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Table 1 Simulated scenarios for sample size determination in the design of a hypothetical study

From: Delta inflation: a bias in the design of randomized controlled trials in critical care medicine

 

Standard Scenario

Relaxed significance level

Relaxed Power

Baseline Mortality shifted away from 50%

Inflated delta

Significance level (two-sided)

0.05

0.1

0.05

0.05

0.05

Power

90%

90%

80%

90%

90%

Baseline (placebo) mortality rate

50%

50%

50%

40%

50%

Delta (ARR)

10%

10%

10%

10%

15%

Required sample size

1076

884

816

992

480

  1. Inflation of delta has a substantially larger impact on required sample size than changes in the other variables. ARR, absolute risk reduction.