9): 1285-1291.
7.	劉括, 孫殿欽, 廖星, 等. 隨機對照試驗偏倚風險評估工具2. 0修訂版解讀. 中國循證心血管醫學雜志, 2019, 11(3): 284-291.
8.	劉津池, 劉暢, 華成舸. 隨機對照試驗偏倚風險評價工具RoB2(2019修訂版)解讀. 中國循證醫學雜志, 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.	呂曉珍, 孫鳳, 詹思延. 偏倚風險評估系列: (四)整群設計隨機對照試驗. 中華流行病學雜志, 2018, 39(2): 240-244.
16.	武珊珊, 孫鳳, 詹思延. 偏倚風險評估系列: (三)交叉設計隨機對照試驗. 中華流行病學雜志, 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, G?tzsche 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, Savovi? J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019, 366: l4898.
6. 楊智榮, 孫鳳, 詹思延. 偏倚風險評估系列: (二)平行設計隨機對照試驗偏倚評估工具2. 0介紹. 中華流行病學雜志, 2017, 38(9): 1285-1291.
7. 劉括, 孫殿欽, 廖星, 等. 隨機對照試驗偏倚風險評估工具2. 0修訂版解讀. 中國循證心血管醫學雜志, 2019, 11(3): 284-291.
8. 劉津池, 劉暢, 華成舸. 隨機對照試驗偏倚風險評價工具RoB2(2019修訂版)解讀. 中國循證醫學雜志, 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. 呂曉珍, 孫鳳, 詹思延. 偏倚風險評估系列: (四)整群設計隨機對照試驗. 中華流行病學雜志, 2018, 39(2): 240-244.
16. 武珊珊, 孫鳳, 詹思延. 偏倚風險評估系列: (三)交叉設計隨機對照試驗. 中華流行病學雜志, 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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