Analysis and missingness plan

Specify estimates and attrition handling

Repeated measurements from one person are dependent. Address measurement timing, attrition and clustering, and distinguish descriptive trajectories from causal exposure comparisons.

Flow diagram

Analysis and missingness planF1.S1Specify estimates and objectivesF1.S2Justify information requirementsF1.S3Specify analysis methodsF1.S4Plan missing-data handlingF1.S5Assess attrition and sensitivityF1.S6Document assumptions and limitsF1.N1Analysis specificationsOutcomePopulationMethodDependenceAssumptionsDiagnosticsF1.N2Missingness and sensitivityPatternAssumptionPrimaryapproachAlternativeDiagnosticRationaleF1.N3Survival functionT is time from the specified origin to theevent, and S(t) is the probability ofremaining event-free beyond t. Estimationrequires a censoring assumption appropriateto the method. For a particular cause in thepresence of competing events, use acumulative incidence estimand rather thaninterpreting one minus cause-specificKaplan–Meier survival as its risk.F1.S0 Start flowAnalysis and missingness planF1.S999 End flowEnd flow

Steps

Specify estimates and objectives

Define target population, outcome summary and any comparison.

Justify information requirements

Choose precision or size rationale appropriate to the objectives.

Specify analysis methods

Address repeated observations, clustering and relevant dependence.

Plan missing-data handling

Distinguish intermittent missingness, dropout and informative follow-up.

Assess attrition and sensitivity

Compare plausible missingness and censoring assumptions.

Document assumptions and limits

Separate planned specifications from observed findings.

Analysis and missingness plan

End flow

Tables and supporting information

Analysis specifications

Analysis specificationsOutcomePopulationMethodDependenceAssumptionsDiagnostics

Add rows for each outcome and comparison.

Missingness and sensitivity

Missingness and sensitivityPatternAssumptionPrimaryapproachAlternativeDiagnosticRationale

Address loss to follow-up explicitly.

Survival function

T is time from the specified origin to the event, and S(t) is the probability of remaining event-free beyond t. Estimation requires a censoring assumption appropriate to the method. For a particular cause in the presence of competing events, use a cumulative incidence estimand rather than interpreting one minus cause-specific Kaplan–Meier survival as its risk.

Sources