Cochrane Risk of Bias Tool (RoB 2) — Assessment Guide
The revised Cochrane Risk of Bias tool (RoB 2) assesses risk of bias in randomized controlled trials across five domains. This guide walks through each domain, explains signalling questions, and shows how to reach overall bias judgments.
Audience
Cochrane reviewers, systematic review authors, and clinical trialists.
Use Case
Assess risk of bias in randomized controlled trials for Cochrane and non-Cochrane systematic reviews.
Guide Depth
4 steps · 5 features
Workflow
- 1Select the effect of interest (assignment or adherence).
- 2Work through signalling questions for each of the 5 domains.
- 3Apply the judgment algorithm for each domain.
- 4Generate overall risk of bias judgment and traffic light table.
Outcome Signals
- Consistent, reproducible risk of bias assessments
- Clear documentation for peer review and publication
- Support GRADE evidence certainty ratings
Execution Checklist
- All 5 RoB 2 domains explained with signalling questions
- Judgment criteria: low risk, some concerns, high risk
- Traffic light visualization and summary plots
- Effect-of-assignment vs effect-of-adherence assessment
- Integration with GRADE certainty of evidence framework
Common Questions
Composite Team Feedback
Representative feedback patterns from teams using this kind of medical literature workflow.
Clinician
"Paper review now tells me what the methods and figures actually mean before I rely on a study in practice."
Faster evidence triage for high-stakes reading
Clinical Pharmacist
"We use these workflows to sanity-check new evidence before it changes how we update recommendations."
More confident evidence decisions