Feasibility analysis and refinement

Summarize findings and required changes

Combine numerical progression criteria with prespecified contextual review of delivery, acceptability and safety. Document amendments to the planned definitive trial rather than interpreting lack of statistical significance as lack of benefit.

Flow diagram

Steps

Specify feasibility summaries

Define denominators, intervals, missingness and any qualitative synthesis.

Assess recruitment and delivery barriers

Plan process evaluation, acceptability and safety summaries.

Apply progression criteria

Document how quantitative and contextual evidence inform decisions.

Specify later-study refinement

Link each finding to potential changes in design or procedures.

Plan transparent reporting

Separate feasibility conclusions and exploratory efficacy findings.