Chinese Introduction to Risk of Bias in Nonrandomized Studies of Interventions Version 2 (ROBINS-I V2) in 2024_Chinese Journal of Evidence-Based Medicine

Authors：

HU Zhiqiao ¹ , WANG Liao ² , HUANG Chunpeng ¹ , CHEN Juntian ¹ , LI Jiachi ¹ ,  LIU Chang ² ,  FANG Hongzhi ¹

1. Department of Stomatology, the Third People’s Hospital of Chengdu, Chengdu 610031, P. R. China;
2. State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases & Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

LIU Chang, Email: liu_chang_92@sina.com; FANG Hongzhi, Email: 1127958575@qq.com

Keywords：

Nonrandomized study; Interventional study; Risk of bias; Systematic review; Intervention; Experimental epidemiology

DOI：

10.7507/1672-2531.202412066

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To systematically interpret the updated Risk of Bias in Non-randomized Studies of Interventions Version 2 (ROBINS-I V2) in 2024, summarizing its key improvements, operational procedures, and clinical application value. Methods Through literature review and case studies, the improvements of ROBINS-I V2 were compared with the 2016 version, including the expansion of bias domains, refinement of signaling questions, and optimization of decision flowcharts. A retrospective study in stomatology was used to demonstrate the practical application of the tool. Results The ROBINS-I V2 tool has restructured the hierarchy and refined the definitions of bias domains, optimized the evaluation processes across seven risk-of-bias dimensions, and minimized subjective judgment errors through standardized decision flowcharts. Conclusion ROBINS-I V2 significantly improves the rigor of bias assessment in non-randomized intervention studies through its scientific design and standardized workflow. It is recommended for evidence quality grading and decision-making support in clinical research.

1.	梅凡, 姚明宏, 王雨宁, 等. 随机和非随机干预研究的证据整合研究进展. 中国循证医学杂志, 2023, 23(9): 1102-1109.
2.	Sterne JAC, Higgins JPT, Reeves BC. A Cochrane risk of bias assessment tool: for non-randomized studies of interventions (ACROBAT-NRSI) (Version 1.0. 0, 24 September 2014). 2014.
3.	Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016, 355: i4919.
4.	Schünemann HJ, Cuello C, Akl EA, et al. GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence. J Clin Epidemiol, 2019, 111: 105-114.
5.	Huffman MD, Thomas LE. Tools for evaluating and improving causal inference: introducing JAMA cardiology readers to the risk of bias in nonrandomized studies of interventions (ROBINS-I) Tool. JAMA Cardiol, 2018, 3(10): 907.
6.	孙凤, 高乐, 杨智荣, 等. 偏倚风险评估系列: (五)非随机干预性研究. 中华流行病学杂志, 2018, 39(3): 374-381.
7.	王浩, 唐晓宇, 王和平, 等. ROBINS-I: 评估非随机干预性研究偏倚风险的新工具. 中国循证心血管医学杂志, 2018, 10(7): 789-793.
8.	马佩芬, 李玲玲, 豆欣蔓. 某非随机干预性研究偏倚风险评估工具及使用方法的解读. 中华护理教育, 2021, 18(2): 187-192.
9.	Morgan RL, Thayer KA, Santesso N, et al. Evaluation of the risk of bias in non-randomized studies of interventions (ROBINS-I) and the 'target experiment' concept in studies of exposures: rationale and preliminary instrument development. Environ Int, 2018, 120: 382-387.
10.	Higgins J, Morgan R, Rooney A, et al. Risk of bias in non-randomized studies of exposure (ROBINS-E) (Launch version, 1 June 2022). 2022.
11.	魏来武, 陈削静, 曹钰彬, 等. 暴露类非随机研究偏倚风险评价工具(ROBINS-E2022版)解读. 中国循证医学杂志, 2023, 23(11): 1340-1350.
12.	Higgins J, Morgan R, Rooney A, et al. Risk of bias in non-randomized studies of exposure (ROBINS-E) (Launch version, 20 June 2023). 2023.
13.	ROBINS-I Development Group. The Risk of Bias in Non-Randomized studies - of Interventions Version 2 (ROBINS-I V2) assessment tool (for follow-up studies) November 2024. 2024.
14.	赵厚宇, 李海龙, 詹思延. 药物流行病学研究中的非死亡时间偏倚及其控制. 药物流行病学杂志, 2017, 26(3): 207-212.
15.	程义, 李冬冬, 陈峰, 等. 未亡时间偏倚的常用处理方法及进展. 中国卫生统计, 2022, 39(1): 153-156.
16.	杨召, 周家琛, 陈茹, 等. 肿瘤筛查研究中领先时间偏倚和病程长短偏倚的识别和校正. 中华预防医学杂志, 2019, 53(11): 1183-1187.
17.	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.
18.	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.
19.	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.
20.	曾宪涛, 包翠萍, 曹世义, 等. Meta分析系列之三: 随机对照试验的质量评价工具. 中国循证心血管医学杂志, 2012, 4(3): 183-185.

