Groups and follow-up

Align eligibility exposure and observation

Define eligible alternatives at a common decision point. Consider new-user and active-comparator restrictions when clinically appropriate, and avoid immortal time created by classifying people using future treatment or survival.

Flow diagram

Groups and follow-upF1.S1Define eligible sourcepopulationF1.S2Define exposed and comparatorgroupsF1.S3Align baseline and covariatewindowsF1.S4Align eligibility assignmentand time zeroF1.S5Define exposure and follow-upstrategiesF1.S6Review comparability and exclusionsF1.N1Group definitionsGroupEligibilityExposure ruleIndex dateLook-backComparatorrationaleF1.N2Follow-up specificationStrategyStartEndSwitchingCensoringRationaleF1.S0 Start flowGroups and follow-upF1.S999 End flowEnd flow

Steps

Define eligible source population

Specify criteria, dates, observation coverage and prevalent/new-user choice.

Define exposed and comparator groups

Choose an active or other comparator with explicit rationale.

Align baseline and covariate windows

Measure baseline covariates before exposure assignment.

Align eligibility assignment and time zero

Prevent immortal-time and related timing biases.

Define exposure and follow-up strategies

Specify switching, discontinuation, censoring and competing events.

Review comparability and exclusions

Document selection and data limitations before effect estimation.

Groups and follow-up

End flow

Tables and supporting information

Group definitions

Group definitionsGroupEligibilityExposure ruleIndex dateLook-backComparatorrationale

Retain person and episode identifiers.

Follow-up specification

Follow-up specificationStrategyStartEndSwitchingCensoringRationale

Prespecify how treatment changes affect analysis.

Sources