Table 2

Summary of feasibility outcomes analysis plan

ObjectiveOutcomeCriteria for success of feasibilityMethod of analysis
To determine the feasibility of conducting the multi-centre SAFETY international RCTRecruitment measureEnrolment of pilot sample within 2 yearsDescriptive statistics—reported as counts (percent) for categorical variables and means (SD) for continuous variables with 95% CI
Protocol adherence measureProtocol adherence of 85% or greater
Participant retention measureLoss-to-participant follow-up of 15% or less
Maintenance of data quality measureData completeness of 95% or greater for the definitive primary outcome
Data completeness of 85% or greater for the secondary outcomes
  • RCT, randomised controlled trial; SAFETY, Surveillance After Extremity Tumor Surgery.