ROBINS-I · non-randomised studies

Risk-of-bias example: ROBINS-I for cohort studies

ROBINS-I traffic-light plot for eight cohort studies with the seven ROBINS-I domains, judged low, moderate, serious, critical or no information.

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Risk of bias domainsStudyD1D2D3D4D5D6D7OverallJohansson 2012×+++−+−×Kato 2014−++++−+−Larsen 2015!−+−×+−!Moreau 2016−++++++−Nakamura 2017×+−+−−+×Okafor 2019−−+?++−−Petersen 2020×+++?−+×Quinn 2021−++++++−D1: Bias due to confoundingD2: Bias due to selection of participantsD3: Bias in classification of interventionsD4: Bias due to deviations from intended interventionsD5: Bias due to missing dataD6: Bias in measurement of outcomesD7: Bias in selection of the reported resultJudgement:+Low−Moderate×Serious!Critical?No information
ROBINS-I judgements for eight cohort studies; confounding drives the overall judgements. Illustrative data.

About this example

ROBINS-I rates non-randomised studies of interventions against a hypothetical target trial, on a four-level scale from low to critical risk of bias. Confounding is usually the domain that decides the overall judgement, and this example shows the typical pattern: a column of moderate, serious and one critical judgement in D1.

“No information” gets its own blue symbol, so readers can tell missing reporting from an assessed risk. A study at critical risk in any domain is at critical risk overall, and most reviews leave such studies out of the synthesis.

The data

StudyConfoundingSelectionClassificationDeviationsMissing dataMeasurementReportingOverall
Johansson 2012SeriousLowLowLowModerateLowModerateSerious
Kato 2014ModerateLowLowLowLowModerateLowModerate
Larsen 2015CriticalModerateLowModerateSeriousLowModerateCritical
Moreau 2016ModerateLowLowLowLowLowLowModerate
Nakamura 2017SeriousLowModerateLowModerateModerateLowSerious
Okafor 2019ModerateModerateLowNo informationLowLowModerateModerate
Petersen 2020SeriousLowLowLowNo informationModerateLowSerious
Quinn 2021ModerateLowLowLowLowLowLowModerate

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