| Study design(s) targeted by the tool | Systematic reviewssystematic-review Randomized controlled trials (RCT)randomized-controlled-trial-rct Cohort studiescohort-study Case-control studiescase-control-study Cross-sectional studiescross-sectional-study Case seriescase-series Non-randomised studies of interventionsnrsi |
|---|---|
| Additional details on designs | Studies of adverse effects, studies of drug safety |
| Tool area | Health |
| Link to the tool | Get the PROTECT Checklist |
Details | |
| Website | |
| Primary publication | Faillie JL, Ferrer P, Gouverneur A, Driot D, Berkemeyer S, Vidal X, et al. A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events. J Clin Epidemiol. 2017;86:168-75. |
| DOI | 10.1016/j.jclinepi.2017.04.023 |
| Guidance document | |
| 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 | 14/08/2023 |
Related tools and Publications | |
| Previous versions | None |
| Updated versions | None |
| Related tools | None |
| Evaluations | None known – please contact us if you are aware of any evaluations that should be listed here |
| 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 | No |
| 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 |
