Interpretation of risk of bias instrument for use in systematic reviews for randomized controlled trials (ROBUST-RCT)_Chinese Journal of Evidence-Based Medicine

Authors：

LI Wenjing ¹ , LIU Jiayi ² , GE Long ^2,3 ,  WANG Ying ¹

1. Center for Evidence-Based Medicine, Beijing University of Chinese Medicine, Beijing 102488, P. R. China;
2. Department of Health Policy and Management, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
3. Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, P. R. China;

Corresponding?author：

WANG Ying, Email: yingwwy@163.com

Keywords：

Randomized controlled trial; Risk of bias; Instrument; Systematic review

DOI：

10.7507/1672-2531.202601221

Video：

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Abstract Full text Figures/Tables Video References Cited by

Risk of bias instrument for use in systematic reviews for randomized controlled trials (ROBUST-RCT) is a newly developed instrument for assessing risk of bias of randomized controlled trials included in systematic reviews. It was developed by 19 experts in risk of bias methodology and evidence-based medicine education from 12 countries. The expert panel convened 16 online meetings of 1.5 hours each from February to October 2023 to complete the development of the instrument. This article introduces the background, development process, items, and application of ROBUST-RCT. ROBUST-RCT consists of six core items (random sequence generation, allocation concealment, blinding of participants, blinding of healthcare providers, blinding of outcome assessors, and outcome data not included in analysis) and eight optional items. Assessment of core items employs a two-step approach. User testing confirmed the ease of practical application and user-friendliness of ROBUST-RCT. Because of its rigorously development, clear structure, concise language and practicability, ROBUST-RCT will become an important instrument for assessing risk of bias of randomized trials in systematic reviews.

Citation： LI Wenjing, LIU Jiayi, GE Long, WANG Ying. Interpretation of risk of bias instrument for use in systematic reviews for randomized controlled trials (ROBUST-RCT). Chinese Journal of Evidence-Based Medicine, 2026, 26(8): 951-957. doi: 10.7507/1672-2531.202601221 Copy

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1. Guyatt GH, Rennie D, Meade MO, et al. Users’ guides to the medical literature: a manual for evidence-based clinical practice[Z]. McGraw-Hill Education, 2015.
2. Verhagen AP, de Vet HC, de Bie RA, et al. The art of quality assessment of RCTs included in systematic reviews[J]. J Clin Epidemiol, 2001, 54(7): 651-654.
3. Wang Y, Ghadimi M, Wang Q, et al. Instruments assessing risk of bias of randomized trials frequently included items that are not addressing risk of bias issues[J]. J Clin Epidemiol, 2022, 152: 218-225.
4. CLARITY Group. Methods commentary: risk of bias in randomized trials 1[Z].
5. Akl EA, Sun X, Busse JW, et al. Specific instructions for estimating unclearly reported blinding status in randomized trials were reliable and valid[J]. J Clin Epidemiol, 2012, 65(3): 262-267.
6. Sterne JAC, Savovi? J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials[J]. BMJ, 2019, 366: l4898.
7. Babi? A, Barcot O, Viskovi? T, et al. Frequency of use and adequacy of Cochrane risk of bias tool 2 in non-Cochrane systematic reviews published in 2020: meta-research study[J]. Res Synth Methods, 2024, 15(3): 430-440.
8. Martimbianco ALC, Sá KMM, Santos GM, et al. Most Cochrane systematic reviews and protocols did not adhere to the Cochrane's risk of bias 2. 0 tool[J]. Rev Assoc Med Bras (1992), 2023, 69(3): 469-472.
9. Crocker TF, Lam N, Jord?o M, et al. Risk-of-bias assessment using Cochrane's revised tool for randomized trials (RoB 2) was useful but challenging and resource-intensive: observations from a systematic review[J]. J Clin Epidemiol, 2023, 161: 39-45.
10. 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]. J Clin Epidemiol, 2020, 126: 37-44.
11. Wang Y, Keitz S, Briel M, et al. Development of ROBUST-RCT: risk of bias instrument for use in systematic reviews-for randomised controlled trials[J]. BMJ, 2025, 388: e081199.
12. Guyatt GH, Ebrahim S, Alonso-Coello P, et al. GRADE guidelines 17: assessing the risk of bias associated with missing participant outcome data in a body of evidence[J]. J Clin Epidemiol, 2017, 87: 14-22.
13. Guyatt G, Wang Y, Eachempati P, et al. Core GRADE 4: rating certainty of evidence-risk of bias, publication bias, and reasons for rating up certainty[J]. BMJ, 2025, 389: e083864.
14. 蘭州大學數智循證交叉創新團隊. SmartEBM AI[Z].

Chinese Journal of Evidence-Based Medicine

Interpretation of risk of bias instrument for use in systematic reviews for randomized controlled trials (ROBUST-RCT)

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