Sample size and power
Endpoint and method → effect and variability assumptions → scenarios → selected design → rationale
Flow diagram
Steps
Endpoint, estimand and method
Define the endpoint, comparison, estimator/test and planned analysis population.
Design assumptions and evidence
Specify effect, variability/event rate, allocation, sidedness and design-specific assumptions.
Calculation or simulation method
Record external method/software/version and applicable input domain.
Evaluate scenario grid
Compare plausible assumptions and independently verified calculations.
Select design and sensitivity range
Choose a scenario and explain robustness to uncertainty.
Recruitment, information and feasibility
Distinguish analyzable sample size, recruited population, required events and cluster count.
Record reviewed design specification
Record selected inputs, calculation provenance, reviewer and version.
Tables and supporting information
Sample-size and power scenarios
Enter external calculations. Blank values are unknown, not zero.
Recruitment and information assumptions
Adjustments depend on the method; this table does not calculate inflation.
Evidence for design assumptions
Cite effect, variability, event-rate and retention evidence.
Power definition
Power is defined under a specified alternative and decision rule; this identity is not a sample-size formula.