Emulation sensitivity and feasibility

Evaluate deviations and identifying assumptions

Assess support, protocol-to-data deviations, measurement error and residual confounding. Restrict the target question when the available data cannot support it. TARGET reporting guidance does not certify that causal assumptions hold.

Flow diagram

Emulation sensitivity and feasibilityF1.S1Review protocol deviationsF1.S2Assess empirical supportF1.S3Plan measurement sensitivityF1.S4Plan causal sensitivityF1.S5Document feasible claimsF1.N1Emulation sensitivity registerAssumptionConcernAssessmentAlternativeDecisionUnmeasuredconfoundingPositivityMeasurementTime zeroCensoringF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowEmulation sensitivity and feasibilityF1.S999 End flowEnd flow

Steps

Review protocol deviations

Link each target-to-data mismatch to a plausible bias pathway.

Assess empirical support

Evaluate eligible episodes, outcomes, observation and treatment overlap.

Plan measurement sensitivity

Vary justified code definitions, timing and exposure grace rules.

Plan causal sensitivity

Address unmeasured confounding, informative censoring and optional negative controls.

Document feasible claims

Retain limitations and unsupported estimands alongside primary specifications.

Emulation sensitivity and feasibility

End flow

Tables and supporting information

Emulation sensitivity register

Emulation sensitivity registerAssumptionConcernAssessmentAlternativeDecisionUnmeasuredconfoundingPositivityMeasurementTime zeroCensoring

Specify alternatives before outcome-driven selection.

Assumptions and rationale

Sensitivity analyses assess fragility; they do not certify causal identification.

Method and protocol evidence

Attach the protocol, methodological sources and versioned software specification supporting these decisions. Record citations and provenance; do not enter participant identifiers.

Sources