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 \( \left({P}_{cri{t}_{Ind}}=0.9\right) \) | Bayesian Blinded Hierarchical Model \( \left({P}_{crit_I}=0.9\right) \) | |||
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 | |