Target trial specification

Define hypothetical trial and estimands

Specify the hypothetical trial before looking for convenient proxies. Separate its assignment mechanism from observed treatment choice, and name the causal contrast rather than assuming every comparison estimates an intention-to-treat effect.

Flow diagram

Target trial specificationF1.S1Define causal questionF1.S2Define target eligibility and timezeroF1.S3Specify hypothetical assignmentF1.S4Specify follow-up and estimandsF1.S5Specify target analysisF1.N1Target protocolElementTarget-trialdefinitionRationaleEvidenceEligibilityStrategiesAssignmentTime zeroFollow-upOutcomeEstimandAnalysisF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowTarget trial specificationF1.S999 End flowEnd flow

Steps

Define causal question

Specify treatment strategies and clinically meaningful contrast.

Define target eligibility and time zero

Align eligibility assessment, assignment and follow-up start.

Specify hypothetical assignment

Specify how the hypothetical trial would assign strategies, then state how observed treatment choice will be used in the emulation. Observational data do not supply randomization.

Specify follow-up and estimands

Define outcomes, intercurrent events, treatment-policy or adherence effects and summary measure.

Specify target analysis

Record the target analysis before mapping to observed sources.

Target trial specification

End flow

Tables and supporting information

Target protocol

Target protocolElementTarget-trialdefinitionRationaleEvidenceEligibilityStrategiesAssignmentTime zeroFollow-upOutcomeEstimandAnalysis

Keep hypothetical trial requirements distinct from implementable data definitions.

Assumptions and rationale

The target trial is hypothetical; observational data do not acquire randomization by adopting trial terminology.

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