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
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
Retain person and episode identifiers.
Follow-up specification
Prespecify how treatment changes affect analysis.