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RoB 2

RoB 2 (Cochrane Risk of Bias 2) is a tool for appraising risk of bias in randomised controlled trials. Assessment runs across five domains with signalling questions; each domain receives a judgement (low risk / some concerns / high risk), then an overall judgement is derived.

Applicable study designs

Randomised controlled trials (RCTs), at the level of a specific outcome.

Five domains

  • Randomisation process.
  • Deviations from intended interventions.
  • Missing outcome data.
  • Measurement of the outcome.
  • Selection of the reported result.

How the overall judgement is formed

Each domain is rated from its signalling questions as low risk, some concerns, or high risk. The overall risk for the outcome is driven by the worst domain: high if any domain is high risk or multiple raise concerns.

When to use it

Applied to randomised controlled trials within a systematic review to assess the reliability of the intervention effect.

Primary source

Sterne JAC et al., BMJ 2019;366:l4898

Updated: 01.10.2026.

RoB 2 assessment in Sciente

The platform applies RoB 2 to full-text project articles and shows a supporting excerpt beneath each judgement.

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