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 |