RoB 2| Study design(s) targeted by the tool | Randomized controlled trials (RCT)randomized-controlled-trial-rct |
|---|---|
| Additional details on designs | Test versions for cluster RCTs and cross-over RCTs also available |
| Tool area | Health |
| Link to the tool | Get the RoB 2 tool |
Details | |
| Website | https://www.riskofbias.info/ |
| Primary publication | Sterne JAC, Savovic J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366. |
| DOI | 10.1136/bmj.l4898 |
| Guidance document | Get the guidance for RoB 2 |
| Training | |
| Language | English |
| Translations | None known – please contact us if you are aware of any translations that should be listed here |
| Record last updated | 24/08/2023 |
Related tools and Publications | |
| Previous versions | |
| Updated versions | None |
| Related tools | Test version for cluster randomized trials Test version for cross-over trials |
| Evaluations | Crocker TF, Lam N, Jordão M, Brundle C, Prescott M, Forster A, Ensor J, Gladman J, Clegg A. Risk-of-bias assessment using RoB2 was useful but challenging and resource-intensive: observations from a systematic review. Journal of Clinical Epidemiology. 2023 Jun 24 Minozzi S, Cinquini M, Gianola S, Gonzalez-Lorenzo M, Banzi R. The revised Cochrane risk of bias tool for randomized trials (RoB2) showed low interrater reliability and challenges in its application. J Clin Epidemiol 2020;126:37–44. doi: 10.1016/j.jclinepi.2020.06.015 Minozzi S, Cinquini M, Gianola S, Gonzalez-Lorenzo M, Banzi R. 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. |
| Other publications | None known – please contact us if you are aware of any publications that should be listed here |
Key Criteria | |
| Focuses on risk of bias, or makes a distinction between items that assess risk of bias and other aspects of study quality | Yes |
| Offers a method to reach either a domain specific or overall assessment of risk of bias | Yes |
| Tool development involving a range of stakeholders from different disciplines (e.g. methodologists, statisticians, clinicians) | Yes |
| Avoids recommending use of summary numerical quality scores | Yes |
