Number of studies=5 | Number of patients=100 | Group ratio=1 | Control arm probability=0.001 | Number of simulated data sets=2500 | Between-study SD=0.5 | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|

Excluding BA0E studies | Including BA0E studies | |||||||||||||||

Positive treatment effect | No treatment effect | Positive treatment effect | ||||||||||||||

OR=1.25 | OR=2 | OR=5 | OR=1 | OR=1 | OR=1.25 | OR=2 | OR=5 | |||||||||

Methods | %bias | %bias | %bias | %bias | % bias | %bias | %bias | %bias | ||||||||

IV random effects | 1.11 | −12.6 | 1.45 | −37.9 | 2.28 | −119.3 | 1.01 | 0.8 | 1.00 | <0.1 | 1.03 | −21.4 | 1.13 | −77.0 | 1.56 | −220.5 |

IV fixed effects | 1.11 | −12.6 | 1.46 | −37.0 | 2.28 | −119.3 | 1.01 | 0.7 | 1.00 | <0.1 | 1.03 | −21.4 | 1.15 | −73.9 | 1.56 | −220.5 |

M-H random effects | 1.11 | −12.5 | 1.45 | −37.9 | 2.28 | −119.3 | 1.01 | 0.8 | 1.00 | <0.1 | 1.03 | −21.4 | 1.13 | −77.0 | 1.56 | −220.5 |

M-H fixed effects | 1.11 | −12.6 | 1.46 | −37.0 | 2.30 | −117.4 | 1.01 | 0.8 | 1.00 | <0.1 | 1.03 | −21.4 | 1.15 | −73.9 | 1.62 | −208.6 |

Peto | 1.19 | −5.0 | 1.87 | −7.0 | 3.68 | −35.9 | 1.01 | 1.4 | 1.00 | <0.1 | 1.04 | −20.2 | 1.19 | −68.1 | 1.92 | −160.4 |

Negative treatment effect | No treatment effect | Negative treatment effect | ||||||||||||||

Excluding BA0E studies | Including BA0E studies | |||||||||||||||

OR=0.8 | OR=0.5 | OR=0.2 | OR=0.8 | OR=0.5 | OR=0.2 | |||||||||||

%bias | %bias | %bias | %bias | %bias | %bias | |||||||||||

IV random effects | 0.88 | −9.9 | 0.70 | −40.6 | 0.47 | −133.1 | 0.99 | −23.2 | 0.97 | −93.0 | 0.94 | −370.7 | ||||

IV fixed effects | 0.88 | −9.9 | 0.70 | −40.6 | 0.47 | −133.1 | 0.98 | −23.0 | 0.96 | −92.3 | 0.93 | −367.4 | ||||

M-H random effects | 0.88 | −9.9 | 0.70 | −40.6 | 0.47 | −133.1 | 0.99 | −23.2 | 0.97 | −93.0 | 0.94 | −370.7 | ||||

M-H fixed effects | 0.88 | −9.9 | 0.70 | −40.6 | 0.47 | −133.1 | 0.98 | −23.0 | 0.96 | −92.3 | 0.93 | −367.4 | ||||

Peto | 0.80 | 0.2 | 0.54 | −7.8 | 0.26 | −30.6 | 0.95 | −22.6 | 0.90 | −90.6 | 0.92 | −360.9 |

, when OR <1. , when OR≥1. Negative (−) bias indicates underestimating of treatment effect; positive bias indicates overestimating of treatment effect.

BA0E, both-armed zero-event; IV, inverse variance; M-H, Mantel-Haenszel.