1. 梅凡, 姚明宏, 王雨宁, 等. 随机和非随机干预研究的证据整合研究进展. 中国循证医学杂志, 2023, 23(9): 1102-1109.
2. Sterne JAC, Higgins JPT, Reeves BC. A Cochrane risk of bias assessment tool: for non-randomized studies of interventions (ACROBAT-NRSI) (Version 1.0. 0, 24 September 2014). 2014.
3. Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016, 355: i4919.
4. Schünemann HJ, Cuello C, Akl EA, et al. GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence. J Clin Epidemiol, 2019, 111: 105-114.
5. Huffman MD, Thomas LE. Tools for evaluating and improving causal inference: introducing JAMA cardiology readers to the risk of bias in nonrandomized studies of interventions (ROBINS-I) Tool. JAMA Cardiol, 2018, 3(10): 907.
6. 孙凤, 高乐, 杨智荣, 等. 偏倚风险评估系列: (五)非随机干预性研究. 中华流行病学杂志, 2018, 39(3): 374-381.
7. 王浩, 唐晓宇, 王和平, 等. ROBINS-I: 评估非随机干预性研究偏倚风险的新工具. 中国循证心血管医学杂志, 2018, 10(7): 789-793.
8. 马佩芬, 李玲玲, 豆欣蔓. 某非随机干预性研究偏倚风险评估工具及使用方法的解读. 中华护理教育, 2021, 18(2): 187-192.
9. Morgan RL, Thayer KA, Santesso N, et al. Evaluation of the risk of bias in non-randomized studies of interventions (ROBINS-I) and the 'target experiment' concept in studies of exposures: rationale and preliminary instrument development. Environ Int, 2018, 120: 382-387.
10. Higgins J, Morgan R, Rooney A, et al. Risk of bias in non-randomized studies of exposure (ROBINS-E) (Launch version, 1 June 2022). 2022.
11. 魏来武, 陈削静, 曹钰彬, 等. 暴露类非随机研究偏倚风险评价工具(ROBINS-E2022版)解读. 中国循证医学杂志, 2023, 23(11): 1340-1350.
12. Higgins J, Morgan R, Rooney A, et al. Risk of bias in non-randomized studies of exposure (ROBINS-E) (Launch version, 20 June 2023). 2023.
13. ROBINS-I Development Group. The Risk of Bias in Non-Randomized studies - of Interventions Version 2 (ROBINS-I V2) assessment tool (for follow-up studies) November 2024. 2024.
14. 赵厚宇, 李海龙, 詹思延. 药物流行病学研究中的非死亡时间偏倚及其控制. 药物流行病学杂志, 2017, 26(3): 207-212.
15. 程义, 李冬冬, 陈峰, 等. 未亡时间偏倚的常用处理方法及进展. 中国卫生统计, 2022, 39(1): 153-156.
16. 杨召, 周家琛, 陈茹, 等. 肿瘤筛查研究中领先时间偏倚和病程长短偏倚的识别和校正. 中华预防医学杂志, 2019, 53(11): 1183-1187.
17. 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.
18. 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.
19. 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.
20. 曾宪涛, 包翠萍, 曹世义, 等. Meta分析系列之三: 随机对照试验的质量评价工具. 中国循证心血管医学杂志, 2012, 4(3): 183-185.

Chinese Journal of Evidence-Based Medicine

Latest ArticlesChinese Introduction to Risk of Bias in Nonrandomized Studies of Interventions Version 2 (ROBINS-I V2) in 2024

Abstract Full text Figures/Tables Video References Cited by

Format

Content