Risk bias assessment tool RoB2 (revised version 2019) for randomized controlled trial : an interpretation_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Jinchi , LIU Chang ,  HUA Chengge

State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery & Dept. 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：

Randomized controlled trial; Risk of bias; Tool for assessment; Systematic review

DOI：

10.7507/1672-2531.202011144

Video：

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RoB2 (revised version 2019), an authoritative tool for assessing the risk of bias in randomized controlled trials, has been updated and improved based on the original version. This article elaborated and interpreted the background and main content of RoB2 (revised version 2019), as well as the operation process of the new software. Compared with the previous version of RoB2 (revised version 2018), RoB2 (revised version 2019) has the advantages of rich content, complete details, accurate questions, and simple operation, etc. Additionally, it is more user-friendly for researchers and beginners. The risk bias assessment of randomized controlled trials is more comprehensive and accurate, and it is an authoritative, trustworthy, and popular tool for evaluating the risk of bias in randomized controlled studies in medical practice.

Citation： LIU Jinchi, LIU Chang, HUA Chengge. Risk bias assessment tool RoB2 (revised version 2019) for randomized controlled trial : an interpretation. Chinese Journal of Evidence-Based Medicine, 2021, 21(6): 737-744. doi: 10.7507/1672-2531.202011144 Copy

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1. 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.
2. Moher D, Jadad AR, Tugwell P. Assessing the quality of randomized controlled trials. Current issues and future directions. Int J Technol Assess Health Care, 1996, 12(2): 195-208.
3. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
4. Weintraub M. How to critically assess clinical drug trials. Drug Ther, 1982, 12: 131-148.
5. Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.0. 0 (updated February 2008). The Cochrane Collaboration, 2008. Available at: https://training.cochrane.org/handbook/archive/v5.0.0/.
6. Higgins JPT, Altman DG, Sterne JAC, et al. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.1. 0 (updated March 2011). The Cochrane Collaboration, 2011. Available at: https://training.cochrane.org/handbook/archive/v5.1/.
7. Higgins JPT, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
8. 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.
9. Higgins JPT, Sterne JAC, Savović J, et al. A revised tool for assessing risk of bias in randomized trials. In: Chandler J, McKenzie J, Boutron I, et al. Cochrane methods. Cochrane Database Syst Rev, 2016, 10(Supp 1): CD201601.
10. Higgins JPT, Sterne JAC, Savović J, et al. Revised Cochrane risk of bias tool for randomized trials (RoB 2.0), 2016-10-20. Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/archive-rob-2-0-2016/.
11. Minozzi S, Cinquini M, Gianola S, et al. The revised Cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application. J Clin Epidemiol, 2020, 126: 37-44.
12. Higgins JPT, Sterne JAC, Savović J, et al. Revised Cochrane risk-of-bias tool for randomized trials (RoB 2), 2018-10-09. Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2/.
13. 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.
14. Higgins JPT, Savović J, Page MJ, et al. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins JPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions version 6.0 (updated July 2019). The Cochrane Collaboration, 2019. Available at: ttps://training.cochrane.org/handbook/archive/v6/chapter-08/.
15. Higgins JPT, Savović J, Page MJ, et al. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins JPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions version 6.1 (updated September 2020). The Cochrane Collaboration, 2020. Available at: https://training.cochrane.org/handbook/current/chapter-08/.
16. Higgins JPT, Campbell MK, Campbell MJ, et al. Additional considerations for cluster-randomized trials (RoB 2 CRT), 2020-11-10. Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2/.
17. Higgins JPT, Tianjing L, Jonathan S, et al. Additional consideration for crossover trials, 2020-12-08. Available at: https://www.riskofbias.info/welcome/rob-2-0-tool/current-version-of-rob-2/.
18. 刘畅, 王艳, 潘韦霖, 等. 初始弓丝材料对正畸治疗初始疼痛影响的系统评价与网状 Meta 分析. 华西口腔医学杂志, 2018, 36(3): 296-300.

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