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. 2019 Mar 20;73(0 1):56–68. doi: 10.1080/00031305.2018.1529623

Table 1.

θ= a weighted average of stratum-specific log hazard ratios, each comparing BiV versus RiV pacing; PP0= posterior probability that the study objective has been met, PRR = posterior probability the study objective has not been met.

Decision boundaries
  Conclude objective is met and stop study early Conclude that sample size is sufficient to continue Determine that sample size is insufficient but elect not to increase sample size Conclude that sample size must be increased in increments of 175 Stop study for safety
First Interim Analysis PP0>0.99 0.90PP00.99 PRR > 0.9 PP0<.90 and PRR0.9 P (θ>0|data, prior) 0.90
Sample Size Re-estimation Phase N/A 0.90PP0 PRR > 0.9 PP0<.90 and PRR0.9 N/A
Second Interim Analysis PP0>0.99 If neither the outcome in column 2 nor the outcome in column 6 occurs, then the study will continue with the current sample size. P (θ>0|data, prior) 0.90    

NOTE: See Curtis et al. (2013) for details.