Table 4 Outcomes analysis
Outcome | Data | Method of analysis |
|---|---|---|
Feasibility | ||
 Enrollment rate | # enrolled per month | Descriptive statistics using means, proportions, and variances (no inferential statistics) |
 Retention | % completing 1-year follow-up | |
 Data completeness | % complete data, including: • Safety outcomes • Treatment group allocation • FRI criteria | |
Planned primary endpoint | ||
 Occurrence of fracture-related infection | FRI criteria (time-to-event) | Relative hazard as estimated by two-sided binomial regression with the complementary log-log link, with a type I error rate (alpha) of 0.05. |
Planned secondary endpoints | ||
 Occurrence of nonunion | Nonunion criteria (binary) | Fisher’s exact test on the 2 × 2 cross-tabulation for binary variables Comparison means of active agent group and placebo group using two-tailed Student’s t test (alpha = 0.05) for continuous variables |
 Occurrence of unplanned reoperation | Review of complications (binary) | |
 Health-related quality of life | EQ-5D (continuous) | |
 Radiographic healing | mRUST (continuous) | |
 Clinical healing | FIX-IT (continuous) | |
 Suggestive FRI | FRI criteria (binary) | |
 Lost productivity | WPAI (continuous) | |
 Direct medical costs | Micro-costing (continuous) | |