Supervisor：Ministry of Education of the People's Republic of ChinaSponsor：Sichuan University Editor-in-chief：LI Youping Publishing period：
Monthly
ISSN：1672-2531CN：51–1656/R
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;
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.
Citation：HU Zhiqiao, WANG Liao, HUANG Chunpeng, CHEN Juntian, LI Jiachi, LIU Chang, FANG Hongzhi. Chinese introduction to risk of bias in nonrandomized studies of interventions version 2 (ROBINS-I V2) in 2024. Chinese Journal of Evidence-Based Medicine, 2025, 25(6): 704-709. doi: 10.7507/1672-2531.202412066Copy
Copyright ? the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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.
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.
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.
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.
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.
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.
19. 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.
Click the content below to copy and paste a set citation format。
Citation：HU Zhiqiao, WANG Liao, HUANG Chunpeng, CHEN Juntian, LI Jiachi, LIU Chang, FANG Hongzhi. Chinese introduction to risk of bias in nonrandomized studies of interventions version 2 (ROBINS-I V2) in 2024. Chinese Journal of Evidence-Based Medicine, 2025, 25(6): 704-709. doi: 10.7507/1672-2531.202412066
1/5
WeChat