ROBINS-I| Study design(s) targeted by the tool | Cohort studiescohort-study Non-randomised studies of interventionsnrsi |
|---|---|
| Additional details on designs | Comparative follow-up studies of the effects of interventions; modifications are in process for other designs. These will be added as they become available. |
| Tool area | Health |
| Link to the tool | Get the ROBINS-I tool (Google doc) |
Details | |
| Website | https://www.riskofbias.info/ |
| Primary publication | Sterne JA, Hernan MA, Reeves BC, Savovic J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 2016;355 |
| DOI | 10.1136/bmj.i4919 |
| Guidance document | Get the ROBINS-I guidance (Google doc) |
| Training | None known – please contact us if you are aware of any training that should be listed here |
| 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 | None |
| Updated versions | None |
| Related tools | |
| Evaluations | Jeyaraman MM, Robson RC, Copstein L, Al-Yousif N, Pollock M, Xia J, et al. Customized guidance/training improved the psychometric properties of methodologically rigorous risk of bias instruments for non-randomized studies. J Clin Epidemiol. 2021;136:157-67. Zhang Y, Huang L, Wang D, Ren P, Hong Q, Kang D. The ROBINS-I and the NOS had similar reliability but differed in applicability: A random sampling observational studies of systematic reviews/meta-analysis. J Evid Based Med. 2021;14(2):112-22. Minozzi S, Cinquini M, Gianola S, Castellini G, Gerardi C, Banzi R. Risk of bias in nonrandomized studies of interventions showed low inter-rater reliability and challenges in its application. J Clin Epidemiol. 2019;112:28-35. Losilla JM, Oliveras I, Marin-Garcia JA, Vives J. Three risk of bias tools lead to opposite conclusions in observational research synthesis. J Clin Epidemiol. 2018;101:61-72. |
| Other publications | The Cochrane handbook contains some guidance on how to asssess other non-randomized designs including uncontrolled before-after studies including interrupted time-series and controlled before after-studies.
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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 developed for use across topic areas (i.e. not developed for specific clinical area such as physiotherapy or dentistry) | Yes |
| Avoids recommending use of summary numerical quality scores | Yes |
