Estimation and sensitivity plan
Specify effects and bias analyses
Use an estimator and uncertainty method compatible with the target contrast, adjustment and follow-up. Report absolute measures where useful. Hazard ratios, rate ratios, risk ratios and odds ratios are not interchangeable.
Flow diagram
Steps
Specify target effects
Define effect measures, time horizons and target populations.
Specify effect estimation
Link to adjustment strategy; address dependence and model assumptions.
Assess information and feasibility
Document effective information, event availability and precision.
Address missingness and treatment changes
Specify missingness, switching, censoring and competing-event approaches.
Plan bias and sensitivity analyses
Assess residual confounding, definitions, model choices and informative censoring.
Define interpretation and reporting
Distinguish associational findings from causally identified effects.
Estimation and sensitivity plan
End flow
Tables and supporting information
Effect analysis plan
Specify methods without fabricated results.
Bias and sensitivity scenarios
Document plausible alternative assumptions.
Risk contrast at a fixed horizon
R₁(t) and R₀(t) are risks by the same horizon t for the two specified groups or strategies. State the target population and whether risks are crude, standardized or weighted. A causal interpretation requires justified identification assumptions. Hazard ratios and rate ratios are different quantities and cannot simply be substituted for a risk ratio; handle censoring and competing events consistently.