Stepped-wedge period data and follow-up

Track repeated observations and missingness

Preserve cluster-period keys and repeated-person identifiers when relevant. Record calendar time and time since transition separately; changing participant composition can affect interpretation.

Flow diagram

Stepped-wedge period data and follow-upF1.S1Validate assigned and actualtransitionF1.S2Construct cluster-period recordsF1.S3Link repeated participants whenapplicableF1.S4Track missingness and deviationsF1.S5Freeze analysis populationsF1.N1Cluster-period data rulesFieldDefinitionTime anchorMissingnessPopulation ruleSequenceCalendar periodActualtransitionExposuredurationParticipant IDF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowStepped-wedge period data andfollow-upF1.S999 End flowEnd flow

Steps

Validate assigned and actual transition

Retain sequence, scheduled date and delivered intervention date.

Construct cluster-period records

Record calendar periods, exposure duration and sampling denominators.

Link repeated participants when applicable

Respect closed/open cohort or repeated cross-sectional sampling.

Track missingness and deviations

Separate absent clusters, missing periods and missing individual outcomes.

Freeze analysis populations

Specify transition-window handling and estimand-specific inclusion.

Stepped-wedge period data and follow-up

End flow

Tables and supporting information

Cluster-period data rules

Cluster-period data rulesFieldDefinitionTime anchorMissingnessPopulation ruleSequenceCalendar periodActualtransitionExposuredurationParticipant ID

Do not collapse repeated periods into a single before/after observation.

Assumptions and rationale

Actual transition and assigned schedule differ under deviations; analysis handling must follow the chosen estimand.

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