Crossover Trial Design
Cross-source consensus on Crossover Trial Design from 1 sources and 6 claims.
1 sources · 6 claims
How it works
Dosage & preparation
Highlighted claims
- Each enrolled child undergoes two separate sedation sessions separated by a minimum 5-day washout period. — Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol
- With α = 0.05 and 80% power, 72 participants are required; allowing for 10% dropout sets the target enrolment at 80 children. — Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol
- An independent DSMB reviews data after every 20 enrolled cases and can recommend early termination using a Haybittle-Peto stopping boundary of p < 0.001. — Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol
- The crossover design was selected because within-patient variability is smaller than between-patient variability, enabling a smaller required sample than a parallel-group design. — Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol
- A hierarchical testing strategy controls family-wise type I error, first testing superiority for desaturation and then non-inferiority for psychotomimetic effects. — Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol
- Carryover effects are assessed via a treatment × period interaction term; if significant, a sensitivity analysis uses first-period data only, treating the trial as a parallel-group study. — Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol