Estimation and sensitivity plan

Specify estimates and robustness checks

Choose the measure before the denominator: prevalence, cumulative risk and incidence rate answer different questions. Report descriptive estimates with uncertainty and avoid attributing observed outcomes to a treatment without a comparative causal design.

Flow diagram

Estimation and sensitivity planF1.S1Define descriptive estimandsF1.S2Assess information and precisionF1.S3Specify estimation methodsF1.S4Address missingness and censoringF1.S5Plan sensitivity analysesF1.S6Document interpretation limitsF1.N1Precision scenariosScenarioMeasureExpectedinformationPrecisiontargetMethodRequiredinformationSourceF1.N2Sensitivity planQuestionPrimarydefinitionAlternativeRationaleInterpretationF1.N3Incidence rateD is the number of eligible incident eventsand Tᵢ is observed time at risk for person i.State the time unit and whether the outcomeis first occurrence or recurrent events. Arate is not a probability. An event countdivided by the initial cohort size is not avalid fixed-horizon risk when follow-up isincomplete; specify a survival orcompeting-risk approach as appropriate.F1.S0 Start flowEstimation and sensitivity planF1.S999 End flowEnd flow

Steps

Define descriptive estimands

Specify prevalence, incidence, rates or summaries with their populations and denominators.

Assess information and precision

Use available-data feasibility and interval precision; justify any size requirements.

Specify estimation methods

Specify uncertainty and use person-time for rates. For fixed-horizon risks, account for censoring and competing events; a simple event count divided by entrants is insufficient with incomplete follow-up.

Address missingness and censoring

Assess patterns and prespecify analysis assumptions.

Plan sensitivity analyses

Vary definitions, observation requirements and plausible missingness assumptions.

Document interpretation limits

Keep descriptive claims distinct from causal conclusions.

Estimation and sensitivity plan

End flow

Tables and supporting information

Precision scenarios

Precision scenariosScenarioMeasureExpectedinformationPrecisiontargetMethodRequiredinformationSource

Enter verified calculations only.

Sensitivity plan

Sensitivity planQuestionPrimarydefinitionAlternativeRationaleInterpretation

Keep future estimates separate from this plan.

Incidence rate

D is the number of eligible incident events and Tᵢ is observed time at risk for person i. State the time unit and whether the outcome is first occurrence or recurrent events. A rate is not a probability. An event count divided by the initial cohort size is not a valid fixed-horizon risk when follow-up is incomplete; specify a survival or competing-risk approach as appropriate.

Sources