Bias and sensitivity plan

Assess selection and measurement errors

Consider participation and source-population selection separately from exposure measurement and confounding. Sensitivity analyses should probe plausible mechanisms, rather than only changing a significance threshold.

Flow diagram

Bias and sensitivity planF1.S1Assess selection mechanismsF1.S2Assess exposure measurement errorF1.S3Assess confounding and overmatchingF1.S4Specify bias analysesF1.S5Qualify study conclusionsF1.N1Bias analysis scenariosBias sourceAssumptionAlternativeEvidenceMethodInterpretationF1.S0 Start flowBias and sensitivity planF1.S999 End flowEnd flow

Steps

Assess selection mechanisms

Consider case ascertainment, control sampling and nonparticipation.

Assess exposure measurement error

Consider recall, differential misclassification and observer effects.

Assess confounding and overmatching

Justify matching and adjustment decisions.

Specify bias analyses

Define plausible alternative sampling, definitions or error parameters.

Qualify study conclusions

Document limits and supporting evidence.

Bias and sensitivity plan

End flow

Tables and supporting information

Bias analysis scenarios

Bias analysis scenariosBias sourceAssumptionAlternativeEvidenceMethodInterpretation

Prespecify justified alternatives.

Sources