Self-controlled assumptions and sensitivity

Assess event-dependent exposure and observation

Events may delay exposure or end observation. Assess those mechanisms and recurrence assumptions; use a suitable extension or reconsider the design. Testing alternative windows does not repair every assumption violation.

Flow diagram

Self-controlled assumptions and sensitivityF1.S1Assess event-dependent exposureF1.S2Assess event-dependent observationF1.S3Assess recurrent-event assumptionsF1.S4Plan window and time-effectsensitivityF1.S5Select extensions or limit claimsF1.N1SCCS assumption registerAssumptionEvidenceViolation concernPlanned responseExposureindependenceObservationindependenceEvent recurrenceTime effectsF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowSelf-controlled assumptions andsensitivityF1.S999 End flowEnd flow

Steps

Assess event-dependent exposure

Determine whether an event changes subsequent exposure probability.

Assess event-dependent observation

Evaluate event-related death or observation termination.

Assess recurrent-event assumptions

Document dependence, event spacing and any first-event restriction.

Plan window and time-effect sensitivity

Compare justified age bands, seasonal structures and risk windows.

Select extensions or limit claims

Document why standard or extended SCCS is suitable before inference.

Self-controlled assumptions and sensitivity

End flow

Tables and supporting information

SCCS assumption register

SCCS assumption registerAssumptionEvidenceViolation concernPlanned responseExposureindependenceObservationindependenceEvent recurrenceTime effects

Use a design-specific extension when assumptions fail; no correction is automatically selected.

Assumptions and rationale

A conventional SCCS model cannot be assumed valid in event-dependent settings.

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