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ROBINS-I

ROBINS-I is a risk-of-bias assessment tool for non-randomised studies of interventions. Its seven domains cover the stages before, during and after intervention, with particular attention to confounding factors.

Applicable study designs

Non-randomised studies of interventions (when RCTs are unavailable).

Seven domains

  • Confounding factors.
  • Selection of participants.
  • Classification of interventions.
  • Deviations from interventions.
  • Missing data.
  • Measurement of outcomes.
  • Selection of the reported result.

How the overall judgement is formed

Each domain is rated low, moderate, serious or critical. The overall risk equals the worst domain — by design the study is benchmarked against a hypothetical ideal RCT.

When to use it

Used for non-randomised studies of interventions when RCTs are unavailable.

Primary source

Sterne JAC et al., BMJ 2016;355:i4919

Updated: 01.10.2026.

ROBINS-I assessment in Sciente

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

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