Sample size and precision
Justify information needed for decisions
Choose information needs for the feasibility measures. Report interval uncertainty and operational assumptions; an arbitrary small sample or a definitive efficacy power calculation is not a substitute for this rationale.
Flow diagram
Steps
Define required feasibility information
Specify estimates needed for progression and later-study planning.
Set precision targets
Justify intervals for feasibility rates or other measures.
Evaluate information scenarios
Consider recruitment availability, attrition and measurement uncertainty.
Assess operational feasibility
Balance information with resources and study constraints.
Document selected rationale
Record verified calculation method and limitations; do not default to efficacy power.
Sample size and precision
End flow
Tables and supporting information
Feasibility precision scenarios
Keep all numeric assumptions and outputs empty until entered and verified.