Table 3.
The model comparison for hypothetical observed event rates with probability of flagged trials for the AE of special interest between Beta-Binomial independent model and Bayesian hierarchical model
| Example AEs | Expected Event Rate (πM) | True Proportion (π0) | Proportion of Flagged Trials After N = 53 Subjects Treated |
|
|---|---|---|---|---|
| Beta-Binomial Independent Model |
Bayesian Blinded Hierarchical Model |
|||
|
Pneumothorax Induced by HBO therapy |
2% | 2% | 0.14 | 0.02 |
| 2% | 12% | 1.00 | 0.98 | |
| 2% | 17% | 1.00 | 1.00 | |
| Signs of Pulmonary Dysfunction | 25% | 25% | 0.10 | 0.05 |
| 25% | 35% | 0.83 | 0.75 | |
| 25% | 40% | 0.97 | 0.91 | |
| Pneumonia | 40% | 40% | 0.09 | 0.06 |
| 40% | 50% | 0.76 | 0.72 | |
| 40% | 55% | 0.96 | 0.90 | |
| Critical decreased CPP (< 60 mmHg) | 75% | 75% | 0.10 | 0.07 |
| 75% | 85% | 0.89 | 0.87 | |
| 75% | 90% | 1.00 | 0.99 | |
| Critical hypotension (MAP< 70 mmHg) | 75% | 75% | 0.10 | 0.06 |
| 75% | 85% | 0.89 | 0.88 | |
| 75% | 90% | 1.00 | 0.99 | |
| Seizures during HBO treatment | 1% | 1% | 0.27 | 0.01 |
| 1% | 11% | 1.00 | 0.99 | |
| 1% | 16% | 1.00 | 1.00 | |
| Hypercarbia during transportation (PaCO2 > 45 mmHg) | 10% | 10% | 0.12 | 0.04 |
| 10% | 20% | 0.95 | 0.86 | |
| 10% | 25% | 1.00 | 0.97 | |
| No Signal Pattern | Family-Wise Error Rate (FWER) | |||
|
Overall Adverse Events |
Safe: π0 = πM | 0.62 | 0.19 | |