Skip to main content

Table 5 Final decision rule retained through the sensitivity analysis: thresholds to be applied at each interim analysis and final overall rates of misclassifications, according to the event

From: A Bayesian non-inferiority approach using experts’ margin elicitation – application to the monitoring of safety events

  Event
  Death IVH [2] NEC [3] Retinopathy
Thresholds \(\tau *^{L}_{j}\)[1], to applied in analysis     
1 0.95 0.95 0.95 0.95
2 0.95 0.95 0.95 0.95
3 0.95 0.95 0.95 0.95
4 0.95 0.95 0.95 0.95
5 0.949 0.949 0.950 0.949
6 0.948 0.948 0.949 0.948
7 0.944 0.944 0.948 0.946
8 0.934 0.933 0.944 0.938
9 0.907 0.903 0.932 0.918
10 0.832 0.821 0.902 0.862
11 0.63 0.60 0.82 0.71
Overall rate of errors     
Class a misclassifications [4] 0.09 0.09 0.10 0.10
Class b misclassifications [5] <0.01 0.07 0.20 0.27
  1. 1\(\tau *^{L}_{j}\) : threshold to apply in the Bayesian decision rule for the event k in the subgroup j, at the l interim analysis: the rule will conclude that their is an unacceptable excess if \( {P (\delta ^{l}_{j}) \geq \tau ^{l}_{j}}\)
  2. 2IVH: Intraventricular haemorrhage
  3. 3NEC: Necrotizing enterocolitis
  4. 4Class a misclassifications: Trials that conclude that the difference between arms is Unacceptable, while it is not true
  5. 5Class b misclassifications: Trials that conclude that the difference between arms is Acceptable, while it is not true