Self-controlled observation and risk windows

Partition baseline and risk periods

Partition each person’s observation into nonoverlapping intervals with recorded durations. Define risk windows before inspecting associations and address pre-exposure periods, repeated exposures and age or calendar effects.

Flow diagram

Self-controlled observation and risk windowsF1.S1Define observation start and endF1.S2Construct exposure episodesF1.S3Partition risk and baseline periodsF1.S4Partition age and calendar effectsF1.S5Check nonoverlap and completenessF1.N1Interval specificationPeriodStart ruleEnd ruleOverlap ruleRationaleRisk windowBaselinePre-exposureWashoutAge bandF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowSelf-controlled observation and riskwindowsF1.S999 End flowEnd flow

Steps

Define observation start and end

Document age bounds, registration, death and capture coverage.

Construct exposure episodes

Specify dose dates, repeats and overlapping exposure handling.

Partition risk and baseline periods

Define prespecified risk, washout and optional pre-exposure periods.

Partition age and calendar effects

Record time-varying strata and exact person-time allocation.

Check nonoverlap and completeness

Ensure all included observation time has a documented classification.

Self-controlled observation and risk windows

End flow

Tables and supporting information

Interval specification

Interval specificationPeriodStart ruleEnd ruleOverlap ruleRationaleRisk windowBaselinePre-exposureWashoutAge band

Specify windows without choosing them to maximize observed associations.

Assumptions and rationale

Time-varying confounding is not removed by within-person comparisons; risk windows require clinical justification.

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