Emulation eligibility and strategy assignment

Align entry strategies and time-zero

Eligibility, assignment and follow-up start must align. Grace periods, repeated eligibility and cloning are optional design choices that need explicit implementations; never require future survival to qualify entry.

Flow diagram

Emulation eligibility and strategy assignmentF1.S1Identify candidate episodesF1.S2Assess eligibility at entryF1.S3Align strategy assignmentF1.S4Choose episode implementationF1.S5Create analysis entry definitionsF1.N1Emulation entry rulesElementOperationalruleTime anchorRationaleSensitivityEligibilityStrategyassignmentGrace periodRepeated entryF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowEmulation eligibility and strategyassignmentF1.S999 End flowEnd flow

Steps

Identify candidate episodes

Define the population and whether people can contribute repeated eligible episodes.

Assess eligibility at entry

Use only information available by the specified time zero.

Align strategy assignment

Specify treatment initiation, comparator rules and any grace period.

Choose episode implementation

Use a single baseline, sequential trials or cloning only when required and justified.

Create analysis entry definitions

Retain episode IDs, timing and overlap rules without using future survival to qualify entry.

Emulation eligibility and strategy assignment

End flow

Tables and supporting information

Emulation entry rules

Emulation entry rulesElementOperationalruleTime anchorRationaleSensitivityEligibilityStrategyassignmentGrace periodRepeated entry

Record optional sequential or cloning methods explicitly.

Assumptions and rationale

Avoid immortal-time bias by aligning eligibility, assignment and follow-up; a grace period requires an explicit analytical strategy.

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