Follow-up and disposition

Track visits losses and completion

Missed measurements, withdrawal, loss of contact, treatment cessation and death have different meanings. Retain timing and reasons, and match the handling of each event to the estimand.

Flow diagram

Follow-up and dispositionF1.S1Begin observationF1.S2Conduct scheduled assessmentsF1.S3Document losses and deviationsF1.S4Define completion andcensoringF1.S5Reconcile participant statusF1.N1Visit and retention planVisitWindowMeasuresContact planResponsibilityF1.N2Disposition registerStatusDefinitionDate ruleReasonAnalysisimplicationCountF1.S0 Start flowFollow-up and dispositionF1.S999 End flowEnd flow

Steps

Begin observation

Define enrolled population and follow-up start.

Conduct scheduled assessments

Record visit windows, retention contacts and protocol procedures.

Document losses and deviations

Distinguish missed visits, withdrawal, loss to follow-up and death.

Define completion and censoring

Specify end-of-observation rules and competing events.

Reconcile participant status

Use mutually exclusive disposition groups within each defined time point.

Follow-up and disposition

End flow

Tables and supporting information

Visit and retention plan

Visit and retention planVisitWindowMeasuresContact planResponsibility

Plan retention and measurements.

Disposition register

Disposition registerStatusDefinitionDate ruleReasonAnalysisimplicationCount

Keep reasons and dates blank until observed.

Sources