Table 5 Randomization, blinding, and statistical methods
| CONSORT | ProACT |
|---|---|
| Randomization | |
| Sequence generation |
Patient-level, permuted block design Stratified by center, race, age Randomized equally to each study arm |
| Allocation concealment | Central Web-based randomization, accessible 24 h/day |
| Implementation |
Local center staff enroll patients via Web-based randomization system Web-based system then assigns patients to trial arm, based on computer generated allocation sequence |
| Blinding |
Statistical analysis and post-discharge outcome assessment staff are blinded to study arm By arm outcome data restricted to unblinded statistician and data safety monitoring board |
| Statistical methods |
Intention-to-treat, as per pre-established analysis plan (primary analysis) Per-protocol analysis, where procalcitonin guideline is followed |
