Crossover analysis specification

Specify period sequence and sensitivity

Prespecify treatment and period effects and a suitable repeated-measure covariance structure. Avoid selecting a first-period-only analysis on the basis of a preliminary carryover test. Investigate plausible carryover through design and sensitivity analyses.

Flow diagram

Crossover analysis specificationF1.S1Specify treatment-effect modelF1.S2Account for period and sequenceF1.S3Address carryover concernsF1.S4Handle missing periodsF1.S5Report contrasts and uncertaintyF1.N1Crossover analysis planContrastModelPeriod termsDependenceMissingnessSensitivityPrimarytreatmenteffectPeriodsensitivityIncompletesequencesensitivityF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowCrossover analysis specificationF1.S999 End flowEnd flow

Steps

Specify treatment-effect model

Choose a paired or repeated-measure method appropriate to the outcome.

Account for period and sequence

State model terms and assumptions without treating periods as independent.

Address carryover concerns

Prespecify design-based carryover reasoning and sensitivity. Do not select a first-period-only analysis using a preliminary carryover significance test.

Handle missing periods

Define assumptions and methods for incomplete sequences.

Report contrasts and uncertainty

Report the prespecified within-participant contrasts and uncertainty, period and sequence terms, missing periods and sensitivity results.

Crossover analysis specification

End flow

Tables and supporting information

Crossover analysis plan

Crossover analysis planContrastModelPeriod termsDependenceMissingnessSensitivityPrimarytreatmenteffectPeriodsensitivityIncompletesequencesensitivity

Do not default to an unpaired parallel-group test.

Assumptions and rationale

Do not use a low-power carryover test as an automatic rule to discard later periods or choose a favorable analysis.

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