Stepped-wedge design scenarios and power

Account for time and clustering

Simulate or calculate using the actual rollout schedule and plausible correlation within and across periods. A simple parallel-cluster design effect does not describe stepped-wedge information.

Flow diagram

Stepped-wedge design scenarios and powerF1.S1Define rollout designF1.S2Specify correlation structuresF1.S3Specify time and exposure effectsF1.S4Assess loss and imbalanceF1.S5Evaluate design operatingcharacteristicsF1.N1Stepped-wedge power scenariosScenarioRolloutscheduleCorrelationstructureTime effectsMissingnessPowerPrimaryscheduleDelayedrolloutChangingcorrelationCluster lossF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowStepped-wedge design scenarios andpowerF1.S999 End flowEnd flow

Steps

Define rollout design

Specify clusters, sequences, periods and observation sampling.

Specify correlation structures

Distinguish within-period cluster, between-period cluster and repeated-person correlation.

Specify time and exposure effects

Record secular trends, transition periods and duration-dependent effects.

Assess loss and imbalance

Model unequal cluster sizes, missing periods and delayed rollout.

Evaluate design operating characteristics

Document simulation or design-compatible calculations and reproducibility.

Stepped-wedge design scenarios and power

End flow

Tables and supporting information

Stepped-wedge power scenarios

Stepped-wedge power scenariosScenarioRolloutscheduleCorrelationstructureTime effectsMissingnessPowerPrimaryscheduleDelayedrolloutChangingcorrelationCluster loss

Do not use a parallel-cluster design effect as the full power calculation.

Assumptions and rationale

Power depends on the actual rollout and correlation model; more observations alone may not resolve design weaknesses.

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